UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549


FORM 10-Q


(Mark One)

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


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

For the quarterly period ended SeptemberJune 30, 20172019


OR

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


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

For the transition period from  to


Commission File No. Number: 001-35565


abbvieimage1a25.jpg
AbbVie Inc.
(Exact name of registrant as specified in its charter)
Delaware 32-0375147
(State or other jurisdiction of incorporation or organization) 
(I.R.S. employer identification number)


1 North Waukegan Road
North ChicagoIllinois60064

Telephone: (847) 932-7900
Telephone: (847) 932-7900

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).        Yesx No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” andfiler,” “smaller reporting company”company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large Accelerated Filerx
Accelerated Filer¨
Non-Accelerated FilerSmaller reporting company
  
Non-Accelerated Filer ¨
Smaller reporting company ¨
(Do not check if a smaller reporting company)
Emerging growth company¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

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

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.01 per shareABBVNew York Stock Exchange
Chicago Stock Exchange
As of October 24, 2017,July 29, 2019, AbbVie Inc. had 1,596,429,7401,478,483,838 shares of common stock at $0.01 par value outstanding.







AbbVie Inc. and Subsidiaries
Table of Contents


  Page
   
Item 1.
Item 2.
Item 3.
Item 4.
   
   
Item 1.
Item 1A.
Item 2.
Item 6.




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PART I. FINANCIAL INFORMATION


ITEM 1.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
 
AbbVie Inc. and Subsidiaries
Condensed Consolidated Statements of Earnings (unaudited)


 Three months ended
September 30,
 Nine months ended
September 30,
 Three months ended
June 30,
 Six months ended
June 30,
(in millions, except per share data) 2017 2016 2017 2016 2019 2018 2019 2018
Net revenues $6,995
 $6,432
 $20,477
 $18,842
 $8,255
 $8,278
 $16,083
 $16,212
                
Cost of products sold 1,616
 1,504
 4,760
 4,278
 1,819
 1,934
 3,513
 3,861
Selling, general and administrative 1,452
 1,381
 4,324
 4,202
 1,654
 1,760
 3,334
 3,551
Research and development 1,222
 1,106
 3,580
 3,176
 1,291
 1,322
 2,580
 2,566
Acquired in-process research and development 
 80
 15
 160
 91
 
 246
 69
Other expense 
 500
 
 500
Total operating costs and expenses 4,290
 4,071
 12,679
 11,816
 4,855
 5,516
 9,673
 10,547
Operating earnings 2,705
 2,361
 7,798
 7,026
 3,400
 2,762
 6,410
 5,665
                
Interest expense, net 252
 250
 752
 675
 309
 272
 634
 523
Net foreign exchange loss (gain) 9
 (4) 28
 313
Net foreign exchange loss 6
 8
 12
 16
Other expense, net 349
 101
 484
 152
 2,278
 470
 2,413
 317
Earnings before income tax expense 2,095
 2,014
 6,534
 5,886
 807
 2,012
 3,351
 4,809
Income tax expense 464
 416
 1,277
 1,324
 66
 29
 154
 43
Net earnings $1,631
 $1,598
 $5,257
 $4,562
 $741
 $1,983
 $3,197
 $4,766
                
Per share data                
Basic earnings per share $1.02
 $0.97
 $3.28
 $2.79
 $0.49
 $1.26
 $2.15
 $3.00
Diluted earnings per share $1.01
 $0.97
 $3.27
 $2.78
 $0.49
 $1.26
 $2.14
 $2.99
Cash dividends declared per common share $0.64
 $0.57
 $1.92
 $1.71
                
Weighted-average basic shares outstanding 1,597
 1,632
 1,596
 1,624
 1,480
 1,568
 1,480
 1,579
Weighted-average diluted shares outstanding 1,603
 1,640
 1,602
 1,633
 1,484
 1,572
 1,483
 1,584


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


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AbbVie Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Income (unaudited)


 Three months ended
September 30,
 Nine months ended
September 30,
(in millions)2017 2016 2017 2016
Net earnings$1,631
 $1,598
 $5,257
 $4,562
        
Foreign currency translation adjustments, net of tax expense (benefit) of $7 for the three months and $40 for the nine months ended September 30, 2017 and $10 for the three months and $30 for the nine months ended September 30, 2016183
 31
 602
 164
Net investment hedging activities, net of tax expense (benefit) of $(52) for the three months and $(174) for the nine months ended September 30, 2017 and $— for the three months and $— for the nine months ended September 30, 2016(90) 
 (307) 
Pension and post-employment benefits, net of tax expense (benefit) of $8 for the three months and $23 for the nine months ended September 30, 2017 and $8 for the three months and $23 for the nine months ended September 30, 20168
 15
 21
 48
Marketable security activities, net of tax expense (benefit) of $4 for the three months and $6 for the nine months ended September 30, 2017 and $1 for the three months and $(7) for the nine months ended September 30, 2016(28) 12
 (18) 19
Cash flow hedging activities, net of tax expense (benefit) of $(14) for the three months and $(29) for the nine months ended ended September 30, 2017 and $1 for the three months and $(3) for the nine months ended September 30, 2016(138) (8) (325) (10)
Other comprehensive income (loss)(65) 50
 (27) 221
Comprehensive income$1,566
 $1,648
 $5,230
 $4,783
 Three months ended
June 30,
 Six months ended
June 30,
(in millions)2019 2018 2019 2018
Net earnings$741
 $1,983
 $3,197
 $4,766
        
Foreign currency translation adjustments, net of tax expense (benefit) of $5 for the three months and $6 for the six months ended June 30, 2019 and $(16) for the three months and $(19) for the six months ended June 30, 201871
 (469) (32) (280)
Net investment hedging activities, net of tax expense (benefit) of $(11) for the three months and $8 for the six months ended June 30, 2019 and $61 for the three months and $31 for the six months ended June 30, 2018(37) 209
 28
 105
Pension and post-employment benefits, net of tax expense (benefit) of $6 for the three months and $12 for the six months ended June 30, 2019 and $7 for the three months and $16 for the six months ended June 30, 201820
 49
 45
 71
Marketable security activities, net of tax expense (benefit) of $— for the three months and $— for the six months ended June 30, 2019 and $— for the three months and $— for the six months ended June 30, 20184
 5
 11
 (2)
Cash flow hedging activities, net of tax expense (benefit) of $(2) for the three months and $(9) for the six months ended June 30, 2019 and $18 for the three months and $17 for the six months ended June 30, 2018(33) 197
 (63) 194
Other comprehensive income (loss)25
 (9) (11) 88
Comprehensive income$766
 $1,974
 $3,186
 $4,854


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








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AbbVie Inc. and Subsidiaries

Condensed Consolidated Balance Sheets


(in millions, except share data)September 30,
2017
 December 31,
2016
June 30,
2019
 December 31,
2018
(unaudited)  (unaudited)  
Assets      
Current assets      
Cash and equivalents$8,446
 $5,100
$5,172
 $7,289
Short-term investments1,108
 1,323
244
 772
Accounts receivable, net4,891
 4,758
5,482
 5,384
Inventories1,785
 1,444
1,895
 1,605
Prepaid expenses and other2,700
 3,562
2,307
 1,895
Total current assets18,930
 16,187
15,100
 16,945
      
Investments1,971
 1,783
1,473
 1,420
Property and equipment, net2,697
 2,604
2,879
 2,883
Intangible assets, net28,167
 28,897
20,459
 21,233
Goodwill15,748
 15,416
15,642
 15,663
Other assets1,327
 1,212
1,589
 1,208
Total assets$68,840
 $66,099
$57,142
 $59,352
      
Liabilities and Equity      
Current liabilities      
Short-term borrowings$800
 $377
$306
 $3,699
Current portion of long-term debt and lease obligations3,021
 25
Current portion of long-term debt and finance lease obligations5,335
 1,609
Accounts payable and accrued liabilities9,212
 9,379
11,300
 11,931
Total current liabilities13,033
 9,781
16,941
 17,239
      
Long-term debt and lease obligations33,974
 36,440
Long-term debt and finance lease obligations31,619
 35,002
Deferred income taxes6,147
 6,890
1,148
 1,067
Other long-term liabilities8,999
 8,352
16,000
 14,490
      
Commitments and contingencies

 



 


      
Stockholders’ equity   
Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,767,419,360 shares issued as of September 30, 2017 and 1,754,900,486 as of December 31, 201618
 18
Common stock held in treasury, at cost, 171,296,169 shares as of September 30, 2017 and 162,387,762 as of December 31, 2016(11,419) (10,852)
Stockholders’ equity (deficit)   
Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,781,055,877 shares issued as of June 30, 2019 and 1,776,510,871 as of December 31, 201818
 18
Common stock held in treasury, at cost, 302,685,326 shares as of June 30, 2019 and 297,686,473 as of December 31, 2018(24,505) (24,108)
Additional paid-in capital14,154
 13,678
15,028
 14,756
Retained earnings6,547
 4,378
3,384
 3,368
Accumulated other comprehensive loss(2,613) (2,586)(2,491) (2,480)
Total stockholders’ equity6,687
 4,636
Total stockholders’ equity (deficit)(8,566) (8,446)
      
Total liabilities and equity$68,840
 $66,099
$57,142
 $59,352


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


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AbbVie Inc. and Subsidiaries

Condensed Consolidated Statements of Cash FlowsEquity (unaudited)

 Nine months ended
September 30,
(in millions) (brackets denote cash outflows)2017 2016
Cash flows from operating activities   
Net earnings$5,257
 $4,562
Adjustments to reconcile net earnings to net cash from operating activities:   
Depreciation324
 307
Amortization of intangible assets808
 554
Change in fair value of contingent consideration liabilities547
 143
Stock-based compensation288
 278
Upfront costs and milestones related to collaborations85
 230
Devaluation loss related to Venezuela
 298
Other, net(73) 326
Changes in operating assets and liabilities, net of acquisitions:   
Accounts receivable(163) (129)
Inventories(119) 28
Prepaid expenses and other assets(22) (122)
Accounts payable and other liabilities444
 (975)
Cash flows from operating activities7,376
 5,500
    
Cash flows from investing activities   
Acquisitions of businesses, net of cash acquired
 (2,477)
Other acquisitions and investments(180) (172)
Acquisitions of property and equipment(347) (365)
Purchases of investment securities(1,838) (4,520)
Sales and maturities of investment securities1,890
 1,579
Cash flows from investing activities(475) (5,955)
    
Cash flows from financing activities   
Net change in short-term borrowings423
 (406)
Proceeds from issuance of long-term debt
 7,771
Repayments of long-term debt and lease obligations(18) (2,006)
Debt issuance costs
 (52)
Dividends paid(3,077) (2,784)
Purchases of treasury stock(905) (4,223)
Proceeds from the exercise of stock options214
 210
Payments of contingent consideration liabilities(268) 
Other, net47
 64
Cash flows from financing activities(3,584) (1,426)
Effect of exchange rate changes on cash and equivalents29
 (300)
Net change in cash and equivalents3,346
 (2,181)
Cash and equivalents, beginning of period5,100
 8,399
    
Cash and equivalents, end of period$8,446
 $6,218
    
Supplemental schedule of non-cash investing and financing activities   
Issuance of common shares associated with acquisitions of businesses$
 $3,923
(in millions)Common shares outstanding Common stock Treasury stock Additional paid-in capital Retained earnings Accumulated other comprehensive loss Total
Balance at March 31, 20181,587
 $18
 $(13,331) $14,519
 $4,977
 $(2,630) $3,553
Net earnings
 
 
 
 1,983
 
 1,983
Other comprehensive loss, net of tax
 
 
 
 
 (9) (9)
Dividends declared
 
 
 
 (1,465) 
 (1,465)
Purchases of treasury stock(73) 
 (7,516) 
 
 
 (7,516)
Stock-based compensation plans and other
 
 2
 77
 
 
 79
Balance at June 30, 20181,514
 $18
 $(20,845) $14,596
 $5,495
 $(2,639) $(3,375)
              
Balance at March 31, 20191,478
 $18
 $(24,502) $14,940
 $4,234
 $(2,516) $(7,826)
Net earnings
 
 
 
 741
 
 741
Other comprehensive income, net of tax
 
 
 
 
 25
 25
Dividends declared
 
 
 
 (1,591) 
 (1,591)
Purchases of treasury stock
 
 (3) 
 
 
 (3)
Stock-based compensation plans and other
 
 
 88
 
 
 88
Balance at June 30, 20191,478

$18

$(24,505)
$15,028

$3,384

$(2,491)
$(8,566)
              
Balance at December 31, 20171,592
 $18
 $(11,923) $14,270
 $5,459
 $(2,727) $5,097
Adoption of new accounting standards
 
 
 
 (1,733) 
 (1,733)
Net earnings
 
 
 
 4,766
 
 4,766
Other comprehensive income, net of tax
 
 
 
 
 88
 88
Dividends declared
 
 
 
 (2,997) 
 (2,997)
Purchases of treasury stock(85) 
 (8,947) 
 
 
 (8,947)
Stock-based compensation plans and other7
 
 25
 326
 
 
 351
Balance at June 30, 20181,514
 $18
 $(20,845) $14,596
 $5,495
 $(2,639) $(3,375)
              
Balance at December 31, 20181,479
 $18
 $(24,108) $14,756
 $3,368
 $(2,480) $(8,446)
Net earnings
 
 
 
 3,197
 
 3,197
Other comprehensive loss, net of tax
 
 
 
 
 (11) (11)
Dividends declared
 
 
 
 (3,181) 
 (3,181)
Purchases of treasury stock(5) 
 (422) 
 
 
 (422)
Stock-based compensation plans and other4
 
 25
 272
 
 
 297
Balance at June 30, 20191,478
 $18
 $(24,505) $15,028
 $3,384
 $(2,491) $(8,566)


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


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AbbVie Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (unaudited)

 Six months ended
June 30,
(in millions) (brackets denote cash outflows)2019 2018
Cash flows from operating activities   
Net earnings$3,197
 $4,766
Adjustments to reconcile net earnings to net cash from operating activities:   
Depreciation232
 234
Amortization of intangible assets773
 654
Change in fair value of contingent consideration liabilities2,473
 337
Stock-based compensation276
 276
Upfront costs and milestones related to collaborations321
 656
Other, net(10) 118
Changes in operating assets and liabilities:   
Accounts receivable(96) (805)
Inventories(288) (191)
Prepaid expenses and other assets(97) (546)
Accounts payable and other liabilities(1,287) 12
Cash flows from operating activities5,494
 5,511
    
Cash flows from investing activities   
Acquisitions and investments(440) (401)
Acquisitions of property and equipment(235) (233)
Purchases of investment securities(558) (637)
Sales and maturities of investment securities1,066
 1,511
Cash flows from investing activities(167) 240
    
Cash flows from financing activities   
Net change in commercial paper borrowings(393) 111
Proceeds from issuance of other short-term borrowings
 3,000
Repayments of other short-term borrowings(3,000) 
Repayments of long-term debt and finance lease obligations(4) (3,013)
Debt issuance costs(171) 
Dividends paid(3,180) (2,668)
Purchases of treasury stock(623) (8,947)
Proceeds from the exercise of stock options5
 64
Payments of contingent consideration liabilities(108) (39)
Other, net21
 5
Cash flows from financing activities(7,453) (11,487)
Effect of exchange rate changes on cash and equivalents9
 (20)
Net change in cash and equivalents(2,117) (5,756)
Cash and equivalents, beginning of period7,289
 9,303
    
Cash and equivalents, end of period$5,172
 $3,547

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

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AbbVie Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements (unaudited)
Note 1    Basis of Presentation
 

Basis of Historical Presentation
The unaudited interim condensed consolidated financial statements of AbbVie Inc. (AbbVie or the company) have been prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) have been omitted. These unaudited interim condensed consolidated financial statements should be read in conjunction with the company’s audited consolidated financial statements and notes included in the company’s Annual Report on Form 10-K for the year ended December 31, 2016.

2018.
It is management’s opinion that these financial statements include all normal and recurring adjustments necessary for a fair presentation of the company’s financial position and operating results. Net revenues and net earnings for any interim period are not necessarily indicative of future or annual results. Certain reclassifications were made to conform the prior period interim condensed consolidated financial statements to the current period presentation.
Recent Accounting Pronouncements
Recently Adopted Accounting Pronouncements

ASU No. 2016-02
In January 2017,February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2017-01, Business Combinations2016-02, Leases (Topic 805):Clarifying the Definition of a Business842). The standard provides clarifying guidance to assist in the evaluation of whether transactions are treated as business combinations or asset acquisitions. AbbVie elected to early adopt the changes prospectively in the first quarter of 2017.

In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. AbbVie adopted the standard in the first quarter of 2017. As a result, all excess tax benefits associated with stock-based awards are recognized in the statement of earnings when the awards vest or settle, rather than in stockholders' equity. In addition, excess tax benefits in the statement of cash flows are now classified as an operating activity rather than as a financing activity. AbbVie adopted these changes prospectively. Accordingly, the company recognized excess tax benefits in income tax expense of $14 million for the three months and $53 million for the nine months ended September 30, 2017 and classified them within cash flows from operating activities.

Recent Accounting Pronouncements Not Yet Adopted

In May 2014, the FASB issued ASU No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers (Topic 606) and Other Assets and Deferred Costs-Contracts with Customers (Subtopic 340-40). The amendments in this standard supersede most current revenue recognition requirements. The core principle of the new guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. AbbVie can apply the amendments using one of the following two methods: (i) retrospectively to each prior reporting period presented, or (ii) modified retrospectively with the cumulative effect of initially applying the amendments recognized at the date of initial application. AbbVie will adopt the standard effective the first quarter of 2018 and apply the amendments using the modified retrospective method. The company has made substantial progress in its review of the new standard and will complete its assessment by December 31, 2017. AbbVie does not expect significant changes to the amounts or timing of revenue recognition for product sales, which is its primary revenue stream. However, the company expects that the adoption of the new standard will require a cumulative-effect adjustment to retained earnings on January 1, 2018 of approximately $130 million, net of tax, primarily related to certain deferred license revenues that were originally expected to be recognized through early 2020.

