10-Q 1 q215form10-q.htm 10-Q Q2'15 Form 10-Q

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 
FORM 10-Q
 
 
 
ý
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended June 30, 2015
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. 0-19731
 
 
GILEAD SCIENCES, INC.

(Exact Name of Registrant as Specified in Its Charter)
 
Delaware
94-3047598
(State or Other Jurisdiction of
Incorporation or Organization)
(IRS Employer
Identification No.)
 
 
333 Lakeside Drive, Foster City, California
94404
(Address of principal executive offices)
(Zip Code)
650-574-3000
Registrant’s Telephone Number, Including Area Code
 
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 ý    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 (§232.405 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 ý    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 ý    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 ý
Number of shares outstanding of the issuer’s common stock, par value $0.001 per share, as of July 31, 2015: 1,467,605,502
 




GILEAD SCIENCES, INC.
INDEX

PART I.
 
 
 
 
 
 
 
Item 1.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 2.
 
 
 
 
 
 
 
Item 3.
 
 
 
 
 
 
 
Item 4.
 
 
 
 
 
 
PART II.
 
 
 
 
 
 
 
Item 1.
 
 
 
 
 
 
 
Item 1A.
 
 
 
 
 
 
 
Item 2.
 
 
 
 
 
 
 
Item 3.
 
 
 
 
 
 
 
Item 4.
 
 
 
 
 
 
 
Item 5.
 
 
 
 
 
 
 
Item 6.
 
 
 
 
 
 
 


We own or have rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, HARVONI®, SOVALDI®, TRUVADA®, STRIBILD®, COMPLERA®, EVIPLERA®, VIREAD®, LETAIRIS®, RANEXA®, AMBISOME®, ZYDELIG®, EMTRIVA®, TYBOST®, HEPSERA®, VITEKTA®, CAYSTON®, VOLIBRIS® and RAPISCAN®. ATRIPLA® is a registered trademark belonging to Bristol-Myers Squibb & Gilead Sciences, LLC. LEXISCAN® is a registered trademark belonging to Astellas U.S. LLC. MACUGEN® is a registered trademark belonging to Eyetech, Inc. SUSTIVA® is a registered trademark of Bristol-Myers Squibb Pharma Company. TAMIFLU® is a registered trademark belonging to Hoffmann-La Roche Inc. This report also includes other trademarks, service marks and trade names of other companies.




PART I.
FINANCIAL INFORMATION
Item I.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in millions, except per share amounts)
 
June 30, 2015
 
December 31, 2014
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
7,417

 
$
10,027

Short-term marketable securities
1,194

 
101

Accounts receivable, net
5,331

 
4,635

Inventories
2,039

 
1,386

Deferred tax assets
833

 
508

Prepaid taxes
444

 
391

Prepaid expenses
282

 
194

Other current assets
553

 
472

Total current assets
18,093

 
17,714

Property, plant and equipment, net
1,899

 
1,674

Long-term portion of prepaid royalties
428

 
466

Long-term deferred tax assets
177

 
236

Long-term marketable securities
6,056

 
1,598

Intangible assets, net
10,660

 
11,073

Goodwill
1,172

 
1,172

Other long-term assets
682

 
731

Total assets
$
39,167

 
$
34,664

Liabilities and Stockholders’ Equity
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
1,571

 
$
955

Accrued government and other rebates
4,367

 
2,316

Accrued compensation and employee benefits
268

 
316

Income taxes payable
356

 
105

Other accrued liabilities
1,510

 
1,452

Deferred revenues
501

 
134

Current portion of long-term debt and other obligations, net
352

 
483

Total current liabilities
8,925

 
5,761

Long-term debt, net
11,922

 
11,921

Long-term income taxes payable
883

 
562

Long-term deferred tax liabilities
36

 
51

Other long-term obligations
760

 
535

Commitments and contingencies (Note 9)


 


Equity component of currently redeemable convertible notes
7

 
15

Stockholders’ equity:
 

 
 

Preferred stock, par value $0.001 per share; 5 shares authorized; none outstanding

 

Common stock, par value $0.001 per share; shares authorized of 5,600 at June 30, 2015 and December 31, 2014; shares issued and outstanding of 1,473 at June 30, 2015 and 1,499 at December 31, 2014
2

 
2

Additional paid-in capital

 
2,391

Accumulated other comprehensive income
247

 
301

Retained earnings
16,038

 
12,732

Total Gilead stockholders’ equity
16,287

 
15,426

Noncontrolling interest
347

 
393

Total stockholders’ equity
16,634

 
15,819

Total liabilities and stockholders’ equity
$
39,167

 
$
34,664

See accompanying notes.

2



GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in millions, except per share amounts)

 
 
 
Three Months Ended
 
Six Months Ended
 
 
June 30,
 
June 30,
 
 
2015
 
2014
 
2015
 
2014
Revenues:
 
 
 
 
 
 
 
 
Product sales
 
$
8,126

 
$
6,413

 
$
15,531

 
$
11,284

Royalty, contract and other revenues
 
118

 
122

 
307

 
250

Total revenues
 
8,244

 
6,535

 
15,838

 
11,534

Costs and expenses:
 
 
 
 
 
 
 
 
Cost of goods sold
 
998

 
925

 
1,880

 
1,738

Research and development expenses
 
818

 
584

 
1,514

 
1,179

Selling, general and administrative expenses
 
812

 
614

 
1,457

 
1,162

Total costs and expenses
 
2,628

 
2,123

 
4,851

 
4,079

Income from operations
 
5,616

 
4,412

 
10,987

 
7,455

Interest expense
 
(140
)
 
(102
)
 
(293
)
 
(178
)
Other income (expense), net
 
35

 
(4
)
 
56

 
(22
)
Income before provision for income taxes
 
5,511

 
4,306

 
10,750

 
7,255

Provision for income taxes
 
1,014

 
656

 
1,921

 
1,382

Net income
 
4,497

 
3,650

 
8,829

 
5,873

Net income (loss) attributable to noncontrolling interest
 
5

 
(6
)
 
4

 
(10
)
Net income attributable to Gilead
 
$
4,492

 
$
3,656

 
$
8,825

 
$
5,883

Net income per share attributable to Gilead common stockholders - basic
 
$
3.05

 
$
2.39

 
$
5.96

 
$
3.83

Shares used in per share calculation - basic
 
1,472

 
1,533

 
1,480

 
1,535

Net income per share attributable to Gilead common stockholders - diluted
 
$
2.92

 
$
2.20

 
$
5.68

 
$
3.52

Shares used in per share calculation - diluted
 
1,540

 
1,664

 
1,555

 
1,672

Cash dividends declared per share
 
$
0.43

 
$

 
$
0.43

 
$





















See accompanying notes.

3



GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)
(in millions)
 
 
Three Months Ended
 
Six Months Ended
 
 
June 30,
 
June 30,
 
 
2015
 
2014
 
2015
 
2014
Net income
 
$
4,497

 
$
3,650

 
$
8,829

 
$
5,873

Other comprehensive income (loss):
 
 
 
 
 
 
 
 
Net foreign currency translation gains (losses), net of tax
 
3

 
1

 
(7
)
 
7

Available-for-sale securities:
 
 
 
 
 
 
 
 
Net unrealized gains (losses), net of tax impact of $(1), $1, $2 and $1
 
(3
)
 
1

 
3

 
1

Net change
 
(3
)
 
1

 
3

 
1

Cash flow hedges:
 
 
 
 
 
 
 
 
Net unrealized gains (losses), net of tax impact of $(3), $(2), $3 and $0
 
(110
)
 
32

 
273

 
33

Reclassifications to net income, net of tax impact of $(5), $(1), $(9) and $(2)
 
(182
)
 
20

 
(323
)
 
42

Net change
 
(292
)
 
52

 
(50
)
 
75

Other comprehensive income (loss)
 
(292
)
 
54

 
(54
)
 
83

Comprehensive income
 
4,205

 
3,704

 
8,775

 
5,956

Comprehensive income (loss) attributable to noncontrolling interest
 
5

 
(6
)
 
4

 
(10
)
Comprehensive income attributable to Gilead
 
$
4,200

 
$
3,710

 
$
8,771

 
$
5,966



























See accompanying notes.

