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, 20182019


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 31, 2018,July 29, 2019, AbbVie Inc. had 1,504,216,3271,478,483,838 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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1







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) 2018 2017 2018 2017 2019 2018 2019 2018
Net revenues $8,236
 $6,995
 $24,448
 $20,477
 $8,255
 $8,278
 $16,083
 $16,212
                
Cost of products sold 1,835
 1,616
 5,696
 4,761
 1,819
 1,934
 3,513
 3,861
Selling, general and administrative 1,919
 1,457
 5,470
 4,339
 1,654
 1,760
 3,334
 3,551
Research and development 1,268
 1,228
 3,834
 3,599
 1,291
 1,322
 2,580
 2,566
Acquired in-process research and development 55
 
 124
 15
 91
 
 246
 69
Other expense 
 
 500
 
 
 500
 
 500
Total operating costs and expenses 5,077
 4,301
 15,624
 12,714
 4,855
 5,516
 9,673
 10,547
Operating earnings 3,159
 2,694
 8,824
 7,763
 3,400
 2,762
 6,410
 5,665
                
Interest expense, net 302
 252
 825
 752
 309
 272
 634
 523
Net foreign exchange loss 2
 9
 18
 28
 6
 8
 12
 16
Other expense, net 94
 338
 411
 449
 2,278
 470
 2,413
 317
Earnings before income tax expense 2,761
 2,095
 7,570
 6,534
 807
 2,012
 3,351
 4,809
Income tax expense 14
 464
 57
 1,277
 66
 29
 154
 43
Net earnings $2,747
 $1,631
 $7,513
 $5,257
 $741
 $1,983
 $3,197
 $4,766
                
Per share data                
Basic earnings per share $1.81
 $1.02
 $4.81
 $3.28
 $0.49
 $1.26
 $2.15
 $3.00
Diluted earnings per share $1.81
 $1.01
 $4.79
 $3.27
 $0.49
 $1.26
 $2.14
 $2.99
                
Weighted-average basic shares outstanding 1,511
 1,597
 1,556
 1,596
 1,480
 1,568
 1,480
 1,579
Weighted-average diluted shares outstanding 1,515
 1,603
 1,561
 1,602
 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)2018 2017 2018 2017
Net earnings$2,747
 $1,631
 $7,513
 $5,257
        
Foreign currency translation adjustments, net of tax expense (benefit) of $3 for the three months and $(16) for the nine months ended September 30, 2018 and $7 for the three months and $40 for the nine months ended September 30, 201730
 183
 (250) 602
Net investment hedging activities, net of tax expense (benefit) of $(9) for the three months and $22 for the nine months ended September 30, 2018 and $(52) for the three months and $(174) for the nine months ended September 30, 2017(32) (90) 73
 (307)
Pension and post-employment benefits, net of tax expense (benefit) of $8 for the three months and $24 for the nine months ended September 30, 2018 and $8 for the three months and $23 for the nine months ended September 30, 201728
 8
 99
 21
Marketable security activities, net of tax expense (benefit) of $— for the three months and $— for the nine months ended September 30, 2018 and $4 for the three months and $6 for the nine months ended September 30, 2017
 (28) (2) (18)
Cash flow hedging activities, net of tax expense (benefit) of $1 for the three months and $18 for the nine months ended September 30, 2018 and $(14) for the three months and $(29) for the nine months ended September 30, 201754
 (138) 248
 (325)
Other comprehensive income (loss)80
 (65) 168
 (27)
Comprehensive income$2,827
 $1,566
 $7,681
 $5,230
 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,
2018
 December 31,
2017
June 30,
2019
 December 31,
2018
(unaudited)  (unaudited)  
Assets      
Current assets      
Cash and equivalents$8,015
 $9,303
$5,172
 $7,289
Short-term investments770
 486
244
 772
Accounts receivable, net5,780
 5,088
5,482
 5,384
Inventories1,786
 1,605
1,895
 1,605
Prepaid expenses and other2,114
 4,741
2,307
 1,895
Total current assets18,465
 21,223
15,100
 16,945
      
Investments1,463
 2,090
1,473
 1,420
Property and equipment, net2,950
 2,803
2,879
 2,883
Intangible assets, net26,625
 27,559
20,459
 21,233
Goodwill15,718
 15,785
15,642
 15,663
Other assets943
 1,326
1,589
 1,208
Total assets$66,164
 $70,786
$57,142
 $59,352
      
Liabilities and Equity      
Current liabilities      
Short-term borrowings$3,002
 $400
$306
 $3,699
Current portion of long-term debt and lease obligations1,019
 6,015
Current portion of long-term debt and finance lease obligations5,335
 1,609
Accounts payable and accrued liabilities11,366
 10,226
11,300
 11,931
Total current liabilities15,387
 16,641
16,941
 17,239
      
Long-term debt and lease obligations36,487
 30,953
Long-term debt and finance lease obligations31,619
 35,002
Deferred income taxes1,490
 2,490
1,148
 1,067
Other long-term liabilities15,721
 15,605
16,000
 14,490
      
Commitments and contingencies

 



 


      
Stockholders’ equity (deficit)      
Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,776,109,692 shares issued as of September 30, 2018 and 1,768,738,550 as of December 31, 201718
 18
Common stock held in treasury, at cost, 271,949,381 shares as of September 30, 2018 and 176,607,525 as of December 31, 2017(21,849) (11,923)
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 capital14,680
 14,270
15,028
 14,756
Retained earnings6,789
 5,459
3,384
 3,368
Accumulated other comprehensive loss(2,559) (2,727)(2,491) (2,480)
Total stockholders’ equity (deficit)(2,921) 5,097
(8,566) (8,446)
      
Total liabilities and equity$66,164
 $70,786
$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)2018 2017
Cash flows from operating activities   
Net earnings$7,513
 $5,257
Adjustments to reconcile net earnings to net cash from operating activities:   
Depreciation349
 324
Amortization of intangible assets974
 808
Change in fair value of contingent consideration liabilities432
 547
Stock-based compensation351
 288
Upfront costs and milestones related to collaborations711
 85
Other, net423
 (73)
Changes in operating assets and liabilities:   
Accounts receivable(806) (163)
Inventories(367) (119)
Prepaid expenses and other assets(426) (22)
Accounts payable and other liabilities881
 444
Cash flows from operating activities10,035
 7,376
    
Cash flows from investing activities   
Acquisitions and investments(541) (180)
Acquisitions of property and equipment(515) (347)
Purchases of investment securities(1,581) (1,838)
Sales and maturities of investment securities1,914
 1,890
Cash flows from investing activities(723) (475)
    
Cash flows from financing activities   
Net change in commercial paper borrowings(400) 423
Proceeds from issuance of other short-term borrowings3,002
 
Proceeds from issuance of long-term debt5,963
 
Repayments of long-term debt and lease obligations(5,021) (18)
Debt issuance costs(34) 
Dividends paid(4,129) (3,077)
Purchases of treasury stock(9,956) (905)
Proceeds from the exercise of stock options66
 214
Payments of contingent consideration liabilities(78) (268)
Other, net16
 47
Cash flows from financing activities(10,571) (3,584)
Effect of exchange rate changes on cash and equivalents(29) 29
Net change in cash and equivalents(1,288) 3,346
Cash and equivalents, beginning of period9,303
 5,100
    
Cash and equivalents, end of period$8,015
 $8,446
(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, 2017.2018.
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. 2014-092016-02
In May 2014,February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers2016-02, Leases (Topic 606) and Other Assets and Deferred Costs - Contracts with Customers (Subtopic 340-40)842). The amendments in this standard outlined a comprehensive lease accounting model that superseded most existing revenue recognition requirements.the previous lease guidance and required lessees to recognize lease liabilities and corresponding right-of-use assets for all leases with lease terms greater than 12 months. The core principleguidance also changed the definition of a lease and expanded the new guidance is that an entity should recognize revenue to depict the transferdisclosure requirements 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.lease arrangements. AbbVie adopted the standard in the first quarter of 20182019 using the modified retrospective method. Results for reporting periods beginning after December 31, 20172018 have been presented in accordance with the standard, while results for prior periods have not been adjusted and continue to be reported in accordance with AbbVie’sAbbVie's historical accounting. The cumulative effect of initially applying the new revenueleases standard was recognized as an adjustment to the opening condensed consolidated balance of retained earningssheet as of January 1, 2018.
There were no significant changes to the amounts or timing of revenue recognition for product sales, the company's primary revenue stream. For certain licensing arrangements where revenue was previously deferred and recognized over time, revenue is now recognized at the point in time when the license is granted. Additionally, for certain contract manufacturing arrangements where revenue was previously recognized at a point in time at the end of the manufacturing process, revenue is now recognized over time throughout the manufacturing process.
Under the new standard, on January 1, 2018, the company recognized a cumulative-effect adjustment to retained earnings primarily related to certain deferred license revenues that were originally expected to be recognized through early 2020. The adjustment to the condensed consolidated balance sheet included: (i) a $42 million increase to prepaid expenses and other; (ii) a $39 million decrease to inventories; (iii) a $57 million decrease to accounts payable and accrued liabilities; (iv) a $75 million decrease to other long-term liabilities; (v) a $22 million increase to deferred income taxes; and (vi) a $124 million increase to retained earnings. Other cumulative-effect adjustments to the condensed consolidated balance sheet were insignificant.

