UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 10-Q

 


 

QUARTERLY REPORT(Mark One)

xQUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED SeptemberSEPTEMBER 30, 20042005

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROMTO

 

Commission File NumberCOMMISSION FILE NUMBER: 1-1136

 


 

BRISTOL-MYERS SQUIBB COMPANY

(Exact name of registrant as specified in its charter)EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 


 

DelawareDELAWARE 22-079-035022-0790350

(State or other jurisdiction of Incorporation)

incorporation or organization)

 

(IRSI.R.S. Employer

Identification No.)

 

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

(Address of principal executive offices)(Zip Code)

 

Telephone: (212) 546-4000

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

 


 

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 suchthe filing requirements for at least the past 90 days.    Yes  x    No  ¨

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes  x    No  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes  ¨    No  x

APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY

PROCEEDINGS DURING THE PRECEDING FIVE YEARS

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d)of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.

¨  Yes    ¨  No

APPLICABLE ONLY TO CORPORATE ISSUERS:

 

At September 30, 2004,2005, there were 1,945,607,4941,956,520,637 shares outstanding of the Registrant’s $.10 par value Common Stock.

 



BRISTOL-MYERS SQUIBB COMPANY

INDEX TO FORM 10-Q

SeptemberSEPTEMBER 30, 20042005

 

   Page

PART I—FINANCIAL INFORMATION

   

Item 1.

   

Financial Statements:

   

Consolidated Statement of Earnings for the three and nine months ended September 30, 2004 and 2003

  3

Consolidated Statement of Comprehensive Income and Retained Earnings for the three and nine months ended September 30, 2004 and 2003

  4

Consolidated Balance Sheet at September 30, 2004 and December 31, 2003

  5

Consolidated Statement of Cash Flows for the nine months ended September 30, 2004 and 2003

  6

Notes to Consolidated Financial Statements

  7-317-32

Report of Independent Registered Public Accounting Firm

  3233

Item 2.

   

Management’s Discussion and Analysis of Financial Condition and Results of Operations

  33-5634-66

Item 3.

   

Quantitative and Qualitative Disclosures About Market Risk

  5766

Item 4.

   

Controls and Procedures

  5766

PART II—OTHER INFORMATION

   

Item 1.

   

Legal Proceedings

  5867

Item 2.

   

Changes inUnregistered Sales of Equity Securities and Use of Proceeds and Issuer Purchases of Equity Securities

  58

Item 4.

Submission of Matters to a Vote of Security Holders

5967

Item 6.

   

Exhibits and Reports on Form 8-K

  6068

Signatures

  6169

PART I—FINANCIAL INFORMATION

Item 1.FINANCIAL STATEMENTS

 

BRISTOL-MYERS SQUIBB COMPANY

Item 1. FINANCIAL STATEMENTS

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENT OF EARNINGS

(UNAUDITED)

 

  Three Months
Ended September 30,


 Nine Months
Ended September 30,


   Three Months Ended
September 30,


 Nine Months Ended
September 30,


 
  2004

 2003

 2004

 2003

   2005

 2004

 2005

 2004

 
  (dollars in millions, except per share data)   (in millions, except per share data) 

EARNINGS

      

Net Sales

  $5,427  $5,372  $16,038  $15,229   $4,767  $4,778  $14,188  $14,223 
  


 


 


 


  


 


 


 


Cost of products sold

   2,100   1,929   6,094   5,490    1,483   1,467   4,333   4,324 

Marketing, selling and administrative

   1,209   1,151   3,655   3,398    1,286   1,199   3,737   3,626 

Advertising and product promotion

   325   332   987   1,001    349   325   1,032   987 

Research and development

   615   565   1,823   1,564    669   615   1,971   1,823 

Acquired in-process research and development

   1   —     63   —      —     1   —     63 

Provision for restructuring, net

   (5)  57   —     75 

Litigation (income)/charges, net

   (26)  25   72   404 

Gain on sale of business

   (3)  —     (316)  —      (569)  (3)  (569)  (316)

Provision for restructuring and other items, net

   57   13   75   18 

Litigation settlement expense/(income)

   25   (4)  404   (66)

Equity in net income of affiliates

   (70)  (54)  (204)  (124)   (84)  (70)  (240)  (204)

Other expense, net

   17   79   62   177    38   16   168   62 
  


 


 


 


  


 


 


 


Total expenses

   4,276   4,011   12,643   11,458    3,141   3,632   10,504   10,844 
  


 


 


 


  


 


 


 


Earnings Before Minority Interest and Income Taxes

   1,151   1,361   3,395   3,771 

Earnings from Continuing Operations Before Minority Interest and Income Taxes

   1,626   1,146   3,684   3,379 

Provision for income taxes

   241   345   759   923    507   239   754   753 

Minority interest, net of taxes

   152   110   387   248    155   152   437   387 
  


 


 


 


Earnings from Continuing Operations

   964   755   2,493   2,239 
  


 


 


 


Discontinued Operations

   

Net Earnings

   —     3   (5)  10 

Net Gain on Disposal

   —     —     13   —   
  


 


 


 


   —     3   8   10 
  


 


 


 


  


 


 


 


Net Earnings

  $758  $906  $2,249  $2,600   $964  $758  $2,501  $2,249 
  


 


 


 


  


 


 


 


Earnings per Common Share

      

Basic

  $.39  $.47  $1.16  $1.34    

Earnings from Continuing Operations

  $.49  $.39  $1.28  $1.16 

Discontinued Operations

   

Net Earnings

   —     —     —     —   

Net Gain on Disposal

   —     —     —     —   
  


 


 


 


Net Earnings per Common Share

  $.49  $.39  $1.28  $1.16 
  


 


 


 


Diluted

  $.38  $.47  $1.14  $1.34    

Earnings from Continuing Operations

  $.49  $.38  $1.27  $1.14 

Discontinued Operations

   

Net Earnings

   —     —     —     —   

Net Gain on Disposal

   —     —     —     —   
  


 


 


 


Net Earnings per Common Share

  $.49  $.38  $1.27  $1.14 
  


 


 


 


Average Common Shares Outstanding

      

Basic

   1,942   1,937   1,941   1,936    1,953   1,942   1,951   1,941 

Diluted

   1,975   1,944   1,975   1,942    1,984   1,975   1,983   1,975 

Dividends declared per Common Share

  $.28  $.28  $.84  $.84 

Dividends declared per common share

  $.28  $.28  $.84  $.84 

 

The accompanying notes are an integral part of these financial statements.

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENT OF

COMPREHENSIVE INCOME AND RETAINED EARNINGS

(UNAUDITED)

 

  Three Months
Ended September 30,


  

Nine Months

Ended September 30,


   Three Months Ended
September 30,


 Nine Months Ended
September 30,


 
  2004

 2003

  2004

 2003

   2005

  2004

 2005

 2004

 
  (dollars in millions)   (dollars in millions) 

COMPREHENSIVE INCOME

            

Net Earnings

  $758  $906  $2,249  $2,600   $964  $758  $2,501  $2,249 
  


 

  


 


Other Comprehensive Income/(Loss):

            

Foreign currency translation, net of tax benefit of $8 and $30 for the three months ended September 30, 2004 and 2003, respectively; and net of tax benefit of $28 and tax liability of $24 for the nine months ended September 30, 2004 and 2003, respectively

   22   35   63   165 

Deferred gains (losses) on derivatives qualifying as hedges, net of tax benefit of $5 and tax liability of $7 for the three months ended September 30, 2004 and 2003, respectively; and net of tax liability of $55 and tax benefit of $36 for the nine months ended September 30, 2004 and 2003, respectively

   (19)  39   109   (72)

Available-for-sale securities, net of tax liability of $2 for the three months ended September 30, 2003; and net of tax benefit of $4 and tax liability of $3 for the nine months ended September 30, 2004 and 2003, respectively

   —     12   (7)  17 

Foreign currency translation, net of tax benefit of zero and $8 for the three months ended September 30, 2005 and 2004, respectively; and net of tax liability of $4 and tax benefit of $28 for the nine months ended September 30, 2005 and 2004, respectively

   25   22   (211)  63 

Deferred (losses)/gains on derivatives qualifying as hedges, net of tax liability of $3 and tax benefit of $5 for the three months ended September 30, 2005 and 2004, respectively; and net of tax liability of $103 and $55 for the nine months ended September 30, 2005 and 2004, respectively

   12   (19)  283   109 

Available for sale securities, net of tax benefit of $11 and $4 for the nine months ended September 30, 2005 and 2004, respectively

   —     —     (20)  (7)
  


 

  


 


  

  


 


 


Total Other Comprehensive Income

   3   86   165   110    37   3   52   165 
  


 

  


 


  

  


 


 


Comprehensive Income/(Loss)

  $761  $992  $2,414  $2,710 

Comprehensive Income

  $1,001  $761  $2,553  $2,414 
  


 

  


 


  

  


 


 


RETAINED EARNINGS

            

Retained Earnings, January 1

     $19,439  $18,503       $19,651  $19,439 

Net Earnings

      2,249   2,600        2,501   2,249 

Cash dividends declared

      (1,632)  (1,627)       (1,640)  (1,632)
     


 


      


 


Retained Earnings, September 30

     $20,056  $19,476       $20,512  $20,056 
     


 


      


 


 

The accompanying notes are an integral part of these financial statements.

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEET

(UNAUDITED)

 

  September 30,
2004


 December 31,
2003


   

September 30,

2005


 

December 31,

2004


 
  (dollars in millions)   (dollars in millions) 

ASSETS

      

Current Assets:

      

Cash and cash equivalents

  $3,381  $2,444   $2,129  $3,680 

Marketable securities

   3,872   3,013    1,652   3,794 

Receivables, net of allowance for doubtful accounts of $134 and $154

   3,808   3,566 

Receivables, net of allowances of $202 and $221

   3,305   4,373 

Inventories, including consignment inventory

   1,765   1,601    2,053   1,830 

Deferred income taxes, net of valuation allowances

   712   864    703   805 

Prepaid expenses

   345   310    303   319 
  


 


  


 


Total Current Assets

   13,883   11,798    10,145   14,801 
  


 


Property, plant and equipment, net

   5,655   5,712    5,649   5,765 

Goodwill

   4,908   4,836    4,824   4,905 

Other intangible assets, net

   1,921   1,732    1,988   2,260 

Deferred income taxes, net of valuation allowances

   1,792   1,234    1,636   1,129 

Prepaid pension

   1,095   1,280 

Other assets

   2,017   2,079    272   295 
  


 


  


 


Total Assets

  $30,176  $27,391   $25,609  $30,435 
  


 


  


 


LIABILITIES

      

Current Liabilities:

      

Short-term borrowings

  $1,650  $127   $277  $1,883 

Accounts payable

   1,812   1,893    1,342   2,127 

Accrued expenses

   2,821   2,805    2,524   2,838 

Accrued rebates and returns

   1,023   950    1,036   1,209 

U.S. and foreign income taxes payable

   1,026   707    486   1,023 

Dividends payable

   545   543    547   545 

Accrued litigation liabilities

   171   267    410   186 

Deferred revenue on consigned inventory

   37   76    —     32 
  


 


  


 


Total Current Liabilities

   9,085   7,368    6,622   9,843 
  


 


Other liabilities

   1,888   1,715    1,824   1,927 

Long-term debt

   8,540   8,522    5,895   8,463 
  


 


  


 


Total Liabilities

   19,513   17,605    14,341   20,233 
  


 


  


 


Commitments and contingencies

   

Commitments and contingencies (Note 17)

   

STOCKHOLDERS’ EQUITY

      

Preferred stock, $2 convertible series:

   

Authorized 10 million shares; issued and outstanding 7,516 in 2004 and 8,039 in 2003, liquidation value of $50 per share

   —     —   

Common stock, par value of $.10 per share:

   

Authorized 4.5 billion shares; issued 2,201,344,642 in 2004 and 2,201,012,432 in 2003

   220   220 

Preferred stock, $2 convertible series: Authorized 10 million shares; issued and outstanding 7,190 in 2005 and 7,476 in 2004, liquidation value of $50 per share

   —     —   

Common stock, par value of $.10 per share: Authorized 4.5 billion shares; 2,205 million issued in 2005 and 2,202 million issued in 2004

   220   220 

Capital in excess of par value of stock

   2,475   2,477    2,527   2,491 

Restricted stock

   (64)  (55)   (70)  (57)

Other accumulated comprehensive loss

   (690)  (855)

Accumulated other comprehensive loss

   (740)  (792)

Retained earnings

   20,056   19,439    20,512   19,651 
  


 


  


 


   21,997   21,226    22,449   21,513 

Less cost of treasury stock—255,737,148 common shares in 2004 and 261,029,539 in 2003

   (11,334)  (11,440)

Less cost of treasury stock—248 million common shares in 2005 and 255 million in 2004

   (11,181)  (11,311)
  


 


  


 


Total Stockholders’ Equity

   10,663   9,786    11,268   10,202 
  


 


  


 


Total Liabilities and Stockholders’ Equity

  $30,176  $27,391   $25,609  $30,435 
  


 


  


 


 

The accompanying notes are an integral part of these financial statements.

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENT OF CASH FLOWS

(UNAUDITED)

 

  

Nine Months

Ended September 30,


   Nine Months Ended
September 30,


 
  2004

 2003

   2005

 2004

 
  (dollars in millions)   (dollars in millions) 

Cash Flows From Operating Activities:

      

Net earnings

  $2,249  $2,600   $2,501  $2,249 

Adjustments to reconcile net earnings to net cash provided by operating activities:

      

Depreciation

   427   325    427   427 

Amortization

   227   229    263   227 

Deferred income tax (benefits)/expense

   (454)  197 

Litigation settlement expense/(income)

   404   (65)

Provision for restructuring and other items

   75   65 

Gain on sale of Mead Johnson Adult Nutritional business

   (316)  —   

Deferred income tax benefits

   (561)  (454)

Litigation settlement expense, net of recoveries

   72   404 

Provision for restructuring

   —     75 

Gain on sale of businesses

   (632)  (316)

Acquired in-process research and development

   63   —      —     63 

Loss/(gain) on disposal of property, plant and equipment and investment in other companies

   1   (14)

Undistributed (earnings)/losses of affiliates, net

   29   26 

Impairment charges and asset write-offs

   19   —   

(Gain)/loss on disposal of property, plant and equipment and investment in other companies

   (4)  1 

Undistributed losses of affiliates, net

   61   29 

Unfunded pension expense

   97   47    178   97 

Changes in operating assets and liabilities:

      

Receivables

   (208)  (547)   649   (208)

Inventories

   (166)  (50)   (344)  (166)

Prepaid expenses

   (27)  63    —     (27)

Other assets

   35   21    8   35 

Deferred revenue on consigned inventory

   (38)  (386)   (32)  (38)

Litigation settlement payments

   (500)  (528)

Litigation settlement payments, net of insurance recoveries

   115   (500)

Accounts payable and accrued expenses

   100   372    (511)  100 

Product liability

   63   9    (42)  63 

U.S. and foreign income taxes payable

   358   (63)   (568)  358 

Other liabilities

   74   (40)   (88)  74 
  


 


  


 


Net Cash Provided by Operating Activities

   2,493   2,261    1,511   2,493 
  


 


  


 


Cash Flows From Investing Activities:

      

Purchases, net of sales and maturities, of marketable securities

   (857)  (735)   2,140   (857)

Additions to property, plant and equipment and capitalized software

   (477)  (608)   (537)  (477)

Proceeds from disposal of property, plant and equipment and investment in other companies

   18   39    96   18 

Proceeds from sale of Mead Johnson Adult Nutritional business

   365   —   

Proceeds from sale of businesses

   843   365 

Purchase of Acordis Speciality Fibres

   —     (250)

ImClone milestone payment

   (250)  —      —     (150)

Purchase of Acordis Speciality Fibres

   (150)  —   

Purchase of trademarks, patents, licenses and other businesses

   (129)  (53)

Investment in ImClone

   —     (60)

Purchases of trademarks, patents, licenses and other businesses

   —     (129)

Divestiture and acquisition costs

   (29)  (15)   —     (29)

Other

   —     (3)

Investments in other companies

   (28)  —   
  


 


  


 


Net Cash Used in Investing Activities

   (1,509)  (1,435)

Net Cash Provided by (Used in) Investing Activities

   2,514   (1,509)
  


 


  


 


Cash Flows From Financing Activities:

      

Short-term borrowings, net of repayments

   1,469   (45)

Short-term (repayments)/borrowings

   (1,583)  1,429 

Long-term debt borrowings

   11   1,103    8   11 

Long-term debt repayments

   (2)  (3)   (2,502)  (2)

Issuances of common stock under stock plans

   95   34    154   95 

Dividends paid

   (1,630)  (1,627)   (1,639)  (1,630)
  


 


  


 


Net Cash Used in Financing Activities

   (57)  (538)   (5,562)  (97)
  


 


  


 


Effect of Exchange Rates on Cash and Cash Equivalents

   10   23    (14)  10 
  


 


  


 


Increase (Decrease) in Cash and Cash Equivalents

   937   311 

(Decrease) Increase in Cash and Cash Equivalents

   (1,551)  897 

Cash and Cash Equivalents at Beginning of Period

   2,444   2,367    3,680   2,549 
  


 


  


 


Cash and Cash Equivalents at End of Period

  $3,381  $2,678   $2,129  $3,446 
  


 


  


 


 

The accompanying notes are an integral part of these financial statements.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 1. Basis of Presentation and New Accounting Standards

 

Bristol-Myers Squibb Company (the Company) prepared these unaudited consolidated financial statements following the requirements of the Securities and Exchange Commission (SEC) and U.S. generally accepted accounting principles (GAAP) for interim reporting. Under those rules, certain notesfootnotes and other financial information that are normally required by GAAP for annual financial statements can be condensed or omitted. The Company is responsible for the consolidated financial statements included in this Form 10-Q. These consolidated financial statements include all normal and recurring adjustments necessary for a fair presentation of the Company’s financial position at September 30, 20042005 and December 31, 2003,2004, the results of its operations for the three and nine months ended September 30, 20042005 and 20032004 and cash flows for the nine months ended September 30, 20042005 and 2003.2004. These consolidated financial statements and the related notes should be read in conjunction with the consolidated financial statements and the related notes included in the Company’s Annual Report on Form 10-K/A10-K for the year ended December 31, 2003 (20032004 (2004 Form 10-K/A)10-K). PricewaterhouseCoopers LLP (PwC), an independent registered public accounting firm, has performed a review of the unaudited consolidated financial statements included in this Form 10-Q, and their review report thereon accompanies this Form 10-Q.

 

Revenues, expenses, assets and liabilities can vary during each quarter of the year. Accordingly, the results and trends in these unaudited consolidated financial statements may not be the same as those for the full year.

 

The Company recognizes revenue when substantially all the risks and rewards of ownership have transferred to the customer, primarily at the time of shipment of products. In the case of certain sales made by the Nutritionals and OtherRelated Healthcare segments and certain non-U.S. businesses within the Pharmaceuticals segment, revenue is recognized on the date of receipt by the purchaser. Revenues are reduced at the time of sale to reflect expected returns that are estimated based on historical experience. Additionally, provisions are made at the time of sale for all discounts, rebates and estimated sales allowances based on historical experience updated for changes in facts and circumstances, as appropriate. Such provisions are recorded as a reduction of revenue.

 

In the case of sales made to wholesalers (i) as a result of incentives, (ii) in excess of the wholesaler’s ordinary course of business inventory level, (iii) at a time when there was an understanding, agreement, course of dealing or consistent business practice thataddition, the Company would extend incentives based on levels of excess inventoryincludes alliance revenue in connection with future purchases and (iv) at a time when such incentives would cover substantially all, and vary directly with, the wholesaler’s cost of carrying inventory in excess of the wholesaler’s ordinary course of business inventory level, substantially all the risks and rewards of ownership do not transfer upon shipment and, accordingly, such sales are accounted for using the consignment model. The determination of when, if at all, sales to a wholesaler meet the foregoing criteria involves evaluation of a variety of factors and a number of complex judgments. Under the consignment model, the Company does not recognize revenue upon shipment of product. Rather, upon shipment of product the Company invoices the wholesaler, records deferred revenue at gross invoice sales price and classifies the inventory held by the wholesaler as consignment inventory at the Company’s cost of such inventory.net sales. The Company recognizeshas agreements to promote pharmaceuticals discovered by other companies. Alliance revenue when the consignment inventory is no longer subject to the incentive arrangements described above, but not later than when such inventory is sold through to the wholesalers’ customers, onbased upon a first-in first-out (FIFO) basis. Salespercentage of the Company’s oncology products through the Oncology Therapeutics Network (OTN) business are also accounted for on a consignment basis. OTN uses a third-party distributor to ship these products to its customers. Upon shipment of the products to the distributor, the Company records deferred revenue at gross invoice sales price and classifies the inventory held by the distributor as consignment inventory at the Company’s cost of such inventory. The Company recognizes the revenue (net of the gross tocopromotion partners’ net sales adjustments discussed in “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies,” all of which involve significant estimates and judgements)is earned when the consignment inventory is soldcopromotion partners ship the related product and title passes to OTN’s customers.their customer.

 

The Company’s estimatesCompany accounts for certain costs to obtain internal use software for significant systems projects in accordance with Statement of inventory atPosition (SOP) 98-1. These costs, including external direct costs, interest costs and internal payroll and related costs for employees who are directly associated with such projects are capitalized and amortized over the wholesalers and deferred revenue on consigned inventoryestimated useful life of the software, which ranges from three to ten years. Costs to obtain software for projects that are based on the projected prescription demand-based sales for its products,not significant are expensed as well as the Company’s analysis of third-party information, including information obtained from certain wholesalers with respect to their inventory levels and sell-through to customers and third-party market research data, and the Company’s internal information. The Company’s estimates are subject to inherent limitations of estimates that rely on third-party data, as certain third-party information was itself in the form of estimates, and reflect other limitations.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 1. Basis of Presentation and New Accounting Standards (Continued)incurred.

 

The preparation of financial statements in conformity with GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant assumptions are employed in estimates used in determining values of intangible assets, restructuring charges and accruals, sales rebate and return accruals, legal contingencies and tax assets and liabilities, as well as in estimates used in applying the revenue recognition policy and accounting for retirement and postretirement benefits (including the actuarial assumptions). Actual results could differ from the estimated results.

 

Certain prior period amounts have been reclassified to conform to the current periodyear presentation.

 

In June 2004,May 2005, the Financial Accounting Standards Board (FASB) issued a final Staff Position (FSP) No. 106-2,Accounting and Disclosure Requirements Related to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (the Medicare Act). The Medicare Act introduces a prescription drug benefit under Medicare as well as a federal subsidy to sponsors of retiree health care benefit plans that provide a benefit that is at least actuarially equivalent to Medicare Part D. FSP No. 106-2 requires that the effects of the new law be accounted for under Statement of Financial Accounting Standards (SFAS) No. 106,154,Employers’ Accounting Changes and Error Corrections, which replaces Accounting Principles Board (APB) Opinion No. 20,Accounting Changes and SFAS No. 3,Reporting Accounting Changes in Interim Financial Statements. This pronouncement applies to all voluntary changes in accounting principle, and revises the requirements for Postretirement Benefits Other Than Pensions.accounting for and reporting a change in accounting principle. SFAS No. 154 requires retrospective application to prior periods’ financial statements of a voluntary change in accounting principle, unless it is impracticable to do so. This pronouncement also requires that a change in the method of depreciation, amortization, or depletion for long-lived, non-financial assets be accounted for as a change in accounting estimate that is effected by a change in accounting principle. SFAS No. 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005. The Statement does not change the transition provisions of any existing accounting pronouncements, including those that are in a transition phase as of the effective date of SFAS No. 154. The Company adopted FSP No. 106-2 inis evaluating the third quarterimpact this statement will have on its financial position and results of 2004, retroactive to January 1, 2004. There is an expected reduction in net periodic benefit cost for other benefits of $8 million for the full year of 2004, based on the remeasurement of the accumulated postretirement benefit obligation as of January 1, 2004. The effect of the adoption of FSP No. 106-2 is not material to the Company’s consolidated financial statements, and in accordance with FSP No. 106-2, the Company recorded the year-to-date portion of $6 million as a reduction of third quarter expense. (see “Item 1. Financial Statements—Note 14. Pension and Other Postretirement Benefit Plans”).operations.

 

In March 2004,2005, the Emerging Issues Task Force (EITF) reachedFASB issued FASB Interpretation No. 47,Accounting for Conditional Asset Retirement Obligations (FIN 47). FIN 47 clarifies that an entity must record a consensus on Issue No. 03-06,Participating Securities andliability for a conditional asset retirement obligation if the Two-Class Method Under FAS 128, which requires the usefair value of the two-classobligation can be reasonably estimated. Asset retirement obligations covered by FIN 47 are those for which an entity has a legal obligation to perform an asset retirement activity, even if the timing and method of computing earnings per share for those enterprises with participating securitiessettling the obligation are conditional on a future event that may or multiple classesmay not be within the control of common stock. The consensusthe entity. FIN 47 also clarifies when an entity would have sufficient information to reasonably estimate the fair value of an asset retirement obligation. FIN 47 is effective for fiscal periods beginning afterno later than the dateend of Board ratification on March 31, 2004. The adoption of EITF No. 03-06 did not affect the Company’s consolidated financial statements.

In December 2003, the SEC issued Staff Accounting Bulletin No. 104 (SAB 104),Revenue Recognition, which supersedes SAB 101,Revenue Recognition in Financial Statements. SAB 104’s primary purpose is to rescind accounting guidance contained in SAB 101 related to multiple element revenue arrangements, superseded as a result of the issuance of EITF 00-21,Accounting for Revenue Arrangements with Multiple Deliverables. Additionally, SAB 104 rescinds the SEC’sRevenue Recognition in Financial Statements Frequently Asked Questions and Answers (the FAQ) issued with SAB 101 that had been codified in SEC Topic 13,Revenue Recognition. While the wording of SAB 104 has changed to reflect the issuance of EITF 00-21, the revenue recognition principles of SAB 101 remain largely unchanged by the issuance of SAB 104. The initial adoption of this accounting pronouncement did not have a material effect on the Company’s consolidated financial statements.

In December 2003, the FASB amended SFAS No. 132,Employer’s Disclosures about Pensions and Other Post Retirement Benefits. The amended Statement revises employer’s disclosures about pension plans and other post-retirement benefit plans. It does not change the measurement or recognition of those plans required by FASB Statements No. 87,Employers’ Accounting for Pensions, No. 88,Employers’ Accounting for Settlements and Curtailments of Defined Benefit Pension Plans and for Termination Benefits, and No. 106,Employers’ Accounting for Postretirement Benefits Other Than Pensions. Revisions included in the amended Statement are effective for financial statements for the fiscal years endedending after December 15, 2003.2005. The Company has providedis evaluating the required disclosures (see “Item 1. Financial Statements—Note 14. Pensionimpact this statement will have on its financial position and Other Postretirement Benefit Plans” and “—Note 15. Legal Proceedings and Contingencies”).

In December 2003, the FASB revised Interpretation No. 46,Consolidationresult of Variable Interest Entities (FIN 46). FIN 46 requires a variable interest entity to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entity’s activities or entitled to receive a majority of the entity’s residual returns or both. FIN 46 also requires disclosures about variable interest entities that a company is not required to consolidate but in which it has a significant variable interest. The consolidation requirements of FIN 46 (as revised) apply immediately to variable interest entities created after January 31, 2003 and to existing entities in the first fiscal year or interim period ending after March 15, 2004. Certain of the disclosure requirements apply to all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. The initial adoption of this accounting pronouncement did not have a material effect on the consolidated financial statements.operations.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note1.Note 1. Basis of Presentation and New Accounting Standards (Continued)

 

InvestmentsIn December 2004, the FASB issued FASB Staff Position (FSP) No. 109-1—Application of SFAS No. 109, Accounting for Income Taxes, to the Tax Deduction on Qualified Production Activities Provided by the American Jobs Creation Act of 2004 (FSP No. 109-1). The FSP provides that theDeduction on Qualified Production Activities will be treated as a “special deduction” as described in securities, comprisedSFAS No. 109,Accounting for Income Taxes. Accordingly, the tax effect of marketable equity securities and securities and investments for which market values are not readily available, are included in other assets. Marketable equity securities are classified as available-for-sale andthis deduction will be reported at fair value. Fair value is based on quoted market prices as of the end of the reporting period. Securities and investments for which market values are not readily available are carried at cost. Unrealized gains and losses are reported, net of their related tax effects, as a component of accumulated other comprehensivethe Company’s tax provision and will not have an effect on deferred tax assets and liabilities. The Department of the Treasury recently issued Proposed Tax Regulations with respect to theDeduction on Qualified Production Activities. The Company is evaluating the impact of the Proposed Tax Regulations and the FSP on its income (loss) in stockholders’ equity until sold. At the timetax provision and results of sale, any gains or losses are calculated by the specific identification method and recognized in other income or expense, respectively. Losses are also recognized in other expense when a decline in market value is deemed to be other than temporary.operations.

 

In December 2004, the FASB issued SFAS No. 153,Exchanges of Nonmonetary Assets. The provisions of this Statement are effective for nonmonetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. The provisions of this Statement should be applied prospectively, and eliminates the exception from fair value measurement for nonmonetary exchanges of similar productive assets in paragraph 21(b) of APB Opinion No. 29,Accounting for Nonmonetary Transactions, and replaces it with an exception for exchanges that do not have commercial substance. The adoption of this accounting pronouncement is not expected to have a material effect on the Company’s financial position and results of operations.

In November 2004, the FASB issued SFAS No. 151,Inventory Costs – an Amendment of ARB No. 43, Chapter 4. The standard requires abnormal amounts of idle facility and related expenses to be recognized as current period charges and also requires that allocation of fixed production overheads to the costs of conversion be based on the normal capacity of the production facilities. SFAS No. 151 is effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The Company is evaluating the impact this statement will have on its financial position and results of operations.

In December 2004, the FASB issued revised SFAS No. 123R (SFAS No. 123R),Share-Based Payment. This standard eliminates the ability to account for share-based compensation transactions using the intrinsic value-based method under APB Opinion No. 25,Accounting for Stock Issued to Employees, and requires instead that such transactions be accounted for using a fair-value-based method. In April 2005, the SEC delayed the effective date of SFAS No. 123R to financial statements issued for the first annual period beginning after June 15, 2005. The Company plans to adopt and comply with the requirements of SFAS No. 123R when it becomes effective January 1, 2006, and is evaluating the potential impact of this statement, which could have a material impact on the Company’s results of operations. Currently, the Company discloses the pro forma net income and related pro forma income per share information in accordance with SFAS No. 123,Accounting for Stock-Based Compensation, and SFAS No. 148,Accounting for Stock-Based Compensation-TransitionCompensation Costs—Transition and Disclosure the. The following table summarizes the Company’s results on a pro forma basis as if it had recorded compensation expense based upon the fair value at the grant date for awards under these plans consistent with the methodology prescribed under SFAS No. 123,Accounting for Stock-Based Compensation,, for the three and nine months ended September 30, 20042005 and 2003:2004:

 

  Three Months
Ended
September 30,


 Nine Months
Ended
September 30,


   Three Months Ended
September 30,


 Nine Months Ended
September 30,


 
  2004

 2003

 2004

 2003

   2005

 2004

 2005

 2004

 
  (dollars in millions, except per share data)   (dollars in millions, except per share data) 

Net Earnings:

      

As reported (including restricted stock amortization, net of related taxes of $3 and $3 for the three months ended September 30, 2004 and 2003, respectively; and of $10 and $8 for the nine months ended September 30, 2004 and 2003, respectively)

  $758  $906  $2,249  $2,600 

Deduct : Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects

   (39)  (55)  (86)  (126)

As reported

  $964  $758  $2,501  $2,249 

Total stock-based employee compensation expense, included in reported net earnings, net of related tax effects

   6   5   19   15 

Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects

   (26)  (34)  (88)  (104)
  


 


 


 


  


 


 


 


Pro forma

  $719  $851  $2,163  $2,474   $944  $729  $2,432  $2,160 
  


 


 


 


  


 


 


 


Basic earnings per share:

      

As reported

  $.39  $.47  $1.16  $1.34   $.49  $.39  $1.28  $1.16 

Pro forma

  $.37  $.44  $1.11  $1.28    .48   .38   1.25   1.11 

Diluted earnings per share:

      

As reported

  $.38  $.47  $1.14  $1.34   $.49  $.38  $1.27  $1.14 

Pro forma

  $.36  $.44  $1.10  $1.27    .48   .37   1.23   1.10 

With respect to the accounting treatment of retirement eligibility provisions of employee stock-based compensation awards, the Company has historically followed the nominal vesting period approach. Upon the adoption of SFAS No. 123R, the Company will follow the non-substantive vesting period approach and recognize compensation cost immediately for awards granted to retirement eligible employees, or over the period from the grant date to the date retirement eligibility is achieved. The impact of applying the non-substantive vesting period approach will not be material.

Note 2. Alliances and Investments

 

Sanofi-Aventis

 

The Company has agreements with Sanofi-Aventis (Sanofi) for the codevelopment and cocommercialization of AVAPRO*/AVALIDE*AVALIDE * (irbesartan), an angiotensin II receptor antagonist indicated for the treatment of hypertension, and PLAVIX* (clopidogrel), a platelet aggregation inhibitor. The worldwide alliance operates under the framework of two geographic territories; one in the Americas (principally the United States, Canada, Puerto Rico and Latin American countries) and Australia and the other in Europe and Asia. Accordingly, two territory partnerships were formed to manage central expenses, such as marketing, research and development and royalties, and to supply finished productsproduct 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 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 in the applicable territory.

 

The Company acts as the operating partner for the territory covering the Americas and Australia and owns a 50.1% majority controlling interest in the partnership within this territory. Sanofi’s ownership interest in the partnership within this territory is 49.9%. As such, the Company consolidates all country partnership results for this territory and records Sanofi’s share of the results as a minority interest, net of taxes, which was $149$152 million and $108$149 million for the three months ended September 30, 20042005 and 2003,2004, respectively, and $371$425 million and $230$371 million for the nine months ended September 30, 2005 and 2004, and 2003, respectively. For the three months ended September 30, 2004 and 2003, theThe Company recorded sales in this territory and in comarketing countries outside this territory (Germany, Italy, Spain and Greece) of $1,144$1,231 million

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 2. Alliances and Investments (Continued)

$1,143 million for the three months ended September 30, 2005 and $876 million,2004, respectively, and $3,040$3,467 million and $2,186$3,039 million for the nine months ended September 30, 20042005 and 2003,2004, respectively.

 

Sanofi acts as the operating partner of the territory covering Europe and Asia and owns a 50.1% majority financial controlling interest in the partnerships within this territory. The Company’s ownership interest in the partnerships within this territory is 49.9%. The Company accounts for the investment in partnership entities in this territory under the equity method and records its share of the results in equity in net income of affiliates in the consolidated statement of earnings. The Company’s share of net income from these partnership entities before taxes was $67$85 million and $61$67 million for the three months ended September 30, 20042005 and 2003,2004, respectively, and $201was $251 million and $157$201 million for the nine months ended September 30, 20042005 and 2003,2004, respectively.

 

In 2001, the Company and Sanofi formed an alliance for the copromotion of irbesartan, as part of which the Company contributed the irbesartan distribution rights in the United States and Sanofi paid the Company $150a total of $350 million in 2002 and $200 million in 2001.the two years ended December 31, 2002. The Company accounted for this transaction as a sale of an interest in a license and deferred and amortized the $350 million intoto other income over the expected useful life of the license, which is approximately eleven years. The Company recognized in other income of $8 million in each of the three-monththree month periods ended September 30, 20042005 and 20032004 and $24 million in each of the nine-monthnine month periods ended September 30, 20042005 and 2003.2004. The unamortized portion of the deferred income is recorded in the liabilities section of the consolidated balance sheet and was $224 million as of September 30, 2005 and $248 million as of December 31, 2004.

 

Otsuka

 

The Company has a worldwide commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote ABILIFY* (aripiprazole) for the treatment of schizophrenia and related psychoticpsychiatric disorders, except in Japan, China, Taiwan, North Korea, South Korea, the Philippines, Thailand, Indonesia, Pakistan, and Egypt. The Company began copromoting the product with Otsuka in the U.S. and Puerto Rico in November 2002. In the U.S. and Puerto Rico, the Company purchases products from Otsuka and performs finish manufacturing for supply to Otsuka’s U.S. affiliates. In June 2004, the Company received marketing approval from the European Commission. The product is currently copromoted with Otsuka in the United Kingdom, Germany and Germany,Spain, and will also copromote itbe copromoted in France. ABILIFY* is currently distributed exclusively by the Company in France and Spain.on a temporary basis until copromotion with Otsuka commences. The Company records alliance revenue for its 65% contractual share of theOtsuka’s net sales in these copromotion countries, excluding the United Kingdom, and records all expenses related to the product. Alliance revenue is recorded by the Company as net sales based upon 65% of Otsuka’s net sales in the copromotion countries. The Company recognizes this alliance revenue when ABILIFY* is shipped and all risks and rewards of ownership have transferred to Otsuka’s customers. In the UK, and in France until copromotion with Otsuka commences, the Company records 100% of the net sales and related cost of products sold.

 

The Company also has an exclusive right to sell ABILIFY* in a number of other countries in Europe, the Americas and Asia. In these countries as sales commence, the Company will recordrecords 100% of the net sales and related cost of products sold. Under the terms of the agreement, the Company purchases the product from Otsuka and performs finish manufacturing for sale by the Company to its customers. The agreement expires in November 2012 in the U.S. and Puerto Rico. For the countries in the European Union where the Company has thean exclusive right to sell ABILIFY*, the agreement expires on the tenth anniversary of the first commercial sale.in June 2014. In each other country where the Company has the exclusive right to sell ABILIFY*, the agreement expires on the later of the tenth anniversary of the first commercial sale in such country or expiration of the applicable patent in such country.

Note 2. Alliances and Investments (Continued)

 

The Company recorded revenue for ABILIFY* of $165$260 million and $101$165 million for the three months ended September 30, 20042005 and 2003,2004, respectively, and $402$688 million and $203$402 million for the nine months ended September 30, 20042005 and 2003,2004, respectively. Total milestone payments made to Otsuka from 1999under the agreement through September 20042005 were $217 million, of which $157 million was expensed as acquired in-process research and development in 1999.development. The remaining $60 million ofwas capitalized payments arein other intangible assets and is amortized intoin cost of products sold over the remaining life of the agreement in the U.S., which is approximatelyranging from eight to eleven years. IncludedThe Company amortized in cost of products sold $2 million and $1 million in the $60three months ended September 30, 2005 and 2004, respectively, and $5 million and $3 million in the nine months ended September 30, 2005 and 2004, respectively. The unamortized capitalized payment balance was $42 million as of capitalized payments is a $10September 30, 2005 and $47 million payment made in July 2004 for attainmentas of marketing approval by the European Union.December 31, 2004.

 

ImClone

 

The Company has a commercialization agreement expiring in September 2018 with ImClone Systems, Inc.Inc (ImClone), a biopharmaceutical company focused on developing targeted cancer treatments, for the codevelopment and copromotion of ERBITUX* in the United States. In February 2004, the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for ERBITUX* for use in combination with irinotecan in the treatment of patients with Epidermal Growth Factor Receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. In June 2004, the FDA approved ImClone’s Chemistry, Manufacturing and Controls supplemental BLA for licensure of its BB36 manufacturing facility. In accordance with the terms of the agreement, theThe Company paid ImClone $200 million, of

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 2. Alliances and Investments (Continued)

which $140 million was paid in March 2002 and $60 million was paid in March 2003. The Company paid $250 million in March 2004 as a milestone payment for the initial approval of ERBITUX*. An additional $250 million is payable upon FDA approval for use in treating an additional tumor type. In June 2004, the FDA approved ImClone’s Chemistry, Manufacturing and Controls supplemental BLA for licensure of its BB36 manufacturing facility. In August 2005, ImClone submitted a supplemental Biologics License Application (sBLA) to the FDA for approval of ERBITUX* in treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). The FDA decision is expected by February 2006, and if approved, the Company will pay ImClone the additional $250 million. Under the agreement, ImClone receives a distribution fee based on a flat rate of 39% of product revenues in North America. In addition, theThe Company also has codevelopment and copromotion rights with ImClone in CanadaCanada. In September 2005, Health Canada’s Biologics and Genetic Therapies Directorate approved ERBITUX* as a treatment for metastatic colorectal cancer. In addition, the Company has a 50% share of the codevelopment and copromotion rights ImClone has with Merck KGaA in Japan to the extent the product is commercialized in such countries.that country.

 

With respect to the $200 million of milestone payments the Company paid ImClone in 2002 and 2003, $160 million was expensed in the first quarter of 2002 as acquired in-process research and development, and $40 million was recorded as an additional equity investment to eliminate the income statement effect of the portion of the milestone payment for which the Company has an economic claim through its ownership interest in ImClone. The Company accounts for the $250 million approval milestone paid in March 2004 as a license acquisition and amortizes the payment into cost of products sold over the expected useful life of the license, which is approximately fourteen years. The Company amortized into cost of products sold $4 million for each of the three months ended September 30, 2005 and 2004, and $13 million and $10 million for the nine months ended September 30, 2005 and 2004, respectively. The unamortized portion of the approval payment is recorded in other intangibles, net and was $223 million as of September 30, 2005 and $236 million as of December 31, 2004.

The Company accounts for its investment in ImClone under the equity method and records its share of the results in equity in net income of affiliates in the consolidated statement of earnings. The Company’s recorded investment in ImClone common stock as of September 30, 2005 and December 31, 2004 was $66 million and $72 million, respectively, representing approximately 17% of the ImClone shares outstanding, respectively. On a per share basis, the carrying value of the ImClone investment and the closing market price of the ImClone shares as of September 30, 2005 were $4.56 and $31.45, respectively, compared to $5.03 and $46.08, respectively, as of December 31, 2004.

 

The Company determines its equity share in ImClone’s net income or loss by eliminating from ImClone’s results the milestone revenue ImClone recognizes for the pre-approval milestone payments that were recorded by the Company as additional equity investment. For the three and nine month periods ended September 30, 2004,its share of ImClone’s results of operations, the Company recorded net income of zero and $4 million and $2 million, respectively, for its share of ImClone’s net income. For the three and nine month periodsmonths ended September 30, 2003 the Company recorded2005 and 2004, respectively, and a net loss of $7$6 million and $33 million, respectively, for its share of ImClone’s net losses. The Company records its share of the results in equity in net income of affiliates in$1 million for the consolidated statement of earnings.nine months ended September 30, 2005 and 2004, respectively. The Company recorded net sales for ERBITUX* of $107 million and $84 million infor the three months ended September 30, 2005 and 2004, respectively and $292 million and $173 million since its approval byfor the FDA in February 2004.

The Company’s recorded investment in ImClone common stock as ofnine months ended September 30, 2004 was $65 million. On a per share basis, the carrying value of the ImClone investment2005 and the closing market price of the ImClone shares as of September 30, 2004, were $4.51 and $52.85, respectively.

 

Merck

 

In April 2004, the Company entered into a collaboration agreement with Merck & Co., Inc. (Merck) for worldwide codevelopment and copromotion for muraglitazar,PARGLUVA™ (muraglitazar), the Company’s dual PPAR (peroxisome proliferator activated receptor) agonist, currently in Phase III clinical development for use in treating Typetype 2 diabetes. Under the terms of the agreement, the Company received a $100 million upfront payment in May 2004 and a $55 million milestone payment in January 2005 for submission of the

Note 2. Alliances and Investments (Continued)

New Drug Application (NDA) and is entitled to receive $275$220 million in additional payments upon achievement of certain regulatory milestones. Themilestones, including $100 million for FDA approval of muraglitazar. Under the terms of agreement, the Company and Merck willagreed to jointly develop the clinical and marketing strategy for muraglitazar, share equally in future development and commercialization costs and copromote the product to physicians on a global basis, with Merck to receive payments based on net sales levels. A New Drug Application (NDA) for muraglitazar is expected to be

In December 2004 the Company submitted an NDA to the FDA for regulatory approval of muraglitazar. In September 2005, the Company and Merck announced the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of muraglitazar for the treatment of type 2 diabetes, for use as a monotherapy and in combination with metformin. On October 18, 2005, the FDA issued an approvable letter for muraglitazar requesting additional information from ongoing clinical trials to more fully address the cardiovascular safety profile of muraglitazar. The Company determined that to receive regulatory approval and to achieve commercial success, additional studies may be required because ongoing muraglitazar trials are not designed to answer the questions raised by the endFDA. The additional studies may take approximately five years to complete. The Company will continue discussions with the FDA. Merck advised the Company of 2004 for United States regulatory approval.their intent to terminate the agreement and the Company has agreed to begin discussions to terminate the agreement. The Company is in the process of evaluating a range of options including conducting additional studies or terminating further development of muraglitazar.

 

The upfront paymentand milestone payments of $100$155 million, received waswhich are non-refundable, were deferred and isare being amortized intoto other income over the expected remaining useful life of the agreement which is approximately sixteen years. In the three and nine months ended September 30, 2004, theThe Company recognized $2 million of these payments in other income for each of the three month periods ended September 30, 2005 and September 30, 2004, respectively, and $7 million and $3 million in other income, respectively. In addition, the Company records Merck’s share of codevelopment costs as a reduction to research and development expense and Merck’s share of copromotion costs as a reduction to advertising and product promotion expense. For the three months ended September 30, 2004, the Company recorded $23 million and $1 million as a reduction to its research and development and advertising and product promotion expenses, respectively. Forfor the nine months ended September 30, 2005 and 2004, respectively. The unamortized portion of the Companymilestone payment is recorded $56 millionin other liabilities and $3was $144 million as a reduction to its researchof September 30, 2005 and development and advertising and product promotion expenses, respectively.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)$151 million as of December 31, 2004.

