UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_______________
FORM 10-K

_______________
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934


For the fiscal year ended December 31, 20112013


Commission File Number 1-1136

_______________
BRISTOL-MYERS SQUIBB COMPANY

(Exact name of registrant as specified in its charter)

________________
Delaware 22-0790350

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

345 Park Avenue, New York, N.Y. 10154

(Address of principal executive offices)

Telephone: (212) 546-4000

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Name of each exchange on which registered

Common Stock, $0.10 Par Value New York Stock Exchange
$2 Convertible Preferred Stock, $1 Par ValueNew York Stock Exchange

Securities registered pursuant to Section 12(g) of the Act: None

Title of each class
$2 Convertible Preferred Stock, $1 Par Value
_________________
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  x    No  ¨

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ¨    No  x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x  No  ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.    ¨x

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  x

  

Accelerated filer  ¨

  

Non-accelerated filer  ¨

  

Smaller reporting company  ¨

Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

The aggregate market value of the 1,704,021,7101,644,046,930 shares of voting common equity held by non-affiliates of the registrant, computed by reference to the closing price as reported on the New York Stock Exchange, as of the last business day of the registrant’s most recently completed second fiscal quarter (June 30, 2011)2013) was approximately $49,348,468,709.$73,472,457,302. Bristol-Myers Squibb has no non-voting common equity. At February 1, 2012,2014, there were 1,688,107,0711,650,232,566 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE: Portions of the Proxy Statement for the registrant’s Annual Meeting of Stockholders to be held May 1, 20126, 2014 are incorporated by reference into Part III of this Annual Report on Form 10-K.






PART I

Item 1.BUSINESS.


General


Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us) was incorporated under the laws of the State of Delaware in August 1933 under the name Bristol-Myers Company, as successor to a New York business started in 1887. In 1989, Bristol-Myers Company changed its name to Bristol-Myers Squibb Company as a result of a merger. We are engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis.

Over the last few years, we executed our strategy to transform into a next generation biopharmaceutical company. This transformation encompassed all areas of our business and operations. As part of this strategy, we have divested our non-pharmaceutical businesses, implemented our acquisition and licensing strategy known as the “string-of-pearls”, and executed our productivity transformation initiative (PTI). Our divestitures included Medical Imaging in January 2008, ConvaTec in August 2008, and Mead Johnson in December 2009. Our acquisition and licensing transactions included Kosan Biosciences, Inc. in June 2008, Medarex, Inc. (Medarex) in September 2009, ZymoGenetics, Inc. (ZymoGenetics) in October 2010, Amira Pharmaceuticals, Inc. (Amira) in September 2011, and Inhibitex, Inc. (Inhibitex) in February 2012, as well as several license arrangements.


We continue to review our cost structure with the intent to maintain a modernized, efficient, and robust balance between building competitive advantages, securing innovative products and planning for the future.

We report financial and operating informationoperate in one segment—BioPharmaceuticals. For additional information about business segments, see “Item 8. Financial Statements—Note 2.2. Business Segment Information.”


We compete with other worldwide research-based drug companies, smaller research companies and generic drug manufacturers. Our products are sold worldwide, primarily to wholesalers, retail pharmacies, hospitals, government entities and the medical profession. We manufacture products in the United States (U.S.), Puerto Rico and in 6six foreign countries.

U.S. net sales accounted for 65%


The percentage of total net salesrevenues by significant region were as follows:
  Year Ended December 31,
Dollars in Millions 2013 2012 2011
United States 51% 59% 66%
Europe 24% 21% 18%
Japan 5% 4% 3%
China 4% 3% 2%
       
Total Revenues 16,385
 17,621
 21,244

Acquisitions and Divestitures

Since 2007, we have been transforming BMS into a leading-edge biopharmaceutical company focused exclusively on discovering, developing, and delivering innovative medicines that address serious unmet medical needs. This transformation encompassed all areas of our business and operations. As part of this strategy, we have divested our diabetes and non-pharmaceutical businesses, implemented our acquisition and licensing strategy, and executed our productivity transformation initiative (PTI). Our divestitures included our diabetes business in February 2014, Mead Johnson in December 2009, ConvaTec in August 2008 and Medical Imaging in January 2008. As part of our acquisition and licensing strategy, we acquired Amylin Pharmaceuticals, Inc. (Amylin) in August 2012, Inhibitex, Inc. (Inhibitex) in February 2012, Amira Pharmaceuticals, Inc. (Amira) in September 2011, andZymoGenetics, Inc. (ZymoGenetics) in October 2010 and 63% of total net salesMedarex, Inc. (Medarex) in September 2009 while net sales in Europe accounted for 17%, 18% and 19% of total net sales in 2011, 2010entered into several license and 2009. Net sales in Japan accounted for 3% of total net sales in 2011, 2010other collaboration arrangements. These transactions have allowed and 2009. Net sales in Canada accounted for 3% of total net sales in 2011, 2010continue to allow us to focus our resources behind our growth opportunities that drive the greatest long-term value. From a disease standpoint, we are focused on four core therapeutic areas: oncology, virology, immunology, and 2009.

specialty cardiovascular disease.


Products


Our pharmaceutical products include chemically-synthesized drugs, or small molecules, and an increasing portion of products produced from biological processes (typically involving recombinant DNA technology), called “biologics.” Small molecule drugs are typically administered orally, e.g., in the form of a pill or tablet, although other drug delivery mechanisms are used as well. Biologics are typically administered to patients through injections or by infusion. Most of our revenues come from products in the following therapeutic classes: cardiovascular; virology, including human immunodeficiency virus (HIV) infection; oncology; neuroscience; metabolics; immunoscience; and metabolics.

cardiovascular.


In the pharmaceutical industry, the majority of an innovative product’s commercial value is usually realized during the period in which the product has market exclusivity. Our business is focused on innovative biopharmaceutical products, and we rely on patent rights and othervarious forms of regulatory protection to maintain the market exclusivity of our products. In the U.S., the European Union (EU) and some other countries, when these patent rights and other forms of exclusivity expire and generic versions of a medicine are approved and marketed, there are often substantial and rapid declines in the sales of the original innovative product. For further discussion of patent

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rights and regulatory forms of exclusivity, see “—Intellectual Property and Product Exclusivity” below. For further discussion of the impact of generic competition on our business, see “—Generic Competition” below.


The following chart shows our key products together with the year in which the earliest basic exclusivity loss (patent rights or data exclusivity) occurred or is currently estimated to occur in the U.S., the EU, Japan and Canada.China. We also sell our pharmaceutical products in other countries; however, data is not provided on a country-by-country basis because individual country salesrevenues are not significant outside the U.S., the EU, Japan and Canada.China. In many instances, the basic exclusivity loss date listed below is the expiration date of the patent that claims the active ingredient of the drug or the method of using the drug for the approved indication, if there is only one approved indication. In some instances, the basic exclusivity loss date listed in the chart is the expiration date of the data exclusivity period. In situations where there is only data exclusivity without patent protection, a competitor could seek regulatory approval by submitting its own clinical trial data to obtain marketing approval prior to the expiration of data exclusivity.


We estimate the market exclusivity period for each of our products on a case-by-case basis for the purposes of business planning only. The length of market exclusivity for any of our products is impossible to predict with certainty because of the complex interaction between patent and regulatory forms of exclusivity and the inherent uncertainties regarding patent litigation. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that appears in the estimate or that the exclusivity will be limited to the estimate.

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The following schedule presents net salesrevenues of our key products and estimated basic exclusivity loss in the U.S., EU, JapaneseJapan and Canadian markets:

   Net Sales by Products   Past or Currently Estimated Year of Basic Exclusivity  Loss 
Dollars in Millions  2011   2010   2009   U.S.  EU(a)  Japan  Canada 

Key Products

           

PLAVIX*

  $  7,087   $  6,666   $  6,146    2012    2008 (b)   ++    2011  

AVAPRO*/AVALIDE*

   952    1,176    1,283    2012    2007-2013    ++    2011  

ELIQUIS

   —       N/A     N/A     ++    2022    ++    ++  

ABILIFY*

   2,758    2,565    2,592    2015(c)   2014(d)   ++    2017(e) 

REYATAZ

   1,569    1,479    1,401    2017    2017-2019(f)   2019    2017  

SUSTIVA Franchise

   1,485    1,368    1,277    2013(g)   2013(h)   ++    2013  

BARACLUDE

   1,196    931    734    2015    2011-2016    2016    2011  

ERBITUX*

   691    662    683    2016(i)   ++    2016(j)   2016(j) 

SPRYCEL

   803    576    421    2020    2020(k)   2021    2020  

YERVOY

   360    N/A     N/A     2023(j)   2021(j)   ++    ++  

ORENCIA

   917    733    602    2019    2017(j)   2018(j)   2014(l) 

NULOJIX

   3    N/A     N/A     2023    2021    ++    ++  

ONGLYZA/KOMBIGLYZE

   473    158    24    2021    2021    ++    2021  

China:

  Total Revenues by Product Past or Currently Estimated Year of Basic Exclusivity Loss
Dollars in Millions 2013 2012 2011 U.S.  
EU(a)
  Japan  China
Key Products                 
Virology                 
Baraclude $1,527
 $1,388
 $1,196
 2014
(b) 
 2011-2016   2016   --
Reyataz 1,551
 1,521
 1,569
 2017   2017-2019
(c) 
 2019   2017
Sustiva Franchise 1,614
 1,527
 1,485
 2015
(d) 
 2013
(e) 
 ++   ++
Oncology                 
Erbitux* 696
 702
 691
 2016
(f) 
 ++   2016
(g) 
 ++
Sprycel 1,280
 1,019
 803
 2020  2020  2021   2020
Yervoy 960
 706
 360
 2023
(g) 
 2021
(g) 
 ++   ++
Neuroscience                 
Abilify* 2,289
 2,827
 2,758
 2015
(h) 
 2014
(i) 
 ++   ++
Metabolics(m)
                 
Bydureon* 298
 78
 N/A
 2025
(j) 
 2021
(j) 
 2020
(g) 
 ++
Byetta* 400
 149
 N/A
 2016
(k) 
 2016
(g) 
 2018
(g) 
 ++
Forxiga/Xigduo 23
 
 N/A
 2020   2023   ++   ++
Onglyza/Kombiglyze 877
 709
 473
 2023   2021   ++   2016
Immunoscience                 
Nulojix 26
 11
 3
 2023   2021   ++   ++
Orencia 1,444
 1,176
 917
 2019   2017
(g) 
 2018
(g) 
 ++
Cardiovascular                 
Avapro*/Avalide* 231
 503
 952
 2012   2007-2013   ++   --
Eliquis 146
 2
 
 2023   2022   2022   ++
Plavix* 258
 2,547
 7,087
 2012   2008
(l) 
 ++   ++

Note: The currently estimated earliest year of basic exclusivity loss includes any statutory extensions of exclusivity that have been earned, but not those that have not yet been granted. In some instances, we may be able to obtain an additional six months exclusivity for a product based on the pediatric extension, for example.extension. In certain other instances, there may be later-expiring patents that cover particular forms or compositions of the drug, as well as methods of manufacturing or methods of using the drug. Such patents may sometimes result in a favorable market position for our products, but product exclusivity cannot be predicted or assured. Under the U.S. healthcare law enacted in 2010, qualifying biologic products will receive 12 years of data exclusivity before a biosimilar can enter the market, as described in more detail in “—Intellectual Property and Product Exclusivity” below.


*    Indicates brand names of products which are trademarks not owned or wholly owned by BMS. Specific trademark ownership information is included on page 123.
++    We do not currently market the product in the country or region indicated.
--    There is uncertainty about China’s exclusivity laws which has resulted in generic competition in the China market.
*

Indicates brand names of products which are trademarks not owned by Bristol-Myers Squibb or its subsidiaries. Specific trademark ownership information can be found on page 116.

++

We do not currently market the product in the country or region indicated.

(a)

References to the EU throughout this Form 10-K include all 27 member states that were members of the European Union during the year ended December 31, 2011.2013. Basic patent applications have not been filed in all 27 current member states for all of the listed products. In some instances, the date of basic exclusivity loss will be different in various EU member states. For those EU countries where the basic patent was not obtained, there may be data protection available.

(b)

Data exclusivity

In February 2013, the U.S. District Court for the District of Delaware invalidated the composition of matter patent covering Baraclude (entecavir), which was scheduled to expire in 2015, including granted pediatric exclusivity. An appeal is pending and a decision is expected in 2014. We may face generic competition with this product beginning in 2014. The Company is prepared to take legal action in the EU expired in July 2008. In mostevent that Teva Pharmaceutical Industries Ltd. (Teva) chooses to launch its generic product prior to the resolution of the major markets within Europe, the product has national patents, expiring in 2013, which specifically claim the bisulfate form of clopidogrel. However, generic and alternate salt forms of clopidogrel bisulfate are marketed and compete with PLAVIX* throughout the EU.

Company's appeal.
(c)

Our rights to commercialize ABILIFY* (aripiprazole) in the U.S. terminate in 2015.

(d)

Our rights to commercialize ABILIFY* in the EU terminate in 2014.

(e)

Exclusivity period is based on regulatory data protection.

(f)

Data exclusivity in the EU expires in 2014.

2014 and market exclusivity expires between 2017 and 2019.

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(g)

(d)
Exclusivity period relates to the SUSTIVASustiva brand and does not include exclusivity related to any combination therapy. The composition of matter patent for efavirenz in the U.S. expiresexpired in 2013, but a method of use patent for the treatment of HIV infection expires in September 2014.

Pediatric exclusivity has been granted, which provides an additional six month period of exclusivity added to the term of the patents listed in the Orange Book.
(h)

(e)
Exclusivity period relates to the SUSTIVASustiva (efavirenz) brand and does not include exclusivity related to any combination therapy. Market exclusivity for SUSTIVA is expected to expireSustiva expired in November 2013 in countries in the EU. Data exclusivity for SUSTIVASustiva expired in the EU in 2009.

(i)

(f)
Biologic product approved under a Biologics License Application (BLA). Data exclusivity in the U.S. expires in 2016. There is no patent that specifically claims the composition of matter of cetuximab, the active ingredient in ERBITUX*Erbitux*. Our rights to commercialize cetuximab terminate in 2018.

(j)

(g)Exclusivity period is based on regulatory data protection.

(k)

Pending patent application

(h)
Our rights to commercialize Abilify* (aripiprazole) in most EU member states.

the U.S. terminate in 2015.
(i)
Our rights to commercialize Abilify* in the EU terminate in June 2014.
(j)Exclusivity period is based on formulation patents.
(k)Exclusivity period is based on method of use patent.
(l)

Data exclusivity in Canada expiresthe EU expired in 2014.

July 2008. In most of the major markets within Europe, the product has national patents, expired in 2013, which specifically claim the bisulfate form of clopidogrel. Generic and alternate salt forms of clopidogrel bisulfate are marketed and compete with
Plavix* throughout the EU.

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(m)
In February 2014, BMS sold to AstraZeneca PLC (AstraZeneca) the diabetes business of BMS which comprised our global alliance with them, including all rights and ownership to Onglyza/Kombiglyze, Forxiga/Xigduo, Bydureon*, Byetta*, and Symlin*.


Below is a summary of the indication, intellectual property position, product partner, if any, and third-party manufacturing arrangements, if any, for each of the above products in the U.S. and, where applicable, the EU Japan and Canada.

Japan.

PLAVIX*

PLAVIX* (clopidogrel bisulfate) is a platelet aggregation inhibitor, which is approved for protection against fatal or non-fatal heart attack or stroke in patients with a history of heart attack, stroke, peripheral arterial disease or acute coronary syndrome.

Baraclude

Clopidogrel bisulfate

Baraclude (entecavir) is a potent and selective inhibitor of hepatitis B virus that was codevelopedapproved by the U.S. Food and is jointly marketed with Sanofi. For more information about our alliance with Sanofi, see “—Strategic AlliancesDrug Administration (FDA) for the treatment of chronic hepatitis B infection. Baraclude was discovered and Collaborations” below and “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

developed internally.
In February 2013, the U.S. District Court for the District of Delaware invalidated the composition of matter patent covering Baraclude, which was scheduled to expire in 2015. An appeal is pending and a decision is expected in 2014. We may face generic competition with this product beginning in 2014. In December 2013, the FDA granted pediatric exclusivity for Baraclude. In the event that the Company is successful in its appeal, the composition of matter patent including the pediatric extension will expire in August 2015. The Company is prepared to take legal action in the event that Teva chooses to launch its generic product prior to the resolution of the Company's appeal. For more information about this patent litigation matter, see “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies.”
The composition of matter patent expires in the EU between 2011 and 2016 and in Japan in 2016. There is uncertainty about China’s exclusivity laws which has resulted in generic competition in the China market.
Entecavir is manufactured by both the company and a third party. The product is then finished in our facilities.
Reyataz

The composition of matter patent in the U.S. expires on May 17, 2012 (including a pediatric extension).

In the EU, regulatory data exclusivity protection expired in July 2008. In most of the major markets within Europe, PLAVIX* benefits from national patents, expiring in 2013, which specifically claim the bisulfate form of clopidogrel. However, generic and alternative salt forms of clopidogrel bisulfate are marketed and compete throughout the EU.

We obtain our bulk requirements for clopidogrel bisulfate from Sanofi and a third-party. Both the Company and Sanofi finish the product in our own respective facilities.

AVAPRO*/AVALIDE*

AVAPRO*/AVALIDE* (irbesartan/irbesartan-hydrochlorothiazide) is an angiotensin II receptor antagonist indicated for the treatment of hypertension and diabetic nephropathy.

Irbesartan was codeveloped and is jointly marketed with Sanofi. For more information about our alliance with Sanofi, see “—Strategic Alliances and Collaborations” below and “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

The composition of matter patent in the U.S. expires on March 30, 2012 (including a pediatric extension) and in most countries in the EU in 2012 to 2013. Data exclusivity in the EU expired in August 2007 for AVAPRO* and in October 2008 for AVALIDE*. The composition of matter patent expired in Canada in March 2011.

Irbesartan is manufactured by both the Company and Sanofi. We manufacture our bulk requirements for irbesartan and finish AVAPRO*/AVALIDE* in our facilities. For AVALIDE*, we purchase bulk requirements for hydrochlorothiazide from a third-party.

ELIQUIS

ELIQUIS (apixaban) is an oral Factor Xa inhibitor, targeted at the prevention and treatment of venous thromboembolic (VTE) disorders and stroke prevention in atrial fibrillation. It is currently approved in the EU for use in VTE prevention in adult patients who have undergone elective hip or knee replacement surgery and is currently in the registrational process in the U.S. and the E.U. for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Apixaban was discovered internally and is part of our alliance with Pfizer, Inc. (Pfizer). For more information about our alliance with Pfizer, see “Item 8. Financial Statements—Note 3. Alliances and Collaborations.” The composition of matter patent covering apixaban in the U.S. expires in 2023 and in the EU it expires in 2022. Data exclusivity in the EU expires in 2021.

We manufacture our bulk requirements for apixaban and finish the product in our facilities.

ABILIFY*

ABILIFY* (aripiprazole) is an atypical antipsychotic agent for adult patients with schizophrenia, bipolar mania disorder and major depressive disorder. ABILIFY* also has pediatric uses in schizophrenia and bipolar disorder, among others.

We have a global commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), except in Japan, China, Taiwan, North Korea, South Korea, the Philippines, Thailand, Indonesia, Pakistan and Egypt. For more information about our arrangement with Otsuka, see “—Strategic Alliances and Collaborations” below and “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

The basic U.S. composition of matter patent for ABILIFY* and the term of the current ABILIFY* agreement expire in April 2015 (including the granted patent term extension and six month pediatric extension). The basic composition of matter patent protecting aripiprazole is the subject of patent litigation in the U.S. Otsuka has sole rights to enforce this patent. For more information about this litigation matter, see “Item 8. Financial Statements—22. Legal Proceedings and Contingencies.”

A composition of matter patent is in force in Germany, the United Kingdom (UK), France, Italy, the Netherlands, Romania, Sweden, Switzerland, Spain and Denmark. The original expiration date of 2009 has been extended to 2014 by grant of a supplementary protection certificate in all of the above countries except Romania and Denmark. Data exclusivity and the rights to commercialize in the EU expire in 2014. Data exclusivity in Canada expires in 2017.

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We obtain our bulk requirements for aripiprazole from Otsuka. Both the Company and Otsuka finish the product in our own respective facilities.

REYATAZ

REYATAZ (atazanavir

Reyataz (atazanavir sulfate) is a protease inhibitor for the treatment of HIV.

human immunodeficiency virus (HIV).
We developed atazanavir under a worldwide license from Novartis Pharmaceutical Corporation (Novartis) for which a royalty is paid based on a percentage of net product sales. We are entitled to promote Reyataz for use in combination with Norvir* (ritonavir) under a non-exclusive license agreement with AbbVie Inc. (AbbVie), as amended, for which a royalty is paid based on a percentage of net product sales. We have a licensing agreement with Gilead Sciences, Inc. (Gilead) to develop and commercialize a fixed-dose combination containing atazanavir and one of Gilead’s compounds in development.
Market exclusivity for Reyataz is expected to expire in 2017 in the U.S. and China and 2019 in the major EU member countries and Japan. Data exclusivity in the EU expires in 2014.
We manufacture our bulk requirements for atazanavir and finish the product in our facilities.
Sustiva Franchise

We developed atazanavir under a worldwide license from Novartis Pharmaceutical Corporation (Novartis) for which a royalty is paid based on a percentage of net sales. We are entitled to promote REYATAZ for use in combination with NORVIR* (ritonavir) under a non-exclusive license agreement with Abbott Laboratories (Abbott), as amended, for which a royalty is paid based on a percentage of net sales. We recently entered into a licensing agreement with Gilead Sciences, Inc. to develop and commercialize a fixed-dose combination containing REYATAZ and one of Gilead’s compounds in development.

Market exclusivity for REYATAZ is expected to expire in 2017 in the U.S., Canada and the major EU member countries and in 2019 in Japan. Data exclusivity in the EU expires in 2014.

We manufacture our bulk requirements for atazanavir and finish the product in our facilities.

SUSTIVA Franchise

SUSTIVA

Sustiva (efavirenz) is a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV. The SUSTIVASustiva Franchise includes SUSTIVA,Sustiva, an antiretroviral drug used in the treatment of HIV, and as well as bulk efavirenz which is included in the combination therapy ATRIPLA*Atripla* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimen combining our SUSTIVASustiva and Gilead Sciences, Inc.’s (Gilead) TRUVADA*Gilead’s Truvada* (emtricitabine and tenofovir disoproxil fumarate). ATRIPLA* is the first complete Highly Active Antiretroviral Therapy treatment product for HIV available in the U.S. in a fixed-dose combination taken once daily. Fixed-dose combinations contain multiple medicines formulated together and help simplify HIV therapy for patients and providers. For more information about our arrangement with Gilead, see “—Strategic Alliances and Collaborations”Alliances” below and “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

Alliances”
Rights to market efavirenz in the U.S., Canada, the UK, France, Germany, Ireland, Italy and Spain are licensed from Merck & Co., Inc. (Merck) for a royalty based on a percentage of revenues. Efavirenz is marketed by another company in Japan.
The composition of matter patent for efavirenz in the U.S. expired in 2013, but a method of use patent for the treatment of HIV infection expires in September 2014, with an additional six month period of pediatric exclusivity added to the term of these patents.

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Market exclusivity for Sustiva expired in November 2013 in countries in the EU. Data exclusivity for Sustiva expired in the EU in 2009. Certain Atripla* patents are the subject of patent litigation in the U.S. At this time, the U.S. patents covering efavirenz composition of matter and method of use have not been challenged. 
We obtain our bulk requirements for efavirenz from third parties and produce finished goods in our facilities. We supply our third parties’ bulk efavirenz to Gilead, who is responsible for producing the finished Atripla* product.
Erbitux*

Rights to market efavirenz in the U.S., Canada, the United Kingdom (UK), France, Germany, Ireland, Italy and Spain are licensed from Merck & Co., Inc. for a royalty based on a percentage of net sales.

The composition of matter patent for efavirenz in the U.S. expires in 2013, but a method of use patent for the treatment of HIV infection expires in 2014, with a possible additional six month pediatric extension.

Market exclusivity for SUSTIVA is expected to expire in 2013 in countries in the EU. Data exclusivity for SUSTIVA expired in the EU in 2009. We do not, but another company does, market efavirenz in Japan. Certain ATRIPLA* patents are the subject of patent litigation in the U.S. At this time, the U.S. patents covering efavirenz composition of matter and method of use have not been challenged. The EU patent for efavirenz is the subject of litigation in the Netherlands, Germany and the UK. For more information about these litigation matters, see “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies.”

We obtain our bulk requirements for efavirenz from third parties and produce finished goods in our facilities. We provide bulk efavirenz to Gilead, who is responsible for producing the finished ATRIPLA* product.

BARACLUDE

BARACLUDE (entecavir) is a potent and selective inhibitor of hepatitis B virus that was approved by the FDA for the treatment of chronic hepatitis B infection. BARACLUDE was discovered and developed internally. It has also been approved and is marketed in over 50 countries outside of the U.S., including China, Japan and the EU.

We have a composition of matter patent that expires in the U.S. in 2015. This patent is the subject of patent litigation in the U.S. For more information about this litigation matter, see “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies.”

The composition of matter patent expires in the EU between 2011 and 2016 and in Japan in 2016. The composition of matter patent expired in Canada in 2011. There is uncertainty about China’s exclusivity laws which has resulted in generic competition in the China market.

We manufacture our bulk requirements for entecavir and finish the product in our facilities.

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ERBITUX*

ERBITUX*

Erbitux* (cetuximab) is an IgG1 monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types as well as some normal cells. ERBITUX*Erbitux*, a biological product, is approved for the treatment in combination with irinotecan for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) who have failed an irinotecan-based regimen and as monotherapy for patients who are intolerant of irinotecan. The FDA has also approved ERBITUX* for use in the treatment of squamous cell carcinoma of the head and neck. Specifically, ERBITUX* was approvedErbitux* for use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck and, as a single agent, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed. The FDA has also approved ERBITUX*Erbitux* for first-line recurrent locoregional or metastatic head and neck cancer in combination with platinum-based chemotherapy with 5-Fluorouracil.

Erbitux* is marketed in North America by us under an agreement with ImClone Systems Incorporated (ImClone), the predecessor company of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company (Lilly). We share copromotion rights to Erbitux* with Merck KGaA in Japan under a codevelopment and cocommercialization agreement signed in October 2007 with ImClone, Merck KGaA and Merck Serono Japan. Erbitux* received marketing approval in Japan in July 2008 for use in treating patients with advanced or recurrent colorectal cancer and in December 2012 for head and neck cancer. For a description of our alliance with ImClone, see “—Strategic Alliances” below and “Item 8. Financial Statements—Note 3. Alliances”
Data exclusivity for Erbitux*in the U.S. expires in 2016. There is no patent that specifically claims the composition of matter of cetuximab, the active molecule in Erbitux*. Erbitux* has been approved by the FDA and other health authorities for monotherapy, for which there is no use patent. The use of Erbitux* in combination with 5-Fluorouracil (an anti-neoplastic agent) is approved by the FDA. Such combination use is claimed in a granted U.S. patent that expires in 2018 (including the granted patent term extension). The inventorship of this use patent was challenged by three researchers from Yeda Research and Development Company Ltd. (Yeda). Pursuant to a settlement agreement executed and announced in December 2007 by ImClone, Sanofi and Yeda to end worldwide litigation related to the use patent, Sanofi and Yeda granted ImClone a worldwide license under the use patent. Data exclusivity in Japan expires in 2016.
Yeda has the right to license the use patent to others. Yeda’s license of the patent to third parties could result in product competition for Erbitux* that might not otherwise occur. We are unable to assess whether and to what extent any such competitive impact will occur or to quantify any such impact. However, Yeda has granted Amgen Inc. (Amgen) a license under the use patent. Amgen received FDA approval to market an EGFR-product that competes with Erbitux*.
We obtain our finished goods requirements for cetuximab for use in North America from Lilly. Lilly manufactures bulk requirements for cetuximab in its own facilities and filling and finishing is performed by a third-party for which BMS has oversight responsibility. For a description of our supply agreement with Lilly, see “—Manufacturing and Quality Assurance” below.
Sprycel

ERBITUX* is marketed in North America by us under an agreement with ImClone Systems Incorporated (ImClone), the predecessor company of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company (Lilly). We share copromotion rights to ERBITUX* with Merck KGaA in Japan under a codevelopment and cocommercialization agreement signed in October 2007 with ImClone, Merck KGaA and Merck Japan. ERBITUX* received marketing approval in Japan in July 2008 for use in treating patients with advanced or recurrent colorectal cancer. For a description of our alliance with ImClone, see “—Strategic Alliances and Collaborations” below and “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

Data exclusivity in the U.S. expires in 2016. There is no patent that specifically claims the composition of matter of cetuximab, the active molecule in ERBITUX*. ERBITUX* has been approved by the FDA and other health authorities for monotherapy, for which there is no use patent. The use of ERBITUX* in combination with an anti-neoplastic agent is approved by the FDA. Such combination use is claimed in a granted U.S. patent that expires in 2018 (including the granted patent term extension). The inventorship of this use patent was challenged by three researchers from Yeda Research and Development Company Ltd. (Yeda). Pursuant to a settlement agreement executed and announced in December 2007 by ImClone, Sanofi and Yeda to end worldwide litigation related to the use patent, Sanofi and Yeda granted ImClone a worldwide license under the use patent. Data exclusivity in Japan and Canada expire in 2016.

Yeda has the right to license the use patent to others. Yeda’s license of the patent to third parties could result in product competition for ERBITUX* that might not otherwise occur. We are unable to assess whether and to what extent any such competitive impact will occur or to quantify any such impact. However, Yeda has granted Amgen Inc. (Amgen) a license under the use patent. Amgen received FDA approval to market an EGFR-product that competes with ERBITUX*.

We obtain our finished goods requirements for cetuximab for use in North America from Lilly. Lilly manufactures bulk requirements for cetuximab in its own facilities and finishing is performed by a third-party for Lilly. For a description of our supply agreement with Lilly, see “—Manufacturing and Quality Assurance” below.

SPRYCEL

SPRYCEL

Sprycel (dasatinib) is a multi-targeted tyrosine kinase inhibitor approved for the first-line treatment of adults with all phasesPhiladelphia chromosome-positive chronic myeloid leukemia in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including GLEEVEC* (imatinibGleevec* (imatinib mesylate), and for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy. In 2010, the FDA approved SPRYCEL for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

.
Sprycel was internally discovered and is part of our strategic alliance with Otsuka. For more information about our alliance with Otsuka, see “—Strategic Alliances” below and “Item 8. Financial Statements—Note 3. Alliances”
A patent term extension has been granted in the U.S. extending the term on the basic composition of matter patent covering dasatinib until June 2020. In 2013, the Company entered into a settlement agreement with Apotex regarding a patent infringement suit covering the monohydrate form of dasatinib whereby Apotex can launch its generic dasatinib monohydrate aNDA product in September 2024, or earlier in certain circumstances. In the U.S., orphan drug exclusivity expired in 2013, which protected the product from generic applications for the currently approved orphan indications only.
In the majority of the EU countries, we have a composition of matter patent covering dasatinib that expires in April 2020 (excluding potential term extensions). The composition of matter patent expires in 2021 in Japan and in 2020 in China.

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We manufacture our bulk requirements for dasatinib and finish the product in our facilities.
Yervoy

SPRYCEL was internally discovered and is part of our strategic alliance with Otsuka. For more information about our alliance with Otsuka, see “—Strategic Alliances and Collaborations” below and “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

A patent term extension has been granted in the U.S. extending the term on the basic composition of matter patent covering dasatinib until June 2020. Dasatinib is the subject of patent litigation in the U.S. For more information about this litigation matter, see “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies.” In the U.S., orphan drug exclusivity expires in 2013, which protects the product from generic applications for the currently approved orphan indications only.

In several EU countries, the patent is pending and upon grant, would expire in April 2020 (excluding term extensions).

We manufacture our bulk requirements for dasatinib and finish the product in our facilities.

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YERVOY

YERVOY

Yervoy (ipilimumab), a biological product, is a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma. IpilimumabYervoy was approved byin the FDAU.S. in March 2011 and byin the EMAEU in July 2011. It is currently also being studied for other indications including lung cancer as well as adjuvant melanoma and hormone-refractory prostate cancer. For more information, about research and development of YERVOY,Yervoy, see “—Research and Development” below.

YERVOY was discovered by Medarex and codeveloped by the Company and Medarex, which is now our subsidiary.

We own a patent covering ipilimumab as composition of matter that currently expires in 2022 in the U.S. and 2020 in the EU. Data exclusivity expires in 2023 in the U.S. and 2021 in the EU.

We obtain bulk ipilimumab from a third-party manufacturer and finish the product at a third party facility.

Yervoy was discovered by Medarex and codeveloped by the Company and Medarex, which is now our subsidiary. We own a patent covering ipilimumab as composition of matter that currently expires in 2022 in the U.S. and 2020 in the EU (excluding potential patent term extensions). Data exclusivity expires in 2023 in the U.S. and 2021 in the EU.
We obtain bulk ipilimumab from a third-party manufacturer and finish the product in our facilities and at a third-party facility.

ORENCIA

Abilify*

ORENCIA (abatacept), a biological product,

Abilify* (aripiprazole) is a fusion protein with novel immunosuppressive activity targeted initially atan atypical antipsychotic agent for adult patients with moderate to severe rheumatoid arthritis, who have had an inadequate response to certain currently available treatments. Abatacept is availableschizophrenia, bipolar mania disorder and major depressive disorder. Abilify* also has pediatric uses in both an intravenous formulationschizophrenia and beginning in 2011, a subcutaneous formulation in the U.S.. ORENCIA was discovered and developed internally.

bipolar disorder, among others.
We have a global commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), excluding Japan, China and certain other Asian countries. For more information about our arrangement with Otsuka, see “—Strategic Alliances” below and “Item 8. Financial Statements—Note 3. Alliances.”
The basic U.S. composition of matter patent covering aripiprazole and the term of the current Abilify* agreement expire in April 2015 (including the granted patent term extension and six month pediatric extension).
A composition of matter patent is in force in major EU countries. The original expiration date of 2009 has been extended to 2014 by grant of a supplementary protection certificate in most EU countries. Data exclusivity and the rights to commercialize in the EU expire in June 2014.
We obtain our bulk requirements for aripiprazole from Otsuka. Both the Company and Otsuka finish the product in their own respective facilities.
Bydureon*

We have

Bydureon* (exenatide extended-release for injectable suspension) is a seriesonce-weekly glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of patents covering abatacept and its method of use. In the U.S.,type 2 diabetes. Bydureon* was acquired from our Amylin acquisition in August 2012. Bydureon* was internally discovered by Amylin, a patent term extension has been granted for oneformer wholly-owned subsidiary of the compositionCompany. Prior to the sale of matter patents, extendingour diabetes business in February 2014, we had a worldwide development and commercialization agreement with AstraZeneca for Bydureon*. For more information about our arrangement with and the termsale of the U.S. patentour diabetes business to 2019. In the majority of the EU countries, we have a patent covering abatacept that expires in 2012. We have applied for supplementary protection certificatesAstraZeneca, see “Item 8. Financial Statements—Note 3. Alliances” and also pediatric extension of the supplementary protection certificates for protection until 2017. Some of these protection certificates have been granted.

Data exclusivity in the U.S. and EU expires in 2017.

We obtain bulk abatacept from a third-party manufacturer and finish the product in our facilities for both formulations.

“Item 8. Financial Statements—Note 5. Assets Held-For-Sale.”
The formulation patents expire in 2025 in the U.S. and in 2021 in Europe. Data exclusivity expires in 2020 in Japan.
Prior to the sale of the diabetes business, we obtained the bulk requirements for exenatide from third parties and the microspheres manufacturing process required for the extended release formulation was performed by the Company. Following the sale of the diabetes business, AstraZeneca assumed all manufacturing and finishing responsibilities.

NULOJIX

Byetta*
Byetta*(exenatide) is a twice daily GLP-1 receptor agonist for the treatment of type 2 diabetes. Byetta* was acquired from our Amylin acquisition in August 2012. Byetta* was internally discovered by Amylin, a former wholly-owned subsidiary of the Company. Prior to the sale of our diabetes business in February 2014, we had a worldwide development and commercialization agreement with AstraZeneca for Byetta*. For more information about our arrangement with and the sale of our diabetes business to AstraZeneca, see “Item 8. Financial Statements—Note 3. Alliances” and “Item 8. Financial Statements—Note 5. Assets Held-For-Sale.”
The method of use patent expires in 2016 in the U.S. Data exclusivity expires in 2016 in Europe and 2018 in Japan.
Prior to the sale of the diabetes business, we obtained the bulk requirements for exenatide from third parties. Manufacturing and finishing also took place in third-party facilities. Following the sale of the diabetes business, AstraZeneca assumed all manufacturing and finishing responsibilities.

NULOJIX

Forxiga
Forxiga (dapagliflozin) is an oral sodium-glucose cotransporter 2 (SGLT2) for the treatment of type 2 diabetes mellitus. Forxiga is marketed as Farxiga in the U.S. In this document unless specifically noted, we refer to both Forxiga and Farxiga as Forxiga.

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It was approved in the U.S. in January 2014 and in the EU in November 2012 for use in adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise. For further discussion, See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Product and Pipeline Developments.” Forxiga was internally discovered. Prior to the sale of our diabetes business in February 2014, we had a worldwide development and commercialization agreement with AstraZeneca for Forxiga. For more information about our arrangement with and the sale of our diabetes business to AstraZeneca, see “Item 8. Financial Statements—Note 3. Alliances” and “Item 8. Financial Statements—Note 5. Assets Held-For-Sale.”
The composition of matter patent covering dapagliflozin expires in October 2020 in the U.S. and May 2023 in the EU.
Prior to the sale of the diabetes business, we manufactured the bulk requirements for dapagliflozin and finished the product in our own facilities. Following the sale of the diabetes business, BMS will continue to manufacture the bulk requirement and finish the product pursuant to a supply arrangement that was agreed upon in connection with the sale of the diabetes business to AstraZeneca.
Onglyza/Kombiglyze
Onglyza (saxagliptin), a dipeptidyl peptidase-4 inhibitor, is an oral compound indicated for the treatment of type 2 diabetes as an adjunct to diet and exercise.
Kombiglyze (saxagliptin and metformin hydrochloride extended-release) is approved in the U.S. as a combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. Komboglyze (saxagliptin and metformin immediate-release) is approved in the EU as a combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. In this document unless specifically noted, we refer to both Kombiglyze and Komboglyze as Kombiglyze.
Onglyza was internally discovered by the Company and Kombiglyze was codeveloped by the Company and AstraZeneca. Prior to the sale of our diabetes business in February 2014, we had a worldwide (except Japan) codevelopment and cocommercialization agreement with AstraZeneca for saxagliptin. For more information about our arrangement with and the sale of our diabetes business to AstraZeneca and for our arrangement with Otsuka for Japan, see “—Strategic Alliances” below, “Item 8. Financial Statements—Note 3. Alliances” and “Item 8. Financial Statements—Note 5. Assets Held-For-Sale.”
The composition of matter patent covering saxagliptin expires in July 2023 (including granted patent term extension) in the U.S. and expires in the EU in March 2021. In the EU, supplementary protection certificates have been granted for Onglyza in the majority of European countries which expire in October 2024. Supplementary protection certifications for Kombiglyze have been applied for and have been granted in France, Italy and Spain and the application is pending in a number of other European countries. Market exclusivity in China expires in 2016.
Following the sale of the diabetes business, BMS will continue to manufacture the bulk requirement and finish the product pursuant to a supply arrangement that was agreed upon in connection with the sale of the diabetes business to AstraZeneca.
Nulojix
Nulojix (belatacept), a biological product, is a fusion protein with novel immunosuppressive activity for the prevention of kidney transplant rejection. It was approved and launched in the U.S. in June 2011, and approved in the EU in June 2011 and launched in July 2011. Belatacept was internally discovered and developed.

We own a patent covering belatacept as composition of matter that expires in April 2023 in the U.S. and May 2021 in the EU.

Data exclusivity expires in the U.S. in June 2023 and in the EU in June 2021.

We manufacture our bulk requirements for belatacept and finish the products in our facilities.

We own a patent covering belatacept as composition of matter that expires in April 2023 in the U.S. and May 2021 in the EU. Data exclusivity expires in the U.S. in June 2023 and in the EU in June 2021.
We manufacture our bulk requirements for belatacept and finish the products in our facilities.

ONGLYZA/ KOMBIGLYZE

Orencia

ONGLYZA (saxagliptin)

Orencia (abatacept), a dipeptidyl peptidase-4 inhibitor,biological product, is a fusion protein with novel immunosuppressive activity targeted initially at adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to certain currently available treatments. Abatacept is available in both an intravenous formulation and beginning in 2011, a subcutaneous formulation in the U.S. Orencia was discovered and developed internally and has since been approved in the EU and other regions.
We have a series of patents covering abatacept and its method of use. In the U.S., a patent term extension has been granted for one of the composition of matter patents, extending the term of the U.S. patent to 2019. In the EU, the composition of matter patent covering abatacept expired in 2012. In the majority of the EU countries, we have applied for supplementary protection certificates and also pediatric extension of the supplementary

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protection certificates for protection until 2017. Most of these protection certificates have been granted. Data exclusivity expires in 2017 in the U.S. and the EU and 2018 in Japan.
Bulk abatacept is manufactured by both the Company and a third party. We finish both formulations of the product in our own facilities.
See "—Strategic Alliances" below for further discussion of our collaborations with Ono Pharmaceutical Co., LTD. (Ono) for Orencia in Japan.
Avapro*/Avalide*
Avapro*/Avalide* (irbesartan/irbesartan-hydrochlorothiazide) is an oral compoundangiotensin II receptor antagonist indicated for the treatment of type 2 diabetes as an adjunct to diethypertension and exercise.

KOMBIGLYZE (saxagliptin and metformin hydrochloride extended-release) is approved in the U.S. as a combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. KOMBOGLYZE (saxagliptin and metformin immediate-release) is approved in the EU as a combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. In this document unless specifically noted, we refer to both KOMBIGLYZE and KOMBOGLYZE as KOMBIGLYZE.

ONGLYZA was internally discovered by the Company and KOMBIGLYZEdiabetic nephropathy. Irbesartan was codeveloped byand jointly marketed with Sanofi until the Companyend of 2012. In October 2012, BMS and AstraZeneca PLC (AstraZeneca). We haveSanofi announced a worldwide (except Japan) codevelopmentrestructuring of their alliance following the loss of exclusivity of Plavix* and cocommercialization agreement with AstraZeneca for saxagliptin.Avapro*/Avalide* in many major markets. For more information about our arrangementalliance with AstraZenecaSanofi and with Otsuka for Japan,the restructuring of it, see “—Strategic Alliances and Collaborations”Alliances” below and “Item 8. Financial Statements—Note 3. Alliances and Collaborations.3. Alliances.

We own a patent covering saxagliptin as composition of matter that expires in March 2021 in the U.S. and the EU.

The composition of matter patent expired in the U.S. in March 2012 and in most countries in the EU in 2012 and 2013. Data exclusivity in the EU expired in August 2007 for Avapro* and in October 2008 for Avalide*.
Both the Company and Sanofi manufacture bulk requirements for irbesartan and finishing is performed by Sanofi. With the alliance restructuring, BMS’s manufacturing obligations will phase out with Sanofi assuming all the Company’s manufacturing and supply obligations of irbesartan products at the end of 2015.
Eliquis

We manufacture

Eliquis (apixaban) is an oral Factor Xa inhibitor targeted at stroke prevention in atrial fibrillation and the prevention and treatment of venous thromboembolic (VTE) disorders. Apixaban was discovered internally and is part of our bulk requirements for saxagliptin inalliance with Pfizer, Inc. (Pfizer). For more information about our facilities. We obtain the bulk metformin for KOMBIGLYZE from a third party. Both the Company and AstraZeneca finish ONGLYZA in their own facilities. The Company finishes KOMBIGLYZE in its own facility.

alliance with Pfizer, see “Item 8. Financial Statements—Note
3. Alliances.”

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Emerging Markets

The composition of matter patent covering apixaban in the U.S. expires in February 2023 (excluding potential patent term extensions) and in the EU and expires in 2022. We competehave applied for supplementary protection certificates. Some of these supplementary protection certificates have been granted and expire in emerging markets that are encompassed2026. Data exclusivity in the EU expires in 2021.
Apixaban is manufactured by both the Company and a third party. The product is then finished in our various regional organizations. Our Emerging Markets regional organization is comprisedfacilities.
Plavix*
Plavix* (clopidogrel bisulfate) is a platelet aggregation inhibitor, which is approved for protection against fatal or non-fatal heart attack or stroke in patients with a history of heart attack, stroke, peripheral arterial disease or acute coronary syndrome. Clopidogrel bisulfate was codeveloped and is jointly marketed with Sanofi. In October 2012, BMS and Sanofi announced a restructuring of their alliance following the loss of exclusivity of Plavix* and Avapro*/Avalide* in many major markets. For more information about our alliance with Sanofi and the restructuring of it, see “—Strategic Alliances” below and “Item 8. Financial Statements—Note 3. Alliances.”
The composition of Brazil, Russia, India, China and Turkey as we have identified these countries as having significant opportunities for growth. Emerging markets are characterized by strong economic development, a rising gross domestic product, a growing middle class and increasing wealth amongst the middle class as well as a demand for quality healthcare. Emerging markets may provide most of the growth opportunitymatter patent in the pharmaceuticals industry byU.S. expired in May 2012. In the middleEU, regulatory data exclusivity protection expired in July 2008. In Europe, national patents, which specifically claim the bisulfate form of clopidogrel, expired in 2013. Plavix faces generic competition globally.
We obtain our bulk requirements for clopidogrel bisulfate from Sanofi. Prior to January 1, 2013, both the next decade. Our strategy to capitalize on this growth opportunity is an innovation-focused approach. With this approach, we plan to developCompany and commercialize select, innovative productsSanofi finished the product in key high-growth markets, tailoringtheir own respective facilities. Effective January 1, 2013, the approach to each market individually. The emerging public health interests of these countries best align withCompany no longer finishes clopidogrel bisulfate in our strategy as well as our current portfolio and pipeline. These countries have also been identified as having improving intellectual property protection. In order to capitalize on the growth opportunities in the emerging markets, we must balance related risks as well as develop innovative pricing and access strategies to make products accessible to patients and provide a reasonable return on investment. The risks in these markets include intellectual property protection, government-mandated authorized generics, currency volatility, reimbursement issues, government stability and scale issues. We monitor and mitigate against these risks to the extent possible.

facilities.


Research and Development


We invest heavily in research and development (R&D) because we believe it is critical to our long-term competitiveness. We have major R&D facilities in Princeton, Hopewell and New Brunswick, New Jersey and Wallingford, Connecticut. Pharmaceutical researchResearch and development is also carried out at various other facilities throughout the world, including in Belgium, the UK, India and other sites in the U.S. We supplement our internal drug discovery and development programs with alliances and collaborative agreements. These agreements which help us bring new products into the pipeline and help us remain on the cutting edge of technology in the search for novel medicines.pipeline. In drug development, we engage the services of physicians, hospitals, medical schools and other research organizations worldwide to conduct clinical trials to establish the safety and effectiveness of new products. Management continues to emphasize leadership, innovation, productivity and quality as strategies for success in our research and development activities.


We concentrate our biopharmaceutical research and development efforts in the following disease areas with significant unmet medical need: affective (psychiatric) disorders, pain, Alzheimer’s/dementia, cardiovascular, diabetes,needs: oncology, Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS), hepatitis, HIV/AIDS, oncology, immunologic disorders, solid organ transplantcardiovascular and fibrotic disease. We also continue to analyze and may selectively pursue promising leads in other areas. In addition to discovering and developing new molecular entities, we look for ways to expand the value of existing products through new indications and formulations that can provide additional benefits to patients.


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In order for a new drug to reach the market, industry practice and government regulations in the U.S., the EU and most foreign countries provide for the determination of a drug’s effectiveness and safety through preclinical tests and controlled clinical evaluation. The clinical development of a potential new drug includes Phase I, Phase II and Phase III clinical trials that have been designed specifically to support a new drug application for a particular indication, assuming the trials are successful.


Phase I clinical trials involve a small number of healthy patientsvolunteers or patients suffering from the indicated disease to test for safety and proper dosing. Phase II clinical trials involve a larger patient population to investigate side effects, efficacy, and optimal dosage of the drug candidate. Phase III clinical trials are conducted to confirm Phase II results in a significantly larger patient population over a longer term and to provide reliable and conclusive data regarding the safety and efficacy of a drug candidate.


The R&D process typically takes thirteenfourteen years or longer, with overapproximately three years often spent in Phase III, or late-stage, development. We consider our R&D programs in Phase III or late-stage development, to be our significant R&D programs. These programs include both investigational compounds in Phase III development for initial indications and marketed products that are in Phase III development for additional indications or formulations.


Drug development is time consuming, expensive and risky. On average, only about one in 10,000 chemical compounds discovered by pharmaceutical industry researchers proves to be both medically effective and safe enough to become an approved medicine. Drug candidates can fail at any stage of the process, and even late-stage product candidates sometimes fail to receive regulatory approval. According to the KMR Group, based on industry success rates from 2006-2010,2008-2012, approximately 95% of the compounds that enter Phase I development fail to achieve regulatory approval. The failure rate for compounds that enter Phase II development is approximately 90%88% and for compounds that enter Phase III development, it is approximately 54%49%.


Total research and development expenses include the costs of discovery research, preclinical development, early- and late-clinicallate-stage clinical development and drug formulation, as well as clinical trialspost-commercialization and medical support of marketed products, proportionate allocations of enterprise-wide costs, and other appropriate costs. We spentResearch and development spending was $3.7 billion in 2013, $3.9 billion in 2012 and $3.8 billion in 2011 and $3.6 billion in both 2010 and 2009 on research and development activities. Research and development spending includes payments under third-party collaborations and contracts. At the end of 2011,2013, we employed approximately 8,000 people in R&D activities, including a substantial number of physicians, scientists holding graduate or postgraduate degrees and higher-skilled technical personnel.

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We manage our R&D programs on a portfolio basis, investing resources in each stage of research and development from early discovery through late-stage development. We continually evaluate our portfolio of R&D assets to ensure that there is an appropriate balance of early-stage and late-stage programs to support the future growth of the Company. Spending on our late-stage development programs representsrepresented approximately 30-40%30-45% of our annual R&D expenses.expenses in the last three years. No individual investigational compound or marketed product represented 10% or more of our R&D expenses in any of the last three years.



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Listed below are several late-stage investigational compounds that we have in Phase III clinical trials or under regulatory review for at least one potential indication. Whether or not any of these or our other investigational compounds ultimately becomes one of our marketed products depends on the results of clinical studies, the competitive landscape of the potential product’s market and the manufacturing processes necessary to produce the potential product on a commercial scale, among other factors. However, as noted above, there can be no assurance that we will seek regulatory approval of any of these compounds or that, if such approval is sought, it will be obtained. There is also no assurance that a compound that is approved will be commercially successful. At this stage of development, we cannot determine all intellectual property issues or all the patent protection that may, or may not, be available for these investigational compounds. The patent coverage highlighted below includes onlypatent terms and patent term extensions that have been granted.

Brivanib

Asunaprevir
  

BrivanibAsunaprevir is an oral small molecule dual kinaseNS3 protease inhibitor that blocks bothin Phase III development (which commenced in 2012) for the VEGF receptortreatment of hepatitis C virus infection, and the FGF receptor. It is currently in Phase III trials as an anti-cancer treatment with potential usethe registrational process in hepatocellular carcinoma and colorectal cancer.Japan. We own a patent covering brivanibasunaprevir as a composition of matter that expires in 2023 in the U.S.

Dapagliflozin

Daclatasvir
  

DapagliflozinDaclatasvir is an oral SGLT2small molecule NS5A replication complex inhibitor in Phase III development (which commenced in 2011) for the potential treatment of diabetes. Ithepatitis C virus infection and is currently in the registrational process in both the EUJapan and the U.S. It was discovered internally and is part of our alliance with AstraZeneca.EU. We own a patent covering dapagliflozindaclatasvir as a composition of matter that expires in October 20202028 in the U.S. In January 2012, we received a complete response letter regarding our NDA for dapagliflozin. For further discussion see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Product and Pipeline Developments.”

Necitumumab (IMC-11F8)

BMS-791325
 

NecitumumabBMS-791325 is a fully human monoclonal antibody being investigated as an anticancer treatment, which was discovered by ImClone and is part of the alliance between the Company and Lilly. It isoral small molecule non-nucleoside NS5B inhibitor in Phase III trialsdevelopment (which commenced in non small cell lung cancer. Lilly owns2013) for the treatment of hepatitis C virus infection. We own a patent covering necitumumabBMS-791235 as a composition of matter that expires in 20252027 in the U.S.

Elotuzumab

 

Peginterferon lambdaPeginterferon lambda is a novel type 3 interferon in Phase III development (which commenced in 2012) for hepatitis C virus infection. We own a patent covering peginterferon lambda as a composition of matter that expires in 2024 in the U.S.
ElotuzumabElotuzumab is a humanized monoclonal antibody being investigated as an anticancer treatment, which was discovered by PDL BioPharma and became part of the Facet Biotech Corporation (Facet) spin-off. Facet was subsequently acquired by Abbott Laboratories (Abbott) and became part of AbbVie Inc. (AbbVie) following a spin-off from Abbott. Elotuzumab is part of our alliance with Abbott.AbbVie. It is in Phase III trials (which commenced in 2011) in multiple myeloma. AbbottAbbVie owns a patent covering elotuzumab as a composition of matter that expires in 2026 in the U.S.

Daclatasvir

Nivolumab
  

Daclatasvir

Nivolumab is a fully human monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T and NKT cells. It is being investigated as an oral small molecule NS5A replication complex inhibitoranticancer treatment. It is in Phase III development for the treatment of hepatitis C virus.trials (which commenced in 2012) in non-small-cell lung cancer, renal cell cancer and melanoma. We jointly own a patent with Ono covering daclatasvirnivolumab as a composition of matter that expires in 2027 in the U.S.

The FDA has granted Fast Track designation for nivolumab in three tumor types: non-small-cell lung cancer, renal cell carcinoma
and advanced melanoma.


In February 2014, BMS sold to AstraZeneca the diabetes business of BMS which comprised our global alliance with them, including all rights and ownership to metreleptin. Metreleptin is a protein in development for the treatment of lipodystrophy and is currently in the registrational process.

The following table lists potential additional indications and/or formulations of key marketed products that are in Phase III development or currently under regulatory review:

ELIQUIS

Key marketed product
  Potential indications for stroke prevention in atrial fibrillation and for VTE treatmentindication and/or formulation

ORENCIA

Baraclude
  PotentialPediatric extension (EU)
Reyataz
Pediatric extension
Fixed dose combination with cobicistat in additional formulations
Erbitux*Additional indication in lupus nephritis.esophageal cancer

SPRYCEL

Yervoy
  Potential additional indication in prostate cancer.

YERVOY

Potential additional

Additional indications in adjuvant melanoma, prostate cancer, non-small cellnon-small-cell lung cancer and small cell lung cancer.

Potential additionalcancer

Additional indication in first-line metastatic melanoma in the EU.

combination with nivolumab

ERBITUX*

 

Potential additional

OrenciaAdditional indications in first-line colorectal cancer, first-linelupus nephritis and second-line non-small cell lung cancer, and gastric cancer.

psoriatic arthritis

ONGLYZA

 Potential additional use in cardiovascular risk reduction and pediatric extension.

SUSTIVA

Eliquis
  Potential pediatric extension.

BARACLUDE

Potential pediatric extension.Additional indication for VTE treatment and VTE prevention (U.S.)

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The following key developments are currently expected to occur during 20122014 with respect to our significant pipeline programs. The outcome and timing of these expected developments are dependent upon a number of factors including, among other things, the availability of data, the outcome of certain clinical trials, acceptance of presentations at certain medical meetings and/or actions by health authorities. We do not undertake any obligation to publicly update this information, whether as a result of new information, future events, or otherwise.

ELIQUIS

Asunaprevir
  
Potential approval in Japan for hepatitis C virus infection
Planned submission in the U.S. and EU approval for stroke prevention in atrial fibrillationhepatitis C virus infection

Dapagliflozin

 

Daclatasvir
Potential approval in the EU approvaland Japan for treatment of type 2 diabetes

hepatitis C virus infection

Planned submission in the U.S. for hepatitis C virus infection
Nivolumab
Data available from Phase III studies in patients with cardiovascular disease

Data available from Phase III study as an add-on to sitagliptin

clinical trials

Potential submission based on registrational trials

ONGLYZA

 Data available from Phase III study as an add-on to metformin and sulfonylurea

NULOJIX

Sprycel
  Four-yearFive year data available from the Phase III studies and subpopulation analysesin first line CML

ORENCIA

Data available from head-to-head study versus HUMIRA*

Potential EU approval for subcutaneous formulation

Phase III start in lupus nephritis

Phase III start in psoriatic arthritis

YERVOY

Submission of DTIC combination data in U.S. and EU

Ipilimumab plus vemurafenib safety/feasibility data available

Brivanib

Yervoy
  Data available from Phase III study in advanced hepatocellular canceradjuvant melanoma

ERBITUX*

Eliquis
  Potential approval for first-line colorectal cancer

SPRYCEL

Three-year data in first line CML

Daclatasvir

Data available from Phase II hepatitis C combination studiesVTE treatment and VTE prevention (U.S.)


Strategic Alliances and Collaborations


We enter into strategic alliances and collaborations with third parties some of which give usthat transfer rights to develop, manufacture, market and/or sell pharmaceutical products that are owned by third parties and some of which give third parties the rights to develop, manufacture, market and/or sell pharmaceutical products that are owned by us.other parties. These alliances and collaborations can take many forms, includinginclude licensing arrangements, codevelopment and comarketing agreements, copromotion arrangements and joint ventures. SuchWhen such alliances involve sharing research and arrangements reducedevelopment costs, the risk of incurring all research and development expenses for compounds that do not lead to revenue-generating products; however,products is reduced. However, profitability on alliance products areis generally lower sometimes substantially so, than profitability on our own products that are not partnered because profits from alliance products are shared with our alliance partners. While there can be no assurance that new alliances will be formed, weWe actively pursue such arrangements and view alliances as an important complement to our own discovery, development and developmentcommercialization activities.


Each of our strategic alliances and arrangements with third parties who own the rights to manufacture, market and/or sell pharmaceutical products contain customary early termination provisions typically found in agreements of this kind and are generally based on the other party’s material breach or bankruptcy (voluntary or involuntary) and product safety concerns. The amount of notice required for early termination generally ranges from immediately upon notice to 180 days after receipt of notice. Termination immediately upon notice is generally available where the other party files a voluntary bankruptcy petition or if a material safety issue arises with a product such that the medical risk/benefit is incompatible with the welfare of patients to continue to develop or commercialize this product. Termination upon 30 to 90 days notice is generally available where an involuntary bankruptcy petition has been filed (and has not been dismissed) or a material breach by the other party has occurred (and not been cured). A number of alliance agreements also permit the collaboratoralliance partner or us to terminate without cause, typically exercisable with substantial advance written notice and often exercisable only after a specified period of time has elapsed after the collaborationalliance agreement is signed. Our strategic alliances and arrangements typically do not otherwise contain provisions that provide the other party the right to terminate the alliance on short notice.


In general, we do not retain any rights to a product brought to an alliance by another party or to the other party’s intellectual property after an alliance terminates. The loss of rights to one or more products that are marketed and sold by us pursuant to a strategic alliance arrangement could be material to our results of operations and cash flows and, in the case of PLAVIX* or ABILIFY*, could be material to our financial condition and liquidity. As is customary in the pharmaceutical industry, the terms of our strategic alliances and arrangements generally are co-extensive with the exclusivity period and may vary on a country-by-country basis.

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Our most significant current alliances and arrangements for both currently marketed products and investigational compounds are described below.


Current Marketed Products—In-Licensed


Otsuka

Sanofi We have agreements with Sanofi for the codevelopment and cocommercialization of AVAPRO*/AVALIDE* and PLAVIX*. AVAPRO*/AVALIDE* is copromoted in certain countries outside the U.S. under the tradename APROVEL*/COAPROVEL* and comarketed in certain countries outside the U.S. by us under the tradename KARVEA*/KARVEZIDE*. PLAVIX* is copromoted in certain countries outside the U.S. under the tradename PLAVIX* and comarketed in certain countries outside the U.S. by us under the tradename ISCOVER*.

The worldwide alliance operates under the framework of two geographic territories, one covering certain European and Asian countries, referred to as Territory A, and one covering the U.S., Puerto Rico, Canada, Australia and certain Latin American countries, referred to as Territory B. Territory B is managed by two separate sets of agreements: one for PLAVIX* in the U.S. and Puerto Rico and both products in Australia, Mexico, Brazil, Colombia and Argentina and a separate set of agreements for AVAPRO*/AVALIDE* in the U.S. and Puerto Rico only. Within each territory, a territory partnership exists to supply finished product to each country within the territory and to manage or contract for certain central expenses such as marketing, research and development and royalties. Countries within Territories A and B are structured so that our local affiliate and Sanofi’s local affiliate either comarket separate brands (i.e., each affiliate operates independently and competes with the other by selling the same product under different trademarks), or copromote a single brand (i.e., the same product under the same trademark).

Within Territory A, the comarketing countries include Germany, Spain, Italy (irbesartan only), Greece and China (clopidogrel bisulfate only). We sell ISCOVER* and KARVEA*/KARVEZIDE* and Sanofi sells PLAVIX* and APROVEL*/COAPROVEL* in these countries, except China, where we retain the right to, but do not currently comarket ISCOVER*. The Company and Sanofi copromote PLAVIX* and APROVEL*/COAPROVEL* in France, the UK, Belgium, Netherlands, Switzerland and Portugal. In addition, the Company and Sanofi copromote PLAVIX* in Austria, Italy, Ireland, Denmark, Finland, Norway, Sweden, Taiwan, South Korea and Hong Kong, and APROVEL*/COAPROVEL* in certain French export countries. In 2010 and prior, the Company and Sanofi also copromoted PLAVIX* in Singapore. Sanofi acts as the operating partner for Territory A and owns a 50.1% financial controlling interest in this territory. Our ownership interest in this territory is 49.9%. We account for the investment in partnership entities in Territory A under the equity method and recognize our share of the results in equity in net income of affiliates. Our share of net income from these partnership entities before taxes was $298 million in 2011, $325 million in 2010 and $558 million in 2009.

Within Territory B, the Company and Sanofi copromote PLAVIX* and AVAPRO*/AVALIDE* in the U.S., Canada and Puerto Rico. The other Territory B countries, Australia, Mexico, Brazil, Colombia (clopidogrel bisulfate only) and Argentina are comarketing countries. We act as the operating partner for Territory B and own a 50.1% majority controlling interest in this territory. As such, we consolidate all partnership results in Territory B and recognize Sanofi’s share of the results as net earnings attributable to noncontrolling interest, net of taxes, which was $1,536 million in 2011, $1,394 million in 2010 and $1,159 million in 2009.

We recognized net sales in Territory B and Territory A comarketing countries of $8.0 billion in 2011, $7.8 billion in 2010 and $7.4 billion in 2009.

The territory partnerships are governed by a series of committees with enumerated functions, powers and responsibilities. Each territory has two senior committees which have final decision-making authority with respect to that territory as to the enumerated functions, powers and responsibilities within their jurisdictions.

The agreements with Sanofi expire on the later of (i) with respect to PLAVIX*, 2013 and, with respect to AVAPRO*/AVALIDE*, 2012 in the Americas and Australia and 2013 in Europe and Asia, and (ii) the expiration of all patents and other exclusivity rights relating to the products in the applicable territory.

The alliance arrangements may be terminated by Sanofi or us, either in whole or in any affected country or Territory, depending on the circumstances, in the event of (i) voluntary or involuntary bankruptcy or insolvency, which in the case of involuntary bankruptcy continues for 60 days or an order or decree approving same continues unstayed and in effect for 30 days; (ii) a material breach of an obligation under a major alliance agreement that remains uncured for 30 days following notice of the breach except where commencement and diligent prosecution of cure has occurred within 30 days after notice; (iii) deadlocks of one of the senior committees which render the continued commercialization of the product impossible in a given country or Territory; (iv) an increase in the combined cost of goods and royalty which exceeds a specified percentage of the net selling price of the product; or (v) a good faith determination by the terminating party that commercialization of a product should be terminated for reasons of patient safety.

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In the case of each of these termination rights, the agreements include provisions for the termination of the relevant alliance with respect to the applicable product in the applicable country or territory or, in the case of a termination due to bankruptcy or insolvency or material breach, both products in the applicable territory. Each of these termination procedures is slightly different; however, in all events, we could lose all rights to either or both products, as applicable, in the relevant country or territory even in the case of a bankruptcy or insolvency or material breach where we are not the defaulting party.

For further discussion of our strategic alliance with Sanofi, see “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

OtsukaWe maintain a worldwide commercialization agreement with Otsuka to codevelop and copromote ABILIFY*Abilify* (the ABILIFY*Abilify* Agreement), excluding certain Asia PacificAsian countries. In April 2009, the Company and Otsuka agreed to extend theThe U.S. portion of the commercializationagreement was amended in 2009 and manufacturing agreement until2012 and expires upon the expected loss of product exclusivity in April 2015. The agreement expires in all European Union (EU) countries in June 2014 and in each other non-U.S. country where we have the exclusive right to sell Abilify*, the agreement expires on the later of April 2015 or loss of exclusivity in any such country. Otsuka is the principal for third-party product sales in the U.S., United Kingdom, Germany, France, Spain, Italy and certain other European countries and BMS is the principal for third-party product sales when it is the exclusive distributor for or has an exclusive right to sell Abilify* which is in the remaining territories.


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Alliance and other revenue is recognized for only BMS's share of total net sales to third party customers in these territories. In the U.S., BMS's contractual share of ABILIFY* net sales recognized by the Company pursuant to the extension was 65%51.5% in 2009, 58% in 20102012 and 53.5% in 2011. Beginning on January 1, 2012, the2013, BMS’s contractual share changed to the percentages of total U.S. net product sales set forth in the table below. An assessment of BMS's expected annual contractual share is completed each quarterly reporting period and adjusted based upon reported U.S. Abilify* net sales at December 31, 2013. BMS's annual contractual share was 34.0% in 2013. The alliance revenue recognized byin any interim period or quarter does not exceed the Company was further reduced to 51.5%.amounts that are due under the contract.

Annual U.S. Net Product SalesBMS Share as a % of U.S. Net Product Sales
$0 to $2.7 billion50%
$2.7 billion to $3.2 billion20%
$3.2 billion to $3.7 billion7%
$3.7 billion to $4.0 billion2%
$4.0 billion to $4.2 billion1%
In excess of $4.2 billion20%

In the UK, Germany, France, Spain, Italy and Spain,certain other European countries where Otsuka is the Company receives 65%principal, BMS's contractual share of third-party net sales.product sales is 65%. In these countries and the U.S., third-party customers are invoiced by the Company on behalf of Otsukaalliance and allianceother revenue is recognized when ABILIFY*Abilify* is shipped and all risks and rewards of ownership have been transferred to third partythird-party customers. We also haveBMS recognizes all of the net product sales in certain other countries where it is the exclusive distributor for the product or has an exclusive right to sell ABILIFY* in other countries in Europe, the Americas and a number of countries in Asia. In these countries we recognize 100% of the net sales.

Abilify*.


Under the terms of the ABILIFY*Abilify* Agreement, as amended, we purchase the active pharmaceutical ingredient for product from Otsuka and perform finish manufacturing for sale by us or Otsuka to third-party customers. Under the terms of the extension agreement, we paid Otsuka $400 million, which is amortized as a reduction of net salesalliance and other revenues through the extension period. The unamortized balance is includedexpected loss of U.S. exclusivity in other assets.April 2015. Otsuka receives a royalty based on 1.5% of total U.S. net sales, which is included in cost of products sold.product sales. Otsuka iswas responsible for 30% of the U.S. expenses related to the commercialization of ABILIFY*Abilify* from 2010 through 2012. Reimbursements are netted principallyUnder the 2012 U.S. amendment, Otsuka assumed responsibility for providing and funding all sales force efforts effective January 2013. In consideration, BMS paid Otsuka $27 million in marketing, sellingJanuary 2013, and administrativeis responsible for funding certain operating expenses up to $82 million in 2013, $56 million in 2014 and advertising$8 million in 2015. In the EU, Otsuka reimbursed BMS for the sales force effort it provided through March 31, 2013. Otsuka assumed responsibility for providing and product promotion expenses.

funding sales force efforts in the EU effective April 2013.


The ABILIFY*Abilify* Agreement expires in April 2015 in the U.S. and in June 2014 in all EU countries. In each other country where we have the exclusive right to sell ABILIFY*Abilify*, the agreement expires on the later of April 20, 2015 or loss of exclusivity in any such country.

Beginning January 1, 2013, and through the expected loss of U.S. exclusivity in April 2015, we will receive the following percentages of U.S. annual net sales:


Share as a % of U.S. Net
Sales

$0 to $2.7 billion

50%

$2.7 billion to $3.2 billion

20%

$3.2 billion to $3.7 billion

  7%

$3.7 billion to $4.0 billion

  2%

$4.0 billion to $4.2 billion

  1%

In excess of $4.2 billion

20%

During this period, Otsuka will be responsible for 50% of all U.S. expenses related to the commercialization of ABILIFY* in the U.S.

The U.S. portion of the ABILIFY*Abilify* Agreement and the Oncology Agreement described below include a change-of-control provision if we are acquired. If the acquiring company does not have a competing product to ABILIFY*Abilify*, then the new company will assume the ABILIFY*Abilify* Agreement (as amended) and the Oncology Agreement as it currently exists. If the acquiring company has a product that competes with ABILIFY*Abilify*, Otsuka can elect to request the acquiring company to choose whether to divest ABILIFY*Abilify* or the competing product. In the scenario where ABILIFY*Abilify* is divested, Otsuka would be obligated to acquire our rights under the ABILIFY*Abilify* Agreement (as amended) at a price according to a predetermined schedule. The agreements also provide that in the event of a generic competitor to ABILIFY*Abilify*, we have the option of terminating the ABILIFY*Abilify* April 2009 amendment (with the agreement as previously amended remaining in force). If we were to exercise such option then either (i) we would receive a payment from Otsuka according to a pre-determined schedule and the Oncology Agreement would terminate at the same time or (ii) the Oncology Agreement would continue for a truncated period according to a pre-determined schedule.


Early termination of the ABILIFY*Abilify* Agreement is immediate upon notice in the case of (i) voluntary bankruptcy, (ii) where minimum payments are not made to Otsuka, or (iii) first commercial sale has not occurred within three months after receipt of all necessary approvals, 30 days where a material breach has occurred (and not been cured or commencement of cure has not occurred within 90 days after notice of such material breach) and 90 days in the case where an involuntary bankruptcy petition has been filed (and has not been dismissed). In addition, termination is available to Otsuka upon 30 days notice in the event that we were to challenge Otsuka’s patent rights or, on a market-by-market basis, in the event that we were to market a product in direct competition with ABILIFY*Abilify*. Upon termination or expiration of the ABILIFY*Abilify* Agreement, we do not retain any rights to ABILIFY*Abilify*.

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We recognized net salestotal revenues for ABILIFY*Abilify* of $2.3 billion in 2013 and $2.8 billion in 20112012 and $2.6 billion in both 2010 and 2009. In addition to the $400 million extension payment in 2009, total upfront, milestone and other licensing payments made to Otsuka under the ABILIFY* Agreement through 2011 were $217 million.

2011.


For a discussion of our Oncology Agreement with Otsuka, see “—Current Marketed Products—Internally Discovered” below. For further discussion of our strategic alliance with Otsuka, see “Item 8. Financial Statements—Note 3. Alliances and Collaborations.Alliances.



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Gilead

LillyWe have an EGFR commercialization agreement with Lilly through Lilly’s subsidiary ImClone for the codevelopment and copromotion of ERBITUX* and necitumumab (IMC-11F8) in the U.S., Canada and Japan. For more information on the agreement with respect to necitumumab, see “—Investigational Compounds Under Development—In-Licensed” below. Under the EGFR agreement, with respect to ERBITUX* sales in North America, Lilly receives a distribution fee based on a flat rate of 39% of net sales in North America, plus reimbursement of certain royalties paid by Lilly, and the Company and Lilly share one half of the profits and losses evenly in Japan with Merck KgaA receiving the other half of the profits and losses in Japan. The parties share royalties payable to third parties pursuant to a formula set forth in the commercialization agreement. We purchase all of our North American commercial requirements for bulk ERBITUX* from Lilly. The agreement expires as to ERBITUX* in North America in September 2018.

Early termination is available based on material breach and is effective 60 days after notice of the material breach (and such material breach has not been cured or commencement of cure has not occurred), or upon six months notice from us if there exists a significant concern regarding a regulatory or patient safety issue that would seriously impact the long-term viability of the product. Upon termination or expiration of the alliance, we do not retain any rights to ERBITUX*.

We share codevelopment and copromotion rights to ERBITUX* with Merck KGaA in Japan under an agreement signed in October 2007, and expiring in 2032, with Lilly, Merck KGaA and Merck Japan. Lilly has the ability to terminate the agreement after 2018 if it determines that it is commercially unreasonable for it to continue. ERBITUX* received marketing approval in Japan in July 2008 for the use of ERBITUX* in treating patients with advanced or recurrent colorectal cancer.

We recognized net sales for ERBITUX* of $691 million in 2011, $662 million in 2010 and $683 million in 2009.

For further discussion of our strategic alliance with Lilly, see “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

Gilead We have a joint ventureventures with Gilead to develop and commercialize ATRIPLA*Atripla* in the U.S., and Canada and in Europe. The Company and Gilead share responsibility for commercializing ATRIPLA*certain activities related to the commercialization of Atripla* in the U.S., Canada, throughout the EU and certain other European countries, and both provide funding and field-based sales representatives in support of promotional efforts for ATRIPLA*.countries. Gilead recognizes 100% of ATRIPLA*Atripla* revenues in the U.S., Canada and most countries in Europe. Our revenueAlliance and other revenues recognized for Atripla* include only the bulk efavirenz component of Atripla* which is determined by applying a percentagecalculated differently in the EU and the U.S. following the loss of exclusivity of Sustiva in the EU in 2013. The alliance and other revenues are deferred and the related alliance receivable is not recognized until Atripla* is sold to ATRIPLA* revenue to approximate revenue for the SUSTIVA brand.third-party customers. We recognized efavirenz alliance and other revenues of $1,204 million$1.4 billion in 2013, $1.3 billion in 2012 and $1.2 billion in 2011 $1,053 million in 2010 and $869 million in 2009 related to ATRIPLA*Atripla* net product sales.


The joint venture arrangement between the Company and Gilead in the U.S. will continue until terminated by mutual agreement of the parties or otherwise as described below. In the event of a material breach by one party, the non-breaching party may terminate the joint venture only if both parties agree that it is both desirable and practicable to withdraw the combination product from the markets where it is commercialized. At such time as one or more generic versions of a party’s component product(s) appear on the market in the U.S., the other party will have the right to terminate the joint venture and thereby acquire all of the rights to the combination product, both in the U.S. and Canada; however, for three years the terminated party will continue to receive a percentage of the net product sales based on the contribution of bulk component(s) to ATRIPLA*Atripla*, and otherwise retains all rights to its own product(s).


In 2011, we entered into a licensing agreement with Gilead to develop and commercialize a fixed-dose combination containing REYATAZ*Reyataz and Gilead’s cobicistat, a pharmacoenhancing or “boosting” agent currently in Phase III clinical trials that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing.

Cobicistat is currently in the registrational process with the FDA.


For further discussion of our strategic alliance with Gilead, see “Item 8. Financial Statements—Note 3. AlliancesAlliances.”

Lilly

We have an EGFR commercialization agreement with Lilly through Lilly’s subsidiary ImClone for the codevelopment and Collaborations.copromotion of Erbitux* in the U.S., Canada and Japan. Under the EGFR agreement, with respect to Erbitux* net product sales in North America, Lilly receives a distribution fee based on a flat rate of 39% of net product in North America, plus reimbursement of certain royalties paid by Lilly, and the Company and Lilly share one half of the profits and losses evenly in Japan with Merck KgaA receiving the other half of the profits and losses in Japan. The parties share royalties payable to third parties pursuant to a formula set forth in the commercialization agreement. We purchase all of our North American commercial requirements for bulk Erbitux* from Lilly. The agreement expires as to Erbitux* in North America in September 2018.

Early termination is available based on material breach and is effective 60 days after notice of the material breach (and such material breach has not been cured or commencement of cure has not occurred), or upon six months notice from us if there exists a significant concern regarding a regulatory or patient safety issue that would seriously impact the long-term viability of the product. Upon termination or expiration of the alliance, we do not retain any rights to Erbitux* in North America.

We share codevelopment and copromotion rights to Erbitux* with Merck KGaA in Japan under an agreement signed in October 2007, and expiring in 2032, with Lilly, Merck KGaA and Merck Japan. Lilly has the ability to terminate the agreement after 2018 if it determines that it is commercially unreasonable for it to continue. Erbitux* received marketing approval in Japan in July 2008 for the use of Erbitux* in treating patients with advanced or recurrent colorectal cancer and head and neck cancer in December 2012.

We recognized net product sales for Erbitux* of $696 million in 2013, $702 million in 2012 and $691 million in 2011.

For further discussion of our strategic alliance with Lilly, see “Item 8. Financial Statements—Note 3. Alliances.


Sanofi

In September 2012, BMS and Sanofi restructured the terms of the codevelopment and cocommercialization agreements discussed below. Effective January 1, 2013, Sanofi assumed essentially all of the worldwide operations of the alliance with the exception of Plavix* in the U.S. and Puerto Rico. The alliance for Plavix* in these two markets will continue unchanged through December 2019 under the same terms as in the original alliance arrangements described below. In exchange for the rights being assumed by Sanofi, BMS will receive quarterly royalties from January 1, 2013 until December 31, 2018 and a terminal payment from Sanofi of $200 million at the end of 2018.

