10-Q 1 abbv-20160930x10q.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 September 30, 2016

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

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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)
 
 
 

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 October 24, 2016, AbbVie Inc. had 1,625,099,012 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
September 30,
 
Nine months ended
September 30,
(in millions, except per share data)
2016
 
2015
 
2016
 
2015
Net revenues
$
6,432

 
$
5,944

 
$
18,842

 
$
16,459

 
 
 
 
 
 
 
 
Cost of products sold
1,504

 
1,167

 
4,278

 
3,025

Selling, general and administrative
1,381

 
1,474

 
4,202

 
4,650

Research and development
1,106

 
1,418

 
3,176

 
3,210

Acquired in-process research and development
80

 

 
160

 
150

Total operating costs and expenses
4,071

 
4,059

 
11,816

 
11,035

Operating earnings
2,361

 
1,885

 
7,026

 
5,424

 
 
 
 
 
 
 
 
Interest expense, net
250

 
197

 
675

 
487

Net foreign exchange loss (gain)
(4
)
 
13

 
313

 
191

Other expense, net
101

 
28

 
152

 
25

Earnings before income tax expense
2,014

 
1,647

 
5,886

 
4,721

Income tax expense
416

 
408

 
1,324

 
1,094

Net earnings
$
1,598

 
$
1,239

 
$
4,562

 
$
3,627

 
 
 
 
 
 
 
 
Per share data
 
 
 
 
 
 
 
Basic earnings per share
$
0.97

 
$
0.75

 
$
2.79

 
$
2.22

Diluted earnings per share
$
0.97

 
$
0.74

 
$
2.78

 
$
2.21

Cash dividends declared per common share
$
0.57

 
$
0.51

 
$
1.71

 
$
1.53

 
 
 
 
 
 
 
 
Weighted-average basic shares outstanding
1,632

 
1,652

 
1,624

 
1,623

Weighted-average diluted shares outstanding
1,640

 
1,664

 
1,633

 
1,635


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)
2016
 
2015
 
2016
 
2015
Net earnings
$
1,598

 
$
1,239

 
$
4,562

 
$
3,627

 
 
 
 
 
 
 
 
Foreign currency translation adjustments, net of tax (benefit) expense of $10 for the three months and $30 for the nine months ended September 30, 2016 and $10 for the three months and $(98) for the nine months ended September 30, 2015.
31

 
(48
)
 
164

 
(464
)
Pension and post-employment benefits, net of tax expense of $8 for the three months and $23 for the nine months ended September 30, 2016 and $10 for the three months and $28 for the nine months ended September 30, 2015.
15

 
23

 
48

 
91

Unrealized gains (losses) on marketable equity securities, net of tax (benefit) expense of $1 for the three months and $(7) for the nine months ended September 30, 2016 and $3 for the three months and $2 for the nine months ended September 30, 2015.
12

 
(13
)
 
19

 
(4
)
Hedging activities, net of tax expense (benefit) of $1 for the three months and $(3) for the nine months ended September 30, 2016 and $(5) for the three months and $(7) for the nine months ended September 30, 2015.
(8
)
 
(87
)
 
(10
)
 
(91
)
Other comprehensive income (loss)
50

 
(125
)
 
221

 
(468
)
Comprehensive income
$
1,648

 
$
1,114

 
$
4,783

 
$
3,159


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,
2016
 
December 31,
2015
 
(unaudited)
 
 
Assets
 
 
 
Current assets
 
 
 
Cash and equivalents
$
6,218

 
$
8,399

Short-term investments
1,732

 
8

Accounts receivable, net
4,999

 
4,730

Inventories
1,630

 
1,719

Prepaid expenses and other
1,711

 
1,458

Total current assets
16,290

 
16,314

 
 
 
 
Investments
1,378

 
145

Property and equipment, net
2,638

 
2,565

Intangible assets, net
29,113

 
19,709

Goodwill
15,657

 
13,168

Other assets
1,550

 
1,149

Total assets
$
66,626

 
$
53,050

 
 
 
 
Liabilities and Equity
 
 
 
Current liabilities
 
 
 
Short-term borrowings
$

 
$
406

Current portion of long-term debt and lease obligations
26

 
2,025

Accounts payable and accrued liabilities
9,077

 
8,463

Total current liabilities
9,103

 
10,894

 
 
 
 
Long-term debt and lease obligations
37,284

 
29,240

Deferred income taxes
6,124

 
5,276

Other long-term liabilities
7,646

 
3,695

 
 
 
 
Commitments and contingencies


 


 
 
 
 
Stockholders’ equity
 
 
 
Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,762,991,093 shares issued as of September 30, 2016 and 1,749,027,140 as of December 31, 2015.
18

 
17

Common stock held in treasury, at cost, 138,083,499 shares as of September 30, 2016 and 139,134,205 as of December 31, 2015.
(8,760
)
 
(8,839
)
Additional paid-in capital
13,540

 
13,080

Retained earnings
4,011

 
2,248

Accumulated other comprehensive loss
(2,340
)
 
(2,561
)
Total stockholders’ equity
6,469

 
3,945

 
 
 
 
Total liabilities and equity
$
66,626

 
$
53,050


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)
 
Nine months ended
September 30,
(in millions) (brackets denote cash outflows)
2016
 
2015
Cash flows from operating activities
 
 
 
Net earnings
$
4,562

 
$
3,627

Adjustments to reconcile net earnings to net cash from operating activities:
 
 
 
Depreciation
307

 
296

Amortization of intangible assets
554

 
279

Change in fair value of contingent consideration
143

 

Stock-based compensation
278

 
229

Upfront costs and milestones related to collaborations
230

 
280

Devaluation loss related to Venezuela
298

 

Other, net
326

 
369

Changes in operating assets and liabilities, net of acquisitions:
 
 
 
Accounts receivable
(129
)
 
(842
)
Inventories
28

 
(446
)
Prepaid expenses and other assets
(122
)
 
452

Accounts payable and other liabilities
(975
)
 
1,328

Cash flows from operating activities
5,500

 
5,572

 
 
 
 
Cash flows from investing activities
 
 
 
Acquisitions of businesses, net of cash acquired
(2,477
)
 
(11,488
)
Other acquisitions and investments
(172
)
 
(794
)
Acquisitions of property and equipment
(365
)
 
(387
)
Purchases of investment securities
(4,520
)
 
(851
)
Sales and maturities of investment securities
1,579

 
881

Cash flows from investing activities
(5,955
)
 
(12,639
)
 
 
 
 
Cash flows from financing activities
 
 
 
Net change in short-term borrowings
(406
)
 
335

Proceeds from issuance of long-term debt
7,771

 
16,660

Repayments of long-term debt and lease obligations
(2,006
)
 
(15
)
Debt issuance cost
(52
)
 
(179
)
Dividends paid
(2,784
)
 
(2,454
)
Purchases of treasury stock
(4,209
)
 
(6,342
)
Proceeds from the exercise of stock options
207

 
123

Other, net
53

 
55

Cash flows from financing activities
(1,426
)
 
8,183

Effect of exchange rate changes on cash and equivalents
(300
)
 
(241
)
Net increase (decrease) in cash and equivalents
(2,181
)
 
875

Cash and equivalents, beginning of period
8,399

 
8,348

 
 
 
 
Cash and equivalents, end of period
$
6,218

 
$
9,223

Supplemental schedule of non-cash investing and financing activities
 
 
 
Issuance of common shares associated with acquisitions of businesses
$
3,923

 
$
8,405


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    Background and Basis of Presentation
 

Background

The principal business of AbbVie Inc. (AbbVie or the company) is the discovery, development, manufacture, and sale of a broad line of pharmaceutical products. 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. Substantially all of AbbVie’s net revenues in the United States are to three wholesalers. Outside the United States, products are sold primarily to customers or through distributors, depending on the market served.