In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The standard requires several targeted changes including that equity investments (except those accounted for under the equity method of accounting, or those that result in consolidation of the investee) be measured at fair value with changes in fair value recognized in net earnings. These provisions will not impact the accounting for AbbVie's investments

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in debt securities. The new guidance also changes certain disclosure requirements and other aspects of current U.S. GAAP. Amendments are to be applied as a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. This standard will be effective for AbbVie starting with the first quarter of 2018. The standard does not permit early adoption with the exception of certain targeted provisions. AbbVie is unable to estimate the impact of adopting this standard on its financial statements as it will be dependent upon the composition of its equity investment portfolio as of the adoption date and future changes in fair value subsequent to the adoption date. However, based on historical trends, AbbVie does not believe the adoption will have a material impact on its consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The standard outlinesoutlined a comprehensive lease accounting model that supersedessuperseded the currentprevious lease guidance and requiresrequired lessees to recognize lease liabilities and corresponding right-of-use assets for all leases with lease terms greater than 12 months. The guidance also changeschanged the definition of a lease and expandsexpanded the disclosure requirements of lease arrangements. The new standard must beAbbVie adopted using the modified retrospective approach and will be effective for AbbVie starting with the first quarter of 2019, with early adoption permitted. AbbVie will adopt the standard effective in the first quarter of 2019 using the modified retrospective method. Results for reporting periods beginning after December 31, 2018 have been presented in accordance with the standard, while results for prior periods have not been adjusted and is currently assessingcontinue to be reported in accordance with AbbVie's historical accounting. The cumulative effect of initially applying the new leases standard was recognized as an adjustment to the opening condensed consolidated balance sheet as of January 1, 2019.
The company elected a package of practical expedients for leases that commenced prior to January 1, 2019 and did not reassess historical conclusions on: (i) whether any expired or existing contracts are or contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs capitalization for any existing leases.
Under the new standard, on January 1, 2019, the company recognized a cumulative-effect adjustment to its condensed consolidated balance sheet primarily related to the recognition of liabilities and corresponding right-of-use assets for operating leases. The adjustment to the condensed consolidated balance sheet included: (i) a $405 million increase to other assets; (ii) a $115 million increase to accounts payable and accrued liabilities; and (iii) a $290 million increase to other long-term liabilities. Other cumulative-effect adjustments to the condensed consolidated balance sheet were insignificant.
Adoption of the standard did not have a significant impact on AbbVie's condensed consolidated statements of adopting this guidanceearnings for the three and six months ended June 30, 2019.
ASU No. 2018-02
In February 2018, the FASB issued ASU No. 2018-02, Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, which allowed a reclassification from accumulated other comprehensive income (AOCI) to retained earnings for stranded tax effects related to adjustments to deferred taxes resulting from the December 2017 enactment of the Tax Cuts and Jobs Act (the Act). AbbVie adopted the standard in the first quarter of 2019. Upon adoption, the company made an election to not reclassify the income tax effects of the Act from AOCI to retained earnings. Therefore, the adoption of the standard had no impact on itsAbbVie's consolidated financial statements.


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Recent Accounting Pronouncements Not Yet Adopted
ASU No. 2016-13
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326). The standard changes how credit losses are measured for most financial assets and certain other instruments. For trade and other receivables, held-to-maturity debt securities, loans and other financial instruments, the standard requires the use of a new forward-looking "expected credit loss" model that generally will result in the earlier recognition of allowances for losses. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. Additionally, the standard requires new disclosures and will be effective for AbbVie starting with the first quarter of 2020. Early adoption beginning in the first quarter of 2019 is permitted. With certain exceptions, adjustments are to be applied using a modified-retrospective approach by reflecting adjustments through a cumulative-effect impact to retained earnings as of the beginning of the fiscal year of adoption. AbbVie is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements.

In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740). The new standard requires entities to recognize the income tax consequences of an intercompany transfer of an asset other than inventory when the transfer occurs. Under current U.S. GAAP, the income tax consequences of these intercompany asset transfers are deferred until the asset is sold to a third party or otherwise recovered through use. The standard will be effective for AbbVie starting with the first quarter of 2018. Adjustments for this update are to be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings with any adjustments reflected as of the beginning of the fiscal year of adoption. AbbVie is currently assessing the impact of adopting this guidance on its consolidated financial statements. As of September 30, 2017, AbbVie had approximately $1.8 billion of prepaid income tax assets that will be affected by this standard, of which $1.3 billion was included in prepaid expenses and other on the condensed consolidated balance sheet.

In March 2017, the FASB issued ASU No. 2017-07, Compensation - Retirement Benefits (Topic 715): Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost. The standard requires that an employer continue to report the service cost component of net periodic benefit cost in the same income statement line item or items as other employee compensation costs arising from services rendered during the period. The other components of net periodic benefit cost are required to be presented separately outside of income from operations and are not eligible for capitalization. The standard will be effective for AbbVie starting with the first quarter of 2018. Upon adoption, the company will apply the income statement classification provisions of this standard retrospectively and preliminarily expects to reclassify income of approximately $50 million from operating earnings to non-operating income for the year ending December 31, 2017.

In August 2017, the FASB issued ASU No. 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities. The standard simplifies the application of hedge accounting and more closely aligns the accounting with an entity’s risk management activities. The standard will be effective for AbbVie starting with the first quarter of 2019, with early adoption permitted. AbbVie is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements.

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Note 2    Supplemental Financial Information
 

Interest Expense, Net
  Three months ended
June 30,
 Six months ended
June 30,
(in millions) 2019 2018 2019 2018
Interest expense $358
 $320
 $745
 $629
Interest income (49) (48) (111) (106)
Interest expense, net $309
 $272
 $634
 $523

  Three months ended
September 30,
 Nine months ended
September 30,
(in millions) 2017 2016 2017 2016
Interest expense $293
 $271
 $851
 $731
Interest income (41) (21) (99) (56)
Interest expense, net $252
 $250
 $752
 $675
Inventories
(in millions)June 30, 2019 December 31, 2018
Finished goods$638
 $473
Work-in-process969
 862
Raw materials288
 270
Inventories$1,895
 $1,605

Inventories
(in millions)September 30, 2017 December 31, 2016
Finished goods$353
 $223
Work-in-process1,271
 1,080
Raw materials161
 141
Inventories$1,785
 $1,444
Property and Equipment
(in millions)June 30, 2019 December 31, 2018
Property and equipment, gross$8,443
 $8,396
Accumulated depreciation(5,564) (5,513)
Property and equipment, net$2,879
 $2,883
(in millions)September 30, 2017 December 31, 2016
Property and equipment, gross$7,894
 $7,526
Accumulated depreciation(5,197) (4,922)
Property and equipment, net$2,697
 $2,604

Depreciation expense was $111$114 million for the three months and $324$232 million for the ninesix months ended SeptemberJune 30, 20172019 and $96$119 million for the three months and $307$234 million for the ninesix months ended SeptemberJune 30, 2016.2018.

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Note 3    Earnings Per Share
 


AbbVie grants certain restricted stock awards (RSAs) and restricted stock units (RSUs) that are considered to be participating securities. Due to the presence of participating securities, AbbVie calculates earnings per share (EPS) using the more dilutive of the treasury stock or the two-class method. For all periods presented, the two-class method was more dilutive.



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The following table summarizes the impact of the two-class method:


  Three months ended
June 30,
 Six months ended
June 30,
(in millions, except per share data) 2019 2018 2019 2018
Basic EPS        
Net earnings $741
 $1,983
 $3,197
 $4,766
Earnings allocated to participating securities 8
 10
 17
 22
Earnings available to common shareholders $733
 $1,973
 $3,180
 $4,744
Weighted-average basic shares outstanding 1,480
 1,568
 1,480
 1,579
Basic earnings per share $0.49
 $1.26
 $2.15
 $3.00
         
Diluted EPS        
Net earnings $741
 $1,983
 $3,197
 $4,766
Earnings allocated to participating securities 8
 10
 17
 22
Earnings available to common shareholders $733
 $1,973
 $3,180
 $4,744
Weighted-average shares of common stock outstanding 1,480
 1,568
 1,480
 1,579
Effect of dilutive securities 4
 4
 3
 5
Weighted-average diluted shares outstanding 1,484
 1,572
 1,483
 1,584
Diluted earnings per share $0.49
 $1.26
 $2.14
 $2.99

  Three months ended
September 30,
 Nine months ended
September 30,
(in millions, except per share information) 2017 2016 2017 2016
Basic EPS        
Net earnings $1,631
 $1,598
 $5,257
 $4,562
Earnings allocated to participating securities 8
 8
 26
 23
Earnings available to common shareholders $1,623
 $1,590
 $5,231
 $4,539
Weighted-average basic shares outstanding 1,597
 1,632
 1,596
 1,624
Basic earnings per share $1.02
 $0.97
 $3.28
 $2.79
         
Diluted EPS        
Net earnings $1,631
 $1,598
 $5,257
 $4,562
Earnings allocated to participating securities 8
 8
 26
 23
Earnings available to common shareholders $1,623
 $1,590
 $5,231
 $4,539
Weighted-average shares of common stock outstanding 1,597
 1,632
 1,596
 1,624
Effect of dilutive securities 6
 8
 6
 9
Weighted-average diluted shares outstanding 1,603
 1,640
 1,602
 1,633
Diluted earnings per share $1.01
 $0.97
 $3.27
 $2.78


Certain shares issuable under stock-based compensation plans were excluded from the computation of EPS because the effect would have been antidilutive. The number of common shares excluded werewas insignificant for all periods presented.
Note 4Licensing, Acquisitions and Other Arrangements
 


Proposed Acquisition of Stemcentrx

Allergan plc
On June 1, 2016,25, 2019, AbbVie acquired allannounced that it entered into a definitive transaction agreement under which AbbVie will acquire Allergan plc (Allergan) in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie’s common stock of $78.45 on June 24, 2019. Under the terms of the outstanding equity intereststransaction agreement, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in Stemcentrx,cash for each Allergan share.
In connection with the proposed acquisition of Allergan, on June 25, 2019, AbbVie entered into a privately-held biotechnology company. $38.0 billion 364-day bridge credit agreement. On July 12, 2019, AbbVie entered into a term loan credit agreement with an aggregate principal amount of $6.0 billion consisting of a $1.5 billion 364-day term loan tranche, a $2.5 billion three-year term loan tranche and a $2.0 billion five-year term loan tranche, with the commitments under the bridge credit agreement to be reduced by such amount to $32.0 billion. No amounts have been drawn under the bridge credit agreement or term loan credit agreement.
Allergan is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of brands and products primarily focused on key therapeutic areas including medical aesthetics, eye care, neuroscience, gastroenterology and women's health.
The transaction expanded AbbVie’s oncology pipeline by adding the late-stage asset rovalpituzumab tesirine (Rova-T), four additional early-stage clinical compoundsis expected to close in solid tumor indicationsearly 2020, subject to regulatory and a significant portfolio of pre-clinical assets. Rova-T is currently in registrational trials for small cell lung cancer.Allergan shareholder approvals.

Other Licensing & Acquisitions Activity
The acquisition of Stemcentrx was accounted for as a business combination using the acquisition method of accounting. The aggregate upfront considerationCash outflows related to other acquisitions and investments totaled $440 million for the acquisitionsix months ended June 30, 2019 and $401 million for the six months ended June 30, 2018. AbbVie recorded acquired in-process research and development (IPR&D) charges of Stemcentrx consisted$91 million for the three months and $246 million for the six months ended June 30, 2019. AbbVie recorded no acquired IPR&D charges for the three months ended June 30, 2018 and recorded acquired IPR&D charges of approximately 62.4$69 million shares of AbbVie common stock, issued from common stock held in treasury, and cash. AbbVie may make certain contingent payments uponfor the achievement of defined development and regulatory milestones. As of the acquisition date, the maximum aggregate amount payable for development and regulatory milestones was $4.0 billion. The acquisition-date fair value of these milestones was $620 million and was estimated using a combination of probability-weighted discounted cash flow models and Monte Carlo simulation models. The estimate was determined based on significant inputs that are not observable in the market, referred to as Level 3 inputs, as described in more detail in Note 8.six months ended June 30, 2018.



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The following table summarizes total consideration:Calico Life Sciences LLC
(in millions) 
Cash$1,883
Fair value of AbbVie common stock3,923
Contingent consideration620
Total consideration$6,426

The following table summarizes fair values of assets acquiredIn June 2018, AbbVie and liabilities assumed as of the June 1, 2016 acquisition date:
(in millions) 
Assets acquired and liabilities assumed 
Accounts receivable$1
Prepaid expenses and other7
Property and equipment17
Intangible assets - Indefinite-lived research and development6,100
Accounts payable and accrued liabilities(31)
Deferred income taxes(1,933)
Other long-term liabilities(7)
Total identifiable net assets4,154
Goodwill2,272
Total assets acquired and liabilities assumed$6,426

Intangible assets were related to acquired in-process research and development (IPR&D) for Rova-T, four additional early-stage clinical compounds in solid tumor indications and several additional pre-clinical compounds. The estimated fair value of the acquired IPR&D was determined using the multi-period excess earnings model of the “income approach,” which is a valuation technique that providesCalico Life Sciences LLC (Calico) entered into an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. Some of the more significant assumptions inherent in the development of those asset valuations include the estimated annual cash flows for each asset or product (including net revenues, cost of sales, research and development (R&D) costs, selling and marketing costs and working capital/contributory asset charges), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the regulatory approval probabilities, commercial success risks, competitive landscape as well as other factors.

The goodwill recognized represents expected synergies, including the ability to: (i) leverage the respective strengths of each business; (ii) expand the combined company’s product portfolio; (iii) accelerate AbbVie's clinical and commercial presence in oncology; and (iv) establish a strong leadership position in oncology. Goodwill was also impacted by the establishmentextension of a deferred tax liabilitycollaboration to discover, develop and bring to market new therapies for the acquired identifiable intangible assets which have no tax basis. The goodwill is not deductible for tax purposes.

Pro Forma Financial Information

The following table presents the unaudited pro forma combined results of operations of AbbViepatients with age-related diseases, including neurodegeneration and Stemcentrx for the three and nine months ended September 30, 2016 as if the acquisition of Stemcentrx had occurred on January 1, 2015:
  Three months ended
September 30,
 Nine months ended
September 30,
(in millions, except per share information) 2016 2016
Net revenues $6,432
 $18,845
Net earnings 1,579
 4,515
Basic earnings per share $0.97
 $2.72
Diluted earnings per share $0.96
 $2.71

The unaudited pro forma financial information was prepared using the acquisition method of accounting and was based on the historical financial information of AbbVie and Stemcentrx. In order to reflect the occurrence of the acquisition on January 1, 2015 as

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required, the unaudited pro forma financial information includes adjustments to reflect the additional interest expense associated with the issuance of debt to finance the acquisition and the reclassification of acquisition, integration and financing-related costs incurred during 2016 to the three and nine months ended September 30, 2015. The unaudited pro forma financial information is not necessarily indicative of what the consolidated results of operations would have been had the acquisition been completed on January 1, 2015. In addition, the unaudited pro forma financial information is not a projection of the future results of operations of the combined company nor does it reflect the expected realization of any cost savings or synergies associated with the acquisition.

Acquisition of BI 655066 and BI 655064 from Boehringer Ingelheim

On April 1, 2016, AbbVie acquired all rights to risankizumab (BI 655066), an anti-IL-23 monoclonal biologic antibody in Phase 3 development for psoriasis, from Boehringer Ingelheim (BI) pursuant to a global collaboration agreement. AbbVie is also evaluating the potential of this biologic therapy in Crohn’s disease, psoriatic arthritis and asthma. In addition to risankizumab, AbbVie also gained rights to an anti-CD40 antibody, BI 655064, currently in Phase 1 development. BI will retain responsibility for further development of BI 655064, and AbbVie may elect to advance the program after completion of certain clinical achievements. The acquired assets include all patents, data, know-how, third-party agreements, regulatory filings and manufacturing technology related to BI 655066 and BI 655064.

The company concluded that the acquired assets met the definition of a business and accounted for the transaction as a business combination using the acquisition method of accounting.cancer. Under the terms of the agreement, AbbVie madeand Calico will each contribute an upfront payment of $595 million. Additionally, $18additional $500 million of payments to BI, pursuant to a contractual obligation to reimburse BI for certain development costs it incurred prior to the acquisition date, were initially deferred.collaboration and the term was extended for an additional three years. Calico will be responsible for research and early development until 2022 and will advance collaboration projects through Phase 2a through 2027. Following completion of Phase 2a, AbbVie may make certain contingent payments uponwill have the achievement of defined development, regulatory and commercial milestones, as well as royalty payments based on net revenues of licensed products. As of the acquisition date, the maximum aggregate amount payable for development and regulatory milestones was approximately $1.6 billion. The acquisition-date fair value of these milestones was $606 million. The acquisition-date fair value of contingent royalty payments was $2.8 billion. The potential contingent consideration payments were estimated by applying a probability-weighted expected payment model for contingent milestone payments and a Monte Carlo simulation model for contingent royalty payments, which were then discounted to present value. The fair value measurements were based on Level 3 inputs.

The following table summarizes total consideration:
(in millions) 
Cash$595
Deferred consideration payable18
Contingent consideration3,365
Total consideration$3,978

The following table summarizes fair values of assets acquired as of the April 1, 2016 acquisition date:
(in millions) 
Assets acquired 
Identifiable intangible assets - Indefinite-lived research and development$3,890
Goodwill88
Total assets acquired$3,978

The estimated fair value of the acquired IPR&D was determined using the multi-period excess earnings model of the “income approach.” The goodwill recognized represents expected synergies, including an expansion of the company’s immunology product portfolio.

Pro forma results of operations for this acquisition have not been presented because this acquisition is insignificant to AbbVie’s consolidated results of operations.


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Other Licensing & Acquisitions Activity

Excluding the acquisitions above, cash outflows related to other acquisitions and investments totaled $180 million for the nine months ended September 30, 2017 and $172 million for the nine months ended September 30, 2016. AbbVie recorded no IPR&D charges for the three months ended September 30, 2017 and recorded IPR&D charges of $15 million for the nine months ended September 30, 2017. AbbVie recorded IPR&D charges of $80 million for the three months and $160 million for the nine months ended September 30, 2016.

In October 2017, AbbVie entered into a global strategic collaboration with Alector, Inc. (Alector) to develop and commercialize medicines to treat Alzheimer’s disease and other neurodegenerative disorders. AbbVie and Alector have agreed to research a portfolio of antibody targets and AbbVie has an option to globalexclusively license collaboration compounds. AbbVie will support Calico in its early research and development efforts and, upon exercise, would be responsible for late-stage development and commercial rights to two targets. AbbVie will make an initial upfront payment of $205 million, whichactivities. Collaboration costs and profits will be expensed to IPR&Dshared equally by both parties post option exercise. During the six months ended June 30, 2018, AbbVie recorded $500 million in other expense in the fourth quartercondensed consolidated statement of 2017. Alector will conduct exploratory research, drug discovery and development for lead programs upearnings related to its commitments under the conclusion of the proof of concept studies. If the option is exercised, AbbVie will lead development and commercialization activities and could make additional payments to Alector of up to $986 million upon achievement of certain development and regulatory milestones. Alector and AbbVie will co-fund development and commercialization and will share global profits equally.agreement.
Note 5Collaboration with Janssen Biotech, Inc.
 


In December 2011, Pharmacyclics, a wholly-owned subsidiary of AbbVie, entered into a worldwide collaboration and license agreement with Janssen Biotech, Inc. and its affiliates (Janssen), one of the Janssen Pharmaceutical companies of Johnson & Johnson, for the joint development and commercialization of IMBRUVICA, a novel, orally active, selective covalent inhibitor of Bruton's tyrosine kinase (BTK) and certain compounds structurally related to IMBRUVICA, for oncology and other indications, excluding all immune and inflammatory mediated diseases or conditions and all psychiatric or psychological diseases or conditions, in the United States and outside the United States.


The collaboration provides Janssen with an exclusive license to commercialize IMBRUVICA outside of the United States and co-exclusively with AbbVie in the United States. Both parties are responsible for the development, manufacturing and marketing of any products generated as a result of the collaboration. The collaboration has no set duration or specific expiration date and provides for potential future development, regulatory and approval milestone payments of up to $200 million to AbbVie. The collaboration also includes a cost sharing arrangement for associated collaboration activities. Except in certain cases, Janssen is responsible for approximately 60% of collaboration development costs and AbbVie is responsible for the remaining 40% of collaboration development costs.


