GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in millions, except per share amounts)



	Three Months Ended June 30, 2019
	Gilead Stockholders’ Equity													Noncontrolling Interest			Total Stockholders’ Equity
	Common Stock				Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
	Shares		Amount		Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
Balance at March 31, 2019	1,274		$	1	$	2,494		$	130		$	19,326		$	140		$	22,091
Net income (loss)	—		—		—			—			1,880			(5		)	1,875
Other comprehensive loss, net of tax	—		—		—			(28		)	—			—			(28		)
Issuances under equity incentive plans	2		—		41			—			—			—			41
Stock-based compensation	—		—		175			—			—			—			175
Repurchases of common stock	(9	)	—		(26		)	—			(567		)	—			(593		)
Dividends declared ($0.63 per share)	—		—		—			—			(810		)	—			(810		)
Balance at June 30, 2019	1,267		$	1	$	2,684		$	102		$	19,829		$	135		$	22,751



	Six Months Ended June 30, 2019
	Gilead Stockholders’ Equity												Noncontrolling Interest			Total Stockholders’ Equity
	Common Stock				Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)		Retained Earnings
	Shares		Amount		Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)		Retained Earnings
Balance at December 31, 2018	1,282		$	1	$	2,282		$	80	$	19,024		$	147		$	21,534
Net income (loss)	—		—		—			—		3,855			(12		)	3,843
Other comprehensive income, net of tax	—		—		—			22		—			—			22
Issuances under employee stock purchase plan	1		—		63			—		—			—			63
Issuances under equity incentive plans	6		—		82			—		—			—			82
Stock-based compensation	—		—		319			—		—			—			319
Repurchases of common stock	(22	)	—		(62		)	—		(1,434		)	—			(1,496		)
Dividends declared ($1.26 per share)	—		—		—			—		(1,624		)	—			(1,624		)
Cumulative effect from the adoption of new leases standard (Note 1)	—		—		—			—		8			—			8
Balance at June 30, 2019	1,267		$	1	$	2,684		$	102	$	19,829		$	135		$	22,751

See accompanying notes.

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (CONTINUED)

(unaudited)

(in millions, except per share amounts)



	Three Months Ended June 30, 2018
	Gilead Stockholders’ Equity													Noncontrolling Interest		Total Stockholders’ Equity
	Common Stock				Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
	Shares		Amount		Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
Balance at March 31, 2018	1,300		$	1	$	1,564		$	(170	)	$	19,196		$	60	$	20,651
Net income	—		—		—			—			1,817			2		1,819
Other comprehensive income, net of tax	—		—		—			172			—			—		172
Issuances under equity incentive plans	3		—		45			—			—			—		45
Stock-based compensation	—		—		253			—			—			—		253
Repurchases of common stock	(7	)	—		(18		)	—			(441		)	—		(459		)
Dividends declared ($0.57 per share)	—		—		—			—			(747		)	—		(747		)
Balance at June 30, 2018	1,296		$	1	$	1,844		$	2		$	19,825		$	62	$	21,734



	Six Months Ended June 30, 2018
	Gilead Stockholders’ Equity													Noncontrolling Interest		Total Stockholders’ Equity
	Common Stock				Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
	Shares		Amount		Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
Balance at December 31, 2017	1,308		$	1	$	1,264		$	165		$	19,012		$	59	$	20,501
Net income	—		—		—			—			3,355			3		3,358
Other comprehensive income, net of tax	—		—		—			130			—			—		130
Issuances under employee stock purchase plan	1		—		48			—			—			—		48
Issuances under equity incentive plans	8		—		109			—			—			—		109
Stock-based compensation	—		—		477			—			—			—		477
Repurchases of common stock	(21	)	—		(54		)	—			(1,526		)	—		(1,580		)
Dividends declared ($1.14 per share)	—		—		—			—			(1,499		)	—		(1,499		)
Cumulative effect from the adoption of new accounting standards	—		—		—			(293		)	483			—		190
Balance at June 30, 2018	1,296		$	1	$	1,844		$	2		$	19,825		$	62	$	21,734

See accompanying notes.

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in millions)



	Six Months Ended
	June 30,
	2019			2018
Operating Activities:
Net income	$	3,843		$	3,358
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation expense	120			112
Amortization expense	587			601
Stock-based compensation expense	317			472
Deferred income taxes	28			(2		)
Net unrealized (gains) losses from equity securities	(254		)	19
Other	66			130
Changes in operating assets and liabilities:
Accounts receivable, net	(68		)	277
Inventories	(12		)	(34		)
Prepaid expenses and other	(34		)	622
Accounts payable	(166		)	(193		)
Income taxes payable	(274		)	(1,838		)
Accrued liabilities and other	(488		)	319
Net cash provided by operating activities	3,665			3,843

Investing Activities:
Purchases of marketable debt securities	(17,022		)	(2,009		)
Proceeds from sales of marketable debt securities	1,564			676
Proceeds from maturities of marketable debt securities	10,029			11,539
Capital expenditures	(422		)	(509		)
Other	(302		)	(102		)
Net cash provided by (used in) investing activities	(6,153		)	9,595

Financing Activities:
Proceeds from issuances of common stock	141			159
Repurchases of common stock	(1,422		)	(1,489		)
Repayments of debt and other obligations	(1,250		)	(4,500		)
Payments of dividends	(1,617		)	(1,493		)
Other	(75		)	(424		)
Net cash used in financing activities	(4,223		)	(7,747		)
Effect of exchange rate changes on cash and cash equivalents	11			(45		)
Net change in cash and cash equivalents	(6,700		)	5,646
Cash and cash equivalents at beginning of period	17,940			7,588
Cash and cash equivalents at end of period	$	11,240		$	13,234

Nine Months Ended
September 30,
2018 2017
Operating Activities:
Net income $ 5,457
$ 8,480
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation expense 169
155
Amortization expense 902
734
Stock-based compensation expense 670
304
Deferred income taxes 10
127
Other 14
227
Changes in operating assets and liabilities:
Accounts receivable, net 367
473
Inventories (191 ) (79 )
Prepaid expenses and other 749
311
Accounts payable (217 ) (515 )
Income taxes payable (1,551 ) (48 )
Accrued liabilities (324 ) (1,024 )
Net cash provided by operating activities 6,055
9,145

Investing Activities:
Purchases of marketable securities (5,786 ) (18,813 )
Proceeds from sales of marketable securities 1,201
8,966
Proceeds from maturities of marketable securities 17,021
4,164
Capital expenditures (676 ) (370 )
Other (140 ) —
Net cash provided by (used in) investing activities 11,620
(6,053 )

Financing Activities:
Proceeds from issuances of common stock 239
183
Proceeds from debt financing, net of issuance costs —
2,991
Repurchases of common stock (1,938 ) (848 )
Repayments of debt and other obligations (6,250 ) (90 )
Payments of dividends (2,235 ) (2,049 )
Other (464 ) (141 )
Net cash provided by (used in) financing activities (10,648 ) 46
Effect of exchange rate changes on cash and cash equivalents (46 ) 141
Net change in cash and cash equivalents 6,981
3,279
Cash and cash equivalents at beginning of period 7,588
8,229
Cash and cash equivalents at end of period $ 14,569
$ 11,508

See accompanying notes.