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2019.
The impact of adoption on the company’s condensed consolidated statements of earnings for the three and nine months ended September 30, 2018 was as follows:
  Three months ended
September 30, 2018
 Nine months ended
September 30, 2018
(in millions, except per share data) As Reported 
Balances Without Adoption of
ASU 2014-09
 Effect of Change Higher/(Lower) As Reported 
Balances Without Adoption of
ASU 2014-09
 Effect of Change Higher/(Lower)
Net revenues $8,236
 $8,270
 $(34) $24,448
 $24,452
 $(4)
Cost of products sold 1,835
 1,851
 (16) 5,696
 5,696
 
Income tax expense 14
 16
 (2) 57
 52
 5
Net earnings 2,747
 2,763
 (16) 7,513
 7,522
 (9)
Diluted earnings per share $1.81
 $1.82
 $(0.01) $4.79
 $4.80
 $(0.01)
As of September 30, 2018, due to the impact of the adoption of ASU 2014-09, prepaid expenses and other were $81 million higher, inventories were $38 million lower, accounts payable and accrued liabilities were $47 million lower, other long-term liabilities were $32 million lower, deferred income taxes were $14 million higher and retained earnings were $115 million higher on the company’s condensed consolidated balance sheet than they would have been had ASU 2014-09 not been adopted. Other impacts to the condensed consolidated balance sheet were insignificant.
ASU No. 2016-01
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. AbbVie adopted the standard in the first quarter of 2018. The adoption did not impact the accounting for AbbVie's investments in debt securities and did not have a material impact on the company's consolidated financial statements.
ASU No. 2016-16
In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740). The standard requires entities to recognize the income tax consequences of an intercompany transfer of an asset other than inventory when the transfer occurs. Under previous U.S. GAAP, the income tax consequences of these intercompany asset transfers were deferred until the asset was sold to a third party or otherwise recovered through use. AbbVie adopted the standard in the first quarter of 2018 using the modified retrospective method. As a result, on January 1, 2018, the company recorded a cumulative-effect adjustment to its condensed consolidated balance sheet that included a $1.9 billion decrease to retained earnings, a $1.4 billion decrease to prepaid expenses and other and a $0.5 billion decrease to other assets.
ASU No. 2017-07
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. AbbVie adopted the standard in the first quarter of 2018 and applied the income statement classification provisions of this standard retrospectively. As a result, the company reclassified income of $10 million from operating earnings to non-operating income for the three months and $34 million for the nine months ended September 30, 2017. Additionally, the company recorded approximately $8 million of non-operating income for the three months and $26 million for the nine months ended September 30, 2018 which would have been recorded in operating earnings under the previous guidance.
ASU No. 2017-12
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. AbbVie elected to early adopt the standard in the first quarter of 2018. The adoption did not have a material impact on the company's consolidated financial statements.

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Recent Accounting Pronouncements Not Yet Adopted
ASU No. 2016-02
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The standard outlines a comprehensive lease accounting model that supersedes the current lease guidance and requires lessees to recognize lease liabilities and corresponding right-of-use assets for all leases with lease terms greater than 12 months. The guidance also changes the definition of a lease and expands the disclosure requirements of lease arrangements. AbbVie is currently assessing the impact of adopting this guidance on its consolidated financial statements and related disclosures. AbbVie will adopt the standard effective in the first quarter of 2019 and will not restate comparative periods upon adoption. AbbVie will elect a package of practical expedients for leases that commenced prior to January 1, 2019 and willdid not reassess: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. AbbVie does not expect the adoption will have a material impact on its consolidated statement of earnings. However,
Under the new standard, will require AbbVieon January 1, 2019, the company recognized a cumulative-effect adjustment to establishits condensed consolidated balance sheet primarily related to the recognition of liabilities and corresponding right-of-use assets on itsfor operating leases. The adjustment to the condensed consolidated balance sheet for operating leases that exist asincluded: (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 earnings 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, date.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 AbbVie'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.
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 allows 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 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.
Note 2    Revenue RecognitionSupplemental Financial Information
 


AbbVie recognizes revenue when control of promised goods or services is transferred to the company’s customers, in an amount that reflects the consideration AbbVie expects to be entitled to in exchange for those goods or services. Sales, value add and other taxes collected concurrent with revenue-producing activities are excluded from revenue. AbbVie generates revenue primarily from product sales. For the majority of sales, the company transfers control, invoices the customer and recognizes revenue upon shipment to the customer. The company recognizes shipping and handling costs as an expense in cost of products sold when the company transfers control to the customer. Payment terms vary depending on the type and location of the customer, are based on customary commercial terms and are generally less than one year. AbbVie does not adjust revenue for the effects of a significant financing component for contracts where AbbVie expects the period between the transfer of the good or service and collection to be one year or less.
Discounts, rebates, sales incentives to customers, returns and certain other adjustments are accounted for as variable consideration. Provisions for variable consideration are based on current pricing, executed contracts, government pricing legislation and historical data and are provided for in the period the related revenues are recorded. Rebate amounts are typically based upon the volume of purchases using contractual or statutory prices, which may vary by product and by payer. For each type of rebate, factors used in the calculation of the accrual include the identification of the products subject to the rebate, the applicable price terms and the estimated lag time between sale and payment of the rebate, which can be significant. Sales incentives to customers are insignificant.

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In addition to revenue from contracts with customers, the company also recognizes certain collaboration revenues. See Note 6 for additional information related to the collaboration with Janssen Biotech, Inc. Additionally, see Note 14 for disaggregation of revenue by product and geography.
Note 3    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) 2018 2017 2018 2017
Interest expense $339
 $293
 $968
 $851
Interest income (37) (41) (143) (99)
Interest expense, net $302
 $252
 $825
 $752
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, 2018 December 31, 2017
Finished goods$522
 $610
Work-in-process1,054
 822
Raw materials210
 173
Inventories$1,786
 $1,605
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, 2018 December 31, 2017
Property and equipment, gross$8,449
 $8,071
Accumulated depreciation(5,499) (5,268)
Property and equipment, net$2,950
 $2,803

Depreciation expense was $115$114 million for the three months and $349$232 million for the ninesix months ended SeptemberJune 30, 20182019 and $111$119 million for the three months and $324$234 million for the ninesix months ended SeptemberJune 30, 2017.2018.
Note 43    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 data) 2018 2017 2018 2017
Basic EPS        
Net earnings $2,747
 $1,631
 $7,513
 $5,257
Earnings allocated to participating securities 12
 8
 34
 26
Earnings available to common shareholders $2,735
 $1,623
 $7,479
 $5,231
Weighted-average basic shares outstanding 1,511
 1,597
 1,556
 1,596
Basic earnings per share $1.81
 $1.02
 $4.81
 $3.28
         
Diluted EPS        
Net earnings $2,747
 $1,631
 $7,513
 $5,257
Earnings allocated to participating securities 12
 8
 34
 26
Earnings available to common shareholders $2,735
 $1,623
 $7,479
 $5,231
Weighted-average shares of common stock outstanding 1,511
 1,597
 1,556
 1,596
Effect of dilutive securities 4
 6
 5
 6
Weighted-average diluted shares outstanding 1,515
 1,603
 1,561
 1,602
Diluted earnings per share $1.81
 $1.01
 $4.79
 $3.27


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 was insignificant for all periods presented.
Note 54Licensing, Acquisitions and Other Arrangements
 


Proposed Acquisition of Allergan plc
On June 25, 2019, AbbVie announced 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 transaction agreement, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share.
In connection with the proposed acquisition of Allergan, on June 25, 2019, AbbVie entered into a $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 is expected to close in early 2020, subject to regulatory and Allergan shareholder approvals.
Other Licensing & Acquisitions Activity
Cash outflows related to other acquisitions and investments totaled $541$440 million for the ninesix months ended SeptemberJune 30, 20182019 and $180$401 million for the ninesix months ended SeptemberJune 30, 2017.2018. AbbVie recorded $55 million acquired in-process research and development (IPR&D) charges of $91 million for the three months ended September 30, 2018 and $124$246 million for the ninesix months ended SeptemberJune 30, 2018. Abbvie2019. AbbVie recorded no acquired IPR&D charges for the three months ended SeptemberJune 30, 20172018 and recorded acquired IPR&D charges of $15$69 million for the ninesix months ended SeptemberJune 30, 2017.2018.


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Calico Life Sciences LLC
In June 2018, AbbVie and Calico Life Sciences LLC (Calico) entered into an extension of a collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer. Under the terms of the agreement, AbbVie and Calico will each contribute an additional $500 million to the collaboration and the term iswas extended for an additional 3three 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 will have the option to exclusively 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 activities. Collaboration costs and profits will be shared equally by both parties post option exercise. During the ninesix months ended SeptemberJune 30, 2018, AbbVie recorded $500 million in other expense in the condensed consolidated statement of earnings related to its commitments under the agreement.

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Note 65Collaboration 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-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) 2018 2017 2018 2017
United States - Janssen's share of profits (included in cost of products sold) $377
 $268
 $978
 $727
International - AbbVie's share of profits (included in net revenues) 160
 114
 455
 306
Global - AbbVie's share of other costs (included in respective line items) 81
 75
 232
 209


AbbVie’s receivable from Janssen, included in accounts receivable, net, was $230 million at June 30, 2019 and $177 million at September 30, 2018 and $124 million at December 31, 20172018. AbbVie’s payable to Janssen, included in accounts payable and accrued liabilities, was $362$405 million at SeptemberJune 30, 20182019 and $253$376 million at December 31, 20172018.

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Note 76    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, 2017$15,785
Foreign currency translation adjustments(67)
Balance as of September 30, 2018$15,718


The company performs its annual goodwill impairment assessment in the third quarter, or earlier if impairment indicators exist. As of SeptemberJune 30, 2018,2019, there were no accumulated goodwill impairment losses.

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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, 2018 December 31, 2017
(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$15,877
 $(5,394) $10,483
 $16,138
 $(4,982) $11,156
License agreements7,865
 (1,713) 6,152
 7,822
 (1,409) 6,413
Total definite-lived intangible assets23,742
 (7,107) 16,635
 23,960
 (6,391) 17,569
Indefinite-lived research and development9,990
 
 9,990
 9,990
 
 9,990
Total intangible assets, net$33,732
 $(7,107) $26,625
 $33,950
 $(6,391) $27,559

Amortization expense was $320 million for the three months and $974 million for the nine months ended September 30, 2018 and $268 million for the three months and $808 million for the nine months ended September 30, 2017. Amortization expense was included in cost of products sold in the condensed consolidated statements of earnings.