4



GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in millions)
 
 
Six Months Ended
 
 
June 30,
 
 
2015
 
2014
Operating Activities:
 
 
 
 
Net income
 
$
8,829

 
$
5,873

Adjustments to reconcile net income to net cash provided by operating activities:
 
 
 
 
Depreciation expense
 
75

 
53

Amortization expense
 
467

 
454

Stock-based compensation expense
 
188

 
165

Excess tax benefits from stock-based compensation
 
(326
)
 
(214
)
Tax benefits from exercise and vesting of stock-based awards
 
326

 
216

Deferred income taxes
 
(260
)
 
(53
)
Other
 
27

 
29

Changes in operating assets and liabilities:
 
 
 
 
Accounts receivable, net
 
(810
)
 
(1,332
)
Inventories
 
(634
)
 
(21
)
Prepaid expenses and other assets
 
(127
)
 
(522
)
Accounts payable
 
620

 
(90
)
Income taxes payable
 
574

 
298

Accrued liabilities
 
2,045

 
877

Deferred revenues
 
365

 
20

Net cash provided by operating activities
 
11,359

 
5,753

 
 
 
 
 
Investing Activities:
 
 
 
 
Purchases of marketable securities
 
(6,847
)
 
(650
)
Proceeds from sales of marketable securities
 
1,143

 
239

Proceeds from maturities of marketable securities
 
148

 
18

Capital expenditures
 
(295
)
 
(255
)
Net cash used in investing activities
 
(5,851
)
 
(648
)
 
 
 
 
 
Financing Activities:
 
 
 
 
Proceeds from debt financing, net of issuance costs
 

 
3,966

Proceeds from convertible note hedges
 
508

 
1,312

Purchases of convertible note hedges
 

 
(26
)
Repayments of debt and other obligations
 
(650
)
 
(2,439
)
Payments to settle warrants
 
(3,865
)
 

Proceeds from issuances of common stock
 
202

 
163

Repurchases of common stock
 
(3,901
)
 
(1,650
)
Payment of dividend
 
(633
)
 

Excess tax benefits from stock-based compensation
 
326

 
214

Net distributions to noncontrolling interest
 
(50
)
 
(27
)
Net cash provided by (used in) financing activities
 
(8,063
)
 
1,513

Effect of exchange rate changes on cash and cash equivalents
 
(55
)
 

Net change in cash and cash equivalents
 
(2,610
)
 
6,618

Cash and cash equivalents at beginning of period
 
10,027

 
2,113

Cash and cash equivalents at end of period
 
$
7,417

 
$
8,731


See accompanying notes.

5



GILEAD SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of Gilead Sciences, Inc. (Gilead, we or us) believes are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.
The accompanying Condensed Consolidated Financial Statements include the accounts of Gilead, our wholly-owned subsidiaries and certain variable interest entities for which we are the primary beneficiary. For consolidated entities where we own or are exposed to less than 100% of the economics, we record net income (loss) attributable to noncontrolling interests in our Condensed Consolidated Statements of Income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties. All intercompany transactions have been eliminated. The Condensed Consolidated Financial Statements include the results of companies acquired by us from the date of each acquisition for the applicable reporting periods.
The accompanying Condensed Consolidated Financial Statements and related Notes to Condensed Consolidated Financial Statements should be read in conjunction with the audited Consolidated Financial Statements and the related notes thereto for the year ended December 31, 2014, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission.
Significant Accounting Policies, Estimates and Judgments
The preparation of these Condensed Consolidated Financial Statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its significant accounting policies and estimates. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates. Estimates are assessed each period and updated to reflect current information.
Concentrations of Risk
We are subject to credit risk from our portfolio of cash equivalents and marketable securities. Under our investment policy, we limit amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. We are not exposed to any significant concentrations of credit risk from these financial instruments. The goals of our investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return.
We are also subject to credit risk from our accounts receivable related to our product sales. The majority of our trade accounts receivable arises from product sales in the United States and Europe.
As of June 30, 2015, our accounts receivable in Southern Europe, specifically Greece, Italy, Portugal and Spain, totaled approximately $1.5 billion, of which $118 million were greater than 120 days past due and $29 million were greater than 365 days past due. To date, we have not experienced significant losses with respect to the collection of our accounts receivable. We believe that our allowance for doubtful accounts was adequate at June 30, 2015.
Recent Accounting Pronouncements
In April 2015, the Financial Accounting Standards Board (FASB) issued an accounting standard update which requires presentation of debt issuance costs as a direct deduction from the carrying amount of a recognized debt liability on the balance sheet. The update does not change current guidance on the recognition and measurement of debt issuance costs. This guidance will become effective for us for annual periods beginning after December 15, 2015, and interim periods thereafter. At the time of adoption, we will reclassify debt issuance costs to a liability as a direct deduction from the carrying value of the debt,

6



consistent with the presentation of a debt discount. We do not expect that the adoption of this update will have a material impact on our Condensed Consolidated Financial Statements.
In May 2014, the FASB, jointly with the International Accounting Standards Board, issued a comprehensive new standard on revenue recognition from contracts with customers. The standard's core principle is that a reporting entity will recognize revenue when it transfers 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. On July 9, 2015, the FASB decided to delay the effective date of the new standard by one year. The standard would become effective for us beginning in the first quarter of 2018. Early application would be permitted in 2017. Entities would have the option of using either a full retrospective or a modified retrospective approach to adopt this new guidance. We are currently evaluating the impact of our adoption of this standard on our Condensed Consolidated Financial Statements.
2.
FAIR VALUE MEASUREMENTS
We determine the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows:
Level 1 inputs which include quoted prices in active markets for identical assets or liabilities;
Level 2 inputs which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For our marketable securities, we review trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and
Level 3 inputs which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Our Level 3 liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation.
Our financial instruments consist principally of cash and cash equivalents, marketable securities, accounts receivable, foreign currency exchange contracts, accounts payable and short-term and long-term debt. Cash and cash equivalents, marketable securities and foreign currency exchange contracts that hedge accounts receivable and forecasted sales are reported at their respective fair values on our Condensed Consolidated Balance Sheets. Short-term and long-term debt are reported at their amortized cost on our Condensed Consolidated Balance Sheets. The remaining financial instruments are reported on our Condensed Consolidated Balance Sheets at amounts that approximate current fair values.

7



The following table summarizes the assets and liabilities measured at fair value on a recurring basis, by level, within the fair value hierarchy (in millions):
 
June 30, 2015
 
December 31, 2014
 
Level 1
 
Level 2
 
Level 3
 
Total
 
Level 1
 
Level 2
 
Level 3
 
Total
Assets:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Money market funds
$
5,594

 
$

 
$

 
$
5,594

 
$
7,926

 
$

 
$

 
$
7,926

Corporate debt securities

 
3,435

 

 
3,435

 

 
938

 

 
938

U.S. treasury securities
2,085

 

 

 
2,085

 
363

 

 

 
363

Residential mortgage and asset-backed securities

 
914

 

 
914

 

 
269

 

 
269

Certificates of deposit

 
361

 

 
361

 

 

 

 

Foreign currency derivative contracts

 
342

 

 
342

 

 
349

 

 
349

U.S. government agencies securities

 
293

 

 
293

 

 
113

 

 
113

Non-U.S. government securities

 
169

 

 
169

 

 

 

 

Municipal debt securities

 
43

 

 
43

 

 
16

 

 
16

Deferred compensation plan
63

 

 

 
63

 
54

 

 

 
54

 
$
7,742

 
$
5,557

 
$

 
$
13,299

 
$
8,343

 
$
1,685

 
$

 
$
10,028

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Liabilities:
 

 
 

 
 

 
 

 
 

 
 

 
 

 
 

Contingent consideration
$

 
$

 
$
140

 
$
140

 
$

 
$

 
$
133

 
$
133

Deferred compensation plan
63

 

 

 
63

 
54

 

 

 
54

Foreign currency derivative contracts

 
39

 

 
39

 

 

 

 

 
$
63

 
$
39

 
$
140

 
$
242

 
$
54

 
$

 
$
133

 
$
187

Level 2 Inputs
We estimate the fair values of our corporate debt securities, residential mortgage and asset-backed securities, government related securities and certificates of deposit by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data and other observable inputs.
Substantially all of our foreign currency derivative contracts have maturities primarily over an 18-month time horizon and all are with counterparties that have a minimum credit rating of A- or equivalent by Standard & Poor's, Moody's Investors Service, Inc. or Fitch, Inc. We estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that utilizes an income-based industry standard valuation model for which all significant inputs are observable, either directly or indirectly. These inputs include foreign currency rates, London Interbank Offered Rates (LIBOR) and swap rates. These inputs, where applicable, are at commonly quoted intervals.