Pursuant to the Master Restructuring Agreement, the Company returned to Sanofi its rights for clopidogrel and irbesartan in all markets with the exception of clopidogrel in the U.S. and Puerto Rico, where the Company continues to act as the operating partner and own a 50.1% majority controlling interest. All existing local arrangements in Territory A and Territory B (with the exception of clopidogrel in the U.S. and Puerto Rico), were terminated by mutual agreement. No products will continue to be sold through such local country entities

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in these territories. In addition, Sanofi assumed all marketing authorizations for the products, to the extent currently held by the Company or any of its affiliates. As a result, Sanofi assumed control of all activities relating to the distribution, commercialization and medical affairs of clopidogrel and irbesartan in these regions.

Pursuant to the Master Restructuring Agreement and related alliance agreements, Sanofi will assume the Company’s manufacturing and supply obligations of irbesartan products at the end of 2015. The Company does not manufacture bulk clopidogrel and no longer finishes clopidogrel products in its facilities. The Company will retain rights to the intellectual property developed by the alliance necessary to fulfill its continuing obligations under the alliance arrangements.

We had agreements with Sanofi for the codevelopment and cocommercialization of Avapro*/Avalide* and Plavix*. Avapro*/Avalide* is copromoted in certain countries outside the U.S. under the tradename Aprovel*/Coaprovel* and comarketed in certain countries outside the U.S. by us under the tradename Karvea*/Karvezide*. Plavix* was copromoted in certain countries outside the U.S. under the tradename Plavix* and comarketed in certain countries outside the U.S. by us under the tradename Iscover*.

Prior to 2013, the worldwide alliance operated under the framework of two geographic territories, one covering certain European and Asian countries, referred to as Territory A, and one covering the U.S., Puerto Rico, Canada, Australia and certain Latin American countries, referred to as Territory B. Sanofi acted as the operating partner for Territory A and owned a 50.1% financial controlling interest in Territory A and our ownership interest in this territory was 49.9%. In Territory B, we acted as the operating partner and owned a 50.1% majority controlling interest in this territory and consolidated all partnership results in Territory B. Territory B was managed by two separate sets of agreements: one for Plavix* in the U.S. and Puerto Rico and both products in Australia, Mexico, Brazil, Colombia and Argentina and a separate set of agreements for Avapro*/Avalide* in the U.S. and Puerto Rico only. Within each territory, a territory partnership existed to supply finished product to each country within the territory and to manage or contract for certain central expenses such as marketing, research and development and royalties. Countries within Territories A and B were structured so that our local affiliate and Sanofi’s local affiliate either comarket separate brands (i.e., each affiliate operated independently and competed with the other by selling the same product under different trademarks), or copromoted a single brand (i.e., the same product under the same trademark).

Beginning in 2013, all royalties received from Sanofi in Territory B, opt-out markets, and former development royalties are presented in total revenues. We recognized total revenues in Territory B and Territory A comarketing countries of $0.5 billion in 2013, $3.1 billion in 2012 and $8.0 billion in 2011.

The alliance may be terminated by Sanofi or us, in the event of (i) voluntary or involuntary bankruptcy or insolvency, which in the case of involuntary bankruptcy continues for 60 days or an order or decree approving same continues unstayed and in effect for 30 days and (ii) a material breach of an obligation under a major alliance agreement that remains uncured for 30 days following notice of the breach except where commencement and diligent prosecution of cure has occurred within 30 days after notice.

For further discussion of our strategic alliance with Sanofi, see “Item 8. Financial Statements—Note 3. Alliances.”

Current Marketed Products—Internally Discovered

Otsuka


Simultaneously with the extension of the Abilify* Agreement, in April 2009, the Company and Otsuka entered into an Oncology Agreement for Sprycel and Ixempra (ixabepilone), which includes the U.S., Japan and the EU markets (the Oncology Territory). Beginning in 2010 through 2020, a fee is paid to Otsuka annually based on the following percentages of the annual net product sales of Sprycel and Ixempra:
  % of Net Product Sales
  2010 - 2012 2013 - 2020
$0 to $400 million 30% 65%
$400 million to $600 million 5% 12%
$600 million to $800 million 3% 3%
$800 million to $1.0 billion 2% 2%
In excess of $1.0 billion 1% 1%

During these annual periods, Otsuka contributes 20% of the first $175 million of certain commercial operational expenses relating to the Oncology Products in the Oncology Territory and 1% of such costs in excess of $175 million. Beginning in 2011, Otsuka copromotes Sprycel in the U.S. and Japan and beginning in 2012, also copromotes in the top five EU markets.

The Oncology Agreement expires with respect to Sprycel and Ixempra in 2020 and includes the same change-of-control provision if we were acquired as the Abilify* Agreement described above.


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For a discussion of our Abilify* Agreement with Otsuka, see “—Current Marketed Products—In-Licensed” above. For further discussion of our strategic alliance with Otsuka, see “Item 8. Financial Statements—Note 3. Alliances.”

In addition, in January 2007, we granted Otsuka exclusive rights in Japan to develop and commercialize Onglyza. Under that agreement, we are entitled to receive milestone payments based on certain regulatory events, as well as sales-based payments following regulatory approval of Onglyza in Japan, and we retained rights to copromote Onglyza with Otsuka in Japan. Otsuka is responsible for all development costs in Japan. In June 2012, Otsuka assigned all rights to Onglyza, with the exception of specific transition services, to Kyowa Hakko Kirin (KHK). As part of its consent to this assignment, BMS waived its rights to co-promote Onglyza in Japan. BMS will supply finished saxagliptin to KHK.

In February 2014, we sold to AstraZeneca our diabetes business that was comprised of the global alliance with them, including all rights and ownership to Onglyza. See“Item 8. Financial Statements—Note 5. Assets Held-For-Sale” for further discussion.

AstraZeneca

In January 2007, we entered into a worldwide (except for Japan) codevelopment and cocommercialization agreement with AstraZeneca for ONGLYZAOnglyza (the Saxagliptin Agreement) and Forxiga (the SGLT2 Agreement). KOMBIGLYZEIn 2012, BMS and AstraZeneca Pharmaceuticals LP, a wholly-owned subsidiary of AstraZeneca, entered into an alliance regarding the worldwide development and commercialization of Amylin’s portfolio of products, including Bydureon*, Byetta*, Symlin*. Kombiglyze was codeveloped with AstraZeneca under the Saxagliptin Agreement. The exclusive rights to develop and sell ONGLYZAOnglyza in Japan were licensed to Otsuka in December 2006 and in June 2012 were assigned by Otsuka to KHK, which is described below under “above.

In February 2014, we sold to AstraZeneca our diabetes business that was comprised of the global alliance with them, including all rights and ownership to Onglyza, Forxiga, Bydureon*, Byetta*, Symlin* and metreleptin. See“Investigational Compounds Under Development—Internally Discovered.” The CompanyNote 5. Assets Held-For-Sale” for further information. We and AstraZeneca are also partiesterminated our existing alliance agreements in connection with the sale and entered into several new agreements, including a transitional services agreement, a supply agreement and a development agreement. Under the supply agreement, we will continue to a worldwide codevelopment manufacture Onglyza, Kombiglyze and cocommercialization agreement for dapagliflozin, which is described below under “—Investigational Compounds Under Development—Internally Discovered.

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We manufacture ONGLYZA and KOMBIGLYZE and, with certain limited exceptions, recognize net sales in most key markets. We received $300 million in upfront, milestone and other licensing payments from AstraZeneca for meeting certain development and regulatory milestones on ONGLYZA and KOMBIGLYZE, including $50 million received in 2010 and $150 million received in 2009, and could receive up to an additional $300 million if all sales-based milestones are met. The majority of costs under the initial development plans were paid by AstraZeneca and additional development costs are generally shared equally. We expense ONGLYZA and KOMBIGLYZE development costs, net of AstraZeneca’s share, in research and development. The two companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits and losses equally on a global basis, excluding Japan.

Forxiga.


For further discussion of our strategic alliance with AstraZeneca, see “Item 8. Financial Statements—Note 3. AlliancesAlliances” and Collaborations.”

“Investigational Compounds Under Development – Internally Discovered."


Pfizer

Otsuka Simultaneously with the extension of the ABILIFY* Agreement, in April 2009, the Company and Otsuka entered into an Oncology Agreement for SPRYCEL and IXEMPRA, which includes the U.S., Japan and the EU markets (the Oncology Territory). Beginning in 2010 through 2020, the collaboration fees that we will pay to Otsuka annually are the following percentages of the aggregate net sales of SPRYCEL and IXEMPRA in the Oncology Territory:

   % of Net Sales
   2010 - 2012 2013 - 2020

$0 to $400 million

  30% 65%

$400 million to $600 million

    5% 12%

$600 million to $800 million

    3%   3%

$800 million to $1.0 billion

    2%   2%

In excess of $1.0 billion

    1%   1%

During these periods, Otsuka will contribute (i) 20% of the first $175 million of certain commercial operational expenses relating to the oncology products in the Oncology Territory, and (ii) 1% of such commercial operational expenses relating to the products in the Oncology Territory in excess of $175 million. Beginning in 2011, Otsuka copromotes SPRYCEL in the U.S. and Japan and has exercised the right to copromote in the top five EU markets beginning in January 2012.

The Oncology Agreement expires with respect to SPRYCEL and IXEMPRA in 2020 and includes the same change-of-control provision if we were acquired as the ABILIFY* Agreement described above.

For a discussion of our ABILFY* Agreement with Otsuka, see “—Current Marketed Products—In-Licensed” above. For further discussion of our strategic alliance with Otsuka, see “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

PfizerThe Company and Pfizer are parties to a worldwide codevelopment and cocommercialization agreement for ELIQUIS,Eliquis, an anticoagulant discovered by us and being studied for the prevention and treatment of a broad range ofatrial fibrillation and venous and arterial thrombotic conditions which is currently approved and marketed in the EU for VTE prevention.thromboembolic (VTE) disorders. Pfizer funds between 50% and 60% of all development costs since January 2007 and we fund 40%.depending on the study. We have received $559$784 million in upfront, milestone and other licensing payments from Pfizer to date, including $20 million received in January 2012,2014 and could receive up to an additional $325$100 million from Pfizer if all development and regulatory milestones are met. The companies jointly develop the clinical and marketing strategy of ELIQUIS, and share commercialization expenses and profits and losses equally on a global basis.


For further discussion of our strategic alliance with Pfizer, see “Item 8. Financial Statements—Note 3. Alliances and Collaborations.Alliances.


Investigational Compounds Under Development—In-Licensed

Lilly In January 2010, the Company and Lilly restructured the EGFR commercialization agreement to provide for the codevelopment and cocommercialization of necitumumab (IMC-11F8), a fully human antibody currently in Phase III development for non-small cell lung cancer. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Product and Pipeline Developments” for an update on one Phase III trial. As restructured, both companies will share in the cost of developing and will share in the profits and losses upon commercializing necitumumab in the U.S., Canada and Japan. Lilly maintains exclusive rights to necitumumab in all other markets. We will fund 55% of development costs for studies that will be used only in the U.S., 50% for Japan studies, and 27.5% for global studies. We will pay $250 million to Lilly as a milestone payment if first approval is granted in the U.S. In the U.S. and Canada, we will recognize all sales and 55% of the profits and losses for necitumumab. Lilly will provide 50% of the selling effort and the parties will, in general, equally participate in other commercialization efforts. In Japan, the Company and Lilly will share commercial costs and profits evenly. The agreement as it relates to necitumumab continues beyond patent expiration until both parties agree to terminate. Beginning in 2011, Lilly manufactures the bulk requirements and we assume responsibility for fill/finish of necitumumab.

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Abbott


AbbVie

In August 2008, we were granted exclusive rights from Facet Biotech Corporation (now Abbott)AbbVie) for the codevelopment and cocommercialization of elotuzumab, a humanized monoclonal antibody being investigated as treatment for multiple myeloma. Under the terms of the agreement, we fund 80% of the development costs for elotuzumab. Upon commercialization, AbbottAbbVie will share 30% of all profits and losses in the U.S., and will be paid tiered royalties outside of the U.S. We will be solely responsible for commercialization of elotuzumab. In addition, AbbottAbbVie may receive milestone payments from us based on certain regulatory events and sales thresholds, if achieved.


Investigational Compounds Under Development—Internally Discovered

AstraZeneca As mentioned above, we have


Ono

In September 2011, BMS and Ono entered into an alliance agreement (the “2011 Alliance Agreement”) for nivolumab, an anti-PD-1 human monoclonal antibody being investigated as an anti-cancer treatment, which is also subject to a worldwide codevelopmentalliance agreement (the “2006 Alliance Agreement”) entered into in 2006 by Ono and cocommercialization agreement with AstraZeneca for dapagliflozin (the SGLT2 Agreement). Dapagliflozin is being studied forMedarex, now a wholly-owned subsidiary of the potential treatment of diabetes and was discovered by us.

Company.  Under the SGLT22006 Alliance Agreement we have received $170 millionand the 2011 Alliance Agreement, Ono granted BMS the exclusive right to develop, commercialize and manufacture


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any product containing nivolumab in all countries of upfront, milestonethe world except Japan, Korea and other licensing payments from AstraZeneca, including $120 million received during 2011 and could receive up to $230 million more ifTaiwan (where Ono remains responsible for all development and commercialization).  Ono is entitled to receive certain sales-based royalties following regulatory milestones for dapagliflozin are met and up to an additional $390 million ifapprovals in all sales-based milestones for dapagliflozin are met. The majority of costs under the initial plans through 2009 were paid by AstraZeneca and any additional development costs will generally be shared equally except for Japan, where AstraZeneca bears substantially all of the development costs prior to approval of the first indication. We expense dapagliflozin development costs, net of our alliance partner’s share, in research and development. Under the SGLT2 Agreement, liketerritories excluding these three countries.  In connection with the Saxagliptin2011 Alliance Agreement, BMS also entered into an alliance with Ono whereby we granted certain commercialization rights to Ono and Ono shares in the two companies will jointly develop the clinical and marketing strategy and share commercialization expenses, and profits and losses for dapagliflozin equallyOrencia in Japan.  

Other Alliances

In February 2013, BMS and Reckitt Benckiser Group plc (Reckitt) entered into a three year alliance regarding several over-the-counter-products sold primarily in Mexico and Brazil. Reckitt received the right to sell, distribute and market the products through May 2016 and will have certain responsibilities related to regulatory matters in the covered territory. BMS will receive royalties on net product sales and will also exclusively supply certain of the products to Reckitt pursuant to a supply agreement at cost plus a markup. Certain limited assets, including the market authorizations and certain employees directly attributed to the business, were transferred to Reckitt at the start of the alliance period. BMS retained ownership of all other assets related to the business including the trademarks covering the products.

BMS also granted Reckitt an option to acquire the trademarks, inventory and certain other assets exclusively related to the products at the end of the alliance at a price determined based on a global basis,multiple of net product sales (plus the cost of any remaining inventory held by BMS at the time). If the option is not exercised, all assets previously transferred to Reckitt will revert back to BMS. The option may be exercised by Reckitt between May and we will manufacture dapagliflozinNovember 2015, in which case closing would be expected to occur in May 2016. Non-refundable upfront alliance proceeds of $485 million received by BMS were allocated to the rights transferred to Reckitt ($376 million) and with certain limited exceptions, recognize net sales in most key markets. With respect to Japan, AstraZeneca has operational and cost responsibility for all development and regulatory activities on behalfthe fair value of the collaboration, relatedoption to certain trials. All other development costs are shared bypurchase the two companies. The two companies will jointly market the product in Japan, sharing all commercialization expenses and activities and splitting profits and losses equally like in the rest of the world. We will also manufacture dapagliflozin and recognize net sales in Japan, like in the rest of the world. Dapagliflozin is currently being studied in Phase II clinical trials in Japan.

For further discussion of our strategic alliance with AstraZeneca,remaining assets ($109 million). Please see “Item 8. Financial Statements—Note 3. AlliancesAlliances” for more information regarding the alliance.


In February 2013, BMS and Collaborations.”

The Medicines Company entered into a two year alliance regarding Otsuka In January 2007, weRecothrom, a recombinant thrombin for use as a topical hemostat to control non-arterial bleeding during surgical procedures (previously acquired by BMS in connection with its acquisition of ZymoGenetics, Inc. in 2010). The Medicines Company received the right to sell, distribute and market Recothrom on a global basis for two years, and will have certain responsibilities related to regulatory matters in the covered territory. BMS will exclusively supply Recothrom to The Medicines Company pursuant to a supply agreement at cost plus a markup and will also receive royalties on net product sales of Recothrom. Certain employees directly attributed to the business and certain assets were transferred to The Medicines Company at the start of the alliance period, including the Recothrom BLA and related regulatory assets. BMS retained all other assets related to Recothrom including the patents, trademarks and inventory.


BMS also granted Otsuka exclusive rights in JapanThe Medicines Company an option to developacquire the patents, trademarks, inventory and commercialize ONGLYZA. We are entitledcertain other assets exclusively related to receive milestone paymentsRecothrom at a price determined based on certain regulatory events, as well as sales-based payments following regulatory approvala multiple of ONGLYZArevenues (plus the cost of any remaining inventory held by BMS at that time). If the option is not exercised, all assets previously transferred to The Medicines Company will revert back to BMS. The option may be exercised by The Medicines Company between February and August 2014, in Japan. We retainedwhich case closing would be expected to occur in February 2015. Non-refundable upfront alliance proceeds of $115 million received by BMS were allocated to the rights transferred to copromote ONGLYZA with Otsuka in Japan. Otsuka is responsibleThe Medicines Company ($80 million) and the fair value of the option to purchase the remaining assets ($35 million). Please see “Item 8. Financial Statements—Note 3. Alliances” for all development costs in Japan.more information regarding the alliance.

Royalty and


Other Licensing Arrangements


In addition to the strategic alliances described above, we have other in-licensing and out-licensing arrangements. With respect to in-licenses, we have agreements with Novartis for REYATAZReyataz and with Merck for efavirenz, among others. Based on our current expectations with respect to the expiration of market exclusivity in our significant markets, the licensing arrangements with Novartis for REYATAZ are expected to expire in 2017 in the U.S. and the EU and 2019 in Japan. For further discussion of market exclusivity protection, including a chart showing net sales of key products together with the year in which basic exclusivity loss occurred or is expected to occur in the U.S., the EU, Japan and Canada, see “—Products” above.

We also own certain compounds out-licensed to third parties for development and commercialization, including those obtained as a result offrom our acquisitions of ZymoGenetics in October 2010 and Medarex in August 2009.acquisitions. We are entitled to receive milestone payments as these compounds move through the regulatory process and royalties based on net product sales, if and when the products are commercialized.


Intellectual Property and Product Exclusivity


We own or license a number of patents in the U.S. and foreign countries primarily covering our products. We have also developed many brand names and trademarks for our products. We consider the overall protection of our patents, trademarks, licenses and other intellectual property rights to be of material value and act to protect these rights from infringement.


In the pharmaceutical industry, the majority of an innovative product’s commercial value is usually realized during the period in which the product has market exclusivity. A product’s market exclusivity is generally determined by two forms of intellectual property: patent rights held by the innovator company and any regulatory forms of exclusivity to which the innovative drug is entitled.


Patents are a key determinant of market exclusivity for most branded pharmaceuticals. Patents provide the innovator with the right to exclude others from practicing an invention related to the medicine. Patents may cover, among other things, the active ingredient(s),

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various uses of a drug product, pharmaceutical formulations, drug delivery mechanisms and processes for (or intermediates useful in) the manufacture of products. Protection for individual products extends for varying periods in accordance with the expiration dates of patents in the various countries. The protection afforded, which may also vary from country to country, depends upon the type of patent, its scope of coverage and the availability of meaningful legal remedies in the country.


Market exclusivity is also sometimes influenced by regulatory intellectual property rights. Many developed countries provide certain non-patent incentives for the development of medicines. For example, in the U.S., the EU, Japan, Canada and certain other markets,countries, regulatory intellectual property rights are offered as incentives for research on medicines for rare diseases, or orphan drugs, and on medicines useful in treating pediatric patients. These incentives can extend the market exclusivity period on a product beyond the patent term.


The U.S., EU, Japan and CanadaChina also each provide for a minimum period of time after the approval of a new drug during which the regulatory agency may not rely upon the innovator’s data to approve a competitor’s generic copy, or data protection. In some regions such as China, however, it is questionable whether such data protection laws are enforceable. In certain markets where patent protection and other forms of market exclusivity may have expired, data protection can be of particular importance. However, most regulatory forms of exclusivity do not prevent a competitor from gaining regulatory approval prior to the expiration of regulatory data exclusivity on the basis of the competitor’s own safety and efficacy data on its drug, even when that drug is identical to that marketed by the innovator.


Specific aspects of the law governing market exclusivity and data protection for pharmaceuticals vary from country to country. The following summarizes key exclusivity rules in markets representing significant sales:


United States


In the U.S., most of our key products are protected by patents with varying terms depending on the type of patent and the filing date. A significant portion of a product’s patent life, however, is lost during the time it takes an innovative company to develop and obtain regulatory approval of a new drug. As compensation at least in part for the lost patent term, the innovator may, depending on a number of factors, extend the expiration date of one patent up to a maximum term of five years, provided that the extension cannot cause the patent to be in effect for more than 14 years from the date of drug approval.


A company seeking to market an innovative pharmaceutical in the U.S. must submit a complete set of safety and efficacy data to the FDA. If the innovative pharmaceutical is a chemical, the company files a New Drug Application (NDA). If the medicine is a biological product, a Biologics License Application (BLA) is filed. The type of application filed affects regulatory exclusivity rights.


Chemical products


A competitor seeking to launch a generic substitute of a chemical innovative drug in the U.S. must file an abbreviated NDA (aNDA) with the FDA. In the aNDA, the generic manufacturer needs to demonstrate only “bioequivalence” between the generic substitute and the approved NDA drug. The aNDA relies upon the safety and efficacy data previously filed by the innovator in its NDA.


An innovator company is required to list certain of its patents covering the medicine with the FDA in what is commonly known as the Orange Book. Absent a successful patent challenge, the FDA cannot approve an aNDA until after the innovator’s listed patents expire. However, after the innovator has marketed its product for four years, a generic manufacturer may file an aNDA and allege that one or more of the patents listed in the Orange Book under an innovator’s NDA is either invalid or not infringed. This allegation is commonly known as a Paragraph IV certification. The innovator then must decide whether to file a patent infringement suit against the generic manufacturer. From time to time, aNDAs, including Paragraph IV certifications, are filed with respect to certain of our products. We evaluate these aNDAs on a case-by-case basis and, where warranted, file suit against the generic manufacturer to protect our patent rights.


In addition to benefiting from patent protection, certain innovative pharmaceutical products can receive periods of regulatory exclusivity. A NDA that is designated as an orphan drug can receive seven years of exclusivity for the orphan indication. During this time period, neither NDAs nor aNDAs for the same drug product can be approved for the same orphan use. A company may also earn six months of additional exclusivity for a drug where specific clinical trials are conducted at the written request of the FDA to study the use of the medicine to treat pediatric patients, and submission to the FDA is made prior to the loss of basic exclusivity.


Medicines approved under a NDA can also receive several types of regulatory data protection. An innovative chemical pharmaceutical is entitled to five years of regulatory data protection in the U.S., during which competitors cannot file with the FDA for approval of generic substitutes. If an innovator’s patent is challenged, as described above, a generic manufacturer may file its aNDA after the fourth year of the five-year data protection period. A pharmaceutical drug product that contains an active ingredient that has been previously approved in an NDA, but is approved in a new formulation, but not for the drug itself, or for a new indication on the basis of new clinical trials, receives three years of data protection for that formulation or indication.

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Biologic products

Under the


The U.S. healthcare legislation enacted in 2010 regulatorycreated an approval ofpathway for biosimilar versions of innovative biological products can be obtained through an abbreviated path. The abbreviated path for approval of biosimilar products underthat did not previously exist. Prior to that time, innovative biologics had essentially unlimited regulatory exclusivity. Under the U.S. healthcare legislation significantly affects the regulatory data exclusivity for biological products. The 2010 legislation provides anew regulatory mechanism, that allows forthe FDA approval of biologic drugscan approve products that are similar to (but not generic copies of) innovative drugsbiologics on the basis of less extensive data than is required by a full BLA. The legislation created an approval pathway for biosimilar versions of biological products, which did not previously exist. Innovative biological products no longer receive the essentially unlimited regulatory data exclusivity that existed prior to creation of a regulatory path for biosimilar versions. Under the 2010 law, afterAfter an innovator has marketed its biological product for four years, a biosimilarany manufacturer may file an application for approval of a biosimilar“biosimilar” version of the innovator product. However, although an application for approval of a biosimilar may be filed four years after approval of the innovator product, qualified innovative biological products will receive 12 years of regulatory exclusivity, meaning that the FDA may not approve a biosimilar version until 12 years after the innovative biological product was first approved by the FDA. The 2010 law also provides a mechanism for innovators to enforce the patents that protect innovative biological products and for biosimilar applicants to challenge the patents. Such patent litigation may begin as early as four years after the innovative biological productproducts is first approved by the FDA.


In the U.S., the increased likelihood of generic and biosimilar challenges to innovators’ intellectual property has increased the risk of loss of innovators’ market exclusivity. First, generic companies have increasingly sought to challenge innovators’ basic patents covering major pharmaceutical products. Second, statutory and regulatory provisions in the U.S. limit the ability of an innovator company to prevent generic and biosimilar drugs from being approved and launched while patent litigation is ongoing. As a result of all of these developments, it is not possible to predict the length of market exclusivity for a particular product with certainty based solely on the expiration of the relevant patent(s) or the current forms of regulatory exclusivity.


European Union


Patents on pharmaceutical products are generally enforceable in the EU and, as in the U.S., may be extended to compensate for the patent term lost during the regulatory review process. Such extensions are granted on a country-by-country basis.


The primary route we use to obtain marketing authorization of pharmaceutical products in the EU is through the “centralized procedure.” This procedure is compulsory for certain pharmaceutical products, in particular those using biotechnological processes, and is also available for certain new chemical compounds and products. A company seeking to market an innovative pharmaceutical product through the centralized procedure must file a complete set of safety data and efficacy data as part of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA). After the EMA evaluates the MAA, it provides a recommendation to the European Commission (EC) and the EC then approves or denies the MAA. It is also possible for new chemical products to obtain marketing authorization in the EU through a “mutual recognition procedure,” in which an application is made to a single member state, and if the member state approves the pharmaceutical product under a national procedure, then the applicant may submit that approval to the mutual recognition procedure of some or all other member states.


After obtaining marketing authorization approval, a company must obtain pricing and reimbursement for the pharmaceutical product, which is typically subject to member state law. In certain EU countries, this process can take place simultaneously while the product is marketed but in other EU countries, this process must be completed before the company can market the new product. The pricing and reimbursement procedure can take months and sometimes years to complete.


Throughout the EU, all products for which marketing authorizations have been filed after October/November 2005 are subject to an “8+2+1” regime. Eight years after the innovator has received its first community authorization for a medicinal product, a generic company may file a marketing authorization application for that product with the health authorities. If the marketing authorization application is approved, the generic company may not commercialize the product until after either 10 or 11 years have elapsed from the initial marketing authorization granted to the innovator. The possible extension to 11 years is available if the innovator, during the first eight years of the marketing authorization, obtains an additional indication that is of significant clinical benefit in comparison with existing treatments. For products that were filed prior to October/November 2005, there is a 10-year period of data protection under the centralized procedures and a period of either six or 10 years under the mutual recognition procedure (depending on the member state).


In contrast to the U.S., patents in the EU are not listed with regulatory authorities. Generic versions of pharmaceutical products can be approved after data protection expires, regardless of whether the innovator holds patents covering its drug. Thus, it is possible that an innovator may be seeking to enforce its patents against a generic competitor that is already marketing its product. Also, the European patent system has an opposition procedure in which generic manufacturers may challenge the validity of patents covering innovator products within nine months of grant.


In general, EU law treats chemically-synthesized drugs and biologically-derived drugs the same with respect to intellectual property and data protection. In addition to the relevant legislation and annexes related to biologic medicinal products, the EMA has issued guidelines that outline the additional information to be provided for biosimilar products, also known as generic biologics, in order to review an application for marketing approval.

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Japan


In Japan, medicines of new chemical entities are generally afforded eight years of data exclusivity for approved indications and dosage. Patents on pharmaceutical products are enforceable. Generic copies can receive regulatory approval after data exclusivity and patent expirations. As in the U.S., patents in Japan may be extended to compensate for the patent term lost during the regulatory review process.


In general, Japanese law treats chemically-synthesized and biologically-derived drugs the same with respect to intellectual property and market exclusivity.

Canada


China

In Canada as of 2006,China, medicines of new chemical entities are generally afforded eightsix years of data exclusivity for approved indications and dosage. Patents on pharmaceutical products are enforceable.There is uncertainty about China’s exclusivity laws which has resulted in generic competition in the China market. Generic copies can receive regulatory approval after data exclusivity and patent expirations. Currently, unlike the U.S., CanadaChina has no patent term restoration to compensate for the patent term lost during the regulatory review process.


In Canada, biologics are generally treatedgeneral, Chinese law treats chemically-synthesized and biologically-derived drugs the same as chemically-synthesized products with respect to patent rightsintellectual property and regulatorymarket exclusivity. Health Canada has issued draft guidance that outlines the additional information to be provided for Subsequent Entry Biologics, also known as biosimilar products or generic biologics, in order to review an application for marketing approval.


Rest of the World


In countries outside of the U.S., the EU, Japan and Canada,China, there is a wide variety of legal systems with respect to intellectual property and market exclusivity of pharmaceuticals. Most other developed countries utilize systems similar to either the U.S. or the EU (e.g., Switzerland).EU. Among developing countries, some have adopted patent laws and/or regulatory exclusivity laws, while others have not. Some developing countries have formally adopted laws in order to comply with World Trade Organization (WTO) commitments, but have not taken steps to implement these laws in a meaningful way. Enforcement of WTO actions is a long process between governments, and there is no assurance of the outcome. Thus, in assessing the likely future market exclusivity of our innovative drugs in developing countries, we take into account not only formal legal rights but political and other factors as well.


Marketing, Distribution and Customers


We promote the appropriate use of our products directly to healthcare professionals and providers such as doctors, nurse practitioners, physician assistants, pharmacists, technologists, hospitals, Pharmacy Benefit Managers (PBMs) and Managed Care Organizations (MCOs). We also provide information about the appropriate use of our products to consumers in the U.S. through direct-to-consumer print, radio, television, and television advertising.digital advertising and promotion. In addition, we sponsor general advertising to educate the public about our innovative medical research.research and corporate mission. For a discussion of the regulation of promotion and marketing of pharmaceuticals, see “—Government Regulation and Price Constraints” below.


Through our field sales and marketingmedical organizations, we explain the approved uses and risks and benefits of the approved uses of our products to medical professionals. We work to gain access to health authorities, PBMfor our products on formularies and MCO formulariesreimbursement plans (lists of recommended or approved medicines and other products), including Medicare Part D plans, and reimbursement lists by providing information about the clinical profileprofiles of our products. MarketingOur marketing and sales of prescription pharmaceuticals is limited to the approved uses of the particular product, but we continue to develop scientific data and other information about our products and provide such information in response to unsolicited inquiries from doctors, other medical professionals and managed care organizations.


Our operations include several marketing and sales organizations. Each product marketing organization markets a distinct group of productsis supported by a sales force, and is typically basedwhich may be responsible for selling one or more products. We also have marketing organizations that focus on particular therapeutic areascertain classes of customers such as managed care entities or physician groups. Thesecertain types of marketing tools, such as digital or consumer communications. Our sales forces often focus on sellingcommunicating information about new products when they are introduced,or new uses, as well as established products, and promotion to physicians is increasingly targeted at physician specialists and key primary care physicians.

who treat the patients in need of our medicines.


Our products are sold principally to wholesalers, and to a lesser extent, directly to distributors, retailers, hospitals, clinics, government agencies and pharmacies. Gross salesrevenues to the three largest pharmaceutical wholesalers in the U.S. as a percentage of our totalglobal gross salesrevenues were as follows:

   2011  2010  2009 

McKesson Corporation

   26  24  25

Cardinal Health, Inc.

   21  21  20

AmerisourceBergen Corporation

   16  16  15

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  2013 2012 2011
McKesson Corporation 19% 23% 26%
Cardinal Health, Inc. 14% 19% 21%
AmerisourceBergen Corporation 15% 14% 16%

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Our U.S. business has Inventory Management Agreements (IMAs) with substantially all of our direct wholesaler and distributor customers that allow us to monitor U.S. wholesaler inventory levels and requires those wholesalers and distributors to maintain inventory levels that are no more than one month of their demand. The IMAs, including those with our three largest wholesalers, expire onin December 31, 2012,2014 subject to certain termination provisions.


In a number of defined marketscountries outside of the U.S., we have established a full scale distributor model to make medically necessary drugs available to patients. We continue to own the marketing authorization and trademarks for these products, but have contracted the services of a full-service distributor to provide distribution and logistics; regulatory and pharmacovigilance; and sales, advertising and promotion for certain products. These contracts clearly define terms and conditions, along with the services we will provide (such as supply through a firm order period). We monitor in-marketin-country sales and forecasts to ensure that reasonable inventory levels for all products for sale are maintained to fully and continuously meet the demand for the products within the distributor’s territory or responsibility. Sales in these distributor-based marketscountries represented less than 1% of the Company’s net salestotal revenues in 2011.

2013.


Competition


The markets in which we compete are generally broad based and highly competitive. We compete with other worldwide research-based drug companies, many smaller research companies with more limited therapeutic focus and generic drug manufacturers. Important competitive factors include product efficacy, safety and ease of use, price and demonstrated cost-effectiveness, marketing effectiveness, product labeling, customer service and research and development of new products and processes. Sales of our products can be impacted by new studies that indicate a competitor’s product is safer or more effective for treating a disease or particular form of disease than one of our products. Our salesrevenues also can be impacted by additional labeling requirements relating to safety or convenience that may be imposed on products by the FDA or by similar regulatory agencies in different countries. If competitors introduce new products and processes with therapeutic or cost advantages, our products can be subject to progressive price reductions or decreased volume of sales, or both.


Generic Competition


One of the biggest competitive challenges that we face is from generic pharmaceutical manufacturers. In the U.S. and the EU, the regulatory approval process exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allowing generic manufacturers to rely on the safety and efficacy of the innovator product. As a result, generic pharmaceutical manufacturers typically invest far less in research and development than research-based pharmaceutical companies and therefore can price their products significantly lower than branded products. Accordingly, when a branded product loses its market exclusivity, it normally faces intense price competition from generic forms of the product. Upon the expiration or loss of market exclusivity on a product, we can lose the major portion of salesrevenues of that product in a very short period of time.


The rate of salesrevenues decline of a product after the expiration of exclusivity varies by country. In general, the decline in the U.S. market is more rapid than in most other developed countries, though we have observed rapid declines in a number of EU countries as well. Also, the declines in developed countries tend to be more rapid than in developing countries. The rate of salesrevenues decline after the expiration of exclusivity has also historically been influenced by product characteristics. For example, drugs that are used in a large patient population (e.g., those prescribed by key primary care physicians) tend to experience more rapid declines than drugs in specialized areas of medicine (e.g., oncology). Drugs that are more complex to manufacture (e.g., sterile injectable products) usually experience a slower decline than those that are simpler to manufacture.


In certain countries outside the U.S., patent protection is weak or nonexistent and we must compete with generic versions shortly after we launch our innovative products. In addition, generic pharmaceutical companies may introduce a generic product before exclusivity has expired, and before the resolution of any related patent litigation. For more information about market exclusivity, see “—Intellectual Property and Product Exclusivity” above.


We believe our long-term competitive position depends upon our success in discovering and developing innovative, cost-effective products that serve unmet medical needs, together with our ability to manufacture products efficiently and to market them effectively in a highly competitive environment.


Managed Care Organizations


The growth of MCOs in the U.S. is also a major factor in the healthcare marketplace. Over half of the U.S. population now participates in some version of managed care. MCOs can include medical insurance companies, medical plan administrators, health-maintenance organizations, Medicare Part D prescription drug plans, alliances of hospitals and physicians and other physician organizations. Those organizations have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importance to us.



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To successfully compete for business with MCOs, we must often demonstrate that our products offer not only medical benefits but also cost advantages as compared with other forms of care. Most new products that we introduce compete with other products already on the market or products that are later developed by competitors. As noted above, generic drugs are exempt from costly and time-consuming

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clinical trials to demonstrate their safety and efficacy and, as such, often have lower costs than brand-name drugs. MCOs that focus primarily on the immediate cost of drugs often favor generics for this reason. Many governments also encourage the use of generics as alternatives to brand-name drugs in their healthcare programs. Laws in the U.S. generally allow, and in many cases require, pharmacists to substitute generic drugs that have been rated under government procedures to be essentially equivalent to a brand-name drug. The substitution must be made unless the prescribing physician expressly forbids it.


Exclusion of a product from a formulary can lead to its sharply reduced usage in the MCO patient population. Consequently, pharmaceutical companies compete aggressively to have their products included. Where possible, companies compete for inclusion based upon unique features of their products, such as greater efficacy, better patient ease of use or fewer side effects. A lower overall cost of therapy is also an important factor. Products that demonstrate fewer therapeutic advantages must compete for inclusion based primarily on price. We have been generally, although not universally, successful in having our major products included on MCO formularies.


Government Regulation and Price Constraints


The pharmaceutical industry is subject to extensive global regulation by regional, country, state and local agencies. The Federal Food, Drug, and Cosmetic Act (FDC Act), other Federal statutes and regulations, various state statutes and regulations, and laws and regulations of foreign governments govern to varying degrees the testing, approval, production, labeling, distribution, post-market surveillance, advertising, dissemination of information, and promotion of our products. The lengthy process of laboratory and clinical testing, data analysis, manufacturing, development, and regulatory review necessary for required governmental approvals is extremely costly and can significantly delay product introductions in a given market. Promotion, marketing, manufacturing and distribution of pharmaceutical products are extensively regulated in all major world markets. In addition, our operations are subject to complex Federal, state, local, and foreign environmental and occupational safety laws and regulations. We anticipate that the laws and regulations affecting the manufacture and sale of current products and the introduction of new products will continue to require substantial scientific and technical effort, time and expense as well as significant capital investments.


Of particular importance is the FDA in the U.S. It has jurisdiction over virtually all of our activities and imposes requirements covering the testing, safety, effectiveness, manufacturing, labeling, marketing, advertising and post-marketing surveillance of our products. In many cases, FDA requirements have increased the amount of time and money necessary to develop new products and bring them to market in the U.S.


The FDA mandates that drugs be manufactured, packaged and labeled in conformity with current Good Manufacturing Practices (cGMP) established by the FDA. In complying with cGMP regulations, manufacturers must continue to expend time, money and effort in production, recordkeeping and quality control to ensure that products meet applicable specifications and other requirements to ensure product safety and efficacy. The FDA periodically inspects our drug manufacturing facilities to ensure compliance with applicable cGMP requirements. Failure to comply with the statutory and regulatory requirements subjects us to possible legal or regulatory action, such as suspension of manufacturing, seizure of product or voluntary recall of a product. Adverse experiences with the use of products must be reported to the FDA and could result in the imposition of market restrictions through labeling changes or product removal. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy occur following approval.


The Federal government has extensive enforcement powers over the activities of pharmaceutical manufacturers, including authority to withdraw product approvals, commence actions to seize and prohibit the sale of unapproved or non-complying products, to halt manufacturing operations that are not in compliance with cGMPs, and to impose or seek injunctions, voluntary recalls, civil, monetary and criminal penalties. Such a restriction or prohibition on sales or withdrawal of approval of products marketed by us could materially adversely affect our business, financial condition and results of operations and cash flows.


Marketing authorization for our products is subject to revocation by the applicable governmental agencies. In addition, modifications or enhancements of approved products or changes in manufacturing locations are in many circumstances subject to additional FDA approvals, which may or may not be received and which may be subject to a lengthy application process.


The distribution of pharmaceutical products is subject to the Prescription Drug Marketing Act (PDMA) as part of the FDC Act, which regulates such activities at both the Federal and state level. Under the PDMA and its implementing regulations, states are permitted to require registration of manufacturers and distributors who provide pharmaceuticals even if such manufacturers or distributors have no place of business within the state. States are also permitted to adopt regulations limiting the distribution of product samples to licensed practitioners. The PDMA also imposes extensive licensing, personnel recordkeeping, packaging, quantity, labeling, product handling and facility storage and security requirements intended to prevent the sale of pharmaceutical product samples or other product diversions.



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The FDA Amendments Act of 2007 imposed additional obligations on pharmaceutical companies and delegated more enforcement authority to the FDA in the area of drug safety. Key elements of this legislation give the FDA authority to (1) require that companies conduct post-marketing safety studies of drugs, (2) impose certain drug labeling changes relating to safety, (3) mandate risk mitigation measures such as the education of healthcare providers and the restricted distribution of medicines, (4) require companies to publicly disclose data from clinical trials and (5) pre-review television advertisements.

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The marketing practices of all U.S. pharmaceutical manufacturers are subject to Federal and state healthcare laws that are used to protect the integrity of government healthcare programs. The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) oversees compliance with applicable Federal laws, in connection with the payment for products by government funded programs (primarily Medicaid and Medicare). These laws include the Federal anti-kickback statute, which criminalizes the offering of something of value to induce the recommendation, order or purchase of products or services reimbursed under a government healthcare program. The OIG has issued a series of Guidances to segments of the healthcare industry, including the 2003 Compliance Program Guidance for Pharmaceutical Manufacturers (the OIG Guidance), which includes a recommendation that pharmaceutical manufacturers, at a minimum, adhere to the PhRMA Code, a voluntary industry code of marketing practices. We subscribe to the PhRMA Code, and have implemented a compliance program to address the requirements set forth in the OIG Guidance and our compliance with the healthcare laws. Failure to comply with these healthcare laws could subject us to administrative and legal proceedings, including actions by Federal and state government agencies. Such actions could result in the imposition of civil and criminal sanctions, which may include fines, penalties and injunctive remedies, the impact of which could materially adversely affect our business, financial condition and results of operations and cash flows.


We are also subject to the jurisdiction of various other Federal and state regulatory and enforcement departments and agencies, such as the Federal Trade Commission, the Department of Justice and the Department of Health and Human Services in the U.S. We are also licensed by the U.S. Drug Enforcement Agency to procure and produce controlled substances. We are, therefore, subject to possible administrative and legal proceedings and actions by these organizations. Such actions may result in the imposition of civil and criminal sanctions, which may include fines, penalties and injunctive or administrative remedies.


Our activities outside the U.S. are also subject to regulatory requirements governing the testing, approval, safety, effectiveness, manufacturing, labeling and marketing of our products. These regulatory requirements vary from country to country. Whether or not FDA approval or approval of the EMAEC has been obtained for a product, approval of the product by comparable regulatory authorities of countries outside of the U.S. or the EU, as the case may be, must be obtained prior to marketing the product in those countries. The approval process may be more or less rigorous from country to country, and the time required for approval may be longer or shorter than that required in the U.S. Approval in one country does not assure that a product will be approved in another country.


In many markets outside the U.S., we operate in an environment of government-mandated, cost-containment programs. Several governments have placed restrictions on physician prescription levels and patient reimbursements, emphasized greater use of generic drugs and/or enacted across-the-board price cuts as methods of cost control. In most EU countries, for example, the government regulates pricing of a new product at launch often through direct price controls, international price comparisons, controlling profits and/or reference pricing. In other markets, such as the UK and Germany, the government does not set pricing restrictions at launch, but pricing freedom is subsequently limited, such as by the operation of a profit and price control plan in the UK and by the operation of a reference price system in Germany. Companies also face significant delays in market access for new products, mainly in France, Spain, Italy and Belgium, and more than two years can elapse before new medicines become available on some national markets. Additionally, member states of the EU have regularly imposed new or additional cost containment measures for pharmaceuticals. In recent years, Italy, for example, has imposed mandatory price decreases. The existence of price differentials within the EU due to the different national pricing and reimbursement laws leads to significant parallel trade flows.

Both in


In the U.S. and internationally, the healthcare industry is subject to various government-imposed regulations authorizing prices or price controls that have and will continue to have an impact on our net sales.total revenues. We participate in state government Medicaid programs, as well as certain other qualifying Federal and state government programs whereby discounts and rebates are provided to participating state and local government entities. We also participate in government programs that specify discounts to certain government entities, the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs. These entities receive minimum discounts based off a defined “non-federal average manufacturer price” for purchases. In March 2010, the U.S. government enacted healthcare reform legislation, signing into law the Patient Protection and Affordable Care Act (HR 3590) and a reconciliation bill containing a package of changes to the healthcare bill. The legislation makes extensive changes to the current system of healthcare insurance and benefits intended to broaden coverage and reduce costs. These bills significantly change how Americans receive healthcare coverage and how they pay for it. They also have a significant impact on companies, in particular those companies in the pharmaceutical industry and other healthcare related industries, including BMS. We have experienced and will continue to experience additional financial costs and certain other changes to our business as the new healthcare law is implemented. For example, minimum rebates on our Medicaid drug sales have increased from 15.1 percent to 23.1 percent and Medicaid rebates have also been extended to drugs used in risk-based Medicaid managed care plans. In addition, we extend discounts to certain critical access hospitals, cancer hospitals and other covered entities as required by the expansion of the 340B Drug Pricing Program under the Public Health Service Act.

In


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Beginning in 2011, we were also required to provide a 50 percent discount on our brand-name drugs to patients who fall within the Medicare Part D coverage gap, also referred to as the “donut hole” and we willwere also required to pay an annual non-tax-deductible fee to the federal government based on an allocation of our market share of branded prior year sales to certain government programs including Medicare, Medicaid, Department of Veterans Affairs, Department of Defense and TRICARE.

In many markets outside the U.S., we operate in environments of government-mandated, cost-containment programs, or under other regulatory bodies or groups that can exert downward pressure on pricing. Pricing freedom is limited in the UK, for instance, by the

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operation of a profit control plan and in Germany by the operation of a reference price system. Companies also face significant delays in market access for new products as more than two years can elapse after drug approval before new medicines become available in some countries.

Federal and state governments also have pursued direct methods to reduce the cost of drugs for which they pay. We participate in state government Medicaid programs, as well as certain other qualifying Federal and state government programs whereby discounts and rebates are provided to participating state and local government entities. We also participate in government programs that specify discounts to certain government entities, the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs. These entities receive minimum discounts based off a defined “non-federal average manufacturer price” for purchases. Other programs in which we participate provide discounts for outpatient medicines purchased by certain specified entities under Section 340B of the Public Health Service Act.


For further discussion of these rebates and programs, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Net Sales”Total Revenues” and “—Critical Accounting Policies.”


Sources and Availability of Raw Materials


In general, we purchase our raw materials and supplies required for the production of our products in the open market. For some products, we purchase our raw materials and supplies from one source (the only source available to us) or a single source (the only approved source among many available to us), thereby requiring us to obtain such raw materials and supplies from that particular source. We attempt, if possible, to mitigate our raw material supply risks, through inventory management and alternative sourcing strategies. For further discussion of sourcing, see “—Manufacturing and Quality Assurance” below and discussions of particular products.


Manufacturing and Quality Assurance


To meet all expected product demand, we operate and manage our manufacturing network, including our third-party contract manufacturers, and the inventory related thereto, in a manner that permits us to improve efficiency while maintaining flexibility to reallocate manufacturing capacity. Pharmaceutical production processes are complex, highly regulated and vary widely from product to product. Given that shifting or adding manufacturing capacity can be a lengthy process requiring significant capital and out-of-pocketother expenditures as well as regulatory approvals, we maintain and operate our flexible manufacturing network, consisting of internal and external resources that minimize unnecessary product transfers and inefficient uses of manufacturing capacity. For further discussion of the regulatory impact on our manufacturing, see “—Government Regulation and Price Constraints” above.


Our pharmaceutical manufacturing facilities are located in the U.S., Puerto Rico, France, Italy, Ireland, Japan, Mexico and China and require significant ongoing capital investment for both maintenance and compliance with increasing regulatory requirements. In addition, as our product line changes over the next several years, we expect to continue modification of our existing manufacturing network to meet complex processing standards that may be required for newly introduced products, including biologics. Biologics manufacturing involves more complex processes than those of traditional pharmaceutical operations. In February 2007, we purchased an 89-acre site to locateThe FDA approved our large scale multi-product bulk biologics manufacturing facility in Devens, Massachusetts. Construction of the Devens, Massachusetts facility began in early 2007 and was substantially completed in 2010. We submitted the site for regulatory approval in earlyMay 2012 and we expect the FDAcontinue to complete a review of our application by the end of the year.

make capital investments in this facility.


We rely on third parties to manufacture or supply us with certainall or a portion of the active ingredients necessary for us to manufacture various products, including PLAVIX*, BARACLUDE, AVALIDE*, REYATAZ, ABILIFY*, ERBITUX*Baraclude, the SUSTIVASustiva Franchise, ORENCIA, YERVOY, ONGLYZAErbitux*, Yervoy, Reyataz, Abilify*, Kombiglyze, Orencia, Eliquis, Avalide* and KOMBIGLYZE. ToPlavix*. Beginning February 1, 2014, following the sale of our diabetes business to AstraZeneca, AstraZeneca assumed manufacturing responsibilities for Bydureon* and Byetta*.To maintain a stable supply of these products, we take a variety of actions including inventory management and maintenance of additional quantities of materials, when possible, designed to provide for a reasonable level of these ingredients to be held by the third-party supplier, us or both, so that our manufacturing operations are not interrupted. As an additional protection, in some cases, we take steps to maintain an approved back-up source where available. For example, we will rely on the capacity of our Devens, Massachusetts facility and the capacity available at our third-party contract manufacturers to manufacture ORENCIA.

Orencia.


If we or any third-party manufacturer that we rely on for existing or future products is unable to maintain a stable supply of products, operate at sufficient capacity to meet our order requirements, comply with government regulations for manufacturing pharmaceuticals or meet the complex processing requirements for biologics, our business performance and prospects could be negatively impacted. Additionally, if we or any of our third-party suppliers were to experience extended plant shutdowns or substantial unplanned increases in demand or suspension of manufacturing for regulatory reasons, we could experience an interruption in supply of certain products or product shortages until production could be resumed or expanded.


In connection with divestitures, licensing arrangements or distribution agreements of certain of our products, or in certain other circumstances, we have entered into agreements under which we have agreed to supply such products to third parties. In addition to liabilities that could arise from our failure to supply such products under the agreements, these arrangements could require us to invest in facilities for the production of non-strategic products, result in additional regulatory filings and obligations or cause an interruption in the manufacturing of our own products.

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Our success depends in great measure upon customer confidence in the quality of our products and in the integrity of the data that support their safety and effectiveness. Product quality arises from a total commitment to quality in all parts of our operations, including research and development, purchasing, facilities planning, manufacturing, and distribution. We maintain quality-assurance procedures relating to the quality and integrity of technical information and production processes.


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Control of production processes involves detailed specifications for ingredients, equipment and facilities, manufacturing methods, processes, packaging materials and labeling. We perform tests at various stages of production processes and on the final product to ensure that the product meets regulatory requirements and our standards. These tests may involve chemical and physical chemical analyses, microbiological testing, or a combination of these along with other analyses. Quality control is provided by business unit/site quality assurance groups that monitor existing manufacturing procedures and systems used by us, our subsidiaries and third-party suppliers.


Environmental Regulation


Our facilities and operations are subject to extensive U.S. and foreign laws and regulations relating to environmental protection and human health and safety, including those governing discharges of pollutants into the air and water; the use, management and disposal of hazardous, radioactive and biological materials and wastes; and the cleanup of contamination. Pollution controls and permits are required for many of our operations, and these permits are subject to modification, renewal or revocation by the issuing authorities.


Our environment, health and safety group monitors our operations around the world, providing us with an overview of regulatory requirements and overseeing the implementation of our standards for compliance. We also incur operating and capital costs for such matters on an ongoing basis. We expended approximately $19 million in 2013, $21 million in 2012 and $16 million in 2011 $15 million in 2010 and $34 million in 2009 on capital projects undertaken specifically to meet environmental requirements. In addition, we invested in projects that reduce resource use of energy and water. Although we believe that we are in substantial compliance with applicable environmental, health and safety requirements and the permits required for our operations, we nevertheless could incur additional costs, including civil or criminal fines or penalties, clean-up costs, or third-party claims for property damage or personal injury, for violations or liabilities under these laws.


Many of our current and former facilities have been in operation for many years, and over time, we and other operators of those facilities have generated, used, stored or disposed of substances or wastes that are considered hazardous under Federal, state and/or foreign environmental laws, including the U.S. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). As a result, the soil and groundwater at or under certain of these facilities is or may be contaminated, and we may be required to make significant expenditures to investigate, control and remediate such contamination, and in some cases to provide compensation and/or restoration for damages to natural resources. Currently, we are involved in investigation and remediation at 1416 current or former facilities. We have also been identified as a “potentially responsible party” (PRP) under applicable laws for environmental conditions at approximately 2423 former waste disposal or reprocessing facilities operated by third parties at which investigation and/or remediation activities are ongoing.


We may face liability under CERCLA and other Federal, state and foreign laws for the entire cost of investigation or remediation of contaminated sites, or for natural resource damages, regardless of fault or ownership at the time of the disposal or release. In addition, at certain sites we bear remediation responsibility pursuant to contractual obligations. Generally, at third-party operator sites involving multiple PRPs, liability has been or is expected to be apportioned based on the nature and amount of hazardous substances disposed of by each party at the site and the number of financially viable PRPs. For additional information about these matters, see “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies.”


Employees

Employees

As of December 31, 2011,2013, we employed approximately 27,00028,000 people.

This includes approximately 4,000 employees that are in the process of being transferred to AstraZeneca as part of the sale of the diabetes business in February 2014. See “Item 8. Financial Statements—Note 5. Assets Held-For-Sale” for further discussion.


Foreign Operations


We have significant operations outside the U.S. They are conducted both through our subsidiaries and through distributors.


For a geographic breakdown of net sales,total revenues, see the table captioned Geographic Areas in “Item 8. Financial Statements—Note 2. Business Segment Information” and for further discussion of our net salestotal revenues by geographic area see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Net Sales.Total Revenues.


International operations are subject to certain risks, which are inherent in conducting business abroad, including, but not limited to, currency fluctuations, possible nationalization or expropriation, price and exchange controls, counterfeit products, limitations on foreign participation in local enterprises and other restrictive governmental actions. Our international businesses are also subject to government-imposed constraints, including laws on pricing or reimbursement for use of products.

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Depending on the direction of change relative to the U.S. dollar, foreign currency values can increase or decrease the reported dollar value of our net assets and results of operations. The change in foreign exchange rates had a net favorableunfavorable impact on the growth rate of revenues in 2011.2013. While we cannot predict with certainty future changes in foreign exchange rates or the effect they will have on it,the

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growth rate of revenues, we attempt to mitigate their impact through operational means and by using various financial instruments. See the discussions under “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” and “Item 8. Financial Statements—Note 10. Financial Instruments.Instruments and Fair Value Measurements.


Bristol-Myers Squibb Website


Our internet website address iswww.bms.com. On our website, we make available, free of charge, our annual, quarterly and current reports, including amendments to such reports, as soon as reasonably practicable after we electronically file such material with, or furnishes such material to, the U.S. Securities and Exchange Commission (SEC).


Information relating to corporate governance at Bristol-Myers Squibb, including our Standards of Business Conduct and Ethics, Code of Ethics for Senior Financial Officers, Code of Business Conduct and Ethics for Directors, (collectively, the “Codes”), Corporate Governance Guidelines, and information concerning our Executive Committee, Board of Directors, including Board Committees and Committee charters, and transactions in Bristol-Myers Squibb securities by directors and executive officers, is available on our website under the “Investors—Corporate Governance” caption and in print to any stockholder upon request. Any waivers to the Codes by directors or executive officers and any material amendment to the Code of Business Conduct and Ethics for Directors and Code of Ethics for Senior Financial Officers will be posted promptly on our website. Information relating to stockholder services, including our Dividend Reinvestment Plan and direct deposit of dividends, is available on our website under the “Investors—Stockholder Services” caption.

In addition, information about our Sustainability programs is available on our website under the "Responsibility" caption.


We incorporate by reference certain information from parts of our proxy statement for the 20122013 Annual Meeting of Stockholders. The SEC allows us to disclose important information by referring to it in that manner. Please refer to such information. Our proxy statement for the 20122014 Annual Meeting of Stockholders and 20112013 Annual Report will be available on our website under the “Investors—SEC Filings” caption on or about March 21, 2012.

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19, 2014.
Item 1A.RISK FACTORS.


Any of the factors described below could significantly and negatively affect our business, prospects, financial condition, operating results, or credit ratings, which could cause the trading price of our common stock to decline. Additional risks and uncertainties not presently known to us, or risks that we currently consider immaterial, may also impair our operations.

operations or financial condition.


We face intense competition from other pharmaceutical manufacturers, including for both innovative medicines and lower-priced generic products.

BMS is dependent on the uptake and market expansion for marketed brands, new indications and product extensions, as well as co-promotional activities with alliance partners, to deliver future growth. Competition, including lower-priced generic versions of our products, is a major challenge both within the U.S. and internationally. We are facingface patent expirations and increasingly aggressive generic competition. Such competitionCompetition may include (i) new products developed by competitors that have lower prices, real or perceived superior performanceefficacy (benefit) or safety features,(risk) profiles, or that are otherwise competitive with our products; (ii) technological advances and patents attained by our competitors; (iii) earlier-than-expected competition from generic companies; (iv) clinical study results related tofrom our products or a competitor’s products; and (v)(iv) business combinations among our competitors and major customers.customers; and (v) competing interests for external partnerships to develop and bring new products to markets. We could also could experience limited or no market access due to real or perceived differences in value propositions offor our products compared with competing products.

We depend on certain key products for most of our net sales, cash flows and earnings and U.S. market exclusivity for PLAVIX* and AVAPRO*/AVALIDE* in the U.S. is expected to expire in May 2012 and March 2012, respectively.

We derive a majority of our revenue and earnings from a few key products. In 2011, net sales of PLAVIX* were approximately $7.1 billion, representing approximately 33% of total net sales. Net sales of ABILIFY* were approximately $2.8 billion, representing approximately 13% of total net sales. Three other products (REYATAZ, the SUSTIVA Franchise and BARACLUDE) each were more than $1 billion in net sales. A reduction in net sales of one or more of these or other key products could significantly negatively impact our net sales, cash flows and earnings.

PLAVIX* is our top-selling product. In 2011, U.S. net sales were approximately $6.6 billion. We expect that when PLAVIX* loses U.S. exclusivity in May 2012, there will be a rapid, precipitous and material decline in PLAVIX* net sales and a reduction in net income and operating cash flow. AVAPRO*/AVALIDE*, which had 2011 U.S. net sales of $521 million, loses U.S. patent protection in March 2012, after which we expect to experience a precipitous decline in AVAPRO*/AVALIDE* net sales. If we are unable to support and grow our currently marketed products, successfully launch newly approved products, advance our late-stage pipeline and manage our costs effectively, the loss of exclusivity for PLAVIX* and AVAPRO*/AVALIDE* could have a material negative impact on our results of operations, cash flows and financial condition.

competitors.


It is possible that we may lose market exclusivity of a product earlier than expected.

In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is usually realized during the period in which it has market exclusivity. In the U.S. and in some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there are usually very substantial and rapid declines in thea product’s sales. The rate of this decline varies by country and by therapeutic category.

revenues.


Market exclusivity for our products is based upon patent rights and/or certain regulatory forms of exclusivity. The scope of our patent rights may varyvaries from country to country and may also be dependent on the availability of meaningful legal remedies in thata country. The failure to obtain patent and other intellectual property rights, or limitations on the use or loss of such rights, could be material to us. In some countries, including in certain EU member states, basic patent protectionprotections for our products may not exist because certain countries did not historically offer the right to obtain certainspecific types of patents and/or we (or our licensors) did not file in those markets. In addition, the patent environment can be unpredictable and the validity and enforceability of patents cannot be predicted with certainty. Absent relevant patent protection for a product, once the data exclusivity period expires, generic versions of thea product can be approved and marketed, such as generic clopidogrel bisulfate in certain EU markets.marketed. In addition, prior to the expiration of data exclusivity, a competitor could seek regulatory approval by submitting its own clinical trial data to obtain marketing approval.


Manufacturers of generic products are also increasingly seeking to challenge patents before they expire. Key patentsexpire, and we could face earlier-than-expected competition from generic companies for any of our products at any time. Patents covering fourtwo of our key products (ABILIFY*, ATRIPLA*, BARACLUDE,(Sustiva and SPRYCEL)Baraclude) are currently the subject of patent litigation. In some cases, generic manufacturers may choose to launch a generic product “at

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“at risk” before the expiration of the applicable patent(s) and/or before the final resolution of related patent litigation. The lengthFor example, we may face generic competition forBaraclude in the U.S. at any time following a federal court’s decision to invalidate the composition of market exclusivity for any of our productsmatter patent in February 2013. There is difficult to predict with certainty and therefore there can be no assurance that a particular product will enjoy market exclusivity for the full period of time that appears in the estimates disclosed in this Form 10-K. For example, we unexpectedly lost exclusivity for PLAVIX* in Canada in 2011.In addition, some countries, such as India, are allowing competitors to manufacture and sell generic versions of branded products, known as compulsory licensing, which negatively impact the protections afforded the Company.

We face increased


Increased pricing pressure and other restrictions in the U.S. and abroad from managed care organizations, institutional purchasers, and government agencies and programs thatprogram, among others, could negatively affect our net salesrevenues and profit margins.

Pharmaceutical

Our products continue to be subject to increasing price pressures across the portfolio relating to market access, pricing and rebates and other restrictions in the U.S., the EU and other regions around the world, including but not limited to: (i) rules and practices of managed care organizations and institutional and governmental purchasers,purchasers; (ii) judicial decisions and governmental laws and regulations related tofor Medicare, Medicaid and U.S. healthcare reform, including the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the2010 Patient Protection and Affordable Care Act,Act; (iii) the potential impact of importation restrictions, legislative and/or regulatory changes, pharmaceutical reimbursement, Medicare

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Part D Formularies and product pricing in general,general; (iv) delays in gaining reimbursement and/or reductionsreimbursement; (v) government price erosion mechanisms across Europe and in reimbursement amountsother countries, resulting in countries withdeflation for pharmaceutical product pricing; (vi) collection delays in government mandated, cost-containment programs (e.g., major European markets, Japan and Canada), (v)funded public hospitals (vii) the impact on pricing from parallel trade across borders; (viii) other developments in technology and/or industry practices that could directly or indirectly impact the reimbursement policies and practices of third-party payers,payers; and (vi)(ix) limited or no market access due to real or perceived differences in value propositions offor our products compared to competing products.

Our business


We may experience difficulties or delays in the development and resultscommercialization of operationsnew products.
Developing and commercializing new products includes inherent risks and uncertainties, such as (i) compounds or products may appear promising in development but fail to reach market within the expected or optimal timeframe, or fail ever to reach market or be approved for product extensions or additional indications, including due to efficacy or safety concerns, the delay or denial of regulatory approvals, delays or difficulties with producing products at a commercial scale or excessive costs to manufacture them; (ii) failure to enter into or successfully implement optimal alliances for the development and/or commercialization of new products; (iii) failure to maintain a consistent scope and variety of promising late-stage products; (iv) failure of one or more of our products to achieve or maintain commercial viability; and (v) changes in regulatory approval processes that may cause delays or denials of new product approvals. We have observed a recent trend by the U.S. Food & Drug Administration (FDA) to delay its approval decision on a new product beyond its announced action date by six months or longer.

Regulatory approval delays are especially common when a product is expected to have a Risk Evaluation and Mitigation Strategy, as required by the FDA to address significant risk/benefit issues. The inability to bring a product to market or a significant delay in the expected approval and related launch date of a new product could negatively impact our revenues and earnings and, if the product was obtained through acquisition, it could result in a significant impairment of in-process research and development or other intangible assets. Further, if certain acquired pipeline programs are cancelled or if we believe that their commercial prospects have been affected,reduced, we may recognize material non-cash impairment charges for those programs. Finally, a natural or man-made disaster or sabotage of research and development labs, our compound library and/or a loss of key molecules and intermediaries could negatively impact the product development cycle.

Failure to execute our business strategy could adversely impact our growth and profitability.
We are a biopharmaceutical company with a focus on innovative products for significant unmet medical needs in oncology, virology, immunology and specialty cardiovascular disease. We may not be able to consistently maintain a rich pipeline, through internal research and development or transactions with third parties, to support future revenue growth. The competition among major pharmaceutical companies for acquisition and product licensing opportunities is intense, and we may not be able to locate suitable acquisition targets or licensing partners at reasonable prices, or successfully execute such transactions. We also may not be able to successfully realize the expected efficiencies and effectiveness from changes in our structure or operations to further our specialty care strategy, including the recent reorganizations of our research and development organization and our commercial operations as well as the evolution of support functions under our Enterprises Services organization, or from ongoing continuous improvement initiatives. In addition, realizing synergies and other expected benefits from acquisitions, divestitures, mergers, alliances, restructuring or other strategic initiatives, may take longer than expected to complete or may encounter other difficulties, including the need for regulatory approvals where applicable. If we are unable to support and grow our currently marketed products, successfully execute the launches of newly approved products, advance our late-stage pipeline, manage change and transformational issues, and manage our costs effectively, our operating results and financial condition could be negatively impacted. In addition, our failure to hire and retain personnel with the right expertise and experience in critical operations could adversely impact the execution of our business strategy.


26



The public announcement of data from clinical studies or news of any developments related to our late-stage immuno-oncology compounds is likely to cause significant volatility in our stock price. If the development of any of our key immuno-oncology compounds, whether alone or as part of a combination therapy, is delayed or discontinued, our stock price could decline significantly.
As we are evolving to a specialty care biopharmaceutical company, we are focusing more of our efforts and resources in certain disease areas such as oncology, virology, immunology, and specialty cardiovascular disease. With our more focused portfolio, investors are placing heightened scrutiny on some of our late-stage compounds. In particular, nivolumab is an important asset in our immuno-oncology portfolio. During 2014, we expect to receive a significant amount of data from clinical trials evaluating nivolumab, a fully human monoclonal antibody being investigated as an anticancer treatment in non-small-lung cancer, renal cell cancer, and melanoma, along with other tumor types, alone or in combination with other approved cancer products such as Yervoy.

The announcement of data from our clinical studies or news of any developments related to our late-stage immuno-oncology compounds, such as nivolumab, is likely to cause significant volatility in our stock price. Furthermore, the announcement of any negative or unexpected data or the discontinuation of development of any of our key immuno-oncology compounds, whether alone or as part of a combination therapy, or any delay in our anticipated timelines for filing for regulatory approval will likely cause our stock price to decline significantly. There is no assurance that data from our clinical studies will support a filing for regulatory approval or even if approved, that any of our key immuno-oncology compounds will become commercially successful.

The businesses we acquire may underperform, and we may not be able to successfully integrate them into our existing business.
We may continue to be affected, by U.S. healthcare reform legislation in the U.S.

As described under “Item 7. Management’s Discussionsupport our pipeline with compounds or products obtained through licensing and Analysisacquisitions. Future revenues, profits and cash flows of Financial Conditionan acquired company’s products, technologies and Results of Operations—Executive Summary—Business Environment”, the Patient Protection and Affordable Care Act (HR 3590) and a reconciliation bill containing a package of changes to the healthcare bill were signed into law during March 2010. These bills included provisions that reduced our net sales and increased costspipeline candidates, may not materialize due to lower product uptake, delayed or missed pipeline opportunities, the inability to capture expected synergies, increased Medicaid rebate, expanded Medicaid program, additional prescription drug discounts to certain patients under Medicare Part D and a non-tax-deductible annual fee to pharmaceutical companies, amongcompetition, safety concerns, regulatory issues, supply chain problems or other things. We continue to experience significant financialfactors beyond our control. Substantial difficulties, costs and delays could result from integrating our acquisitions including for (i) research & development, manufacturing, distribution, sales, marketing, promotion and information technology activities; (ii) policies, procedures, processes, controls and compliance; (iii) company cultures; (iv) compensation structures and other human resource activities; and (v) tax considerations.


We depend on certain other changeskey products for most of our revenues, cash flows and earnings.
We have historically derived a majority of our revenue and earnings from several key products and while we are not as heavily dependent on one or two products as in past years, our dependence on the profitability of our key products is likely to our business from the implementationcontinue. In 2013, Abilify* revenues of the 2010 U.S. healthcare reform law. The annual EPS impact from U.S. healthcare reform increased from $0.10 in 2010 to $0.24 in 2011. The incremental $0.14 impact was associated with the Medicare Part D coverage gap$2.3 billion represented 14% of revenues. Reyataz and the annual pharmaceutical company fee. The 2010Sustiva franchise, with combined revenues of $3.2 billion, represented 9% and 10% of revenues, respectively. Baraclude, Orencia, and Sprycel revenues totaled $1.5 billion, $1.4 billion and $1.3 billion, respectively. A reduction in revenues of one or more of these products could significantly negatively impact our revenues, cash flows and earnings.

Changes in U.S. healthcare reform law also created a regulatory mechanism that allows for approval of biologic drugs that are similar to (but not generic copies of) innovative drugs on the basis of less extensive data than is the basis for a full BLA.

U.S. andor foreign laws and regulations may negatively affect our net salesrevenues and profit margins.

We could become subject to new government laws and regulations, which could negatively affect our business, our operating results and the financial condition of our Company, such as (i) additional healthcare reform initiatives in the U.S. at the Federal and state level andor in other countries, including additional mandatory discounts; (ii) changesincreasing tax revenues in the U.S. FDA and foreign regulatory approval processes that may cause delays in approving, or preventing the approval of, new products; (iii) changes in corporateother countries as a means to reduce debt by changing tax regulation, including as part of the proposed U.S. budget deficit reduction package, which could includerates; limiting, foreignphasing-out or eliminating deductions or tax credits,credits; modifying tax collection processes; taxing certain tax havens,havens; taxing certain excess income from transferring intellectual property, limiting or disallowing certain U.S. deductions for operating and interest expenses,property; changing rules for earnings repatriationsrepatriations; and eliminating certainchanging other tax credits, as well as changing the tax rate or phasing out currently available tax benefits in the U.S. and in certain foreign countries or other changes in tax law; (iv)laws; (iii) new laws, regulations and judicial or other governmental decisions affecting pricing, drug reimbursement, receivable repayment,payments, and access or marketing within or across jurisdictions; (v)(iv) changes in intellectual property law; (v) changes in accounting standards; (vi) increasing data privacy regulations and (vi)enforcement; (vii) emerging and new regulatory requirements for reporting payments and other matters, such as compulsory licenses that could alter the protections affordedvalue transfers to one or more of our products. Any legal or regulatory changes could negatively affect our business, our operating results and the financial condition of our company. Emerging legislation to reducehealthcare professionals, including for the U.S. Federal budget deficit, if enacted, will further reduce our operating results.

Changes toNational Physician Payment Transparency Program, and (viii) the productpotential impact of importation restrictions, legislative and/or other regulatory changes.


Product labeling changes for any of our marketed products could result in unexpected safety or results from certain studies released after a product is approved could potentiallyefficacy concerns and have a negative impact on that product’s sales.

Therevenues.

Regulatory authorities can change the labeling for any pharmaceutical product can be changed by the regulatory authorities at any time, including after thea product has been on the marketmarketed for several years. These changes are often the result of additional data from post-marketing studies, head-to-head trials, reporting of adverse events from patients or healthcare professionals,reports, studies that identify biomarkers (objective characteristics that can indicate a particular response to a product or therapy), or other studies that produce important additional information about a product. The newNew information added to a product’s label can affect the safety (risk) and/or the efficacy (benefit) profile of the product.a product, leading to potential product recalls, withdrawals, or declining revenue, as well as product liability claims. Sometimes the additional information from these studies identifies a portion of the patient population that may be non-responsive to a medicine. Labelingmedicine and labeling changes based on such studies may limit the patient population, such as the changes to the labeling for PLAVIX* and ERBITUX* a few years ago.population. The studies providing such additional information may be sponsored by us, but they can also be sponsored by our competitors, insurance companies, government institutions, managed care organizations, influential scientists, investigators, or other interested parties. While additional safety and efficacy information from thesesuch studies assist us and healthcare providers in identifying the best patient population for each of our products, it can also have negatively impact our revenues for a negative impact on sales for any such product due to the extent that theproduct returns and a more limited patient population or product labeling becomes more limited. going forward.

27



Additionally, certain study results, especially from head-to-head trials, could affect a product’s formulary listing, which could also adversely affect sales.

revenues.


We maycould experience difficulties and delays in the manufacturing, distribution and sale of our products.

We may experience difficulties

Our product supply and delays inherent in the manufacturing, distribution and sale of our products, such asrelated patient access could be negatively impacted by, among other things: (i) seizure or recalls of products or forced closings of manufacturing plants; (ii) supply chain continuity including as a result of afrom natural or man-made disasterdisasters at one of our facilities or at a critical supplier, or vendor as well as our failure or the failure of any of our vendors or suppliers to comply with Current Good Manufacturing Practices and other applicable regulations andor quality assurance guidelines that could lead to manufacturing shutdowns, product shortages and delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays due to our consolidation and rationalization of manufacturing facilities and the sale or closure of certain sites;delays; (iv) the failure of a sole source or single source supplier to provide us with necessary raw materials, supplies or finished goods for an extended period of time that could impact continuous supply;time; (v) the failure of a third-party manufacturer to supply us with finished product on time; (vi) construction or regulatory approval delays related tofor new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics products; (vii) the failure to meet new and (vii)emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; and (viii) other manufacturing or distribution problemsissues, including limits to manufacturing capacity due to regulatory requirements;requirements, and changes in the types of products produced, such as biologics; physical limitations or other business interruptions that could impact continuous supply.

26


We may experience difficulties or delaysinterruptions.


Adverse outcomes in the development and commercialization of new products.

We may experience difficulties and delays in the development and commercialization of new products, including the inherent risks and uncertainties in developing products, such as (i) compounds or products that may appear promising in development but fail to reach market within the expected or optimal timeframe, or fail ever to reach market, or to be approved for product extensions or additional indications for any number of reasons, including efficacy or safety concerns, the delay or denial of necessary regulatory approvals, delays or difficulties with producing products at a commercial scale level or excessive costs to manufacture products; (ii) failure to enter into or successfully implement optimal alliances, where applicable, for the development and/or commercialization of products; (iii) failure to maintain a consistent scope and variety of promising late-stage products; or (iv) failure of one or more of our products to achieve or maintain commercial viability. In addition, we have observed a recent trend by the U.S. FDA to delay its approval decision on a new product beyond its announced action date, sometimes by as much as six months or longer. Regulatory approval delays are especially common when the product is expected to have a Risk Evaluation and Mitigation Strategy to address significant risk/benefit issues. The inability to bring a product to market or a significant delay in the expected approval and related launch date of a new product could potentially have a negative impact on our net sales and earnings and could result in a significant impairment of in-process research and development or other intangible assets. In January 2012, BMS and our collaboration partner, AstraZeneca, received a complete response letter regarding our NDA for dapagliflozin. The complete response letter requests additional data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials. Finally, a natural or man-made disaster or sabotage of research and development labs, our compound library and/or a loss of key molecules and intermediaries could negatively impact the product development cycle.

There are legal matters in which adverse outcomes could negatively affect our business.

We are currently involved in

Current or could in the future become involved in various lawsuits, claims, proceedings and government investigations any of which could preclude or delay the commercialization of our products or could adversely affect our operations, profitability, liquidity or financial condition, after any possible insurance recoveries, where available. Such legal matters include (i) intellectual property disputes; (ii) sales and marketing practices in the U.S. and internationally; (iii) adverse decisions in litigation, including product liability and commercial cases; (iii) antibribery regulations such as the U.S. Foreign Corrupt Practice Act or UK Anti-Bribery Act, (iv) recalls or withdrawals of pharmaceutical products or forced closings of manufacturing plants; (v) the failure to fulfill obligations under supply contracts with the government and other customers which may result in liability;customers; (vi) product pricing and promotional matters; (vii) lawsuits and claims asserting, or investigations into, violations of securities, antitrust, federalFederal and state pricing, consumer protection, antibribery (such as the U.S. Foreign Corrupt Practice Act or UK Anti-Bribery Act)data privacy and other laws; (viii) environmental, health and safety matters; and (ix)(iv) tax liabilities. There can be no assurance that there will not be an increase in scope in any or all of these matters or that there will not be additional lawsuits, claims, proceedings or investigations in the future; nor is there any assurance that any or all of these matters will not have a material adverse impact on us.


We relydepend on third parties to meet their contractual, regulatory, and other obligations.

We rely on suppliers, vendors, andoutsourcing partners, including alliances with other pharmaceutical companies for the manufacturing, development and commercialization of products,alliance partners and other third parties to research, develop, manufacture, commercialize, co-promote and sell our products; manage certain marketing, selling, human resource, finance, information technology and other business unit and functional services; and meet their contractual, regulatory, and other obligations in relation to their arrangements with us. Some of these third-party providers are located in markets that are subject to political and social risk, corruption, infrastructure problems and natural disasters in addition to country specific privacy and data security risks given current legal and regulatory environments. The failure of any critical third party to meet its obligations, including for future royalty and milestone payments; adequately deploy business continuity plans in the event of a crisis; and/or the development ofsatisfactorily resolve significant disagreements with us or address other factors, that materially disrupt the ongoing commercial relationship and prevent optimal alignment between the third parties and their activities, could have a material adverse impact on us.the Company’s operations and results. In addition, if these third parties violate or are alleged to have violated any laws or regulations, including the local pharmaceutical code, U.S. Foreign Corrupt Practice Act, U.K. Bribery Act and other similar laws and regulations, during the performance of their obligations for us, it is possible that we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences.