Indefinite-Lived Intangible Assets
Indefinite-lived intangible assets represent acquired IPR&D associated with products that have not yet received regulatory approval. Indefinite-lived intangible assets as of September 30, 2018 and December 31, 2017 relate to the 2016 acquisitions of Stemcentrx and Boehringer Ingelheim compounds. The company performs its annual impairment assessment of indefinite-lived intangible assets in the third quarter, or earlier if impairment indicators exist. No indefinite-lived intangible asset impairment charges were recorded for the ninesix months ended SeptemberJune 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 2017.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 87    Restructuring Plans
 


AbbVie recorded restructuring charges of $22$19 million for the three months and $45$186 million for the ninesix months ended SeptemberJune 30, 20182019 and $7$1 million for the three months and $34$23 million for the ninesix months ended SeptemberJune 30, 2017.2018. 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, 2018:2019:
(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, 2017$86
Restructuring charges34
Payments and other adjustments(33)
Accrued balance as of September 30, 2018$87

Note 9    Financial Instruments and Fair Value Measures8 Leases    
 

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, 20172018 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 $1.9 billion$503 million at SeptemberJune 30, 20182019 and $2.2$1.4 billion at December 31, 2017,2018, are designated as cash flow hedges and are recorded at fair value. The durations of these forward exchange contracts were

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12




generally less than eighteen18 months. Accumulated gains and losses as of SeptemberJune 30, 20182019 will be reclassified from 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 $11.1$7.9 billion at SeptemberJune 30, 20182019 and $7.7$8.6 billion at December 31, 2017.

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. The company designatedcontinued to designate €3.6 billion aggregate principal amount of senior Euro notes as net investment hedges at SeptemberJune 30, 20182019 and December 31, 2017.2018. 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 instruments as net investment hedges. The company uses the spot method of assessing 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, 20182019 and December 31, 2017.2018. 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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14




No amounts are excluded from the assessment of effectiveness for cash flow hedges net investment 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,
2018
December 31, 2017 Balance sheet captionSeptember 30,
2018
December 31, 2017Balance 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
$95
$1
 Accounts payable and accrued liabilities$2
$120
Prepaid expenses and
other
$22
$113
 Accounts payable and accrued liabilities$
$
Designated as cash flow hedgesOther assets3

 Other long-term liabilities

Designated as net investment hedgesPrepaid expenses and
other
11

 Accounts payable and accrued liabilities1

Not designated as hedges
Prepaid expenses and
other
17
22
 Accounts payable and accrued liabilities14
29
Prepaid expenses and
other
40
19
 Accounts payable and accrued liabilities38
26
Interest rate swaps designated as fair value hedgesPrepaid expenses and other

 Accounts payable and accrued liabilities7
8
Prepaid expenses and other

 Accounts payable and accrued liabilities8

Interest rate swaps designated as fair value hedgesOther assets

 Other long-term liabilities700
393
Other assets24

 Other long-term liabilities117
466
Total derivatives $115
$23
 $723
$550
 $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 (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) 2018 2017 2018 2017
Foreign currency forward exchange contracts $1
 $(114) $122
 $(253)


Assuming market rates remain constant through contract maturities, the company expects to transferreclass pre-tax gains of $63$90 million into cost of products sold for foreign currency cash flow hedges during the next 12 months.


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13





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 $41$49 million for the three months and a pre-tax gain of $95$35 million for the ninesix months ended SeptemberJune 30, 20182019 and recognized pre-tax losses in other comprehensive income (loss)gains of $142$270 million for the three months and $481$136 million for the ninesix months ended SeptemberJune 30, 2017.

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 net gains (losses) reclassified out of AOCI into net earnings. See Note 11 for the amount of net gains (losses) reclassified out of AOCI.


   Three months ended
June 30,
 Six months ended
June 30,
(in millions)Statement of earnings caption 2019 2018 2019 2018
Foreign currency forward exchange contracts         
Designated as cash flow hedgesCost of products sold $37
 $(46) $77
 $(90)
Designated as net investment hedgesInterest expense, net 9
 
 9
 
Not designated as hedgesNet foreign exchange loss (25) 128
 (40) 69
Interest rate swaps designated as fair value hedgesInterest expense, net 253
 (59) 365
 (243)
Debt designated as hedged item in fair value hedgesInterest expense, net (253) 59
 (365) 243


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15
   Three months ended
September 30,
 Nine months ended
September 30,
(in millions)Statement of earnings caption 2018 2017 2018 2017
Foreign currency forward exchange contracts         
Designated as cash flow hedgesCost of products sold $(54) $38
 $(144) $101
Not designated as hedgesNet foreign exchange loss 22
 (17) 91
 (88)
Interest rate swaps designated as fair value hedgesInterest expense, net (63) 11
 (306) 43
Debt designated as hedged item in fair value hedgesInterest expense, net 63
 (11) 306
 (43)






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, 2018:2019:
  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$8,015
 $653
 $7,362
 $
$5,172
 $1,388
 $3,784
 $
Time deposits559
 
 559
 
Debt securities1,591
 
 1,591
 
1,573
 
 1,573
 
Equity securities5
 5
 
 
79
 79
 
 
Interest rate hedges24
 
 24
 
Foreign currency contracts115
 
 115
 
73
 
 73
 
Total assets$10,285
 $658
 $9,627
 $
$6,921
 $1,467
 $5,454
 $
Liabilities              
Interest rate hedges$707
 $
 $707
 $
$125
 $
 $125
 $
Foreign currency contracts16
 
 16
 
39
 
 39
 
Contingent consideration4,866
 
 
 4,866
6,789
 
 
 6,789
Total liabilities$5,589
 $
 $723
 $4,866
$6,953
 $
 $164
 $6,789



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1416







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, 2017:2018:
   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$9,303
 $849
 $8,454
 $
Debt securities2,524
 
 2,524
 
Equity securities4
 4
 
 
Foreign currency contracts23
 
 23
 
Total assets$11,854
 $853
 $11,001
 $
Liabilities       
Interest rate hedges$401
 $
 $401
 $
Foreign currency contracts149
 
 149
 
Contingent consideration4,534
 
 
 4,534
Total liabilities$5,084
 $
 $550
 $4,534


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. Equity securities consist 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, 2018,2019, a 50 basis point increase/decrease in the assumed discount rate would have decreased/increased the value of the contingent consideration liabilities by approximately $170$270 million. Additionally, at SeptemberJune 30, 2018,2019, 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 $410$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) 2018 2017
Beginning balance $4,534
 $4,213
Change in fair value recognized in net earnings 432
 547
Milestone payments (100) (305)
Ending balance $4,866
 $4,455
The change in fair value recognized in net earnings is recorded in other expense, net in the condensed consolidated statements of earnings. 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 the treatment of moderate to severe plaque psoriasis.


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1517








Certain 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, 2019 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
 $

The book values, approximate fair values and bases used to measure the approximate fair values of certain financial instruments as of December 31, 2018 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)
Liabilities        
Short-term borrowings$3,002
$3,002
 $
 $3,002
 $
Current portion of long-term debt and lease obligations, excluding fair value hedges1,026
1,025
 999
 26
 
Long-term debt and lease obligations, excluding fair value hedges37,187
36,392
 36,320
 72
 
Total liabilities$41,215
$40,419
 $37,319
 $3,100
 $


AbbVie also holds investments in equity securities that do not have readily determinable fair values. The company records these investments at cost and remeasures them to fair value based on certain observable price changes or impairment events as they occur. The carrying amount of these investments was $78$65 million as of SeptemberJune 30, 2019 and $84 million as of December 31, 2018. No significant cumulative upward or downward adjustments have been recorded for these investments as of SeptemberJune 30, 2018. Prior to the adoption of ASU No. 2016-01 discussed in Note 1, these investments were accounted for under the cost method and disclosed in the table below as of December 31, 2017.

The book values, approximate fair values and bases used to measure the approximate fair values of certain financial instruments as of December 31, 2017 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)
Assets        
Investments$48
$48
 $
 $
 $48
Total assets$48
$48
 $
 $
 $48
Liabilities        
Short-term borrowings$400
$400
 $
 $400
 $
Current portion of long-term debt and lease obligations, excluding fair value hedges6,023
6,034
 4,004
 2,030
 
Long-term debt and lease obligations, excluding fair value hedges31,346
32,846
 32,763
 83
 
Total liabilities$37,769
$39,280
 $36,767
 $2,513
 $

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2019.
Available-for-sale Securities

Substantially all of the company’s investments in debt securities were classified as available-for-sale with changes in fair value recognized in other comprehensive income. Debt securities classified as short-term were $210$244 million as of SeptemberJune 30, 20182019 and $482$204 million as of December 31, 2017.2018. 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, 2018:2019:
 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


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18
 Amortized cost Gross unrealized Fair value
(in millions) Gains Losses 
Asset backed securities$447
 $
 $(2) $445
Corporate debt securities1,050
 3
 (3) 1,050
Other debt securities97
 
 (1) 96
Total$1,594
 $3
 $(6) $1,591





The following table is a summary ofsummarizes available-for-sale securities by type as of December 31, 2017:2018:
 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
 Amortized cost Gross unrealized Fair value
(in millions) Gains Losses 
Asset backed securities$930
 $1
 $(3) $928
Corporate debt securities1,451
 4
 (2) 1,453
Other debt securities144
 
 (1) 143
Equity securities4
 2
 (2) 4
Total$2,529
 $7
 $(8) $2,528


AbbVie had no other-than-temporary impairments as of SeptemberJune 30, 2018.2019. Net realized gains (losses)and losses were insignificant for both the three and ninesix months ended SeptemberJune 30, 20182019 and 2017.

2018.
Concentrations of Risk

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 $270 million as of September 30, 2018 and $255 million as of December 31, 2017. The company also continues to do business with foreign governments in certain oil-exporting countries that have 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 $147 million as of September 30, 2018 and $149 million as of December 31, 2017. Outstanding governmental receivables related to Russia, net of allowances for doubtful accounts, were $104 million as of September 30, 2018 and $152 million as of December 31, 2017. 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.

Of total net accounts receivable, three U.S. wholesalers accounted for 61%66% as of SeptemberJune 30, 20182019 and 56%63% as of December 31, 2017,2018, 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 61%58% of AbbVie’s total net revenues for the ninesix months ended SeptemberJune 30, 20182019 and 66%61% for the ninesix months ended SeptemberJune 30, 2017.