8



The fair values of our convertible senior notes and senior unsecured notes were determined using Level 2 inputs based on their quoted market values. The following table summarizes the carrying values and fair values of our convertible senior notes and senior unsecured notes (in millions):
 
 
 
 
June 30, 2015
 
December 31, 2014
Type of Borrowing
 
Description
 
Carrying Value
 
Fair Value
 
Carrying Value
 
Fair Value
Convertible Senior
 
May 2016 Notes
 
$
352

 
$
1,851

 
$
483

 
$
2,097

Senior Unsecured
 
April 2021 Notes
 
995

 
1,094

 
995

 
1,108

Senior Unsecured
 
December 2016 Notes
 
700

 
720

 
700

 
727

Senior Unsecured
 
December 2021 Notes
 
1,248

 
1,366

 
1,248

 
1,377

Senior Unsecured
 
December 2041 Notes
 
998

 
1,152

 
998

 
1,229

Senior Unsecured
 
April 2019 Notes
 
499

 
501

 
499

 
500

Senior Unsecured
 
April 2024 Notes
 
1,748

 
1,789

 
1,747

 
1,836

Senior Unsecured
 
April 2044 Notes
 
1,747

 
1,809

 
1,747

 
1,954

Senior Unsecured
 
February 2020 Notes
 
499

 
502

 
499

 
504

Senior Unsecured
 
February 2025 Notes
 
1,748

 
1,759

 
1,748

 
1,797

Senior Unsecured
 
February 2045 Notes
 
1,740

 
1,735

 
1,740

 
1,872

Level 3 Inputs
As of June 30, 2015 and December 31, 2014, the only assets or liabilities that were measured using Level 3 inputs were contingent consideration liabilities of $140 million and $133 million. Our policy is to recognize transfers into or out of Level 3 classification as of the actual date of the event or change in circumstances that caused the transfer.
The contingent consideration liabilities included the potential future contingent consideration payments resulting from the acquisition of Arresto Biosciences, Inc. for royalty obligations on future sales once specified sales-based milestones are achieved, and the acquisitions of CGI Pharmaceuticals, Inc. and Calistoga Pharmaceuticals, Inc. upon achievement of development or regulatory approval-based milestones.
3.
AVAILABLE-FOR-SALE SECURITIES
Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in our Condensed Consolidated Balance Sheets (in millions):
 
 
June 30, 2015
 
December 31, 2014
 
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Estimated
Fair Value 
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Estimated
Fair Value 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Money market funds
 
$
5,594

 
$

 
$

 
$
5,594

 
$
7,926

 
$

 
$

 
$
7,926

Corporate debt securities
 
3,438

 
2

 
(5
)
 
3,435

 
941

 

 
(3
)
 
938

U.S. treasury securities
 
2,083

 
2

 

 
2,085

 
363

 

 

 
363

Residential mortgage and asset-backed securities
 
914

 
1

 
(1
)
 
914

 
269

 

 

 
269

Certificates of deposit
 
361

 

 

 
361

 

 

 

 

U.S. government agencies securities
 
293

 

 

 
293

 
113

 

 

 
113

Non-U.S. government securities
 
169

 

 

 
169

 

 

 

 

Municipal debt securities
 
43

 

 

 
43

 
16

 

 

 
16

Total
 
$
12,895

 
$
5

 
$
(6
)
 
$
12,894

 
$
9,628

 
$

 
$
(3
)
 
$
9,625


9



The following table summarizes the classification of the available-for-sale securities on our Condensed Consolidated Balance Sheets (in millions):
 
 
June 30, 2015
 
December 31, 2014
Cash and cash equivalents
 
$
5,644

 
$
7,926

Short-term marketable securities
 
1,194

 
101

Long-term marketable securities
 
6,056

 
1,598

Total
 
$
12,894

 
$
9,625

Cash and cash equivalents in the table above exclude cash of $1.8 billion as of June 30, 2015 and $2.1 billion as of December 31, 2014.
The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in millions):
 
 
June 30, 2015
 
 
Amortized Cost
 
Fair Value
Less than one year
 
$
6,838

 
$
6,838

Greater than one year but less than five years
 
5,999

 
5,998

Greater than five years but less than ten years
 
34

 
34

Greater than ten years
 
24

 
24

Total
 
$
12,895

 
$
12,894

The following table summarizes our available-for-sale debt securities that were in a continuous unrealized loss position, but were not deemed to be other-than-temporarily impaired (in millions):
 
 
Less Than 12 Months
 
12 Months or Greater
 
Total
 
 
Gross
Unrealized
Losses
 
Estimated
Fair Value
 
Gross
Unrealized
Losses
 
Estimated
Fair Value
 
Gross
Unrealized
Losses
 
Estimated
Fair Value
June 30, 2015
 
 
 
 
 
 
 
 
 
 
 
 
Corporate debt securities
 
$
(5
)
 
$
2,101

 
$

 
$
21

 
$
(5
)
 
$
2,122

Residential mortgage and asset-backed securities
 
(1
)
 
499

 

 
16

 
(1
)
 
515

U.S. treasury securities
 

 
378

 

 

 

 
378

U.S. government agencies securities
 

 
100

 

 

 

 
100

Non-U.S. government securities
 

 
151

 

 

 

 
151

Municipal debt securities
 

 
13

 

 

 

 
13

Total
 
$
(6
)
 
$
3,242

 
$

 
$
37

 
$
(6
)
 
$
3,279

 
 
 

 
 

 
 

 
 

 
 

 
 

December 31, 2014
 
 

 
 

 
 

 
 

 
 

 
 

Corporate debt securities
 
$
(3
)
 
$
802

 
$

 
$

 
$
(3
)
 
$
802

Residential mortgage and asset-backed securities
 

 
227

 

 
1

 

 
228

U.S. treasury securities
 

 
206

 

 

 

 
206

U.S. government agencies securities
 

 
22

 

 

 

 
22

Municipal debt securities
 

 
2

 

 

 

 
2

Total
 
$
(3
)
 
$
1,259

 
$

 
$
1

 
$
(3
)
 
$
1,260

We held a total of 1,034 positions as of June 30, 2015 and 468 positions as of December 31, 2014 that were in an unrealized loss position. The unrealized losses were immaterial both individually and in aggregate. We did not record any other-than-temporary impairments on these securities as of June 30, 2015, because we do not intend to sell these securities nor do we believe that we will be required to sell them before they recover their amortized costs at maturity.