In the United States, both parties have co-exclusive rights to commercialize the products; however, AbbVie is the principal in the end customerend-customer product sales. AbbVie and Janssen share pre-tax profits and losses equally from the commercialization of products. Sales of IMBRUVICA are included in AbbVie's net revenues. Janssen's share of profits is included in AbbVie's cost of products sold. Other costs incurred under the collaboration are reported in their respective expense line items, net of Janssen's share.


Outside the United States, Janssen is responsible for and has exclusive rights to commercialize IMBRUVICA. AbbVie and Janssen share pre-tax profits and losses equally from the commercialization of products. AbbVie's share of profits is included in AbbVie's net revenues. Other costs incurred under the collaboration are reported in their respective expense line items, net of Janssen's share.


The following table shows the profit and cost sharing relationship between Janssen and AbbVie:


  Three months ended
June 30,
 Six months ended
June 30,
(in millions) 2019 2018 2019 2018
United States - Janssen's share of profits (included in cost of products sold) $422
 $325
 $808
 $601
International - AbbVie's share of profits (included in net revenues) 213
 157
 406
 295
Global - AbbVie's share of other costs (included in respective line items) 77
 80
 149
 151

  Three months ended
September 30,
 Nine months ended
September 30,
(in millions) 2017 2016 2017 2016
United States - Janssen's share of profits (included in cost of products sold) $268
 $211
 $727
 $540
International - AbbVie's share of profits (included in net revenues) 114
 64
 306
 175
Global - AbbVie's share of other costs (included in respective line items) 75
 70
 209
 195


AbbVie’s receivable from Janssen, included in accounts receivable, net, was $230 million at June 30, 2019 and $177 million at December 31, 2018. AbbVie’s payable to Janssen, included in accounts payable and accrued liabilities, was $405 million at June 30, 2019 and $376 million at December 31, 2018.

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Note 6    Goodwill and Intangible Assets
 


Goodwill


The following table summarizes the changes in the carrying amount of goodwill:
(in millions) 
Balance as of December 31, 2018$15,663
Foreign currency translation adjustments(21)
Balance as of June 30, 2019$15,642

(in millions) 
Balance as of December 31, 2016$15,416
Foreign currency translation adjustments332
Balance as of September 30, 2017$15,748


The latestcompany performs its annual goodwill impairment assessment of goodwill was completed in the third quarter of 2017. As of September 30, 2017, there were no accumulated goodwill impairment losses. Future impairment tests for goodwill will be performed annually in the third quarter, or earlier if impairment indicators exist.

As of June 30, 2019, there were no accumulated goodwill impairment losses.
Intangible Assets, Net


The following table summarizes intangible assets:
 June 30, 2019 December 31, 2018
(in millions)Gross
carrying
amount
 Accumulated
amortization
 Net
carrying
amount
 Gross
carrying
amount
 Accumulated
amortization
 Net
carrying
amount
Definite-lived intangible assets           
Developed product rights$19,611
 $(5,963) $13,648
 $15,872
 $(5,614) $10,258
License agreements7,798
 (2,017) 5,781
 7,865
 (1,810) 6,055
Total definite-lived intangible assets27,409
 (7,980) 19,429
 23,737
 (7,424) 16,313
Indefinite-lived research and development1,030
 
 1,030
 4,920
 
 4,920
Total intangible assets, net$28,439
 $(7,980) $20,459
 $28,657
 $(7,424) $21,233

 September 30, 2017 December 31, 2016
(in millions)Gross
carrying
amount
 Accumulated
amortization
 Net
carrying
amount
 Gross
carrying
amount
 Accumulated
amortization
 Net
carrying
amount
Definite-lived intangible assets           
Developed product rights$16,456
 $(4,805) $11,651
 $16,464
 $(4,256) $12,208
License agreements7,869
 (1,343) 6,526
 7,809
 (1,110) 6,699
Total definite-lived intangible assets24,325
 (6,148) 18,177
 24,273
 (5,366) 18,907
Indefinite-lived research and development9,990
 
 9,990
 9,990
 
 9,990
Total intangible assets, net$34,315
 $(6,148) $28,167
 $34,263
 $(5,366) $28,897
Indefinite-Lived Intangible Assets

Amortization expense was $268 million for the three months and $808 million for the nine months ended September 30, 2017 and $208 million for the three months and $554 million for the nine months ended September 30, 2016. Amortization expense was included in cost of products sold in the condensed consolidated statements of earnings.

For the nine months ended September 30, 2017, no impairment charges were recorded to intangible assets. For the nine months ended September 30, 2016, an impairment charge of $39 million was recorded related to certain developed product rights in the United States due to a decline in the market for the product. The fair value was determined based on a discounted cash flow analysis and the charge was included in cost of products sold in the condensed consolidated statement of earnings.

The indefinite-livedIndefinite-lived intangible assets represent acquired IPR&D associated with products that have not yet received regulatory approval. The indefinite-lived intangible assets as of September 30, 2017 and December 31, 2016 primarily related to the acquisitions of Stemcentrx and BI compounds. See Note 4 for additional information. The latestcompany performs its annual impairment assessment of indefinite-lived intangible assets was completed in the third quarter of 2017. No impairment charges were recorded for the nine months ended September 30, 2017 and 2016. Future impairment tests for indefinite-lived intangible assets will be performed annually in the third quarter, or earlier if impairment indicators exist. No indefinite-lived intangible asset impairment charges were recorded for the six months ended June 30, 2019 and 2018.

In April 2019, the U.S. Food and Drug Administration (FDA) and the European Commission approved SKYRIZI (risankizumab) for the treatment of moderate to severe plaque psoriasis. As a result, AbbVie reclassified $3.9 billion of indefinite-lived intangible assets related to SKYRIZI to developed product rights definite-lived intangible assets. This amount will be amortized over its estimated useful life using the estimated pattern of economic benefit.
In the fourth quarter of 2018, the company recorded an impairment charge of $5.1 billion related to IPR&D acquired as part of the 2016 Stemcentrx acquisition following the decision to stop enrollment in the TAHOE trial. AbbVie continues to evaluate information as it becomes available with respect to the Stemcentrx-related clinical development programs and will monitor the remaining $1.0 billion of IPR&D assets for further impairment.
Definite-Lived Intangible Assets
Amortization expense was $388 million for the three months and $773 million for the six months ended June 30, 2019 and $324 million for the three months and $654 million for the six months ended June 30, 2018. Amortization expense was included in cost of products sold in the condensed consolidated statements of earnings. No definite-lived intangible asset impairment charges were recorded for the six months ended June 30, 2019 and 2018.

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Note 7    Restructuring Plans
 


AbbVie recorded restructuring charges of $7$19 million for the three months and $34$186 million for the ninesix months ended SeptemberJune 30, 20172019 and $5$1 million for the three months and $35$23 million for the ninesix months ended SeptemberJune 30, 2016.2018. Restructuring charges for the three and six months ended June 30, 2019 primarily related to severance costs.


The following table summarizes the cash activity in the restructuring reserve for the ninesix months ended SeptemberJune 30, 2017:2019:
(in millions) 
Accrued balance as of December 31, 2018$99
Restructuring charges172
Payments and other adjustments(80)
Accrued balance as of June 30, 2019$191
(in millions) 
Accrued balance as of December 31, 2016$87
Restructuring charges34
Payments and other adjustments(65)
Accrued balance as of September 30, 2017$56

Note 8 Financial Instruments and Fair Value MeasuresLeases    
 

AbbVie's lease portfolio primarily consists of real estate properties, vehicles and equipment. Short-term leases with a term of 12 months or less are not recorded on the balance sheet. For leases commencing or modified in 2019 or later, AbbVie does not separate lease components from non-lease components.
The company records lease liabilities based on the present value of lease payments over the lease term. AbbVie generally uses an incremental borrowing rate to discount its lease liabilities, as the rate implicit in the lease is typically not readily determinable. Certain lease agreements include renewal options that are under the company's control. AbbVie includes optional renewal periods in the lease term only when it is reasonably certain that AbbVie will exercise its option.
Variable lease payments include payments to lessors for taxes, maintenance, insurance and other operating costs as well as payments that are adjusted based on an index or rate. The company's lease agreements do not contain any significant residual value guarantees or restrictive covenants.
The following table summarizes the amounts and location of operating and finance leases on the condensed consolidated balance sheet:
(in millions)Balance sheet captionJune 30,
2019
Assets  
OperatingOther assets$380
FinanceProperty and equipment, net27
Total lease assets $407
Liabilities  
Operating  
CurrentAccounts payable and accrued liabilities$111
NoncurrentOther long-term liabilities290
Finance  
CurrentCurrent portion of long-term debt and finance lease obligations9
NoncurrentLong-term debt and finance lease obligations22
Total lease liabilities $432


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The following table summarizes the lease costs recognized in the condensed consolidated statements of earnings:
  Three months ended
June 30,
 Six months ended
June 30,
(in millions) 2019 2019
Operating lease cost $32
 $64
Finance lease cost    
Amortization of right-of-use assets 2
 4
Interest on lease liabilities 
 
Short-term lease cost 9
 15
Variable lease cost 14
 29
Total lease cost $57
 $112

Sublease income was insignificant for the three and six months ended June 30, 2019.
The following table presents the weighted-average remaining lease term and weighted-average discount rate for operating and finance leases:
June 30,
2019
Weighted-average remaining lease term (in years)
Operating6
Finance3
Weighted-average discount rate
Operating4.0%
Finance4.4%

The following table presents supplementary cash flow information regarding the company's operating and finance leases:
 Six months ended
June 30,
(in millions)2019
Cash paid for amounts included in the measurement of lease liabilities 
Operating cash flows from operating leases$58
Operating cash flows from finance leases
Financing cash flows from finance leases4
Right-of-use assets obtained in exchange for new finance lease liabilities
Right-of-use assets obtained in exchange for new operating lease liabilities15


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The following table summarizes the future maturities of AbbVie's operating and finance lease liabilities as of June 30, 2019:
(in millions)
Operating
leases
 
Finance
leases
 
Total (a)(b)
2019$65
 $8
 $73
2020121
 11
 132
2021100
 9
 109
202255
 3
 58
202335
 1
 36
Thereafter79
 
 79
Total lease payments455
 32
 487
Less: Interest54
 1
 55
Present value of lease liabilities$401
 $31
 $432

(a) Total lease payments exclude approximately $350 million of contractual minimum lease payments for leases executed but not yet commenced. These leases will commence between years 2019 and 2020 with lease terms of approximately 11 years.
(b) Lease payments recognized as part of lease liabilities for optional renewal periods are insignificant.
Note 9    Financial Instruments and Fair Value Measures

Risk Management Policy


See Note 10 to the company's Annual Report on Form 10-K for the year ended December 31, 20162018 for a summary of AbbVie's risk management policy and use of derivative instruments.

Financial Instruments


Various AbbVie foreign subsidiaries enter into foreign currency forward exchange contracts to manage exposures to changes in foreign exchange rates for anticipated intercompany transactions denominated in a currency other than the functional currency of the local entity. These contracts, with notional amounts totaling $3.0 billion$503 million at SeptemberJune 30, 20172019 and $2.2$1.4 billion at December 31, 2016,2018, are designated as cash flow hedges and are recorded at fair value. The durations of these forward exchange contracts were generally less than eighteen18 months. Accumulated gains and losses as of SeptemberJune 30, 20172019 will be reclassified from accumulated other comprehensive loss (AOCI)AOCI and included in cost of products sold at the time the products are sold, generally not exceeding six months from the date of settlement.


The company also enters into foreign currency forward exchange contracts to manage its exposure to foreign currency denominated trade payables and receivables and intercompany loans. These contracts are not designated as hedges and are recorded at fair value. Resulting gains or losses are reflected in net foreign exchange gain or loss in the consolidated statements of earnings and are generally offset by losses or gains on the foreign currency exposure being managed. These contracts had notional amounts totaling $7.4$7.9 billion at SeptemberJune 30, 20172019 and $6.6$8.6 billion at December 31, 2016.

2018.
The company also uses foreign currency forward exchange contracts or foreign currency denominated debt to hedge its net investments in certain foreign subsidiaries and affiliates. In the fourth quarter of 2016, theThe company issuedcontinued to designate €3.6 billion aggregate principal amount of senior Euro notes as net investment hedges at June 30, 2019 and December 31, 2018. In addition, in the second quarter of 2019, the company entered into foreign currency forward exchange contracts with notional amounts totaling €971 million, £204 million and CHF62 million and designated the principal amountsinstruments as net investment hedges. The company uses the spot method of this foreign denominated debtassessing hedge effectiveness for derivative instruments designated as net investment hedges. Realized and unrealized gains and losses from these hedges are included in AOCI.AOCI and the initial fair value of hedge components excluded from the assessment of effectiveness is recognized in interest expense, net over the life of the hedging instrument.


AbbVie is a party to interest rate hedge contracts designated as fair value hedges with notional amounts totaling $11.8$10.8 billion at SeptemberJune 30, 20172019 and December 31, 2016.2018. The effect of the hedge contracts is to change a fixed-rate interest obligation to a floating rate for that portion of the debt. AbbVie records the contracts at fair value and adjusts the carrying amount of the fixed-rate debt by an offsetting amount.




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No amounts are excluded from the assessment of effectiveness for cash flow hedges or fair value hedges.

The following table summarizes the amounts and location of AbbVie’s derivative instruments on the condensed consolidated balance sheets:
Fair value –
Derivatives in asset position
 Fair value –
Derivatives in liability position
Fair value –
Derivatives in asset position
 Fair value –
Derivatives in liability position
(in millions)Balance sheet captionSeptember 30,
2017
December 31, 2016 Balance sheet captionSeptember 30,
2017
December 31, 2016Balance sheet captionJune 30,
2019
December 31, 2018 Balance sheet captionJune 30,
2019
December 31, 2018
Foreign currency forward exchange contracts        
Designated as cash flow hedges
Prepaid expenses and
other
$1
$170
 Accounts payable and accrued liabilities$150
$5
Prepaid expenses and
other
$22
$113
 Accounts payable and accrued liabilities$
$
Designated as cash flow hedgesOther assets

 Other long-term liabilities6

Designated as net investment hedgesPrepaid expenses and
other
11

 Accounts payable and accrued liabilities1

Not designated as hedges
Prepaid expenses and
other
52
55
 Accounts payable and accrued liabilities47
33
Prepaid expenses and
other
40
19
 Accounts payable and accrued liabilities38
26
Interest rate swaps designated as fair value hedgesOther assets

 Other long-term liabilities295
338
Prepaid expenses and other

 Accounts payable and accrued liabilities8

Interest rate swaps designated as fair value hedgesOther assets24

 Other long-term liabilities117
466
Total derivatives $53
$225
 $498
$376
 $97
$132
 $164
$492


While certain derivatives are subject to netting arrangements with the company’s counterparties, the company does not offset derivative assets and liabilities within the condensed consolidated balance sheets.


The following table presents the pre-tax amounts of gains (losses) from derivative instruments recognized in other comprehensive income/income (loss):
  Three months ended
June 30,
 Six months ended
June 30,
(in millions) 2019 2018 2019 2018
Foreign currency forward exchange contracts        
Designated as cash flow hedges $2
 $169
 $5
 $121
Designated as net investment hedges 10
 
 10
 

  Three months ended
September 30,
 Nine months ended
September 30,
(in millions) 2017 2016 2017 2016
Foreign currency forward exchange contracts $(114) $(5) $(253) $7


The amount of hedge ineffectiveness was insignificant for all periods presented. Assuming market rates remain constant through contract maturities, the company expects to transferreclass pre-tax unrealized lossesgains of $117$90 million into cost of products sold for foreign currency cash flow hedges during the next 12 months.


Related to AbbVie’s non-derivative, foreign currency denominated debt designated as net investment hedges, the company recognized a pre-tax loss in other comprehensive income (loss) a pre-tax loss of $142$49 million for the three months and $481a pre-tax gain of $35 million for the ninesix months ended SeptemberJune 30, 2017.

2019 and recognized pre-tax gains of $270 million for the three months and $136 million for the six months ended June 30, 2018.
The following table summarizes the pre-tax amounts and location of derivative instrument net gains (losses) recognized in the condensed consolidated statements of earnings, including the effective portions of the net gains (losses) reclassified out of AOCI into net earnings. See Note 1011 for the amount of net gains (losses) reclassified out of AOCI.

 Three months ended
September 30,
 Nine months ended
September 30,
 Three months ended
June 30,
 Six months ended
June 30,
(in millions)Statement of earnings caption 2017 2016 2017 2016Statement of earnings caption 2019 2018 2019 2018
Foreign currency forward exchange contracts                
Designated as cash flow hedgesCost of products sold $38
 $4
 $101
 $23
Cost of products sold $37
 $(46) $77
 $(90)
Designated as net investment hedgesInterest expense, net 9
 
 9
 
Not designated as hedgesNet foreign exchange loss (17) (15) (88) (122)Net foreign exchange loss (25) 128
 (40) 69
Non-designated treasury rate lock agreementsOther expense, net 
 
 
 (12)
Interest rate swaps designated as fair value hedgesInterest expense, net 11
 (49) 43
 321
Interest expense, net 253
 (59) 365
 (243)
Total $32
 $(60) $56
 $210
Debt designated as hedged item in fair value hedgesInterest expense, net (253) 59
 (365) 243


The gain (loss) related to outstanding interest rate swaps designated as fair value hedges is recognized in interest expense, net and directly offsets the (loss) gain on the underlying hedged item, the fixed-rate debt, resulting in no net impact to interest expense, net for all periods presented.



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Fair Value Measures


The fair value hierarchy consists of the following three levels:


Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets that the company has the ability to access;
Level 2 – Valuations based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuations in which all significant inputs are observable in the market; and
Level 3 – Valuations using significant inputs that are unobservable in the market and include the use of judgment by the company’s management about the assumptions market participants would use in pricing the asset or liability.