We are dependent on our outsourcing arrangements.

We are dependent on third-party providers for certain outsourced services, including certain research and development capabilities, certain financial outsourcing arrangements, certain human resource functions, and information technology activities and systems. Many of these third-party providers are located in markets that are subject to political risk, corruption, infrastructure problems and natural disasters in addition to country specific privacy and data security risks given current legal and regulatory environments. The failure of these service providers to meet their obligations, adequately deploy business continuity plans in the event of a crisis and/or the development of significant disagreements, natural or man-made disasters or other factors that materially disrupt our ongoing relationship with these providers could negatively affect operations.

Failure to execute our business strategy could adversely impact our growth and profitability.

Over the last several years, we have transformed from a diversified pharmaceutical and related healthcare products company into a biopharmaceutical company with a focus on innovative products in areas of high unmet medical need. We are focused on sustaining our business and building a foundation for the future after PLAVIX*, our largest selling product, loses exclusivity in the U.S. in May 2012. We plan to achieve this foundation by continuing to support and grow our currently marketed products, advancing our late-stage pipeline, managing our costs, and maintaining and improving our financial strength with a strong balance sheet and cash

27


position. There are risks associated with this strategy. We may not be able to consistently replenish our innovative pipeline, through internal research and development or transactions with third parties. The competition among major pharmaceutical companies for acquisition and product licensing opportunities has become more intense, eliminating some opportunities and making others more expensive. We may not be able to locate suitable acquisition targets or licensing partners at reasonable prices or successfully execute such transactions. Additionally, changes in our structure, operations, revenues, costs, or efficiency resulting from major transactions such as acquisitions, divestitures, mergers, alliances, restructurings or other strategic initiatives, may result in greater than expected costs, may take longer than expected to complete or may encounter other difficulties, including the need for regulatory approval where appropriate. The inability to expand our product portfolio with new products or maintain a competitive cost basis could materially and adversely affect our future results of operations. If we are unable to support and grow our currently marketed products, successfully execute the launches of newly approved products, advance our late-stage pipeline and manage our costs effectively, we could experience a significant or material negative impact on our results of operations and financial condition. In addition, our failure to hire and retain personnel with the right expertise and experience in operations that are critical to our business functions could adversely impact the execution of our business strategy.


We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including cybersecurityfrom cyber security and data leakage risks.

We are increasingly dependent on information technology systems and infrastructure. Anyleakage.

A significant breakdown, invasion, corruption, destruction or interruption of thesecritical information technology systems or infrastructure, by employees,our workforce, others with authorized access to our systems, or unauthorized persons could negatively impact operations. There isThe ever-increasing use and evolution of technology, including cloud-based computing, creates opportunities for the unintentional dissemination, intentional destruction of confidential information stored in our systems or in non-encrypted portable media or storage devices. We could also a risk that we could experience a business interruption, information theft of confidential information, or reputational damage as a result of afrom industrial espionage attacks, malware or other cyber attack, such as an infiltration of aattacks, which may compromise our system infrastructure or lead to data center, or data leakage, of confidential information either internally or at our third-party providers. WhileAlthough the aggregate impact on our operations and financial condition has not been material to date, we have been the target of events of this nature and expect them to continue. We have invested heavily in the protectionindustry appropriate protections and monitoring practices of our data and information technology to reduce these risks thereand continue to monitor our systems on an ongoing basis for any current or potential threats. There can be no assurance, however, that our efforts will prevent breakdowns or breaches into our or our third party providers’ databases or systems that could adversely affect our business.

The expansion of social


Social media platforms presents newpresent risks and challenges.

The inappropriate and/or unauthorized use of certain media vehicles could cause brand damage or information leakage or could lead to legal implications, including from the improper collection and/or dissemination of personally identifiable information. In addition, negative or inaccurate posts or comments about us on any social networking web site could seriously damage our reputation.reputation, brand image and goodwill. Further, the disclosure of non-public company sensitiveCompany-sensitive information by our workforce or others through external media

28



channels could lead to information loss, as there might not be structured processes in place to secure and protect information. Identifying new points of entry as social media continues to expand presents new challenges.


Adverse changes in U.S., global, regional or regionallocal economic conditions could haveadversely affect our profitability.
Global economic risks pose significant challenges to a continuing adverse effect oncompany’s growth and profitability and are difficult to mitigate. The world’s major economies hold historically-high debt levels while experiencing slow growth and high unemployment. Several risks lie ahead, including the profitabilitymanagement of some or all of our businesses.

High government debt burdens and continued high unemployment rates, rising prices, including those related to commodities and energy, and lower economic growth has adversely affected commercial activity in the U.S., debt level and the European sovereign debt crisis. We have significant operations in Europe, and other regions of the worldincluding for manufacturing. We have exposure to customer credit risks in which we do business. Further government austerity measures or declines in economic activityEurope, including from government-guaranteed hospital receivables in markets in which we do business could adversely affect demand and pricing for our products, thus reducing our revenues, earnings and cash flow, as well as have pass-through effectswhere payments are not received on us resulting from any significant financial instability from our customers, distributors, alliance partners, suppliers, critical vendors, service providers and counterparties to certain financial instruments, such as marketable securities and derivatives. Futuretime. In addition, future pension plan funding requirements continue to be sensitive to global economic conditions and the related impact on equity markets.

We are also exposed to other commercial risks and economic factors over which we have no control, which could pose significant challenges to our underlying profitability.


Changes in foreign currency exchange rates and interest rates could have a material adverse effect on our operating results of operations.

and liquidity.

We have significant operations outside of the U.S. Revenuesrevenues from operations outside of the U.S. accounted for approximately 35%49% of our revenues in 2011.2013. As such, we are exposed to fluctuations in foreign currency exchange rates.rates which can be difficult to mitigate. We are also have some borrowings which are exposed to changes in interest rates. We are also exposedOur ability to other economic factors over which we have no control.

access the money markets and/or capital markets could be impeded if adverse liquidity market conditions occur.


The illegal distribution and sale by third parties of counterfeit versions of our products or stolen products could have a negative impact on our reputation and business.

Third parties may illegally distribute and sell counterfeit versions of our products, which do not meet theour rigorous manufacturing and testing standards that our products undergo.standards. A patient who receives a counterfeit drug may be at risk for a number of dangerous health consequences. Our reputation and business could suffer harm as a result of counterfeit drugs sold under our brand name. In addition, thefts of inventory at warehouses, plants or while in-transit, which are then not properly stored and which are later sold through unauthorized channels, could adversely impact patient safety, our reputation and our business.

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Item 1B.UNRESOLVED STAFF COMMENTS.


None.


Item 2.PROPERTIES.

Our world headquarters are located at 345 Park Avenue, New York, NY, where we lease approximately 81,000 square feet of floor space. We own or lease approximately 185194 properties in 4449 countries.

We manufacture products at 12 worldwide locations, all of which are owned by us. Our manufacturing locations and aggregate square feet of floor space by geographic area were as follows at December 31, 2011:

   Number of
Locations
   Square Feet 

United States

   4    2,202,000 

Europe

   5    1,531,000 

Japan, Asia Pacific and Canada

   1    128,000 

Latin America, Middle East and Africa

   1    200,000 

Emerging Markets

   1    186,000 
  

 

 

   

 

 

 

Total

��  12    4,247,000 
  

 

 

   

 

 

 

2013:

  Number of Locations Square Feet
United States 5
 2,767,000
Europe 4
 1,531,000
Rest of the World 3
 514,000
Total 12
 4,812,000
Portions of these manufacturing locations and the other properties owned or leased by us in the U.S. and elsewhere are used for research and development, administration, storage and distribution. For further information about our properties, see “Item 1. Business—Manufacturing and Quality Assurance.

"
Item 3.LEGAL PROCEEDINGS.


Information pertaining to legal proceedings can be found in “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies” and is incorporated by reference herein.


Item 4.MINE SAFETY DISCLOSURES.

Not applicable.

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PART IA

Executive Officers of the Registrant

Listed below is information on our executive officers as of February 17, 2012.14, 2014. Executive officers are elected by the Board of Directors for an initial term, which continues until the first Board meeting following the next Annual Meeting of Stockholders, and thereafter, are elected for a one-year term or until their successors have been elected. All executive officers serve at the pleasure of the Board of Directors.

Name and Current Position

 

Age

 

Employment History for the Past 5 Years

Lamberto Andreotti

Chief Executive Officer and Director

Member of the Senior Management Team

 6163
 

2005 to 2007 – Executive Vice President and President, Worldwide Pharmaceuticals, a division of the Company. Pharmaceuticals.
2007 to 2008 – Executive Vice President and Chief Operating Officer, Worldwide Pharmaceuticals, a division of the Company.

Pharmaceuticals.

2008 to 2009 – Executive Vice President and Chief Operating Officer.

2009 to 2010 – President and Chief Operating Officer and Director of the Company.

2010 to present – Chief Executive Officer and Director of the Company.

Charles Bancroft

Executive Vice President and Chief Financial Officer

Member of the Senior Management Team

 5254
 

2005 to 2009 – Vice President, Finance, Worldwide Pharmaceuticals, a division of the Company.

Pharmaceuticals.

2010 to 2011 – Chief Financial Officer of the Company.

2011 to present – Executive Vice President and Chief Financial Officer of the Company.

Giovanni Caforio, M.D.

Executive Vice President U.S. Pharmaceuticals

and Chief Commercial Officer

Member of the Senior Management Team

 4749
 

2007 to 2009 – Senior Vice President, U.S. Oncology, Worldwide Pharmaceuticals, a division of the Company.

Oncology.

2009 to 2010 – Senior Vice President, Oncology, U.S. and Global Commercialization.

2011 to 2011 – Senior Vice President, Oncology and Immunoscience,Immunology, Global Commercialization.

2011 to 2013 – President, U.S. Pharmaceuticals
2013 to present – Executive Vice President U.S. Pharmaceuticals.

and Chief Commercial Officer

Joseph C. Caldarella

Senior Vice President and Corporate Controller

 5658
 

2005 to 2010 – Vice President and Corporate Controller.

2010 to present – Senior Vice President and Corporate Controller.

Beatrice Cazala

Francis Cuss, MB BChir, FRCP
Executive Vice President Commercial Operations

and Chief Scientific Officer

Member of the Senior Management Team

 5559
 

2004 to 2008 – President, EMEA, Worldwide Medicines International.

2008 to 2009 – President, EMEA and Asia Pacific, Worldwide Medicines International.

2009 to 2010 – President, Global Commercialization, and President, Europe.

2010 to 2011 – Senior Vice President, Commercial Operations, and President, Global Commercialization, Europe and Emerging Markets.

2011 to present – Executive Vice President, Commercial Operations.

John E. Celentano

Senior Vice President, Human Resources, Public

Affairs and Philanthropy

Member of the Senior Management Team

52

2005 to 2008 – President, Health Care Group, a division of the Company.

2008 to 2009 – Senior Vice President, Strategy and Productivity Transformation.

2009 to 2010 – President, Emerging Markets and Asia Pacific.

2010 to present – Senior Vice President, Human Resources, Public Affairs and Philanthropy.

30


Francis Cuss, MB BChir, FRCP

Senior Vice President, Research and Development

Member of the Senior Management Team

57

2006 to 2010 – Senior Vice President, Discovery and Exploratory Clinical Development.

Research.

2010 to present2013 – Senior Vice President, Research, ResearchResearch.
2013 to present – Executive Vice President and Development.

Chief Scientific Officer

Brian Daniels, M.D.

Senior Vice President, Global Development and

Medical Affairs,Research and Development

Member of the Senior Management Team

 

52

54

 

2004 to 2008 – Senior Vice President, Global Clinical Development, Research and Development, a division of the Company.

Development.

2008 to present – Senior Vice President, Global Development and Medical Affairs, Research and Development.

Affairs.

Sandra Leung

General Counsel

John E. Elicker
Senior Vice President, Public Affairs and Corporate Secretary

Investor Relations

Member of the Senior Management Team

 

51

54

 

2000 to 2002 – Senior Director, Investor Relations.
2002 to 2010 –Vice President, Investor Relations.
2010 to 2012 – Senior Vice President, Investor Relations.
2012 to present – Senior Vice President, Public Affairs and Investor Relations.
Frances Heller
Senior Vice President, Business Development
Member of the Senior Management Team
47
2003 to 2008 – Head, Strategic Alliances at Novartis Pharmaceuticals.
2008 to 2011 – Executive Vice President, Exelixis.
2011 to 2012 – Instructor, Stanford University.
2012 to present – Senior Vice President, Business Development.
Sandra Leung
General Counsel and Corporate Secretary
Member of the Senior Management Team
53
2006 to 2007 – Vice President, Corporate Secretary and Acting General Counsel.

2007 to present – General Counsel and Corporate Secretary.

Louis S. Schmukler

Samuel J. Moed
Senior Vice President, Technical Operations

Strategic Planning and Analysis

Member of the Senior Management Team

 

56

51

 

2005 to 2010 – Senior Vice President, Worldwide Strategy and Operations.
2010 to 2012 – Senior Vice President, Strategy.
2012 to present – Senior Vice President, Strategic Planning and Analysis.

30



Name and Current PositionAgeEmployment History for the Past 5 Years
Anne Nielsen
Senior Vice President and Chief Compliance and Ethics Officer
Member of the Senior Management Team
53
2001 to 2009 – Vice President and Senior Counsel
2009 to 2013 – Vice President and Associate General Counsel
2013 to 2013 – Senior Vice President and Deputy General Counsel
2013 to present – Senior Vice President and Chief Compliance and Ethics Officer
Louis S. Schmukler
President, Global Manufacturing and Supply
Member of the Senior Management Team
58
2007 to 2009 – Senior Vice President, Pharmaceutical Operating Unit, Wyeth.

Wyeth Pharmaceuticals, Inc.

2009 to 2011 – Senior Vice President, Specialty/Biotechnology Operating Unit, Pfizer.

2011 to present – President, Technical Operations.

Global Manufacturing and Supply.

Elliott Sigal, M.D., Ph.D.

Executive

Paul von Autenried
Senior Vice President, Enterprise Services and Chief ScientificInformation Officer and

President, Research and Development, and Director

Member of the Senior Management Team

 

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52

 

2006 to 2011 – Executive Vice President, Chief Scientific Officer and President, Research and Development.

2011 to present – Executive Vice President, Chief Scientific Officer and President, Research and Development, and Director of the Company.

Paul von Autenried

Senior Vice President and Chief Information Officer

Member of the Senior Management Team

50

2007 to 2011 – Vice President and Chief Information Officer.

2011 to present2012 – Senior Vice President and Chief Information Officer.

2012 to present – Senior Vice President, Enterprise Services and Chief Information Officer.


31




PART II


Item 5.MARKET FOR THE REGISTRANT’S COMMON STOCK AND OTHER STOCKHOLDER MATTERS.

Market Prices

Bristol-Myers Squibb common and preferred stocks arestock is traded on the New York Stock Exchange (NYSE) (Symbol: BMY). A quarterly summary of the high and low market prices is presented below:

   2011   2010 
   High   Low   High   Low 

Common:

        

First Quarter

  $27.29   $24.97   $27.00   $23.89 

Second Quarter

   29.33    26.46    26.95    22.44 

Third Quarter

   31.49    26.38    27.93    24.65 

Fourth Quarter

   35.29    30.15    27.51    25.24 

Preferred:

        

First Quarter

  $*      $*      $501.00   $432.01 

Second Quarter

       570.10        570.10        525.04        400.00 

Third Quarter

   *       *       *       *    

Fourth Quarter

   *       *       570.00    570.00 

*During the first, third and fourth quarters of 2011 and during the third quarter of 2010, there were no observable trades of the Company’s preferred stock.

  2013 2012
  High Low High Low
Common:        
First Quarter $41.19
 $32.71
 $35.01
 $31.85
Second Quarter 47.68
 39.68
 35.95
 32.47
Third Quarter 47.53
 41.32
 36.15
 31.57
Fourth Quarter 53.84
 46.41
 34.38
 30.81

Holders of Common Stock


The number of record holders of common stock at December 31, 20112013 was 56,874.

51,115.

The number of record holders is based upon the actual number of holders registered on our books at such date and does not include holders of shares in “street names” or persons, partnerships, associations, corporations or other entities identified in security position listings maintained by depository trust companies.

Dividends

Our Board of Directors declared the following dividends per share, which were paid in 20112013 and 20102012 in the quarters indicated below:

   Common   Preferred 
   2011   2010   2011   2010 

First Quarter

  $0.33   $0.32   $0.50   $0.50 

Second Quarter

   0.33    0.32    0.50    0.50 

Third Quarter

   0.33    0.32    0.50    0.50 

Fourth Quarter

       0.33        0.32        0.50        0.50 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $1.32   $1.28   $2.00   $2.00 
  

 

 

   

 

 

   

 

 

   

 

 

 

  Common Preferred
  2013 2012 2013 2012
First Quarter $0.35
 $0.34
 $0.50
 $0.50
Second Quarter 0.35
 0.34
 0.50
 0.50
Third Quarter 0.35
 0.34
 0.50
 0.50
Fourth Quarter 0.35
 0.34
 0.50
 0.50
  $1.40
 $1.36
 $2.00
 $2.00
In December 2011,2013, our Board of Directors declared a quarterly dividend of $0.34$0.36 per share on our common stock which was paid on February 1, 20123, 2014 to shareholders of record as of January 6, 2012.3, 2014. The Board of Directors also declared a quarterly dividend of $0.50 per share on our preferred stock, payable on March 1, 20123, 2014 to shareholders of record as of February 3, 2012.

7, 2014.



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Issuer Purchases of Equity Securities

The following table summarizes the surrenders and repurchases of our equity securities during the 12 month period ended December 31, 2011:

Period

  Total Number of
Shares Purchased(a)
  Average Price
Paid

per Share(a)
  Total Number of Shares
Purchased as Part of
Publicly Announced
Plans or Programs(b)
  Approximate Dollar Value
of Shares that May Yet Be
Purchased Under the
Plans or Programs(b)
 
Dollars in Millions, Except Per Share Data             

January 1 to 31, 2011

   2,911,859   $25.93    2,897,837   $2,338  

February 1 to 28, 2011

   2,473,453   $25.53    2,458,416   $2,275  

March 1 to 31, 2011

   2,064,597   $24.92       $2,275  
  

 

 

   

 

 

  

Three months ended March 31, 2011

   7,449,909     5,356,253   
  

 

 

   

 

 

  

April 1 to 30, 2011

   6,971   $26.30       $2,275  

May 1 to 31, 2011

   4,383,833   $28.54    4,375,600   $2,150  

June 1 to 30, 2011

   4,401,073   $28.04    4,396,800   $2,027  
  

 

 

   

 

 

  

Three months ended June 30, 2011

   8,791,877     8,772,400   
  

 

 

   

 

 

  

July 1 to 31, 2011

   4,195,186   $29.06    4,191,050   $1,905  

August 1 to 31, 2011

   9,332,353   $27.62    9,324,241   $1,647  

September 1 to 30, 2011

   3,062,826   $30.08    3,060,000   $1,555  
  

 

 

   

 

 

  

Three months ended September 30, 2011

   16,590,365     16,575,291   
  

 

 

   

 

 

  

October 1 to 31, 2011

   4,259,392   $32.41    4,234,995   $1,418  

November 1 to 30, 2011

   4,827,619   $31.19    4,807,888   $1,268  

December 1 to 31, 2011

   2,373,460   $34.27    2,369,063   $1,187  
  

 

 

   

 

 

  

Three months ended December 31, 2011

   11,460,471     11,411,946   
  

 

 

   

 

 

  
  

 

 

   

 

 

  

Twelve months ended December 31, 2011

   44,292,622     42,115,890   
  

 

 

   

 

 

  

2013:
Period 
Total Number of
Shares Purchased(a)
 
Average Price
Paid
per Share(a)
 
Total Number of  Shares
Purchased as Part of
Publicly Announced
Plans or Programs(b)
 
Approximate Dollar Value
of Shares that May Yet Be
Purchased Under the
Plans or Programs(b)
Dollars in Millions, Except Per Share Data        
January 1 to 31, 2013 3,206,822
 $34.25
 3,191,812
 $1,672
February 1 to 28, 2013 2,466,156
 $36.67
 2,452,642
 $1,583
March 1 to 31, 2013 4,780,971
 $38.45
 2,510,200
 $1,484
Three months ended March 31, 2013 10,453,949
   8,154,654
  
April 1 to 30, 2013 675,677
 $40.85
 665,458
 $1,456
May 1 to 31, 2013 519,070
 $41.65
 487,187
 $1,436
June 1 to 30, 2013 402,285
 $46.30
 391,002
 $1,418
Three months ended June 30, 2013 1,597,032
   1,543,647
  
July 1 to 31, 2013 793,859
 $44.44
 784,977
 $1,383
August 1 to 31, 2013 342,124
 $43.59
 334,261
 $1,368
September 1 to 30, 2013 7,113
 $41.90
 
 $1,368
Three months ended September 30, 2013 1,143,096
   1,119,238
  
October 1 to 31, 2013 29,164
 $47.22
 
 $1,368
November 1 to 30, 2013 20,603
 $52.50
 
 $1,368
December 1 to 31, 2013 6,026
 $51.65
 
 $1,368
Three months ended December 31, 2013 55,793
   
  
Twelve months ended December 31, 2013 13,249,870
   10,817,539
  

(a)

The difference between total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due todifferent because shares of common stock are withheld by us from employee restricted stock awards in order to satisfy our applicable tax withholding obligations.

(b)

In May 2010, we announced that the Board of Directors authorized the purchaserepurchase of up to $3.0 billion of our common stock. In June 2012, the Board of Directors increased its authorization for the repurchase of common stock by an additional $3.0 billion. The repurchase program does not have an expiration date and is expected to take place over a few years.

we may consider future repurchases.


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Item 6.SELECTED FINANCIAL DATA.

Five Year Financial Summary

Amounts in Millions, except per share data  2011   2010   2009   2008   2007 

Income Statement Data:(a)

          

Net Sales

  $21,244   $19,484   $18,808   $17,715   $15,617 

Continuing Operations:

          

Net Earnings

   5,260    4,513    4,420    3,686    2,052 

Net Earnings Attributable to Noncontrolling Interest

   1,551    1,411    1,181    989    756 

Net Earnings Attributable to BMS

   3,709    3,102    3,239    2,697    1,296 

Net Earnings per Common Share Attributable to BMS:

          

Basic

  $2.18   $1.80   $1.63   $1.36   $0.65 

Diluted

  $2.16   $1.79   $1.63   $1.35   $0.65 

Average common shares outstanding:

          

Basic

   1,700    1,713    1,974    1,977    1,970 

Diluted

   1,717    1,727    1,978    1,999    1,977 

Dividends paid on BMS common and preferred stock

  $2,254   $2,202   $2,466   $2,461   $2,213 

Dividends declared per common share

  $1.33   $1.29   $1.25   $1.24   $1.15 

Financial Position Data at December 31:

          

Cash and cash equivalents

  $5,776   $5,033   $7,683   $7,976   $1,801 

Marketable securities(b)

   5,866    4,949    2,200    477    843 

Total Assets

     32,970      31,076      31,008      29,486      25,867 

Long-term debt

   5,376    5,328    6,130    6,585    4,381 

Equity

   15,867    15,638    14,785    12,208    10,535 

Amounts in Millions, except per share data 2013 2012 2011 2010 2009
Income Statement Data:(a)
          
Total Revenues $16,385
 $17,621
 $21,244
 $19,484
 $18,808
Continuing Operations:          
Net Earnings 2,580
 2,501
 5,260
 4,513
 4,420
Net Earnings Attributable to:          
Noncontrolling Interest 17
 541
 1,551
 1,411
 1,181
BMS 2,563
 1,960
 3,709
 3,102
 3,239
           
Net Earnings per Common Share Attributable to BMS:          
Basic $1.56
 $1.17
 $2.18
 $1.80
 $1.63
Diluted $1.54
 $1.16
 $2.16
 $1.79
 $1.63
           
Average common shares outstanding:          
Basic 1,644
 1,670
 1,700
 1,713
 1,974
Diluted 1,662
 1,688
 1,717
 1,727
 1,978
           
Cash dividends paid on BMS common and preferred stock $2,309
 $2,286
 $2,254
 $2,202
 $2,466
           
Cash dividends declared per common share $1.41
 $1.37
 $1.33
 $1.29
 $1.25
           
Financial Position Data at December 31:          
Cash and cash equivalents $3,586
 $1,656
 $5,776
 $5,033
 $7,683
Marketable securities(b)
 4,686
 4,696
 5,866
 4,949
 2,200
Total Assets 38,592
 35,897
 32,970
 31,076
 31,008
Long-term debt(c)
 7,981
 7,232
 5,376
 5,328
 6,130
Equity 15,236
 13,638
 15,867
 15,638
 14,785

(a)For a discussion of items that affected the comparability of results for the years 2011, 20102013, 2012 and 2009,2011, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Financial Measures.”
(b)Marketable securities includeIncludes current and non-current assets.marketable securities.

(c)Also includes the current portion of long-term debt.

34




Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Item 7.        MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

EXECUTIVE SUMMARY


Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us) is a global specialty care biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We license, manufacture, market, distribute and sell pharmaceutical products on a global basis.

We continued


The comparability of total revenues and earnings to executethe prior year periods was impacted by the reduction in our string-of-pearls strategy withshare of Abilify* (aripiprazole) revenues from 51.5% in 2012 to 34.0% in 2013, the acquisition of Amira Pharmaceuticals, Inc. (Amira)Amylin and expanded diabetes alliance arrangement with AstraZeneca in September 2011, 2012, the loss of exclusivity of Plavix* in 2012,and Inhibitex, Inc. (Inhibitex)a $1.8 billion intangible asset impairment charge in 2012.

As we transitioned away from Plavix* and Avapro*/Avalide*, we continued to grow our key brands. We also shifted our strategic focus in early-stage research and development and advanced our immuno-oncology portfolio, our hepatitis C portfolio and the rest of our late-stage pipeline.

In February 2014, BMS sold to AstraZeneca the diabetes business of BMS which comprised our global alliance with them, including all rights and ownership to Onglyza (saxagliptin), Forxiga (dapagliflozin), Bydureon* (exenatide extended-release for injectable suspension), Byetta* (exenatide), Symlin* (pramlintide acetate) and metreleptin. AstraZeneca paid $2.7 billion to BMS at closing, a $600 million milestone in February 2012, and through various collaboration agreements entered into during the year.

YERVOY (ipilimumab) was launched in the United States (U.S.) and the European Union (EU)2014 for the treatmentapproval of adult patients with unresectable (inoperable) or metastatic melanoma. We also launched a subcutaneous formulation of ORENCIA (abatacept)Farxiga (dapagliflozin) in the U.S., NULOJIX (belatacept) in the U.S. and the EUwill make contingent regulatory and sales-based milestone payments of up to $800 million and royalty payments based on net sales through 2025. See “Item 8. Financial Statements—Note 5. Assets Held-For-Sale” for the prevention of organ rejection in adult patients receiving a kidney transplant and ELIQUIS (apixaban) in the EU for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone hip or knee replacement surgery.

We announced the main results of the ARISTOTLE trial of ELIQUIS which compared with warfarin significantly reduced the risk for stroke or systemic embolism and had both our New Drug Application (NDA) in the U.S. and our Marketing Authorization Application (MAA) in the EU for ELIQUIS accepted for review.

In January 2012, we received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding our NDA for dapagliflozin. The complete response letter requests additional clinical data from ongoing studies and may require information from new clinical trials.

further discussion.


Highlights

The following table is a summary ofsummarizes our financial highlights:

   Year Ended December 31, 
Dollars in Millions, except per share data  2011  2010  2009 

Net Sales

  $21,244  $19,484  $18,808 

Total Expenses

     14,263     13,413     13,206 

Earnings from Continuing Operations before Income Taxes

   6,981   6,071   5,602 

Provision for Income Taxes

   1,721   1,558   1,182 

Effective tax rate

   24.7   25.7   21.1 

Net Earnings from Continuing Operations Attributable to BMS

    

GAAP

   3,709   3,102   3,239 

Non-GAAP

   3,921   3,735   3,667 

Diluted Earnings Per Share from Continuing Operations Attributable to BMS

    

GAAP

   2.16   1.79   1.63 

Non-GAAP

   2.28   2.16   1.85 

Cash, Cash Equivalents and Marketable Securities

   11,642   9,982   9,883 

information:

  Year Ended December 31,
Dollars in Millions, except per share data 2013 2012 2011
Total Revenues $16,385
 $17,621
 $21,244
Total Expenses 13,494
 15,281
 14,263
Earnings before Income Taxes 2,891
 2,340
 6,981
Provision for/(Benefit from) Income Taxes 311
 (161) 1,721
Effective tax/(benefit) rate 10.8% (6.9)% 24.7%
       
Net Earnings Attributable to BMS      
GAAP 2,563
 1,960
 3,709
Non-GAAP 3,019
 3,364
 3,921
       
Diluted Earnings Per Share      
GAAP 1.54
 1.16
 2.16
Non-GAAP 1.82
 1.99
 2.28
       
Cash, Cash Equivalents and Marketable Securities 8,272
 6,352
 11,642

Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items which represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For a detailed listing of all specified items and further information and reconciliations of non-GAAP financial measures see “—Non-GAAP Financial Measures” below.


Business Environment

Our business is primarily conducted within the


The pharmaceutical/biotechnology industry which is highly competitive and subject to numerous government regulations. Many competitive factors may significantly affect salesrevenues of our products, including product efficacy, safety, price, demand, competition and cost-effectiveness; marketing effectiveness; market access; product labeling; quality control and quality assurance of our manufacturing operations; and research and development of new products. To successfully compete for business in the healthcare industry, we must demonstrate that our products offer medical benefits as well asand cost advantages. Sometimes, ourOur new product introductions often compete with other products already on

35



the market in the same therapeutic category, in addition to potential competition of new products that competitors may introduce in the future. We manufacture branded products, which are priced higher than generic products. Generic competition is one of our leading challenges globally.

35


key challenges.


In the pharmaceutical/biotechnology industry, the majority of an innovative product’s commercial value is usually realized during its market exclusivity period. Afterwards, it is no longer protected by a patent and is subject to new competing products in the form of generic brands. Upon exclusivity loss, we can loseexperience a major portionsignificant reduction of that product’s sales in a short period of time. Competitors seeking approval of biological products under a full Biologics License Application (BLA) must file their own safety and efficacy data and address the challenges of biologics manufacturing, which involveinvolving more complex processes and are more costlycosts than those of other pharmaceutical operations. Under the U.S. healthcare legislation enacted in 2010, which is described more fully below, there is now an abbreviated path for regulatory approval of genericbiosimilar versions of biological products. This path for approval of biosimilar products under the U.S. healthcare legislation significantly affects the regulatory data exclusivity for biological products. The legislation provides a regulatory mechanism that allowsallowing for regulatory approval of biologic drugs that are similar to (but not necessarily generic copies of) innovative drugs on the basis of less extensive data than is required by a full BLA. It is not possible at this time to reasonably assess the impact of the U.S. biosimilar legislation on the Company.

Globally, the healthcare industry is subject to various government-imposed regulations authorizing prices or price controls that will continue to have an impact on our net sales.total revenues. In March 2010, the U.S. government enacted healthcare reform legislation, signing into law the Patient Protection and Affordable Care Act (HR 3590) and a reconciliation bill containing a package of changes to the healthcare bill. The legislation made extensive changes to the healthcare insurance and benefits system with the intention of broadening coverage and reducing costs. These bills significantly changed how Americans receive healthcare coverage and how they pay for it. They also have a significant impact on companies, in particular those companies in the pharmaceutical industry and other healthcare related industries, including BMS. We have experienced and will continue to experience additional financial costs and certain other changes to our business as the healthcare law provisions become effective. For example, in 2010, minimum rebates on our Medicaid drug sales have increased from 15.1 percent to 23.1 percent and Medicaid rebates have also been extended to drugs used in risk-based Medicaid managed care plans.

Two additional provisions that impact our financial results went into effect on January 1, 2011. The first is a 50 percent discount on our brand-name drugs to patients within the Medicare Part D coverage gap, also referred to as the “donut hole.” The second is an annual non-tax-deductible pharmaceutical company fee payable to the Federal government based on an allocation of our market share of branded prior year sales to certain U.S. government programs including Medicare, Medicaid, Department of Veterans Affairs, Department of Defense and TRICARE.

The annual EPS impact of U.S. healthcare reform increased from $0.10 in 2010 to $0.24 in 2011. In 2011, net sales were reduced by $310 million resulting from new discounts associated with the Medicare Part D coverage gap. Marketing, selling and administrative expenses increased by $220 million due to the new annual non-tax-deductible pharmaceutical company fee. The incremental $0.14 impact was associated with the Medicare Part D coverage gap and the annual pharmaceutical company fee.


The aggregate financial impact of U.S. healthcare reform over the next few years depends on a number of factors, including but not limited to pending implementation guidance, potential changes in sales volume eligible for the new rebates, discounts or fees, and the impact of cost sharing arrangements with certain alliance partners. A positive impact on our net sales from the expected increase in the number of people with healthcare coverage could potentially occur infrom the future, but is not expected until 2014 at the earliest.

Patient Protection and Affordable Care Act.


In many marketsregions outside the U.S., we operate in environments of government-mandated, cost-containment programs, or under other regulatory bodies or groups that can exertexerting downward pressure on pricing. PricingFor example, pricing freedom is limited in the UK, for instance,United Kingdom (UK) by the operation of a profit control plan and in Germany by the operation of a reference price system. Many European countries have continuing fiscal challenges as healthcare payers, including government agencies, have reduced and are expected to continue to reduce the cost of healthcare through actions that directly or indirectly impose additional price restrictions. Companies also face significant delays in market access for new products as more than two years can elapse after drug approval before new medicines becomeare available in some countries.


The growth of Managed Care Organizations (MCOs) in the U.S. has significantly impacted competition that surroundsin the healthcare industry. MCOs seek to reduce healthcare expenditures for participants by makingthrough volume purchases and entering into long-term contracts to negotiatecontractual discounts with various pharmaceutical providers. Because of the market potential created by the large pool of participants, marketing prescription drugs to MCOs has becomeis an important part of our strategy. Companies compete for inclusion in MCO formularies and we generally have beenare successful in having our key products included. We believe that developments in the managed care industry, including continuedon going consolidation, have had and will continue to have a downward pressure on prices.


Pharmaceutical and biotechnology production processes are complex, highly regulated and vary widely from product toby product. Shifting or adding manufacturing capacity can beis usually a lengthy process requiring significant capital expenditures and regulatory approvals. Biologics manufacturing involves more complex processes than those of traditional pharmaceutical operations. As biologics become a larger percentage of our product portfolio, we will continue to makemaintain supply arrangements with third-party manufacturers and to makeincur substantial investments to increase our internal capacity to produce biologics on a commercial scale. One such investment is a new, state-of-the-artThe United States Food and Drug Administration (FDA) approved our large scale multi-product bulk biologics manufacturing facility for the production of biologics in Devens, Massachusetts. We submitted the site for regulatory approvalMassachusetts in May 2012 and we expectcontinue to make capital investments in the FDA to complete a review of our application by the end of the year.

36


facility.


We have maintainedmaintain a competitive position in the market and strive to uphold this position, which is dependentdepending on our success in discovering, developing and delivering innovative, cost-effective products to help patients prevail over serious diseases.


We are the subject of a number of significant pending lawsuits, claims, proceedings and investigations. It is not possible at this time to reasonably assess the final outcomes of these investigations or litigations. For additional discussion of legal matters, see “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies.”


Strategy

Over the past few years,


Since 2007, we have transformed our Companybeen transforming BMS into a leading-edge biopharma company focused biopharmaceutical company, a transformationexclusively on discovering, developing, and delivering innovative medicines that encompasses all areas of our business and operations. This has not only focused our portfolio of products but has yielded and will continue to yield substantial cost savings and cost avoidance. This in turn increases our financial flexibility to take advantage of attractive market opportunities that may arise.

In May 2012, we expect to lose exclusivity in the U.S. for our largest product, PLAVIX*, after which time we expect a rapid, precipitous, and material decline in PLAVIX* net sales and a reduction in net income and operating cash flow. We also expect a decline in AVAPRO*/AVALIDE* (irbesartan/irbesartan-hydrochlorothiazide) net sales immediately following the loss of exclusivity in the U.S. in March 2012. Such events are the norm in the industry when companies experience the loss of exclusivity of a product. Recognizing this fact, we continue to focus on sustaining our business and building a robust foundation for the future. We plan to achieve this foundation by continuing to support and grow our currently marketed products, advancing our pipeline, and maintaining and improving our financial strength, all of which are part of an overall strategy to build the Company.

address serious unmet medical needs. We continue to expandevolve driven by this fundamental objective as we grow our biologics capabilities. We still rely significantly on small molecules as our strongest, most reliable starting point for discovering potential new medicines, but large molecules, or biologics, derived from recombinant DNA technologies, are becoming increasingly important. Currently, more than one in three of our pipeline compounds are biologics, as are four of our key marketed products including YERVOY.

Our strategy also includes a focus on certain emerging markets,and progress our acquisition and licensing strategy known as “string-of-pearls,” optimizing our mature brands portfolio and managing costs. Our strategy in emerging markets is to develop and commercialize innovative products in key high-growth markets, tailoring the approach to each market. pipeline.



36



We are continuing to focus on our core biopharmaceuticals and maximizing the value of our mature brands portfolio.

We completed the following strategic transactions in 2011:

We acquired Amira Pharmaceutical, Inc. (Amira), a small-molecule pharmaceutical company focused on fibroticfour core therapeutic areas: oncology, virology, immunology, and specialty cardiovascular disease.

We entered into an agreement with Ono Pharmaceuticals Co. Within oncology, we are pioneering innovative medicines in the area of immuno-oncology which unlock the body’s own immune system to battle cancer. Yervoy (ipilimumab), Ltd. (Ono) to expand our territorial rights to develop and commercialize an antibody to PD-1, an investigational cancer immunotherapy, and to create a strategic alliance for the codevelopment and cocommercialization of ORENCIAfirst immuno-oncology agent, was introduced in Japan.

We obtained exclusive worldwide rights from Ambrx Inc. (Ambrx) to research, develop and commercialize novel biologics in diabetes and heart disease.

We obtained exclusive worldwide rights from Innate Pharma S.A. (Innate) to develop and commercialize IPH 2102, a novel immune-oncology biologic in Phase I development.

We entered into a clinical collaboration with Roche to evaluate the utility of YERVOY in combination with Roche’s investigational BRAF inhibitor, vermurafenib, in treating patients with a specific type of metastatic melanoma.

We announced a licensing agreement with Gilead Sciences, Inc. (Gilead) for the development and commercialization of a new fixed-dose combination containing REYATAZ and Gilead’s cobicistat2011 for the treatment of HIV.

metastatic melanoma and we continue to invest significantly in our deep pipeline of innovative medicines in this area covering a broad array of cancers.


We enteredare evolving our commercial model and growing our marketed product portfolio in a manner consistent with our overall strategy. In oncology, we are building on the success of Yervoy, which yielded 2013 revenues of nearly $1 billion, and other products such as Sprycel (dasatinib) and Erbitux* (cetuximab). Beyond oncology, we continue to support key brands in our virology franchise such as Reyataz (atazanavir sulfate) and Baraclude (entecavir) (together accounting for approximately $3 billion in revenues in 2013), in addition to investing in Orencia (abatacept), the key brand in our immunology portfolio, which accounted for approximately $1.4 billion in revenues in 2013. Additionally, we are strongly committed to Eliquis (apixaban), a novel oral anti-coagulant, which launched globally in 2013.

In February 2014, we divested our diabetes portfolio which allows us to further accelerate the evolution of our business model into a strategic partnership with ASLAN Pharmaceuticals for developmentleading specialty care biopharma company. This transaction also allows us to focus our resources behind our growth opportunities that drive the greatest long-term value.

Looking ahead, we will continue to implement our biopharma strategy by driving the growth of BMS-777607, an investigational small molecule inhibitorkey brands, executing new product launches, investing in our pipeline, maintaining a culture of the MET receptor tyrosine kinase for treatment of solid tumors.

We entered into a clinical collaboration agreement with Tibotec Pharmaceuticals (Tibotec), one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), our investigational NS5A replication complex inhibitor, in combination with Tibotec’s investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus.

We agreed to codevelop BMS-795311, our preclinical small molecule inhibitor of the Cholesteryl Ester Transfer Protein (CETP) that could potentially raise HDL (good cholesterol) levelscontinuous improvement, and help prevent cardiovascular disease, with Simcere Pharmaceutical Group (Simcere).

pursuing disciplined capital allocation, including through business development.

We entered into a clinical collaboration with Pharmasset, Inc. (Pharmasset), now a wholly owned subsidiary of Gilead, to evaluate the utility of declatasvir (BMS-790052), our NS5A replication complex inhibitor, in combination with PSI-7977, Pharmasset’s nucleotide polymerase inhibitor for the treatment of chronic hepatitis C virus and subsequently announced the addition of four additional treatment arms to the Phase IIa trial.


In February 2012, we acquired Inhibitex, Inc. (Inhibitex), a clinical-stage biopharmaceutical company focused on developing products to treat the hepatitis C virus and other serious infectious diseases.

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Product and Pipeline Developments

We manage our research and development (R&D) programs on a portfolio basis, investing resources in each stage of research and development from early discovery through late-stage development. We continually evaluate our portfolio of R&D assets to ensure that there is an appropriate balance of early-stage and late-stage programs to support future growth. We consider our R&D programs that have entered into Phase III development to be significant, as these programs constitute our late-stage development pipeline. These Phase III development programs include both investigational compounds in Phase III development for initial indications and marketed products that are in Phase III development for additional indications or formulations. Spending on these programs represents approximately 30-40%30-45% of our annual R&D expenses. No individual investigational compound or marketed product represented 10% or more of our R&D expenses in any of the last three years. While we do not expect all of our late-stage development programs to make it to market, our late-stage development programs are the R&D programs that could potentially have an impact on our revenue and earnings within the next few years. The following are the recent significant developments in our marketed products and our late-stage pipeline:

YERVOY –


Hepatitis C Portfolio - (Daclatasvir - a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma, which currently is also being studied for other indications including lung cancer as well as adjuvant melanoma and hormone-refractory prostate cancer

NS5A replication complex inhibitor in development; Asunaprevir - a NS3 protease inhibitor in development; BMS-791325 - a NS5B non-nucleoside polymerase inhibitor in development)


In July 2011,January 2014, the Company announced that the European Commission approved YERVOYMedicines Agency (EMA) has validated the marketing authorization application (MAA) for the use of daclatasvir for the treatment of adult patientsadults with previously-treated advanced melanoma.

In June 2011, the Company announced at the 47th Annual Meeting of the American Society of Clinical Oncology the results on the 024 study which evaluated newly-diagnosed patients treated with YERVOY 10mg/kg in combination with dacarbazine versus dacarbazine alone. There was a significant improvement in overall survival for patients treated with YERVOY plus dacarbazine versus those who received dacarbazine alone. Higher estimated survival rates were observed at one year, two years and three years in patients treated with YERVOY plus dacarbazine versus those that received dacarbazine alone.

In June 2011,chronic hepatitis C with compensated liver disease, including genotype 1, 2, 3 and 4. The application seeks the Company announced that it has entered into a clinical collaboration with Roche to evaluate the utilityapproval of YERVOYdaclatasvir for use in combination with Roche’s investigational BRAF inhibitor, vermurafenib, in treating patients with a specific type of metastatic melanoma.

In March 2011, the FDA approved YERVOYother agents, including sofosbuvir, for the treatment of chronic hepatitis C. The EMA's validation marks the start of an accelerated regulatory review process.


In November 2013, the Company announced the submission of a New Drug Application (NDA) to Japan's Pharmaceutical and Medical Devices Agency. The submission was based on results from a Phase III study demonstrating that the 24-week, all-oral regimen of daclatasvir and asunaprevir achieved an overall sustained virologic response 24 weeks after the end of treatment of 84.7% in Japanese patients with newly diagnosedchronic hepatitis genotype 1b who were either interferon ineligible/intolerant or previously-treated unresectable (inoperable) or metastatic melanoma.

ELIQUIS – an oral Factor Xa inhibitor indicated in the EU for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgerynon-responders (null and in development for stroke prevention in patients with atrial fibrillation (AF) and the prevention and treatment of venous thromboembolic disorders that is part of our strategic alliance with Pfizer, Inc. (Pfizer)

partial) to interferon-based therapies.

In November 2011, the FDA accepted for review the NDA for ELIQUIS. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 28, 2012. We also have a validated application in the EU.

In November 2011, the Company and Pfizer announced the results of the Phase III ADOPT trial, which evaluated ELIQUIS versus enoxaparin in acutely ill medical patients, did not meet the primary efficacy outcome of superiority to enoxaparin for the endpoint of VTE and VTE-related deaths.

In August 2011April 2013, at the European SocietyAssociation for the Study of Cardiology Congress,the Liver in Amsterdam, the Company announced new Phase II data demonstrating that 12- and Pfizer announced the main results24-week triple direct-acting antiviral treatment regimens of the Phase III ARISTOTLE trial, which evaluated ELIQUIS compareddaclatasvir, asunaprevir, and BMS-791325 showed high rates of sustained virologic response of up to warfarin94% in treatment-naïve, genotype 1 chronic hepatitis C patients, at time points ranging from 4 to 36 weeks post-treatment. The FDA designated this triple-DAA regimen as a Breakthrough Therapy for the preventiontreatment of stroke or systemic embolism in patients with atrial fibrillation and at least one risk factor for stroke. ELIQUIS as compared with warfarin significantly reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent and mortality by 11 percent.

chronic hepatitis C.

In June 2011, the Company and Pfizer announced that the Phase III ARISTOTLE trial of ELIQUIS met the primary efficacy objective of non-inferiority to warfarin on the combined outcome of stroke (ischemic, hemorrhagic or unspecified type) and systemic embolism. In addition, ELIQUIS met the key secondary endpoints of superiority on efficacy and on International Society of Thrombosis and Haemostasis (ISTH) major bleeding compared to warfarin.


In May 2011, the Company and Pfizer announced that the European Commission approved ELIQUISBaraclude (entecavir) - an oral antiviral agent for the preventiontreatment of VTE in adult patients who have undergone elective hip or knee replacement surgery.

chronic hepatitis B


In February 2011, the Company and Pfizer published the full results of the AVERROES study of ELIQUIS inThe New England Journal of Medicine. The study demonstrated that, for patients with AF who were expected or demonstrated to be unsuitable for a vitamin K antagonist therapy such as warfarin, ELIQUIS was statistically superior to aspirin in reducing the composite of stroke or systemic embolism, without a significant increase in major bleeding, fatal bleeding or intracranial bleeding. There were no significant differences in the risk of hemorrhagic stroke between ELIQUIS and aspirin. The study results also showed that ELIQUIS demonstrated superiority for its secondary efficacy endpoint in reducing the composite of stroke, systemic embolism, myocardial infarction or vascular death for patients with AF when compared with aspirin.

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NULOJIX – a fusion protein with novel immunosuppressive activity for the prevention of kidney transplant rejection

In June 2011,December 2013, the Company announced that the FDA has granted an additional six month period of exclusivity to market Baraclude.



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In February 2013, the U.S. District Court for the District of Delaware invalidated the composition of matter patent covering Baraclude, which was scheduled to expire in 2015. See "Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies" for further discussion. The Company is prepared to take legal action in the European Commission approved NULOJIX for prophylaxisevent that Teva Pharmaceutical Industries Ltd. (Teva) chooses to launch its generic product prior to the resolution of organ rejection in adult patients receivingthe Company's appeal.

Sustiva (efavirenz) - a kidney transplant.

New data on NULOJIX was presented at the 2011 American Transplant Congress and the European Society for Organ Transplantation (ESOT) meeting including: (i) three-year outcomes from BENEFIT: A Phase III study of NULOJIX vs. cyclosporine in kidney transplant recipients, (ii) three-year safety profile of NULOJIX in kidney transplant recipients from the BENEFIT and BENEFIT-EXT studies, (iii) renal function at two years in kidney transplant recipients switched from cyclosporine or tacrolimus to NULOJIX: results from the long-term extension of a Phase II study, and (iv) three-year outcomes by donor type in Phase III studies of NULOJIX vs. cyclosporine in kidney transplantation (BENEFIT & BENEFIT-EXT).

Dapagliflozin – an oral SGLT2non-nucleoside reverse transcriptase inhibitor for the treatment of diabetes that is part of our strategic alliance with AstraZeneca PLC (AstraZeneca)

Human Immunodeficiency Virus (HIV)


In January 2012, the FDA issued a complete response letter regarding the NDA for dapagliflozin. The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials. The companies will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures.

In December 2011,February 2013, the Company and AstraZeneca announced at the International Diabetes Federation 2011 World Diabetes Conference the results of a Phase III study of dapagliflozin that showed reductions on blood sugar levels (glycosylated hemoglobin levels or HbA1c) seen at 24 weeks with dapagliflozin and existing glimepiride (sulfonylurea) therapy, compared to placebo added to glimepiride were maintained at 48 weeks in adults with type 2 diabetes. Patients taking dapagliflozin added to glimepiride also maintained reductions in fasting plasma glucose levels, post-prandial glucose and total body weight.

In November 2011, the Company and AstraZeneca presented a meta-analysis of clinical data on cardiovascular safety in adult patients with type 2 diabetes that showed that dapagliflozin was not associated with an unacceptable increase in cardiovascular risk relative to all comparators pooled in the clinical programs.

In July 2011, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted nine to six that the efficacy and safety data did not provide substantial evidence to support approval of the NDA for dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In June 2011 at the American Diabetes Association meeting, the Company and AstraZeneca presented the results from several Phase III clinical studies examining dapagliflozin added to metformin.

The MAA for dapagliflozin has been validated by the EMA. The MAA submission for dapagliflozin was filed in December 2010.

ORENCIA – a fusion protein indicated for rheumatoid arthritis

In November 2011 at the American College of Rheumatology Annual Scientific Meeting, the Company presented new data on ORENCIA from clinical trials that support the recent FDA approval of the subcutaneous formulation of ORENCIA for the reduction of signs and symptoms in adults with moderate to severe arthritis. Other data presented included long-term immunogenicity data with the intravenous formulation, long-term safety data in rheumatoid arthritis and results from a Phase II/III study in lupus nephritis.

In August 2011, the MAA for the subcutaneous formulation of ORENCIA was validated for review by the European Medicine Agency.

In July 2011, the FDA approved a subcutaneous formulation of ORENCIA for the treatment of adults with moderate to severe rheumatoid arthritis.

ONGLYZA/KOMBIGLYZE (saxagliptin/saxagliptin and metformin) – a treatment for type 2 diabetes that is part of our strategic alliance with AstraZeneca

In December 2011, the FDA approved ONGLYZA for use as a combination therapy with insulin (with or without metformin) to improve blood sugar in adult patients with type 2 diabetes.

In November 2011, the European Commission approved KOMBIGLYZE (known in the EU as KOMBOGLYZE) for the treatment of type 2 diabetes.

In November 2011, the European Commission approved ONGLYZA for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycemic) control in adult patients with type 2 diabetes.

In September 2011 at the 47th European Association for the Study of Diabetes annual meeting, the Company and AstraZeneca announced results from an investigational Phase IIIb clinical study which reported that ONGLYZA 5 mg added to insulin (with or without metformin) maintained glycemic control (glycosylated hemoglobin levels or HbA1c) in adult patients with type 2 diabetes compared to the addition of placebo at 24 to 52 weeks.

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In June 2011, the Company and AstraZeneca announced results from an investigational Phase IIIb clinical study which reported that ONGLYZA 5 mg added to insulin (with or without metformin) significantly reduced blood sugar levels (glycosylated hemoglobin levels or HbA1c) at 24 weeks compared to treatment with placebo added to insulin (with or without metformin).

In May 2011, the Company and AstraZeneca announced that the State Food and Drug Administration approved ONGLYZA in China.

In February 2011, the Company and AstraZeneca announced that the European Commission approved a label update for ONGLYZA in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment making ONGLYZA the first dipeptidyl peptidase-4 (DDP-4) inhibitor in Europe available for type 2 diabetes patients with moderate or severe renal impairment.

In February 2011, the Company and AstraZeneca announced that the FDA approvedhas granted an additional six-month period of exclusivity to market Sustiva. Exclusivity for Sustiva in the inclusion of data from two clinical studiesU.S. is now scheduled to expire in an updateMarch 2015.


Nivolumab - a fully human monoclonal antibody that binds to the ONGLYZA U.S. Prescribing Information for adultsprogrammed death receptor-1 (PD-1) on T and NKT cells that is being investigated as an anti-cancer treatment.

In October 2013, the Company announced long-term follow-up results from the lung cancer cohort (n=129) of the expanded Phase I dose-ranging study (003) of nivolumab. Results showed sustained activity in heavily pre-treated patients with type 2 diabetes. The U.S. label update provides further evidence regarding use in renally impaired adultsnon-small-cell lung cancer as defined by one- and two-year survival rates of 42% and 24%, respectively, across dose cohorts.
In June 2013, the Company announced the results from Study 004, a dose-ranging Phase I trial evaluating the safety and anti-tumor activity of nivolumab combined either concurrently or sequentially with type 2 diabetes as well as comparisons between glipizide and ONGLYZAYervoy in patients also taking metformin.

with advanced melanoma. In patients who received the dose used in the Phase III trial (1 mg/kg nivolumab + 3 mg/kg
Yervoy) in the concurrent regimen, 53% had confirmed objective responses by modified World Health Organization criteria. In all nine of the responders, tumors shrank by at least 80% by the time of the first scheduled clinical treatment assessment (12 weeks), including three complete responses.

SPRYCEL


Sprycel (dasatanib) - an oral inhibitor of multiple tyrosine kinases indicated for the first-line treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including GLEEVEC*Gleevec* (imatinib meslylate) and first-line treatment of adults. SPRYCEL. Sprycel is part of our strategic alliance with Otsuka.

In December 2013, at the American Society of Hematology, the Company and Otsuka Pharmaceuticals, Inc. (Otsuka)announced four-year follow-up data from the Phase III DASISION study of Sprycel 100 mg once daily vs. Gleevec* (400 mg daily) in the first-line treatment of adults with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia. At four years, 76% of Sprycel patients vs. 63% of Gleevec* patients achieved a major molecular response Additionally, 84% of Sprycel patients vs. 64% of Gleevec* patients achieved BCR-ABL ≤10% at three months, which is considered an optimal molecular response as defined by treatment guidelines (2013 European LeukemiaNet guidelines).

In September 2011, China’s State Food Patients in both arms who achieved this response at three months had improved overall survival and Drug Administration approved SPRYCELprogression-free survival at four years versus those who did not. At four years, 67% of Sprycel patients (n=172) and 65% of Gleevec* patients (n=168) remained on treatment.


Yervoy (ipilimumab) - a monoclonal antibody for the treatment of adultspatients with chronic, acceleratedunresectable (inoperable) or lymphoid or myeloid chronic myeloid leukemia with resistance or intolerance to prior therapy of imatinib.

metastatic melanoma


In June 2011, regulatory authorities in JapanNovember 2013, the EMA has approved the use of SPRYCELYervoy in first line (chemotherapy naïve) advanced melanoma patients.
In September 2013, at the European Cancer Congress, results were presented from a pooled analysis of survival data for 12 studies in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy at different doses and regimens, including the investigational dose of 10 mg/kg and some patients who were followed for up to 10 years. The analysis found that a plateau in the survival curve begins at three years, with some patients followed for up to ten years. At three years, 22% of patients were alive.
In September 2013, the Company announced results from the Phase III randomized, double-blind clinical trial (Study 043) comparing Yervoy to placebo following radiation in patients with advanced metastatic castration-resistant prostate cancer who have received prior treatment with docetaxel. The study's primary endpoint of overall survival did not reach statistical significance. However, antitumor activity was observed across some efficacy endpoints, including progression free-survival.

Elotuzumab - a humanized monoclonal antibody being investigated as a first-line treatment of chronic myeloid leukemia.

In June 2011, the Company and Otsuka announced that five-year follow up data for SPRYCEL 100 mg once daily demonstrated 78% overall survival in patients with chronic-phase myeloid leukemia resistant or intolerant to GLEEVEC*. The results were announced at the 47th Annual Meeting of the American Society of Clinical Oncology.

PLAVIX* – a platelet aggregation inhibitor thatan anticancer treatment. Elotuzumab is part of our strategic alliance with Sanofi

AbbVie Inc. (AbbVie).


In January 2011,June 2013, the Company and SanofiAbbVie announced updated efficacy and safety data from a small, randomized Phase II, open-label study in patients with previously-treated multiple myeloma that evaluated two doses of elotuzumab in combination with lenalidomide and low-dose dexamethasone. In the FDA has granted10 mg/kg arm, which is the companies an additional six-month period of exclusivity to market PLAVIX*. Exclusivity for PLAVIX*dose used in the U.S. is now scheduled to expire on May 17, 2012.

BARACLUDE (entecavir) – an oral antiviral agent forongoing Phase III trials, median progression-free survival (PFS), or the treatmenttime without disease progression, was 33 months after a median follow-up of chronic hepatitis B

In November 2011 at the 62nd annual meeting of the American Association for the Study of Liver Disease, the Company announced the results of the 96-week BE-LOW study, a Phase IIIb clinical trial, that showed no statistical difference between BARACLUDE monotherapy (0.5 mg once daily) 20.8 months

38



and BARACLUDE (0.5 mg once daily) plus tenovir (300 mg once daily) in treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease.

In February 2011, the European Commission approved BARACLUDE forobjective response rate (ORR) was 92%. As previously reported, median PFS was 18 months in the treatment20 mg/kg arm after a median follow-up of hepatitis B in adult patients with decompensated liver disease.

17.1 months and ORR was 76%.

ABILIFY*


Abilify* (aripiprazole) - an antipsychotic agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder and is part of our strategic alliance with Otsuka

In January 2013, the European Commission (EC) approved Abilify* for the treatment of pediatric bipolar mania.

Metreleptin - a protein in development for the treatment of lipodystrophy that was part of our strategic alliance with AstraZeneca and included in our sale of the diabetes business to them

In June 2013, the Company and AstraZeneca announced the FDA has accepted the filing and granted a Priority Review designation for the BLA. In July 2013, the FDA notified the Company and its partner, AstraZeneca, that it will require a three-month extension to complete its review of the data supporting the BLA. In December 2013, the Company and AstraZeneca announced the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD). EMDAC did not recommend metreleptin in patients with partial LD for the indication currently proposed. The Company and AstraZeneca remain committed to pursuing metreleptin for treatment in patients with metabolic disorders associated with partial LD. The Companies acknowledged the EMDAC's feedback and will continue to work with the FDA to identify the appropriate patients with partial LD who may benefit from metreleptin. The Prescription Drug User Free Act (PDUFA) date, the date by which a decision by the FDA is expected, is February 27, 2014.

Farxiga/Xigduo (dapagliflozin and metformin hydrochloride) - an oral sodium-glucose cotransporter (SGLT2) inhibitor for the treatment of diabetes that was part of our strategic alliance with AstraZeneca and included in our sale of the diabetes business to them

In January 2014, the Company and AstraZeneca announced that Xigduo has been granted marketing authorization by the European Commission for the treatment of type 2 diabetes in the EU.
In January 2014, the Company and AstraZeneca announced the FDA has approved Farxiga to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
In September 2013, at the Annual Meeting of the European Association for the Study of Diabetes (EASD), the Company and AstraZeneca announced results from a Phase III study evaluating dapagliflozin in adult patients with type 2 diabetes who were inadequately controlled on combination treatment with metformin plus sulfonylurea. Patients treated with dapagliflozin as an add on therapy to metformin plus sulfonylurea demonstrated significant improvements in glycosylated hemoglobin levels (HbA1c) and, among key secondary endpoints, significant reductions in fasting plasma glucose and body weight compared to placebo at 24 weeks. Significant improvements were also observed in seated systolic blood pressure at eight weeks in patients treated with dapagliflozin compared to placebo.
In June 2013, the Company and AstraZeneca announced the results of a two-week Phase IIa pilot study evaluating Farxiga added to insulin in 70 adult patients with sub-optimally controlled type 1 diabetes, which showed that the mean of daily blood glucose derived from 7-point glucose measurements trended downward in all treatment groups through day seven and reductions in total daily insulin dosing at day seven were observed with Farxiga.
In March 2013, the Japanese Ministry of Health, Labor and Welfare also accepted for review the regulatory submission for Farxiga for the treatment of type 2 diabetes.
In January 2013, China‘s State Food and Drug Administration accepted for review the regulatory submission for Farxiga for the treatment of type 2 diabetes.

Onglyza (saxagliptin) - a once-daily oral tablet for the treatment of type 2 diabetes that is part of our strategic alliance with Otsuka

AstraZeneca and included in our sale of the diabetes business to them


In February 2011,2014, the FDA announced that it is requesting clinical trial data to investigate a possible association between use of Onglyza/Kombiglyze and heart failure. The FDA stated that this request is part of a broader evaluation that the FDA is conducting of all type 2 diabetes drug therapies and cardiovascular risk.

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In September 2013 at the European Society of Cardiology, the Company and OtsukaAstraZeneca announced the full results of the SAVOR clinical trial in adult patients with type 2 diabetes. In this study, Onglyza met the primary safety objective, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke, when added to a patient's current standard of care (with or without other anti-diabetic therapies), as compared to placebo. Onglyza did not meet the primary efficacy endpoint of superiority to placebo for the same composite endpoint. Patients treated with Onglyza experienced improved glycemic control and reduced development and progression of microalbuminuria over two years as assessed in exploratory analyses. At a subsequent meeting (the Annual Meeting of the EASD) additional subanalyses from SAVOR were presented. These subanalyses found no increased rate of hypoglycemia among patients treated with Onglyza compared to placebo when added to metformin monotherapy, at baseline. These subanalyses also found higher rates of hypoglycemia only in the Onglyza group compared to the placebo group among patients taking sulfonylureas, agents known to cause hypoglycemia, at baseline. In addition, the subanalyses found that rates of adjudication-confirmed pancreatitis were balanced between the Onglyza and placebo treatment groups. Observed rates of pancreatic cancer were also low (5 patients in the Onglyza arm versus 12 patients in the placebo arm).

Orencia (abatacept) - a fusion protein indicated for adult patients with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more currently available treatments, such as methotrexate or anti-tumor necrosis factor therapy.

In June 2013, the Company and Ono Pharmaceutical Co., Ltd. announced that the FDAJapanese Ministry of Health Labour and Welfare approved ABILIFY* as an adjunct to the mood stabilizers lithium or valproate for the maintenance treatmentsubcutaneous formulation of Bipolar I Disorder. European approval for this use was received in January 2011.

REYATAZ (atazanavir sulfate) – a protease inhibitor Orencia for the treatment of HIV

rheumatoid arthritis in cases where existing treatments are inadequate.

In February 2011,June 2013, the FDA approvedCompany announced the results of year two data from AMPLE which compared the subcutaneous formulation of Orencia versus Humira* (adalimumab), each on a background of methotrexate in biologic naïve patients with moderate to severe rheumatoid arthritis. AMPLE met its primary endpoint as measured by non-inferiority of American College of Rheumatology 20% improvement at year one. The Orencia regimen achieved comparable rates of efficacy versus the Humira* regimen (64.8% vs 63.4%, respectively).

Eliquis - an update tooral Factor Xa inhibitor, targeted at stroke prevention in nonvalvular atrial fibrillation (NVAF) and the labeling for REYATAZ to include dose recommendations in HIV-infected pregnant women. In HIV combination therapy, treatment with the recommended adult dose of REYATAZ 300 mg, boosted with 100 mg of ritonavir, achieved minimum plasma concentrations (24 hours post-dose) during the third trimester of pregnancy comparable to that observed historically in HIV-infected adults. During the post partum period, atazanavir concentrations may be increased; therefore, while no dose adjustment is necessary, patients should be monitored for two months after delivery.

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ERBITUX* (cetuximab) – a monoclonal antibody designed to exclusively targetprevention and block the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells in multiple tumor types as well as normal cells and is currently indicated for use against colorectal cancer and head and neck cancer. ERBITUX* is part of our alliance with Eli Lilly and Company (Lilly).

In November 2011, the FDA approved ERBITUX*, in combination with platinum-based chemotherapy with 5-fluorouracil, for the first line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck.

Necitumumab (IMC-11F8) – an investigational anti-cancer agent, whichvenous thromboembolic (VTE) disorders. Eliquis is part of our strategic alliance with Lilly

Pfizer.


In February 2011,December 2013, the Company and LillyPfizer announced that enrollment was stoppedthe FDA has accepted for review a Supplemental New Drug Application for Eliquis for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the Phase III INSPIRE studyrisk of necitumumab as a first-linerecurrent DVT and PE. The PDUFA date is August 25, 2014.

In November 2013, the European Medicines Agency accepted for review an application for Eliquis for the treatment for advanced non-small cell lung cancer. The trial is evaluating the addition of necitumumab to a combinationDVT and PE, and prevention of ALIMTA* (pemetrexed for injection)recurrent DVT and cisplatin. The decision to stop enrollment followed an independent Data Monitoring Committee (DMC) recommendation that no new or recently enrolled patients continue treatment in the trial because of safety concerns related to thromboembolism in the experimental arm of the study. The DMC also noted that patients who have already received two or more cycles of necitumumab appear to have a lower ongoing risk for these safety concerns. Those patients could choose to remain on the trial, after being informed of the additional potential risks. Investigators will continue to assess patients after two cycles to determine if there is a potential benefit from treatment. Necitumumab continues to be studied in another Phase III trial named SQUIRE. This study is evaluating necitumumab as a potential treatment for a different type of lung cancer called squamous non-small cell lung cancer in combination with GEMZAR* (gemcitabine HCl for injection) and cisplatin. The same independent DMC recommended that this trial continue because no safety concerns have been observed.

PE.

Brivanib – an investigational anti-cancer agent


In January 2012September 2013 at the AmericanEuropean Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium,Cardiology (ESC) Congress, the National Cancer Institute of Canada (NCIC) Clinical Trials GroupCompany and the Australasian Gastro-Intestinal Trials Group (AGITG) presentedPfizer announced the results of a posthoc subanalysis from the Phase III randomizedARISTOTLE trial, of cetuximab plus either brivanib alaninate or placebowhich evaluated Eliquis compared to warfarin in patients with metastatic, chemotherapy refractory, K-RAS wild type colorectal carcinoma. The primary endpointor without other types of improvement in overall survival was not metvalvular heart disease (VHD) who were eligible for enrollment in the trial.

ARISTOTLE trial, including mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or valve surgery. The results of this subanalysis were consistent with the results of the overall ARISTOTLE trial and demonstrated that Eliquis compared with warfarin reduced stroke or systemic embolism, caused fewer major bleeding events, and reduced all-cause mortality in NVAF patients with or without VHD.

In December 2011,August 2013 at the ESC, the Company reported thatand Pfizer announced the results of a post-hoc subanalysis from the Phase III BRISK-PS (Brivanib StudyARISTOTLE trial which showed comparable rates of clinical events versus the warfarin treatment arm in HCC Patientsa 30-day period following a procedure which required the temporary discontinuation of an anticoagulant prior to and following the procedure.

In July 2013, the Company and Pfizer announced that the FDA has accepted for review a Supplemental New Drug Application for Eliquis, for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in adult patients who have undergone hip or knee replacement surgery. The PDUFA date is March 15, 2014.
In June 2013, the Company and Pfizer announced that results from the Phase III AMPLIFY trial, which evaluated Eliquis versus the current standard of care for the treatment of acute venous thromboembolism, were published online by the New England Journal of Medicine and presented at Risk Post Sorafenib) clinicalthe International Society on Thrombosis and Haemostasis congress in Amsterdam. The results showed that Eliquis demonstrated comparable efficacy and significantly lower rates of major bleeding in patients compared to the current standard of care.

40



In May 2013, the Company and Pfizer announced the results from a prespecified subanalysis of the ARISTOTLE trial were published in Circulation, the peer-reviewed journal of the American Heart Association. The trends across the subgroup analysis were consistent with the overall study results that had demonstrated Eliquis' superiority versus warfarin in the reduction of stroke or systemic embolism and the number of major bleeding events and mortality in patients with hepatocellular carcinoma (HCC; liver cancer)NVAF.
Eliquis received regulatory approval for the reduction of the risk of stroke and systemic embolism in patients with NVAF in South Korea in January, in Israel and Russia in February, and in Mexico and Colombia in April 2013.
Eliquis received regulatory approval for the prevention of venous thromboembolic events in adult patients who failedhave undergone elective hip or are intolerant to sorafenib did not meet the primary endpoint of improving overall survival versus placebo.

knee replacement surgery in China in January and in Mexico in April 2013.


RESULTS OF OPERATIONS

Net Sales


Total Revenues
The composition of the changes in net salesrevenues was as follows:

  

    Year Ended December 31,    

  

    2011 vs. 2010    

  

    2010 vs. 2009    

  Net Sales  

Analysis of % Change

  

Analysis of % Change

Dollars in Millions 2011  2010  2009  

Total

Change

 Volume  

Price

 Foreign
Exchange
  

Total

Change

 

Volume

 

Price

 

Foreign

Exchange

United States

 $  13,845  $  12,613  $  11,867  10%  3%   7%     6% 3% 3% 

Europe

  3,667   3,448   3,625  6%  5%   (4)%  5%   (5)% 2% (3)% (4)%

Japan, Asia Pacific and Canada

  1,862   1,651   1,522  13%  6%   (1)%  8%   8% 3% (4)% 9%

Latin America, the Middle East and Africa

  894   856   843  4%  3%     1%   2% (3)% 3% 2%

Emerging Markets

  887   804   753  10%  13%   (6)%  3%   7% 5% (2)% 4%

Other

  89   112   198  (21)%  N/A   N/A     (43)% N/A N/A 
 

 

 

  

 

 

  

 

 

         

Total

 $21,244  $19,484  $18,808  9%  4%   3%  2%   4% 2% 1% 1%
 

 

 

  

 

 

  

 

 

         

Our

  Year Ended December 31, 2013 vs. 2012 2012 vs. 2011
  Total Revenues Analysis of % Change Analysis of % Change
        Total     Foreign Total     Foreign
Dollars in Millions 2013 2012 2011 Change Volume Price Exchange Change Volume Price Exchange
United States $8,318
 $10,384
 $14,039
 (20)% (19)% (1)% 
 (26)% (30)% 4 % 
Europe 3,930
 3,706
 3,879
 6 % 7 % (3)% 2 % (4)% 6 % (3)% (7)%
Rest of the World 3,295
 3,204
 3,237
 3 % 11 % (2)% (6)% (1)% 2 % (1)% (2)%
Other(a)
 842
 327
 89
 **
 N/A
 N/A
 
 **
 N/A
 N/A
 
Total $16,385
 $17,621
 $21,244
 (7)% (5)% (1)% (1)% (17)% (17)% 2 % (2)%

(a)Other total revenues include royalties and other alliance-related revenues for products not sold by our regional commercial organizations.
**Change in excess of 100%.

No single country outside the U.S. contributed more than 10% of total sales growthrevenues in any period presented. In general, our business is not seasonal.

The change in U.S. revenues in both periods attributed to volume reflects the exclusivity loss of Plavix* in May 2012 and Avapro*/Avalide* in March 2012, partially offset by increased demand for most key products and Amylin-related product revenues following the completion of our acquisition in August 2012.

The change in U.S. revenues in 2013 attributed to price was attributablea result of the reduction in our share of Abilify* (aripiprazole) revenues from 51.5% in 2012 to higher volume,34.0% in 2013 (8% impact) partially offset by higher average net selling prices favorable foreign exchangeof Abilify* and reflects continued growth in mostother key products offset by declines in sales of AVAPRO*/AVALIDE* and mature brands across all regions and international sales of PLAVIX*.

products. The change in U.S. net salesrevenues in 2012 attributed to price was a result of higher average net selling prices for PLAVIX* in both periods of Abilify* and ABILIFY* in 2011,other key products partially offset by the reduction in our contractual share of ABILIFY* net salesAbilify* revenues from 65%53.5% to 58%51.5% in 2010 and a further reduction to 53.5% in 2011, and higher rebates and discounts resulting from U.S. healthcare reform legislation. The change in U.S. net sales in 2011 attributed to volume reflects the recent launch of YERVOY and increased demand for several key products partially offset by decreased prescription demand for AVAPRO*/AVALIDE* and PLAVIX*, which we expect to continue to

41


decrease as a result of the expected loss of exclusivity of each of those products in 2012. The change in U.S. net sales in 2010 attributed to volume reflects increased demand for several key products. See “—Key Products” for further discussion of salestotal revenues by key product.

Net sales


Revenues in Europe increased in 20112013 due to volume growth for most key products, Amylin-related product revenues following the transition of non-U.S. operations in the the second quarter of 2013 and favorable foreign exchange and sales growth of most key products partially offset by the restructured Sanofi agreement. See "Item 8. Financial Statements—Note 3. Alliances" for further discussion. Revenues decreased in 2012 primarily due to unfavorable foreign exchange and lower salesrevenues of certain mature brands from divestitures and generic competition as well as generic competition for PLAVIX*Plavix* and AVAPRO*Avapro*/AVALIDE*. Net sales in Europe decreased in 2010 due to unfavorable foreign exchange and the previously mentioned generic competition which more thanAvalide* partially offset salesby volume growth infor most key products. Net salesRevenues in both periods werecontinued to be negatively impacted by continuing fiscal challenges in many European countries as healthcare payers, including government agencies, have reduced and are expected to continue to reduce the cost of healthcare costs through actions that directly or indirectly impose additional price reductions. These measures include, but are not limited to, mandatory discounts, rebates, other price reductions and other restrictive measures.

Net sales


Revenues in Japan, Asia Pacific and Canadathe Rest of the World increased in both periods primarily2013 due to higher demandvolume growth for BARACLUDE and SPRYCEL. Net sales in 2011 also increased from the recent launch of ORENCIA in Japan and the approval of SPRYCEL for first line indication in Japan. These impacts weremost key products partially offset by the restructured Sanofi agreement, unfavorable foreign exchange (particularly in Japan), and generic competition for AVAPRO*/AVALIDE*mature brands. Revenues in Canadathe Rest of the World decreased in 20112012 due to generic competition for Plavix* and Avapro*/Avalide* and lower salesrevenues of mature brands from generic competition and divestitures in both periods.

Our Emerging Markets region is comprised of Brazil, Russia, India, China, and Turkey. Net sales growth in both periods was driven by increased sales volume primarily in China and Brazil, which was partially offset by pricing pressuresvolume growth for most key products.


Other revenues increased in Turkey2013 due to higher royalties resulting from the restructured Sanofi agreement and Russia. Higher net sales in China were primarily attributablealliance and other revenue attributed to BARACLUDE and certain mature brands and over-the-counter products alliances. Other revenues increased in both periods. Higher net sales2012 due to enhanced royalty-related

41



revenues and higher revenues attributed to active pharmaceutical ingredient supply agreements resulting from divestitures of manufacturing facilities and restructured alliance agreements. These revenues are expected to decline in Brazil were primarily attributable to REYATAZ in 20112015 and ABILIFY* in 2010.

No single country outside the U.S. contributed more than 10% of our total net sales in 2011, 2010 or 2009.

In general, our business is not seasonal. For information on U.S. pharmaceutical prescriber demand, reference is made to the table within “—Estimated End-User Demand” below, which sets forth a comparison of changes in net sales to the estimated total prescription growth (for both retail and mail order customers) for certain of our key products. U.S. and non-U.S. net sales are categorized based2016 upon the locationexpiration of certain royalty and alliance agreements. See "Item 8. Financial Statements—Note 3. Alliances" for further discussion of the customer.

alliances.


In February 2014, BMS sold to AstraZeneca the diabetes business of BMS which comprised our global alliance with them, including all rights and ownership to Onglyza, Forxiga, Bydureon*, Byetta*, Symlin* and metreleptin. Total revenues of these products were $1.7 billion in 2013. See "Item 8. Financial Statements—Note 5. Assets Held-For-Sale" for further discussion.

We recognize revenue net of gross-to-net sales adjustments that are further described in “—"—Critical Accounting Policies” below.Policies". Our contractual share of ABILIFY*certain Abilify* and ATRIPLA* salesAtripla* revenues is reflected net of all gross-to-net sales adjustments in gross sales.

alliance and other revenues. Although not presented as a gross-to-net adjustment in the below tables, our share of Abilify* and Atripla* gross-to-net adjustments were approximately $1.1 billion in 2013, $1.5 billion in 2012 and $1.3 billion in 2011. Changes in these gross-to-net adjustments were impacted by additional rebates and discounts required under U.S. healthcare reform and a reduction in our share of Abilify* revenues.