AbbVie was incorporated in Delaware on April 10, 2012. On January 1, 2013, AbbVie became an independent, publicly-traded company as a result of the distribution by Abbott Laboratories (Abbott) of 100% of the outstanding common stock of AbbVie to Abbott’s shareholders. In connection with the separation, AbbVie and Abbott entered into transition services agreements covering certain corporate support and back office services that AbbVie historically received from Abbott. Such services included information technology, accounts payable, payroll, receivables collection, treasury and other financial functions, as well as order entry, warehousing, engineering support, quality assurance support and other administrative services. These agreements facilitated the separation by allowing AbbVie to operate independently prior to establishing stand-alone back office functions across its organization. The transition services agreements had original terms of up to 24 months, with an option for a one-year extension. The majority of these transaction service agreements expired without extension at December 31, 2014. With certain limited exceptions, the remaining transition services agreements terminated on or prior to December 31, 2015.

Basis of Historical Presentation

The unaudited interim condensed consolidated financial statements of AbbVie 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, 2015.

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

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 supersede most current revenue recognition requirements. The core principal of the new guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. AbbVie can apply the amendments using one of the following two methods: (i) retrospectively to each prior reporting period presented, or (ii) modified retrospectively with the cumulative effect of initially applying the amendments recognized at the date of initial application. This standard will be effective for AbbVie starting with the first quarter of 2018. Early application is permitted for AbbVie only for annual reporting periods starting with the first quarter of 2017. AbbVie is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements and the implementation approach to be used.

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

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Amendments are to be applied as a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. This standard will be effective for AbbVie starting with the first quarter of 2018. The standard does not permit early adoption with the exception of certain targeted provisions. AbbVie is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). ASU 2016-02 outlines a comprehensive lease accounting model and supersedes the current lease guidance. The new standard requires lessees to recognize lease liabilities and corresponding right-of-use assets for all leases with lease terms greater than 12 months. It 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. Early adoption is permitted. AbbVie is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements.

In March 2016, FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. Under the new guidance, excess tax benefits associated with share-based awards will be recognized in the statement of earnings when the awards vest or settle, rather than in stockholders’ equity. The standard also permits entities to make a policy election to account for forfeitures as they occur and clarifies the statement of cash flows presentation for certain components of share-based awards. The guidance will be effective for AbbVie starting with the first quarter of 2017. Early adoption is permitted with any adjustments reflected as of the beginning of the fiscal year of adoption. AbbVie is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements.

In June 2016, 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 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. The standard additionally 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.

Note 2    Supplemental Financial Information
 

Interest Expense, Net
 
Three months ended
September 30,
 
Nine months ended
September 30,
(in millions)
2016
 
2015
 
2016
 
2015
Interest expense
$
271

 
$
207

 
$
731

 
$
511

Interest income
(21
)
 
(10
)
 
(56
)
 
(24
)
Interest expense, net
$
250

 
$
197

 
$
675

 
$
487


Inventories
(in millions)
September 30, 2016
 
December 31, 2015
Finished goods
$
315

 
$
469

Work-in-process
1,184

 
1,081

Raw materials
131

 
169

Inventories
$
1,630

 
$
1,719




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Property and Equipment
(in millions)
September 30, 2016
 
December 31, 2015
Property and equipment, gross
$
7,710

 
$
7,334

Less accumulated depreciation
(5,072
)
 
(4,769
)
Property and equipment, net
$
2,638

 
$
2,565


Depreciation expense was $96 million for the three months and $307 million for the nine months ended September 30, 2016
and $102 million for the three months and $296 million for the nine months ended September 30, 2015.

Note 3    Earnings Per Share
 

AbbVie grants certain shares of 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.

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

 
Three months ended
September 30,
 
Nine months ended
September 30,
(in millions, except per share information)
2016
 
2015
 
2016
 
2015
Basic EPS
 
 
 
 
 
 
 
Net earnings
$
1,598

 
$
1,239

 
$
4,562

 
$
3,627

Earnings allocated to participating securities
8

 
7

 
23

 
18

Earnings available to common shareholders
$
1,590

 
$
1,232

 
$
4,539

 
$
3,609

Weighted-average basic shares outstanding
1,632

 
1,652

 
1,624

 
1,623

Basic earnings per share
$
0.97

 
$
0.75

 
$
2.79

 
$
2.22

 
 
 
 
 
 
 
 
Diluted EPS


 


 


 


Net earnings
$
1,598

 
$
1,239

 
$
4,562

 
$
3,627

Earnings allocated to participating securities
8

 
7

 
23

 
18

Earnings available to common shareholders
$
1,590

 
$
1,232

 
$
4,539

 
$
3,609

Weighted-average shares of common stock outstanding
1,632

 
1,652

 
1,624

 
1,623

Effect of dilutive securities
8

 
12

 
9

 
12

Weighted-average diluted shares outstanding
1,640

 
1,664

 
1,633

 
1,635

Diluted earnings per share
$
0.97

 
$
0.74

 
$
2.78

 
$
2.21


As further described in Note 10, in both 2015 and 2016, AbbVie entered into and executed an accelerated share repurchase agreement (ASR) with third party financial institutions. For purposes of calculating EPS, AbbVie reflected the ASRs as a repurchase of AbbVie common stock in the relevant periods.

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 were insignificant for all periods presented.


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Note 4    Licensing, Acquisitions and Other Arrangements
 

Acquisition of Stemcentrx

On June 1, 2016, AbbVie acquired all of the outstanding equity interests in Stemcentrx, a privately held biotechnology company. The transaction expands AbbVie’s oncology pipeline by adding the late-stage asset rovalpituzumab tesirine (Rova-T), four additional early-stage clinical compounds in solid tumor indications, and a significant portfolio of pre-clinical assets. Rova-T is currently in registrational trials for small cell lung cancer.

The aggregate upfront consideration for the acquisition of Stemcentrx consisted of approximately 62.4 million shares of AbbVie common stock, issued from common stock held in treasury, and cash. AbbVie may make up to $4.0 billion in additional payments upon the achievement of certain development and regulatory milestones. The acquisition-date fair value of this contingent consideration totaled $620 million and was estimated using a combination of probability-weighted discounted cash flow models and Monte Carlo simulation models. The estimate was based on significant inputs that are not observable in the market, referred to as Level 3 inputs, as described in more detail in Note 8. The following table summarizes total consideration:
(in millions)
 
Cash
$
1,883

Fair value of AbbVie common stock
3,923

Contingent consideration
620

Total consideration
$
6,426


The acquisition of Stemcentrx has been accounted for as a business combination using the acquisition method of accounting. This method requires, among other things, that assets acquired and liabilities assumed be recognized at fair value as of the acquisition date.