The following table summarizes the bases used to measure certain assets and liabilities carried at fair value on a recurring basis on the condensed consolidated balance sheet as of SeptemberJune 30, 2017:2019:
  Basis of fair value measurement  Basis of fair value measurement
(in millions)Total Quoted prices in active markets for identical
assets
(Level 1)
 Significant
other observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Total 
Quoted prices in active markets for
identical assets
(Level 1)
 
Significant other
observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Assets              
Cash and equivalents$8,446
 $669
 $7,777
 $
$5,172
 $1,388
 $3,784
 $
Time deposits500
 
 500
 
Debt securities2,475
 
 2,475
 
1,573
 
 1,573
 
Equity securities57
 57
 
 
79
 79
 
 
Interest rate hedges24
 
 24
 
Foreign currency contracts53
 
 53
 
73
 
 73
 
Total assets$11,531
 $726
 $10,805
 $
$6,921
 $1,467
 $5,454
 $
Liabilities              
Interest rate hedges$295
 $
 $295
 $
$125
 $
 $125
 $
Foreign currency contracts203
 
 203
 
39
 
 39
 
Contingent consideration4,455
 
 
 4,455
6,789
 
 
 6,789
Total liabilities$4,953
 $
 $498
 $4,455
$6,953
 $
 $164
 $6,789



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The following table summarizes the bases used to measure certain assets and liabilities carried at fair value on a recurring basis on the condensed consolidated balance sheet as of December 31, 2016:2018:
   Basis of fair value measurement
(in millions)Total 
Quoted prices in active markets for
identical assets
(Level 1)
 
Significant other
observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Assets       
Cash and equivalents$7,289
 $1,209
 $6,080
 $
Time deposits568
 
 568
 
Debt securities1,536
 
 1,536
 
Equity securities4
 4
 
 
Foreign currency contracts132
 
 132
 
Total assets$9,529
 $1,213
 $8,316
 $
Liabilities       
Interest rate hedges$466
 $
 $466
 $
Foreign currency contracts26
 
 26
 
Contingent consideration4,483
 
 
 4,483
Total liabilities$4,975
 $
 $492
 $4,483
   Basis of fair value measurement
(in millions)Total Quoted prices in active markets for identical
assets
(Level 1)
 Significant
other observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Assets       
Cash and equivalents$5,100
 $1,191
 $3,909
 $
Time deposits1,014
 
 1,014
 
Debt securities1,974
 
 1,974
 
Equity securities76
 76
 
 
Foreign currency contracts225
 
 225
 
Total assets$8,389
 $1,267
 $7,122
 $
Liabilities       
Interest rate hedges$338
 $
 $338
 $
Foreign currency contracts38
 
 38
 
Contingent consideration4,213
 
 
 4,213
Total liabilities$4,589
 $
 $376
 $4,213


The fair values of time deposits approximate their amortized cost due to the short maturities of these instruments. The fair values of available-for-sale debt securities were determined based on prices obtained from commercial pricing services. Available-for-sale equityEquity securities consistsconsist of investments for which the fair values were determined by using the published market price per unit multiplied by the number of units held, without consideration of transaction costs. The derivatives entered into by the company were valued using publicizedpublished spot curves for interest rate hedges and publicizedpublished forward curves for foreign currency contracts. The fair value measurements of the contingent consideration liabilities were determined based on significant unobservable inputs, including the discount rate, estimated probabilities and timing of achieving specified development, regulatory and commercial milestones and the estimated amount of future sales of the acquired products still in development.products. Changes to the fair value of the contingent consideration liabilities can result from changes to one or a number of inputs, including discount rates, the probabilities of achieving the milestones, the time required to achieve the milestones and estimated future sales. Significant judgment is employed in determining the appropriateness of these inputs. Changes to the inputs described above could have a material impact on the company's financial position and results of operations in any given period. At SeptemberJune 30, 2017,2019, a 50 basis point increase/decrease in the assumed discount rate would have decreased/increased the value of the contingent consideration liabilities by approximately $160$270 million. Additionally, at SeptemberJune 30, 2017,2019, a five percentage point increase/decrease in the assumed probability of success across all potential indications still in development would have increased/decreased the value of the contingent consideration liabilities by approximately $340$210 million.

There have been no transfers of assets or liabilities between the fair value measurement levels. The following table presents the changes in fair value of contingent consideration liabilities which are measured using Level 3 inputs:
  Six months ended
June 30,
(in millions) 2019 2018
Beginning balance $4,483
 $4,534
Change in fair value recognized in net earnings 2,473
 337
Milestone payments (167) (50)
Ending balance $6,789
 $4,821

  Nine months ended
September 30,
(in millions) 2017 2016
Beginning balance $4,213
 $
Additions (see Note 4) 
 3,985
Change in fair value recognized in net earnings 547
 143
Milestone payments (305) 
Ending balance $4,455
 $4,128
The change in fair value recognized in net earnings wasis recorded in other expense, net in the condensed consolidated statements of earningsearnings. During the second quarter of 2019, the company recorded a $2.3 billion increase in the SKYRIZI contingent consideration liability due to higher probabilities of success, higher estimated future sales and declining interest rates. The higher probabilities of success resulted from the April 2019 regulatory approvals of SKYRIZI for both the three and nine months ended September 30, 2017 and 2016.treatment of moderate to severe plaque psoriasis.



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In addition to the financial instruments that the company carries at fair value on the condensed consolidated balance sheets, certainCertain financial instruments are carried at historical cost or some basis other than fair value. The book values, approximate fair values and bases used to measure the approximate fair values of certain financial instruments as of SeptemberJune 30, 20172019 are shown in the table below:

    Basis of fair value measurement
(in millions)Book valueApproximate fair value 
Quoted prices
in active markets for
identical assets
(Level 1)
 
Significant
other 
observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Liabilities        
Short-term borrowings$306
$306
 $
 $306
 $
Current portion of long-term debt and finance lease obligations, excluding fair value hedges5,343
5,357
 5,348
 9
 
Long-term debt and finance lease obligations, excluding fair value hedges31,712
32,753
 32,731
 22
 
Total liabilities$37,361
$38,416
 $38,079
 $337
 $
    Basis of fair value measurement
(in millions)Book ValueApproximate fair value 
Quoted prices in 
active markets for identical assets
(Level 1)
 
Significant
other 
observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Assets        
Investments$47
$47
 $
 $2
 $45
Total assets$47
$47
 $
 $2
 $45
Liabilities        
Short-term borrowings$800
$800
 $
 $800
 $
Current portion of long-term debt and lease obligations3,021
3,027
 3,004
 23
 
Long-term debt and lease obligations, excluding fair value hedges34,269
35,647
 33,575
 2,072
 
Total liabilities$38,090
$39,474
 $36,579
 $2,895
 $


The book values, approximate fair values and bases used to measure the approximate fair values of certain financial instruments as of December 31, 20162018 are shown in the table below:

    Basis of fair value measurement
(in millions)Book valueApproximate fair value 
Quoted prices
in active markets for
identical assets
(Level 1)
 
Significant
other 
observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Liabilities        
Short-term borrowings$3,699
$3,693
 $
 $3,693
 $
Current portion of long-term debt and finance lease obligations, excluding fair value hedges1,609
1,617
 1,609
 8
 
Long-term debt and finance lease obligations, excluding fair value hedges35,468
34,052
 34,024
 28
 
Total liabilities$40,776
$39,362
 $35,633
 $3,729
 $

    Basis of fair value measurement
(in millions)Book ValueApproximate fair value 
Quoted prices in 
active markets for identical assets
(Level 1)
 
Significant
other 
observable
inputs
(Level 2)
 Significant
unobservable
inputs
(Level 3)
Assets        
Investments$42
$42
 $
 $5
 $37
Total assets$42
$42
 $
 $5
 $37
Liabilities        
Short-term borrowings$377
$377
 $
 $377
 $
Current portion of long-term debt and lease obligations25
25
 
 25
 
Long-term debt and lease obligations, excluding fair value hedges36,778
36,664
 34,589
 2,075
 
Total liabilities$37,180
$37,066
 $34,589
 $2,477
 $

Investments primarily consist ofAbbVie also holds investments in equity securities that do not have readily determinable fair values. The company records these investments at cost method investments, for which the company takes into consideration recent transactions and financial information of the investee, which represents a Level 3 basis ofremeasures them to fair value measurement.based on certain observable price changes or impairment events as they occur. The fair values of short-term borrowings approximate the carrying values due to the short maturitiesamount of these instruments.

The fair valuesinvestments was $65 million as of long-term debt, excluding fair value hedgesJune 30, 2019 and the term loans, were determined by using the published market price$84 million as of December 31, 2018. No significant cumulative upward or downward adjustments have been recorded for the debt instruments, without considerationthese investments as of transaction costs, which represents a Level 1 basis of fair value measurement. The fair values of the term loans were determined based on a discounted cash flow analysis using quoted market rates, which represents a Level 2 basis of fair value measurement. The counterparties to financial instruments consist of select major international financial institutions.


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June 30, 2019.
Available-for-sale Securities

Substantially all of the company’s investments in debt and equity securities were classified as available-for-sale.available-for-sale with changes in fair value recognized in other comprehensive income. Debt securities classified as short-term were $549$244 million as of SeptemberJune 30, 20172019 and $309$204 million as of December 31, 2016.2018. Long-term debt securities mature primarily within five years. Estimated fair values of available-for-sale debt securities were generally determined based on prices obtained from commercial pricing services.

The following table is a summary ofsummarizes available-for-sale securities by type as of SeptemberJune 30, 2017:2019:
 Amortized cost Gross unrealized Fair value
(in millions) Gains Losses 
Asset backed securities$375
 $
 $(1) $374
Corporate debt securities1,095
 4
 (2) 1,097
Other debt securities102
 
 
 102
Total$1,572
 $4
 $(3) $1,573

 Amortized Cost Gross unrealized Fair Value
(in millions) Gains Losses 
Asset backed securities$904
 $1
 $(2) $903
Corporate debt securities1,424
 4
 (1) 1,427
Other debt securities145
 
 
 145
Equity securities18
 41
 (2) 57
Total$2,491
 $46
 $(5) $2,532

The following table is a summary of available-for-sale securities by type as of December 31, 2016:
 Amortized Cost Gross unrealized Fair Value
(in millions) Gains Losses 
Asset backed securities$891
 $1
 $(4) $888
Corporate debt securities961
 1
 (2) 960
Other debt securities127
 
 (1) 126
Equity securities18
 60
 (2) 76
Total$1,997
 $62
 $(9) $2,050

AbbVie had no other-than-temporary impairments as of September 30, 2017. Net realized gains were $39 million for the three months and $49 million for the nine months ended September 30, 2017. Net realized gains for the three and nine months ended September 30, 2016 were insignificant.

Concentrations of Risk

The functional currency of the company’s Venezuela operations is the U.S. dollar due to the hyperinflationary status of the Venezuelan economy. During the first quarter of 2016, in consideration of declining economic conditions in Venezuela and a decline in transactions settled at the official rate, AbbVie determined that its net monetary assets denominated in the Venezuelan bolivar (VEF) were no longer expected to be settled at the official rate of 10 VEF per U.S. dollar, but rather at the Divisa Complementaria (DICOM) rate. Therefore, during the first quarter of 2016, AbbVie recorded a charge of $298 million to net foreign exchange loss to revalue its bolivar-denominated net monetary assets using the DICOM rate then in effect of approximately 270 VEF per U.S. dollar. As of September 30, 2017 and December 31, 2016, AbbVie’s net monetary assets in Venezuela were insignificant.

AbbVie continues to do business with foreign governments in certain countries, including Greece, Portugal, Italy and Spain, which have historically experienced challenges in credit and economic conditions. Substantially all of AbbVie’s trade receivables in Greece, Portugal, Italy and Spain are with government health systems. Outstanding governmental receivables in these countries, net of allowances for doubtful accounts, totaled $246 million as of September 30, 2017 and $244 million as of December 31, 2016. The company also continues to do business with foreign governments in certain oil-exporting countries that have recently experienced a deterioration in economic conditions, including Saudi Arabia and Russia, which may result in delays in the collection of receivables. Outstanding governmental receivables related to Saudi Arabia, net of allowances for doubtful accounts, were $141 million as of September 30, 2017 and $122 million as of December 31, 2016. Outstanding governmental receivables related to Russia, net of allowances for doubtful accounts, were $142 million as of September 30, 2017 and $110 million as of December 31, 2016. Global economic conditions and customer-specific factors may require the company to periodically re-evaluate the collectability of its receivables and the company could potentially incur credit losses.



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The following table summarizes available-for-sale securities by type as of December 31, 2018:
 Amortized cost Gross unrealized Fair value
(in millions) Gains Losses 
Asset backed securities$423
 $
 $(2) $421
Corporate debt securities1,042
 1
 (9) 1,034
Other debt securities81
 
 
 81
Total$1,546
 $1
 $(11) $1,536

AbbVie had no other-than-temporary impairments as of June 30, 2019. Net realized gains and losses were insignificant for both the three and six months ended June 30, 2019 and 2018.
Concentrations of Risk
Of total net accounts receivable, three U.S. wholesalers accounted for 56%66% as of SeptemberJune 30, 20172019 and 51%63% as of December 31, 2016,2018, and substantially all of AbbVie’s net revenues in the United States were to these three wholesalers.

HUMIRA (adalimumab) is AbbVie’s single largest product and accounted for approximately 66%58% of AbbVie’s total net revenues for the ninesix months ended SeptemberJune 30, 20172019 and 63%61% for the ninesix months ended SeptemberJune 30, 2016.

2018.
Debt and Credit Facilities
Short-Term Borrowings
Short-term borrowings included commercial paper borrowings of $800$306 million as of SeptemberJune 30, 20172019 and $377$699 million as of December 31, 2016.2018. The weighted-average interest rate on commercial paper borrowings was 1.2%2.7% for the ninesix months ended SeptemberJune 30, 20172019 and 0.6%1.9% for the ninesix months ended SeptemberJune 30, 2016.2018.
In March 2019, AbbVie repaid its $3.0 billion 364-day term loan credit agreement that was scheduled to mature in June 2019.
In connection with the proposed acquisition of Allergan, on June 25, 2019, AbbVie entered into a 364-day bridge credit agreement and on July 12, 2019, AbbVie entered into a term loan credit agreement. See Note 4 for additional information.
Note 9    10Post-Employment Benefits
 


The following is a summary oftable summarizes net periodic benefit costscost relating to the company’s defined benefit and other post-employment plans:
 Defined
benefit plans
 Other post-
employment plans
 Three months ended
June 30,
 Six months ended
June 30,
 Three months ended
June 30,
 Six months ended
June 30,
(in millions)2019 2018 2019 2018 2019 2018 2019 2018
Service cost$68
 $72
 $135
 $144
 $7
 $5
 $13
 $13
Interest cost66
 57
 130
 114
 9
 4
 15
 12
Expected return on plan assets(119) (110) (238) (221) 
 
 
 
Amortization of actuarial losses and prior service cost (credit)29
 39
 55
 76
 1
 (3) 
 1
Net periodic benefit cost$44
 $58
 $82
 $113
 $17
 $6
 $28
 $26

The components of net periodic benefit cost other than service cost are included in other expense, net in the condensed consolidated statements of earnings.

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 Defined
benefit plans
 Other post-
employment plans
 Three months ended
September 30,
 Nine months ended
September 30,
 Three months ended
September 30,
 Nine months ended
September 30,
(in millions)2017 2016 2017 2016 2017 2016 2017 2016
Service cost$59
 $52
 $176
 $158
 $6
 $6
 $19
 $19
Interest cost52
 50
 153
 151
 6
 6
 18
 18
Expected return on plan assets(96) (88) (286) (266) 
 
 
 
Amortization of actuarial losses and prior service costs27
 22
 80
 64
 1
 
 1
 
Net periodic benefit cost$42
 $36
 $123
 $107
 $13
 $12
 $38
 $37


AbbVie's principal domestic defined benefit plan is the AbbVie Pension Plan. AbbVie made voluntary contributions to this plan of $150 million in both the nine months ended September 30, 2017 and 2016.



Note 1011 Equity
 


Stock-Based Compensation


Stock-based compensation expense is principally related to awards issued pursuant to the AbbVie 2013 Incentive Stock Program and is summarized as follows:
  Three months ended
June 30,
 Six months ended
June 30,
(in millions) 2019 2018 2019 2018
Cost of products sold $5
 $12
 $20
 $16
Research and development 33
 35
 105
 107
Selling, general and administrative 49
 38
 151
 153
Pre-tax compensation expense 87
 85
 276
 276
Tax benefit 16
 19
 49
 48
After-tax compensation expense $71
 $66
 $227
 $228

  Three months ended
September 30,
 Nine months ended
September 30,
(in millions) 2017 2016 2017 2016
Cost of products sold $7
 $6
 $20
 $19
Research and development 30
 6
 127
 161
Selling, general and administrative 34
 35
 141
 141
Pre-tax compensation expense 71
 47
 288
 321
Tax benefit 20
 13
 85
 83
After-tax compensation expense $51
 $34
 $203
 $238


Stock Options


During the ninesix months ended SeptemberJune 30, 2017,2019, primarily in connection with the company's annual grant, AbbVie granted 1.21.0 million stock options with a weighted-average grant-date fair value of $9.80.$12.54. As of SeptemberJune 30, 2017, $202019, $8.5 million of unrecognized compensation cost related to stock options is expected to be recognized as expense over approximately the next two years.


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RSAs, RSUs and Performance Shares


During the ninesix months ended SeptemberJune 30, 2017,2019, primarily in connection with the company's annual grant, AbbVie granted 6.15.4 million RSUs and performance shares with a weighted-average grant-date fair value of $61.68.$78.68. As of SeptemberJune 30, 2017, $2922019, $434 million of unrecognized compensation cost related to RSAs, RSUs and performance shares is expected to be recognized as expense over approximately the next two years.


Cash Dividends


The following table summarizes quarterly cash dividends declared during 20172019 and 2016:2018:
2019 2018
Date Declared Payment Date Dividend Per Share Date Declared Payment Date Dividend Per Share
06/20/19 08/15/19 $1.07
 11/02/18 02/15/19 $1.07
02/21/19 05/15/19 $1.07
 09/07/18 11/15/18 $0.96

 
 

 06/14/18 08/15/18 $0.96

 
 

 02/15/18 05/15/18 $0.96


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2017 2016
Date Declared Payment Date Dividend Per Share Date Declared Payment Date Dividend Per Share
10/27/17 02/15/18 $0.71
 10/28/16 02/15/17 $0.64
09/08/17 11/15/17 $0.64
 09/09/16 11/15/16 $0.57
06/22/17 08/15/17 $0.64
 06/16/16 08/15/16 $0.57
02/16/17 05/15/17 $0.64
 02/18/16 05/16/16 $0.57






Stock Repurchase Program

On February 16, 2017, AbbVie's board of directors authorized a $5.0 billion increase to AbbVie's existing stock repurchase program. The company's stock repurchase authorization permits purchases of AbbVie shares from time to time in open-market or private transactions at management's direction depending on the company's cash flows, net debt level and market conditions.discretion. The program has no time limit and can be discontinued at any time. Shares repurchased under this programthese programs are recorded at acquisition cost, including related expenses, and are available for general corporate purposes.

AbbVie repurchased approximately 7.84 million shares in the open market for $500$300 million during the ninesix months ended SeptemberJune 30, 2017. During2019 and 84 million shares for $8.8 billion during the ninesix months ended SeptemberJune 30, 2017, AbbVie cash-settled $285 million of its open market purchases made at the end of 2016.2018. AbbVie's remaining stock repurchase authorization was $4.5approximately $4.0 billion as of SeptemberJune 30, 2017.

2019.
Accumulated Other Comprehensive Loss

The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for the ninesix months ended SeptemberJune 30, 2017:2019:
(in millions)Foreign currency
translation adjustments
 
Net investment
hedging activities
 
Pension 
and post-
employment
benefits
 
Marketable
security activities
 Cash flow hedging
activities
 Total
Balance as of December 31, 2018$(830) $(65) $(1,722) $(10) $147
 $(2,480)
Other comprehensive income (loss) before reclassifications(32) 35
 2
 10
 7
 22
Net losses (gains) reclassified from accumulated other comprehensive loss
 (7) 43
 1
 (70) (33)
Net current-period other comprehensive income (loss)(32) 28
 45
 11
 (63) (11)
Balance as of June 30, 2019$(862) $(37) $(1,677) $1
 $84
 $(2,491)

(in millions)Foreign
currency
translation
adjustments
 Net investment hedging activities 
Pension 
and post-
employment
benefits
 
Marketable
security activities
 Cash flow hedging
activities
 Total
Balance as of December 31, 2016$(1,435) $140
 $(1,513) $46
 $176
 $(2,586)
Other comprehensive income (loss) before reclassifications602
 (307) (37) 31
 (229) 60
Net losses (gains) reclassified from accumulated other comprehensive loss
 
 58
 (49) (96) (87)
Net current-period other comprehensive income (loss)602
 (307) 21
 (18) (325) (27)
Balance as of September 30, 2017$(833) $(167) $(1,492) $28
 $(149) $(2,613)


Other comprehensive incomeloss for the ninesix months ended SeptemberJune 30, 20172019 included foreign currency translation adjustments totaling a gainloss of $602$32 million, which was principally due to the impactweakening of the improvement in the Euro in the ninesix months ended SeptemberJune 30, 20172019 on the translation of the company’s assets denominated in the Euro.


