10-Q 1 abbv-20180331x10q.htm 10-Q Document


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

FORM 10-Q

(Mark One)

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

For the quarterly period ended March 31, 2018

OR

o
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. 001-35565

abbvieimage1a13.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 Chicago, Illinois 60064

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.        Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).        Yes x No ¨

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

As of April 27, 2018, AbbVie Inc. had 1,586,879,451 shares of common stock at $0.01 par value outstanding.




AbbVie Inc. and Subsidiaries
Table of Contents



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PART I.    FINANCIAL INFORMATION

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

 
 
Three months ended
March 31,
(in millions, except per share data)
 
2018
 
2017
Net revenues
 
$
7,934

 
$
6,538

 
 
 
 
 
Cost of products sold
 
1,927

 
1,616

Selling, general and administrative
 
1,791

 
1,373

Research and development
 
1,244

 
1,142

Acquired in-process research and development
 
69

 

Total operating costs and expenses
 
5,031

 
4,131

Operating earnings
 
2,903

 
2,407

 
 
 
 
 
Interest expense, net
 
251

 
247

Net foreign exchange loss
 
8

 
13

Other (income) expense, net
 
(153
)
 
61

Earnings before income tax expense
 
2,797

 
2,086

Income tax expense
 
14

 
375

Net earnings
 
$
2,783

 
$
1,711

 
 
 
 
 
Per share data
 
 
 
 
Basic earnings per share
 
$
1.74

 
$
1.07

Diluted earnings per share
 
$
1.74

 
$
1.06

Cash dividends declared per common share
 
$
0.96

 
$
0.64

 
 
 
 
 
Weighted-average basic shares outstanding
 
1,591

 
1,597

Weighted-average diluted shares outstanding
 
1,596

 
1,603


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
March 31,
(in millions)
2018
 
2017
Net earnings
$
2,783

 
$
1,711

 
 
 
 
Foreign currency translation adjustments, net of tax expense (benefit) of $(3) for the three months ended March 31, 2018 and $— for the three months ended March 31, 2017
189

 
170

Net investment hedging activities, net of tax expense (benefit) of $(30) for the three months ended March 31, 2018 and $(36) for the three months ended March 31, 2017
(104
)
 
(64
)
Pension and post-employment benefits, net of tax expense (benefit) of $9 for the three months ended March 31, 2018 and $8 for the three months ended March 31, 2017
22

 
11

Marketable security activities, net of tax expense (benefit) of $— for the three months ended March 31, 2018 and $(1) for the three months ended March 31, 2017
(7
)
 
(8
)
Cash flow hedging activities, net of tax expense (benefit) of $(1) for the three months ended March 31, 2018 and $(13) for the three months ended March 31, 2017
(3
)
 
(65
)
Other comprehensive income
97

 
44

Comprehensive income
$
2,880

 
$
1,755


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)
March 31,
2018
 
December 31,
2017
 
(unaudited)
 
 
Assets
 
 
 
Current assets
 
 
 
Cash and equivalents
$
9,007

 
$
9,303

Short-term investments
467

 
486

Accounts receivable, net
5,841

 
5,088

Inventories
1,738

 
1,605

Prepaid expenses and other
3,391

 
4,741

Total current assets
20,444

 
21,223

 
 
 
 
Investments
2,057

 
2,090

Property and equipment, net
2,828

 
2,803

Intangible assets, net
27,230

 
27,559

Goodwill
15,880

 
15,785

Other assets
903

 
1,326

Total assets
$
69,342

 
$
70,786

 
 
 
 
Liabilities and Equity
 
 
 
Current liabilities
 
 
 
Short-term borrowings
$
367

 
$
400

Current portion of long-term debt and lease obligations
6,014

 
6,015

Accounts payable and accrued liabilities
10,677

 
10,226

Total current liabilities
17,058

 
16,641

 
 
 
 
Long-term debt and lease obligations
30,906

 
30,953

Deferred income taxes
2,304

 
2,490

Other long-term liabilities
15,521

 
15,605

 
 
 
 
Commitments and contingencies


 


 
 
 
 
Stockholders’ equity
 
 
 
Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,775,505,540 shares issued as of March 31, 2018 and 1,768,738,550 as of December 31, 2017
18

 
18

Common stock held in treasury, at cost, 188,735,571 shares as of March 31, 2018 and 176,607,525 as of December 31, 2017
(13,331
)
 
(11,923
)
Additional paid-in capital
14,519

 
14,270

Retained earnings
4,977

 
5,459

Accumulated other comprehensive loss
(2,630
)
 
(2,727
)
Total stockholders’ equity
3,553

 
5,097

 
 
 
 
Total liabilities and equity
$
69,342

 
$
70,786


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)
 
Three months ended
March 31,
(in millions) (brackets denote cash outflows)
2018
 
2017
Cash flows from operating activities
 
 
 
Net earnings
$
2,783

 
$
1,711

Adjustments to reconcile net earnings to net cash from operating activities:
 
 
 