The activities and ending reserve balances for each significant category of gross-to-net adjustments were as follows:
Dollars in Millions 
Charge-Backs
Related to
Government
Programs
 
Cash
Discounts
 
Healthcare
Rebates  and
Other
Contract
Discounts
 
Medicaid
Rebates
 
Sales
Returns
 
Other
Adjustments
 Total
Balance at January 1, 2012 $51
 $28
 $417
 $411
 $161
 $181
 $1,249
Provision related to sale made in:              
Current period 651
 191
 351
 423
 256
 451
 2,323
Prior period 
 1
 (67) (37) (8) (17) (128)
Returns and payments (663) (208) (561) (459) (88) (435) (2,414)
Amylin acquisition 2
 1
 34
 13
 23
 3
 76
Impact of foreign currency translation 
 
 1
 
 1
 
 2
Balance at December 31, 2012 $41
 $13
 $175
 $351
 $345
 $183
 $1,108
Provision related to sale made in:              
Current period 563
 154
 504
 360
 114
 540
 2,235
Prior period 
 
 (5) (85) (52) (6) (148)
Returns and payments (565) (153) (477) (388) (107) (479) (2,169)
Assets/related liabilities held-for-sale (2) (2) (48) (11) (20) (1) (84)
Impact of foreign currency translation 
 
 (2) 
 (1) (1) (4)
Balance at December 31, 2013 $37
 $12
 $147
 $227
 $279
 $236
 $938
The reconciliation of gross product sales to net product sales by each significant category of gross-to-net sales adjustments was as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Gross Sales

  $24,007  $21,681  $20,555 

Gross-to-Net Sales Adjustments

    

Charge-Backs Related to Government Programs

   (767  (605  (513

Cash Discounts

   (282  (255  (253

Managed Healthcare Rebates and Other Contract Discounts

   (752  (499  (439

Medicaid Rebates

   (536  (453  (229

Sales Returns

   (76  (88  (101

Other Adjustments

   (350  (297  (212
  

 

 

  

 

 

  

 

 

 

Total Gross-to-Net Sales Adjustments

   (2,763  (2,197  (1,747
  

 

 

  

 

 

  

 

 

 

Net Sales

  $  21,244  $  19,484  $  18,808 
  

 

 

  

 

 

  

 

 

 

42


The activities and ending balances

  Year Ended December 31, % Change
Dollars in Millions 2013 2012 2011 2013 vs. 2012 2012 vs. 2011
Gross product sales $14,391
 $15,849
 $20,385
 (9)% (22)%
Gross-to-Net Adjustments          
Charge-Backs Related to Government Programs (563) (651) (767) (14)% (15)%
Cash Discounts (154) (192) (282) (20)% (32)%
Managed Healthcare Rebates and Other Contract Discounts (499) (284) (752) 76 % (62)%
Medicaid Rebates (275) (386) (536) (29)% (28)%
Sales Returns (62) (248) (76) (75)% **
Other Adjustments (534) (434) (350) 23 % 24 %
Total Gross-to-Net Adjustments (2,087) (2,195) (2,763) (5)% (21)%
Net product sales $12,304
 $13,654
 $17,622
 (10)% (23)%

**    Change in excess of each significant category of gross-to-net sales reserve adjustments were as follows:

Dollars in Millions  Charge-Backs
Related to
Government
Programs
  Cash
Discounts
  Managed
Healthcare
Rebates and
Other
Contract
Discounts
  Medicaid
Rebates
  Sales
Returns
  Other
Adjustments
  Total 

Balance at January 1, 2010

  $42  $26  $199  $166  $169  $88  $690 

Provision related to sales made in current period

   606   255   496   454   118   302   2,231 

Provision related to sales made in prior periods

   (1      3   (1  (30  (5  (34

Returns and payments

   (599  (252  (482  (292  (69  (256  (1,950

Impact of foreign currency translation

                   (1  (2  (3
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2010

  $48  $29  $216  $327  $187  $127  $934 

Provision related to sales made in current period

   767   282   752   541   120   357   2,819 

Provision related to sales made in prior periods

               (5  (44  (7  (56

Returns and payments

   (764  (283  (550  (452  (101  (296  (2,446

Impact of foreign currency translation

           (1      (1      (2
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2011

  $51  $28  $417  $411  $161  $181  $1,249 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

100%



42



Gross-to-net sales adjustments as a percentage of worldwide gross sales were 11.5% in 2011, 10.1% in 2010 and 8.5% in 2009 andadjustment rates are primarily a function of gross sales trends, changes in salesrevenues mix and contractual and legislative discounts and rebates. Gross-to-net sales adjustments increaseddecreased in 2013 and 2012 due to:

Charge-backs

Chargebacks related to government programs, increasedcash discounts and Medicaid rebates decreased in both periods primarily due to reimbursements for price increases in excessas a result of current inflation rates in the U.S.

lower
Plavix* revenues following its loss of exclusivity.

Managed healthcare rebates and other contract discounts in 2013 increased in 2011primarily due to Amylin-related net product sales. Managed healthcare rebates and other contract discounts in 2012 decreased primarily as a result of lower Plavix* revenues following its loss of exclusivity. Managed healthcare rebates and other contract discounts in 2012 also decreased due to a $67 million reduction in the 50% discount for patients withinestimated amount of Medicare Part D coverage gap discounts attributable to prior period rebates after receiving actual invoices and the nonrenewal of Plavix* contract discounts in the Medicare Part D coverage gap.

program as of January 1, 2012.

In 2010,The estimated Medicaid rebates increased dueattributable to the changeprior period sales were reduced by $85 million in minimum rebates on drug sales2013 and $37 million in 2012 after receiving actual invoices and other information from 15.1% to 23.1% and the extension of thecertain state Medicaid rebate rate to drugs sold to risk-based Medicaid managed care organizations. In 2011, Medicaid rebates continued to increase due to the full year impact of the expansion of Medicaid rebates to drugs used in risk-based Medicaid managed care plans and higher average net selling pricesadministrative offices.

The provision for PLAVIX*, and higher Medicaid channel sales.

The increase in unpaid rebates was due in part to timing and an increasing lag in payments attributed to government agencies administrative delays.

In 2011, sales returns included a $29 million reduction of a $44 million U.S. return reserve establishedwas higher in 2010 in connection with a recall of certain lots of AVALIDE* due to lower returns than expected. Sales returns attributable to 2012 sales are expected to increase as a result of the loss of exclusivity of PLAVIX*Plavix* and AVAPRO*Avapro*/AVALIDE*Avalide*. The U.S. sales return reserves for these products were $147 million and $173 million at December 31, 2013 and 2012, respectively, and were determined after considering several factors including estimated inventory levels in 2012.

the distribution channels. In accordance with Company policy, these products are eligible to be returned between six months prior and twelve months after product expiration. Adjustments to these reserves might be required in the future for revised estimates to various assumptions including actual returns, which are mostly expected to occur in 2014.

Other adjustments increased in 2013 primarily due to higher government rebates in non-U.S. markets. Other adjustments increased in 2012 due to U.S. co-pay and coupon programs.


43




Key Products

Net sales

Revenues of key products represented 86%83% of total net salesrevenue in 2011,2013, 84% in 20102012 and 81%86% in 2009.2011. The following table presents U.S. and international net salesrevenues by key product, the percentage change from the prior period and the foreign exchange impact when compared to the prior period. Commentary detailing the reasons for significant variances for key products is provided below:

  Year Ended December 31,  % Change % Change
Attributable  to
Foreign Exchange
 
Dollars in Millions 2011  2010  2009  2011 vs. 2010  

2010 vs. 2009

 2011 vs. 2010  2010 vs. 2009 

Key Products

       

PLAVIX* (clopidogrel bisulfate)

 $  7,087  $  6,666  $  6,146   6 %   8 %        

U.S.

  6,622   6,154   5,556   8 %   11 %        

Non-U.S.

  465   512   590   (9)%   (13)%  3 %    4 %  

AVAPRO*/AVALIDE*

(irbesartan/irbesartan-hydrochlorothiazide)

  952   1,176   1,283   (19)%   (8)%  2 %    2 %  

U.S.

  521   642   722   (19)%   (11)%        

Non-U.S.

  431   534   561   (19)%   (5)%  4 %    3 %  

ABILIFY* (aripiprazole)

  2,758   2,565   2,592   8 %   (1)%  2 %      

U.S.

  2,037   1,958   2,082   4 %   (6)%        

Non-U.S.

  721   607   510   19 %   19 %  6 %    (2)%  

REYATAZ (atazanavir sulfate)

  1,569   1,479   1,401   6 %   6 %  2 %      

U.S.

  760   754   727   1 %   4 %        

Non-U.S.

  809   725   674   12 %   8 %  5 %    (1)%  

SUSTIVA (efavirenz) Franchise

  1,485   1,368   1,277   9 %   7 %  2 %    (1)%  

U.S.

  940   881   803   7 %   10 %        

Non-U.S.

  545   487   474   12 %   3 %  5 %    (3)%  

BARACLUDE (entecavir)

  1,196   931   734   28 %   27 %  5 %    3 %  

U.S.

  207   179   160   16 %   12 %        

Non-U.S.

  989   752   574   32 %   31 %  7 %    3%  

ERBITUX* (cetuximab)

  691   662   683   4 %   (3)%        

U.S.

  672   646   671   4 %   (4)%        

Non-U.S.

  19   16   12   19 %   33 %  3 %    5 %  

SPRYCEL (dasatinib)

  803   576   421   39 %   37 %  3 %      

U.S.

  294   188   123   56 %   53 %        

Non-U.S.

  509   388   298   31 %   30 %  6 %    1 %  

YERVOY (ipilimumab)

  360   N/A    N/A    N/A   N/A  N/A    N/A  

U.S.

  322   N/A    N/A    N/A   N/A  N/A    N/A  

Non-U.S.

  38   N/A    N/A    N/A   N/A  N/A    N/A  

ORENCIA (abatacept)

  917   733   602   25 %   22 %  2 %      

U.S.

  615   547   467   12 %   17 %        

Non-U.S.

  302   186   135   62 %   38 %  8 %    1 %  

NULOJIX (belatacept)

  3   N/A    N/A    N/A   N/A  N/A    N/A  

U.S.

  3   N/A    N/A    N/A   N/A  N/A    N/A  

Non-U.S.

      N/A    N/A    N/A   N/A  N/A    N/A  

ONGLYZA/KOMBIGLYZE (saxagliptin/saxagliptin and metformin)

  473   158   24   **   **  3 %      

U.S.

  339   119   22   **   **        

Non-U.S.

  134   39   2   **   **  **      

Mature Products and All Other

  2,950   3,170   3,645   (7)%   (13)%  4 %    1 %  

U.S.

  513   545   534   (6)%   2 %        

Non-U.S.

  2,437   2,625   3,111   (7)%   (16)%  5 %    1 %  

**Change in excess of 100%.

  Year Ended December 31, % Change 
% Change Attributable  to
Foreign Exchange
Dollars in Millions 2013 2012 2011 2013 vs. 2012 2012 vs. 2011 2013 vs. 2012 2012 vs. 2011
Key Products              
Virology              
Baraclude (entecavir) $1,527
 $1,388
 $1,196
 10 % 16 % (3)% (2)%
U.S. 289
 241
 208
 20 % 16 % 
 
Non-U.S. 1,238
 1,147
 988
 8 % 16 % (3)% (2)%
               
Reyataz (atazanavir sulfate) 1,551
 1,521
 1,569
 2 % (3)% (1)% (3)%
U.S. 769
 783
 771
 (2)% 2 % 
 
Non-U.S. 782
 738
 798
 6 % (8)% (2)% (6)%
               
Sustiva (efavirenz) Franchise 1,614
 1,527
 1,485
 6 % 3 % 
 (2)%
U.S. 1,092
 1,016
 950
 7 % 7 % 
 
Non-U.S. 522
 511
 535
 2 % (4)% 1 % (5)%
               
Oncology              
Erbitux* (cetuximab) 696
 702
 691
 (1)% 2 % 
 
U.S. 682
 688
 681
 (1)% 1 % 
 
Non-U.S. 14
 14
 10
 
 40 % 
 (2)%
               
Sprycel (dasatinib) 1,280
 1,019
 803
 26 % 27 % (4)% (4)%
U.S. 541
 404
 299
 34 % 35 % 
 
Non-U.S. 739
 615
 504
 20 % 22 % (7)% (6)%
               
Yervoy (ipilimumab) 960
 706
 360
 36 % 96 % 
 N/A
U.S. 577
 503
 323
 15 % 56 % 
 
Non-U.S. 383
 203
 37
 89 % **
 
 N/A
               
Neuroscience              
Abilify* (aripiprazole) 2,289
 2,827
 2,758
 (19)% 3 % 
 (1)%
U.S. 1,519
 2,102
 2,052
 (28)% 2 % 
 
Non-U.S. 770
 725
 706
 6 % 3 % 1 % (7)%
               
Metabolics              
Bydureon* (exenatide extended-release for injectable suspension) 298
 78
 N/A
 **
 N/A
 N/A
 N/A
U.S. 263
 75
 N/A
 **
 N/A
 
 N/A
Non-U.S. 35
 3
 N/A
 **
 N/A
 N/A
 N/A
               
Byetta* (exenatide) 400
 149
 N/A
 **
 N/A
 N/A
 N/A
U.S. 304
 147
 N/A
 **
 N/A
 
 N/A
Non-U.S. 96
 2
 N/A
 **
 N/A
 N/A
 N/A
               
Forxiga (dapagliflozin)
 23
 
 N/A
 N/A
 N/A
 N/A
 N/A
U.S. N/A
 N/A
 N/A
 N/A
 N/A
 
 N/A
Non-U.S. 23
 
 N/A
 N/A
 N/A
 N/A
 N/A
               
Onglyza/Kombiglyze
(saxagliptin/saxagliptin and metformin)
 877
 709
 473
 24 % 50 % 
 (2)%
U.S. 591
 516
 346
 15 % 49 % 
 
Non-U.S. 286
 193
 127
 48 % 52 % (2)% (9)%

44


PLAVIX*



  Year Ended December 31, % Change 
% Change Attributable  to
Foreign Exchange
Dollars in Millions 2013 2012 2011 2013 vs. 2012 2012 vs. 2011 2013 vs. 2012 2012 vs. 2011
Key Products (continued)              
Immunoscience              
Nulojix (belatacept) $26
 $11
 $3
 **
 **
 
 N/A
U.S. 20
 9
 3
 **
 **
 
 
Non-U.S. 6
 2
 
 **
 N/A
 
 N/A
               
Orencia (abatacept) 1,444
 1,176
 917
 23 % 28 % (2)% (2)%
U.S. 954
 797
 621
 20 % 28 % 
 
Non-U.S. 490
 379
 296
 29 % 28 % (8)% (6)%
               
Cardiovascular              
Avapro*/Avalide*
(irbesartan/irbesartan-hydrochlorothiazide)
 231
 503
 952
 (54)% (47)% 
 (1)%
U.S. (7) 155
 549
 **
 (72)% 
 
Non-U.S. 238
 348
 403
 (32)% (14)% 
 (3)%
               
Eliquis (apixaban) 146
 2
 
 **
 N/A
 
 N/A
U.S. 97
 
 N/A
 N/A
 N/A
 
 
Non-U.S. 49
 2
 
 **
 N/A
 
 N/A
               
Plavix* (clopidogrel bisulfate)
 258
 2,547
 7,087
 (90)% (64)% 
 
U.S. 153
 2,424
 6,709
 (94)% (64)% 
 
Non-U.S. 105
 123
 378
 (15)% (67)% 3 % (1)%
               
Mature Products and All Other 2,765
 2,756
 2,950
 
 (7)% (1)% (3)%
U.S. 474
 524
 527
 (10)% (1)% 
 
Non-U.S. 2,291
 2,232
 2,423
 3 % (8)% (1)% (3)%
**    Change in excess of 100%

Baracludea platelet aggregation inhibitor that is partan oral antiviral agent for the treatment of our alliance with Sanofi

chronic hepatitis B

U.S. net sales increasedrevenues in both periods primarilyincreased due to higher average net selling prices. Estimated total U.S. prescription demand decreased 5%prices and 1% in 2011 and 2010, respectively.higher demand. We expectmay experience a rapid and materialsignificant decline in PLAVIX* sales following the loss of exclusivityU.S. revenues beginning in May 2012. PLAVIX* sales will depend on erosion rates from2014 due to possible generic competition wholesale and retail inventory levels and expected returns.

following a Federal court’s decision in February 2013 invalidating the composition of matter patent.

International net sales continue to be impacted by the launch of generic clopidogrel products in the EU and Australia. This has a negative impact on both our net sales in EU comarketing countries and Australia and our equity in net income of affiliates as it relates to our share of sales from our partnership with sanofi in Europe and Asia. We expect the continued erosion of PLAVIX* net sales in the EU, which will impact both our international net sales and our equity in net income of affiliates. We also expect erosion of international net sales following the recent loss of exclusivity of PLAVIX* in Canada.

See “Item 8. Financial Statements—Note 22. Legal Proceedings and Contingencies—PLAVIX* Litigation,” for further discussion on PLAVIX* exclusivity litigationrevenues increased in both the U.S. and EU.

AVAPRO*/AVALIDE* (known in the EU as APROVEL*/KARVEA*) — an angiotensin II receptor blocker for the treatment of hypertension and diabetic nephropathy that is also part of the Sanofi alliance

U.S. net sales decreased in 2011periods due to market share losses subsequent to the AVALIDE* supply shortage in the first quarter of 2011 associated with previously reported recalls. Total estimated U.S. prescriptionhigher demand decreased 39% in 2011. The decrease in U.S. net sales was partially offset by higher average net selling prices and the reduction in 2011 of previously established reserves for estimated returns in connection with the recall of certain lots of AVALIDE* during 2010 due to lower actual returns than expected. We expect a rapid, material decline in AVAPRO*/AVALIDE* sales following the loss of exclusivity in March 2012. International net sales decreased in 2011 due to lower demand including generic competition in certain EU markets and Canada.

unfavorable foreign exchange.

U.S. and international net sales decreased in 2010 primarily due to decreased overall demand due to generic competition in the EU and reduced supply of AVALIDE* in addition to a $44 million sales return adjustment recorded as a result of the AVALIDE* recall. Estimated total U.S. prescription demand decreased 17% in 2010.


ELIQUIS — an oral Factor Xa inhibitor for the prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery and in development for the prevention and treatment of venous thromboembolic disorders and stroke prevention in patients with atrial fibrillation that is part of our strategic alliance with Pfizer

ELIQUIS was approved in the EU for VTE prevention in May 2011 and was launched in a limited number of EU countries beginning in May 2011. Net sales were less than $1 million.

ABILIFY* — an antipsychotic agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder and is part of our strategic alliance with Otsuka

U.S. net sales increased in 2011 due to higher overall demand and average net selling prices partially offset by the reduction in our contractual share of net sales from 58% in 2010 to 53.5% in 2011. Estimated total U.S. prescription demand increased 5% in 2011.

U.S. net sales decreased in 2010 primarily due to the reduction in our contractual share of net sales from 65% to 58% and higher Medicaid rebates from healthcare reform. The decrease was partially offset by higher average net selling prices and overall demand. Estimated total U.S. prescription demand increased 5% in 2010.

In both periods, international net sales increased due to higher demand.

REYATAZReyataz — a protease inhibitor for the treatment of the HIV

U.S. revenues in 2013 decreased due to lower demand partially offset by higher average net sales were relatively flatselling prices. U.S. revenues in 2011 and2012 increased in 2010 primarily due to higher demand. Estimated total prescription demandaverage net selling prices.

International revenues in 2013 increased 2% in 2011 and 4% in 2010.

In both periods, international net sales increased primarily due to higher demand.

demand and the timing of government purchases in certain countries. International revenues in 2012 decreased due to unfavorable foreign exchange, the timing of government purchases in certain countries and lower demand resulting from competing products.

SUSTIVA


Sustiva Franchise — a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, which includes SUSTIVA,Sustiva, an antiretroviral drug, and bulk efavirenz, which is also included in the combination therapy, ATRIPLA*Atripla* (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a product sold through our joint venturealliance with Gilead

U.S. net salesrevenues in 2013 increased in 2011 primarily due to higher average net selling prices and higher estimated totalpartially offset by lower demand. U.S. prescription demand of 7%. U.S. net sales increasedrevenues in 2010 primarily due to higher estimated total U.S. prescription demand of 7%.

In both periods, international net sales2012 increased primarily due to higher demand.

demand and higher average net selling prices.

45


BARACLUDE — an oral antiviral agent for the treatment of chronic hepatitis B

Net salesInternational revenues in both periods2013 increased primarily due to higher demand.

favorable foreign exchange. International revenues in 2012 decreased due to unfavorable foreign exchange.

ERBITUX*



45



Erbitux* — a monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells in multiple tumor types as well as normal cells and is currently indicated for use against colorectal cancer and head and neck cancer. ERBITUX*Erbitux* is part of our strategic alliance with Lilly.

Sold by us almost exclusivelyU.S. revenues in the U.S., net sales increased in 2011 primarily due to higher demand, including demand from the approval of ERBITUX* for the first-line treatment of recurrent locally or regionally advanced metastatic squamous cell carcinoma of the head and neck. Net sales in 2010 decreased primarily due to lower demand and lower average net selling prices.

both periods remained relatively flat.

SPRYCEL


Sprycel — an oral inhibitor of multiple tyrosine kinases indicated for the first-line treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including GLEEVEC*Gleevec* (imatinib meslylate) and first-line treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. SPRYCEL. Sprycel is part of our strategic alliance with Otsuka.

Net salesU.S. revenues in both periods increased primarily due to higher demand and higher average net selling prices. Demand

International revenues in 2011 was positively impactedboth periods increased primarily due to higher demand partially offset by the approval of SPRYCEL for first-line treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase in the U.S. and the EU in the fourth quarter of 2010.

unfavorable foreign exchange.

YERVOY


Yervoy — a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma

YERVOYU.S. revenues in both periods increased due to higher demand. U.S. revenues in 2013 were also favorably impacted by the recognition of $27 million of revenues that were previously deferred until sufficient historical experience to estimate sales returns was launcheddeveloped.

International revenues in both periods increased due to higher demand.

Abilify* — an antipsychotic agent for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder and is part of our strategic alliance with Otsuka
U.S. revenues decreased due to a reduction in our contractual share of revenues from 51.5% in 2012 to a 34.0% in 2013, which was partially offset by higher average net selling prices. U.S. revenues in 2012 increased due to higher average net selling prices and a $62 million reduction in BMS’s share in the estimated amount of customer rebates and discounts attributable to 2011 based on actual invoices received.
International revenues in both periods increased primarily due to higher demand. International revenues were impacted by unfavorable foreign exchange in 2012.

Bydureon* — a once-weekly GLP-1 receptor agonist for the treatment of type 2 diabetes and was part of our strategic alliance with AstraZeneca
U.S. revenues are included in our results since the completion of our Amylin acquisition in August 2012.
The transition of international operations of Bydureon* in a majority of markets from Lilly was completed in the second quarter of 20112013. See "Item 8. Financial Statements—Note 3. Alliances" for further discussion.

Byetta* — a twice daily glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes and was part of our strategic alliance with AstraZeneca
U.S. revenues are included in our results since the completion of our Amylin acquisition in August 2012.
The transition of international operations of Byetta* in a majority of markets from Lilly was completed in the second quarter of 2013. See "Item 8. Financial Statements—Note 3. Alliances" for further discussion.

Forxiga — an oral sodium-glucose cotransporter (SGLT2) inhibitor for the treatment of type 2 diabetes and was part of our strategic alliance with AstraZeneca
Forxiga was launched for the treatment of type 2 diabetes in a limited number of EU countriesmarkets during the fourth quarter of 2012 and continues to be launched in various EU markets.

Onglyza/Kombiglyze (known in the thirdEU as Onglyza/Komboglyze) — a once-daily oral tablet for the treatment of type 2 diabetes and fourth quarterswas part of 2011.

our strategic alliance with AstraZeneca

Net sales of $27 million were deferred until patient infusionU.S. revenues in 2013 increased primarily due to higher average net selling prices. U.S. revenues in 2012 increased primarily due to higher overall demand and higher average net selling prices.

International revenues increased in both periods primarily due to higher demand, which was partially offset by unfavorable foreign exchange in 2012.

Nulojixa returns policy establishedfusion protein with novel immunosuppressive activity targeted at prevention of kidney transplant rejection
Nulojix was approved and launched in the third quarter of 2011 in the U.S.

and EU during 2011.

ORENCIA


46



Orencia — a fusion protein indicated for adult patients with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more currently available treatments, such as methotrexate or anti-tumor necrosis factor therapy

U.S. net sales increasedrevenues in both periods increased primarily due to higher demand including the launch of the ORENCIA subcutaneous formulation, and higher average net selling prices.

International net sales increasedrevenues in both periods increased primarily due to higher demand.

demand, partially driven by the launch of the subcutaneous formulation of
Orencia in certain EU markets beginning in the second quarter of 2012, partially offset by unfavorable foreign exchange.

NULOJIX


Avapro*/Avalide* (known in the EU as Aprovel*/Karvea*)a fusion protein with novel immunosuppressive activityan angiotensin II receptor blocker for the treatment of hypertension and diabetic nephropathy that is also part of the Sanofi alliance
U.S. revenues are no longer recognized following the restructured Sanofi agreement, effective January 1, 2013. Negative sales in 2013 were due to an increase in the sales return reserve for Avalide*. U.S. revenues decreased in 2012 due to the loss of exclusivity in March 2012.
International revenues were impacted by changes attributed to the restructured Sanofi agreement. See "Item 8. Financial Statements—Note 3. Alliances" for further discussion. International revenues in 2012 decreased due to lower demand including from generic competition in certain EU markets and Canada.

Eliquis — an oral Factor Xa inhibitor, targeted at stroke prevention in atrial fibrillation and the prevention and treatment of kidney transplant rejection

VTE disorders.
Eliquis is part of our strategic alliance with Pfizer.

NULOJIX was approved and launched in the U.S. and EU during 2011.

ONGLYZA/KOMBIGLYZE — treatment for type 2 diabetes

ONGLYZA/KOMBIGLYZE increased in both periods primarily due to higher overall demand and launches in various countries. KOMBIGLYZEEliquis was launched in the U.S., Europe, Japan and Canada in the fourthfirst quarter of 2010.

2013 and continues to be launched in various markets for the reduction of the risk of stroke and systemic embolism in patients with NVAF.

Eliquis was approved in the EU for VTE prevention in May 2011 and was launched in a limited number of EU countries beginning in May 2011.

Plavix* — a platelet aggregation inhibitor that is part of our alliance with Sanofi
U.S. revenues in both periods decreased due to the loss of exclusivity in May 2012.
International revenues in 2013 were impacted by changes attributed to the restructured Sanofi agreement. See "Item 8. Financial Statements—Note 3. Alliances" for further discussion. International revenues in 2012 were negatively impacted by generic clopidogrel products in the EU, Canada, and Australia.

Mature Products and All Other — includes all other products, including those which have lost exclusivity in major markets, over-the-counter brands and over the counter brands

royalty-related revenue

International net sales

U.S. revenues decreased in 2010both periods from generic erosion of certain products which was partially offset by sales of Symlin* following the completion of our Amylin acquisition in August 2012.
International revenues increased in 2013 due to certain alliances which were partially offset by the continued generic erosion of other products. International revenues in 2012 decreased due to the continued generic erosion of certain products, lower average net selling pricesbrands and unfavorable foreign exchange.
International revenues are expected to decline in Europe,2015 and 2016 upon the year over year impactexpiration of the rationalizationcertain royalty and divestitures of our non-strategic product portfolio and lower demand for certain over the counter products.

alliance agreements.

The estimated U.S. prescription change data provided throughout this report includes information only from the retail and mail order channels and does not reflect product demand within other channels such as hospitals, home health care, clinics, federal facilities including Veterans Administration hospitals, and long-term care, among others. The data is provided by Wolters Kluwer Health (WK), except for SPRYCEL, and is based on the Source Prescription Audit. As of December 31, 2011, SPRYCEL demand is based upon information from the Next-Generation Prescription Service (NGPS) version 2.0 of the National Prescription Audit provided by the IMS Health (IMS). The data is a product of each respective service providers’ own recordkeeping and projection processes and therefore subject to the inherent limitations of estimates based on sampling and may include a margin of error.

Prior to December 31, 2011, SPRYCEL demand was calculated based upon data obtained from the IMS Health (IMS) National Sales Perspectives Audit. Since management believes information from IMS’ National Prescription Audit more accurately reflects subscriber demands trends versus pill data from IMS’ National Sales Perspectives Audit, all prior year SPRYCEL data has been restated to reflect information from IMS’ National Prescription Audit.

46


We continuously seek to improve the quality of our estimates of prescription change amounts and ultimate patient/consumer demand by reviewing the calculation methodologies employed and analyzing internal and third-party data. We expect to continue to review and refine our methodologies and processes for calculation of these estimates and will monitor the quality of our own and third parties’ data used in such calculations.

We calculated the estimated total U.S. prescription change on a weighted-average basis to reflect the fact that mail order prescriptions include a greater volume of product supplied, compared to retail prescriptions. Mail order prescriptions typically reflect a 90-day prescription whereas retail prescriptions typically reflect a 30-day prescription. The calculation is derived by multiplying mail order prescription data by a factor that approximates three and adding to this the retail prescriptions. We believe that a calculation of estimated total U.S. prescription change based on this weighted-average approach provides a superior estimate of total prescription demand in retail and mail order channels. We use this methodology for our internal demand reporting.


Estimated End-User Demand

The following tables set forth for each of our key products sold in the U.S. for the years ended December 31, 2011, 2010 and 2009: (i) change in reported U.S. net sales for each year; (ii) estimated total U.S. prescription change for the retail and mail order channels calculated by us based on third-party data on a weighted-average basis, and (iii) months of inventory on hand in the wholesale distribution channel.

      Year Ended December 31,    At December 31, 
    Change in U.S.
Net Sales
  % Change in U.S.
Total Prescriptions
  Months on
Hand
 
Dollars in Millions  2011  2010  2009  2011  2010  2009  2011   2010   2009 

PLAVIX*

   8  11  13  (5)  (1)  4  0.5    0.5    0.5 

AVAPRO*/AVALIDE*

   (19)  (11)  (2)  (39)  (17)  (9)  0.6    0.4    0.4 

ABILIFY*

   4  (6)  24  5  5  26  0.5    0.4    0.4 

REYATAZ

   1  4  9  2  4  8  0.5    0.5    0.5 

SUSTIVA Franchise(a)

   7  10  11  7  7  10  0.6    0.4    0.5 

BARACLUDE

   16  12  14  9  12  13  0.6    0.6    0.5 

ERBITUX*(b)

   4  (4)  (9)  N/  N/  N/  0.6    0.5    0.5 

SPRYCEL

   56  53  34  30  21  27  0.7    0.6    0.7 

YERVOY(b)(c)

   N/  N/  N/  N/  N/  N/  0.6    N/A     N/A  

ORENCIA(b)

   12  17  29  N/  N/  N/  0.5    0.6    0.5 

NULOJIX(b)(c)

   N/  N/  N/  N/  N/  N/  3.5    N/A     N/A  

ONGLYZA/KOMBIGLYZE(d)

   *  *  N/  *  *  N/  0.5    0.8    3.7 

(a)

The SUSTIVA Franchise (total revenue) includes sales of SUSTIVA and revenue of bulk efavirenz included in the combination therapy ATRIPLA*. The months on hand relates only to SUSTIVA.

(b)

ERBITUX*, YERVOY, ORENCIA and NULOJIX are parenterally administered products and do not have prescription-level data as physicians do not write prescriptions for these products.

(c)

YERVOY and NULOJIX were launched in the U.S. in the second quarter of 2011.

(d)

ONGLYZA was launched in the U.S. in the third quarter of 2009. KOMBIGLYZE was launched in the U.S. in the fourth quarter of 2010. ONGLYZA had 0.5 month of inventory on hand at December 31, 2010. KOMBIGLYZE had 51.8 months of inventory on hand at December 31, 2010 to support the initial product launch.

**

Change in excess of 100%.


Pursuant to the U.S. Securities and Exchange Commission (SEC) Consent Order described below under “—SEC Consent Order”, we monitor the level of inventory on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We are obligated to disclose products with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception. Estimated levels of inventory in the distribution channel in excess of one month on hand for these products were not material as of the dates indicated above. Below areNo U.S. products that had estimated levels of inventory in the distribution channel in excess of one month on hand at December 31, 2011, and2013. Below are international products that had estimated levels of inventory in the distribution channel in excess of one month on hand at September 30, 2011.

NULOJIX had 3.5 months of inventory on hand in the U.S. to support the initial product launch. The inventory is nominal and is expected to be worked down in less than that amount of time as demand for this new product increases post launch.

DAFALGAN,2013.


Dafalgan, an analgesic product sold principally in Europe, had 1.1 months of inventory on hand at direct customers compared to 1.4 months of inventory on hand at September 30, 2013 and December 31, 2010.2012. The level of inventory on hand was primarily due to ordering patterns of pharmacists in France.

FERVEX, a cold and flu product,


Reyataz had 3.01.1 months of inventory on hand internationally at direct customersSeptember 30, 2013 compared to 6.4 months0.7 month of inventory on hand at December 31, 2010. The level of inventory on hand decreased due to higher demand in France and Russia.

47


LUFTAL, an antacid product, had 1.5 months of inventory on hand internationally at direct customers compared to 1.3 months of inventory on hand at December 31, 2010.2012. The level of inventory on hand was primarily due to government purchasing patterns in Brazil.



47



In the U.S., for all products sold exclusively through wholesalers or through distributors, we generally determineddetermine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which account for approximately 90% of total gross sales of U.S. products, and provided by our distributors.products. Factors that may influence our estimates include generic competition, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted by their recordkeeping processes.


For our businesses outside of the U.S., we have significantly more direct customers. Limited information on direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information, where available, varies widely. In cases whereWhen direct customer product level inventory, ultimate patient/consumer demand or out-movement data does not exist or is otherwise not available, we have developed a variety of other methodologies to estimate such data, including using such factors as historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Accordingly, we rely on a variety of methods to estimate direct customer product level inventory and to calculate months on hand. Factors that may affect our estimates include generic competition, seasonality of products, direct customer purchases in light of price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business for the year ended December 31, 20112013 is not available prior to the filing of this annual report on Form 10-K. We will disclose any product with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception, in the next quarterly report on Form 10-Q.


Expenses

   Net Sales  % Change 
   2011  2010  2009  2011 vs.
2010
  2010 vs.
2009
 

Cost of products sold

  $5,598  $5,277  $5,140   6  3

Marketing, selling and administrative

   4,203   3,686   3,946   14  (7)

Advertising and product promotion

   957   977   1,136   (2)  (14)

Research and development

   3,839   3,566   3,647   8  (2)

Provision for restructuring

   116   113   136   3  (17)

Litigation expense, net

       (19  132   (100)   ** 

Equity in net income of affiliates

   (281  (313  (550  (10)  (43)

Other (income)/expense

   (169  126   (381   **    ** 
  

 

 

  

 

 

  

 

 

   

Total Expenses

  $  14,263  $  13,413  $  13,206   6  2
  

 

 

  

 

 

  

 

 

   

**Change is in excess of 100%.

        % Change
Dollar in Millions 2013 2012 2011 2013 vs. 2012 2012 vs. 2011
Cost of products sold $4,619
 $4,610
 $5,598
 
 (18)%
Marketing, selling and administrative 4,084
 4,220
 4,203
 (3)% 
Advertising and product promotion 855
 797
 957
 7 % (17)%
Research and development 3,731
 3,904
 3,839
 (4)% 2 %
Impairment charge for BMS-986094 intangible asset 
 1,830
 
 (100)% N/A
Other (income)/expense 205
 (80) (334) **
 (76)%
Total Expenses $13,494
 $15,281
 $14,263
 (12)% 7 %
**    Change in excess of 100%

Cost of products sold


Cost of products sold consists ofinclude material costs, internal labor and overhead from our owned manufacturing sites, third-party processing costs, other supply chain costs and the settlement of foreign currency forward contracts that are used to hedge forecasted intercompany inventory purchase transactions. Essentially all of these costs are managed primarily throughby our global manufacturing organization, referred to as Technical Operations. Discoveryand supply organization. Cost of products also includes royalties and profit sharing attributed to licensed products in connection withand alliances, profit sharing payments in certain collaborations, and the amortization of acquired developed technology costs from business combinations and milestone payments that occur on or after regulatory approval are also included in cost of products sold.

approval.


Cost of products sold can vary between periods as a result of product mix (particularly resulting from royalties and profit sharing expenses in connection with our alliances), price, inflation and costs attributed to the rationalization of manufacturing sites resulting in accelerated depreciation, impairment charges and other stranded costs. In addition, changes in foreign currency may also provide volatility given a high percentage of totalas certain costs are denominated in foreign currencies.

The increase in cost of products sold in both periods was primarily attributable to higher sales volume resulting in additional royalties, collaboration fees, and profit sharing expense, and unfavorable foreign exchange. Cost of products sold as a percentage of net salestotal revenues were 28.2% in 2013, 26.2% in 2012, and 26.4% in 2011, 27.1% in 2010, and 27.3% in 2009 and reflected more2011. These changes were primarily attributed to a less favorable product mix as a result of royalties and profit sharing expenses in connection with our alliances.


Cost of products sold in 2013 was relatively flat as higher profit sharing expenses in connection with our alliances (including those resulting from the Amylin acquisition in August 2012) and higher net amortization costs attributable to the Amylin acquisition were partially offset by lower royalties following the loss of exclusivity of Plavix* and Avapro*/Avalide* and higher impairment charges during 20112012.
The decrease in cost of products sold in 2012 was primarily attributed to lower sales volume following the loss of exclusivity of Plavix* and 2010.

Avapro*/Avalide* which resulted in lower royalties in connection with our Sanofi alliance and favorable foreign exchange partially offset by impairment charges discussed below and higher amortization costs resulting from the Amylin acquisition (net of the amortization of the Amylin alliance proceeds).

Impairment charges of $147 million were recognized in 2012, including $120 million related to continued competitive pricing pressures and a reduction in the undiscounted projected cash flows to an amount less than the carrying value of a developed technology intangible asset. The remaining $27 million impairment charge related to the abandonment of a manufacturing facility resulting from the outsourcing of a manufacturing process.

48




Marketing, selling and administrative


Marketing, selling and administrative expenses consist ofinclude salary and benefit costs, third-party professional and marketing fees, outsourcing fees, shipping and handling costs and other expenses that are not attributed to product manufacturing costs or research and development expenses. Most of theseThese expenses are managed through regional commercialization functionsorganizations or global functionscorporate organizations such as finance, law, information technology and human resources.

The increaseMarketing, selling and administrative expenses in 2011 was primarily attributed2013 decreased due to the annualaccelerated vesting of stock options and restricted stock units related to the Amylin acquisition ($67 million) in 2012, a lower pharmaceutical company fee ($220 million), unfavorable foreign exchangeassessed by the Federal government, and, higher marketing costs to support new launches and key products and to a lesser extent, higher bad debt expense in the EU, charitable funding and information technology expenses.

The decrease in 2010 was primarily attributed to the reduction in sales related activities offor certain key products to coincide with their respective life cycle; prior year impactlifecycles partially offset by higher spending to support the launch of new key products and additional spending following the Amylin acquisition.

Marketing, selling and administrative expenses in 2012 increased primarily as a $100result of the Amylin acquisition ($125 million, funding payment made toincluding the BMS Foundation;accelerated vesting of stock options and restricted stock units), partially offset by a reduction in our ABILIFY* sales force as Otsuka established it own sales forcesales-related activities for promotion of ABILIFY*, SPRYCELPlavix* and IXEMPRA; reduced project standardization implementation costs from the 2009 role out of new accountingAvapro*/Avalide*. Marketing, selling and human resource related systems; and overall efficiencies gained from continuous improvement initiatives.

administrative expenses were also impacted by favorable foreign exchange.


Advertising and product promotion


Advertising and product promotion expenses consist of relatedinclude media, sample and direct to consumer programs.

The decreaseAdvertising and product promotion expenses in 2010 was2013 increased primarily attributeddue to higher spending for recently launched key products.

Advertising and product promotion expenses in 2012 decreased primarily due to lower spending on the promotion of Plavix*, Avapro*/Avalide*, Abilify*, and certain key productsmature brands in the U.S. to coincide with their product life cycle and Otsuka’s reimbursement of certain ABILIFY*, SPRYCEL and IXEMPRA advertising and product promotion expenses partially offset by increased spending for the ONGLYZA launch and other pipeline products.

cycle.


Research and development


Research and development expenses consist ofinclude salary and benefit costs, third-party grants and fees paid to clinical research organizations, supplies and facility costs. Total research and development expenses include the costs of discovery research, preclinical development, early- and late-clinical development and drug formulation, as well as clinical trials and medical support of marketed products, proportionate allocations of enterprise-wide costs, facilities, information technology, and employee stock compensation costs, and other appropriate costs. These expenses also include third-partyUpfront licensing fees that are typically paid upfront as well as whenand other related payments upon the achievement of regulatory or other contractual milestones are met.also included. Certain expenses are shared with alliance partners based upon contractual agreements.


Most expenses are managed by our global research and development organization of which, approximately $2.2 billion, $1.9 billion and $2.0 billion of the total spend in 2013, 2012 and 2011, respectively, was attributed to development activities with the remainder attributed to preclinical and research activities. These expenses can vary between periods for a number of reasons, including the timing of upfront, milestone and other licensing payments.

The increaseResearch and development expenses in 2011 was attributed2013 decreased primarily due to higher upfront, milestoneprior year impairment charges, accelerated vesting of stock options and other licensing payments, unfavorable foreign exchange,restricted stock units related to the Amylin acquisition and additional development costs resulting from the acquisition of ZymoGenetics. Upfront, milestone and other licensing payments were $207 million in 2011 which included an $88 million payment associated with an amendment of an intellectual property license agreement for YERVOY prior to its FDA approval and payments to Abbott Laboratories (Abbott), Innate, Ambrx, Alder Biopharmaceuticals, Inc. (Alder), and Nissan Chemical Industries, Ltd. and Teijin Pharma Limited (Nissan and Teijin) for exclusive licenses to develop and commercialize certain programs and compounds.

The decrease in 2010 was attributed to lower upfront, milestone and other licensing payments partially offset by additional spendingcosts following the Amylin acquisition and higher clinical grant spending.

Research and development expenses in 2012 increased primarily from $60 million of expenses related to support our maturing pipelinethe Amylin acquisition (including accelerated vesting of Amylin stock options and compounds obtained from our string-of-pearls strategy. Upfront,restricted stock units of $27 million) partially offset by favorable foreign exchange and the net impact of upfront, milestone, and other licensing payments were $132and IPRD impairment charges. Refer to “Specified Items” included in “—Non-GAAP Financial Measures” for amounts attributed to each period. IPRD impairment charges relate to projects previously acquired in the Medarex, Inc. (Medarex) acquisition and Inhibitex, Inc (Inhibitex) acquisition (including $45 million in 2010 primarily attributed2012 related to Exelixis, Allergan Inc.FV-100, a nucleoside inhibitor for the reduction of shingles-associated pain) resulting from unfavorable clinical trial results and Abbottdecisions to cease further development.

Impairment charge for BMS-986094 intangible asset

A $1.8 billion impairment charge was recognized in 2012 when the development of BMS-986094 (formerly INX-189), a compound which we acquired as part of our acquisition of Inhibitex to treat hepatitis C virus infection, was discontinued in the interest of patient safety. See “Item 8. Financial Statements —Note 14. Goodwill and $347 millionOther Intangible Assets” for further information.

Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for recently launched products or IPRD.  These assets are initially measured at fair value and therefore a reduction in 2009 primarily attributedexpectations used in the valuations could potentially lead to ZymoGenetics, Alder, and Nissan and Teijin.

Provisionan impairment. See “—Critical Accounting Policies” for restructuring

The provisionfurther discussion.

49



Other (income)/expense
Other (income)/expense include:
  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Interest expense $199
 $182
 $145
Investment income (104) (106) (91)
Provision for restructuring 226
 174
 116
Litigation charges/(recoveries) 20
 (45) 6
Equity in net income of affiliates (166) (183) (281)
Out-licensed intangible asset impairment 
 38
 
Gain on sale of product lines, businesses and assets (2) (53) (37)
Other income received from alliance partners, net (148) (312) (140)
Pension curtailments and settlements 165
 158
 10
Other 15
 67
 (62)
Other (income)/expense $205
 $(80) $(334)

Interest expense increased in both periods due to higher average borrowings.
Provision for restructuring was primarily attributable to employee termination benefits for continuous improvement initiatives.

Litigation expense, net

benefits. Employee termination costs of $145 million were incurred in 2013 as a result of workforce reductions in several European countries. The 2009 amount wasemployee reductions are primarily attributed to sales force reductions resulting from the restructuring of the Sanofi and Otsuka agreements and streamlining operations due to a $125challenging market conditions in Europe.

Litigation charges/(recoveries) in 2012 included $172 million securities litigation settlement.

Equity in net incomefor our share of affiliatesthe Apotex damages award concerning

Plavix*.

Equity in net income of affiliates wasis primarily related to our international partnership with Sanofi in Europe and varies basedAsia which decreased in both periods as a result of our restructuring of the Sanofi agreement and continues to be negatively impacted by generic competition for Plavix* in Europe and Asia. Equity in net income of affiliates in 2012 decreased due to the continued impact of generic competition on international PLAVIX*Plavix* net sales, included within this partnership.

The decrease in 2010 is attributedthe conversion of certain territories to opt-out markets and the impact of an alternative salt formunfavorable foreign exchange.

Out-licensed intangible asset impairment charges in 2012 are related to assets acquired in the Medarex and ZymoGenetics, Inc. (ZymoGenetics) acquisitions and resulted from unfavorable clinical trial results and/or abandonment of clopidogrel and generic clopidogrel competition on international PLAVIX* net sales that commenced in 2009. For additional information, see “Item 8. Financial Statements—Note 3. Alliances and Collaborations.”

49


Other (income)/expense

Other (income)/expense include:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Interest expense

  $    145  $    145  $    184 

Interest income

   (91  (75  (54

Impairment and loss on sale of manufacturing operations

       236     

Gain on sale of product lines, businesses and assets

   (37  (39  (360

Other income received from alliance partners

   (140  (136  (148

Pension curtailment and settlement charges

   10   28   43 

Litigation charges/(recoveries)

   (25        

Product liability charges/ (recoveries)

   31   17   (6

Other

   (62  (50  (40
  

 

 

  

 

 

  

 

 

 

Other (income)/expense

  $(169 $126  $(381
  

 

 

  

 

 

  

 

 

 

Impairment and loss on sale of manufacturing operations was primarily attributed to the disposal of our manufacturing operations in Latina, Italy in 2010.

programs.

Gain on sale of product lines, businesses and assets was primarily related to the sale of a building in Mexico in 2012 and the sale of mature brands including businesses within Indonesia and Australia in 2009.

2011.

Other income from alliance partners includes income earned from the Sanofi partnershiproyalties and amortization of certain upfront, milestone and other licensing payments related to othercertain alliances.

The decrease in U.S.
Plavix* net product sales resulted in lower development royalties owed to Sanofi in 2013. Royalties received from Sanofi (except in Europe and Asia) are presented in revenues beginning in 2013 as a result of the restructured Sanofi agreement. See "Item 8. Financial Statements—Note 3. Alliances" for further discussion.

Pension curtailment and settlement charges were primarily attributed to amendments which eliminatedrecognized after determining the crediting of future benefits related toannual lump sum payments would exceed the annual interest and service costs for certain pension plans, including the primary U.S. pension plan participants. These amendments resulted in a curtailment charge of $6 million2013 and $25 million during 2010 and 2009, respectively.2012. The remainder ofcharges included the charges resulted from lump sum payments in certain plans which exceeded the sum of plan interest costs and service costs, resulting in an acceleration of a portion of previously deferredunrecognized actuarial losses. AdditionalSimilar charges may be recognizedoccur in the future, particularly with the U.S. pension plans due to a lower threshold resulting from the elimination of service costs and potentially higher lump sum payments.future. See “Item 8. Financial Statements—Note 19. Pension, Postretirement and Postemployment Liabilities” for further detail.

Product liabilityThe change in Other is primarily related to higher acquisition costs and losses on debt repurchases in 2012 and sales tax reimbursements, gains on debt repurchases, and higher upfront, milestone and licensing receipts in 2011.


Income Taxes
Dollars in Millions2013 2012 2011
Earnings Before Income Taxes$2,891
 $2,340
 $6,981
Provision for/(benefit from) income taxes311
 (161) 1,721
Effective tax/(benefit) rate10.8% (6.9)% 24.7%

The change in the effective tax rates was primarily due to a $392 million tax benefit in 2012 attributed to a capital loss deduction resulting from the tax insolvency of Inhibitex. The impact of this deduction reduced the effective tax rate by 16.7 percentage points in 2012. Other changes resulted from tax benefits attributable to higher impairment charges in 20112012 (including an $1,830 million impairment charge for the BMS-986094 intangible asset in the U.S.); favorable earnings mix between high and 2010 werelow tax jurisdictions attributable to lower Plavix* revenues and to a lesser extent, an internal transfer of intellectual property in the fourth quarter of 2012; the legal enactment of the 2012 and 2013 research and development tax credit during 2013, and higher charges from contingent tax matters.


50



Historically, the effective income tax rate is lower than the U.S. statutory rate of 35% due to our decision to indefinitely reinvest the earnings for additional reservescertain of our manufacturing operations in connectionIreland and Puerto Rico. We have favorable tax rates in Ireland and Puerto Rico under grants not scheduled to expire prior to 2023.

Noncontrolling Interest

See “Item 8. Financial Statements—Note 3. Alliances” for a discussion of our Plavix* and Avapro*/Avalide* partnerships with Sanofi for the breast implant settlement programterritory covering the Americas. The decrease in noncontrolling interest in both periods resulted from the exclusivity loss in the U.S. of Plavix* in May 2012 and hormone replacement therapy products.

Avapro*/Avalide* in March 2012. A summary of noncontrolling interest is as follows:

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Sanofi partnerships $36
 $844
 $2,323
Other 1
 14
 20
Noncontrolling interest-pre-tax 37
 858
 2,343
Income taxes (20) (317) (792)
Net earnings attributable to noncontrolling interest-net of taxes $17
 $541
 $1,551

Non-GAAP Financial Measures


Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that due to their significant and/or unusual nature are evaluated on an individual basis. These items are excluded from segment income. Similar charges or gains for some of these items have been recognized in prior periods and it is reasonably possible that they could reoccur in future periods. Non-GAAP information is intended to portray the results of our baseline performance which include the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceutical products on a global basis and to enhance an investor’s overall understanding of our past financial performance and prospects for the future. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP.

50



51



Specified items were as follows:

   Year Ended December 31, 
Dollars in Millions, except per share data  2011  2010  2009 

Cost of products sold*

  $75  $113  $123 

Process standardization implementation costs

   29   35   110 

BMS foundation funding initiative

           100 
  

 

 

  

 

 

  

 

 

 

Marketing, selling and administrative

   29   35   210 

Upfront, milestone and other licensing payments

   207   132   347 

IPRD impairment

   28   10     
  

 

 

  

 

 

  

 

 

 

Research and development

   235   142   347 

Provision for restructuring

   116   113   136 

Litigation expense/ (recoveries)

       (19  132 

Impairment and loss on sale of manufacturing operations

       236     

Gain on sale of product lines, businesses and assets

   (12      (360

Pension curtailment and settlement charges

   13   18   36 

Acquisition related items

       10   (10

Litigation charges/(recoveries)

   (22        

Product liability charges/(recoveries)

   31   17   (5

Loss on sale of investments

           31 

Debt repurchase

           (7

Upfront, milestone and other licensing receipts

   (20        
  

 

 

  

 

 

  

 

 

 

Other (income)/expense

   (10  281   (315

Decrease to pretax income

   445   665   633 

Income tax on items above

   (136  (180  (205

Out-of period tax adjustment

       (59    

Specified tax (benefit)/charge**

   (97  207     
  

 

 

  

 

 

  

 

 

 

Income taxes

   (233  (32  (205
  

 

 

  

 

 

  

 

 

 

Decrease to net earnings

  $212  $633  $428 
  

 

 

  

 

 

  

 

 

 

*Specified items included in cost of products sold include accelerated depreciation, asset impairment, and other shutdown costs.
**The 2011 specified tax benefit relates to releases of tax reserves that were specified in prior periods. The 2010 specified tax charge relates to a tax charge from additional U.S. taxable income from earnings of foreign subsidiaries previously considered to be permanently reinvested offshore.

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Accelerated depreciation, asset impairment and other shutdown costs $36
 $147
 $75
Amortization of acquired Amylin intangible assets 549
 229
 
Amortization of Amylin alliance proceeds (273) (114) 
Amortization of Amylin inventory adjustment 14
 23
 
Cost of products sold 326
 285
 75
       
Stock compensation from accelerated vesting of Amylin awards 
 67
 
Process standardization implementation costs 16
 18
 29
Marketing, selling and administrative 16
 85
 29
       
Stock compensation from accelerated vesting of Amylin awards 
 27
 
Upfront, milestone and other licensing payments 16
 47
 207
IPRD impairment 
 142
 28
Research and development 16
 216
 235
       
Impairment charge for BMS-986094 intangible asset 
 1,830
 
       
Provision for restructuring 226
 174
 116
Gain on sale of product lines, businesses and assets 
 (51) (12)
Pension settlements 161
 151
 13
Acquisition and alliance related items (10) 43
 
Litigation charges/(recoveries) (23) (45) 9
Upfront, milestone and other licensing receipts (14) (10) (20)
Out-licensed intangible asset impairment 
 38
 
Loss on debt repurchases 
 27
 
Other (income)/expense 340
 327
 106
       
Increase to pretax income 698
 2,743
 445
       
Income tax on items above (242) (947) (136)
Specified tax benefit(a)
 
 (392) (97)
Income taxes (242) (1,339) (233)
Increase to net earnings $456
 $1,404
 $212

(a)    The 2012 specified tax benefit relates to a capital loss deduction. The 2011 specified tax benefit relates to releases of tax reserves that were specified in prior periods.
The reconciliations from GAAP to Non-GAAP were as follows:

   Year Ended December 31, 
Dollars in Millions, except per share data  2011  2010  2009 

Net Earnings Attributable to BMS—GAAP

  $  3,709  $  3,102  $  3,239 

Earnings attributable to unvested restricted shares

   (8  (12  (17
  

 

 

  

 

 

  

 

 

 

Net Earnings Attributable to BMS used for Diluted EPS Calculation—GAAP

  $3,701  $3,090  $3,222 
  

 

 

  

 

 

  

 

 

 

Net Earnings Attributable to BMS—GAAP

  $3,709  $3,102  $3,239 

Less Specified Items

   212   633   428 
  

 

 

  

 

 

  

 

 

 

Net Earnings Attributable to BMS—Non-GAAP

   3,921   3,735   3,667 

Earnings attributable to unvested restricted shares

   (8  (12  (17
  

 

 

  

 

 

  

 

 

 

Net Earnings Attributable to BMS used for Diluted EPS Calculation—Non-GAAP

  $3,913  $3,723  $3,650 
  

 

 

  

 

 

  

 

 

 

Average Common Shares Outstanding—Diluted

   1,717   1,727   1,978 

Diluted EPS Attributable to BMS—GAAP

  $2.16  $1.79  $1.63 

Diluted EPS Attributable to Specified Items

   0.12   0.37   0.22 
  

 

 

  

 

 

  

 

 

 

Diluted EPS Attributable to BMS—Non-GAAP

  $2.28  $2.16  $1.85 
  

 

 

  

 

 

  

 

 

 

Income Taxes

The effective income tax rate on earnings from continuing operations before income taxes was 24.7% in 2011, 25.7% in 2010 and 21.1% in 2009. The effective income tax rate is lower than the U.S. statutory rate of 35% due to our decision to indefinitely reinvest the earnings for certain of our manufacturing operations in Ireland and Puerto Rico. We have favorable tax rates in Ireland and Puerto Rico under grants not scheduled to expire prior to 2023.

51

  Year Ended December 31,
Dollars in Millions, except per share data 2013 2012 2011
Net Earnings Attributable to BMS — GAAP $2,563
 $1,960
 $3,709
Earnings attributable to unvested restricted shares 
 (1) (8)
Net Earnings Attributable to BMS used for Diluted EPS Calculation — GAAP $2,563
 $1,959
 $3,701
       
Net Earnings Attributable to BMS — GAAP $2,563
 $1,960
 $3,709
Less Specified Items 456
 1,404
 212
Net Earnings Attributable to BMS — Non-GAAP 3,019
 3,364
 3,921
Earnings attributable to unvested restricted shares 
 (1) (8)
Net Earnings Attributable to BMS used for Diluted EPS Calculation — Non-GAAP $3,019
 $3,363
 $3,913
       
Average Common Shares Outstanding — Diluted 1,662
 1,688
 1,717
       
Diluted EPS Attributable to BMS — GAAP $1.54
 $1.16
 $2.16
Diluted EPS Attributable to Specified Items 0.28
 0.83
 0.12
Diluted EPS Attributable to BMS — Non-GAAP $1.82
 $1.99
 $2.28


52

Fluctuations in the effective tax rate were impacted by a $207 million tax charge in 2010, earnings mix between high and low tax jurisdictions, contingent tax matters and changes in prior period estimates upon finalizing tax returns. For a detailed discussion of changes in the effective tax rate, see “Item 8. Financial Statements—Note 8. Income Taxes.” Our future effective tax rate will also be adversely affected if the research and development tax credit is not extended.

Discontinued Operations

On December 23, 2009, we completed a split-off of our remaining interest in Mead Johnson by means of an exchange offer to BMS shareholders. See “Item 8. Financial Statements—Note 5. Mead Johnson Nutrition Company Initial Public Offering and Split-off.”

Noncontrolling Interest

Noncontrolling interest is primarily related to our partnerships with sanofi for the territory covering the Americas related to PLAVIX* net sales. See “Item 8. Financial Statements—Note 3. Alliances and Collaborations.” The increase in noncontrolling interest corresponds to increased net sales of PLAVIX* in the U.S. Following the expected loss of exclusivity of PLAVIX* and AVAPRO*/AVALIDE* in the U.S. during 2012, we expect a significant decrease in net earnings attributable to noncontrolling interest. Net earnings from discontinued operations attributable to noncontrolling interest primarily relates to the 16.9% publicly owned portion of Mead Johnson prior to our complete divestiture from the split-off. A summary of noncontrolling interest is as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Sanofi partnerships

  $  2,323  $  2,074  $  1,717 

Other

   20   20   26 
  

 

 

  

 

 

  

 

 

 

Noncontrolling interest—pre-tax

   2,343   2,094   1,743 

Income taxes

   (792  (683  (562
  

 

 

  

 

 

  

 

 

 

Net earnings from continuing operations attributable to noncontrolling interest—net of taxes

   1,551   1,411   1,181 

Net earnings from discontinued operations attributable to noncontrolling interest—net of taxes

           69 
  

 

 

  

 

 

  

 

 

 

Net earnings attributable to noncontrolling interest—net of taxes

  $1,551  $1,411  $1,250 
  

 

 

  

 

 

  

 

 

 




Financial Position, Liquidity and Capital Resources


Our net cashdebt position was as follows:

Dollars in Millions  2011  2010 

Cash and cash equivalents

  $5,776  $5,033 

Marketable securities—current

   2,957   2,268 

Marketable securities—non-current

   2,909   2,681 
  

 

 

  

 

 

 

Total cash, cash equivalents and marketable securities

   11,642   9,982 

Short-term borrowings, including current portion of long-term debt

   (115  (117

Long-term debt

   (5,376  (5,328
  

 

 

  

 

 

 

Net cash position

  $6,151  $4,537 
  

 

 

  

 

 

 

We maintain a significant level of working capital, which was approximately $7.5 billion at December 31, 2011 and $6.5 billion at December 31, 2010. In 2012 and future periods, we expect cash generated by our U.S. operations, together with existing cash, cash equivalents, marketable securities and borrowings from the capital markets, to be sufficient to cover cash needs for dividends, common stock repurchases, debt repurchases, strategic alliances and acquisitions (including the acquisition of Inhibitex for $2.5 billion), milestone payments, working capital and capital expenditures. We do not rely on short-term borrowings to meet our current liquidity needs.

Dollars in Millions 2013 2012
Cash and cash equivalents $3,586
 $1,656
Marketable securities — current 939
 1,173
Marketable securities — non-current 3,747
 3,523
Total cash, cash equivalents and marketable securities 8,272
 6,352
Short-term borrowings and current portion of long-term debt (359) (826)
Long-term debt (7,981) (6,568)
Net debt position $(68) $(1,042)

Cash, cash equivalents and marketable securities held in the U.S. was $8.7were approximately $2.2 billion at December 31, 2011. Approximately $2.3 billion2013. Most of the remaining $2.9$6.1 billion is held primarily in low taxlow-tax jurisdictions and is attributable to earnings that are expected to be indefinitely reinvested offshore. Cash repatriations are subject to restrictions in certain jurisdictions and may be subject to withholding and otheradditional U.S. income taxes.


We started issuing commercial paper to meet near-term domestic liquidity requirements during 2012. The average amount of commercial paper outstanding was $259 million at a weighted-average interest rate of 0.12% during 2013. The maximum month-end amount of commercial paper outstanding was $820 million with no outstanding borrowings at December 31, 2013. We will continue to issue commercial paper on an as-needed basis.

In February 2014, BMS sold to AstraZeneca the diabetes business of BMS which comprised our global alliance with them. Under the terms of the agreement, AstraZeneca made an upfront payment of $2.7 billion to the Company. BMS also received a $600 million milestone payment in February 2014 for the approval of Farxiga in the U.S. See“Item 8. Financial Statements—Note 5. Assets Held-For-Sale” for further discussion. In January 2014, notices were provided to the holders of the 5.45% Notes due 2018 that BMS will exercise its call option to redeem the notes in their entirety in February 2014. The outstanding principal amount of the notes is $582 million.

Our investment portfolio includes non-current marketable securities which are subject to changes in fair value as a result of interest rate fluctuations and other market factors, which may impact our results of operations. Our investment policy places limits on these investments and the amount and time to maturity of investments with any institution. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. See “Item 8. Financial Statements—Note 10. Financial Instruments.Instruments and Fair Value Measurements.

52


As discussed in “—Strategy” above,


We have two separate $1.5 billion five-year revolving credit facilities from a syndicate of lenders. The facilities provide for customary terms and conditions with no financial covenants and are extendable on any anniversary date with the lossconsent of exclusivity in the U.S. for our largest product, PLAVIX*, in May 2012 is expected to resultlenders. No borrowings were outstanding under either revolving credit facility at December 31, 2013 or 2012.

In October 2013, BMS issued $1.5 billion of senior unsecured notes in a rapid, precipitous, material declineregistered public offering consisting of $500 million in operating cash flow. aggregate principal amount of 1.750% Notes due 2019, $500 million in aggregate principal amount of 3.250% Notes due 2023 and $500 million in aggregate principal amount of 4.500% Notes due 2044. The proceeds were used for general corporate purposes, including the repayment of our commercial paper borrowings.

Additional regulations in the U.S. could be passed in the future which could further reduce our results of operations, operating cash flow, liquidity and financial flexibility. We also continue to monitor the potential impact of the economic conditions in certain European countries and the related impact on prescription trends, pricing discounts, creditworthiness of our customers, and our ability to collect outstanding receivables from our direct customers. Currently, we believe these economic conditions in the EU will not have a material impact on our liquidity, cash flow or financial flexibility.


As a mechanism to limit our overall credit exposures, and an additional source of liquidity, we sell trade receivables to third parties, principally from wholesalers in Japan and certain government-backed entities in Italy, Portugal, and Spain. Sales of trade receivables totaled approximately $1.1 billion in 2011, $932 million in 2010, and $660 million in 2009. The amount of trade receivables sold in Italy, Portugal and Spain waswere $509 million in 2013, $322 million in 2012 and $484 million in 2011, $4772011. Sales of receivables in Japan were $522 million in 2010, and $4132013, $634 million in 2009,2012 and may not be available to be factored$593 million in the future due to the ongoing European sovereign debt crisis.2011. Our sales agreements do not allow for recourse in the event of uncollectibility and we do not retain interest to the underlying assetassets once sold.

In September 2011, the Company replaced its $2.0 billion revolving credit facility with a new $1.5 billion five year revolving credit facility from a syndicate of lenders, which contains customary terms and conditions and is extendable on any anniversary date with the consent of the lenders. There are no financial covenants under the new facility. There were no borrowings outstanding under either revolving credit facility at December 31, 2011 or December 31, 2010.


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We continue to manage our operating cash flows with initiatives designed to improveby focusing on working capital items that are most directly affected by changes in sales volume, such as receivables, inventories, and accounts payable. The following summarizes these components expressed as a percentage of trailing twelve months’ net sales:

Dollars in Millions  December 31,
2011
  % of Trailing
Twelve Month
Net Sales
  December 31,
2010
  % of Trailing
Twelve Month
Net Sales
 

Net trade receivables

  $2,250   10.6  $1,985   10.2 

Inventories

   1,384   6.5   1,204   6.2 

Accounts payable

   (2,603  (12.2)  (1,983  (10.2)
  

 

 

   

 

 

  

Total

  $1,031   4.9  $1,206   6.2 
  

 

 

   

 

 

  

Dollars in MillionsDecember 31, 2013 December 31, 2012
Net trade receivables$1,690
 $1,708
Inventories1,498
 1,657
Accounts payable(2,559) (2,202)
Total$629
 $1,163

Credit Ratings


Moody’s Investors Service (Moody’s) long-term and short-term credit ratings are currently A2 and Prime-1, respectively, and their long-term credit outlook remains stable.was revised from stable to negative in September 2013. Standard & Poor’s (S&P) long-term and short-term credit ratings are currently A+ and A-1,A-1+, respectively, and their long-term credit outlook remains stable. Fitch Ratings (Fitch)lowered our long-term andcredit rating from A to A-, lowered our short-term credit ratings are currently A+rating from F1 to F2, and F1, respectively, and theirrevised our long-term credit outlook remains negative.from negative to stable in July 2013 and from stable to negative in December 2013. Our credit ratings are considered investment grade. TheseOur long-term ratings designatereflect the agencies' opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. TheseOur short-term ratings designatereflect the agencies' opinion that we have the strongestgood to extremely strong capacity for timely repayment.


Cash Flows

The following is a discussion of cash flow activities:

Dollars in Millions  2011  2010  2009 

Cash flow provided by/(used in):

      

Operating activities

  $4,840  $4,491    $4,065 

Investing activities

   (1,437  (3,812    (4,380

Financing activities

   (2,657  (3,343    (17

Dollars in Millions 2013 2012 2011
Cash flow provided by/(used in):      
Operating activities $3,545
 $6,941
 $4,840
Investing activities (572) (6,727) (1,437)
Financing activities (1,068) (4,333) (2,657)

Operating Activities


Cash flow from operating activities represents the cash receipts and cash disbursements from all of our activities other than investing activities and financing activities. Operating cash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash and when the transactions are recognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliance partners; payments to suppliers, alliance partners and employees; pension contributionscontributions; and tax payments in the ordinary course of business. Our

The changes in cash provided by operating activities in both periods were primarily attributable to:

Upfront, milestone and contingent alliance proceeds of $967 million in 2013, $3.7 billion in 2012 ($3.6 billion from AstraZeneca as consideration for entering into the Amylin alliance) and $205 million in 2011.
Lower operating cash flow continuedflows of $700 million in 2013 and $1.5 billion in 2012 attributed to benefit from improved operating performance,Plavix* and Avapro*/Avalide* revenue reductions following the loss of exclusivity of these products in 2012; and
Other changes including working capital initiatives,requirements in each period.

Investing Activities

The changes in cash used in investing activities were primarily attributable to:

Cash was used to fund the acquisitions of Amylin ($5.0 billion) and higher unpaid rebates dueInhibitex ($2.5 billion) in part to timing2012 and an increasing lagAmira ($360 million) in payments to managed care organizations attributed to government agencies’ administrative delays.

53


Investing Activities

2011.

NetCash used in the sales, purchases and maturities of marketable securities werewas $44 million in 2013 and $859 million in 2011, $2.6 billion in 2010 and $1.4 billion in 2009. Investmentswhich was primarily attributed to the timing of investments in time deposits and highly-rated corporate debt securities with maturities greater than 90 days were increased to manage our return on investment.

days. Cash generated from the sales, purchases, and maturities of marketable securities was $1.3 billion in 2012. The cash was used to partially fund the acquisitions in 2012.

Other investing activities included litigation recoveries of Amira for $360 million (including a $50 million contingent payment) in 2011, ZymoGenetics for $829$102 million in 2010 and Medarex for $2.22011.


54



Financing Activities

The changes in cash used in financing activities were primarily attributable to:

Cash used to repurchase common stock was $433 million in 2013, $2.4 billion in 2009.

Capital expenditures were $367 million2012 and $1.2 billion in 2011, $424 million in2011. In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion. In June 2012, the Board of Directors increased its authorization for the repurchase of stock by an additional $3.0 billion. The repurchase program does not have an expiration date and $730 million in 2009, including costs related to our Devens biologics facility and other costs to support several manufacturing initiatives.

we may consider future repurchases.

Proceeds of $310 million were received from the sale of businesses within the Asia-Pacific region in 2009.

Mead Johnson cash included in the 2009 split-off transaction was $561 million.

Financing Activities

Dividend payments were $2.3$2.3 billion in 2011, $2.2 billion in 20102013, 2012 and $2.5 billion in 2009.2011. Dividends declared per common share were $1.41 in 2013, $1.37 in 2012 and $1.33 in 2011, $1.29 in 2010 and $1.25 in 2009.2011. In December 2011,2013, we declared a quarterly dividend of $0.34$0.36 per common share and expect to pay a dividend for the full year of 20122014 of $1.36$1.44 per share. Dividend decisions are made on a quarterly basis by our Board of Directors.

A $3.0Proceeds from the issuance of senior unsecured notes were $1.5 billion stock repurchase programin 2013 and $2.0 billion in 2012.

The $597 million principal amount of our 5.25% Notes matured and was authorizedrepaid in May 2010, resulting2013. Repayments of debt assumed in the repurchase of common stock of $1.2Amylin acquisition were $2.0 billion in 2011 and $576 million in 2010.

2012.

Management periodically evaluates potential opportunities to repurchase certain debt securities and terminate certain interest rate swap contracts prior to their maturity. Cash outflows related to the repurchase of debt were $109 million in 2012 and $78 million in 2011, $855 million in 2010 and $132 million in 2009.2011. Proceeds from the termination of interest rate swap contracts were $296 million in 2011, $146 million in 2010 and $194 million in 2009.

2011.

Proceeds from the issuances of common stock resulting from stock option exercises were $601$435 million (including $48(excluding $129 million of cash retained from excess tax benefits) in 2011, $2522013, $392 million (excluding $71 million of cash retained from excess tax benefits) in 20102012 and $45$554 million (excluding $47 million of cash retained from excess tax benefits) in 2009.2011. The issuanceamount of common stock as a result of stock option exercises willproceeds vary each period based upon fluctuations in the market value of our stock relative to the exercise price of the stock options and other factors.

Proceeds of $2.3 billion were received from the Mead Johnson initial public offering and the issuance of Mead Johnson Notes in 2009.


Contractual Obligations

Payments due by period for our contractual obligations at December 31, 20112013 were as follows:

    Obligations Expiring by Period 
Dollars in Millions  Total   2012   2013   2014   2015   2016   Later Years 

Short-term borrowings

  $115   $115   $    $    $    $    $  

Long-term debt

   4,669         597              652    3,420 

Interest on long-term debt(a)

   4,733    251    252    223    227    230    3,550 

Operating leases

   722    136    122    113    96    93    162 

Purchase obligations

   2,067    659    494    382    206    171    155 

Uncertain tax positions(b)

   105    105                          

Other long-term liabilities

   384         59    43    41    33    208 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total(c)

  $  12,795   $  1,266   $  1,524   $  761   $  570   $  1,179   $  7,495 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

  Obligations Expiring by Period
Dollars in Millions Total 2014 2015 2016 2017 2018 Later Years
Short-term borrowings $359
 $359
 $
 $
 $
 $
 $
Long-term debt 7,566
 
 
 684
 750
 631
 5,501
Interest on long-term debt(a)
 5,567
 257
 269
 294
 287
 219
 4,241
Operating leases 614
 145
 137
 117
 77
 65
 73
Purchase obligations 1,476
 703
 379
 200
 133
 61
 
Uncertain tax positions(b)
 114
 114
 
 
 
 
 
Other long-term liabilities 627
 
 101
 164
 47
 39
 276
    Total(c)
 $16,323
 $1,578
 $886
 $1,459
 $1,294
 $1,015
 $10,091

(a)

(a)
Includes estimated future interest payments on our short-term and long-term debt securities. Also includes accrued interest payable recognized on our consolidated balance sheets, which consists primarily of accrued interest on short-term and long-term debt as well as accrued periodic cash settlements of derivatives.

(b)

(b)
Due to the uncertainty related to the timing of the reversal of uncertain tax positions, only the short-term uncertain tax benefits have been provided in the table above. See “Item 8. Financial Statements—Note 8. Income Taxes” for further detail.

(c)

(c)
The table above excludes future contributions by us to our pensions, postretirement and postemployment benefit plans. Required contributions are contingent upon numerous factors including minimum regulatory funding requirements and the funded status of each plan. Due to the uncertainty of such future obligations, they are excluded from the table. Contributions for both U.S. and international plans are expected to be up to $430$100 million in 2012.2014. See “Item 8. Financial Statements—Note 19. Pension, Postretirement and Postemployment Liabilities” for further detail.

In addition to the above, we are committed to $5.5$3.6 billion (in the aggregate) of potential future research and development milestone payments to third parties as part of in-licensing and development programs. Early stageEarly-stage milestones, defined as milestones achieved through Phase III clinical trials, comprised $1.0 billion$700 million of the total committed amount. Late stageLate-stage milestones, defined as milestones achieved post Phase III clinical trials, comprised $4.5$2.9 billion of the total committed amount. Payments under these agreements generally are due and payable only upon achievement of certain developmental and regulatory milestones, for which the specific timing cannot be predicted. In addition to certain royalty obligations that are calculated as a percentage of net product sales, some of these

54


agreements also provide for sales-based milestones aggregating $2.0$1.6 billion that we would be obligated to pay to alliance partners upon achievement of certain sales levels. We also have certain manufacturing, development, and commercialization obligations in connection with alliance arrangements. It is not practicable to estimate the amount of these obligations. See “Item 8. Financial Statements—Note 3. Alliances and Collaborations”Alliances” for further information regarding our alliances.

For a discussion of contractual obligations, see “Item 8. Financial Statements—Note 19. Pension, Postretirement and Postemployment Liabilities,” “—Note 10. Financial Instruments”Instruments and Fair Value Measurements” and “—Note 21. Leases.”


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SEC Consent Order


As previously disclosed, on August 4, 2004, we entered into a final settlement with the SEC, concluding an investigation concerning certain wholesaler inventory and accounting matters. The settlement was reached through a Consent, a copy of which was attached as Exhibit 10 to our quarterly report on Form 10-Q for the period ended September 30, 2004.


Under the terms of the Consent, we agreed, subject to certain defined exceptions, to limit sales of all products sold to our direct customers (including wholesalers, distributors, hospitals, retail outlets, pharmacies and government purchasers) based on expected demand or on amounts that do not exceed approximately one month of inventory on hand, without making a timely public disclosure of any change in practice. We also agreed in the Consent to certain measures that we have implemented including: (a) establishing a formal review and certification process of our annual and quarterly reports filed with the SEC; (b) establishing a business risk and disclosure group; (c) retaining an outside consultant to comprehensively study and help re-engineer our accounting and financial reporting processes; (d) publicly disclosing any sales incentives offered to direct customers for the purpose of inducing them to purchase products in excess of expected demand; and (e) ensuring that our budget process gives appropriate weight to inputs that come from the bottom to the top, and not just from the top to the bottom, and adequately documenting that process.


We have established a company-wide policy to limit our sales to direct customers for the purpose of complying with the Consent. This policy includes the adoption of various procedures to monitor and limit sales to direct customers in accordance with the terms of the Consent. These procedures include a governance process to escalate to appropriate management levels potential questions or concerns regarding compliance with the policy and timely resolution of such questions or concerns. In addition, compliance with the policy is monitored on a regular basis.


We maintain inventory management agreements (IMAs) with our U.S. pharmaceutical wholesalers, which account for nearly 100% of totalour gross sales of U.S. biopharmaceuticals products.revenues. Under the current terms of the IMAs, our wholesaler customers provide us with weekly information with respect to months on hand product-level inventories and the amount of out-movement of products. The three largest wholesalers currently account for approximately 90% of totalour gross sales of U.S. BioPharmaceuticals products.revenues. The inventory information received from our wholesalers, together with our internal information, is used to estimate months on hand product level inventories at these wholesalers. We estimate months on hand product inventory levels for our U.S. BioPharmaceuticals business’s wholesaler customers other than the three largest wholesalers by extrapolating from the months on hand calculated for the three largest wholesalers. In contrast, for our biopharmaceuticalsnon-U.S. business outside of the U.S., we havehas significantly more direct customers, limited information on direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information, where available, varies widely. Accordingly, we rely on a variety of methods to estimate months on hand product level inventories for these business units.


We believe the above-described procedures provide a reasonable basis to ensure compliance with the Consent.


Recently Issued Accounting Standards

See “Item 8.


In July 2013, the Financial Statements—Note 1. Accounting Policies”Standards Board issued an update that clarified existing guidance on the presentation of unrecognized tax benefits when various qualifying tax benefit carryforwards exist, including when the unrecognized tax benefit should be presented as a reduction to deferred tax assets or as a liability. This update is required to be adopted for discussion of the impact relatedall annual periods and interim reporting periods beginning after December 15, 2013, with early adoption permitted. The reduction to recently issued accounting standards.

deferred tax assets is expected to be approximately $250 million.


Critical Accounting Policies

We prepare our financial statements in conformity with accounting principles generally accepted in the U.S.


The preparation of financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities including disclosure of contingent assets and contingent liabilities, at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.expenses. Our critical accounting policies are those that are both most important tosignificantly impact our financial condition and results of operations and require the most difficult, subjective or complex judgments, on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. New discounts under the 2010 U.S. healthcare reform law, such as the Medicare coverage gap and managed Medicaid require additional assumptions due to the lack of historical claims experience and increasing lag in claims data. In addition, the new pharmaceutical company fee estimate is subject to external data including the Company’s relative share of industry results. Because of thethis uncertainty, of factors surrounding the estimates or judgments used in the preparation of the consolidated financial statements, actual results may vary from these estimates. These accounting policies were discussed with the Audit Committee of the Board of Directors.

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Revenue Recognition


Our accounting policy for revenue recognition has a substantial impact on reported results and relies on certain estimates. We recognize revenue when persuasive evidence of an arrangement exists, the sales price is fixed and determinable, collectability is reasonably assured and title and substantially all of the risks and rewards of ownership have transferred, which is generally at time of shipment (net of theshipment. Revenue is also reduced for gross-to-net sales adjustments discussed below, all of which involve significant estimates and judgments).