During the three months ended September 30, 2016, the company made a measurement period adjustment, including a refinement of the discount rate assumption, to increase the fair value of consideration transferred by $273 million and made measurement period adjustments to the preliminary purchase price allocation, including (i) an increase to indefinite-lived research and development intangible assets of $330 million, (ii) an increase to deferred income tax liabilities of $120 million and (iii) an increase to goodwill of $63 million. The company made these measurement period adjustments to reflect facts and circumstances that existed as of the acquisition date and did not result from intervening events subsequent to such date. These adjustments did not have a significant impact on AbbVie's results of operations. Finalization of valuation efforts could result in additional changes in the amounts recorded for the acquisition-date fair value of contingent consideration, intangible assets, goodwill and associated deferred tax liabilities. The amounts recognized will be finalized as the information necessary to complete the analysis is obtained, but no later than one year from the acquisition date.

The following table summarizes preliminary fair values of assets acquired and liabilities assumed as of the June 1, 2016 acquisition date:
(in millions)
 
Assets acquired and liabilities assumed
 
Accounts receivable
$
1

Prepaid expenses and other
7

Property and equipment
17

Intangible assets - Indefinite-lived research and development
6,100

Accounts payable and accrued liabilities
(31
)
Deferred income taxes
(1,975
)
Other long-term liabilities
(7
)
Total identifiable net assets
4,112

Goodwill
2,314

Total assets acquired and liabilities assumed
$
6,426


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

Goodwill was calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from the other assets acquired that could not be individually identified and separately recognized. Specifically, the goodwill recognized from the acquisition of Stemcentrx represents expected synergies, including the ability to (i) leverage the respective strengths of each business, (ii) expand the combined company’s product portfolio, (iii) accelerate AbbVie's clinical and commercial presence in oncology and (iv) establish a strong leadership position in oncology, and was impacted by the establishment of a deferred tax liability for the acquired identifiable intangible assets which have no tax basis. The goodwill is not deductible for tax purposes.

Following the acquisition date, the operating results of Stemcentrx have been included in the company's financial statements. AbbVie’s condensed consolidated statements of earnings for the nine months ended September 30, 2016 included no net revenues and an operating loss of $114 million associated with Stemcentrx's operations. This operating loss included $43 million of post-acquisition stock-based compensation expense for Stemcentrx options.

Pro Forma Financial Information

The following table presents the unaudited pro forma combined results of operations of AbbVie and Stemcentrx for the three and nine months ended September 30, 2016 and 2015 as if the acquisition of Stemcentrx had occurred on January 1, 2015:
 
Three months ended
September 30,
 
Nine months ended
September 30,
(in millions, except per share information)
2016
 
2015
 
2016
 
2015
Net revenues
$
6,432

 
$
5,947

 
$
18,845

 
$
16,468

Net earnings
$
1,579

 
$
1,206

 
$
4,515

 
$
3,427

Basic earnings per share
$
0.97

 
$
0.70

 
$
2.72

 
$
2.03

Diluted earnings per share
$
0.96

 
$
0.70

 
$
2.71

 
$
2.02


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

Acquisition of BI 655066 and BI 655064 from Boehringer Ingelheim

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

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Under the terms of the agreement, AbbVie made an upfront payment of $595 million. AbbVie will make $18 million of additional payments to BI pursuant to a contractual obligation to reimburse BI for certain development costs it incurred prior to the acquisition date. In addition, AbbVie may make additional contingent payments upon the achievement of defined development, regulatory, and commercial milestones as well as royalty payments based on net sales of licensed products. The maximum aggregate amount payable for development and regulatory milestones is approximately $1.6 billion. The acquisition-date fair value of these milestones was $606 million. In addition, the acquisition-date fair value of contingent royalty payments was $2.8 billion. The potential contingent consideration payments were estimated by applying a probability-weighted expected payment model for contingent milestone payments and a Monte Carlo simulation model for contingent royalty payments, which were then discounted to present value. The fair value measurements were based on Level 3 inputs.

The following table summarizes total consideration:
(in millions)
 
Cash
$
595

Deferred consideration payable
18

Contingent consideration
3,365

Total consideration
$
3,978


The company concluded that the acquired assets met the definition of a business and accounted for the transaction as a business combination using the acquisition method of accounting.

During the three months ended September 30, 2016, the company made a measurement period adjustment to decrease the fair value of consideration transferred by $397 million and made measurement period adjustments to the preliminary purchase price allocation, including (i) a decrease to indefinite-lived research and development intangible assets of $460 million and (ii) an increase to goodwill of $63 million. The company made these measurement period adjustments to reflect facts and circumstances that existed as of the acquisition date and did not result from intervening events subsequent to such date. As a result of these measurement period adjustments, other expense, net for the three months ended September 30, 2016 included a charge of $31 million that would have been recorded in the previous reporting period if the adjustments had been recognized as of the acquisition date. Finalization of valuation efforts could result in additional changes in the amounts recorded for the acquisition-date fair value of contingent consideration, intangible assets, goodwill, and associated deferred tax assets and liabilities. The amounts recognized will be finalized as the information necessary to complete the analysis is obtained, but no later than one year from the acquisition date.

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

Goodwill
88

Total assets acquired
$
3,978


The estimated fair value of the acquired IPR&D was determined using the multi-period excess earnings model of the “income approach.”

Goodwill was calculated as the excess of consideration transferred over the net assets recognized and represents future economic benefits arising from the other assets acquired that could not be individually identified and separately recognized. Specifically, the goodwill recognized from this acquisition includes expected synergies, including an expansion of the combined company’s immunology product portfolio.

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


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Acquisition of Pharmacyclics

On May 26, 2015, AbbVie acquired Pharmacyclics, a biopharmaceutical company that develops and commercializes novel therapies for people impacted by cancer. Pharmacyclics markets IMBRUVICA® (ibrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, targeting B-cell malignancies. The total consideration for the acquisition of Pharmacyclics consisted of cash and approximately 128 million shares of AbbVie common stock, and is summarized as follows:
(in millions)
 
Cash
$
12,365

Fair value of AbbVie common stock
8,405

Total consideration
$
20,770


The acquisition of Pharmacyclics was accounted for as a business combination using the acquisition method of accounting. In the second quarter of 2016, the company finalized its valuation of the acquisition date assets acquired and liabilities assumed. There were no measurement period adjustments in 2016.

The following table summarizes the final fair values of assets acquired and liabilities assumed as of the May 26, 2015 acquisition date:
(in millions)
 
Assets acquired and liabilities assumed
 
Cash and equivalents
$
877

Short-term investments
11

Accounts receivable
106

Inventories
492

Other assets
212

Intangible assets
 
Definite-lived developed product rights
4,590

Definite-lived license agreements
6,780

Indefinite-lived research and development
7,180

Accounts payable and accrued liabilities
(381
)
Deferred income taxes
(6,453
)
Other long-term liabilities
(254
)
Total identifiable net assets
13,160

Goodwill
7,610

Total assets acquired and liabilities assumed
$
20,770


The amortization of the fair market value step-up for acquired inventory was included in cost of products sold and R&D in the condensed consolidated statements of earnings. The related amortization was $127 million for the three months and $218 million for the nine months ended September 30, 2016 and $45 million for the three months and $64 million for the nine months ended September 30, 2015.