Depreciation
115

 
103

Amortization of intangible assets
330

 
271

Change in fair value of contingent consideration liabilities
(148
)
 
85

Stock-based compensation
191

 
141

Upfront costs and milestones related to collaborations
101

 
28

Other, net
101

 
45

Changes in operating assets and liabilities:
 
 
 
Accounts receivable
(681
)
 
(34
)
Inventories
(71
)
 
71

Prepaid expenses and other assets
(267
)
 
(53
)
Accounts payable and other liabilities
191

 
(266
)
Cash flows from operating activities
2,645

 
2,102

 
 
 
 
Cash flows from investing activities
 
 
 
Acquisitions and investments
(372
)
 
(63
)
Acquisitions of property and equipment
(119
)
 
(95
)
Purchases of investment securities
(267
)
 
(970
)
Sales and maturities of investment securities
311

 
444

Cash flows from investing activities
(447
)
 
(684
)
 
 
 
 
Cash flows from financing activities
 
 
 
Net change in short-term borrowings
(33
)
 
23

Repayments of long-term debt and lease obligations
(7
)
 
(6
)
Dividends paid
(1,137
)
 
(1,027
)
Purchases of treasury stock
(1,431
)
 
(895
)
Proceeds from the exercise of stock options
62

 
85

Other, net
37

 
26

Cash flows from financing activities
(2,509
)
 
(1,794
)
Effect of exchange rate changes on cash and equivalents
15

 
16

Net change in cash and equivalents
(296
)
 
(360
)
Cash and equivalents, beginning of period
9,303

 
5,100

 
 
 
 
Cash and equivalents, end of period
$
9,007

 
$
4,740


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.
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. 2014-09
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers (Topic 606) and Other Assets and Deferred Costs - Contracts with Customers (Subtopic 340-40). The amendments in this standard superseded most existing revenue recognition requirements. The core principle of the new guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. AbbVie adopted the standard in the first quarter of 2018 using the modified retrospective method. Results for reporting periods beginning after December 31, 2017 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’s historical accounting. The cumulative effect of initially applying the new revenue standard was recognized as an adjustment to the opening balance of retained earnings 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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The impact of adoption on the company’s condensed consolidated statement of earnings for the three months ended March 31, 2018 was as follows:
 
 
Three months ended
March 31, 2018
(in millions, except per share data)
 
As Reported
 
Balances Without Adoption of
ASU 2014-09
 
Effect of Change Higher/(Lower)
Net revenues
 
$
7,934

 
$
7,891

 
$
43

Cost of products sold
 
1,927

 
1,906

 
21

Income tax expense
 
14

 
7

 
7

Net earnings
 
2,783

 
2,768

 
15

Diluted earnings per share
 
$
1.74

 
$
1.73

 
$
0.01

As of March 31, 2018, due to the impact of the adoption of ASU 2014-09, prepaid expenses and other were $100 million higher, inventories were $60 million lower, accounts payable and accrued liabilities were $48 million lower, other long-term liabilities were $61 million lower, deferred income taxes were $19 million higher and retained earnings were $139 million higher in 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 $12 million from operating earnings to non-operating income for the three months ended March 31, 2017. Additionally, the company recorded approximately $4 million of non-operating income for the three months ended March 31, 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. The new standard must be adopted using the modified retrospective approach and will be effective for AbbVie starting with the first quarter of 2019, with early adoption permitted. AbbVie will adopt the standard effective in the first quarter of 2019 and is currently assessing the impact of adopting this guidance on its consolidated financial statements and related disclosures. AbbVie does not expect the adoption will have a material impact on its consolidated statement of earnings. However, the new standard will require AbbVie to establish liabilities and corresponding right-of-use assets on its consolidated balance sheet for operating leases that exist as of the January 1, 2019 adoption date.
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 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 Recognition
 

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
March 31,
(in millions)
 
2018
 
2017
Interest expense
 
$
309

 
$
273

Interest income
 
(58
)
 
(26
)
Interest expense, net
 
$
251

 
$
247

Inventories
(in millions)
March 31, 2018
 
December 31, 2017
Finished goods
$
632

 
$
610

Work-in-process
913

 
822

Raw materials
193

 
173

Inventories
$
1,738

 
$
1,605

Property and Equipment
(in millions)
March 31, 2018
 
December 31, 2017
Property and equipment, gross
$
8,231

 
$
8,071

Accumulated depreciation
(5,403
)
 
(5,268
)
Property and equipment, net
$
2,828

 
$
2,803

Depreciation expense was $115 million for the three months ended March 31, 2018 and $103 million for the three months ended March 31, 2017.
Note 4    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
March 31,
(in millions, except per share data)
 
2018
 
2017
Basic EPS
 
 
 
 
Net earnings
 
$
2,783

 
$
1,711

Earnings allocated to participating securities
 
12

 
9

Earnings available to common shareholders
 
$
2,771

 
$
1,702

Weighted-average basic shares outstanding
 
1,591

 
1,597

Basic earnings per share
 
$
1.74

 
$
1.07

 
 