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 of normal recurring adjustments that the management of Gilead Sciences, Inc. (Gilead, we, our 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. All intercompany transactions have been eliminated. For consolidated entities where we own or are exposed to less than 100% of the economics, we record net income (loss) attributable to noncontrolling interest 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.

We assess whether we are the primary beneficiary of a variable interest entity (VIE) at the inception of the arrangement and at each reporting date. This assessment is 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 of ~~September~~June 30, ~~2018,~~2019, we did not have any material VIEs.

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, ~~2017,~~2018, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange ~~Commission (SEC).~~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, we evaluate our 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. Estimates are assessed each period and updated to reflect current information. Actual results may differ significantly from these estimates.

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. 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 as of ~~September~~June 30, ~~2018.~~2019.

Recently Adopted Accounting ~~Pronouncements~~Standards

In ~~May 2014,~~February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. ~~2014-09 “Revenue from Contracts with Customers” (Topic 606)~~2016-02 “Leases” (ASU 2016-02) and subsequently issued supplemental adoption guidance and clarification (collectively, Topic 842). Topic ~~606 supersedes the revenue recognition requirements in Topic 605 “Revenue Recognition” (Topic 605) and requires entities~~842 amends a number of aspects of lease accounting, including requiring lessees to recognize ~~revenue in an amount that reflects the consideration to which the entity expects to be entitled when promised goods or services are transferred to~~right-of-use assets and lease liabilities for operating leases with a ~~customer. Entities adopting~~lease term greater than one year. Topic ~~606 had the option of using either a full retrospective or a modified retrospective approach.~~ 842 supersedes Topic 840 “Leases.”

On January 1, ~~2018,~~2019, we adopted Topic ~~606~~842 using the modified retrospective ~~method applied to those contracts which were not completed as of January 1, 2018. As such, results~~approach. Results for reporting periods beginning after January 1, ~~2018~~2019 are presented under Topic ~~606,~~842, while prior period amounts are not adjusted and continue to be reported in accordance with our historical accounting under Topic ~~605.~~

~~As discussed further in Note 2, Revenues, our product sales are recognized when control~~840. We elected the package of ~~the product transfers, generally upon shipment or delivery to the customer. Certain product sales that were deferred~~practical expedients permitted under the sell-through or cash basis methods of accounting because fees were not fixed or determinable prior to the adoption of Topic 606 are now recognized upon transfer of control. Royalty revenue is recognized in the period in which the corresponding sales by our corporate partners occur. Prior to the adoption of Topic 606, royalty revenue was generally recognized in the quarter following the quarter in which the corresponding sales by our corporate partners occurred.

~~The cumulative effect of the changes made to our Condensed Consolidated Balance Sheets as of January 1, 2018 for the adoption of Topic 606 was as follows (in millions):~~

December 31, 2017 Adjustments Due to Topic 606 January 1, 2018
Prepaid and other current assets $ 1,661
$ 96
$ 1,757
Other long-term assets $ 2,722
$ 10
$ 2,732
Other accrued liabilities $ 3,370
$ (115 ) $ 3,255
Other long-term obligations $ 558
$ 31
$ 589
Retained earnings $ 19,012
$ 190
$ 19,202

~~For the three and nine months ended September 30, 2018, the impact to our Condensed Consolidated Financial Statements as a result of applying Topic 606 in place of Topic 605 was not material.~~

In January 2016, the FASB issued Accounting Standards Update No. 2016-01 “Financial Instruments - Overall: Recognition and Measurement of Financial Assets and Financial Liabilities” (ASU 2016-01). ASU 2016-01 changes accounting for equity investments, financial liabilities under the fair value option and the presentation and disclosure requirements for financial instruments. Additionally, ASU 2016-01 clarifiestransition guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. On January 1, 2018, we adopted this standard using a modified retrospective approach. The standard requires that equity investments with readily determinable fair values be measured at fair value with any changes in fair value recognized in earnings. As a result of the adoption, we reclassified $293 million of unrealized net gain from accumulated other comprehensive income (AOCI) to retained earnings on January 1, 2018, which primarily consisted of $278 million unrealized gain from our equity investment in Galapagos NV.

In August 2017, the FASB issued Accounting Standards Update No. 2017-12 “Derivatives and Hedging: Targeted Improvements to Accounting for Hedging Activities” (ASU 2017-12). The amendments in ASU 2017-12 more closely align the results of hedge accounting with risk management activities. ASU 2017-12 also amends the presentation and disclosure requirements and eases documentation and effectiveness assessment requirements. Pursuant to the provisions of ASU 2017-12, we are no longer required to separately measure and recognize hedge ineffectiveness for highly effective hedges. On January 1, 2018, we early adopted this standard on a prospective basis. Upon adoption of ASU 2017-12, we no longer recognize hedge ineffectiveness in our Condensed Consolidated Statements of Income, but we instead recognize the entire change in the fair value of the hedge contract in AOCI. The adoption did not have a material impact on our Condensed Consolidated Financial Statements. The primary impact of adoption was required disclosure changes. See Note 5, Derivative Financial Instruments, for additional information.

In March 2018, the FASB issued Accounting Standards Update No. 2018-05 “Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118” (ASU 2018-05). ASU 2018-05 amends Topic 740 by incorporating the SEC Staff Accounting Bulletin No. 118 (SAB 118) issued on December 22, 2017. SAB 118 provides guidance on accounting for the effects of the Tax Cuts and Jobs Act (Tax Reform) and allows a company to record provisional amounts during a measurement period not to extend beyond one year from the enactment date. See Note 14, Income Taxes, for additional information.