 

Note 3. Restructuring and Other Items

 

In the third quarter of 2004,2005, the Company recorded pre-tax charges of $2 million related to employee termination benefits for approximately 13 selling and administrative personnel and asset impairment charges, which were offset by a $7 million adjustment reflecting a change in estimate for restructuring actions taken in prior periods.

The following table presents a detail of the charges by segment and type for the three months ended September 30, 2005. The Company expects to substantially complete these activities by late 2005.

   Employees

  

Termination

Benefits


  

Asset

Write-Downs


  Total

 
   (dollars in millions) 

Pharmaceuticals

  —    $—    $1  $1 

Nutritionals

  13   1   —     1 

Changes in estimates

  —     (7)  —     (7)
   
  


 

  


Restructuring as reflected in the statement of earnings

  13  $(6) $1  $(5)
   
  


 

  


In the nine months ended September 30, 2005, the Company recorded pre-tax chargecharges of $59$8 million related to the termination benefits and other related costs for workforce reductions and downsizing and streamlining of worldwide operations primarily in Latin America, Europe, the United States, CanadaAfrica and Puerto Rico.Asia. Of this charge, $58these charges, $6 million relatesrelated to employee termination benefits and related expenses for approximately 1,060122 selling and administrative manufacturing and research and development personnel, $1 million related to retention bonuses and $1 million relatesrelated to the consolidation of certain research facilities.asset impairments. These charges were partially offset by an $8 million adjustment toreflecting changes in estimates for restructuring actions taken in prior period restructuring reserve of $2 million, primarily due to a reduction of estimated separation expenses.periods.

 

The following table presents a detail of the charges by segment and type for the threenine months ended September 30, 2004.2005. The Company expects to substantially complete these activities by late 2004.2005.

 

   Employees

  Termination
Benefits


  Relocation
and
Retention


  Total

 
      (dollars in million) 

Pharmaceuticals

  1,060  $58  $1  $59 

Other Healthcare

  —     —     —     —   

Corporate/Other

  —     —     —     —   
   
  

  

  


   1,060  $58  $1   59 
   
  

  

     

Reduction of reserves for changes in estimates

              (2)
              


Restructuring and other as reflected in the statement of earnings

             $57 
              


   Employees

  

Termination

Benefits


  

Other

Exit Costs


  

Relocation

and Retention


  

Asset

Write-Downs


  Total

 
   (dollars in millions) 

Pharmaceuticals

  102  $3  $1  $1  $1  $6 

Nutritionals

  13   1   —     —     —     1 

Related Healthcare

  7   1   —     —     —     1 

Changes in estimates

  —     (7)  (1)  —     —     (8)
   
  


 


 

  

  


Restructuring as reflected in the statement of earnings

  122  $(2) $—    $1  $1  $ —   
   
  


 


 

  

  


Note 3. Restructuring (Continued)

 

In addition, the Company also recorded $48 million in accelerated depreciation, including $47 million as cost of products sold, and $1 million as research and development related to the closure of certain manufacturing facilities in North America and Europe expected to be closed by the end of 2006. The Company also recorded a $10 million upfront milestone payment, as research and development expense, to Solvay Pharmaceuticals (Solvay) as part of a worldwide codevelopment and cocommercialization agreement.

 

In the secondthird quarter of 2004, the Company recorded a pre-tax chargecharges of $11$59 million related to the termination benefits and other related costs for workforce reductions and downsizing and streamlining of worldwide operations primarily in the United States, Canada, Europe and Puerto Rico. Of this charge, $9these charges, $58 million was related to employee termination benefits and related expenses for approximately 1201,060 selling, administrative and manufacturing personnel, and $2$1 million related to the consolidation of certain research facilities. These charges were partially offset by ana $2 million adjustment toreflecting changes in estimates for restructuring actions taken in prior periodperiods.

The following table presents a detail of the charges by segment and type for the three months ended September 30, 2004. The Company has substantially completed these restructuring reserve of $5 million, primarily due to a reduction of estimated separation expenses. In addition, the Company also recorded $11 million in accelerated depreciation as cost of products sold related to the closure of certain manufacturing facilities in North America expected to be closed by the end of 2006, and a $25 million milestone payment to Pierre Fabre Medicament S.A. (Pierre Fabre) as part of an in-license agreement related to JAVLOR*, a novel investigational anti-cancer agent, as research and development expense.activities.

   Employees

  

Termination

Benefits


  

Other

Exit Costs


  

Relocation

and Retention


  Total

 
   (dollars in millions) 

Pharmaceuticals

  1,060  $58  $—    $1  $59 

Changes in estimates

  —     —     (2)  —     (2)
   
  

  


 

  


Restructuring as reflected in the statement of earnings

  1,060  $58  $(2) $1  $57 
   
  

  


 

  


 

In the first quarter ofnine months ended September 30, 2004, the Company recorded a pre-tax chargecharges of $12$82 million related to the termination benefits and other related costs for workforce reductions and downsizing and streamlining of worldwide operations primarily in Israel, and the United States.States, Canada, Europe and Puerto Rico. Of this charge, $9these charges, $75 million was primarily related to employee termination benefits and related expenses for approximately 901,270 selling, administrative and administrativemanufacturing personnel, and $3$1 million related to relocation expenses and retention benefits. Additionally, the Company also recorded $17 million in accelerated depreciation and asset impairments, $5 million of which $13 million was recorded to cost of products sold, and $4 million to other expense net, related to the closureconsolidation of certain manufacturingresearch facilities in North America expected to be closed by the end of 2006. These assets will continue to be depreciated until the facility closures are complete. The Company also paid $5 million to Flamel Technologies S.A. (Flamel) as part of an in-license agreement related to the product Basulin, which was recorded as research and development expense. The in-license agreement with Flamel was terminated in September 2004.

In the third quarter of 2003, the Company recorded $31 million of pre-tax charges related to the downsizing and streamlining of worldwide operations and $7 million related to relocation expenses. The charges related to downsizing and streamlining of worldwide operations included $9 million related to termination benefits for workforce reductions of approximately 100 employees in the Other Healthcare and Pharmaceuticals segments due to the rationalization of worldwide operations in Europe, North America, and Central America, $21 million of accelerated depreciation of assets in manufacturing facilities in North America expected to be closed by the end of 2006 recorded in cost of products sold and $1 million forof retention benefits. The charge of $9 million wasbonuses. These charges were partially offset by a gain$7 million adjustment reflecting changes in estimates for restructuring actions taken in prior periods.

The following table presents a detail of $3 million from the sale of assets previously written off. In addition,charges by segment and type for the Company recorded $21 million in research and development related to the up-front payments for two licensing agreements.nine months ended September 30, 2004. The Company also reported $1 million for a milestone payment received related to a developmental project sold in previous years.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)has substantially completed these restructuring activities.

 

Note 3. Restructuring and Other Items (Continued)

In the second quarter of 2003, the Company recorded $18 million of pre-tax charges related to the rationalization of its manufacturing facilities, including $13 million related to termination benefits for workforce reductions of approximately 430 manufacturing employees in the Pharmaceutical segment and downsizing and streamlining of worldwide manufacturing operations and $5 million related to relocation expenses and retention benefits. The charge of $18 million was offset by an adjustment to prior period restructuring reserves of $25 million primarily due to higher than anticipated recovery on assets previously written off as restructuring, and a reduction of estimated separation expenses. The Company also recorded $11 million primarily related to accelerated depreciation for certain manufacturing facilities in North America expected to be closed by the end of 2006 recorded in cost of products sold. These assets will continue to be depreciated until the facility closures are complete.

In the first quarter of 2003, the Company recorded a pre-tax charge of $12 million, related to termination benefits for workforce reductions of 340 manufacturing employees in the Pharmaceuticals segment and downsizing and streamlining of worldwide manufacturing operations. In addition, the Company recorded $10 million in cost of products sold for asset impairments and $4 million in cost of products sold for accelerated depreciation of certain manufacturing facilities in North America that were closed in April 2004.

   Employees

  

Termination

Benefits


  

Other

Exit Costs


  

Asset

Write-Downs


  

Relocation

and Retention


  Total

 
   (dollars in millions) 

Pharmaceuticals

  1,212  $67  $3  $1  $6  $77 

Related Healthcare

  15   2   —     —     —     2 

Corporate/Other

  43   3   —     —     —     3 

Changes in estimates

  —     (3)  (3)  (1)  —     (7)
   
  


 


 


 

  


Restructuring as reflected in the statement of earnings

  1,270  $69  $—    $—    $6  $75 
   
  


 


 


 

  


 

Restructuring charges and spending against accrued liabilities associated with prior and current actions are as follows:

 

  Employee
Termination
Liability


 Other Exit Cost
Liability


 Total

   

Employee

Termination

Liability


 

Other Exit Costs

Liability


 Total

 
  (dollars in millions) 

Balance at December 31, 2002

  $67  $42  $109 

Charges

   47   3   50 

Spending

   (56)  (35)  (91)

Changes in estimate

   (7)  (3)  (10)
  


 


 


  (dollars in millions) 

Balance at December 31, 2003

   51   7   58   $51  $7  $58 

Charges

   71   4   75    102   5   107 

Spending

   (28)  (7)  (35)   (68)  (9)  (77)

Changes in estimate

   (6)  —     (6)

Changes in estimates

   (8)  —     (8)
  


 


 


  


 


 


Balance at September 30, 2004

  $88  $4  $92 

Balance at December 31, 2004

   77   3   80 

Charges

   5   1   6 

Spending

   (38)  (3)  (41)

Changes in estimates

   (7)  (1)  (8)
  


 


 


  


 


 


Balance at September 30, 2005

  $37  $—    $37 
  


 


 


Note 4. Acquisitions and Divestitures

 

In February 2004,September 2005, the Company entered into a definitive agreement to sell its inventory, trademark, patent and intellectual property rights related to DOVONEX in the United States to Warner Chilcott Company, Inc. for $200 million in cash. In addition, the Company will receive a royalty based on 5% of net sales of DOVONEX through the end of 2007. The transaction is expected to close in early 2006, subject to customary regulatory approvals.

In the third quarter of 2005, the Company completed the divestituresale of its Adult Nutritional BusinessU.S. and Canadian Consumer Medicines business and related assets (Consumer Medicines) to Novartis AG (Novartis). Under the terms of the agreement, Novartis acquired the trademarks, patents and intellectual property rights of Consumer Medicines for $387$661 million in cash, including $20the impact of a working capital adjustment, of which $15 million contingent onis attributable to a post-closing supply arrangement between the achievementCompany and Novartis. The related assets include the rights to the U.S. Consumer Medicines brands in Latin America, Europe, the Middle East and Africa. The transaction was accounted for in accordance with SFAS No. 144,Accounting for the Impairment or Disposal of contractual requirements andLong-Lived Assets. The results of operations of Consumer Medicines are included in the Company’s consolidated statement of earnings up to the date of disposal. As a $22 million upfront payment for a supply agreement. Theresult of this transaction, the Company recorded a preliminary pre-tax gain of $316$569 million which included($370 million net of tax) in the $20 million payment received as a resultthird quarter of the satisfaction of contractual requirements, and a $5 million reduction in Company goodwill associated with the Mead Johnson product lines. The Company will record future adjustments to the gain upon the satisfaction of other post-closing matters.2005.

 

In April 2004, the Company completed the acquisition of Acordis Speciality Fibres (Acordis), which is headquartered in the United Kingdom and supplies materials to ConvaTec for its Wound Therapeutics line. The acquisition is expected to strengthen the Company’s leadership position in wound therapies.. The Company purchased all the stock of Acordis for $150 million and incurred $8 million of acquisition costs in connection with the transaction. An additional $10 million payment is contingent on the achievement of future salesproduction volumes. The purchase price for the acquisition was allocated to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values at the acquisition date. Of the $158 million, $63 million was allocated to in-process research and development, which represents the estimated fair value of acquired in-process projects, consisting primarily of Medicel, a wound therapeutics product, which had not yet reached technological feasibility and had no alternative future use, and was therefore written off. The estimated fair value of these projects was determined by employment of a discounted cash flow model;immediately expensed, and $22 million was assigned to identifiable intangible assets, predominantly patents. The excess of the purchase price over the estimated fair values of net assets acquired was approximately $73 million and was recorded as goodwill. This acquisition was accounted for by the purchase method, and, accordingly, results of operations have been included in the accompanying consolidated financial statements from the date of acquisition.

In February 2004, the Company completed the divestiture of its Adult Nutritional business to Novartis for $386 million, including $20 million contingent on the achievement of contractual requirements, which were satisfied, and a $22 million upfront payment for a supply agreement. The Company recorded a total pre-tax gain of $320 million ($198 million net of tax), which included the $20 million contingent payment and a $5 million reduction in Company goodwill associated with the Mead Johnson product lines.

BRISTOL-MYERS SQUIBB COMPANYNote 5. Discontinued Operations

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)In May 2005, the Company completed the sale of Oncology Therapeutics Network (OTN) to One Equity Partners LLC for cash proceeds of $197 million, including the impact of a working capital adjustment. The Company recorded a pre-tax gain of $63 million ($13 million net of tax), presented as a gain on sale of discontinued operations in the consolidated statement of earnings.

The following amounts related to the OTN business have been segregated from continuing operations and reported as discontinued operations through the date of disposition, and do not reflect costs of certain services provided to OTN by the Company. Such costs, which were not allocated by the Company to OTN, were for services which included legal counsel, insurance, external audit fees, payroll processing, and certain human resource services and information technology systems support.

   Three Months Ended
September 30,


  Nine Months Ended
September 30,


   2005

  2004

  2005

  2004

   (dollars in millions)

Net sales

  $—    $649  $1,015  $1,815

Earnings/(loss) before income taxes

   —     5   (8)  16

Net earnings/(loss) from discontinued operations

   —     3   (5)  10

The consolidated statement of cash flows includes the OTN business through the date of disposition. The Company uses a centralized approach to the cash management and financing of its operations and accordingly, debt was not allocated to this business. Cash flows from operating and investing activities of discontinued operations consist of outflows of $265 million and inflows of $90 million for the nine months ended September 30, 2005 and 2004, respectively.

Note 5.6. Earnings Per Share

 

The numerator for basic earnings per share is net earnings less preferred stock dividends.available to common stockholders. The numerator for diluted earnings per share is net earnings plusavailable to common stockholders with interest expense onadded back for the assumed conversion of the convertible debt net of tax, less preferred stock dividends.into common stock. The denominator for basic earnings per common share is the weighted average number of common sharesstock outstanding during the period. The denominator for diluted earnings per common share is the weighted average number of common shares outstanding duringadjusted for the period, plus the incremental shares outstanding assuming the exerciseeffect of dilutive stock options and assumed conversion of the convertible debt bonds.into common stock. The computations for basic and diluted earnings per common share are as follows:

 

  Three Months
Ended
September 30,


  Nine Months
Ended
September 30,


  Three Months Ended
September 30,


  Nine Months Ended
September 30,


  2004

  2003

  2004

  2003

  2005

  2004

  2005

 2004

  (in millions, except per share data)  (dollars in millions, except per share amounts)

Basic:

                     

Earnings from Continuing Operations

  $964  $755  $2,493  $2,239

Discontinued Operations

         

Net Earnings

   —     3   (5)  10

Net Gain on Disposal

   —     —     13   —  
  

  

  


 

Net Earnings

  $758  $906  $2,249  $2,600  $964  $758  $2,501  $2,249
  

  

  

  

  

  

  


 

Basic Earnings Per Share:

         

Average Common Shares Outstanding

   1,942   1,937   1,941   1,936   1,953   1,942   1,951   1,941
  

  

  

  

Net Earnings per Share

  $.39  $.47  $1.16  $1.34

Earnings from Continuing Operations

  $.49  $.39  $1.28  $1.16

Discontinued Operations

         

Net Earnings

   —     —     —     —  

Net Gain on Disposal

   —     —     —     —  
  

  

  


 

Net Earnings per Common Share

  $.49  $.39  $1.28  $1.16
  

  

  

  

  

  

  


 

Diluted:

                     

Earnings from Continuing Operations

  $964  $755  $2,493  $2,239

Interest expense on conversion of convertible debt bonds, net of tax

   6   1   15   4

Discontinued Operations

         

Net Earnings

  $758  $906  $2,249  $2,600   —     3   (5)  10

Interest Expense on Convertible Debt, net of tax

   1   —     4   —  

Net Gain on Disposal

   —     —     13   —  
  

  

  


 

Net Earnings

  $970  $759  $2,516  $2,253
  

  

  


 

Diluted Earnings Per Share:

         

Average Common Shares Outstanding

   1,953   1,942   1,951   1,941

Conversion of convertible debt bonds

   29   29   29   29

Incremental shares outstanding assuming the exercise of dilutive stock options

   2   4   3   5
  

  

  

  

  

  

  


 

  $759  $906  $2,253  $2,600   1,984   1,975   1,983   1,975
  

  

  

  

  

  

  


 

Average Common Shares Outstanding

   1,942   1,937   1,941   1,936

Assumed conversion of Convertible Debt Bonds

   29   —     29   —  

Incremental Shares Outstanding Assuming the Exercise of Dilutive Stock Options

   4   7   5   6
  

  

  

  

Earnings from Continuing Operations

  $.49  $.38  $1.27  $1.14

Discontinued Operations

         

Net Earnings

   —     —     —     —  

Net Gain on Disposal

   —     —     —     —  
   1,975   1,944   1,975   1,942  

  

  


 

Net Earnings per Common Share

  $.49  $.38  $1.27  $1.14
  

  

  

  

  

  

  


 

Net Earnings per Share

  $.38  $.47  $1.14  $1.34
  

  

  

  

 

Weighted-average shares issuable upon the exercise of stock options, which were not included in the diluted earnings per share calculation because they were not dilutive, were 139 million for the three and nine month periods ended September 30, 2005 and 129 million for the three and nine month periods ended September 30, 2004 and 116 million for the three and nine month periods ended September 30, 2003.2004.

Note 6.7. Other (Income)/Expense, Net

 

The components of other (income)/expense, net are:

 

  Three Months
Ended
September 30,


 Nine Months
Ended
September 30,


   Three Months Ended
September 30,


 Nine Months Ended
September 30,


 
  2004

 2003

 2004

 2003

   2005

 2004

 2005

 2004

 
  (dollars in millions)   (dollars in millions) 

Interest expense

  $80  $48  $219  $207   $79  $80  $249  $219 

Interest income

   (28)  (15)  (67)  (47)   (28)  (29)  (96)  (67)

Foreign exchange transaction (gains)/losses, net

   (20)  44   35   10 

Foreign exchange transaction (gains)/losses

   —     (20)  47   35 

Other, net

   (15)  2   (125)  7    (13)  (15)  (32)  (125)
  


 


 


 


  


 


 


 


Other expense, net

  $17  $79  $62  $177   $38  $16  $168  $62 
  


 


 


 


  


 


 


 


 

Interest expense was reduced by net interest rate swap gains of $39$7 million and $33$39 million for the three months ended September 30, 20042005 and 2003,2004, respectively, and $120$50 million and $79$120 million for the nine months ended September 30, 20042005 and 2003,2004, respectively. Interest income relates primarily to cash, cash equivalents and investments in marketable securities. Other income includes income from third-party contract manufacturing, royalty income, gains and losses on disposal of investments and property, plant and equipment and debt securities.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)retirement costs.

 

Note 7.8. Income Taxes

 

The effective income tax rate on earnings from continuing operations before minority interest and income taxes was 31.2% and 20.5% for the three and nine months ended September 30, 2005, respectively, compared with 20.9% and 22.4%22.3% for the three and nine months ended September 30, 2004, respectively, compared with 25.4% and 24.5%respectively. The higher effective tax rate for the three months ended September 30, 2005 was due primarily to a higher concentration of pre-tax earnings in the U.S. and Canada attributable to the sale of Consumer Medicines and lower foreign tax credits. The lower effective tax rate for the nine months ended September 30, 2003, respectively. The lower effective2005 was due primarily to a tax rate was primarily drivenbenefit associated with the release of contingency reserves resulting from the settlement of examinations by lower earningsthe Internal Revenue Service for the years 1998 through 2001, a change in estimate related to the reduction of a deferred tax provision established in the U.S. as a resultfourth quarter of increased reserves2004 for litigation and restructuring, and product exclusivity losses. The rate was also affected by the favorable resolution of certain tax contingencies.

Congress recently approvedspecial dividends under the American Jobs Creation Act of 2004 (the “Jobs Creation Act”). The Jobs Creation Act contains a number(AJCA), partially offset by higher taxes on the sale of provisions that might affectConsumer Medicines, lower foreign tax credits, and the Company’s future effective tax rate. The most significant provision would allowunfavorable treatment of certain litigation reserves.

In the fourth quarter of 2004, the Company to elect to deduct from its taxable income 85% of certain eligible dividends received by the Company from non-U.S. subsidiaries before the end of 2005 if those dividends are reinvested in the U.S. for eligible purposes. The Company estimatesdisclosed that up toit anticipated repatriating approximately $9 billion in special dividends in 2005 and recorded a $575 million provision for deferred taxes pursuant to the AJCA as enacted and other pending matters. In the first quarter of 2005, the Company repatriated approximately $6.2 billion in special dividends from its non-U.S.foreign subsidiaries could potentially be eligible for this deduction. The Company is currently evaluatingand anticipates repatriating the amountremainder of such eligible dividends that its non-U.S. subsidiaries will remit. The Company anticipates accruing a provision for taxes associated with eligible dividendsthe $9 billion in the fourth quarter of 2004. Pending resolution of certain matters, and subject to further guidance from the Department of the Treasury, the Company estimates that such provision for taxes would be 5.25% of the amount of eligible dividends.2005. The Company is also evaluating the impact the Jobs Creation Act will have on its effective tax rate for 2004, 2005 and later years.

To the extent the Company determinesexpects that it will make qualifying remittances,use the special dividends in accordance with requirements established by the AJCA and the U.S. Treasury Department. During the second quarter of 2005, the U.S. Treasury Department issued AJCA related guidance clarifying that the “gross-up” for foreign taxes associated with the special dividends also qualifies for the 5.25% tax rate established by the AJCA. As a result of this guidance, the Company reduced the $575 million provision by recording a benefit of approximately $135 million in its tax provision for the second quarter of 2005. Except for earnings associated with the special dividends discussed above, U.S. income taxes willhave not bebeen provided on the balance of unremitted earnings of non-U.S. subsidiaries, since it continuesthe Company has invested or expects to be management’s practice and intent to keep theseinvest such earnings permanently invested offshore.

 

Note 8.9. Inventories

 

The major categories of inventories follow:

 

  September 30,
2004


  December 31,
2003


  

September 30,

2005


  

December 31,

2004


  (dollars in millions)  (dollars in millions)

Finished goods

  $1,023  $1,001  $916  $1,097

Work in process

   483   416   789   458

Raw and packaging materials

   257   180   348   275

Consignment inventory

   2   4
  

  

  

  

  $1,765  $1,601  $2,053  $1,830
  

  

  

  

The Company has acquired raw and bulk materials in preparation for the manufacturing of potential products in anticipation of their commercialization. If regulatory approval is not granted or delayed, the value of inventory could be impaired. As of September 30, 2005, the carrying value of these inventories were $125 million and no allowance has been provided. Of the total carrying value of inventories that could be impaired, ORENCIA®, a biologic compound proposed for the treatment of rheumatoid arthritis which the Company has filed a BLA with the FDA and is awaiting FDA’s actions, represents a significant portion of the total.

15


Note 9.10. Property, Plant and Equipment

 

The major categories of property, plant and equipment follow:

 

   September 30,
2004


  December 31,
2003


   (dollars in millions)

Land

  $258  $241

Buildings

   4,490   3,917

Machinery, equipment and fixtures

   4,433   4,197

Construction in progress

   565   1,087
   

  

    9,746   9,442

Less: Accumulated depreciation

   4,091   3,730
   

  

Property, plant and equipment, net

  $5,655  $5,712
   

  

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

   

September 30,

2005


  

December 31,

2004


   (dollars in millions)

Land

  $282  $290

Buildings

   4,533   4,497

Machinery, equipment and fixtures

   4,519   4,686

Construction in progress

   578   536
   

  

    9,912   10,009

Less accumulated depreciation

   4,263   4,244
   

  

Property, plant and equipment, net

  $5,649  $5,765
   

  

 

Note 10.11. Goodwill

 

The changes in the carrying amount of goodwill for the year ended December 31, 20032004 and the nine months ended September 30, 2004,2005 were as follows:

 

   Pharmaceuticals
Segment


  Nutritionals
Segment


  Other
Healthcare
Segment


  Total

 
   (dollars in millions) 

Balance as of December 31, 2002 and 2003

  $4,528  $118  $190  $4,836 

Divestiture of Adult Nutritional Business

   —     (5)  —     (5)

Acquisition of Acordis Speciality Fibres and other businesses

   —     —     77   77 
   

  


 

  


Balance as of September 30, 2004

  $4,528  $113  $267  $4,908 
   

  


 

  


   

Pharmaceuticals

Segment


  

Nutritionals

Segment


  

Related

Healthcare

Segment


  Discontinued
Operations


  Total

 
   (dollars in millions) 

Balance as of December 31, 2003

  $4,448  $118  $190  $80  $4,836 

Purchase accounting adjustments:

                     

Reduction due to sale of Adult Nutritional Business

   —     (5)  —     —     (5)

Purchase price and allocation adjustments

   —     —     74   —     74 
   

  


 


 


 


Balance as of December 31, 2004

   4,448   113   264   80   4,905 

Purchase accounting adjustments:

                     

Reduction due to sale of OTN

   —     —     —     (80)  (80)

Reduction due to sale of Consumer Medicines

   —     —     (1)  —     (1)
   

  


 


 


 


Balance as of September 30, 2005

  $4,448  $113  $263  $—    $4,824 
   

  


 


 


 


 

Note 11.12. Other Intangible Assets

 

As of September 30, 20042005 and December 31, 2003,2004, other intangible assets consisted of the following:

 

  September 30,
2004


  December 31,
2003


  

September 30,

2005


  

December 31,

2004


  (dollars in millions)  (dollars in millions)

Patents / Trademarks

  $275  $253  $270  $278

Less accumulated amortization

   106   90
  

  

Patents / Trademarks, net

   164   188
  

  

Licenses

   531   248   459   523

Less accumulated amortization

   106   116
  

  

Licenses, net

   353   407
  

  

Technology

   1,783   1,783   1,787   1,787

Less accumulated amortization

   636   516
  

  

  

  

Technology, net

   1,151   1,271
   2,589   2,284  

  

Less: Accumulated amortization

   668   552

Capitalized Software

   714   710

Less accumulated amortization

   394   316
  

  

  

  

Net Carrying Amount

  $1,921  $1,732

Capitalized Software, net

   320   394
  

  

  

  

Total other intangible assets, net

  $1,988  $2,260
  

  

Note 12. Other Intangible Assets (Continued)

 

Amortization expense for other intangible assets (the majority of which is included in cost of products sold) for the three months ended September 30, 2005 and 2004 and 2003 was $59$84 million and $58$83 million, respectively, and for the nine months ended September 30, 2005 and 2004 and 2003 was $163$263 million and $176$227 million, respectively.

Expected amortization expense related to the current net carrying amount of other intangible assets is as follows:

 

  (dollars in millions)

  (dollars in millions)

For the year ended December 31:

      

2004

  $59

2005

   234  352

2006

   231  347

2007

   230  321

2008

   229  267

2009 and thereafter

   938

2009

  235

Later Years

  738

 

Note 12.13. Short-term Borrowings and Long-term Debt

Short-term borrowings were $277 million at September 30, 2005, compared with $1,883 million at December 31, 2004, primarily as result of the retirement of U.S. commercial paper. The balance of commercial paper outstanding at December 31, 2004 was $1,665 million, with an average interest rate of 2.3% per annum.

Long-term debt was $5,895 million at September 30, 2005 compared to $8,463 million at December 31, 2004. During the second quarter of 2005, the Company repurchased all of its outstanding $2.5 billion aggregate principal amount 4.75% Notes due 2006, and incurred an aggregate pre-tax loss of approximately $69 million in connection with the early redemption of the Notes and termination of related interest rate swaps.

In August 2005 a wholly-owned subsidiary of the Company entered into a new $2.5 billion term loan facility with a syndicate of lenders. Borrowings under this facility will be guaranteed by the Company, the subsidiaries of the borrower and by certain European subsidiaries of the Company. This facility contains a five-year tranche of up to $2.0 billion and a two-year tranche of up to $500 million. The Company is subject to substantially the same covenants as those included in its December 2004 Revolving Credit facility. The Company is also subject to further restrictions, including certain financial covenants. Prior to borrowing any proceeds against the facility, the Company obtained a waiver from the lenders for a covenant default under this facility due to a one-time intercompany distribution.

Note 14. Accumulated Other Comprehensive Income (Loss)

 

   Foreign
Currency
Translation


  Available
for Sale
Securities


  Deferred
Loss on
Effective
Hedges


  Minimum
Pension
Liability
Adjustment


  Total
Accumulated Other
Comprehensive Loss


 
   (dollars in millions) 

Balance at December 31, 2003

  $(491) $24  $(258) $(130) $(855)

Other comprehensive income (loss)

   63   (7)  109   —     165 
   


 


 


 


 


Balance at September 30, 2004

  $(428) $17  $(149) $(130) $(690)
   


 


 


 


 


The accumulated balances related to each component of other comprehensive income (loss) are as follows:

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
   

Foreign

Currency

Translation


  

Deferred

Loss on

Effective

Hedges


  

Available

for Sale

Securities


  

Minimum

Pension

Liability

Adjustment


  

Total

Accumulated Other

Comprehensive Loss


 
   (dollars in millions) 

Balance at December 31, 2003

  $(491) $(258) $24  $(130) $(855)

Other comprehensive income (loss)

   63   109   (7)  —     165 
   


 


 


 


 


Balance at September 30, 2004

  $(428) $(149) $17  $(130) $(690)
   


 


 


 


 


Balance at December 31, 2004

  $(283) $(309) $23  $(223) $(792)

Other comprehensive income (loss)

   (211)  283   (20)  —     52 
   


 


 


 


 


Balance at September 30, 2005

  $(494) $(26) $3  $(223) $(740)
   


 


 


 


 


(UNAUDITED)

Note 13.15. Business Segments

 

The Company has fourthree reportable segments—Pharmaceuticals, Oncology Therapeutics Network, Nutritionals and OtherRelated Healthcare. The Pharmaceuticals segment is comprised of the global pharmaceutical and international (excluding Japan) consumer medicines businesses. The Oncology Therapeutics Network segment is a specialty distributor of anticancer medicines and related products. The Nutritionals segment consists of Mead Johnson, Nutritionals, primarily an infant formula business. The OtherRelated Healthcare segment consists of the ConvaTec, Medical Imaging and Consumer Medicines (United States and Japan)Canada) businesses.

   Three Months Ended September 30,

  Nine Months Ended September 30,

 
   Net Sales

  Earnings Before
Minority Interest
and Income Taxes


  Net Sales

  Earnings Before
Minority Interest
and Income Taxes


 
   (dollars in millions) 
   2004

  2003

  2004

  2003

  2004

  2003

  2004

  2003

 

Pharmaceuticals

  $3,831  $3,847  $1,120  $1,205  $11,353  $10,843  $3,282  $3,318 

Oncology Therapeutics Network

   649   574   4   6   1,815   1,652   15   14 

Nutritionals

   484   518   126   155   1,496   1,497   466   399 

Other Healthcare

   463   433   138   115   1,374   1,237   423   298 
   

  

  


 


 

  

  


 


Total Segments

   5,427   5,372   1,388   1,481   16,038   15,229   4,186   4,029 

Corporate/Other

   —     —     (237)  (120)  —     —     (791)  (258)
   

  

  


 


 

  

  


 


Total Company

  $5,427  $5,372  $1,151  $1,361  $16,038  $15,299  $3,395  $3,771 
   

  

  


 


 

  

  


 


Corporate/Other consists principally consists of interest expense,income, interest income,expense, certain administrative expenses litigation matters and allocations to the segments.business segments for certain programs. In the nine months ended September 30, 2004, Pharmaceuticals and Corporate/Other includethird quarter of 2005, the following items: Pharmaceuticals—$75 million of accelerated depreciation for certain manufacturing facilities in North America expected to be closed by 2006 and $6 million of relocation expenses and retention benefits. Corporate/Other—$491 million for litigation and other legal matters, $63 million write-off of acquired in-process research and development forCompany completed the Acordis transaction, $40 million of milestone payments primarily to Pierre Fabre and Solvay, and $70 million of charges primarily related to the downsizing and streamlining of worldwide operations, partially offset by $316 million of pre-tax gain on sale of its Consumer Medicines business of which the Mead Johnson Adult Nutritional business.gain was recorded in Corporate/Other. For additional information on the sale of Consumer Medicines, see “—Note 4. Acquisitions and Divestitures.”

 

In the nine months ended September 30, 2003, Pharmaceuticals and Corporate/Other include the following items: Pharmaceuticals—income of $21 million from a vitamins litigation settlement, $35 million of accelerated depreciation expense for facilities expected to be abandoned, $11 million of asset impairment charges and $13 million of relocation expenses and retention benefits; Corporate/Other—$45 million of income from litigation settlements and the reimbursement of patent defense costs and $29 million of income primarily related to adjustments of prior period restructuring reserves, partially offset by expense of $34 million related to termination benefits for workforce reductions and downsizing and streamlining of worldwide manufacturing operations, and $21 million in up-front payments for two licensing agreements.

   

Three Months Ended

September 30,


  

Nine Months Ended

September 30,


 
   Net Sales

  Earnings Before
Minority Interest
and Income Taxes


  Net Sales

  Earnings Before
Minority Interest
and Income Taxes


 
   (dollars in millions)

  (dollars in millions)

 
   2005

  2004

  2005

  2004

  2005

  2004

  2005

  2004

 

Pharmaceuticals

  $3,778  $3,848  $915  $1,127  $11,242  $11,414  $2,884  $3,309 

Nutritionals

   547   484   150   126   1,621   1,496   494   466 

Related Healthcare

   442   446   125   131   1,325   1,313   365   396 
   

  

  

  


 

  

  


 


Total Segments

   4,767   4,778   1,190   1,384   14,188   14,223   3,743   4,171 

Corporate/Other

   —     —     436   (238)  —     —     (59)  (792)
   

  

  

  


 

  

  


 


Total

  $4,767  $4,778  $1,626  $1,146  $14,188  $14,223  $3,684  $3,379 
   

  

  

  


 

  

  


 


 

Note 14.16. Pension and Other Postretirement Benefit Plans

 

The Company and somecertain of its subsidiaries have defined benefit pension plans and defined contribution plans for regular full-time employees. The principal pension plan is the Bristol-Myers Squibb Retirement Income Plan. The funding policy is to contribute amounts to provide for current service and to fund past service liability. Plan benefits are based primarily on the participant’s years of credited service and on the participant’s compensation. Plan assets consist principally of equity and fixed-income securities.

 

The Company also provides comprehensive medical and group life benefits for substantially all U.S. retirees who elect to participate in its comprehensive medical and group life plans. The medical plan is contributory. Contributions are adjusted periodically and vary by date of retirement and the original retiring company.Company. The life insurance plan is noncontributory. Plan assets consist principally of equity and fixed-income securities. Similar plans exist for employees in a number ofcertain countries outside of the U.S.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 14. Pension and Other Postretirement Benefit Plans (Continued)United States.

 

Cost of the Company’s deferred benefits and postretirement benefit plans included the following components for the three and nine months ended September 30, 20042005 and 2003:2004:

 

   Three Months Ended
September 30,


  Nine Months Ended
September 30,


 
   Pension
Benefits


  Other Benefits

  Pension Benefits

  Other Benefits

 
   (dollars in millions) 
   2004

  2003

  2004

  2003

  2004

  2003

  2004

  2003

 

Service cost-benefits earned during the period

  $45  $32  $1  $2  $130  $112  $6  $7 

Interest cost on projected benefit obligation

   76   61   4   11   226   214   30   40 

Expected return on plan assets

   (95)  (78)  (2)  (4)  (280)  (275)  (11)  (13)

Net amortization and deferral

   40   16   1   2   119   56   11   6 
   


 


 


 


 


 


 


 


Net periodic benefit cost

   66   31   4   11   195   107   36   40 

Curtailments and settlements

   —     —     —     —     —     —     —     —   
   


 


 


 


 


 


 


 


Total net periodic benefit cost

  $66  $31  $4  $11  $195  $107  $36  $40 
   


 


 


 


 


 


 


 


In connection with the Medicare Act, the Company adopted FSP No. 106-2 in the third quarter of 2004, retroactive to January 1, 2004. There is an expected reduction in net periodic benefit cost for other benefits of $8 million for the full year of 2004, based on the remeasurement of the accumulated postretirement benefit obligation as of January 1, 2004. The effect of the adoption of FSP No. 106-2 is not material to the Company’s consolidated financial statements, and in accordance with FASB FSP No. 106-2, the Company recorded the year-to-date portion of $6 million as a reduction of third quarter expense.

   

Three Months Ended

September 30,


  

Nine Months Ended

September 30,


 
   Pension
Benefits


  Other
Benefits


  

Pension

Benefits


  Other
Benefits


 
   2005

  2004

  2005

  2004

  2005

  2004

  2005

  2004

 
   (dollars in millions)  (dollars in millions) 

Service cost — benefits earned during the period

  $63  $45  $3  $1  $166  $130  $8  $6 

Interest cost on projected benefit obligation

   97   76   10   4   259   226   31   30 

Expected return on plan assets

   (118)  (95)  (6)  (2)  (314)  (280)  (18)  (11)

Net amortization and deferral

   62   40   —     1   166   119   —     11 
   


 


 


 


 


 


 


 


Total net periodic benefit cost

  $104  $66  $7  $4  $277  $195  $21  $36 
   


 


 


 


 


 


 


 


 

Contributions

 

As previously disclosed in its 2003 Form 10-K/A, due to improved investment returns in 2003For the three and significant contributions in recent years, the Company does not currently plan to makenine months ended September 30, 2005, there were no cash contributions to the U.S. pension plans, in 2004.and $49 million and $87 million, respectively, were contributed to the international pension plans. The Company expects contributions to the international pension plans for the year ended December 31, 20042005 will be in the range of $110$90 million to $130$110 million.

In the first nine months of 2004, there were no cash contributions to the U.S. pension plans, and $52 million and $83 million were contributed to the international pension plans for the three and nine month periods ended September 30, 2004, respectively. There was no cash funding for other benefits.

 

Those cash benefit payments from the Company, which are classified as contributions in the FASSFAS No. 132 disclosure, totaled $6 million and $20 million for pension benefits for the three and nine month periodsmonths ended September 30, 2004,2005, totaled $3 million and $12 million, respectively, for pension benefits, and $16 million and $46$49 million, respectively, for other benefits for the three and nine month periods ended September 30, 2004, respectively.benefits.

Note 15.17. Legal Proceedings and Contingencies

 

Various lawsuits, claims, proceedings and investigations are pending against the Company and certain of its subsidiaries. In accordance with SFAS No. 5,Accounting for Contingencies, the Company records 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 antitrust, securities, patent infringement, the Employee Retirement Income Security Act of 1974, as amended (ERISA), pricing, sales and marketing practices, environmental, health and safety matters, product liability and insurance coverage. The most significant of these matters are described below. There can be no assurance that there will not be an increase in the scope of these matters or that any future lawsuits, claims, proceedings or investigations will not be material. Management continues to believe, as previously disclosed, that during the next few years, the aggregate impact, beyond current reserves, of these and other legal matters affecting the Company is reasonably likely to be material to the Company’s results of operations and cash flows, and may be material to its financial condition and liquidity.

 

The Company’s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. As a result of external factors, the availability of insurance has become more restrictive while the cost has increased significantly. The Company has evaluated its risks and has determined that the cost of obtaining insurance outweighs the benefits of coverage protection against losses and as such, isbecame self-insured for product liabilities effective July 1, 2004. The Company will continue to evaluate these risks and benefits to determine its insurance needs in the future.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

 

PLAVIX* Litigation

PLAVIX* is currently the Company’s largest product ranked by net sales. Net sales of PLAVIX* were approximately $3.3 billion for the year ended December 31, 2004. The PLAVIX* patents are subject to a number of challenges in the United States and Canada as described below.

Currently, the Company expects PLAVIX* to have market exclusivity in the United States until 2011. If the composition of matter patent for PLAVIX* is found not infringed, invalid and/or unenforceable at the U.S. District Court level, the FDA could then approve the defendants’ ANDAs to sell generic clopidogrel, and generic competition for PLAVIX* could begin before the Company has exhausted its appeals. Such generic competition would likely result in substantial decreases in the sales of PLAVIX* in the United States. The statutory stay imposed on the approval of the first-filed ANDA by the filing of the lawsuit on the ‘265 patent under the Hatch-Waxman Act expired May 17, 2005. Accordingly, the company that filed the first ANDA could obtain final approval at any time and decide to launch a generic product at risk assuming the ANDA application meets the regulatory requirements for approval. Thus there is no legal impediment to final approval of an ANDA and a corresponding generic launch at any time assuming the ANDA application meets the regulatory requirements for approval.

 

United States

 

The Company’s U.S. territory partnership under its alliance with Sanofi is a plaintiff in threefour pending patent infringement lawsuits instituted in the U.S. District Court for the Southern District of New York entitled Sanofi-Synthelabo, Sanofi-Synthelabo Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex Inc. and Apotex Corp. (Apotex), 02-CV-2255 (SHS); Sanofi-Synthelabo, Sanofi-Synthelabo Inc. and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Dr. Reddy’s Laboratories, LTD, and Dr. Reddy’s Laboratories, Inc., 02-CV-3672 (SHS); and Sanofi-Synthelabo, Sanofi-Synthelabo Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership vs. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries, Ltd., 04-CV-7458.04-CV-7458 and Sanofi-Aventis, Sanofi-Synthelabo Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Cobalt Pharmaceuticals Inc., 05-CV-8055 (SHS). Teva Pharmaceuticals Industries, Ltd. has since been dismissed from the case. Proceedings involving PLAVIX* also have been instituted outside the United States. The most significant of these proceedings is pending in Canada and is described below.

 

The U.S. suits were filed on March 21, 2002, May 14, 2002, and September 23, 2004 and September 16, 2005 respectively, and were based on U.S. Patent No. 4,847,265, a composition of matter patent, which discloses and claims, among other things, the hydrogen sulfate salt of clopidogrel, which is marketed as PLAVIX*. The first two suits were also based on U.S. Patent No. 5,576,328, which discloses and claims, among other things, the use of clopidogrel to prevent a secondary ischemic event. The plaintiffs later withdrew Patent No. 5,576,328 from the two lawsuits. Plaintiffs’ infringement position is based on defendants’ filing of their Abbreviated New Drug Applications (ANDA) with the FDA, seeking approval to sell generic clopidogrel bisulfate prior to the expiration of the composition of matter patent in 2011. The defendants responded by alleging that the patent is invalid and/or unenforceable. Apotex has added antitrust counterclaims. The first two cases were consolidated for discovery. Fact discovery closed on October 15, 2003 and expert discovery is underwaywas completed in them.November 2004. The trialjoint pretrial order was submitted May 27, 2005, and the court approved it. The court has not set ascheduled trial date but it could be in the first halfApotex matter to begin on April 3, 2006. The Apotex case will be tried without a jury. Plaintiffs filed a motion to consolidate the Dr. Reddy’s case with the Apotex case for trial. That motion is pending before the court. In a stipulation approved by the U.S. District Court for the Southern District of New York on April 15, 2005, all parties to the patent infringement litigation against Teva have agreed that the Teva litigation will be stayed, pending resolution of the Apotex and Dr. Reddy’s litigation, and that the parties to the Teva litigation will be bound by the outcome of the litigation in the District Court against Apotex or Dr. Reddy. On April 18, 2005, the Court denied as moot the pending motion to consolidate the Teva litigation with the litigation against Apotex and Dr. Reddy’s, as a result of the Court’s approval of the stipulation. A similar stipulation was submitted to the court for approval in the Cobalt case on October 12, 2005.

On April 20, 2005, Apotex filed a complaint for declaratory judgment against Sanofi-Aventis, Sanofi-Aventis, Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership. The complaint seeks a declaratory judgment that the ‘265 patent is unenforceable due to alleged inequitable conduct committed during the prosecution of the patent. The defendants responded by submitting a motion to dismiss, which the court granted on September 12, 2005. Apotex has filed an appeal to the United States Court of Appeals for the Federal Circuit.

 

The Company’s U.S. territory partnership under its alliance with Sanofi is a plaintiff in another pending patent infringement lawsuit instituted in the U.S. District Court for the District of New Jersey entitled Sanofi-Synthelabo, Sanofi-Synthelabo Inc. and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. 2:04-CV-4926. The suit was filed October 7, 2004 and was based on U.S. patent 6,429,210, which discloses and claims a particular crystalline or polymorph form of the hydrogen sulfate salt of clopidogrel, which is marketed as PLAVIX.

Net sales of PLAVIX* were approximately $2.5 billion and $2.4 billion for the year ended December 31, 2003 and nine months ended September 30, 2004, respectively, and are expected to grow substantially over the next several years.. The Company anticipates that this revenue growth will be an important factor in offsetting expected decreases in sales of the Company’s other products that recently have or will experience exclusivity losses during this period.

Currently, the Company expects PLAVIX* to have market exclusivitycase is in the United States until 2011. If the composition of matter patent for PLAVIX*discovery phase. Fact discovery is found not infringed, invalid and/or unenforceable at the district court level, the FDA could then approve the defendants’ ANDAsscheduled to sell generic clopidogrel,close on January 16, 2006.