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Pro Forma Financial Information

The following table presents the unaudited pro forma combined results of operations of AbbVie and Pharmacyclics for the three and nine months ended September 30, 2015 as if the acquisition of Pharmacyclics had occurred on January 1, 2014:
 
Three months ended
September 30,
 
Nine months ended
September 30,
(in millions, except per share information)
2015
 
2015
Net revenues
$
5,944

 
$
16,815

Net earnings
$
1,332

 
$
3,780

Basic earnings per share
$
0.81

 
$
2.23

Diluted earnings per share
$
0.80

 
$
2.22


The unaudited pro forma financial information was prepared using the acquisition method of accounting and was based on the historical financial information of AbbVie and Pharmacyclics. In order to reflect the occurrence of the acquisition on January 1, 2014 as required, the unaudited pro forma financial information includes adjustments to reflect the incremental amortization expense to be incurred based on the fair values of the identifiable intangible assets acquired; the incremental cost of products sold related to the fair value adjustments associated with the acquisition-date inventory; the additional interest expense associated with the issuance of debt to finance the acquisition; and the reclassification of acquisition, integration, and financing-related costs incurred during the three and nine months ended September 30, 2015 to the three and nine months ended September 30, 2014. The unaudited pro forma financial information is not necessarily indicative of what the consolidated results of operations would have been had the acquisition been completed on January 1, 2014. In addition, the unaudited pro forma financial information is not a projection of the future results of operations of the combined company nor does it reflect the expected realization of any cost savings or synergies associated with the acquisition.

Other Licensing & Acquisitions Activity

The company recorded IPR&D charges of $80 million for the three months and $160 million for the nine months ended September 30, 2016. Excluding the Stemcentrx and BI acquisitions, cash outflows related to acquisitions and investments totaled $172 million for the nine months ended September 30, 2016 and primarily represented upfront payments made in connection with new licensing and collaboration agreements.

For the nine months ended September 30, 2015, the company recorded IPR&D charges of $150 million. There were no IPR&D charges incurred in the three months ended September 30, 2015. Excluding the acquisition of Pharmacyclics, cash outflows related to other acquisitions and investments totaled $794 million for the nine months ended September 30, 2015, and included a $500 million payment to Calico Life Sciences LLC (Calico) as a result of the satisfaction of certain conditions under the R&D collaboration with Calico for which a charge to other operating expense was recorded in 2014.

C2N Diagnostics

In March 2015, AbbVie entered into an exclusive worldwide license agreement with C2N Diagnostics to develop and commercialize anti-tau antibodies for the treatment of Alzheimer’s disease and other neurological disorders. As part of the agreement, AbbVie made an initial upfront payment of $100 million, which was expensed to IPR&D in the nine months ended September 30, 2015. In June 2016, a $35 million development milestone was achieved, which was recorded in R&D expense and subsequently paid in July 2016. Upon the achievement of certain development, regulatory, and commercial milestones, AbbVie could make additional payments of up to $650 million, as well as royalties on net sales.

Note 5    Collaboration with Janssen Biotech, Inc.
 

In December 2011, Pharmacyclics entered into a worldwide collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical companies of Johnson & Johnson (Janssen), for the joint development and commercialization of IMBRUVICA, a novel, orally active, selective covalent inhibitor of 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.

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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 includes a cost sharing arrangement for associated collaboration activities. Except in certain cases, in general, Janssen is responsible for approximately 60% of collaboration development costs and AbbVie is responsible for the remaining 40% of collaboration development costs. AbbVie and Janssen share pre-tax profits and losses equally from the commercialization of products. Janssen is responsible for and has exclusive rights to commercialize IMBRUVICA outside the United States. While both parties have co-exclusive rights to commercialize the products in the United States, AbbVie is the principal in the end customer product sales. Operating expenses for costs incurred under the collaboration were reported in their respective expense line items, net of any payments due to or reimbursements due from Janssen. For sales of IMBRUVICA in the United States, revenues were included in net revenues and profit share costs were included in cost of products sold. Amounts payable to AbbVie by Janssen for IMBRUVICA sales outside the United States were included in net revenues.

Janssen’s share of the pre-tax profits in the United States under the collaboration were $211 million for the three months and $540 million for the nine months ended September 30, 2016 and $124 million for the three months and $169 million for the nine months ended September 30, 2015. AbbVie’s share of pre-tax profits outside the United States under the collaboration were $64 million for the three months and $175 million for the nine months ended September 30, 2016 and $37 million for the three months and $47 million for the nine months ended September 30, 2015. AbbVie’s share of the cost sharing expenses under the collaboration were $70 million for the three months and $195 million for the nine months ended September 30, 2016 and $65 million for the three months and $87 million for the nine months ended September 30, 2015.
Note 6    Goodwill and Intangible Assets
 

Goodwill

The following table summarizes the changes in the carrying amount of AbbVie’s goodwill:
(in millions)
 
Balance as of December 31, 2015
$
13,168

Additions (see Note 4)
2,402

Foreign currency translation adjustments
87

Balance as of September 30, 2016
$
15,657


The latest impairment assessment of goodwill was completed in the third quarter of 2016. As of September 30, 2016, there were no accumulated goodwill impairment losses. Future impairment tests for goodwill will be performed annually in the third quarter, or earlier if indicators of impairment exist.

Intangible Assets, Net

The following table summarizes AbbVie’s intangible assets:
 
September 30, 2016
 
December 31, 2015
(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
$
16,481

 
$
(4,155
)
 
$
12,326

 
$
9,103

 
$
(3,944
)
 
$
5,159

License agreements
7,806

 
(1,009
)
 
6,797

 
8,000

 
(1,023
)
 
6,977

Total definite-lived intangible assets
24,287

 
(5,164
)
 
19,123

 
17,103

 
(4,967
)
 
12,136

Indefinite-lived research and development
9,990

 

 
9,990

 
7,573

 

 
7,573

Total intangible assets, net
$
34,277

 
$
(5,164
)
 
$
29,113

 
$
24,676

 
$
(4,967
)
 
$
19,709


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During the nine months ended September 30, 2016, AbbVie reclassified an aggregate $7.6 billion of indefinite-lived research and development intangible assets to developed product rights and license agreements intangible assets upon receiving certain regulatory approvals related to IMBRUVICA and Zinbryta. These intangible assets will be amortized over their estimated useful lives using the estimated pattern of economic benefit. During the nine months ended September 30, 2016, AbbVie adjusted fully amortized amounts totaling $396 million from gross balances and accumulated amortization for developed product rights and license agreements no longer generating cash flow.

Amortization expense was $208 million for the three months and $554 million for the nine months ended September 30, 2016 and $125 million for the three months and $279 million for the nine months ended September 30, 2015. Amortization expense was included in cost of products sold in the condensed consolidated statements of earnings. The anticipated annual amortization expense for definite-lived intangible assets is as follows:
(in billions)
2016
 
2017
 
2018
 
2019
 
2020
Anticipated annual amortization expense
$
0.8

 
$
1.1

 
$
1.3

 
$
1.6

 
$
1.8


For the nine months ended September 30, 2016, an impairment charge of $39 million was recorded related to certain developed product rights in the United States due to a decline in the market for the product. The fair value was based on a discounted cash flow analysis and the charge was included in cost of products sold in the condensed consolidated statement of earnings.