2018.
Debt and Credit Facilities
In September 2018, the company issued $6.0 billion aggregate principal amount of unsecured senior notes, consisting of $1.25 billion aggregate principal amount of 3.375% senior notes due 2021, $1.25 billion aggregate principal amount of 3.75% senior notes due 2023, $1.75 billion aggregate principal amount of 4.25% senior notes due 2028 and $1.75 billion aggregate principal amount of

2018 Form 10-Q | abbvieimage2a10.gif
17




4.875% senior notes due 2048. These senior notes rank equally with all other unsecured and unsubordinated indebtedness of the company. AbbVie may redeem the senior notes prior to maturity at a redemption price equal to the principal amount of the senior notes redeemed plus a make-whole premium and, except for the 3.375% notes due 2021, AbbVie may redeem the senior notes at par between one and six months prior to maturity. In connection with the offering, debt issuance costs incurred totaled $37 million and debt discounts totaled $37 million and are being amortized over the respective terms of the senior notes to interest expense, net in the condensed consolidated statements of earnings. Of the $5.9 billion net proceeds, $2.0 billion was used to repay the company's outstanding term loan that was due to mature in November 2018. The company intends to use the remaining proceeds to repay senior note obligations in 2018 and term loan obligations in 2019 as they become due.
In May 2018, the company also repaid $3.0 billion aggregate principal amount of 1.80% senior notes at maturity.
Short-Term Borrowings
Short-term borrowings included commercial paper borrowings of $400$306 million as of June 30, 2019 and $699 million as of December 31, 2017. There were no commercial paper borrowings outstanding as of September 30, 2018. The weighted-average interest rate on commercial paper borrowings was 2.7% for the six months ended June 30, 2019 and 1.9% for the ninesix months ended September 30, 2018 and 1.2% for the nine months ended September 30, 2017.
In August 2018, AbbVie replaced its existing revolving credit facility with a new $3.0 billion five-year revolving credit facility that matures in August 2023. The new facility enables the company to borrow funds on an unsecured basis at variable interest rates and contains various covenants, all of which the company was in compliance with as of SeptemberJune 30, 2018.
In May 2018,March 2019, AbbVie entered into arepaid its $3.0 billion 364-day term loan credit agreement (term loan). that was scheduled to mature in June 2019.
In connection with the proposed acquisition of Allergan, on June 2018, the company drew25, 2019, AbbVie entered into a 364-day bridge credit agreement and on thisJuly 12, 2019, AbbVie entered into a term loan and as of September 30, 2018, $3.0 billion was outstanding and was included in short-term borrowings on the condensed consolidated balance sheet. Borrowings under the term loan bear interest at one month LIBOR plus applicable margin. The term loan may be prepaid without penalty upon prior notice and contains customary covenants, all of which the company was in compliance with as of September 30, 2018.credit agreement. See Note 4 for additional information.
Note 10Post-Employment Benefits
 


The following is a summary oftable summarizes net periodic benefit cost 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
 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)2018 2017 2018 2017 2018 2017 2018 2017
Service cost$70
 $59
 $214
 $176
 $7
 $6
 $20
 $19
Interest cost57
 52
 171
 153
 6
 6
 18
 18
Expected return on plan assets(109) (96) (330) (286) 
 
 
 
Amortization of actuarial losses and prior service costs38
 27
 114
 80
 
 1
 1
 1
Net periodic benefit cost$56
 $42
 $169
 $123
 $13
 $13
 $39
 $38

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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1819







Note 11 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) 2018 2017 2018 2017
Cost of products sold $7
 $7
 $23
 $20
Research and development 32
 30
 139
 127
Selling, general and administrative 36
 34
 189
 141
Pre-tax compensation expense 75
 71
 351
 288
Tax benefit 13
 20
 61
 85
After-tax compensation expense $62
 $51
 $290
 $203


Stock Options


During the ninesix months ended SeptemberJune 30, 2018,2019, primarily in connection with the company's annual grant, AbbVie granted 0.61.0 million stock options with a weighted-average grant-date fair value of $21.63.$12.54. As of SeptemberJune 30, 2018, $82019, $8.5 million of unrecognized compensation cost related to stock options is expected to be recognized as expense over approximately the next two years.


RSAs, RSUs and Performance Shares


During the ninesix months ended SeptemberJune 30, 2018,2019, primarily in connection with the company's annual grant, AbbVie granted 3.95.4 million RSUs and performance shares with a weighted-average grant-date fair value of $114.37.$78.68. As of SeptemberJune 30, 2018, $3312019, $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 20182019 and 2017:2018:
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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2018 2017
Date Declared Payment Date Dividend Per Share Date Declared Payment Date Dividend Per Share
11/02/18 02/15/19 $1.07
 10/27/17 02/15/18 $0.71
09/07/18 11/15/18 $0.96
 09/08/17 11/15/17 $0.64
06/14/18 08/15/18 $0.96
 06/22/17 08/15/17 $0.64
02/15/18 05/15/18 $0.96
 02/16/17 05/15/17 $0.64





Stock Repurchase Program

On February 15, 2018, AbbVie's board of directors authorized a new $10.0 billionThe company's stock repurchase program, which superseded AbbVie's previous stock repurchase program. The new stock repurchase programauthorization permits purchases of AbbVie shares from time to time in open-market or private transactions including accelerated share repurchases, at management's 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.

Under the new authorization, AbbVie repurchased 83.24 million shares for $8.5$300 million during the six months ended June 30, 2019 and 84 million shares for $8.8 billion during the ninesix months ended SeptemberJune 30, 2018. AbbVie's remaining stock repurchase authorization was $1.5approximately $4.0 billion as of SeptemberJune 30, 2018.


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Prior to the new $10.0 billion authorization, AbbVie repurchased 10.9 million shares in the open market for $1.3 billion during the nine months ended September 30, 2018.

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, 2018:2019:
(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, 2017$(439) $(203) $(1,919) $
 $(166) $(2,727)
Other comprehensive income (loss) before reclassifications(250) 73
 7
 (6) 110
 (66)
Net losses reclassified from accumulated other comprehensive loss
 
 92
 4
 138
 234
Net current-period other comprehensive income (loss)(250) 73
 99
 (2) 248
 168
Balance as of September 30, 2018$(689) $(130) $(1,820) $(2) $82
 $(2,559)


Other comprehensive incomeloss for the ninesix months ended SeptemberJune 30, 20182019 included foreign currency translation adjustments totaling a loss of $250$32 million, which was principally due to the weakening of the Euro in the ninesix months ended SeptemberJune 30, 20182019 on the translation of the company’s assets denominated in the Euro.


The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for the ninesix months ended SeptemberJune 30, 2017:2018:
(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
 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 lossincome for the ninesix months ended SeptemberJune 30, 20172018 included foreign currency translation adjustments totaling a gainloss of $602$280 million, which was principally due to the impactweakening of the improvement in the Euro in the ninesix months ended SeptemberJune 30, 20172018 on the translation of the company’s assets denominated in the 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 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) 2018 2017 2018 20172019 2018 2019 2018
Pension and post-employment benefits               
Amortization of actuarial losses and other(a)
 $38
 $28
 $115
 $81
$30
 $36
 $55
 $77
Tax benefit (8) (8) (23) (23)(7) (7) (12) (15)
Total reclassifications, net of tax $30
 $20
 $92
 $58
$23
 $29
 $43
 $62
Cash flow hedging activities               
Losses (gains) on designated cash flow hedges(b)
 $54
 $(38) $144
 $(101)$(37) $46
 $(77) $90
Tax expense (benefit) 
 
 (6) 5
2
 (4) 7
 (6)
Total reclassifications, net of tax $54
 $(38) $138
 $(96)$(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 10).
(b) Amounts are included in cost of products sold (see Note 9).
(c) Amounts are included in interest expense, net (see Note 9).
Note 12 Income Taxes
 


The effective tax rate was 1% for the three and nine months ended September 30, 2018 and 22%8% for the three months and 20%5% for the ninesix months ended SeptemberJune 30, 2017.2019 and 2% for the three months and 1% for the six months ended June 30, 2018. The effective tax rate in each period differed from the U.S. statutory tax ratesrate of 21% in 2018 and 35% in 2017, 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.

The changeincrease in the effective tax rate for both the three and ninesix months ended SeptemberJune 30, 20182019 over the prior year was principally due to the effectsbeneficial impact of the enactment of the Tax Cuts and Jobs Act (the “Act”) in December 2017. The Act significantly changes the U.S. corporate tax system, reducing the U.S. federal corporate tax rate from 35% to 21%, requiring companies to pay a one-time transition tax on a mandatory deemed repatriation of earnings of certain foreign subsidiaries that were previously untaxed and creating new taxes on certain foreign sourced earnings. The Act also creates a territorial tax system that generally excludes dividends from foreign subsidiaries from U.S. taxation. Specific to 2018, there is a beneficial impact due to timing of provisions of the Act related to the earnings from certain foreign subsidiaries.

Given the complexity of the Actsubsidiaries in prior year and anticipated guidance from the U.S. Treasury about implementing the Act, the company’s analysis and accounting for the tax effects of the enactment of the Act is preliminary. In the fourth quarter of 2017, the company recorded, as a direct result of the Act, $4.5 billion of transition tax expense, as well as $4.1 billion of net tax benefit for deferred tax remeasurement. Both of these amounts are provisional estimates, as the company has not fully completed its analysis and calculation of foreign earnings subject to the transition tax or its analysis of certain other aspects of the Act that could result in adjustments to the remeasurement of deferred tax balances. Upon completion of the analysis in 2018, these estimates may be adjusted through income tax expensechanges in the consolidated statementjurisdictional mix of earnings. No adjustments to these provisional estimatesearnings, including a change in fair value of contingent consideration liabilities. These increases were made duringpartially offset by the three and nine months ended September 30, 2018. The Act also created a minimumfavorable resolution of various tax on certain foreign sourced earnings. The taxability of the foreign sourced earnings and the applicable tax rates are dependent on future events. While the company is still evaluating its accounting policy for the minimum tax on foreign sourced earnings, the provisional estimates of the tax effects of the Act were reported on the basis that the minimum tax will be recognized in tax expensepositions in the year it is incurred as a period expense.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 $550$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. 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.