10



4.
DERIVATIVE FINANCIAL INSTRUMENTS
Our operations in foreign countries expose us to market risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and various foreign currencies, the most significant of which is the Euro. In order to manage this risk, we hedge a portion of our foreign currency exposures related to outstanding monetary assets and liabilities as well as forecasted product sales using foreign currency exchange forward or option contracts. In general, the market risk related to these contracts is offset by corresponding gains and losses on the hedged transactions. The credit risk associated with these contracts is driven by changes in interest and currency exchange rates and, as a result, varies over time. By working only with major banks and closely monitoring current market conditions, we seek to limit the risk that counterparties to these contracts may be unable to perform. We also seek to limit our risk of loss by entering into contracts that permit net settlement at maturity. Therefore, our overall risk of loss in the event of a counterparty default is limited to the amount of any unrecognized gains on outstanding contracts (i.e., those contracts that have a positive fair value) at the date of default. We do not enter into derivative contracts for trading purposes.
We hedge our exposure to foreign currency exchange rate fluctuations for certain monetary assets and liabilities of our foreign subsidiaries that are denominated in a non-functional currency. The derivative instruments we use to hedge this exposure are not designated as hedges, and as a result, changes in their fair value are recorded in other income (expense), net on our Condensed Consolidated Statements of Income.
We hedge our exposure to foreign currency exchange rate fluctuations for forecasted product sales that are denominated in a non-functional currency. The derivative instruments we use to hedge this exposure are designated as cash flow hedges and have maturity dates of 18 months or less. Upon executing a hedging contract and quarterly thereafter, we assess prospective hedge effectiveness using regression analysis which calculates the change in cash flow as a result of the hedge instrument. On a monthly basis, we assess retrospective hedge effectiveness using a dollar offset approach. We exclude time value from our effectiveness testing and recognize changes in the time value of the hedge in other income (expense), net. The effective component of our hedge is recorded as an unrealized gain or loss on the hedging instrument in accumulated other comprehensive income (OCI) within stockholders' equity. When the hedged forecasted transaction occurs, the hedge is de-designated and the unrealized gains or losses are reclassified into product sales. The majority of gains and losses related to the hedged forecasted transactions reported in accumulated OCI at June 30, 2015 will be reclassified to product sales within 12 months.
The cash flow effects of our derivative contracts for the six months ended June 30, 2015 and 2014 are included within net cash provided by operating activities in the Condensed Consolidated Statements of Cash Flows.
We had notional amounts on foreign currency exchange contracts outstanding of $6.8 billion at June 30, 2015 and $6.4 billion at December 31, 2014.
While all of our derivative contracts allow us the right to offset assets or liabilities, we have presented amounts on a gross basis. Under the International Swap Dealers Association, Inc. master agreements with the respective counterparties of the foreign currency exchange contracts, subject to applicable requirements, we are allowed to net settle transactions of the same currency with a single net amount payable by one party to the other. The following table summarizes the classification and fair values of derivative instruments on our Condensed Consolidated Balance Sheets (in millions):
 
 
June 30, 2015
 
 
Asset Derivatives
 
Liability Derivatives
 
 
Classification
 
Fair Value 
 
Classification
 
Fair Value
Derivatives designated as hedges:
 
 
 
 
 
 
 
 
Foreign currency exchange contracts
 
Other current assets
 
$
340

 
Other accrued liabilities
 
$
(29
)
Foreign currency exchange contracts
 
Other long-term assets
 
2

 
Other long-term obligations
 
(10
)
Total derivatives
 
 
 
$
342

 
 
 
$
(39
)
 

11



 
 
December 31, 2014
 
 
Asset Derivatives
 
Liability Derivatives
 
 
Classification
 
Fair Value 
 
Classification
 
Fair Value
Derivatives designated as hedges:
 
 
 
 
 
 
 
 
Foreign currency exchange contracts
 
Other current assets
 
$
314

 
Other accrued liabilities
 
$

Foreign currency exchange contracts
 
Other long-term assets
 
35

 
Other long-term obligations
 

Total derivatives
 
 
 
$
349

 
 
 
$

The following table summarizes the effect of our foreign currency exchange contracts on our Condensed Consolidated Financial Statements (in millions):
 
 
Three Months Ended
 
Six Months Ended
 
 
June 30,
 
June 30,
 
 
2015
 
2014
 
2015
 
2014
Derivatives designated as hedges:
 
 
 
 
 
 
 
 
Gains (losses) recognized in accumulated OCI (effective portion)
 
$
(113
)
 
$
30

 
$
276

 
$
33

Gains (losses) reclassified from accumulated OCI into product sales (effective portion)
 
$
187

 
$
(19
)
 
$
332

 
$
(40
)
Gains (losses) recognized in other income (expense), net (ineffective portion and amounts excluded from effectiveness testing)
 
$
6

 
$
(4
)
 
$
7

 
$
(4
)
Derivatives not designated as hedges:
 
 
 
 
 
 
 
 
Gains (losses) recognized in other income (expense), net
 
$
(40
)
 
$
8

 
$
68

 
$
9

From time to time, we may discontinue cash flow hedges and as a result, record related amounts in other income (expense), net on our Condensed Consolidated Statements of Income. There were no material amounts recorded in other income (expense), net for the three and six months ended June 30, 2015 and 2014 as a result of the discontinuance of cash flow hedges.
As of June 30, 2015 and December 31, 2014, we held one type of financial instrument, derivative contracts related to foreign currency exchange contracts. The following table summarizes the potential effect of offsetting derivatives by type of financial instrument on our Condensed Consolidated Balance Sheets (in millions):
As of June 30, 2015
Offsetting of Derivative Assets/Liabilities
 
 
 
 
 
 
 
 
Gross Amounts Not Offset
in the Condensed
Consolidated Balance Sheet
 
 
Description
 
Gross Amounts of Recognized Assets/Liabilities
 
Gross Amounts Offset in the Condensed Consolidated Balance Sheet
 
Amounts of Assets/Liabilities Presented
in the Condensed Consolidated
Balance Sheet
 
Derivative Financial Instruments
 
Cash Collateral Received/Pledged
 
Net Amount (Legal Offset)
Derivative assets
 
$
342

 
$

 
$
342

 
$
(38
)
 
$

 
$
304

Derivative liabilities
 
(39
)
 

 
(39
)
 
38

 

 
(1
)
As of December 31, 2014
Offsetting of Derivative Assets/Liabilities
 
 
 
 
 
 
 
 
Gross Amounts Not Offset
in the Condensed
Consolidated Balance Sheet
 
 
Description
 
Gross Amounts of Recognized Assets/Liabilities
 
Gross Amounts Offset in the Condensed Consolidated Balance Sheet
 
Amounts of Assets/Liabilities Presented
in the Condensed Consolidated
Balance Sheet
 
Derivative Financial Instruments
 
Cash Collateral Received/Pledged
 
Net Amount (Legal Offset)
Derivative assets
 
$
349

 
$

 
$
349

 
$

 
$

 
$
349

Derivative liabilities
 

 

 

 

 

 


12



5.
INVENTORIES
Inventories are summarized as follows (in millions):
 
 
June 30, 2015
 
December 31, 2014
Raw materials
 
$
1,206

 
$
909

Work in process
 
706

 
500

Finished goods
 
592

 
466

Total
 
$
2,504

 
$
1,875

 
 
 
 
 
Reported as:
 
 
 
 
Inventories
 
$
2,039

 
$
1,386

Other long-term assets
 
465

 
489

Total
 
$
2,504

 
$
1,875

Amounts reported as other long-term assets primarily consisted of raw materials as of June 30, 2015 and December 31, 2014.
The joint venture formed by Gilead Sciences, LLC and Bristol-Myers Squibb Company (BMS) (See Note 7, Collaborative Arrangements), which is included in our Condensed Consolidated Financial Statements, held efavirenz active pharmaceutical ingredient in inventory. This efavirenz inventory was purchased from BMS at BMS's estimated net selling price of efavirenz and totaled $1.4 billion as of June 30, 2015 and $806 million as of December 31, 2014.
6.
INTANGIBLE ASSETS
The following table summarizes the carrying amounts of our intangible assets (in millions):
 
 
June 30, 2015
 
December 31, 2014
Finite-lived intangible assets
 
$
10,228

 
$
10,641

Indefinite-lived intangible assets
 
432

 
432

Total intangible assets
 
$
10,660

 
$
11,073

Finite-Lived Intangible Assets
The following table summarizes our finite-lived intangible assets (in millions):
 