Note 17. Legal Proceedings and generic competition for PLAVIX* could begin before the Company has exhausted its appeals. Such generic competition would likely result in substantial decreases in the sales of PLAVIX* in the United States.

Although the plaintiffs intend to vigorously pursue enforcement of their patent rights in PLAVIX*, it is not possible at this time reasonably to assess the outcome of these lawsuits, or, if the Company were not to prevail in these lawsuits, the timing of potential generic competition for PLAVIX*. However, if generic competition were to occur, the Company believes it is very unlikely to occur before the second quarter of 2005. It also is not possible reasonably to estimate the impact of these lawsuits on the Company.

However, loss of market exclusivity of PLAVIX* and the subsequent development of generic competition would be material to the Company’s sales of PLAVIX* and results of operations and cash flows and could be material to its financial condition and liquidity.Contingencies (Continued)

 

Canada

 

Sanofi-Synthelabo and Sanofi-Synthelabo Canada Inc. have instituted a prohibition action in the Federal Court of Canada against Apotex Inc. (Apotex) and the Minister of Health in response to a Notice of Allegation from Apotex Inc. directed against Canadian Patent 1,336,777 covering clopidogrel bisulfate. Apotex’s Notice of Allegation (NOA) indicated that it had filed an Abbreviated New Drug Submission (ANDS) for clopidogrel bisulfate tablets and that it sought approval (a Notice of Compliance) of that ANDS before the expiration of Canadian Patent 1,336,777, which expires August 12, 2012. Apotex’s NOA further alleged that the ‘777 patent was invalid or not infringed. This action is scheduled forA hearing onwas held from February 21 to February 25, 2005. On March 21, 2005, the Canadian Federal Court of Ottawa rejected Apotex’s challenge to the Canadian PLAVIX* patent and aheld 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 Inc. That order of prohibition will preclude approval of Apotex’s ANDS until the patent expires in 2012, unless the Federal Court’s decision is expected before April 28, 2005, the date the statutory 24 month stay imposedreversed on Apotex’s ANDS expires.appeal. Apotex has filed an appeal.

 

IfSanofi-Synthelabo and Sanofi-Synthelabo Canada Inc. also instituted a decisionprohibition action in the Federal Court of Canada against Apotex and the Minister of Health in response to a NOA directed against Canadian Patent 2,334,870 covering the form 2 polymorph of clopidogrel bisulfate. Apotex seeks approval of its ANDS before expiration of the ‘870 patent in 2019. Apotex alleges in its NOA that it does not infringe the ‘870 patent and that it is favorableinvalid. That action was discontinued.

Sanofi-Aventis and Sanofi-Synthelabo Canada Inc. instituted a prohibition action in the Federal Court of Canada against Novopharm Limited (Novopharm) and the Minister of Health in response to a Notice of Allegation from Novopharm directed against Canadian Patent 1,336,777 covering clopidogrel bisulfate. Novopharm’s NOA indicated that it had filed an ANDS for clopidogrel bisulfate tablets and that it sought approval (a Notice of Compliance) of that ANDS before the expiration of Canadian Patent 1,336,777, which expires August 12, 2012. Novopharm’s NOA further alleged that the ‘777 patent was invalid. Novopharm has since withdrawn its NOA and agreed to be bound by the result in the Apotex proceeding. The prohibition action has therefore been discontinued.

Sanofi-Aventis and Sanofi-Synthelabo Canada instituted a prohibition action in the Federal Court of Canada against Cobalt Pharmaceuticals Inc. and the Minister of Health in response to a Notice of Allegation from Cobalt directed against Canadian patents 1,336,777 and 2,334,870. Cobalt’s NOA indicated that it has filed an ANDS for clopidogrel bisulfate tablets and that it sought a Notice of Compliance for that ANDS before the expiration of the ‘777 and ‘870 patents. Cobalt alleged that the ‘777 patent was invalid and that the ‘870 patent was invalid and not infringed. The proceeding is in its early stages.

United Kingdom

In December 2004, Aircoat Limited (Aircoat) filed a nullity petition in the Court of Session in Glasgow, Scotland. By its nullity petition, Aircoat seeks revocation of European Patent 0 281 459, which has been registered in the United Kingdom. European Patent 0 281 459 covers,inter alia, clopidogrel bisulfate, the active ingredient in PLAVIX*. Aircoat specifically alleges that the claims of European Patent 0 281 459 are invalid and the UK patent should be revoked on the grounds of lack of novelty and/or lack of inventive step. Aircoat withdrew its nullity petition and the court dismissed the action on August 4, 2005. Aircoat has no right to appeal the dismissal of the action.

Although the plaintiffs intend to vigorously pursue enforcement of their patent rights in PLAVIX*, it could resultis not possible at this time reasonably to assess the outcome of these lawsuits, or, if the Company were not to prevail in athese lawsuits, the timing of potential generic productcompetition for PLAVIX*. It also is not possible reasonably to estimate the impact of these lawsuits on the Company.

However, loss of market in Canada inexclusivity of PLAVIX* and the second quartersubsequent development of 2005.generic competition would be material to the Company’s sales of PLAVIX* and results of operations and cash flows, and could be material to its financial condition and liquidity.

Note 17. Legal Proceedings and Contingencies (Continued)

OTHER PATENT LITIGATION

 

TEQUIN. The Company and Kyorin Pharmaceuticals Co., Ltd. (Kyorin) commenced a patent infringement action on March 23, 2004, against Teva USA and Teva Industries in the United States District Court for the Southern District of New York, relating to the antibiotic gatifloxacin, for which Kyorin holds the composition of matter patent and which the Company sells as TEQUIN. Teva Industries has since been dismissed from the case. This action relates to Teva’s filing of an ANDA for a generic version of gatifloxacin tablets with a certification that the composition of matter patent, which expires in December 2007 but which has been granted a patent term extension until December 2009, is invalid or not infringed. The filing of the suit places a stay on the approval of Teva’s generic product until June 2007, unless there is a court decision adverse to the Company and Kyorin before that date. Trial in this matter has been scheduled to begin on May 1, 2006.

 

Abatacept.TEQUIN (injectable form) On August 17, 2000, Repligen Corporation (Repligen). The Company and Kyorin commenced patent infringement actions on March 8, 2005, against Apotex Inc. and Apotex Corp., and against Sicor Pharmaceuticals, Inc., Sicor Inc., Sicor Pharmaceuticals Sales Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd. in the UniversityUnited States District Court for the Southern District of Michigan instituted a lawsuit againstNew York, relating to injectable forms of the antibiotic gatifloxacin, for which Kyorin holds the composition of matter patent and which the Company insells as TEQUIN. The action related to Apotex’s and Sicor’s filing of ANDAs for generic versions of injectable gatifloxacin with p(IV) certifications that the composition of the matter patent, which expires December 2007 but which was granted a patent term extension until December 2009, is invalid. The filing of the lawsuits places stays on the approvals of both Apotex’s and Sicor’s generic products until July/August 2007, unless there is a court decision adverse to the Company and Kyorin before that date. The Sicor case was consolidated with the above proceeding. In a stipulation approved by the U.S. District Court for the EasternSouthern District of Michigan. The suit allegedNew York on August 22, 2005, the parties agreed that Dr. Craig Thompson, formerly a professor at the University of Michigan, had been involved in a collaboration with certainApotex case will be stayed pending resolution of the Company’s scientists,Teva and Sicor cases, and that Thompson’s activity in the collaboration made him a rightful inventor on several patents thatparties will be bound by the Company later obtained covering

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

soluble formsoutcome of CTLA4 and related methods of use. After conducting a trial, in September 2003 the District Court ruled that Repligen and the University of Michigan had failed to prove that Thompson made any inventive contribution to the patents in suit, and thus he was not entitled to be added as a sole or joint inventor on the Company’s patents. Repligen and the University of Michigan appealed the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit. On July 12, 2004, the Federal Circuit affirmed the trial court’s ruling. This decision is final and these proceedings have been concluded.above litigation.

 

ERBITUX*.On October 28, 2003, a complaint was filed by Yeda Research and Development Company Ltd. (Yeda) against ImClone and Aventis Pharmaceuticals, Inc. in the U.S. District Court for the Southern District of New York. This action alleges and seeks that three individuals associated with Yeda should also be named as coinventorsco-inventors on U.S. Patent No. 6,217,866, which covers the therapeutic combination of any EGFR-specific monoclonal antibody and anti-neoplastic agents, such as chemotherapeutic agents, for use in the treatment of cancer. If Yeda’s action were successful, Yeda could be in a position to practice, or to license others to practice, the invention. This could result in product competition for ERBITUX* that might not otherwise occur. The Company, which is not a party to this action, is unable to predict the outcome at this stage in the proceedings.

 

On May 5, 2004, RepligenRepliGen Corporation (Repligen) and Massachusetts Institute of Technology (MIT) filed a lawsuit in the United States District Court for the District of Massachusetts against ImClone claiming that ImClone’s manufacture and sale of ERBITUX* infringes a patent which generally covers a process for protein production in mammalian cells. Repligen and MIT seek damages based on sales of ERBITUX* which commenced in February 2004. The patent expired on May 5, 2004, although Repligen and MIT are seeking extension of the patent. The Company, which is not a party to this action, is unable to predict the outcome at this stage in the proceedings.

 

ABILIFY*. On August 11, 2004, Otsuka filed with the United States Patent and Trademark Office (USPTO) a Request for Reexamination of the basic U.S. composition of matter patent covering ABILIFY* (aripiprazole), an antipsychotic agent used for the treatment of schizophrenia and related psychiatric disorders (U.S. Patent Number No. 5,006,528, the “528 Patent”) that expires in 2009, and may be extended until 2014 if pending supplemental protection extensions are granted. Otsuka has determined that the original ‘528 Patent application contained an error in that the description of a prior art reference was identified by the wrong patent number. In addition, Otsuka has taken the opportunity to bring other citationsinformation to the attention of the USPTO. The USPTO has granted the Request for Reexamination if granted byand the USPTO,reexamination proceeding is ongoing. The reexamination proceeding will allow the USPTO to consider the patentability of the patent claims in light of the corrected patent number and newly cited documents.information. The USPTO is expected to make a final decision on the reexamination withinbefore the next ten to fifteen months.end of 2006.

 

The Company and Otsuka believe that the invention claimed in the ‘528 Patent is patentable over the prior art and expect that the USPTO will reconfirm that in the reexamination. However, there can be no guarantee as to the outcome. If the patentability of the ‘528 Patent were not reconfirmed following a reexamination, there may be sooner than expected loss of market exclusivity of ABILIFY* and the subsequent development of generic competition which would be material to the Company.

Note 17. Legal Proceedings and Contingencies (Continued)

SECURITIES LITIGATION

 

VANLEV Litigation

 

In April, May and June 2000, the Company, its former chairman of the board and chief executive officer, Charles A. Heimbold, Jr., and its former chief scientific officer, Peter S. Ringrose, Ph.D., were named as defendants in a number of class action lawsuits alleging violations of federal securities laws and regulations. These actions have been consolidated into one action in the U.S. District Court for the District of New Jersey. The plaintiff claims that the defendants disseminated materially false and misleading statements and/or failed to disclose material information concerning the safety, efficacy and commercial viability of, its product VANLEV, a drug in development, during the period November 8, 1999 through April 19, 2000.

 

In May 2002, the plaintiff submitted an amended complaint adding allegations that the Company, its presentformer chairman of the board and current chief executive officer, Peter R. Dolan, its former chairman of the board and chief executive officer, Charles A. Heimbold, Jr., and its former chief scientific officer, Peter S. Ringrose, Ph.D., disseminated materially false and misleading statements and/or failed to disclose material information concerning the safety, efficacy, and commercial viability of VANLEV during the period April 19, 2000 through March 20, 2002. A number of related class actions, making essentially the same allegations, were also filed in the U.S. District Court for the Southern District of New York. These actions have been transferred to the U.S. District Court for the District of New Jersey.

 

The Company filed a motion for partial judgment in its favor based upon the pleadings. The plaintiff opposed the motion, in part by seeking again to amend its complaint. The court granted in part and denied in part the company’sCompany’s motion and ruled that plaintiffsthe plaintiff may amend theirits complaint to challenge certain alleged misstatements.

 

The court has certified two separate classes: a class relating to the period from November 8, 1999 to April 19, 2000 (the “First Class Period”) and a class relating to the period from March 22, 2001 to March 20, 2002.2002 (the “Second Class Period”). The First Class Period involves claims related to VANLEV’s efficacy, safety and/or potential to be a blockbuster drug. The Second Class Period involves claims related to VANLEV’s potential to be a blockbuster drug. The class certification and proposed class certificationcertifications are without prejudice to defendants’ rights to fully contest the merits of plaintiff’s claims. The plaintiff purports to seekseeks compensatory damages, costs and expenseexpenses on behalf of shareholders with respect to the two class periods.

On December 17, 2004, the Company and the other defendants made a motion for summary judgment as to all of plaintiff’s claims. In January 2005, the plaintiff moved for leave to file a third amended complaint, seeking to combine the two class periods into one expanded class period from October 19, 1999 through March 19, 2002 and to add further allegations that the Company, Peter R. Dolan, Charles A. Heimbold, Jr., and Peter S. Ringrose, Ph.D. disseminated materially false and misleading statements and or failed to disclose material information concerning the safety, efficacy and commercial viability of VANLEV. The Magistrate Judge denied the plaintiff’s motion. Plaintiff appealed to the District Court.

On August 17, 2005, the Court granted in part and denied in part the summary judgment motion and also affirmed the Magistrate Judge’s denial of plaintiff’s motion for leave to amend their complaint. The Court also dismissed two of the three individual defendants, Peter R. Dolan and Peter S. Ringrose, from the case.

On October 18, 2005 the parties participated in a court-ordered mediation of the litigation. The parties are required to respond to the mediator’s proposed class period.number to settle the litigation on November 15, 2005. A settlement of the matter could be material to results of operations.

 

It is not possible at this time reasonably to assess the final outcome of this litigation or reasonably to estimate the possible loss or range of loss with respect to this litigation. If the Company were not to prevail in final, non-appealable determinations of this litigation, the impact could be material.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)material to results of operations.

 

Other Securities Matters

 

During the period March through MayIn 2002, the Company and a numbercertain of its current and former officers were named as defendants in a number of securities class actions, which were consolidated in the United States District Court for the Southern District of New York. In 2003, the plaintiffs filed a consolidated amended class action suits. The suits variously allegedcomplaint alleging violations of federal securities laws and regulations in connection with three different matters: (1) VANLEV (as discussed above), (2) sales incentives and wholesaler inventory levels and (3) ImClone, and ImClone’s product, ERBITUX*. As discussed above,In 2004, the allegations concerning VANLEV have been transferred to the U.S. District Court for the District of New Jersey and consolidated withcertified the action pending there. The remaining actions have been consolidated and are pending in the U.S. District Court for the Southern District of New York. Plaintiffs filedas a consolidated class action, complaint on April 11, 2003 againstapproved a settlement of the Company and certain current and former officers alleging a class period of October 19, 1999 through March 10, 2003. The consolidated class action, complaint alleges violations of federal securities laws in connection with, among other things, the Company’s investment in and relationship with ImClone and ImClone’s product, ERBITUX*, and certain accounting issues, including issues related to wholesaler inventory and sales incentives, the establishment of reserves, and accounting for certain asset and other sales. The plaintiffs seek compensatory damages, costs and expenses. On March 29, 2004, the U.S. District Court granted the Company’s motion to dismiss the consolidated class action complaint and dismissed the case with prejudice. Plaintiffs appealed that dismissal to the Second Circuit Court of Appeals (Court of Appeals). While that appeal was pending, the parties reached an agreement in principle to settle the action. On July 26, 2004, the Court of Appeals stayed the appeal

Note 17. Legal Proceedings and remanded the action to the District Court so that the District Court could consider the settlement. On July 30, 2004, the District Court vacated the Clerk’s Judgment in order to consider the settlement. Also on that day, the District Court entered an order preliminarily approving the settlement and certifying a class for settlement purposes only. Pursuant to the terms of the proposed settlement, all claims in the action will be dismissed, the litigation will be terminated, the defendants will receive releases, and the Company will pay $300 million to a fund for class members. On November 9, 2004, after a fairness hearing, the District Court approved the settlement and a judgment dismissing the case with prejudice. The settlement will become final in 30 days if no appeal is filed. At this time, there can be no assurance that no appeal will be filed or that any appeal that is filed will be resolved in favor of the settlement. Contingencies (Continued)

Approximately 58 million shares have beenwere excluded from thethis class action settlement pursuant to requests for exclusion. Of those, plaintiffs purporting to hold approximately 4044.5 million shares are held by plaintiffs in the two pending actions discussed below.

In addition, an action was filed in early October 2003,brought four suits in New York State Supreme Court, making similar factual allegationsCourt. Those four actions have been settled and asserting a variety of claims including, among others, common law fraud and negligent misrepresentation. No discovery has been taken in this matter. On January 9, 2004, the Company moved to dismiss the complaint. Oral arguments on the motion were held on April 16, 2004. There has been no decision on the motion. A related action was filed in September 2004, also in New York State Supreme Court, making similar factual allegations and asserting claims similar to those made in the New York State Supreme Court action filed in October 2003, but also containing allegations similar to the SEC Complaint issued in August 2004. The Company intends to file a motion to dismiss this case, and is in the process of negotiatingdismissed with plaintiffs, a schedule for briefing that motion.prejudice.

 

The CompanyAlso in 2002 and a number of the Company’s current and former officers were named as defendants in a purported class action filed on October 6, 2004 in the State Court in Cook County, Illinois. The complaint makes similar factual allegations as those made in the settled federal class action in the Southern District of New York and asserts common law fraud and breach of fiduciary duty claims. The complaint purports to assert those claims on behalf of stockholders who purchased company stock before October 19, 1999 and held onto their stock through March 10, 2003.

Beginning in October 2002, a number2003, certain of the Company’s current and former officers and directors were named as defendants in three shareholdera number of derivative suits, pendingwhich were consolidated in the U.S.United States District Court for the Southern District of New York. A number of the Company’s current and former officers and directors were named as defendants in three shareholder derivative suits filed during the period March 2003 through May 2003 in the U.S. District Court for the District of New Jersey. In July 2003 the U.S. District Court for the District of New Jersey ordered the three shareholder derivative lawsuits that were filed in that court transferred to the U.S. District Court for the Southern District of New York. Subsequently, the U.S. District Court for the Southern District of New York ordered all six

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

federal shareholder derivative suits consolidated. Plaintiffs have filed a consolidated, amended, verified shareholderderivative complaint against certain members of the board of directors, current and former officers, and PwC the Company’s independent auditors. As is customary in derivative suits, the Company has been named as a defendant in this action. As a nominal defendant, the Company is not liable for any damages in the suit nor is any specific relief sought againstand the Company. The consolidated amendedThat complaint alleges,alleged, among other things, violations of federal securities laws and breaches of fiduciary duty by certain individual defendants in connection with the Company’s conduct concerning, among other things: safety, efficacy and commercial viability of VANLEV (as discussed above); the Company’s sales incentives to certain wholesalers and the inventory levels of those wholesalers; the Company’s investment in and relations with ImClone and ImClone’s product ERBITUX*; and alleged anticompetitive behavior in connection with BUSPAR and TAXOL.TAXOL®. The lawsuit also allegesalleged malpractice (negligent misrepresentation and negligence) by PwC. The plaintiffs seek restitutionparties reached a settlement of the action, under which the Company agreed to adopt certain corporate governance enhancements and rescission of certain officers’ and directors’ compensation and alleged improper insider trading proceeds; injunctive relief; fees, costs and expenses; contribution from certain officersnot to oppose plaintiffs’ attorneys’ request for alleged liabilityup to $4.75 million in fees. On May 13, 2005, the consolidated securities class action pending in the U.S. District Court forapproved the Southern Districtsettlement and dismissed the action with prejudice. In July 2005, the Court awarded plaintiffs $3.5 million in attorneys fees, which were paid from directors’ and officers’ liability insurance proceeds. On June 8, 2005, a shareholder filed a notice of New York (as discussed above); and contribution and indemnification from PwC. No discovery has been taken in this matter.appeal with the Second Circuit. On December 19, 2003, the Company moved to dismiss the consolidated amended complaint. Oral argument on the motion to dismiss has not yet been scheduled.August 17, 2005, that appeal was dismissed. Two similar actions arewhich were pending in New York State Court. Plaintiffs seek equitable relief, damages, costscourt have been dismissed with respect to the Company and attorneys’ fees.its current and former officers and directors.

 

As previously disclosed, onOn August 4, 2004, the Company 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 is attached to this Form 10-Q as Exhibit10S. The settlement was filed in the federal court in Newark, New Jersey. In the Consent, the Company agreed, without admitting or denying any liability, not to violate certain provisions of the securities laws. The Company also agreed to establish a $150 million fund, for a class of shareholders to be distributed under the court’s supervision. The $150 million fund, which includes a $100 million civil penalty, will be distributed to certain Company shareholders under a plan of distribution to be established by the SEC.

Under the terms of the Consent, the Company agreed, subject to certain defined exceptions, to limit sales of all products sold to wholesalers 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. The Company also agreed in the consent to certain measures that it has implemented or will implement, including: (a) establishing a formal review and certification process of its 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 the Company’s accounting and financial reporting processes; (d) publicly disclosing any sales incentives offered to wholesalers for the purpose of inducing them to purchase products in excess of expected demand; (e) ensuring that the Company’s budget process gives appropriate weight to inputs that come from the bottom to the top, and not just those that come from the top to the bottom, and adequately documents that process.

The Company also agreed in the Consent to retain an “Independent Adviser” through the date that Bristol-Myers’s Form 10-K for the year ended 2005 is filed with the SEC. The Consent defines certain powers and responsibilities of the Independent Adviser. The Consent includes a process for the Independent Adviser to make recommendations regarding the Company’s compliance with applicable federal securities laws and corporate obligations. The Company has agreed in the Consent to adopt the Independent Adviser’s recommendations regarding compliance with applicable federal securities laws and corporate obligations.

 

The settlement does not resolve the ongoing investigation by the SEC of the activities of certain current and former members of the Company’s management in connection with the wholesaler inventory issues and other accounting matters, which investigationmatters. The Company is ongoing. In addition, an investigation bycontinuing to cooperate with this investigation.

On June 15, 2005, the U.S.United States Attorney’s Office for the District of New Jersey (the Office) filed a criminal complaint charging the Company with conspiracy to commit securities fraud in connection with a previously disclosed investigation by that Office, concerning the inventory and various accounting matters covered by the Company’s settlement with the SEC. In connection with the filing of that complaint, the Company and the Office entered into a Deferred Prosecution Agreement. Pursuant to that Agreement, the Company agreed to maintain and continue to implement remedial measures pursuant to the settlement with the SEC, is continuing. The Company is continuingtake certain additional remedial actions and continue to cooperate with the U.S. Attorney’s Office, including with respect to the ongoing investigation regarding individual current and former employees of the Company, as well as to make an additional payment of $300 million into the fund for shareholders established pursuant to the Company’s settlement with the SEC. If the Company fulfills its obligations under the Deferred Prosecution Agreement, the Office will dismiss the criminal complaint two years from the date of its filing.

The Company and a number of the Company’s current and former officers were named as defendants in a purported class action filed in 2004 in the Circuit Court of Cook County, Illinois. The complaint made factual allegations similar to those investigations.made in the settled federal class action in the Southern District of New York and asserted common law fraud and breach of fiduciary duty claims on behalf of stockholders who purchased the Company’s stock before October 19, 1999 and held their stock through March 10, 2003. The Company removed the action to the United States District Court for the Northern District of Illinois and on July 1, 2005, the District Court dismissed the case with prejudice. On September 21, 2005, a similar case was filed in New York State Supreme Court. On October 7, 2005, the Company removed that case to the United States District Court for the Southern District of New York.

On November 18, 2004, a class action complaint was filed in the United States District Court for the Eastern District of Missouri against the Company, D&K Healthcare Resources, Inc. (D&K) and several current and former D&K directors and officers on behalf of purchasers of D&K stock between August 10, 2000 and September 16, 2002. The complaint alleges that the Company participated in fraudulently inflating the value of D&K stock by allegedly engaging in improper “channel-stuffing” agreements with D&K. BMS filed a motion to dismiss this case on January 28, 2005. That motion is under consideration by the court. Under the Private Securities Litigation Reform Act, discovery is automatically stayed pending the outcome of the motion to dismiss. The plaintiff has moved to partially lift the automatic stay. The court is considering that motion.

Note 17. Legal Proceedings and Contingencies (Continued)

 

ERISA Litigation

 

In December 2002 and the first quarter of 2003, the Company and others were named as defendants in five class actions brought under the ERISAEmployee Retirement Income Security Act (ERISA) in the U.S. District Courts for the Southern District of New York and the District of New Jersey. These actions have been consolidated in the Southern District of New York under the captionIn re Bristol-Myers Squibb Co. ERISA Litigation, 02 CV 10129 (LAP). An Amended Consolidated Complaint alleging a class period of January 1, 1999 through March 10, 2003 was served on August 18, 2003. TheA Second Amended Consolidated Complaint was broughtfiled on May 27, 2005 on behalf of four named plaintiffs and a putative class consisting of all participants in, or beneficiaries of, the Bristol-Myers Squibb Company Savings and Investment Program (Savings Plan) and their beneficiaries for whose benefit the Savings Plan held and/or acquired Company stock at any time during the class period (excluding the defendants, their heirs, predecessors, successorsbetween January 1, 1999 and assigns).March 10, 2003 whose accounts included investment in Company stock. The named defendants are the Company, the Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

Company Savings Plan Committee (Committee), thirteen individuals who presently serve on the Committee or who served on the Committee in the recent past, Charles A. Heimbold, Jr. and Peter R. Dolan (the past and present Chief Executive Officers, respectively, and the Company). The Second Amended Consolidated Complaint generally alleges that the defendants breached their fiduciary duties under ERISA during the class period by, among other things, continuing to offer the Company Stock Fund and Company stock as investment alternatives underimprudently investing assets of the Savings Plan; continuing to investPlan in Company matching contributions in the Company Stock Fund and Company stock; misrepresenting and failing to disclose that investments intruthful and adequate information about Company stock were (allegedly) imprudent. Theas a Savings Plan’s purchasesPlan investment; and operating under conflicts of Company stock after January 1, 1999 areinterest. In addition, all defendants except Heimbold and Dolan were alleged to have been transactions prohibited by ERISA. Finally, Defendants Heimbold and Dolan are alleged to have breached their fiduciary duties under ERISA by failingfailed to monitor the actions of the Committee.other Savings Plan fiduciaries. These ERISA claims are predicated upon factual allegations similar to those raised in “Other Securities Matters” above, concerning, among other things: the safety, efficacy and commercial viability of VANLEV; the Company’s sales incentives to certain wholesalers and the inventory levels of those wholesalers; the Company’s investment in and relations with ImClone and ImClone’s product ERBITUX*; and alleged anticompetitive behavior in connection with BUSPAR and TAXOL.TAXOL®.

 

There has not been significant discoveryOn June 6, 2005, counsel for plaintiffs and the Company entered into a Stipulation and Agreement of Settlement (Settlement). The Settlement provides, among other things, that the Company pay to datethe BMS Savings Plan Master Trust approximately $41 million less plaintiffs’ attorneys’ fees, costs and discovery is currently stayed.certain expenses (including notice costs). Additionally, the Company agreed to certain structural changes relating to plan administration and participant education. The Settlement provides for certification, for Settlement purposes only, of a class consisting of all persons who were participants in, or beneficiaries of, (i) the Bristol-Myers Squibb Company Savings and Investment Program; (ii) the Bristol-Myers Squibb Puerto Rico, Inc. Savings and Investment Program; and (iii) the Bristol-Myers Squibb Company Employee Incentive Thrift Plan, at any time between January 1, 1999 and March 10, 2003 and whose accounts in such plans included investments in the Bristol-Myers Squibb Company Stock Fund (excluding the individual defendants). The U.S. District Court for the Southern District of New York preliminarily approved the Settlement on June 22, 2005. Notice of the Settlement was completed by August 22, 2005. On October 2, 2003,12, 2005, the Company and all other defendants moved to dismiss the Amended Consolidated Complaint. The plaintiffs have opposed the motion to dismiss, and the defendants have replied. The motions to dismiss have been administratively withdrawn without prejudice. Any party has the right to have the motions reinstated on request. In the second quarter of 2004, the Company established reserves for liabilities for this litigation of $20 million. It is not possible at this time reasonably to assess theCourt conducted a fairness hearing, issued final outcome of this litigation. In accordance with GAAP, the Company has determined that the reserves established represent the minimum expected probable losses with respect to this litigation. Eventual losses related to this litigation may exceed reserves, and the further impact could be material. The Company does not believe that the top-endapproval of the range for these losses can be estimated. If the Company were not to prevail in final, non-appealable determination of this matter, the impact could be material.Settlement and awarded attorneys’ fees.

 

Pricing, Sales and Promotional Practices Litigation and Investigations

 

The Company, together with a number of other pharmaceutical manufacturers, is a defendant in several private class actions and in actions brought by the Nevada, Montana, Pennsylvania, Wisconsin, Kentucky, Illinois, Alabama and WisconsinCalifornia Attorneys General, the City of New York and the Counties of Suffolk, Westchester and Rockland,several New York counties that are pending in federal and state courts relating to the pricing of certain Company products. The federal cases, and some related state court cases that were removed to federal courts, have been consolidated for pre-trial purposes under the captionIn re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, Civ. Action No. 01-CV-12257-PBS, before United States District Court Judge Patti B. Saris in the U.S.United States District Court for the District of Massachusetts (AWP Multidistrict Litigation). On June 18, 2003 the Court in the AWP Multidistrict Litigation granted the private plaintiffs’ motion for leave to file an amended Master consolidated Complaint (Amended master Complaint). The Amended Master Complaint contains two sets of allegations against the Company. First, it alleges that the Company’s and many other pharmaceutical manufacturers’ reporting of prices for certain drug products (20 listed drugs in the Company’s case) had the effect of falsely overstating the Average Wholesale Price (AWP) published in industry compendia, which in turn improperly inflated the reimbursement paid to medical providers, pharmacists, and others who prescribed, and administered or sold those products.products to consumers. Second, it alleges that the Company and certain other defendant pharmaceutical manufacturers conspired with one another in a program called the “Together Rx Card Program” to fix AWPs for certain drugs made available to consumers through the Program. The Amended Master Complaint asserts claims under the federal RICO and antitrust statutes and state consumer protection and fair trade statutes.

 

The Amended Master Complaint is brought on behalf of two main proposed classes, whose definitions have been subject to further amendment as the firstcase has progressed. As of which is divided into sub-classes:December 17, 2004, those proposed classes may be summarized as: (1) all persons or entities who, from 1991 forward, (a) directlypaid or through a pharmacy benefit manager reimbursed all or paid forpart of a listed drug based onunder Medicare Part B or under a private contract whichthat expressly used AWP as a pricing standard or (b) made a co-payment for a listed drug under Medicare Part B; and (2) all persons or entities who, from 2002 forward, paid or reimbursed any portion of the purchase price of a drug covered by the Together Rx Card Program based in whole or in part on AWP.

The Company andfirst class is further divided into several proposed subclasses depending on whether the other defendants moved to dismiss the Amended Master Complaint on the grounds it fails to state claims under the applicable statutes. These motions were denied on February 24, 2004, although the Court dismissed one of the plaintiffs’ claims for failure to pleadlisted drug in question is physician-administered, self-administered, sold through a cognizable RICO “enterprise”. Accordingly, the Company and the other defendants were required to answer the Amended Master Complaint. In addition, the Companypharmacy benefits manager or specialty pharmacy, or is one of five (5) defendants who have been ordered by Judge Saris to engage in fast track discovery. Discovery will continue as to these five defendants until January 30, 2005.a brand-name or generic drug. On September 3, 2004, plaintiffs in the plaintiffsAWP Multidistrict Litigation moved for certification of a proposed plaintiff class. The parties briefed that motion, as it related to the amended proposed definition of the first main class includingand sub-classes discussed above. The parties are currently briefing thatabove, and motion which is scheduled to bewas heard by the courtCourt on December 15, 2004.February 10, 2005.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15.17. Legal Proceedings and Contingencies (Continued)

 

In a Memorandum and Order dated August 16, 2005, the Court declined to certify any proposed classes as to pharmacy-dispensed drugs. It did, however, certify a class under the Massachusetts consumer fraud statute for persons and entities that paid for certain physician-administered drugs based on AWPs. The Court indicated that it would also certify a nationwide class of individual Medicare Part B beneficiaries who made an AWP-based co-payment for physician-administered drugs if plaintiffs were able to find suitable class representatives. Defendants have petitioned the United States Court of Appeals for the First Circuit for permission to appeal the certification of the Massachusetts-based classes. That petition is pending.

Discovery in the AWP Multidistrict Litigation closed as to the Company and four other defendant manufacturers on August 31, 2005. The current schedule calls for identification of proposed class representatives for the Medicare Part B class, challenges to those proposed representatives, expert reports, expert depositions and summary judgment briefing on liability issues during the second half of 2005 into early 2006.

The cases commenced by the Nevada, Montana, Pennsylvania, Wisconsin, Kentucky, Illinois, Alabama, and California Attorneys General complaints assert(the Attorneys General AWP Cases) and the cases commenced by New York City and several New York counties (the New York City & County AWP Cases) include fraud and consumer protection claims, or in the case of California, state False Claims Act claims, similar to those in the Amended Master Complaint under state law, butComplaint. Certain of the states, city and counties also assert claims inhave made additional allegations that defendants, including the name of their respective States for alleged violations ofCompany, have violated state Medicaid fraud statutes. The Nevadastatutes by, among other things, failing to provide the states with adequate rebates required under federal law.

In a series of decisions in June, September, and October 2004, affecting the Montana Attorneys General cases were originally commenced in their respective state courts but were later removed toAttorney General’s case and the New York City & County AWP Multidistrict Litigation. Each Attorney General moved to have its case remanded to state court on the ground that there is no federal jurisdiction. On June 11, 2003, the CourtCases which are proceeding in the AWP Multidistrict Litigation ruledin coordination with the private class actions, the Court declined to find that the Nevada action, in which the Company is named, should be remanded to state court on the ground that not all defendants had joined in the original removal petition. The case is now proceeding in Nevada state court where defendants, including the Company, filed a motion to dismiss. In a decision filed July 16, 2004, the Nevada state court denied the motion to dismiss except as to the state RICO claim. The court granted the Attorney General leave to replead. The Court in the AWP Multi-district Litigation retained jurisdiction over the Montana case. The defendants moved to dismiss the Montana and a second Nevada case, in which the Company is not named.

In an opinion dated June 10, 2004, the court in the AWP Multidistrict LitigationMedicaid rebate claims were preempted by federal law, but nevertheless dismissed somemany of the states’ Medicaid claims relating to “rebate” payments made by several drug manufacturers, including those claims relating to the Company but otherwise upheldas insufficiently pled. The Court allowed to proceed the complaints.state law claims that allege that the Company misreported AWPs. The Company has filed its answer to the claims remaining in the Montana Attorney General’s complaint. On June 15, 2005, New York City and all of the Counties that have sued thus far (except Suffolk, Nassau and Erie Counties, which continue to proceed separately) served the Company and other manufacturers with a Consolidated Complaint. The Consolidated Complaint contains claims similar to those in the prior, individual complaints of the City and Counties. Defendants anticipate moving to dismiss the Consolidated Complaint.

The Company also has joined with other defendants in a motion to dismiss the Pennsylvania Attorney General’s action which is pending in.In a decision filed February 1, 2005, the Pennsylvania state court. ThatCommonwealth Court granted the motion was heardto dismiss on September 8, 2004, but no decision has yet been rendered. The Company was servedthe ground that the plaintiff had failed to plead the complaint with the Wisconsinrequisite particularity. The Attorney General’s actionGeneral has since served an Amended Complaint to which defendants have objected. Defendants’ objections to the Pennsylvania Complaint have been fully briefed and were heard by the Commonwealth Court on June 21, 2004.8, 2005. On July 16, 2004, the Nevada court denied the Company’s and other defendants’ motions to dismiss the complaint except as to the state RICO claim and granted the Attorney General leave to replead, in an opinion that was based on the prior rulings of the AWP Multidistrict Litigation Court. The Nevada court subsequently entered an order coordinating all discovery in that case with that in the AWP Multidistrict Litigation. The Company and other defendants removedalso have made motions to dismiss in the other Attorneys General AWP Cases, with the exception of the California case which was not unsealed as to Wisconsin federalthe Company until August 2005. Those motions to dismiss are currently pending.

The Company is also one of a number of defendants in a private class action making AWP based claims in Arizona state court however, on October 5, 2004 that court remanded the action back to Wisconsinand New Jersey state court. The Company anticipates that the WisconsinArizona case will now proceed in the state forum.

Finally, the Company is a defendant in related state court proceedings commenced in New York,currently stayed. The New Jersey California, Arizona and Tennessee, and in federal court proceedings commenced by the City of New York and the Counties of Suffolk, Westchester and Rockland, New York (collectively, the New York City & Counties AWP cases). Those proceedings were transferredcase has been removed to the AWP Multidistrict Litigation Court where a motion is pending that will determine whether the case remains for pre-trial purposes although plaintiffs in the California, Arizona andthat Court or is remanded to New Jersey actions sought to remand their cases to the state courts. The California remand motions were denied, the Arizona remand motion was granted, and the New Jersey remand motion remains pending. With respect to the case remanded to Arizona state court, defendants filed motions to dismiss or for a stay. The Arizona court denied the motions in their entirety and the case is proceeding to the class action certification state and discovery. The New York City & Counties AWP cases allege RICO claims similar to those made in the Amended Master Consolidated Complaint in the AWP Multidistrict Litigation, however, the claims are on behalf of the counties as contributors to New York State’s Medicaid obligations. Defendants in the first-filed Suffolk County case moved to dismiss the amended complaint in that action. In a decision dated September 30, 2004, the Court in the AWP Multidistrict Litigation granted the motion to dismiss the RICO and certain other claims, but sustained a number of the state law claims. The Company expects that it and the other Defendants in all the New York City & Counties AWP cases will answer those complaints in the near future.court.

 

On or about October 8, 2004, the Company was added as a defendant in a putative class action previously commenced against other drug manufacturers in Alabama federal court.court in Alabama. The case iswas brought by two health care providers that are allegedly entitled under a federal statute, Section 340B of the Public Health Service Act, to discounted prices on prescription drugs dispensed to the poor in the provider’s

providers’ local areas. The plaintiff health care providers contend that they and an alleged class of other providers authorized to obtain discounted prices under the staturestatute may in fact not have received the level of discounts to which they are entitled. The Amended Complaint against the Company and the other manufacturers asserts claims directly under the federal statue,statute, as well as under state law for unjust enrichment and for an accounting. The Company anticipates that it will joinjoined in a motion to dismiss the complaintComplaint that was filed by the original manufacturer defendants and that, has, with the court’s approval, beenwas made applicable to the Amended Complaint. By order dated September 30, 2005, the Alabama federal court denied the motion to dismiss. Accordingly, the Company anticipates filing an answer to the Amended Complaint in the Alabama Section 340B case. In August 2005, the Company was among several drug manufacturers named as a defendant in a similar case involving Section 340B of the Public Health Service Act filed in California state court by the County of Santa Clara. The defendants have removed that case to federal court in California.

Note 17. Legal Proceedings and Contingencies (Continued)

 

These cases are at a very preliminary stage, and the Company is unable to assess the outcome and any possible effecteffects on its business and profitability, or reasonably estimate possible loss or range of loss with respect to these cases. If the Company were not to prevail in final, non-appealable determinations of these litigations and investigations, the impact could be material.

 

The Company, together with a number of other pharmaceutical manufacturers, also has received subpoenas and other document requests from various government agencies seeking records relating to its pricing, sales and marketing practices, and “Best Price” reporting for drugs covered by Medicare and/or Medicaid. The requests for records have come from the U.S. Attorneys’ Offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Northern District of Texas, the Civil Division of the Department of Justice, the Offices of the Inspector General of the Department of Health and Human Services and the Office of Personnel Management (each in conjunction with the Civil Division of the Department of Justice), and several states. In addition,

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

requests for information have come from the House Committee on Energy & Commerce and the Senate Finance Committee in connection with investigations that the committees are currently conducting into Medicaid Best Price issues.issues and the use of educational grants by pharmaceutical companies.

 

As previously disclosed, in mid-2003, the Company initiated an internal review of certain of its sales and marketing practices, focusing on whether these practices comply with applicable anti-kickback laws and analyzing these practices with respect to compliance with (1) Best Price reporting and rebate requirements under the Medicaid program and certain other U.S. governmental programs, which reference the Medicaid rebate program and (2) applicable FDA requirements. The Company has met with representatives of the U.S. Attorney’s Office for the District of Massachusetts to discuss the review and has received related subpoenas from that U.S. Attorney’s Office.Office, including a subpoena received on May 5, 2005 for documents relating to possible off label promotion of ABILIFY*. The Company’s internal review is expected to continue until resolution of pending governmental investigations of related matters.

The Company is also analyzing its past and proposed systems for calculating prices for reporting under governmental rebate and pricing programs. The results of this analysis have identified the need for revisions to the calculation system methodology and processes used for calculating past rebate amounts and reported pricing. The Company’s methodology review is substantially complete. Based on the results of the Company’s analysis to date, the Company has recorded a liability equal to the estimated additional rebate liability resulting from these revisions. This estimated additional liability, which was not material, primarily resulted from errors in accounting. The Company’s analysis is ongoing. Completion of the analysis could result in additional estimated rebate liability. The Company expects to reflect any resulting changes in this estimate in its year end results. The Company’s proposed revisions and its updated estimate will be submitted for review to the Federal government agency with primary responsibility for these rebate and price reporting obligations (CMS). CMS’s review could result in further revisions to the Company’s methodologies and processes. The amount of additional rebate liability owed by the Company following completion of the Company’s analysis, or following review by CMS, if any, could materially exceed the estimate recorded in the third quarter. The Company also has strengthened and continues to strengthen its internal controls over these systems to remediate the processes and procedures the Company believes resulted in these proposed revisions.

Finally, the Company received a civil investigative demand from the Attorney General of the State of Missouri relating to direct-to-consumer advertising for PRAVACHOL for the period of 2001-2003. The Company received written confirmation from the Attorney General in July 2004 concluding its investigation with no action taken against the Company. The Company also received notice of a putative class action lawsuit involving issues related to the direct-to consumer advertising, filed on February 23, 2004, in circuit court of Jackson County Missouri at Kansas City, captionRichard Summers v. Bristol-Myers Squibb Company. The Company was served with this complaint on March 23, 2004 and removed the action to federal court. The action has been remanded to state court.

 

The Company is producing documents and actively cooperating in the investigations, which could result in the assertion of civil and/or criminal claims. In the second quarter of 2004, theThe Company increasedhas reserves for liabilities in relation to pharmaceutical pricing and sales and marketing practices described in this section by $34 million, bringing the total reserves for liabilities for these matters toof $134 million. It is not possible at this time to reasonably assess the final outcome of these matters. In accordance with GAAP, the Company has determined that the above amount represents minimum expected probable losses with respect to these matters, which losses could include the imposition of fines, penalties, administrative remedies and/or liability for additional rebate amounts. Eventual losses related to these matters may exceed these reserves, and the further impact could be material. The Company does not believe that the top-endtop–end of the range for these losses can be estimated. If the Company were not to prevail in final, non-appealablenon–appealable determinations of these litigations and investigations, the impact could be material.

As previously disclosed, in 2004 the Company undertook an analysis of its methods and processes for calculating prices for reporting under governmental rebate and pricing programs related to its U.S. Pharmaceuticals business. The analysis was completed in early 2005. Based on the analysis, the Company identified the need for revisions to the methodology and processes used for calculating reported pricing and related rebate amounts and implemented these revised methodologies and processes beginning with its reporting to the Federal government agency with primary responsibility for these rebate and price reporting obligations, the Centers for Medicare and Medicaid Services (CMS) in the first quarter of 2005. In addition, using the revised methodologies and processes, the Company also has recalculated the “Best Price and “Average Manufacturer’s Price” required to be reported under the Company’s federal Medicaid rebate agreement and certain state agreements, and the corresponding revised rebate liability amounts under those programs for the three-year period 2002 to 2004. Upon completion of the analysis in early 2005, the Company determined that the estimated rebate liability for those programs for the three-year period 2002 to 2004 was actually less than the rebates that had been paid by the Company for such period. Accordingly, in the fourth quarter of 2004, the Company recorded a reduction to the rebate liability in the amount of the estimated overpayment. The Company’s proposed revisions and an updated estimate have been submitted for review to CMS. The Department of Justice (DOJ) has informed the Company that it also is reviewing the submission in conjunction with the previously disclosed subpoena received by the Company from the DOJ relating to, among other things, “Best Price” reporting for drugs covered by Medicaid as discussed in more detail above, and has requested the Company to provide additional information regarding the proposed revisions and estimate. These agencies may take the position that further revisions to the Company’s methodologies and calculations are required. Upon completion of governmental review, the Company will determine whether any further recalculation of the liability from the Company under the identified programs for any period or under any other similar programs is necessary or appropriate. The Company believes, based on current information, that any such recalculation is not likely to result in material rebate liability. However, due to the uncertainty surrounding the recoverability of the Company’s estimated overpayment arising from the review process described above, the Company recorded a reserve in an amount equal to the estimated overpayment.