Gross-to-Net Sales Adjustments

The following categoriesjudgment after considering legal interpretations of gross-to-net sales adjustments involve significant estimatesapplicable laws and judgmentsregulations, historical experience, payer channel mix (e.g. Medicare or Medicaid), current contract prices under applicable programs, unbilled claims and require usprocessing time lags and inventory levels in the distribution channel.


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Estimates are assessed each period and adjusted as required to userevised information from external sources.or actual experience. In addition, See “—Net Sales”Total Revenues” above for further discussion and analysis of each significant category of gross-to-net sales adjustments.


Gross-to-Net Adjustments

The following categories of gross-to-net adjustments involve significant estimates, judgments and information obtained from external sources.

Charge-backs related to government programs


Our U.S. businesses participatebusiness participates in programs with government entities, the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs, and other parties, including covered entities under the 340B Drug Pricing Program, whereby pricing on products is extended below wholesaler list price to participating entities. These entities purchase products through wholesalers at the lower program price and the wholesalers then charge us the difference between their acquisition cost and the lower program price. We accountAccounts receivable is reduced for these charge-backs by reducing accounts receivable in anthe estimated amount equal to our estimate of unprocessed charge-back claims attributable to a sale. Our estimate of these charge-backs is primarily based on historical experience regarding these programs’ charge-backs and current contract prices under the programs. We consider chargeback payments, levels of inventory in the distribution channel, and our claim processingsale (typically within a two to four week time lag and adjust the reserve to reflect actual experience.

lag).


Cash discounts


In the U.S. and certain other countries, we offer cash discounts are offered as an incentive for prompt payment, generally approximating 2% of the sales price. We accountAccounts receivable is reduced for the estimated amount of unprocessed cash discounts by reducing accounts receivable based on historical claims experience and adjust the reserve to reflect actual experience.

(typically within a one month time lag).


Managed healthcare rebates and other contract discounts

We offer rebates


Rebates and discounts are offered to managed healthcare organizations in the U.S. which managemanaging prescription drug programs and Medicare Advantage prescription drug plans covering the Medicare Part D drug benefit in addition to their commercial plans, as well as globally to other contract counterparties such as hospitals and group purchasing organizations.organizations globally. Beginning in 2011, the rebates for the Medicare Part D program included a 50% discount on the Company’s brand-name drugs to patients who fall within the Medicare Part D coverage gap. In addition, we accrue rebatesRebates are also required under the U.S. Department of Defense TRICARE Retail Pharmacy Refund Program. We accountThe estimated amount for these unpaid or unbilled rebates and discounts by establishing an accrual primarily based on historical experience and current contract prices. We considerare presented as a liability. A $67 million reversal for the sales performanceestimated amount of products subject to these rebates and2011 Medicare Part D coverage gap discounts an increasing leveloccurred in 2012 after receipt of unbilled claims, and levels of inventory in the distribution channel and adjust the accrual to reflect actual experience.

invoices.


Medicaid rebates


Our U.S. businesses participateparticipates in state government Medicaid programs as well as certainand other qualifying Federal and state government programs wherebyrequiring discounts and rebates are provided to participating state and local government entities. DiscountsAll discounts and rebates provided through these programs are included in our Medicaid rebate accrual and are considered Medicaid rebates for the purposes of this discussion.accrual. Retroactive to January 1, 2010, minimum rebates on Medicaid drug sales increased from 15.1% to 23.1%. Medicaid rebates have also been extended to drugs used in managed Medicaid plans beginning in March 2010. We accountThe estimated amount for these unpaid or unbilled rebates is presented as a liability. The estimated Medicaid rebates attributable to prior period revenues were reduced by establishing an accrual primarily based on historical experience as well as any expansion on a prospective basis of our participation$85 million in programs, legal interpretations of applicable laws,2013 and any new information regarding changes$37 million in the Medicaid programs’ regulations and guidelines that would impact the amount of the rebates. We consider outstanding Medicaid claims, an increasing amount of unbilled managed Medicaid claims, and levels of inventory in the distribution channel and adjust the accrual to reflect actual experience.

2012.


Sales returns

We account for sales returns by establishing an accrual in an amount equal to our estimate of sales recognized for which the related products


Products are expectedtypically eligible to be returned primarily as a result ofbetween six months prior to and twelve months after product expirations. Forexpiration, in accordance with our policy. Estimated returns offor established products we determine our estimate of the sales return accrual primarily based onare determined after considering historical experience regarding sales returns, but also considerand other factors that could impact sales returns. These factors includeincluding levels of inventory in the distribution channel, estimated shelf life, product recalls,

56


product discontinuances, price changes of competitive products, introductions of generic products, introductions of competitive new products and instances of expected precipitous declines in demand such as following the loss of exclusivity. We consider allThe estimated amount for product returns is presented as a liability. Reserves were established for Plavix* and Avapro*/Avalide* ($147 million and $173 million at December 31, 2013 and 2012, respectively) after considering the relevant factors as well as estimated future retail and wholesale inventory work down that would occur after the loss of these factors and adjust the accrual to reflect actual experience.

Salesexclusivity.


Estimated returns accruals fromfor new products are estimated and primarily based on thedetermined after considering historical sales returnsreturn experience of similar products, such as those within the same line of product or those within the sameline or similar therapeutic category. InWe defer recognition of revenue until the right of return expires or until sufficient historical experience to estimate sales returns is developed in limited circumstances, wherecircumstances. This typically occurs when the new product is not an extension of an existing line of product or where we have nowhen historical experience with products in a similar therapeutic category such that we cannot reliably estimate expected returns of the new product, we defer recognition of revenue until the right of return no longer exists or until we have developed sufficient historical experience to estimate sales returns.is lacking. Estimated levels of inventory in the distribution channel and projected demand are also considered in estimating sales returns for new products. YERVOY net sales of $27 million were deferred until patient infusion due to a returns policy established in the third quarter of 2011 in the U.S.

Pharmaceutical Company Fee (Pharma Fee)

In 2011, we began paying an annual non-tax-deductible fee to the federal government based on an allocation of our market share of branded prior year sales to certain government programs including Medicare, Medicaid, Department of Veterans Affairs, Department of Defense and TRICARE. The 2011 Pharma fee amount will not be finalized until 2012 and preliminary funding in 2011 was based on information that is on a one-year lag. The Pharma fee is calculated based on market data of the Company as well as other industry participants for which the Company does not have full visibility. This fee is classified for financial reporting purposes as an operating expense.




57



Use of information from external sources

We use information


Information from external sources is used to estimate gross-to-net sales adjustments. Our estimate of inventory at the wholesalers are based on the projected prescription demand-based sales for our products and historical inventory experience, as well as our analysis of third-party information, including written and oral information obtained from certain wholesalers with respect to their inventory levels and sell-through to customers and third-party market research data, and our internal information. The inventory information received from wholesalers is a product of their recordkeeping process and excludes inventory held by intermediaries to whom they sell, such as retailers and hospitals.


We have also continued the practice of combining retail and mail prescription volume on a retail-equivalent basis. We use this methodology for internal demand forecasts. We also use information from external sources to identify prescription trends, patient demand and average selling prices. Our estimates are subject to inherent limitations of estimates that rely on third-party information, as certain third-party information was itself in the form of estimates, and reflect other limitations including lags between the date as of which third-party information is generated and the date on which we receive third-party information.


Retirement Benefits

Pension


Accounting for pension and postretirement benefit plans are accounted for usingrequires actuarial valuations that include keybased on significant assumptions for discount rates and expected long-term rates of return on plan assets. In consultation with our actuaries, these keysignificant assumptions and others such as salary growth, retirement, turnover, healthcare trends and mortality rates are evaluated and selected based on expectations or actual experience during each remeasurement date. Pension expense could vary within a range of outcomes and have a material effect on reported earnings, projected benefit obligations and future cash funding. Actual results in any given year may differ from those estimated because of economic and other factors.


The yield on high quality corporate bonds that coincides with the cash flows of the plans’ estimated payouts is used in determining the discount rate. The Citigroup Pension Discount curve is used for the U.S. plans. The U.S. plans’ pension expense for 20112013 was determined using a 5.25%4.15% weighted-average discount rate. The present value of benefit obligations at December 31, 20112013 for the U.S. pension plans was determined using a 4.25%4.62% discount rate. If the discount rate used in determining the U.S. plans’ pension expense for 2011 had been2013 was reduced by an additional 1%, such expense would have increasedincrease by approximately $16$10 million. If the assumed discount rate used in determining the U.S. pension plans’ projected benefit obligation at December 31, 2011 had been2013 was reduced by an additional 1%, the projected benefit obligation would have increasedincrease by approximately $1.1 billion.

$950 million.


The expected long-term rate of return on plan assets is estimated considering expected returns for individual asset classes with input from external advisors. We also consider long-term historical returns including actual performance compared to benchmarks for similar investments. The U.S. plans’ pension expense for 20112013 was determined using an 8.75%8.63% expected long-term rate of return on plan assets. If the expected long-term rate of return on plan assets used in determining the U.S. plans’ pension expense for 2011 had been2013 was reduced by 1%, such expense would have increasedincrease by $42$53 million.


For a more detailed discussion on retirement benefits, see “Item 8. Financial Statements—Note 19. Pension, Postretirement and Postemployment Liabilities.”

57



Business Combinations


Goodwill and other intangible assets acquired in business combinations, licensing and other transactions were $15.6 billion (representing 41% of total assets), including $6.2 billion included in assets held-for-sale at December 31, 2013.

Assets acquired and liabilities assumed are recognized at the date of acquisition at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recognized as goodwill. When determining theThe fair value of intangible assets, including IPRD, weis typically usedetermined using the “income method.” This method starts with a forecast of all of the expected future net cash flows, which are risk adjusted based onfor estimated probabilities of technical and regulatory success (for IPRD) and are then adjusted to present value by applyingusing an appropriate discount rate that reflects the risk associated with the cash flow streams. All assets are valued from a market participant view.view which might be different than specific BMS views. The following approachesvaluation process is very complex and requires significant input and judgment using internal and external sources. Although the valuations are utilizedrequired to be finalized within a one-year period, it must consider all and only those facts and evidence available at the acquisition date. The most complex and judgmental matters applicable to the valuation process are summarized below:

Unit of accounting – Most intangible assets are valued as single global assets rather than multiple assets for each jurisdiction or indication after considering the development stage, expected levels of incremental costs to obtain additional approvals, risks associated with further development, amount and timing of benefits expected to be derived in the future, expected patent lives in various jurisdictions and the intention to promote the asset as a global brand.

58



Estimated useful life – The asset life expected to contribute meaningful cash flows is determined after considering all pertinent matters associated with the asset, including expected regulatory approval dates (if unapproved), exclusivity periods and other legal, regulatory or contractual provisions as well as the effects of any obsolescence, demand, competition, and other economic factors, including barriers to entry.
Probability of Technical and Regulatory Success (PTRS) Rate – PTRS rates are determined based upon industry averages considering the respective programs development stage and disease indication and adjusted for specific intangible assets acquired:

IPRD values where we have a pre-existing relationship withinformation or data known at the acquiree, we consideracquisition date. Subsequent clinical results or other internal or external data obtained could alter the terms ofPTRS rate and materially impact the respective collaboration arrangement including cost and profit sharing splits. The project’s unit of account is typically a global view and would consider all potential jurisdictions and indications.

Technology related to specific platforms is valued based upon the expected annual number of antibodies achieving an early candidate nomination status.

Technology for commercial products is valued utilizing the multi-period excess-earnings method of the income approach under the premise that theestimated fair value of the intangible asset is equalin subsequent periods leading to impairment charges.

Projections – Future revenues are estimated after considering many factors such as initial market opportunity, pricing, sales trajectories to peak sales levels, competitive environment and product evolution. Future costs and expenses are estimated after considering historical market trends, market participant synergies and the present valuetiming and level of additional development costs to obtain the after-taxinitial or additional regulatory approvals, maintain or further enhance the product. We generally assume initial positive cash flows solelyto commence shortly after the receipt of expected regulatory approvals which typically may not occur for a number of years. Actual cash flows attributed to the intangible asset.

Licensesproject are valued utilizing a discounted cash flow method based on estimates of future risk-adjusted milestone and royalty payments projectedlikely to be earned overdifferent than those assumed since projections are subjected to multiple factors including trial results and regulatory matters which could materially change the ultimate commercial success of the asset as well as significantly alter the costs to develop the respective products estimated economic term.

asset into commercially viable products.

Some

Tax rates – The expected future income is tax effected using a market participant tax rate. Our recent valuations typically use a U.S. tax rate (and applicable state taxes) after considering the jurisdiction in which the intellectual property is held and location of research and manufacturing infrastructure. We also considered that any earnings repatriation would likely have U.S. tax consequences.
Discount rate – Discount rates are selected after considering the risks inherent in the future cash flows; the assessment of the more significant estimatesasset’s life cycle and assumptions include:

Estimates of projected cash flows –Cash flow projections represent those that would be realizable by a market participant purchaser. For IPRD, we assume initial positive cash flows to commence shortly after the receipt of expected regulatory approvals which typically may not occur for a number of years. Actual cash flows attributed to the project are likely to be different than those assumed since projections are subjected to multiple factors including trial results and regulatory matters which could materially change the respective IPRDs’ ultimate commercial success as well as significantly alter the costs to develop the respective IPRD into commercially viable products.

Probability to Regulatory Success (PTRS) Rate –PTRS rates are based upon industry averages considering the respective IPRD’s development stage and sought after disease indications adjusted for specific information or data known about the IPRD at the time of the acquisition. Subsequent clinical results or other internal or external data obtained could alter the PTRS rate which can materially impact the intangible value.

Discount rate –We select a discount rate that measures the risks inherent in the future cash flows; the assessment of the asset’s life cycle and the competitive trends impacting the asset, including consideration of any technical, legal, regulatory, or economic barriers to entry, as well as expected changes in standards of practice for indications addressed by the asset.

Useful life –Determining the useful life of an intangible asset is based upon the period over which it is expected to contribute to future cash flows. All pertinent matters associated with the asset and the environment for which it operates are considered, including, legal, regulatory or contractual provisions as well as the effects of any obsolescence, demand, competition, and other economic factors.

the competitive trends impacting the asset, including consideration of any technical, legal, regulatory, or economic barriers to entry, as well as expected changes in standards of practice for indications addressed by the asset.


See “Item 8. Financial Statements—Note 4. Acquisitions” for specific details and values assigned to assets acquired and liabilities assumed in our acquisitions of Amylin and Inhibitex in 2012 and Amira on September 7, 2011, ZymoGenetics on October 12, 2010 and Medarex on September 1, 2009.in 2011. Significant estimates utilized at the time of the valuations to support the fair values of the lead compounds within the acquisitions include:

Dollars in Millions  Fair value   Discount
rate utilized
  

Phase of
Development as
of acquisition date

  PTRS Rate
utilized
  Year of first
projected positive
cash flow
 

Amira - AM152

  $160    12.5 Phase II   12.5  2020 

ZymoGenetics – pegylated-interferon lambda

   310    13.5 Phase IIb   47.6  2015 

Medarex - YERVOY

   1,046    12.0 Phase III   36.2  2011 

Dollars in Millions Fair value Discount rate utilized Estimated
useful life (in years)
 Phase of
Development as of acquisition date
 PTRS  Rate utilized Year of first
projected positive cash flow
Commercialized products:            
Bydureon* $5,260
 11.1% 13
 N/A N/A
 N/A
Byetta* 770
 10.0% 7
 N/A N/A
 N/A
Symlin* 310
 10.0% 9
 N/A N/A
 N/A
Recothrom 230
 11.0% 10
 N/A N/A
 N/A
             
IPRD:            
BMS-986094 (formerly INX-189) 1,830
 12.0% N/A
 Phase II 38.0% 2017
Metreleptin 120
 12.0% N/A
 Phase III 75.0% 2017
AM152 160
 12.5% N/A
 Phase I 12.5% 2021

Impairment


Goodwill


Goodwill was $7.1 billion at December 31, 2013. Goodwill is tested at least annually for impairment usingon an enterprise level by assessing qualitative factors or performing a two-step process. The first stepquantitative analysis in determining whether it is to identify a potential impairment, and the second step measures the amount of the impairment loss, if any. Goodwill is considered impaired ifmore likely than not that its fair value exceeds the carrying amountvalue. Examples of a reporting unit’s goodwill exceeds its estimatedqualitative factors assessed in the current year included our share price, our financial performance compared to budgets, long-term financial plans, macroeconomic, industry and market conditions as well as the substantial excess of fair value. Geographical reporting units are aggregated for impairment testing purposes. Based upon our most recentvalue over the carrying value of net assets from the annual impairment test completed duringperformed in the first quarterprior year. Positive and negative influences of 2011,each relevant factor were assessed both individually and in the fair value of goodwill is substantially in excess of the related carrying value.

58


aggregate and as a result it was concluded that no additional quantitative testing was required.


For discussion on goodwill, acquired in-process research and development and other intangible assets, see “Item 8. Financial Statements—Note 1. Accounting Policies—Goodwill, Acquired In-Process Research and Development and Other Intangible Assets.”

Indefinite-Lived




59



Other Intangible Assets, including IPRD

Indefinite-lived


Other intangible assets not subject to amortizationwere $2.3 billion at December 31, 2013, including licenses ($525 million), developed technology rights ($1.0 billion), capitalized software ($241 million) and IPRD ($548 million). Intangible assets are tested for impairment annually,whenever current facts or circumstances warrant a review, although IPRD is required to be tested at least annually. Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for recently launched products or IPRD. These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more frequently, if eventscommon potential risks leading to impairment include competition, earlier than expected loss of exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to obtain regulatory approval and additional development costs, inability to achieve expected synergies, higher operating costs, changes in circumstances indicate thattax laws and other macro-economic changes. The complexity in estimating the asset might be impaired. We consider various factors including the stagefair value of development, current legal and regulatory environment and the competitive landscape. Adverse trial results, significant delays in obtaining marketing approval, and the inability to bring the respective product to market could result in the related intangible assets in connection with an impairment test is similar to be partially or fully impaired. For commercialized products, the inability to meet sales forecasts could result ininitial valuation.

Considering the related intangible assets to be partially or fully impaired.

Consideringhigh risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPRD impairment charges mayare likely to occur in future periods. We recognized charges of $28$2.1 billion in 2012 including a $1.8 billion charge resulting from the discontinued development of BMS-986094 and for other projects previously acquired in the Medarex, Inc. and Inhibitex acquisitions resulting from unfavorable clinical trial results, additional development costs, extended development periods and decisions to cease further development. We also recognized charges of $30 million in 2011 and $10 million in 2010 related to three Medarex projects for which development has ceased.

IPRD is closely monitored and assessed each period for impairment.


In addition to IPRD, commercial assets are also subject to impairment. For example, an impairment charge of $120 million was recognized in 2012 related to a non-key product from a prior acquisition after continuing competitive pricing pressures.

We operate in a very dynamic market and regulatory environment in which events can occur causing our expectations to change quickly and thus leading to potential impairment charges. Specific intangible assets with material carrying values at December 31, 2013, that are exposed to potential impairment include IPRD assets peginterferon lambda ($310 million) in Phase III development for the treatment of hepatitis C virus and AM152 ($160 million)in Phase II development for the treatment of fibrosis. These assets are monitored for changes in expectations from those used in the initial valuation.

Property, Plant and Equipment

Property, plant and equipment is tested for impairment whenever current facts or circumstances warrant a review. Additionally, these long-lived assets are periodically reviewed to determine if any change in facts or circumstances would result in a change to the estimated useful life of the asset, possibly resulting in the acceleration of depreciation. If such circumstances exist, an estimate of undiscounted future cash flows generated by the asset, or the appropriate grouping of assets, is compared to the carrying value to determine whether an impairment exists at its lowest level of identifiable cash flows. If an asset is determined to be impaired, the loss is measured based on the difference between the asset’s fair value and its carrying value. Expectations of future cash flows are subject to change based upon the near and long-term production volumes and margins generated by the asset as well as any potential alternative future use.

Contingencies


In the normal course of business, we are subject to contingencies, such as legal proceedings and claims arising out of our business, that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, contractual claims and tax matters. We recognize accruals for such contingencies when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated. These estimates are subject to uncertainties that are difficult to predict and, as such, actual results could vary from these estimates.


For discussions on contingencies, see “Item 8. Financial Statements—Note 1. Accounting Policies—Contingencies,” “—Note 8. Income Taxes” and “—Note 22. Legal Proceedings and Contingencies.”


Income Taxes


Valuation allowances are recognized to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment including the long-range forecastforecasts of future taxable income and the evaluation of tax planning initiatives. These judgments are subject to change. Adjustments to the deferred tax valuation allowances are made to earnings in the period when such assessments are made. Our deferred tax assets were $3.2$4.8 billion net of valuation allowances of $3.9$4.6 billion at December 31, 20112013 and $3.1$5.1 billion, net of valuation allowances of $1.9$4.4 billion at December 31, 2010.

We recognized deferred2012.


Deferred tax assets at December 31, 2011 related to a U.S. Federal net operating loss carryforward of $251$138 million and a U.S. Federal research and development tax credit carryforward of $109 million.$23 million were recognized at December 31, 2013. The net operating loss carryforward expires in varying amounts beginning in 2022. The research and developmentU.S. Federal tax credit carryforwards expirecarryforward expires in varying amounts beginning in 2018.2017. The realization of these carryforwards is

60



dependent on generating sufficient domestic-sourced taxable income prior to their expiration. Although realization is not assured, we believe it is more likely than not that these deferred tax assets will be realized.

We do


In addition, a deferred tax asset related to a U.S. Federal and state capital loss of $784 million was recognized at December 31, 2013 that can be carried back three years and carried forward five years. The realization of this carryforward is dependent upon generating sufficient capital gains prior to its expiration. A $383 million valuation allowance was established for this item at December 31, 2013.

Taxes are not provide for taxesprovided on undistributed earnings of foreign subsidiaries that are expected to be reinvested indefinitely offshore. During 2010, the Company completed an internal reorganization of certain legal entities which contributed to a $207 million tax charge recognized in the fourth quarter of 2010. It is possible that U.S. tax authorities could assert additional material tax liabilities arising from the reorganization. If such assertion were to occur, the Company would vigorously challenge any such assertion and believes it would prevail; however there can be no assurance of such a result.


Prior to the Mead Johnson Nutrition Company (Mead Johnson) split-off in 2009, the following transactions occurred: (i) an internal spin-off of Mead Johnson shares while still owned by us; (ii) conversion of Mead Johnson Class B shares to Class A shares; and; (iii) conversion of Mead Johnson & Company to a limited liability company. These transactions as well as the split-off of Mead Johnson through the exchange offer should qualify as tax-exempt transactions under the Internal Revenue Code based upon a private letter ruling received from the Internal Revenue Service related to the conversion of Mead Johnson Class B shares to Class A shares, and outside legal opinions. We have relied upon certain

Certain assumptions, representations and covenants by Mead Johnson were relied upon regarding the future conduct of its business and other matters which could effectaffect the tax treatment of the exchange. For example, the current tax law generally creates a presumption that the exchange would be taxable to us, if Mead Johnson or its shareholders were to engage in transactions that result in a 50% or greater change in its stock ownership during a four year period beginning two years before the exchange offer, unless it is established that the exchange offer were not part of a plan or series of related transactions to effect such a change in ownership. If the internal spin-off or exchange offer were determined not to qualify as a tax exempt transaction, wethe transaction could be subject to tax as if the exchange was a taxable sale by us at market value.

59



In addition, we had a negative basis or excess loss account (ELA) existed in our investment in stock of Mead Johnson prior to these transactions. We received an opinion from outside legal counsel to the effect that it is more likely than not that we eliminated the ELA as part of these transactions and do not have taxable income with respect to the ELA. The tax law in this area is complex and it is possible that even if the internal spin-off and the exchange offer is tax exempt under the Internal Revenue Code, the IRS could assert that we have additional taxable income for the period with respect to the ELA. We could be exposed to additional taxes if this were to occur. Based upon our understanding of the Internal Revenue Code and opinion from outside legal counsel, a tax reserve of $244 million was established reducing the gain on disposal of Mead Johnson included in discontinued operations.

operations in 2009.


We agreed to certain tax related indemnities with Mead Johnson as set forth in the tax sharing agreement. For example, Mead Johnson has agreed to indemnify us for potential tax effects resulting from the breach of certain representations discussed above as well as certain transactions related to the acquisition of Mead Johnson’s stock or assets. We have agreed to indemnify Mead Johnson for certain taxes related to its business prior to the completion of the IPO and created as part of the restructuring to facilitate the IPO.


We established liabilities for possible assessments by tax authorities resulting from known tax exposures including, but not limited to, transfer pricing matters, tax credits and deductibility of certain expenses. Such liabilities represent a reasonable provision for taxes ultimately expected to be paid and may need to be adjusted over time as more information becomes known.


For discussions on income taxes, see “Item 8. Financial Statements—Note 1. Accounting Policies—Income Taxes” and “—Note 8. Income Taxes.”


Special Note Regarding Forward-Looking Statements


This annual report on Form 10-K (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”, “guidance”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, our goals, plans and projections regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years. We have included important factors in the cautionary statements included in this Annual Report on Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.


Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. We undertake no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.

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61



Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.


We are exposed to market risk due toresulting from changes in currency exchange rates and interest rates. As a result, certainCertain derivative financial instruments are used when available on a cost-effective basis to hedge our underlying economic exposure. All of our financial instruments, including derivatives, are subject to counterparty credit risk which we considerconsidered as part of the overall fair value measurement. Derivative financial instruments are not used for trading purposes.


Foreign Exchange Risk

A significant portion


Significant amounts of our revenues, earnings and cash flow is exposed to changes in foreign currency rates. Our primary net foreign currency translation exposures are the euro,Euro, Japanese yen, Chinese renminbi, Canadian dollar, Chinese renminbi and Australian dollar.South Korean won. Foreign currency forward contracts are used to manage foreign exchange risk that primarily arises from certain intercompany purchase transactions and we designate these derivative instrumentsare designated as foreign currency cash flow hedges when appropriate. In addition, we are exposed to foreign exchange transaction risk that arises from non-functional currency denominated assets and liabilities and earnings denominated in non-U.S. dollar currencies. Foreign currency forward contracts are used to offset a portion of these exposures and are not designated as hedges. Changes in the fair value of these derivatives are recognized in earnings as incurred.


We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar at December 31, 2011, with(with all other variables held constant,constant) would decrease the fair value of foreign exchange forward contracts heldby $135 million at December 31, 2011 by $177 million and, if2013. If realized, this appreciation would negatively affect earnings over the remaining life of the contracts.


We are also exposed to translation risk on non-U.S. dollar-denominated net assets. Non-U.S. dollar borrowings are used to hedge the foreign currency exposures of our net investment in certain foreign affiliates and are designated as hedges of net investments. The effective portion of foreign exchange gains or losses on these hedges is recognized as part of the foreign currency translation component of accumulated OCI.other comprehensive income/(loss). If our net investment were to fall below the equivalent value of the euronon-U.S. debt borrowings, the change in the remeasurement basis of the debt would be subject to recognition in income as changes occur. For additional information, see “Item 8. Financial Statements—Note 10. Financial Instruments.Instruments and Fair Value Measurements.


Interest Rate Risk


Fixed-to-floating interest rate swapsswap contracts are used and designated as fair-value hedges as part of our interest rate risk management strategy. The swapsThese contracts are intended to provide us with an appropriate balance of fixed and floating rate debt. We estimate that an increase of 100 basis points in short-term or long-term interest rates would decrease the fair value of our interest rate swapsswap contracts by $64$161 million, excluding the effects of our counterparty and our own credit risk and, ifrisk. If realized, the fair value reduction would affect earnings over the remaining life of the swaps.

contracts.


We estimate that an increase of 100 basis points in long-term interest rates would decrease the fair value of long-term debt by $697 million. Our marketable securities are subject to changes in fair value as a result of interest rate fluctuations and other market factors. Our policy is to invest only in institutions that meet high credit quality standards. We estimate that an increase of 100 basis points in interest rates in general would decrease the fair value of our debt security portfolio by approximately $66$104 million.


Credit Risk

Our exposure to European sovereign-backed trade receivables is


Although not material, as we continue to limit our credit exposure in certain countries more significantly impacted by the sovereign debt crisis in Europe. We have identifiedEuropean government-backed entities with a higher risk of default were identified by monitoring social and economic factors including credit ratings, credit-default swap rates and debt-to-gross domestic product ratios. Although not material, we have provided additional badratios in addition to entity specific factors. Historically, our exposure was limited by factoring receivables. Our credit exposures in Europe may increase in the future due to reductions in our factoring arrangements and the ongoing sovereign debt reserves in Italy, Greece, Portugal and Spain. We also defer an immaterial amount of revenues from certain government-backed entitiescrisis. Our credit exposure to trade receivables in Greece, Portugal, Italy and Spain as collections are not reasonably assured. We periodically sell certain non-U.S. trade receivables as a means to reduce collectability risk. Our sales agreements do not provide for recourse in the eventwas approximately $172 million at December 31, 2013, of uncollectibility and we do not retain interest in the underlying asset once sold. The volume of trade receivables sold in Italy, Portugal, and Spain may not be sustainable in future years due to the ongoing European sovereign debt crisis.

which approximately 80% was from government-backed entities.


We monitor our investments with counterparties with the objective of minimizing concentrations of credit risk. Our investment policy places limits on the amount and time to maturity of investments with any individual counterparty. The policy also requires that investments are made primarilyonly entered into with highly rated corporate and financial U.S. government and government supported institutions.

institutions that meet high credit quality standards.


The use of derivative instruments exposes us to credit risk. When the fair value of a derivative instrument contract is positive, we are exposed to credit risk if the counterparty fails to perform. When the fair value of a derivative instrument contract is negative, the counterparty is exposed to credit risk if we fail to perform our obligation. Under the terms of the agreements, posting of collateral is not required by any party whether derivatives are in an asset or liability position. We have a policy of diversifying derivatives with counterparties to mitigate the overall risk of counterparty defaults. For additional information, see “Item 8. Financial Statements—Note 10. Financial Instruments.Instruments and Fair Value Measurements.

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62

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF EARNINGS

Dollars and Shares in Millions, Except Per Share Data



Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

   Year Ended December 31, 
   2011  2010  2009 

EARNINGS

    

Net Sales

  $  21,244   $  19,484  $  18,808 
  

 

 

  

 

 

  

 

 

 

Cost of products sold

   5,598    5,277   5,140 

Marketing, selling and administrative

   4,203    3,686   3,946 

Advertising and product promotion

   957    977   1,136 

Research and development

   3,839    3,566   3,647 

Provision for restructuring

   116    113   136 

Litigation expense, net

       (19  132 

Equity in net income of affiliates

   (281  (313  (550

Other (income)/expense

   (169  126   (381
  

 

 

  

 

 

  

 

 

 

Total Expenses

   14,263    13,413   13,206 
  

 

 

  

 

 

  

 

 

 

Earnings from Continuing Operations Before Income Taxes

   6,981    6,071   5,602 

Provision for income taxes

   1,721    1,558   1,182 
  

 

 

  

 

 

  

 

 

 

Net Earnings from Continuing Operations

   5,260    4,513   4,420 
  

 

 

  

 

 

  

 

 

 

Discontinued Operations:

    

Earnings, net of taxes

           285 

Gain on disposal, net of taxes

           7,157 
  

 

 

  

 

 

  

 

 

 

Net Earnings from Discontinued Operations

           7,442 
  

 

 

  

 

 

  

 

 

 

Net Earnings

   5,260    4,513   11,862 
  

 

 

  

 

 

  

 

 

 

Net Earnings Attributable to Noncontrolling Interest

   1,551    1,411   1,250 
  

 

 

  

 

 

  

 

 

 

Net Earnings Attributable to Bristol-Myers Squibb Company

  $3,709   $3,102  $10,612 
  

 

 

  

 

 

  

 

 

 

Amounts Attributable to Bristol-Myers Squibb Company:

    

Net Earnings from Continuing Operations

  $3,709   $3,102  $3,239 

Net Earnings from Discontinued Operations

           7,373 
  

 

 

  

 

 

  

 

 

 

Net Earnings Attributable to Bristol-Myers Squibb Company

  $3,709   $3,102  $10,612 
  

 

 

  

 

 

  

 

 

 

Earnings per Common Share from Continuing Operations Attributable to
Bristol-Myers Squibb Company:

    

Basic

  $2.18   $1.80  $1.63 

Diluted

  $2.16   $1.79  $1.63 

Earnings per Common Share Attributable to Bristol-Myers Squibb Company:

    

Basic

  $2.18   $1.80  $5.35 

Diluted

  $2.16   $1.79  $5.34 

Dividends declared per common share

  $1.33   $1.29  $1.25 

  Year Ended December 31,
EARNINGS 2013 2012 2011
Net product sales $12,304
 $13,654
 $17,622
Alliance and other revenues 4,081
 3,967
 3,622
Total Revenues 16,385
 17,621
 21,244
       
Cost of products sold 4,619
 4,610
 5,598
Marketing, selling and administrative 4,084
 4,220
 4,203
Advertising and product promotion 855
 797
 957
Research and development 3,731
 3,904
 3,839
Impairment charge for BMS-986094 intangible asset 
 1,830
 
Other (income)/expense 205
 (80) (334)
Total Expenses 13,494
 15,281
 14,263
       
Earnings Before Income Taxes 2,891
 2,340
 6,981
Provision for/(Benefit from) Income Taxes 311
 (161) 1,721
Net Earnings 2,580
 2,501
 5,260
Net Earnings Attributable to Noncontrolling Interest 17
 541
 1,551
Net Earnings Attributable to BMS $2,563
 $1,960
 $3,709
       
Earnings per Common Share      
Basic $1.56
 $1.17
 $2.18
Diluted $1.54
 $1.16
 $2.16
       
Cash dividends declared per common share $1.41
 $1.37
 $1.33
The accompanying notes are an integral part of these consolidated financial statements.

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63

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

Dollars in Millions

   Year Ended December 31, 
   2011  2010  2009 

COMPREHENSIVE INCOME

    

Net Earnings

  $  5,260  $  4,513  $  11,862 

Other Comprehensive Income/(Loss):

    

Foreign currency translation

   (27)��  37   159 

Foreign currency translation reclassified to net earnings due to business divestitures

           (40

Foreign currency translation on net investment hedges

   11   84   (38

Derivatives qualifying as cash flow hedges, net of taxes of $(4) in 2011, $(3) in 2010 and $9 in 2009

   24   15   (19

Derivatives qualifying as cash flow hedges reclassified to net earnings, net of taxes of $(20) in 2011, $5 in 2010 and $5 in 2009

   32   (5  (27

Derivatives reclassified to net earnings due to business divestitures, net of taxes of $(1) in 2009

           2 

Pension and postretirement benefits, net of taxes of $421 in 2011, $66 in 2010 and $41 in 2009

   (830  (88  (115

Pension and postretirement benefits reclassified to net earnings, net of taxes of $(38) in 2011, $(44) in 2010 and $(49) in 2009

   88   83   109 

Pension and postretirement benefits reclassified to net earnings due to business divestitures, net of taxes of $(62) in 2009

           106 

Available for sale securities, net of taxes of $(7) in 2011, $(3) in 2010 and $(4) in 2009

   28   44   35 

Available for sale securities reclassified to net earnings, net of taxes of $(3) in 2009

           6 
  

 

 

  

 

 

  

 

 

 

Total Other Comprehensive Income/(Loss)

   (674  170   178 
  

 

 

  

 

 

  

 

 

 

Comprehensive Income

   4,586   4,683   12,040 
  

 

 

  

 

 

  

 

 

 

Comprehensive Income Attributable to Noncontrolling Interest

   1,558   1,411   1,260 
  

 

 

  

 

 

  

 

 

 

Comprehensive Income Attributable to Bristol-Myers Squibb Company

  $3,028  $3,272  $10,780 
  

 

 

  

 

 

  

 

 

 



  Year Ended December 31,
COMPREHENSIVE INCOME 2013 2012 2011
Net Earnings $2,580
 $2,501
 $5,260
Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:      
Derivatives qualifying as cash flow hedges: 7
 (27) 56
Pension and postretirement benefits 1,166
 (118) (742)
Available for sale securities (37) 3
 28
Foreign currency translation (75) (15) (16)
Total Other Comprehensive Income/(Loss) 1,061
 (157) (674)
       
Comprehensive Income 3,641
 2,344
 4,586
Comprehensive Income Attributable to Noncontrolling Interest 17
 535
 1,558
Comprehensive Income Attributable to BMS $3,624
 $1,809
 $3,028
The accompanying notes are an integral part of these consolidated financial statements.

63


64

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEETS

Dollars in Millions, Except Share and Per Share Data

   December 31, 
   2011  2010 

ASSETS

   

Current Assets:

   

Cash and cash equivalents

  $5,776  $5,033 

Marketable securities

   2,957   2,268 

Receivables

   3,743   3,480 

Inventories

   1,384   1,204 

Deferred income taxes

   1,200   1,036 

Prepaid expenses and other

   258   252 
  

 

 

  

 

 

 

Total Current Assets

   15,318   13,273 
  

 

 

  

 

 

 

Property, plant and equipment

   4,521   4,664 

Goodwill

   5,586   5,233 

Other intangible assets

   3,124   3,370 

Deferred income taxes

   688   850 

Marketable securities

   2,909   2,681 

Other assets

   824   1,005 
  

 

 

  

 

 

 

Total Assets

  $32,970  $31,076 
  

 

 

  

 

 

 

LIABILITIES

   

Current Liabilities:

   

Short-term borrowings

  $115  $117 

Accounts payable

   2,603   1,983 

Accrued expenses

   2,791   2,740 

Deferred income

   337   402 

Accrued rebates and returns

   1,170   857 

U.S. and foreign income taxes payable

   167   65 

Dividends payable

   597   575 
  

 

 

  

 

 

 

Total Current Liabilities

   7,780   6,739 
  

 

 

  

 

 

 

Pension, postretirement and postemployment liabilities

   2,017   1,297 

Deferred income

   866   895 

U.S. and foreign income taxes payable

   573   755 

Other liabilities

   491   424 

Long-term debt

   5,376   5,328 
  

 

 

  

 

 

 

Total Liabilities

   17,103   15,438 
  

 

 

  

 

 

 

Commitments and contingencies (Note 22)

   

EQUITY

   

Bristol-Myers Squibb Company Shareholders’ Equity:

   

Preferred stock, $2 convertible series, par value $1 per share: Authorized 10 million shares; issued and outstanding 5,268 in 2011 and 5,269 in 2010, liquidation value of $50 per share

         

Common stock, par value of $0.10 per share: Authorized 4.5 billion shares; 2.2 billion issued in both 2011 and 2010

   220   220 

Capital in excess of par value of stock

   3,114   3,682 

Accumulated other comprehensive loss

   (3,045  (2,371

Retained earnings

   33,069   31,636 

Less cost of treasury stock — 515 million common shares in 2011 and 501 million in 2010

   (17,402  (17,454
  

 

 

  

 

 

 

Total Bristol-Myers Squibb Company Shareholders’ Equity

   15,956   15,713 

Noncontrolling interest

   (89  (75
  

 

 

  

 

 

 

Total Equity

   15,867   15,638 
  

 

 

  

 

 

 

Total Liabilities and Equity

  $32,970  $31,076 
  

 

 

  

 

 

 



  December 31,
  2013 2012
ASSETS    
Current Assets:    
Cash and cash equivalents $3,586
 $1,656
Marketable securities 939
 1,173
Receivables 3,360
 3,083
Inventories 1,498
 1,657
Deferred income taxes 1,701
 1,597
Prepaid expenses and other 412
 355
Assets held-for-sale 7,420
 
Total Current Assets 18,916
 9,521
Property, plant and equipment 4,579
 5,333
Goodwill 7,096
 7,635
Other intangible assets 2,318
 8,778
Deferred income taxes 508
 203
Marketable securities 3,747
 3,523
Other assets 1,428
 904
Total Assets $38,592
 $35,897
     
LIABILITIES    
     
Current Liabilities:    
Short-term borrowings and current portion of long-term debt $359
 $826
Accounts payable 2,559
 2,202
Accrued expenses 2,152
 2,573
Deferred income 756
 825
Accrued rebates and returns 889
 1,054
Income taxes payable 160
 193
Dividends payable 634
 606
Liabilities related to assets held-for-sale 4,931
 
Total Current Liabilities 12,440
 8,279
Pension, postretirement and postemployment liabilities 718
 1,882
Deferred income 769
 4,024
Income taxes payable 750
 648
Deferred income taxes 73
 383
Other liabilities 625
 475
Long-term debt 7,981
 6,568
Total Liabilities 23,356
 22,259
     
Commitments and contingencies (Note 22) 
 
     
EQUITY    
     
Bristol-Myers Squibb Company Shareholders’ Equity:    
Preferred stock, $2 convertible series, par value $1 per share: Authorized 10 million shares; issued and outstanding 4,369 in 2013 and 5,117 in 2012, liquidation value of $50 per share 
 
Common stock, par value of $0.10 per share: Authorized 4.5 billion shares; 2.2 billion issued in both 2013 and 2012 221
 221
Capital in excess of par value of stock 1,922
 2,694
Accumulated other comprehensive loss (2,141) (3,202)
Retained earnings 32,952
 32,733
Less cost of treasury stock — 559 million common shares in 2013 and 570 million in 2012 (17,800) (18,823)
Total Bristol-Myers Squibb Company Shareholders' Equity 15,154
 13,623
Noncontrolling interest 82
 15
Total Equity 15,236
 13,638
Total Liabilities and Equity $38,592
 $35,897

The accompanying notes are an integral part of these consolidated financial statements.

64


65

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Dollars in Millions

   Year Ended December 31, 
   2011  2010  2009 

Cash Flows From Operating Activities:

    

Net earnings

  $5,260  $4,513  $11,862 

Adjustments to reconcile net earnings to net cash provided by operating activities:

    

Net earnings attributable to noncontrolling interest

   (1,551  (1,411  (1,250

Depreciation

   448   473   469 

Amortization

   353   271   238 

Deferred income tax expense

   415   422   163 

Stock-based compensation expense

   161   193   183 

Impairment charges

   28   228     

Gain related to divestitures of discontinued operations

           (7,275

Other adjustments

   (147  (32  (367

Changes in operating assets and liabilities:

    

Receivables

   (220  (270  227 

Inventories

   (193  156   82 

Accounts payable

   593   315   472 

Deferred income

   (115  117   135 

U.S. and foreign income taxes payable

   (134  (236  58 

Other

   (58  (248  (932
  

 

 

  

 

 

  

 

 

 

Net Cash Provided by Operating Activities

   4,840   4,491   4,065 
  

 

 

  

 

 

  

 

 

 

Cash Flows From Investing Activities:

    

Proceeds from sale and maturities of marketable securities

   5,960   3,197   2,075 

Purchases of marketable securities

   (6,819  (5,823  (3,489

Additions to property, plant and equipment and capitalized software

   (367  (424  (730

Proceeds from sale of businesses and other investing activities

   149   67   557 

Mead Johnson’s cash at split-off

           (561

Purchase of businesses, net of cash acquired

   (360  (829  (2,232
  

 

 

  

 

 

  

 

 

 

Net Cash Used in Investing Activities

   (1,437  (3,812  (4,380
  

 

 

  

 

 

  

 

 

 

Cash Flows From Financing Activities:

    

Short-term debt repayments

   (1  (33  (26

Long-term debt borrowings

       6   1,683 

Long-term debt repayments

   (78  (936  (212

Interest rate swap terminations

   296   146   194 

Issuances of common stock

   601   252   45 

Common stock repurchases

   (1,221  (576    

Dividends paid

   (2,254  (2,202  (2,483

Proceeds from Mead Johnson initial public offering

           782 
  

 

 

  

 

 

  

 

 

 

Net Cash Used in Financing Activities

   (2,657  (3,343  (17
  

 

 

  

 

 

  

 

 

 

Effect of Exchange Rates on Cash and Cash Equivalents

   (3  14   39 
  

 

 

  

 

 

  

 

 

 

Increase/(Decrease) in Cash and Cash Equivalents

   743   (2,650  (293

Cash and Cash Equivalents at Beginning of Year

   5,033   7,683   7,976 
  

 

 

  

 

 

  

 

 

 

Cash and Cash Equivalents at End of Year

  $5,776  $5,033  $7,683 
  

 

 

  

 

 

  

 

 

 



  Year Ended December 31,
  2013 2012 2011
Cash Flows From Operating Activities:      
Net earnings $2,580
 $2,501
 $5,260
Adjustments to reconcile net earnings to net cash provided by operating activities:      
Net earnings attributable to noncontrolling interest (17) (541) (1,551)
Depreciation and amortization, net 763
 681
 628
Deferred income taxes (491) (1,230) 415
Stock-based compensation 191
 154
 161
Impairment charges 40
 2,180
 28
Proceeds from Amylin diabetes alliance 
 3,570
 
Other (9) (35) (147)
Changes in operating assets and liabilities:      
Receivables (504) 648
 (220)
Inventories (45) (103) (193)
Accounts payable 412
 (232) 593
Deferred income 965
 295
 58
Income taxes payable 126
 (50) (134)
Other (466) (897) (58)
Net Cash Provided by Operating Activities 3,545
 6,941
 4,840
Cash Flows From Investing Activities:      
Proceeds from sale and maturities of marketable securities 1,815
 4,890
 5,960
Purchases of marketable securities (1,859) (3,607) (6,819)
Additions to property, plant and equipment and capitalized software (537) (548) (367)
Proceeds from sale of businesses and other investing activities 9
 68
 149
Purchase of businesses, net of cash acquired 
 (7,530) (360)
Net Cash Used in Investing Activities (572) (6,727) (1,437)
Cash Flows From Financing Activities:      
Short-term debt borrowings/(repayments) 198
 49
 (1)
Proceeds from issuance of long-term debt 1,489
 1,950
 
Repayments of long-term debt (597) (2,108) (78)
Interest rate swap contract terminations 20
 2
 296
Issuances of common stock 564
 463
 601
Repurchases of common stock (433) (2,403) (1,221)
Dividends (2,309) (2,286) (2,254)
Net Cash Used in Financing Activities (1,068) (4,333) (2,657)
Effect of Exchange Rates on Cash and Cash Equivalents 25
 (1) (3)
Increase/(Decrease) in Cash and Cash Equivalents 1,930
 (4,120) 743
Cash and Cash Equivalents at Beginning of Year 1,656
 5,776
 5,033
Cash and Cash Equivalents at End of Year $3,586
 $1,656
 $5,776
The accompanying notes are an integral part of these consolidated financial statements.

65


66



Note 1. ACCOUNTING POLICIES


Basis of Consolidation


The consolidated financial statements are prepared in conformity with United States (U.S.) generally accepted accounting principles (GAAP), includeincluding the accounts of Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS, or the Company) and all of its controlled majority-owned subsidiaries. All intercompany balances and transactions have beenare eliminated. Material subsequent events are evaluated and disclosed through the report issuance date.

Codevelopment, cocommercialization


Alliance and license arrangements are entered into with other parties for various therapeutic areas, with terms including upfront licensing and contingent payments. These arrangements are assessed to determine whether the terms giveprovide economic or other control over the entity which may requirerequiring consolidation of thean entity. Entities that are consolidated because they are controlled by means other than a majority voting interest are referred to as variable interest entities. ArrangementsThere were no arrangements with material variable interest entities including those associated with these codevelopment, cocommercialization and license arrangements, were determined not to exist.

during any of the periods presented.


Use of Estimates


The preparation of financial statements requires the use of management estimates and assumptions that are based on complex judgments.assumptions. The most significant assumptions are employed in estimates used in determining the fair value and potential impairment of intangible assets, restructuring charges and accruals,assets; sales rebate and return accruals, including those related to U.S. healthcare reform,accruals; legal contingencies, tax assetscontingencies; income taxes; and tax liabilities, stock-based compensation expense, pension and postretirement benefits (including the actuarial assumptions, see “—Note 19. Pension, Postretirement and Postemployment Liabilities”), fair value of financial instruments with no direct or observable market quotes, inventory obsolescence, potential impairment of long-lived assets, allowances for bad debt, as well as in estimates used in applying the revenue recognition policy. New discounts under the 2010 U.S. healthcare reform law, such as the Medicare coverage gap and managed Medicaid require additional assumptions due to the lack of historical claims experience. In addition, the new pharmaceutical company fee estimate is subject to external data as well as a calculation based on the Company’s relative share of industry results.benefits. Actual results may differ from estimated results.


Reclassifications

Certain prior period amounts were reclassified to conform to the current period presentation. Net product sales and alliance and other revenues previously presented in the aggregate as net sales in the consolidated statements of earnings are now presented separately.

Revenue Recognition


Revenue is recognized when persuasive evidence of an arrangement exists, the sales price is fixed and determinable, collectability is reasonably assured and title and substantially all of the risks and rewards of ownership haveis transferred, which is generally at time of shipment.shipment (including the supply of commercial products to alliance partners when they are the principal in the end customer sale). However, certain sales made byrevenue of non-U.S. businesses areis recognized on the date of receipt by the purchaser. Seecustomer and alliance and other revenue related to Abilify* and Atripla* is not recognized until the products are sold to the end customer by the alliance partner. Royalties based on third party sales are recognized as earned in accordance with the contract terms when the third party sales are reliably measurable and collectability is reasonably assured. Refer to “—Note 3. Alliances and Collaborations”3. Alliances” for further discussion of revenue recognition related todetail regarding alliances.

Provisions are made at the time of revenue recognition for expected sales returns, discounts, rebates and estimated sales allowances based on historical experience updated for changes in facts and circumstances including the impact of newapplicable healthcare legislation. Such provisions are recognized as a reduction of revenue.

In limited circumstances, whererevenue.When a new product is not an extension of an existing line of product or there is no historical experience with products in a similar therapeutic category, exists, revenue is deferred until the right of return no longer exists or sufficient historical experience to estimate sales returns is developed.


Income Taxes


The provision for income taxes is determined using the asset and liability approach of accounting for income taxes. Under this approach, deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. The provision for income taxes representsincludes income taxes paid or payable for the current year plus the change in deferred taxes during the year. Deferred taxes result from differences between the financial and tax basis of assets and liabilities and are adjusted for changes in tax rates and tax laws when changes are enacted. Valuation allowances are recognized to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment including the long-range forecast of future taxable income and the evaluation of tax planning initiatives. Adjustments to the deferred tax valuation allowances are made to earnings in the period when such assessments are made.


Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement.

Cash and Cash Equivalents


Cash and cash equivalents consist ofinclude U.S. Treasury securities, government agency securities, bank deposits, time deposits and money market funds. Cash equivalents consist of highly liquid investments with original maturities of three months or less at the time of purchase and are recognized at cost, which approximates fair value.

66



67



Marketable Securities and Investments in Other Companies

All marketable


Marketable securities wereare classified as “available-for-sale” on the date of purchase and were reported at fair value at December 31, 2011 and 2010.value. Fair value is determined based on observable market quotes or valuation models using assessments of counterparty credit worthiness, credit default risk or underlying security and overall capital market liquidity. Declines in fair value considered other than temporary are charged to earnings and those considered temporary are reported as a component of accumulated other comprehensive income (OCI) in shareholders’ equity. Declines in fair value determined to be credit related are charged to earnings. An average cost method is used in determining realized gains and losses on the sale of “available-for-sale” securities.


Investments in 50% or less owned companies for which the ability to exercise significant influence is maintained are accounted for using the equity method of accounting.accounting when the ability to exercise significant influence is maintained. The share of net income or losses of equity investments is included in equity in net income of affiliates in the consolidated statements of earnings.other (income)/expense. Equity investments are reviewed for impairment by assessing if the decline in market value of the investment below the carrying value is other than temporary, which considers the intent and ability to retain the investment, the length of time and extent to whichthat the market value has been less than cost, and the financial condition of the investee.


Inventory Valuation


Inventories are stated at the lower of average cost or market.


Property, Plant and Equipment and Depreciation


Expenditures for additions, renewals and improvements are capitalized at cost. Depreciation is computed on a straight-line method based on the estimated useful lives of the related assets. The estimated useful lives of depreciable assets rangeranging from 20 to 50 years for buildings and 3 to 20 years for machinery, equipment, and fixtures.


Impairment of Long-Lived Assets


Current facts or circumstances are periodically evaluated to determine if the carrying value of depreciable assets to be held and used may not be recoverable. If such circumstances exist, an estimate of undiscounted future cash flows generated by the long-lived asset, or the appropriate grouping of assets, is compared to the carrying value to determine whether an impairment exists at its lowest level of identifiable cash flows. If an asset is determined to be impaired, the loss is measured based on the difference between the asset’s fair value and its carrying value. An estimate of the asset’s fair value is based on quoted market prices in active markets, if available. If quoted market prices are not available, the estimate of fair value is based on various valuation techniques using Level 3 fair value inputs, including a discounted value of estimated future cash flows. Long-lived assets held for sale are reported at the lower of its carrying value or its estimated net realizable value.


Capitalized Software

Certain


Eligible costs to obtain internal use software for significant systems projects are capitalized and amortized over the estimated useful life of the software. CostsInsignificant costs to obtain software for projects that are not significant are expensed as incurred.


Business Combinations


Businesses acquired are included in the consolidated financial statements upon obtaining control of the acquiree. AssetsThe fair value of assets acquired and liabilities assumed are recognized at the date of acquisition at their respective fair values.acquisition. Any excess of the purchase price over the estimated fair values of the net assets acquired is recognized as goodwill. Legal, costs, audit, fees, business valuation, costs, and all other business acquisition costs are expensed when incurred.


Goodwill, Acquired In-Process Research and Development and Other Intangible Assets

Goodwill is tested for impairment annually using a two-step process. The first step identifies a potential impairment, and the second step measures the amount of the impairment loss, if any. Goodwill is impaired if the carrying amount of a reporting unit’s goodwill exceeds its estimated fair value. Geographical reporting units were aggregated for impairment testing purposes. The annual goodwill impairment assessment was completed in the first quarter of 2011 and subsequently monitored for potential impairment in the remaining quarters of 2011, none of which indicated an impairment of goodwill.


The fair value of in-process research and development (IPRD) acquired in a business combination is determined based on the present value of each research project’s projected cash flows using an income approach. Future cash flows are predominately based on the net income forecast of each project, consistent with historical pricing, margins and expense levels of similar products. Revenues are estimated based on relevant market size and growth factors, expected industry trends, individual project life cycles and the life of each research project’s underlying patent. In determining the fair value of each research project, expected revenues are first adjusted for probability to regulatory success. The resulting cash flows are then discounted at a rate approximating the Company’s weighted-average cost of capital.

67


IPRD is initially capitalized and considered indefinite-lived assets subject to annual impairment reviews or more often upon the occurrence of certain events. The review requires the determination of the fair value of the respective intangible assets. If the fair value of the intangible assets is less than its carryingtypically determined using the “income method” which utilizes Level 3 fair value an impairment loss is recognizedinputs. The market participant valuations assume a global view considering all potential jurisdictions and indications based on discounted after-tax cash flow projections, risk adjusted for the difference. For those compoundsestimated probability of technical and regulatory success (for IPRD).


Finite-lived intangible assets, including licenses, developed technology rights and IPRD projects that reach commercialization the assets are amortized over the expected useful lives.

Patents/trademarks, licenses and technology are amortized on a straight-line basis over their estimated useful life. Estimated useful lives are monitoreddetermined considering the period in which the assets are expected to contribute to future cash flows.


Goodwill is tested at least annually for impairment triggers,by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net assets are below their carrying amounts. Examples of qualitative factors assessed in 2013 include our share price, our financial performance compared to budgets, long-term financial plans, macroeconomic, industry and market conditions as well as the substantial excess of fair value over the carrying value of net assets from the annual impairment test performed in the prior year. Each relevant factor is assessed both individually and in the aggregate.


68



IPRD is tested for impairment on an annual basis and more frequently if events occur or circumstances change that would indicate a potential reduction in the fair values of the assets below their carrying value. If the carrying value of IPRD is determined to exceed the fair value, an impairment loss is recognized for the difference.

Finite-lived intangible assets are considered impaired if their nettested for impairment when facts or circumstances suggest that the carrying value of the asset may not be recoverable. If the carrying value exceeds theirthe projected undiscounted pre-tax cash flows of the intangible asset, an impairment loss equal to the excess of the carrying value over the estimated fair value.

value (discounted after-tax cash flows) is recognized.


Restructuring


Restructuring charges are recognized as a result of actions to streamline operations and rationalize manufacturing facilities. Judgment is used when estimating the impact of restructuring plans, including future termination benefits and other exit costs to be incurred when the actions take place. Actual results could vary from these estimates.


Contingencies


Loss contingencies from legal proceedings and claims may occur from a wide range of matters, including government investigations, shareholder lawsuits, product and environmental liability, contractual claims and tax matters. Accruals are recognized when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. Gain contingencies (including contingent proceeds related to the divestitures) are not recognized until realized. Legal fees are expensed as incurred.


Derivative Financial Instruments

Derivative financial instruments


Derivatives are used principally in the management of interest rate and foreign currency exposures and are not held or issuedused for trading purposes.

Derivative instruments


Derivatives are recognized at fair value. Changesvalue with changes in a derivative’s fair value are recognized in earnings unless specific hedge criteria are met. If the derivative is designated as a fair value hedge, changes in the fair value of the derivative and of the hedged item attributable to the hedged risk are recognized in earnings. If the derivative is designated as a cash flow hedge, the effective portions of changes in the fair value of the derivative are reported in accumulated other comprehensive incomeincome/(loss) (OCI) and subsequently recognized in earnings when the hedged item affects earnings. Cash flows are classified consistent with the underlying hedged item.

Derivatives are designated and assigned as hedges of forecasted transactions, specific assets or specific liabilities. When hedged assets or liabilities are sold or extinguished or the forecasted transactions being hedged are no longer probable to occur, a gain or loss is immediately recognized on the designated hedge in earnings.

Non-derivative instruments, primarily euro denominated long-term debt, are also designated as hedges of net investments in foreign affiliates. These non-derivative instruments are mainly euro denominated long-term debt. The effective portion of the designated non-derivative instrument is recognized in the foreign currency translation section of OCI and the ineffective portion is recognized in earnings.


Shipping and Handling Costs


Shipping and handling costs are included in marketing, selling and administrative expenses and were $119 million in 2013, $125 million in 2012 and $139 million in 2011, $135 million in 2010 and $208 million in 2009, of which $68 million in 2009 was included in discontinued operations.

2011.


Advertising and Product Promotion Costs


Advertising and product promotion costs are expensed as incurred.


Foreign Currency Translation


Foreign subsidiary earnings are translated into U.S. dollars using average exchange rates. The net assets of foreign subsidiaries are translated into U.S. dollars using current exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recognized in OCI. The net assets of subsidiaries in highly inflationary economies are remeasured as if the functional currency were the reporting currency. The remeasurement is recognized in earnings.


Research and Development


Research and development costs are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Strategic alliances with third parties provide rights to develop, manufacture, market and/or sell pharmaceutical products, the rights to which are owned

68


by the other party. Certain research and development payments to alliance partners are contingent upon the achievement of certain pre-determined criteria. Milestone payments achieved prior to regulatory approval of the product are expensed as research and development. Milestone payments made in connection with regulatory approvals are capitalized and amortized to cost of products sold over the remaining useful life of the asset. Capitalized milestone payments are tested for recoverability periodically or whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable. Research and development is recognized net of reimbursements in connection with collaborationalliance agreements.

Upfront licensing and milestone receipts obtained during development are deferred and amortized over the estimated life of the product in other income. If the Company has no future obligation for development, upfront licensing and milestone receipts are recognized immediately in other income. The amortization period of upfront licensing and milestone receipts for each new or materially modified arrangement after January 1, 2011 is assessed and determined after considering the terms of such arrangements.



69



Recently Issued Accounting Standards


In January 2011,July 2013, the Financial Accounting Standards Board issued an update that clarified existing guidance on the presentation of unrecognized tax benefits when various qualifying tax benefit carryforwards exist, including when the unrecognized tax benefit should be presented as a new revenue recognition standard wasreduction to deferred tax assets or as a liability. This update is required to be adopted for new or materially modified revenue arrangements with upfront licensing feesall annual periods and contingent milestones relating to research and development deliverables. The guidance provides principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated and the consideration allocated. The adoption of this standard did not impact the consolidated financial statements.

In September 2011, the FASB amended its guidance for goodwill impairment testing. The amendment allows entities to first assess qualitative factors in determining whether or not the fair value of ainterim reporting unit exceeds its carrying value. If an entity concludes from this qualitative assessment that it is more likely than not that the fair value of a reporting unit exceeds its carrying value, then performing a two-step impairment test is unnecessary. This standard is effective for fiscal yearsperiods beginning after December 15, 2011 and2013, with early adoption permitted. The reduction to deferred tax assets is not expected to have an impact on the consolidated financial statements.

be approximately $250 million.

Note 2. BUSINESS SEGMENT INFORMATION

BMS operates in a single segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines that help patients prevail over serious diseases. A global research and development organization and a global supply chain organization are utilized and responsible for the development and delivery of products to the market. ProductsRegional commercial organizations are distributedused to distribute and sold through regional organizations that servesell the United States; Europe; Latin America, Middle East and Africa; Japan, Asia Pacific and Canada; and Emerging Markets defined as Brazil, Russia, India, China and Turkey.product. The business is also supported by global corporate staff functions. The segmentSegment information presented below is consistent with the financial information regularly reviewed by the chief operating decision maker, the chief executive officer for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting future periods.

Products are sold principally to wholesalers, and to a lesser extent, directly to distributors, retailers, hospitals, clinics, government agencies and pharmacies. Gross salesrevenues to the three largest pharmaceutical wholesalers in the U.S. as a percentage of totalglobal gross salesrevenues were as follows:

   2011  2010  2009 

McKesson Corporation

   26  24  25

Cardinal Health, Inc.

   21  21  20

AmerisourceBergen Corporation

   16  16  15

  2013 2012 2011
McKesson Corporation 19% 23% 26%
Cardinal Health, Inc. 14% 19% 21%
AmerisourceBergen Corporation 15% 14% 16%
Selected geographic area information was as follows:

   Net Sales   Property, Plant and
Equipment
 
Dollars in Millions  2011   2010   2009   2011   2010 

United States

  $13,845   $12,613   $11,867   $3,032   $3,119 

Europe

   3,667    3,448    3,625    884    922 

Japan, Asia Pacific and Canada

   1,862    1,651    1,522    18    20 

Latin America, Middle East and Africa

   894    856    843    534    557 

Emerging Markets

   887    804    753    53    46 

Other

   89    112    198           
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $  21,244   $  19,484   $  18,808   $  4,521   $  4,664 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

69

  Total Revenues Property, Plant and Equipment
Dollars in Millions 2013 2012 2011 2013 2012
United States $8,318
 $10,384
 $14,039
 $3,708
 $4,464
Europe 3,930
 3,706
 3,879
 729
 740
Rest of the World 3,295
 3,204
 3,237
 142
 129
Other(a) 
 842
 327
 89
 
 
Total $16,385
 $17,621
 $21,244
 $4,579
 $5,333

(a)Other total revenues include royalties and other alliance-related revenues for products not sold by our regional commercial organizations.

70

Net sales



Total revenues of key products were as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

PLAVIX* (clopidogrel bisulfate)

  $7,087  $6,666  $6,146 

AVAPRO*/AVALIDE* (irbesartan/irbesartan-hydrochlorothiazide)

   952   1,176   1,283 

ABILIFY* (aripiprazole)

   2,758   2,565   2,592 

REYATAZ (atazanavir sulfate)

   1,569   1,479   1,401 

SUSTIVA (efavirenz) Franchise

   1,485   1,368   1,277 

BARACLUDE (entecavir)

   1,196   931   734 

ERBITUX* (cetuximab)

   691   662   683 

SPRYCEL (dasatinib)

   803   576   421 

YERVOY (ipilimumab)

   360         

ORENCIA (abatacept)

   917   733   602 

NULOJIX (belatacept)

   3         

ONGLYZA/KOMBIGLYZE (saxagliptin/saxagliptin and metformin)

   473   158   24 

Mature Products and All Other

   2,950   3,170   3,645 
  

 

 

  

 

 

  

 

 

 

Net Sales

  $  21,244  $  19,484  $  18,808 
  

 

 

  

 

 

  

 

 

 

Capital expenditures

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Virology      
Baraclude (entecavir) $1,527
 $1,388
 $1,196
Reyataz (atazanavir sulfate) 1,551
 1,521
 1,569
Sustiva (efavirenz) Franchise(a)
 1,614
 1,527
 1,485
Oncology      
Erbitux* (cetuximab) 696
 702
 691
Sprycel (dasatinib) 1,280
 1,019
 803
Yervoy (ipilimumab) 960
 706
 360
Neuroscience      
Abilify* (aripiprazole)(b)
 2,289
 2,827
 2,758
Metabolics      
Bydureon* (exenatide extended-release for injectable suspension) 298
 78
 N/A
Byetta* (exenatide) 400
 149
 N/A
Forxiga (dapagliflozin) 23
 
 N/A
Onglyza/Kombiglyze (saxagliptin/saxagliptin and metformin) 877
 709
 473
Immunoscience      
Nulojix (belatacept) 26
 11
 3
Orencia (abatacept) 1,444
 1,176
 917
Cardiovascular      
Avapro*/Avalide* (irbesartan/irbesartan-hydrochlorothiazide) 231
 503
 952
Eliquis (apixaban) 146
 2
 
Plavix* (clopidogrel bisulfate) 258
 2,547
 7,087
       
Mature Products and All Other 2,765
 2,756
 2,950
Total Revenues $16,385
 $17,621
 $21,244

(a)
Includes $1,366 million in 2013, $1,267 million in 2012 and $1,203 million in 2011 presented in alliance and other revenue.
(b)Includes $1,840 million in 2013, $2,340 million in 2012 and $2,303 million in 2011 presented in alliance and other revenue.

Note 3. ALLIANCES

BMS enters into collaboration arrangements with third parties for the development and depreciationcommercialization of certain products. Although each of these arrangements is unique in nature, both parties are active participants in the operating activities of the collaboration and exposed to significant risks and rewards depending on the commercial success of the activities. BMS may either in-license intellectual property plantowned by the other party or out-license its intellectual property to the other party. These arrangements also typically include research, development, manufacturing, and/or commercial activities and equipment withincan cover a single investigational compound or commercial product or multiple compounds and/or products in various life cycle stages. We refer to these collaborations as alliances and our partners as alliance partners.

Payments between alliance partners are accounted for and presented in the segment wereresults of operations after considering the specific nature of the payment and the underlying activities to which the payments relate. Multiple alliance activities, including the transfer of rights, are only separated into individual units of accounting if they have standalone value from other activities that occur over the life of the arrangements. In these situations, the arrangement consideration is allocated to the activities or rights on a relative selling price basis. If multiple alliance activities or rights do not have standalone value, they are combined into a single unit of accounting.

The most common activities between BMS and its alliance partners are presented in results of operations as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Capital expenditures

  $       367  $       424  $       634  

Depreciation

   373   380   346 

Segment


When BMS is the principal in the end customer sale, 100% of third-party product sales are included in net product sales. When BMS's alliance partner is the principal in the end customer sale, BMS's contractual share of the third-party sales and/or royalty income excludesare included in alliance and other revenue as the impactsale of significant itemscommercial products are considered part of BMS's ongoing major or central operations. Refer to "Revenue Recognition" included in "—Note 1. Accounting Policies" for information regarding recognition criteria.
Amounts payable to BMS by alliance partners (who are the principal in the end customer sale) for supply of commercial products are included in alliance and other revenue as the sale of commercial products are considered part of BMS's ongoing major or central operations.

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Amounts payable by BMS to alliance partners for profit sharing, royalties and other sales-based fees are included in cost of products sold as incurred.
Cost reimbursements between the parties are recognized as incurred and included in cost of products sold; marketing, selling and administrative expenses; advertising and product promotion expenses; or research and development expenses, based on the underlying nature of the related activities subject to reimbursement.
Upfront and contingent development and approval milestones payable to BMS by alliance partners for investigational compounds and commercial products are deferred and amortized over the shorter of the contractual term or the periods in which the related compounds or products are expected to contribute to future cash flows. The amortization is presented consistent with the nature of the payment under the arrangement. For example, amounts received for investigational compounds are presented in other (income)/expense as the activities being performed at that time are not indicativerelated to the sale of currentcommercial products that are part of BMS’s ongoing major or central operations; amounts received for commercial products are presented in alliance and other revenue as the sale of commercial products are considered part of BMS’s ongoing major or central operations (except for the AstraZeneca PLC (AstraZeneca) alliance pertaining to the Amylin products – see further discussion under the specific AstraZeneca alliance disclosure herein).
Upfront and contingent approval milestones payable by BMS to alliance partners for commercial products are capitalized and amortized over the shorter of the contractual term or the periods in which the related products are expected to contribute to future cash flows. The amortization is included in cost of products sold.
Upfront and contingent milestones payable by BMS to alliance partners prior to regulatory approval are expensed as incurred and included in research and development expenses.
Equity in net income of affiliates is included in other (income)/expense.
All payments between BMS and its alliance partners are presented in cash flows from operating performance or ongoing results, and earningsactivities.

Selected financial information pertaining to our alliances was as follows, including net product sales when BMS is the principal in the third-party customer sale for products subject to the alliance. Expenses summarized below do not include all amounts attributed to Sanofithe activities for the products in the alliance, but only the payments between the alliance partners or the related amortization if the payments were deferred or capitalized.
 Year Ended December 31,
Dollars in Millions2013 2012 2011
Revenues from alliances:     
Net product sales$4,417
 $6,124
 $10,460
Alliance and other revenues3,804
 3,748
 3,548
Total Revenues8,221
 9,872
 14,008
      
Payments to/(from) alliance partners:     
Cost of products sold$1,356
 $1,706
 $2,823
Marketing, selling and administrative(125) (80) (9)
Advertising and product promotion(58) (97) (86)
Research and development(140) 4
 89
Other (income)/expense(313) (489) (317)
      
Net earnings attributable to noncontrolling interest, pre-tax36
 844
 2,323
Selected Alliance Balance Sheet Information: December 31,
Dollars in Millions 2013 2012
Receivables – from alliance partners $1,122
 $857
Accounts payable – to alliance partners 1,396
 1,052
Deferred income from alliances(a)
 5,089
 4,647

(a)Includes deferred income classified as liabilities related to assets held-for-sale of $3,671 million at December 31, 2013.

Specific information pertaining to each of our significant alliances is discussed below, including their nature and purpose; the significant rights and obligations of the parties; specific accounting policy elections; and the income statement classification of and amounts attributable to payments between the parties.


72



Otsuka

BMS has a worldwide commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote Abilify*, excluding certain Asian countries. The U.S. portion of the agreement was amended in 2009 and 2012 and expires upon the expected loss of product exclusivity in April 2015. The agreement expires in all European Union (EU) countries in June 2014 and in each other non-U.S. country where we have the exclusive right to sell Abilify*, the agreement expires on the later of April 2015 or loss of exclusivity in any such country.

Both parties actively participate in joint executive governance and operating committees. Although Otsuka assumed responsibility for providing and funding all sales force efforts effective January 2013 (under the 2012 U.S. amendment), BMS is responsible for funding certain operating expenses up to various annual limits in 2013 through 2015. BMS purchases the active pharmaceutical ingredient (API) from Otsuka and completes the manufacture of the product for subsequent sale to third-party customers in the U.S. and certain other countries. Otsuka assumed responsibility for providing and funding sales force efforts in the EU effective April 2013. BMS also provides certain other services including distribution, customer management and pharmacovigilence. Otsuka is the principal for third-party product sales in the U.S., United Kingdom (UK), Germany, France, Spain and Italy (beginning March 1, 2013) and BMS is the principal for third-party product sales when it is the exclusive distributor for or has an exclusive right to sell Abilify* which is in the remaining territories.

Alliance and other noncontrolling interest.revenue is recognized for only BMS’s share of total net sales to third-party customers in these territories. In the U.S., BMS’s contractual share was 51.5% in 2012 and 53.5% in 2011. Beginning January 1, 2013, BMS’s contractual share changed to the percentages of total U.S. net sales set forth in the table below. An assessment of BMS's expected annual contractual share is completed each quarterly reporting period and adjusted based upon reported U.S. Abilify* net sales at December 31, 2013. BMS's annual contractual share was 34.0% in 2013. The reconciliationalliance and other revenue recognized in any interim period or quarter does not exceed the amounts that are due under the contract.
Annual U.S. Net SalesBMS Share as a % of U.S. Net Sales
$0 to $2.7 billion50%
$2.7 billion to $3.2 billion20%
$3.2 billion to $3.7 billion7%
$3.7 billion to $4.0 billion2%
$4.0 billion to $4.2 billion1%
In excess of $4.2 billion20%

In the United Kingdom, Germany, France, Spain, and Italy (beginning on March 1, 2013), BMS’s contractual share of third-party net sales is 65%. In these countries and the U.S., alliance and other revenue is recognized when Abilify* is shipped and all risks and rewards of ownership have been transferred to earningsthird-party customers.

Under the terms of the 2009 U.S. amendment, BMS paid Otsuka $400 million in 2009, which is amortized as a reduction of alliance and other revenue through the expected loss of U.S. exclusivity in April 2015. The unamortized balance is included in other assets. Otsuka receives a royalty based on 1.5% of total U.S. net sales, which is included in cost of products sold. Otsuka was responsible for 30% of the U.S. expenses related to the commercialization of Abilify* from continuing operations before income taxes2010 through 2012.

BMS and Otsuka also have an alliance for Sprycel and Ixempra (ixabepilone) in the U.S., Japan and the EU. While both parties actively participate in various governance committees, BMS has control over the decision making. Both parties co-promote the product. BMS is responsible for the development and manufacture of the product. BMS is also the principal in the end-customer product sales.

A fee is paid to Otsuka based on the following percentages of annual net sales of Sprycel and Ixempra:
 % of Net Sales
 2010 - 2012 2013 - 2020
$0 to $400 million30% 65%
$400 million to $600 million5% 12%
$600 million to $800 million3% 3%
$800 million to $1.0 billion2% 2%
In excess of $1.0 billion1% 1%

During these annual periods, Otsuka contributes 20% of the first $175 million of certain commercial operational expenses relating to the Oncology Products in the Oncology Territory and 1% of such costs in excess of $175 million.

The U.S. extension and the oncology alliance include a change-of-control provision in the case of an acquisition of BMS. If the acquiring company does not have a competing product to Abilify*, then the new company will assume the Abilify* agreement (as amended) and the oncology alliance as it exists today. If the acquiring company has a product that competes with Abilify*, Otsuka can elect to request

73



the acquiring company to choose whether to divest Abilify* or the competing product. In the scenario where Abilify* is divested, Otsuka would be obligated to acquire the rights of BMS under the Abilify* agreement (as amended). The agreements also provide that in the event of a generic competitor to Abilify* after January 1, 2010, BMS has the option of terminating the Abilify* April 2009 amendment (with the agreement as previously amended remaining in force). If BMS were to exercise such option then either (i) BMS would receive a payment from Otsuka according to a pre-determined schedule and the oncology alliance would terminate at the same time or (ii) the oncology alliance would continue for a truncated period according to a pre-determined schedule.
Summarized financial information related to this alliance was as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Segment income

  $5,083  $4,642  $4,492 

Reconciling items:

    

Provision for restructuring

   (116  (113  (136

Impairment and loss on sale of manufacturing operations

       (236    

Accelerated depreciation, asset impairment and other shutdown costs

   (75  (113  (115

Process standardization implementation costs

   (29  (35  (110

Gain on sale of product lines, businesses and assets

   12       360 

Litigation recovery/(charges)

   22   19   (132

Upfront, milestone and other licensing payments

   (187  (132  (347

BMS Foundation funding initiative

           (100

Other

   (72  (55  (53

Noncontrolling interest

   2,343   2,094   1,743 
  

 

 

  

 

 

  

 

 

 

Earnings from continuing operations before income taxes

  $    6,981  $    6,071  $    5,602 
  

 

 

  

 

 

  

 

 

 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Revenues from Otsuka alliances:      
Net product sales $1,543
 $1,386
 $1,181
Alliance and other revenues(a)
 1,840
 2,340
 2,303
Total Revenues 3,383
 3,726
 3,484
       
Payments to/(from) Otsuka:      
Cost of products sold:      
Oncology fee 295
 138
 134
Royalties 86
 78
 72
Amortization of intangible assets 
 5
 6
Cost of product supply 135
 153
 145
       
Cost reimbursements to/(from) Otsuka (10) (47) (45)
Selected Alliance Balance Sheet information: December 31,
Dollars in Millions 2013 2012
Other assets – extension payment $87
 $153

(a)Includes the amortization of the extension payment as a reduction to alliance and other revenue of $66 million in 2013, 2012 and 2011.

AstraZeneca

BMS and AstraZeneca had a diabetes alliance consisting of three worldwide codevelopment and commercialization agreements. The first agreement covered Onglyza and related combination products sold under various names. The second agreement covered Forxiga (will be commercialized as Farxiga in the U.S.) and related combination products. The third agreement covered Amylin's portfolio of products (Bydureon*, Byetta*, Symlin* (pramlintide acetate) and metreleptin, which is currently in development) as well as certain assets owned by Amylin, included a manufacturing facility. The Onglyza agreement excluded Japan.

Upon entering into each of the separate agreements, co-exclusive license rights for the product or products underlying each agreement were granted to AstraZeneca in exchange for an upfront payment and potential milestone payments, and both parties assumed certain obligations to actively participate in the alliance. Both parties actively participated in a joint executive committee and various other operating committees and had joint responsibilities for the research, development, distribution, sales and marketing activities of the alliance using resources in their own infrastructures. BMS manufactured the products in all three alliances and was the principal in the end-customer product sales in substantially all countries.

For each alliance agreement, we have determined that the rights transferred to AstraZeneca did not have standalone value as such rights were not sold separately by BMS or any other party, nor could AstraZeneca have received any benefit for the delivered rights without the fulfillment of other ongoing obligations by BMS under the alliance agreements, including the exclusive supply arrangement. As such, each global alliance was treated as a single unit of accounting. As a result, up-front proceeds and any subsequent contingent milestone proceeds were amortized over the life of the related products.