 
June 30, 2015
 
December 31, 2014
 
 
Gross Carrying
Amount
 
Accumulated
Amortization
 
Gross Carrying
Amount
 
Accumulated
Amortization
Intangible asset - sofosbuvir
 
$
10,720

 
$
1,106

 
$
10,720

 
$
757

Intangible asset - Ranexa
 
688

 
320

 
688

 
277

Other
 
455

 
209

 
455

 
188

Total
 
$
11,863

 
$
1,635

 
$
11,863

 
$
1,222


13



Amortization expense related to finite-lived intangible assets included primarily in cost of goods sold on our Condensed Consolidated Statements of Income totaled $207 million and $413 million for the three and six months ended June 30, 2015 and $200 million and $399 million for the three and six months ended June 30, 2014. As of June 30, 2015, the estimated future amortization expense associated with our finite-lived intangible assets for the remaining six months of 2015 and each of the five succeeding fiscal years is as follows (in millions):
Fiscal Year
 
Amount
2015 (remaining six months)
 
$
413

2016
 
832

2017
 
846

2018
 
853

2019
 
741

2020
 
713

Total
 
$
4,398

Indefinite-Lived Intangible Assets
The following table summarizes our indefinite-lived intangible assets as of June 30, 2015 and December 31, 2014 (in millions):
 
 
Amount
Indefinite-lived intangible asset - momelotinib (formerly CYT387)
 
$
308

Indefinite-lived intangible assets - Other
 
117

 
 
425

Foreign currency translation adjustment
 
7

Total
 
$
432

7.
COLLABORATIVE ARRANGEMENTS
We enter into collaboration arrangements with third parties for the development and commercialization of certain products. Both parties are active participants in the operating activities of the collaboration and are exposed to significant risks and rewards depending on the commercial success of the activities. Collaboration arrangements are assessed at their inception, and at each reporting date to determine whether we are the primary beneficiary of an entity determined to be a variable interest entity (VIE) and therefore would be required to consolidate the third party.
For VIEs, we may be required to consolidate an entity if the contractual terms of the arrangement essentially provide us with control over the entity, even if we do not have a majority voting interest. We assess whether we are the primary beneficiary of a VIE based on our power to direct the activities of the VIE that most significantly impact the VIE's economic performance and our obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE. As such, we have consolidated those entities in our consolidated financial statements. As of June 30, 2015, the only material VIE was our North America joint venture with BMS which is described below.
Bristol-Myers Squibb Company
North America
In 2004, we entered into a collaboration arrangement with BMS to develop and commercialize a single tablet regimen containing our Truvada and BMS's Sustiva (efavirenz) in the United States. This combination was approved for use in the United States in 2006 and is sold under the brand name Atripla. We and BMS structured this collaboration as a joint venture that operates as a limited liability company named Bristol-Myers Squibb & Gilead Sciences, LLC, which we consolidate. We and BMS granted royalty free sublicenses to the joint venture for the use of our respective company owned technologies and, in return, were granted a license by the joint venture to use any intellectual property that results from the collaboration. In 2006, we and BMS amended the joint venture's collaboration agreement to allow the joint venture to sell Atripla in Canada. The economic interests of the joint venture held by us and BMS (including a share of revenues and out-of-pocket expenses) are based on the portion of the net selling price of Atripla attributable to efavirenz and Truvada. Since the net selling price for Truvada may change over time relative to the net selling price of efavirenz, both our and BMS's respective economic interests in the joint venture may vary annually.

14



We and BMS shared marketing and sales efforts. Starting in the second quarter of 2011, except for a limited number of activities that will be jointly managed, the parties no longer coordinate detailing and promotional activities in the United States, and the parties reduced their joint promotional efforts since we launched Complera in August 2011 and Stribild in August 2012. The parties will continue to collaborate on activities such as manufacturing, regulatory, compliance and pharmacovigilance. The daily operations of the joint venture are governed by four primary joint committees formed by both BMS and Gilead. We are responsible for accounting, financial reporting, tax reporting, manufacturing and product distribution for the joint venture. Both parties provide their respective bulk active pharmaceutical ingredients to the joint venture at their approximate market values. The agreement will continue until terminated by the mutual agreement of the parties. In addition, either party may terminate the other party's participation in the collaboration within 30 days after the launch of at least one generic version of such other party's single agent products (or the double agent products). The terminating party then has the right to continue to sell Atripla and become the continuing party, but will be obligated to pay the terminated party certain royalties for a three-year period following the effective date of the termination.
As of June 30, 2015 and December 31, 2014, the joint venture held efavirenz active pharmaceutical ingredient which it purchased from BMS at BMS's estimated net selling price of efavirenz in the U.S. market. These amounts were primarily included in inventories on our Condensed Consolidated Balance Sheets.
Selected financial information for the joint venture was as follows (in millions):
 
 
June 30, 2015
 
December 31, 2014
Total assets
 
$
2,751

 
$
2,138

Cash and cash equivalents
 
245

 
250

Accounts receivable, net
 
279

 
297

Inventories
 
2,225

 
1,590

Total liabilities
 
1,910

 
1,157

Accounts payable
 
1,501

 
749

Other accrued liabilities
 
408

 
408

These asset and liability amounts do not reflect the impact of intercompany eliminations that are included in our Condensed Consolidated Balance Sheets. Although we consolidate the joint venture, the legal structure of the joint venture limits the recourse that its creditors will have over our general credit or assets. Similarly, the assets held in the joint venture can be used only to settle obligations of the joint venture.
Europe
In 2007, Gilead Sciences Ireland Unlimited Company, our wholly-owned subsidiary, and BMS entered into a collaboration agreement with BMS which sets forth the terms and conditions under which we and BMS commercialize and distribute Atripla in the European Union (EU), Iceland, Liechtenstein, Norway and Switzerland (collectively, the European Territory). The parties formed a limited liability company which we consolidate, to manufacture Atripla for distribution in the European Territory using efavirenz that it purchases from BMS at BMS's estimated net selling price of efavirenz in the European Territory. We are responsible for manufacturing, product distribution, inventory management and warehousing. Through our local subsidiaries, we have primary responsibility for order fulfillment, collection of receivables, customer relations and handling of sales returns in all the territories where we and BMS promote Atripla. In general, the parties share revenues and out-of-pocket expenses in proportion to the net selling prices of the components of Atripla, Truvada and efavirenz.
Starting in 2012, except for a limited number of activities that will be jointly managed, the parties no longer coordinate detailing and promotional activities in the region. We are responsible for accounting, financial reporting and tax reporting for the collaboration. As of June 30, 2015 and December 31, 2014, efavirenz purchased from BMS at BMS's estimated net selling price of efavirenz in the European Territory is included in inventories on our Condensed Consolidated Balance Sheets.
The parties also formed a limited liability company to hold the marketing authorization for Atripla in Europe. We have primary responsibility for regulatory activities. In the major market countries, both parties have agreed to independently continue to use commercially reasonable efforts to promote Atripla.

15



The agreement will terminate upon the expiration of the last-to-expire patent which affords market exclusivity to Atripla or one of its components in the European Territory. In addition, since December 31, 2013, either party may terminate the agreement for any reason and such termination will be effective two calendar quarters after notice of termination. The non-terminating party has the right to continue to sell Atripla and become the continuing party, but will be obligated to pay the terminating party certain royalties for a three-year period following the effective date of the termination. In the event the continuing party decides not to sell Atripla, the effective date of the termination will be the date Atripla is withdrawn in each country or the date on which a third party assumes distribution of Atripla, whichever is earlier.
8.
DEBT AND CREDIT FACILITY
Financing Arrangements
The following table summarizes the carrying amounts of our borrowings under various financing arrangements (in millions):
Type of Borrowing
 