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, 2016 primarily related to the acquisition of Stemcentrx and Boehringer Ingelheim. See Note 4 for additional information. The latest impairment assessment of indefinite-lived intangible assets was completed in the third quarter of 2016 and no impairment charges were recorded for the nine months ended September 30, 2016 and 2015. Future impairment tests for indefinite-lived intangible assets will be performed annually in the third quarter, or earlier if indicators of impairment exist.

Note 7    Restructuring Plans
 

AbbVie recorded restructuring charges of $5 million for the three months and $35 million for the nine months ended September 30, 2016 and $22 million for the three months and $50 million for the nine months ended September 30, 2015.

The following table summarizes the cash activity in the restructuring reserve for the nine months ended September 30, 2016:
(in millions)
 
Accrued balance as of December 31, 2015
$
148

2016 restructuring charges
35

Payments and other adjustments
(93
)
Accrued balance as of September 30, 2016
$
90


Note 8    Financial Instruments and Fair Value Measures
 

Risk Management Policy

The company is exposed to foreign currency exchange rate and interest rate risks related to its business operations. The company’s hedging policy attempts to manage these risks to an acceptable level based on the company’s judgment of the appropriate trade-off between risk, opportunity and costs. The company uses derivative instruments to reduce its exposure to foreign currency exchange rates. The company is also exposed to the risk that its earnings and cash flows could be adversely impacted by fluctuations in interest rates. The company periodically enters into interest rate swaps, based on judgment, to manage interest costs in which the company agrees to exchange, at specified intervals, the difference between fixed and floating interest amounts calculated by reference to an agreed-upon notional amount. Derivative instruments are not used for trading purposes or to manage exposure to changes in interest rates for investment securities and none of the company’s outstanding derivative instruments contain credit risk related contingent features; collateral is generally not required.

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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 $2.9 billion as of September 30, 2016 and $1.5 billion as of December 31, 2015 were designated as cash flow hedges and were recorded at fair value. The duration of these forward exchange contracts were generally less than eighteen months. Accumulated gains and losses as of September 30, 2016 will be 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 were not designated as hedges and were recorded at fair value. Resulting gains or losses were reflected in net foreign exchange loss in the consolidated statements of earnings and were generally offset by losses or gains on the foreign currency exposure being managed. The notional amounts of these foreign currency forward exchange contracts were $6.5 billion as of September 30, 2016 and $6.8 billion as of December 31, 2015.

AbbVie is a party to interest rate hedge contracts designated as fair value hedges with notional amounts totaling $15.8 billion at September 30, 2016 and $11.0 billion at December 31, 2015. The effect of the hedge is to change a fixed-rate interest obligation to a floating rate for that portion of the debt. AbbVie recorded the contracts at fair value and adjusted the carrying amount of the fixed-rate debt by an offsetting amount. Additionally, in the nine months ended September 30, 2016, AbbVie entered into treasury rate lock agreements in order to mitigate the risks associated with changes in interest rates related to an issuance of long-term debt. The treasury rate locks were not designated as hedges and were terminated upon the issuance of debt. In the nine months ended September 30, 2016, AbbVie recorded a charge of $12 million related to the treasury rate locks which was classified in other expense, net in the condensed consolidated statements of earnings.

The following table summarizes the amounts and location of AbbVie’s derivative instruments as of September 30, 2016:
 
Fair value –
Derivatives in asset position
 
Fair value –
Derivatives in liability position
(in millions)
Balance sheet caption
Amount
 
Balance sheet caption
Amount
Foreign currency forward exchange contracts —
 
 
 
 
 
Hedging instruments
Prepaid expenses and other
$
41

 
Accounts payable and accrued liabilities
$
10

Hedging instruments
Other long-term assets
3

 
Other long-term liabilities
1

Others not designated as hedges
Prepaid expenses and other
11

 
Accounts payable and accrued liabilities
20

Interest rate swaps designated as fair value hedges
Other long-term assets
250

 
Other long-term liabilities
1

Total derivatives
 
$
305

 
 
$
32


The following table summarizes the amounts and location of AbbVie’s derivative instruments as of December 31, 2015:
 
Fair value –
Derivatives in asset position
 
Fair value –
Derivatives in liability position
(in millions)
Balance sheet caption
Amount
 
Balance sheet caption
Amount
Foreign currency forward exchange contracts —
 
 
 
 
 
Hedging instruments
Prepaid expenses and other
$
33

 
Accounts payable and accrued liabilities
$

Others not designated as hedges
Prepaid expenses and other
28

 
Accounts payable and accrued liabilities
21

Interest rate swaps designated as fair value hedges
Other long-term assets
9

 
Other long-term liabilities
81

Total derivatives
 
$
70

 
 
$
102


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.


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The following table summarizes the impact of the effective portions of the derivative instruments designated as cash flow hedges recognized in other comprehensive income (loss), net of tax. The amount of hedge ineffectiveness was insignificant for all periods presented.
 
Three months ended
September 30,
 
Nine months ended
September 30,
(in millions)
2016
 
2015
 
2016
 
2015
Unrealized gain/(loss)
$
(4
)
 
$
2

 
$
13

 
$
78


The following table summarizes the location in the condensed consolidated statements of earnings and the amount of gain/(loss) recognized into net earnings for derivative instruments, including the effective portions of the gain/(loss) reclassified out of accumulated other comprehensive loss into net earnings:
 
 
Three months ended
September 30,
 
Nine months ended
September 30,
(in millions) (brackets denote losses)
Statement of earnings caption
2016
 
2015
 
2016
 
2015
Foreign currency forward exchange contracts —
 
 
 
 
 
 
 
 
Designated as cash flow hedges
Cost of products sold
$
4

 
$
89

 
$
23

 
$
171

Not designated as hedges
Net foreign exchange loss
(15
)
 
(5
)
 
(122
)
 
(170
)
Non-designated treasury rate lock agreements
Other expense, net

 

 
(12
)
 

Interest rate swaps designated as fair value hedges
Interest expense, net
(49
)
 
235

 
321

 
236


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

Fair Value Measures

The fair value hierarchy under the accounting standard for fair value measurements 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.


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The following table summarizes the bases used to measure certain assets and liabilities that were carried at fair value on a recurring basis in the condensed consolidated balance sheet as of September 30, 2016:
 
 
 
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
$
6,218

 
$
991

 
$
5,227

 
$

Time deposits
1,500

 

 
1,500

 

Debt securities
1,476

 

 
1,476

 

Equity securities
93

 
93

 

 

Interest rate hedges
250

 

 
250

 

Foreign currency contracts
55

 

 
55

 

Total assets
$
9,592

 
$
1,084

 
$
8,508

 
$

Liabilities
 
 
 
 
 
 
 
Interest rate hedges
$
1

 
$

 
$
1

 
$

Foreign currency contracts
31

 

 
31

 

Contingent consideration
4,128

 

 

 
4,128

Total liabilities
$
4,160

 
$

 
$
32

 
$
4,128


The following table summarizes the bases used to measure certain assets and liabilities that were carried at fair value on a recurring basis in the condensed consolidated balance sheet as of December 31, 2015:
 
 
 
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
$
8,399

 
$
798

 
$
7,601

 
$

Time deposits
8

 

 
8

 

Equity securities
111

 
111

 

 