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The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for the ninesix months ended SeptemberJune 30, 2016:2018:
(in millions)Foreign currency
translation adjustments
 
Net investment
hedging activities
 
Pension 
and post-
employment
benefits
 
Marketable
 security activities
 Cash flow hedging
activities
 Total
Balance as of December 31, 2017$(439) $(203) $(1,919) $
 $(166) $(2,727)
Other comprehensive income (loss) before reclassifications(280) 105
 9
 (6) 110
 (62)
Net losses reclassified from accumulated other comprehensive loss
 
 62
 4
 84
 150
Net current-period other comprehensive income (loss)(280) 105
 71
 (2) 194
 88
Balance as of June 30, 2018$(719) $(98) $(1,848) $(2) $28
 $(2,639)

(in millions)Foreign
currency
translation
adjustments
 
Pension 
and post-
employment
benefits
 
Marketable
 security activities
 Cash flow hedging
activities
 Total
Balance as of December 31, 2015$(1,270) $(1,378) $47
 $40
 $(2,561)
Other comprehensive income before reclassifications164
 7
 23
 13
 207
Net losses (gains) reclassified from accumulated other comprehensive loss
 41
 (4) (23) 14
Net current-period other comprehensive income (loss)164
 48
 19
 (10) 221
Balance as of September 30, 2016$(1,106) $(1,330) $66
 $30
 $(2,340)


Other comprehensive income for the ninesix months ended SeptemberJune 30, 20162018 included foreign currency translation adjustments totaling a gainloss of $164$280 million, which was principally due to the impactweakening of the improvementEuro in the Euro and Japanese yen in the ninesix months ended SeptemberJune 30, 20162018 on the translation of the company’s assets denominated in the Euro and Japanese yen.Euro.



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The following table below presents the impact on AbbVie’s condensed consolidated statements of earnings for significant amounts reclassified out of each component of AOCI:accumulated other comprehensive loss:
 Three months ended
September 30,
 Nine months ended
September 30,
Three months ended
June 30,
 Six months ended
June 30,
(in millions) (brackets denote gains) 2017 2016 2017 20162019 2018 2019 2018
Pension and post-employment benefits               
Amortization of actuarial losses and other(a)
 $28
 $22
 $81
 $64
$30
 $36
 $55
 $77
Tax benefit (8) (8) (23) (23)(7) (7) (12) (15)
Total reclassifications, net of tax $20
 $14
 $58
 $41
$23
 $29
 $43
 $62
Cash flow hedging activities               
Gains on designated cash flow hedges(b)
 $(38) $(2) $(101) $(21)
Losses (gains) on designated cash flow hedges(b)
$(37) $46
 $(77) $90
Tax expense (benefit) 
 (2) 5
 (2)2
 (4) 7
 (6)
Total reclassifications, net of tax $(38) $(4) $(96) $(23)$(35) $42
 $(70) $84
Net investment hedging activities       
Gains on derivative amount excluded from effectiveness testing(c)
$(9) $
 $(9) $
Tax expense2
 
 2
 
Total reclassifications, net of tax$(7) $
 $(7) $


(a) Amounts are included in the computation of net periodic benefit cost (see Note 9)10).
(b) Amounts are included in cost of products sold (see Note 8)9).
(c) Amounts are included in interest expense, net (see Note 9).
Note 1112 Income Taxes
 


The effective tax rate was 22%8% for the three months and 20%5% for the ninesix months ended SeptemberJune 30, 20172019 and 21%2% for the three months and 22%1% for the ninesix months ended SeptemberJune 30, 2016.2018. The effective tax rate in each period differed from the U.S. statutory tax rate of 21% principally due to the benefit from foreign operations which reflects the impact of lower income tax rates in locations outside the United States, tax exemptions and incentives in Puerto Rico and other foreign tax jurisdictions and business development activities together with the cost of repatriation decisions.activities. The changeincrease in the effective tax rate for the three and ninesix months ended SeptemberJune 30, 20172019 over the prior year was principally due to the beneficial impact of the timing of provisions of the Act related to earnings from certain foreign subsidiaries in prior year and changes in the jurisdictional mix of earnings, as well as certain discrete factors and events, including collaborations,a change in fair value of contingent consideration liabilities. These increases were partially offset by the impactfavorable resolution of various tax positions in the prior year non-deductible devaluation loss related to Venezuela and the impact of the adoption of ASU No. 2016-09, which changed the accounting treatment for excess tax benefits associated with stock-based awards. See Note 1 for additional information related to the adoption of this accounting pronouncement.current year.


Due to the potential for resolution of federal, state and foreign examinations and the expiration of various statutes of limitations, it is reasonably possible that the company’s gross unrecognized tax benefits balance may change within the next twelve months by up to $246$41 million. At the time of separation, AbbVie and Abbott Laboratories (Abbott) entered into a tax sharing agreement which provides that Abbott is liable for and has indemnified AbbVie against all income tax liabilities for periods prior to the separation.

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Accordingly, Abbott will indemnify and hold AbbVie harmless if the tax positions are settled for amounts in excess of recorded liabilities, and AbbVie will not benefit if prior tax positions are resolved more favorably than recorded amounts.
Note 1213 Legal Proceedings and Contingencies
 


AbbVie is subject to contingencies, such as various claims, legal proceedings and investigations regarding product liability, intellectual property, commercial, securities and other matters that arise in the normal course of business. Loss contingency provisions are recorded for probable losses at management’s best estimate of a loss, or when a best estimate cannot be made, a minimum loss contingency amount within a probable range is recorded. The recorded accrual balance for litigation was approximately $215$330 million as of SeptemberJune 30, 20172019 and $225$350 million as of December 31, 2016.2018. Initiation of new legal proceedings or a change in the status of existing proceedings may result in a change in the estimated loss accrued by AbbVie. While it is not feasible to predict the outcome of all proceedings and exposures with certainty, management believes that their ultimate disposition should not have a material adverse effect on AbbVie’s consolidated financial position, results of operations or cash flows.



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Subject to certain exceptions specified in the separation agreement by and between Abbott and AbbVie, AbbVie assumed the liability for, and control of, all pending and threatened legal matters related to its business, including liabilities for any claims or legal proceedings related to products that had been part of its business, but were discontinued prior to the distribution, as well as assumed or retained liabilities, and will indemnify Abbott for any liability arising out of or resulting from such assumed legal matters.


Several pendingFour lawsuits filed against Unimed Pharmaceuticals, Inc., Solvay Pharmaceuticals, Inc. (a company Abbott acquired in February 2010 and now known as AbbVie Products LLC) and others are consolidated for pre-trial purposes in the United States District Court for the Northern District of Georgia under the Multi-District Litigation (MDL) Rules as In re: AndroGel Antitrust Litigation, MDL No. 2084. These cases, brought by private plaintiffs and the Federal Trade Commission (FTC),direct AndroGel purchasers, generally allege Solvay's patent litigation involving AndroGel was sham litigation and the 2006 patent litigation settlement agreements and related agreements with three generic companies violate federal antitrust laws. Plaintiffs generally seek monetary damages and/or injunctive relief and attorneys' fees. These cases include: (a) four individual plaintiff lawsuits; (b) three purported class actions; and (c) Federal Trade Commission v. Actavis, Inc. et al. Following the district court's dismissal of all plaintiffs' claims, appellate proceedings led to the reinstatement of the claims regarding the patent litigation settlements, which are proceeding in the district court.


Lawsuits are pending against AbbVie and others generally alleging that the 2005 patent litigation settlement involving Niaspan entered into between Kos Pharmaceuticals, Inc. (a company acquired by Abbott in 2006 and presently a subsidiary of AbbVie) and a generic company violates federal and state antitrust laws and state unfair and deceptive trade practices and unjust enrichment laws. Plaintiffs generally seek monetary damages and/or injunctive relief and attorneys' fees. The lawsuits consist of four individual plaintiff lawsuits and two consolidated purported class actions: one brought by three namedNiaspan direct purchasers of Niaspan and the otherone brought by ten named end-payor purchasers of Niaspan.Niaspan end-payers. The cases are consolidated for pre-trial proceedingspending in the United States District Court for the Eastern District of Pennsylvania for coordinated or consolidated pre-trial proceedings under the MDL Rules as In re: Niaspan Antitrust Litigation, MDL No. 2460. In October 2016, the Orange County, California District Attorney’s Office filed a lawsuit on behalf of the State of California filed a lawsuit regarding the Niaspan patent litigation settlement in Orange County Superior Court, asserting a claim under the unfair competition provision of the California Business and Professions Code seeking injunctive relief, restitution, civil penalties and attorneys’ fees. In May 2018, the California Court of Appeal ruled that the District Attorney’s Office may not bring monetary claims beyond the scope of Orange County, which the District Attorney’s Office is appealing.


In September 2014, the FTC filed suita lawsuit against AbbVie and others in the United States District Court for the Eastern District of Pennsylvania, against AbbVie and others, alleging that the 2011 patent litigation with two generic companies regarding AndroGel was sham litigation and the patentsettlements of that litigation settlement with one of those generic companies violatesviolated federal antitrust laws. The FTC's complaint seeks monetary damages and injunctive relief.law. In May 2015, the court dismissed the FTC'sFTC’s settlement-related claim. In June 2018, following a bench trial, the court found for the FTC on its sham litigation claim regardingand ordered a disgorgement remedy of $448 million, plus prejudgment interest. The court denied the patent litigation settlement.FTC’s request for injunctive relief. AbbVie is appealing the court’s liability and disgorgement rulings and, based on an assessment of the merits of that appeal, no liability has been accrued for this matter. The FTC is also appealing aspects of the court’s trial ruling and the dismissal of its settlement-related claim. One purported class action on behalf of direct AndroGel purchasers based on the trial court’s ruling in the FTC’s case is also pending in the United States District Court for the Eastern District of Pennsylvania and is stayed pending the appeals in the FTC’s case.


In March 2015,January and February 2019, two shareholder derivative lawsuits, Brown v. Gonzalez, et al., and Elfers v. Gonzalez, et al., were filed in the United States District Court for the Northern District of Illinois, alleging that certain AbbVie directors and officers breached their fiduciary duties in connection with HUMIRA patient and reimbursement support services and other services and items of value, as alleged in the State of Louisiana filed a lawsuit, State of Louisiana v. Fournier Industrie et Sante, et al., against AbbVie, AbbottCalifornia case discussed below.

Between March and affiliated Abbott entities in Louisiana state court. Plaintiff alleges that patent applications and patent litigation filed and other alleged conduct from the early 2000's and before related to the drug TriCor violated Louisiana State antitrust and unfair trade practices laws. The lawsuit seeks monetary damages and attorneys' fees. In August 2015, the court dismissed the case as time-barred. In December 2016, the appellate court for the state’s appeal remanded for the trial court to determine whether the state is a proper party in interest. On remand, the trial court denied AbbVie’s motion to dismiss.

In August 2013, aMay 2019, 12 putative class action lawsuit, Sidney Hillman Health Center of Rochester, et al. v. AbbVie Inc., et al., waslawsuits were filed against AbbVie in the United States District Court for the Northern District of Illinois by three healthcare benefit providersindirect HUMIRA purchasers, alleging violationsthat AbbVie’s settlements with biosimilar manufacturers and AbbVie’s HUMIRA patent portfolio violate state and federal antitrust laws.


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of Federal Racketeer Influenced and Corrupt Organizations (RICO) statutes and state deceptive business practice and unjust enrichment laws in connection with reimbursements for certain uses of Depakote from 1998 to 2012. Plaintiffs seek monetary damages and/or equitable relief and attorneys' fees. In February 2017, the court dismissed this lawsuit with prejudice and in October 2017, the United States Court of Appeals for the Seventh Circuit affirmed the dismissal.

In November 2014, a putative class action lawsuit, Medical Mutual of Ohio v. AbbVie Inc., et al., was filed against several manufacturers of testosterone replacement therapies (TRTs), including AbbVie, in the United States District Court for the Northern District of Illinois on behalf of all insurance companies, health benefit providers, and other third party payorspayers who paid for TRTs, including AndroGel. The claims asserted include violations of the federal RICO Act and state consumer fraud and deceptive trade practices laws. The complaint seeks monetary damages and injunctive relief. A similarIn July 2018, the court denied the plaintiff’s motion for class certification. In February 2019, the court granted the defendants’ summary judgment motion.

In September 2018, the Commissioner of the California Department of Insurance intervened in a qui tam lawsuit, Allied Services Division Welfare FundState of California and Lazaro Suarez v. AbbVie Inc., et al., filedbrought under the California Insurance Frauds Prevention Act, in California Superior Court for Alameda County. The Department of Insurance’s complaint alleges that, through patient and reimbursement support services and other services and items of value provided in connection with HUMIRA, AbbVie caused the same courtsubmission of fraudulent commercial insurance claims for HUMIRA in October 2015 on behalfviolation of the same putative class membersCalifornia statute. The complaint seeks injunctive relief, an assessment of up to three times the amount of the claims at issue, and civil penalties. In addition, a putative class of consumers, was voluntarily dismissed in September 2017.federal securities lawsuit (Holwill v. AbbVie Inc., et al.) is


Product liability cases are
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pending in which plaintiffs generally allege that AbbVie and other manufacturers of TRTs did not adequately warn about risks of certain injuries, primarily heart attacks, strokes and blood clots. Approximately 4,300 claims are consolidated for pre-trial purposes in the United States District Court for the Northern District of Illinois underIllinois) against AbbVie, its chief executive officer and former chief financial officer, alleging that reasons stated for HUMIRA sales growth in financial filings between 2013 and 2017 were misleading because they omitted the MDL Rules as In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545. Approximately 210 claims are pending in various state courts. Plaintiffs generally seek compensatory and punitive damages. In July 2017, a juryconduct alleged in the United States District Court for the Northern DistrictDepartment of Illinois reached a verdict in the first case to be tried. The jury found for AbbVie on the plaintiff's strict liability and negligence claims and for the plaintiff on the plaintiff's fraud claim, but awarded no compensatory damages. The jury's award of $150 million in punitive damages without an underlying compensatory damage award will be subject to post-trial briefing. AbbVie expects the punitive damage award will not stand. In August 2017, a jury in the Circuit Court of Cook County, Illinois, reached a verdict for AbbVie on all claims. In October 2017, a jury in the United States District Court for the Northern District of Illinois reached a verdict for AbbVie on strict liability but for the plaintiff on remaining claims and awarded $140,000 in compensatory damages and $140 million in punitive damages, which will be the subject of post-trial proceedings.Insurance’s complaint.


Product liability cases are pending in which plaintiffs generally allege that AbbVie did not adequately warn about risk of certain injuries, primarily various birth defects, arising from use of Depakote. Over ninety percent of the approximately 625 claims are pending in the United States District Court for the Southern District of Illinois, and the rest are pending in various other federal and state courts. Plaintiffs generally seek compensatory and punitive damages.

In November 2014, five individuals filed a putative class action lawsuit, Rubinstein, et al. v Gonzalez, et al., on behalf of purchasers and sellers of certain Shire plc (Shire) securities between June 20 and October 14, 2014, against AbbVie and its chief executive officer in the United States District Court for the Northern District of Illinois alleging that the defendants made and/or are responsible for material misstatements in violation of federal securities laws in connection with AbbVie's proposed transaction with Shire. In July 2019, the court granted preliminary approval to the parties’ settlement agreement.


In June 2016, a lawsuit, Elliott Associates, L.P., et al. v. AbbVie Inc., was filed by five investment funds against AbbVie in the Cook County, Illinois Circuit Court alleging that AbbVie made misrepresentations and omissions in connection with its proposed transaction with Shire. Similar lawsuits were filed between July 2017 and September 2017October 2018 against AbbVie and in some instances its chief executive officer in the same court by twelve additional investment funds. Plaintiffs seek compensatory and punitive damages.


In May 2017, a shareholder derivative lawsuit, Ellis v. Gonzalez, et al., wasProduct liability cases were filed in Delaware Chancerywhich plaintiffs generally allege that AbbVie and other manufacturers of TRTs did not adequately warn about risks of certain injuries, primarily heart attacks, strokes and blood clots. Approximately 3,900 claims against AbbVie are consolidated for pre-trial purposes in the United States District Court allegingfor the Northern District of Illinois under the MDL Rules as In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545. Approximately 200 claims against AbbVie are pending in various state courts. Plaintiffs generally seek compensatory and punitive damages. In November 2018, AbbVie entered into a Master Settlement Agreement with the Plaintiffs’ Steering Committee in the MDL encompassing existing claims in all courts. All proceedings in pending cases are effectively stayed during the settlement administration process.

Product liability cases are pending in which plaintiffs generally allege that AbbVie's directors breached their fiduciary dutiesAbbVie did not adequately warn about risk of certain injuries, primarily various birth defects, arising from use of Depakote. Approximately 150 cases are pending in connectionthe United States District Court for the Southern District of Illinois, and approximately six others are pending in various state courts. Plaintiffs generally seek compensatory and punitive damages. Approximately ninety percent of these pending cases, plus other unfiled claims, are subject to confidential settlement agreements and are expected to be dismissed with statements made regarding the Shire transaction. The lawsuit seeks unspecified compensatory damages for AbbVie, among other relief.prejudice.


Beginning in May 2016, the Patent Trial & Appeal Board of the U.S. Patent & Trademark Office (PTO) instituted five inter partes review proceedings brought by Coherus Biosciences and Boehringer Ingelheim related to three AbbVie patents covering methods of treatment of rheumatoid arthritis using adalimumab. In these proceedings, the PTO reviewed the validity of the patents and issued decisions of invalidity in May, June and July of 2017. AbbVie’s appeal of the decisions is pending in the Court of Appeals for the Federal Circuit.


AbbVie is seeking to enforce certain patent rights related to adalimumab (a drug AbbVie sells under the trademark HUMIRA®). In a case filed in United States District Court for the District of Delaware in August 2016, AbbVie alleged that Amgen Inc.’s and Amgen Manufacturing, Limited’s proposed biosimilar adalimumab product infringed certain AbbVie patents. AbbVie sought declaratory and injunctive relief. In September 2017, the parties settled this case and it was dismissed without prejudice.


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In March 2017, AbbVie filed a lawsuit, AbbVie Inc. v. Novartis Vaccines and Diagnostics, Inc. and Grifols Worldwide Operations Ltd., in the United States District Court for the Northern District of California against Novartis Vaccines and Grifols Worldwide seeking a declaratory judgment that eleven11 HCV-related patents licensed to AbbVie in 2002 are invalid.


AbbVie is seeking to enforce certain patent rights related to adalimumab (a drug AbbVie sells under the trademark HUMIRA®). In a case filed in United States District Court for the District of Delaware in August 2017, AbbVie alleges that Boehringer Ingelheim International GmbH’s, Boehringer Ingelheim Pharmaceutical, Inc.’s, and Boehringer Ingelheim Fremont, Inc.’s proposed biosimilar adalimumab product infringes certain AbbVie patents. AbbVie seeks declaratory and injunctive relief. In May 2019, the parties settled this case and it was dismissed without prejudice.