Description
 
Issue Date
 
Due Date
 
Interest Rate
 
June 30,
2015
 
December 31, 2014
Convertible Senior
 
May 2016 Notes
 
July 2010
 
May 2016
 
1.625%
 
$
352

 
$
483

Senior Unsecured
 
April 2021 Notes
 
March 2011
 
April 2021
 
4.50%
 
995

 
995

Senior Unsecured
 
December 2016 Notes
 
December 2011
 
December 2016
 
3.05%
 
700

 
700

Senior Unsecured
 
December 2021 Notes
 
December 2011
 
December 2021
 
4.40%
 
1,248

 
1,248

Senior Unsecured
 
December 2041 Notes
 
December 2011
 
December 2041
 
5.65%
 
998

 
998

Senior Unsecured
 
April 2019 Notes
 
March 2014
 
April 2019
 
2.05%
 
499

 
499

Senior Unsecured
 
April 2024 Notes
 
March 2014
 
April 2024
 
3.70%
 
1,748

 
1,747

Senior Unsecured
 
April 2044 Notes
 
March 2014
 
April 2044
 
4.80%
 
1,747

 
1,747

Senior Unsecured
 
February 2020 Notes
 
November 2014
 
February 2020
 
2.35%
 
499

 
499

Senior Unsecured
 
February 2025 Notes
 
November 2014
 
February 2025
 
3.50%
 
1,748

 
1,748

Senior Unsecured
 
February 2045 Notes
 
November 2014
 
February 2045
 
4.50%
 
1,740

 
1,740

Total debt, net
 
12,274

 
12,404

Less current portion
 
352

 
483

Total long-term debt, net
 
$
11,922

 
$
11,921

Convertible Senior Notes
During the six months ended June 30, 2015, a portion of our convertible senior notes due in May 2016 (the May 2016 Notes) was settled and we repaid $140 million of principal balance related to these notes. We also paid $508 million in cash related to the conversion spread of the May 2016 Notes, which represents the conversion value in excess of the principal amount, and received $508 million in cash from the convertible note hedges related to the May 2016 Notes. The initial conversion rate for the May 2016 Notes was 44.0428 shares per $1,000 principal amount (which represented an initial conversion price of approximately $22.71 per share). As of June 30, 2015, the conversion rate was 44.2023 (which represented a conversion price of approximately$22.62 per share). The adjustment to the conversion rate was due to a declaration of a dividend in the second quarter of 2015.
As of June 30, 2015 and December 31, 2014, the May 2016 Notes were classified as current given that their conversion criteria had been met. As a result, the related unamortized discount of $7 million and $15 million, as of June 30, 2015 and December 31, 2014, respectively, were classified as equity component of currently redeemable convertible notes on our Condensed Consolidated Balance Sheets.
As of December 31, 2014, there were 55 million shares of our common stock underlying our warrants expiring in 2016 (the 2016 Warrants). Under the terms of the original agreements, the 2016 Warrants had a strike price of $30.05 per share and were due to expire during the 40 trading-day period commencing August 1, 2016.
During the second quarter of 2015, we entered into modified agreements with our warrant counterparties which changed the timing of the expiration for 46 million of our 2016 Warrants. The modified agreements allowed us to settle the 46 million warrants at our option, in cash or shares. According to the terms of the modified agreements, these warrants expired during a 32 trading-day period which commenced on May 11, 2015 and ended on June 24, 2015. We exercised our option to settle in cash, and as a result, paid $3.9 billion as the market value of our common stock at the time of the exercise of the warrants exceeded their strike prices. Because these warrants could have been settled at our option, in cash or shares of common stock, under both the original and the modified agreements and these contracts met all of the applicable criteria for equity classification, the

16



settlement payments were recorded as a reduction to additional paid-in capital on our Condensed Consolidated Balance Sheet. As additional paid-in capital was reduced to zero, the remainder of the warrants settlement was recorded as a reduction in retained earnings. Please see Note 10, Stockholders' Equity for additional information.
As of June 30, 2015, 9 million of the 2016 Warrants remained outstanding and have a strike price of $29.62 per share and are due to expire during the 40 trading-day period commencing August 1, 2016. The change to the strike price was due to a declaration of a dividend in the second quarter of 2015. There were no other changes in terms for the remaining 9 million 2016 Warrants.
Credit Facility
There were no amounts outstanding under the revolving credit facility credit agreement as of June 30, 2015.
We are required to comply with certain covenants under the credit agreement and note indentures and as of June 30, 2015, we were not in violation of any covenants.
9.
COMMITMENTS AND CONTINGENCIES
We are a party to various legal actions. The most significant of these are described below. It is not possible to determine the outcome of these matters, and we cannot reasonably estimate the maximum potential exposure or the range of possible loss.
Litigation Related to Sofosbuvir
In January 2012, we acquired Pharmasset, Inc. (Pharmasset). Through the acquisition, we acquired sofosbuvir, a nucleotide analog that acts to inhibit the replication of the hepatitis C virus (HCV). In December 2013, we received U.S. Food and Drug Administration (FDA) approval of sofosbuvir, now known commercially as Sovaldi. In October 2014, we also received approval of the fixed-dose combination of ledipasvir and sofosbuvir, now known commercially as Harvoni. We have received a number of contractual and intellectual property claims regarding sofosbuvir. While we have carefully considered these claims both prior to and following the acquisition and believe they are without merit, we cannot predict the ultimate outcome of such claims or range of loss.
We own patents and patent applications that claim sofosbuvir (Sovaldi) as a chemical entity and its metabolites and the fixed-dose combination of ledipasvir and sofosbuvir (Harvoni). Third parties may have, or may obtain rights to, patents that allegedly could be used to prevent or attempt to prevent us from commercializing Sovaldi or Harvoni. For example, we are aware of patents and patent applications owned by other parties that have been or may in the future be alleged by such parties to cover the use of Sovaldi and Harvoni. We cannot predict the ultimate outcome of intellectual property claims related to Sovaldi or Harvoni. We have spent, and will continue to spend, significant resources defending against these claims.
If third parties successfully obtain valid and enforceable patents, and successfully prove infringement of those patents by Sovaldi and/or Harvoni, we could be prevented from selling these products unless we were able to obtain a license under such patents. Such a license may not be available on commercially reasonable terms or at all.
Interference Proceedings and Litigation with Idenix Pharmaceuticals, Inc. (Idenix)
In February 2012, we received notice that the U.S. Patent and Trademark Office (USPTO) had declared Interference No. 105,871 (First Idenix Interference) between our U.S. Patent No. 7,429,572 (the ’572 patent) and Idenix's pending U.S. Patent Application No. 12/131,868. An interference is an administrative proceeding before the USPTO designed to determine who was the first to invent the subject matter claimed by both parties. On January 29, 2014, the USPTO Patent Trial and Appeal Board (PTAB) determined that Pharmasset and not Idenix was the first to invent the compounds in dispute and accordingly Gilead prevailed in the First Idenix Interference. Idenix has appealed the PTAB’s decisions to the U.S. District Court for the District of Delaware.
In December 2013, after receiving our request to do so, the USPTO declared Interference No. 105,981 (Second Idenix Interference) between our pending U.S. Patent Application No. 11/854,218 and Idenix’s U.S. Patent No. 7,608,600 (the ’600 patent). The ’600 patent includes claims directed to methods of treating HCV with nucleoside compounds similar to those which were involved in the First Idenix Interference. The purpose of the Second Idenix Interference was to determine who was first to invent the claimed methods of treating HCV with compounds similar to those which were involved in the First Idenix Interference. On March 23, 2015, the PTAB determined that Pharmasset and not Idenix was the first to invent the claimed methods of treating HCV. Idenix appealed this decision in both the U.S. District Court for the District of Delaware and the U.S. Court of Appeal for the Federal Circuit (CAFC). We have filed a motion to dismiss the appeal in Delaware and will respond to the appeal filed in the CAFC.