 
 
 
Diluted EPS
 
 
 
 
Net earnings
 
$
2,783

 
$
1,711

Earnings allocated to participating securities
 
12

 
9

Earnings available to common shareholders
 
$
2,771

 
$
1,702

Weighted-average shares of common stock outstanding
 
1,591

 
1,597

Effect of dilutive securities
 
5

 
6

Weighted-average diluted shares outstanding
 
1,596

 
1,603

Diluted earnings per share
 
$
1.74

 
$
1.06


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 5 Licensing, Acquisitions and Other Arrangements
 

Cash outflows related to acquisitions and investments totaled $372 million for the three months ended March 31, 2018 and $63 million for the three months ended March 31, 2017. AbbVie recorded acquired in-process research and development (IPR&D) charges of $69 million for the three months ended March 31, 2018 and recorded no IPR&D charges for the three months ended March 31, 2017.
Note 6 Collaboration 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

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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
March 31,
(in millions)
 
2018
 
2017
United States - Janssen's share of profits (included in cost of products sold)
 
$
276

 
$
212

International - AbbVie's share of profits (included in net revenues)
 
138

 
94

Global - AbbVie's share of other costs (included in respective line items)
 
71

 
59


AbbVie’s receivable from Janssen, included in accounts receivable, net, was $153 million at March 31, 2018 and $124 million at December 31, 2017. AbbVie’s payable to Janssen, included in accounts payable and accrued liabilities, was $251 million at March 31, 2018 and $253 million at December 31, 2017.
Note 7    Goodwill and Intangible Assets
 

Goodwill

The following table summarizes the changes in the carrying amount of goodwill:
(in millions)
 
Balance as of December 31, 2017
$
15,785

Foreign currency translation adjustments
95

Balance as of March 31, 2018
$
15,880


The company performs its annual goodwill impairment assessment in the third quarter, or earlier if impairment indicators exist. As of March 31, 2018, there were no accumulated goodwill impairment losses.

Intangible Assets, Net

The following table summarizes intangible assets:
 
March 31, 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
$
16,141

 
$
(5,207
)
 
$
10,934

 
$
16,138

 
$
(4,982
)
 
$
11,156

License agreements
7,822

 
(1,516
)
 
6,306

 
7,822

 
(1,409
)
 
6,413

Total definite-lived intangible assets
23,963

 
(6,723
)
 
17,240

 
23,960

 
(6,391
)
 
17,569

Indefinite-lived research and development
9,990

 

 
9,990

 
9,990

 

 
9,990

Total intangible assets, net
$
33,953

 
$
(6,723
)
 
$
27,230

 
$
33,950

 
$
(6,391
)
 
$
27,559


Amortization expense was $330 million for the three months ended March 31, 2018 and $271 million for the three months ended March 31, 2017. Amortization expense was included in cost of products sold in the condensed consolidated statements of earnings.


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11




Indefinite-lived intangible assets represent acquired IPR&D associated with products that have not yet received regulatory approval. Indefinite-lived intangible assets as of March 31, 2018 and December 31, 2017 related 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 impairment charges were recorded for the three months ended March 31, 2018 and 2017.
Note 8    Restructuring Plans
 

AbbVie recorded restructuring charges of $22 million for the three months ended March 31, 2018 and $16 million for the three months ended March 31, 2017.

The following table summarizes the cash activity in the restructuring reserve for the three months ended March 31, 2018:
(in millions)
 
Accrued balance as of December 31, 2017
$
86

Restructuring charges
22

Payments and other adjustments
(7
)
Accrued balance as of March 31, 2018
$
101

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, 2017 for a summary of AbbVie's risk management policy and use of derivative instruments.

Financial Instruments

Various AbbVie foreign subsidiaries enter into foreign currency forward exchange contracts to manage exposures to changes in foreign exchange rates for anticipated intercompany transactions denominated in a currency other than the functional currency of the local entity. These contracts, with notional amounts totaling $3.2 billion at March 31, 2018 and $2.2 billion at December 31, 2017, are designated as cash flow hedges and are recorded at fair value. The durations of these forward exchange contracts were generally less than eighteen months. Accumulated gains and losses as of March 31, 2018 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 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 $10.5 billion at March 31, 2018 and $7.7 billion at December 31, 2017.

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 designated €3.6 billion aggregate principal amount of senior Euro notes as net investment hedges at March 31, 2018 and December 31, 2017. Realized and unrealized gains and losses from these hedges are included in AOCI.

AbbVie is a party to interest rate hedge contracts designated as fair value hedges with notional amounts totaling $11.8 billion at March 31, 2018 and December 31, 2017. 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.