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Note 13 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 $770$330 million as of SeptemberJune 30, 20182019 and $445$350 million as of December 31, 2017.2018. 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. In July 2018, the court denied the plaintiffs' motion for class certification.


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-payer 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 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 AppealsAppeal ruled that the District Attorney’s Office may not bring monetary claims beyond the scope of Orange County.County, which the District Attorney’s Office is appealing.


In September 2014, the FTC filed a lawsuit against AbbVie and others in the United States District Court for the Eastern District of Pennsylvania, alleging that the 2011 patent litigation with two generic companies regarding AndroGel was sham litigation and the settlements of that litigation violated federal antitrust law. In May 2015, the court dismissed the FTC’s settlement-related claim. In June 2018, following a bench trial, the court found for the FTC on its sham litigation claim and ordered a disgorgement remedy of $448 million, plus prejudgment interest. The court denied the 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. In July and August 2018, severalOne purported class action on behalf of direct AndroGel purchasers brought two individual and one class action casesbased 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 alleging sham litigation based on the court’s trial ruling in the FTC’s case. Those cases areand 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 LouisianaCalifornia case discussed below.

Between March and May 2019, 12 putative class action lawsuits were filed a lawsuit, Statein the United States District Court for the Northern District of Louisiana v. Fournier Industrie et Sante, et al., against AbbVie, AbbottIllinois by indirect HUMIRA purchasers, alleging that AbbVie’s settlements with biosimilar manufacturers and affiliated Abbott entities in LouisianaAbbVie’s HUMIRA patent portfolio violate 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 Statefederal antitrust and unfair trade practices laws. The lawsuit seeks monetary damages and attorneys' fees.


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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 payers 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. In July 2018, the court denied the plaintiff’s motion for class certification.

Product liability cases are 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 4,067 claims are consolidated for pre-trial purposes in the United States District Court for the Northern District of Illinois under the MDL Rules as In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545. Approximately 205 claims against AbbVie are pending in various state courts. Plaintiffs generally seek compensatory and punitive damages. Six cases have gone to trial. Four of those have resulted in complete verdicts for AbbVie: three by juries in the United States District Court for the Northern District of Illinois in January, May, and June 2018, and one by a jury in the Cook County, Illinois Circuit Court in August 2017. Another case in the United States District Court for the Northern District of Illinois resulted in a jury verdict for AbbVie on two claims and for the plaintiff on one claim and an award of $150 million in punitive damages with no compensatory damages in July 2017. In orders from December 2017 and February 2018,2019, the court vacated that verdict and ordered a new trial. Ingranted the March 2018 retrial, the jury reached a verdict for AbbVie on strict liability and fraud and for the plaintiff on negligence and awarded $200,000 in compensatory damages and $3 million in punitive damages, which is the subject of post-trial proceedings. Another case in the United States District Court for the Northern District of Illinois resulted in a jury verdict for AbbVie on strict liability and for the plaintiff on remaining claims and an award of $140,000 in compensatory damages and $140 million in punitive damages in August 2017. In July 2018, the court vacated that verdict and ordered a new trial. In September 2018, AbbVie entered into a confidential term sheet with representatives of the Plaintiffs’ Steering Committee in the MDL proceeding for the settlement of existing claims in all courts. That settlement is subject to the execution of a definitive settlement agreement and other contingencies.defendants’ summary judgment motion.

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 595 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. Over ninety percent of the claims pending in all courts, plus other unfiled claims, are subject to confidential settlement agreements and are expected to be dismissed with prejudice.

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 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 October 2018 against AbbVie and in some instances its chief executive officer in the same court by additional investment funds. Plaintiffs seek compensatory and punitive damages.

In May 2017, a shareholder derivative lawsuit, Ellis v. Gonzalez, et al., was filed in Delaware Chancery Court, alleging that AbbVie's directors breached their fiduciary duties in connection with statements made regarding the Shire transaction. The lawsuit sought unspecified compensatory damages for AbbVie, among other relief. In July 2018, the court dismissed this case with prejudice. In August 2018, plaintiff appealed that dismissal to the Delaware Supreme Court.

In September 2018, the Commissioner of the California Department of Insurance intervened in a qui tam lawsuit, State of California and Lazaro Suarez v. AbbVie Inc., et al., brought 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 submission of fraudulent commercial insurance claims for HUMIRA in violation of the California 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, twoa federal securities lawsuits were filed in Septemberlawsuit (Pippins v. AbbVie Inc., et al., in the United States District Court for the Central District of California) and October (Holwill v. AbbVie Inc., et al.,) is

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pending in the United States District Court for the Northern District of Illinois) against AbbVie, its chief executive officer and then-chiefformer chief financial officer, alleging that reasons stated for HUMIRA sales growth in financial filings between 2013 and 2017 were misleading because they omitted the conduct alleged in the Department of Insurance’s complaint.


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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 October 2018 against AbbVie and in some instances its chief executive officer in the same court by additional investment funds. Plaintiffs seek compensatory and punitive damages.


Product liability cases were filed 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 3,900 claims against AbbVie are consolidated for pre-trial purposes in the United States District Court for 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 did not adequately warn about risk of certain injuries, primarily various birth defects, arising from use of Depakote. Approximately 150 cases are pending in the 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 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.


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, four separate 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; Shilpa Medicare Limited, Sun Pharma Global FZE and Sun Pharmaceutical Industries Ltd.; Cipla Limited and Cipla USA Inc.; and Zydus Worldwide DMCC, Cadila Healthcare Limited, Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., 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

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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 14 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) 2018 2017 2018 2017
Immunology        
HUMIRA        
United States $3,546
 $3,151
 $10,070
 $9,048
International 1,578
 1,550
 4,948
 4,487
Total $5,124
 $4,701
 $15,018
 $13,535
Hematologic Oncology        
IMBRUVICA        
United States $812
 $574
 $2,129
 $1,559
Collaboration revenues 160
 114
 455
 306
Total $972
 $688
 $2,584
 $1,865
VENCLEXTA        
United States $69
 $25
 $157
 $60
International 27
 8
 63
 18
Total $96
 $33
 $220
 $78
HCV        
MAVYRET        
United States $444
 $60
 $1,206
 $60
International 395
 35
 1,413
 35
Total $839
 $95
 $2,619
 $95
VIEKIRA        
United States $
 $
 $3
 $64
International 23
 181
 132
 605
Total $23
 $181
 $135
 $669
Other Key Products        
Creon        
United States $239
 $215
 $667
 $596
Lupron        
United States $173
 $161
 $530
 $488
International 41
 40
 126
 117
Total $214
 $201
 $656
 $605
Synthroid        
United States $192
 $191
 $567
 $576
Synagis        
International $97
 $116
 $462
 $456
AndroGel        
United States $135
 $147
 $393
 $437
Duodopa        
United States $19
 $16
 $57
 $44
International 87
 78
 260
 211
Total $106
 $94
 $317
 $255
Sevoflurane        
United States $18
 $19
 $54
 $56
International 68
 81
 251
 255
Total $86
 $100
 $305
 $311
Kaletra        
United States $16
 $16
 $42
 $54
International 72
 69
 210
 256
Total $88
 $85
 $252
 $310
All other $25
 $148
 $253
 $689
Total net revenues $8,236
 $6,995
 $24,448
 $20,477



20182019 Form 10-Q | abbvieimage2a12.gif
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, 20182019 and December 31, 20172018 and the results of operations for the three and ninesix months ended SeptemberJune 30, 20182019 and 2017.2018. 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 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; 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, oncology and 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 30,000 employees. AbbVie operates in one business segment—pharmaceutical products.
2018On 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.
2019 Strategic Objectives
AbbVie'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 by diversifying revenue streams, driving late-stage pipeline assets to the market and ensuring strong commercial execution of new product launches; (ii) continued investment and expansion in its pipeline in support of opportunities in immunology, oncology and neurologyneuroscience, with additional targeted investment in cystic fibrosis and women's health as well as continued investment in key on-market products; (iii) expanding operating margins; and (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, 20182019 included delivering worldwide net revenues of $24.4$16.1 billion, operating earnings of $8.8$6.4 billion, diluted earnings per share of $4.79$2.14 and cash flows from operations of $10.0$5.5 billion. Worldwide net revenues grewdecreased by 18%0.8% and increased 0.9% on a constant currency basis, primarily driven primarily by the continued strength of HUMIRA and revenue growth related to IMBRUVICA and HCV product MAVYRET.VENCLEXTA as well as the continued strength of U.S. HUMIRA revenues, offset by international HUMIRA biosimilar competition.
Diluted earnings per share was $4.79$2.14 for the ninesix months ended SeptemberJune 30, 20182019 and included the following after-tax costs: (i) $801 million related to the amortization of intangible assets; (ii) $500 million as a result of a collaboration agreement extension with Calico Life Sciences LLC (Calico); (iii) $432 million$2.5 billion for the change in fair value of contingent consideration liabilities; (iv) litigation reserve charges(ii) $639 million related to the amortization of $276 million; (v) charitable contributions of $182 million as part of AbbVie's previously announced plan to make contributions to U.S. not-for-profit organizations in 2018; (vi) $124intangible assets; (iii) $241 million for acquired in-process research and development (IPR&D); (iv) $139 million of restructuring charges; (v) $75 million for milestone payments; and (vii) milestone payments(vi) $27 million of $87 million. Financial results forexpenses related to the nine months ended September 30, 2018proposed Allergan acquisition. These costs were also impactedpartially offset by U.S.an after-tax benefit of $267 million due to the favorable resolution of various tax reform and the timing of the new legislation's phase in on certain subsidiaries.positions. Additionally,

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26




financial results reflected continued added funding to support all stages of AbbVie’s emerging pipeline assets and continued investment in AbbVie’s growthon-market brands.