17



We believe that the Idenix claims involved in the First and Second Idenix Interferences, and similar U.S. and foreign patents claiming the same compounds, metabolites and uses thereof, are invalid. As a result, we filed an Impeachment Action in the Federal Court of Canada to invalidate Idenix Canadian Patent No. 2,490,191 (the ’191 patent), which is the Canadian patent that corresponds to the ’600 patent and the Idenix patent application that was the subject of the First Idenix Interference. Idenix has asserted that the commercialization of Sovaldi in Canada will infringe its ’191 patent and that our Canadian Patent No. 2,527,657, corresponding to the ’572 patent involved in the First Idenix Interference, is invalid. A trial on these issues was held in January and February 2015 and we are awaiting a decision.
We filed a similar legal action in Norway in the Oslo District Court seeking to invalidate Idenix's Norwegian patent corresponding to the ’600 patent. In September 2013, Idenix filed an invalidation action in the Norwegian proceedings against our Norwegian Patent No. 333700 patent, which corresponds to the ’572 patent. On March 21, 2014, the Norwegian court found all claims in the Idenix Norwegian patent to be invalid and upheld the validity of all claims in the challenged Gilead patent. On April 30, 2014, Idenix appealed the March 21, 2014 decision to the Norwegian Court of Appeal. The appeal hearing from the March 2014 decision is scheduled for February 2016.
In January 2013, we filed a legal action in the Federal Court of Australia seeking to invalidate Idenix’s Australian patent corresponding to the ’600 patent. In April 2013, Idenix asserted that the commercialization of Sovaldi in Australia will infringe its Australian patent corresponding to the ’600 patent. A trial on these issues is scheduled to commence in September 2015 in Sydney.
On March 12, 2014 the European Patent Office (EPO) granted Idenix European Patent No. 1 523 489 (the ’489 patent), which corresponds to the ’600 patent. The same day that the ’489 patent was granted, we filed an opposition with the EPO seeking to revoke the ’489 patent. Also on that day, Idenix initiated infringement proceedings against Gilead in the United Kingdom (UK), Germany and France alleging that the commercialization of Sovaldi would infringe the UK, German and French counterparts of the ’489 patent. A trial was held in the UK in October 2014 to determine the issues of infringement and validity of the Idenix UK patent. In December 2014, the High Court of Justice of England and Wales (UK Court) invalidated all challenged claims of the ’489 patent on multiple grounds. The UK Court has granted Idenix permission to appeal the December 1, 2014 judgment. On March 12, 2015, the German court in Düsseldorf determined that the Idenix patent was highly likely to be invalid and stayed the infringement proceedings pending the outcome of the opposition filed in the EPO. Idenix has not appealed this decision of the German court staying the proceedings. Upon Idenix's request, the French proceedings have been stayed.
Idenix has not been awarded patents corresponding to the ’600 patent in Japan or China. In the event such patents are issued, we expect to challenge them in proceedings similar to those we invoked in other countries.
In December 2013, Idenix, Universita Degli Studi di Cagliari (UDSG), Centre National de la Recherche Scientifique and L’Université Montpellier II sued us in U.S. District Court for the District of Delaware alleging that the commercialization of sofosbuvir will infringe the ’600 patent and that an interference exists between the ’600 patent and our U.S. Patent No. 8,415,322. Also in December 2013, Idenix and UDSG sued us in the U.S. District Court for the District of Massachusetts alleging that the commercialization of sofosbuvir will infringe U.S. Patent Nos. 6,914,054 and 7,608,597. On June 30, 2014, the court transferred the Massachusetts litigation to the U.S. District Court for the District of Delaware. The district court has set trial dates in October 2016 and December 2016 for resolution of these issues. A decision by the district court may be appealed by either party to the CAFC.
Idenix was acquired by Merck in August 2014. While the acquisition does not change our view of the lack of merit in the claims made by Idenix, Merck has greater resources than Idenix and may therefore choose to fund the litigation at higher levels than Idenix.
Litigation with Merck
In August 2013, Merck contacted us requesting that we pay royalties on the sales of sofosbuvir and obtain a license to U.S. Patent Nos. 7,105,499 and 8,481,712, which it co-owns with Isis Pharmaceuticals, Inc. In August 2013, we filed a lawsuit in the U.S. District Court for the Northern District of California seeking a declaratory judgment that the Merck patents are invalid and not infringed. Merck’s U.S. Patent Nos. 7,105,499 and 8,481,712 cover compounds which do not include, but may relate to, sofosbuvir. During patent prosecution, Merck amended its patent application in an attempt to cover compounds related to sofosbuvir. If the court determines that Merck’s patents are valid and that we have infringed those claims, we may be required to obtain a license from and pay royalties to Merck to commercialize sofosbuvir. Either party may appeal a decision by the District Court to the CAFC. The court has set a trial date of March 7, 2016 for this lawsuit.

18



Litigation with AbbVie, Inc. (AbbVie)
AbbVie has obtained U.S. Patent Nos. 8,466,159, 8,492,386, 8,680,106, 8,685,984, and 8,809,265 (AbbVie Patents) which purport to cover the use of a fixed dose combination of ledipasvir and sofosbuvir (LDV/SOF), now known commercially as Harvoni for the treatment of HCV. Gilead is aware that AbbVie has pending patent applications in the United States and granted and pending applications in other countries. We own published and pending patent applications directed to the use of combinations for the treatment of HCV, and, specifically, to the combination of ledipasvir and sofosbuvir. Certain of our applications were filed before the AbbVie Patents. For this reason and others, we believe the AbbVie Patents are invalid.
Accordingly, in December 2013, we filed a lawsuit in the U.S. District Court for the District of Delaware seeking declaratory judgment that the AbbVie Patents are invalid and unenforceable, as well as other relief. We believe that Abbott Laboratories, Inc. and AbbVie conspired to eliminate competition in the HCV market by falsely representing to the USPTO that they, and not Gilead, invented methods of treating HCV using a combination of LDV/SOF. In February and March 2014, AbbVie responded to our lawsuit by also filing two lawsuits in the U.S. District Court for the District of Delaware alleging that our fixed-dose combination of LDV/SOF will infringe its patents. All of those lawsuits have been consolidated into a single action. In the United States, either party may appeal a decision by the District Court to the CAFC. The AbbVie Patents have not blocked or delayed the commercialization of our combination product in the United States, Canada, or Europe. We do not expect any other foreign patents to block or delay the commercialization around the world. The court has set a trial date of September 12, 2016 for this lawsuit.
Additionally, AbbVie has obtained U.S. Patent No. 9,034,832 which purports to cover a solid oral dosage form containing ledipasvir. Accordingly, in May 2015, we filed a lawsuit in the U.S. District Court for the District of Delaware seeking declaratory judgment that AbbVie’s patent is invalid, as well as other relief. We do not expect AbbVie’s patent to block the commercialization of our combination product. No trial date has been set.
If a court determines that the AbbVie Patents are valid and that we have infringed those claims, we may be required to obtain a license from and pay royalties to AbbVie to commercialize sofosbuvir combination products.
European Patent Claims
In February 2015, several parties filed oppositions in the EPO requesting revocation of our granted European patent covering sofosbuvir that expires in 2028. While we are confident in the strength of our sofosbuvir patent, we cannot predict the ultimate outcome of these actions. If we are unsuccessful in defending these oppositions, some or all of our patent claims may be narrowed or revoked and the patent protection for sofosbuvir in Europe could be substantially shortened or eliminated entirely. If the sofosbuvir patent is revoked, and no other European patents are granted covering sofosbuvir, our exclusivity will be based entirely on regulatory exclusivity granted by the European Medicines Agency (EMA). Sovaldi has been granted regulatory exclusivity that will prevent generic sofosbuvir from entering the EU for 10 years following approval of Sovaldi, or January 2024. If we lose exclusivity for Sovaldi prior to 2028, our expected revenues and results of operation could be negatively impacted for the years including and succeeding the year in which such exclusivity is lost.
Litigation with Generic Manufacturers
As part of the approval process for some of our products, the FDA granted us a New Chemical Entity (NCE) exclusivity period during which other manufacturers' applications for approval of generic versions of our product will not be approved. Generic manufacturers may challenge the patents protecting products that have been granted NCE exclusivity one year prior to the end of the NCE exclusivity period. Generic manufacturers have sought and may continue to seek FDA approval for a similar or identical drug through an abbreviated new drug application (ANDA), the application form typically used by manufacturers seeking approval of a generic drug. The sale of generic versions of these products earlier than their patent expiration would have a significant negative effect on our revenues and results of operations.
Current legal proceedings of significance with some of our generic manufacturers include:
Mylan
In April 2014, we received notice that Mylan Inc. (Mylan) submitted an ANDA to the FDA requesting permission to manufacture and market a generic version of Truvada. In the notice, Mylan alleges that two of the patents associated with emtricitabine and one of our patents associated with the fixed-dose combination of emtricitabine with tenofovir disoproxil fumarate are invalid, unenforceable and/or will not be infringed by Mylan's manufacture, use or sale of a generic version of Truvada.