~~Recently Issued Accounting Pronouncements Not Yet Adopted~~

~~In February 2016, the FASB issued Accounting Standards Update No. 2016-02 “Leases” (Topic 842).~~within Topic 842, ~~amends a number of aspects of~~which allowed us to carry forward the historical lease accounting, including requiring lessees to recognize leases with a term greater than one year as a right-of-use asset and corresponding liability, measured at the present value of the lease payments. In July 2018, the FASB issued supplemental adoption guidance and clarification to Topic 842 within ASU 2018-10 “Codification Improvements to Topic 842, Leases” and ASU 2018-11 “Leases (Topic 842): Targeted Improvements.” The guidance will become effective for us beginning in the first quarter of 2019 and early adoption is permitted. We plan to adopt these standards on the effective date by recording a cumulative effect adjustment to the opening balance of retained earnings on January 1, 2019.

As we continue to evaluate the impact of the adoption of these standards, we anticipate recognition of additional assets and corresponding liabilities related to leases on our Condensed Consolidated Balance Sheets with no material impact to our Condensed Consolidated Statements of Income. We plan to elect the practical expedients upon transition that willclassification, retain the ~~lease classification~~

~~and~~ initial direct costs for any leases that existed prior to the adoption of ~~these standards. We will~~the standard and not reassess whether any contracts entered into prior to the adoption are leases. We ~~are~~also elected to account for lease and nonlease components in ~~the process of implementing a new lease accounting system and updating our controls and procedures for maintaining and accounting for~~ our lease ~~portfolio under~~agreements as a single lease component in determining lease assets and liabilities. In addition, we elected not to recognize the ~~new guidance.~~right-of-use assets and liabilities for leases with lease terms of one year or less.

Upon adoption of Topic 842, we recorded$441 million of right-of-use assets within Other long-term assets and$490 million of operating lease liabilities, classified primarily within Other long-term obligations on our Condensed Consolidated Balance Sheet, as of January 1, 2019. The adoption did not have a material impact on our Condensed Consolidated Statements of Income or Condensed Consolidated Statements of Cash Flows. See Note 10. Leases for additional information.

Recently Issued Accounting Standards Not Yet Adopted

In June 2016, the FASB issued Accounting Standards Update No. 2016-13 “Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments” (ASU 2016-13). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. ~~This~~In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04 “Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments.” The guidance will become effective for us beginning in the first quarter of 2020 and must be adopted using a modified retrospective approach, with certain exceptions. ~~Early~~We are evaluating the impact of the adoption of these standards, but we currently do not expect a material impact on our Condensed Consolidated Financial Statements.

In November 2018, the FASB issued Accounting Standards Update No. 2018-18 “Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606” (ASU 2018-18). ASU 2018-18 clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is ~~permitted~~a customer. In addition, the update precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue if the counterparty is not a customer for that transaction. This guidance will become effective for us beginning in the first quarter of ~~2019.~~2020 and will be applied retrospectively to January 1, 2018 when we initially adopted Topic 606. Early adoption is permitted. We are evaluating the impact of the adoption of this standard, but we currently do not expect a material impact on our Condensed Consolidated Financial Statements.


2.	REVENUES

~~On January 1, 2018, we adopted Topic 606 using the modified retrospective method. As a result, we have changed our accounting policies for revenue recognition as detailed below.~~

~~Product Sales~~

We recognize revenue from product sales when control of the product transfers, generally upon shipment or delivery, to the customer. Upon recognition of revenue from product sales, provisions are made for various forms of variable consideration, which include government and other rebates such as Medicaid reimbursements, customer incentives such as cash discounts for prompt payment, distributor fees and expected returns of expired products, as appropriate. Our payment terms to customers generally range from 30 to 90 days.

~~Royalty, Contract and Other Revenues~~

~~Royalty revenue is recognized in the period in which the obligation is satisfied and the corresponding sales by our corporate partners occur.~~

~~Policy Elections and Practical Expedients Taken~~

~~We account for shipping and handling activities that are performed after a customer has obtained control of a good as fulfillment costs rather than as separate performance obligations; and~~

If we expect, at contract inception, that the period between the transfer of control and corresponding payment from the customer will be one year or less, we do not adjust the amount of consideration for the effects of a significant financing component.

~~Variable Consideration~~

~~Rebates and Chargebacks~~

We estimate reductions to our revenues for amounts paid to payers and healthcare providers in the United States, including Medicaid rebates, AIDS Drug Assistance Program rebates and chargebacks, Veterans Administration and Public Health Service chargebacks and other rebates, as well as foreign government rebates. Rebates and chargebacks are based on contractual arrangements or statutory requirements which may vary by product, payer and individual payer plans. Our estimates are based on products sold, historical payer mix, and as available, pertinent third-party industry information, estimated patient population, known market events or trends, and for our U.S. product sales, channel inventory data obtained from our major U.S. wholesalers in accordance with our inventory management agreements. We also take into consideration, as available, new information regarding changes in programs’ regulations and guidelines that would impact the amount of the actual rebates and/or our expectations regarding future payer mix for these programs. Government and other chargebacks that are payable to our direct customers are classified as reductions of Accounts receivable on our Condensed Consolidated Balance Sheets. Government and other rebates that are invoiced directly to us are recorded in Accrued government and other rebates on our Condensed Consolidated Balance Sheets.

~~Cash Discounts~~

~~We estimate cash discounts based on contractual terms, historical customer payment patterns and our expectations regarding future customer payment patterns.~~

~~Distributor Fees~~

Under our inventory management agreements with our significant U.S. wholesalers, we pay the wholesalers a fee primarily for compliance with certain contractually determined covenants such as the maintenance of agreed upon inventory levels. These distributor fees are based on a contractually determined fixed percentage of sales.

~~Product Returns~~

We do not provide our customers with a general right of product return, but typically permit returns if the product is damaged or defective when received by the customer, or in the case of product sold in the United States and certain countries outside the United States, if the product has expired. We will accept returns for product that will expire within six months or that have expired up to one year after their expiration dates. Our estimates for expected returns of expired products are based primarily on an ongoing analysis of our historical return patterns, historical industry information reporting the return rates for similar products and contractual agreements intended to limit the amount of inventory maintained by our wholesalers.

~~Revenues Recognized from Performance Obligations Satisfied in Prior Periods~~

During the three and nine months ended September 30, 2018, revenues recognized from performance obligations satisfied in prior years related to royalties for licenses of our intellectual property were $167 million and $395 million, respectively. Changes in estimates for variable consideration related to sales made in prior years were not material during the three and nine months ended September 30, 2018.