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26




In November 2018, the company announced that its board of directors declared an increase in the company's quarterly cash dividend from $0.96 per share to $1.07 per share beginning with the dividend payable in February 2019. This reflects an increase of approximately 11.5% over the previous quarterly rate.
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 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 January 2018,February 2019, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designationaccepted for priority review AbbVie's New Drug Application (NDA) for upadacitinib, an investigational oral JAK1-selective inhibitor, infor the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
In April 2018, AbbVie announced that top-line results from the Phase 3 SELECT-COMPARE clinical trial evaluating upadacitinib met all primary and ranked secondary endpoints in patients with moderate to severe rheumatoid arthritis (RA) who are on a stable background of methotrexate and who have an inadequate response. The safety profile of upadacitinib was consistent with previously reported clinical trials and no new safety signals were detected..
In June 2018, AbbVie announced that top-line results from the Phase 3 SELECT-EARLY clinical trial evaluating upadacitinib versus methotrexate in adult patients with moderate to severe RA who were methotrexate-naïve met all primary and ranked secondary endpoints. The safety profile of upadacitinib was consistent with previously reported clinical trials and no new safety signals were detected.
In July 2018, AbbVie initiated two Phase 3 clinical trials to evaluate the efficacy and safety of upadacitinib in subjects with moderate to severe atopic dermatitis.
In September 2018,February 2019, AbbVie initiated a Phase 3 clinical trial to evaluate the efficacy and safety of upadacitinib in subjects with moderate to severe ulcerative colitis.giant cell arteritis.
RisankizumabSKYRIZI
In January 2018,March 2019, AbbVie initiated two Phase 3 clinical trials to evaluate the efficacy and safety of risankizumab, an investigational interleukin-23 (IL-23) inhibitor, versus placebo during induction therapy in subjects with moderately to severely active Crohn’s disease.psoriatic arthritis.
In February 2018, AbbVie announced that top-line results from two Phase 3 clinical trials evaluating risankizumab with 12-week dosing compared to ustekinumab met ranked additional secondary endpointsApril 2019, the FDA approved SKYRIZI (risankizumab) for the treatment of patients with moderate to severe chronic plaque psoriasis. The initial results from these clinical trials were previously announcedpsoriasis in October 2017. The safety profile was consistent with all previously reported studies, and there were no new safety signals detected across the two studies.

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27




adults who are candidates for systemic therapy or phototherapy.
In April 2018, AbbVie submitted a Biologics License Application (BLA) to the FDA and a Marketing Authorisation Application (MAA) to2019, the European Medicines Agency (EMA)Commission granted marketing authorization for risankizumabSKYRIZI for the treatment of moderate to severe plaque psoriasis in adults.
In May 2018, AbbVie initiated a Phase 2b/3 clinical trial to evaluate the efficacy and safety of risankizumab versus placebo in subjects with moderately to severely active ulcerative colitis.adult patients who are candidates for systemic therapy.
Oncology
IMBRUVICA
In April 2018, AbbVie initiated a Phase 3 clinical trial to evaluateJanuary 2019, the safety and efficacy ofFDA approved IMBRUVICA, in combination with VENCLEXTA versus chlorambucil plus GAZYVA (obinutuzumab), for the first-line treatment of subjectsadult patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
In May 2018,June 2019, AbbVie announced that results from the Phase 3 iLLUMINATE studyCLL12 trial, evaluating IMBRUVICA in combination with GAZYVA in previously untreated CLL/SLL met its primary endpoint.
In June 2018, AbbVie announced that results from an interim analysis of the Phase 3 iNNOVATE study evaluating IMBRUVICA plus Rituxan (rituximab) in previously untreated and relapsed/refractory (R/R) patients with Waldenström’s macroglobulinemia (WM) met its primary endpoint.
In July 2018, AbbVie announced that results from a Phase 3 study evaluating the addition of IMBRUVICA to a chemotherapy regimen consisting of five different agents used in combination did not meet its primary endpoint in a subset of untreated diffuse large B-cell lymphoma patients identified to have the non-germinal center B-cell or activated B-cell subtypes of this disease.
In August 2018, the FDA approved IMBRUVICA, in combination with Rituxan, for the treatment of adult patients with WM.
In October 2018, the FDA accepted for priority review AbbVie's supplemental New Drug Application (sNDA) for IMBRUVICA in combination with GAZYVA in patients with previously untreated CLL/SLL.CLL, which demonstrated that IMBRUVICA significantly improved event- and progression-free survival.
VENCLEXTA
In January 2018,March 2019, AbbVie submitted an sNDAannounced that the 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 BELLINI 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 monotherapy 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 who are refractory to or have relapsed B-cell receptor pathway inhibitors.acute myeloid leukemia (AML).
In June 2018,May 2019, the FDA approved VENCLEXTA, in combination with Rituxanobinutuzumab, for the treatment ofadult patients with previously untreated CLL/SLL, with or without 17p deletion, who have received at least one prior therapy. VENCLEXTA plus Rituxan is the first oral-based, chemotherapy-free combination in CLL that allows patients an option for fixed treatment duration.SLL.
In July 2018,June 2019, AbbVie submitted an sNDA to the FDA for VENCLEXTA in combination with a hypomethylating agent or in combination with low dose cytarabine for treatment of newly diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy. In August, AbbVie was granted priority review for VENCLEXTA by the FDA.
In September 2018, the FDA expanded the label for VENCLEXTA in combination with Rituxan to include information about patients with previously-treated CLL who achieved minimal residual disease (MRD)-negativity in the Phase 3 MURANO trial.
In October 2018, the European Commission approved the type-II variation application for VENCLYXTO in combination with Rituxan for the treatment of patients with R/R CLL who have received at least one prior therapy.
In October 2018, AbbVie announced that the results from the Phase 3 CLL14 study comparing thetrial, 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 coexisting medical conditions met its primary endpoint.achieved higher rates of complete response and minimal residual disease-negativity compared to commonly used standard of care obinutuzumab plus chlorambucil.

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Rova-TDepatux-M
In March 2018, AbbVie announced top-line results from the Phase 2 TRINITY study evaluating rovalpituzumab tesirine (Rova-T) for third-line R/R small cell lung cancer (SCLC). Although Rova-T demonstrated single agent responses in advanced SCLC patients, after consulting with the FDA, based on the magnitude of effect across multiple parameters in this single-arm study, the company will not seek accelerated approval for Rova-T in third-line R/R SCLC. Ongoing Phase 3 studies will continue to investigate Rova-T in first- and second-line SCLC.
Other
In August 2018, Bristol-Myers Squibb Company (BMS) announced that the FDA accepted for priority review its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies. This submission followed the BMS announcement in June 2018 that results from the Phase 2 ELOQUENT-3 study evaluating the combination of Empliciti with pomalidomide/dexamethasone in RRMM patients met its primary endpoint. BMS and AbbVie are co-developing Empliciti, with BMS solely responsible for commercial activities.
Neurology
In March 2018, Biogen andMay 2019, AbbVie announced the voluntary worldwide withdrawaldecision to discontinue the Phase 3 INTELLANCE-1 study of marketing authorizationsdepatuxizumab 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 ZINBRYTA, a prescription medicine usedpatients receiving Depatux-M compared with placebo when added to treat adults with relapsing formsthe standard regimen of multiple sclerosis.radiation and temozolomide. Enrollment has been halted in all ongoing Depatux-M studies.
OtherVeliparib
In February 2018,July 2019, AbbVie announced that top-line results from the Phase 3 ELARIS UF-IBROCADE3 study evaluating elagolix,veliparib, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigatedoral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, in combination with low-dose hormone (add-back) therapy for uterine fibroidscarboplatin and paclitaxel met its primary efficacy endpoint and all ranked secondary endpoints.of progression-free survival in patients with HER2 negative germline BRCA-mutated advanced breast cancer.
In March 2018,July 2019, AbbVie announced that top-line results from the Phase 3 ELARIS UF-IIVELIA study, conducted in collaboration with the GOG Foundation, Inc., evaluating veliparib with carboplatin and paclitaxel followed by veliparib maintenance therapy met its primary endpoint of progression-free survival in patients with newly diagnosed ovarian cancer, regardless of biomarker status.
Neuroscience
In May 2019, AbbVie initiated a Phase 3 clinical trial to evaluate the safety and tolerability of ABBV-951, a subcutaneous levodopa/carbidopa delivery system, in subjects with Parkinson's disease.
In July 2019, AbbVie announced the decision to discontinue the Phase 2 ARISE study evaluating ABBV-8E12, an investigational anti-tau antibody, in patients with progressive supranuclear palsy, after an Independent Data Monitoring Committee recommended stopping the trial for futility after the trial showed that ABBV-8E12 did not provide efficacy.
Other
In July 2019, AbbVie submitted an NDA to the FDA for elagolix in combination with low-dose hormone (add-back)estradiol/norethindrone acetate (E2/NETA) daily add-back therapy for uterine fibroids met its primary efficacy endpoint and all ranked secondary endpoints.
In July 2018, the FDA approved ORILISSA (elagolix) for the management of moderate to severe painheavy menstrual bleeding associated with endometriosis.
In August 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-EXTEND study evaluating elagolix in combination with low-dose hormone therapy for uterine fibroids were consistent with findings observed in the ELARIS UF-I and ELARIS UF-II Phase 3 studies.
In October 2018, AbbVie announced that it will assume full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF). Under a revised agreement, AbbVie will assume full development and commercial responsibility over the investigational program comprising several clinical and pre-clinical compounds originally discovered and developed jointly by AbbVie and Galapagos. Galapagos will not pursue further research and development in CF, but is eligible for future milestones and royalties on commercialized programs.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, 2017.2018.