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


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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
(in millions)
Balance sheet caption
March 31,
2018
December 31, 2017
 
Balance sheet caption
March 31,
2018
December 31, 2017
Foreign currency forward exchange contracts
 
 
 
 
 
 
 
Designated as cash flow hedges
Prepaid expenses and
other
$
3

$
1

 
Accounts payable and accrued liabilities
$
106

$
120

Designated as cash flow hedges
Other assets
1


 
Other long-term liabilities
2


Not designated as hedges
Prepaid expenses and
other
14

22

 
Accounts payable and accrued liabilities
19

29

Interest rate swaps designated as fair value hedges
Prepaid expenses and other


 
Accounts payable and accrued liabilities
10

8

Interest rate swaps designated as fair value hedges
Other assets


 
Other long-term liabilities
575

393

Total derivatives
 
$
18

$
23

 
 
$
712

$
550


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 losses from derivative instruments recognized in other comprehensive income:
 
 
Three months ended
March 31,
(in millions)
 
2018
 
2017
Foreign currency forward exchange contracts
 
$
(48
)
 
$
(61
)

Assuming market rates remain constant through contract maturities, the company expects to transfer pre-tax unrealized losses of $178 million into cost of products sold for foreign currency cash flow hedges during the next 12 months.

Related to AbbVie’s non-derivative, foreign currency denominated debt designated as net investment hedges, the company recognized pre-tax losses in other comprehensive income of $134 million for the three months ended March 31, 2018 and $100 million for the three months ended March 31, 2017.

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
March 31,
(in millions)
Statement of earnings caption
 
2018
 
2017
Foreign currency forward exchange contracts
 
 
 
 
 
Designated as cash flow hedges
Cost of products sold
 
$
(44
)
 
$
17

Not designated as hedges
Net foreign exchange loss
 
(59
)
 
(46
)
Interest rate swaps designated as fair value hedges
Interest expense, net
 
(184
)
 
(15
)
Debt designated as hedged item in fair value hedges
Interest expense, net
 
184

 
15


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Fair Value Measures

The fair value hierarchy consists of the following three levels:

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

The following table summarizes the bases used to measure certain assets and liabilities carried at fair value on a recurring basis on the condensed consolidated balance sheet as of March 31, 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
$
9,007

 
$
1,021

 
$
7,986

 
$

Time deposits
8

 

 
8

 

Debt securities
2,471

 

 
2,471

 

Equity securities
1

 
1

 

 

Foreign currency contracts
18

 

 
18

 

Total assets
$
11,505

 
$
1,022

 
$
10,483

 
$

Liabilities
 
 
 
 
 
 
 
Interest rate hedges
$
585

 
$

 
$
585

 
$

Foreign currency contracts
127

 

 
127

 

Contingent consideration
4,386

 

 

 
4,386

Total liabilities
$
5,098

 
$

 
$
712

 
$
4,386



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The following table summarizes the bases used to measure certain assets and liabilities carried at fair value on a recurring basis on the condensed consolidated balance sheet as of December 31, 2017:
 
 
 
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 securities
2,524

 

 
2,524

 

Equity securities
4

 
4

 

 

Foreign currency contracts
23

 

 
23

 

Total assets
$
11,854

 
$
853

 
$
11,001

 
$

Liabilities
 
 
 
 
 
 
 
Interest rate hedges
$
401

 
$

 
$
401

 
$

Foreign currency contracts
149

 

 
149

 

Contingent consideration
4,534

 

 

 
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. The derivatives entered into by the company were valued using publicized spot curves for interest rate hedges and publicized 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. 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 March 31, 2018, a 50 basis point increase/decrease in the assumed discount rate would have decreased/increased the value of the contingent consideration liabilities by approximately $160 million. Additionally, at March 31, 2018, a five percentage point increase/decrease in the assumed probability of success across all potential indications would have increased/decreased the value of the contingent consideration liabilities by approximately $370 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:
 
 
 
Three months ended
March 31,
(in millions)
 
2018
 
2017
Beginning balance
 
$
4,534

 
$
4,213

Change in fair value recognized in net earnings
 
(148
)
 
85

Ending balance
 
$
4,386

 
$
4,298

 
The change in fair value recognized in net earnings is recorded in other expense, net in the condensed consolidated statements of earnings.

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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 March 31, 2018 are shown in the table below:

 
 
 
 
Basis of fair value measurement
(in millions)
Book value
Approximate 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
$
367

$
367

 
$

 
$
367

 
$

Current portion of long-term debt and lease obligations, excluding fair value hedges
6,024

6,026

 
3,997

 
2,029

 

Long-term debt and lease obligations, excluding fair value hedges
31,481

31,572

 
31,494

 
78

 

Total liabilities
$
37,872

$
37,965

 
$
35,491

 
$
2,474

 
$


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 $44 million as of March 31, 2018. No cumulative upward or downward adjustments have been recorded for these investments as of March 31, 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 value
Approximate 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 hedges
6,023

6,034

 
4,004

 
2,030

 

Long-term debt and lease obligations, excluding fair value hedges
31,346

32,846

 
32,763

 
83

 

Total liabilities
$
37,769

$
39,280

 
$
36,767

 
$
2,513

 
$


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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 $458 million as of March 31, 2018 and $482 million as of December 31, 2017. 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 of available-for-sale securities by type as of March 31, 2018:
 