~~Contract Assets~~

Our contract assets, which consist of unbilled amounts primarily from arrangements where the licensing of intellectual property is the only or predominant performance obligation, totaled $117 million and $132 million as of September 30, 2018 and January 1, 2018, respectively.

Disaggregation of Revenues

The following table disaggregates our product sales by product and geographic region and disaggregates our royalty, contract and other revenues by geographic region (in millions):



	Three Months Ended June 30, 2019								Three Months Ended June 30, 2018
	U.S.		Europe		Other International		Total		U.S.		Europe		Other International		Total
Product sales:
Atripla	$	122	$	26	$	4	$	152	$	274	$	39	$	36	$	349
Biktarvy	1,023		73		20		1,116		183		2		—		185
Complera/Eviplera	42		72		9		123		82		103		14		199
Descovy	246		69		43		358		311		78		14		403
Genvoya	733		177		70		980		904		207		49		1,160
Odefsey	266		111		10		387		303		77		5		385
Stribild	78		24		6		108		144		34		9		187
Truvada	657		41		20		718		649		86		30		765
Other HIV⁽¹⁾	9		1		5		15		11		3		5		19
Revenue share – Symtuza⁽²⁾	55		29		—		84		—		13		—		13
AmBisome	10		60		35		105		14		55		34		103
Ledipasvir/Sofosbuvir⁽³⁾	86		22		85		193		230		22		79		331
Letairis	204		—		—		204		244		—		—		244
Ranexa	19		—		—		19		208		—		—		208
Sofosbuvir/Velpatasvir⁽⁴⁾	219		156		118		493		239		168		93		500
Vemlidy	71		5		40		116		59		3		14		76
Viread	9		28		38		75		16		32		34		82
Vosevi	53		15		7		75		86		20		3		109
Yescarta	99		21		—		120		68		—		—		68
Zydelig	12		14		—		26		17		22		—		39
Other⁽⁵⁾	41		97		2		140		27		41		47		115
Total product sales	4,054		1,041		512		5,607		4,069		1,005		466		5,540
Royalty, contract and other revenues	19		58		1		78		14		79		15		108
Total revenues	$	4,073	$	1,099	$	513	$	5,685	$	4,083	$	1,084	$	481	$	5,648



	Six Months Ended June 30, 2019								Six Months Ended June 30, 2018
	U.S.		Europe		Other International		Total		U.S.		Europe		Other International		Total
Product sales:
Atripla	$	255	$	42	$	26	$	323	$	502	$	90	$	71	$	663
Biktarvy	1,762		121		26		1,909		218		2		—		220
Complera/Eviplera	86		134		18		238		149		212		28		389
Descovy	479		137		84		700		585		153		26		764
Genvoya	1,461		370		164		1,995		1,757		393		92		2,242
Odefsey	548		217		19		784		582		135		10		727
Stribild	145		42		17		204		277		63		21		361
Truvada	1,208		74		42		1,324		1,156		183		78		1,417
Other HIV⁽¹⁾	20		2		10		32		20		4		8		32
Revenue share – Symtuza⁽²⁾	97		53		—		150		—		20		—		20
AmBisome	18		117		63		198		31		111		68		210
Ledipasvir/Sofosbuvir⁽³⁾	203		49		166		418		464		78		137		679
Letairis	401		—		—		401		448		—		—		448
Ranexa	174		—		—		174		403		—		—		403
Sofosbuvir/Velpatasvir⁽⁴⁾	449		310		225		984		508		366		162		1,036
Vemlidy	136		9		72		217		106		6		22		134
Viread	21		42		84		147		23		62		94		179
Vosevi	98		31		9		138		172		36		8		216
Yescarta	189		27		—		216		108		—		—		108
Zydelig	23		29		1		53		31		40		1		72
Other⁽⁵⁾	77		117		8		202		56		56		109		221
Total product sales	7,850		1,923		1,034		10,807		7,596		2,010		935		10,541
Royalty, contract and other revenues	41		114		4		159		34		131		30		195
Total revenues	$	7,891	$	2,037	$	1,038	$	10,966	$	7,630	$	2,141	$	965	$	10,736



____________________
Notes:
(1)	Includes Emtriva and Tybost
(2)	Represents our revenue from cobicistat (C), emtricitabine (FTC) and tenofovir alafenamide (TAF) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland UC (Janssen)
(3)	Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by our separate subsidiary, Asegua Therapeutics LLC
(4)	Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by our separate subsidiary, Asegua Therapeutics LLC
(5)	Includes Cayston, Hepsera and Sovaldi

Revenues Recognized from Performance Obligations Satisfied in Prior Periods

Revenues recognized from performance obligations satisfied in prior years related to royalties for licenses of our intellectual property were $171 million and $326 million for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019, respectively, and ~~2017. The information~~$131 million and $228 million for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017 has~~2018, respectively. Changes in estimates for variable consideration related to sales made in prior years resulted in a $193 million and $300 million increase in revenues for the three and six months ended June 30, 2019, respectively, and a $91 million and $4 million increase for the three and six months ended June 30, 2018, respectively.

Contract Balances

Our contract assets, which consist of unbilled amounts primarily from arrangements where the licensing of intellectual property is the only or predominant performance obligation, totaled $149 million and $125 million as of June 30, 2019 and December 31, 2018, respectively.

Contract liabilities were not ~~been adjusted in accordance with our modified retrospective adoption~~material as of ~~Topic 606~~June 30, 2019 and ~~continues to be reported in accordance with our historical accounting under Topic 605.~~

Three Months Ended September 30, 2018 Three Months Ended September 30, 2017
(In millions) U.S. Europe Other International Total U.S. Europe Other International Total
Product sales:
Atripla $ 221
$ 29
$ 8
$ 258
$ 324
$ 79
$ 36
$ 439
Biktarvy 375
11
—
386
—
—
—
—
Complera/Eviplera 61
67
11
139
91
133
13
237
Descovy 310
81
15
406
241
65
10
316
Genvoya 921
203
52
1,176
810
146
32
988
Odefsey 323
95
5
423
255
37
4
296
Stribild 111
20
15
146
181
40
8
229
Truvada 665
62
30
757
604
154
53
811
Other HIV⁽¹⁾
10
2
2
14
13
2
—
15
Revenue share - Symtuza⁽²⁾
8
14
—
22
—
—
—
—
AmBisome 9
59
34
102
9
51
32
92
Epclusa 225
136
116
477
543
263
76
882
Harvoni 185
38
88
311
718
110
145
973
Letairis 241
—
—
241
213
—
—
213
Ranexa 178
—
—
178
164
—
—
164
Vemlidy 66
2
19
87
34
2
1
37
Viread 17
10
43
70
137
55
82
274
Vosevi 78
21
4
103
117
5
1
123
Yescarta 75
—
—
75
—
—
—
—
Zydelig 15
4
1
20
18
22
—
40
Other⁽³⁾
37
19
8
64
70
33
170
273
Total product sales 4,131
873
451
5,455
4,542
1,197
663
6,402
Royalty, contract and other revenues 20
102
19
141
21
74
15
110
Total revenues $ 4,151
$ 975
$ 470
$ 5,596
$ 4,563
$ 1,271
$ 678
$ 6,512