19



In June 2014, we filed a lawsuit against Mylan in U.S. District Court for the Northern District of West Virginia for infringement of our patents. In June 2014, we received notice that Mylan submitted petitions for Inter Partes Review (IPR) to the PTAB alleging that four patents associated with tenofovir disoproxil fumarate are invalid. We opposed Mylan’s petitions. In December 2014, the PTAB issued decisions denying each of Mylan’s petitions for IPR against the tenofovir disoproxil fumarate-associated patents on the grounds that Mylan had not established a reasonable likelihood of success that it would prevail in its challenge to each of these patents. In January 2015, Mylan requested a rehearing on the basis that it believes the PTAB decision is wrong. In August 2015, the PTAB denied Mylan's request for a rehearing on the three patents covering the tenofovir disoproxil prodrug.
In August 2015, we received notice that Mylan submitted an ANDA to the FDA requesting permission to manufacture and market a generic version of Complera. In the notice, Mylan alleges that our patents associated with emtricitabine, rilpivirine and the fixed-dose combination are invalid, unenforceable and/or will not be infringed by Mylan's manufacture, use or sale of a generic version of Complera. We are currently evaluating Mylan's notice.
Apotex
In June 2014, we received notice that Apotex Corp. (Apotex) submitted an abbreviated new drug submission (ANDS) to Health Canada requesting permission to manufacture and market a generic fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate and a separate ANDS requesting permission to manufacture and market a generic version of Viread. In the notice, Apotex alleges that three of the patents associated with Truvada and two of the patents associated with Viread are invalid, unenforceable and/or will not be infringed by Apotex's manufacture, use or sale of a generic version of Truvada or Viread. In August 2014, we filed a lawsuit against Apotex in the Federal Court of Canada seeking an order of prohibition against approval of this ANDS.
Teva
In August 2012, Teva Pharmaceuticals (Teva) filed an Impeachment Action in the Federal Court of Canada seeking invalidation of our two Canadian patents associated with Viread. In September 2013, a hearing on the consolidated requests for orders of prohibition in connection with all three of Teva’s ANDS filings to Health Canada (for Teva’s generic versions of Viread, Truvada, and Atripla) took place. In December 2013, the court issued our requested order prohibiting the Canadian Minister of Health from issuing a Notice of Compliance for Teva’s generic versions of our Viread, Truvada, and Atripla products until expiry of our patent in July 2017. Teva appealed the decision of the court prohibiting Health Canada from issuing the Notices of Compliance until expiry of our patent in July 2017. This decision did not rule on the validity of the patents and accordingly the only issue on appeal is whether Health Canada should be prohibited from issuing the Notices of Compliance for Teva’s products. The appeal will be heard by the Canadian Federal Court of Appeal after the trial in the Impeachment Action. Separately, the court will determine the validity of the patents in the pending Impeachment Action. A trial in the Impeachment Action is scheduled for November 2016. If Teva is successful in invalidating our patents, Teva may be able to launch generic versions of our Viread, Truvada and Atripla products in Canada prior to the expiry of our patents.
Watson
In February 2015, we received notice that Watson Laboratories, Inc. (Watson) submitted an ANDA to the FDA requesting permission to manufacture and market a generic version of Letairis. In the notice, Watson alleges that one of the patents associated with ambrisentan tablets is invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of a generic version of Letairis. In April 2015, we filed a lawsuit against Watson in the U.S. District Court for the District of New Jersey.
SigmaPharm
In June 2015, we received notice that SigmaPharm Laboratories, LLC (SigmaPharm) submitted an ANDA to the FDA requesting permission to manufacture and market a generic version of Letairis. In the notice, SigmaPharm alleges that one of the patents associated with ambrisentan tablets is invalid, unenforceable and/or will not be infringed by SigmaPharm’s manufacture, use or sale of a generic version of Letairis. In June 2015, we filed a lawsuit against SigmaPharm in the U.S. District Court for the District of New Jersey and we also filed a protective suit with the U.S. District Court for the District of Pennsylvania.

20



Department of Justice Investigation
In June 2011, we received a subpoena from the U.S. Attorney's Office for the Northern District of California requesting documents related to the manufacture, and related quality and distribution practices, of Complera, Atripla, Truvada, Viread, Emtriva, Hepsera and Letairis. We cooperated with the government’s inquiry. In April 2014, the U.S. Department of Justice informed us that, following an investigation, it declined to intervene in a False Claims Act lawsuit filed by two former employees. In April 2014, the former employees served a First Amended Complaint. In January 2015, the federal district court issued an order granting in its entirety, without prejudice, our motion to dismiss the First Amended Complaint. In February 2015, the plaintiffs filed a Second Amended Complaint. We moved to dismiss the Second Amended Complaint and in June 2015, the federal district court issued an order granting our motion to dismiss the Second Amended Complaint. In July 2015, the plaintiffs filed a notice of appeal in the U.S. Court of Appeals for Ninth Circuit.
Other Matters
We are a party to various legal actions that arise in the ordinary course of our business. We do not believe that these other legal actions will have a material adverse impact on our consolidated business, financial position or results of operations.
10.
STOCKHOLDERS’ EQUITY
The following table summarizes the changes in stockholders' equity (in millions):
 
 
Gilead Stockholders' Equity 
 
Noncontrolling
Interest
 
Total
Stockholders' 
Equity
 
Common Stock 
 
Additional
Paid-In
Capital
 
Accumulated
Other
Comprehensive 
Income (Loss)
 
Retained
Earnings
 
 
Shares
 
Amount
 
 
Balance at December 31, 2014
 
1,499

 
$
2

 
$
2,391

 
$
301

 
$
12,732

 
$
393

 
$
15,819

Net income
 

 

 

 

 
8,825

 
4

 
8,829

Other comprehensive loss, net of tax
 

 

 

 
(54
)
 

 

 
(54
)
Change in noncontrolling interest
 

 

 

 

 

 
(50
)
 
(50
)
Issuances under employee stock purchase plan
 
1

 

 
52

 

 

 

 
52

Issuances under equity incentive plans
 
14

 

 
151

 

 

 

 
151

Stock-based compensation
 

 

 
188

 

 

 

 
188

Tax benefits from employee stock plans
 

 

 
326

 

 

 

 
326

Repurchases of common stock
 
(41
)
 

 
(85
)
 

 
(4,046
)
 

 
(4,131
)
Convertible notes settlement
 

 

 
(508
)
 

 

 

 
(508
)
Convertible notes hedge settlement
 

 

 
508

 

 

 

 
508

Dividends
 

 

 

 

 
(639
)
 

 
(639
)
Warrants settlement
 

 

 
(3,031
)
 

 
(834
)
 

 
(3,865
)
Reclassification to equity component of currently redeemable convertible notes
 

 

 
8

 

 

 

 
8

Balance at June 30, 2015
 
1,473

 
$
2

 
$

 
$
247

 
$
16,038

 
$
347

 
$
16,634

Accumulated Other Comprehensive Income (Loss)
The following table summarizes the changes in accumulated OCI by component, net of tax (in millions):
 
 
Foreign Currency Items
 
Unrealized Gains and Losses on Available-for-Sale Securities
 
Unrealized Gains and Losses on Cash Flow Hedges
 
Total
Balance at December 31, 2014
 
$
(54
)
 
$
12

 
$
343

 
$
301

Other comprehensive income (loss) before reclassifications
 
(7
)
 
3

 
273

 
269

Amounts reclassified from accumulated other comprehensive income (loss)
 

 

 
(323
)
 
(323
)
Net current period other comprehensive income (loss)
 
(7
)