Note 17. Legal Proceedings and Contingencies (Continued)

General Commercial Litigation

 

The Company, together with a number of other pharmaceutical manufacturers, has been named as a defendant in an action filed in California State Superior Court in Oakland,James Clayworth et al. v. Bristol-Myers Squibb Company, et al., alleging that the defendants have conspired to fix the prices of pharmaceuticals by preventing the importation of foreignagreeing to charge more for their drugs intoin the United States than they charge outside the United States, particularly Canada, and asserting claims under California’s Cartwright Act and unfair competition law. The plaintiffs seek treble damages for any damages they have sustained; restitution of any profit obtained by defendants through charging artificially higher prices to plaintiffs; an injunction barring the defendants from charging the plaintiffs higher prices offered to other customers; an award of reasonable attorneys’ fees and costs; and any other relief the Court deems proper. The company intends to file a motion to dismiss this action. The plaintiffs have propounded interrogatories to the defendants, and defendants’ response is currently due on December 1, 2004.

 

This case is at a very preliminary stage, and the Company is unable to assess the outcome and any possible effect on its business and profitability, or reasonably estimate possible loss or range of loss with respect to this case. If the Company were not to prevail in a final, non-appealable determination of this litigation, the impact could be material.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)The Company also has been named as a defendant, along with many other pharmaceutical companies, in an action brought by the Utility Consumers Action Network, a consumer advocacy organization which focuses on privacy issues. The lawsuit, filed in California State Superior Court, San Diego County, and entitled Utility Consumers Action Network on behalf of the Privacy Rights Clearinghouse, et al. v. Bristol-Myers Squibb Co., et al, was originally directed only at retail drug stores but was amended in July, 2004 to add the Company and the other pharmaceutical companies as defendants. Another lawsuit, Rowan Klein, a Representative Action on Behalf of Similarly Situated Persons and the Consuming Public, v. Walgreen’s, et al., was filed in February 2005, also in California State Superior Court, San Diego County, against retail pharmacies, the Company and other pharmaceutical companies, and is substantially the same as the Utility Consumers Action Network lawsuit (jointly referred to as “the Complaints”). The Complaints seek equitable relief, monetary damages and attorneys’ fees based upon allegedly unfair business practices and untrue and misleading advertising under various California statutes, including the California Confidentiality of Medical Information Act. Specifically, the Complaints allege that through the “Drug Marketing Program”, retail stores are selling consumers’ confidential medical information to companies. The Complaints further allege that the companies are using consumers’ medical information for direct marketing that increase the sale of targeted drugs.

 

Note 15. Legal ProceedingsBoth cases are at a very preliminary stage, and Contingencies (Continued)the Company is unable to assess the outcome and any possible effect on its business and profitability, or reasonably estimate possible loss or range of loss with respect to this case. If the Company were not to prevail in a final, non-appealable determination of these two lawsuits, the impact could be material.

 

Product Liability Litigation

 

The Company is a party to product liability lawsuits involving allegations of injury caused by the Company’s pharmaceutical and over-the-counter medications. The majority of theseThese lawsuits involve certain over-the-counter medications containing phenylpropanolamine (PPA), orwhile others involve hormone replacement therapy (HRT) products, and the Company’s SERZONE and STADOL NS prescription drugs. In addition to lawsuits, the Company also faces unfiled claims involving the same products.

 

PPA. In May 2000, Yale University published the results of its Hemorrhagic Stroke Project, which concluded that there was evidence of a suggestion that PPA may increase the risk of hemorrhagic stroke in a limited population. In November 2000, the FDA issued a Public Health Advisory and requested that manufacturers of PPA-containing products voluntarily cease manufacturing and marketing them. At that time, the only PPA-containing products manufactured or sold by the Company were COMTREX (liquid gel formulations only) and NALDECON. On or about November 6, 2000, the Company, as well as other manufacturers of PPA- containing products, discontinued the manufacture and marketing of PPA-containing products and allowed customers to return any unused product that they had in their possession.

In January 2001, the Company was served with its first PPA lawsuit. The Company currently isremains a defendant in approximately 68 personal injury14 lawsuits filed on behalf of approximately 10214 plaintiffs in federal and state courts throughoutalleging damages for personal injuries resulting from the United States.ingestion of PPA-containing products. The majority of these lawsuits involve multiple defendants. Among other claims, plaintiffs allege thatCompany has established reserves with respect to the PPA causes hemorrhagic and ischemic strokes,product liability litigation. The Company believes that the defendants were aware ofremaining matters will be resolved within the risk, failed to warn consumers and failed to remove PPA from their products. Plaintiffs seek compensatory and punitive damages. All of the federal cases have been transferred to the U.S. District Court for the Western District of Washington,In re Phenylpropanolamine (PPA) Products Liability Litigation, MDL No. 1407. The District Court has denied all motions for class certification and there are no class action lawsuits pending against the Company in this litigation.amounts reserved.

On June 18, 2003, the District Court issued a ruling effectively limiting the plaintiffs’ claims to hemorrhagic and ischemic strokes. Rulings favorable for the defendants included the inadmissibility of expert testimony in cases alleging injuries occurring more than three days after ingestion of a PPA-containing product and cases involving psychoses, seizures and cardiac injuries. The Company expects to be dismissed from additional cases in which its products were never used by the plaintiffs and where plaintiffs’ alleged injury occurred more than three days after ingestion of a PPA-containing product or where a plaintiff suffered from cardiac injuries or psychoses.

 

SERZONE. SERZONE (nefazodone hydrochloride) is an antidepressant that was launched by the Company in May 1994 in Canada and in March 1995 in the United States. In December 2001, the Company added a black box warning to its SERZONE label warning of the potential risk of severe hepatic events including possible liver failure and the need for transplantation and risk of death. Within several months of the black box warning being added to the package insert for SERZONE, a number of lawsuits, including several class actions, were filed against the Company. Plaintiffs allege that the Company knew or should have known about the hepatic risks posed by SERZONE and failed to adequately warn physicians and users of the risks. They seek compensatory and punitive damages, medical monitoring, and refunds for the costs of purchasing SERZONE. In May 2004, the Company announced that, following an evaluation of the commercial potential of the product after generic entry into the marketplace and rapidly declining brand sales, it had decided to discontinue the manufacture and sale of the product in the U.S. effective June 14, 2004.

 

At present, the Company has 187approximately 217 lawsuits, on behalf of approximately 2,0102,631 plaintiffs, pending against it in federal and state courts throughout the United States. Twenty-sixTwenty-seven of these cases are pending in New York State Court and have been consolidated for pretrial discovery. In addition, there are approximately 763654 alleged, but unfiled, claims of injury associated with SERZONE. In August 2002, the federal cases were transferred to the U.S. District Court for the Southern District of West Virginia,In Re

Note 17. Legal Proceedings and Contingencies (Continued)

re Serzone Products Liability Litigation, MDL 1477. Although discovery is still at a very early stage it appears that very few of these cases involve liver failure. In June 2003, the District Court dismissed the class claims in all but two of the class action complaints. A purported class action has also been filed in Illinois. Although a number of the class action complaints filed against the Company had sought the certification of one or more personal injury classes, the remaining class action complaints do not seek the certification of personal injury classes. In addition to the cases filed in the United States, there are threefour national class actions filed in Canada.

 

Without admitting any wrongdoing or liability, on or around October 15, 2004, the Company entered into a settlement agreement with respect to all claims in the United States and its territories regarding SERZONE. The settlement agreement embodies a schedule of payments dependantdependent upon whether the class member has developed a qualifying medical condition, whether he or she can demonstrate that they purchased or took SERZONE, and whether certain other criteria apply. ThePursuant to the settlement is subject to final approval byagreement, plaintiffs’ class counsel filed a class action complaint seeking relief for the District Court and any appeals therefrom. A motion for preliminary approval was filed on October 28, 2004; the Company expects a notice plan and a final fairness hearing will be scheduled shortly.settlement class. Pursuant to the terms of the proposed settlement, all claims will be dismissed, the litigation will be terminated, the defendants will receive releases, and the Company commits to paying at least $70

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

million to funds for class members. Class Counsel will have the right to petitionhas petitioned the court for an award of reasonable attorneys’ fees and expenses; the fees will be paid by the Company and will not reduce the amount of money paid to class members as part of the settlement. The Company may terminate the settlement based upon the number of claims submitted or the number of purported class members who opt not to participate in the settlement and instead pursue individual claims. On November 18, 2004, the District Court conditionally certified the temporary settlement class and preliminarily approved the settlement. The opt-out period ended on April 8, 2005. Potential class members could have entered the settlement up to and including May 13, 2005. The fairness hearing occurred on June 29, 2005. On September 2, 2005, the Court issued an opinion granting final approval of the settlement; the order approving the settlement was entered on September 9, 2005.

 

In the second quarter of 2004, the Company established reserves for liabilities for these lawsuits of $75 million.million, including reasonable attorney’s fees and expenses. It is not possible at this time to reasonably assess the final outcome of these lawsuits.lawsuits due to a number of contingencies that could affect the settlement. In accordance with GAAP, the Company has determined that the above amounts represent minimum expected probable losses with respect to these lawsuits. Eventual losses related to these lawsuits may exceed these reserves, and the further impact could be material. The Company does not believe that the top-end of the range for these losses can be estimated.

 

STADOL NS. The Company remains a defendant in 8 lawsuits filed on behalf of 27 plaintiffs alleging damages for personal injuries resulting from the use of STADOL NS; the Company is finalizing the settlement of 7 of those lawsuits involving 26 plaintiffs. The Company has established reserves with respect to the STADOL NS was approved in 1992 byproduct liability litigation. The Company believes that the FDA as an unscheduled opioid analgesic nasal spray. In February 1995remaining matters will be resolved within the Company asked the FDA to schedule STADOL NS as a Schedule IV, low potential for abuse, drug due to post-marketing reports suggestive of inappropriate use of the product. On October 31, 1997, it became a Schedule IV drug. Since 1997, the Company has received a number of lawsuits involving STADOL. In late 2002, the number of filed suits increased due to newly passed tort reform legislation, which became effective on January 1, 2003. Most, if not all, of the plaintiffs in these new suits had previously asserted claims against the Company for their alleged injuries. In May 2004, the Company announced that, following an evaluation of the commercial potential of the product after generic entry in the marketplace and rapidly declining brand sales, it had decided to discontinue the manufacture and sale of the product effective June 14, 2004.amounts reserved.

 

The Company is a partyentered into agreements in approximately 40 cases pending, on behalf of a total of approximately 672 plaintiffs, in federal2004 and state courts throughout the United States. Plaintiffs claim that the Company committed fraud on the FDA and wrongfully promoted STADOL NS as non-addictive. Further, plaintiffs allege that the Company failed to adequately warn of the addiction and dependency risk associated with the use of STADOL NS. The Company has reached an agreement in principle2005, totaling $113 million, to settle 32 of the lawsuits involving approximately 660 plaintiffs. In addition to these lawsuits, there are approximately 15 active, alleged and unfiled claims. The majority of the cases and claims are pending in Mississippi.

In addition to the cases filed in the United States, there are two class actions and one individual case filed in Canada. The Company has entered into a settlement agreementcoverage disputes with its various insurers with respect to claims in Canada regarding the product. The settlement was approved by the Canadian court in Ontario in June 2004STADOL NS and the Canadian court in Quebec in July 2004.

In the second quarter of 2004, the Company recovered insurance proceeds of $25 million with respect to these cases.SERZONE cases as discussed above.

 

BREAST IMPLANT LITIGATION. The Company, together with its subsidiary Medical Engineering Corporation (MEC) and certain other companies, remains a defendant in a number of claims andfew lawsuits alleging damages for personal injuries of various types resulting from polyurethane-covered breast implants and smooth-walled breast implants formerly manufactured by MEC or a related company. The vast majority of claims against the Company in directsimilar lawsuits have beenwere resolved through settlements or trial.

 

Likewise, claims or potential claims againstThe Company remains subject to the Company registered in theterms of a nationwide class action settlement approved by the Federal District Court in Birmingham, Alabama (Revised Settlement), have been or that will be resolvedrun through the Revised Settlement.2010. The Company has established accrualsreserves in respect of breast implant product liability litigation. The Company believes that any possible loss in addition to the amounts accruedreserved will not be material.

 

HORMONE REPLACEMENT THERAPY (HRT) LITIGATION.In 1991, The National Institute of Health (NIH) launched the Women’s Health Initiative (WHI) clinical trials involving Prempro (estrogen and progestin) and Premarin (estrogen), both of which are manufactured by Wyeth. A July 2002, article in the Journal of the American Medical Association reported that among the Prempro subjects, there were increased risks of breast cancer, heart attacks, blood clots and strokes, and decreased risks of hip fractures and colorectal cancer. The Prempro phase of the study was stopped on July 9, 2002. The Premarin phase continued, only to be stopped on March 1, 2004 when the NIH informed study participants that they should stop study medications in the trial of conjugated equine estrogens (Premarin, Estrogen-alone) versus placebo. Women will continue to be followed for several more years, including ascertainment of outcomes and mammogram reports. The first legal complaints were filed against Wyeth shortly after WHI was halted in July 2002. In July 2003, the Company was served with its first HRT lawsuit. The Company marketed products containing estrogen, specifically involved in this litigation are:

Note 17. Legal Proceedings and Contingencies (Continued)

ESTRACE® (an estrogen-only tablet); ESTRADIOL (generic estrogen-only tablet); DELESTROGEN® (an injectable estrogen); and OVCON until 2001. ® (an oral contraceptive containing both estrogen and progestin). All of these products were sold to other companies between January 2000 and August 2001, but the Company maintains the ESTRACE® ANDA, and continues to manufacture some of the products under a supply agreement.

The Company currently is a defendant in approximately 372 HRT640 lawsuits involving the above-mentioned products, filed on behalf of 535approximately 1,242 plaintiffs, in federal and state courts throughout the United States. All of these lawsuits involve multiple defendants. The first lawsuit was served on the Company expects to be dismissed from many cases in July 2003.which its products were never used. Plaintiffs allege, among other things, that the HRTthese products cause breast cancer, stroke, blood clots, cardiac and other injuries in post-menopausal women, that the defendants were aware of these risks and failed to warn consumers. The federal cases are being transferred to the U.S. District Court for the Eastern District of Arkansas,In re Prempro (Wyeth) Products Liability Litigation,MDL No., 1507.

The Company is vigorously defending its product liability lawsuits and believes that the majority of these cases and claims are without merit. While it is not possible at this time reasonably to assess the final outcome of the Company’s pending product liability lawsuits and unfiled claims with certainty, management is of the opinion that the ultimate disposition of these matters should not have a material adverse effect on the Company’s financial position. The Company believes that it has adequate self-insurance reserves and commercially available excess insurance to cover potential material losses related to its product liability cases and claims.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

PLATINOL Litigation

On February 13, 2004, a class action complaint was filed by North Shore Hematology-Oncology Associates, P.C. against the Company in the U.S. District Court for the District of Columbia. This was a punative class action brought on behalf of direct purchasers of PLATINOL that alleged that the Company violated federal antitrust laws by maintaining a monopoly in the U.S. market. The allegations focused on the Company’s actions concerning U.S. Patent No. 5,562,925 (‘925 patent), including the procurement of the ‘925 patent, submission of information relating to the ‘925 patent for listing in the Orange Book, and initiation of previous lawsuits against potential generic manufacturers based on the ‘925 patent. Plaintiffs sought declaratory judgment and damages (including treble damages).

The Company markets PLATINOL under exclusive patent licenses from Research Corporation Technologies (RCT). Generic versions of PLATINOL (cisplatin) have been approved and marketed since 1999.

The Company has reached an agreement with the plaintiffs to settle this action. On September 28, 2004, the court entered an order preliminarily approving the settlement, certifying a class for settlement purposes only and scheduling a fairness hearing for November 30, 2004, at which time the Court will consider whether to finally approve the settlement. Pursuant to the terms of the proposed settlement, all claims in the action will be dismissed with prejudice, the litigation will be terminated, the Company and RCT will receive releases, and the Company will pay $50 million to a settlement fund for class members. The settlement is subject to final approval by the Court at the fairness hearing and any appeals therefrom. In addition, the Company may terminate the settlement if purported class members who purchased more than a certain percentage of the Company’s stock purchased during the class period opt not to participate in the settlement.

The Federal Trade Commission (FTC) also initiated an investigation relating to PLATINOL. This matter was settled with the entry of a consent decree, which is in effect until April 14, 2013.

In the second quarter of 2004, the Company established reserves for liabilities for the litigation of $25 million, and increased the reserves by $25 million in the third quarter of 2004, bringing the total reserve to $50 million as of September 30, 2004.

TAXOL Litigation

In 2000, 2001 and 2002, a number of putative class actions were brought against the Company, alleging antitrust, consumer protection and similar claims concerning the Company’s actions to obtain and enforce patent rights relating to TAXOL. A number of state attorneys general brought similar claims, and certain insurers asserted similar claims without filing suits. All of these matters have been settled, and those that required court approval had been given final approval by the supervising court. The total amount of the settlements was $144 million. Of that amount, $135 million was accrued in 2002. The remaining $9 million was accrued in 2003.

The FTC also opened an investigation relating to TAXOL. This matter was settled with the entry of a consent decree, which is in effect until April 14, 2013.

An additional case based on the same allegations was brought by Xechem, a small generic drug manufacturer in 2003. The Company moved to dismiss that case, and the court granted the motion in July 2003. The plaintiff filed an appeal in the U.S. Court of Appeals for the Seventh Circuit, and the Seventh Circuit reversed the lower court’s decision. The case has been remanded to the lower court for discovery and further proceedings.

It is not possible at this time reasonably to assess the final outcome of this suit or reasonably to estimate the possible loss or range of loss with respect to this litigation. If the Company were not to prevail in a final, non-appealable determination of the action, the impact could be material.

 

Environmental Proceedings

 

The following discussion describes (1) environmental proceedings with a governmental authority which may involve potential monetary sanctions of $100,000 or more (the threshold prescribed by specific SEC rule), (2) a civil action or an environmental claim that could result in significant liabilities, (3) updates of ongoing matters, or the resolution of other matters, disclosed in recent public filings and (4) a summary of environmental remediation costs.

 

The preliminary results of an internal audit performed at the Company’s facility in Hopewell, N.J. indicate that operations at the site’s wastewater treatment plant and related discharges may not be in compliance with the New Jersey Water Pollution Control Act and its

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

implementing regulations or the terms of the Company’s discharge permits. The Company reported its findings to the New Jersey Department of Environmental Protection (NJDEP) in February 2004, and is currently engaged in settlement discussions with the State. None of the results of the audit suggest that there has been any adverse impact to public health. The Company has taken, and will continue to take, corrective actions to address identified deficiencies and to prevent future occurrences.

The U.S. Environmental Protection Agency (EPA) is investigating industrial and commercial facilities throughout the U.S. that use refrigeration equipment containing ozone-depleting substances (ODS) and enforcing compliance with regulations governing the prevention, service and repair of leaks (ODS requirements). Recently,In 2004, the Company beganperformed a voluntary corporate-wide audit at its facilities in the U.S. and Puerto Rico that use ODS-containing refrigeration equipment. Although theThe Company submitted an audit is still on-going, the Company sent a letterreport to the EPA in July,November 2004, reporting preliminary findings that someidentifying potential violations of the Company’s facilities may not be in compliance with certain ODS requirements.requirements at several of its facilities. In addition to the matters covered in the Company’s preliminary audit report letter to the EPA, the EPA previously sent the Company’s wholly owned subsidiary, Mead Johnson, a request for information regarding compliance with ODS requirements at its facility in Evansville, Indiana. The Company responded to the request in June 2004, and, has not received any further correspondence fromas a result, identified potential violations at the EPA.Evansville facility. The company currently is in discussions with EPA to resolve both the potential violations discovered during the audit and those identified as a result of the EPA request for information to the Evansville facility. If the EPA determines that the Evansville facility, or any other facilities, was, or is, in violation of applicable ODS requirements, the Company could be subject to penalties and/or be required to convert or replace refrigeration equipment to use non-ODS approved substitutes.

 

In January 2004, the NJDEP sentMarch 2005, the Company commenced a voluntary environmental audit of the Barceloneta and approximately five other companies an information request letter relatingHumacao facilities to determine their compliance with EPA’s regulations regarding the maximum achievable control technology requirements for emissions of hazardous air pollutants from pharmaceuticals production (Pharmaceutical MACT). In May 2005, the Company disclosed potential violations of the Pharmaceutical MACT requirements at both facilities and is currently in the process of analyzing the potential violations to provide more details to EPA. To date, the Company has not been contacted by EPA with respect to these potential violations; however, if EPA determines that the Barceloneta and Humacao facilities violated the Pharmaceutical MACT requirements, the Company could be subject to civil penalties and/or be required to make investments in the facilities to ensure their compliance with the Pharmaceutical MACT.

In October 2003, the Company was contacted by counsel representing the North Brunswick, NJ Board of Education regarding a site in North Brunswick Township, N.J. where waste materials from E.R. Squibb &and Sons, (Squibb), a wholly owned subsidiary of the Company, may have been disposed from the 1940s1940’s through the 1960s.1960’s. Fill material containing industrial waste and heavy metals in excess of residential standards was discovered in Fall 2003 during an expansion project at the North Brunswick Township High School, as well as at a number of neighboring residential properties.properties and adjacent public park areas. In January 2004, the New Jersey Department of Environmental Protection (NJDEP) sent the Company and approximately five other companies an information request letter about possible waste disposal at the site, to which the Company responded in March 2004. The school board and the Township, who are the current owners of school property and the site, have begunpark, are conducting and jointly financing soil remediation work under a workplanwork plan approved by the NJDEP, and are evaluating the need to conduct response actions to remediate or contain potentially impacted ground water. In addition, the school board reportedly is facing unexpected project cost increases due to contractor claims that discovery of the waste material has delayed and complicated performance of site work. The site owner entities have asked the Company to contribute to the cost of remediation.remediation, and to contribute funds on an interim basis to assure uninterrupted performance of necessary site work in the face of unbudgeted cost increases. The Company is in discussionsactively monitoring the clean-up project, including its costs, and has offered to negotiate with the NJDEP,school board and Township on the terms of a cooperative funding agreement and allocation process. Municipal records indicate the Township operated a municipal landfill at the site ownersin the 1940’s through the 1960’s, and other potentially responsible parties. Thethe Company is actively investigating the historic use of the site, investigation is ongoing, andincluding the Company’s possible connection. To date, no claims have been asserted against the Company.

Note 17. Legal Proceedings and Contingencies (Continued)

 

In September 2003, the NJDEP issued an administrative enforcement Directive and Notice under the New Jersey Spill Compensation and Control Act requiring the Company and approximately 65 other companies to perform an assessment of natural resource damages and to implement unspecified interim remedial measures to restore conditions in the Lower Passaic River. The Directive alleges that the Company is liable because it historically sent bulk waste to the former Inland Chemical Company facility in Newark, N.J. (now owned by McKesson Corp.) for reprocessing, and that releases of hazardous substances from this facility have migrated into Newark Bay and continue to have an adverse impact on the Lower Passaic River watershed. Subsequently, the EPA also issued a notice letter under the U.S. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to numerous parties—but not including the Company—seeking their cooperation in a study of conditions in substantially the same stretch of the Passaic River that is the subject of the NJDEP’s Directive. A group of these other parties entered into a consent agreement with EPA in 2004 to finance a portion of that study. The EPA estimates this study will cost $20 million.million, of which roughly half will be financed by this private party group. This study may also lead to clean-up actions, directed by the EPA and the Army Corps of Engineers. The Company is working cooperatively with a group of the parties that received the NJDEP Directive and/or the EPA notice to explore potential resolutions of the Directive and to address the risk of collateral claims. The extent of any liability, under either the Directive or the EPA’s notice letter, cannot yet be determined. Although the Company does not believe it has caused or contributed to any contamination in the Lower Passaic River watershed, the Company has informed the NJDEP that it is willing to discuss theirNJDEP’s allegations against the Company. In the Directive and in more recent communications to the cooperating group, NJDEP has stated that if the responsible parties do not cooperate, the NJDEP may perform the damage assessment and restoration and take civil action to recover its remedial costs, and treble damages for administrative costs and penalties. Also, in late 2004, a group of federal agencies designated as trustees of natural resources affected by contamination in the Passaic River watershed approached the cooperating group about funding a cooperative study of possible natural resources damages (NRD) in the area. This study presumably would dovetail with the ongoing EPA study, and ideally would be joined by the NJDEP, to coordinate actions NJDEP may seek under the Directive. Discussions with the federal trustees are ongoing. In early 2005, McKesson asserted that the Company is obligated to reimburse a fixed percentage of costs that McKesson ultimately may face in this matter by operation of a 1993 cost-sharing agreement governing performance of an on-site remedy at the former Inland facility. The Company has denied the obligation but has proposed to enter an agreement to toll the running of any limitations bars on any claims McKesson may have to allow consideration of such claims in the larger context of facts and claims that may develop with respect to the NJDEP Directive and/or the EPA remedial process. The extent of any liability the Company may face, under either the Directive, the EPA’s notice letter, or with respect to future NRD actions or claims by the federal trustees, or in contribution to McKesson or other responsible parties, cannot yet be determined.

 

On October 16, 2003, the Michigan Department of Environmental Quality (MDEQ) sent the Company a Letter of Violation (LOV) alleging that, over an unspecified period of time, emissions from certain digestion tanks at Mead Johnson’s Zeeland, Michigan facility exceeded an applicable limit in the facility’s renewable operating air permit. The LOV requires the Company to take corrective action and to submit a compliance program report. Although theThe MDEQ has not demanded fines or penalties, and has not taken further enforcement action could result in penalties or injunctive relief.action. The Company is contestingand the allegations inMDEQ completed revisions to the LOV.Company’s air use permit which appear to have resolved the matter.

 

In MayOn December 1, 2003, the Environmental Quality Board of Puerto Rico (EQB) issued a notice toCompany and the Company alleging fiveNJDEP entered an Administrative Consent Order (ACO) concerning alleged violations of the federal Resource RecoveryNew Jersey Air Pollution Control Act and Conservation Act relating to recordkeeping or storage requirements for hazardous wastesits implementing regulations at the Company’s New Brunswick facility. Pursuant to the ACO, the Company agreed to submit a permit application creating a facility-wide emissions cap and to pay an administrative fine of approximately $28,000. Both of these obligations were satisfied in early 2004. Subsequently, on February 15, 2005, the ACO was amended to provide that the Company would install a new cogeneration turbine at its New Brunswick facility in Humacao. This matter has been settledby December 31, 2006, and would obtain air permits, including those required for $6,400.

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)the cogeneration turbine, by December 31, 2005. The estimated cost of the new cogeneration turbine is approximately $5 million.

 

The Company is one of several defendants, including most of the major U.S. pharmaceutical companies, in a purported class action suit filed in superior court in Puerto Rico in February 2000 by residents of three wards from the Municipality of Barceloneta, alleging that air emissions from a government owned and operated wastewater treatment facility in Barcelonetathe Municipality have caused respiratory and other ailments, and violated local air rules.rules and adversely impacted property values. The Company believes its wastewater discharges to the treatment facility are in material compliance with the terms of the Company’s permit. Discovery in the case is ongoing, and the plaintiffs’ motion to certify the class is pending at this time. In September 2005 the parties stipulated to the dismissal (with prejudice) of all claims for property damage and personal injury, leaving only claims related to nuisance remaining in the case. The court had scheduled a hearing on the class certification motion for September 30, 2005, but that hearing was adjourned on account of ongoing settlement discussions and problems with the plaintiffs’ expert report, which was rejected by the court. The Company believes that this litigation will be resolved for an immaterial amount, nevertheless, this suit is still at an initial stage and,which may bring the matter to resolution. However, in the event of an adverse judgment, the Company’s ultimate financial liability could be greater than anticipated.

In August 2005, the Company received a notice letter from the U.S. Department of Justice (DOJ), on behalf of the U.S. Environmental Protection Agency (EPA) alleging that waste materials from the Company’s Calgon Vestal Laboratories (CVL) facility were among those found at the Sauget Area Two Superfund Site in suburban St. Louis, Illinois. EPA reportedly has incurred over $3 million in initial site response actions, and currently is conducting a comprehensive site characterization study designed to

Note 17. Legal Proceedings and Contingencies (Continued)

allow EPA to develop and select a final site remedy. As a result, remaining site costs cannot be estimated at this time. Inquiries are underway within the cooperating potentially responsible parties (PRP) group and with EPA to learn more about the nature and extent of CVL’s possible transactional connection to this site. However, initial research indicates this type of liability is among those retained by the Company’s predecessor (Merck), from whom the Company acquired CVL pursuant to a 1994 sales agreement. Merck has been put on notice of this claim, and discussions are underway to determine if Merck should assume responsibility for this claim.

In September 2005, the Company received a notice letter from a PRP Group cooperating in the clean-up of the former Philip Services Corp. incinerator and disposal site in South Carolina, alleging a nexus from the former E.R. Squibb facility in Kenly, North Carolina. The Group is performing site investigation work under a consent agreement with the South Carolina Department of Health and Environmental Control; as a result, no information is available on potential site costs. The Group has invited the Company to join the group in lieu of litigation; that offer currently is being evaluated, which, among other things, would allow the Company access to the Group’s compilation of site records documenting the transactional connection of the Company and others. Internal investigation also is underway, including whether other Company facilities may have used the site. At this time, no estimate can be made of the Company’s potential liability at the site.

 

The Company is also responsible under various state, federal and foreign laws, including 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. The Company typically estimates these costs based on information obtained from the EPA, or counterpart state 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 (PRP)PRP. The Company accrues liabilities when they are probable and reasonably estimable. As of September 30, 2004,2005, the Company estimated its share of the total future costs for these sites isto be approximately $60$58 million, recorded as other liabilities, which represents the sum of best estimates or, where no simple estimate can reasonably be made, estimates of minimumsthe minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties, which are not currently expected). The Company has paid less than $4 million (excluding legal fees) in each of the last five years for investigation and remediation of such matters, including liabilities under CERCLA and for other on-site remediations.

remedial obligations. Although it is not possible to predict with certainty the outcome of these environmental proceedings or the ultimate costs of remediation, the Company does not believe that any reasonably possible expenditures that the Company may incur in excess of existing reserves will have a material adverse effect on its business, financial position, or results of operations.

 

Other Matters

 

On October 25, 2004, the SEC notified the Company that it is conducting an informal inquiry into the activities of certain of the Company’s German pharmaceutical subsidiaries and its employees and/or agents. The Company believes the SEC’s informal inquiry may encompass matters currently under investigation by the Staatsanwaltin prosecutor in Munich, German.Germany. Although, uncertain at this time, the Company believes the inquiry and investigation may concern potential violations of the Foreign Corrupt Practices Act and/or German law. The Company is cooperating with both the SEC and the German authorities. It is not possible at this time reasonably to assess the final outcome of these matters or to reasonably estimate the possible loss or range of loss.

The Company is conductinghas established an internal review of its pharmaceutical operations in Mexicoaccrual which had sales of $153 million forrepresents minimum expected probable losses with respect to the nine months ended September 30, 2004. This broad review includes areas of compliance with legal, financial and regulatory requirements andinvestigation by the company’s Standards of Business Conduct and Ethics. The reviews are ongoing. At this time, the Company is unable to assess the impact, if any, the results these investigations may have on the Company.Staatsanwaltin prosecutor.

 

Indemnification of Officers and Directors

 

The Company’s corporate by-laws require that, to the extent permitted by law, the Company shall indemnify its officers and directors against judgments, fines, penalties and amounts paid in settlement, including legal fees and all appeals, incurred in connection with civil or criminal actions or proceedings, as it relates to their services to the Company and its subsidiaries. The by-laws provide no limit on the amount of indemnification. Indemnification is not permitted in the case of willful misconduct, knowing violation of criminal law, or improper personal benefit. As permitted under the laws of the state of Delaware, the Company has for many years purchased directors and officers insurance coverage to cover claims made against the directors and officers. The amounts and types of coverage have varied from period to period as dictated by market conditions. There are various excess policies that provide additional coverage.

The litigation matters and regulatory actions described above involve certain of the Company’s current and former directors and officers, all of whom are covered by the aforementioned indemnity and if applicable, certain prior period insurance policies.However,policies. However, certain indemnification payments may not be covered under the Company’s directors and officersofficers’ insurance coverage. The Company cannot predict with certainty the extent to which the Company will recover from its insurers the indemnification payments made in connection with the litigation matters and regulatory actions described above.

 

On July 31, 2003, one of the Company’s insurers, Federal Insurance Company (Federal), filed a lawsuit in the New York Supreme Court against the Company and several current and former officers and members of the board of directors, seeking rescission, or in the alternative, declarations allowing Federal to avoid payment under certain Directors and Officers insurance policies and certain

Note 17. Legal Proceedings and Contingencies (Continued)

Fiduciary Liability insurance policies with respect to potential liability arising in connection with the matters described under the “—VANLEV Litigation,” “—Other Securities Matters” and “—ERISA Litigation” sections above. No discovery has been taken in this

BRISTOL-MYERS SQUIBB COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 15. Legal Proceedings and Contingencies (Continued)

matter. On October 3, 2003, anotherThe parties negotiated a settlement of these disputes. Pursuant to the settlement, the Company received substantially all of the Company’s insurers, SR International Business Insurance Co. Ltd. (SRI), informed the Company that it intended to try to avoid certain$203 million in insurance policies issued to the Company on grounds of alleged material misrepresentation or non-disclosure, and that it had initiated arbitration proceedingsproceeds which were reflected in London, England. SRI has indicated that it intends to rely upon allegations similar to those described in the “—Other Securities Matters” section above in support of its avoidance action.financial statements.

 

Note 16.18. Subsequent Events

 

On November 7, 2004,In October 2005, the Company entered into a worldwide collaborationborrowed, through its subsidiary, $2.0 billion against its existing $2.5 billion term loan facility. For additional information, see “—Note 13. Short-term Borrowings and share purchase agreement with Medarex, Inc. (Medarex) to codevelop and copromote MDX-010, a fully human antibody currently in Phase III development for the treatment of metastatic melanoma. Long-term Debt.”

The Company previously disclosed that it anticipated to repatriate approximately $9.0 billion in special dividends in 2005 pursuant to the AJCA, of which approximately $6.2 billion was repatriated in the first quarter of 2005. In November 2005, the Company will makerepatriate a cash paymentsubstantial portion of $25 million to Medarex which will be expensed as researchthe remaining special dividends, and developmentanticipates completing the repatriation of special dividends in the fourth quarter of 2004. The Company will also make2005. For additional information on the AJCA, see “—Note 8. Income Taxes.”

On October 18, 2005, the FDA issued an equity investment in Medarexapprovable letter for muraglitazar requesting additional information from ongoing clinical trials to more fully address the cardiovascular safety profile of $25 million, $1 million of which represent a premium over current market value and will be expensed in the fourth quarter of 2004. Further milestone payments are expected to be made upon the successful achievement of various regulatory and sales-related stages. The Company and Medarex will also share in future development and commercialization costs. The agreement is subject to regulatory approval under the Hart Scott Rodino Act and the receipt of consent from the U.S. Public Health Service of the sublicense tomuraglitazar. On October 27, 2005, Merck advised the Company of Medarex’s rightstheir intent to MDX-1379, a vaccine that is being developed in conjunction with MDX-010.terminate the collaborative agreement and the Company has agreed to begin discussions to terminate the agreement. For additional information related to the approvable letter, see “—Note 2. Alliances and Investments.”

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors

and Stockholders of

Bristol-Myers Squibb Company:

 

We have reviewed the accompanying consolidated balance sheet of Bristol-Myers Squibb Company and its subsidiaries as of September 30, 2004,2005, and the related consolidated statements of earnings and comprehensive income and retained earnings and of cash flows for each of the three-month and nine-month periods ended September 30, 2005 and 2004 and 2003.the consolidated statements of retained earnings and cash flows for the nine-month periods ended September 30, 2005 and 2004. These interim financial statements are the responsibility of the Company’s management.

 

We conducted our review in accordance with the standards of the Public Company Accounting Oversight Board (United States). A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with the standards of the Public Company Accounting Oversight Board, the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.

 

Based on our review, we are not aware of any material modifications that should be made to the accompanying consolidated interim financial statements for them to be in conformity with accounting principles generally accepted in the United States of America.

 

We have previously audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheet as of December 31, 2003,2004, and the related consolidated statements of earnings, comprehensive income and retained earnings and of cash flows for the year then ended, (not presented herein),management’s assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2004 and the effectiveness of the Company’s internal control over financial reporting as of December 31, 2004; and in our report dated March 9, 20043, 2005, we expressed an unqualified opinion on thoseopinions thereon. The consolidated financial statements.statements and management’s assessment of the effectiveness of internal control over financial reporting referred to above are not presented herein. In our opinion, the information set forth in the accompanying consolidated balance sheet as of December 31, 2003,2004, is fairly stated in all material respects in relation to the consolidated balance sheet from which it has been derived.

 

/s/ PricewaterhouseCoopers LLP

PricewaterhouseCoopers LLP

Philadelphia, Pennsylvania

November 2, 2005

Philadelphia, Pennsylvania

November 8, 2004

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the consolidated financial statements and related notes contained herein.

 

Summary

Bristol-Myers Squibb Company (BMS, the Company or Bristol-Myers Squibb) is a worldwide pharmaceutical and related healthcare products company whose mission is to extend and enhance human life. The Company is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals and other healthcare related products.

The Company continues to execute its strategy of serving specialists and high-value primary care physicians by transitioning its product portfolio to focus on disease areas of significant unmet need, where innovative medicines can help patients with serious illnesses.

During the third quarter of 2005, among the Company’s full-development programs, ORENCIA®, a potential therapy for rheumatoid arthritis was recommended for approval by the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee and saxagliptin, the Company’s DPP4 inhibitor for the potential treatment of diabetes transitioned to Phase III.

On October 18, 2005, as previously disclosed, the FDA issued an approvable letter for PARGLUVA™ (muraglitazar), the Company’s investigational oral medicine for the treatment of type 2 diabetes. The FDA has requested additional information from ongoing clinical trials to more fully address the cardiovascular safety profile of muraglitazar. The Company determined that to receive regulatory approval and to achieve commercial success, additional studies may be required because ongoing muraglitazar trials are not designed to answer the questions raised by the FDA. The additional studies may take approximately five years to complete. The Company will continue discussions with the FDA. Merck advised the Company of their intent to terminate the collaborative agreement and the Company has agreed to begin discussions to terminate the agreement. The Company is in the process of evaluating a range of options including conducting additional studies or terminating further development of muraglitazar.

The Company invested $669 million in research and development in the third quarter of 2005, a 9% increase over 2004. For the quarter, research and development dedicated to pharmaceutical products, was $616 million and as a percentage of Pharmaceutical sales was 16.3% compared to $566 million and 14.7% in 2004.

 

For the third quarter of 2004, Bristol-Myers Squibb2005, the Company (the Company) reported global sales from continuing operations of $5.4$4.8 billion. Sales increased 1%remained constant from the prior year level resulting from a 1%due to the favorable impact from foreign exchange rate fluctuations, a 2%an increase due to changes in average selling prices, which were offset by a decrease in volume. U.S. sales remained constant at $2.7 billion in both 2005 and 2004, while international sales decreased 1% to $2.1 billion, including a 2% decrease in volume, primarily due to exclusivity losses. U.S. sales decreased 2%, primarily due to exclusivity losses, partially offset by increased sales of new products. International sales increased 5%, primarily due to a 4% favorable foreign exchange impact.

Earnings before minority interest and income taxes decreased 15% to $1,151 million in 2004 from $1,361 million in 2003, primarily due to increases in cost of products sold as a result of a change in product mix, product exclusivity losses, increased investments in research and development, and restructuring and accelerated depreciation charges primarily related to downsizing and streamlining of the U.S. and European operations. Net earnings were $758 million, or $.39 and $.38 per share on a basic and diluted basis, respectively, in 2004 compared to $906 million, or $.47 per share on both a basic and diluted basis in 2003. While the Company expects exclusivity losses and new product mix to challenge its margins, the Company remains committed to invest significantly behind its businesses to maximize key growth drivers and to advance its late-stage pipeline. Several items affected the comparability of the results between 2004 and 2003, as discussed below under “—Earnings.”

At September 30, 2004, the Company held $7.3 billion in cash, cash equivalents, and marketable securities. Substantially all of such cash, cash equivalents, and marketable securities were held by the Company’s foreign subsidiaries. Congress recently approved the American Jobs Creation Act of 2004, which allows the Company to elect to deduct from its taxable income 85% of certain eligible dividends received by the Company from non-U.S. subsidiaries before the end of 2005 if those dividends are reinvested in the U.S. for eligible purposes. The Company estimates that up to approximately $9 billion in dividends from its non-U.S. subsidiaries could potentially be eligible for this deduction. The Company is currently evaluating the amount of such eligible dividends that its non-U.S. subsidiaries will remit. The Company anticipates accruing a provision for taxes associated with eligible dividends in the fourth quarter of 2004. Pending resolution of certain matters, and subject to further guidance from the Department of the Treasury, the Company estimates that such provision for taxes would be 5.25% of the amount of eligible dividends. Income taxes will not be provided on the balance of unremitted earnings since it continues to be management’s practice and intent to keep these earnings permanently invested offshore. For additional discussion of this matter, see “Item 1. Financial Statements—Note 7. Income Taxes.”

Long-term debt was $8.5 billion at September 30, 2004 and December 31, 2003. Cash provided from operating activities was $2.5 billion in the first nine months of 2004. Working capital was $4.8 billion at September 30, 2004, an improvement of $0.5 billion primarily driven by increases in cash and cash equivalents, partially offset by issuance of commercial paper.

 

The Company and its subsidiaries are the subject of a number of significant pending lawsuits, claims, proceedings and investigations. It is not possible at this time reasonably to assess the final outcome of these investigations or litigations. Management continues to believe, as previously disclosed, that during the next few years, the aggregate impact, beyond current reserves, of these and other legal matters affecting the Company is reasonably likely to be material to the Company’s results of operations and cash flows, and may be material to its financial condition and liquidity. For additional discussion of this matter, see “Item 1. Financial Statements—Note 15.17. Legal Proceedings and Contingencies.”

 

In the third quarterThe following discussion of 2004, consistent with the Company’s missionthree and nine-month results of continuing operations excludes the results related to extend and enhance human life by developing the highest-quality products, the Company invested $615 million in research and development, a 9% growth over 2003. Research and development dedicated to pharmaceutical products, including milestone payments for in-licensing and development programs, was $566 million andOncology Therapeutics Network (OTN) business, which were previously presented as a percentage of pharmaceutical sales was 14.8% compared to 13.4% in 2003.separate segment, and has been segregated from continuing operations and reflected as discontinued operations for all periods presented. See “—Discontinued Operations” below.

 

Three Months Results of Operations

 

   Three Months Ended
September 30,


  

% Change


 
   2005

  2004

  
   (dollars in millions)    

Net Sales

  $4,767  $4,778  —   

Earnings from continuing operations before minority interest and income tax

  $1,626  $1,146  42%

% of net sales

   34.1%  24.0%   

Provision on income taxes

  $507  $239  112%

Effective tax rate

   31.2%  20.9%   

Earnings from continuing operations

  $964  $755  28%

% of net sales

   20.2%  15.8%   

Net Sales

Worldwide sales from continuing operations for the third quarter of 2004 increased 1% to $5,427 million from $5,3722005 remained constant at $4,767 in 2005 and $4,778 million in 2003. The increase in sales in the third quarter of 2004 resulted from a 1% favorable impact from foreign exchange rate fluctuation, a 2% increase due to changes in selling prices and a 2% decrease in volume primarily due to exclusivity losses, primarily offset by increased sales of new products.2004. U.S. sales decreased 2% to $3,282remained constant at $2,638 million in 2005 and $2,633 million in 2004, from $3,334 million in 2003 due to exclusivity losses, partially offset by increasedwhile international sales of new products. International sales increased 5%decreased 1%, primarily due toincluding a 4%2% favorable foreign exchange impact, to $2,129 million in 2005 from $2,145 million in 2004 from $2,038 million2004.

The composition of the net increase/(decrease) in 2003. sales is as follows:

Three Months Ended

September 30,


     Analysis of % Change

  Total Change

  Volume

 Price

 Foreign Exchange

2005 vs. 2004

  —    (2)% 1% 1%

In general, the Company’s business is not seasonal. For information on U.S. pharmaceuticals

prescriber demand, reference is made to the table within Business Segments under the Pharmaceuticals section below, which sets forth a comparison of changes in net sales to the estimated total U.S. prescription growth (for both retail and mail order customers) for certain of the Company’s primary care pharmaceutical products.

 

Under U.S. generally accepted accounting principles (GAAP), revenue is recognized when substantially allThe Company operates in three reportable segments—Pharmaceuticals, Nutritionals and Related Healthcare. In May 2005, the risks and rewardsCompany completed the sale of ownership have transferred. In the case of sales made to wholesalers (1)OTN, which was previously presented as a resultseparate segment. As such, the results of incentives, (2) in excess of the wholesaler’s ordinary course of business inventory level, (3) at a time when there was an understanding, agreement, course of dealing or consistent business practice that the Company would extend incentives based on levels of excess inventory in connection with future purchases and (4) at a time when such incentives would cover substantially all, and vary directly with, the wholesaler’s cost of carrying inventory in excess of the wholesaler’s ordinary course of business inventory level, substantially all the risks and rewards of ownership do not transfer upon shipment and, accordingly, such salesoperations for OTN are accounted for using the consignment model. The determination of when, if at all, sales to a wholesaler meet the foregoing criteria involves evaluation of a variety of factors and a number of complex judgments.

Under the consignment model, the Company does not recognize revenue upon shipment of product. Rather, upon shipment of product the Company invoices the wholesaler, records deferred revenue at gross invoice sales price and classifies the inventory held by the wholesalerspresented as consignment inventory at the Company’s cost of such inventory. The Company recognizes revenue (net of the gross to net sales adjustments discussed below, all of which involve significant estimates and judgments) when the consignment inventory is no longer subject to the incentive arrangements described above, but not later than when such inventory is sold through to the wholesalers’ customers, on a first-in first-out (FIFO) basis.