Nine Months Ended September 30, 2018 Nine Months Ended September 30, 2017
(In millions) U.S. Europe Other International Total U.S. Europe Other International Total
Product Sales:
Atripla $ 723
$ 119
$ 79
$ 921
$ 974
$ 259
$ 133
$ 1,366
Biktarvy 593
13
—
606
—
—
—
—
Complera/Eviplera 210
279
39
528
315
385
44
744
Descovy 895
234
41
1,170
682
149
22
853
Genvoya 2,678
596
144
3,418
2,189
358
67
2,614
Odefsey 905
230
15
1,150
688
87
6
781
Stribild 388
83
36
507
632
161
38
831
Truvada 1,821
245
108
2,174
1,635
527
175
2,337
Other HIV⁽¹⁾
30
6
10
46
34
5
2
41
Revenue share - Symtuza⁽²⁾
8
34
—
42
—
—
—
—
AmBisome 40
170
102
312
26
153
97
276
Epclusa 733
502
278
1,513
2,142
649
154
2,945
Harvoni 649
116
225
990
2,628
583
515
3,726
Letairis 689
—
—
689
654
—
—
654
Ranexa 581
—
—
581
517
—
—
517
Vemlidy 172
8
41
221
66
3
1
70
Viread 40
72
137
249
395
202
237
834
Vosevi 250
57
12
319
117
5
1
123
Yescarta 183
—
—
183
—
—
—
—
Zydelig 46
44
2
92
52
57
1
110
Other⁽³⁾
93
75
117
285
228
279
496
1,003
Total product sales 11,727
2,883
1,386
15,996
13,974
3,862
1,989
19,825
Royalty, contract and other revenues 54
233
49
336
62
226
45
333
Total revenues $ 11,781
$ 3,116
$ 1,435
$ 16,332
$ 14,036
$ 4,088
$ 2,034
$ 20,158

____________________
⁽¹⁾ Includes Emtriva and Tybost
⁽²⁾Represents Gilead’s revenue from cobicistat (C), emtricitabine (FTC) and tenofovir alafenamide (TAF) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen
⁽³⁾ Includes Cayston, Hepsera and Sovaldi
December 31, 2018.


3.	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 include quoted prices in active markets for identical assets or liabilities;

Level 2 inputs 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 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 assets and 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 primarily of cash and cash equivalents, marketable debt securities, accounts receivable, foreign currency exchange contracts, equity securities, accounts payable and short-term and long-term debt. Cash and cash equivalents, marketable debt ~~and~~securities, certain equity securities and foreign currency exchange contracts are reported at their respective fair values on our Condensed Consolidated Balance Sheets. Equity securities without readily determinable fair values are recorded using the measurement alternative of cost less impairment, if any, adjusted for observable price changes in orderly transactions for identical or similar investments of the same issuer. Short-term and long-term debt are reported at their amortized costs on our Condensed Consolidated Balance Sheets. The remaining financial instruments are reported in our Condensed Consolidated Balance Sheets at amounts that approximate current fair values. There were no transfers between Level 1, Level 2 and Level 3 in the periods presented.

The following table summarizes the types of assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in millions):



	June 30, 2019								December 31, 2018
	Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3		Total
Assets:
Available-for-sale debt securities:
U.S. treasury securities	$	3,916	$	—	$	—	$	3,916	$	3,969	$	—	$	—	$	3,969
Certificates of deposit	—		5,385		—		5,385		—		4,361		—		4,361
U.S. government agencies securities	—		1,531		—		1,531		—		938		—		938
Non-U.S. government securities	—		420		—		420		—		305		—		305
Corporate debt securities	—		13,271		—		13,271		—		13,067		—		13,067
Residential mortgage and asset-backed securities	—		536		—		536		—		1,524		—		1,524
Equity securities:
Money market funds	3,007		—		—		3,007		5,305		—		—		5,305
Publicly traded equity securities	1,172		16		—		1,188		881		—		—		881
Deferred compensation plan	156		—		—		156		124		—		—		124
Foreign currency derivative contracts	—		48		—		48		—		78		—		78
Total	$	8,251	$	21,207	$	—	$	29,458	$	10,279	$	20,273	$	—	$	30,552
Liabilities:
Deferred compensation plan	$	156	$	—	$	—	$	156	$	124	$	—	$	—	$	124
Foreign currency derivative contracts	—		6		—		6		—		1		—		1
Total	$	156	$	6	$	—	$	162	$	124	$	1	$	—	$	125

September 30, 2018 December 31, 2017
Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total
Assets:
Available-for-sale debt securities:
U.S. treasury securities $ 3,075
$ —
$ —
$ 3,075
$ 4,061
$ —
$ —
$ 4,061
Certificates of deposit —
4,392
—
4,392
—
5,131
—
5,131
U.S. government agencies securities —
932
—
932
—
926
—
926
Non-U.S. government securities —
260
—
260
—
664
—
664
Corporate debt securities —
12,757
—
12,757
—
14,747
—
14,747
Residential mortgage and asset-backed securities —
2,037
—
2,037
—
4,058
—
4,058
Marketable equity securities:
Money market funds 5,138
—
—
5,138
4,714
—
—
4,714
Equity securities 825
—
—
825
635
—
—
635
Deferred compensation plan 139
—
—
139
116
—
—
116
Foreign currency derivative contracts —
42
—
42
—
13
—
13
Total $ 9,177
$ 20,420
$ —
$ 29,597
$ 9,526
$ 25,539
$ —
$ 35,065
Liabilities:

Deferred compensation plan $ 139
$ —
$ —
$ 139
$ 116
$ —
$ —
$ 116
Foreign currency derivative contracts —
6
—
6
—
93
—
93
Total $ 139
$ 6
$ —
$ 145
$ 116
$ 93
$ —
$ 209

~~For the three and nine months ended September 30, 2018, changes~~Changes in the fair value of ~~marketable~~ equity securities resulted in net unrealized gains of ~~$168~~$57 million and ~~$149~~$254 million for the three and six months ended June 30, 2019, respectively, and net unrealized losses of $64 million and $19 million for the three and six months ended June 30, 2018, respectively, which were included in Other income (expense), net on our Condensed Consolidated

Statements of Income. Investments in equity securities without readily determinable fair values were not material for the periods presented.