Amortized cost
 
Gross unrealized
 
Fair value
(in millions)
 
Gains
 
Losses
 
Asset backed securities
$
911

 
$
1

 
$
(6
)
 
$
906

Corporate debt securities
1,455

 
4

 
(4
)
 
1,455

Other debt securities
111

 

 
(1
)
 
110

Total
$
2,477

 
$
5

 
$
(11
)
 
$
2,471


The following table is a summary of available-for-sale securities by type as of December 31, 2017:
 
Amortized cost
 
Gross unrealized
 
Fair value
(in millions)
 
Gains
 
Losses
 
Asset backed securities
$
930

 
$
1

 
$
(3
)
 
$
928

Corporate debt securities
1,451

 
4

 
(2
)
 
1,453

Other debt securities
144

 

 
(1
)
 
143

Equity securities
4

 
2

 
(2
)
 
4

Total
$
2,529

 
$
7

 
$
(8
)
 
$
2,528


AbbVie had no other-than-temporary impairments as of March 31, 2018. Net realized gains were insignificant for the three months ended March 31, 2018 and 2017.

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 $320 million as of March 31, 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 $143 million as of March 31, 2018 and $149 million as of December 31, 2017. Outstanding governmental receivables related to Russia, net of allowances for doubtful accounts, were $106 million as of March 31, 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 52% as of March 31, 2018 and 56% as of December 31, 2017, 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 59% of AbbVie’s total net revenues for the three months ended March 31, 2018 and 63% for the three months ended March 31, 2017.

Debt and Credit Facilities
 
Short-term borrowings included commercial paper borrowings of $367 million as of March 31, 2018 and $400 million as of December 31, 2017. The weighted-average interest rate on commercial paper borrowings was 1.8% for the three months ended March 31, 2018 and 1.1% for the three months ended March 31, 2017.

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Note 10 Post-Employment Benefits
 

The following is a summary of 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
March 31,
 
Three months ended
March 31,
(in millions)
2018
 
2017
 
2018
 
2017
Service cost
$
72

 
$
58

 
$
8

 
$
7

Interest cost
57

 
50

 
8

 
6

Expected return on plan assets
(111
)
 
(95
)
 

 

Amortization of actuarial losses and prior service costs
37

 
26

 
4

 
1

Net periodic benefit cost
$
55

 
$
39

 
$
20

 
$
14

The components of net periodic benefit cost other than service cost are included in other (income) expense, net in the condensed consolidated statements of earnings.
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
March 31,
(in millions)
 
2018
 
2017
Cost of products sold
 
$
4

 
$
3

Research and development
 
72

 
64

Selling, general and administrative
 
115

 
74

Pre-tax compensation expense
 
191

 
141

Tax benefit
 
29

 
47

After-tax compensation expense
 
$
162

 
$
94


Stock Options

During the three months ended March 31, 2018, primarily in connection with the company's annual grant, AbbVie granted 0.6 million stock options with a weighted-average grant-date fair value of $21.63. As of March 31, 2018, $15 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 three months ended March 31, 2018, primarily in connection with the company's annual grant, AbbVie granted 3.7 million RSUs and performance shares with a weighted-average grant-date fair value of $115.20. As of March 31, 2018, $467 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.


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Cash Dividends

The following table summarizes quarterly cash dividends declared during 2018 and 2017:
2018
 
2017
Date Declared
 
Payment Date
 
Dividend Per Share
 
Date Declared
 
Payment Date
 
Dividend Per Share
02/15/18
 
05/15/18
 
$
0.96

 
10/27/17
 
02/15/18
 
$
0.71

 
 

 
 
 
09/08/17
 
11/15/17
 
$
0.64

 
 

 


 
06/22/17
 
08/15/17
 
$
0.64

 
 

 


 
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 billion stock repurchase program, which superseded AbbVie's previous stock repurchase program. The new stock repurchase program 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 program are recorded at acquisition cost, including related expenses, and are available for general corporate purposes.

As part of this repurchase program, on May 1, 2018, AbbVie announced a modified "Dutch auction" tender offer to purchase for cash up to $7.5 billion of its common stock at a price not less than $99.00 per share and not more than $114.00 per share. The tender offer expires at midnight Eastern Time, at the end of the day on May 29, 2018, unless extended or terminated by AbbVie.

Prior to the new authorization, AbbVie repurchased approximately 10.9 million shares in the open market for $1.3 billion during the three months ended March 31, 2018. AbbVie's stock repurchase authorization was $10.0 billion as of March 31, 2018.

Accumulated Other Comprehensive Loss

The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for the three months ended March 31, 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
189

 
(104
)
 
(11
)
 
(7
)
 
(45
)
 
22

Net losses reclassified from accumulated other comprehensive loss

 

 
33

 

 
42

 
75

Net current-period other comprehensive income (loss)
189

 
(104
)
 
22

 
(7
)
 
(3
)
 
97

Balance as of March 31, 2018
$
(250
)
 
$
(307
)
 
$
(1,897
)
 
$
(7
)
 
$
(169
)
 
$
(2,630
)

Other comprehensive income for the three months ended March 31, 2018 included foreign currency translation adjustments totaling a gain of $189 million, which was principally due to the impact of the improvement in the Euro in the three months ended March 31, 2018 on the translation of the company’s assets denominated in the Euro.