Interest rate hedges
9

 

 
9

 

Foreign currency contracts
61

 

 
61

 

Total assets
$
8,588

 
$
909

 
$
7,679

 
$

Liabilities
 
 
 
 
 
 
 
Interest rate hedges
$
81

 
$

 
$
81

 
$

Foreign currency contracts
21

 

 
21

 

Total liabilities
$
102

 
$

 
$
102

 
$


The fair values for time deposits included in cash and equivalents and short-term investments were determined based on a discounted cash flow analysis reflecting quoted market rates for the same or similar instruments. 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 based on prices obtained from commercial pricing services. Available-for-sale equity securities consists 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 publicized spot curves for interest rate hedges and publicized forward curves for foreign currency contracts. The fair value measurements of the contingent consideration were determined based on significant unobservable inputs, including the estimated probabilities and timing of achieving specified development, regulatory, and commercial milestones and the estimated amount of future sales of the product candidates acquired. Changes in discount rates or changes which increase or decrease the probabilities of achieving the

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milestones, shorten or lengthen the time required to achieve the milestones, or increase or decrease estimated future sales would result in corresponding changes in the fair values of the contingent consideration.

There have been no transfers of assets or liabilities between the fair value measurement levels. The following table is a reconciliation of the fair value measurements that use significant unobservable inputs (Level 3), which consist of contingent payments related to the acquisitions of Stemcentrx and BI. See Note 4 for additional information.
(in millions)
 
Fair value as of December 31, 2015
$

Additions
3,985

Change in fair value recognized in net earnings
143

Fair value as of September 30, 2016
$
4,128

 
The change in fair value recognized in net earnings was recorded in other expense, net in the condensed consolidated statements of net earnings for the three and nine months ended September 30, 2016.

In addition to the financial instruments that the company is required to recognize at fair value on the condensed consolidated balance sheets, the company has certain financial instruments that were recognized 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 September 30, 2016 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
$
41

$
42

 
$

 
$
5

 
$
37

Total assets
$
41

$
42

 
$

 
$
5

 
$
37

Liabilities
 
 
 
 
 
 
 
 
Current portion of long-term debt and lease obligations
$
26

$
26

 
$

 
$
26

 
$

Long-term debt and lease obligations, excluding fair value hedges
37,035

38,426

 
36,358

 
2,068

 

Total liabilities
$
37,061

$
38,452

 
$
36,358

 
$
2,094

 
$



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The book values, approximate fair values and bases used to measure the approximate fair values of certain financial instruments as of December 31, 2015 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
$
34

$
37

 
$

 
$

 
$
37

Total assets
$
34

$
37

 
$

 
$

 
$
37

Liabilities
 
 
 
 
 
 
 
 
Short-term borrowings
$
406

$
406

 
$

 
$
406

 
$

Current portion of long-term debt and lease obligations
2,025

2,016

 

 
2,016

 

Long-term debt and lease obligations, excluding fair value hedges
29,312

29,143

 
27,061

 
2,082

 

Total liabilities
$
31,743

$
31,565

 
$
27,061

 
$
4,504

 
$


Investments primarily consist of cost method investments. To determine the fair values of other cost method investments, the company takes into consideration recent transactions, as well as the financial information of the investee, which represents a Level 3 basis of fair value measurement. The fair values of short-term and current borrowings approximate the carrying values due to the short maturities of these instruments.

The fair values of long-term debt, excluding fair value hedges and the term loans, were determined by using the published market price for the debt instruments, without consideration of transaction costs, which represents a Level 1 basis of fair value measurement. The fair values of the term loans were determined based on a discounted cash flow analysis using quoted market rates, which represents a Level 2 basis of fair value measurement. The counterparties to financial instruments consist of select major international financial institutions.

Available-for-sale Securities

Substantially all of the company’s investments in debt and equity securities were classified as available-for-sale. As of September 30, 2016, $232 million of debt securities were classified as short-term. Long-term debt securities mature primarily within five years. There were no significant debt securities outstanding as of December 31, 2015. Estimated fair values of available-for-sale securities were generally based on prices obtained from commercial pricing services. The following table is a summary of available-for-sale securities by type as of September 30, 2016:
 
Amortized Cost
 
Gross unrealized
 
Fair Value
(in millions)
 
Gains
 
Losses
 
Asset backed securities
$
670

 
$
1

 
$

 
$
671

Corporate debt securities
726

 
2

 

 
728

Other debt securities
77

 

 

 
77

Equity securities
19

 
74

 

 
93

Total
$
1,492

 
$
77

 
$

 
$
1,569


AbbVie periodically assesses its investment securities for other-than-temporary impairment losses. This evaluation is based on a number of factors, including the length of time and the extent to which the fair value has been below the cost basis and adverse conditions related specifically to the security including any changes to the credit rating of the security, and the intent to sell, or whether AbbVie will more likely than not be required to sell the security before recovery of its amortized cost basis. AbbVie’s assessment of whether a security is other-than-temporarily impaired could change in the future due to new developments or changes in assumptions related to any particular security. Based on a review of these securities, AbbVie had no other-than-temporary impairments on these securities as of September 30, 2016.

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Realized gains and losses on sales of investments were computed using the first-in, first-out method adjusted for any other-than-temporary declines in fair value that were recorded in net earnings. For the three and nine months ended September 30, 2016 and 2015, realized gains and losses were insignificant.

Concentrations of Risk

The functional currency of the company’s Venezuela operations is the U.S. dollar due to the hyperinflationary status of the Venezuelan economy. At December 31, 2015, there were three legal exchange mechanisms administered by the Venezuelan government. These were the official rate of 6.3 Venezuelan bolivars (VEF) per U.S. dollar, the Supplementary System for the Administration of Foreign Currency (SICAD) rate of approximately 13.5 VEF per U.S. dollar, and the Foreign Exchange Marginal System (SIMADI) rate of approximately 200 VEF per U.S. dollar. Effective March 10, 2016, the Venezuelan government devalued the official rate of 6.3 to 10 VEF per U.S. dollar, eliminated the SICAD rate, and replaced SIMADI with a new exchange mechanism, Divisa Complementaria (DICOM). As of September 30, 2016, the DICOM rate was approximately 658 VEF per U.S. dollar.

During the first quarter of 2016, in consideration of declining economic conditions in Venezuela and a decline in transactions settled at the official rate, AbbVie determined that its net monetary assets denominated in the Venezuelan bolivar were no longer expected to be settled at the official rate of 10 VEF per U.S. dollar, but rather at the DICOM rate. Therefore, during the first quarter of 2016, AbbVie recorded a charge of $298 million to net foreign exchange loss to revalue its bolivar-denominated net monetary assets using the DICOM rate then in effect of approximately 270 VEF per U.S. dollar. As of September 30, 2016, AbbVie’s net monetary assets in Venezuela were approximately $3 million.

AbbVie continues to do business with foreign governments in certain countries, including Greece, Portugal, Italy and Spain, which have experienced a deterioration in credit and economic conditions. Substantially all of AbbVie’s trade receivables in Greece, Portugal, Italy and Spain are with government health systems. Outstanding net governmental receivables in these countries totaled $401 million at September 30, 2016 and $525 million at December 31, 2015. The company also continues to do business with foreign governments in certain oil-exporting countries, which have experienced a deterioration in economic conditions, including Saudi Arabia and Russia. Outstanding net governmental receivables were $160 million related to Saudi Arabia and $139 million related to Russia as of September 30, 2016. Due to the decline in the price of oil compared to the prior year, liquidity issues in certain countries may result in delays in the collection of receivables. Global economic conditions and customer-specific factors may require the company to 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 47% as of September 30, 2016 and 51% as of December 31, 2015 and substantially all of AbbVie’s net revenues in the United States are to these three wholesalers.