Salespart of the Company’s oncology products throughresults from discontinued operations in accordance with Statement of Financial Standards (SFAS) No. 144, “Accounting for the Oncology Therapeutics Network (OTN) business are also accounted for on a consignment basis.Impairment or Disposal of Long-Lived Assets.” Accordingly, OTN uses a third-party distributorresults of operations in prior periods have been reclassified to ship these productsdiscontinued operations to its customers. Upon shipmentconform with current year presentations. The percent of the products to the distributor, the Company records deferred revenue at gross invoice sales price and classifies the inventory held by the distributor as consignment inventory at the Company’s cost of such inventory. The Company recognizes the revenue (net of the gross to net sales adjustments discussed below, all of which involve significant estimates and judgments) when the consignment inventory is sold to OTN’s customer.by segment were as follows:

 

In the case of new products for which the product introduction is not an extension of an existing line of product or where the Company has determined that there are not products in a similar therapeutic category, such that the Company cannot reliably estimate expected returns of the new product, the Company defers recognition of revenue until the right of return no longer exists or until the Company has developed sufficient historical experience to estimate sales returns.

Revenues of the Nutritionals and Other Healthcare segments and certain non-U.S. businesses within the Pharmaceuticals segment are recognized on the date of receipt by the purchaser.

   Net Sales

    
   Three Months Ended
September 30,


  

% Change


 
   2005

  2004

  
   (dollars in millions)    

Pharmaceuticals

  $3,778  $3,848  (2)%

% of net sales

   79.3%  80.6%   

Nutritionals

  $547  $484  13%

% of net sales

   11.5%  10.1%   

Related Healthcare

  $442  $446  (1)%

% of net sales

   9.2%  9.3%   

Total

  $4,767  $4,778  —   

 

The Company recognizes revenue net of various sales adjustments to arrive at net sales as reported on the Consolidated Statement of Earnings. These adjustments are referred to as gross-to-net sales adjustments. The following table sets forth the reconciliation of the Company’s gross sales to net sales by each significant category of gross-to-net sales adjustments:

 

  Three Months Ended
September 30,


 
  Three Months Ended
September 30,


   2005

 2004

 
  2004

 2003

   (dollars in millions) 

Gross Sales

  $6,588  $6,468   $5,674  $5,925 
  


 


  


 


Gross to Net Sales Adjustments

   

Gross-to-Net Sales Adjustments

   

Prime Vendor Charge-Backs

   (315)  (279)   (241)  (314)

Women, Infants and Children (WIC) Rebates

   (227)  (221)   (212)  (227)

Managed Health Care Rebates and Other Contract Discounts

   (195)  (189)

Managed Healthcare Rebates and Other Contract Discounts

   (129)  (194)

Medicaid Rebates

   (149)  (150)   (143)  (149)

Cash Discounts

   (91)  (86)   (67)  (80)

Sales Returns

   (62)  (88)   (46)  (61)

Other Adjustments

   (122)  (83)   (69)  (122)
  


 


  


 


Total Gross to Net Sales Adjustments

   (1,161)  (1,096)

Total Gross-to-Net Sales Adjustments

   (907)  (1,147)
  


 


  


 


Net Sales

  $5,427  $5,372   $4,767  $4,778 
  


 


  


 


The decrease in prime vendor charge-backs in 2005 was primarily due to lower relative sales volume in this segment due to product mix. The decrease in managed healthcare rebates was primarily attributable to lower sales volume through managed healthcare companies. The decrease in other adjustments was due to lower sales discounts in the international businesses.

Pharmaceuticals

 

The increasecomposition of the net decrease in gross-to-netpharmaceutical sales adjustments for prime vendor charge-backs to $315 million from $279 million in 2003 was due to a shift in sales to products with higher charge-backs. No material revisions were made to the estimates for gross-to-net sales adjustments foris as follows:

Three Months Ended

September 30,


  
 Analysis of % Change

  Total Change

 Volume

 Price

 Foreign Exchange

2005 vs. 2004

  (2)% (5)% 2% 1%

For the three months ended September 30, 2004 and 2003.

Earnings

In the third quarter of 2004, earnings before minority interest and income taxes2005, worldwide Pharmaceuticals sales decreased 15%2% to $1,151$3,778 million. Domestic pharmaceutical sales decreased 3% to $2,082 million from $1,361$2,154 million in 2003. The decrease was principally due to $105 million of termination benefits and accelerated depreciation charges related to the downsizing and streamlining of worldwide operations primarily in the U.S. and Europe, increases in cost of products sold as a result of a change in product mix, products losing exclusivity and increased investments in research and development. Net earnings in the third quarter of 2004 decreased 16% to $758 million compared to $906 million in 2003. The effective income tax rate on earnings before minority interest and income taxes was 20.9% in the third quarter of 2004 compared with 25.4% in 2003. The lower effective tax rate was primarily driven by lower earnings in the U.S. as a result of increased reserves for litigation and restructuring, and product exclusivity losses. In 2004, basic earnings per share decreased 17% to $.39 from $.47 in 2003, while diluted earnings per share decreased 19% to $.38 from $.47 in 2003. Basic and diluted average shares outstanding for the third quarter of 2004 were 1,942 million and 1,975 million, respectively, compared to 1,937 million and 1,944 million, respectively, in 2003.

During the quarters ended September 30, 2004 and 2003, the Company recorded several (income)/expense items that affected the comparability of results of the periods presented herein, which are set forth in the following tables. For a discussion of these items, see “Item 1. Financial Statements—Note 3. Restructuring and Other Items”,”—Note 4. Acquisitions and Divestitures” and “—Note 15. Legal Proceedings and Contingencies”.

Three Months Ended September 30, 2004

   Cost of
Products
Sold


  Research
and
Development


  Acquired In-
process
Research
and
Development


  Gain on
Sale of
Business


  Provision for
Restructuring
and Other
Items, net


  Litigation
settlement
expense/
(income)


  Other
Expense,
net


  Total

 
   (dollars in millions) 

Litigation Matters:

                                 

Product liability

  $—    $—    $—    $—    $—    $—    $11  $11 

Anti-trust litigation

   —     —     —     —     —     25   —     25 
   

  

  

  


 

  

  

  


    —     —     —     —     —     25   11   36 

Other:

                                 

Gain on sale of Adult Nutritional business

   —     —     —     (3)  —     —     —     (3)

Accelerated depreciation

   47   1   —     —     —     —     —     48 

Downsizing and streamlining of worldwide operations

   —     —     —     —     57   —     —     57 

Milestone payment

   —     10   —     —     —     —     —     10 

Acordis IPR&D write-off

   —     —     1   —     —     —     —     1 
   

  

  

  


 

  

  

  


   $47  $11  $1  $(3) $57  $25  $11   149 
   

  

  

  


 

  

  

     

Income taxes on items above

                               49 
                               


                               $100 
                               


Three Months Ended September 30, 2003

   Cost of
Products
Sold


  Research
and
Development


  Provision for
Restructuring
and Other
Items, net


  Litigation
settlement
expense/
(income)


  Total

 
   (dollars in millions) 

Litigation Matters:

                     

Litigation settlement income

  $—    $—    $—    $(4) $(4)
   

  

  


 


 


    —     —     —     (4)  (4)

Other:

                     

Up-front payments for two licensing agreements

   —     21   —     —     21 

Accelerated depreciation and asset impairment charges

   21   —     —     —     21 

Termination benefits and other exit costs

   —     —     9   —     9 

Relocation and retention

   —     —     8   —     8 

Change in estimates

   —     —     (4)  —     (4)
   

  

  


 


 


   $21  $21  $13  $(4)  51 
   

  

  


 


    

Income taxes on items above

                   13 
                   


                   $38 
                   


Gross margin percentages were 61.3% and 64.1% for the three months ended September 30, 2004 and 2003, respectively. Gross margins were negatively impacted in 2004, primarily due to increased salesthe continued impact of lower-margin products in the OTN segment, unfavorable mix and exclusivity losses in the U.S. pharmaceuticals business,for PARAPLATIN and VIDEX EC, increased competition for PRAVACHOL, partially offset by the salescontinued growth of ABILIFY*PLAVIX*, REYATAZ and PLAVIX*.

Expenses

Total costs and expenses, as a percentage of sales, were 78.8% in the third quarter of 2004 compared to 74.7% in 2003.

Cost of products sold, as a percentage of sales, increased to 38.7% in 2004 from 35.9% in 2003. This increase is primarily due to increased sales of lower margin products from OTN and the unfavorable impact of U.S. Pharmaceuticals sales mix. Cost of products sold also included $47 million of accelerated depreciation in 2004, and in 2003, $21 million which primarily consisted of accelerated depreciation related to the closure of manufacturing facilities in North America expected to be completed by the end of 2006.

Marketing, selling, and administrative expenses increased 5% to $1,209 million in 2004 from $1,151 million in 2003. As a percentage of sales, marketing, selling and administrative expenses increased to 22.3% in the third quarter of 2004 from 21.4% in 2003. The increase was primarily driven by increased sales and marketing support for new products, including additional sales support for ABILIFY*. In addition, the increase was also related to costs associated with the compliance with the Sarbanes-Oxley Act of 2002 and unfavorable foreign exchange driven by the strengthening of the euro.

Expenditures for advertising and product promotion in support of new and existing products were $325 million in 2004 compared with $332 million 2003, reflecting lower spending on in-line products in the U.S. pharmaceutical business, partially offset by increased investments in ABILIFY*, REYATAZ and ERBITUX*.

Research and development expenditures increased 9% to $615 million in 2004 from $565 million in 2003. In aggregate, estimated wholesaler inventory levels of the Company’s key pharmaceutical products sold by the U.S. Pharmaceutical research and development spending increased 10% frombusiness at the prior year and, as a percentageend of pharmaceutical sales, was 14.8% in the third quarter of 2004 and 13.4% in the third quarter of 2003. This increase is primarily driven by the Company’s continuing investments in compounds in late stage development, including muraglitazar, a dual PPAR (peroxisome proliferators activated receptor) agonist for diabetes; abatacept for rheumatoid arthritis; and entecavir, for hepatitis B, partially offset by Merck’s share of codevelopment costs related to muraglitazar. The increase also reflects the Company’s strategic focus on ten disease areas – oncology, HIV/AIDS, psychiatric disorders, atherosclerosis/thrombosis, diabetes, Alzheimer’s disease, hepatitis, obesity, rheumatoid arthritis and solid organ transplantation.

Restructuring programs were implemented in the third quarter of 2004 to downsize and streamline worldwide operations. The programs include costs for the termination of approximately 1,060 selling, administrative, manufacturing and research and development employees primarily in the Pharmaceuticals segment primarily in Europe, the U.S., Canada and Puerto Rico. As a result of these actions, the Company expects the annual benefit to earnings before minority interest and income taxes to be approximately $125 million in future periods. The Company expects to substantially complete these activities bydown from the end of 2004. For additional information on restructuring, see “Item 1. Financial Statements—Note 3. Restructuringthe second quarter of 2005, by approximately one-tenth of a month to two-and-a-half weeks. Individually, estimated wholesaler inventory levels of major brands such as PLAVIX*, PRAVACHOL and Other Items.”AVAPRO*/AVALIDE* decreased to approximately two weeks.

 

Litigation settlement expense/(income) were $25 million of expense in 2004 related to increased reserves for anti-trust litigation regarding PLATINOL and $4 million of income in 2003. For additional information on litigation, see “Item 1. Financial Statements—Note 15. Legal Proceedings and Contingencies.”

Equity in net income of affiliates for the three months ended September 30, 2004 and 2003 was $70 million and $54 million, respectively. Equity in net income of affiliates principally related to the Company’s joint venture with Sanofi-Aventis (Sanofi) and investment in ImClone Systems, Inc. (ImClone). In 2004, the increase in equity in net income of affiliates primarily relates to higher net income in both the Sanofi joint venture and ImClone. For additional information on equity in net income of affiliates, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

Other expense, net was $17International pharmaceutical sales remained unchanged, including a 2% favorable foreign exchange impact, at $1,696 million in the third quarter of 20042005 compared to $79 million2004. The sales decrease excluding the favorable impact of foreign exchange was primarily due to a decline in TAXOL® and PRAVACHOL sales resulting from increased generic competition, partially offset by increased sales of newer products including REYATAZ and ABILIFY*, as well as growth of PLAVIX*.

Key pharmaceutical products and their sales, representing 81% of total pharmaceutical sales in the third quarter of 2003. Other expense, net, includes interest expense, interest income, foreign exchange gainsboth 2005 and losses, income from contract manufacturing, royalty income, and gains and losses on disposal of property, plant and equipment. The favorability was primarily due to higher income from third party manufacturing, lower net foreign exchange losses, partially offset by higher litigation settlements and higher net interest expense.

Business Segments

Pharmaceuticals

Sales for the Pharmaceuticals segment in the three months ended September 30, 2004, were $3,831 million as compared to $3,847 million in 2003. U.S. pharmaceutical sales decreased 2% to $2,154 million in the third quarter of 2004 from $2,201 million in 2003. U.S. pharmaceutical sales were negatively affected by the increased competition for PRAVACHOL and PARAPLATIN, and exclusivity losses of the GLUCOPHAGE* franchise. International sales for the Pharmaceuticals segment increased 2% to $1,677 million in 2004, including a 4% favorable foreign exchange impact, from $1,646 million in 2003.

The following table sets forth the reconciliation of the U.S. Pharmaceuticals’ gross sales to net sales by each significant category of gross-to-net sales adjustments:

   Three Months Ended
September 30,


 
   2004

  2003

 

Gross Sales

  $2,830  $2,860 
   


 


Gross to Net Sales Adjustments

         

Prime Vendor Charge-Backs

   (288)  (249)

Managed Health Care Rebates and Other Contract Discounts

   (156)  (152)

Medicaid Rebates

   (147)  (150)

Cash Discounts

   (55)  (54)

Sales Returns

   (30)  (50)

Other Adjustments

   —     (4)
   


 


Total Gross to Net Sales Adjustments

   (676)  (659)
   


 


Net Sales

  $2,154  $2,201 
   


 


The increase in U.S. Pharmaceuticals’ gross-to-net sales adjustments for prime vendor charge-backs to $288 million from $249 million in 2003 was due to a shift in sales to products with higher charge-backs. No material revisions were made to the estimates for gross-to-net sales adjustments for the three months ended September 30, 2004 and 2003.

Sales of selected products in the third quarter of 2004 wereare as follows:

 

Total revenue for ABILIFY* which is primarily alliance revenue for the Company’s 65% share of net sales in co-promotion countries with Otsuka Pharmaceutical Co. Ltd. (Otsuka), increased 63% to $165 million from $101 million in 2003. The antipsychotic agent, used for treatment of schizophrenia, was introduced in the U.S. in November 2002 and has achieved a weekly new prescription share of the U.S. antipsychotic market of approximately 10%. The Company and Otsuka received an approvable letter for a Supplemental New Drug Application (sNDA) for ABILIFY* for the treatment of acute mania in patients with bipolar disorder. An sNDA for bipolar maintenance was also submitted to the U.S. Food and Drug Administration (FDA) early this year. In June 2004, the European Commission granted marketing authorization for ABILIFY* and public sales also commenced in June 2004. In September 2004, the FDA approved ABILIFY* for the treatment of acute bipolar mania in the U.S. Market exclusivity for ABILIFY* is expected to expire in 2009 in the U.S. (and may be extended until 2014 if a pending statutory term extension is granted). Market exclusivity for ABILIFY* is expected to expire in 2009 for major markets in the EU (but may be extended until 2014 if supplementary protection certificates are issued). In addition, the pre-clinical and clinical data supporting ABILIFY* have ten years of regulatory data protection/data exclusivity in the EU through June 2014. The Company currently copromotes ABILIFY* with Otsuka in the United Kingdom and Germany, and will also copromote it in France and Spain. The Company also has exclusive rights to sell ABILIFY* in a number of other countries in Europe, the Americas and Asia. The Company’s right to market ABILIFY* expires in November 2012 in the U.S. and Puerto Rico and, for the countries in the EU where the Company has the exclusive right to market ABILIFY* in June 2014. For additional information on revenue recognition of ABILIFY*, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”
   Three Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Cardiovascular

            

PLAVIX*

  $980  $902  9%

PRAVACHOL

   527   598  (12)%

AVAPRO*/AVALIDE*

   251   241  4%

MONOPRIL

   49   69  (29)%

COUMADIN

   57   65  (12)%

Virology

            

SUSTIVA

   170   157  8%

REYATAZ

  ��176   106  66%

ZERIT

   51   69  (26)%

VIDEX/VIDEX EC

   41   67  (39)%

Infectious Diseases

            

CEFZIL

   48   54  (11)%

BARACLUDE™

   2   —    —   

Oncology

            

TAXOL®

   175   243  (28)%

ERBITUX*

   107   84  27%

PARAPLATIN

   42   177  (76)%

Affective (Psychiatric) Disorders

            

ABILIFY* (total revenue)

   260   165  58%

Metabolics

            

GLUCOPHAGE* Franchise

   43   43  —   

Other Pharmaceuticals

            

EFFERALGAN

   66   61  8%

ERBITUX*, an injection used in combination with irinotecan in the treatment of patients with Epidermal Growth Factor Receptor (EGFR)-expressing metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and as a single agent in the treatment of patients with EGFR-expressing metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy, was approved by the FDA in February 2004. Sales of ERBITUX*, which is sold almost exclusively in the U.S., were $84 million for the third quarter. A patent relating to combination therapy with ERBITUX* expires in September 2018 in the U.S. and Japan. The Company does not, but others do, market ERBITUX* in countries in the EU.

Sales of PLAVIX*, a platelet aggregation inhibitor, sold by the Company primarily in the U.S., increased 30%9%, including a 1% favorable foreign exchange impact, to $980 million from $902 million in 20042004. Domestic sales increased 7% to $833 million from $694$781 million in 2003,2004, primarily due to strongincreased demand, partially offset by a reduction in U.S. wholesaler inventory levels in 2005. Estimated U.S. prescription growth of 23% in the U.S. market and price increases.demand grew approximately 12% compared to 2004. PLAVIX* is a cardiovascular product that was launched from the alliance between the Company and Sanofi.Sanofi-Aventis (Sanofi). Market exclusivity for PLAVIX* is expected to expire in 2011 in the U.S. and 2013 in the European Union (EU). Statements on exclusivity are subject to any adverse determination that may occur with respect to the PLAVIX* patent litigation. For additional information on the PLAVIX* patent litigation, see “Item 1. Financial Statements—Note 15.17. Legal Proceedings and Contingencies.”

 

Sales of PRAVACHOL, an HMG Co-A reductase inhibitor, decreased 12% to $527 million from $598 million in 2004. Domestic sales decreased 7% to $297 million in 2005, primarily due to lower demand resulting from increased competition and the related reduction in wholesaler inventory levels, partially offset by lower managed healthcare rebate costs in 2005. Estimated U.S. prescriptions declined by 18% compared to 2004. International sales decreased 18%, including a 1% favorable foreign exchange impact, to $230 million, reflecting generic competition in key European markets. Market exclusivity protection for PRAVACHOL is expected to expire in April 2006 in the U.S. Market exclusivity in the EU expired in 2004, with the exception of France and Sweden, for which expiration will occur in August and March 2006, respectively, and in Italy, for which expiration will occur in January 2008.

Sales of AVAPRO*/AVALIDE*, an angiotensin II receptor blocker for the treatment of hypertension, also part of the Sanofi alliance, increased 32%4%, including a 2% favorable foreign exchange impact, to $251 million from $241 million in 20042004. Domestic sales decreased 1% to $147 million from $182$148 million in 20032004, primarily due to stronga reduction in wholesaler inventory levels in 2005, partially offset by increased demand. Estimated U.S. prescription growth ofincreased approximately 15%. AVAPRO*/AVALIDE* are cardiovascular products launched11% compared to 2004. International sales increased 12%, including a 4% favorable foreign exchange impact, to $104 million from the alliance between the Company$93 million in 2004, primarily due to increased sales in Canada and Sanofi.Australia. Market exclusivity for AVAPRO*/AVALIDE* (known in the EU as

APROVEL*/KARVEA*) is expected to expire in 2011 in the U.S. and 2012 in countries in the EU; AVAPRO*/AVALIDE* is not currently marketed in Japan.

APROVEL/KARVEA) is expected to expire in 2011 in the U.S. and 2012 in countries in the EU; AVAPRO*/AVALIDE* is not currently marketed in Japan.

 

Worldwide salesSales of PRAVACHOL,MONOPRIL, a second generation angiotesin converting enzyme (ACE) inhibitor for the Company’s cholesterol-lowering agent,treatment of hypertension, decreased 24%29%, including a 2% favorable foreign exchange impact, to $598 million in 2004 from $787 million in 2003. PRAVACHOL sales in the U.S. decreased 31% to $318$49 million due to increased generic competition from established brands and new entrants. Total U.S. prescriptions decreased approximately 13%. PRAVACHOL wholesaler inventory levelsin key European markets. Market exclusivity protection for MONOPRIL expired in 2003 in the U.S. are now estimated at two-thirdsand has expired or is expected to expire between 2001 and 2008 in countries in the EU. MONOPRIL is not currently marketed in Japan.

Sales of a month. International salesCOUMADIN, an oral anti-coagulant used predominately in patients with atrial fibrillation or deep venous thrombosis/pulmonary embolism, decreased 15%12%, including a 5%1% favorable foreign exchange impact, to $280$57 million primarilyin 2005 compared to $65 million in 2004 due to exclusivity loss in select European markets, including Germany and the U.K. in the third quarter ofcontinued competition. Estimated U.S. prescriptions declined by approximately 22% compared to 2004. Market exclusivity for PRAVACHOL is expected to expire in 2006 in the U.S. and between 2002 and 2007 in countries in the EU. The Company does not (but Sankyo does) market pravastatin in Japan.

TAXOL and PARAPLATIN, the Company’s leading anti-cancer agents, recorded sales of $243 million and $177 million, respectively, compared to $238 million and $245 million, respectively, in 2003. Sales of TAXOL, which are almost exclusively international, increased 2%, including a 5% favorable foreign exchange impact, to $243 million from $238 million in 2003. Generic competition for TAXOL in the major European markets began in the second quarter and has increased in the third quarter of 2004. PARAPLATIN sales decreased by 28% due to generic competition beginning at the end of the second quarter of 2004. Market exclusivity for TAXOL ended in 2002 in the U.S., in 2003 in the EU and is expected to expire sometime before 2013 in Japan. Market exclusivity for PARAPLATIN expiresCOUMADIN expired in the U.S. in October 2004. Market exclusivity for PARAPLATIN expired in 2000 in the EU and in 1998 in Japan. For additional information on PARAPLATIN market exclusivity, see “Item 1. Financial Statements—Note 15. Legal Proceedings and Contingencies.”

Sales of the GLUCOPHAGE* franchise decreased 82% to $43 million in 2004 from $236 million in 2003 due to generic competition.1997.

 

Sales of SUSTIVA, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV/AIDS,HIV, increased 65%8% to $170 million in 2005 from $157 million in 2004, from $95 million in 2003, primarily due to increased demand inan estimated U.S. prescription growth of approximately 6% for the third quarter of 2004 and lower sales in the third quarter of 2003 primarily due to workdown of wholesaler inventory.2005. Market exclusivity protection for SUSTIVA is expected to expire betweenin 2013 and 2014 in the U.S. and in countries in the EU. TheEU; the Company does not, (butbut others do)do, market SUSTIVA in Japan.

 

Sales of REYATAZ, a protease inhibitor for the treatment of HIV/AIDS launchedHIV, increased 66%, including a 1% favorable foreign exchange impact, to $176 million in 2005 compared to $106 million in 2004 primarily due to increased demand. REYATAZ has achieved an estimated monthly new prescription share of the U.S. protease inhibitors market of approximately 31%. European sales increased 152% to $53 million in the third quarter of 2003 and2005 from $21 million in Europe in the second quarter of 2004, were $106 million. REYATAZ has achieved a 20% share of protease inhibitor class sales in the initial launch countries.2004. Market exclusivity for REYATAZ is expected to expire in 2017 in the U.S., in countries in the EU and Japan.

 

Sales of ZERIT, an antiretroviral agent used in the treatment of HIV, decreased 26% to $51 million in 2005 from $69 million in 2004, primarily resulting from a decrease in estimated U.S. prescriptions of approximately 31% compared to 2004. Market exclusivity protection for ZERIT is expected to expire in 2008 in the U.S., between 2007 and 2011 in countries in the EU and 2008 in Japan.

Sales of VIDEX/VIDEX EC, increased 18%an antiretroviral agent used in the treatment of HIV, decreased 39% to $41 million in 2005 from $67 million from $57 million in 2003, mainly due to an increase2004, primarily as a result of generic competition in domestic sales while international sales remained constant.the U.S. which began in the fourth quarter of 2004. The Company has a licensing arrangementagreement with the U.S. Government for VIDEX/VIDEX EC, which by its terms became non-exclusive in 2001. The U.S. Government’s method of use patent expires in 2007 in the U.S. (which includes an earned pediatric extension) and in Japan, and between 2006 and 2009 in countries in the EU. Because theThe license to the Company is non-exclusive, which has allowed another company to obtain a license from the U.S. Government can issue licenses to competitors at any time.and receive approval for marketing. With respect to VIDEX/VIDEX EC, the Company has patents covering athe reduced mass formulation of VIDEX/VIDEX EC that expire in 2012 in the U.S., the EU and Japan. However, these patents apply only to the type of reduced mass formulation specified in the patent. Other reduced mass formulations may exist. There is currently no issued patent covering the VIDEX EC formulationformulation.

Sales of CEFZIL, an antibiotic for the treatment of mild to moderately severe bacterial infections, decreased 11%, including a 1% favorable foreign exchange impact, to $48 million in 2005 from $54 million in 2004 due to lower demand. Market exclusivity is expected to expire in December 2005 in the U.S. and between 2007 and 2009 in the EU.

BARACLUDE™, the Company’s internally developed oral antiviral agent for the treatment of chronic hepatitis B, was approved by the FDA in March 2005, and generated domestic sales of $7 million since its U.S. launch in April 2005. BARACLUDE™ received approvals from international authorities in Brazil, Indonesia and Argentina during the third quarter of 2005. The Company has a composition of matter patent that expires in the U.S. in 2010.

Sales of TAXOL®, an anti-cancer agent sold almost exclusively in the non-U.S. markets, were $175 million in 2005 compared to $243 million in 2004. Sales of TAXOL® decreased 28%, including a 1% favorable foreign exchange impact, primarily as a result of increased generic competition in Europe. Market exclusivity protection for TAXOL® expired in 2002 in the U.S., in 2003 in the EU and is expected to expire between 2005 and 2013 in Japan.

Sales of ERBITUX*, used to treat refractory metastatic colorectal cancer, which is sold almost exclusively in the U.S., increased 27% to $107 million in 2005 compared to $84 million in 2004. ERBITUX* is marketed by the Company under a distribution and copromotion agreement with ImClone Systems Incorporated (ImClone). A patent relating to combination therapy with ERBITUX* expires in 2017. The Company’s right to market ERBITUX* in North America and Japan expires in September 2018. The Company does not, but others do, market ERBITUX* in countries in the EU.

Sales of PARAPLATIN, an anticancer agent, decreased 76% to $42 million in 2005 from $177 million in 2004 due to increased generic competition. Domestic sales decreased 94% to $9 million in 2005 from $145 million in 2004. Market exclusivity protection for PARAPLATIN expired in October 2004 in the U.S., in 2000 in the EU and in 1998 in Japan.

Total revenue for ABILIFY* increased 58% to $260 million in 2005 from $165 million in 2004, primarily due to strong growth in domestic demand and the continued growth in Europe, which achieved sales of $40 million in the third quarter of 2005. Estimated U.S. wholesale inventory levels at the end of the third quarter increased to nine-tenths of a month. Estimated U.S. prescription demand grew approximately 38% compared to 2004. ABILIFY* is an antipsychotic agent for the treatment of schizophrenia, acute bipolar mania and Bipolar I Disorder. Total revenue for ABILIFY* primarily consists of alliance revenue for the Company’s 65% share of net sales in copromotion countries with Otsuka Pharmaceutical Co., Ltd. (Otsuka). Market exclusivity protection for ABILIFY* is expected to expire in 2009 in the U.S. (and may be extended until 2014 if a pending patent term extension is granted). The Company also has the right to copromote ABILIFY* in several European countries (the United Kingdom, France, Germany and Spain) and to act as exclusive distributor for the product in the rest of the EU. Market exclusivity protection for ABILIFY* is expected to expire in 2009 for the EU (and may be extended until 2014 if pending supplemental protection certificates are granted). The Company’s right to market ABILIFY* expires in November 2012 in the U.S. and Puerto Rico and, for the countries in the EU where the Company has the exclusive right to market ABILIFY* until June 2014. Statements on exclusivity are subject to any adverse determination that may occur with respect to the ABILIFY* patent reexamination. For additional information on the VIDEX/VIDEX EC patent challenge,this matter, see “Item 1. Financial Statements – Note 17. Legal Proceedings and Contingencies.” For additional information on revenue recognition of ABILIFY*, see “Item 1. Financial Statements—Note 15. Legal Proceedings2. Alliances and Contingencies.Investments.

GLUCOPHAGE* franchise sales remained constant at $43 million in 2005 compared to 2004. Market exclusivity protection expired in March 2000 for GLUCOPHAGE* IR, in October 2003 for GLUCOPHAGE* XR (Extended Release), and in January 2004 for GLUCOVANCE*. The Company does not, but others do, market these products in the EU and Japan.

 

Sales of ZERIT, an antiretroviral agent, were $69EFFERALGAN, a pain relief acetaminophen, increased 8% to $66 million in 2005 from $61 million in 2004 an increase of 6%, including a 3% favorable foreign exchange impact, from $65 million in 2003. Market exclusivity for ZERIT is expecteddue to expire in 2008product back-orders in the U.S., between 2007 and 2011 in countriessecond quarter of 2005 which were resolved in the EUthird quarter.

The estimated prescription and 2008 in Japan.prescription growth data provided above includes information only from the retail and mail order channels and do not reflect information from other channels, such as hospitals, institutions and long-term care, among others. The estimated prescription and prescription growth data are based on National Prescription Audit (NPA) data provided by IMS Health (IMS) as described below.

 

In most instances, the basic exclusivity loss date indicated above 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. In some instances, the basic exclusivity loss date indicated 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. The Company assesses the market exclusivity period for each of its products on a case-by-case basis. The length of market exclusivity for any of the Company’s products is difficult to predict with certainty because of the complex interaction between patent and regulatory forms of exclusivity and other factors. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that the Company currently anticipates. For further discussionThe estimates of market exclusivity, including a chart showing net sales of key products

together with the year in which basic exclusivity loss occurred or is expectedexclusivities reported above are for business planning purposes only and are not intended to occur in the U.S., the EU and Japan, see “Item 1. Business—Products” and “—Intellectual Property and Product Exclusivity” inreflect the Company’s Annual Report on Form 10-K/A forlegal opinion regarding the year ended December 31, 2003.strength or weakness of any particular patent or other legal position.

The following table sets forth a comparisonfor each of the Company’s top 15 pharmaceutical products sold by the U.S. Pharmaceuticals business (based on 2004 annual net sales), for the three months ended September 30, 2005 and 2004 compared to the same periods in the prior year: (a) changes in reported U.S. net sales changes andfor the period; (b) estimated total U.S. prescription growth (for bothfor the retail and mail order customers) for certainchannels and the estimated U.S. therapeutic category share of the Company’s U.S. pharmaceutical prescription products. The estimated prescription growth amounts areapplicable product, calculated by the Company based on third-partyNPA data provided by IMS, Health, a supplier of market research tofor the pharmaceutical industry. A significant portionindustry; and (c) estimated total U.S. prescription growth for the retail and mail order channels and the estimated U.S. therapeutic category share of the Company’s domestic pharmaceutical sales is made to wholesalers. Where changes in reported net sales differ from prescription growth, this change in net sales may not reflect underlying prescriber demand.applicable product, calculated by the Company based on Next-Generation Prescription Services (NGPS) data provided by IMS.

 

  

Three Months Ended

September 30, 2004


 

Three Months Ended

September 30, 2003


   

Three Months Ended

September 30, 2005


 

Month Ended

September 30, 2005


  % Change in
U.S. Net Sales(a)


 % Change in
Total U.S.
Prescriptions(b)


 % Change in
U.S. Net Sales(a)


 % Change in
Total U.S.
Prescriptions(b)


   

% Change
in U.S.

Net Sales(a)


  

% Change

in U.S. Total Prescriptions


 

Estimated TRx

Therapeutic Category
Share %(e)


  (unaudited)    NPA Data (b)

 NGPS Data (c)

 NPA
Data(b)


  NGPS
Data(c)


ABILIFY* (total revenue)

  41  38  36  11  11

AVAPRO*/AVALIDE*

  (1) 11  11  15  15

CEFZIL

  (10) (15) (17) 2  2

COUMADIN

  (16) (22) (25) 21  20

DOVONEX

  (9) (7) (8) 2  3

ERBITUX*(d)

  28  N/A  N/A  N/A  N/A

GLUCOPHAGE* Franchise

  (3) (46) (45) 2  2

PARAPLATIN(d)

  (94) N/A  N/A  N/A  N/A

PLAVIX*

  32  23  54  28   7  12  11  86  86

PRAVACHOL

  (31) (13) 9  4   (7) (18) (17) 7  7

AVAPRO*/AVALIDE*

  36  15  60  14 

REYATAZ

  40  35  30  13  13

SUSTIVA

  121  4  (39) 18   6  6  7  23  23

ABILIFY* (total revenue)

  52  85  *  * 

MONOPRIL

  (78) (81) 2  (15)

GLUCOVANCE*

  (87) (79) 47  1 

TEQUIN

  (32) (36) (35) 1  1

VIDEX/VIDEX EC

  (74) (72) (72) 3  3

ZERIT

  48  (29) (66) (25)  (29) (31) (31) 7  7

CEFZIL

  58  (26) (44) (2)

COUMADIN

  (5) (18) (22) (14)

VIDEX/VIDEX EC

  59  (3) (47) 4 

   

Three Months Ended

September 30, 2004


  

Month Ended

September 30, 2004


   

% Change
in U.S.

Net Sales(a)


  

% Change

in U.S. Total Prescriptions


  Estimated TRx
Therapeutic Category
Share %(e)


    NPA Data (b)

  NGPS Data (c)

  NPA
Data (b)


  NGPS
Data(c)


ABILIFY* (total revenue)

  52  85  85  8  8

AVAPRO*/AVALIDE*

  36  15  17  15  15

CEFZIL

  58  (26) (24) 2  2

COUMADIN

  (5) (18) (23) 28  28

DOVONEX

  —    (9) (7) 3  3

ERBITUX*(d)

  —    N/A  N/A  N/A  N/A

GLUCOPHAGE* Franchise

  (83) (74) (75) 4  4

PARAPLATIN(d)

  (31) N/A  N/A  N/A  N/A

PLAVIX*

  32  23  26  84  84

PRAVACHOL

  (31) (13) (12) 10  10

REYATAZ

  103  ** ** 11  11

SUSTIVA

  121  4  10  23  23

TEQUIN

  (9) (21) (19) 2  2

VIDEX/VIDEX EC

  59  (3) 3  9  9

ZERIT

  48  (29) (26) 9  9

(a)Reflects percentage change in net sales in dollar terms, compared with the same period in the prior year, including change in average selling prices and wholesaler buying patterns.

(b)Reflects change in totalBased on a simple average of the estimated number of prescriptions in unit terms, comparedthe retail and mail order channels as provided by IMS.
(c)Based on a weighted average of the estimated number of prescription units (pills) in each of the retail and mail order channels based on data provided by IMS.
(d)ERBITUX* and PARAPLATIN specifically, and oncology products in general, do not have prescription-level data because physicians do not write prescriptions for these products. The Company believes therapeutic category share information provided by third parties for these products may not be reliable and accordingly, none is presented here.
(e)The therapeutic categories are determined by the Company as those products considered to be in direct competition with the same periodCompany’s own products. The products listed above compete in the prior year, based on third-party data.following therapeutic categories: ABILIFY* (antipsychotics), AVAPRO*/AVALIDE* (angiotensin receptor blockers), CEFZIL (branded oral solid and liquid antibiotics), COUMADIN (warfarin), DOVONEX (anti-inflamatory-antipsoriasis), GLUCOPHAGE* Franchise (oral antidiabetics), PLAVIX* (antiplatelets), PRAVACHOL (HMG CoA reductase inhibitors), REYATAZ (antiretrovirals—third agents), SUSTIVA (antiretrovirals—third agents), TEQUIN (branded oral solid antibiotics), VIDEX/VIDEX EC (nucleoside reverse transcriptase inhibitors) and ZERIT (nucleoside reverse transcriptase inhibitors).
**In excess of 200%.

The Company has historically reported estimated total U.S. prescription growth and estimated therapeutic category share based on NPA data, which IMS makes available to the public on a subscription basis, and a simple average of the estimated number of prescriptions in the retail and mail order channels. For the third quarter, the Company is disclosing estimated total U.S. prescription growth and estimated therapeutic category share based on both NPA and NGPS data. NGPS

data is collected by IMS under a new, revised methodology and has been released by IMS on a limited basis through a pilot program. IMS has publicly announced it expects to make NGPS data available to the public on a subscription basis in 2007. The Company believes that the NGPS data provided by IMS provides a superior estimate of prescription data for the Company’s products in the retail and mail order channels. The Company has calculated the estimated total U.S. prescription growth and the estimated therapeutic category share based on NGPS data on a weighted average basis to reflect the fact that mail order prescriptions include a greater volume of product supplied compared with retail prescriptions. The Company believes that calculation of the estimated total U.S. prescription growth and the estimated therapeutic category share based on the NGPS data and the weighted average approach with respect to the retail and mail order channels provides a superior estimate of total prescription demand. The Company now uses this methodology for its internal demand forecasts.

The estimated prescription growth data and estimated therapeutic category share provided above only include information from the retail and mail order channels and do not reflect information from other channels, such as hospitals, institutions and long-term care, among others. The data provided by IMS is a product of IMS’s own record-keeping processes and is itself an estimate based on sampling procedures, subject to the inherent limitations of estimates based on sampling. In addition, the NGPS data is part of a pilot program which is still being refined by IMS.

The Company continuously seeks to improve the quality of its estimates of prescription growth amounts and the estimated therapeutic category share percentages through review of its methodologies and processes for calculation of these estimates and review and analysis of its own and third parties’ data used in such calculations. The Company expects that it will continue to review and refine its methodologies and processes for calculation of these estimates and will continue to review and analyze its own and third parties’ data used in such calculations.

 

The following table sets forth for each of the Company’s keytop 15 pharmaceutical products sold by the Company’s U.S. Pharmaceuticals business the amount of(based on 2004 annual net sales), the U.S. Pharmaceuticals business’s net sales of the applicable product for each of the three monthsfive quarters ended September 30, 2004 through September 30, 2005, and the estimated number of months on hand of the applicable product in the U.S. wholesaler distribution channel as of September 30, 2004.the end of each of the five quarters.

 

  

Net Sales

(in millions)


  

Months on

Hand


  September 30, 2005

  June 30, 2005

  March 31, 2005

 
  

Net Sales

(dollar in millions)


  Months
on Hand


  Net Sales
(dollar in millions)


 Months
on Hand


  Net Sales
(dollar in millions)


  Months
on Hand


 

ABILIFY* (total revenue)

  $214  0.9  $200  0.7  $161  0.7 

AVAPRO*/AVALIDE*

   147  0.5   157  0.6   102  0.8 

CEFZIL

   27  0.7   30  0.8   50  0.7 

COUMADIN

   49  0.6   42  0.7   42  1.0 

DOVONEX

   31  0.6   36  0.7   30  0.6 

ERBITUX*

   106  —     97  —     87  **

GLUCOPHAGE* Franchise

   38  0.7   44  0.8   39  1.0 

PARAPLATIN

   9  1.1   (1) 0.8   15  0.9 

PLAVIX*

  $781  0.6   833  0.4   823  0.6   673  0.8 

PRAVACHOL

   318  0.6   297  0.5   353  0.7   258  0.8 

ABILIFY

   152  0.6

AVAPRO*/AVALIDE*

   148  0.6

PARAPLATIN

   145  1.0

REYATAZ

   105  0.6   98  0.8   92  0.8 

SUSTIVA

   95  0.7   101  0.6   97  0.8   103  0.8 

REYATAZ

   75  0.6

COUMADIN

   58  0.8

GLUCOVANCE*/

GLUCOPHAGE*IR/

GLUCOPHAGE*XR

   39  0.9

TEQUIN

   21  0.9   22  0.8   38  0.7 

VIDEX/VIDEX EC

   7  1.1   5  1.0   10  1.2 

ZERIT

   34  0.7   24  0.8   26  0.8   26  0.8 

TEQUIN

   31  0.8

CEFZIL

   30  0.6

VIDEX/VIDEX EC

   27  0.6

MONOPRIL

   13  0.9

   December 31, 2004

  September 30, 2004

   

Net Sales

(dollar in millions)


  

Months

on Hand


  

Net Sales

(dollar in millions)


  Months
on Hand


ABILIFY* (total revenue)

  $170  0.9  $152  0.6

AVAPRO*/AVALIDE*

   154  0.9   148  0.6

CEFZIL

   60  1.1   30  0.6

COUMADIN

   69  1.0   58  0.9

DOVONEX

   40  0.9   34  0.7

ERBITUX*

   88  0.2   83  0.2

GLUCOPHAGE* Franchise

   48  1.1   39  1.0

PARAPLATIN

   (12) 1.2   145  1.2

PLAVIX*

   816  0.9   781  0.6

PRAVACHOL

   433  1.0   318  0.6

REYATAZ

   99  0.9   75  0.6

SUSTIVA

   103  0.8   95  0.7

TEQUIN

   39  0.9   31  0.7

VIDEX/VIDEX EC

   25  0.9   27  0.6

ZERIT

   31  0.9   34  0.7


**Less than 0.1 months on hand.

The

For all products other than ERBITUX*, the Company determines the above months on hand estimates by dividing the estimated amount of the product in the U.S. wholesaler distribution channel by the estimated amount of out-movement of the product from the U.S. wholesaler distribution channel over a period of one monththirty-one days, all calculated as described below. Factors that may influence the Company’s estimates include generic competition, seasonality of products, wholesaler purchases in light of increases in wholesalewholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, such estimates are calculated using data from third parties which data are a product of the third parties’ own record-keeping processes and such third-party data also may reflect estimates.

 

At December 31, 2004, the estimated value of CEFZIL inventory in the U.S. wholesaler distribution channel exceeded one month on hand by approximately $1.6 million. Prescriptions for CEFZIL, an antibiotic product, are typically higher in the winter months in the U.S. As a result, the Company’s U.S. wholesalers build higher inventories of the product in the fourth quarter to meet that expected higher demand. At March 31, 2005, the Company had worked down U.S. wholesaler inventory levels of CEFZIL to less than one month on hand, and remained at less than one month on hand in subsequent quarters.

At December 31, 2004, the estimated value of GLUCOPHAGE* Franchise products inventory (GLUCOPHAGE* XR, GLUCOPHAGE* IR, GLUCOVANCE* and METAGLIP*) in the U.S. wholesaler distribution channel exceeded one month on hand by approximately $1.6 million. As with all products, the months on hand estimate for the GLUCOPHAGE* Franchise products is an average of months on hand for all stock-keeping units (SKUs) of the product group. The increase in months on hand of the GLUCOPHAGE* Franchise products at the end of the fourth quarter to above one month on hand resulted primarily from the purchase by wholesalers of certain SKUs. After giving effect to these purchases, the increased months on hand for these SKUs were less than one month on hand. However, when the increased months on hand for these SKUs were averaged with all SKUs for the GLUCOPHAGE* Franchise products, the aggregate estimated months on hand exceeded one month. At March 31, 2005, the estimated value of GLUCOPHAGE* Franchise products inventory in the U.S. wholesaler distribution channel had been worked down to approximately one month on hand, and has been worked down to less than one month on hand at June 30 and September 30, 2005.

In October 2004, the U.S. patent for PARAPLATIN (carboplatin) expired, and the product lost exclusivity. The resulting generic competition for PARAPLATIN led to a significant decrease in demand for PARAPLATIN, which in turn led to the months on hand of the product in the U.S. wholesaler distribution channel exceeding one month at September 30, 2004, December 31, 2004 and September 30, 2005. The estimated value of PARAPLATIN inventory in the U.S. wholesaler distribution channel over one month on hand was approximately $6.6 million at September 30, 2004, $6.0 million at December 31, 2004 and $0.7 million at September 30, 2005. The Company plans to continue to monitor PARAPLATIN sales with the intention of working down wholesaler inventory levels to less than one month on hand.

At March 31 and September 30, 2005, the estimated value of VIDEX/VIDEX EC inventory in the U.S. wholesaler distribution channel exceeded one month on hand by approximately $1.1 million and $0.2 million, respectively. As a result of generic competition in the U.S. commencing in the fourth quarter of 2004, demand for VIDEX EC decreased significantly. The Company plans to continue to monitor VIDEX/VIDEX EC sales with the intention of working down wholesaler inventory levels to less than one month on hand.