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2928







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 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) 2018 2017 2018
2017  2019 2018 2019 2018 
United States $5,597
 $4,586
 22.0% 22.0% $15,836
 $13,284
 19.2% 19.2% $5,964
 $5,449
 9.5 % 9.5 % $11,234
 $10,239
 9.7 % 9.7 %
International 2,639
 2,409
 9.6% 11.7% 8,612
 7,193
 19.7% 15.3% 2,291
 2,829
 (19.0)% (14.4)% 4,849
 5,973
 (18.8)% (14.3)%
Net revenues $8,236
 $6,995
 17.8% 18.5% $24,448
 $20,477
 19.4% 17.8% $8,255
 $8,278
 (0.3)% 1.3 % $16,083
 $16,212
 (0.8)% 0.9 %


20182019 Form 10-Q | abbvieimage2a12.gif
3029







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) 2018 2017  2018 2017 
Immunology                
HUMIRA                
United States $3,546
 $3,151
 12.5 % 12.5 % $10,070
 $9,048
 11.3 % 11.3 %
International 1,578
 1,550
 1.8 % 4.2 % 4,948
 4,487
 10.3 % 5.9 %
Total $5,124
 $4,701
 9.0 % 9.8 % $15,018
 $13,535
 11.0 % 9.5 %
Hematologic Oncology                
IMBRUVICA                
United States $812
 $574
 41.5 % 41.5 % $2,129
 $1,559
 36.6 % 36.6 %
Collaboration revenues 160
 114
 40.1 % 40.1 % 455
 306
 48.5 % 48.5 %
Total $972
 $688
 41.3 % 41.3 % $2,584
 $1,865
 38.5 % 38.5 %
VENCLEXTA                
United States $69
 $25
 >100.0%
 >100.0%
 $157
 $60
 >100.0%
 >100.0%
International 27
 8
 >100.0%
 >100.0%
 63
 18
 >100.0%
 >100.0%
Total $96
 $33
 >100.0%
 >100.0%
 $220
 $78
 >100.0%
 >100.0%
HCV                
MAVYRET                
United States $444
 $60
 >100.0%
 >100.0%
 $1,206
 $60
 >100.0%
 >100.0%
International 395
 35
 >100.0%
 >100.0%
 1,413
 35
 >100.0%
 >100.0%
Total $839
 $95
 >100.0%
 >100.0%
 $2,619
 $95
 >100.0%
 >100.0%
VIEKIRA                
United States $
 $
 n/m
 n/m
 $3
 $64
 (96.3)% (96.3)%
International 23
 181
 (87.0)% (86.1)% 132
 605
 (78.1)% (78.9)%
Total $23
 $181
 (87.1)% (86.2)% $135
 $669
 (79.8)% (80.6)%
Other Key Products                
Creon                
United States $239
 $215
 11.3 % 11.3 % $667
 $596
 11.8 % 11.8 %
Lupron                
United States $173
 $161
 7.6 % 7.6 % $530
 $488
 8.7 % 8.7 %
International 41
 40
 1.5 % 7.2 % 126
 117
 7.4 % 6.9 %
Total $214
 $201
 6.4 % 7.5 % $656
 $605
 8.4 % 8.3 %
Synthroid                
United States $192
 $191
 0.7 % 0.7 % $567
 $576
 (1.5)% (1.5)%
Synagis                
International $97
 $116
 (16.2)% (14.1)% $462
 $456
 1.3 % (2.2)%
AndroGel                
United States $135
 $147
 (8.3)% (8.3)% $393
 $437
 (10.1)% (10.1)%
Duodopa                
United States $19
 $16
 18.7 % 18.7 % $57
 $44
 30.0 % 30.0 %
International 87
 78
 10.8 % 12.2 % 260
 211
 22.8 % 15.6 %
Total $106
 $94
 12.1 % 13.3 % $317
 $255
 24.0 % 18.1 %
Sevoflurane                
United States $18
 $19
 (2.8)% (2.8)% $54
 $56
 (2.8)% (2.8)%
International 68
 81
 (15.7)% (12.2)% 251
 255
 (1.5)% (2.8)%
Total $86
 $100
 (13.2)% (10.4)% $305
 $311
 (1.7)% (2.7)%
Kaletra                
United States $16
 $16
 (2.9)% (2.9)% $42
 $54
 (21.4)% (21.4)%
International 72
 69
 5.3 % 8.2 % 210
 256
 (18.1)% (19.0)%
Total $88
 $85
 3.7 % 6.0 % $252
 $310
 (18.7)% (19.5)%
All other $25
 $148
 (82.7)% (82.0)% $253
 $689
 (63.1)% (73.8)%
Total net revenues $8,236
 $6,995
 17.8 % 18.5 % $24,448
 $20,477
 19.4 % 17.8 %
   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

2018 Form 10-Q | abbvieimage2a10.gif
31




The following discussion and analysis of AbbVie’s net revenues by product is presented on a constant currency basis.


Global HUMIRA sales increased 10%decreased 5% for the three months and 9%4% for the ninesix months ended SeptemberJune 30, 20182019 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 13%8% for the three months and 11%7% for the ninesix months ended SeptemberJune 30, 20182019 driven by market growth across all indications and favorable pricing.indications. Internationally, HUMIRA sales increased 4%decreased 31% for the three months and 6%27% for the ninesix months ended September

2019 Form 10-Q | abbvieimage2a12.gif
30




June 30, 20182019 primarily driven primarily by market growth across indications. In October 2018,direct biosimilar competition in certain international markets following the expiration of the European Union composition of matter patent for adalimumab expired and biosimilars of HUMIRA launched in Europe.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.

Net revenues for IMBRUVICA represent product sales in the United States and collaboration revenues outside of the United States related to AbbVie’s 50% share of IMBRUVICA profit. AbbVie's global IMBRUVICA revenues increased 41%29% for the three months and 39%32% for the ninesix months ended SeptemberJune 30, 20182019 as a result of continued penetration of IMBRUVICA for patients with chronic lymphocytic leukemia (CLL)CLL as well as favorable pricing.


Global HCV salesNet revenues for VENCLEXTA increased by more than 100% for both the three and ninesix months ended SeptemberJune 30, 2018 as a result2019 primarily due to market share gains following additional regulatory approvals of VENCLEXTA for the launchtreatment of patients with relapsed/refractory CLL and AML in 2018.

Global MAVYRET sales decreased by 14% for the three months and 10% for the six months ended June 30, 2019 primarily driven by lower patient volumes in certain geographies beginning in the second half of 2017 partially offset by a decrease in revenues of VIEKIRA.international markets.


Net revenues for Creon increased 11%18% for the three months and 12%13% for the ninesix months ended SeptemberJune 30, 20182019 primarily driven primarily by continued market growth and higher market share.favorable pricing. Creon maintains market leadership in the pancreatic enzyme market.


Net revenues for Duodopa increased 13%11% for the three months and 18%13% for the ninesix months ended SeptemberJune 30, 20182019 primarily as a result ofdriven by increased market 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) 2018 2017 % change 2018 2017 % change 2019 2018 % change 2019 2018 % change
Gross margin $6,401
 $5,379
 19% $18,752
 $15,716
 19% $6,436
 $6,344
 1% $12,570
 $12,351
 2%
as a % of net revenues 78% 77%   77% 77%   78% 77%   78% 76%  
Gross margin as a percentage of net revenues increased for the three months and was flat for the ninesix months ended SeptemberJune 30, 20182019 compared to the prior year. Gross margin percentage for the three and six months ended SeptemberJune 30, 20182019 was favorably impacted primarily by the reductionexpiration of HUMIRA royalty expense and foreign exchangeroyalties, partially offset by higher intangible asset amortization and the IMBRUVICA profit sharing arrangement. Gross margin percentage for the nine months ended September 30, 2018 was favorably impacted by the reduction of HUMIRA royalty expense offset by the IMBRUVICA profit sharing arrangement and foreign exchange.

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) 2018 2017 % change
2018
2017
% change 2019 2018 % change 2019 2018 % change
Selling, general and administrative $1,919
 $1,457
 32% $5,470
 $4,339
 26% $1,654
 $1,760
 (6)% $3,334
 $3,551
 (6)%
as a % of net revenues 23% 21%   22% 21%   20% 21%   21% 22%  
Selling, general and administrative (SG&A) expenses as a percentage of net revenues increaseddecreased for both the three and ninesix months ended SeptemberJune 30, 20182019 compared to the prior year. SG&A expense percentage for the three and six months ended June 30, 2019 was favorably impacted by 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 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 was unfavorably impacted by restructuring charges, offset by a $98 million decrease in litigation reserves charges that increased by $224 million for the three months and $249 million for the nine months ended September 30, 2018 compared to the prior year and charitable contributions of $115 million for the three months and $235 million for the nine months ended September 30, 2018 to select organizations as part of AbbVie's previously announced plan to make $350 million in contributions to U.S. not-for-profit organizations in 2018. Additionally, new product launch expenses unfavorably impacted SG&A expense percentage for both the three and nine months ended September 30, 2018.reserve charges.


20182019 Form 10-Q | abbvieimage2a12.gif
3231







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) 2018 2017 % change 2018 2017 % change 2019 2018 % change 2019 2018 % change
Research and development $1,268
 $1,228
 3% $3,834
 $3,599
 7% $1,291
 $1,322
 (2)% $2,580
 $2,566
 1%
as a % of net revenues 15% 18%   16% 18%   16% 16%   16% 16%  
Acquired in-process research and development $55
 $
 n/m
 $124
 $15
 >100%
 $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, 2018 increased2019 compared to the prior year principally due to increasedyear. R&D expenses included continued funding to support all stages of the company’scompany'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 during both the three and ninesix months ended SeptemberJune 30, 20182019 and 2017.2018.
Other Operating Expenses
There were no other operating expenses for the three and six months ended June 30, 2019. Other operating expenses for the ninesix months ended SeptemberJune 30, 2018 included a $500 million charge related to the extension of the previously announced collaboration with Calico collaborationLife 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) 2018 2017 2018 2017 2019 2018 2019 2018
Interest expense $339
 $293
 $968
 $851
 $358
 $320
 $745
 $629
Interest income (37) (41) (143) (99) (49) (48) (111) (106)
Interest expense, net $302
 $252
 $825
 $752
 $309
 $272
 $634
 $523
                
Net foreign exchange loss $2
 $9
 $18
 $28
 $6
 $8
 $12
 $16
Other expense, net 94
 338
 411
 449
 2,278
 470
 2,413
 317
Interest expense, net increased for both the three and ninesix months ended SeptemberJune 30, 20182019 compared to the prior year primarily due to the unfavorable impact of higher interest rates on the company's debt obligations.obligations and higher average outstanding debt balances.