HUMIRA® (adalimumab) is AbbVie’s single largest product and accounted for approximately 63% of AbbVie’s total net revenues for the nine months ended September 30, 2016 and 63% for the nine months ended September 30, 2015.

Debt and Credit Facilities
 
In May 2016, the company issued $7.8 billion aggregate principal amount of unsecured senior notes, consisting of $1.8 billion aggregate principal amount of its 2.30% senior notes due 2021, $1.0 billion aggregate principal amount of its 2.85% senior notes due 2023, $2.0 billion aggregate principal amount of its 3.20% senior notes due 2026, $1.0 billion aggregate principal amount of its 4.30% senior notes due 2036, and $2.0 billion aggregate principal amount of its 4.45% senior notes due 2046. 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. In connection with the offering, debt issuance costs totaled $52 million and debt discounts incurred totaled $29 million and are being amortized over the respective terms of the notes to interest expense, net in the condensed consolidated statements of earnings.

Of the $7.7 billion net proceeds, $2.0 billion was used to repay the company’s outstanding term loan that was due to mature in November 2016, approximately $1.9 billion was used to finance the acquisition of Stemcentrx and approximately $3.8 billion was used to finance an ASR with a third party financial institution. See Note 4 for additional information related to the acquisition of Stemcentrx and Note 10 for additional information related to the ASR.

In May 2015, the company issued $16.7 billion aggregate principal amount of unsecured senior notes. Debt issuance costs incurred in connection with the offering totaled $93 million and are being amortized over the respective terms of the notes to interest expense, net in the condensed consolidated statements of earnings. Of the $16.6 billion net proceeds, approximately $11.5 billion was used to

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finance the acquisition of Pharmacyclics and approximately $5.0 billion was used to finance an ASR with a third party financial institution.

In March 2015, AbbVie entered into a bridge loan in support of the then planned acquisition of Pharmacyclics. No amounts were drawn under the bridge loan, which was terminated as a result of the company’s May 2015 issuance of the senior notes. Interest expense, net included costs related to the bridge loan of $86 million for the nine months ended September 30, 2015.

Short-term borrowings included commercial paper of $400 million as of December 31, 2015. There were no short term borrowings outstanding as of September 30, 2016. The weighted-average interest rate on commercial paper borrowings was 0.6% for the nine months ended September 30, 2016 and was 0.2% for the nine months ended September 30, 2015.

Note 9    Post-Employment Benefits
 

The following is a summary of net periodic benefit costs relating to the company’s defined benefit and other post-employment plans:
 
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)
2016
 
2015
 
2016
 
2015
 
2016
 
2015
 
2016
 
2015
Service cost
$
52

 
$
57

 
$
158

 
$
171

 
$
6

 
$
7

 
$
19

 
$
19

Interest cost
50

 
54

 
151

 
164

 
6

 
6

 
18

 
18

Expected return on plan assets
(88
)
 
(81
)
 
(266
)
 
(244
)
 

 

 

 

Amortization of actuarial losses and prior service costs
22

 
31

 
64

 
95

 

 

 

 
1

Net periodic benefit cost
$
36

 
$
61

 
$
107

 
$
186

 
$
12

 
$
13

 
$
37

 
$
38


Effective December 31, 2015, AbbVie elected to change the method it uses to estimate the service and interest cost components of net periodic benefit costs. Historically, AbbVie estimated these service and interest cost components of this expense utilizing a single weighted-average discount rate derived from the yield curve used to measure the benefit obligation at the beginning of the period. In late 2015, AbbVie elected to utilize a full yield curve approach in the estimation of these components by applying the specific spot rates along the yield curve used in the determination of the benefit obligation to the relevant projected cash flows. AbbVie elected to make this change to provide a more precise measurement of service and interest costs by improving the correlation between projected benefit cash flows to the corresponding spot yield curve rates. AbbVie has accounted for this change prospectively as a change in accounting estimate that is inseparable from a change in accounting principle. Based on current economic conditions, this change is expected to reduce AbbVie’s net periodic benefit cost by approximately $41 million in 2016. This change had no effect on the 2015 expense and will not affect the measurement of AbbVie’s total benefit obligations.

AbbVie made voluntary contributions, primarily to its domestic defined benefit pension plans, of $202 million in the nine months ended September 30, 2016 and $150 million in the nine months ended September 30, 2015.

Note 10    Equity
 

Stock-Based Compensation

AbbVie grants stock-based awards to qualifying participants pursuant to the AbbVie 2013 Incentive Stock Program (2013 ISP), adopted at the time of the separation from Abbott, which authorized the post-separation grant of several different forms of benefits, including nonqualified stock options, RSAs, RSUs, and various performance-based awards. Under the 2013 ISP, 100 million shares of AbbVie common stock were reserved for issuance with respect to post-separation awards for participants. The 2013 ISP also facilitated the assumption of certain awards granted to AbbVie employees under Abbott’s incentive stock program which were adjusted and converted into new Abbott and AbbVie stock-based awards immediately prior to the separation.


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Stock-based compensation expense principally related to awards issued pursuant to the 2013 ISP and is summarized as follows:
 
Three months ended
September 30,
 
Nine months ended
September 30,
(in millions)
2016
 
2015
 
2016
 
2015
Cost of products sold
$
6

 
$
6

 
$
19

 
$
17

Research and development
6

 
24

 
161

 
87

Selling, general and administrative
35

 
25

 
141

 
125

Total
$
47

 
$
55

 
$
321

 
$
229


Stock-based compensation expense for the three and nine months ended September 30, 2016 also included the post-combination impact related to Stemcentrx options. See Note 4 for additional information related to the Stemcentrx acquisition.

Stock Options

Stock options awarded pursuant to the 2013 ISP typically have a contractual term of 10 years and generally vest in one-third increments over a three-year period. The exercise price is at least equal to 100% of the market value on the date of grant. The fair value is determined using the Black-Scholes model. The weighted-average grant-date fair values of the stock options granted were $9.29 during the nine months ended September 30, 2016 and $9.96 during the nine months ended September 30, 2015.

The following table summarizes the activity for AbbVie stock options for the nine months ended September 30, 2016:
(options in thousands, aggregate intrinsic value in millions)
Options
 
Weighted-
average
exercise 
price
 
Weighted-
average
remaining life
(in years)
 
Aggregate
intrinsic value
Outstanding as of December 31, 2015
23,569

 
$
30.64

 
3.0
 
$
674

Granted
1,143

 
54.99

 
 
 
 
Granted in acquisition
1,076

 
12.85

 
 
 
 
Exercised
(7,672
)
 
26.50

 
 
 
 
Lapsed
(106
)
 
23.62

 
 
 
 
Outstanding as of September 30, 2016
18,010

 
$
32.48

 
3.8
 
$
543

Exercisable as of September 30, 2016
14,857

 
$
30.49

 
2.8
 
$
484


The aggregate intrinsic value in the table above represents the difference between the exercise price and the company’s closing stock price on the last day of trading for the relevant period. The total intrinsic value of options exercised was $57 million for the three months and $253 million for the nine months ended September 30, 2016 and $43 million for the three months and $186 million for the nine months ended September 30, 2015. On June 1, 2016, AbbVie issued stock options for 1.1 million AbbVie shares to holders of unvested Stemcentrx options as a result of the conversion of such options in connection with the Stemcentrx acquisition. These options were fair-valued using a lattice valuation model. See Note 4 for additional information related to the Stemcentrx acquisition.