The Company maintains inventory management agreements (IMAs) with most of its U.S. pharmaceutical wholesalers which account for nearly 100% of total gross sales of U.S. Pharmaceuticalpharmaceutical products. Under the current terms of the IMAs, these wholesalers dothe Company’s three largest wholesaler customers provide the Company with weekly information with respect to inventory levels of product on hand and the amount of out-movement of products. These three wholesalers currently account for over 90% of total gross sales of U.S. pharmaceutical products. The inventory information received from these wholesalers is a product of their record-keeping process and excludes inventory held by intermediaries to whom they sell, such as retailers and hospitals.hospitals, and excludes goods in transit to such wholesalers. The Company uses the information provided by these three wholesalers as of the Friday closest to quarter end to calculate the amount of inventory on hand for these wholesalers at the applicable quarter end. This amount is then increased by the Company’s estimate of goods in transit to these wholesalers as of the applicable Friday which have not been reflected in the weekly data provided by the wholesalers. Under the Company’s revenue recognition policy, sales are recorded when substantially all the risks and rewards of ownership are transferred, which in the U.S. Pharmaceutical business is generally when product is shipped. In such cases, goods in transit to a wholesaler are owned by the applicable wholesaler and, accordingly, are reflected in the calculation of inventories in the wholesaler distribution channel. The Company estimates the amount of goods in transit by using information provided by these wholesalers with respect to their open orders as of the applicable Friday and the Company’s records of sales to these wholesalers with respect to such open orders. The Company determines the amount of out-movement of a product from these wholesalers over a period of one monththirty-one days by using the most recent prior four weeks of out-movement of a product as provided by these wholesalers.wholesalers and extrapolating such amount to a thirty-one day basis. The Company also determines the above monthsestimates inventory levels on hand estimates by usingand out-movements for its U.S. Pharmaceutical business’s wholesaler customers other than the three largest wholesalers for each product based on the assumption that such amounts bear the same relationship to the three largest wholesalers’ inventory levels and out-movements for such product as the percentage of aggregate sales for all products to these other wholesalers in the applicable quarter bears to aggregate sales for all products to the Company’s three largest wholesalers in such quarter. Finally, the Company considers whether any adjustments are necessary to these extrapolated amounts based on such factors as historical sales of individual products made to thosesuch other wholesalers and from third-party market research data related to prescription trends and patient demand. In addition, the Company receives inventory information from these other wholesalers on a selective basis for certain key products.

 

EarningsThe Company’s U.S. pharmaceuticals business, through the IMAs discussed above, has arrangements with substantially all of its direct wholesaler customers that allow the Company to monitor U.S. wholesaler inventory levels and require those wholesalers to maintain inventory levels at approximately one month or less of their demand. In the third quarter of 2005, the Company negotiated amendments to its IMAs with its three largest wholesalers. The amendments extended the original agreements through December 31, 2005 and established lower limits than the original agreements for inventory levels of Company pharmaceutical products held by the wholesalers. The Company is in discussions to extend the agreements for periods beyond 2005.

To help maintain the product quality of the Company’s biologic oncology product, ERBITUX*, the product is shipped only to end-users and not to other intermediaries (such as wholesalers) to hold for later sales. During 2004 and through May 2005, one of the Company’s wholesalers provided warehousing, packing and shipping services for ERBITUX*. Such wholesaler held ERBITUX* inventory on consignment and, under the Company’s revenue recognition policy, the Company recognized revenue when such inventory was shipped by the wholesaler to the end-user. The above estimates of months on hand for the three months ended March 31, 2005, were calculated by dividing the inventories of ERBITUX* held by the wholesaler for its own account as reported by the wholesaler as of the end of the quarter by the Company’s net sales for the last calendar month of the quarter. The inventory levels reported by the wholesaler are a product of the wholesaler’s own record-keeping process. Upon the divestiture of OTN in May 2005, the Company discontinued the consignment arrangement with the wholesaler and thereafter did not have ERBITUX* consignment inventory. Following the divestiture, the Company sells ERBITUX* to intermediaries (such as specialty oncology distributors) and ships ERBITUX* directly to the end users of the product who are the customers of those intermediaries. The Company recognizes revenue upon such shipment consistent with its revenue recognition policy. Accordingly, subsequent to June 30, 2005, there was no ERBITUX* inventory held by wholesalers.

As previously disclosed, for the Company’s pharmaceuticals business outside of the United States, nutritionals and related healthcare business units around the world, the Company has 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, the Company relies on a variety of methods to estimate direct customer product level inventory and to calculate months on hand for these business units. As such, the information required to estimate months on hand in the direct customer distribution channel for non-U.S. Pharmaceuticals business for the quarter ended September 30, 2005 is not available prior to the filing of this quarterly report on Form 10-Q. The Company will disclose this information on its website approximately 60 days after the end of the quarter and in the Company’s Form 10-K for the period ending December 31, 2005.

The following table, which was posted on the Company’s website and furnished on Form 8-K, sets forth for each of the Company’s key products sold by the reporting segments listed below, the net sales of the applicable product for the three months ended June 30, 2005 and March 31, 2005 and the estimated number of months on hand of the applicable product in the direct customer distribution channel for the reporting segment as of June 30, 2005 and March 31, 2005. The estimates of months on hand for key products described below

for the International Pharmaceuticals reporting segment are based on data collected for all of the Company’s significant business units outside of the United States. Also described further below is information on non-key product(s) where the amount of inventory on hand at direct customers is more than approximately one month and the impact is not de minimis. For the other reporting segments, estimates are based on data collected for the United States and all significant business units outside of the United States.

   Three Months Ended
June 30, 2005


  Three Months Ended
March 31, 2005


   

Net Sales

(dollars in millions)


  Months
on Hand


  

Net Sales

(dollars in millions)


  

Months

on Hand


International Pharmaceuticals

              

ABILIFY* (total revenue)

  $40  0.6  $27  0.6

AVAPRO*/AVALIDE*

   101  0.4   94  0.4

BUFFERIN

   32  1.0   26  0.5

CAPOTEN

   42  0.8   42  0.8

DAFALGAN

   33  0.8   40  1.3

EFFERALGAN

   55  0.5   88  0.9

MAXIPIME

   52  0.8   46  0.7

MONOPRIL

   52  0.7   56  0.6

PARAPLATIN

   34  0.6   29  0.6

PERFALGAN

   42  0.6   42  0.5

PLAVIX*

   145  0.5   141  0.7

PRAVACHOL

   272  0.7   262  0.7

REYATAZ

   85  0.8   57  0.6

SUSTIVA

   70  0.6   70  0.5

TAXOL®

   182  0.5   201  0.5

VIDEX/VIDEX EC

   38  0.9   39  0.8

ZERIT

   33  0.6   33  0.6

Nutritionals

              

ENFAMIL

   250  0.9   235  0.9

NUTRAMIGEN

   47  1.0   44  1.0

Related Healthcare

              

ConvaTec

              

Ostomy

   139  0.9   127  0.9

Wound Therapeutics

   103  0.8   97  0.8

Medical Imaging

              

CARDIOLITE

   108  0.7   102  0.7

Consumer Medicines

              

EXCEDRIN

   39  1.5   38  1.6

The above months on hand information represents the Company’s estimates of aggregate product level inventory on hand at direct customers as of June 30, 2005 and March 31, 2005 divided by the expected demand for the applicable product. Expected demand is the estimated ultimate patient/consumer demand calculated based on estimated end-user consumption or direct customer outmovement data over the most recent thirty-one day period or other reasonable period. Factors that may affect the Company’s 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.

The Company relies on a variety of methods to calculate months on hand for these reporting segments. Where available, the Company relies on information provided by third parties to determine estimates of aggregate product level inventory on hand at direct customers and expected demand. For the reporting segments listed above, however, the Company has limited information on direct customer product level inventory, end-user consumption and direct customer outmovement data. Further, the quality of third party information, where available, varies widely. In some circumstances, such as the case with new products or seasonal products, such historical end-user consumption or outmovement information may not be available or applicable. In such cases, the Company uses estimated prospective demand. In cases where direct customer product level inventory, ultimate patient/consumer demand or outmovement data do not exist or are otherwise not available, the Company has developed a variety of other methodologies to calculate estimates of 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.

As of March 31, 2005, DAFALGAN, a non-key analgesic product sold principally in Europe, had net sales of $40 million and approximately 1.3 months, or $16 million, of inventory on hand at direct customers. The level of inventory on hand is due primarily to private pharmacists purchasing DAFALGAN approximately once every eight weeks, which has been worked down to less than one month on hand at June 30, 2005.

As of June 30, 2005 and March 31, 2005, Excedrin, an analgesic product sold principally in the U.S., had approximately 1.5 months and 1.6 months, respectively, of inventory on hand at direct customers. The level of inventory on hand is due to the customary practice of direct customers holding within their warehouses and stores one and one-half to two months of product on hand. EXCEDRIN was included in the third quarter 2005 sale of the Company’s Consumer Medicines business.

The Company continuously seeks to improve the quality of its estimates of months on hand of inventories held by its direct customers including thorough review of its methodologies and processes for calculation of these estimates and review and analysis of its own and third parties’ data used in such calculations. The Company expects that it will continue to review and refine its methodologies and processes for calculation of these estimates and will continue to review and analyze its own and third parties’ data in such calculations. The Company also has and will continue to take steps to expedite the receipt and processing of data for the non-U.S. Pharmaceuticals business.

Nutritionals

The composition of the net increase in nutritional sales is as follows:

Three Months Ended

September 30,


    Analysis of % Change

  Total Change

 Volume

 Price

 Foreign Exchange

2005 vs. 2004

  13% 10% 1% 2%

Key Nutritional product lines and their sales, representing 94% of total Nutritional sales in the third quarter of both 2005 and 2004, are as follows:

   Three Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Infant Formulas

  $373  $339  10%

ENFAMIL

   230   203  13%

Toddler/Children’s Nutritionals

   140   116  21%

Worldwide Nutritional sales increased 13%, including a 2% favorable foreign exchange impact, to $547 million in 2005 from $484 million in 2004.

International Nutritional sales increased 11%, including a 4% favorable foreign exchange impact, to $281 million from $254 million in 2004, primarily due to increased sales in Toddler/Children’s Nutritional products.

Domestic Nutritional sales increased 16% to $266 million in 2005 from $230 million in 2004, primarily due to increased sales in ENFAMIL.

Sales of ENFAMIL, the Company’s best-selling infant formula, increased 13%, including a 1% favorable foreign exchange impact, to $230 million in 2005 from $203 million in 2004, primarily due to strong sales growth in the U.S. and the launch of ENFAMIL GENTLEASE LIPIL infant formula in August 2005.

Related Healthcare

The Related Healthcare segment includes ConvaTec, the Medical Imaging business and Consumer Medicines in the United States and Canada. The composition of the net decrease in Related Healthcare segment sales is as follows:

Three Months Ended

September 30,


    Analysis of % Change

  Total Change

 Volume

 Price

 Foreign Exchange

2005 vs. 2004

  (1)% 1% (2)% —  

Related Healthcare sales by business and their key products for the three months ended September 30 were as follows:

   Three Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

ConvaTec

  $250  $237  5%

Ostomy

   139   135  3%

Wound Therapeutics

   104   99  5%

Medical Imaging

   150   145  3%

CARDIOLITE

   106   101  5%

Consumer Medicines

   42   64  (34)%

ConvaTec sales increased 5%, including a 1% favorable foreign exchange impact to $250 million in 2005 compared to $237 million in 2004, primarily due to the increase in worldwide sales of wound therapeutic and ostomy products. Sales of wound therapeutic products increased 5%, including a 1% favorable foreign exchange impact, to $104 million in 2005 from $99 million in 2004, primarily due to increased sales of AQUACEL®. Ostomy sales increased 3%, including a 1% favorable foreign exchange impact, to $139 million in 2005 from $135 million in 2004, primarily due to the introduction of new products.

Medical Imaging sales increased 3% to $150 million in 2005 compared to $145 million in 2004. Sales of CARDIOLITE increased 5% to $106 million in 2005 from $101 million in 2004, primarily due to increased demand.

Consumer Medicines sales decreased 34% to $42 million in 2005 from $64 million in 2004. During the third quarter of 2005, the Company completed the sale of the U.S. and Canadian Consumer Medicines business and related assets. For additional information, see “Item 1. Financial Statements — Note 4. Acquisitions and Divestitures.”

Geographic Areas

In general, the Company’s products are available in most countries in the world. The largest markets are in the United States, France, Japan, Spain, Italy, Germany, Canada, and the UK. The Company’s sales by geographic areas were as follows:

   Three Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

United States

  $2,638  $2,633  —   

% of Total

   55%  55%   

Europe, Middle East and Africa

   1,222   1,346  (9)%

% of Total

   26%  28%   

Other Western Hemisphere

   392   342  15%

% of Total

   8%  7%   

Pacific

   515   457  13%

% of Total

   11%  10%   
   


 


   

Total

  $4,767  $4,778  —   
   


 


   

Sales in the United States remained constant in 2005, with decreased sales in PARAPLATIN due to generic competition that began at the end of 2004, being offset by increased sales of growth drivers including PLAVIX*, ABILIFY*, REYATAZ and ERBITUX*.

Sales in Europe, Middle East and Africa decreased 9% as a result of sales decline of TAXOL® and PRAVACHOL from exclusivity losses. This decrease in sales was partially offset by increased sales in major European markets of ABILIFY* and REYATAZ, which were both launched in Europe in the second quarter of 2004.

Sales in the Other Western Hemisphere countries increased 15%, including a 11% favorable foreign exchange impact, primarily due to increased sales of PLAVIX* across all markets, and REYATAZ in Brazil and Canada.

Sales in the Pacific region increased 13%, including a 2% favorable foreign exchange impact, as a result of increased sales of TAXOL® in Japan, and ENFAGROW in China, Malaysia and Vietnam.

Expenses

   Three Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Cost of products sold

  $1,483  $1,467  1%

% of net sales

   31.1%  30.7%   

Marketing, selling and administrative

  $1,286  $1,199  7%

% of net sales

   27.0%  25.1%   

Advertising and product promotion

  $349  $325  7%

% of net sales

   7.3%  6.8%   

Research and development

  $669  $615  9%

% of net sales

   14.0%  12.9%   

Acquired in-process and development

  $—    $1  (100)%

% of net sales

   —     —      

Provision for restructuring, net

  $(5) $57  (109)%

% of net sales

   (0.1)%  1.2%   

Litigation (income)/charges, net

  $(26) $25  **

% of net sales

   (0.5)%  0.5%   

Gain on sale of business

  $(569) $(3) **

% of net sales

   (11.9)%  (0.1)%   

Equity in net income of affiliates

  $(84) $(70) (20)%

% of net sales

   (1.8)%  (1.5)%   

Other expense, net

  $38  $16  138%

% of net sales

   0.8%  0.4%   

Total Expenses, net

  $3,141  $3,632  (14)%

% of net sales

   65.9%  76.0%   

**In excess of 200%.

Cost of products sold, as a percentage of sales, increased to 31.1% in the third quarter of 2005 compared with 30.7% in the third quarter of 2004, primarily due to the unfavorable impact of pharmaceutical sales mix, partially offset by sales growth of ABILIFY*, REYATAZ and PLAVIX*.

Marketing, selling and administrative expenses, as a percentage of sales, were 27.0% in the third quarter of 2005 and 25.1% in the third quarter of 2004. In 2005, marketing, selling and administrative expenses increased 7% to $1,286 million from 2004, primarily due to higher legal costs, higher pension expenses reflecting increased amortization of unrecognized net losses as well as changes in actuarial assumptions, and increased expenditures on late-stage compounds.

Advertising and product promotion expenditures increased 7% to $349 million in 2005 from 2004, primarily for increased investments behind PLAVIX* and the launch of BARACLUDE™, in addition to increased costs associated with pre-launch activities.

The Company’s investment in research and development totaled $669 million in the third quarter of 2005, an increase of 9% over 2004, and as a percentage of sales were 14.0% in the third quarter of 2005 compared with 12.9% in the third quarter of 2004. The increase in research and development expenses reflects continued investments in late-stage compounds. In 2005, investment in pharmaceutical research and development equaled 16.3% of Pharmaceuticals sales compared to 14.7% in 2004.

Acquired in-process research and development of $1 million in 2004 is related to the acquisition of Acordis. For additional information on the acquisition, see “Item 1. Financial Statements—Note 4. Acquisitions and Divestitures.”

Restructuring programs have been implemented to downsize, realign and streamline operations in order to increase productivity, reduce operating expenses and to rationalize the Company’s manufacturing network, research facilities, and the sales and marketing organizations. Actions under the third quarter 2005 restructuring program are expected to be complete by late 2005, while actions under the third quarter 2004 restructuring program are substantially completed. As a result of these actions, the Company expects the future annual benefit to earnings from continuing operations before minority interest and income taxes to be approximately $1 million and $125 million for the Pharmaceuticals segment decreasedthird quarter 2005 and 2004 programs, respectively. For additional information on restructuring, see “Item 1. Financial Statements—Note 3. Restructuring.”

In the third quarter of 2005, the Company recorded litigation insurance recovery of $26 million in aggregate as a result of agreements to $1,120settle coverage disputes primarily related to product liability with its various insurers. In the third quarter of 2004, the Company recorded litigation charges of $25 million, related to anti-trust litigation regarding PLATINOL. For additional information on litigation charges, see “Item 1. Financial Statements — Note 17. Legal Proceedings and Contingencies — Other Securities Matters.”

The gain on sale of business of $569 million ($370 million net of tax) in the third quarter of 2005 is related to sale of the U.S. and Canadian Consumer Medicines business and related assets. The gain on sale of business of $3 million in 2004 is related to the sale of the Mead Johnson Adult Nutritional business. For additional information on these sales, see “Item 1. Financial Statements — Note 4. Acquisitions and Divestitures.”

Equity in net income of affiliates for the third quarter of 2005 was $84 million, compared with $70 million in the third quarter of 2004 from $1,2052004. Equity in net income of affiliates is principally related to the Company’s joint venture with Sanofi and investment in ImClone. The $14 million increase in equity in net income of affiliates primarily reflects the increase in net income in the Sanofi joint venture. For additional information on equity in net income of affiliates, see “Item 1. Financial Statements — Note 2. Alliances and Investments.”

Other expenses, net of income, were $38 million and $16 million in 2003.the third quarters of 2005 and 2004, respectively. Other expenses include net interest expense, foreign exchange gains and losses, income from third-party contract manufacturing and royalty income and litigation matters. The decrease$22 million increase in other expenses in 2005 was primarily due to net foreign exchange gains recognized in 2004. For additional information, see “Item 1. Financial Statements — Note 7. Other (Income) / Expense, Net.”

During the quarters ended September 30, 2005 and 2004, the Company recorded several (income)/expense items that affected the comparability of results of the periods presented herein, which are set forth in the following table.

Three Months Ended September 30, 2005

   Cost of
products
sold


  

Gain on sale

of business


  Provision for
restructuring
and other
items, net


  Litigation
settlement
income


  

Other

expense, net


  Total

 
   (dollars in millions) 

Litigation Matters:

                         

Insurance recoveries

  $—    $—    $—    $(26) $—    $(26)

Other:

                         

Gain on sale of Consumer Medicines business

   —     (569)  —     —     —     (569)

Loss on sale of fixed assets

   —     —     —     —     1   1 

Accelerated depreciation and asset impairment

   35   —     —     —     —     35 

Downsizing and streamlining of worldwide operations

   —     —     (5)  —     —     (5)
   

  


 


 


 

  


   $35  $(569) $(5) $(26) $1   (564)
   

  


 


 


 

     

Income taxes on items above

                       202 
                       


Increase to Net Earnings from Continuing Operations

                      $(362)
                       


Three Months Ended September 30, 2004

   Cost of
products
sold


  Research and
development


  Acquired
in-process
research and
development


  Gain on sale
of business


  Provision for
restructuring
and other
items, net


  Litigation
settlement
expense


  Other
expense,
net


  Total

 
   (dollars in millions) 

Litigation Matters:

                                 

Product liability

  $—    $—    $—    $—    $—    $—    $11  $11 

Anti-trust litigation

   —     —     —     —     —     25   —     25 
   

  

  

  


 

  

  

  


    —     —     —     —     —     25   11   36 

Other:

                                 

Gain on sale of Adult Nutritional business

   —     —     —     (3)  —     —     —     (3)

Accelerated depreciation

   47   1   —     —     —     —     —     48 

Downsizing and streamlining of worldwide operations

   —     —     —     —     57   —     —     57 

Milestone payment

   —     10   —     —     —     —     —     10 

Acordis IPR&D write-off

   —     —     1   —     —     —     —     1 
   

  

  

  


 

  

  

  


   $47  $11  $1  $(3) $57  $25  $11   149 
   

  

  

  


 

  

  

     

Income taxes on items above

                               (39)
                               


Reduction to Net Earnings from Continuing Operations

                              $110 
                               


Earnings Before Minority Interest and Income Taxes

   Earnings From Continuing
Operations Before Minority
Interest and Income Taxes


    
   Three Months Ended September 30,

    
   2005

  2004

  % Change

 
   (dollars in millions)    

Pharmaceuticals

  $915  $1,127  (19)%

Nutritionals

   150   126  19%

Related Healthcare

   125   131  (5)%
   

  


   

Total segments

   1,190   1,384  (14)%

Corporate/Other

   436   (238) **
   

  


   

Total

  $1,626  $1,146  42%
   

  


   

**in excess of 200%.

In the third quarter of 2005, earnings from continuing operations before minority interest and income taxes increased 42% to $1,626 million from $1,146 million in the third quarter of 2004. The $480 million increase was primarily driven by gross margin erosion due to generic competitionthe gain on sale of the U.S. and product mix, additional sales representatives supporting ABILIFY*Canadian Consumer Medicines business and higher spending in research and development.related assets.

 

Oncology Therapeutics NetworkPharmaceutical

Sales by OTN, a specialty distributor of third-party anti-cancer medicines and related products, increased 13% to $649 million in 2004 from $574 million in 2003. The increase in sales compared to the previous year was due to new product launches from other manufacturers.

As is characteristic of the U.S. market for oncology pharmaceuticals, a small number of products account for a majority of OTN sales. OTN’s top ten revenue-generating products for 2003 comprised 77% of 2003 revenues. One is a monoclonal antibody that comprised 11% of 2003 revenues, five are chemotherapeutic agents that comprised 28% of 2003 revenues, and four are colony-stimulating factors that comprised 38% of 2003 revenues.

 

Earnings before minority interest and income taxes decreased to $4$915 million in the third quarter of 2005 from $1,127 million in the third quarter of 2004 from $6 millionprimarily due to lower sales and gross margin erosion as a result of an unfavorable shift in 2003.the sales mix, investments in research and development, legal costs and marketing expenditures on late-stage compounds.

 

NutritionalsNutritional

Worldwide Nutritional sales decreased 7%, including a 1% unfavorable foreign exchange impact, to $484 million from $518 million in 2003. Excluding the Adult Nutritional business, which was divested in February 2004, sales increased 5%, to $484 million from $459 million in 2003, including a 1% unfavorable foreign exchange impact. Also excluding the Adult Nutritional business, international sales increased 16%, including a 2% unfavorable foreign exchange impact, from increased sales of infant formula and children’s nutritional products, while U.S. sales decreased 6%, from decreased sales under the WIC program. Mead Johnson continues to be the leader in the U.S. infant formula market. During the third quarter of 2004 and 2003, the Nutritionals business recorded $227 million and $221 million, respectively, as a reduction to gross sales, for WIC rebate claims.

 

Earnings before minority interest and income taxes forincreased to $150 million in the Nutritionals segment decreased tothird quarter of 2005 from $126 million in the third quarter of 2004, primarily from $155 million in 2003, driven by lowersales growth of both infant formula sales in the U.S. and the negative impact of the divestiture of the Adult Nutritional business.children’s nutritional products.

 

OtherRelated Healthcare

Sales in the Other Healthcare segment increased 7%, including a 3% favorable foreign exchange impact, to $463 million in 2004 from $433 million in 2003. The Other Healthcare segment is comprised of the ConvaTec, Medical Imaging and Consumer Medicines (United States and Japan) businesses.

ConvaTec sales for the three months ended September 30, 2004 increased 8%, including a 5% favorable foreign exchange impact, to $237 million from $219 million in 2003.

Medical Imaging sales for the three months ended September 30, 2004, increased 12% to $145 million from $129 million in 2003, primarily due to a 22% increase in CARDIOLITE sales to $101 million in 2004 from $83 million in 2003.

Consumer Medicines sales for the three months ended September 30, 2004 decreased 5% to $81 million from $85 million in 2003.

 

Earnings before minority interest and income taxes forin the OtherRelated Healthcare segment increaseddecreased to $138$125 million in 2004the third quarter of 2005 from $115$131 million in 2003the third quarter of 2004, primarily due to sales growththe sale of the U.S. and Canadian Consumer Medicines business and related assets.

Income Taxes

The effective income tax rate on earnings from continuing operations before minority interest and income taxes was 31.2% in the ConvaTecthird quarter of 2005 compared with 20.9% in the third quarter of 2004. The higher effective tax rate for the three months ended September 30, 2005 was due primarily to a higher concentration of pre-tax earnings in the U.S. and Medical Imaging businesses.Canada attributable to the sale of the Consumer Medicines business and related assets, and lower foreign tax credits. In the third quarter of 2005, as a result of the sale of the Consumer Medicines business and other changes in assumptions regarding future taxable profits, the Company recorded a net benefit of approximately $3 million in its tax provision associated with the reduction of its valuation allowance on certain deferred tax assets.

Net Earnings

Net earnings from continuing operations increased 28% in the third quarter of 2005 to $964 million from $755 million in the third quarter of 2004. In the third quarter of 2005, basic earnings per share from continuing operations increased 26% to $0.49 from $0.39 in the third quarter of 2004, while diluted earnings per share from continuing operations increased 29% to $0.49 from $0.38 in 2004.

 

Nine Months Results of Operations

 

   

Nine Months Ended

September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Net Sales

  $14,188  $14,223  —   

Earnings from continuing operations before minority interest
and income tax

   3,684   3,379  9%

% of net sales

   26.0%  23.8%   

Provision on income taxes

   754   753  —   

Effective tax rate

   20.5%  22.3%   

Earnings from continuing operations

   2,493   2,239  11%

% of net sales

   17.6%  15.7%   

Net Sales

Except as noted below, the factors affecting the third quarter comparisons all affected the nine month comparisons.

 

WorldwideNet sales from continuing operations for the first nine months of 2004 increased 5% to $16,0382005 remained constant at $14,188 million from $15,229$14,223 million in 2003. The increase in worldwide net sales in the first nine months of 2004 resulted from a 1% increase in volume, a 3% favorable impact from foreign exchange rate fluctuations and a 1% increase due to changes in selling prices.2004. U.S. sales increaseddecreased 2% to $9,618$7,616 million in 2005 from $7,803 million in 2004, from $9,430 million in 2003 due to growth in prescription demand for key brands and new product introductions, partially offset by lower sales in the third quarter as a result of exclusivity losses. Internationalwhile international sales increased 11%2%, primarily due to an 8%including a 3% favorable foreign exchange impact, to $6,572 million in 2005 from $6,420 million in 2004 from $5,799 million2004.

The composition of the net (decrease)/increase in 2003. In general, the Company’s businesssales is not seasonal. For information on U.S. pharmaceuticals prescriber demand, reference is made to the table within Business Segments under the Pharmaceuticals section 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 certainas follows:

Nine Months Ended

September 30,


     Analysis of % Change

  Total Change

  Volume

 Price

  Foreign Exchange

2005 vs. 2004

  —    (2)% —    2%

The percent of the Company’s primary care pharmaceutical products.net sales by segment were as follows:

   Net Sales

    
   

Nine Months Ended

September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Pharmaceuticals

  $11,242  $11,414  (2)%

% of net sales

   79.2%  80.3%   

Nutritionals

   1,621   1,496  8%

% of net sales

   11.4%  10.5%   

Related Healthcare

   1,325   1,313  1%

% of net sales

   9.4%  9.2%   

Total

  $14,188  $14,223  —   

 

The following table sets forth the reconciliation of the Company’s gross sales to net sales by each significant category of gross-to-net sales adjustments:

 

  Nine Months Ended
September 30,


 
  Nine Months Ended
September 30,


   2005

 2004

 
  2004

 2003

   (dollars in millions) 

Gross Sales

  $19,413  $18,424   $17,103  $17,561 
  


 


  


 


Gross to Net Sales Adjustments

   

Gross-to-Net Sales Adjustments

   

Prime Vendor Charge-Backs

   (958)  (906)   (863)  (958)

WIC Rebates

   (633)  (671)

Managed Health Care Rebates and Other Contract Discounts

   (527)  (510)

Women, Infants and Children (WIC) Rebates

   (630)  (634)

Managed Healthcare Rebates and Other Contract Discounts

   (409)  (524)

Medicaid Rebates

   (470)  (376)   (464)  (469)

Cash Discounts

   (262)  (253)   (202)  (233)

Sales Returns

   (225)  (242)   (130)  (220)

Other Adjustments

   (300)  (237)   (217)  (300)
  


 


  


 


Total Gross to Net Sales Adjustments

   (3,375)  (3,195)

Total Gross-to-Net Sales Adjustments

   (2,915)  (3,338)
  


 


  


 


Net Sales

  $16,038  $15,229   $14,188  $14,223 
  


 


  


 


 

The decrease in prime vendor charge-backs in 2005 was primarily due to lower relative sales volume in this segment due to product mix. The decrease in managed healthcare rebates was primarily attributable to lower sales volume through managed healthcare companies. The decrease in sales returns was primarily due to lower returns for certain products including TEQUIN, PRAVACHOL and SUSTIVA. The decrease in other adjustments was due to lower sales discounts in the international businesses and lower rebates to foreign governments.

The following table sets forth the activities and ending balances of each significant category of gross-to-net sales adjustmentsadjustments:

   Prime
Vendor
Charge-
Backs


  Women,
Infants and
Children
(WIC)
Rebates


  Managed
Healthcare
Rebates and
Other Contract
Discounts


  Medicaid
Rebates


  Cash
Discounts


  Sales Returns

  Other
Adjustments


  Total

 
   (dollars in millions) 

Balance at December 31, 2003

  $101  $208  $249  $233  $30  $268  $124  $1,213 

Provision related to sales made in current period

   1,314   843   646   618   311   270   463   4,465 

Provision related to sales made in prior periods

   5   3   14   55   —     6   (32)  51 

Returns and payments

   (1,314)  (820)  (711)  (534)  (308)  (316)  (385)  (4,388)

Impact of foreign currency translation

   —     —     —     —     —     1   6   7 
   


 


 


 


 


 


 


 


Balance at December 31, 2004

   106   234   198   372   33   229   176   1,348 

Provision related to sales made in current period

   868   630   403   428   202   149   248   2,928 

Provision related to sales made in prior periods

   (5)  —     6   36   —     (19)  (31)  (13)

Returns and payments

   (871)  (638)  (425)  (505)  (209)  (159)  (290)  (3,097)

Impact of foreign currency translation

   —     —     (3)  —     —     (2)  —     (5)
   


 


 


 


 


 


 


 


Balance at September 30, 2005

  $98  $226  $179  $331  $26  $198  $103  $1,161 
   


 


 


 


 


 


 


 


In the first nine months of 2005, the Company recorded gross-to-net sales adjusting charges and credits related to sales made in prior periods. The significant items included charges of $36 million for Medicaid rebates primarily as a result of higher than expected Medicaid utilization of various products; charges of $6 million for managed care rebates due to changes in estimates of managed care claims; credits of $5 million for prime vendor charge-backs primarily resulting from a resolution of intermediary pricing discrepancies impacting the Company’s oncology business, partially offset by charges for other adjustments; credits of $19 million for sales returns resulting from lower returns for certain products; and Medicaidcredits of $31 million for other adjustments primarily as a result of lower than expected rebates increased to $958 million and $470 million in 2004, respectively, from $906 million and $376 million in 2003, respectively. These increases were primarily due to a shift in sales to products with higher discounts in prime vendor and Medicaid programs.foreign governments. No materialother significant revisions were made to the estimates for gross-to-net sales adjustments for the nine months ended September 30, 2004 and 2003.in 2005.

 

EarningsPharmaceuticals

The composition of the net decrease in pharmaceutical sales is as follows:

Nine Months Ended

September 30,


  Total Change

 Analysis of % Change

   Volume

 Price

 Foreign Exchange

2005 vs. 2004  (2)% (3)% (1)% 2%

 

For the nine months ended September 30, 2004, earnings before minority interest and income taxes2005, worldwide Pharmaceuticals sales decreased 10%2% to $3,395$11,242 million. Domestic pharmaceutical sales decreased 4% to $5,956 million from $3,771$6,191 million in 2003. The decrease was principally2004, while international pharmaceutical sales increased 1%, including a 3% favorable foreign exchange impact to $5,286 million in the first nine months of 2005 from $5,223 million in 2004.

Key pharmaceutical products and their sales, representing 80% of total pharmaceutical sales in the first nine months of both 2005 and 2004, respectively, are as follows:

   Nine Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Cardiovascular

            

PLAVIX*

  $2,762  $2,368  17%

PRAVACHOL

   1,672   1,925  (13)%

AVAPRO*/AVALIDE*

   705   671  5%

MONOPRIL

   162   206  (21)%

COUMADIN

   156   179  (13)%

Virology

            

SUSTIVA

   510   449  14%

REYATAZ

   508   266  91%

ZERIT

   169   205  (18)%

VIDEX/VIDEX EC

   133   207  (36)%

Infectious Diseases

            

CEFZIL

   184   181  2%

BARACLUDE™

   7   —    —   

Oncology

            

TAXOL®

   566   735  (23)%

ERBITUX*

   292   173  69%

PARAPLATIN

   119   646  (82)%

Affective (Psychiatric) Disorders

            

ABILIFY* (total revenue)

   688   402  71%

Metabolics

            

GLUCOPHAGE Franchise

   137   283  (52)%

Other Pharmaceuticals

            

EFFERALGAN

   209   198  6%

Sales of PLAVIX* increased 17%, including a 1% favorable foreign exchange impact, to $2,762 million from $2,368 million in 2004. Domestic sales increased 15% to $2,329 million from $2,017 million in 2004, primarily due to a $491 million increase in reserves primarily for liabilities related to previously disclosed legal matters and product liability, $151 millioncontinued estimated prescription growth of restructuring and accelerated depreciation charges related to the downsizing and streamlining of worldwide operations primarilyapproximately 14% in the U.S. market.

Sales of PRAVACHOL decreased 13%, including a 1% favorable foreign exchange impact, to $1,672 million from $1,925 million in 2004. Domestic sales decreased 8% to $908 million in 2005. Estimated U.S. prescriptions decreased approximately 16%. International sales decreased 19%, including a 3% favorable foreign exchange impact, to $764 million.

Sales of AVAPRO*/AVALIDE* increased 5%, including a 2% favorable foreign exchange impact, to $705 million from $671 million in 2004. Domestic sales were $406 million in 2005 compared with $408 million in 2004, while international sales increased 14%, including a 5% favorable foreign exchange impact, to $299 million from $263 million in 2004 primarily due to increased sales in Canada, Germany, Australia and France.

Sales of MONOPRIL decreased 21%, including a 3% favorable foreign exchange impact, to $162 million.

Sales of COUMADIN decreased 13%, including a 1% favorable foreign exchange impact, to $156 million in 2005 compared to $179 million in 2004.

Sales of SUSTIVA increased 14%, including a 2% favorable foreign exchange impact, to $510 million in 2005 from $449 million in 2004, primarily due to estimated U.S. prescription growth of approximately 5%, higher average selling prices and lower sales returns.

Sales of REYATAZ were $508 million in 2005 compared to $266 million in 2004. Sales in Europe continued to grow since its introduction in the write-offsecond quarter of 2004, achieving sales of $148 million in the first nine months of 2005.

Sales of ZERIT decreased 18%, including a 2% favorable foreign exchange impact, to $169 million in 2005 from $205 million in 2004, as a result of a decrease in estimated U.S. prescriptions of approximately 31% compared to 2004.

Sales of VIDEX/VIDEX EC decreased 36%, including a 2% favorable foreign exchange impact, to $133 million in 2005 from $207 million in 2004.

Sales of CEFZIL increased 2%, including a 2% favorable foreign exchange impact, to $184 million in 2005 from $181 million in 2004.

BARACLUDE™ generated sales of $7 million since its launch in the U.S. in April 2005.

Sales of TAXOL® were $566 million in 2005, a decrease of 23% including a 2% favorable foreign exchange impact, compared to $735 million in 2004.

Sales of ERBITUX* were $292 million in 2005 compared to $173 million in 2004 after its introduction in February 2004.

Sales of PARAPLATIN decreased 82% to $119 million in 2005 from $646 million in 2004. Domestic sales decreased 96% to $23 million in 2005 from $549 million in 2004.

Total revenue for ABILIFY* increased 71%, including a 1% favorable foreign exchange impact, to $688 million in 2005 from $402 million in 2004. Estimated U.S. prescription demand increased approximately 46% compared to 2004. Total revenue for ABILIFY* in Europe has continued to grow since its launch, to $98 million in the first nine months of 2005.

GLUCOPHAGE* franchise sales decreased 52% to $137 million in 2005, compared to $283 million in 2004, primarily resulting from increased generic competition.

Sales of EFFERALGAN increased 6%, including a 4% favorable foreign exchange impact, to $209 million in 2005 from $198 million in 2004.

The estimated prescription and prescription growth data provided above includes information only from the retail and mail order channels and do not reflect information from other channels, such as hospitals, institutions and long-term care, among others. The estimated prescription and prescription growth data are based on NPA data provided by IMS.

The following table sets forth for each of the Company’s top 15 pharmaceutical products sold by the U.S. Pharmaceuticals business (based on 2004 annual net sales), for the nine months ended September 30, 2005 and 2004 compared to the same periods in the prior year: (a) changes in reported U.S. net sales for the period; (b) estimated total U.S. prescription growth for the retail and mail order channels calculated by the Company based on NPA data provided by IMS, a supplier of market research for the pharmaceutical industry; and (c) estimated total U.S. prescription growth for the retail and mail order channels calculated by the Company based on NGPS provided by IMS.

   Nine Months Ended September 30,

 
   2005

  2004

 
   

% Change
in U.S.
Net Sales(a) 


  

% Change

in U.S. Total Prescriptions


  

% Change
in U.S.
Net Sales(a)


  

% Change

in U.S. Total Prescriptions


 
    NPA Data (b)

  NGPS Data (c)

   NPA Data (b)

  NGPS Data (c)

 

ABILIFY* (total revenue)

  50  46  44  91  127  127 

AVAPRO*/AVALIDE*

  —    13  14  26  16  18 

CEFZIL

  6  (9) (9) (30) (28) (27)

COUMADIN

  (16) (18) (18) (31) (18) (23)

DOVONEX

  (3) (6) (7) 14  (8) (7)

ERBITUX*(d)

  69  N/A  N/A  —    N/A  N/A 

GLUCOPHAGE* Franchise

  (55) (66) (65) (62) (55) (56)

PARAPLATIN(d)

  (96) N/A  N/A  (9) N/A  N/A 

PLAVIX*

  15  14  14  44  26  29 

PRAVACHOL

  (8) (16) (16) (18) (8) (8)

REYATAZ

  43  44  42  ** ** **

SUSTIVA

  15  5  8  4  5  12 

TEQUIN

  (5) (30) (28) (26) (18) (17)

VIDEX/VIDEX EC

  (73) (62) (62) (1) (1) 5 

ZERIT

  (14) (31) (29) (37) (29) (27)

(a)Reflects percentage change in net sales in dollar terms, including change in average selling prices and wholesaler buying patterns.
(b)Based on a simple average of the estimated number of prescriptions in the retail and mail order channels as provided by IMS.
(c)Based on a weighted average of the estimated number of prescription units (pills) in each of the retail and mail order channels based on data provided by IMS.
(d)ERBITUX* and PARAPLATIN specifically, and oncology products in general, do not have prescription-level data because physicians do not write prescriptions for these products. The Company believes therapeutic category share information provided by third parties for these products may not be reliable and accordingly, none is presented here.
**In excess of 200%.

For an explanation of the data presented above and the calculation of such data. See “—Three Months Results of Operations”.

Nutritionals

The composition of the net increase in nutritional sales is as follows:

Nine Months Ended

September 30,


  

Total Change


 Analysis of % Change

   Volume

 Price

 Foreign Exchange

2005 vs. 2004

  8% 5% 2% 1%

Key Nutritional product lines and their sales, representing 95% and 93% of total Nutritional sales in the first nine months of 2005 and 2004, respectively, are as follows:

   Nine Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Infant Formulas

  $1,145  $1,043  10%

ENFAMIL

   715   635  13%

Toddler/Children’s Nutritionals

   390   348  12%

Worldwide Nutritional sales increased 8%, including a 1% favorable foreign exchange impact and a 2% unfavorable impact from the divestiture of the Adult Nutritional business in 2004, to $1,621 million in 2005 from 2004. International sales increased 10% to $833 million, including a 3% favorable foreign exchange impact and a 1% unfavorable impact from the divestiture of the Adult Nutritional business in 2004. Domestic sales increased 6% to $788 million, including a 4% unfavorable impact from the divestiture of the Adult Nutritional business in 2004.

Sales of ENFAMIL increased 13%, including a 1% favorable foreign exchange impact, to $715 million in 2005 from $635 million in 2004.

Related Healthcare

The composition of the net increase in Related Healthcare segment sales is as follows:

Nine Months Ended

September 30,


  

Total Change


 Analysis of % Change

   Volume

  Price

 Foreign Exchange

2005 vs. 2004

  1% —    (1)% 2%

Related Healthcare sales by business and their key products for the nine months ended September 30 were as follows:

   Nine Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

ConvaTec

  $725  $688  5%

Ostomy

   405   399  2%

Wound Therapeutics

   304   280  9%

Medical Imaging

   446   435  3%

CARDIOLITE

   316   298  6%

Consumer Medicines

   154   190  (19)%

ConvaTec sales increased 5%, including a 3% favorable foreign exchange impact to $725 million in 2005 from $688 million in 2004. Sales of wound therapeutic products increased 9%, including a 2% favorable foreign exchange impact, to $304 million in 2005 from $280 million in 2004, while ostomy sales increased 2%, including a 3% favorable foreign exchange impact, to $405 million in 2005 from $399 million in 2004.

Medical Imaging sales increased 3%, including a 1% favorable foreign exchange impact to $446 million in 2005 from $435 million in 2004. Sales of CARDIOLITE increased 6% to $316 million in 2005 from $298 million in 2004.

Consumer Medicines sales decreased 19% to $154 million from $190 million in 2004.

Geographic Areas

The Company’s sales by geographic areas were as follows:

   

Nine Months Ended

September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

United States

  $7,616  $7,803  (2)%

% of Total

   54%  55%   

Europe, Middle East and Africa

   3,940   4,021  (2)%

% of Total

   28%  28%   

Other Western Hemisphere

   1,148   1,035  11%

% of Total

   8%  7%   

Pacific

   1,484   1,364  9%

% of Total

   10%  10%   
   


 


   

Total

  $14,188  $14,223  —   
   


 


   

Sales in the United States decreased 2% in 2005, with lower sales of PARAPLATIN, the GLUCOPHAGE* franchise as a result of generic competition, PRAVACHOL due to increased competition, partially offset by increased sales of growth drivers.

Sales in Europe, Middle East and Africa decreased 2%, including a 3% favorable foreign exchange impact as a result of sales decline in France, Germany, the UK, Italy, partially offset by increased sales in Spain.

Sales in the Other Western Hemisphere countries increased 11%, including a 7% favorable foreign exchange impact, primarily due to increased sales in Latin American countries.

Sales in the Pacific region increased 9%, including a 2% favorable foreign exchange impact, as a result of increased sales in Japan, China and Australia.

Expenses

   Nine Months Ended
September 30,


    
   2005

  2004

  % Change

 
   (dollars in millions)    

Cost of products sold

  $4,333  $4,324  —   

% of net sales

   30.5%  30.4%   

Marketing, selling and administrative

  $3,737  $3,626  3%

% of net sales

   26.3%  25.5%   

Advertising and product promotion

  $1,032  $987  5%

% of net sales

   7.3%  6.9%   

Research and development

  $1,971  $1,823  8%

% of net sales

   13.9%  12.8%   

Acquired in-process research and development

  $—    $63  (100)%

% of net sales

   —     0.5%   

Provision for restructuring, net

  $—    $75  (100)%

% of net sales

   —     0.5%   

Litigation (income)/charges, net

  $72  $404  (82)%

% of net sales

   0.5%  2.8%   

Gain on sale of business

  $(569) $(316) (80)%

% of net sales

   (4.0)%  (2.2)%   

Equity in net income of affiliates

  $(240) $(204) (18)%

% of net sales

   (1.7)%  (1.4)%   

Other expense, net

  $168  $62  171%

% of net sales

   1.2%  0.4%   

Total expenses

  $10,504  $10,844  (3)%

% of net sales

   74.0%  76.2%   

Cost of products sold, as a percentage of sales, increased to 30.5% in the first nine months of 2005 compared with 30.4% in the first nine months of 2004. The increase is primarily due to the unfavorable impact of U.S. Pharmaceutical sales mix in 2005, partially offset by $76 million of net litigation charges recorded 2004.

Marketing, selling and administrative expenses, as a percentage of sales, were 26.3% in the first nine months of 2005 and 25.5% in the first nine months of 2004.

Advertising and product promotion expenditures increased 5% to $1,032 million from 2004, primarily due to the launch of BARACLUDE™ and continued investments in growth drivers, partially offset by lower spending on mature products.

The Company’s investment in research and development totaled $1,971 million in the first nine months of 2005, an increase of 8% over 2004. In 2005, research and development spending dedicated to pharmaceutical products increased to 16.0% of Pharmaceuticals sales compared with 14.7% in 2004.

Acquired in-process research and development of $63 million resultingin the first nine months of 2004 is related to the acquisition of Acordis. For additional information on the sale, see “Item 1. Financial Statements—Note 4. Acquisitions and Divestitures.”