In 2012, BMS received a $3.6 billion non-refundable, upfront payment from AstraZeneca in consideration for entering into the Amylin alliance. In 2013, AstraZeneca exercised its option for equal governance rights over certain key strategic and financial decisions regarding the Amylin alliance and paid BMS $135 million as consideration. These payments were accounted for as deferred income and amortized based on the relative fair value of the predominant elements included in the alliance over their estimated useful lives (intangible assets related to Bydureon* with an estimated useful life of 13 years, Byetta* with an estimated useful life of 7 years, Symlin* with an estimated life of 9 years, metreleptin with an estimated useful life of 12 years, and the Amylin manufacturing plant with an estimated useful life of 15 years). The amortization was presented as a reduction to cost of products sold because the alliance assets were acquired shortly before

74



the commencement of the alliance and AstraZeneca was entitled to share in the proceeds from the sale of any of the assets. The amortization of the acquired Amylin intangible assets and manufacturing plant was also presented in cost of products sold. BMS was entitled to reimbursements for 50% of capital expenditures related to the acquired Amylin manufacturing facility. BMS and AstraZeneca also shared in certain tax attributes related to the Amylin alliance.

BMS received $300 million in non-refundable upfront, milestone and other licensing payments related to Onglyza to date. BMS also received $250 million in non-refundable upfront, milestone and other licensing payments related to Forxiga to date. Amortization of the Onglyza and Forxiga deferred income was included in other income as Onglyza and Forxiga were not commercial products at the commencement of the alliance.

Both parties equally shared most commercialization and development expenses, as well as profits and losses.

Summarized financial information related to the AstraZeneca alliances was as follows:
  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Revenues from AstraZeneca alliances:      
Net product sales $1,658
 $962
 $472
Alliance and other revenues 16
 10
 1
Total Revenues $1,674
 $972
 $473
       
Payments to/(from) AstraZeneca:      
Cost of products sold:      
Profit sharing 673
 425
 207
Amortization of deferred income (307) (126) 
       
Cost reimbursements to/(from) AstraZeneca recognized in:      
Cost of products sold (25) (4) 
Marketing, selling and administrative (127) (66) (14)
Advertising and product promotion (45) (43) (21)
Research and development (86) (25) 35
       
Other (income)/expense:      
Amortization of deferred income (31) (38) (38)
Provision for restructuring (25) (21) 
       
Selected Alliance Cash Flow information:      
Non-refundable upfront, milestone and other licensing payments received:      
Amylin-related products 135
 3,547
 
Forxiga 80
 
 120
Selected Alliance Balance Sheet information: December 31,
Dollars in Millions 2013 2012
Deferred income – Non-refundable upfront, milestone and other licensing receipts(a)
    
Amylin-related products $3,288
 $3,423
Onglyza 191
 208
Forxiga 192
 206

(a)Included in liabilities related to assets held-for-sale at December 31, 2013.

In February 2014, BMS sold to AstraZeneca the diabetes business of BMS which comprised our global alliance with them, including all rights and ownership to Onglyza, Forxiga, Bydureon*, Byetta*, Symlin* (pramlintide acetate) and metreleptin. The transaction included the shares of Amylin, and the resulting transfer of its manufacturing plant; the intellectual property related to Onglyza and Forxiga and the future purchase of BMS’s manufacturing facility located in Mount Vernon, Indiana no earlier than 18 months following the closing of the transaction. The parties terminated their existing alliance agreements in connection with the sale and entered into several new agreements, including a transitional services agreement, a supply agreement and a development agreement. See “—Note 3. ALLIANCES AND COLLABORATIONS5. Assets Held-For-Sale” for further information.


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Gilead

SanofiBMS and Gilead Sciences, Inc. (Gilead) have joint ventures in the U.S. (for the U.S. and Canada) and in Europe to develop and commercialize

Atripla* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), combining Sustiva, a product of BMS, and Truvada* (emtricitabine and tenofovir disoproxil fumarate), a product of Gilead. The joint ventures are consolidated by Gilead.


Both parties actively participate in a joint executive committee and various other operating committees with direct oversight over the activities of the joint ventures. The joint ventures purchase Sustiva and Truvada* API in bulk form from the parties and complete the finishing of Atripla*. In the U.S. and Canada, the joint venture sells and distributes Atripla* and is the principal in third-party customer sales. In Europe, Gilead and its affiliates sell and distribute Atripla* and are the principal in third-party customer sales. The parties no longer coordinate joint promotional activities.

Alliance and other revenue recognized for Atripla* include only the bulk efavirenz component of Atripla* which is based on the relative ratio of the average respective net selling prices of Truvada* and Sustiva. Alliance and other revenue is deferred and the related alliance receivable is not recognized until the combined product is sold to third-party customers.

In Europe, following the 2013 loss of exclusivity of Sustiva and effective January 1, 2014, the percentage of Atripla* net sales that BMS will recognize will be based on the ratio of the difference in the average net selling prices of Atripla* and Truvada* to the Atripla* average net selling price. This alliance will continue until either party terminates the arrangement or the last patent expiration occurs for Atripla*, Truvada*, or Sustiva.

In the U.S., the agreement may be terminated by Gilead upon the launch of a generic version of Sustiva or by BMS upon the launch of a generic version of Truvada*.  In the event Gilead terminates the agreement upon the loss of exclusivity for Sustiva, BMS will receive a quarterly royalty payment for 36 months following termination.  Such payment in the first 12 months following termination is equal to 55% of Atripla* net sales multiplied by the ratio of the difference in the average net selling prices of Atripla* and Truvada* to the Atripla* average net selling price.  In the second and third years following termination, the payment to BMS is reduced to 35% and 15%, respectively, of Atripla* net sales multiplied by the price ratio described above. BMS will continue to supply Sustiva at cost plus a markup to the joint ventures during this three-year period, unless either party elects to terminate the supply arrangement.

Summarized financial information related to this alliance was as follows:
  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Revenues from Gilead alliances:      
Net product sales $
 $
 $1
Alliance and other revenues 1,366
 1,267
 1,203
Total Revenues 1,366
 1,267
 1,204
       
Equity in net loss of affiliates 17
 18
 16
Selected Alliance Balance Sheet information: December 31,
Dollars in Millions 2013 2012
Deferred revenue $468
 $339

Lilly

BMS has a commercialization agreement with Eli Lilly and Company (Lilly) through Lilly’s November 2008 acquisition of ImClone Systems Incorporated (ImClone) for the codevelopment and promotion of Erbitux* in the U.S. which expires in September 2018. Both parties actively participate in a joint executive committee and various other operating committees and have shared responsibilities for the research and development of the alliance using resources in their own infrastructures. Lilly is responsible for supplying the product to BMS for distribution and sale. BMS is responsible for promotional efforts for the product in North America although Lilly has the right to copromote at their own expense. BMS also has codevelopment and copromotion rights in Canada and Japan. BMS is the principal in third-party customer sales in North America. Under the commercialization agreement, BMS pays Lilly a distribution fee based on a flat rate of 39% of net sales of Erbitux* in North America plus a share of certain royalties paid by Lilly.

In Japan, BMS shares rights to Erbitux* under an agreement with Lilly and Merck KGaA and receives 50% of the pre-tax profit from Merck KGaA’s net sales of Erbitux* in Japan which is further shared equally with Lilly.


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In March 2013,BMS and Lilly terminated its arrangement for necitumumab (IMC-11F8), with all rights returning to Lilly. Discovered by ImClone, necitumumab is a fully human monoclonal antibody that was part of the alliance between BMS and Lilly.

BMS is amortizing $500 million of license acquisition costs associated with the Erbitux* allianceagreement through 2018.

Summarized financial information related to this alliance was as follows:
  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Revenues from Lilly alliance:      
Net product sales $696
 $702
 $691
       
Payments to/(from) Lilly:      
Cost of products sold:      
Distribution fees and royalties 289
 291
 287
Amortization of intangible asset 37
 38
 37
Cost of product supply 65
 81
 73
       
Cost reimbursements to/(from) Lilly (13) 23
 5
Other (income)/expense – Japan commercialization fee (30) (37) (34)
Selected Alliance Balance Sheet information December 31,
Dollars in Millions 2013 2012
Other intangible assets – Non-refundable upfront, milestone and other licensing payments $174
 $211

BMS acquired Amylin Pharmaceuticals, Inc. (Amylin) on August 8, 2012 (see “—Note 4. Acquisitions” for further information). Amylin had previously entered into a settlement and termination agreement with Lilly regarding their alliance for the global development and commercialization of Byetta* and Bydureon* (exenatide products) under which the parties agreed to transition full responsibility of these products to Amylin. The transition of the U.S. operations was completed by the time of the acquisition. The transition of non-U.S. operations of the exenatide products in a majority of markets was completed on April 1, 2013 terminating Lilly's exclusive right to non-U.S. commercialization of the exenatide products. Promissory notes assumed in the acquisition of Amylin aggregating $1.4 billion were repaid to Lilly during 2012.

Sanofi

In September 2012, BMS and Sanofi restructured the terms of the codevelopment and cocommercialization agreements for Plavix* and Avapro*/Avalide*. Effective January 1, 2013, Sanofi assumed essentially all of the worldwide operations of the alliance with the exception of Plavix* in the U.S. and Puerto Rico. The alliance for Plavix* in these markets will continue unchanged through December 2019 under the same terms as in the original alliance arrangements described below. In exchange for the rights being assumed by Sanofi, BMS will receive quarterly royalties from January 1, 2013 until December 31, 2018 and a terminal payment from Sanofi of $200 million at the end of 2018. All ongoing disputes between the companies were resolved including an $80 million payment by BMS to Sanofi related to the Avalide* supply disruption in the U.S. in 2011 (accrued for in 2011).

Beginning in 2013, all royalties received from Sanofi in the territory covering the Americas and Australia, opt-out markets, and former development royalties are presented in alliance and other revenues ($220 million). Development and opt-out royalty income of $143 million in 2012 and $126 million in 2011 were included in other (income)/expense. Development royalty expense of $67 million in 2012 and $182 million in 2011 was included in other (income)/expense. Royalties attributed to the territory covering Europe and Asia continue to be earned by the territory partnership and are included in equity in net income of affiliates. Additionally, equity in net income of affiliates in 2013 included $22 million of profit that was deferred prior to the restructuring of the agreement. Alliance and other revenues attributed to the supply of irbesartan API to Sanofi were $116 million in 2013, $117 million in 2012 and $33 million in 2011. The supply arrangement for irbesartan expires in 2015.

Prior to the restructuring, BMS’s worldwide alliance with Sanofi for the codevelopment and cocommercialization of AVAPRO*Avapro*/AVALIDE*, an angiotensin II receptor antagonist indicated for the treatment of hypertensionAvalide* and diabetic nephropathy, and PLAVIX*, a platelet aggregation inhibitor. The worldwide alliance operatesPlavix* operated under the framework of two geographic territories;territories: one in the Americas (principally the U.S., Canada, Puerto Rico and Latin American countries) and Australia, and the other in Europe and Asia. Accordingly,These two territory partnerships were formed to managemanaged central expenses, such as marketing, research and development and royalties, and to supply of finished product to the individual countries. In general, at the country level, agreements either to copromote (whereby a partnership was formed between the parties to sell each brand) or to comarket (whereby the parties operate and sell their brands independently of each other) are in place. The agreements expire upon the expiration of all patents and other exclusivity rights in the applicable territory.

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BMS actsacted as the operating partner and ownsowned a 50.1% majority controlling interest in the territory covering the Americas and Australia and consolidates all country partnership results for this territory with Sanofi’s 49.9% share of the results reflected as a noncontrolling interest. BMS recognizesalso recognized net product sales in this territory and in comarketing countries outside this territory (e.g. Germany, Italy for irbesartan only, SpainGermany, Greece and Greece)Spain). Royalties owed to


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Sanofi are included in cost of products sold (other than development royalties). Sanofi actsacted as the operating partner and ownsowned a 50.1% majority controlling interest in the territory covering Europe and Asia.Asia and BMS has a 49.9% ownership interest in this territory and accounts for it under the equity method. Distributions of profits relating to the partnerships are included in operating activities.

BMS and Sanofi have a separate partnership governing the copromotion of irbesartan in the U.S. BMS recognizes other income related to the amortization of deferred income associated with Sanofi’s $350 million payment to BMS for their acquisition of an interest in the irbesartan license for the U.S. upon formation of the alliance. Certain supply activities and development and opt-out royalties with Sanofi are reflected on a net basis in other (income)/expense.

During the fourth quarter of 2011, BMS established an $80 million reserve related to the AVALIDE* supply disruption in early 2011 in connection with ongoing negotiations with Sanofi. The charge was included in other expense.

territory.


Summarized financial information related to this alliance iswas as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Territory covering the Americas and Australia:

    

Net sales

  $  7,761  $  7,464  $  6,912 

Royalty expense

   1,583   1,527   1,404 

Noncontrolling interest – pre-tax

   2,323   2,074   1,717 

Profit distributions to Sanofi

   (2,335  (2,093  (1,717

Territory covering Europe and Asia:

    

Equity in net income of affiliates

   (298  (325  (558

Profit distributions to BMS

   283   313   554 

Other:

    

Net sales in Europe comarketing countries and other

   279   378   517 

Amortization (income)/expense – irbesartan license fee

   (31  (31  (32

Supply activities and development and opt-out royalty (income)/expense

   23   (3  (41

   December 31, 
Dollars in Millions  2011   2010 

Investment in affiliates – territory covering Europe and Asia

  $       37   $       22 

Deferred income – irbesartan license fee

   29    60 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Revenues from Sanofi alliances:      
Net product sales $153
 $2,930
 $8,003
Alliance and other revenues 336
 120
 37
Total Revenues 489
 3,050
 8,040
       
Payments to/(from) Sanofi:      
Cost of product supply 4
 81
 245
Cost of products sold – Royalties
 4
 530
 1,583
Equity in net income of affiliates (183) (201) (298)
Other (income)/expense (18) (171) 72
Noncontrolling interest – pre-tax 36
 844
 2,323
       
Selected Alliance Cash Flow information:      
Distributions (to)/from Sanofi - Noncontrolling interest 43
 (742) (2,335)
Distributions from Sanofi - Investment in affiliates 149
 229
 283
       
Selected Alliance Balance Sheet information:   December 31,
Dollars in Millions   2013 2012
Investment in affiliates – territory covering Europe and Asia(a)
   43
 9
Noncontrolling interest   49
 (30)

(a)Included in alliance receivables.

The following is the summarized financial information for interests in the partnerships with Sanofi for the territory covering Europe and Asia, which are not consolidated but are accounted for using the equity method:

   Year Ended December 31, 
Dollars in Millions  2011   2010  2009 

Net sales

  $  1,469   $  1,879  $2,984 

Cost of products sold

   811    1,047   1,510 
  

 

 

   

 

 

  

 

 

 

Gross profit

   658    832   1,474 

Marketing, selling and administrative

   75    129   219 

Advertising and product promotion

   15    29   68 

Research and development

   5    16   61 

Other (income)/expense

   1    (1    
  

 

 

   

 

 

  

 

 

 

Net income

  $562   $659  $1,126 
  

 

 

   

 

 

  

 

 

 

Current assets

  $584   $751  $  1,305 

Current liabilities

   584    751   1,305 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Net sales $395
 $1,077
 $1,469
Gross profit 319
 453
 658
Net income $313
 $394
 $562

Cost of products sold for the territory covering Europe and Asia includes discovery royalties of $38 million in 2013, $133 million in 2012 and $184 million in 2011, $307 million in 2010 and $446 million in 2009, which are paid directly to Sanofi. All other expenses are shared based on the applicable ownership percentages. Current assets and current liabilities include approximately $108 million in 2013, $293 million in 2012 and $400 million in 2011 $567 million in 2010 and $1.0 billion in 2009 related to receivables/payables attributed to the respective years and net cash distributions to BMS and Sanofi as well as intercompany balances between partnerships within the territory. The remaining current assets and current liabilities consist of third-party trade receivables, inventories and amounts due to BMS and Sanofi for the purchase of inventories, royalties and expense reimbursements.

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Pfizer

Otsuka

BMS has a worldwide commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote ABILIFY*, for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder, excluding certain Asia Pacific countries. The U.S. portion of the amended commercialization and manufacturing agreement expires upon the expected loss of product exclusivity in April 2015. The contractual share of ABILIFY* net sales recognized by BMS was 65% in 2009, 58% in 2010 and 53.5% in 2011. Beginning on January 1, 2012, the contractual share of revenue recognized by BMS was further reduced to 51.5%.

In the UK, Germany, France and Spain, BMS receives 65% of third-party net sales. In these countries and the U.S., third-party customers are invoiced by BMS on behalf of Otsuka and alliance revenue is recognized when ABILIFY* is shipped and all risks and rewards of ownership have transferred to third party customers. In certain countries where BMS is presently the exclusive distributor for the product or has an exclusive right to sell ABILIFY*, BMS recognizes all of the net sales.

BMS purchases the product from Otsuka and performs finish manufacturing for sale to third-party customers by BMS or Otsuka. Under the terms of the amended agreement, BMS paid Otsuka $400 million, which is amortized as a reduction of net sales through the expected loss of U.S. exclusivity in April 2015. The unamortized balance is included in other assets. Otsuka receives a royalty based on 1.5% of total U.S. net sales, which is included in cost of products sold. Otsuka is responsible for 30% of the U.S. expenses related to the commercialization of ABILIFY* from 2010 through 2012. Reimbursements are netted principally in marketing, selling and administrative and advertising and product promotion expenses.

Beginning January 1, 2013, and through the expected loss of U.S. exclusivity in April 2015, including an expected six month pediatric extension, BMS will receive the following percentages of U.S. annual net sales:

Share as a % of U.S. Net
Sales

$0 to $2.7 billion

50%

$2.7 billion to $3.2 billion

20%

$3.2 billion to $3.7 billion

  7%

$3.7 billion to $4.0 billion

  2%

$4.0 billion to $4.2 billion

  1%

In excess of $4.2 billion

20%

During this period, Otsuka will be responsible for 50% of all U.S. expenses related to the commercialization of ABILIFY*.

BMS and Otsuka also entered into an oncology collaboration for SPRYCEL and IXEMPRA for the U.S., Japan and European Union (EU) markets (the Oncology Territory). A collaboration fee, classified in cost of products sold, is paid to Otsuka based on the following percentages of annual net sales of SPRYCEL and IXEMPRA in the Oncology Territory:

   % of Net Sales
   2010 - 2012 2013 - 2020

$0 to $400 million

  30% 65%

$400 million to $600 million

    5% 12%

$600 million to $800 million

    3%   3%

$800 million to $1.0 billion

    2%   2%

In excess of $1.0 billion

    1%   1%

During these periods, Otsuka contributes (i) 20% of the first $175 million of certain commercial operational expenses relating to the oncology products, and (ii) 1% of such commercial operational expenses relating to the products in the territory in excess of $175 million. Beginning in 2011, Otsuka copromotes SPRYCEL in the U.S. and Japan, and has exercised the right to copromote in the top five EU markets beginning in January 2012.

The U.S. extension and the oncology collaboration include a change-of-control provision in the case of an acquisition of BMS. If the acquiring company does not have a competing product to ABILIFY*, then the new company will assume the ABILIFY* agreement (as amended) and the oncology collaboration as it exists today. If the acquiring company has a product that competes with ABILIFY*, Otsuka can elect to request the acquiring company to choose whether to divest ABILIFY* or the competing product. In the scenario where ABILIFY* is divested, Otsuka would be obligated to acquire the rights of BMS under the ABILIFY* agreement (as amended). The agreements also provide that in the event of a generic competitor to ABILIFY* after January 1, 2010, BMS has the option of terminating the ABILIFY* April 2009 amendment (with the agreement as previously amended remaining in force). If BMS were to exercise such option then either (i) BMS would receive a payment from Otsuka according to a pre-determined schedule and the oncology collaboration would terminate at the same time or (ii) the oncology collaboration would continue for a truncated period according to a pre-determined schedule.

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For the EU, the agreement remained unchanged and will expire in June 2014. In other countries where BMS has the exclusive right to sell ABILIFY*, the agreement expires on the later of the 10th anniversary of the first commercial sale in such country or expiration of the applicable patent in such country.

In addition to the $400 million extension payment, total milestone payments made to Otsuka under the agreement through December 2011 were $217 million, of which $157 million was expensed as IPRD in 1999. The remaining $60 million was capitalized in other intangible assets and is amortized in cost of products sold over the remaining life of the original agreement in the U.S.

Summarized financial information related to this alliance is as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

ABILIFY* net sales, including amortization of extension payment

  $  2,758  $  2,565  $  2,592 

Oncology Products collaboration fee expense

   134   128     

Royalty expense

   72   62   58 

Reimbursement of operating expenses to/(from) Otsuka

   (88  (101    

Amortization (income)/expense – extension payment

   66   66   49 

Amortization (income)/expense – upfront, milestone and other licensing payments

   6   6   6 

   December 31, 
Dollars in Millions  2011   2010 

Other assets – extension payment

  $     219   $     285 

Other intangible assets – upfront, milestone and other licensing payments

   5    11 

In January 2007, BMS granted Otsuka exclusive rights to develop and commercialize ONGLYZA in Japan. BMS expects to receive milestone payments based on certain regulatory events, as well as sales-based payments following regulatory approval of ONGLYZA in Japan, and retained rights to copromote ONGLYZA with Otsuka in Japan. Otsuka is responsible for all development costs in Japan.

Lilly

BMS has an Epidermal Growth Factor Receptor (EGFR) commercialization agreement with Eli Lilly and Company (Lilly) through Lilly’s 2008 acquisition of ImClone Systems Incorporated (ImClone) for the codevelopment and promotion of ERBITUX* and necitumumab (IMC-11F8) in the U.S., which expires as to ERBITUX* in September 2018. BMS also has codevelopment and copromotion rights to both products in Canada and Japan. ERBITUX* is indicated for use in the treatment of patients with metastatic colorectal cancer and for use in the treatment of squamous cell carcinoma of the head and neck. Under the EGFR agreement, with respect to ERBITUX* sales in North America, Lilly receives a distribution fee based on a flat rate of 39% of net sales in North America plus reimbursement of certain royalties paid by Lilly, which is included in cost of products sold.

In 2007, BMS and ImClone amended their codevelopment agreement with Merck KGaA (Merck) to provide for cocommercialization of ERBITUX* in Japan. The rights under this agreement expire in 2032; however, Lilly has the ability to terminate the agreement after 2018 if it determines that it is commercially unreasonable for Lilly to continue. ERBITUX* received marketing approval in Japan in 2008 for the use of ERBITUX* in treating patients with advanced or recurrent colorectal cancer. BMS receives 50% of the pre-tax profit from Merck sales of ERBITUX* in Japan which is further shared equally with Lilly. Profit sharing from commercialization in Japan attributed to BMS is included in other income.

BMS is amortizing $500 million of license acquisition costs through 2018.

In 2010, BMS and Lilly restructured the EGFR commercialization agreement described above between BMS and ImClone as it relates to necitumumab, a novel targeted cancer therapy currently in Phase III development for non-small cell lung cancer. As restructured, both companies will share in the cost of developing and potentially commercializing necitumumab in the U.S., Canada and Japan. Lilly maintains exclusive rights to necitumumab in all other markets. BMS will fund 55% of development costs for studies that will be used only in the U.S., 50% for Japan studies, and will fund 27.5% for global studies. BMS will pay $250 million to Lilly as a milestone payment upon first approval in the U.S. In the U.S. and Canada, BMS will recognize all sales and 55% of the profits of losses for necitumumab. Lilly will provide 50% of the selling effort and the parties will, in general, equally participate in other commercialization efforts. In Japan, BMS and Lilly will share commercial costs and profits evenly. The agreement as it relates to necitumumab continues beyond patent expiration until both parties agree to terminate. It may be terminated at any time by BMS with 12 months advance notice (18 months if prior to launch), by either party for uncured material breach by the other or if both parties agree to terminate. Lilly is responsible for manufacturing the bulk requirements and BMS is responsible for the fill/finish of necitumumab.

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Summarized financial information related to this alliance is as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Net sales

  $  691  $  662  $  683 

Distribution fees and royalty expense

   287   275   279 

Research and development expense reimbursement to Lilly – necitumumab

   12   12   5 

Amortization (income)/expense – upfront, milestone and other licensing payments

   37   37   37 

Japan commercialization fee (income)/expense

   (34  (39  (28

   December 31, 
Dollars in Millions  2011   2010 

Other intangible assets – upfront, milestone and other licensing payments

  $  249   $  286 

Gilead

BMS and Gilead Sciences, Inc. (Gilead) have a joint venture to develop and commercialize ATRIPLA* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimen for the treatment of human immunodeficiency virus (HIV) infection, combining SUSTIVA, a product of BMS, and TRUVADA* (emtricitabine and tenofovir disoproxil fumarate), a product of Gilead, in the U.S., Canada and Europe. BMS accounts for its participation in the U.S. joint venture under the equity method of accounting.

Net sales of the bulk efavirenz component of ATRIPLA* are deferred until the combined product is sold to third-party customers. Net sales for the efavirenz component are based on the relative ratio of the average respective net selling prices of TRUVADA* and SUSTIVA.

Summarized financial information related to this alliance is as follows:

   Year Ended December 31, 
Dollars in Millions  2011   2010   2009 

Net sales

  $  1,204   $  1,053   $  869 

Equity in net loss of affiliates

   16    12    10 

AstraZeneca

BMS maintains two worldwide codevelopment and cocommercialization agreements with AstraZeneca PLC (AstraZeneca) for ONGLYZA/KOMBIGLYZE (excluding Japan), and dapagliflozin. ONGLYZA and KOMBIGLYZE are both indicated for use in the treatment of diabetes. Dapagliflozin is currently being studied for the treatment of diabetes. ONGLYZA and dapagliflozin were discovered by BMS. KOMBIGLYZE was codeveloped with AstraZeneca. Both companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits and losses equally on a global basis and also share in development costs. BMS manufactures both products. BMS has the option to decline involvement in cocommercialization in a given country and instead receive a tiered royalty based on net sales.

Reimbursements for development and commercial cost sharing are included in research and development, advertising and product promotion and marketing, selling and administrative expenses. The expense attributable to AstraZeneca’s share of profits is included in costs of products sold.

BMS received $300 million in upfront, milestone and other licensing payments related to saxagliptin as of December 31, 2011 and could receive up to an additional $300 million for sales-based milestones. BMS also received $170 million in upfront, milestone and other licensing payments related to dapagliflozin as of December 31, 2011 and could potentially receive up to an additional $230 million for development and regulatory milestones and up to an additional $390 million for sales-based milestones. Upfront, milestone and other licensing payments are deferred and amortized over the estimated useful life of the products in other income.

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Summarized financial information related to this alliance is as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Net sales

  $  473  $  158  $  24 

Profit sharing expense

   207   67   11 

Commercialization expense reimbursements to/(from) AstraZeneca

   (40  (33  (15

Research and development expense reimbursements to/(from) AstraZeneca

   40   19   (38

Amortization (income)/expense – upfront, milestone and other licensing payments

   (38  (28  (16

Upfront, milestone and other licensing payments received

    

Saxagliptin

       50   150 

Dapagliflozin

   120         

   December 31, 
Dollars in Millions  2011   2010 

Deferred income – upfront, milestone and other licensing payments

    

Saxagliptin

  $  230   $  254 

Dapagliflozin

   142    36 

Pfizer

BMS and Pfizer Inc. (Pfizer) maintain a worldwide codevelopment and cocommercialization agreement for ELIQUIS,Eliquis, an anticoagulant discovered by BMS for the prevention and treatment of atrial fibrillation and other arterial thrombotic conditions.BMS. Pfizer funds between 50% and 60% of all development costs underdepending on the initial development plan effective January 1, 2007.study. The companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits and losses equally on a global basis. In certain countries not in the BMS global commercialization network, Pfizer will commercialize Eliquis alone and will pay BMS compensation based on a percentage of net sales.


Upon entering into the agreement, co-exclusive license rights for the product was granted to Pfizer in exchange for an upfront payment and potential milestone payments, and both parties assumed certain obligations to actively participate in the alliance. Both parties actively participate in a joint executive committee and various other operating committees and have joint responsibilities for the research, development, distribution, sales and marketing activities of the alliance using resources in their own infrastructures. BMS manufactures the product. Reimbursementsproduct in the alliance and is the principal in the end-customer product sales in substantially all countries.

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We have determined that the rights transferred to Pfizer did not have standalone value as such rights were not sold separately by BMS or any other party, nor could Pfizer have received any benefit for development coststhe delivered rights without the fulfillment of other ongoing obligations by BMS under the alliance agreement, including the exclusive supply arrangement. As such, the global alliance was treated as a single unit of accounting. As a result, up-front proceeds and commercial cost sharing are included in research and development, advertising and product promotion, and marketing, selling and administrative expenses.

any subsequent contingent milestone proceeds were amortized over the life of the related product.


BMS received $559$784 million in non-refundable upfront, milestone and other licensing payments for ELIQUISrelated to Eliquis to date, including $20 million received in January 20122014, and could receive up to an additional $325$100 million for development and regulatory milestones. These payments are deferred and amortized over the estimated useful lifeAmortization of the productsEliquis deferred income is included in other income.

income as Eliquis was not a commercial product at the commencement of the alliance.

Summarized financial information related to this alliance iswas as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Commercialization expense reimbursements to/(from) Pfizer

  $(10 $(8 $1 

Research and development reimbursements to/(from) Pfizer

   (65    (190    (190

Amortization (income)/expense – upfront, milestone and other licensing payments

   (33  (31  (28

Upfront, milestone and other licensing payments received

       65   10   150 

   December 31, 
Dollars in Millions  2011   2010 

Deferred income – upfront, milestone and other licensing payments

  $  434   $  382 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Revenues from Pfizer alliance:      
Net product sales $144
 $2
 $
Alliance and other revenues 2
 
 
Total Revenues 146
 2
 
       
Payments to/(from) Pfizer:      
Cost of products sold – Profit sharing 69
 1
 
Cost reimbursements to/(from) Pfizer 4
 (11) (75)
Other (income)/expense – Amortization of deferred income (41) (37) (33)
       
Selected Alliance Cash Flow information:      
Non-refundable upfront, milestone and other licensing payments receipts 205
 20
 65
       
Selected Alliance Balance Sheet information:   December 31,
Dollars in Millions   2013 2012
Deferred income   $581
 $397

Reckitt Benckiser Group

In May 2013, BMS and Reckitt Benckiser Group plc (Reckitt) entered into a three-year alliance for several over-the-counter-products sold primarily in Mexico and Brazil. Net sales of these products were approximately $100 million in 2012. Reckitt received the right to sell, distribute and market the products through May 2016 and will have certain responsibilities related to regulatory matters in the covered territory. BMS will receive royalties on net sales of the products and will also exclusively supply certain of the products to Reckitt pursuant to a supply agreement at cost plus a markup. Certain limited assets, including the market authorizations and certain employees directly attributed to the business, were transferred to Reckitt at the start of the alliance period. BMS retained ownership of all other assets related to the business including the trademarks covering the products.

BMS also granted Reckitt an option to acquire the trademarks, inventory and certain other assets exclusively related to the products at the end of the alliance period at a price determined based on a multiple of sales (plus the cost of any remaining inventory held by BMS at the time). If the option is not exercised, all assets previously transferred to Reckitt will revert back to BMS. The option may be exercised by Reckitt between May and November 2015, in which case closing would be expected to occur in May 2016.

Non-refundable upfront proceeds of $485 million received by BMS were allocated to two units of accounting, including the rights transferred to Reckitt ($376 million) and the fair value of the option to purchase the remaining assets ($109 million) using the best estimate of the selling price for these elements after considering various market factors. These market factors included an analysis of any estimated excess of the fair value of the business over the potential purchase price if the option is exercised. The fair value of the option was determined using Level 3 inputs and included in other liabilities. Changes in the estimated fair value of the option liability were not significant in 2013. The amount allocated to the rights transferred to Reckitt is amortized as alliance and other revenue over the contractual term. Alliance and other revenue was $116 million in 2013, including product supply and royalties.


79



The Medicines Company

In February 2013, BMS and The Medicines Company entered into a two-year alliance for Recothrom, a recombinant thrombin for use as a topical hemostat to control non-arterial bleeding during surgical procedures (previously acquired by BMS in connection with its acquisition of ZymoGenetics, Inc in 2010). Net product sales of Recothrom were $67 million in 2012. The Medicines Company received the right to sell, distribute and market Recothrom on a global basis for two years, and will have certain responsibilities related to regulatory matters in the covered territory. BMS will exclusively supply Recothrom to The Medicines Company pursuant to a supply agreement at cost plus a markup and will also receive royalties on net sales of Recothrom. Certain employees directly attributed to the business and certain assets were transferred to The Medicines Company at the start of the alliance period, including the Recothrom Biologics License Application and related regulatory assets. BMS retained all other assets related to Recothrom including the patents, trademarks and inventory.

BMS also granted The Medicines Company an option to acquire the patents, trademarks, inventory and certain other assets exclusively related to Recothrom at a price determined based on a multiple of sales (plus the cost of any remaining inventory held by BMS at that time). If the option is not exercised, all assets previously transferred to The Medicines Company will revert back to BMS. The option may be exercised by The Medicines Company between February and August 2014, in which case closing would be expected to occur in February 2015.

Non-refundable upfront proceeds of $115 million received by BMS were allocated to two units of accounting, including the rights transferred to The Medicines Company ($80 million) and the fair value of the option to purchase the remaining assets ($35 million) using the best estimate of the selling price for these elements after considering various market factors. These market factors included an analysis of any estimated excess of the fair value of the business over the potential purchase price if the option is exercised. The fair value of the option was determined using Level 3 inputs and included in other liabilities. Changes in the estimated fair value of the option liability were not significant in 2013. The amount allocated to the rights transferred to The Medicines Company is amortized as alliance and other revenue over the contractual term. Alliance and other revenue was $74 million in 2013, including product supply and royalties.

Valeant

In October 2012, BMS and PharmaSwiss SA, a wholly-owned subsidiary of Valeant Pharmaceuticals International Inc. (Valeant) entered into a alliance for certain mature brand products in Europe. Valeant received the right to sell, distribute, and market the products in Europe through December 31, 2014 and will have certain responsibilities related to regulatory matters in the covered territory. During the alliance term, BMS will also exclusively supply the products to Valeant pursuant to a supply agreement at cost plus a markup.

BMS also granted Valeant an option to acquire the trademarks and intellectual property exclusively related to the products at a price determined based on a multiple of sales. If the option is not exercised, all rights transferred to Valeant will revert back to BMS. The option may be exercised by Valeant between January and June 2014, in which case closing would be expected to occur in December 2014.

Non-refundable upfront proceeds of $79 million received by BMS were allocated to two units of accounting, including the rights transferred to Valeant ($61 million) and the fair value of the option to purchase the remaining assets ($18 million) using the best estimate of the selling price for these elements after considering various market factors. These market factors included an analysis of any estimated excess of the fair value of the business over the potential purchase price if the option is exercised. The fair value of the option was determined using Level 3 inputs and included in accrued expenses. Changes in the estimated fair value of the option liability were not significant in 2013 and 2012. The amount allocated to the rights transferred to Valeant is amortized as alliance and other revenue over the contractual term. Alliance and other revenue was $49 million in 2013 and $5 million in 2012, including product supply. Net product sales recognized during a transitional period were $4 million in 2013 and $5 million in 2012.
Note 4. ACQUISITIONS
Amylin Pharmaceuticals, Inc. Acquisition
On August 8, 2012, BMS completed its acquisition of the outstanding shares of Amylin, a biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines to treat diabetes and other metabolic diseases. Acquisition costs of $29 million were included in other expenses.

BMS obtained full U.S. commercialization rights to Amylin’s two primary commercialized assets,

Bydureon*, a once-weekly diabetes treatment and Byetta*, a daily diabetes treatment, both of which are glucagon-like peptide-1 (GLP-1) receptor agonists approved in certain countries to improve glycemic control in adults with type 2 diabetes. BMS also obtained full commercialization rights to Symlin*, an amylinomimetic approved in the U.S. for adjunctive therapy to mealtime insulin to treat diabetes. Goodwill generated from this acquisition was primarily attributed to the expansion of our diabetes franchise.



80



IPRD was attributed to metreleptin, an analog of the human hormone leptin being studied and developed for the treatment of diabetes and/or hypertriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy. The estimated useful life and the cash flows utilized to value metreleptin assumed initial positive cash flows to commence shortly after the expected receipt of regulatory approvals, subject to trial results.

See "—Note 5. Assets Held-For-Sale" for a discussion of the sale of the Company's diabetes business, including Amylin, to AstraZeneca which comprised our global diabetes alliance with them.
Inhibitex, Inc. Acquisition
On February 13, 2012, BMS completed its acquisition of the outstanding shares of Inhibitex, Inc. (Inhibitex), a clinical-stage biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. Acquisition costs of $12 million were included in other expense.

BMS obtained Inhibitex’s lead asset, INX-189, an oral nucleotide polymerase (NS5B) inhibitor in Phase II development for the treatment of chronic hepatitis C virus infections. Goodwill generated from this acquisition was primarily attributed to the potential to offer a full portfolio of therapy choices for hepatitis virus infections as well as to provide additional levels of sustainability to BMS’s virology pipeline.

IPRD was primarily attributed to INX-189. INX-189 was expected to be most effective when used in combination therapy and it was assumed all market participants would inherently maintain franchise synergies attributed to maximizing the cash flows of their existing virology pipeline assets. The cash flows utilized to value INX-189 included such synergies and also assumed initial positive cash flows to commence shortly after the expected receipt of regulatory approvals, subject to trial results.

In August 2012, the Company discontinued development of INX-189 in the interest of patient safety. As a result, the Company recognized a non-cash, pre-tax impairment charge of $1.8 billion related to the IPRD intangible asset in the third quarter of 2012. For further information discussion of the impairment charge, see “—Note 14. Goodwill and Other Intangible Assets.”
Amira Pharmaceuticals, Inc.

Acquisition

On September 7, 2011, BMS acquired 100%completed its acquisition of the outstanding shares of Amira Pharmaceuticals, Inc. (Amira) for $325 million in cash plus three separate, contingent $50 million payments due upon achievement of certain development and sales-based milestones. The first contingent payment was made in the fourth quarter of 2011. The purchase price of Amira includes the estimated fair value of the total contingent consideration wasof $58 million, which was recorded in other liabilities. Acquisition costs of $1 million were included in other expense. Amira was a privately-held biotechnology company primarily focused on the discovery and development of therapeutic products for the treatment of cardiovascular and fibrotic inflammatory diseases. The acquisition provides BMS with: 1) full rights to develop and commercialize AM152 which has completed Phase I clinical studies and the remainder of the Amira lysophosphatidic acid 1 receptor antagonist program; 2) researchers with fibrotic expertise; and 3) a pre-clinical autotaxin program. Goodwill generated from the acquisition was primarily attributed to acquired scientific expertise in fibrotic diseases allowing for expansion into a new therapeutic class.


The contingent liability was estimated utilizing a model that assessedtotal consideration transferred and the probabilityallocation of achieving each milestonethe acquisition date fair values of assets acquired and discountedliabilities assumed in the amount of each potential payment based on the expected timing. Estimates used in evaluating the contingent liabilityAmylin, Inhibitex, and Amira acquisitions were consistent

75

as follows:

Dollars in Millions      
Identifiable net assets: Amylin Inhibitex Amira
Cash $179
 $46
 $15
Marketable securities 108
 17
 
Inventory 173
 
 
Property, plant and equipment 742
 
 
Developed technology rights 6,340
 
 
IPRD 120
 1,875
 160
Other assets 136
 
 
Debt obligations (2,020) (23) 
Other liabilities (339) (10) (16)
Deferred income taxes (1,068) (579) (41)
Total identifiable net assets 4,371
 1,326
 118
Goodwill 847
 1,213
 265
Total consideration transferred $5,218
 $2,539
 $383

81

with those used in evaluating the acquired IPRD. The discount rate for each payment was consistent with market debt yields




Cash paid for the non-callable, publicly-traded bondsacquisition of BMS with similar maturitiesAmylin included payments of $5,093 million to eachits outstanding common stockholders and $219 million to holders of the estimated potential payment dates. This fair value measurementits stock options and restricted stock units (including $94 million attributed to accelerated vesting that was based on significant inputs not observableaccounted for as stock compensation expense in the market and therefore represents a Level 3 measurement.

third quarter of 2012).


The results of Amira’s operations and cash flows from acquired companies are included in the consolidated financial statements from September 7, 2011.

ZymoGenetics, Inc. Acquisition

On October 12, 2010, BMS acquired 100% of the outstanding shares of common stock of ZymoGenetics, Inc. (ZymoGenetics) in October 2010 for an aggregate purchase price of approximately $885 million. Acquisition costs of $10 million were included in other expense. ZymoGenetics is focused on developing and commercializing therapeutic protein-based products for the treatment of human diseases. The companies collaborated on the development of pegylated-interferon lambda, a novel interferon in Phase IIb development at the acquisition date, for the treatment of Hepatitis C infection. The acquisition provides the Company with full rights to develop and commercialize pegylated-interferon lambda, valued at $310 million in IPRD as of the acquisition date, and also brings proven capabilities with therapeutic proteins and revenue from RECOTHROM, an FDA approved specialty surgical biologic. Goodwill generated from the acquisition was primarily attributed to full ownership rights to pegylated-interferon lambda.

The results of ZymoGenetics operations were included in the consolidated financial statements from October 8, 2010.

Medarex, Inc. Acquisition

On September 1, 2009, BMS acquired, by means of a tender offer and second-step merger, 100% of the remaining outstanding shares (and stock equivalents) of Medarex not already owned for a total purchase price of $2,331 million. Acquisition costs of $11 million were included in other expense. Medarex is focused on the discovery, development and commercialization of fully human antibody-based therapeutic products to address major unmet healthcare needs in the areas of oncology, inflammation, autoimmune disorders and infectious diseases. As a result of the acquisition, the full rights over YERVOY (ipilimumab), valued at $1.0 billion as of the acquisition date, were received that increases the biologics development pipeline creating a more balanced portfolio of both small molecules and biologics. Goodwill generated from this acquisition was primarily attributed to a more balanced portfolio associated with the BioPharma model and the potential to optimize the existing YERVOY programs.

The results of Medarex operations were included in the consolidated financial statements from August 27, 2009.

The purchase price allocations were as follows:

Dollars in Millions  Amira  ZymoGenetics  Medarex 

Purchase price:

    

Cash

  $  325  $  885  $  2,285 

Fair value of contingent consideration

   58         

Fair value of the Company’s equity held prior to acquisition(1)

           46 
  

 

 

  

 

 

  

 

 

 

Total

   383   885   2,331 
  

 

 

  

 

 

  

 

 

 
    

Identifiable net assets:

    

Cash

   15   56   53 

Marketable securities

       91   269 

Inventory(2)

       98     

Other current and long-term assets(3)

       29   127 

IPRD

   160   448   1,475 

Intangible assets - Technology

       230   120 

Intangible assets - Licenses

           217 

Short-term borrowings

           (92

Accrued expenses

   (16        

Other current and long-term liabilities

       (91  (92

Deferred income taxes

   (41  9   (318
  

 

 

  

 

 

  

 

 

 

Total identifiable net assets

   118   870   1,759 
  

 

 

  

 

 

  

 

 

 

Goodwill

  $265  $15  $572 
  

 

 

  

 

 

  

 

 

 

(1)Other income of $21 million was recognized from the remeasurement to fair value of the equity interest in Medarex held at the acquisition date.
(2)Inventory related to the ZymoGenetics acquisition includes $63 million recorded in other long term assets as inventory that is expected to be utilized in excess of one year.
(3)Other current and long term assets related to the Medarex acquisition includes a 5.1% ownership interest in Genmab, Inc. ($64 million) and an 18.7% ownership in Celldex Therapeutics, Inc. ($17 million), which were subsequently sold during 2009 for a loss of $33 million.

76


date. Pro forma supplemental financial information areis not provided as the impacts of thesethe acquisitions were not material to operating results in the year of acquisition. Goodwill, IPRD and all other intangible assets valued in these acquisitions are non-deductible for tax purposes.


Note 5. MEAD JOHNSON NUTRITION COMPANY INITIAL PUBLIC OFFERING AND SPLIT-OFF

ASSETS HELD-FOR-SALE


Mead Johnson Nutrition Company Initial Public Offering

In February 2009, Mead Johnson Nutrition Company (Mead Johnson) completed an initial public offering (IPO)2014, BMS sold to AstraZeneca the diabetes business of BMS which comprised our global alliance with them, including all rights and ownership to Onglyza, in which it sold 34.5 million shares of its Class A common stock at $24 per share. Net proceeds of $782 million, after deducting $46 million of underwriting discounts, commissionsForxiga, Bydureon*, Byetta*, Symlin* and offering expenses, were allocated to noncontrolling interest and capital in excess of par value of stock.

Upon completion of the IPO, 42.3 million shares of Mead Johnson Class A common stock and 127.7 million shares of Mead Johnson Class B common stock were held by BMS, representing an 83.1% interest in Mead Johnson and 97.5% of the combined voting power of the outstanding common stock.metreleptin. The rights of the holders oftransaction included the shares of Class A common stockAmylin (previously acquired by BMS in August 2012), and Class B common stock were identical, except with regardthe resulting transfer of its manufacturing facility in West Chester, Ohio; the intellectual property related to votingOnglyza and conversion. Each shareForxiga; and the future purchase of Class A common stock was entitled to one vote per share. Each share of Class B common stock was entitled to ten votes per share and was convertible at any time atBMS’s manufacturing facility located in Mount Vernon, Indiana no earlier than 18 months following the electionclosing of the holder into one share of Class A common stock. The Class B common stock automatically converted into shares of Class A common stock.

Various agreements relatedtransaction. Substantially all employees dedicated to the separation of Mead Johnsondiabetes business were entered into, including a separation agreement, a transitional services agreement, a tax matters agreement, a registration rights agreement and an employee matters agreement.

Mead Johnson Nutrition Company Split-off

The split-offtransferred to AstraZeneca upon the closing of the remaining interesttransaction.


As consideration for the transaction, AstraZeneca paid $2.7 billion to BMS at closing, a $600 million milestone in Mead JohnsonFebruary 2014 for the approval of Farxiga in the U.S., and will make contingent regulatory and sales-based milestone payments of up to $800 million and royalty payments based on net sales through 2025. In addition, AstraZeneca will make payments of up to $225 million if and when certain assets are transferred including the Mount Vernon manufacturing site and the diabetes business in China.

The business was completed ontreated as a single disposal group held for sale as of December 23, 2009. The split-off31, 2013. No write-down was effected through the exchange offer of previously held 170 million shares of Mead Johnson, after converting its Class B common stock to Class A common stock, for 269 million outstanding shares of the Company’s stock resulting in a pre-tax gain of $7,275 million, $7,157 million net of taxes.

The shares received in connection with the exchange were valued using the closing price on December 23, 2009 of $25.70 and reflectedrequired as treasury stock. The gain on the exchange was determined using the sum of the fair value of the shares received plusbusiness less costs to sell exceeded the net deficitrelated carrying value. The following assets and liabilities of Mead Johnson attributable to BMS less taxes andthe diabetes business held-for-sale is presented separately from BMS’s other direct expenses related to the transaction, including a tax reserve of $244 million which was established.

Transitional Relationships with Discontinued Operations

Subsequent to the respective dispositions, cash flows and income associated with the Mead Johnson business will continue to be generated through September 2012, relating to activities that are transitional in nature, result from agreements that are intended to facilitate the orderly transfer of business operations and include, among others, services for accounting, customer service, distribution and manufacturing. The income generated from these transitional activities, which were substantially completeaccounts as of December 31, 2011, 2013.

Dollars in Millions December 31, 2013
Assets  
Receivables $83
Inventories 163
Deferred income taxes - current 125
Prepaid expenses and other 20
Property, plant and equipment 678
Goodwill(a)
 550
Other intangible assets 5,682
Other assets 119
Total assets held-for-sale 7,420
   
Liabilities  
Short-term borrowings and current portion of long-term debt 27
Accounts payable 30
Accrued expenses 148
Deferred income - current 352
Accrued rebates and returns 81
Deferred income - noncurrent 3,319
Deferred income taxes - noncurrent 946
Other liabilities 28
Total liabilities related to assets held-for-sale 4,931

(a)    The allocation of goodwill was not material to any period presented.

The following summarized financial information relatedbased on the relative fair value of the diabetes business (as of December 31, 2013) being divested to the Mead JohnsonCompany's reporting unit.


The stock and asset purchase agreement contains multiple elements that will be delivered subsequent to the closing of the transaction. Each element of the transaction was determined to have standalone value and as a result, a portion of the consideration received at closing will be allocated to the undelivered elements using the relative selling price method including the China diabetes business, is segregated from continuing operationsthe Mount Vernon manufacturing facility, the development agreement and reported as discontinued operations through the dateincremental discount attributed to the supply agreement. The remaining amount of disposition.

   Year Ended December 31, 
Dollars in Millions  2009 

Net Sales

  $    2,826 

Earnings before income taxes

   674 

Provision for income taxes

   (389
  

 

 

 

Earnings, net of taxes

   285 
  

 

 

 

Gain on disposal

   7,275 

Provision for income taxes

   (118
  

 

 

 

Gain on disposal, net of taxes

   7,157 
  

 

 

 

Net earnings from discontinued operations

   7,442 

Less net earnings from discontinued operations attributable to noncontrolling interest

   (69
  

 

 

 

Net earnings from discontinued operations attributable to BMS

  $7,373 
  

 

 

 

77

consideration received at closing will be included in the calculation of the estimated net gain on disposal.



82



All contingent consideration, including royalties and milestone payments, if and when received, will also be allocated to the underlying elements of the transaction on a relative selling price basis. Amounts allocated to the sale of the business will be immediately recognized.  Amounts allocated to the other elements will either be recognized immediately or deferred, in whole or in part, to the extent each element has been delivered.
Note 6. OTHER (INCOME)/EXPENSE
Other (income)/expense includes:
  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Interest expense $199
 $182
 $145
Investment income (104) (106) (91)
Provision for restructuring (See Note 7) 226
 174
 116
Litigation charges/(recoveries) 20
 (45) 6
Equity in net income of affiliates (166) (183) (281)
Out-licensed intangible asset impairment 
 38
 
Gain on sale of product lines, businesses and assets (2) (53) (37)
Other income received from alliance partners, net (148) (312) (140)
Pension curtailments and settlements 165
 158
 10
Other 15
 67
 (62)
Other (income)/expense $205
 $(80) $(334)

Note 7. RESTRUCTURING


The following is the provision for restructuring:

   Year Ended December 31, 
Dollars in Millions  2011   2010   2009 

Employee termination benefits

  $  85   $  102   $  128 

Other exit costs

   31    11    8 
  

 

 

   

 

 

   

 

 

 

Provision for restructuring

  $     116   $     113   $     136 
  

 

 

   

 

 

   

 

 

 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Employee termination benefits $211
 $145
 $85
Other exit costs 15
 29
 31
Provision for restructuring $226
 $174
 $116

Restructuring charges included termination benefits for workforce reductions of manufacturing, selling, administrative, and research and development personnel across all geographic regions of approximately 8221,450 in 2011, 9952013, 1,205 in 20102012 and 1,350822 in 2009.

2011.


The following table represents the activity of employee termination and other exit cost liabilities:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Liability at beginning of year

  $     126  $     173  $     209 

Charges

   128   121   158 

Change in estimates

   (12  (8  (22
  

 

 

  

 

 

  

 

 

 

Provision for restructuring

   116   113   136 

Foreign currency translation

   2   (5    

Charges in discontinued operations

           15 

Spending

   (167  (155  (182

Mead Johnson split-off

           (5
  

 

 

  

 

 

  

 

 

 

Liability at end of year

  $77  $126  $173 
  

 

 

  

 

 

  

 

 

 

Note 7. OTHER (INCOME)/EXPENSE

Other (income)/expense includes:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Interest expense

  $     145  $     145  $     184 

Interest income

   (91  (75  (54

Impairment and loss on sale of manufacturing operations

       236     

Gain on sale of product lines, businesses and assets

   (37  (39  (360

Other income received from alliance partners

   (140  (136  (148

Pension curtailment and settlement charges

   10   28   43 

Litigation charges/(recoveries)

   (25        

Product liability charges/(recoveries)

   31   17   (6

Other

   (62  (50  (40
  

 

 

  

 

 

  

 

 

 

Other (income)/expense

  $(169 $126  $(381
  

 

 

  

 

 

  

 

 

 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Liability at January 1 $167
 $77
 $126
Charges 249
 178
 128
Change in estimates (23) (4) (12)
Provision for restructuring 226
 174
 116
Foreign currency translation 4
 (1) 2
Amylin acquisition 
 26
 
Liabilities related to assets held-for-sale (67) 
 
Spending (228) (109) (167)
Liability at December 31 $102
 $167
 $77


83



Note 8. INCOME TAXES


The provision/(benefit) for income taxes attributable to continuing operations consisted of:

   Year Ended December 31, 
Dollars in Millions  2011   2010  2009 

Current:

     

U.S.

  $864   $797  $410 

Non-U.S.

   442    339   646 
  

 

 

   

 

 

  

 

 

 

Total Current

   1,306    1,136   1,056 
  

 

 

   

 

 

  

 

 

 

Deferred:

     

U.S.

   406    438   222 

Non-U.S

   9    (16  (96
  

 

 

   

 

 

  

 

 

 

Total Deferred

   415    422   126 
  

 

 

   

 

 

  

 

 

 

Total Provision

   $1,721    $1,558   $1,182 
  

 

 

   

 

 

  

 

 

 

78


  
 Year Ended December 31,
Dollars in Millions 2013 2012 2011
Current:      
U.S. $375
 $627
 $864
Non-U.S. 427
 442
 442
Total Current 802
 1,069
 1,306
Deferred:      
U.S. (390) (1,164) 406
Non-U.S (101) (66) 9
Total Deferred (491) (1,230) 415
Total Provision/(Benefit) $311
 $(161) $1,721

Effective Tax Rate


The reconciliation of the effective taxtax/(benefit) rate to the U.S. statutory Federal income tax rate was:

   % of Earnings Before Income Taxes 
Dollars in Millions  2011  2010  2009 

Earnings from continuing operations before income taxes:

       

U.S.

  $   4,336   $   3,833   $   2,705  

Non-U.S.

   2,645    2,238    2,897  
  

 

 

   

 

 

   

 

 

  

Total

  $6,981   $6,071   $5,602  
  

 

 

   

 

 

   

 

 

  

U.S. statutory rate

   2,443   35.0  2,125   35.0  1,961   35.0

Non-tax deductible annual pharmaceutical company fee

   80   1.2                

Tax effect of foreign subsidiaries’ earnings previously considered indefinitely reinvested offshore

           207   3.4         

Foreign tax effect of certain operations in Ireland, Puerto

       

Rico and Switzerland

   (593  (8.5)%   (694  (11.4)%   (598  (10.7)% 

State and local taxes (net of valuation allowance)

   33   0.5  43   0.7  14   0.3

U.S. Federal, state and foreign contingent tax matters

   (161  (2.3)%   (131  (2.1)%   (64  (1.1)% 

U.S. Federal research and development tax credit

   (69  (1.0)%   (61  (1.0)%   (81  (1.4)% 

Foreign and other

   (12  (0.2)%   69   1.1   (50  (1.0)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
  $1,721   24.7  $1,558   25.7  $1,182   21.1 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

 % of Earnings Before Income Taxes
Dollars in Millions2013 2012 2011
Earnings/(Loss) before income taxes:           
U.S.$(135)   $(271)   $4,336
  
Non-U.S.3,026
   2,611
   2,645
  
Total$2,891
   $2,340
   $6,981
  
U.S. statutory rate1,012
 35.0 % 819
 35.0 % 2,443
 35.0 %
Non-tax deductible annual pharmaceutical company fee63
 2.2 % 90
 3.8 % 80
 1.2 %
Foreign tax effect of certain operations in Ireland, Puerto Rico and Switzerland(620) (21.4)% (688) (29.4)% (593) (8.5)%
State and local taxes (net of valuation allowance)25
 0.9 % 20
 0.9 % 33
 0.5 %
U.S. Federal, state and foreign contingent tax matters134
 4.6 % 66
 2.8 % (161) (2.3)%
U.S. Federal research and development tax credit(181) (6.3)% 
 
 (69) (1.0)%
U.S. tax effect of capital losses
 
 (392) (16.7)% 
 
Foreign and other(122) (4.2)% (76) (3.3)% (12) (0.2)%
 $311
 10.8 % $(161) (6.9)% $1,721
 24.7 %

The decreasechange in the 20112013 effective tax rate from 20102012 was due to:

A $207tax benefit in 2012 of $392 million attributable to a capital loss deduction resulting from the tax insolvency of Inhibitex;

Tax benefits attributable to higher impairment charges in 2012 (including an $1,830 million impairment charge recognizedfor the BMS-986094 intangible asset in the U.S.); and
Higher charges from contingent tax matters ($134 million in 2013 and $66 million in 2012)

Partially offset by:
Favorable earnings mix between high and low tax jurisdictions primarily attributable to lower Plavix* revenues in 2013 and to a lesser extent the impact of an internal transfer of intellectual property in the fourth quarter of 2010,2012; and
A favorable impact on the current year rate from the legal enactment of the 2012 and 2013 research and development tax credit during 2013. The retroactive reinstatement of the 2012 research and development tax credit recognized in 2013 was $82 million.

84



The change in the 2012 effective tax rate from 2011 was due to:
A tax benefit of $392 million attributable to a capital loss deduction resulting from the tax insolvency of Inhibitex; and
Favorable earnings mix between high and low tax jurisdictions primarily attributed to lower Plavix* revenues and a $1,830 million impairment charge for BMS-986094 intangible asset in the U.S. and to a lesser extent, an internal transfer of intellectual property.

Partially offset by:
Contingent tax matters which resulted primarilyin a $66 million charge in 2012 and $161 million benefit in 2011;
An unfavorable impact on the current year rate from additional U.S. taxable income from earningsthe delay in the legal enactment of foreign subsidiaries previously considered to be indefinitely reinvested offshore;

the research and development tax credit, which was not extended as of December 31, 2012; and

Changes in prior period estimates upon finalizing U.S. tax returns resulting in a $54 million benefit in 2011 and a $30 million charge in 2010; and

2011.

Higher tax benefits from contingent tax matters primarily related to the effective settlements and remeasurements of uncertain tax positions ($161 million in 2011 and $131 million in 2010).


Partially offset by:

An unfavorable earnings mix between high and low tax jurisdictions compared to the prior year;

The non-tax deductible annual pharmaceutical company fee effective January 1, 2011 (tax impact of $80 million); and

An out-of-period tax adjustment of $59 million in 2010 for previously unrecognized net deferred tax assets primarily attributed to deferred profits related to certain alliances as of December 31, 2009 (not material to any prior periods).

The increase in the 2010 effective tax rate from 2009 was due to:

A $207 million charge recognized in the fourth quarter of 2010 discussed above;

Changes in prior period estimates upon finalizing the 2009 U.S. tax return resulting in a $30 million charge in 2010 and a $67 million benefit in 2009 upon finalizing the 2008 U.S. tax return; and

An unfavorable earnings mix between high and low tax jurisdictions compared to the prior year.

Partially offset by:

Higher tax benefits from contingent tax matters primarily related to the effective settlements and remeasurements of uncertain tax positions ($131 million in 2010 and $64 million in 2009); and

An out-of-period tax adjustment of $59 million in 2010 discussed above.

79


Deferred Taxes and Valuation Allowance


The components of current and non-current deferred income tax assets/(liabilities) were as follows:

   December 31, 
Dollars in Millions  2011  2010 

Deferred tax assets

   

Foreign net operating loss carryforwards

  $3,674  $1,600 

Milestone payments and license fees

   574   557 

Deferred income

   573   554 

U.S. Federal net operating loss carryforwards

   251   351 

Pension and postretirement benefits

   755   348 

State net operating loss and credit carryforwards

   344   337 

Intercompany profit and other inventory items

   331   311 

U.S. Federal research and development tax credit carryforwards

   109   243 

Other foreign deferred tax assets

   112   167 

Share-based compensation

   111   131 

Legal settlements

   46   20 

Other

   233   299 
  

 

 

  

 

 

 

Total deferred tax assets

   7,113   4,918 

Valuation allowance

   (3,920  (1,863
  

 

 

  

 

 

 

Net deferred tax assets

   3,193   3,055 

Deferred tax liabilities

   

Depreciation

   (118  (52

Repatriation of foreign earnings

   (31  (21

Acquired intangible assets

   (593  (525

Other

   (676  (630
  

 

 

  

 

 

 

Total deferred tax liabilities

   (1,418  (1,228
  

 

 

  

 

 

 

Deferred tax assets, net

  $  1,775  $  1,827 
  

 

 

  

 

 

 

Recognized as:

   

Deferred income taxes – current

  $1,200  $1,036 

Deferred income taxes – non-current

   688   850 

U.S. and foreign income taxes payable – current

   (6  (5

Other liabilities – non-current

   (107  (54
  

 

 

  

 

 

 

Total

  $1,775  $1,827 
  

 

 

  

 

 

 

  December 31,
Dollars in Millions 2013 2012
Deferred tax assets    
Foreign net operating loss carryforwards $3,892
 $3,722
Milestone payments and license fees 483
 550
Deferred income 2,168
 2,083
U.S. capital losses 784
 794
U.S. Federal net operating loss carryforwards 138
 170
Pension and postretirement benefits 120
 693
State net operating loss and credit carryforwards 377
 346
Intercompany profit and other inventory items 495
 288
U.S. Federal tax credit carryforwards 23
 31
Other foreign deferred tax assets 187
 197
Share-based compensation 107
 111
Legal settlements 20
 45
Repatriation of foreign earnings 49
 86
Internal transfer of intellectual property 223
 
Other 357
 344
Total deferred tax assets 9,423
 9,460
Valuation allowance (4,623) (4,404)
Net deferred tax assets 4,800
 5,056
     
Deferred tax liabilities    
Depreciation (148) (147)
Acquired intangible assets (2,567) (2,768)
Other (780) (734)
Total deferred tax liabilities (3,495) (3,649)
Deferred tax assets, net $1,305
 $1,407
     
Recognized as:    
Assets held-for-sale $125
 $
Deferred income taxes – current 1,701
 1,597
Deferred income taxes – non-current 508
 203
U.S. and foreign income taxes payable – current (10) (10)
Liabilities related to assets held-for-sale (946) 
Deferred income taxes – non-current (73) (383)
Total $1,305
 $1,407


85



The U.S. Federal net operating loss carryforwards were $717$396 million at December 31, 2011.2013. These carryforwards were acquired as a result of certain acquisitions and are subject to limitations under Section 382 of the Internal Revenue Code. The net operating loss carryforwards expire in varying amounts beginning in 2022. The research and developmentU.S. Federal tax credit carryforwards expire in varying amounts beginning in 2018.2017. The realization of the research and developmentU.S. Federal tax credit carryforwards is dependent on generating sufficient domestic-sourced taxable income prior to their expiration. Although realization is not assured, management believes itThe capital loss available of $2,196 million can be carried back to 2009 and carried forward to 2017. The foreign and state net operating loss carryforwards expire in varying amounts beginning in 2014 (certain amounts have unlimited lives).

Management has established a valuation allowance when a deferred tax asset is more likely than not that these deferred tax assets willto be realized.

At December 31, 2011,2013, a valuation allowance of $3,920$4,623 million was established for the following items: $3,574$3,849 million primarily for foreign net operating loss and tax credit carryforwards, $332$378 million for state deferred tax assets including net operating loss and tax credit carryforwards, and $14$13 million for U.S. Federal net operating loss carryforwards. Foreign holding companies net operating lossescarryforwards and their corresponding valuation allowances included an increase of $2,027$383 million as a result of statutory impairment charges that are not required in consolidated net earnings. These foreign holding companies had a higher asset basis for statutory purposes than the basis used in the consolidated financial statements due to an internal reorganization of certain legal entities in prior periods. U.S. Federal capital losses.


Changes in the valuation allowance were as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Balance at beginning of year

  $1,863  $1,791  $1,795 

Provision

   2,410   92   17 

Utilization

   (135  (22  (74

Foreign currency translation

   (222  (6  (8

Other

   4   8   61 
  

 

 

  

 

 

  

 

 

 

Balance at end of year

  $  3,920  $  1,863  $  1,791 
  

 

 

  

 

 

  

 

 

 

80


  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Balance at beginning of year $4,404
 $3,920
 $1,863
Provision 252
 494
 2,410
Utilization (68) (145) (135)
Foreign currency translation 40
 39
 (222)
Acquisitions (5) 96
 4
Balance at end of year $4,623
 $4,404
 $3,920

Income tax payments were $478 million in 2013, $676 million in 2012 and $597 million in 2011, $672 million in 2010 and $885 million in 2009.2011. The current tax benefit realized as a result of stock related compensation credited to capital in excess of par value of stock was $129 million in 2013, $71 million in 2012 and $47 million in 2011, $8 million in 2010 and $5 million in 2009.

At December 31, 2011, 2011.


U.S. taxes have not been provided on approximately $18.5$24 billion of undistributed earnings of foreign subsidiaries as these undistributed earnings are indefinitely invested offshore. If, in the future,offshore at December 31, 2013. Additional tax provisions will be required if these earnings are repatriated in the future to the U.S., or if such earnings are determined to be remitted in the foreseeable future, additional tax provisions would be required.future. Due to complexities in the tax laws and the assumptions that would have to be made, it is not practicable to estimate the amounts of income taxes that wouldwill have to be provided. As a result, BMS has favorable tax rates in Ireland and Puerto Rico under grants not scheduled to expire prior to 2023.

During 2010, BMS completed an internal reorganization of certain legal entities resulting in a $207 million charge. It is possible that U.S. tax authorities could assert additional material tax liabilities arising from the reorganization. If any such assertion were to occur, BMS would vigorously challenge any such assertion and believes it would prevail; however, there can be no assurance of such a result.


Business is conducted in various countries throughout the world and is subject to tax in numerous jurisdictions. As a result, aA significant number of tax returns are filed and subject to examination by various Federal, state and local tax authorities. Tax examinations are often complex, as tax authorities may disagree with the treatment of items reported and may requirerequiring several years to resolve. Liabilities are established for possible assessments by tax authorities resulting from known tax exposures including, but not limited to, transfer pricing matters, tax credits and deductibility of certain expenses. Such liabilities represent a reasonable provision for taxes ultimately expected to be paid and may need to be adjusted over time as more information becomes known. The effect of changes in estimates related to contingent tax liabilities is included in the effective tax rate reconciliation above.


A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Balance at beginning of year

  $845  $968  $791 

Gross additions to tax positions related to current year

   44   57   335 

Gross reductions to tax positions related to current year

           (11

Gross additions to tax positions related to prior years

   106   177   97 

Gross reductions to tax positions related to prior years

   (325  (196  (180

Settlements

   (30  (153  (37

Reductions to tax positions related to lapse of statute

   (7  (7  (29

Cumulative translation adjustment

   (5  (1  2 
  

 

 

  

 

 

  

 

 

 

Balance at end of year

  $  628  $  845  $  968 
  

 

 

  

 

 

  

 

 

 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Balance at beginning of year $642
 $628
 $845
Gross additions to tax positions related to current year 74
 46
 44
Gross additions to tax positions related to prior years 108
 66
 105
Gross additions to tax positions assumed in acquisitions 
 31
 1
Gross reductions to tax positions related to prior years (87) (57) (325)
Settlements 26
 (54) (30)
Reductions to tax positions related to lapse of statute (8) (19) (7)
Cumulative translation adjustment 1
 1
 (5)
Balance at end of year $756
 $642
 $628


86



Additional information regarding unrecognized tax benefits is as follows:
  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Unrecognized tax benefits that if recognized would impact the effective tax rate $508
 $633
 $570
Accrued interest 83
 59
 51
Accrued penalties 34
 32
 25
Interest expense 24
 14
 10
Penalty expense 3
 16
 7

Uncertain tax benefits reduce deferred tax assets to the extent the uncertainty directly related to that asset; otherwise, they are recognized as either current or non-current U.S. and foreign income taxes payable. The unrecognized tax benefits that, if recognized, would impact the effective tax rate were $570 million, $818 million and $964 million at December 31, 2011, 2010, and 2009, respectively.

Gross additions to tax positions for the year ended December 31, 2009 include $287 million in tax reserves related to both the transfer of various international units to Mead Johnson prior to its IPO and the split-off transaction which is recognized in discontinued operations. Gross reductions to tax positions for the year ended December 31, 2009 include $10 million in liabilities related to Mead Johnson.

Accrued interest and penalties payable for unrecognized tax benefits are included in either current or non-current U.S. and foreign income taxes payable. Accrued interest related to unrecognized tax benefits were $51 million, $51 million, and $39 million at December 31, 2011, 2010, and 2009, respectively. Accrued penalties related to unrecognized tax benefits were $25 million, $23 million, and $19 million at December 31, 2011, 2010, and 2009, respectively.

Interest and penalties related to unrecognized tax benefits are included in income tax expense. Interest on unrecognized tax benefits was an expense of $10 million in 2011 and $12 million in 2010 and a benefit of $25 million in 2009. Penalties on unrecognized tax benefits was an expense of $7 million in 2011 and $4 million in 2010 and a benefit of $1 million in 2009.


BMS is currently under examination by a number of tax authorities, including all ofbut not limited to the major tax jurisdictions listed in the table below, which have proposed adjustments to tax for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. BMS estimates that it is reasonably possible that the total amount of unrecognized tax benefits at December 31, 20112013 will decrease in the range of approximately $70$350 million to $100$400 million in the next twelve months as a result of the settlement of certain tax audits and other events. The expected change in unrecognized tax benefits, primarily settlement related, will involve the payment of additional taxes, the

81


adjustment of certain deferred taxes and/or the recognition of tax benefits. BMS also anticipates that it is reasonably possible that new issues will be raised by tax authorities which may require increases to the balance of unrecognized tax benefits; however, an estimate of such increases cannot reasonably be made at this time. BMS believes that it has adequately provided for all open tax years by tax jurisdiction.


The following is a summary of major tax jurisdictions for which tax authorities may assert additional taxes based upon tax years currently under audit and subsequent years that will likely be audited:

U.S.

  2008 to 20112013

Canada

2006 to 2013
France2011 to 2013
Germany2007 to 2013
Italy  2003 to 20112013

France

Mexico
  20082006 to 2011

Germany

2007 to 2011

Italy

2002 to 2011

Mexico

2003 to 20112013

Note 9. EARNINGS PER SHARE

   Year Ended December 31, 
Amounts in Millions, Except Per Share Data  2011  2010  2009 

Basic EPS Calculation:

    

Income from Continuing Operations Attributable to BMS

  $    3,709  $    3,102  $3,239 

Earnings attributable to unvested restricted shares

   (8  (12  (18
  

 

 

  

 

 

  

 

 

 

Income from Continuing Operations Attributable to BMS common shareholders

   3,701   3,090   3,221 

Net Earnings from Discontinued Operations Attributable to BMS(1)

           7,331 
  

 

 

  

 

 

  

 

 

 

EPS Numerator – Basic

  $3,701  $3,090  $10,552 
  

 

 

  

 

 

  

 

 

 

EPS Denominator – Basic:

    

Average Common Shares Outstanding

   1,700   1,713   1,974 
  

 

 

  

 

 

  

 

 

 

EPS – Basic:

    

Continuing Operations

  $2.18  $1.80  $1.63 

Discontinued Operations

           3.72 
  

 

 

  

 

 

  

 

 

 

Net Earnings

  $2.18  $1.80  $5.35 
  

 

 

  

 

 

  

 

 

 

EPS Numerator – Diluted:

    

Income from Continuing Operations Attributable to BMS

  $3,709  $3,102  $3,239 

Earnings attributable to unvested restricted shares

   (8  (12  (17
  

 

 

  

 

 

  

 

 

 

Income from Continuing Operations Attributable to BMS common shareholders

   3,701   3,090   3,222 

Net Earnings from Discontinued Operations Attributable to BMS(1)

           7,331 
  

 

 

  

 

 

  

 

 

 

EPS Numerator – Diluted

  $3,701  $3,090  $  10,553 
  

 

 

  

 

 

  

 

 

 

EPS Denominator – Diluted:

    

Average Common Shares Outstanding

   1,700   1,713   1,974 

Contingently convertible debt common stock equivalents

   1   1   1 

Incremental shares attributable to share-based compensation plans

   16   13   3 
  

 

 

  

 

 

  

 

 

 

Average Common Shares Outstanding and Common Share Equivalents

   1,717   1,727   1,978 
  

 

 

  

 

 

  

 

 

 

EPS – Diluted:

    

Continuing Operations

  $2.16  $1.79  $1.63 

Discontinued Operations

           3.71 
  

 

 

  

 

 

  

 

 

 

Net Earnings

  $2.16  $1.79  $5.34 
  

 

 

  

 

 

  

 

 

 

(1)    Net Earnings of Discontinued Operations used for EPS Calculation:

    

Net Earnings from Discontinued Operations Attributable to BMS

  $   $   $7,373 

Earnings attributable to unvested restricted shares

           (42
  

 

 

  

 

 

  

 

 

 

Net Earnings from Discontinued Operations Attributable to BMS used for EPS calculation

  $   $   $7,331 
  

 

 

  

 

 

  

 

 

 

Anti-dilutive weighted-average equivalent shares – stock incentive plans

   13   51   117 
  

 

 

  

 

 

  

 

 

 

82

  Year Ended December 31,
Amounts in Millions, Except Per Share Data 2013 2012 2011
Net Earnings Attributable to BMS $2,563
 $1,960
 $3,709
Earnings attributable to unvested restricted shares 
 (1) (8)
Net Earnings Attributable to BMS common shareholders $2,563
 $1,959
 $3,701
       
Earnings per share - basic $1.56
 $1.17
 $2.18
       
Weighted-average common shares outstanding - basic 1,644
 1,670
 1,700
Contingently convertible debt common stock equivalents 1
 1
 1
Incremental shares attributable to share-based compensation plans 17
 17
 16
Weighted-average common shares outstanding - diluted 1,662
 1,688
 1,717
       
Earnings per share - diluted $1.54
 $1.16
 $2.16
       
Anti-dilutive weighted-average equivalent shares - stock incentive plans 
 2
 13


87



Note 10. FINANCIAL INSTRUMENTS

AND FAIR VALUE MEASUREMENTS


Financial instruments include cash and cash equivalents, marketable securities, accounts receivable and payable, debt instruments and derivatives. Due to their short term maturity, the carrying amount of receivables and accounts payable approximate fair value.

BMS has exposure to market risk due to changes


Changes in currency exchange rates and interest rates. As a result, certainrates create exposure to market risk. Certain derivative financial instruments are used when available on a cost-effective basis to hedge the underlying economic exposure. These instruments qualify as cash flow, net investment and fair value hedges upon meeting certain criteria, including effectiveness of offsetting hedged exposures. Changes in fair value of derivatives that do not qualify for hedge accounting are recognized in earnings as they occur. Derivative financial instruments are not used for trading purposes.

Counterparty


Financial instruments are subject to counterparty credit risk which is considered as part of the overall fair value measurement, as well as the effect of credit risk when derivatives are in a liability position.measurement. Counterparty credit risk is monitored on an ongoing basis and is mitigated by limiting amounts outstanding with any individual counterparty, utilizing conventional derivative financial instruments and only entering into agreements with counterparties that meet high credit quality standards. The consolidated financial statements would not be materially impacted if any counterparty failed to perform according to the terms of its agreement. Under the terms of the agreements, posting of collateralCollateral is not required by any party whether derivatives are in an asset or liability position.

position under the terms of the agreements.


Fair Value Measurements –The fair values of financial instruments are classified into one of the following categories:

Level 1 inputs utilize non-binding quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. These instruments include U.S. treasury bills and U.S. government agency securities.


Level 2 inputs utilize observable prices for similar instruments, non-binding quoted prices for identical or similar instruments in markets that are not active, and other observable inputs that can be corroborated by market data for substantially the full term of the assets or liabilities. These instruments include corporate debt securities, commercial paper, Federal Deposit Insurance Corporation (FDIC) insured debt securities, certificates of deposit, money market funds, foreign currency forward contracts, and interest rate swap contracts.contracts, equity funds, fixed income funds and long-term debt. Additionally, certain corporate debt securities utilize a third-party matrix pricing model that uses significant inputs corroborated by market data for substantially the full term of the assets. Equity and fixed income funds are primarily invested in publicly traded securities and are valued at the respective net asset value of the underlying investments. There were no significant unfunded commitments or restrictions on redemptions related to equity and fixed income funds as of December 31, 2013. Level 2 derivative instruments are valued using London Interbank Offered Rate (LIBOR) and Euro Interbank Offered Rate (EURIBOR) yield curves, less credit valuation adjustments, and observable forward foreign exchange rates at the reporting date. Valuations of derivative contracts may fluctuate considerably from period-to-period due to volatility in underlying foreign currencies and underlying interest rates, which are driven by market conditions and the duration of the contract. Credit adjustment volatility may have a significant impact on the valuation of interest rate swaps due to changes in thecounterparty credit ratings and credit default swap spreads of BMS or its counterparties.

spreads.


Level 3 unobservable inputs are used when little or no market data is available. The fair value of written options to sell the assets of certain businesses in connection with alliance agreements (see “—Note 3. Alliances” for further discussion) is based on an option pricing methodology that considers revenue and profitability projections, volatility, discount rates, and potential exercise price assumptions.The fair value of contingent consideration related to an acquisition (See "—Note 4. Acquisitions") was estimated utilizing a model that considered the probability of achieving each milestone and discount rates. Valuation models for the ARSAuction Rate Security (ARS) and FRSFloating Rate Security (FRS) portfolio are based on expected cash flow streams and collateral values including assessments of counterparty credit quality, default risk underlying the security, discount rates and overall capital market liquidity. A majorityThe fair value of the ARS which are private placement securities with long-term nominal maturities, were rated ‘A’ by Standard and Poor’s as of December 31, 2011 and 2010, and primarily represent interests in insurance securitizations. The fair valueFRS was determined using internally developed valuations that were based in part on indicative bids received on the underlying assets of the securities and other evidence of fair value. Due to the current lack of an active market for FRS and the general lack of transparency into their underlying assets, other qualitative analysis is relied upon to value FRS including discussions with brokers and fund managers, default risk underlying the security and overall capital markets liquidity.