Pharmacyclics LLC, a wholly owned subsidiary of AbbVie, is seeking to enforce its patent rights relating to ibrutinib capsules (a drug Pharmacyclics sells under the trademark IMBRUVICA®). In February 2018, cases were filed in the United States District Court for the District of Delaware against the following defendants: Fresenius Kabi USA, LLC, Fresenius Kabi USA, Inc., and Fresenius Kabi Oncology Limited; Sun Pharma Global FZE and Sun Pharmaceutical Industries Ltd.; Cipla Limited and Cipla USA Inc.; and Zydus Worldwide DMCC, Cadila Healthcare Limited, Sandoz Inc., and Lek Pharmaceuticals D.D. In each case, Pharmacyclics alleges the defendant’s proposed generic ibrutinib product infringes certain Pharmacyclics patents and seeks declaratory and injunctive relief. Janssen Biotech, Inc. which is in a global collaboration with Pharmacyclics concerning the development and marketing of IMBRUVICA, is the co-plaintiff in these suits.

Pharmacyclics LLC, a wholly owned subsidiary of AbbVie, is seeking to enforce its patent rights relating to ibrutinib tablets (a drug Pharmacyclics sells under the trademark IMBRUVICA®). In a case filed in the United States District Court for the District of Delaware in March 2019, Pharmacyclics alleges that Alvogen Pine Brook LLC’s and Natco Pharma Ltd.’s proposed generic ibrutinib tablet

2019 Form 10-Q | abbvieimage2a12.gif
24




product infringes certain Pharmacyclics patents. Pharmacyclics seeks declaratory and injunctive relief. Janssen Biotech, Inc. which is in a global collaboration with Pharmacyclics concerning the development and marketing of IMBRUVICA, is the co-plaintiff in this suit.
Note 1314 Segment Information
 


AbbVie operates in one business segment—pharmaceutical products. The following table details AbbVie’s worldwide net revenues:
   Three months ended
June 30,
 Six months ended
June 30,
    
(in millions)  2019 2018 2019 2018
Immunology        
HUMIRAUnited States $3,793
 $3,521
 $7,008
 $6,524
 International 1,077
 1,664
 2,308
 3,370
 Total $4,870
 $5,185
 $9,316
 $9,894
SKYRIZIUnited States $42
 $
 $42
 $
 International 6
 
 6
 
 Total $48
 $
 $48
 $
Hematologic Oncology        
IMBRUVICAUnited States $886
 $693
 $1,715
 $1,317
 Collaboration revenues 213
 157
 406
 295
 Total $1,099
 $850
 $2,121
 $1,612
VENCLEXTAUnited States $117
 $47
 $222
 $88
 International 52
 18
 98
 36
 Total $169
 $65
 $320
 $124
HCV        
MAVYRETUnited States $396
 $422
 $799
 $762
 International 384
 510
 771
 1,018
 Total $780
 $932
 $1,570
 $1,780
VIEKIRAUnited States $
 $
 $
 $3
 International 4
 41
 29
 109
 Total $4
 $41
 $29
 $112
Other Key Products        
CreonUnited States $257
 $219
 $484
 $428
LupronUnited States $168
 $180
 $359
 $357
 International 41
 43
 79
 85
 Total $209
 $223
 $438
 $442
SynthroidUnited States $203
 $193
 $385
 $375
SynagisInternational $38
 $44
 $325
 $365
DuodopaUnited States $24
 $20
 $46
 $38
 International 91
 88
 180
 173
 Total $115
 $108
 $226
 $211
SevofluraneUnited States $18
 $19
 $35
 $36
 International 73
 94
 148
 183
 Total $91
 $113
 $183
 $219
KaletraUnited States $10
 $13
 $23
 $26
 International 67
 78
 132
 138
 Total $77
 $91
 $155
 $164
AndroGelUnited States $22
 $128
 $96
 $258
ORILISSAUnited States $18
 $
 $31
 $
 International 1
 
 1
 
 Total $19
 $
 $32
 $
All other  $254
 $86
 $355
 $228
Total net revenues $8,255
 $8,278
 $16,083
 $16,212

  Three months ended
September 30,
 Nine months ended
September 30,
(in millions) 2017 2016 2017 2016
HUMIRA $4,701
 $4,060
 $13,535
 $11,786
IMBRUVICA 688
 501
 1,865
 1,321
HCV 276
 378
 764
 1,211
Lupron 201
 193
 605
 602
Creon 215
 187
 596
 517
Synagis 116
 96
 456
 460
Synthroid 191
 188
 576
 558
AndroGel 147
 174
 437
 501
Kaletra 85
 137
 310
 416
Sevoflurane 100
 102
 311
 327
Duodopa 94
 74
 255
 215
All other 181
 342
 767
 928
Total net revenues $6,995
 $6,432
 $20,477
 $18,842



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25







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


The following is a discussion and analysis of the financial condition of AbbVie Inc. (AbbVie or the company) as of SeptemberJune 30, 20172019 and December 31, 20162018 and the results of operations for the three and ninesix months ended SeptemberJune 30, 20172019 and 2016.2018. This commentary should be read in conjunction with the condensed consolidated financial statements and accompanying notes appearing in Item 1, “Financial Statements and Supplementary Data.”
EXECUTIVE OVERVIEW
Company Overview
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories (Abbott). AbbVie’s mission is to useAbbVie uses its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie’s products are focused on treating conditions such as chronic autoimmune diseases in rheumatology, gastroenterology and dermatology; oncology, including blood cancers; virology, including hepatitis C virus (HCV) and human immunodeficiency virus (HIV); neurological disorders, such as Parkinson’s disease and multiple sclerosis;disease; metabolic diseases, including thyroid disease and complications associated with cystic fibrosis; pain associated with endometriosis; as well as other serious health conditions. AbbVie also has a pipeline of promising new medicines in clinical development across such important medical specialties as immunology, virology, oncology and neurology,neuroscience, with additional targeted investment in cystic fibrosis and women’s health.

AbbVie’s products are generally sold worldwide directly to wholesalers, distributors, government agencies, health care facilities, specialty pharmacies and independent retailers from AbbVie-owned distribution centers and public warehouses. In the United States, AbbVie distributes pharmaceutical products principally through independent wholesale distributors, with some sales directly to pharmacies and patients. Outside the United States, sales are made either directlyAbbVie sells products primarily to customers or through distributors, depending on the market served. Certain products are co-marketed or co-promoted with other companies. AbbVie has approximately 29,00030,000 employees. AbbVie operates in one business segment—pharmaceutical products.

On June 25, 2019, AbbVie announced that it entered into a definitive transaction agreement under which AbbVie will acquire Allergan plc (Allergan). See Note 4 to the condensed consolidated financial statements for additional information on the proposed acquisition.
20172019 Strategic Objectives

AbbVie’sAbbVie's mission is to be an innovation-driven, patient-focused specialty biopharmaceutical company capable of achieving top-tier financial performance through outstanding execution and a consistent stream of innovative new medicines. AbbVie intends to continue to advance its mission in a number of ways, including: (i) growing revenues throughby diversifying revenue streams, driving late-stage pipeline assets to the market and ensuring strong commercial execution of new product launches; (ii) continued strong performance from its existing portfolio of on-market products, including its flagship brands, HUMIRAinvestment and IMBRUVICA as well as growth from pipeline products; (ii) expanding operating margins; (iii) continued investmentexpansion in its pipeline in support of opportunities in immunology, oncology virology and neurologyneuroscience, with additional targeted investment in cystic fibrosis and women's health as well as continued investment in key on-market products; (iv) augmentation of its pipeline through concerted focus on strategic licensing, acquisition(iii) expanding operating margins; and partnering activity with a focus on identifying compelling programs that fit AbbVie’s strategic criteria; and (v)(iv) returning cash to shareholders via dividends and share repurchases. In addition, AbbVie anticipates several regulatory submissions and key data readouts from key clinical trials in the next twelve months.

Financial Results

The company's financial performance for the ninesix months ended SeptemberJune 30, 20172019 included delivering worldwide net revenues of $20.5$16.1 billion, operating earnings of $7.8$6.4 billion, and diluted earnings per share of $3.27.$2.14 and cash flows from operations of $5.5 billion. Worldwide net revenues grewdecreased by 9%0.8% and increased 0.9% on a constant currency basis, primarily driven primarily by the continued strength of HUMIRA, revenue growth related to IMBRUVICA and revenue growth from other key products including Creon and Duodopa. These increases were partiallyVENCLEXTA as well as the continued strength of U.S. HUMIRA revenues, offset by a decline in net revenues of HCV product VIEKIRA.international HUMIRA biosimilar competition.

Diluted earnings per share was $3.27$2.14 for the ninesix months ended SeptemberJune 30, 20172019 and included the following after-tax costs: (i) $606 million related to the amortization of intangible assets; (ii) $546 million$2.5 billion for the change in fair value of contingent consideration liabilities; (ii) $639 million related to the amortization of intangible assets; (iii) milestone payments of $68 million; (iv) litigation reserve charges of $65 million; (v) acquisition related costs of $49 million; and (vi) $15$241 million for acquired in-process research and development (IPR&D).; (iv) $139 million of restructuring charges; (v) $75 million for milestone payments; and (vi) $27 million of expenses related to the proposed Allergan acquisition. These costs were partially offset by an after-tax benefit of $267 million due to the favorable resolution of various tax positions. Additionally, financial results for the nine months ended September 30, 2017 reflected continued added funding to support AbbVie’s emerging mid- and late-stage pipeline assets and continued investment in AbbVie’s growth brands.



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26







The company generated cash flows from operationsfinancial results reflected continued funding to support all stages of $7.4 billion for the nine months ended September 30, 2017, which AbbVie utilized to continue to enhance itsAbbVie’s emerging pipeline through licensingassets and collaboration activities, pay cash dividends to stockholders of $3.1 billion and repurchase approximately 7.8 million shares for $500 millioncontinued investment in the open market. In September 2017, AbbVie’s board of directors declared a quarterly cash dividend of $0.64 per share of common stock payable in November 2017. In October 2017, the company announced that its board of directors declared an increase in the company's quarterly cash dividend from $0.64 per share to $0.71 per share beginning with the dividend payable in February 2018. This reflects an increase of approximately 11% over the previous quarterly rate.

on-market brands.
In addition to these financial results, AbbVie continued to advance and augment its pipeline as further described below under the heading “Research and Development.”

Research and Development

Research and innovation are the cornerstones of AbbVie’s business as a global biopharmaceutical company. AbbVie’s long-term success depends to a great extent on its ability to continue to discover and develop innovative pharmaceutical products and acquire or collaborate on compounds currently in development by other biotechnology or pharmaceutical companies.

AbbVie’s pipeline currently includes more than 6050 compounds or indications in clinical development individually or under collaboration or license agreements and is focused on such important medical specialties as immunology, oncology virology and neurologyneuroscience along with targeted investments in cystic fibrosis and women’s health. Of these programs, more thanapproximately 30 are in mid- and late-stage development.

The following sections summarize transitions of significant programs from Phase 2 development to Phase 3 development as well as developments in significant Phase 3 and registration programs. AbbVie expects multiple Phase 2 programs to transition into Phase 3 programs in the next twelve months.

Significant Programs and Developments

Immunology

Upadacitinib

In June 2017, AbbVie announced that top-line results from the Phase 3 SELECT-NEXT clinical trial evaluating upadacitinib (ABT-494), the company’s selective JAK1 inhibitor currently in late-stage development for rheumatoid arthritis (RA), met all primary and ranked secondary endpoints in patients with moderate to severe RA who did not adequately respond to treatment with conventional synthetic disease modifying anti-rheumatic drugs (DMARDs). The safety profile of upadacitinib was consistent with previously reported Phase 2 trials and no new safety signals were detected.

In September 2017, AbbVie announced that top-line results from the Phase 3 SELECT-BEYOND clinical trial evaluating upadacitinib met all primary and ranked secondary endpoints in patients with moderate to severe RA who did not adequately respond or were intolerant to treatment with biologic DMARDs. The safety profile of upadacitinib was consistent with previously reported Phase 2 trials and the Phase 3 SELECT-NEXT clinical trial, with no new safety signals detected.

Risankizumab

In October 2017, AbbVie announced that top-line results from three Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, with 12-week dosing compared to ustekinumab and adalimumab met all co-primary and ranked secondary endpoints for the treatment of patients with moderate to severe chronic plaque psoriasis. The safety profile was consistent with all previously reported studies, and there were no new safety signals detected across the three studies.

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Oncology

IMBRUVICA

In January 2017, AbbVie announced thatFebruary 2019, the U.S. Food and Drug Administration (FDA) approved IMBRUVICAaccepted for the treatment of patients with relapsed/refractory marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. MZL is a slow-growing form of non-Hodgkin's lymphoma.

In August 2017, AbbVie announced that the FDA approved IMBRUVICApriority review AbbVie's New Drug Application (NDA) for upadacitinib, an investigational oral JAK1-selective inhibitor, for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. IMBRUVICA is the first therapy specifically approved for adults with cGVHD, amoderate to severe and potentially life-threatening consequence of stem cell or bone marrow transplant. This marks the sixth U.S. disease indication for IMBRUVICA since the medication's initial approval in 2013 and the first approved indication outside of cancer.

Venetoclax

rheumatoid arthritis (RA).
In February 2017, AbbVie initiated a Phase 3 clinical trial to study the safety and efficacy of venetoclax in combination with azacitidine in untreated (treatment-naïve) elderly subjects with acute myeloid leukemia (AML) who are ineligible for standard induction therapy (high-dose chemotherapy).

In May 2017, AbbVie initiated a Phase 3 clinical trial to evaluate if venetoclax when co-administered with low dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment naïve subjects with AML.

In September 2017, AbbVie announced that top-line results from the Phase 3 MURANO clinical trial evaluating venetoclax tablets in combination with Rituxan (rituximab) met the primary endpoint of prolonged progression-free survival compared with bendamustine in combination with Rituxan in patients with relapsed/refractory chronic lymphocytic leukemia.

Rova-T

In February 2017,2019, AbbVie initiated a Phase 3 clinical trial to evaluate the efficacy and safety of Rova-T as maintenance therapy following first-line platinum based chemotherapyupadacitinib in participantssubjects with extensive stage smallgiant cell lung cancer (SCLC).arteritis.

SKYRIZI
In March 2019, AbbVie initiated two Phase 3 clinical trials to evaluate the efficacy and safety of risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in subjects with psoriatic arthritis.
In April 2017, AbbVie initiated a Phase 3 clinical trial2019, the FDA approved SKYRIZI (risankizumab) for the treatment of moderate to evaluate Rova-T compared with topotecansevere plaque psoriasis in adults who are candidates for subjects with advancedsystemic therapy or metastatic SCLC with high levels of delta-like protein 3 who have first disease progression during or following front-line platinum-based chemotherapy.

Veliparib

phototherapy.
In April 2017,2019, the European Commission granted marketing authorization for SKYRIZI for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Oncology
IMBRUVICA
In January 2019, the FDA approved IMBRUVICA, in combination with GAZYVA (obinutuzumab), for adult patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
In June 2019, AbbVie announced results from the Phase 3 CLL12 trial, evaluating IMBRUVICA in patients with previously untreated CLL, which demonstrated that IMBRUVICA significantly improved event- and progression-free survival.
VENCLEXTA
In March 2019, AbbVie announced that twothe FDA placed a partial clinical hold on all clinical trials evaluating VENCLEXTA for the investigational treatment of multiple myeloma (MM). The partial clinical hold followed a review of data from the ongoing Phase 3 studiesBELLINI trial, a study in relapsed/refractory MM, in which a higher proportion of deaths was observed in the VENCLEXTA arm compared to the control arm of the trial. In June 2019, AbbVie announced that the FDA lifted the partial clinical hold placed on the Phase 3 CANOVA trial, evaluating VENCLEXTA for the investigational treatment of relapsed/refractory MM positive for the translocation (11;14) abnormality, based upon agreement on revisions to the

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27




CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria. All other clinical trials evaluating VENCLEXTA in patients with MM remain on partial clinical hold while next steps continue to be evaluated with the FDA. This action does not impact any of the approved indications for VENCLEXTA, such as CLL or acute myeloid leukemia (AML).
In May 2019, the FDA approved VENCLEXTA, in combination with obinutuzumab, for adult patients with previously untreated CLL/SLL.
In June 2019, AbbVie announced results from the Phase 3 CLL14 trial, evaluating efficacy and safety of VENCLEXTA plus obinutuzumab versus obinutuzumab plus chlorambucil in previously untreated patients with CLL, which demonstrated that VENCLEXTA plus obinutuzumab prolonged progression-free survival and achieved higher rates of complete response and minimal residual disease-negativity compared to commonly used standard of care obinutuzumab plus chlorambucil.
Depatux-M
In May 2019, AbbVie announced the decision to discontinue the Phase 3 INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) in patients with newly diagnosed glioblastoma, whose tumors have EGFR (epidermal growth factor receptor) amplification, at an interim analysis. An Independent Data Monitoring Committee recommended stopping enrollment in INTELLANCE-1 due to lack of survival benefit for patients receiving Depatux-M compared with placebo when added to the standard regimen of radiation and temozolomide. Enrollment has been halted in all ongoing Depatux-M studies.
Veliparib
In July 2019, AbbVie announced that top-line results from the Phase 3 BROCADE3 study evaluating veliparib, an investigational, oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, in combination with chemotherapy did not meet theircarboplatin and paclitaxel met its primary endpoints. The studies evaluatedendpoint of progression-free survival in patients with HER2 negative germline BRCA-mutated advanced breast cancer.
In July 2019, AbbVie announced that top-line results from the Phase 3 VELIA study, conducted in collaboration with the GOG Foundation, Inc., evaluating veliparib in combination with carboplatin and paclitaxel followed by veliparib maintenance therapy met its primary endpoint of progression-free survival in patients with squamous non-small cell lungnewly diagnosed ovarian cancer, (NSCLC) and triple negative breast cancer (TNBC). Ongoingregardless of biomarker status.
Neuroscience
In May 2019, AbbVie initiated a Phase 3 studies include non-squamous non-small cell lung cancer, BRCA1/2 breast cancerclinical trial to evaluate the safety and ovarian cancer.

Virology/Liver Disease

In February 2017, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) grantedtolerability of ABBV-951, a positive opinion for a shorter, eight-week treatment of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) as an option for previously untreated adult patientssubcutaneous levodopa/carbidopa delivery system, in subjects with genotype 1b chronic HCV and minimal to moderate fibrosis.

Parkinson's disease.
In July 2017,2019, AbbVie announced that the European Commission granted marketing authorization for MAVIRET (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with HCV infection across all major genotypes (GT1-6). MAVIRET is also indicated fordecision to discontinue the Phase 2 ARISE study evaluating ABBV-8E12, an investigational anti-tau antibody, in patients with specific treatment challenges, including those with compensated

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28




cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV infection.