Actions under the restructuring program for the first nine months of 2005 are expected to be complete by late 2005, while actions under the restructuring program for the first nine months 2004 are substantially completed. As a result of these actions, the Company expects the future annual benefit to earnings from continuing operations before minority interest and income taxes to be approximately $7 million and $142 million for the Acordis acquisition,two restructuring programs for the first nine months of 2005 and 2004, respectively. For additional information on restructuring, see “Item 1. Financial Statements—Note 3. Restructuring.”

For the first nine months of 2005, the Company recorded net litigation charges of $72 million, reflecting an increase to the reserves for liabilities related to private litigations and governmental investigations of $373 million, ERISA litigation and

other matters of $20 million, partially offset by insurance recoveries of $321 million. The $404 million litigation expense recorded in 2004 consisted of $320 million related to private litigation and governmental investigations related to wholesaler inventory issues and accounting matters, $50 million related to the PLATINOL litigation settlement and $34 million related to pharmaceutical pricing and sales and practices. For additional information on litigation charges, see “Item 1. Financial Statements — Note 17. Legal Proceedings and Contingencies.”

In 2005 the Company recorded a pre-tax gain of $569 million on the sale of the U.S. and Canadian Consumer Medicines business and related assets. The gain on sale of business of $316 million onin 2004 related to the sale of the Mead Johnson Adult Nutritional business. In addition,For additional information on these sales, see “Item 1. Financial Statements—Note 4. Acquisitions and Divestitures.”

Equity in net income of affiliates for the decrease in 2004first nine months of 2005 was also due to increases in cost of products sold as a result of a change in product mix, products losing exclusivity and increased investment in research and development, mainly offset by higher sales. Net earnings$240 million, compared with $204 million in the first nine months of 2004 decreased 14%2004. Equity in net income of affiliates is principally related to $2,249the Company’s joint venture with Sanofi and investment in ImClone. The $36 million compared to $2,600increase in equity in net income of affiliates primarily reflects an increase in net income in the Sanofi joint venture, partially offset by a net loss from the investment in ImClone. For additional information on equity in net income of affiliates, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

Other expenses, net of income, were $168 million in 2003. The effective income tax rate on earnings before minority interest and income taxes was 22.4%$62 million in the first nine months of 2005 and 2004, compared with 24.5%respectively. Other expenses include net interest expense, foreign exchange gains and losses, income from third-party contract manufacturing, royalty income, gains and losses on disposal of property, plant and equipment, and debt retirement costs. The increase in 2003. The lower effective tax rateother expenses in 2005 was primarily drivendue to debt retirement costs in connection with the repurchase of the $2.5 billion Notes due 2006, partially offset by lower earnings in the U.S. as a resultgain on sale of increased reserves for litigationan equity investment. For additional information on the repurchase of the $2.5 billion Notes, see “Item 1. Financial Statements—Note 13. Short-term Borrowings and restructuring, product exclusivity losses and favorable resolution of certain tax contingencies. In 2004, basic earnings per share decreased 13% to $1.16 from $1.34 in 2003, while diluted earnings per share decreased 15% to $1.14 from $1.34 in 2003. Basic and diluted average shares outstanding for the first nine months of 2004 were 1,941 million and 1,975 million, respectively, compared to 1,936 million and 1,942 million, respectively, in 2003.

Long-term Debt.”

 

During the nine months ended September 30, 20042005 and 2003,2004, the Company recorded several (income)/expense items that affected the comparability of results of the periods presented herein, which are set forth in the following tables. For a discussion of these items, see

“Item 1. Financial Statements “—Note 3. Restructuring and Other Items”, “—Note 4. Acquisitions and Divestitures” and “—Note 15. Legal Proceedings and Contingencies”.table.

 

Nine Months Ended September 30, 2005

   Cost of
products
sold


  Research and
development


  

Gain on sale

of business


  Litigation
settlement
expense/(income)


  Other
(income) /
expense, net


  Total

 
   (dollars in millions) 

Litigation Matters:

                         

Private litigations and governmental investigations

  $—    $—    $—    $373  $—    $373 

ERISA liability and other matters

   —     —     —     20   —     20 

Insurance recoveries

   —     —     —     (321)  —     (321)
   

  

  


 


 


 


    —     —     —     72   —     72 

Other:

                         

Gain on sale of equity investment

   —     —     —     —     (27)  (27)

Loss on sale of fixed assets

   —     —     —     —     18   18 

Accelerated depreciation and asset impairment

   69   2   —     —     —     71 

Gain on sale of Consumer Medicines businesses

   —     —     (569)  —     —     (569)

Upfront and milestone payments

   —     35   —     —     —     35 

Debt retirement costs

   —     —     —     —     69   69 
   

  

  


 


 


 


   $69  $37  $(569) $72  $60   (331)
   

  

  


 


 


    

Income taxes on items above

                       178 

Adjustment to taxes on repatriation of foreign earnings

                       (135)
                       


Increase to Net Earnings from Continuing Operations

                      $(288)
                       


Nine Months Ended September 30, 2004

 

   Cost of
Products
Sold


  Research and
Development


  Acquired In-
process
Research and
Development


  Gain on Sale
of Business


  Provision for
Restructuring
and Other Items,
net


  Litigation
settlement
expense/(income)


  Other
Expense, net


  Total

 
   (dollars in millions) 

Litigation Matters:

                                 

Private litigation and governmental investigations(a)

  $—    $—    $—    $—    $—    $320  $—    $320 

Product liability

   75   —     —     —     —     —     11   86 

Pharmaceutical pricing and sales litigation(b)

   —     —     —     —     —     34   —     34 

Commercial litigation

   26   —     —     —     —     —     —     26 

Anti-trust litigation

   —     —     —     —     —     50   —     50 

Product liability insurance recovery

   (25)  —     —     —     —     —     —     (25)
   


 

  

  


 

  

  

  


    76   —     —     —     —     404   11   491 

Other:

                                 

Gain on sale of Adult Nutritional business

   —     —     —     (316)  —     —     —     (316)

Accelerated depreciation

   70   1   —     —     —     —     4   75 

Downsizing and streamlining of worldwide operations

   1   —     —     —     75   —     —     76 

Milestone payment

   —     40   —     —     —     —     —     40 

Acordis IPR&D write-off

   —     —     63   —     —     —     —     63 
   


 

  

  


 

  

  

  


   $147  $41  $63  $(316) $75  $404  $15   429 
   


 

  

  


 

  

  

     

Income taxes on items above

                               94 
                               


                               $335 
                               


(a)Relates to wholesaler inventory and accounting matters consisting of $320 million disclosed by the Company in the second quarter of 2004, which is incremental to the $150 million recorded in 2003, bringing the total reserve to $470 million.

(b)Incremental to the $100 million reserve recorded by the Company in 2003, bringing the total reserve to $134 million.
   Cost of
products
sold


  Research and
development


  

Acquired in-

process
research and
development


  Gain on sale
of business


  

Provision for

restructuring

and other
items, net


  Litigation
settlement
expense


  Other
expense,
net


  Total

 
   (dollars in millions) 

Litigation Matters:

                                 

Private litigation and governmental investigations

  $—    $—    $—    $—    $—    $320  $—    $320 

Product liability

   75   —     —     —     —     —     11   86 

Pharmaceutical pricing and sales litigation

   —     —     —     —     —     34   —     34 

Commercial litigation

   26   —     —     —     —     —     —     26 

Anti-trust litigation

   —     —     —     —     —     50   —     50 

Product liability insurance recovery

   (25)  —     —     —     —     —     —     (25)
   


 

  

  


 

  

  

  


    76   —     —     —     —     404   11   491 

Other:

                                 

Gain on sale of Adult Nutritional business

   —     —     —     (316)  —     —     —     (316)

Accelerated depreciation

   70   1   —     —     —     —     4   75 

Downsizing and streamlining of worldwide operations

   1   —     —     —     75   —     —     76 

Milestone payments

   —     40   —     —     —     —     —     40 

Acordis IPR&D write-off

   —     —     63   —     —     —     —     63 
   


 

  

  


 

  

  

  


   $147  $41  $63  $(316) $75  $404  $15   429 
   


 

  

  


 

  

  

     

Income taxes on items above

                               (94)
                               


Reduction to Net Earnings from Continuing Operations

                              $335 
                               


 

Nine Months Ended September 30, 2003Earnings Before Minority Interest and Income Taxes

 

   Cost of
Products
Sold


  Research and
Development


  Provision for
Restructuring
and Other Items,
net


  Litigation
settlement
expense/(income)


  Total

 
   (dollars in millions) 

Litigation Matters:

                     

Litigation settlement income

  $—    $—    $—    $(66) $(66)
   

  

  


 


 


    —     —     —     (66)  (66)

Other:

                     

Up-front payments for two licensing agreements

   —     21   —     —     21 

Accelerated depreciation

   35   —     —     —     35 

Termination benefits and other exit costs

   —     —     34   —     34 

Asset impairment charges

   11   —     —     —     11 

Relocation and retention

   —     —     13   —     13 

Change in estimates

   —     —     (29)  —     (29)
   

  

  


 


 


   $46  $21  $18  $(66)  19 
   

  

  


 


    

Income taxes on items above

                   5 
                   


                   $24 
                   


   Earnings From Continuing
Operations Before Minority
Interest and Income Taxes


    
   Nine Months ended September 30,

    
   2005

  2004

  % Change

 
   (dollars in millions)    

Pharmaceuticals

  $2,884  $3,309  (13)%

Nutritionals

   494   466  6%

Related Healthcare

   365   396  (8)%
   


 


   

Total segments

   3,743   4,171  (10)%

Corporate/Other

   (59)  (792) 93%
   


 


   

Total

  $3,684  $3,379  9%
   


 


   

 

Gross margin percentages were 62.0%In the first nine months of 2005, earnings from continuing operations before minority interest and 64.0%income taxes increased 9% to $3,684 million from $3,379 million in the first nine months of 2004. The $305 million increase included a $569 million gain on sale of the U.S. and Canadian Consumer Medicines business and related assets in the third quarter of 2005 and a $316 million gain in the first quarter of 2004 from the sale of the Adult Nutritional business. The increase was offset by higher spending on research and development and marketing, selling and administrative costs in 2005.

Pharmaceutical

Earnings before minority interest and income taxes decreased to $2,884 million in the first nine months of 2005 from $3,309 million in the first nine months of 2004.

Nutritional

Earnings before minority interest and income taxes increased to $494 million in the first nine months of 2005 from $466 million in the first nine months of 2004.

Related Healthcare

Earnings before minority interest and income taxes in the Related Healthcare segment decreased to $365 million in the first nine months of 2005 from $396 million in the first nine months of 2004. The $31 million decrease was primarily due to lower earnings in the Consumer Medicines business.

Income Taxes

The effective income tax rate on earnings from continuing operations before minority interest and income taxes was 20.5% in the first nine months of 2005 compared with 22.3% in the first nine months of 2004. The lower effective tax rate for the nine months ended September 30, 2004 and 2003, respectively. Gross margins were negatively impacted2005 was due primarily to a tax benefit associated with the release of contingency reserves resulting from the settlement of examinations by the Internal Revenue Service for the years 1998 through 2001, a change in 2004 dueestimate related to increased salesthe reduction of lower-margin productsa deferred tax provision established in the OTN segment, unfavorable mix and exclusivity losses infourth quarter of 2004 for special dividends under the U.S. pharmaceuticals business, product liability related to SERZONE,American Jobs Creation Act of 2004 (AJCA), partially offset by higher taxes on the sales growthsale of ABILIFY*, REYATAZthe Consumer Medicines business, lower foreign tax credits, and PLAVIX*.

the unfavorable treatment of certain litigation reserves. The Company has recorded valuation allowances for certain state net deferred tax assets, state net operating loss and tax credit carryforwards, foreign net operating loss and tax credit carryforwards, and charitable contribution carryforwards. The Company currently believes that the state net deferred tax assets, state net operating loss and tax credit carryforwards, foreign net operating loss and tax credit carryforwards, and charitable contribution carryforwards for which valuation allowances have been provided, more likely than not, will not be realized in the future. In the third quarter of 2005, as a result of the sale of the Consumer Medicines business and other changes in assumptions regarding future taxable profits, the Company recorded a net benefit of approximately $3 million in its tax provision associated with the reduction of its valuation allowance on certain deferred tax assets.

As a result of Temporary Regulations issued by the Internal Revenue Service, the Company is evaluating certain changes to its global legal entity structure and their effects on its projected effective tax rate for 2005 and beyond. Such changes are not expected to have a current cash income tax effect.

ExpensesNet Earnings

 

Total costs and expenses, excluding gain on saleNet earnings from continuing operations increased 11% in the first nine months of business, as a percentage2005 to $2,493 million from $2,239 million in the first nine months of sales, were 80.8%2004. In the first nine months of 2005, basic earnings per share from continuing operations increased 10% to $1.28 from $1.16 in the first nine months of 2004, comparedwhile diluted earnings per share from continuing operations increased 11% to 75.2%$1.27 from $1.14 in 2003.2004.

 

CostDiscontinued Operations

In May 2005, the Company completed the sale of products sold,OTN to One Equity Partners LLC for cash proceeds of $197 million. The Company recorded a pre-tax gain of $63 million ($13 million net of tax), presented as a percentagegain on sale of sales, increased to 38.0%discontinued operations in 2004 from 36.0% in 2003. This increase is primarily due to a $75 million increase in product liability reserve, as well as increased salesthe consolidated statement of lower margin products from OTN, the unfavorable impact of U.S. Pharmaceuticals sales mix, partially offset by the sales growth of ABILIFY, REYATAZ and PLAVIX. Cost of products sold also included $26 million of commercial litigation expense, $25 million of product liability insurance recovery and $70 million which consisted primarily of accelerated depreciation in 2004, and in 2003, a $46 million charge for asset impairments and accelerated depreciationearnings.

The following amounts related to the closure of manufacturing facilities in North America expected to be completed by the end of 2006.OTN business have been segregated from continuing operations and are reflected as discontinued operations for all periods presented:

   Three Months Ended
September 30,


  Nine Months Ended
September 30,


   2005

  2004

  2005

  2004

   (dollars in millions)

Net sales

  $—    $649  $1,015  $1,815

Earnings before income taxes

   —     5   (8)  16

Net (loss)/earnings from discontinued operations

   —     3   (5)  10

Developments

 

Marketing, selling and administrative expenses increased 8% to $3,655 million in 2004 from $3,398 million in 2003. As a percentage of sales, marketing, selling and administrative expenses increased to 22.8% inOn October 18, 2005, the first nine months of 2004 from 22.3% in 2003. The increase was primarily driven by increased sales and marketing supportFDA issued an approvable letter for in-line products, including additional sales representatives supporting ABILIFY*. In addition, the increase was also related to costs associated with the compliance with the Sarbanes-Oxley Act of 2002 and unfavorable foreign exchange driven by the strengthening of the euro.

Expenditures for advertising and product promotion in support of new and existing products were $987 in 2004 compared with $1,001 million in 2003, reflecting lower spending on in-line and non-exclusive products, mostly offset by increased spending on new products including ABILIFY*, ERBITUX* and REYATAZ.

Research and development expenditures increased 17% to $1,823 million in 2004 from $1,564 million in 2003. Pharmaceutical research and development spending increased 15% from the prior year and, as a percentage of pharmaceutical sales, was 14.7% in the first nine months of 2004 compared to 13.4% in the first nine months of 2003. This increase is primarily due to higher spending on new development projects, including new alliances, investments in late stage development and investments in the area of biologics, partially offset by Merck’s share of codevelopment costs related to muraglitazar. The increase also reflects the Company’s strategic focus on ten disease areas – oncology, HIV/AIDS, psychiatric disorders, atherosclerosis/thrombosis, diabetes, Alzheimer’s disease, hepatitis, obesity, rheumatoid arthritis and solid organ transplantation.

Acquired in-process research and development of $63 million relates to the purchase of Acordis, a U.K. based company which is expected to strengthen the Company’s leadership position in wound therapies.

Restructuring programs were implemented in the first nine months of 2004 to downsize and streamline worldwide operations. The programs include costsmuraglitazar, an investigational oral medicine for the terminationtreatment of approximately 1,270 selling, administrative, manufacturing and research and development personnel primarily intype 2 diabetes. The FDA has requested additional information from ongoing clinical trials to more fully address the Pharmaceuticals segment. As a resultcardiovascular safety profile of these actions, the Company expects the annual benefit to earnings before minority interest and income taxes to be approximately $142 million in future periods. The Company expects to substantially complete these activities by the end of 2004.muraglitazar. For additional information on restructuring, see “Item 1. Financial Statements—Note 3. Restructuring and Other Items.”

Litigation settlement expense/(income) were $404 million of expense in 2004 and $66 million of income in 2003. The $404 million of expense in 2004 consisted of $320 million related to private litigation and governmental investigations related to wholesaler inventory issues and accounting matters, $50 million related to the PLATINOL litigation settlement and $34 million related to pharmaceutical pricing and sales and practices. The $66 million of income in 2003 consisted of $30 million income for patent defense cost reimbursement, $27 million in litigation settlement income, $21 million from the settlement of the anti-trust litigation involving vitamin manufacturers, partially offset by $12 million in TAXOL/BUSPAR litigation settlement expense. For additional information on litigation, see “Item 1. Financial Statements—Note 15. Legal Proceedings and Contingencies.”

Gain on sale of business of $316 million in 2004 relates to the sale of the Mead Johnson Adult Nutritional business. The Company expects to record future adjustments to the gain upon the satisfaction of post-closing matters. For additional information on the sale of the Adult Nutritional business, see “Item 1. Financial Statements—Note 4. Acquisitions and Divestitures.”

Equity in net income of affiliates for the first nine months of 2004 and 2003 was $204 million and $124 million, respectively. Equity in net income of affiliates principally related to the Company’s joint venture with Sanofi and investment in ImClone. In 2004, the increase in equity in net income of affiliates primarily relates to higher net income in both the Sanofi joint venture and ImClone. For additional information on equity in net income of affiliates,approvable letter, see “Item 1. Financial Statements—Note 2. Alliances and Investments.”

 

Other expense, net was $62 million inIn September 2005, the first nine monthsFDA’s Arthritis Advisory Committee unanimously recommended approval of 2004 compared to $177 million in the first nine months of 2003. Other expense, net, includes interest expense, interest income, foreign exchange gains and losses, income from contract manufacturing, royalty income, and gains and losses on disposal of property, plant and equipment. The favorability was primarily due to higher

income from third party manufacturing, lower litigation settlements, higher insurance recoveries and lower net interest expense, partially offset by higher net foreign exchange losses.

ORENCIABusiness Segments®

Pharmaceuticals

Sales for the Pharmaceuticals segment in the nine months ended September 30, 2004 increased 5% (abatacept), including a 4% favorable foreign exchange impact, to $11,353 million from $10,843 million in 2003. Domestic pharmaceutical sales were $6,191 million in the first nine months of 2004 compared to $6,164 million in 2003. The domestic pharmaceutical business had increased sales of PLAVIX*, AVAPRO*/AVALIDE*, ABILIFY* and REYATAZ, and the launch of ERBITUX* in February 2004. This growth was offset by declining sales of PARAPLATIN, GLUCOVANCE*, GLUCHOPHAGE* XR and MONOPRIL due to lost exclusivity, CEFZIL and TEQUIN due to a weak flu season, PRAVACHOL due to increased competition, as well as ZERIT, COUMADIN and SERZONE. The Company recorded sales adjustments of $29 million for rebate claims from prior years by certain states, primarily in relation to Medicaid utilization of oncology products that states had not previously reported to the Company. The potential amount of such claims from other states cannot reasonably be estimated at this time.

International sales for the Pharmaceuticals segment increased 10% to $5,162 million in 2004, including a 9% favorable foreign exchange impact, from $4,679 million in 2003. Sales in Europe increased 11%, primarily due to a 10% favorable foreign exchange impact, partially offset by price declines in Germany, Italy and Spain. Japan realized sales growth of 7% primarily as a result of favorable foreign exchange. The growth was driven by AVAPRO*/AVALIDE*, PLAVIX*, SUSTIVA, the European launch of REYATAZ, analgesics in Europe and TAXOL in Japan.

The following table sets forth the reconciliation of the U.S. Pharmaceuticals’ gross sales to net sales by each significant category of gross-to-net sales adjustments:

   Nine Months Ended
September 30,


 
   2004

  2003

 

Gross Sales

  $8,237  $8,057 
   


 


Gross to Net Sales Adjustments

         

Prime Vendor Charge-Backs

   (892)  (820)

Managed Health Care Rebates and Other Contract Discounts

   (398)  (397)

Medicaid Rebates

   (468)  (376)

Cash Discounts

   (158)  (157)

Sales Returns

   (128)  (131)

Other Adjustments

   (2)  (12)
   


 


Total Gross to Net Sales Adjustments

   (2,046)  (1,893)
   


 


Net Sales

  $6,191  $6,164 
   


 


The gross-to-net sales adjustments for prime vendor charge-backs and Medicaid rebates increased to $892 million and $468 million in 2004, respectively, from $820 million and $376 million in 2003, respectively. These increases were primarily due to a shift in sales to products with higher discounts in prime vendor and Medicaid programs. No material revisions were made to the estimates for gross-to-net sales adjustments for the nine months ended September 30, 2004 and 2003.

Sales of selected products in the first nine months of 2004 were as follows:

Total revenue for ABILIFY* increased 98% to $402 million from $203 million in 2003.

Sales of ERBITUX* for the first nine months were $173 million.

Sales of PLAVIX* increased 43%, including a 2% favorable foreign exchange impact, to $2,368 million in 2004 from $1,659 million in 2003. Domestic sales of PLAVIX* increased 44% to $2,017 million in 2004 from $1,397 million in 2003 primarily due to strong prescription growth and the effect of the declines in wholesaler inventories in the first three months of 2003.

Sales of AVAPRO*/AVALIDE* increased 27%, including a 5% favorable foreign exchange impact, to $671 million in 2004 from $527 million in 2003.

Worldwide sales of PRAVACHOL decreased 8%, including a 5% favorable foreign exchange impact, to $1,925 million in 2004 from $2,098 million in 2003, largely due to increased competition from established brands and new entrants. PRAVACHOL sales in the U.S. were $987 million compared with the prior year at $1,198 million primarily due to a reduction in wholesaler inventory levels and an increased level of managed care rebates in 2004.

Sales of TAXOL and PARAPLATIN were $735 million and $646 million, respectively, compared to $695 million and $701 million, respectively in 2003. Sales of TAXOL, which are almost exclusively international, increased 6%, including favorable foreign exchange effect of 9%, to $735 million from $695 million in 2003, led by sales growth in Japan. Generic competition in the major European markets began in the second quarter and has increased in the third quarter of 2004. PARAPLATIN sales decreased by 8% to $695 million due to generic competition.

Sales of the GLUCOPHAGE* franchise decreased 61% to $283 million in 2004 from $723 million in 2003 due to generic competition.

Sales of SUSTIVA increased 11%, including a 5% favorable foreign exchange impact, to $449 million in 2004 from $405 million in 2003, primarily due to higher demand.

Sales of REYATAZ were $266 million. REYATAZ has achieved a 20% share of the protease inhibitor class sales in the initial launch markets.

Sales of VIDEX/VIDEX EC increased 4% to $207 million from $199 million in 2003, mainly due to a 6% favorable foreign exchange impact.

Sales of ZERIT were $205 million in 2004, a decrease of 26%, including a 4% favorable foreign exchange impact, from $278 million in 2003.

The following table sets forth a comparison of reported net sales changes and the estimated total prescription growth (for both retail and mail order customers) for certain of the Company’s U.S. pharmaceutical prescription products. The estimated prescription growth amounts are based on third-party data provided by IMS Health, a supplier of market research to the pharmaceutical industry. A significant portion of the Company’s domestic pharmaceutical sales is made to wholesalers. Where changes in reported net sales differ from prescription growth, this change in net sales may not reflect underlying prescriber demand.

   Nine Months Ended
September 30, 2004


  Nine Months Ended
September 30, 2003


 
   % Change in
U.S. Net Sales(a)


  % Change in
Total U.S.
Prescriptions(b)


  % Change in
U.S. Net Sales(a)


  % Change in
Total U.S.
Prescriptions(b)


 
   (unaudited) 

PLAVIX*

  44  26  21  29 

PRAVACHOL

  (18) (8) 23  2 

AVAPRO*/AVALIDE*

  26  16  21  14 

SUSTIVA

  4  5  10  19 

ABILIFY* (total revenue)

  91  127  *  * 

MONOPRIL

  (86) (76) 3  (14)

GLUCOVANCE*

  (49) (39) 85  5 

ZERIT

  (37) (29) (27) (23)

CEFZIL

  (30) (28) 14  (5)

COUMADIN

  (31) (18) 5  (14)

VIDEX/VIDEX EC

  (1) (1) (14) 3 

(a)Reflects change in net sales in dollar terms, compared with the same period in the prior year, including change in average selling prices and wholesaler buying patterns.

(b)Reflects change in total prescriptions in unit terms, compared with the same period in the prior year, based on third-party data.

Earnings before minority interest and income taxes for the Pharmaceuticals segment decreased to $3,282 million in the first nine months of 2004 from $3,318 million in 2003. The decrease in earnings before minority interest and income taxes was driven by gross margin erosion due to generic competition and product mix, additional sales representatives supporting ABILIFY*, higher spending in research and development, higher non-clinical grants and litigation settlement income in 2003, mostly offset by higher sales.

Oncology Therapeutics Network

Sales by OTN, a specialty distributor of third-party anti-cancer medicines and related products, increased 10% to $1,815 million in 2004 from $1,652 million in 2003. The lower growth rate compared to 2003 was due to competitive pricing pressures.

Earnings before minority interest and income taxes increased to $15 million in the first nine months of 2004 from $14 million in 2003 primarily due to margin erosion on certain major OTN products.

Nutritionals

Worldwide Nutritional sales were $1,496 million in 2004 compared to $1,497 million in 2003, with no impact from foreign exchange fluctuations. Excluding the Adult Nutritional business divested in February 2004, sales increased 9% to $1,457 million from $1,337 million in 2003, with no foreign exchange impact. Also excluding the Adult Nutritional business, international sales increased 14%, with no foreign exchange impact, from increased sales of infant formula and children’s nutritional products, while U.S. sales also increased 4%. Mead Johnson continues to be the leader in the U.S. infant formula market. For the nine months ended September 30, 2004 and 2003, the Nutritionals business recorded $633 million and $671 million, respectively, as a reduction to gross sales, for WIC rebate claims.

Earnings before minority interest and income taxes for the Nutritionals segment increased to $466 million in 2004 from $399 million in 2003, driven by increased global infant formula sales, price increase in the infant formula line, favorable manufacturing variances and tight operating expense management.

Other Healthcare

Sales in the Other Healthcare segment increased 11%, including a 5% favorable foreign exchange impact, to $1,374 million in 2004 from $1,237 million in 2003. The Other Healthcare segment is comprised of the ConvaTec, Medical Imaging and Consumer Medicines (United States and Japan) businesses.

ConvaTec sales for the nine months ended September 30, 2004 increased 14%, including an 8% favorable foreign exchange impact, to $688 million from $602 million in 2003. Sales of ostomy products increased 8% to $399 million in 2004 compared to prior year sales of $370 million. Sales of modern wound therapeutics products increased 24% to $280 million in 2004 compared to prior year sales of $225 million primarily due to the growth of the wound therapeutics market.

Medical Imaging sales for the nine months ended September 30, 2004, increased 15%, including a 1% favorable foreign exchange impact, to $435 million from $379 million in 2003. The increase in Medical Imaging sales was primarily due to a 22% increase in CARDIOLITE sales to $298 million in 2004 from $244 million in 2003. This increase was partially due to a change in the timing of revenue recognition as a result of new distribution agreements entered into in January 2004.

Consumer Medicines sales for the nine months ended September 30, 2004 decreased 2% to $251 million from $256 million in 2003, including a 2% favorable foreign exchange impact, primarily due to lower sales of BUFFERIN in Japan, mostly offset by increased sales of EXCEDRIN and other over-the-counter medications.

Earnings before minority interest and income taxes for the Other Healthcare segment increased to $423 million in 2004 from $298 million in 2003 primarily due to sales growth in the ConvaTec and Medical Imaging businesses, in addition to favorable pricing and product mix.

Developments

In October 2004, the Company announced the submission of a New Drug Application to the FDA for entecavir, an investigational antiviral agentselective modulator of T-cell co-stimulation under development for the treatment of chronic Hepatitis B. rheumatoid arthritis. The Company completed its submission of a Biologics License Application to the FDA for ORENCIA® in March 2005, and the original FDA action date of October 1, 2005 has been postponed to December 31, 2005.

In the European Union,August 2005, the Company alsoand ImClone announced that ImClone has submitted a marketing authorization application for entecavirsupplemental Biologics License Application to the European Medicines Evaluation Agency.

In September 2004,FDA for approval of ERBITUX*, an IgG1 monoclonal antibody in the FDA approved ABILIFY*treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). The application seeks U.S. marketing approval for the use of ERBITUX* in combination with radiation for locally or regionally advanced SCCHN, and as monotherapy in patients with recurrent and/or metastatic SCCHN where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate. ImClone has requested priority review of the application. ERBITUX* is currently indicated for the treatment of acute bipolar mania in the U.S.refractory metastatic colorectal cancer.

 

In September 2004, the Company terminated its licensing and commercialization agreement with Flamel Technologies S.A. to develop and market BAUSALIN.

In August 2004, the FDA approved the Company’s sNDA to include new long-term virologic and clinical data from BMS Study 006 in its prescribing information related to SUSTIVA (efavirenz). The new data demonstrate the long-term durability of virologic

response in people living with HIV-1 who are naïve to protease inhibitors, lamivudine (3TC) and non-nucleoside reverse transriptase inhibitors (NNRTI) through more than three years of treatment on a combination regimen containing SUSTIVA.

In July 2004, the FDA approved the Company’s supplemental New Drug Application (sNDA) to include new scientific data and dosing in its package insert or labeling related to REYATAZ. With the sNDA, the REYATAZ labeling now includes data indicating that combination HIV treatments containing REYATAZ/ritonavir and Kaletra (lopinavir/ritonavir; Abbott Laboratories, Inc.) were similar for the primary efficacy outcome measurement of time-averaged difference in change from baseline in HIV RNA level in HIV-infected patients previously taking anti-HIV medicines.

In June 2004, the FDA approved ImClone’s Chemistry, Manufacturing and Controls supplemental BLA for licensure of its BB36 manufacturing facility for ERBITUX*.

In June 2004, the Company and Otsuka announced that the European Commission has granted marketing authorization for ABILIFY* (aripiprazole), an antipsychotic medication, for the treatment of schizophrenia. Otsuka Pharmaceutical Europe Ltd., Otsuka’s European holding company, holds the marketing authorization for ABILIFY* in Europe. The Company and Otsuka currently copromote ABILIFY* in the United Kingdom and Germany, and will also copromote it in France and Spain. In addition, the Company also has an exclusive right to sell ABILIFY* in a number of other countries in Europe.

In May 2004, the Company entered into a worldwide codevelopment and cocommercialization agreement with Solvay Pharmaceuticals (Solvay) to codevelop and copromote the investigational compound SLV319 which is currently in Phase I development with potential for use in treating obesity and other metabolic disorders. The Company may also elect to develop and market two additional investigational compounds selected from Solvay’s pool of eligible compounds. The Company paid Solvay an upfront milestone payment of $10 million in July 2004, which was expensed as research and development. Further milestone payments are expected to be made upon the successful outcome of certain development and regulatory stages.

In April 2004, the Company entered into a collaboration agreement with Merck & Co., Inc. (Merck) for worldwide codevelopment and copromotion for muraglitazar, the Company’s dual PPAR (peroxisome proliferator activated receptor) agonist, currently in Phase III clinical development for use in treating Type 2 diabetes. Under the terms of the agreement, the Company received a $100 million upfront payment in May 2004, and is entitled to receive $275 million in additional payments upon the achievement of certain regulatory milestones. The Company and Merck will jointly develop the clinical and marketing strategy for muraglitazar, share equally in future development and commercialization costs and copromote the product to physicians on a global basis, with Merck to receive payments based on net sales levels. An NDA for muraglitazar is expected to be submitted to the FDA by the end of 2004 for U.S. regulatory approval.

In April, 2004, the Company and Pierre Fabre Medicament S.A. (Pierre Fabre), entered into an agreement to develop and commercialize JAVLOR* (vinflunine), a novel investigational anti-cancer agent. JAVLOR* is currently in Phase III clinical trials in Europe for the treatment of bladder and non-small cell lung cancer, and Phase II clinical trials in breast and ovarian cancer. Under the terms of the agreement, the Company received an exclusive license to JAVLOR* in the United States, Canada, Japan, Korea, and select Southeast Asian markets. Pierre Fabre will be responsible for the development and marketing of JAVLOR* in all other countries, including Europe. The agreement has been cleared under the Hart Scott Rodino Act. Under the agreement, the Company made and expensed an upfront payment of $25 million in the secondthird quarter of 2004, with the potential for an additional $185 million in milestone payments over time.

In April 2004, the Company announced the completion of the acquisition of Acordis, a privately held company based in the U.K. that licenses patent rights and supplies materials to ConvaTec for its Wound Therapeutics line. The newly acquired business will be incorporated as part of the Company’s ConvaTec division. This acquisition will enable ConvaTec to strengthen its position in the field of wound care management and continue to provide new treatment options for patients with acute or chronic wound care needs. See “Item 1. Financial Statements—Note 4. Acquisitions and Divestitures.”

In April 2004, the Company announced the creation within the Pharmaceutical Research Institute (PRI) of the Development Center of Excellence, which is intended to combine the pharmaceutical development and related manufacturing activities of PRI and Technical Operations in a single unit, with significant cost savings.

In March 2004, the Company announced that its Medical Imaging business entered into an agreement with Kereos, Inc. (Kereos) for the development and commercialization of novel molecular imaging agents. Under the terms of the agreement, the companies will work together to develop molecular imaging agents for cardiovascular diseases and cancer using Kereos’ core technology. Medical Imaging has obtained exclusive worldwide rights to develop and commercialize select cardiovascular molecular imaging agents for magnetic resonance imaging (MRI). Kereos has obtained exclusive worldwide rights to use a family of Medical Imaging targeting molecules with Kereos’ core technology to develop and commercialize molecular cancer imaging agents and targeted therapeutics, including KI-001 — Kereos’ lead candidate for early MRI detection of tumors.

In February 2004, the FDA approved the Biologics License Application (BLA) for ERBITUX*, the anticancer agent that the Company is developing in partnership with ImClone. ERBITUX* Injection is for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. In accordance with the agreement, the Company paid ImClone $250 million in March 2004 as a milestone payment for the approval of ERBITUX* by the FDA. An additional $250 million is payable upon FDA approval for use in treating an additional tumor type. Sales recorded for ERBITUX* were $173 million since its approval by the FDA in February 2004.

The Company is the exclusive distributor of ERBITUX* in North America through OTN. Under the terms of an agreement with McKesson, McKesson provides OTN with warehousing, packing and shipping for filling orders for ERBITUX*. To maintain the integrity of the product, special storage conditions and handling are required. Accordingly, all sales of ERBITUX*, including purchase requests from other wholesalers, are processed through OTN, and McKesson will only ship ERBITUX* to end-users of the product and not to other intermediaries to hold for later sales. Either the Company or McKesson may unilaterally terminate the agreement on not less than six months prior notice to the other party.

In February 2004, Mead Johnson, a wholly owned subsidiary of2005, the Company completed the sale of its Adult NutritionalU.S. and Canadian Consumer Medicines business brands,and related assets (Consumer Medicines) to Novartis AG (Novartis). Under the terms of the agreement, Novartis acquired the trademarks, patents and intellectual property rights of Consumer Medicines for $661 million in cash, of which $15 million is attributable to Novartis for $387 million, including $20 million contingent ona post-closing supply arrangement between the achievement of contractual requirementsCompany and a $22 million upfront payment for a supply agreement.Novartis. The related assets include the rights to the U.S. Consumer Medicines brands in Latin America, Europe, the Middle East and Africa. As a result of this transaction, the Company recorded a pre-tax gain of $316$569 million ($370 million net of tax) in the first nine monthsthird quarter of 2004. The Company will record future adjustments to the gain upon the satisfaction of the contractual requirements and other post-closing matters. In 2003, adult nutritional products recorded sales of over $200 million.2005.

 

Financial Position, Liquidity and Capital Resources

 

Cash, cash equivalents and marketable debt securities totaled approximately $7.3$3.8 billion at September 30, 20042005 compared to $5.5$7.5 billion at December 31, 2003.2004. The Company continues to maintain a highsufficient level of working capital, which was $4.8approximately $3.5 billion and $5.0 billion at September 30, 2004, increasing from $4.3 billion at2005 and December 31, 2003. Substantially all of such cash, cash equivalents and marketable securities were held by the Company’s foreign subsidiaries. Congress recently approved the American Jobs Creation Act of 2004, (the “Act”), which would allow the Company to elect to deduct from its taxable income 85% of certain eligible dividends received by the Company from non-U.S. subsidiaries before the end ofrespectively. In 2005 if those dividends are reinvested in the U.S. for eligible purposes. The Company estimates that up to approximately $9 billion in dividends from its non-U.S. subsidiaries could potentially be eligible for this deduction. The Company is currently evaluating the amount of such eligible dividends that its non-U.S. subsidiaries will remit. Use of the proceeds is subject to the pending resolution of certain matters and the issuance of further guidance from the Department of the Treasury. In 2004 and future periods, the Company expects cash generated by its U.S. operations, together with existing cash and borrowings from the capital markets, to sufficiently cover cash needs for working capital, capital expenditures, milestone payments and dividends paid in the United States. Cash and cash equivalents, marketable securities, the conversion of other working-capital items and borrowings are expected to fund near-term operations.

 

In the fourth quarter of 2004, the Company disclosed that it anticipated repatriating approximately $9 billion in special dividends in 2005 and recorded a $575 million provision for deferred taxes pursuant to the American Jobs Creation Act of 2004 (AJCA) as enacted and other pending matters. In the first quarter of 2005, the Company repatriated approximately $6.2 billion in special dividends from foreign subsidiaries and will repatriate the remainder of the $9 billion in the fourth quarter of 2005. The Company expects that it will use the special dividends in accordance with requirements established by the U.S. Treasury Department. During the second quarter of 2005, the U.S. Treasury Department issued AJCA related guidance clarifying that the “gross-up” for foreign taxes associated with the special dividends also qualifies for the 5.25% tax rate established by the AJCA. As a result of this guidance, the Company reduced the $575 million provision by recording a benefit of approximately $135 million in its tax provision for the second quarter of 2005. Except for earnings associated with the special dividends discussed above, U.S. income taxes have not been provided on the balance of unremitted earnings of non-U.S. subsidiaries, since the Company has invested or expects to invest such earnings permanently offshore.

Cash and cash equivalents at September 30, 20042005 primarily consisted of U.S. dollar denominated bank deposits with an original maturity of three months or less. Marketable securities at September 30, 20042005 primarily consisted of U.S. dollar denominated floating rate instruments with an ‘AAA/Aaa’aaa’ credit rating. Due to the nature of these instruments, the Company considers it reasonable to expect that their fair market values will not be significantly impacted by a change in interest rates, and that they can be liquidated for cash at short notice.

 

Short-term borrowings were $1,650$277 million at September 30, 2004,2005, compared with $127$1,883 million at December 31, 2003,2004, primarily as a result of the issuanceretirement of commercial paper.

 

Long-term debt remained constant at $8.5was $5.9 billion at September 30, 2004 and2005 compared to $8.5 billion at December 31, 2003.2004. During the second quarter of 2005, the Company repurchased all of its outstanding $2.5 billion aggregate principal amount 4.75% Notes due 2006, and incurred an aggregate pre-tax loss of approximately $69 million in connection with the early redemption of the Notes and termination of related interest rate swaps. The Moody’s Investors Service (Moody’s) long-term and short-term credit ratings for the Company are currently A1 and Prime-1, respectively. On November 1, 2005, Moody’s placed the long-term creditA1 senior rating remains on negative outlook. On August 16, 2004,of the Company’s debt under review for possible downgrade, while affirming the short-term Prime-1 rating. Standard & Poor’s (S&P) downgraded thelong-term and short-term credit ratingratings for the Company to A1are currently A+ and the long-term credit rating of the Company to A+.A-1, respectively. S&P’s long-term credit rating remains on negative outlook. Fitch Ratings Ltd. (Fitch) long-term and short-term credit ratings for the Company are currently A+ and F1, respectively. On September 16, 2005, Fitch’s long-term credit rating on the Company was changed from negative to stable outlook.

 

In August 2005, a wholly-owned subsidiary of the Company entered into a new $2.5 billion term loan facility with a syndicate of lenders. Borrowings under this facility will be guaranteed by the Company, the subsidiaries of the borrower and by certain European subsidiaries of the Company. This facility contains a five-year tranche of up to $2.0 billion and a two-year tranche of up to $500 million. The Company is subject to substantially the same covenants as those included in its December 2004 Revolving Credit facility. The Company is also subject to further restrictions, including certain financial covenants. Prior to borrowing any proceeds against the facility, the Company obtained a waiver from the lenders for a covenant default under this facility due to a one-time intercompany distribution. In October 2005, the Company, through its subsidiary, borrowed $2 billion against this facility.

The following is a discussion of working capital and cash flow activities:

   September 30,
2005


  December 31,
2004


 
   (dollars in millions) 

Working capital

  $3,523  $4,958 
   Nine Months Ended
September 30,


 
   2005

  2004

 
   (dollars in millions) 

Cash flow provided by/(used in):

         

Operating activities

  $1,511  $2,493 

Investing activities

   2,514   (1,509)

Financing activities

   (5,562)  (97)

The decrease in working capital of $1,435 million from December 31, 2004 to September 30, 2005 was primarily due to: a reduction in net cash (cash, cash equivalents and marketable securities less short-term borrowings) primarily used for the early redemption of the $2.5 billion Notes; lower receivables resulting from collection of foreign withholding taxes and lower sales volume; higher reserves for litigation matters; and unfavorable translation impact due to the strengthening of the U.S. Dollar; partially offset by lower accrued liability for royalties, product liability and lower unrealized losses from derivatives resulting from the weakening of the Euro; reduction in income taxes payable resulting from payments related to the repatriation of special dividends under the AJCA; and higher inventories due to increased demand of newer products and existing key brands.

Net cash provided by operating activities was $2.5 billion$1,511 million in the nine months ended September 30, 2004 as compared to $2.3 billion in 2003. The increase in net cash provided by operating activities for 2004 is mainly attributable to effective management of working capital, partially offset by lower earnings. The significant changes in working capital between the first nine months of 2004 compared to2005 and $2,493 million in the first nine months of 20032004. The $982 million decrease is mainly attributable to lower earnings and higher usage of working capital. The significant changes in operating assets and liabilities between 2005 and 2004 are: a $339$926 million decrease in receivablesincome tax payable primarily due to an improvement in the collection of customer receivables; a $348 million decrease in deferred revenue on consigned inventory duerelated to the workdownsettlement of examinations by the consignment inventory in 2003;Internal Revenue Service for the years 1998 through 2001 and the payment of taxes related to the repatriation of special dividends under the AJCA; a $272$611 million decrease in accounts payable and accrued expenses including royalties, advertising and promotion, deferred revenue for ABILIFY*, milestoneprimarily due to vendor payments and higher purchasing activities in the fourth quarter of 2003.

Net cash used in investing activities was $1.5 billion in the nine months ended September 30, 2004 comparedprior to $1.4 billion in 2003. The increase in net cash flow used in investing activities is mainly attributable to a milestone payment of $250 million to ImClone, $150 million payment for the Acordis acquisition and increased investment in marketable securities offset by $365 million cash proceeds from the sale of the Company’s Adult Nutritional business.

OTN business and lower accrued rebates and returns, interest and royalties; a $178 million increase in inventories due to the growth of newer products and in anticipation of new product launches; and a $857 million decrease in receivables primarily due to lower sales volume and foreign withholding taxes.

 

Net cash provided by investing activities was $2,514 million in the first nine months of 2005 compared to net cash used of $1,509 million in the first nine months of 2004. The $4,023 million increase is attributable to the sale of marketable securities in 2005, proceeds from sale of the Consumer Medicines business for $646 million in 2005 and a one time $250 million milestone payment to ImClone in 2004.

Net cash used in financing activities decreased by $481was $5,562 million in the first nine months of 2005 and $97 million in the first nine months of 2004. The $5,465 million decrease was mainly attributable to an increase in short term borrowings in 2004 offset by the issuanceretirement of convertiblecommercial paper and long-term debt in 2003. 2005.

During the nine months ended September 30, 20042005 and 2003,2004, the Company did not purchase any of its common stock.

 

For each of the three and nine month periods ended September 30, 20042005 and 2003,2004, dividends declared per common share were $.28 and $.84, respectively. The Company paid $544$549 million and $1,630$1,639 million in dividends for the three and nine months of 20042005 and $543$544 million and $1,627$1,630 million for the three and nine months of 2003,2004, respectively. Dividend decisions are made on a quarterly basis by the Board of Directors.

 

Contractual Obligations

 

For a discussion of the Company’s contractual obligations, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s 20032004 Form 10-K/A. In September10-K.

SEC Consent Order and Deferred Prosecution Agreement

As previously disclosed, on August 4, 2004, the Company committedentered 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 10s to $14 million of advertising expenditures to be incurred in the fourth quarter ofCompany’s quarterly report on Form 10-Q for the period ended September 30, 2004.