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The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for the three months ended March 31, 2017:
(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 reclassifications
170

 
(64
)
 
(8
)
 
2

 
(49
)
 
51

Net losses (gains) reclassified from accumulated other comprehensive loss

 

 
19

 
(10
)
 
(16
)
 
(7
)
Net current-period other comprehensive income (loss)
170

 
(64
)
 
11

 
(8
)
 
(65
)
 
44

Balance as of March 31, 2017
$
(1,265
)
 
$
76

 
$
(1,502
)
 
$
38

 
$
111

 
$
(2,542
)

Other comprehensive income for the three months ended March 31, 2017 included foreign currency translation adjustments totaling a gain of $170 million, which was principally due to the impact of the improvement in the Euro in the three months ended March 31, 2017 on the translation of the company’s assets denominated in the Euro.

The 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
March 31,
(in millions) (brackets denote gains)
 
2018
 
2017
Pension and post-employment benefits
 
 
 
 
Amortization of actuarial losses and other(a)
 
$
41

 
$
27

Tax (benefit)
 
(8
)
 
(8
)
Total reclassifications, net of tax
 
$
33

 
$
19

Cash flow hedging activities
 
 
 
 
Losses (gains) on designated cash flow hedges(b)
 
$
44

 
$
(17
)
Tax expense (benefit)
 
(2
)
 
1

Total reclassifications, net of tax
 
$
42

 
$
(16
)

(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).
Note 12 Income Taxes
 

The effective tax rate was 1% for the three months ended March 31, 2018 and 18% for the three months ended March 31, 2017. The effective tax rate in each period differed from the U.S. statutory tax rates 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 change in the effective tax rate for the three months ended March 31, 2018 over the prior year was principally due to the effects 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 related to the earnings from certain foreign subsidiaries.

Given the complexity of the Act 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

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20




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 expense in the consolidated statement of earnings. No adjustments to these provisional estimates were made during the three months ended March 31, 2018. The Act also created a minimum 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 expense in the year it is incurred as a period expense.

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 $38 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.
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 $560 million as of March 31, 2018 and $445 million as of December 31, 2017. 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.

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 pending 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), generally allege Solvay's patent litigation involving AndroGel was sham litigation and the 2006 patent litigation settlement agreements and related agreements with three generic companies violate federal antitrust laws. Plaintiffs generally seek monetary damages and/or injunctive relief and attorneys' fees. These cases include: (a) four individual plaintiff lawsuits; (b) three purported class actions; and (c) Federal Trade Commission v. Actavis, Inc. et al. Following the district court's dismissal of all plaintiffs' claims, appellate proceedings led to the reinstatement of the claims regarding the patent litigation settlements, which are proceeding in the district court.

Lawsuits are pending against AbbVie and others generally alleging that the 2005 patent litigation settlement involving Niaspan entered into between Kos Pharmaceuticals, Inc. (a company acquired by Abbott in 2006 and presently a subsidiary of AbbVie) and a generic company violates federal and state antitrust laws and state unfair and deceptive trade practices and unjust enrichment laws. Plaintiffs generally seek monetary damages and/or injunctive relief and attorneys' fees. The lawsuits consist of four individual plaintiff lawsuits and two consolidated purported class actions: one brought by three named direct purchasers of Niaspan and the other brought by ten named end-payer purchasers of Niaspan. The cases are consolidated for pre-trial proceedings in the United States District Court for the Eastern District of Pennsylvania under the MDL Rules as In re: Niaspan Antitrust Litigation, MDL No. 2460. In October 2016, the State of California filed a lawsuit regarding the Niaspan patent litigation settlement in Orange County Superior Court, asserting a claim under the unfair competition provision of the California Business and Professions Code seeking injunctive relief, restitution, civil penalties and attorneys’ fees.


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In September 2014, the FTC filed suit in the United States District Court for the Eastern District of Pennsylvania against AbbVie and others, alleging that the 2011 patent litigation with two generic companies regarding AndroGel was sham litigation and the patent litigation settlement with one of those generic companies violates federal antitrust laws. The FTC's complaint seeks monetary damages and injunctive relief. In May 2015, the court dismissed the FTC's claim regarding the patent litigation settlement.

In March 2015, the State of Louisiana filed a lawsuit, State of Louisiana v. Fournier Industrie et Sante, et al., against AbbVie, Abbott and affiliated Abbott entities in Louisiana state court. Plaintiff alleges that patent applications and patent litigation filed and other alleged conduct from the early 2000's and before related to the drug TriCor violated Louisiana State antitrust and unfair trade practices laws. The lawsuit seeks monetary damages and attorneys' fees.

In 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.