The following table summarizes the classification of our equity securities in our Condensed Consolidated Balance Sheets (in millions):



	June 30, 2019		December 31, 2018
Cash and cash equivalents	$	3,007	$	5,305
Prepaid and other current assets	1,178		863
Other long-term assets	166		142
Total	$	4,351	$	6,310

Our available-for-sale debt securities are classified as cash equivalents, short-term marketable securities and long-term marketable ~~securities.~~securities on our Condensed Consolidated Balance Sheets. See Note 4,4. Available-for-Sale Debt Securities for additional information.

~~The following table summarizes the classification of our marketable equity securities in our Condensed Consolidated Balance Sheets (in millions):~~

September 30, 2018 December 31, 2017
Cash and cash equivalents $ 5,138
$ 4,714
Prepaid and other current assets 829
637
Other long-term assets 135
114
Total $ 6,102
$ 5,465

Level 2 Inputs

We estimate the fair values of Level 2 instruments by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income-based and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate the 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 within an 18-month time horizon and all are with counterparties that have a minimum credit rating of A- or equivalent by S&P Global Ratings, Moody’s Investors Service, Inc. or Fitch Ratings, Inc. We estimate the fair values of these contracts by taking into consideration the 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 exchange rates, London Interbank Offered Rates (LIBOR) and swap rates. These inputs, where applicable, are observable at commonly quoted intervals.

The total estimated fair values of our short-term and long-term debt, determined using Level 2 inputs based on their quoted market values, were approximately ~~$27.5~~$28.0 billion and ~~$35.5~~$27.1 billion as of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, respectively, and the carrying values were ~~$27.3~~$26.1 billion and ~~$33.5~~$27.3 billion as of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, respectively.


4.	AVAILABLE-FOR-SALE DEBT SECURITIES

The following table summarizes our available-for-sale debt securities (in millions):



	June 30, 2019									December 31, 2018
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Estimated Fair Value		Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Estimated Fair Value
U.S. treasury securities	$	3,917	$	1	$	(2	)	$	3,916	$	3,978	$	—	$	(9	)	$	3,969
Certificates of deposit	5,385		—		—			5,385		4,361		—		—			4,361
U.S. government agencies securities	1,531		—		—			1,531		943		—		(5		)	938
Non-U.S. government securities	420		—		—			420		307		—		(2		)	305
Corporate debt securities	13,272		3		(4		)	13,271		13,095		1		(29		)	13,067
Residential mortgage and asset-backed securities	537		—		(1		)	536		1,532		—		(8		)	1,524
Total	$	25,062	$	4	$	(7	)	$	25,059	$	24,216	$	1	$	(53	)	$	24,164

September 30, 2018 December 31, 2017
Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Estimated
Fair Value Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Estimated
Fair Value
U.S. treasury securities $ 3,090
$ —
$ (15 ) $ 3,075
$ 4,090
$ —
$ (29 ) $ 4,061
Certificates of deposit 4,392
—
—
4,392
5,131
—
—
5,131
U.S. government agencies securities 938
—
(6 ) 932
934
—
(8 ) 926
Non-U.S. government securities 262
—
(2 ) 260
668
—
(4 ) 664
Corporate debt securities 12,792
2
(37 ) 12,757
14,790
3
(46 ) 14,747
Residential mortgage and asset-backed securities 2,049
—
(12 ) 2,037
4,072
1
(15 ) 4,058
Total $ 23,523
$ 2
$ (72 ) $ 23,453
$ 29,685
$ 4
$ (102 ) $ 29,587

The following table summarizes the classification of our available-for-sale debt securities in our Condensed Consolidated Balance Sheets (in millions):



	June 30, 2019		December 31, 2018
Cash and cash equivalents	$	6,065	$	10,592
Short-term marketable securities	15,943		12,149
Long-term marketable securities	3,051		1,423
Total	$	25,059	$	24,164

September 30, 2018 December 31, 2017
Cash and cash equivalents $ 7,178
$ 481
Short-term marketable securities 13,897
17,922
Long-term marketable securities 2,378
11,184
Total $ 23,453
$ 29,587

The following table summarizes our available-for-sale debt securities by contractual maturity (in millions):



	June 30, 2019
	Amortized Cost		Fair Value
Within one year	$	22,010	$	22,008
After one year through five years	3,016		3,015
After five years through ten years	19		19
After ten years	17		17
Total	$	25,062	$	25,059

September 30, 2018
Amortized Cost Fair Value
Within one year $ 21,130
$ 21,075
After one year through five years 2,313
2,299
After five years through ten years 58
57
After ten years 22
22
Total $ 23,523
$ 23,453

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, 2019
U.S. treasury securities	$	(1	)	$	1,401	$	(1	)	$	470	$	(2	)	$	1,871
Certificates of deposit	—			8		—			—		—			8
U.S. government agencies securities	—			391		—			393		—			784
Non-U.S. government securities	—			11		—			161		—			172
Corporate debt securities	(1		)	922		(3		)	1,988		(4		)	2,910
Residential mortgage and asset-backed securities	—			26		(1		)	437		(1		)	463
Total	$	(2	)	$	2,759	$	(5	)	$	3,449	$	(7	)	$	6,208

December 31, 2018
U.S. treasury securities	$	—		$	896	$	(9	)	$	1,383	$	(9	)	$	2,279
U.S. government agencies securities	—			30		(5		)	553		(5		)	583
Non-U.S. government securities	—			86		(2		)	192		(2		)	278
Corporate debt securities	(1		)	1,600		(28		)	4,204		(29		)	5,804
Residential mortgage and asset-backed securities	—			192		(8		)	1,186		(8		)	1,378
Total	$	(1	)	$	2,804	$	(52	)	$	7,518	$	(53	)	$	10,322

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
September 30, 2018
U.S. treasury securities $ (1 ) $ 1,339
$ (14 ) $ 1,613
$ (15 ) $ 2,952
U.S. government agencies securities —
285
(6 ) 612
(6 ) 897
Non-U.S. government securities —
—
(2 ) 234
(2 ) 234
Corporate debt securities (6 ) 2,636
(31 ) 3,602
(37 ) 6,238
Residential mortgage and asset-backed securities (1 ) 409
(11 ) 1,300
(12 ) 1,709
Total $ (8 ) $ 4,669
$ (64 ) $ 7,361
$ (72 ) $ 12,030