 

Retirement BenefitsUnder the terms of the Consent, the Company has agreed, subject to certain defined exceptions, to limit sales of all products sold to its 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. The Company has also agreed in the Consent to certain measures that it has implemented including: (a) establishing a formal review and certification process of its 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 the Company’s 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 the Company’s budget process gives appropriate weight to inputs that come from the bottom to the top, and not just those that come from the top to the bottom, and adequately documenting that process.

 

For a discussionFurther, the Company agreed in the Consent to retain an “Independent Adviser” through the date that the Company’s Form 10-K for the year ended 2005 is filed with the SEC. The Consent defines certain powers and responsibilities of the Independent Adviser. The Consent includes a process for the Independent Adviser to make recommendations regarding the Company’s retirement benefits, see “Item 7. Management’scompliance with applicable federal securities laws and corporate obligations. The Company has agreed in the Consent to adopt the Independent Adviser’s recommendations regarding compliance with applicable federal securities laws and corporate obligations.

As previously disclosed, on June 15, 2005, the Company entered into a Deferred Prosecution Agreement (DPA) with the United States Attorney’s Office (USAO) for the District of New Jersey resolving the investigation by USAO of the Company relating to wholesaler inventory and various accounting matters covered by the Company’s settlement with the SEC. Pursuant to the DPA, the USAO filed a criminal complaint against the Company alleging conspiracy to commit securities fraud, but will defer prosecution of the Company and dismiss the complaint after two years if the Company satisfies all of the requirements of the DPA. A copy of the DPA was filed as Exhibit 99.2 to a Form 8-K filed by the Company on June 16, 2005 and is incorporated by reference hereto as Exhibit 10w.

Under the DPA, among other things, the Company has agreed to include in its Forms 10-Q and 10-K filed with SEC and in its annual report to shareholders the following information: (a) estimated wholesaler/direct customer inventory levels of the top fifteen (15) products sold by the U.S. Pharmaceuticals business; (b) for major non-U.S. countries, estimated aggregate wholesaler/direct-customer inventory levels of the top fifteen (15) pharmaceutical products sold in such countries taken as a whole measured by aggregate annual sales in such countries; (c) arrangements with and policies concerning wholesaler/direct customers and other distributors for these products, including efforts by the Company to control and monitor wholesaler/distributor inventory levels; and (d) data concerning prescriptions or other measures of end-user demand for these products. Pursuant to the DPA, the Company also will include in such filings and reports information on acquisition, divestiture, and restructuring reserve policies and activity, and rebate accrual policies and activity.

Under the DPA, the Company also agreed to implement remedial measures already undertaken or mandated in the Consent and in the settlements of the derivative litigation and the federal securities class action relating to wholesaler inventory and various accounting matters. In addition, the Company agreed to undertake additional remedial actions, corporate reforms and other actions, including: (a) appointing an additional non-executive Director acceptable to the USAO; (b) establishing and maintaining a training and education program on topics that include corporate citizenship and financial reporting obligations; (c) making an additional $300 million payment into the shareholder compensation fund established in connection with the Consent; (d) not engaging in or attempting to engage in any criminal conduct as that term is defined in the DPA; (e) continuing to cooperate with the USAO, including with respect to the ongoing investigation regarding individual current and former employees of the Company; and (f) retaining an independent Monitor. Also as part of the DPA, the Board of Directors separated the roles of Chairman and Chief Executive Office of the Company and on June 15, 2005, elected a Non-Executive Chairman.

The independent Monitor, who also serves as the Independent Advisor pursuant to the Consent, has defined powers and responsibilities under the DPA, including the responsibility to oversee at least through April 2007, the Company’s compliance with all of the terms of the DPA, the Consent and the settlements of the derivative action and the federal securities class action. The Monitor has the authority to require the Company to take any steps he believes necessary to comply with the terms of the DPA and the Company is required to adopt all recommendations made by the Monitor, unless the Company objects to the recommendation and

the USAO agrees that adoption of the recommendation should not be required. In addition, the independent Monitor will report to the USAO, on at least a quarterly basis, as to the Company’s compliance with the DPA and the implementation and effectiveness of the internal controls, financial reporting, disclosure processes and related compliance functions of the Company.

The Company has established a company-wide policy to limit its 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 will be monitored on a regular basis.

The Company maintains inventory management agreements (IMAs) with most of its U.S. pharmaceutical wholesalers which account for nearly 100% of total gross sales of U.S. pharmaceutical products. Under the current terms of the IMAs, the Company’s three largest wholesaler customers provide the Company with weekly information with respect to months on hand product level inventories and the amount of out-movement of products. These three wholesalers currently account for over 90% of total gross sales of U.S. pharmaceutical products. The inventory information received from these wholesalers, together with the Company’s internal information, is used to estimate months on hand product level inventories at these wholesalers. The Company estimates months on hand product inventory levels for its U.S. Pharmaceutical business’s wholesaler customers other than the three largest wholesalers by extrapolating from the months on hand calculated for three largest wholesalers. The Company considers whether any adjustments are necessary to these extrapolated amounts based on such factors as historical sales of individual products made to such other wholesalers and third-party market research data related to prescription trends and patient demand. In contrast, for the Company’s Pharmaceutical business outside of the United States, Nutritionals and Related Healthcare business units around the world, the Company has 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, the Company relies on a variety of methods to estimate months on hand product level inventories for these business units.

The Company will disclose for each of its top fifteen (15) pharmaceutical products sold by the U.S. Pharmaceutical business (based on 2004 net sales) the amount of net sales and the estimated number of months on hand in the U.S. wholesaler distribution channel as of the end of the immediately preceding quarter and as of the end of the applicable quarter in its quarterly and annual reports on Forms 10-Q and 10-K. This information for the quarter ended September 30, 2005 is included in Management Discussion and Analysis in this Form 10-Q. The Company will disclose corresponding information for the top fifteen (15) pharmaceutical products sold within its major non-U.S. countries, as described above. For all other business units, the Company will continue to disclose on a quarterly basis the key product level inventories. The information required to estimate months on hand product level inventories in the direct customer distribution for the non-U.S. Pharmaceutical businesses is not available prior to the filing of Financial Conditionthe quarterly report on Form 10-Q for an applicable quarter. Accordingly, the Company will disclose this information on its website approximately 60 days after the end of the applicable quarter, and Results of Operations” in the Company’s 2003 Form 10-K/A.10-Q for the following quarter. Information for these products for the quarter ended September 30, 2005 is expected to be disclosed on the Company’s website on or about November 30, 2005 and in the Company’s Form 10-K for the quarter ended December 31, 2005. In addition to the foregoing quarterly disclosure, the Company will include all the foregoing information for all business units for each quarter in its Annual Report on Form 10-K. For non-key products, if the inventory at direct customers exceeds approximately one month on hand, the Company will disclose the estimated months on hand for such product(s), except where the impact on the Company is de minimis.

The Company has and will continue to enhance its methods to estimate months on hand product inventory levels for the U.S. Pharmaceutical business and for the non-U.S. Pharmaceutical businesses around the world, taking into account the complexities described above. The Company also has and will continue to take steps to expedite the receipt and processing of data for the non-U.S. Pharmaceutical businesses.

The Company believes the above-described procedures provide a reasonable basis to ensure compliance with both the Consent Order and the DPA and provides sufficient information to comply with disclosure requirements of both.

 

Critical Accounting Policies

 

For a discussion of the Company’s critical accounting policies, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s 20032004 Form 10-K/A.10-K.

 

The Company prepares its financial statements in conformity with accounting principles generally accepted in the United States. The preparation of financial statements in conformity with 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. The Company’s critical accounting policies are those that are both most important to the Company’s 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. Because of the uncertainty of factors surrounding the estimates or judgments used in the preparation of the consolidated financial statements, actual results may vary from these estimates.

The Company believes that the following discussion of its revenue recognition policy and significant gross to net sales adjustments, together with the other critical accounting policies previously disclosed in the Company’s Form 10-K/A for the year ended December 31, 2003, represents its critical accounting policies. For a discussion of the Company’s other critical accounting policies, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form 10-K/A for the year ended December 31, 2003. Management and the Company’s independent registered public accounting firm have discussed the Company’s critical accounting policies with the Audit Committee of the Board of Directors.

Revenue Recognition

The Company recognizes revenue in accordance with SAB No. 101,Revenue Recognition in Financial Statements, as amended by SAB No. 104,Revenue Recognition. The Company’s accounting policy for revenue recognition has a substantial impact on its reported results and relies on certain estimates that require difficult, subjective and complex judgments on the part of management. The Company recognizes revenue for sales when substantially all the risks and rewards of ownership have transferred to the customer, which generally occurs on the date of shipment, with the exceptions described below.

Certain transactions with the Company’s U.S. Pharmaceuticals wholesalers are accounted for using the consignment model. In the case of sales made to wholesalers (1) as a result of incentives, (2) in excess of the wholesaler’s ordinary course of business inventory level, (3) at a time when there was an understanding, agreement, course of dealing or consistent business practice that the Company would extend incentives based on levels of excess inventory in connection with future purchases and (4) at a time when such incentives would cover substantially all, and vary directly with, the wholesaler’s cost of carrying inventory in excess of the

wholesaler’s ordinary course of business inventory level, substantially all the risks and rewards of ownership do not transfer upon shipment and, accordingly, such sales should be accounted for using the consignment model. The determination of when, if at all, sales to a wholesaler meet the foregoing criteria involves evaluation of a variety of factors and a number of complex judgments. Under the consignment model, the Company does not recognize revenue upon shipment of product. Rather, upon shipment of product the Company invoices the wholesaler, records deferred revenue at gross invoice sales price and classifies the inventory held by the wholesalers as consignment inventory at the Company’s cost of such inventory. The Company recognizes revenue (net of the gross to net sales adjustments discussed below, all of which involve significant estimates and judgments) when the consignment inventory is no longer subject to the incentive arrangements described above, but not later than when such inventory is sold through to the wholesalers’ customers, on a FIFO basis.

Sales of the Company’s oncology products through OTN are also accounted for on a consignment basis. OTN uses a third-party distributor to ship these products to its customers. Upon shipment of the products to the distributor, the Company records deferred revenue at gross invoice sales price and classifies the inventory held by the distributor as consignment inventory at the Company’s cost of such inventory. The Company recognizes the revenue (net of the gross to net sales adjustments discussed below, all of which involve significant estimates and judgments) when the consignment inventory is sold to OTN’s customer.

In the case of new products for which the product introduction is not an extension of an existing line of product or where the Company has determined that there are not products in a similar therapeutic category, such that the Company cannot reliably estimate expected returns of the new product, the Company defers recognition of revenue until the right of return no longer exists or until the Company has developed sufficient historical experience to estimate sales returns.

Revenues of the Nutritionals and Other Healthcare segments and certain non-U.S. businesses within the Pharmaceuticals segment are recognized on the date of receipt by the purchaser.

Gross to Net Sales Adjustments

The Company has the following significant categories of gross to net sales adjustments which impact the Company’s four reportable segments: prime vendor charge-backs, WIC rebates, managed health care rebates and other contract discounts, Medicaid rebates, cash discounts, sales returns and other adjustments, all of which involve significant estimates and judgments and require the Company to use information from external sources. The Company accounts for these gross to net sales adjustments in accordance with EITF Issue No. 01-9,Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products), and SFAS 48,Revenue Recognition When Right of Return Exists (SFAS 48), as applicable.

Prime vendor charge-backs

The Company’s U.S. businesses participate in prime vendor 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 whereby pricing on products is extended below wholesaler list price to participating entities. These entities purchase products through wholesalers at the lower prime vendor price, and the wholesalers charge the difference between their acquisition cost and the lower prime vendor price back to the Company. The Company accounts for prime vendor charge-backs by reducing accounts receivable in an amount equal to the Company’s estimate of charge-back claims attributable to a sale. The Company determines its estimate of the prime vendor charge-backs primarily based on historical experience regarding prime vendor charge-backs and current contract prices under the prime vendor programs. The Company considers prime vendor payments, levels of inventory in the distribution channel and the Company’s claim processing time lag and adjusts the reduction to accounts receivable periodically throughout each quarter to reflect actual experience.

WIC rebates

The Company’s U.S. Nutritionals business participates on a competitive bidding basis in nutrition programs sponsored by states, tribal governments, the Commonwealth of Puerto Rico and the Territory of Guam for women, infants and children (WIC). Under these programs, the Company reimburses these entities for the difference between wholesaler list price and the contract price on eligible products. The Company accounts for WIC rebates by establishing an accrual in an amount equal to the Company’s estimate of WIC rebate claims attributable to a sale. The Company determines its estimate of the WIC rebate accrual primarily based on historical experience regarding WIC rebates and current contract prices under the WIC programs. The Company considers levels of inventory in the distribution channel, new WIC contracts, terminated WIC contracts, changes in existing WIC contracts and WIC participations and adjusts the accrual periodically throughout each quarter to reflect actual experience.

Managed health care rebates and other contract discounts

The Company offers rebates and discounts to managed health care organizations in the U.S., and globally to other contract counterparties such as hospitals and group purchasing organizations. The Company accounts for managed health care rebates and other contract discounts by establishing an accrual in an amount equal to the Company’s estimate of managed health care rebates and other contract discounts attributable to a sale. The Company determines its estimate of the managed health care rebates and other contract discounts accrual primarily based on historical experience regarding these rebates and discounts and current contract prices. The Company considers the sales performance of products subject to managed health care rebates and other contract discounts and levels of inventory in the distribution channel and adjusts the accrual periodically throughout each quarter to reflect actual experience.

Medicaid rebates

The Company’s U.S. businesses participate in state government-managed 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. Discounts and rebates provided through these latter programs are included in the Company’s Medicaid rebate accrual and are considered Medicaid rebates for the purposes of this discussion. The Company accounts for Medicaid rebates by establishing an accrual in an amount equal to the Company’s estimate of Medicaid rebate claims attributable to a sale. The Company determines its estimate of the Medicaid rebates accrual primarily based on historical experience regarding Medicaid rebates, as well as any expansion on a prospective basis of its participation in the non-mandatory aspects of the qualifying federal and state government programs, legal interpretations of the applicable laws related to the Medicaid and qualifying federal and state government programs and any new information regarding changes in the Medicaid programs’ regulations and guidelines that would impact the amount of the rebates. The Company considers outstanding Medicaid claims, Medicaid payments and levels of inventory in the distribution channel and adjusts the accrual periodically throughout each quarter to reflect actual experience.

[The Company, together with a number of other pharmaceutical manufacturers, also has received subpoenas and other document requests from various government agencies seeking records relating to its pricing, sales and marketing practices, and “Best Price” reporting for drugs covered by Medicare and/or Medicaid. In mid-2003, the Company initiated an internal review of certain of its sales and marketing practices, focusing on whether these practices comply with applicable anti-kickback laws and analyzing these practices with respect to compliance with (1) Best Price reporting and rebate requirements under the Medicaid program and certain other U.S. governmental programs, which reference the Medicaid rebate program and (2) applicable FDA requirements. The Company is also analyzing its past and proposed systems for calculating prices for reporting under governmental rebate and pricing programs. The results of this analysis have identified the need for revisions to the calculation system methodology and processes used for calculating past rebate amounts and reported pricing. The Company’s methodology review is substantially complete. Based on the results of the Company’s analysis to date, the Company has recorded a liability equal to the estimated additional rebate liability resulting from these revisions. This estimated additional liability, which was not material, primarily resulted from errors in accounting. The Company’s analysis is ongoing. The Company also has strengthened its internal controls over these calculations to remediate the processes and procedures the Company believes resulted in these proposed revisions. For additional information, see “Note 15. Legal Proceedings and Contingencies — Pricing, Sales and Promotional Practices Litigation and Investigations.”]

Cash Discounts

In the U.S. and some other countries, the Company offers cash discounts, generally approximately 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the full amount of the discounts. The Company considers payment performance and adjusts the accrual to reflect actual experience.

Sales Returns

The Company accounts for sales returns in accordance with SFAS 48, by establishing an accrual in an amount equal to the Company’s estimate of sales recorded but for which the related products are expected to be returned.

For returns of established products, the Company determines its estimate of the sales return accrual primarily based on historical experience regarding sales returns but also considers other factors that could impact sales returns. These factors include levels of inventory in the distribution channel, estimated shelf life, product recalls, product discontinuances, price changes of competitive products, introductions of generic products and introductions of competitive new products. The Company considers sales returns and these other factors and adjusts the accrual periodically throughout each quarter to reflect actual experience.

The Company considers the level of inventory in the distribution channel and determines whether it believes an adjustment to the sales return accrual is appropriate. For example, if levels of inventory in the distribution channel increase, the Company analyzes

the reasons for the increase and if the reasons indicate that sales returns will be larger than expected, the Company adjusts the sales return accrual, taking into account historical experience, the Company’s returned goods policy and the shelf life of the Company’s products, which ranges, on average, from approximately 12 to 48 months. In situations where the Company is aware of products in the distribution channel nearing their expiration date, the Company analyzes the situation and if the analysis indicates that sales returns will be larger than expected, the Company adjusts the sales return accrual, taking into account historical experience, the Company’s returned goods policy and levels of inventory in the distribution channel.

In the event of a product recall or product discontinuance, the Company considers the reasons for and impact of such actions and adjusts the sales return accrual as appropriate, taking into account historical experience, levels of inventory in the distribution channel and, for product discontinuances, estimates of continuing demand.

Although the Company considers price changes of competitive products, introductions of generic products and introductions of competitive new products, the Company generally does not believe that these factors impact sales returns based on historical experience and the Company’s returned goods policy.

For returns from new products, which are significantly more difficult for the Company to assess, the Company determines its estimate of the sales return accrual primarily based on the historical sales returns experience of similar products, such as those within the same line of product or those within the same or similar therapeutic category. In limited circumstances, where the new product is not an extension of an existing line of product or where the Company has no historical experience with products in a similar therapeutic category, such that the Company cannot reliably estimate expected returns of the new product, the Company defers recognition of revenue until the right of return no longer exists or until the Company has developed sufficient historical experience to estimate sales returns. The Company also considers the shelf life of new products and determines whether it believes an adjustment to the sales return accrual is appropriate. The shelf life in connection with new products tends to be shorter than the shelf life for more established products because the Company may still be developing an optimal manufacturing process for the new product that would lengthen its shelf life or an amount of launch quantities may have been manufactured in advance of the launch date to ensure sufficient supply exists to satisfy market demand. In those cases, the Company assesses the reduced shelf life, together with levels of inventory in the distribution channel and projected demand, and determines whether it believes an adjustment to the sales return accrual is appropriate.

Other adjustments

In addition to the significant gross to net sales adjustments described above, the Company makes other gross to net sales adjustments. For example, the Company offers sales discounts, most significantly in its non-U.S. businesses, and also offers consumer coupons and rebates, most significantly in its U.S. Nutritionals, Consumer Medicines and Pharmaceuticals businesses. In addition, in a number of countries outside the U.S., including major European countries, the Company provides rebates to government entities. The Company generally accounts for these other gross to net adjustments by establishing an accrual in an amount equal to the Company’s estimate of the adjustments attributable to a sale. The Company generally determines its estimates of the accruals for these other gross to net sales adjustments primarily based on historical experience, performance on commitments to government entities and other relevant factors, including levels of inventory in the distribution channel in some cases, and adjusts the accruals periodically throughout each quarter to reflect actual experience.

Use of Information from External Sources

The Company uses information from external sources to estimate its significant gross to net sales adjustments. The Company’s estimates of inventory at the wholesalers and deferred revenue on consigned inventory are based on the projected prescription demand-based sales for its products and historical inventory experience, as well as the Company’s 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 the Company’s internal information. The inventory information received from wholesalers is a product of their record-keeping process and excludes inventory held by intermediaries to whom they sell, such as retailers and hospitals. The Company receives information from IMS Health, a supplier of market research to the pharmaceutical industry, which it uses to project the prescription demand-based sales for many of its U.S. Pharmaceutical products. The Company also uses information from external sources to identify prescription trends, patient demand and average selling prices. The Company’s 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 the Company receives third-party information.

Outlook

 

As previously disclosed, the Company expects substantial incremental sales losses in each of 2005, 2006 and 2007 representing continuing declines in sales of the products that lost or will lose exclusivity protection in 2003 and 2004 and additional declines attributable to products that will lose exclusivity protection primarily in 2005 and 2006. These products (and the years in which they lose exclusivity protection) include GLUCOPHAGE*/GLUCOVANCE*/GLUCOPHAGE* XR in the United States (2002 to 2004), TAXOL in Europe (2003), MONOPRIL in the United States and Canada (2003), PRAVACHOL in the United States (2006) and in Europe (2002 to 2007), PARAPLATIN in the United States (2004), MONOPRIL in Europe (2001 to 2008), ZERIT in the United States (2008) and in Europe (2007 to 2011), CEFZIL in the United States (2005) and in Europe (2004 to 2009) and VIDEX/VIDEX EC (2004 to 2009—the Company has a patent license expiring in 2007, the license became non-exclusive in 2001 though no other licenses have yet been granted). The timing and amounts of sales reductions from exclusivity losses, their realization in particular periods and the eventual levels of remaining sales revenues are uncertain and dependent on the levels of sales at the time exclusivity protection ends, the timing and degree of development of generic competition (speed of approvals, market entry and impact) and other factors.

The Company also expects to have growth opportunities during this period. These opportunities include growth from its in-line and recently launched products, primarily PLAVIX*, AVAPRO*/AVALIDE*, ABILIFY*, REYATAZ and ERBITUX* and the Company’s compounds in late stage development, subject to marketing approval from regulatory authorities, which include muraglitazar, a dual PPAR agonist for diabetes, abatacept, for rheumatoid arthritis, and entecavir, for hepatitis B. Expectations of continued sales growth are subject to the outcome of the previously disclosed PLAVIX* patent litigation, competitive factors including those relating to PRAVACHOL discussed below and risks of product development and regulatory approval.

Althoughalthough anticipated sales declines due to continued exclusivity losses during 2005 and 2006 are expected to be more or less offset by growth in sales of the Company’s in-line, recently launched and potential new products during the same period, changes in product mix will adversely impact gross margins because the products that have lost or are expected to lose exclusivity generally have higher margins. In addition, earnings will be adversely affected by the Company’s investments to support the introduction of new products and the development and launch of additional new compounds. In 2007, based on management’s

current estimates of growth of the Company’s in-line and recently launched products and a risk-adjusted assessment of potential new product launches, the Company expects earnings growth that should be sustained for a period of time will resume. The Company has and will continue to rationalize its cost base in line with its strategy to increase its sales and marketing emphasis on specialists and high value primary care physicians.

As previously disclosed, the Company has experienced substantial revenue losses in the last few years due to the expiration of market exclusivity protection for certain of its products. The Company expects substantial incremental revenue losses in each of 2005, 2006 and 2007 representing continuing declines in revenues of those products as well as declines in revenues of certain additional products that will lose market exclusivity primarily in 2005 and 2006. For 2005, the Company estimates reductions of net sales in the range of $1.4 billion to $1.5 billion from the 2004 levels for products which have lost or will lose exclusivity protection in 2003, 2004 or 2005, specifically MONOPRIL in the United States, Canada and Europe, GLUCOPHAGE* XR and GLUCOVANCE* in the United States, CEFZIL in the United States, PARAPLATIN in the United States, VIDEX EC in the United States, TAXOL® in Europe and PRAVACHOL in Europe. The Company also expects substantial incremental revenue losses in each of 2006 and 2007 representing continuing declines in net sales of the products that lost exclusivity protection in 2002, 2003 and 2004 and additional declines attributable to products that will lose exclusivity protection primarily in 2005 and 2006. These products (and the years in which they lose exclusivity protection) include GLUCOPHAGE*/GLUCOVANCE*/GLUCOPHAGE*XR in the United States (2002 to 2004), TAXOL® in Europe and Japan (2003), PRAVACHOL in the United States (2006) and in Europe (2002 to 2007), PARAPLATIN in the United States (2004), MONOPRIL in the United States (2003), Canada (2003) and Europe (2001 to 2008), ZERIT in the United States (2008) and in Europe (2007 to 2011), CEFZIL in the United States (2005) and in Europe (2004 to 2009) and VIDEX/VIDEX EC (2004 to 2009). The timing and amounts of sales reductions from exclusivity losses, their realization in particular periods and the eventual levels of remaining sales revenues are uncertain and dependent on the levels of sales at the time exclusivity protection ends, the timing and degree of development of generic competition (speed of approvals, market entry and impact) and other factors.

PRAVACHOL, an HMG Co-A reductase inhibitor (statin), had net sales of $1.7 billion in the first nine months of 2005. The Company continues to experience increased competition for PRAVACHOL from established brands and new entrants. U.S. prescriptions for PRAVACHOL declined 16% in the first nine months of 2005 compared to 2004. While the product has begun to lose exclusivity in some markets between now and its anticipated loss of U.S. exclusivity in April 2006, its expected rate of decline in sales and in market share could be accelerated by increased competition from established brands and new entrants.

 

The Company’s expectations for future sales growth described above include substantial expected increases in sales of PLAVIX*, which had net sales of approximately $2.4$3.3 billion for the nine months ended September 30, 2004, and is currently the Company’s largest product ranked by net sales. The composition of matter patent for PLAVIX*, which expires in 2011, is currently the subject of litigation in the United States. Similar proceedings involving PLAVIX* have been instituted outside the United States. The Company continues to believe that the patent is valid and that it is infringed, and with its alliance partner and patent-holder Sanofi, is vigorously pursuing these cases. It is not possible at this time reasonably to assess the outcome of these litigations, or if there were an adverse determination in these litigations, the timing of potential generic competition for PLAVIX*. The Company anticipates a court decision sometime in the first half of 2005.

PRAVACHOL, an HMG Co-A reductase inhibitor (statin), had net sales of $1.9 billion in the first nine months of 2004. While the product has begun to lose exclusivity in some markets, between now and its anticipated loss of U.S. exclusivity in 2006, its expected rate of decline in sales and in market share could be accelerated by increased competition from established brands and new entrants. PRAVACHOL U.S. sales declined 18% and 31% and U.S. total prescriptions declined 9% and 13% in the second and third quarters, respectively, of 2004 compared to 2003.

 

The Company and its subsidiaries are the subject of a number of significant pending lawsuits, claims, proceedings and investigations. It is not possible at this time reasonably to assess the final outcome of these investigations or litigations. Management continues to believe, as previously disclosed, that during the next few years, the aggregate impact, beyond current reserves, of these and other legal matters affecting the Company is reasonably likely to be material to the Company’s results of operations and cash flows, and may be material to its financial condition and liquidity. The Company’s expectations for the next several years described above do not reflect the potential impact of litigation on the Company’s results of operations.

 

For additional discussion of legal matters including PLAVIX* patent litigation, see “Item 8.Financial Statements and Supplementary Data-Note 22 Legal Proceedings and Contingencies” in the Company’s Form 10-K/A Annual Report for 2003. Information on the dates of expected loss of exclusivity protection and sales for the most recent year for the Company’s major products are set forth in “Item 1. Business” of the Company’s Form 10-K/A Annual Report for 2003, and interim sales information is included under “Third Quarter Business Segment Net Sales—Pharmaceuticals” above.

Cautionary Factors that May Affect Future Results

 

This Quarterly Reportquarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements the Company makes 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”, “will”, “project”, “guidance”, “intend”, “plan”,

“believe” “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, the Company’s goals, plans and projections regarding its 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.

Although it is not possible to predict or identify all factors, they may include but are not limited to the following:

New government laws and regulations, such as (i) health care reform initiatives in the United States at the state and federal level and in other countries; (ii) changes in the FDA and foreign regulatory approval processes that may cause delays in approving, or preventing the approval of, new products; (iii) tax changes such as the phasing out of tax benefits heretofore available in the United States and certain foreign countries; (iv) new laws, regulations and judicial decisions affecting pricing or marketing within or across jurisdictions; and (v) changes in intellectual property law.

 

Competitive factors, such as (i) new products developed by competitors that have lower prices or superior performance features or that are otherwise competitive with the Company’s current products; (ii) generic competition as the Company’s products mature and patents expire on products; (iii) technological advances and patents attained by competitors; (iv) problems with licensors, suppliers and distributors; and (v) business combinations among the Company’s competitors or major customers.

 

Difficulties and delays inherent in product development, manufacturing and sale, such as (i) products that may appear promising in development but fail to reach market or be approved for additional indications for any number of reasons, including efficacy or safety concerns, the inability to obtain necessary regulatory approvals and the difficulty or excessive cost to manufacture; (ii) failure of any of our products to achieve or maintain commercial viability; (iii) seizure or recalls of pharmaceutical products or forced closings of manufacturing plants; (iv) the failure to obtain, the imposition of limitations on the use of, or loss of patent and other intellectual property rights; (v) failure of the Company or any of its vendors or suppliers to comply with Current Good Manufacturing Practices and other application regulations and quality assurance guidelines that could lead to temporary manufacturing shutdowns, product shortages and delays in product manufacturing; and (vi) other manufacturing or distribution problems including changes in manufacturing production sites and manufacturing capacity due to regulatory requirements, changes in types of products produced, such as biologics, or physical limitations that could impact continuous supply.

New government laws and regulations, such as (i) health care reform initiatives in the United States at the state and federal level and in other countries; (ii) changes in the FDA and foreign regulatory approval processes that may cause delays in approving, or preventing the approval of, new products; (iii) tax changes such as the phasing out of tax benefits heretofore available in the United States and certain foreign countries; (iv) new laws, regulations and judicial decisions affecting pricing or marketing within or across jurisdictions; and (v) changes in intellectual property law.

 

Legal difficulties, including lawsuits, claims, proceedings and investigations, any of which can preclude or delay commercialization of products or adversely affect operations, profitability, liquidity or financial condition, including (i) intellectual property disputes;disputes, including the outcome of the PLAVIX* litigation in the U.S.; (ii) sales and marketing practices in the U.S. and internationally; (iii) adverse decisions in litigation, including product liability and commercial cases; (iii)(iv) the inability to obtain adequate insurance with respect to this type of liability; (iv)(v) recalls or withdrawals of pharmaceutical products or forced closings of manufacturing plants; (v)(vi) the failure to fulfill obligations under supply contracts with the government and other customers which may result in liability; (vii) government investigations including those relating to wholesaler inventory, financial restatement and product pricing and promotion; (vi)(viii) claims asserting violations of securities, antitrust, federal and state pricing and other laws; (vii)(ix) environmental, health and safety matters; (x) tax liabilities; and (viii) tax liabilities.(xi) compliance with the Deferred Prosecution Agreement. There can be no assurance that there will not be an increase in scope of these matters or that any future lawsuits, claims, proceedings or investigations will not be material.

 

Increasing pricing pressures worldwide, including rules and practices of managed care groups and institutional and governmental purchasers, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and healthcare reform and potential impact of importation legislative or otherwise, pharmaceutical reimbursement and pricing in general.

 

Fluctuations in buying patterns and inventory levels of major distributors, retail chains and other trade buyers, which may result from seasonality, pricing, wholesaler buying decisions (including the effect of incentives offered), the Company’s wholesaler inventory management policies (including the workdown or other changes in wholesaler inventory levels) or other factors.

 

Reliance of the Company on vendors, partners and other third parties to meet their contractual, regulatory and other obligations in relation to their arrangements with the Company.

Greater than expected costs and other difficulties, including unanticipated effects and difficulties of acquisitions, dispositions and other events, including obtaining regulatory approvals in connection with evolving business strategies, legal defense costs, insurance expense, settlement costs and the risk of an adverse decision related to litigation.

 

Changes to advertising and promotional spending and other categories of spending that may affect sales.

Changes in product mix that may affect margins.

Changes in the Company’s structure, operations, revenues, costs, staffing or efficiency resulting from acquisitions, divestitures, mergers, alliances, restructurings or other strategic initiatives.initiatives, and the need to obtain governmental approvals, as appropriate.

 

Economic factors over which the Company has no control such as changes of business and economic conditions including, but not limited to, changes in interest rates and fluctuation of foreign currency exchange rates.

 

Changes in business, political and economic conditions due to political or social instability, military or armed conflict, nationalization of assets, debt or payment moratoriums, other restrictions on commerce, and actual or threatened terrorist attacks in the United States or other parts of the world and related military action.

 

Changes in accounting standards promulgated by the FASB, the SEC or the AICPA, which may require adjustments to financial statements.

 

Capacity, efficiency, reliability, security and potential breakdown, invasion, destruction or interruption of information systems.

 

Reliance of the Company on vendors, partners and other third parties to meet their contractual, regulatory and other obligations in relation to their arrangements with the Company.

Results of clinical studies relating to the Company’s or a competitor’s products.

 

Although the Company believes it has been prudent in its 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. The Company undertakes no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.

Item 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

For a discussion of the Company’s market risk, see “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in the Company’s 20032004 Form 10-K/A.10-K.

 

In the nine months ended September 30, 2004,2005, the Company purchased $204 million notional amount of foreign exchange Japanese yen call options, sold $1,931$463 million notional amount of forward contracts (primarily European(in several currencies) and bought $596 million notional amount of primarily Japanese yen forward contracts to partially hedge the foreign exchange impact primarily related to forecasted intercompany inventory purchases for up to the next 2621 months. In addition, the Company bought $415 million notional amount of Japanese yen forward contracts to hedge the exchange impact related to Japanese yen denominated third party payables and sold a net $5,715 million notional amount of forward contracts (in several currencies) to partially hedge the exchange impact primarily related to non-functional currency denominated intercompany loans. As of September 30, 2005 exposures related to these forward contracts have been largely eliminated.

 

Additionally,In April 2005, in connection with the three months ended September 30, 2004,early redemption of its $2.5 billion Notes due 2006, the Company executed several fixed to floatingterminated $2.0 billion notional amount of fixed-to-floating interest rate swapsswap agreements and incurred a loss of $28 million. In June 2005, the Company terminated $500 million notional amount of fixed-to-floating interest rate swap agreements related to convert an additional $700 millionits $2.5 billion Notes due 2011, and incurred a loss of $23 million. This loss will be amortized to interest expense over the remaining life of the Company’s fixedNotes, due 2011. In September 2005, the Company also terminated $350 million notional amount of fixed-to-floating interest rate debtswap agreements related to its $350 million Debentures due 2026, and received a gain of $39 million. This gain will be paid in 2023 and 2026amortized to variable rate debt.interest expense over the remaining life of the Debentures due 2026.

Item 4.CONTROLS AND PROCEDURES

 

AsItem 4. CONTROLS AND PROCEDURES

Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures. Based on their evaluation, as of the end of the period covered by this Form 10-Q, the Company carried out an evaluation, underCompany’s Chief Executive Officer and Chief Financial Officer have concluded that the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of itsCompany’s disclosure controls and procedures (as defined in Rule 13a-15e or 15d-15eRules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934.)

In making this evaluation the Company has considered the “reportable condition” (as defined under standards established by the American Institute of Certified Public Accountants) relating to its1934, as amended) are effective. There have been no significant changes in internal controlscontrol over its financial reporting, for income taxesthe period covered by this report, that was identified and communicated to the Company and its Audit Committee by PricewaterhouseCoopers (PwC), an independent registered public accounting firm. The reportable condition identified by PwC was the need to enhance the tax accounting function to provide for timely analysis and reconciliation of the tax provision and related tax assets and liabilities. This reportable condition initially was identified and communicated by PwC in connection with their audit of the Company’s consolidated financial statements for the year ended December 31, 2002. The Company engaged in extensive remediation efforts with respect to this reportable condition in 2003, including engaging an outside consultant to assist the Company’s personnel to conduct a comprehensive and detailed review of certain of the Company’s tax reporting and accounting, in particular with respect to developing more effective processes for establishing and monitoring deferred income taxes, valuation allowances and the Company’s annual effective tax rate. In connection with their audit of the Company’s consolidated financial statements for the year ended December 31, 2003, the Company’s outside auditors communicated to the Company and its Audit Committee that, despite the Company’s extensive 2003 remediation efforts, they believed a reportable condition still existed at December 31, 2003 with respect to income tax accounting. In connection with the Company’s evaluation of its financial and internal controls at September 30, 2004, the Company considered the mitigating controls established with respect to its financial reporting for income taxes pending remediation of this reportable condition. The Company’s efforts to strengthen its financial and internal controls continue (including its financial and internal controls over its financial reporting for income taxes), and the Company expects to complete remediation of this reportable condition before the end of 2004.

Based on this evaluation, the Company’s chief executive officer and chief financial officer concluded that as of the evaluation date, such disclosure controls and procedures were reasonably designed to ensure that information required to be disclosed by the Company in reports it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.

Other than as described above, since the evaluation date by the Company’s management of its internal controls over financial reporting, there have not been any change in the Company’s internal controls over financial reporting that has materially affected, or isare reasonably likely to materially affect, the Company’s internal controlscontrol over financial reporting.

As a result of Section 404 of the Sarbanes-Oxley Act of 2002 and the rules issued thereunder, the Company will be required to include in its Annual Report on Form 10-K for the year ended December 31, 2004 a report on management’s assessment of the effectiveness of the Company’s internal control over financial reporting. PwC will also be required to attest to and report on management’s assessment. In the course of its ongoing assessment, management has identified areas requiring remediation including improvements to controls over the calculation of prices for reporting under governmental rebate and reimbursement programs (see “Item 1. Financial Statements—Note 15. Legal Proceedings and Contingencies.”) The Company has strengthened and continues to strengthen its internal controls in these areas to remediate identified deficiencies, although there can be no guarantee as to timely outcome. Management will consider these matters when assessing the effectiveness of the Company’s internal control over financial reporting at year end.

PART II—OTHER INFORMATION

Item 1.LEGAL PROCEEDINGS

Item 1. LEGAL PROCEEDINGS

 

Information pertaining to legal proceedings can be found in “Item 1. FinancialFinal Statements—Note 15.17. Legal Proceedings and Contingencies”,Contingencies,” to the interim consolidated financial statements, and is incorporated by reference herein.

 

Item 2.CHANGES IN SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

The following table summarizes the surrenders of the Company’s equity securities in connection with stock option and restricted stock programs during the nine-month period ended September 30, 2004:2005:

 

Period


  Total Number of
Shares Purchased **


  Average Price
Paid per
Share **


  Total Number of
Shares Purchased
as Part of
Publicly
Announced Plans
or Programs *


  Approximate
Dollar Value of
Shares that May
Yet Be Purchased
Under the Plans
or Programs *


            (dollars in
millions)

January 1 to 31, 2004

  30,335  $29.27  372,351,413  $2,220

February 1 to 29, 2004

  3,650  $28.53  372,351,413  $2,220

March 1 to 31, 2004

  213,827  $25.17  372,351,413  $2,220
   
      
    

Three months ended March 31, 2004

  247,812      372,351,413    
   
      
    

April 1 to 30, 2004

  110,686  $24.58  372,351,413  $2,220

May 1 to 31, 2004

  1,320  $25.41  372,351,413  $2,220

June 1 to 30, 2004

  1,082  $25.22  372,351,413  $2,220
   
      
    

Three months ended June 30, 2004

  113,088      372,351,413    
   
      
    

July 1 to 31, 2004

  9,537  $23.25  372,351,413  $2,220

August 1 to 31, 2004

  2,335  $23.02  372,351,413  $2,220

September 1 to 30, 2004

  54,270  $23.64  372,351,413  $2,220
   
      
    

Three months ended September 30, 2004

  66,142      372,351,413    
   
      
    

Nine months ended September 30, 2004

  427,042      372,351,413    
   
      
    

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)

January 1 to 31, 2005

  31,445  $25.38  372,351,413  $2,220

February 1 to 28, 2005

  42,276  $24.11  372,351,413  $2,220

March 1 to 31, 2005

  246,720  $25.44  372,351,413  $2,220
   
      
    

Three months ended March 31, 2005

  320,441      372,351,413    
   
      
    

April 1 to 30, 2005

  9,798  $25.52  372,351,413  $2,220

May 1 to 31, 2005

  9,880  $25.77  372,351,413  $2,220

June 1 to 30, 2005

  5,162  $25.43  372,351,413  $2,220
   
      
    

Three months ended June 30, 2005

  24,840      372,351,413    
   
      
    

July 1 to 31, 2005

  30,322  $25.17  372,351,413  $2,220

August 1 to 31, 2005

  43,398  $25.09  372,351,413  $2,220

September 1 to 30, 2005

  4,648  $24.60  372,351,413  $2,220
   
      
    

Three months ended September 30, 2005

  78,368      372,351,413    
   
      
    

Nine months ended September 30, 2005

  423,649      372,351,413    
   
      
    

*In June 2001, the Company announced that the Board of Directors authorized the purchase of up to $14 billion of Company common stock. During the first nine months of 2004, no shares were repurchased pursuant to this program and no purchases of any shares under this program are expected for the remainder of 2004.

**(a)Reflects the following transactions during the first nine months of 2004:2005: (i) the deemed surrender to the Company of 375,778343,968 shares of Common Stock to pay the exercise price and to satisfy tax withholding obligations in connection with the exercise of employee stock options, and (ii) the surrender to the Company of 51,26479,681 shares of Common Stock to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees.
(b)In June 2001, the Company announced that the Board of Directors authorized the purchase of up to $14 billion of Company common stock. During the first nine months of 2005, no shares were repurchased pursuant to this program and no purchases of any shares under this program are expected for the remainder of 2005.

Item 6. EXHIBITS

Item 4.SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

Exhibits (listed by number corresponding to the Exhibit Table of Item 4 of Form 10-Q/A for the quarterly period ended March 31, 2004 is hereby incorporated by reference.601 in Regulation S-K).

Item 6.EXHIBITS AND REPORTS ON FORM 8-K

a)Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).

 

Exhibit Number and Description

  Page

3b10y. BylawsSingle Currency Term Facility Agreement for $2,500,000,000 dated August 5, 2005, between BMS Omega Bermuda Holdings Finance Ltd., as a borrower, the entities listed therein as Original Guarantors, BNP Paribas and the Royal Bank if Scotland plc, as arrangers, the financial institutions therein as Original Lenders and the Royal Bank of Bristol-Myers Squibb Company,Scotland plc, as amended September 14, 2004E-3
10rForm of Agreement entered into between Bristol-Myers Squibb Company and each of the following officers effective on the following dates: Edward M. Dwyer, July 26, 2004; and Robert T. Zito, July 19, 2004 (incorporated herein by reference to Exhibit 10q to the Form 10-Q for the quarterly period ended September 30, 1999).**
10sSEC Consent Orderagent.  E-10-1
10t10z. Form of Non-Qualifed Stock OptionWaiver letter relating to the Single Currency Term Facility Agreement for $2,500,000,000 dated September 29, 2005.  E-10-2
10u10aa. Form of Restricted Stock AwardSeparation Agreement between Bristol-Myers Squibb Company and Donald J. Hayden.  E-10-3
10vForm of Long-Term Performance Award AgreementE-10-4
1515. Letter Regarding Unaudited Interim Financial InformationInformation.  E-15
31a31a. Section 302 Certification LetterLetter.  E-31-1
31b31b. Section 302 Certification LetterLetter.  E-31-2
32a32a. Section 906 Certification LetterLetter.  E-32-1
32b32b. Section 906 Certification LetterLetter.  E-32-2

**Previously filed.

b)Reports on Form 8-K

On July 29, 2004, the Registrant filed a Form 8-K attaching its press release dated July 29, 2004 regarding earnings for the second quarter of 2004 and certain supplemental information not included in the press release.

On July 30, 2004, the Registrant filed a Form 8-K attaching its press release dated July 30, 2004 concerning the announcement that it has reached an agreement to settle its securities class action lawsuit,In re BMS Securities Litigation, Master File, No. 02-CV-2251 LAP.

On August 5, 2004, the Registrant filed a Form 8-K attaching its press release dated August 4, 2004, confirming that it has reached a final settlement with the SEC, concluding an investigation concerning wholesaler inventory and accounting matters that began in April 2002.

On September 3, 2004, the Registrant filed a Form 8-K announcing that Otsuka Pharmaceutical Co., Ltd. filed with the United States Patent and Trademark Office a Request for Reexamination of the basic U.S. composition of matter patent covering Abilify (aripiprazole).

On September 17, 2004, the Registrant filed a Form 8-K announcing that the Registrant’s Bylaws were amended to state that the Board of Directors may not delegate to the Executive Committee any final action with respect to acquisitions, divestitures and equity investment transactions in excess of $25 million in upfront payments or $100 million in upfront and conditional milestone payments.

On October 29, 2004, the Registrant filed a Form 8-K attaching its press release dated October 29, 2004 regarding its financial results for the third quarter of 2004 and certain supplemental information not included in the press release.

On November 8, 2004, the Registrant filed a Form 8-K announcing that the Registrant’s Compensation and Management Development Committee accelerated shares of restricted stock previously awarded to James Palmer, former Chief Scientific Officer, and granted Dr. Palmer full-term participation of Long-Term Performance Awards previously granted to him.


*Indicates, in this Form 10-Q, brand names of products which are registered trademarks not owned by the Company or its subsidiaries. ERBITUX is a trademark of ImClone Systems Incorporated; AVAPRO/AVALIDE (known in the EU as APROVEL/KARVEA) and PLAVIX are trademarks of Sanofi-Aventis;Sanofi-Synthelabo S.A.; GLUCOPHAGE, GLUCOPHAGE XR and GLUCOVANCE are trademarks of Merck Sante S.A.S., an associate of Merck KGaA of Darmstadt, Germany; JAVLOR is a trademark of Pierre Fabre Medicament S.A. and ABILIFY is a trademark of Otsuka Pharmaceutical Company, Ltd.

SIGNATURES

 

Pursuant to the requirements 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)

Date: November 9, 20042, 2005 By: 

/s/ Peter R. Dolan


    

Peter R. Dolan

    Chairman of the Board and Chief Executive Officer
Date: November 9, 20042, 2005 By: 

/s/ Andrew R. J. Bonfield


    

Andrew R. J. Bonfield

    Senior Vice President and Chief Financial Officer

 

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