83


Available-For-Sale Securities and Cash Equivalents

The following table summarizes available-for-sale securitiesnot material at December 31, 20112013 and 2010:

   Amortized   Unrealized
Gain in
Accumulated
   Unrealized
Loss in
Accumulated
  Fair   Fair Value 
Dollars in Millions  Cost   OCI   OCI  Value   Level 1   Level 2   Level 3 

December 31, 2011

             

Marketable Securities:

             

Certificates of Deposit

  $1,051   $    $   $  1,051   $    $  1,051   $  

Corporate Debt Securities

   2,908    60    (3  2,965         2,965      

Commercial Paper

   1,035             1,035         1,035      

U.S. Treasury Bills

   400    2        402    402           

FDIC Insured Debt Securities

   302    1        303         303      

Auction Rate Securities (ARS)

   80    12        92              92 

Floating Rate Securities (FRS)

   21         (3  18              18 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

   

 

 

 

Total Marketable Securities

  $5,797   $75   $(6 $  5,866   $402   $  5,354   $110 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

   

 

 

 

December 31, 2010

             

Marketable Securities:

             

Certificates of Deposit

  $1,209   $    $   $  1,209   $    $  1,209   $  

Corporate Debt Securities

   1,996    26    (10  2,012         2,012      

Commercial Paper

   482             482         482      

FDIC Insured Debt Securities

   353    3        356         356      

U.S. Treasury Bills

   400    4        404    404           

U.S. Government Agency Securities

   375    1        376    376           

Auction Rate Securities (ARS)

   80    11        91              91 

Floating Rate Securities (FRS)

   21         (2  19              19 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

   

 

 

 

Total Marketable Securities

  $4,916   $45   $(12 $  4,949   $780   $  4,059   $110 
  

 

 

   

 

 

   

 

 

  

 

 

   

 

 

   

 

 

   

 

 

 

The following table summarizes the classification of available-for-sale securities in the consolidated balance sheet:

   December 31, 
Dollars in Millions  2011   2010 

Current Marketable Securities

  $  2,957   $  2,268 

Non-current Marketable Securities

   2,909    2,681 
  

 

 

   

 

 

 

Total Marketable Securities

  $5,866   $4,949 
  

 

 

   

 

 

 

Money market funds2012.



88



Financial assets and other securities aggregating $5,469 million and $4,332 millionliabilities measured at December 31, 2011 and 2010, respectively, were included in cash and cash equivalents and valued using Level 2 inputs. Cash and cash equivalents maintained in foreign currencies were $508 million at December 31, 2011 andfair value on a recurring basis are subject to currency rate risk.

At December 31, 2011, $2,817 million of non-current available for sale corporate debt securities, U.S. treasury bills, FDIC insured debt securities and floating rate securities mature within five years. All auction rate securities mature beyond 10 years.

summarized below:

  December 31, 2013 December 31, 2012
Dollars in Millions Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total
Cash and cash equivalents - Money market and other securities $
 $3,201
 $
 $3,201
 $
 $1,288
 $
 $1,288
Marketable securities                
Certificates of deposit 
 122
 
 122
 
 34
 
 34
Corporate debt securities 
 4,432
 
 4,432
 
 4,377
 
 4,377
U.S. Treasury securities 
 
 
 
 150
 
 
 150
Equity funds 
 74
 
 74
 
 57
 
 57
Fixed income funds 
 46
 
 46
 
 47
 
 47
ARS and FRS 
 
 12
 12
 
 
 31
 31
Derivative assets:                
Interest rate swap contracts 
 64
 
 64
 
 146
 
 146
Foreign currency forward contracts 
 50
 
 50
 
 59
 
 59
Derivative liabilities:                
Interest rate swap contracts 
 (27) 
 (27) 
 
 
 
Foreign currency forward contracts 
 (35) 
 (35) 
 (30) 
 (30)
Written option liabilities(a)
 
 
 (162) (162) 
 
 (18) (18)
Contingent consideration liability(b)
 
 
 (8) (8) 
 
 (8) (8)

(a)Written option liabilities of $18 million and $144 million are included in accrued expenses and other liabilities, respectively. See "Note 3. Alliances" for further information.
(b)The contingent consideration liability is included in other liabilities. See "Note 4. Acquisitions" for further information.
The following table summarizes the activity forthe financial assets utilizing Level 3 fair value measurements:

   2011   2010 

Fair value at January 1

  $  110   $  179 

Settlements

        (93

Unrealized gains/(losses)

        24 
  

 

 

   

 

 

 

Fair value at December 31

  $  110   $  110 
  

 

 

   

 

 

 

84

  2013 2012
Dollars in Millions Written option liabilities Contingent consideration liability ARS and FRS Written option liabilities Contingent consideration liability ARS and FRS
Fair value at January 1 $(18) $(8) $31
 $
 $(8) $110
Additions from new alliances (144) 
 
 (18) 
 
Unrealized gains 
 
 1
 
 
 2
Sales 
 
 (20) 
 
 (81)
Fair value at December 31 $(162) $(8) $12
 $(18) $(8) $31

Available-for-sale Securities

The following table summarizes available-for-sale securities:
 Dollars in Millions Amortized
Cost
 Gross
Unrealized
Gain in
Accumulated
OCI
 Gross
Unrealized
Loss in
Accumulated
OCI
 Fair Value
 
 December 31, 2013        
 Certificates of deposit $122
 $
 $
 $122
 Corporate debt securities 4,401
 44
 (13) 4,432
 ARS 9
 3
 
 12
 Total 4,532
 47
 (13) 4,566
          
 December 31, 2012        
 Certificates of deposit $34
 $
 $
 $34
 Corporate debt securities 4,305
 72
 
 4,377
 U.S. Treasury securities 150
 
 
 150
 ARS and FRS 29
 3
 (1) 31
 Total 4,518
 75
 (1) 4,592


89



Available-for-sale securities included in current marketable securities were $819 million at December 31, 2013. Non-current available-for-sale corporate debt securities maturing within five years were $3,735 million at December 31, 2013. Auction rate securities maturing beyond 10 years were $12 million at December 31, 2013.

Fair Value Option for Financial Assets

The Company invests in equity and fixed income funds that are designed to offset the changes in fair value of certain employee retirement benefits. Investments in equity and fixed income funds are included in current marketable securities and were $74 million and $46 million, respectively, at December 31, 2013 and $57 million and $47 million, respectively, at December 31, 2012. Investment income resulting from the change in fair value for the investments in equity and fixed income funds was $14 million in 2013 and $5 million in 2012.

Qualifying Hedges and Non-Qualifying Derivatives

The following summarizes the fair value of outstanding derivatives:

      December 31, 2011  December 31, 2010 
          Fair Value      Fair Value 
Dollars in Millions  

Balance Sheet Location

  Notional   (Level 2)  Notional   (Level 2) 

Derivatives designated as hedging instruments:

         

Interest rate swap contracts

  

Other assets

  $579   $135  $3,526   $234 

Foreign currency forward contracts

  

Other assets

   1,347    88   691    26 

Foreign currency forward contracts

  

Accrued expenses

   480    (29  732    (48

    December 31, 2013 December 31, 2012
Dollars in Millions Balance Sheet Location Notional Fair Value Notional Fair Value
Derivatives designated as hedging instruments:          
Interest rate swap contracts Other assets $673
 $64
 $573
 $146
Interest rate swap contracts Other liabilities 1,950
 (27) 
 
Foreign currency forward contracts Prepaid expenses and other 301
 44
 
 
Foreign currency forward contracts Other assets 100
 6
 735
 59
Foreign currency forward contracts Accrued expenses 704
 (31) 916
 (30)
Foreign currency forward contracts Other liabilities 263
 (4) 
 

Cash Flow Hedges —Foreign currency forward contracts are primarily utilized to hedge forecasted intercompany inventory purchase transactions in certain foreign currencies. These forward contracts are designated as cash flow hedges with the effective portion of changes in fair value being temporarily reported in accumulated OCI and recognized in earnings when the hedged item affects earnings. As of December 31, 2011, significant outstanding foreign currency forward contracts were primarily attributed to Euro and Japanese yen foreign currency forward contracts in the notional amount of $946 million and $557 million, respectively.

The net gains on foreign currency forward contracts qualifying for cash flow hedge accounting are expected to be reclassified to cost of products sold within the next two years, including $46$14 million of pre-tax gains to be reclassified within the next 12 months. The notional amount of outstanding foreign currency forward contracts was primarily attributed to the Euro ($780 million) and Japanese yen ($247 million) at December 31, 2013.


Cash flow hedge accounting is discontinued when the forecasted transaction is no longer probable of occurring on the originally forecasted date, or 60 days thereafter, or when the hedge is no longer effective. Assessments to determine whether derivatives designated as qualifying hedges are highly effective in offsetting changes in the cash flows of hedged items are performed at inception and on a quarterly basis. Any ineffective portion of the change in fair value is included in current period earnings. The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not significant during 2011, 2010 and 2009.

all periods presented.


Net Investment Hedges —Non-U.S. dollar borrowings of €541 million ($707741 million) are designated to hedge the foreign currency exposures of the net investment in certain foreign affiliates. These borrowings are designated as net investment hedges and recognized in long term debt. The effective portion of foreign exchange gains or losses on the remeasurement of the debt is recognized in the foreign currency translation component of accumulated OCI with the related offset in long term debt.


Fair Value Hedges — Fixed-to-floating interest rate swap contracts are designated as fair value hedges and are used as part of an interest rate risk management strategy to create an appropriate balance of fixed and floating rate debt. The swaps and underlying debt for the benchmark risk being hedged are recorded at fair value. The effective interest rate paid on fixed-to-floating interest rate swaps is one-month LIBOR (0.295%(0.17% as of December 31, 2011)2013) plus an interest rate spread ranging from 1.3%(0.8)% to 2.9%4.4%. When the underlying swap is terminated prior to maturity, the fair value basis adjustment to the underlying debt instrument is amortized into earnings as a reduction to interest expense over the remaining life of the debt.

During 2010, fixed-to-floating


Fixed-to-floating interest rate swap contracts were executed in 2013 to convert $332$2,050 million notional amount of 6.80% Debentures due 2026 and $147 million notional amount of 7.15% Debentures due 2023 from fixed rate debt to variable rate debt. During 2009, fixed-to-floating interest rate swap contracts were executed to convert $200 million notional amount of 5.45% Notes due 2018 and $597 notional amount of 5.25% Notes due 2013 from fixed rate debt to variable rate debt. These contracts qualified as a fair value hedge for each debt instrument.


During 2011, fixed-to-floating interest rate swap contracts of $1.6 billion notional amount and €1.0 billion notional amount were terminated generating total proceeds of $356 million (including accrued interest of $66 million). During 2010, fixed-to-floating interest rate swap contracts of $237 million notional amount and €500 million notional amount were terminated generating total proceeds of $116 million (including accrued interest of $18 million). During 2009, $1,061 million notional amount of fixed-to-floating interest rate swap contracts were terminated generating proceeds of $204 million (including accrued interest of $17 million).

Non-Qualifying Foreign Exchange Contracts —Foreign currency forward contracts are used to offset exposure to foreign currency-denominated monetary assets, liabilities and earnings. The primary objective of these contracts is to protect the U.S. dollar value of foreign currency-denominated monetary assets, liabilities and earnings from the effects of volatility in foreign exchange rates that might occur prior to their receipt or settlement in U.S. dollars. These contracts are not designated as hedges and are adjusted to fair value through other (income)/expense as they occur, and substantially offset the change in fair value of the underlying foreign currency denominated monetary asset, liability or earnings. The effect of non-qualifying hedges on earnings was not significant for the years ended December 31, 2011, 2010, and 2009.

85



90

Short-Term Borrowings and Long-Term



Debt

Obligations

Short-term borrowings include:

   December 31, 
Dollars in Millions  2011   2010 

Bank drafts

  $  113   $  100 

Other short-term borrowings

   2    17 
  

 

 

   

 

 

 

Total

  $115   $117 
  

 

 

   

 

 

 

and the current portion of long-term debt includes:

  December 31,
Dollars in Millions 2013 2012
Bank drafts and short-term borrowings $359
 $162
Current portion of long-term debt 
 664
Total $359
 $826

Long-term debt and the current portion of long-term debt includes:

   December 31, 
Dollars in Millions  2011  2010 

Principal Value:

   

5.875% Notes due 2036

  $638  $709 

4.375% Euro Notes due 2016

   652   656 

4.625% Euro Notes due 2021

   652   656 

5.45% Notes due 2018

   600   600 

5.25% Notes due 2013

   597   597 

6.125% Notes due 2038

   500   500 

6.80% Debentures due 2026

   332   332 

7.15% Debentures due 2023

   304   304 

6.88% Debentures due 2097

   287   287 

0% - 5.75% Other—maturing 2023 - 2030

   107   108 
  

 

 

  

 

 

 

Subtotal

   4,669   4,749 
  

 

 

  

 

 

 

Adjustments to Principal Value:

   

Fair value of interest rate swaps

   135   234 

Unamortized basis adjustment from swap terminations

   594   369 

Unamortized bond discounts

   (22  (24
  

 

 

  

 

 

 

Total

  $  5,376  $  5,328 
  

 

 

  

 

 

 

  December 31,
Dollars in Millions 2013 2012
Principal Value:    
5.25% Notes due 2013 $
 $597
4.375% Euro Notes due 2016 684
 659
0.875% Notes due 2017 750
 750
5.45% Notes due 2018 582
 582
1.75% Notes due 2019 500
 
4.625% Euro Notes due 2021 684
 659
2.000% Notes due 2022 750
 750
7.15% Debentures due 2023 304
 304
3.250% Notes due 2023 500
 
6.80% Debentures due 2026 330
 330
5.875% Notes due 2036 625
 625
6.125% Notes due 2038 480
 480
3.250% Notes due 2042 500
 500
4.500% Notes due 2044 500
 
6.88% Debentures due 2097 260
 260
0% - 5.75% Other - maturing 2014 - 2030 144
 135
Subtotal 7,593
 6,631
     
Adjustments to Principal Value:    
Fair value of interest rate swap contracts 37
 146
Unamortized basis adjustment from swap terminations 442
 509
Unamortized bond discounts (64) (54)
Total $8,008
 $7,232
     
Current portion of long-term debt(a)
 $27
 $664
Long-term debt 7,981
 6,568

(a)Included in liabilities related to assets held-for-sale at December 31, 2013.

Included in other debt is $50$49 million of Floating Rate Convertible Senior Debentures due 2023 which can be redeemed by the holders at par on September 15, 2013 and 2018 or if a fundamental change in ownership occurs. The Debentures are callable at par at any time by the Company. The Debentures have a current conversion price of $40.42,$39.58, equal to a conversion rate of 24.742925.2623 shares for each $1,000 principal amount, subject to certain anti-dilutive adjustments.

In February 2009, Mead Johnson entered into


The average amount of commercial paper outstanding was $259 million at a three-year syndicated revolving credit facility agreement. Inweighted-average interest rate of 0.12% during 2013. The maximum month end amount of commercial paper outstanding was $820 million with no outstanding borrowings at December 31, 2013.

During the fourth quarter of 2009, Mead Johnson borrowed $200 million under the revolving credit facility and issued various Notes totaling2013, $1.5 billion of senior unsecured notes were issued: $500 million in aggregate principal amount of 1.750% Notes due 2019, $500 million in aggregate principal amount of 3.250% Notes due 2023 and $500 million in aggregate principal amount of 4.500% Notes due 2044 in a registered public offering . Interest on the notes will be paid semi-annually. The notes rank equally in right of payment with all of BMS’s existing and future senior unsecured indebtedness. BMS may redeem the notes, in whole or in part, at any time at a predetermined redemption price. The net proceeds of the note issuances were $1,477 million, which is net of a discount of $12 million and deferred loan issuance costs of $11 million.


91



During the third quarter of 2012, $2.0 billion of senior unsecured notes were usedissued: $750 million in aggregate principal amount of 0.875% Notes due 2017, $750 million in aggregate principal amount of 2.000% Notes due 2022 and $500 million in aggregate principal amount of 3.250% Notes due 2042 in a registered public offering. Interest on the notes will be paid semi-annually. The notes rank equally in right of payment with all of BMS’s existing and future senior unsecured indebtedness. BMS may redeem the notes, in whole or in part, at any time at a predetermined redemption price. The net proceeds of the note issuances were $1,950 million, which is net of a discount of $36 million and deferred loan issuance costs of $14 million.

The $597 million principal amount of 5.25% Notes Due 2013 matured and was repaid in the third quarter of 2013. Substantially all of the $2.0 billion debt obligations assumed in the acquisition of Amylin were repaid during the third quarter of 2012, including a promissory note with Lilly with respect to repay certain intercompany debt priora revenue sharing obligation and Amylin senior notes due 2014. In January 2014, notices were provided to the split-off.

holders of the 5.45% Notes due 2018 that BMS will exercise its call option to redeem the notes in their entirety in February 2014. The outstanding principal amount of the notes is $582 million.


The principal value of long-term debt obligations was $4,669$7,593 million at December 31, 20112013, of which $597$27 million is due in 2013, $6522014, $684 million is due in 2016, $750 million is due in 2017, $631 million is due in 2018 and the remaining $3,420$5,501 million is due in 20172019 or thereafter. The fair value of long-term debt was $6,406$8,487 million and $5,861$8,285 million at December 31, 20112013 and 2010,2012, respectively, and was estimated based upon the quoted market prices for the same or similar debt instruments. The fair value of short-term borrowings approximates the carrying value due to the short maturities of the debt instruments.


There were no debt repurchases in 2013. Debt repurchase activity for 2012 and 2011, including repayment of the Amylin debt obligations, was as follows:

Dollars in Millions  2011  2010   2009 

Principal amount

  $  71  $  750   $  117 

Repurchase price

   78   855    132 

Notional amount of interest rate swaps terminated

   34   319    53 

Swap termination proceeds

   6   48    7 

Total (gain)/loss

   (10  6    (7

Dollars in Millions 2012 2011
Principal amount $2,052
 $71
Carrying value 2,081
 88
Repurchase price 2,108
 78
Notional amount of interest rate swap contracts terminated 6
 34
Swap termination proceeds 2
 6
Total loss/(gain) 27
 (10)

Interest payments were $268 million in 2013, $241 million in 2012 and $171 million in 2011 $178 in 2010 and $206 million in 2009 net of amounts related to interest rate swap contracts.

In September 2011, the Company replaced its $2.0


BMS has two separate $1.5 billion five-year revolving credit facility with a new $1.5 billion five year revolving credit facilityfacilities from a syndicate of lenders, which islenders. The facilities provide for customary terms and conditions with no financial covenants and are extendable on any anniversary date with the consent of the lenders. There are no financial covenants under the new facility. ThereNo borrowings were no borrowings outstanding under either revolving credit facility at December 31, 2011 and 2010.

86


2013 or 2012.


At December 31, 2011, $2332013, $633 million of financial guarantees were provided in the form of stand-by letters of credit and performance bonds. The stand-by letters of credit are issued through financial institutions in support of guarantees made by BMS and its affiliates for various obligations. The performance bonds were issued to support a range of ongoing operating activities, including sale of products to hospitals and foreign ministries of health, bonds for customs, duties and value added tax and guarantees related to miscellaneous legal actions. A significant majority of the outstanding financial guarantees will expire within the year and are not expected to be funded.


Note 11. RECEIVABLES


Receivables include:

   December 31, 
Dollars in Millions  2011  2010 

Trade receivables

  $  2,397  $  2,092 

Less allowances

   (147  (107
  

 

 

  

 

 

 

Net trade receivables

   2,250   1,985 

Alliance partners receivables

   1,081   1,076 

Prepaid and refundable income taxes

   256   223 

Miscellaneous receivables

   156   196 
  

 

 

  

 

 

 

Receivables

  $3,743  $3,480 
  

 

 

  

 

 

 

Receivables are netted with deferred income related to alliance partners until recognition of income. As a result, alliance partner receivables and deferred income were reduced by $901 million and $734 million at December 31, 2011 and 2010, respectively. For additional information regarding alliance partners, see “—Note 3. Alliances and Collaborations.”

  December 31,
Dollars in Millions 2013 2012
Trade receivables $1,779
 $1,812
Less allowances (89) (104)
Net trade receivables 1,690
 1,708
Alliance partners receivables 1,122
 857
Prepaid and refundable income taxes 262
 319
Miscellaneous receivables 286
 199
Receivables $3,360
 $3,083


92



Non-U.S. receivables sold on a nonrecourse basis were $1,031 million in 2013, $956 million in 2012, and $1,077 million in 2011, $932 million in 2010, and $660 million in 2009.2011. In the aggregate, receivables due from three pharmaceutical wholesalers in the U.S. represented 55%40% and 51%37% of total trade receivables at December 31, 20112013 and 2010,2012, respectively.


Changes to the allowances for bad debt, charge-backs and cash discounts were as follows:

   Year Ended December 31, 
Dollars in Millions  2011  2010  2009 

Balance at beginning of year

  $107  $103  $128 

Provision

   1,094   864   776 

Utilization

   (1,054  (860  (800

Discontinued operations

           (1
  

 

 

  

 

 

  

 

 

 

Balance at end of year

  $147  $107  $103 
  

 

 

  

 

 

  

 

 

 

  Year Ended December 31,
Dollars in Millions 2013 2012 2011
Balance at beginning of year $104
 $147
 $107
Provision 720
 832
 1,094
Utilization (731) (875) (1,054)
Assets held-for-sale (4) 
 
Balance at end of year $89
 $104
 $147

Note 12. INVENTORIES


Inventories include:

   December 31, 
Dollars in Millions  2011   2010 

Finished goods

  $478   $397 

Work in process

   646    608 

Raw and packaging materials

   260    199 
  

 

 

   

 

 

 

Inventories

  $  1,384   $  1,204 
  

 

 

   

 

 

 

  December 31,
Dollars in Millions 2013 2012
Finished goods $491
 $572
Work in process 757
 814
Raw and packaging materials 250
 271
Inventories $1,498
 $1,657

Inventories expected to remain on-hand beyond one year are included in non-current other assets and were $260 million (including $92 million of capitalized costs which are subject to regulatory approval prior to being sold) at December 31, 2011 and $297$351 million at December 31, 2010. The status of the regulatory approval process2013 and the probability of future sales were considered in assessing the recoverability of these costs.

87


$424 million at December 31, 2012.

Note 13. PROPERTY, PLANT AND EQUIPMENT


Property, plant and equipment includes:

   December 31, 
Dollars in Millions  2011  2010 

Land

  $137  $133 

Buildings

   4,545   4,565 

Machinery, equipment and fixtures

   3,437   3,423 

Construction in progress

   262   139 
  

 

 

  

 

 

 

Gross property, plant and equipment

   8,381   8,260 

Less accumulated depreciation

   (3,860  (3,596
  

 

 

  

 

 

 

Property, plant and equipment

  $4,521  $4,664 
  

 

 

  

 

 

 

  December 31,
Dollars in Millions 2013 2012
Land $109
 $114
Buildings 4,748
 4,963
Machinery, equipment and fixtures 3,699
 3,695
Construction in progress 287
 611
Gross property, plant and equipment 8,843
 9,383
Less accumulated depreciation (4,264) (4,050)
Property, plant and equipment $4,579
 $5,333

Property, plant and equipment related to the Mount Vernon, Indiana manufacturing facility was approximately $300 million as of December 31, 2013. The facility is expected to be sold no earlier than 18 months following the closing of the diabetes business transaction. It was not included in assets held-for-sale because the assets were not available for immediate sale in their present condition and are not expected to be sold within a year. See "—Note 3. Alliances” for further discussion on the sale of the diabetes business.

Depreciation expense was $453 million in 2013, $382 million in 2012 and $448 million in 2011, $473 million in 2010 and $469 million in 2009, of which $51 million in 2009 was included in discontinued operations. Capitalized interest was $8 million in 2010 and $13 million in 2009.

2011.

93




Note 14. GOODWILL AND OTHER INTANGIBLE ASSETS


Changes in the carrying amount of goodwill were as follows:

Dollars in Millions    

Balance at January 1, 2010

  $  5,218 

ZymoGenetics acquisition

   15 
  

 

 

 

Balance at December 31, 2010

   5,233 

Amira acquisition

   265 

Other

   88 
  

 

 

 

Balance at December 31, 2011

  $5,586 
  

 

 

 

Other includes an out-of-period adjustment recorded to correct

  December 31,
Dollars in Millions 2013 2012
Carrying amount of goodwill at January 1 $7,635
 $5,586
Acquisitions:    
Inhibitex 
 1,213
Amylin 11
 836
Assets held-for-sale (550) 
Carrying amount of goodwill at December 31 $7,096
 $7,635

In the first quarter of 2013, the purchase price allocation was finalized for the September 2009 MedarexAmylin acquisition resulting in an $11 million adjustment to goodwill and a $24deferred income taxes. Goodwill of $550 million contingent milestone payment from a prior acquisition. The Medarex purchase price adjustment decreased other intangiblewas allocated to the sale of the diabetes business and included in assets by $98 million and increased deferred tax assets by $34 million and goodwill by $64 million. The effect of this adjustment was not materialheld-for-sale. See“—Note 5. Assets Held-For-Sale” for the current or any prior periods.

further discussion.


Other intangible assets include:

   Estimated
Useful Lives
   December 31, 2011   December 31, 2010 
Dollars in Millions    Gross
Carrying
Amount
   Accumulated
Amortization
   Net
Carrying
Amount
   Gross
Carrying
Amount
   Accumulated
Amortization
   Net
Carrying
Amount
 

Licenses

   2  – 15 years    $1,218   $443   $775   $965   $368   $597 

Technology

   9  – 15 years     2,608    1,194    1,414    1,562    1,001    561 

Capitalized software

   3  – 10 years     1,147    857    290    1,140    841    299 
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total finite-lived intangible assets

     4,973    2,494    2,479    3,667    2,210    1,457 
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

IPRD

     645         645    1,913         1,913 
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other intangible assets

    $  5,618   $  2,494   $  3,124   $  5,580   $  2,210   $  3,370 
    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

In 2011, $1.0 billion of IPRD was reclassified to technology upon approval of YERVOY in the U.S. and $367 million of IPRD was reclassified to licenses for out-licensed compounds that have no further performance obligations.

    December 31, 2013 December 31, 2012
Dollars in Millions 
Estimated
Useful Lives
 
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net
Carrying
Amount
 
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net
Carrying
Amount
Licenses 5 – 15 years $1,162
 $637
 $525
 $1,160
 $534
 $626
Developed technology rights 9 – 15 years 2,486
 1,482
 1,004
 8,827
 1,604
 7,223
Capitalized software 3 – 10 years 1,240
 999
 241
 1,200
 939
 261
Total finite-lived intangible assets   4,888
 3,118
 1,770
 11,187
 3,077
 8,110
IPRD   548
 
 548
 668
 
 668
Total other intangible assets   $5,436
 $3,118
 $2,318
 $11,855
 $3,077
 $8,778

Changes in other intangible assets were as follows:

Dollars in Millions  2011  2010  2009 

Other intangible assets carrying amount at January 1

  $  3,370  $  2,865  $  1,151 

Capitalized software and other additions

   75   107   96 

Acquisitions

   160   678   1,910 

Mead Johnson split-off

           (50

Amortization – licenses and technology

   (271  (199  (170

Amortization – capitalized software

   (82  (72  (68

Impairment charges

   (30  (10    

Other

   (98  1   (4
  

 

 

  

 

 

  

 

 

 

Other intangible assets carrying amount at December 31

  $3,124  $3,370  $2,865 
  

 

 

  

 

 

  

 

 

 

88


Amortization expense included in discontinued operations was $9

Dollars in Millions 2013 2012 2011
Other intangible assets carrying amount at January 1 $8,778
 $3,124
 $3,370
Capitalized software and other additions 80
 60
 75
Acquisitions 
 8,335
 160
Amortization expense (858) (607) (353)
Impairment charges 
 (2,134) (30)
Assets held-for-sale (5,682) 
 
Other 
 
 (98)
Other intangible assets, net carrying amount at December 31 $2,318
 $8,778
 $3,124

Developed technology rights of $5,562 million in 2009.

Amortizationand IPRD of $120 million related to the sale of the diabetes business were reclassified to assets held-for-sale as of December 31, 2013. See “—Note 5. Assets Held-For-Sale” for further discussion.


Annual amortization expense of other intangible assets is expected to be $350 million in 2012, $275 million in 2013, $263approximately $300 million in 2014, $236$200 million in 2015, $218$200 million in 2016, $200 million in 2017, $150 million in 2018 and $1,138$720 million thereafter.


BMS announced the discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of the hepatitis C virus infection in August 2012. The decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a Phase II study that was voluntarily suspended on August 2012. BMS acquired BMS-986094 with its acquisition of Inhibitex in February 2012. As a result of the termination of this development program, a $1,830 million pre-tax impairment charge was recognized for the IPRD intangible asset.

An impairment charge of $120 million was recognized in 2012 related to continued competitive pricing pressures and a partial write-down to fair value of developed technology rights related to a previously acquired non-key product.


94



Note 15. ACCRUED EXPENSES


Accrued expenses include:

   December 31, 
Dollars in Millions  2011   2010 

Employee compensation and benefits

  $783   $718 

Royalties

   571    576 

Accrued research and development

   450    411 

Restructuring—current

   58    108 

Pension and postretirement benefits

   46    47 

Accrued litigation

   32    54 

Other

   851    826 
  

 

 

   

 

 

 

Total accrued expenses

  $  2,791   $  2,740 
  

 

 

   

 

 

 
  December 31,
Dollars in Millions 2013 2012
Employee compensation and benefits $735
 $844
Royalties 173
 152
Accrued research and development 380
 418
Restructuring - current 73
 120
Pension and postretirement benefits 47
 49
Accrued litigation 65
 162
Other 679
 828
Total accrued expenses $2,152
 $2,573

Note 16. SALES REBATES AND RETURN ACCRUALS


Reductions to trade receivables and accrued rebates and returns liabilities are as follows:

         December 31,       
Dollars in Millions  2011   2010 

Charge-backs related to government programs

  $51   $48 

Cash discounts

   28    29 
  

 

 

   

 

 

 

Reductions to trade receivables

  $79   $77 
  

 

 

   

 

 

 

Managed healthcare rebates and other contract discounts

  $417   $216 

Medicaid rebates

   411    327 

Sales returns

   161    187 

Other adjustments

   181    127 
  

 

 

   

 

 

 

Accrued rebates and returns

  $1,170   $857 
  

 

 

   

 

 

 

  December 31,
Dollars in Millions 2013 2012
Charge-backs related to government programs $37
 $41
Cash discounts 12
 13
Reductions to trade receivables $49
 $54
     
Managed healthcare rebates and other contract discounts $147
 $175
Medicaid rebates 227
 351
Sales returns 279
 345
Other adjustments 236
 183
Accrued rebates and returns $889
 $1,054

Note 17. DEFERRED INCOME


Deferred income includes:

         December 31,       
Dollars in Millions  2011   2010 

Upfront, milestone and other licensing receipts

  $882   $797 

ATRIPLA* deferred revenue

   113    227 

Gain on sale-leaseback transactions

   120    147 

Other

   88    126 
  

 

 

   

 

 

 

Total deferred income

  $1,203   $1,297 
  

 

 

   

 

 

 

Current portion

  $337   $402 

Non-current portion

   866    895 

  December 31,      
Dollars in Millions 2013 2012
Upfront, milestone and other licensing receipts $970
 $4,346
Atripla* deferred revenue
 468
 339
Gain on sale-leaseback transactions 71
 99
Other 16
 65
Total deferred income $1,525
 $4,849
     
Current portion $756
 $825
Non-current portion 769
 4,024

Upfront, milestone and other licensing receipts are being amortized over the expected life of the product. See “—Note 3. Alliances and Collaborations” forFor further information pertaining to revenue recognitionupfront, milestone and other transactions with allianceslicensing receipts and collaborations. The deferred revenue related to Atripla*, see“—Note 3. Alliances”. Deferred gains on several sale-leaseback transactions are being amortized over the remaining lease terms of the related facilities through 2018 and were $282018. Amortization of deferred income was $548 million in 2011, $272013, $308 million in 20102012 and $28$173 million in 2009.

89

2011.


Deferred income of $3,671 million was included in liabilities related to assets held-for-sale at December 31, 2013. See“—Note 5. Assets Held-For-Sale” for further discussion.

95



Note 18. EQUITY

           Capital in  Excess
of Par Value
of Stock
             
   Common Stock    Retained
Earnings
  Treasury Stock  Non-Controlling
Interest
 
Dollars and Shares in Millions  Shares   Par Value     Shares          Cost          

Balance at January 1, 2009

   2,205   $220   $2,757  $  22,549   226  $(10,566 $(33

Net earnings attributable to BMS

                 10,612             

Cash dividends declared

                 (2,401            

Mead Johnson IPO

             942               (160

Adjustments to the Mead Johnson net asset transfer

             (7              7 

Mead Johnson split-off

                     269   (6,921  105 

Employee stock compensation plans

             76       (4  123     

Net earnings attributable to non-controlling interest

                             1,808 

Other comprehensive income attributable to noncontrolling interest

                             10 

Distributions

                             (1,795
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2009

   2,205    220    3,768   30,760   491   (17,364  (58

Net earnings attributable to BMS

                 3,102             

Cash dividends declared

                 (2,226            

Stock repurchase program

                     23   (587    

Employee stock compensation plans

             (86      (13  497     

Net earnings attributable to non-controlling interest

                             2,091 

Distributions

                             (2,108
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2010

   2,205    220    3,682   31,636   501   (17,454  (75

Net earnings attributable to BMS

                 3,709             

Cash dividends declared

                 (2,276            

Stock repurchase program

                     42   (1,226    

Employee stock compensation plans

             (568      (28  1,278     

Net earnings attributable to non-controlling interest

                             2,333 

Other comprehensive income attributable to noncontrolling interest

                             7 

Distributions

                             (2,354
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2011

   2,205    220   $3,114  $33,069   515  $(17,402 $(89
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

  Common Stock 
Capital in  Excess
of Par Value
of Stock
 
Retained
Earnings
 Treasury Stock 
Noncontrolling
Interest
Dollars and Shares in Millions Shares Par Value  Shares Cost         
Balance at January 1, 2011 2,205
 $220
 $3,682
 $31,636
 501
 $(17,454) $(75)
Net earnings 
 
 
 3,709
 
 
 2,333
Cash dividends declared 
 
 
 (2,276) 
 
 
Stock repurchase program 
 
 
 
 42
 (1,226) 
Employee stock compensation plans 
 
 (568) 
 (28) 1,278
 
Other comprehensive income attributable to noncontrolling interest 
 
 
 
 
 
 7
Distributions 
 
 
 
 
 
 (2,354)
Balance at December 31, 2011 2,205
 220
 3,114
 33,069
 515
 (17,402) (89)
Net earnings 
 
 
 1,960
 
 
 850
Cash dividends declared 
 
 
 (2,296) 
 
 
Stock repurchase program 
 
 
 
 73
 (2,407) 
Employee stock compensation plans 3
 1
 (420) 
 (18) 986
 
Other comprehensive income attributable to noncontrolling interest 
 
 
 
 
 
 (6)
Distributions 
 
 
 
 
 
 (740)
Balance at December 31, 2012 2,208
 221
 2,694
 32,733
 570
 (18,823) 15
Net earnings 
 
 
 2,563
 
 
 38
Cash dividends declared 
 
 
 (2,344) 
 
 
Stock repurchase program 
 
 
 
 11
 (413) 
Employee stock compensation plans 
 
 (772) 
 (22) 1,436
 
Distributions 
 
 
 
 
 
 29
Balance at December 31, 2013 2,208
 $221
 $1,922
 $32,952
 559
 $(17,800) $82

Treasury stock is recognized at the cost to reacquire the shares. Treasury shares acquired from the Mead Johnson split-off were recognized at the fair value of the stock as of the split-off date. Shares issued from treasury are recognized utilizing the first-in first-out method.


In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock. Repurchases may be made either inIn June 2012, the open market or through private transactions, including underBoard of Directors increased its authorization for the repurchase plans established in accordance with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended.stock by an additional $3.0 billion. The stock repurchase program does not have an expiration date and we may be suspended or discontinued at any time.

consider future repurchases.


Noncontrolling interest is primarily related to thePlavix* and Avapro*/Avalide* partnerships with Sanofi for the territory covering the Americas for net sales of PLAVIX*.Americas. Net earnings attributable to noncontrolling interest are presented net of taxes of $20 million in 2013, $317 million in 2012 and $792 million in 2011 $683 million in 2010 and $589 million in 2009, in the consolidated statements of earnings with a corresponding increase to the provision for income taxes. Distribution of the partnership profits to Sanofi and Sanofi’s funding of ongoing partnership operations occur on a routine basis. The above activity includes the pre-tax income and distributions related to these partnerships. Net earnings from noncontrolling interest included in discontinued operations was $69 million in 2009.

90


96



The components of other comprehensive income/(loss) were as follows:
Dollars in Millions Pretax Tax After Tax
2011      
Derivatives qualifying as cash flow hedges:(a)
      
Unrealized gains $28
 $(4) $24
Reclassified to net earnings 52
 (20) 32
Derivatives qualifying as cash flow hedges 80
 (24) 56
Pension and other postretirement benefits:      
Actuarial losses (1,251) 421
 (830)
Amortization(b)
 115
 (34) 81
Settlements and curtailments(c)
 11
 (4) 7
Pension and other postretirement benefits (1,125) 383
 (742)
Available for sale securities, unrealized gains 35
 (7) 28
Foreign currency translation (16) 
 (16)
  $(1,026) $352
 $(674)
       
2012      
Derivatives qualifying as cash flow hedges:(a)
      
Unrealized gains $26
 $(17) $9
Reclassified to net earnings (56) 20
 (36)
Derivatives qualifying as cash flow hedges (30) 3
 (27)
Pension and other postretirement benefits:      
Actuarial losses (432) 121
 (311)
Amortization(b)
 133
 (43) 90
Settlements and curtailments(c)
 159
 (56) 103
Pension and other postretirement benefits (140) 22
 (118)
Available for sale securities:      
Unrealized gains 20
 (8) 12
Realized gains(d)
 (11) 2
 (9)
Available for sale securities 9
 (6) 3
Foreign currency translation (15) 
 (15)
  $(176) $19
 $(157)
2013      
Derivatives qualifying as cash flow hedges:(a)
      
Unrealized gains $58
 $(17) $41
Reclassified to net earnings (56) 22
 (34)
Derivatives qualifying as cash flow hedges 2
 5
 7
Pension and other postretirement benefits:      
Actuarial gains 1,475
 (504) 971
Amortization(b)
 129
 (43) 86
Settlements(c)
 165
 (56) 109
Pension and other postretirement benefits 1,769
 (603) 1,166
Available for sale securities:      
Unrealized losses (35) 3
 (32)
Realized gains(d)
 (8) 3
 (5)
Available for sale securities (43) 6
 (37)
Foreign currency translation (75) 
 (75)
  $1,653
 $(592) $1,061

(a)Reclassifications to net earnings of derivatives qualifying as effective hedges are recognized in costs of products sold.
(b)Actuarial losses and prior service cost/(credits) are amortized into cost of products sold, research and development, and marketing, selling and administrative expenses.
(c)Pension settlements and curtailments are recognized in other (income)/expense.
(d)Realized (gains)/losses on available for sale securities are recognized in other (income)/expense.

97



The accumulated balances related to each component of other comprehensive income/(loss) (OCI), net of taxes, were as follows:

Dollars in Millions  Foreign
Currency
Translation
  Derivatives
Qualifying as
Effective
Hedges
  Pension  and
Other

Postretirement
Benefits
  Available for
Sale Securities
  Accumulated
Other
Comprehensive
Income/(Loss)
 

Balance at January 1, 2009

  $(424 $14  $(2,258 $(51 $(2,719

Other comprehensive income/(loss)

   81   (44  100   41   178 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2009

   (343  (30  (2,158  (10  (2,541

Other comprehensive income/(loss)

   121   10   (5  44   170 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2010

   (222  (20  (2,163  34   (2,371

Other comprehensive income/(loss)

   (16  56   (742  28   (674
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at December 31, 2011

  $  (238)   $  36  $  (2,905)   $62  $  (3,045)  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
  December 31,
Dollars in Millions 2013 2012
Derivatives qualifying as cash flow hedges $16
 $9
Pension and other postretirement benefits (1,857) (3,023)
Available for sale securities 28
 65
Foreign currency translation (328) (253)
Accumulated other comprehensive income/(loss) $(2,141) $(3,202)

Note 19. PENSION, POSTRETIREMENT AND POSTEMPLOYMENT LIABILITIES

The Company and certain of its subsidiaries sponsor defined benefit pension plans, defined contribution plans and termination indemnity plans for regular full-time employees. The principal defined benefit pension plan is the Bristol-Myers Squibb Retirement Income Plan, which covers most U.S. employees and represents approximately 70%71% and 64% of the consolidated pension plan assets and obligations.obligations respectively. The funding policy is to contribute at least the minimum amount required by the Employee Retirement Income Security Act of 1974 (ERISA). Plan benefits are based primarily on the participant’s years of credited service and final average compensation. Plan assets consist principally of equity and fixed-income securities.


Comprehensive medical and group life benefits are provided for substantially all U.S. retirees who elect to participate in comprehensive medical and group life plans. The medical plan is contributory. Contributions are adjusted periodically and vary by date of retirement. The life insurance plan is noncontributory. Plan assets consist principally of equity and fixed-income securities. Similar plans exist for employees in certain countries outside of the U.S.


The net periodic benefit (credit)/cost of defined benefit pension and postretirement benefit plans includes:

   Pension Benefits  Other Benefits 
Dollars in Millions  2011  2010  2009  2011  2010  2009 

Service cost — benefits earned during the year

  $43  $44  $178  $8  $6  $6 

Interest cost on projected benefit obligation

   337   347   381   26   30   37 

Expected return on plan assets

   (464  (453  (453  (26  (24  (19

Amortization of prior service cost/(benefit)

   (1      4   (3  (3  (3

Amortization of net actuarial loss

   112   95   94   7   10   10 

Curtailments

   (3  5   24   (1        

Settlements

   15   22   29             

Special termination benefits

       1                 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total net periodic benefit cost

  $39  $61  $257  $11  $19  $31 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Continuing operations

  $39  $61  $242  $11  $19  $28 

Discontinued operations

           15           3 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total net periodic benefit cost

  $39  $61  $257  $11  $19  $31 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net actuarial loss and prior service cost of $140 million is expected to be amortized from accumulated OCI into net periodic benefit cost for pension and postretirement benefit plans in 2012.

The U.S. Retirement Income Plan and several other plans

  Pension Benefits Other Benefits
Dollars in Millions 2013 2012 2011 2013 2012 2011
Service cost — benefits earned during the year $38
 $32
 $43
 $8
 $8
 $8
Interest cost on projected benefit obligation 302
 319
 337
 13
 22
 26
Expected return on plan assets (519) (508) (464) (26) (25) (26)
Amortization of prior service credits (4) (3) (1) (2) (2) (3)
Amortization of net actuarial loss 134
 129
 112
 1
 10
 7
Curtailments 
 (1) (3) 
 
 (1)
Settlements 165
 160
 15
 
 
 
Total net periodic benefit (credit)/cost $116
 $128
 $39
 $(6) $13
 $11

Pension settlement charges were amended during June 2009. The amendments eliminate the crediting of future benefits relating to service effective December 31, 2009. Salary increases will continue to be considered for an additional five-year period inrecognized after determining the benefit obligation related to prior service. Theannual lump sum payments will exceed the annual interest and service costs for certain pension plans, including the primary U.S. pension plan amendments were accounted for as a curtailment. As a result, the applicable plan assetsin 2013 and obligations were remeasured. The remeasurement resulted in a $455 million reduction to accumulated OCI ($295 million net of taxes) and a corresponding decrease to the funded status of the plan due to the curtailment, updated plan asset valuations and a change in the discount rate from 7.0% to 7.5%. A curtailment charge of $25 million was also recognized in other expense during the second quarter of 2009 for the remaining amount of unrecognized prior service cost. In addition, all participants were reclassified as inactive for benefit plan purposes and actuarial gains and losses will be amortized over the expected weighted-average remaining lives of plan participants (32 years).

In connection with the plan amendment, contributions to principal defined contribution plans in the U.S. and Puerto Rico increased effective January 1, 2010. The net impact of the above actions is expected to reduce the future retiree benefit costs, although future costs will continue to be subject to market conditions and other factors including actual and expected plan asset performance, interest rate fluctuations and lump-sum benefit payments.

91

2012.



98

In 2009, certain plan assets and related obligations were transferred from the U.S. Retirement Income Plan and several other plans to new plans sponsored by Mead Johnson for active Mead Johnson participants resulting in a $170 million reduction to accumulated OCI ($110 million net of taxes) in the first quarter of 2009 and a corresponding decrease to the funded status of the plan due to updated plan asset valuations and a change in the discount rate from 6.5% to 7.0%.



Changes in defined benefit and postretirement benefit plan obligations, assets, funded status and amounts recognized in the consolidated balance sheets were as follows:

   Pension Benefits  Other Benefits 
Dollars in Millions  2011  2010  2011  2010 

Benefit obligations at beginning of year

  $6,704  $  6,386  $589  $579 

Service cost—benefits earned during the year

   43   44   8   6 

Interest cost

   337   347   26   30 

Plan participants’ contributions

   3   3   25   25 

Curtailments

   (3  2   (1    

Settlements

   (41  (50  (2    

Plan amendments

   (40      (1    

Actuarial losses

   876   397   6   16 

Retiree Drug Subsidy

           12   10 

Benefits paid

   (386  (377  (79  (78

Special termination benefits

       1         

Exchange rate losses/(gains)

   6   (49  (1  1 
  

 

 

  

 

 

  

 

 

  

 

 

 

Benefit obligations at end of year

  $7,499  $  6,704  $582  $589 
  

 

 

  

 

 

  

 

 

  

 

 

 

Fair value of plan assets at beginning of year

  $5,766  $5,103  $315  $278 

Actual return on plan assets

   66   697   10   37 

Employer contributions

   432   431   24   43 

Plan participants’ contributions

   3   3   25   25 

Settlements

   (41  (50  (2    

Retiree Drug Subsidy

           12   10 

Benefits paid

   (386  (377  (79  (78

Exchange rate gains/(losses)

   2   (41        
  

 

 

  

 

 

  

 

 

  

 

 

 

Fair value of plan assets at end of year

  $5,842  $  5,766  $305  $315 
  

 

 

  

 

 

  

 

 

  

 

 

 

Funded status

  $(1,657 $(938 $  (277 $  (274
  

 

 

  

 

 

  

 

 

  

 

 

 

Assets/Liabilities recognized:

     

Other assets

  $39  $37  $   $  

Accrued expenses

   (33  (33  (12  (13

Pension and other postretirement liabilities

   (1,663  (942  (265  (261
  

 

 

  

 

 

  

 

 

  

 

 

 

Funded status

  $  (1,657 $(938 $  (277 $  (274
  

 

 

  

 

 

  

 

 

  

 

 

 

Recognized in accumulated other comprehensive loss:

     

Net actuarial loss

  $4,297  $3,150  $166  $151 

Net obligation at adoption

   1   1         

Prior service cost/(benefit)

   (39      (8  (10
  

 

 

  

 

 

  

 

 

  

 

 

 

Total

  $4,259  $  3,151  $158  $141 
  

 

 

  

 

 

  

 

 

  

 

 

 

  Pension Benefits Other Benefits
Dollars in Millions 2013 2012 2013 2012
Benefit obligations at beginning of year $8,200
 $7,499
 $460
 $582
Service cost—benefits earned during the year 38
 32
 8
 8
Interest cost 302
 319
 13
 22
Plan participants’ contributions 2
 2
 23
 24
Curtailments 
 (19) 
 
Settlements (350) (260) 
 
Plan amendments (1) (8) 
 
Actuarial losses/(gains) (761) 838
 (43) (107)
Retiree Drug Subsidy 
 
 6
 6
Benefits paid (206) (227) (63) (76)
Exchange rate losses 9
 24
 
 1
Benefit obligations at end of year $7,233
 $8,200
 $404
 $460
         
Fair value of plan assets at beginning of year $6,542
 $5,842
 $311
 $305
Actual return on plan assets 1,154
 761
 61
 41
Employer contributions 251
 396
 9
 11
Plan participants’ contributions 2
 2
 23
 24
Settlements (350) (260) 
 
Retiree Drug Subsidy 
 
 6
 6
Benefits paid (206) (227) (63) (76)
Exchange rate gains 13
 28
 
 
Fair value of plan assets at end of year $7,406
 $6,542
 $347
 $311
         
Funded status $173
 $(1,658) $(57) $(149)
         
Assets/(Liabilities) recognized:        
Other assets $731
 $22
 $87
 $12
Accrued expenses (35) (37) (12) (12)
Pension and other postretirement liabilities (523) (1,643) (132) (149)
Funded status $173
 $(1,658) $(57) $(149)
         
Recognized in accumulated other comprehensive loss:        
Net actuarial losses/(gains) $2,878
 $4,572
 $(44) $34
Net obligation at adoption 
 1
 
 
Prior service credit (41) (44) (4) (6)
Total $2,837
 $4,529
 $(48) $28

The accumulated benefit obligation for all defined benefit pension plans was $7,322$7,125 million and $6,407$8,068 million at December 31, 20112013 and 2010,2012, respectively.


Additional information related to pension plans was as follows:

Dollars in Millions  2011   2010 

Pension plans with projected benefit obligations in excess of plan assets:

    

Projected benefit obligation

  $  7,236   $  6,436 

Fair value of plan assets

   5,540    5,461 

Pension plans with accumulated benefit obligations in excess of plan assets:

    

Accumulated benefit obligation

  $  6,867   $  6,112 

Fair value of plan assets

   5,327    5,415 

92

Dollars in Millions 2013 2012
Pension plans with projected benefit obligations in excess of plan assets:    
Projected benefit obligation $1,291
 $8,112
Fair value of plan assets 732
 6,432
Pension plans with accumulated benefit obligations in excess of plan assets:
    
Accumulated benefit obligation $1,101
 $7,987
Fair value of plan assets 608
 6,432

99



Actuarial Assumptions

Weighted-average assumptions used to determine benefit obligations at December 31 were as follows:

   Pension Benefits  Other Benefits 
   2011  2010  2011  2010 

Discount rate

   4.4  5.2  4.1  4.8

Rate of compensation increase

   2.3  2.4  2.0  2.0

  Pension Benefits Other Benefits
  2013 2012 2013 2012
Discount rate 4.4% 3.7% 3.8% 3.0%
Rate of compensation increase 2.3% 2.3% 2.1% 2.0%

Weighted-average actuarial assumptions used to determine net periodic benefit (credit)/cost for the years ended December 31 were as follows:

   Pension Benefits  Other Benefits 
   2011  2010  2009  2011  2010  2009 

Discount rate

   5.2  5.6  6.9  4.8  5.5  7.0

Expected long-term return on plan assets

   8.3  8.3  8.2  8.8  8.8  8.8

Rate of compensation increase

   2.4  3.7  3.6  2.0  3.5  3.5

  Pension Benefits Other Benefits
  2013 2012 2011 2013 2012 2011
Discount rate 4.1% 4.4% 5.2% 3.0% 4.1% 4.8%
Expected long-term return on plan assets 8.0% 8.2% 8.3% 8.8% 8.8% 8.8%
Rate of compensation increase 2.3% 2.3% 2.4% 2.1% 2.0% 2.0%

The yield on high quality corporate bonds that matches the duration of the benefit obligations is used in determining the discount rate. The Citigroup Pension Discount curve is used in developing the discount rate for the U.S. plans.


Several factors are considered in developing the expected return on plan assets, including long-term historical returns and input from external advisors. Individual asset class return forecasts were developed based upon market conditions, for example, price-earnings levels and yields and long-term growth expectations. The expected long-term rate of return is the weighted-average of the target asset allocation of each individual asset class. Historical long-term actual annualized returns for U.S. pension plans were as follows:

   2011  2010  2009 

10 years

   5.6  4.7  3.6

15 years

   7.0  7.9  8.4

20 years

   8.1  9.3  8.4

Pension and postretirement liabilities were increased by $1.3 billion at December 31, 2011 with a corresponding charge to

  2013 2012 2011
10 years 8.0% 8.5% 5.6%
15 years 6.8% 6.5% 7.0%
20 years 8.8% 8.5% 8.1%

The accumulated other comprehensive incomeloss was reduced by $1,475 million during 2013 as a result of loweractuarial gains attributed to the benefit obligation ($805 million) and higher than expected return on plan assets ($414 million) and actuarial losses attributed to the benefit obligation ($882670 million). These actuarial lossesgains resulted from prevailing equity and fixed income market conditions and a reductionan increase in interest rates in 2011.

2013.


The expected return on plan assets was determined using the expected rate of return and a calculated value of assets, referred to as the “market-related value.” The market-related value exceeded the fair value of plan assets by $151 million at December 31, 2011.value”. The fair value of plan assets exceeded the market-related value by $313$455 million at December 31, 2010.2013. Differences between the assumed and actual returns are amortized to the market-related value on a straight-line basis over a three-year period.


Gains and losses have resulted from changes in actuarial assumptions (such as changes in the discount rate) and from differences between assumed and actual experience (such as differences between actual and expected return on plan assets). These gains and losses (except those differences being amortized to the market-related value) are only amortized to the extent they exceed 10% of the higher of the market-related value or the projected benefit obligation for each respective plan. As a result, approximately $900 million related to pension benefits is not expected to be amortized during 2012. The majority of the remaining actuarial losses are amortized over the life expectancy of the plans’ participants for U.S. plans (28 years) and expected remaining service periods for most other plans.

plans into cost of products sold, research and development, and marketing, selling and administrative expenses. The amortization of net actuarial loss and prior service credit is expected to be approximately $100 million in 2014.


Assumed healthcare cost trend rates at December 31 were as follows:

   2011  2010  2009 

Healthcare cost trend rate assumed for next year

   7.4  7.9  8.4

Rate to which the cost trend rate is assumed to decline (the ultimate trend rate)

   4.5  4.5  4.5

Year that the rate reaches the ultimate trend rate

   2018   2018   2018 

  2013 2012 2011
Healthcare cost trend rate assumed for next year 6.4% 6.8% 7.4%
Rate to which the cost trend rate is assumed to decline (the ultimate trend rate) 4.5% 4.5% 4.5%
Year that the rate reaches the ultimate trend rate 2019
 2018
 2018
Assumed healthcare cost trend rates have an effect on the amounts reported for the healthcare plans. A one-percentage-point change in assumed healthcare cost trend rates would not have a material impact on the following effects:

Dollars in Millions  1-Percentage-
Point Increase
   1-Percentage-
Point Decrease
 

Effect on total of service and interest cost

  $1   $(1

Effect on postretirement benefit obligation

   15    (11

93

service and interest cost or post retirement benefit obligation.


100



Plan Assets

The fair value of pension and postretirement plan assets by asset category at December 31, 20112013 and 20102012 was as follows:

   December 31, 2011  December 31, 2010 
Dollars in Millions  Level 1  Level 2   Level 3   Total  Level 1  Level 2   Level 3   Total 

Equity Funds

  $236  $  1,559   $4   $  1,799  $237  $  1,665   $7   $  1,909 

Equity Securities

   1,679             1,679   1,752             1,752 

Fixed Income Funds

   203   419         622   181   367         548 

Venture Capital and Limited Partnerships

            408    408            415    415 

Government Mortgage Backed Securities

       372    8    380       391         391 

Corporate Debt Securities

       315    10    325       309    14    323 

Short-Term Investment Funds

       306         306       244         244 

U.S. Treasury and Agency Securities

       304         304   26   112         138 

Insurance Contracts

            125    125            144    144 

Event Driven Hedge Funds

       86         86       86         86 

Collateralized Mortgage Obligation Bonds

       63    7    70       87    10    97 

State and Municipal Bonds

       34         34       24         24 

Asset Backed Securities

       17    4    21       24    7    31 

Real Estate

       12         12       11         11 

Cash and Cash Equivalents

   (24            (24  (32            (32
  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

 

Total plan assets at fair value

  $  2,094  $3,487   $566   $6,147  $  2,164  $3,320   $597   $6,081 
  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

 

  December 31, 2013 December 31, 2012
Dollars in Millions Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total
Equity Securities $1,804
 $
 $
 $1,804
 $2,196
 $
 $
 $2,196
Equity Funds 534
 1,679
 
 2,213
 410
 1,555
 
 1,965
Fixed Income Funds 238
 657
 
 895
 234
 401
 
 635
Corporate Debt Securities 
 1,410
 
 1,410
 
 453
 3
 456
Venture Capital and Limited Partnerships 
 
 369
 369
 
 
 381
 381
Government Mortgage Backed Securities 
 1
 
 1
 
 350
 8
 358
U.S. Treasury and Agency Securities 
 514
 
 514
 
 259
 
 259
Short-Term Investment Funds 
 122
 
 122
 
 189
 
 189
Insurance Contracts 
 
 142
 142
 
 
 132
 132
Event Driven Hedge Funds 
 122
 
 122
 
 92
 
 92
Collateralized Mortgage Obligation Bonds 
 
 
 
 
 50
 6
 56
State and Municipal Bonds 
 24
 
 24
 
 44
 3
 47
Asset Backed Securities 
 
 
 
 
 23
 3
 26
Real Estate 4
 
 
 4
 3
 
 
 3
Cash and Cash Equivalents 133
 
 
 133
 58
 
 
 58
Total plan assets at fair value $2,713
 $4,529
 $511
 $7,753
 $2,901
 $3,416
 $536
 $6,853
The investment valuation policies per investment class are as follows:

Level 1 inputs utilize quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. These instruments include equity securities, equity funds, real estate funds and fixed income funds publicly traded on a national securities exchange, U.S. treasury and agency securities, and cash and cash equivalents. Cash and cash equivalents are highly liquid investments with original maturities of three months or less at the time of purchase and are recognized at cost, which approximates fair value. Pending trade sales and purchases are included in cash and cash equivalents until final settlement.


Level 2 inputs include observable prices for similar instruments, quoted prices for identical or similar instruments in markets that are not active, and other observable inputs that can be corroborated by market data for substantially the full term of the assets or liabilities. Equity funds, fixed income funds, event driven hedge funds and short-term investment funds classified as Level 2 within the fair value hierarchy are valued at the net asset value of their shares held at year end. There were no significant unfunded commitments or restrictions on redemptions related to investments valued at NAV as of December 31, 2013. Corporate debt securities, government mortgage backed securities, collateralized mortgage obligation bonds, asset backed securities, U.S. treasury and agency securities, and state and municipal bonds and real estate interests classified as Level 2 within the fair value hierarchy are valued utilizing observable prices for similar instruments and quoted prices for identical or similar instruments in markets that are not active.


Level 3 unobservable inputs are used when little or no market data is available. Equity funds, ventureVenture capital and limited partnership investmentspartnerships classified as Level 3 within the fair value hierarchy invest in underlying securities whose market values are valued at estimated fair value. The estimateddetermined using pricing models, discounted cash flow methodologies, or similar techniques. Some of the most significant unobservable inputs used in the valuation methodologies include discount rates, Earning Before Interest, Taxes, Depreciation and Amortization (EBITDA) multiples, and revenue multiples. Significant changes in any of these inputs could result in significantly lower or higher fair value is based on the fair value of the underlying investment values or cost plus or minus accumulated earnings or losses which approximates fair value.measurements. Insurance contract interests are carried at contract value, which approximates the estimated fair value and is based on the fair value of the underlying investment of the insurance company. Insurance contracts are held by certain foreign pension plans. Valuation models for corporate debt securities, government mortgage backed securities, collateralized mortgage obligation bonds and asset backed securities classified as Level 3 within the fair value hierarchy are based on estimated bids from brokers or other third-party vendor sources that utilize expected cash flow streams and collateral values including assessments of counterparty credit quality, default risk, discount rates and overall capital market liquidity.

94



101



The following summarizes the activity for financial assets utilizing Level 3 fair value measurements:

Dollars in Millions  Venture Capital
and Limited
Partnerships
  Insurance
Contracts
  Other  Total 

Fair value at January 1, 2010

  $391  $141  $53  $  585 

Purchases

   43   6   3   52 

Sales

   (2  (17  (19  (38

Settlements

   (66  —      (3  (69

Realized (losses)/gains

   34   —      (2  32 

Unrealized gains/(losses)

   15    14   7   36 
  

 

 

  

 

 

  

 

 

  

 

 

 

Fair value at December 31, 2010

   415   144   39   598 

Purchases

   53   8   5   66 

Sales

   (5  (31  (3  (39

Settlements

   (48  —      (4  (52

Realized (losses)/gains

   56   —      3   59 

Unrealized gains/(losses)

   (63  4   (7  (66
  

 

 

  

 

 

  

 

 

  

 

 

 

Fair value at December 31, 2011

  $408  $125  $33  $566 

Dollars in Millions 
Venture Capital
and Limited
Partnerships
 
Insurance
Contracts
 Other Total
Fair value at January 1, 2012 $408
 $125
 $33
 $566
Purchases 43
 5
 
 48
Sales (8) (7) (10) (25)
Settlements (51) 
 (2) (53)
Realized (losses)/gains 53
 
 (4) 49
Unrealized gains/(losses) (64) 9
 6
 (49)
Fair value at December 31, 2012 381
 132
 23
 536
Purchases 22
 4
 
 26
Sales (12) (8) (4) (24)
Settlements (101) 
 (19) (120)
Realized gains 48
 5
 
 53
Unrealized gains 31
 9
 
 40
Fair value at December 31, 2013 $369
 $142
 $
 $511

The investment strategy emphasizes equities in order to achieve higher expected returns and lower expenses and required cash contributions over the long-term. A target asset allocation of 70%53% public equity (58%(20% U.S. and 12% international)20% international and 13% global), 8%7% private equity and 22%40% long-duration fixed income is maintained for the U.S. pension plans. Investments are well diversified within each of the three major asset categories. Approximately 82%95% of the U.S. pension plans equity investments are actively managed. Venture capital and limited partnerships are typically valued on a three month lag. Bristol-Myers Squibb Companylag using latest available information. BMS common stock represents less than 1% of the plan assets at December 31, 20112013 and 2010.

2012.


Contributions


Contributions to the U.S. pension plans were $184 million in 2013, $335 million in 2012 and $343 million in 2011, $341 million in 2010 and $656 million in 2009 (including $27 million by Mead Johnson). Contributions to the U.S. pension plans are expected to approximate $340 million during 2012, of which $300 million was contributed in January 2012.

2011. Contributions to the international pension plans were $67 million in 2013, $61 million in 2012 and $88 million in 2011, $90 million in 2010 and $133 million in 2009. Contributions2011. Aggregate contributions to the U.S. and international plans are expected to range from $75 million to $90be approximately $100 million in 2012.

2014.


Estimated Future Benefit Payments

Dollars in Millions  Pension
Benefits
   Other
Benefits
 

2012

  $      384   $50 

2013

     395    51 

2014

     406    47 

2015

     407    45 

2016

     415    44 

Years 2017 – 2021

     2,083    202 

  Pension Other
Dollars in Millions Benefits Benefits
2014 $411
 $44
2015 366
 42
2016 377
 40
2017 382
 38
2018 380
 35
Years 2019 – 2023 1,974
 144

Savings Plan

Plans


The principal defined contribution plan is the Bristol-Myers Squibb Savings and Investment Program. The contribution is based on employee contributions and the level of Company match. The qualifiedexpense attributed to defined contribution plans in the U.S. were amended to allow for increased matching$190 million in both 2013 and additional Company contributions effective in 2010. The expense related to the plan was2012 and $181 million in 2011, $188 million in 2010 and $50 million in 2009.

2011.


Post Employment Benefit Plan

Plans


Post-employment liabilities for long-term disability benefits were $92$63 million and $90 million at both December 31, 20112013 and 2010. The2012, respectively, with a related credit of $8 million in 2013 and expense related to these benefits wasof $17 million in 2012 and $18 million in 2011 and 2010 and $21 million in 2009.

95


2011.


Termination Indemnity Plans

Statutory


International statutory termination obligations in Europe are recognized on an undiscounted basis assuming employee termination at each measurement date. The liability recognized for these obligations was $25$23 million and $29 million at both December 31, 20112013 and 2010.

2012, respectively.

102




Note 20. EMPLOYEE STOCK BENEFIT PLANS

On May 1, 2007,2012, the shareholders approved the 20072012 Stock Award and Incentive Plan (the 20072012 Plan), which replaced the 20022007 Stock Incentive Plan that expired on May 31, 2007.Plan. Shares of common stock reserved for issuance pursuant to stock plans, options and conversions of preferred stock were 302262 million at December 31, 2011.2013. Shares available to be granted for the active plans, adjusted for the combination of plans, were 108114 million at December 31, 2011.2013. Shares for the stock option exercise and share unit vesting are issued from treasury stock. Only shares actually delivered to participants in connection with an award after all restrictions have lapsed will reduce the number of shares reserved. Shares tendered in a prior year to pay the purchase price of options and shares previously utilized to satisfy withholding tax obligations upon exercise continue to be available and reserved.


Executive officers and key employees may be granted options to purchase common stock at no less than the market price on the date the option is granted. Options generally become exercisable ratably over 4four years and have a maximum term of 10ten years. Additionally, the plan provides for the granting of stock appreciation rights whereby the grantee may surrender exercisable rights and receive common stock and/or cash measured by the excess of the market price of the common stock over the option exercise price.


Common stock or stock units may be granted to key employees, subject to restrictions as to continuous employment. Restrictions expire over a four year period from date of grant. Compensation expense is recognized over the vesting period. A stock unit is a right to receive stock at the end of the specified vesting period but has no voting rights.

Beginning in 2010, market


Market share units were granted to certain executives.executives beginning in 2010. Vesting of market share units is conditioned upon continuous employment until vesting date and the payout factor equals at least 60%. of the share price on the award date. The payout factor is the share price on vesting date divided by share price on award date, with a maximum of 200%. The share price used in the payout factor is calculated using an average of the closing prices on the grant or vest date, and the nine trading days immediately preceding the grant or vest date. Vesting occurs ratably over four years.


Long-term performance awards have a three year cycle and are delivered in the form of a target number of performance share units. The number of shares ultimately issued is calculated based on actual performance compared to earnings targets and other performance criteria established at the beginning of each year of the three year performance period.cycle. The awards have annual goals with a maximum payout of 167.5%. If threshold targets are not met for a performance period, no payment is made under the plan for that annual period. Vesting occurs at the end of the three year period.


Stock-based compensation expense is based on awards ultimately expected to vest and is recognized over the vesting period. The acceleration of unvested stock options and restricted stock units in connection with the acquisition of Amylin resulted in stock-based compensation expense in 2012. Forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. Stock-based compensation expense was as follows:

   Years Ended December 31, 
Dollars in Millions  2011   2010   2009 

Stock options

  $27   $50   $78 

Restricted stock

   79    83    76 

Market share units

   23    13      

Long-term performance awards

   32    47    29 
  

 

 

   

 

 

   

 

 

 

Total stock-based compensation expense

  $161   $193   $183 
  

 

 

   

 

 

   

 

 

 

Continuing operations

  $161   $193   $165 

Discontinued operations

             18 
  

 

 

   

 

 

   

 

 

 

Total stock-based compensation expense

  $161   $193   $183 
  

 

 

   

 

 

   

 

 

 
      
  

 

 

   

 

 

   

 

 

 

Deferred tax benefit related to stock-based compensation expense

  $56   $63   $60 
  

 

 

   

 

 

   

 

 

 

96

  Years Ended December 31,
Dollars in Millions 2013 2012 2011
Stock options $2
 $7
 $27
Restricted stock 74
 64
 79
Market share units 29
 23
 23
Long-term performance awards 86
 60
 32
Amylin stock options and restricted stock units (see Note 4) 
 94
 
Total stock-based compensation expense $191
 $248
 $161
       
Income tax benefit $64
 $82
 $56

103



Share-based compensation activities were as follows:

   Stock Options   Restricted Stock Units   Market Share Units   Long-Term
Performance Awards
 
Shares in Thousands  Number of
Options
Outstanding
  Weighted-
Average
Exercise Price
of Shares
   Number
of
Nonvested
Awards
  Weighted-
Average
Grant-Date
Fair Value
   Number
of
Nonvested
Awards
  Weighted-
Average
Grant-Date
Fair Value
   Number
of
Nonvested
Awards
  Weighted-
Average
Grant-Date
Fair Value
 

Balance at January 1, 2011

   104,724  $29.02    9,343  $21.53    1,248  $24.69    4,550    $19.83 

Granted

            3,358   26.04    1,353   25.83    1,642     25.30 

Released/Exercised

   (23,703  23.49    (3,400  21.92    (325  24.70    (2,831    18.89 

Adjustments for actual payout

                     (17  24.70    277     25.38 

Forfeited

   (10,797  54.08    (885  22.20    (277  25.17    (227    24.38 
  

 

 

    

 

 

    

 

 

    

 

 

    

Balance at December 31, 2011

   70,224   27.04    8,416   23.10    1,982   25.39    3,411     23.53 
  

 

 

    

 

 

    

 

 

    

 

 

    

  Stock Options Restricted Stock Units Market Share Units Long-Term Performance Awards
  
Number of
Options Outstanding
 
Weighted-
Average
Exercise Price of Shares
 
Number
of
Nonvested Awards
 
Weighted-
Average
Grant-Date Fair Value
 
Number
of
Nonvested Awards
 
Weighted-
Average
Grant-Date Fair Value
 
Number
of
Nonvested Awards
 
Weighted-
Average
Grant-Date Fair Value
Shares in Thousands        
Balance at January 1, 2013 41,965
 $23.21
 7,568
 $27.18
 2,204
 28.46
 4,096
 28.44
Granted 
 
 2,653
 38.73
 1,025
 37.40
 2,464
 37.40
Released/Exercised (18,029) 23.62
 (3,050) 24.36
 (809) 27.08
 (2,072) 27.26
Adjustments for actual payout 
 
 
 
 (298) 27.08
 38
 37.40
Forfeited/Canceled (813) 23.19
 (619) 30.97
 (290) 31.51
 (234) 34.66
Balance at December 31, 2013 23,123
 22.88
 6,552
 32.81
 1,832
 33.82
 4,292
 33.75
                 
Vested or expected to vest 23,123
 22.88
 6,053
 32.81
 1,692
 33.82
 3,965
 33.75

Total compensation costs related to share-based payment awards not yet recognized and the weighted-average period over which such awards are expected to be recognized at December 31, 20112013 were as follows:

Dollars in Millions  Stock
Options
   Restricted
Stock Units
   Market
Share Units
   Long-Term
Performance
Awards
 

Unrecognized compensation cost

  $13   $135   $27     $30 

Expected weighted-average period in years of compensation cost to be recognized

   1.1    2.5    2.9      1.5 

  Restricted Market 
Long-Term
Performance
Dollars in Millions Stock Units Share Units Awards
Unrecognized compensation cost $155
 $32
 $27
Expected weighted-average period in years of compensation cost to be recognized 2.7
 2.6
 1.4
Additional information related to share-based compensation awards is summarized as follows:

Amounts in Millions, except per share data  2011   2010   2009 

Weighted-average grant date fair value (per share):

      

Stock options

  $    $    $3.60 

Restricted stock units

   26.04    24.80    17.77 

Market share units

   25.83    24.69      

Long-term performance awards

   25.30    23.65    15.59 

Fair value of options or awards that vested during the year:

      

Stock options

  $45   $73   $103 

Restricted stock units

   75    79    74 

Market share units

   8           

Long-term performance awards

   21    56    21 

Total intrinsic value of stock options exercised during the year

  $154   $47   $6 

Amounts in Millions, except per share data 2013 2012 2011
Weighted-average grant date fair value (per share):      
Restricted stock units $38.73
 $32.71
 $26.04
Market share units 37.40
 31.85
 25.83
Long-term performance awards 37.40
 32.33
 25.30
       
Fair value of options or awards that vested during the year:      
Stock options $11
 $23
 $45
Restricted stock units 74
 74
 75
Market share units 30
 18
 8
Long-term performance awards 90
 56
 21
       
Total intrinsic value of stock options exercised during the year $323
 $153
 $154

The fair value of restricted stock units and long-term performance awards are determined based on the closing trading price of the Company’s common stock on the grant date. The fair value of market share units approximated the closing trading price of the Company's common stock on the grant date and was estimated on the date of the grant considering the payout formula and the probability of satisfying market conditions.
The following table summarizes significant ranges of outstanding and exercisable options at December 31, 20112013 (amounts in millions, except per share data):

   Options Outstanding   Options Exercisable 

Range of Exercise Prices

  Number
Outstanding
(in thousands)
   Weighted-
Average
Remaining
Contractual
Life
(in years)
   Weighted-
Average
Exercise
Price Per
Share
   Aggregate
Intrinsic
Value
   Number
Exercisable
   Weighted-
Average
Remaining
Contractual
Life
(in years)
   Weighted-
Average
Exercise
Price Per
Share
   Aggregate
Intrinsic
Value
 

$1 - $20

   13,062    7.16   $17.48   $232    5,997    7.14   $17.37   $107 

$20 - $30

   47,186    3.64    25.25    472    44,986    3.48    25.40    443 

$30 - $40

   28    3.82    30.97         28    3.82    30.97      

$40 and up

   9,948    0.17    48.10         9,948    0.17    48.10      
  

 

 

       

 

 

   

 

 

       

 

 

 
   70,224    3.80    27.04   $704    60,959    3.33    28.32   $550 
  

 

 

       

 

 

   

 

 

       

 

 

 

  Options Outstanding and Exercisable
 Range of Exercise Prices 
Number
Outstanding and Exercisable (in thousands)
 
Weighted-Average
Remaining Contractual
Life (in years)
 
Weighted-Average
Exercise Price 
Per Share
 
Aggregate
Intrinsic Value
$1 - $20 6,457
 5.16 $17.51
 $230
$20 - $30 16,660
 2.49 24.96
 470
$30 - $40 6
 3.47 31.30
 
  23,123
 3.24 22.88
 $700
The aggregate intrinsic value in the preceding table represents the total pre-tax intrinsic value, based on the closing stock price of $35.24$53.15 on December 31, 2011.

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2013.


104

Fair Value Assumptions

The fair value of stock options was estimated on the grant date using the Black-Scholes option pricing model for stock options with a service condition, and a model applying multiple input variables that determine the probability of satisfying market conditions for options with service and market conditions. The following weighted-average assumptions were used in the valuation:

2009

Expected volatility

35.8%

Risk-free interest rate

2.4%

Dividend yield

5.7%

Expected life

7.0 yrs

The expected volatility assumption required in the Black-Scholes model was derived by calculating a 10-year historical volatility and weighting that equally with the derived implied volatility. The blended historical and implied volatility approach of expected volatility is believed to be more representative of future stock price trends than using only historical volatility.

The risk-free interest rate assumption is based upon the U.S. Treasury yield curve in effect on the grant date. The dividend yield assumption is based on historical and expected dividend payouts.

The expected life of stock options represents the weighted-average period the stock options will remain outstanding and is a derived output of a lattice-binomial model. The expected life is impacted by all of the underlying assumptions and calibration of the model. The model assumes that employees’ exercise behavior is a function of the option’s remaining vested life and the extent to which the option is in-the-money. The model estimates the probability of exercise as a function of these two variables based on historical exercises and cancellations on prior option grants made.

The fair value of restricted stock units and long-term performance awards is determined based on the closing trading price of the Company’s common stock on the grant date. Beginning in 2010, the fair value of performance share units granted was not discounted because they participate in dividends. The fair value of performance share units granted prior to 2010 was discounted using the risk-free interest rate on the date of grant because they do not participate in dividends.

The fair value of the market share units was estimated on the date of grant using a model applying multiple input variables that determine the probability of satisfying market conditions. The model uses the following input variables:

   2011   2010 

Expected volatility

   24.3%     24.8%  

Risk-free interest rate

   1.8%     1.9%  

Dividend yield

   4.9%     5.8%  

Expected volatility is based on the four year historical volatility levels on the Company’s common stock and the current implied volatility. The four-year risk-free interest rate was derived from the Federal Reserve, based on the market share units’ contractual term. Expected dividend yield is based on historical dividend payments.




Note 21. LEASES


Minimum rental commitments for non-cancelable operating leases (primarily real estate and motor vehicles) in effect at December 31, 2011,2013, were as follows:

Years Ending December 31,

  Dollars in Millions 

2012

  $136 

2013

   122 

2014

   113 

2015

   96 

2016

   93 

Later years

   162 
  

 

 

 

Total minimum rental commitments

  $722 
  

 

 

 

Years Ending December 31, Dollars in Millions
2014 $145
2015 137
2016 117
2017 77
2018 65
Later years 73
Total minimum rental commitments $614

Operating lease expense was $144 million in 2013, $142 million in 2012 and $136 million in 2011, $145 million in 2010 and $149 million in 2009, of which $17 million in 2009 was included in discontinued operations.2011. Sublease income was not material for the years ended December 31, 2011, 2010 and 2009.

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all periods presented.

Note 22. LEGAL PROCEEDINGS AND CONTINGENCIES

The Company and certain of its subsidiaries are involved in various lawsuits, claims, government investigations and other legal proceedings that arise in the ordinary course of business. The Company recognizes accruals for such contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. These matters involve patent infringement, antitrust, securities, pricing, sales and marketing practices, environmental, commercial, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage. Litigation expense, net included a $41 million insurance reimbursement from prior litigation offset by additional reserves for certain average wholesale prices (AWP) litigation in 2010, and a $125 million securities litigation settlement in 2009. Legal proceedings that are material or that the Company believes could become material are described below.