Other expense, net included charges related to changes in fair value of the Boehringer Ingelheim and Stemcentrx contingent consideration liabilities of $95$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 $432$337 million for the ninesix months ended SeptemberJune 30, 2018 compared to charges of $401 million for the three months and $547 million for the nine months ended September 30, 2017.2018. 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 six months ended SeptemberJune 30, 2018,2019, the change in fair value primarily represented higher probabilities of success, higher estimated future sales and declining interest rates. The higher probabilities of success resulted from the passageApril 2019 regulatory approvals of time.SKYRIZI for the treatment of moderate to severe plaque psoriasis. For the ninethree and six months ended SeptemberJune 30, 2018, the change in fair value represented higher estimated future sales and the passage of time partially offset by the effect of rising interest rates. For the three and nine months ended September 30, 2017, the change in fair value represented mainly higher probabilities of success and the passage of time.


2019 Form 10-Q | abbvieimage2a12.gif
32




Income Tax Expense

The effective tax rate was 1% for the three and nine months ended September 30, 2018 and 22%8% for the three months and 20%5% for the ninesix months ended SeptemberJune 30, 2017.2019 and 2% for the three months and 1% for the six months ended June 30, 2018. The effective tax rate in each period differed from the U.S. statutory tax ratesrate of 21% in 2018 and 35% in 2017, 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.

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33




The changeincrease in the effective tax rate for both the three and ninesix months ended SeptemberJune 30, 20182019 over the prior year was principally due to the effectsbeneficial impact of the enactmenttiming of provisions of the Tax Cuts and Jobs Act (the “Act”) in December 2017. The Act significantly changes the U.S. corporate tax system, reducing the U.S. federal corporate tax rate from 35% to 21%, requiring companies to pay a one-time transition tax on a mandatory deemed repatriation of earnings of certain foreign subsidiaries that were previously untaxed and creating new taxes on certain foreign sourced earnings. The Act also creates a territorial tax system that generally excludes dividends from foreign subsidiaries from U.S. taxation. Specific to 2018, there is a beneficial impact due to timing of provisionsAct) related to the earnings from certain foreign subsidiaries.subsidiaries in prior year and changes in the jurisdictional mix of earnings, including a change in fair value of contingent consideration liabilities. These increases were partially offset by the favorable resolution of various tax positions in the current year.
FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES
Nine months ended
September 30,
Six months ended
June 30,
(in millions)2018 20172019 2018
Cash flows provided by (used in):      
Operating activities$10,035
 $7,376
$5,494
 $5,511
Investing activities(723) (475)(167) 240
Financing activities(10,571) (3,584)(7,453) (11,487)
Operating cash flows for the ninesix months ended SeptemberJune 30, 2018 increased from2019 were flat compared to the prior year due to improved results of operations resulting from revenue growth and an improvementincrease in operating earnings. Operating cash flows also reflectedearnings and lower defined benefit plan contributions, offset by higher payments for income taxes and interest. AbbVie’s voluntary contributions to its principal domestic defined benefit plan of $150 million for both the nine months ended September 30, 2018 and 2017. The company also made an additional voluntary contribution of $600 million to various other defined benefit plans inwere $203 million for the six months ended June 30, 2019 and $822 million for the six months ended June 30, 2018.


Investing cash flows for the ninesix months ended SeptemberJune 30, 20182019 included payments made for acquisitions and investments of $541 million, capital expenditures of $515 million and net sales and maturities of investment securities totaling $333 million. Investing cash flows for the nine months ended September 30, 2017 included capital expenditures of $347$508 million, payments made for acquisitions and investments of $180$440 million and capital expenditures of $235 million. Investing cash flows for the six months ended June 30, 2018 included net sales and maturities of investment securities totaling $52$874 million, payments made for acquisitions and investments of $401 million and capital expenditures of $233 million.


Financing cash flows for the ninesix months ended SeptemberJune 30, 20182019 included proceeds from the issuancerepayment of aAbbVie's $3.0 billion 364-day term loan credit agreement (term loan) entered into in May 2018. In June 2018, the company drew on this term loan and as of September 30, 2018, $3.0 billion was outstanding and was included in short-term borrowings on the condensed consolidated balance sheet. Borrowings under the term loan bear interest at one month LIBOR plus applicable margin. The term loan may be prepaid without penalty upon prior notice and contains customary covenants, all of which the company was in compliance with as of September 30, 2018. In September 2018, the company issued $6.0 billion aggregate principal amount of unsecured senior notes. The company used a portion of the proceeds to repay the company's outstanding $2.0 billion term loan that was duescheduled to mature in November 2018. Financing cash flows for the nine months ended September 30, 2018 also included the May 2018 repayment of $3.0 billion aggregate principal amount of the company's 1.80% senior notes at maturity.June 2019.


The company made cash dividend payments of $4.1$3.2 billion for the ninesix months ended SeptemberJune 30, 20182019 and $3.1$2.7 billion for the ninesix months ended SeptemberJune 30, 2017.2018. The increase in cash dividend payments was driven by an increase in the quarterly dividend rate. On September 7, 2018,June 20, 2019, the board of directors declared a quarterly cash dividend of $0.96$1.07 per share for stockholders of record at the close of business on OctoberJuly 15, 2018,2019, payable on NovemberAugust 15, 2018. On November 2, 2018, the company announced that its board of directors declared an increase in the company's quarterly cash dividend from $0.96 per share to $1.07 per share beginning with the dividend payable on February 15, 2019 to stockholders of record as of January 15, 2019. This reflects an increase of approximately 11.5% over the previous quarterly rate. 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 15, 2018, AbbVie's board of directors authorized a new $10.0 billionThe company's stock repurchase program, which superseded AbbVie's previous stock repurchase program. The new stock repurchase programauthorization permits purchases of AbbVie shares from time to time in open-market or private transactions including accelerated share repurchases, at management's discretion. The program has

2018 Form 10-Q | abbvieimage2a10.gif
34




no time limit and can be discontinued at any time. Under the new authorization, AbbVie repurchased 83.24 million shares for $8.5$300 million during the six months ended June 30, 2019 and 84 million shares for $8.8 billion during the ninesix months ended SeptemberJune 30, 2018.

Prior to the new $10.0 billion authorization, AbbVie repurchased 10.9cash-settled $201 million sharesof its December 2018 open-market purchases in the open market for $1.3 billion during the nine months ended September 30, 2018.

January 2019.
During the ninesix months ended SeptemberJune 30, 2018,2019, AbbVie paid $100made $167 million of contingent consideration to Boehringer Ingelheimpayments related to BLA and MAA acceptance milestones. $78the commercial launch of SKYRIZI in certain geographies. $108 million of these payments were included in financing cash flows and $22$59 million of the payments were included in operating cash flows. During the nine months ended September 30, 2017, AbbVie paid $305 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.
During the ninesix months ended SeptemberJune 30, 20182019 and 2017,2018, the company issued and redeemed commercial paper. The balance of commercial paper outstanding was $400$306 million as of June 30, 2019 and $699 million as of December 31, 2017. There were no commercial paper borrowings outstanding as of September 30, 2018. AbbVie may issue additional commercial paper or retire commercial paper to meet liquidity requirements as needed.

2019 Form 10-Q | abbvieimage2a12.gif
33




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 to the condensed consolidated financial statements for additional information. During the six months ended June 30, 2019, AbbVie paid debt issuance costs of $171 million related to the 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 $270 million as of September 30, 2018 and $255 million as of December 31, 2017. The company also continues to do business with foreign governments in certain oil-exporting countries that have 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 $147 million as of September 30, 2018 and $149 million as of December 31, 2017. Outstanding governmental receivables related to Russia, net of allowances for doubtful accounts, were $104 million as of September 30, 2018 and $152 million as of December 31, 2017. 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, 2018.
Credit Facility, Access to Capital and Credit Ratings
Credit Facility
In September 2018, AbbVie replaced its existing revolving credit facility withcurrently has a new $3.0 billion five-year revolving credit facility.facility which matures in August 2023. The newrevolving credit facility enables the company to borrow funds on an unsecured basis at variable interest rates and contains various covenants. At SeptemberJune 30, 2018,2019, 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 company's credit facilitiesfacility as of SeptemberJune 30, 20182019 and December 31, 2017.2018.
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

2018 Form 10-Q | abbvieimage2a10.gif
35




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
There were no changes inOn June 25, 2019, following the company’sannouncement 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 ratings duringrating by one notch to BBB+ from A- and the nine months ended September 30, 2018. short-term rating to A-2 from A-1 when the acquisition is complete.
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, “Summary of Significant Accounting Policies” in AbbVie's Annual Report on Form 10-K for the year ended December 31, 2017.2018. Significant changes in the company’s application of its critical accounting policies include the adoption of a new accounting standard that establishes a new revenue recognitionlease accounting framework. See Notes 1 and 28 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, 2017,2018, 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, 2017.2018.


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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, 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, 2018.2019.


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 errors 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 13 to the condensed 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, 2018 – July 31, 20181,157
(1) 
$96.23
(1) 

 $2,500,000,000 
August 1, 2018 – August 31, 201810,392,841
(1) 
$96.23
(1) 
10,391,816
 $1,500,000,050 
September 1, 2018 – September 30, 20181,145
(1) 
$93.73
(1) 

 $1,500,000,050 
Total10,395,143
(1) 
$96.23
(1) 
10,391,816
 $1,500,000,050 
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 purchased on the open market for the benefit of participants in the AbbVie Employee Stock Purchase Plan – 1,1571,204 in July; 1,025April; 1,371 in August;May; and 1,1451,138 in September.June.


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
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
101 The following financial statements and notes from the AbbVie Inc. Quarterly Report on Form 10-Q for the quarter ended SeptemberJune 30, 2018,2019, filed on November 7, 2018,August 5, 2019, formatted in XBRL: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 (v)(vi) the Notes to Condensed Consolidated Financial Statements.


*  Incorporated herein by reference. Commission file number 001-35565.001-35565.

** Denotes management contract or compensatory plan or arrangement required to 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/ Robert A. Michael
  Robert A. Michael
  SeniorExecutive Vice President,
  Chief Financial Officer




Date: November 7, 2018August 5, 2019


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