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 4,300 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 200 claims are pending in various state courts. Plaintiffs generally seek compensatory and punitive damages. In March 2018, a jury in the United States District Court for the Northern District of Illinois reached a verdict in the retrial of the first case that had been tried in July 2017. In orders from December 2017 and February 2018, the court vacated the original verdict in that case for AbbVie on two claims and for the plaintiff on one claim and the jury’s award of $150 million in punitive damages with no compensatory damages, and ordered a new trial. In the 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 to post-trial proceedings. In a second trial, a jury in the Cook County, Illinois Circuit Court reached a verdict for AbbVie in August 2017 on all claims, which is the subject of post-trial proceedings. In a third trial, a jury in the United States District Court for the Northern District of Illinois reached a verdict for AbbVie in October 2017 on strict liability but for the plaintiff on remaining claims and awarded $140,000 in compensatory damages and $140 million in punitive damages, which is the subject of post-trial proceedings. In a fourth trial, a jury in the United States District Court for the Northern District of Illinois reached a verdict for AbbVie in January 2018 on all claims.

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 619 claims are pending in the United States District Court for the Southern District of Illinois, and the rest are pending in various other federal and state courts. Plaintiffs generally seek compensatory and punitive damages.

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

In 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 and September 2017 against AbbVie and in some instances its chief executive officer in the same court by twelve additional investment funds. Plaintiffs seek compensatory and punitive damages.

In May 2017, a shareholder derivative lawsuit, Ellis v. Gonzalez, et al., 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 seeks unspecified compensatory damages for AbbVie, among other relief.

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.


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In March 2017, AbbVie filed a lawsuit, AbbVie Inc. v. Novartis Vaccines and Diagnostics, Inc. and Grifols Worldwide Operations Ltd., in the United States District Court for the Northern District of California against Novartis Vaccines and Grifols Worldwide seeking a declaratory judgment that eleven 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.

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.

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Note 14 Segment Information
 

AbbVie operates in one business segment—pharmaceutical products. The following table details AbbVie’s worldwide net revenues:
 
 
Three months ended
March 31,
 
 
(in millions)
 
2018
 
2017
HUMIRA
 
 
 
 
United States
 
$
3,003

 
$
2,696

International
 
1,706

 
1,422

Total
 
$
4,709

 
$
4,118

IMBRUVICA
 
 
 
 
United States
 
$
624

 
$
457

Collaboration revenues
 
138

 
94

Total
 
$
762

 
$
551

HCV
 
 
 
 
United States
 
$
343

 
$
38

International
 
576

 
225

Total
 
$
919

 
$
263

Creon
 
 
 
 
United States
 
$
209

 
$
185

Lupron
 
 
 
 
United States
 
$
177

 
$
155

International
 
42

 
39

Total
 
$
219

 
$
194

Synthroid
 
 
 
 
United States
 
$
182

 
$
192

Synagis
 
 
 
 
International
 
$
321

 
$
300

AndroGel
 
 
 
 
United States
 
$
130

 
$
136

Duodopa
 
 
 
 
United States
 
$
18

 
$
14

International
 
85

 
66

Total
 
$
103

 
$
80

Sevoflurane
 
 
 
 
United States
 
$
17

 
$
18

International
 
89

 
89

Total
 
$
106

 
$
107

Kaletra
 
 
 
 
United States
 
$
13

 
$
19

International
 
60

 
96

Total
 
$
73

 
$
115

All other
 
$
201

 
$
297

Total net revenues
 
$
7,934

 
$
6,538




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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 March 31, 2018 and December 31, 2017 and the results of operations for the three months ended March 31, 2018 and 2017. 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 (HCV) and human immunodeficiency virus (HIV); neurological disorders, such as Parkinson’s disease; metabolic diseases, including thyroid disease and complications associated with cystic fibrosis; as well as other serious health conditions. AbbVie also has a pipeline of promising new medicines 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 directly to customers or through distributors, depending on the market served. Certain products are co-marketed or co-promoted with other companies. AbbVie has approximately 29,000 employees. AbbVie operates in one business segment—pharmaceutical products.
2018 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 neurology 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 three months ended March 31, 2018 included delivering worldwide net revenues of $7.9 billion, operating earnings of $2.9 billion and diluted earnings per share of $1.74. Worldwide net revenues grew by 18% on a constant currency basis, driven primarily by the continued strength of HUMIRA, revenue growth related to IMBRUVICA and HCV product MAVYRET. These increases were partially offset by a decline in net revenues of HCV product VIEKIRA.
Diluted earnings per share was $1.74 for the three months ended March 31, 2018 and included the following after-tax costs: (i) $272 million related to the amortization of intangible assets; (ii) litigation reserve charges of $100 million; (iii) $69 million for acquired in-process research and development (IPR&D); and (iv) milestone payments of $32 million. These costs were partially offset by an after-tax benefit of $148 million for the change in fair value of contingent consideration liabilities. Financial results for the three months ended March 31, 2018 were also impacted by U.S. tax reform and the timing of the new legislation's phase in on certain subsidiaries. Additionally, financial results reflected continued added funding to support AbbVie’s emerging mid- and late-stage pipeline assets and continued investment in AbbVie’s growth brands.
The company generated cash flows from operations of $2.6 billion for the three months ended March 31, 2018, which AbbVie utilized to continue to enhance its pipeline through licensing and collaboration activities, repurchase approximately 10.9 million shares for $1.3 billion in the open market and pay cash dividends to stockholders of $1.1 billion. In February 2018, the company announced that its board of directors declared an increase in the company's quarterly cash dividend from $0.71 per share to $0.96