As of September 30, 2016, $42 million of unrecognized compensation cost related to stock options is expected to be recognized as expense over approximately the next two years.

RSAs & RSUs

RSUs awarded pursuant to the 2013 ISP generally vest in one-third increments over a three-year period. AbbVie also grants certain performance-based equity awards to its senior executives and other key employees. Outstanding performance-based RSAs and RSUs awarded prior to 2016 have a five-year term and generally vest in one-third increments over a three-year period with vesting contingent upon AbbVie achieving a minimum return on equity (ROE) each year. Recipients are entitled to receive dividends or dividend equivalents as dividends are declared as of the record date during the vesting term of the award.

Performance-based awards granted in 2016 to senior executives and other key employees consist of a combination of performance-vested RSUs and performance shares. The performance-vested RSUs have the potential to vest in one-third increments during a three-year performance period based on AbbVie’s ROE relative to a defined peer group of pharmaceutical, biotech and life sciences

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companies. The recipient may receive one share of AbbVie common stock for each vested award. The performance shares have the potential to vest over a three-year performance period and may be earned based on AbbVie’s EPS achievement and AbbVie’s total stockholder return (TSR) (a market condition) relative to a defined peer group of pharmaceutical, biotech and life sciences companies. Dividend equivalents on performance-vested RSUs and performance shares accrue during the performance period and are payable at vesting only to the extent that shares are earned.

The weighted-average grant-date fair value of RSAs and RSUs (including performance-based awards) generally is determined based on the number of shares granted and the quoted price of AbbVie’s common stock on the date of grant. The weighted-average grant-date fair values of performance shares with a TSR market condition are determined using the Monte Carlo simulation model.

The following table summarizes the activity for AbbVie RSAs and RSUs, including performance-based awards, for the nine months ended September 30, 2016:
(share units in thousands)
Share units
 
Weighted-
average
grant date 
fair value
Outstanding as of December 31, 2015
12,490

 
$
51.66

Granted
5,480

 
55.17

Vested
(6,418
)
 
46.13

Lapsed
(644
)
 
56.90

Outstanding as of September 30, 2016
10,908

 
$
56.36


The fair market value of RSAs and RSUs vested was $7 million for the three months and $343 million for the nine months ended September 30, 2016 and $6 million for the three months and $330 million for the nine months ended September 30, 2015.

As of September 30, 2016, $277 million of unrecognized compensation cost related to RSAs and RSUs is expected to be recognized as expense over approximately the next two years.

Cash Dividends

The following table summarizes quarterly cash dividends for the nine months ended September 30, 2016 and 2015:
2016
 
2015
Date Declared
 
Payment Date
 
Dividend Per Share
 
Date Declared
 
Payment Date
 
Dividend Per Share
10/28/16
 
02/15/17
 
$
0.64

 
10/30/15
 
02/16/16
 
$
0.57

09/09/16
 
11/15/16
 
$
0.57

 
09/11/15
 
11/16/15
 
$
0.51

06/16/16
 
08/15/16
 
$
0.57

 
06/18/15
 
08/14/15
 
$
0.51

02/18/16
 
05/16/16
 
$
0.57

 
02/19/15
 
05/15/15
 
$
0.51




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Stock Repurchase Program

AbbVie's board of directors authorized increases to its existing stock repurchase program of $4.0 billion in April 2016 in anticipation of executing an ASR in connection with the Stemcentrx acquisition and of $5.0 billion in March 2015 in anticipation of executing an ASR in connection with the Pharmacyclics acquisition. The stock repurchase authorization permits purchases of AbbVie shares from time to time in open-market or private transactions at management’s direction depending on the company’s cash flows, net debt level, and market conditions. The program has no time limit and can be discontinued at any time. Shares repurchased under these programs are recorded at acquisition cost, including related expenses, and are available for general corporate purposes. The following table shows details about AbbVie’s ASR transactions:

(shares in millions, repurchase amounts in billions)
 
 
 
Execution date
Purchase amount
 
Initial delivery of shares
 
Final delivery of shares
Related acquisition
05/26/15
$
5.0

 
68.1

 
5.0

Pharmacyclics
06/01/16
$
3.8

 
54.4

 
5.4

Stemcentrx

On June 2, 2016, the initial 54.4 million shares of AbbVie’s common stock related to the 2016 ASR were received. The 2016 ASR transaction was completed on September 28, 2016, resulting in the receipt of an additional 5.4 million shares. AbbVie recorded the aggregate $3.8 billion purchase price of the 2016 ASR as a reduction to common stock held in treasury on the condensed consolidated balance sheet as of September 30, 2016.

In addition to the ASR transactions, AbbVie repurchased approximately 21 million shares in the open market for $1.2 billion during the nine months ended September 30, 2015. During the nine months ended September 30, 2016, AbbVie cash-settled $300 million of its open market purchases made at the end of 2015. AbbVie's remaining stock repurchase authorization was $2.1 billion as of September 30, 2016.

Accumulated Other Comprehensive Loss

The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for the nine months ended September 30, 2016:
(in millions)
Foreign
currency
translation
adjustments
 
Pension 
and post-
employment
benefits
 
Unrealized
gains on
marketable
equity
 securities
 
Hedging
activities
 
Total
Balance as of December 31, 2015
$
(1,270
)
 
$
(1,378
)
 
$
47

 
$
40

 
$
(2,561
)
Other comprehensive income before reclassifications
164

 
7

 
23

 
13

 
207

Net losses (gains) reclassified from accumulated other comprehensive loss

 
41

 
(4
)
 
(23
)
 
14

Net current-period other comprehensive income (loss)
164

 
48

 
19

 
(10
)
 
221

Balance as of September 30, 2016
$
(1,106
)
 
$
(1,330
)
 
$
66

 
$
30

 
$
(2,340
)

Other comprehensive income for the nine months ended September 30, 2016 included foreign currency translation adjustments totaling a gain of $164 million, which was principally due to the impact of the improvement in the Euro and Japanese yen in the nine months ended September 30, 2016 on the translation of the company’s assets denominated in the Euro and Japanese yen.


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The following table summarizes the changes in each component of accumulated other comprehensive loss, net of tax, for the nine months ended September 30, 2015:
(in millions)
Foreign
currency
translation
adjustments
 
Pension 
and post-
employment
benefits
 
Unrealized
gains on
marketable
equity
 securities
 
Hedging
activities
 
Total
Balance as of December 31, 2014
$
(603
)
 
$
(1,608
)
 
$
3

 
$
177

 
$
(2,031
)
Other comprehensive income before reclassifications
(464
)
 
23

 

 
78

 
(363
)
Net losses (gains) reclassified from accumulated other comprehensive loss