December 31, 2017
U.S. treasury securities $ (2 ) $ 821
$ (27 ) $ 3,240
$ (29 ) $ 4,061
U.S. government agencies securities (1 ) 206
(7 ) 700
(8 ) 906
Non-U.S. government securities (1 ) 203
(3 ) 461
(4 ) 664
Corporate debt securities (14 ) 7,674
(32 ) 3,561
(46 ) 11,235
Residential mortgage and asset-backed securities (4 ) 2,245
(11 ) 1,206
(15 ) 3,451
Total $ (22 ) $ 11,149
$ (80 ) $ 9,168
$ (102 ) $ 20,317

We held a total of ~~1,523~~593 and ~~2,957~~1,348 positions, which were in an unrealized loss position, as of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, respectively.

Based on our review of these securities, we believe we had no other-than-temporary impairments as of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, because we do not intend to sell these securities nor do we believe that we will be required to sell these securities before the recovery of their amortized cost basis. Gross realized gains and gross realized losses were not material for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 and ~~2017.~~2018.


5.	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, primarily the Euro. ~~In order to~~To manage this risk, we may 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~~unrealized 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 entities 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 maturities of 18 months or less. Upon executing a hedging contract and quarterly thereafter, we assess hedge effectiveness using regression analysis. Prior to January 2018, we excluded time value from our effectiveness testing and recognized changes in the time value of the hedge in Other income (expense), net, on our Condensed Consolidated Statements of Income. Starting in January 2018, we include time value in our effectiveness testing and the entire change in the value of hedge contracts is recorded as unrealized gains or losses in AOCI within Stockholders’ equity on our Condensed Consolidated Balance Sheets. The unrealized gains or losses in ~~AOCI~~Accumulated other comprehensive income (AOCI) are reclassified into product sales when the respective hedged transactions affect earnings. AsThe majority of ~~September 30, 2018, the amount of unrealized~~ gains and losses related to the hedged forecasted transactions reported in AOCI ~~that is~~as of June 30, 2019 are expected to be reclassified ~~into~~to product sales within ~~the next~~ 12 ~~months was not material.~~

months.

The cash flow effects of our derivative contracts for the ~~nine~~six months ended ~~September~~June 30, 2019 and 2018 ~~and 2017 are~~were included within Net cash provided by operating activities on our Condensed Consolidated Statements of Cash Flows.

We had notional amounts on foreign currency exchange contracts outstanding of ~~$2.5~~$2.9 billion and ~~$2.8~~$2.2 billion as of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, respectively.

While all of our derivative contracts allow us the right to offset assets and liabilities, we have presented amounts on a gross basis. The following table summarizes the classification and fair values of derivative instruments in our Condensed Consolidated Balance Sheets (in millions):


	September 30, 2018							June 30, 2019
	Asset Derivatives			Liability Derivatives				Asset Derivatives			Liability Derivatives
	Classification	Fair Value		Classification	Fair Value			Classification	Fair Value		Classification	Fair Value
Derivatives designated as hedges:
Foreign currency exchange contracts	Other current assets	$	40	Other accrued liabilities	$	(5	)	Other current assets	$	47	Other accrued liabilities	$	(4	)
Foreign currency exchange contracts	Other long-term assets	2		Other long-term obligations	(1		)	Other long-term assets	1		Other long-term obligations	(2		)
Total derivatives designated as hedges		42			(6		)		48			(6		)
Derivatives not designated as hedges:
Foreign currency exchange contracts	Other current assets	—		Other accrued liabilities	—			Other current assets	—		Other accrued liabilities	—
Total derivatives not designated as hedges		—			—				—			—
Total derivatives		$	42		$	(6	)		$	48		$	(6	)



	December 31, 2018
	Asset Derivatives			Liability Derivatives
	Classification	Fair Value		Classification	Fair Value
Derivatives designated as hedges:
Foreign currency exchange contracts	Other current assets	$	73	Other accrued liabilities	$	(1	)
Foreign currency exchange contracts	Other long-term assets	5		Other long-term obligations	—
Total derivatives designated as hedges		78			(1		)
Derivatives not designated as hedges:
Foreign currency exchange contracts	Other current assets	—		Other accrued liabilities	—
Total derivatives not designated as hedges		—			—
Total derivatives		$	78		$	(1	)

December 31, 2017
Asset Derivatives Liability Derivatives
Classification Fair Value Classification Fair Value
Derivatives designated as hedges:
Foreign currency exchange contracts Other current assets $ 2
Other accrued liabilities $ (89 )
Foreign currency exchange contracts Other long-term assets 1
Other long-term obligations (3 )
Total derivatives designated as hedges 3
(92 )
Derivatives not designated as hedges:

Foreign currency exchange contracts Other current assets 10
Other accrued liabilities (1 )
Total derivatives not designated as hedges 10
(1 )
Total derivatives $ 13
$ (93 )

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,
	2019			2018			2019			2018
Derivatives designated as hedges:
Gains recognized in AOCI	$	1		$	119		$	29		$	58
Gains (losses) reclassified from AOCI into product sales	36			(45		)	65			(93		)
Derivatives not designated as hedges:
Gains (losses) recognized in Other income (expense), net	$	(5	)	$	10		$	(11	)	$	(4	)

Three Months Ended Nine Months Ended
September 30, September 30,
2018 2017 2018 2017
Derivatives designated as hedges:
Gains (losses) recognized in AOCI $ (6 ) $ (78 ) $ 52
$ (289 )
Gains (losses) reclassified from AOCI into product sales $ (8 ) $ (26 ) $ (101 ) $ 4
Gains recognized in Other income (expense), net $ —
$ 10
$ —
$ 32
Derivatives not designated as hedges:
Gains (losses) recognized in Other income (expense), net $ 15
$ (2 ) $ 11
$ (112 )

The following table summarizes the potential effect of offsetting our foreign currency exchange contracts on our Condensed Consolidated Balance Sheets (in millions):