Although the Company believes it has substantial defenses in these matters, there can be no assurance that there will not be an increase in the scope of pending matters or that any future lawsuits, claims, government investigations or other legal proceedings will not be material. Unless otherwise noted, the Company is unable to assess the outcome of the respective litigation nor is it able to provide an estimated range of potential loss. Furthermore, failure to enforce our patent rights would likely result in substantial decreases in the respective product salesrevenues from generic competition.

INTELLECTUAL PROPERTY
Atripla

PLAVIX* Litigation – U.S.*

Patent Infringement Litigation against ApotexIn April 2009, Teva Pharmaceutical Industries Ltd. (Teva) filed an abbreviated New Drug Application (aNDA) to manufacture and Related Mattersmarket a generic version of

Atripla*. Atripla* is a single tablet three-drug regimen combining the Company’s Sustiva (efavirenz) and Gilead’s Truvada*. As previously disclosed,of this time, the Company’s U.S. territory partnership under its alliance with Sanofi ispatent rights covering Sustiva’s composition of matter and method of use have not been challenged. Teva sent Gilead a plaintiff inParagraph IV certification letter challenging two of the fifteen Orange Book-listed patents for Atripla*. In May 2009, Gilead filed a pending patent infringement lawsuit institutedaction against Teva in the United StatesU.S. District Court for the Southern District of New York (District Court) entitled Sanofi-Synthelabo, Sanofi-Synthelabo, Inc.(SDNY). In January 2010, the Company received a notice that Teva has amended its aNDA and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex. The suit is based on U.S. Patent No. 4,847,265 (the ‘265 Patent),challenging eight additional Orange Book-listed patents for Atripla*. In March 2010, the Company and Merck, Sharp & Dohme Corp. (Merck) filed a composition of matter patent which discloses and claims, among other things, the hydrogen sulfate salt of clopidogrel, a medicine made availableinfringement action against Teva also in the SDNY relating to two U.S. bypatents which claim crystalline or polymorph forms of efavirenz. In August 2013, the Companies as PLAVIX*. Also, as previously reported, the District Court upheld the validityCompany, Merck and enforceability of the ‘265 Patent, maintaining the main patent protection for PLAVIX* in the U.S. through the life of the patent term which now expires on May 17, 2012. The District Court also ruled that Apotex’s generic clopidogrel bisulfate product infringed the ‘265 Patent and permanently enjoined Apotex from engaging in any activity that infringes the ‘265 Patent, including marketing its generic product in the U.S. until after the patent expires.

Apotex appealed the District Court’s decision and on December 12, 2008, the United States Court of Appeals for the Federal Circuit (Circuit Court) affirmed the District Court’s ruling sustaining the validity of the ‘265 Patent. Apotex filedTeva reached a petition with the Circuit Court for a rehearingen banc, and in March 2009, the Circuit Court denied Apotex’s petition. The case was remandedsettlement relating to the District Court for further proceedings relating to damages. In July 2009, Apotex filed a petition for writ of certiorari withtwo efavirenz polymorph patents and the U.S. Supreme Court requesting the Supreme Court to review the Circuit Court’s decision. In November 2009, the U.S. Supreme Court denied the petition, declining to review the Circuit Court’s decision. In December 2009, the Companies filed a motion in the District Court for summary judgment on damages, and in January 2010, Apotex filed a motion seeking a stay of the ongoing damages proceedings pending the outcome of the reexamination of the PLAVIX* patent by the U.S. Patent and Trademark Office (PTO) described below. In April 2010, the District Court denied Apotex’s motion to stay the proceedings. In October 2010, the District Court granted the Companies’ summary judgment motion and awarded $442 million in damages plus costs and interest. Apotex appealed the amount of the damages award; however, the validity of the patent claiming clopidogrel bisulfatecase has been finally judicially determined in favor of the Companies maintaining patent protection and market exclusivity for PLAVIX* in the U.S. until May 17, 2012 (including additional six-month pediatric exclusivity period).dismissed. In October 2011, the Circuit Court upheld the $442 million damages award and reversed the District Court’s award of prejudgment interest. In February 2012, the Companies received payment of the $442 million damages award plus costs and post-judgment interest of which BMS received $172 million.

As previously disclosed, the Company’s U.S. territory partnership under its alliance with Sanofi is also a plaintiff in five additional patent infringement lawsuits against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, LTD (Dr. Reddy’s), Teva Pharmaceuticals USA, Inc. (Teva), Cobalt Pharmaceuticals Inc. (Cobalt), Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. (Watson) and Sun Pharmaceuticals (Sun). The lawsuits against Dr. Reddy’s, Teva and Cobalt relate to the ‘265 Patent. In May 2009, Dr. Reddy’s signed a consent judgment in favor of Sanofi and BMS conceding the validity and infringement of the ‘265 Patent. As previously reported, theMarch 2010, Gilead filed two patent infringement actions against Teva in the SDNY relating to six Orange Book-listed patents for Atripla*and Cobalt were stayed pendingin April 2013, Gilead and Teva reached an agreement in principle to settle the lawsuit on the patents covering tenofovir disoproxil fumarate contained in the Atripla* and Truvada* products.

Baraclude
In August 2010, Teva filed an aNDA to manufacture and market generic versions of Baraclude. The Company received a Paragraph IV certification letter from Teva challenging the one Orange Book-listed patent for Baraclude, U.S. Patent No. 5,206,244 (the ‘244 Patent), covering the entecavir molecule. In September 2010, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware (Delaware District Court) against Teva for infringement. In February 2013, the Delaware District Court ruled against the Company and invalidated the ‘244 Patent. The Company has appealed the Delaware District Court’s decision and a decision is expected during the first-half of 2014. In October 2013, Teva's aNDA for its generic version of entecavir was tentatively approved by the FDA. The Company is prepared to take legal action in the event that Teva chooses to launch its generic product prior to the resolution of the Apotex litigation,

105



Company's appeal. There could be a rapid and significant negative impact on U.S. net product sales of Baraclude beginning in early 2014. Net product sales of Baraclude in the parties to thoseU.S. were $289 million in 2013.
Baraclude — South Korea

In 2013, Daewoong Pharmaceutical Co. Ltd. and Hanmi Pharmaceuticals Co., Ltd. initiated separate invalidity actions agreed to be bound byin the Korean Intellectual Property Office (KIPO) against Korean Patent No. 160,523 (the ‘523 patent).  The ‘523 patent expires in October 2015 and is the Korean equivalent of the ‘244 Patent, the U.S. composition of matter patent.  The invalidity actions are pending and a decision is expected in the first half of 2014.  Although the outcome of the litigation against Apotex. Consequently, on July 12, 2007, the District Court entered judgments against Cobalt and Teva and permanently enjoined Cobalt and Teva from engaging in any activity that infringes the ‘265 Patent until after the patent expires. Cobalt and Teva each filed an appeal. In July 2009, the Circuit Court issued a mandate in the Teva appeal binding Teva to the decision in the Apotex litigation. In August 2009, Cobalt consented to entry of judgment in its appeal agreeing to be bound by Circuit Court’s decision in the Apotex litigation. The lawsuit against Watson, filed in October 2004, was based on U.S. Patent No. 6,429,210 (the ‘210 Patent), which discloses and claims a particular crystalline or polymorph form of the hydrogen sulfate salt of clopidogrel, which is marketed as PLAVIX*. In December 2005, the Court permitted

99


Watson to pursue its declaratory judgment counterclaim with respect to U.S. Patent No. 6,504,030. In January 2006, the Court approved the parties’ stipulation to stay this case pending the outcome of the trial in the Apotex matter. On May 1, 2009, BMS and Watson entered into a stipulation to dismiss the case. In April 2007, Pharmastar filed a request forinter partes reexamination of the ‘210 Patent at the PTO. The PTO granted this request in July of 2007 and in July 2009, the PTO vacated the reexamination proceeding. The lawsuit against Sun, filed on July 11, 2008, was based on infringement of the ‘265 Patent and the ‘210 Patent. With respect to the ‘265 Patent, Sun agreed to be bound by the outcome of the Apotex litigation. With respect to the ‘210 Patent, the parties have settled and in December 2011, the case was dismissed.

Additionally, on November 13, 2008, Apotex filed a lawsuit in New Jersey Superior Court entitled,Apotex Inc., et al. v. sanofi-aventis, et al., seeking payment of $60 million, plus interest, related to the break-up of the March 2006 proposed settlement agreement. In April 2011, the New Jersey Superior Court granted the Companies’ cross-motion for summary judgment motion and denied Apotex’s motion for summary judgment. Apotex has appealed these decisions. It is not possibleactions are unclear at this time, there is a risk that a decision invalidating the patent will encourage generic companies to determine the outcomelaunch generic versions of any appeal from the New Jersey Superior Court’s decisions.

In January 2011, Apotex filed a lawsuitBaraclude prior to October 2015. Net product sales of Baraclude in Florida State Court, Broward County, alleging breach of contract relating to the parties’ May 2006 proposed settlement agreement. Discovery is ongoing.

South Korea were $158 million in 2013.

PLAVIX* Litigation – InternationalPlavix*

PLAVIX* – Australia

As previously disclosed, Sanofi was notified that, in August 2007, GenRx Proprietary Limited (GenRx) obtained regulatory approval of an application for clopidogrel bisulfate 75mg tablets in Australia. GenRx, formerly a subsidiary of Apotex Inc. (Apotex), has since changed its name to Apotex. In August 2007, Apotex filed an application in the Federal Court of Australia (the Federal Court) seeking revocation of Sanofi’s Australian Patent No. 597784 (Case No. NSD 1639 of 2007). Sanofi filed counterclaims of infringement and sought an injunction. On September 21, 2007, the Australian courtFederal Court granted Sanofi’s injunction. A subsidiary of the Company was subsequently added as a party to the proceedings. In February 2008, a second company, Spirit Pharmaceuticals Pty. Ltd., also filed a revocation suit against the same patent. This case was consolidated with the Apotex case and a trial occurred in April 2008. On August 12, 2008, the Federal Court of Australia held that claims of Patent No. 597784 covering clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate salts were valid. The Federal Court also held that the process claims, pharmaceutical composition claims, and claim directed to clopidogrel and its pharmaceutically acceptable salts were invalid. The Company and Sanofi filed notices of appeal in the Full Court of the Federal Court of Australia (Full Court) appealing the holding of invalidity of the claim covering clopidogrel and its pharmaceutically acceptable salts, process claims, and pharmaceutical composition claims which have stayed the Federal Court’s ruling. Apotex filed a notice of appeal appealing the holding of validity of the clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate claims. A hearing on the appeals occurred in February 2009. On September 29, 2009, the Full Federal Court of Australia held all of the claims of Patent No. 597784 invalid. In November 2009, the Company and Sanofi applied to the High Court of Australia (High Court) for special leave to appeal the judgment of the Full Court. In March 2010, the High Court denied the Company and Sanofi’s request to hear the appeal of the Full Court decision. The case has been remanded to the Federal Court for further proceedings related to damages.damages sought by Apotex.  The Australian government has intervened in this matter and is also seeking damages for alleged losses experienced during the period when the injunction was in place. It is expectednot possible at this time to predict the amountoutcome of damages will not be material tothe Australian government’s claim or its impact on the Company.


PLAVIX* – EUPlavix*

As previously disclosed, in 2007, YES Pharmaceutical Development Services GmbH (YES Pharmaceutical) filed an application for marketing authorization in Germany for an alternate salt form of clopidogrel. This application relied on data from studies that were originally conducted by Sanofi and BMS for PLAVIX* and were still the subject of data protection in the EU. Sanofi and BMS have filed an action against YES Pharmaceutical and its partners in the administrative court in Cologne objecting to the marketing authorization. This matter is currently pending, although these specific marketing authorizations now have been withdrawn from the market.

PLAVIX* – Canada (Apotex, Inc.)

On April 22, 2009, Apotex filed an impeachment action against Sanofi in the Federal Court of Canada alleging that Sanofi’s Canadian Patent No. 1,336,777 (the ‘777 Patent) is invalid. The ‘777 Patent covers clopidogrel bisulfate and was the patent at issue in the prohibition action in Canada previously disclosed in which the Canadian Federal Court of Ottawa rejected Apotex’s challenge to the ‘777 Patent, held that the asserted claims are novel, not obvious and infringed, and granted Sanofi’s application for an order of prohibition against the Minister of Health and Apotex, precluding approval of Apotex’s Abbreviated New Drug Submission until the patent expires in August 2012, which decision was affirmed on appeal by both the Federal Court of Appeal and the Supreme Court of Canada. On June 8, 2009, Sanofi filed its defense to the impeachment action and filed a suit against Apotex for infringement of the ‘777 Patent. The trial was completed in June 2011 and in December 2011, the Federal Court of Canada issued a decision that the ‘777 Patent is invalid. Sanofi is appealing thisIn July 2013, the Federal Court of Appeal reversed the Federal Court of Canada's decision though generic companies have entered the market.

100


OTHER INTELLECTUAL PROPERTY LITIGATION

ABILIFY*

As previously disclosed, Otsuka has filed patent infringement actions against Teva, Barr Pharmaceuticals, Inc. (Barr), Sandoz Inc. (Sandoz), Synthon Laboratories, Inc (Synthon), Sun Pharmaceuticals (Sun), Zydus Pharmaceuticals USA, Inc. (Zydus), and Apotex relating to U.S. Patent No. 5,006,528, (‘528 Patent) which covers aripiprazole and expires in April 2015 (including the additional six-month pediatric exclusivity period). Aripiprazole is comarketed by the Company and Otsuka in the U.S. as ABILIFY*. A non-jury trial in the U.S. District Court for the District of New Jersey (NJ District Court) against Teva/Barr and Apotex was completed in August 2010. In November 2010, the NJ District Court upheld the validity and enforceability of the ‘528 Patent, maintaining the main patent protection for ABILIFY* in the U.S. until April 2015.'777 Patent. The NJ District Court also ruled that the defendants’ generic aripiprazole product infringed the ‘528 Patent and permanently enjoined them from engaging in any activity that infringes the ‘528 Patent, including marketing their generic product in the U.S. until after the patent (including the six-month pediatric extension) expires. Sandoz, Synthon, Sun and Zydus are also bound by the NJ District Court’s decision. In December 2010, Teva/Barr and Apotex appealed this decisioncase was remanded to the U.S.Federal Court of AppealsCanada to consider the damages owed to the Company by Apotex for the Federal Circuit. Oral argument was held in February 2012.

It is not possible at this time to determine the outcome of any appeal of the NJ District Court’s decision. If Otsuka were not to prevail in an appeal, generic competition would likely result in substantial decreases in the sales of ABILIFY* in the U.S., which would have a material adverse effect on the results of operations and cash flows and could be material to financial condition.

ATRIPLA*

In April 2009, Teva filed an aNDA to manufacture and market a generic version of ATRIPLA*. ATRIPLA* is a single tablet three-drug regimen combining the Company’s SUSTIVA and Gilead’s TRUVADA*. As of this time, the Company’s U.S. patent rights covering SUSTIVA’s composition of matter and method of use have not been challenged. Teva sent Gilead a Paragraph IV certification letter challenging two of the fifteen Orange Book listed patents for ATRIPLA*. ATRIPLA* is the product of a joint venture between the Company and Gilead. In May 2009, Gilead filed a patent infringement action against Teva in the U.S. District Court for the Southern District of New York (SDNY). In January 2010, the Company received a notice that Teva has amended its aNDA and is challenging eight additional Orange Book listed patents for ATRIPLA*. In March 2010, the Company and Merck, Sharp & Dohme Corp. filed a patent infringement action against Teva also in the SDNY relating to two U.S. Patents which claim crystalline or polymorph forms of efavirenz. In March 2010, Gilead filed two patent infringement actions against Teva in the SDNY relating to six Orange Book listed patents for ATRIPLA*. Discovery in these matters is ongoing. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

BARACLUDE

In August 2010, Teva filed an aNDA to manufacture and market generic versions of BARACLUDE. The Company received a Paragraph IV certification letter from Teva challenging the one Orange Book listed patent for BARACLUDE, U.S. Patent No. 5,206,244. In September 2010, the Company filed a patent infringement lawsuit in the Delaware District Court against Teva for infringement of the listed patent covering BARACLUDE, which triggered an automatic 30-month stay of approval of Teva’s aNDA. Discovery in this matter is ongoing. It is not possible at this time to reasonably assess the outcome of this lawsuit or its impact on the Company. A trial is currently scheduled for October 2012.

SPRYCEL

‘777 patent. In September 2010,2013, Apotex filed an aNDAsought leave to manufacture and market generic versions of SPRYCEL. The Company received a Paragraph IV certification letter from Apotex challengingappeal the four Orange Book listed patents for SPRYCEL, including the composition of matter patent. In November 2010, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Apotex for infringementdecision of the four Orange Book listed patents covering SPRYCEL, which triggered an automatic 30-month stayFederal Court of approvalAppeal to the Supreme Court of Apotex’s aNDA. In October 2011,Canada and in February 2014, the Company received a Paragraph IV notice letter from Apotex informingSupreme Court of Canada decided to hear the Company that it is seeking approval of generic versions of the 80 mg and 140 mg dosage strengths of SPRYCEL and challenging the same four Orange Book listed patents. In November 2011, BMS filed a patent infringement suit against Apotex on the 80 mg and 140 mg dosage strengths in the New Jersey District Court. This case has been consolidated with the suit filed in November 2010. Discovery in this matter is ongoing. It is not possible at this time to reasonably assess the outcome of this lawsuit or its impact on the Company.

SUSTIVA – EU

In January 2012, Teva obtained a European marketing authorization for Efavirenz Teva 600 mg tablets. In February 2012, the Company and Merck Sharp & Dohme (“Merck”) filed lawsuits and requests for injunctions against Teva in the Netherlands, Germany and the U.K. for infringement of Merck’s European Patent No. 0582455 and Supplementary Protection Certificates expiring in November 2013. It is not possible at this time to reasonably assess the outcome of these lawsuits or their impact on the Company.

101


case.

GENERAL COMMERCIAL LITIGATION
Remaining Apotex Matters Related to

Clayworth LitigationPlavix

*

As previously disclosed, in November 2008, Apotex filed a lawsuit in New Jersey Superior Court against the Company together withand Sanofi, seeking payment of $60 million, plus interest calculated at the rate of 1% per month, until paid, related to the break-up of a number of other pharmaceutical manufacturers, was named as a defendant in an action filed in California StateMarch 2006 proposed settlement agreement relating to the-then pending Plavix* patent litigation against Apotex. In April 2011, the New Jersey Superior Court in Oakland, James Clayworth et al. v. Bristol-Myers Squibb Company, et al., alleging that the defendants conspired to fix the prices of pharmaceuticals by agreeing to charge more for their drugs in the U.S. than they charge outside the U.S., particularly Canada, and asserting claims under California’s Cartwright Act and unfair competition law. The plaintiffs sought trebled monetary damages, injunctive relief and other relief. In December 2006, the Court granted the CompanyCompany’s cross-motion for summary judgment motion and the other manufacturers’denied Apotex’s motion for summary judgment based onjudgment. Apotex appealed these decisions and the pass-on defense, and judgment was then entered in favor of defendants. In July 2008, judgment in favor of defendants was affirmed by the California Court of Appeals. In July 2010, the California Supreme CourtNew Jersey Appellate Division reversed the Courtgrant of Appeal’s judgment andsummary judgments remanding the matter was remandedcase back to the Superior Court for furtheradditional proceedings. The parties have now agreed to resolve this matter through binding arbitration, which is currently scheduled for March 2014. The resolution of this matter is not expected to have a material impact on the Company.

In January 2011, Apotex filed a lawsuit in Florida State Court, Broward County, alleging breach of contract relating to the May 2006 proposed settlement agreement with Apotex relating to the then pending Plavix* patent litigation. A trial was held in March 2011, the defendants’ motion for summary judgment2013 and a jury verdict was granted and judgment was entereddelivered in favor of the defendants. Plaintiffs haveCompany. Apotex has appealed this decision.


106



PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION AND INVESTIGATIONS
Abilify*

ABILIFY* Federal Subpoena

In January 2012, the Company received a subpoena from the United States Attorney’s Office for the Southern District of New YorkSDNY requesting information related to, among other things, the sales and marketing of ABILIFY*Abilify*. It is not possible at this time to assess the outcome of this matter or its potential impact on the Company.

ABILIFY* Abilify*State Attorneys General Investigation

In March 2009, the Company received a letter from the Delaware Attorney General’s Office advising of a multi-state coalition investigating whether certain ABILIFY*Abilify* marketing practices violated those respective states’ consumer protection statutes. The Company has entered into a tolling agreement with the states. It is not possible at this time to reasonably assess the outcome of this investigation or its potential impact on the Company.

Abilify*Co-Pay Assistance Litigation
In March 2012, the Company and its partner Otsuka were named as co-defendants in a putative class action lawsuit filed by union health and welfare funds in the SDNY. Plaintiffs are challenging the legality of the Abilify* co-pay assistance program under the Federal Antitrust and the Racketeer Influenced and Corrupt Organizations (RICO) laws, and seeking damages. The Company and Otsuka filed a motion to dismiss the complaint. In June 2013, the Court granted the Company's motion, dismissing all claims but allowing plaintiffs to re-plead the RICO claim. In August 2013, the plaintiffs moved for leave to file an amended complaint, which motion the Court granted in part. One claim alleging tortious interference with contract remains outstanding against the Company. It is not possible at this time to reasonably assess the outcome of this litigation or its potential impact on the Company, although at this time, the resolution of this matter is not expected to have a material impact on the Company.
AWP Litigation

As previously disclosed, the Company, together with a number of other pharmaceutical manufacturers, has been a defendant in a number of private class actions as well as suits brought by the attorneys general of various states. In these actions, plaintiffs allege that defendants caused the Average Wholesale Prices (AWPs) of their products to be inflated, thereby injuring government programs, entities and persons who reimbursed prescription drugs based on AWPs. The Company isremains a defendant in fourtwo state attorneys general suits pending in state courts around the country.in Pennsylvania and Wisconsin. Beginning in August 2010, the Company was the defendant in a trial in the Commonwealth Court of Pennsylvania (Commonwealth Court), brought by the Commonwealth of Pennsylvania. In September 2010, the jury issued a verdict for the Company, finding that the Company was not liable for fraudulent or negligent misrepresentation; however, the Commonwealth Court Judgejudge issued a decision on a Pennsylvania consumer protection claim that did not go to the jury, finding the Company liable for $28 million and enjoining the Company from contributing to the provision of inflated AWPs. The Company has moved to vacate the decision and the Commonwealth has moved for a judgment notwithstanding the verdict, which the Court denied. The Company and the Commonwealth have appealed the decision to the Pennsylvania Supreme Court.

Court and oral argument took place in May 2013.

Qui Tam Litigation

In March 2011, the Company was served with an unsealed qui tam complaint filed by three former sales representatives in California Superior Court, County of Los Angeles. The California Department of Insurance has elected to intervene in the lawsuit. The complaint alleges the Company paid kickbacks to California providers and pharmacies in violation of California Insurance Frauds Prevention Act, Cal. Ins. Code § 1871.7. It is not possible at this time to reasonably assess the outcome of this lawsuit or its impact on the Company.

PRODUCT LIABILITY LITIGATION

The Company is a party to various product liability lawsuits. As previously disclosed, in addition to lawsuits, the Company also faces unfiled claims involving its products.

Plavix*
PLAVIX*

As previously disclosed, the Company and certain affiliates of Sanofi are defendants in a number of individual lawsuits in various federalstate and statefederal courts claiming personal injury damage allegedly sustained after using PLAVIX*Plavix*. Currently, over 2505,700 claims involving injury plaintiffs as well as claims by spouses and/or other beneficiaries, are filed primarily in state and federal courts in various states including California, Illinois, New Jersey, Delaware and New York. In February 2013, the Judicial Panel on Multidistrict Litigation granted the Company and Sanofi’s motion to establish a multidistrict litigation to coordinate Federal courtspretrial proceedings in Plavix* product liability and related cases in New Jersey Illinois, New York and Pennsylvania. The Company has also executed a tolling agreement with respect to unfiled claims by potential additional plaintiffs.Federal Court. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.

102


107



Reglan*
Reglan

The Company is one of a number of defendants in numerous lawsuits, on behalf of approximately 2,5003,000 plaintiffs, including injury plaintiffs claiming personal injury allegedly sustained after using ReglanReglan* or another brand of the generic drug metoclopramide, a product indicated for gastroesophageal reflux and certain other gastrointestinal disorders.disorders, as well as claims by spouses and/or other beneficiaries. The Company, through its generic subsidiary, Apothecon, Inc., distributed metoclopramide tablets manufactured by another party between 1996 and 2000. It is not possible at this time to reasonably assess the outcome of these lawsuits. The resolution of these pending lawsuits, or the potentialhowever, is not expected to have a material impact on the Company.

Hormone Replacement Therapy

The Company is one of a number of defendants in a mass-tort litigation in which plaintiffs allege, among other things, that various hormone therapy products, including hormone therapy products formerly manufactured by the Company (ESTRACE*(Estrace*, Estradiol, DELESTROGEN*Delestrogen* and OVCON*Ovcon*) cause breast cancer, stroke, blood clots, cardiac and other injuries in women, that the defendants were aware of these risks and failed to warn consumers. The Company has agreed to resolve the claims of approximately 400 plaintiffs. As of December 31, 2011, theplaintiffs and has also reached a settlement in principle to resolve an additional 29 claims. The Company remains a defendant in approximately 39three actively pending lawsuits in federal and state courts throughout the U.S. All of the Company’s hormone therapy products were sold to other companies between January 2000 and August 2001.

The resolution of these remaining lawsuits is not expected to have a material impact on the Company.

Byetta*
Amylin, a former subsidiary of the Company, and Lilly are co-defendants in product liability litigation related to Byetta*. To date, there are over 280 separate lawsuits pending on behalf of approximately 1,100 plaintiffs, which include injury plaintiffs as well as claims by spouses and/or other beneficiaries, in various courts in the U.S. The Company has agreed in principle to resolve over 350 of these claims. The majority of these cases have been brought by individuals who allege personal injury sustained after using Byetta*, primarily pancreatic cancer and pancreatitis, and, in some cases, claiming alleged wrongful death. The majority of cases are pending in Federal Court in San Diego in a recently established multidistrict litigation, with the next largest contingent of cases pending in a coordinated proceeding in California Superior Court in Los Angeles. Amylin and Lilly are currently scheduled for trial in a single-plaintiff case in February 2014 in California Superior Court in Los Angeles. Amylin has product liability insurance covering a substantial number of claims involving Byetta* and any additional liability to Amylin with respect to Byetta* is expected to be shared between the Company and AstraZeneca. It is not possible to reasonably predict the outcome of any lawsuit, claim or proceeding or the potential impact on the Company. 
BMS-986094

In August 2012, the Company announced that it had discontinued development of BMS-986094, an investigational compound which was being tested in clinical trials to treat the hepatitis C virus infection due to the emergence of a serious safety issue. To date, the Company is aware of ten lawsuits that have been filed against the Company by plaintiffs in Texas, Oklahoma and Virginia, most of which were removed to Federal Court, alleging that they participated in clinical trials of BMS-986094 and suffered injuries as a result thereof. The Company has settled the vast majority of known claims, including eight of the filed claims. One claim filed in state court remains outstanding. The resolution of the remaining lawsuits and any other potential future lawsuits is not expected to have a material impact on the Company.
ENVIRONMENTAL PROCEEDINGS

As previously reported, the Company is a party to several environmental proceedings and other matters, and is responsible under various state, federal and foreign laws, including the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), for certain costs of investigating and/or remediating contamination resulting from past industrial activity at the Company’s current or former sites or at waste disposal or reprocessing facilities operated by third-parties.

CERCLA Matters

With respect to CERCLA matters for which the Company is responsible under various state, federal and foreign laws, the Company typically estimates potential costs based on information obtained from the U.S. Environmental Protection Agency, or counterpart state or foreign agency and/or studies prepared by independent consultants, including the total estimated costs for the site and the expected cost-sharing, if any, with other “potentially responsible parties,” and the Company accrues liabilities when they are probable and reasonably estimable. The Company estimated its share of future costs for these sites to be $69$66 million at December 31, 2011,2013, which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties).


108



New Brunswick Facility – Facility—Environmental & Personal Injury Lawsuits

Since May 2008, over 250 lawsuits have been filed against the Company in New Jersey Superior Court by or on behalf of current and former residents of New Brunswick, NJNew Jersey who live or have lived adjacent to the Company’s New Brunswick facility. The complaints either allege various personal injuries damages resulting from alleged soil and groundwaterenvironmental contamination on their property stemming from historical operations at the New Brunswick facility and historical operations at that site, or are claims for medical monitoring. A portion of these complaints also assert claims for alleged property damage. In October 2008, the New Jersey Supreme Court granted Mass Tort status to these cases and transferred them to the New Jersey Superior Court in Atlantic County for centralized case management purposes. The Company intends to defend itself vigorously in this litigation. Discovery is ongoing. InSince October 2011, 50over 150 additional cases werehave been filed in New Jersey Superior Court and removed by the Company to United States District Court, District of New Jersey. Accordingly, there are in excess of 400 cases between the state and federal court in Trenton, NJ. Plaintiffs have movedactions. Discovery is ongoing. The first trial is currently scheduled to remand the cases tocommence in state court which thein August 2014. The Company has opposed.intends to defend itself vigorously in this litigation. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.

North Brunswick Township Board of Education

As previously disclosed, in October 2003, the Company was contacted by counsel representing the North Brunswick, NJ Board of Education (BOE) regarding a site where waste materials from E.R. Squibb and Sons may have been disposed from the 1940’s through the 1960’s. Fill material containing industrial waste and heavy metals in excess of residential standards was discovered during an expansion project at the North Brunswick Township High School, as well as at a number of neighboring residential properties and adjacent public park areas. In January 2004, the New Jersey Department of Environmental Protection (NJDEP) sent the Company and others an information request letter about possible waste disposal at the site, to which the Company responded in March 2004. The BOE and the Township, as the current owners of the school property and the park, are conducting and jointly financing soil remediation work and ground water investigation work under a work plan approved by the NJDEP, and have asked the Company to contribute to the cost. The Company is actively monitoring the clean-up project, including its costs. To date, neither the school board

103


nor the Township has asserted any claim against the Company. Instead, the Company and the local entities have negotiated an agreement to attempt to resolve the matter by informal means, and avoid litigation. A central component of the agreement is the provision by the Company of interim funding to help defray cleanup costs and assure the work is not interrupted. The Company transmitted interim funding payments in December 2007 and November 2009. The parties commenced mediation in late 2008; however, those efforts were not successful and the parties moved to a binding allocation process. The parties are expected to conduct fact and expert discovery, followed by formal evidentiary hearings and written argument. Hearings likely will beare scheduled for mid-to-late 2012.to commence in March 2014. In addition, in September 2009, the Township and BOE filed suits against several other parties alleged to have contributed waste materials to the site. The Company does not currently believe that it is responsible for any additional amounts beyond the two interim payments totaling $4 million already transmitted. Any additional possible loss is not expected to be material.

OTHER PROCEEDINGS

Italy Investigation

In July 2011, the Public Prosecutor in Florence, Italy (“Italian Prosecutor”) initiated a criminal investigation against the Company’s subsidiary in Italy (“BMS Italy”). The allegations against the Company relate to alleged activities of a former employee who left the Company in the 1990s. The Italian Prosecutor has requested as an interim measure that a judicial administrator be appointed to temporarily run the operations of BMS Italy. This request is pending before the Florence Court. It is not possible at this time to assess the outcome of this investigation or its potential impact on the Company.

SEC Germany Investigation

As previously disclosed, in

In October 2004,2006, the SEC notifiedinformed the Company that it was conducting an informalhad begun a formal inquiry into the activities of certain of the Company’s German pharmaceutical subsidiaries and its employees and/or agents. In October 2006, the SEC informed the Company that its inquiry had become formal.  The SEC’s inquiry encompasses matters formerly under investigation by the German prosecutor in Munich, Germany, which have since been resolved. The Company understands the inquiry concerns potential violations of the Foreign Corrupt Practices Act.Act (FCPA). The Company has been cooperating with the SEC.
FCPA Investigation
In March 2012, the Company received a subpoena from the SEC. The subpoena, issued in connection with an investigation under the FCPA, primarily relates to sales and marketing practices in various countries. The Company is cooperating with the SEC.

government in its investigation of these matters.



109



Note 23. SUBSEQUENT EVENT

On February 13, 2012, BMS completed its acquisition of 100% of the outstanding shares of Inhibitex, Inc. (Inhibitex), a clinical-stage biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases, for an aggregate purchase price of approximately $2.5 billion. Acquisition related costs are expected to approximate $20 million and will be included in other expense. BMS obtained Inhibitex’s lead asset, INX-189, an oral nucleotide polymerase (NS5B) inhibitor in Phase II development for the treatment of chronic hepatitis C infections as well as a few other programs in various stages of development. Although the preliminary purchase price allocation is currently in process; most of the purchase price is expected to be allocated to goodwill and INX-189.

104


Note 24. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)

Dollars in Millions, except per share data  First Quarter   Second Quarter   Third Quarter   Fourth Quarter   Year 

2011

                    

Net Sales

  $  5,011   $  5,434   $  5,345   $  5,454   $  21,244 

Gross Margin

   3,668    3,953    3,938    4,087    15,646 

Net Earnings

   1,367    1,307    1,355    1,231    5,260 

Less Net Earnings Attributable to Noncontrolling Interest

   381    405    386    379    1,551 

Net Earnings Attributable to BMS

   986    902    969    852    3,709 

EPS - Basic(1)

  $0.58   $0.53   $0.57   $0.50   $2.18 

EPS - Diluted(1)

  $0.57   $0.52   $0.56   $0.50   $2.16 

Dividends declared per common share

  $0.33   $0.33   $0.33   $0.34   $1.33 

Cash and cash equivalents

  $3,405   $3,665   $4,471   $5,776   $5,776 

Marketable securities(2)

   6,453    6,739    6,541    5,866    5,866 
Dollars in Millions, except per share data  First Quarter   Second Quarter   Third Quarter   Fourth Quarter   Year 

2010

                    

Net Sales

  $  4,807   $  4,768   $  4,798   $  5,111   $  19,484 

Gross Margin

   3,501    3,491    3,518    3,697    14,207 

Net Earnings

   1,101    1,268    1,302    842    4,513 

Less Net Earnings Attributable to Noncontrolling Interest

   358    341    353    359    1,411 

Net Earnings Attributable to BMS

   743    927    949    483    3,102 

EPS - Basic(1)

  $0.43   $0.54   $0.55   $0.28   $1.80 

EPS - Diluted(1)

  $0.43   $0.53   $0.55   $0.28   $1.79 

Dividends declared per common share

  $0.32   $0.32   $0.32   $0.33   $1.29 

Cash and cash equivalents

  $5,135   $5,918   $7,581   $5,033   $5,033 

Marketable securities(2)

   4,638    4,331    3,340    4,949    4,949 

Dollars in Millions, except per share data First Quarter Second Quarter Third Quarter Fourth Quarter Year
2013          
Total Revenues $3,831
 $4,048
 $4,065
 $4,441
 $16,385
Gross Margin 2,768
 2,940
 2,890
 3,168
 11,766
Net Earnings 623
 530
 692
 735
 2,580
Net Earnings/(Loss) Attributable to:          
Noncontrolling Interest 14
 (6) 
 9
 17
BMS 609
 536
 692
 726
 2,563
           
Earnings per Share - Basic(1)
 $0.37
 $0.33
 $0.42
 $0.44
 $1.56
Earnings per Share - Diluted(1)
 0.37
 0.32
 0.42
 0.44
 1.54
           
Cash dividends declared per common share $0.35
 $0.35
 $0.35
 $0.36
 $1.41
           
Cash and cash equivalents $1,355
 $1,821
 $1,771
 $3,586
 $3,586
Marketable securities(2)
 4,420
 4,201
 4,574
 4,686
 4,686
Total Assets 35,958
 36,252
 36,804
 38,592
 38,592
Long-term debt(3)
 7,180
 7,122
 6,562
 7,981
 7,981
Equity 13,699
 14,373
 14,714
 15,236
 15,236
           
Dollars in Millions, except per share data First Quarter Second Quarter Third Quarter Fourth Quarter Year
2012          
Total Revenues $5,251
 $4,443
 $3,736
 $4,191
 $17,621
Gross Margin 3,948
 3,198
 2,749
 3,116
 13,011
Net Earnings/(Loss) 1,482
 808
 (713) 924
 2,501
Net Earnings/(Loss) Attributable to:          
Noncontrolling Interest 381
 163
 (2) (1) 541
BMS 1,101
 645
 (711) 925
 1,960
           
Earnings/(Loss) per Share - Basic(1)
 $0.65
 $0.38
 $(0.43) $0.56
 $1.17
Earnings/(Loss) per Share - Diluted(1)
 0.64
 0.38
 (0.43) 0.56
 1.16
           
Cash dividends declared per common share $0.34
 $0.34
 $0.34
 $0.35
 $1.37
           
Cash and cash equivalents $2,307
 $2,801
 $1,503
 $1,656
 $1,656
Marketable securities(2)
 6,307
 5,968
 5,125
 4,696
 4,696
Total Assets 32,408
 31,667
 36,044
 35,897
 35,897
Long-term debt(3)
 5,270
 5,209
 7,227
 7,232
 7,232
Equity 16,246
 15,812
 13,900
 13,638
 13,638

(1)Earnings per share for the quarters may not add to the amounts for the year, as each period is computed on a discrete basis.
(2)Marketable securities includes current and non-current assets.

105

(3)Also includes the current portion of long-term debt.

110



The following specified items affected the comparability of results in 20112013 and 2010:

2012:

20112013

Dollars in Millions  First Quarter  Second Quarter  Third Quarter  Fourth Quarter  Year 

Provision for restructuring

  $44  $40  $8  $24  $116 

Accelerated depreciation, asset impairment and other shutdown costs

   23   18   19   15   75 

Pension curtailment and settlement charges

               13   13 

Process standardization implementation costs

   4   10   5   10   29 

Gain on sale of product lines, businesses and assets

           (12      (12

Litigation charges/(recoveries)

   (102          80   (22

Upfront, milestone and other licensing payments, net

   88   50   69   (20  187 

IPRD impairment

   15       13       28 

Product liability charges

   26       10   (5  31 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total

   98   118   112   117   445 

Income taxes on items above

   (28  (34  (37  (37  (136

Specified tax benefit*

   (56  (15      (26  (97
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Decrease to Net Earnings

  $14  $69  $75  $54  $212 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Dollars in Millions 
First
Quarter
 
Second
Quarter
 
Third
Quarter
 
Fourth
Quarter
 Year
Accelerated depreciation, asset impairment and other shutdown costs $
 $
 $
 $36
 $36
Amortization of acquired Amylin intangible assets 138
 137
 137
 137
 549
Amortization of Amylin alliance proceeds (67) (67) (68) (71) (273)
Amortization of Amylin inventory adjustment 14
 
 
 
 14
Cost of products sold 85
 70
 69
 102
 326
           
Marketing, selling and administrative(a)
 1
 1
 4
 10
 16
           
Research and development(b)
 
 
 
 16
 16
           
Provision for restructuring 33
 173
 6
 14
 226
Pension settlements 
 99
 37
 25
 161
Acquisition and alliance related items 
 (10) 
 
 (10)
Litigation charges/(recoveries) 
 (23) 
 
 (23)
Upfront, milestone and other licensing receipts (14) 


 
 (14)
Other (income)/expense 19
 239
 43
 39
 340
           
Increase to pretax income 105
 310
 116
 167
 698
Income tax on items above (35) (116) (40) (51) (242)
Increase to net earnings $70
 $194
 $76
 $116
 $456
*
Relates to releases of tax reserves that were specified
(a)Specified items in prior periods.marketing, selling and administrative are process standardization implementation costs.
(b)Specified items in research and development are upfront, milestone and other licensing payments.


111



20102012

Dollars in Millions  First Quarter  Second Quarter  Third Quarter  Fourth Quarter  Year 

Provision for restructuring

  $11  $24  $15  $63  $113 

Impairment and loss on sale of manufacturing operations

   200   15   10   11   236 

Accelerated depreciation, asset impairment and other shutdown costs

   31   27   27   28   113 

Pension curtailment and settlement charges

       5   3   10   18 

Process standardization implementation costs

   13   6   8   8   35 

Litigation charges/(recoveries)

           22   (41  (19

Upfront, milestone and other licensing payments

   55   17       60   132 

IPRD impairment

               10   10 

Acquisition related items

               10   10 

Product liability charges

           13   4   17 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total

   310   94   98   163   665 

Income taxes on items above

   (86  (18  (30  (46  (180

Out-of-period tax adjustment

       (59          (59

Specified tax charge*

               207   207 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Decrease to Net Earnings

  $224  $17  $68  $324  $633 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Dollars in Millions 
First
Quarter
 
Second
Quarter
 
Third
Quarter
 
Fourth
Quarter
 Year
Accelerated depreciation, asset impairment and other shutdown costs $
 $147
 $
 $
 $147
Amortization of acquired Amylin intangible assets 
 
 91
 138
 229
Amortization of Amylin alliance proceeds 
 
 (46) (68) (114)
Amortization of Amylin inventory adjustment 
 
 9
 14
 23
Cost of products sold 
 147
 54
 84
 285
           
Stock compensation from accelerated vesting of Amylin awards 
 
 67
 
 67
Process standardization implementation costs 8
 5
 3
 2
 18
Marketing, selling and administrative 8
 5
 70
 2
 85
           
Stock compensation from accelerated vesting of Amylin awards 
 
 27
 
 27
Upfront, milestone and other licensing payments 
 
 21
 26
 47
IPRD impairment 58
 45
 
 39
 142
Research and development 58
 45
 48
 65
 216
           
Impairment charge for BMS-986094 intangible asset 
 
 1,830
 
 1,830
           
Provision for restructuring 22
 20
 29
 103
 174
Gain on sale of product lines, businesses and assets 
 
 
 (51) (51)
Pension settlements 
 
 
 151
 151
Acquisition and alliance related items 12
 1
 29
 1
 43
Litigation charges/(recoveries) (172) 22
 50
 55
 (45)
Upfront, milestone and other licensing receipts 
 
 
 (10) (10)
Out-licensed intangible asset impairment 38
 
 
 
 38
Loss on debt repurchases 19
 
 8
 
 27
Other (income)/expense (81) 43
 116
 249
 327
           
Increase to pretax income (15) 240
 2,118
 400
 2,743
           
Income tax on items above 8
 (77) (722) (156) (947)
Specified tax benefit(a)
 
 
 
 (392) (392)
Income taxes 8
 (77) (722) (548) (1,339)
Increase/(Decrease) to Net Earnings $(7) $163
 $1,396
 $(148) $1,404
*
Relates
(a)Specified tax benefit relates to a tax charge from additional U.S. taxable income from earnings of foreign subsidiaries previously considered to be permanently reinvested offshore.capital loss deduction.

106


112



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM


To the Board of Directors and Shareholders of

Bristol-Myers Squibb Company


We have audited the accompanying consolidated balance sheets of Bristol-Myers Squibb Company and subsidiaries (the “Company”) as of December 31, 20112013 and 2010,2012, and the related consolidated statements of earnings, comprehensive income, and cash flows for each of the three years in the period ended December 31, 2011.2013. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.


We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.


In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of Bristol-Myers Squibb Company and subsidiaries as of December 31, 20112013 and 2010,2012, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2011,2013, in conformity with accounting principles generally accepted in the United States of America.


We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of December 31, 2011,2013, based on the criteria established inInternal Control—IntegratedControl-Integrated Framework(1992) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated
February 17, 201214, 2014 expressed an unqualified opinion on the Company’s internal control over financial reporting.


/s/ DELOITTE & TOUCHE LLP


Parsippany, New Jersey

February 17, 2012

107

14, 2014



113



Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

None.


Item 9A.CONTROLS AND PROCEDURES


Evaluation of Disclosure Controls and Procedures


As of December 31, 2011,2013, management carried out an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of its disclosure controls and procedures as such term is defined under Exchange Act Rule 13a-15(e). Based on this evaluation, management has concluded that as of December 31, 2011,2013, such disclosure controls and procedures were effective.


Management’s Report on Internal Control Over Financial Reporting


Management is responsible for establishing and maintaining adequate internal control over financial reporting. Under the supervision and with the participation of management, including the chief executive officer and chief financial officer, management assessed the effectiveness of internal control over financial reporting as of December 31, 20112013 based on the framework in “Internal���Internal Control—Integrated Framework” (1992) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that assessment, management has concluded that the Company’s internal control over financial reporting was effective at December 31, 20112013 to provide reasonable assurance regarding the reliability of its financial reporting and the preparation of its financial statements for external purposes in accordance with United States generally accepted accounting principles. Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.


Deloitte & Touche LLP, an independent registered public accounting firm, has audited the Company’s financial statements included in this report on Form 10-K and issued its report on the effectiveness of the Company’s internal control over financial reporting as of December 31, 2011,2013, which is included herein.


Changes in Internal Control Over Financial Reporting


As of December 31, 2013, we have included Amylin Pharmaceuticals, Inc., which was acquired in 2012, in our assessment of the effectiveness of our internal control over financial reporting. There were no changes in the Company’sour internal control over financial reporting duringin the fourth quarter ended December 31, 2011of 2013 that have materially affected, or are reasonably likely to materially affect the Company’s internal control over financial reporting.


Item 9B.OTHER INFORMATION

None.

108


The Compensation and Management Development Committee of our Board of Directors has approved new equity award guidelines for all executives at the company.  Beginning with the equity awards granted in March 2014, the award guidelines will be expressed as a percentage of salary rather than a fixed dollar amount for each grade level.  The Committee approved the new guidelines with respect to our Named Executive Officers at the Committee’s regularly scheduled meeting on February 13, 2014.  The specific amounts will not be determined until awards are granted in March 2014.


114



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM


To the Board of Directors and Shareholders of

Bristol-Myers Squibb Company


We have audited the internal control over financial reporting of Bristol-Myers Squibb Company and subsidiaries (the “Company”) as of December 31, 2011,2013, based on criteria established inInternal Control — IntegratedControl-Integrated Framework(1992) issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.


We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.


A company’s internal control over financial reporting is a process designed by, or under the supervision of, the company’s principal executive and principal financial officers, or persons performing similar functions, and effected by the company’s board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.


Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.


In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of
December 31, 2011,2013, based on the criteria established inInternal Control — IntegratedControl-Integrated Framework(1992) issued by the Committee
of Sponsoring Organizations of the Treadway Commission.


We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States),
the consolidated financial statements of the Company as of and for the year ended December 31, 20112013 of the Company and our report dated
February 17, 201214, 2014 expressed an unqualified opinion on those consolidated financial statements.


/s/ DELOITTE & TOUCHE LLP


Parsippany, New Jersey

February 17, 2012

109

14, 2014



115



PART III


Item 10.DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT.

(a)

Reference is made to the 20122014 Proxy Statement to be filed on or about March 20, 201219, 2014 with respect to the Directors of the Registrant, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.

(b)The information required by Item 10 with respect to the Executive Officers of the Registrant has been included in Part IA of this Form 10-K in reliance on General Instruction G of Form 10-K and Instruction 3 to Item 401(b) of Regulation S-K.


Item 11.EXECUTIVE COMPENSATION.

Reference is made to the 20122014 Proxy Statement to be filed on or about March 20, 201219, 2014 with respect to Executive Compensation, which is incorporated herein by reference and made a part hereof in response to the information required by Item 11.


Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

Reference is made to the 20122014 Proxy Statement to be filed on or about March 20, 201219, 2014 with respect to the security ownership of certain beneficial owners and management, which is incorporated herein by reference and made a part hereof in response to the information required by Item 12.

Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.

Reference is made to the 20122014 Proxy Statement to be filed on or about March 20, 201219, 2014 with respect to certain relationships and related transactions, which is incorporated herein by reference and made a part hereof in response to the information required by Item 13.

Item 14.AUDITOR FEES.

Reference is made to the 20122014 Proxy Statement to be filed on or about March 20, 201219, 2014 with respect to auditor fees, which is incorporated herein by reference and made a part hereof in response to the information required by Item 14.

110


116




PART IV

Item 15.EXHIBITS and FINANCIAL STATEMENT SCHEDULE.

(a)

(a)Page
Number
1.

Consolidated Financial Statements

Consolidated Statements of Earnings

62

Consolidated Statements of Comprehensive Income

63

Consolidated Balance Sheets

64

Consolidated Statements of Cash Flows

65

Notes to Consolidated Financial Statements

66-106

Report of Independent Registered Public Accounting Firm

107

All other schedules not included with this additional financial data are omitted because they are not applicable or the required information is included in the financial statements or notes thereto.

2.

Exhibits Required to be filed by Item 601 of Regulation S-K

113-116

   
  
Page
Number
1.Consolidated Financial Statements 
 
 
 
 
 
 
   
All other schedules not included with this additional financial data are omitted because they are not applicable or the required information is included in the financial statements or notes thereto.
   
2.
The information called for by this Item is incorporated herein by reference to the Exhibit Index in this Form 10-K.

111


117



SIGNATURES

Pursuant to the requirements of Section 13 or 15 (d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

BRISTOL-MYERS SQUIBB COMPANY

(Registrant)

By

 

/s/ LAMBERTO ANDREOTTI

  Lamberto Andreotti
  Chief Executive Officer

Date: February 17, 2012

14, 2014

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

Signature

TitleDate
   

Title

Date

/s/ LAMBERTO ANDREOTTI

LAMBERTO ANDREOTTI Chief Executive Officer and Director February 17, 201214, 2014
(Lamberto Andreotti) (Principal Executive Officer) 

/s/ CHARLES BANCROFT

 
/s/ CHARLES BANCROFT Chief Financial Officer February 17, 201214, 2014
(Charles Bancroft) (Principal Financial Officer) 

/s/ JOSEPH C. CALDARELLA

 
/s/ JOSEPH C. CALDARELLA Senior Vice President and Corporate Controller February 17, 201214, 2014
(Joseph C. Caldarella) (Principal Accounting Officer) 

/s/ JAMES M. CORNELIUS

 
/s/ JAMES M. CORNELIUS Chairman of the Board of Directors February 17, 201214, 2014
(James M. Cornelius)  
 

/s/ LEWIS B. CAMPBELL

 
/s/ LEWIS B. CAMPBELL Director February 17, 201214, 2014
(Lewis B. Campbell)  
 

/s/ LOUIS J. FREEH

 
/s/ LAURIE H. GLIMCHER, M.D. Director February 17, 2012
(Louis J. Freeh)

/s/ LAURIE H. GLIMCHER, M.D.

DirectorFebruary 17, 201214, 2014
(Laurie H. Glimcher, M.D.)  
 

/s/ MICHAEL GROBSTEIN

 
/s/ MICHAEL GROBSTEIN Director February 17, 201214, 2014
(Michael Grobstein)  
 

/s/ ALAN J. LACY

 
/s/ ALAN J. LACY Director February 17, 201214, 2014
(Alan J. Lacy)  
 

/s/ VICKI L. SATO, PH.D.

 
/s/ THOMAS J. LYNCH Director February 17, 201214, 2014
(Thomas J. Lynch)
/s/ DINESH C. PALIWALDirectorFebruary 14, 2014
(Dinesh C. Paliwal)

/s/ VICKI L. SATO, PH.D.DirectorFebruary 14, 2014
(Vicki L. Sato, Ph.D.)  
 

/s/ ELLIOTT SIGAL, M.D., PH.D.

 
/s/ GERALD L. STORCH Director February 17, 2012
(Elliott Sigal, M.D., Ph.D.)

/s/ GERALDL.STORCH

DirectorFebruary 17, 201214, 2014
(Gerald L. Storch)  
 

/s/ TOGO D. WEST, JR.

 
/s/ TOGO D. WEST, JR. Director February 17, 201214, 2014
(Togo D. West, Jr.)  

/s/ R. SANDERS WILLIAMS, M.D.

DirectorFebruary 17, 2012
(R. Sanders Williams, M.D.)

112


118



EXHIBIT INDEX

The Exhibits listed below are identified by numbers corresponding to the Exhibit Table of Item 601 of Regulation S-K. The Exhibits designated by two asterisks (**)the symbol ‡‡ are management contracts or compensatory plans or arrangements required to be filed pursuant to Item 15. An asterisk (*)The symbol ‡ in the Page column indicates that the Exhibit has been previously filed with the Commission and is incorporated herein by reference. Unless otherwise indicated, all Exhibits are part of Commission File Number 1-1136.

Exhibit No.

  

Description

    

Page No.

3a.  

Amended and Restated Certificate of Incorporation of Bristol-Myers Squibb Company (incorporated herein by reference to Exhibit 3a to the Form 10-Q for the quarterly period ended June 30, 2005).

    *
3b.  

Certificate of Correction to the Amended and Restated Certificate of Incorporation, effective as of December 24, 2009 (incorporated herein by reference to Exhibit 3b to the Form 10-K for the fiscal year ended December 31, 2010).

    *
3c.  

Certificate of Amendment to the Amended and Restated Certificate of Incorporation, effective as of May 7, 2010 (incorporated herein by reference to Exhibit 3a to the Form 8-K dated May 4, 2010 and filed on May 10, 2010).

    *
3d.  

Certificate of Amendment to the Amended and Restated Certificate of Incorporation, effective as of May 7, 2010 (incorporated herein by reference to Exhibit 3b to the Form 8-K dated May 4, 2010 and filed on May 10, 2010).

    *
3e.  

Bylaws of Bristol-Myers Squibb Company, as amended as of May 4, 2010December 10, 2013 (incorporated herein by reference to Exhibit 3.1 to the Form 8-K dated May 4, 2010December 10, 2013 and filed on May 10, 2010)December 11, 2013).

    *
4a.  

Letter of Agreement dated March 28, 1984 (incorporated herein by reference to Exhibit 4 to the Form 10-K for the fiscal year ended December 31, 1983).

    *
4b.  

Indenture, dated as of June 1, 1993, between Bristol-Myers Squibb Company and JPMorgan Chase Bank (as successor trustee to The Chase Manhattan Bank (National Association)) (incorporated herein by reference to Exhibit 4.1 to the Form 8-K dated May 27, 1993 and filed on June 3, 1993).

    *
4c.  

Form of 7.15% Debenture due 2023 of Bristol-Myers Squibb Company (incorporated herein by reference to Exhibit 4.2 to the Form 8-K dated May 27, 1993 and filed on June 3, 1993).

    *
4d.  

Form of 6.80% Debenture due 2026 of Bristol-Myers Squibb Company (incorporated herein by reference to Exhibit 4e to the Form 10-K for the fiscal year ended December 31, 1996).

    *
4e.  

Form of 6.875% Debenture due 2097 of Bristol-Myers Squibb Company (incorporated herein by reference to Exhibit 4f to the Form 10-Q for the quarterly period ended September 30, 1997).

    *
4f.  

Third Supplemental Indenture, dated August 18, 2003, between Bristol-Myers Squibb Company and JPMorgan Chase Bank, as Trustee, to the indenture dated June 1, 1993 (incorporated herein by reference to Exhibit 4k to the Form 10-Q for the quarterly period ended September 30, 2003).

*
4g.

Form of 5.25% Senior Note due 2013 (incorporated herein by reference to Exhibit 4o to the Form 10-Q for the quarterly period ended September 30, 2003).

*
4h.

Indenture, dated October 1, 2003, between Bristol-Myers Squibb Company, as Issuer, and JPMorgan Chase Bank, as Trustee (incorporated herein by reference to Exhibit 4q to the Form 10-Q for the quarterly period ended September 30, 2003).

    *
4i. 

4g.Form of Floating Rate Convertible Senior Debenture due 2023 (incorporated herein by reference to Exhibit 4s to the Form 10-Q for the quarterly period ended September 30, 2003).

    *
4j. 

4h.Specimen Certificate of Common Stock (incorporated herein by reference to Exhibit 4s to the Form 10-K for the fiscal year ended December 31, 2003).

    *
4k. 

Specimen Certificate of Convertible Preferred Stock (incorporated herein by reference to Exhibit 4s to the Form 10-K for the fiscal year ended December 31, 2003).

 *
4l.4i.  

Form of Fourth Supplemental Indenture between Bristol-Myers Squibb Company and The Bank of New York, as Trustee, to the indenture dated June 1, 1993 (incorporated herein by reference to Exhibit 4r to the Form 8-K dated November 20, 2006 and filed November 27, 2006).

*
4m.

Form of FifthSixth Supplemental Indenture between Bristol-Myers Squibb Company and The Bank of New York, as Trustee, to the indenture dated June 1, 1993 (incorporated herein by reference to Exhibit 4.1 to the Form 8-K dated May 1, 2008July 26, 2012 and filed on May 7, 2008)July 31, 2012).

    *
4n. 

4j.Form of 5.875% Notes due 2036 (incorporated herein by reference to Exhibit 4s to the Form 8-K dated November 20, 2006 and filed November 27, 2006).

    *
4o. 

4k.Form of 4.375% Notes due 2016 (incorporated herein by reference to Exhibit 4t to the Form 8-K dated November 20, 2006 and filed November 27, 2006).

    *
4p.4l. 

Form of 4.625% Notes due 2021 (incorporated herein by reference to Exhibit 4u to the Form 8-K dated November 20, 2006 and filed November 27, 2006).


 *
4q. 

4m.Form of 5.45% Notes due 2018 (incorporated herein by reference to Exhibit 4.2 to the Form 8-K dated May 1, 2008 and filed on May 7, 2008).

 *
4r. 

4n.
Form of 6.125% Notes due 2038 (incorporated herein by reference to Exhibit 4.3 to the Form 8-K dated May 1, 2008 and filed on May 7, 2008).


 *
4o.
Form of 0.875% Notes Due 2017 (incorporated herein by reference to Exhibit 4.1 to the Form 8-K dated July 26, 2012 and filed on July 31, 2012).

113


119



4p.
Form of 2.000% Notes Due 2022 (incorporated herein by reference to Exhibit 4.1 to the Form 8-K dated July 26, 2012 and filed on July 31, 2012).

4q.
Form of 3.250% Notes Due 2042 (incorporated herein by reference to Exhibit 4.1 to the Form 8-K dated July 26, 2012 and filed on July 31, 2012).

4r.Seventh Supplemental Indenture, dated as of October 31, 2013, between Bristol-Myers Squibb Company and The Bank of New York Mellon, as Trustee to the Indenture dated as of June 1, 1993 (incorporated herein by reference to Exhibit 4.1 to the Form 8-K dated and filed on October 31, 2013).
4s.Form of 1.750% Notes Due 2019 (incorporated herein by reference to Exhibit 4.2 to the Form 8-K dated and filed on October 31, 2013).
4t.Form of 3.250% Notes Due 2023 (incorporated herein by reference to Exhibit 4.3 to the Form 8-K dated and filed on October 31, 2013).
4u.Form of 4.500% Notes Due 2044 (incorporated herein by reference to Exhibit 4.4 to the Form 8-K dated and filed on October 31, 2013).
10a. 

$1,500,000,000 Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of September 29, 2011 among Bristol-Myers Squibb Company, the borrowing subsidiaries, the lenders named in the agreement, BNP Paribas and The Royal Bank of Scotland plc, as documentation agents, Bank of America N.A., as syndication agent, and JPMorgan Chase Bank, N.A. and Citibank, N.A., as administrative agents (incorporated herein by reference to Exhibit 10.1 to the Form 8-K dated September 29, 2011 and filed on October 4, 2011).

 *
10b. 

First Amendment dated June 21, 2013 to the Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of September 29, 2011 among Bristol-Myers Squibb Company, the several financial institutions from time to time party to the agreement, and JPMorgan Chase Bank, N.A. and Citibank N.A. as administrative agents (incorporated herein by reference to Exhibit 10a to the Form 10-Q for the quarterly period ended June 30, 2013).

10c.Extension notice dated June 3, 2013 for the Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of September 29, 2011 among Bristol-Myers Squibb Company, the several financial institutions from time to time party to the agreement, and JPMorgan Chase Bank, N.A. and Citibank N.A. as administrative agents (incorporated herein by reference to Exhibit 10b to the Form 10-Q for the quarterly period ended June 30, 2013).
10d.$1,500,000,000 Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of July 31, 2012 among Bristol-Myers Squibb Company, the borrowing subsidiaries, the lenders named in the agreement, Bank of America N.A., Barclays Bank plc, Deutsche Bank Securities Inc., and Wells Fargo Bank, National Association as documentation agents, Citibank, N.A. and JPMorgan Chase Bank, N.A., as administrative agents (incorporated herein by reference to Exhibit 10.1 to the Form 8-K dated July 26, 2012 and filed on July 31, 2012).
10e.Extension notice dated May 31, 2013 for the Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of July 30, 2012 among Bristol-Myers Squibb Company, the several financial institutions from time to time party to the agreement, and JPMorgan Chase Bank, N.A. and Citibank N.A. as administrative agents (incorporated herein by reference to Exhibit 10c to the Form 10-Q for the quarterly period ended June 30, 2013).
10f.SEC Consent Order (incorporated herein by reference to Exhibit 10s to the Form 10-Q for the quarterly period ended September 30, 2004).

 *
10c. 

Bylaws

10g.
Master Restructuring Agreement between Bristol-Myers Squibb Company and Sanofi dated as of September 27, 2012 (incorporated by reference herein to Exhibit 10a to the Form 10-Q for the quarterly period ended September 30, 2012). †

10h.
Side Letter to Master Restructuring Agreement between Bristol-Myers Squibb Company and Sanofi dated as of January 1, 2013 (incorporated herein by reference to Exhibit 10p to the Form 10-K for the fiscal year ended December 31, 2012). †

10i.
Amended and Restated Articles of Association (Statuts) of Sanofi Pharma Bristol-Myers Squibb, a partnership (societe en nom collectif) organized under French law, dated as of June 6, 1997.January 1, 2013. English Translation (incorporated herein by reference herein to Exhibit 10.110q to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012).


 *
10d. 

10j.
Amended and Restated Internal Regulation (Reglement Interieur) of Sanofi Pharma Bristol-Myers Squibb dated as of June 6, 1997 and effectivedated as of January 1, 1997.2013. English Translation (incorporated herein by reference herein to Exhibit 10.210r to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012).†


 *

120



10e.10k. 

Amendment to the Partnership Agreement of Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership between sanofi-aventis U.S. LLC (as successor-in-interest to Sanofi Pharmaceuticals, Inc.) and Bristol-Myers Squibb Company Investco, Inc. dated as of January 1, 19972013 (incorporated herein by reference herein to Exhibit 10.310s to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012).†


 *
10f. 

10l.
Termination Agreement of Territory A Alliance Support Agreement between Sanofi and Bristol-Myers Squibb Company dated as of January 1, 19972013 (incorporated herein by reference herein to Exhibit 10.410t to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012).†


 *
10g. 

10m.
Amendment No. 1No.4 to the Territory A Alliance Support Agreement between Sanofi-Synthelabo and Bristol-Myers Squibb Company dated as of October 17, 2001 (incorporated by reference herein to Exhibit 10.5 to the Form 8-K filed on August 17, 2009).†

*
10h.

Territory B Alliance Support Agreement between Sanofi and Bristol-Myers Squibb Company dated as of January 1, 19972013 (incorporated herein by reference herein to Exhibit 10.610u to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012). †


 *
10i. 

Amendment No. 1 to the Territory B Alliance Support Agreement between Sanofi-Synthelabo and Bristol-Myers Squibb Company dated as of October 17, 2001 (incorporated by reference herein to Exhibit 10.7 to the Form 8-K filed on August 17, 2009).†

 *
10j.10n. 

Amended and Restated Clopidogrel Intellectual Property License and Supply Agreement between Sanofi and Sanofi Pharma Bristol-Myers Squibb dated as of January 1, 19972013 (incorporated herein by reference herein to Exhibit 10.810v to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012). †


 *
10k. 

10o.
Amended and Restated Clopidogrel Intellectual Property License and Supply Agreement between Sanofi and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership dated as of January 1, 19972013 (incorporated herein by reference herein to Exhibit 10.910w to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012). †


 *
10l. 

10p.
Amended and Restated Territory A Product Know-How License Agreement among Sanofi, Bristol-Myers Squibb Company and Sanofi Pharma Bristol-Myers Squibb dated as of January 1, 19972013 (incorporated herein by reference herein to Exhibit 10.1010x to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012).†


 *
10m. 

10q.
Amended and Restated Territory B Product Know-How License Agreement among Sanofi, Bristol-Myers Squibb Company and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership dated as of January 1, 19972013 (incorporated herein by reference herein to Exhibit 10.1110y to the Form 8-K filed on August 17, 2009)10-K for the fiscal year ended December 31, 2012). †


 *
10n. 

10r.
Amended and Restated Territory B1 Product Know-How License Agreement among Sanofi, Bristol-Myers Squibb Company and Sanofi-Aventis U.S. LLC dated as of January 1, 2013 (incorporated herein by reference to Exhibit 10z to the Form 10-K for the fiscal year ended December 31, 2012). †

10s.
Assignment Agreement among Sanofi, Bristol-Myers Squibb Company and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership dated as of January 1, 2013 (incorporated herein by reference to Exhibit 10aa to the Form 10-K for the fiscal year ended December 31, 2012). †

10t.
Restated Development and Commercialization Collaboration Agreement between Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company dated as of October 23, 2001 (incorporated by reference herein to Exhibit 10.12 to the Form 8-K filed on August 17, 2009).†


 *
10o. 

10u.
Amendment No. 3 to the Restated Development and Commercialization Collaboration Agreement between Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company dated as of September 25, 2006 (incorporated by reference herein to Exhibit 10.13 to the Form 8-K filed on August 17, 2009).†


 *
10p. 

10v.
Amendment No. 5 to the Restated Development and Commercialization Collaboration Agreement between Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company effective as of April 4, 2009 (incorporated by reference herein to Exhibit 10.14 to the Form 8-K filed on August 17, 2009).†


 *
**10q. 

10w.
Amendment No. 9 to the Restated Development and Commercialization Collaboration Agreement between Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company 1997 Stock Incentive Plan, effective as of May 6, 1997 and as amended effective July 17, 2002October 29, 2012 (incorporated herein by reference to Exhibit 10a1ee to the Form 10-Q10-K for the quarterly periodfiscal year ended June 30, 2002)December 31, 2012).


 *
**10r. 

10x.Amended and Restated Stock and Asset Purchase Agreement between Bristol-Myers Squibb Company and AstraZeneca AB (PUBL) dated as of January 31, 2014 (filed herewith). ††
‡‡10y.
Bristol-Myers Squibb Company 2002 Stock Incentive Plan, effective as of May 7, 2002 and as amended effective June 10, 2008 (incorporated herein by reference to Exhibit 10.1 to the Form 10-Q for the quarterly period ended September 30, 2008).


 *
**10s. 

‡‡10z.
Bristol-Myers Squibb Company 2012 Stock Award and Incentive Plan, effective as of May 1, 2012 (incorporated herein by reference to Exhibit B to the 2012 Proxy Statement dated March 20, 2012).

‡‡10aa.
Bristol-Myers Squibb Company 2007 Stock Award and Incentive Plan, effective as of May 1, 2007 and as amended effective June 10, 2008 (incorporated herein by reference to Exhibit 10.2 to the Form 10-Q for the quarterly period ended September 30, 2008).


 *

121



**10t.‡‡10bb. 

Bristol-Myers Squibb Company TeamShare Stock Option Plan, as amended and restated effective September 10, 2002 (incorporated herein by reference to Exhibit 10c to the Form 10-K for the fiscal year ended December 31, 2002).


 *
**10u. 

‡‡10cc.
Form of Non-Qualified Stock Option Agreement under the 2002 Stock Award and Incentive Plan (incorporated herein by reference to Exhibit 10s to the Form 10-K for the fiscal year ended December 31, 2005).


 *
**10v. 

Form of Non-Qualified Stock Option Agreement under the 2007 Stock Award and Incentive Plan (incorporated herein by reference to Exhibit 10s to the Form 10-Q for the quarterly period ended March 31, 2007).

 *
**10w.‡‡10dd. 

Form of Performance Shares Agreement for the 2009-2011 Performance Cycle (incorporated herein by reference to Exhibit 10m to the Form 10-K for the fiscal year ended December 31, 2008).

*
**10x.

Form of Performance Share Units Agreement for the 2010-2012 Performance Cycle (incorporated herein by reference to Exhibit 10aa to the Form 10-K for the fiscal year ended December 31, 2009).


 *

114


**10y. 

‡‡10ee.
Form of Performance Share Units Agreement for the 2011-2013 Performance Cycle (incorporated herein by reference to Exhibit 10aa to the Form 10-K for the fiscal year ended December 31, 2010).


 *
**10z. 

‡‡10ff.
Form of Performance Share Units Agreement for the 2012-2014 Performance Cycle (filed herewith).

E-10-1
**10aa.

Form of Restricted Stock Units Agreement under the 2002 Stock Award and Incentive Plan (incorporated herein by reference to Exhibit 10v10z to the Form 10-K for the fiscal year ended December 31, 2006)2011).


 *
**10bb. 

‡‡10gg.
Form of Performance Share Units Agreement for the 2013-2015 Performance Cycle (incorporated by reference to Exhibit 10oo to the Form 10-K for the fiscal year ended December 31, 2012).

‡‡10hh.Form of Performance Share Units Agreement for the 2014-2016 Performance Cycle (filed herewith)
‡‡10ii.
Form of Restricted Stock Units Agreement with five year vesting under the 20072012 Stock Award and Incentive Plan (filed herewith).


 E-10-2
**10cc. 

‡‡10jj.
Form of Restricted Stock Units Agreement with four year vesting under the 20072012 Stock Award and Incentive Plan (filed herewith).


 E-10-3
**10dd. 

‡‡10kk.
Form of Market Share Units Agreement under the 20072012 Stock Award and Incentive Plan (filed herewith).


 E-10-4
**10ee. 

‡‡10ll.
Bristol-Myers Squibb Company Performance Incentive Plan, as amended (as adopted, incorporated herein by reference to Exhibit 2 to the Form 10-K for the fiscal year ended December 31, 1978; as amended as of January 8, 1990, incorporated herein by reference to Exhibit 19b to the Form 10-K for the fiscal year ended December 31, 1990; as amended on April 2, 1991, incorporated herein by reference to Exhibit 19b to the Form 10-K for the fiscal year ended December 31, 1991; as amended effective January 1, 1994, incorporated herein by reference to Exhibit 10d to the Form 10-K for the fiscal year ended December 31, 1993; and as amended effective January 1, 1994, incorporated herein by reference to Exhibit 10d to the Form 10-K for the fiscal year ended December 31, 1994).


 *
**10ff. 

‡‡10mm.
Bristol-Myers Squibb Company Executive Performance Incentive Plan effective January 1, 1997 (incorporated herein by reference to Exhibit 10b to the Form 10-K for the fiscal year ended December 31, 1996).


 *
**10gg. 

‡‡10nn.
Bristol-Myers Squibb Company Executive Performance Incentive Plan (effectiveeffective January 1, 2003 and as amended effective June 10, 2008 incorporated(incorporated herein by reference to Exhibit 10.3 to the Form 10-Q for the quarterly period ended September 30, 2008).


 *
**10hh. 

‡‡10oo.
Bristol-Myers Squibb Company 2007 Senior Executive Performance Incentive Plan (as amended and restated effective June 8, 2010 and incorporated herein by reference to Exhibit 10a. to the Form 10-Q for the quarterly period ended June 30, 2010).


 *
**10ii. 

‡‡10pp.
Bristol-Myers Squibb Company Benefit Equalization Plan of Bristol-Myers Squibb Company and its Subsidiary or Affiliated Corporations Participating in the Bristol-Myers Squibb Company Retirement Income Plan or the Bristol-Myers Squibb Puerto Rico, Inc. Retirement Income Plan, as amended (as amended and restated effective as of January 1, 1993, as amended effective October 1, 1993, incorporated2012, (incorporated herein by reference to Exhibit 10e10ww to the Form 10-K for the fiscal year ended December 31, 1993; and as amended effective February 1, 1995, incorporated herein by reference to Exhibit 10e to the Form 10-K for the fiscal year ended December 31, 1996)2012).


 *
**10jj. 

‡‡10qq.
Bristol-Myers Squibb Company Benefit Equalization Plan of Bristol-Myers Squibb Company and its Subsidiary or Affiliated Corporations Participating in the Bristol-Myers Squibb Company Savings and Investment Program, as amended and restated effective as of January 1, 19962012 (incorporated herein by reference to Exhibit 10h10xx to the Form 10-K for the fiscal year ended December 31, 2001)2012).


 *
**10kk. 

‡‡10rr.
Squibb Corporation Supplementary Pension Plan, as amended (as previously amended and restated, incorporated herein by reference to Exhibit 19g to the Form 10-K for the fiscal year ended December 31, 1991; as amended as of September 14, 1993, and incorporated herein by reference to Exhibit 10g to the Form 10-K for the fiscal year ended December 31, 1993).


 *
**10ll. 

‡‡10ss.
Senior Executive Severance Plan, effective as of April 26, 2007 and as amended effective February 16, 2012 (filed herewith)(incorporated by reference to Exhibit 10ll to the Form 10-K for the fiscal year ended December 31, 2011).


 E-10-5
**10mm. 

‡‡10tt.
Form of Agreement entered into between the Registrant and each of the named executive officers and certain other executives effective January 1, 2009 (incorporated herein by reference to Exhibit 10bb to the Form 10-K for the fiscal year ended December 31, 2008).


 *

122



**10nn.‡‡10uu. 

Form of Corrective Amendment between the Registrant and each of the named executive officers and certain other executives effective January 1, 2009 (incorporated herein by reference to Exhibit 10b to the Form 10-Q for the quarterly period ended June 30, 2012).

‡‡10vv.
Bristol-Myers Squibb Company Retirement Income Plan for Non-Employee Directors, as amended March 5, 1996 (incorporated herein by reference to Exhibit 10k to the Form 10-K for the fiscal year ended December 31, 1996).


 *
**10oo. 

‡‡10ww.
Bristol-Myers Squibb Company 1987 Deferred Compensation Plan for Non-Employee Directors, as amended December 17, 2009 (incorporated herein by reference to Exhibit 10tt to the Form 10-K for the fiscal year ended December 31, 2009).


 *
**10pp. 

‡‡10xx.
Bristol-Myers Squibb Company Non-Employee Directors’ Stock Option Plan, as amended (as approved by the Stockholders on May 1, 1990, incorporated herein by reference to Exhibit 28 to Registration Statement No. 33-38587 on Form S-8; as amended May 7, 1991, incorporated herein by reference to Exhibit 19c to the Form 10-K for the fiscal year ended December 31, 1991), as amended January 12, 1999 (incorporated herein by reference to Exhibit 10m to the Form 10-K for the fiscal year ended December 31, 1998).


 *
**10qq. 

‡‡10yy.
Bristol-Myers Squibb Company Non-Employee Directors’ Stock Option Plan, as amended (as approved by the Stockholders on May 2, 2000, incorporated herein by reference to Exhibit A to the 2000 Proxy Statement dated March 20, 2000).


 *
**10rr. 

‡‡10zz.
Squibb Corporation Deferral Plan for Fees of Outside Directors, as amended (as adopted, incorporated herein by reference to Exhibit 10e Squibb Corporation 1991 Form 10-K for the fiscal year ended December 31, 1987, File No. 1-5514; as amended effective December 31, 1991 incorporated herein by reference to Exhibit 10m to the Form 10-K for the fiscal year ended December 31, 1992).


 *
**10ss. 

‡‡10aaa.Amendment to all of the Company’s plans, agreements, legal documents and other writings, pursuant to action of the Board of Directors on October 3, 1989, to reflect the change of the Company’s name to Bristol-Myers Squibb Company (incorporated herein by reference to Exhibit 10v to the Form 10-K for the fiscal year ended December 31, 1989).

    *

115


12. 

12Statement re computation of ratios (filed herewith).

    E-12-1
21. 

21Subsidiaries of the Registrant (filed herewith).

    E-21-1
23. 

23Consent of Deloitte & Touche LLP (filed herewith).

    E-23-1
31a.  

Section 302 Certification Letter (filed herewith).

    E-31-1
31b.  

Section 302 Certification Letter (filed herewith).

    E-31-2E-31-1
32a.  

Section 906 Certification Letter (filed herewith).

    E-32-1
32b.  

Section 906 Certification Letter (filed herewith).

    E-32-2
101.  

The following financial statements from the Bristol-Myers Squibb Company Annual Report on Form 10-K for the years ended December 31, 2011, 20102013, 2012 and 2009,2011, formatted in Extensible Business Reporting Language (XBRL): (i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.

    

Confidential treatment has been granted for certain portions which are omitted in the copy of the exhibit electronically filed with the Commission.

††Confidential treatment has been requested for certain portions which are omitted in the copy of the exhibit electronically filed with the Commission.  The omitted information has been filed separately with the Commission pursuant to the Company’s application for confidential treatment.


*

Indicates, in this Form 10-K, brand names of products, which are registered trademarks not solely owned by BMSthe Company or its subsidiaries. ERBITUX, ALIMTAByetta, Bydureon, and GEMZARSymlin are trademarks of Eli LillyAmylin Pharmaceuticals, LLC and Company; AVAPRO/AVALIDEAstraZeneca Pharmaceuticals LP; Erbitux is a trademarks of ImClone LLC; Avapro/Avalide (known in the EU as APROVEL/KARVEA)Aprovel/Karvea), ISCOVER, KARVEZIDE, COAPROVELIscover, Karvezide, Coaprovel and PLAVIXPlavix are trademarks of Sanofi; ABILIFYAbilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; TRUVADATruvada is a trademark of Gilead Sciences, Inc.; GLEEVECGleevec is a trademark of Novartis AG; ATRIPLAAtripla is a trademark of Bristol-Myers Squibb and Gilead Sciences, LLC; NORVIRNorvir is a trademark of Abbott Laboratories; ESTRACEEstrace and OVCONOvcon are trademarks of Warner-Chilcott Company, LLC; DELESTROGENDelestrogen is a trademark of JHP Pharmaceuticals, Inc.; and HUMIRALLC; Reglan is a trademark of Abbott Laboratories.ANIP Acquisition Company and Humira is a trademark of AbbVie Biotechnology LTD. Brand names of products that are in all capitalitalicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.

116


123