In August 2017, AbbVie announcedprogressive supranuclear palsy, after an Independent Data Monitoring Committee recommended stopping the trial for futility after the trial showed that the FDA approved MAVYRET (glecaprevir/pibrentasvir) for the treatment of patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, butABBV-8E12 did not both. MAVYRET/MAVIRET is a new 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.

provide efficacy.
Other

In September 2017,July 2019, AbbVie announced that it had submitted a New Drug Applicationan NDA to the FDA for elagolix an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being evaluatedin combination with estradiol/norethindrone acetate (E2/NETA) daily add-back therapy for the management of endometriosisheavy menstrual bleeding associated with associated pain. In October, AbbVie was granted priority review for elagolix by the FDA.

uterine fibroids.
For a more comprehensive discussion of AbbVie’s products and pipeline, see the company’s Annual Report on Form 10-K for the year ended December 31, 2016.2018.

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28




RESULTS OF OPERATIONS
Net Revenues
The comparisons presented at constant currency rates reflect comparative local currency net revenues at the prior year’s foreign exchange rates. This measure provides information on the change in net revenues assuming that foreign currency exchange rates had not changed between the prior and the current periods. AbbVie believes that the non-GAAP measure of change in net revenues at constant currency rates, when used in conjunction with the GAAP measure of change in net revenues at actual currency rates, may provide a more complete understanding of the company’s operations and can facilitate analysis of the company’s results of operations, particularly in evaluating performance from one period to another.

 Three months ended
September 30,
 Percent change Nine months ended
September 30,
 Percent change Three months ended
June 30,
 Percent change Six months ended
June 30,
 Percent change
 At actual
currency rates
 At constant
currency rates
 At actual
currency rates
 At constant
currency rates
 At actual
currency rates
 At constant
currency rates
 At actual
currency rates
 At constant
currency rates
(dollars in millions) 2017 2016 2017
2016  2019 2018 2019 2018 
United States $4,586
 $4,081
 12.4% 12.4% $13,284
 $11,695
 13.6% 13.6% $5,964
 $5,449
 9.5 % 9.5 % $11,234
 $10,239
 9.7 % 9.7 %
International 2,409
 2,351
 2.4% 0.3% 7,193
 7,147
 0.6% 1.0% 2,291
 2,829
 (19.0)% (14.4)% 4,849
 5,973
 (18.8)% (14.3)%
Net revenues $6,995
 $6,432
 8.8% 8.1% $20,477
 $18,842
 8.7% 8.8% $8,255
 $8,278
 (0.3)% 1.3 % $16,083
 $16,212
 (0.8)% 0.9 %




20172019 Form 10-Q | abbvieimage2a12.gif
29







The following table details AbbVie’s worldwide net revenues:

  Three months ended
September 30,
 Percent change Nine months ended
September 30,
 Percent change
   At actual
currency rates
 At constant
currency rates
  At actual
currency rates
 At constant
currency rates
(dollars in millions) 2017 2016  2017 2016 
HUMIRA                
United States $3,151
 $2,647
 19.1 % 19.1 % $9,048
 $7,554
 19.8 % 19.8 %
International 1,550
 1,413
 9.7 % 6.8 % 4,487
 4,232
 6.0 % 6.8 %
Total $4,701
 $4,060
 15.8 % 14.8 % $13,535
 $11,786
 14.8 % 15.1 %
IMBRUVICA                
United States $574
 $437
 31.0 % 31.0 % $1,559
 $1,146
 36.0 % 36.0 %
Collaboration revenues 114
 64
 80.7 % 80.7 % 306
 175
 75.4 % 75.4 %
Total $688
 $501
 37.3 % 37.3 % $1,865
 $1,321
 41.2 % 41.2 %
HCV                
United States $60
 $76
 (19.5)% (19.5)% $124
 $288
 (56.6)% (56.6)%
International 216
 302
 (28.7)% (29.8)% 640
 923
 (30.7)% (30.5)%
Total $276
 $378
 (26.8)% (27.7)% $764
 $1,211
 (36.9)% (36.7)%
Lupron                
United States $161
 $155
 4.1 % 4.1 % $488
 $485
 0.6 % 0.6 %
International 40
 38
 3.5 % 1.6 % 117
 117
 (0.1)% (0.5)%
Total $201
 $193
 4.0 % 3.6 % $605
 $602
 0.5 % 0.4 %
Creon                
United States $215
 $187
 14.8 % 14.8 % $596
 $517
 15.3 % 15.3 %
Synagis                
International $116
 $96
 21.0 % 23.5 % $456
 $460
 (0.8)% (1.7)%
Synthroid                
United States $191
 $188
 1.5 % 1.5 % $576
 $558
 3.1 % 3.1 %
AndroGel                
United States $147
 $174
 (14.9)% (14.9)% $437
 $501
 (12.7)% (12.7)%
Kaletra                
United States $16
 $27
 (39.2)% (39.2)% $54
 $90
 (39.9)% (39.9)%
International 69
 110
 (38.2)% (40.4)% 256
 326
 (21.7)% (24.3)%
Total $85
 $137
 (38.4)% (40.2)% $310
 $416
 (25.7)% (27.7)%
Sevoflurane                
United States $19
 $19
 0.5 % 0.5 % $56
 $58
 (2.4)% (2.4)%
International 81
 83
 (3.4)% (3.3)% 255
 269
 (5.5)% (3.8)%
Total $100
 $102
 (2.7)% (2.6)% $311
 $327
 (4.9)% (3.5)%
Duodopa                
United States $16
 $10
 56.4 % 56.4 % $44
 $26
 70.8 % 70.8 %
International 78
 64
 21.5 % 16.6 % 211
 189
 11.7 % 12.3 %
Total $94
 $74
 26.3 % 22.0 % $255
 $215
 18.7 % 19.2 %
All other $181
 $342
 (46.9)% (47.4)% $767
 $928
 (17.4)% (17.1)%
Total net revenues $6,995
 $6,432
 8.8 % 8.1 % $20,477
 $18,842
 8.7 % 8.8 %
   Three months ended
June 30,
 Percent change Six months ended
June 30,
 Percent change
    At actual
currency rates
 At constant
currency rates
  At actual
currency rates
 At constant
currency rates
(dollars in millions) 2019 2018  2019 2018 
Immunology                
HUMIRAUnited States $3,793
 $3,521
 7.7 % 7.7 % $7,008
 $6,524
 7.4 % 7.4 %
 International 1,077
 1,664
 (35.2)% (31.0)% 2,308
 3,370
 (31.5)% (27.0)%
 Total $4,870
 $5,185
 (6.1)% (4.8)% $9,316
 $9,894
 (5.8)% (4.3)%
SKYRIZIUnited States $42
 $
 n/m
 n/m
 $42
 $
 n/m
 n/m
 International 6
 
 n/m
 n/m
 6
 
 n/m
 n/m
 Total $48
 $
 n/m
 n/m
 $48
 $
 n/m
 n/m
Hematologic Oncology                
IMBRUVICAUnited States $886
 $693
 27.9 % 27.9 % $1,715
 $1,317
 30.2 % 30.2 %
 Collaboration revenues 213
 157
 35.9 % 35.9 % 406
 295
 37.6 % 37.6 %
 Total $1,099
 $850
 29.3 % 29.3 % $2,121
 $1,612
 31.6 % 31.6 %
VENCLEXTAUnited States $117
 $47
 >100.0%
 >100.0%
 $222
 $88
 >100.0%
 >100.0%
 International 52
 18
 >100.0%
 >100.0%
 98
 36
 >100.0%
 >100.0%
 Total $169
 $65
 >100.0%
 >100.0%
 $320
 $124
 >100.0%
 >100.0%
HCV                
MAVYRETUnited States $396
 $422
 (6.0)% (6.0)% $799
 $762
 4.8 % 4.8 %
 International 384
 510
 (24.7)% (20.4)% 771
 1,018
 (24.3)% (20.5)%
 Total $780
 $932
 (16.3)% (14.0)% $1,570
 $1,780
 (11.8)% (9.6)%
VIEKIRAUnited States $
 $
 n/m
 n/m
 $
 $3
 (100.0)% (100.0)%
 International 4
 41
 (88.8)% (86.4)% 29
 109
 (72.7)% (69.1)%
 Total $4
 $41
 (90.3)% (87.9)% $29
 $112
 (74.2)% (70.6)%
Other Key Products                
CreonUnited States $257
 $219
 17.5 % 17.5 % $484
 $428
 13.1 % 13.1 %
LupronUnited States $168
 $180
 (6.4)% (6.4)% $359
 $357
 0.5 % 0.5 %
 International 41
 43
 (4.5)% 3.2 % 79
 85
 (6.7)% 1.0 %
 Total $209
 $223
 (6.0)% (4.5)% $438
 $442
 (0.9)% 0.6 %
SynthroidUnited States $203
 $193
 4.9 % 4.9 % $385
 $375
 2.7 % 2.7 %
SynagisInternational $38
 $44
 (11.9)% (3.9)% $325
 $365
 (10.9)% (6.6)%
DuodopaUnited States $24
 $20
 12.8 % 12.8 % $46
 $38
 20.1 % 20.1 %
 International 91
 88
 3.6 % 11.0 % 180
 173
 3.9 % 11.3 %
 Total $115
 $108
 5.3 % 11.3 % $226
 $211
 6.8 % 12.8 %
SevofluraneUnited States $18
 $19
 (3.3)% (3.3)% $35
 $36
 (2.0)% (2.0)%
 International 73
 94
 (21.9)% (16.3)% 148
 183
 (19.1)% (13.2)%
 Total $91
 $113
 (18.8)% (14.1)% $183
 $219
 (16.3)% (11.4)%
KaletraUnited States $10
 $13
 (33.9)% (33.9)% $23
 $26
 (15.0)% (15.0)%
 International 67
 78
 (12.9)% (6.8)% 132
 138
 (3.9)% 1.7 %
 Total $77
 $91
 (16.0)% (10.8)% $155
 $164
 (5.7)% (1.0)%
AndroGelUnited States $22
 $128
 (83.0)% (83.0)% $96
 $258
 (62.8)% (62.8)%
ORILISSAUnited States $18
 $
 n/m
 n/m
 $31
 $
 n/m
 n/m
 International 1
 
 n/m
 n/m
 1
 
 n/m
 n/m
 Total $19
 $
 n/m
 n/m
 $32
 $
 n/m
 n/m
All other  $254
 $86
 >100.0%
 >100.0%
 $355
 $228
 55.2 % 61.3 %
Total net revenues $8,255
 $8,278
 (0.3)% 1.3 % $16,083
 $16,212
 (0.8)% 0.9 %

n/m – Not meaningful
The following discussion and analysis of AbbVie’s net revenues by product is presented on a constant currency basis.


Global HUMIRA sales increased 15%decreased 5% for both the three months and nine4% for the six months ended SeptemberJune 30, 20172019 primarily as a result of direct biosimilar competition in certain international markets, partially offset by market growth across therapeutic categories and geographies as well as favorable pricing in certain geographies.categories. In the United States, HUMIRA sales increased 19%8% for the three months and 20%7% for the ninesix months ended SeptemberJune 30, 20172019 driven by market growth across all indications and favorable pricing.indications. Internationally, HUMIRA sales increased 7%decreased 31% for both the three months and nine27% for the six months ended September

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June 30, 20172019 primarily driven primarily by market growth.direct biosimilar competition in certain international markets following the expiration of the European Union composition of matter patent for adalimumab in October 2018. Biosimilar competition for HUMIRA is not expected in the United States until 2023. AbbVie continues to pursue strategies intended to further differentiate HUMIRA from competing products and add to the sustainability and future growth of HUMIRA.



Net revenues for SKYRIZI were $48 million for the three and six months ended June 30, 2019 following the April 2019 regulatory approvals for the treatment of moderate to severe plaque psoriasis.
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Net revenues for IMBRUVICA represent product revenuessales in the United States and collaboration revenues outside of the United States related to AbbVie’s 50% share of IMBRUVICA profit. GlobalAbbVie's global IMBRUVICA salesrevenues increased 37%29% for the three months and 41%32% for the ninesix months ended SeptemberJune 30, 20172019 as a result of continued penetration of IMBRUVICA as a first-line treatment for patients with chronic lymphocytic leukemia (CLL)CLL as well as favorable pricing.


Net revenues for VENCLEXTA increased by more than 100% for the three and six months ended June 30, 2019 primarily due to market share gains following additional regulatory approvals of VENCLEXTA for the treatment of patients with relapsed/refractory CLL and AML in 2018.

Global HCVMAVYRET sales decreased 28%by 14% for the three months and 37%10% for the ninesix months ended SeptemberJune 30, 2017 as a result of market contraction,2019 primarily driven by lower market share and price erosion of VIEKIRA. These factors were partially offset by the launch of MAVYRETpatient volumes in certain geographies during the third quarter of 2017.international markets.


Net revenues for Creon increased 15%18% for both the three months and nine13% for the six months ended SeptemberJune 30, 20172019 primarily driven primarily by continued market growth and higher market share.favorable pricing. Creon maintains market leadership in the pancreatic enzyme market.

Synagis is a seasonal product with the majority of sales occurring in the first and fourth quarters. Synagis revenues increased 23% for the three months ended September 30, 2017 primarily due to seasonal acceleration in certain geographies and tender timing. Synagis revenues for the nine months ended September 30, 2017 decreased 2%.


Net revenues for Duodopa increased 22%11% for the three months and 19%13% for the ninesix months ended SeptemberJune 30, 20172019 primarily as a result ofdriven by increased market penetration and geographic expansion.penetration.
Gross Margin

 Three months ended
September 30,
 Nine months ended
September 30,
 Three months ended
June 30,
 Six months ended
June 30,
(dollars in millions) 2017 2016 % change 2017 2016 % change 2019 2018 % change 2019 2018 % change
Gross margin $5,379
 $4,928
 9% $15,717
 $14,564
 8% $6,436
 $6,344
 1% $12,570
 $12,351
 2%
as a % of net revenues 77% 77%   77% 77%   78% 77%   78% 76%  
Gross margin as a percentage of net revenues was flatincreased for both the three and ninesix months ended SeptemberJune 30, 20172019 compared to the prior year. Gross margin percentage for both the three and ninesix months ended SeptemberJune 30, 20172019 was favorably impacted primarily by product mix and operational efficiencies,the expiration of HUMIRA royalties, partially offset by the unfavorable impact of higher intangible asset amortization and the IMBRUVICA profit sharing arrangement.

Selling, General and Administrative

 Three months ended
September 30,

Nine months ended
September 30,
 Three months ended
June 30,
 Six months ended
June 30,
(dollars in millions) 2017 2016 % change
2017
2016
% change 2019 2018 % change 2019 2018 % change
Selling, general and administrative $1,452
 $1,381
 5% $4,324
 $4,202
 3% $1,654
 $1,760
 (6)% $3,334
 $3,551
 (6)%
as a % of net revenues 21% 21%   21% 22%   20% 21%   21% 22%  

SG&ASelling, general and administrative (SG&A) expenses as a percentage of net revenues was flatdecreased for the three months and decreased for the ninesix months ended SeptemberJune 30, 20172019 compared to the prior year. SG&A expense percentage for both the three and ninesix months ended SeptemberJune 30, 20172019 was favorably impacted by continued leverage from revenue growth,lower charitable contributions, as $120 million of prior year contributions to certain U.S. not-for-profit organizations did not recur, and by international HUMIRA expense reductions, partially offset by new product launch expenses.expenses and $24 million of transaction costs associated with the proposed Allergan acquisition. In addition, for the six months ended June 30, 2019, SG&A expense percentage for the nine months ended September 30, 2017 was also unfavorably impacted by restructuring charges, offset by a $98 million decrease in litigation reserve charges of $97 million.charges.


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31







Research and Development and Acquired In-Process Research and Development

 Three months ended
September 30,
 Nine months ended
September 30,
 Three months ended
June 30,
 Six months ended
June 30,
(dollars in millions) 2017 2016 % change 2017 2016 % change 2019 2018 % change 2019 2018 % change
Research and development $1,222
 $1,106
 11 % $3,580
 $3,176
 13 % $1,291
 $1,322
 (2)% $2,580
 $2,566
 1%
as a % of net revenues 17% 17%   17% 17%   16% 16%   16% 16%  
Acquired in-process research and development $
 $80
 (100)% $15
 $160
 (91)% $91
 $
 n/m
 $246
 $69
 >100%

Research and Developmentdevelopment(R&D) expenses as a percentage of net revenues were flat for both the three and ninesix months ended SeptemberJune 30, 2017 increased2019 compared to the prior year principally due to increasedyear. R&D expenses included continued funding to support the company’s emerging mid- and late-stage pipeline assets and the impactall stages of the post-acquisition R&D expenses of Stemcentrx and Boehringer Ingelheim (BI) compounds. These increases were partially offset by lower acquisition related costs, which decreased by $54 million for the three months and $130 million for the nine months ended September 30, 2017 compared to the prior year.company's emerging pipeline assets.


Acquired in-process research and development (IPR&D)IPR&D expenses reflect upfront payments related to various collaborations. There were no individually significant transactions or cash flows during both the three and ninesix months ended SeptemberJune 30, 20172019 and 2016.2018.

Other Operating Expenses
There were no other operating expenses for the three and six months ended June 30, 2019. Other operating expenses for the six months ended June 30, 2018 included a $500 million charge related to the extension of the previously announced collaboration with Calico Life Sciences LLC (Calico) to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer.
Other Non-Operating Expenses

 Three months ended
September 30,
 Nine months ended
September 30,
 Three months ended
June 30,
 Six months ended
June 30,
(in millions) 2017 2016 2017 2016 2019 2018 2019 2018
Interest expense $293
 $271
 $851
 $731
 $358
 $320
 $745
 $629
Interest income (41) (21) (99) (56) (49) (48) (111) (106)
Interest expense, net $252
 $250
 $752
 $675
 $309
 $272
 $634
 $523
                
Net foreign exchange loss (gain) $9
 $(4) $28
 $313
Net foreign exchange loss $6
 $8
 $12
 $16
Other expense, net 349
 101
 484
 152
 2,278
 470
 2,413
 317
Interest expense, net was flatincreased for the three and six months ended SeptemberJune 30, 2017 compared to the prior year. The increase for the nine months ended September 30, 20172019 compared to the prior year was primarily due to the May 2016 issuanceunfavorable impact of $7.8 billion aggregate principal amount of senior notes, which were issued to financehigher interest rates on the acquisition of Stemcentrxcompany's debt obligations and to repay anhigher average outstanding term loan.debt balances.

Net foreign exchange loss for the nine months ended September 30, 2016 included losses totaling $298 million related to the devaluation of AbbVie’s net monetary assets denominated in the Venezuelan bolivar. See Note 8 to the Condensed Consolidated Financial Statements for additional information regarding the Venezuelan devaluation.


Other expense, net included charges related to changes in fair value of the BI and Stemcentrx contingent consideration liabilities which totaled $401of $2.3 billion for the three months and $2.5 billion for the six months ended June 30, 2019 compared to charges of $485 million for the three months and $547$337 million for the ninesix months ended SeptemberJune 30, 2017 compared to $104 million for the three months and $145 million for the nine months ended September 30, 2016 following the initial recognition of these liabilities in the second quarter of 2016.2018. The fair value of contingent consideration liabilities is impacted by the passage of time and multiple other inputs, including the probability of success of achieving regulatory/commercial milestones, discount rates, the estimated amount of future sales of the acquired products and other market-based factors. For the three and ninesix months ended SeptemberJune 30, 2017,2019, the change in fair value represented mainly higher probabilities of success, higher estimated future sales and declining interest rates. The higher probabilities of success resulted from the April 2019 regulatory approvals of SKYRIZI for the treatment of moderate to severe plaque psoriasis. For the three and six months ended June 30, 2018, the change in fair value represented higher estimated future sales and the passage of time. See Note 4 totime partially offset by the Condensed Consolidated Financial Statements for additional information regarding the acquisitionseffect of Stemcentrx and BI compounds. Other expense, net also included realized gains on available-for-sale investment securities of $39 million for the three months and $49 million for the nine months ended September 30, 2017.rising interest rates.