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per share beginning with the dividend payable in May 2018. This reflects an increase of approximately 35% 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 60 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 neurology along with targeted investments in cystic fibrosis and women’s health. Of these programs, more than 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, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for upadacitinib, an investigational oral JAK1-selective inhibitor, in 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.
Risankizumab
In January 2018, 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.
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 endpoints for the treatment of patients with moderate to severe chronic plaque psoriasis. The initial results from these clinical trials were previously announced 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.
In April 2018, AbbVie submitted a Biologics License Application (BLA) to the FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for risankizumab for the treatment of plaque psoriasis in adults.
Oncology
IMBRUVICA
In April 2018, AbbVie submitted a supplemental New Drug Application (sNDA) to the FDA for IMBRUVICA in combination with Rituxan (rituximab) in patients with Waldenström’s macroglobulinemia.
VENCLEXTA
In January 2018, AbbVie submitted an sNDA to the FDA for VENCLEXTA monotherapy in patients with chronic lymphocytic leukemia (CLL) who are refractory to or have relapsed B-cell receptor pathway inhibitors.

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In January 2018, AbbVie submitted a Type II variation to the EMA to extend the current approved indication based on the results of the Phase 3 MURANO study. The new additional proposed indication is venetoclax tablets in combination with Rituxan for treatment of adult patients with CLL who have received at least one prior therapy. This submission followed the December 2017 sNDA submission to the FDA for VENCLEXTA in combination with Rituxan in patients with relapsed or refractory CLL.
Rova-T
In March 2018, AbbVie announced top-line results from the Phase 2 TRINITY study evaluating rovalpituzumab tesirine (Rova-T) for third-line relapsed/refractory (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.
Neurology
In March 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal of marketing authorizations for ZINBRYTA, a prescription medicine used to treat adults with relapsing forms of multiple sclerosis.
Other
In February 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-I study evaluating elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated in combination with low-dose hormone (add-back) therapy for uterine fibroids met its primary efficacy endpoint and all ranked secondary endpoints.
In March 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-II study evaluating elagolix in combination with low-dose hormone (add-back) therapy for uterine fibroids met its primary efficacy endpoint and all ranked secondary endpoints.
In April 2018, AbbVie announced notification by the FDA that extended time is required to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to the third quarter of 2018.
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.
RESULTS OF OPERATIONS
Net Revenues
The comparisons presented at constant currency rates reflect comparative local currency net revenues at the prior year’s foreign exchange rates. This measure provides information on the change in net revenues assuming that foreign currency exchange rates had not changed between the prior and the current periods. AbbVie believes that the non-GAAP measure of change in net revenues at constant currency rates, when used in conjunction with the GAAP measure of change in net revenues at actual currency rates, may provide a more complete understanding of the company’s operations and can facilitate analysis of the company’s results of operations, particularly in evaluating performance from one period to another.

 
 
Three months ended
March 31,
 
Percent change
 
 
 
At actual
currency rates
 
At constant
currency rates
(dollars in millions)
 
2018

2017
 
United States
 
$
4,790

 
$
4,052

 
18.3
%
 
18.3
%
International
 
3,144

 
2,486

 
26.4
%
 
16.6
%
Net revenues
 
$
7,934

 
$
6,538

 
21.4
%
 
17.6
%

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The following table details AbbVie’s worldwide net revenues:

 
 
Three months ended
March 31,
 
Percent change
 
 
 
At actual
currency rates
 
At constant
currency rates
(dollars in millions)
 
2018
 
2017
 
HUMIRA
 
 
 
 
 
 
 
 
United States
 
$
3,003

 
$
2,696

 
11.4
 %
 
11.4
 %
International
 
1,706

 
1,422

 
20.0
 %
 
9.3
 %
Total
 
$
4,709

 
$
4,118

 
14.4
 %
 
10.7
 %
IMBRUVICA
 
 
 
 
 
 
 
 
United States
 
$
624

 
$
457

 
36.7
 %
 
36.7
 %
Collaboration revenues
 
138

 
94

 
47.2
 %
 
47.2
 %
Total
 
$
762

 
$
551

 
38.5
 %
 
38.5
 %
HCV
 
 
 
 
 
 
 
 
United States
 
$
343

 
$
38

 
>100.0

 
>100.0

International
 
576

 
225

 
>100.0

 
>100.0

Total
 
$
919

 
$
263

 
>100.0

 
>100.0

Creon