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32







Income Tax Expense

The effective tax rate was 22%8% for the three months and 20%5% for the ninesix months ended SeptemberJune 30, 20172019 and 21%2% for the three months and 22%1% for the ninesix months ended SeptemberJune 30, 2016.2018. The effective tax rate in each period differed from the U.S. statutory tax rate of 21% principally due to the benefit from foreign operations which reflects the impact of lower income tax rates in locations outside the United States, tax exemptions and incentives in Puerto Rico and other foreign tax jurisdictions and business development activities together with the cost of repatriation decisions.activities. The changeincrease in the effective tax rate for both the three and ninesix months ended SeptemberJune 30, 20172019 over the prior year was principally due to the beneficial impact of the timing of provisions of the Tax Cuts and Jobs Act (the Act) related to earnings from certain foreign subsidiaries in prior year and changes in the jurisdictional mix of earnings, as well as certain discrete factors and events, including collaborations,a change in fair value of contingent consideration liabilities. These increases were partially offset by the impactfavorable resolution of various tax positions in the prior year non-deductible devaluation loss related to Venezuela and the impact of the adoption of ASU No. 2016-09, which changed the accounting treatment for excess tax benefits associated with stock-based awards. See Note 1 to the Condensed Consolidated Financial Statements for additional information related to the adoption of this accounting pronouncement.current year.
FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES
Nine months ended
September 30,
Six months ended
June 30,
(in millions)2017 20162019 2018
Cash flows provided by (used in):      
Operating activities$7,376
 $5,500
$5,494
 $5,511
Investing activities(475) (5,955)(167) 240
Financing activities(3,584) (1,426)(7,453) (11,487)
Operating cash flows for the ninesix months ended SeptemberJune 30, 2017 reflected2019 were flat compared to the prior year due to improved results of operations resulting from revenue growth and an improvementincrease in operating earnings as well as favorability from the timing ofand lower defined benefit plan contributions, offset by higher payments for income tax payments compared to the prior year. Cash provided by operating activities reflectedtaxes and interest. AbbVie’s voluntary contributions to its principal domestic defined benefit plan of $150 million for both the nine months ended September 30, 2017 and 2016. Realized excess tax benefits associated with stock-based compensation totaled $53plans were $203 million for the ninesix months ended SeptemberJune 30, 20172019 and were presented within cash flows from operating activities as a result of$822 million for the adoption of a new accounting pronouncement. In the ninesix months ended SeptemberJune 30, 2016, prior to the adoption of the new accounting pronouncement, realized excess tax benefits of $47 million were presented within cash flows from financing activities. See Note 1 to the Condensed Consolidated Financial Statements for additional information regarding the adoption of this new accounting pronouncement.2018.


Investing cash flows for the ninesix months ended SeptemberJune 30, 20172019 included net sales and maturities of investment securities totaling $52$508 million, payments made for acquisitions and investments of $440 million and capital expenditures of $235 million. ForInvesting cash flows for the ninesix months ended SeptemberJune 30, 2016, investing activities primarily2018 included $1.9 billion of cash consideration paid to acquire Stemcentrx in June 2016, a $595 million upfront payment to acquire certain BI compounds in April 2016net sales and net purchasesmaturities of investment securities totaling $2.9 billion. Cash flows from investing activities$874 million, payments made for the nine months ended September 30, 2017acquisitions and 2016 also reflectedinvestments of $401 million and capital expenditures and other acquisitions and investments.of $233 million.


Financing cash flows for the six months ended June 30, 2019 included the repayment of AbbVie's $3.0 billion 364-day term loan credit agreement that was scheduled to mature in June 2019.

The company made cash dividend payments of $3.1$3.2 billion for the ninesix months ended SeptemberJune 30, 20172019 and $2.8$2.7 billion for the ninesix months ended SeptemberJune 30, 2016.2018. The increase in cash dividend payments was driven by an increase in the quarterly dividend rate from $0.57 per share to $0.64 per share beginning with the dividend that was paid in February 2017.rate. On September 8, 2017,June 20, 2019, the board of directors declared a quarterly cash dividend of $0.64$1.07 per share for stockholders of record at the close of business on October 13, 2017,July 15, 2019, payable on NovemberAugust 15, 2017. On October 27, 2017, the company announced that its board of directors declared an increase in the company's quarterly cash dividend from $0.64 per share to $0.71 per share beginning with the dividend payable on February 15, 2018 to stockholders of record as of January 12, 2018. This reflects an increase of approximately 11% over the previous quarterly rate.2019. The timing, declaration, amount of and payment of any dividends by AbbVie in the future is within the discretion of its board of directors and will depend upon many factors, including AbbVie’s financial condition, earnings, capital requirements of its operating subsidiaries, covenants associated with certain of AbbVie’s debt service obligations, legal requirements, regulatory constraints, industry practice, ability to access capital markets and other factors deemed relevant by its board of directors.


On February 16, 2017, AbbVie's board of directors authorized a $5.0 billion increase to AbbVie's existing stock repurchase program. Under this program, the company repurchased approximately 7.8 million shares for $500 million in the open market in the nine months ended September 30, 2017. Additionally, during the nine months ended September 30, 2017, AbbVie cash-settled $285 million of its open market purchases made at the end of 2016. The company's stock repurchase authorization permits purchases of AbbVie

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33




shares from time to time in open-market or private transactions at management's direction depending on the company's cash flows, net debt level and market conditions.discretion. The program has no time limit and can be discontinued at any time.

AbbVie repurchased 4 million shares for $300 million during the six months ended June 30, 2019 and 84 million shares for $8.8 billion during the six months ended June 30, 2018. AbbVie cash-settled $201 million of its December 2018 open-market purchases in January 2019.
During the ninesix months ended SeptemberJune 30, 20172019, AbbVie made $167 million of contingent consideration payments related to the commercial launch of SKYRIZI in certain geographies. $108 million of these payments were included in financing cash flows and 2016,$59 million of the payments were included in operating cash flows.
During the six months ended June 30, 2019 and 2018, the company issued and redeemed commercial paper. The balance of commercial paper outstanding was $800$306 million as of SeptemberJune 30, 20172019 and $377$699 million as of December 31, 2016.2018. AbbVie may issue additional commercial paper or retire commercial paper to meet liquidity requirements as needed.


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33




In May 2016,connection with the company issued $7.8 billion aggregate principal amountproposed acquisition of senior notes. Approximately $2.0 billion of the net proceeds were used to repay an outstandingAllergan, on June 25, 2019, AbbVie entered into a 364-day bridge credit agreement and on July 12, 2019, AbbVie entered into a term loan that was duecredit agreement. See Note 4 to mature in November 2016, approximately $1.9 billion of the net proceeds were used to financecondensed consolidated financial statements for additional information. During the acquisition of Stemcentrx and approximately $3.8 billion of the net proceeds were used to finance an accelerated share repurchase agreement.

In the third quarter of 2017,six months ended June 30, 2019, AbbVie paid $305debt issuance costs of $171 million of contingent consideration to BI related to a Phase 3 enrollment milestone. $268 million of this milestone was included in financing cash flows and $37 million was included in operating cash flows for the nine months ended September 30, 2017.

Cash and equivalents were impacted by net favorable exchange rate changes totaling $29 million for the nine months ended September 30, 2017 and net unfavorable exchange rate changes totaling $300 million for the nine months ended September 30, 2016. The unfavorable exchange rate changes in 2016 were primarily due to the devaluation of AbbVie’s net monetary assets denominated in the Venezuelan bolivar. While a significant portion of cash and equivalents as of September 30, 2017 were considered reinvested indefinitely in foreign subsidiaries, AbbVie does not expect such reinvestment to affect its liquidity and capital resources. If these funds were needed for operations in the United States, AbbVie would be required to accrue and pay U.S. income taxes to repatriate these funds. AbbVie believes that it has sufficient sources of liquidity to support its assumption that the amount of undistributed earnings as of September 30, 2017 has been reinvested indefinitely.

bridge credit agreement.
Credit Risk

AbbVie monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. AbbVie regularly communicates with its customers regarding the status of receivable balances, including their payment plans and obtains positive confirmation of the validity of the receivables. AbbVie establishes an allowance against accounts receivable when it is probable they will not be collected. AbbVie may also utilize factoring arrangements to mitigate credit risk, although the receivables included in such arrangements have historically not been a significant amount of total outstanding receivables.

AbbVie continues to do business with foreign governments in certain countries, including Greece, Portugal, Italy and Spain, which have historically experienced challenges in credit and economic conditions. Substantially all of AbbVie’s trade receivables in Greece, Portugal, Italy and Spain are with government health systems. Outstanding governmental receivables in these countries, net of allowances for doubtful accounts, totaled $246 million as of September 30, 2017 and $244 million as of December 31, 2016. The company also continues to do business with foreign governments in certain oil-exporting countries that have recently experienced a deterioration in economic conditions, including Saudi Arabia and Russia, which may result in delays in the collection of receivables. Outstanding governmental receivables related to Saudi Arabia, net of allowances for doubtful accounts, were $141 million as of September 30, 2017 and $122 million as of December 31, 2016. Outstanding governmental receivables related to Russia, net of allowances for doubtful accounts, were $142 million as of September 30, 2017 and $110 million as of December 31, 2016. Global economic conditions and customer-specific factors may require the company to periodically re-evaluate the collectability of its receivables and the company could potentially incur credit losses.

Currently, AbbVie does not believe the economic conditions in oil-exporting countries will have a significant impact on the company’s liquidity, cash flow or financial flexibility. However, if government funding were to become unavailable in these countries or if significant adverse changes in their reimbursement practices were to occur, AbbVie may not be able to collect the entire balance outstanding as of September 30, 2017.


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Credit Facility, Access to Capital and Credit Ratings

Credit Facility

AbbVie currently has a $3.0 billion five-year revolving credit facility which matures in October 2019.August 2023. The revolving credit facility enables the company to borrow funds on an unsecured basis at variable interest rates and contains various covenants. At SeptemberJune 30, 2017,2019, the company was in compliance with all its credit facility covenants. Commitment fees under the credit facility were insignificant. ThereNo amounts were no amounts outstanding under the credit facility as of SeptemberJune 30, 20172019 and December 31, 2016.

2018.
Access to Capital

The company intends to fund short-term and long-term financial obligations as they mature through cash on hand, future cash flows from operations or by issuing additional debt. The company’s ability to generate cash flows from operations, issue debt or enter into financing arrangements on acceptable terms could be adversely affected if there is a material decline in the demand for the company’s products or in the solvency of its customers or suppliers, deterioration in the company’s key financial ratios or credit ratings or other material unfavorable changes in business conditions. At the current time, the company believes it has sufficient financial flexibility to issue debt, enter into other financing arrangements and attract long-term capital on acceptable terms to support the company’s growth objectives.

Credit Ratings

On June 25, 2019, following the announcement of the proposed acquisition of Allergan, Moody's Investor Service affirmed its Baa2 senior unsecured long-term rating and Prime-2 short-term rating with a stable outlook. S&P Global Ratings revised its ratings outlook to negative from stable and expects to lower the issuer credit rating by one notch to BBB+ from A- and the short-term rating to A-2 from A-1 when the acquisition is complete.
There were no changes in the company’s credit ratings during the nine months ended September 30, 2017. Unfavorable changes to the ratings may have an adverse impact on future financing arrangements; however, they would not affect the company’s ability to draw on its credit facility and would not result in an acceleration of scheduled maturities of any of the company’s outstanding debt.

CRITICAL ACCOUNTING POLICIES

A summary of the company’s significant accounting policies is included in Note 2, entitled “Summary of Significant Accounting Policies” to the company’sin AbbVie's Annual Report on Form 10-K for the year ended December 31, 2016. There have been no significant2018. Significant changes in the company’s application of its critical accounting policies duringinclude the nine months ended September 30, 2017.adoption of a new accounting standard that establishes a new lease accounting framework. See Notes 1 and 8 to the condensed consolidated financial statements for additional information.


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FORWARD-LOOKING STATEMENTS

Some statements in this quarterly report on Form 10-Q may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project,” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s Annual Report on Form 10-K for the year ended December 31, 2016,2018, which has been filed with the Securities and Exchange Commission. AbbVie notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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 AbbVie's Annual Report on Form 10-K for the year ended December 31, 2016.2018.


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ITEM 4. CONTROLS AND PROCEDURES
 


DISCLOSURE CONTROLS AND PROCEDURES


Evaluation of disclosure controls and procedures. The Chief Executive Officer, Richard A. Gonzalez, and the Chief Financial Officer, William J. Chase,Robert A. Michael, evaluated the effectiveness of AbbVie’s disclosure controls and procedures as of the end of the period covered by this report, and concluded that AbbVie’s disclosure controls and procedures were effective to ensure that information AbbVie is required to disclose in the reports that it files or submits with the Securities and Exchange Commission under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms, and to ensure that information required to be disclosed by AbbVie in the reports that it files or submits under the Exchange Act is accumulated and communicated to AbbVie’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.


INTERNAL CONTROL OVER FINANCIAL REPORTING


Changes in internal control over financial reporting. There were no changes in AbbVie’s internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that have materially affected, or are reasonably likely to materially affect, AbbVie’s internal control over financial reporting during the quarter ended SeptemberJune 30, 2017.2019.


Inherent Limitations on Effectiveness of Controls. AbbVie’s management, including its Chief Executive Officer and its Chief Financial Officer, do not expect that AbbVie’s disclosure controls or internal control over financial reporting will prevent or detect all errorerrors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls.


The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.


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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
 


Information pertaining to legal proceedings is provided in Note 1213 to the Condensed Consolidated Financial Statementscondensed consolidated financial statements and is incorporated by reference herein.
ITEM 1A. RISK FACTORS

There have been no material changes to the risk factors disclosed in AbbVie’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, except for the following:
The proposed acquisition of Allergan plc (“Allergan”) may not be completed on the currently contemplated timeline or terms, or at all, and may not achieve the intended benefits.
Consummation of the acquisition of Allergan by AbbVie is conditioned on, among other things, obtaining necessary governmental, regulatory and Allergan shareholder approvals. If any of the conditions to the acquisition is not satisfied, it could delay or prevent the proposed acquisition from occurring, which could negatively impact AbbVie’s share price and future business and financial results. Further, as a condition to their approval of the acquisition, agencies may impose requirements, limitations or costs or require divestitures or place restrictions on the conduct of AbbVie’s business after the closing. These requirements, limitations, costs, divestitures or restrictions could jeopardize or delay the consummation of the acquisition or may reduce the anticipated benefits of the transaction. AbbVie will incur increased indebtedness to fund the cash consideration for the acquisition and such indebtedness could adversely affect AbbVie's business, financial condition, or results of operations. Following the proposed acquisition, AbbVie may not realize the proposed acquisition’s intended benefits within the expected timeframe or at all.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 


(c)  Issuer Purchases of Equity Securities


Period
(a) Total
Number of
Shares 
(or Units)
Purchased
 (b) Average
Price Paid
per Share
(or Unit)
 (c) Total Number
of Shares (or
Units) Purchased
as Part of Publicly
Announced Plans
or Programs
 

(d) Maximum
Number (or
Approximate
Dollar Value) of
Shares (or Units)
that May Yet Be
Purchased Under
the Plans or
Programs
July 1, 2017 – July 31, 201724,680
(1) 
$72.78
(1) 

 $4,536,288,945
August 1, 2017 – August 31, 20172,731
(1) 
$70.45
(1) 

 $4,536,288,945
September 1, 2017 – September 30, 20174,266
(1) 
$83.29
(1) 

 $4,536,288,945
Total31,677
(1) 
$74.00
(1) 

 $4,536,288,945
Period
(a) Total
Number of
Shares 
(or Units)
Purchased
 (b) Average
Price Paid
per Share
(or Unit)
 (c) Total Number
of Shares (or
Units) Purchased
as Part of Publicly
Announced Plans
or Programs
 

(d) Maximum
Number (or
Approximate
Dollar Value) of
Shares (or Units)
that May Yet Be
Purchased Under
the Plans or
Programs
 
April 1, 2019 – April 30, 20191,204
(1) 
$83.93
(1) 

 $3,950,021,071 
May 1, 2019 – May 31, 20191,371
(1) 
$77.84
(1) 

 $3,950,021,071 
June 1, 2019 – June 30, 20191,138
(1) 
$77.58
(1) 

 $3,950,021,071 
Total3,713
(1) 
$79.74
(1) 

 $3,950,021,071 


1.In addition to AbbVie shares repurchased on the open market under a publicly announced program, if any, these shares also included the shares deemed surrendered topurchased on the open market for the benefit of participants in the AbbVie to pay the exercise priceEmployee Stock Purchase Plan – 1,204 in connection with the exercise of employee stock options – 3,738April; 1,371 in July; 1,293May; and 1,138 in August; and 2,974 in September, with average exercise prices of $72.84 in July; $69.87 in August; and $86.51 in September.June.

These shares also included the shares purchased on the open market for the benefit of participants in the AbbVie Employee Stock Purchase Plan - 20,942 in July; 1,438 in August; and 1,292 in September.


These shares do not include the shares surrendered to AbbVie to satisfy minimum tax withholding obligations in connection with the vesting or exercise of stock-based awards.

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ITEM 6. EXHIBITS
 


Exhibits 32.1 and 32.2 are furnished herewith and should not be deemed to be “filed” under the Securities Exchange Act of 1934.

Exhibit No.Exhibit Description
101The following financial statements and notes from the AbbVie Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed on August 5, 2019, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Condensed Consolidated Statements of Earnings; (ii) Condensed Consolidated Statements of Comprehensive Income; (iii) Condensed Consolidated Balance Sheets; (iv) Condensed Consolidated Statements of Equity; (v) Condensed Consolidated Statements of Cash Flows; and (vi) the Notes to Condensed Consolidated Financial Statements.

*  Incorporated herein by referencereference. Commission file number 001-35565.
** Denotes management contract or compensatory plan or arrangement required to the Exhibit Index included herewith.be filed as an exhibit hereto.






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SIGNATURE


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.




  ABBVIE INC.
   
   
 By:/s/ William J. ChaseRobert A. Michael
  William J. ChaseRobert A. Michael
  Executive Vice President,
  Chief Financial Officer




Date: November 7, 2017August 5, 2019





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EXHIBIT INDEX

Exhibits 32.1 and 32.2 are furnished herewith and should not be deemed to be “filed” under the Securities Exchange Act of 1934.

Exhibit No.Exhibit Description
��
101The following financial statements and notes from the AbbVie Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed on November 7, 2017, formatted in XBRL: (i) Condensed Consolidated Statements of Earnings; (ii) Condensed Consolidated Statements of Comprehensive Income; (iii) Condensed Consolidated Balance Sheets; (iv) Condensed Consolidated Statements of Cash Flows; and (v) the Notes to Condensed Consolidated Financial Statements.