									Gross Amounts Not Offset on our Condensed Consolidated Balance Sheets
Description	Gross Amounts of Recognized Assets/Liabilities			Gross Amounts Offset on our Condensed Consolidated Balance Sheets		Amounts of Assets/Liabilities Presented on our Condensed Consolidated Balance Sheets			Derivative Financial Instruments			Cash Collateral Received/ Pledged		Net Amount (Legal Offset)
As of June 30, 2019
Derivative assets	$	48		$	—	$	48		$	(6	)	$	—	$	42
Derivative liabilities	(6		)	—		(6		)	6			—		—
As of December 31, 2018
Derivative assets	$	78		$	—	$	78		$	(1	)	$	—	$	77
Derivative liabilities	(1		)	—		(1		)	1			—		—

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~~was no ~~material amounts recorded in Other income (expense), net, on our Condensed Consolidated Statements~~discontinuance of ~~Income~~cash flow hedges for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 and ~~2017 as a result of the discontinuance of cash flow hedges.~~

As of September 30, 2018 and December 31, 2017, we held one type of financial instrument, which was 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):

Gross Amounts Not Offset
on our Condensed
Consolidated Balance Sheets

Description
Gross Amounts
of Recognized
Assets/Liabilities

Gross Amounts
Offset on our
Condensed
Consolidated
Balance Sheets

Amounts of Assets/Liabilities Presented
on our Condensed Consolidated
Balance Sheets

Derivative
Financial
Instruments

Cash Collateral
Received/
Pledged

Net Amount
(Legal Offset)
As of September 30, 2018
Derivative assets $ 42
$ —
$ 42
$ (6 ) $ —
$ 36
Derivative liabilities $ (6 ) $ —
$ (6 ) $ 6
$ —
$ —
As of December 31, 2017
Derivative assets $ 13
$ —
$ 13
$ (8 ) $ —
$ 5
Derivative liabilities $ (93 ) $ —
$ (93 ) $ 8
$ —
$ (85 )
2018.


6.	~~ACQUISITION, COLLABORATIONS~~COLLABORATIVE AND OTHER ARRANGEMENTS

~~Acquisition~~

On October 3, 2017 (the Kite acquisition date), we completed a tender offer for all of the outstanding common stock of Kite Pharma, Inc. (Kite) for $180 per share in cash. As a result, Kite became our wholly-owned subsidiary. The acquisition of Kite helps establish our foundation for improving the treatment of hematological malignancies and solid tumors.

The consideration transferred for the acquisition of Kite was $11,155 million, consisting of $10,420 million in cash to the outstanding Kite common stockholders, $645 million cash payment to vested equity award holders, $15 million to warrant holders and $75 million representing the portion of the replaced stock-based awards attributable to the pre-combination period. In addition, $733 million was excluded from the consideration transferred, representing the portion of the replaced stock-based awards attributable to the post combination period, which is expected to be recognized through 2021.

The acquisition of Kite was 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 Kite acquisition date. The determination of estimated fair value requires us to make significant estimates and assumptions. During the nine months ended September 30, 2018, we recorded a $42 million reduction to goodwill primarily due to revision of deferred income taxes as a result of finalization of Kite’s pre-acquisition federal income tax return. The fair value estimates for the assets acquired and liabilities assumed in the acquisition have been completed.

~~The following table summarizes the Kite acquisition date fair values of assets acquired and liabilities assumed, and the consideration transferred (in millions):~~

Cash and cash equivalents $ 652
Identifiable intangible assets:
Indefinite-lived intangible assets - in-process research and development (IPR&D) 8,950
Outlicense acquired 91
Deferred income taxes (1,564 )
Other assets acquired (liabilities assumed), net 81
Total identifiable net assets 8,210
Goodwill 2,945
Total consideration transferred $ 11,155

~~Collaborations and Other Arrangements~~

We enter into collaborations and other similar arrangements with third parties for the ~~research~~development and ~~development~~commercialization of certain products and product candidates. These arrangements may include non-refundable up-front payments, payments by us for options to acquire certain rights, contingent obligations by us for potential development and regulatory milestone payments and/or sales-based milestone payments, royalty payments, revenue or profit sharing arrangements, cost sharing arrangements and equity investments. ~~While we do not consider any collaborations~~

During the three and ~~other arrangements entered into during 2018 to be individually material, notable~~

terms of these arrangements are described below. Amounts related to collaborations entered into during 2018 that are not specifically presented are included in the aggregate as Other Collaboration Arrangements.

~~Gadeta B.V. (Gadeta):~~

In July 2018, we entered into a collaboration arrangement with Gadeta, a privately-held company based in Utrecht, the Netherlands, to develop gamma delta T cell receptor therapies for various cancers. Under the financial terms, we will provide research and development (R&D) funding for the collaboration and Gadeta will be eligible to receive future payments upon achievement of certain regulatory milestones. In addition, we made an upfront purchase of equity in Gadeta from Gadeta’s shareholders upon entering into the collaboration arrangement and may acquire additional equity in Gadeta upon achievement of certain R&D milestones. We also have the exclusive option to acquire the remaining equity in Gadeta for €300 million, adjusted for closing cash, transaction expenses and closing indebtedness. The option is exercisable at our discretion.

Gadeta is a VIE, and we are its primary beneficiary because we have the power to direct the activities of Gadeta that most significantly impact its economic performance and as a result of the financial terms described above. Upon the initial consolidation of Gadeta we recorded $82 million to noncontrolling interest, primarily reflecting acquired intangible assets related to IPR&D with a fair value of $117 million. Gadeta does not meet the definition of a business as defined in ASC 805 - Business Combinations, and as a result, no goodwill was recognized.

~~Other Collaboration Arrangements:~~

~~For the nine~~six months ended ~~September~~June 30, 2019 and 2018, we entered into several collaborative and other ~~collaboration~~similar arrangements, including equity investments and licensing arrangements, that ~~resulted in cash~~we do not consider to be individually material. Cash outflows and accrued up-front payments related to these arrangements totaled $206 million and $393 million for the three and six months ended June 30, 2019, respectively, and $284 million and $304 million for the three and six months ended June 30, 2018, respectively. We recorded up-front collaboration and licensing expenses related to these arrangements of ~~$333~~$165 million ~~of which~~and $291 million for the three and six months ended June 30, 2019, respectively, and $160 million ~~was recorded as up-front collaboration expense~~for both the three and six months ended June 30, 2018 within Research and development expenses on our Condensed Consolidated Statements of Income and the remaining amounts were recorded in ~~current~~Prepaid and other current assets and Other long-term assets on our Condensed Consolidated Balance Sheets.

Under the financial terms of these arrangements, we may be required to make payments upon achievement of various developmental, regulatory and commercial milestones, which could be significant. Future milestone payments, if any, will be reflected on our Condensed Consolidated Statements of Income when the corresponding events become probable. In addition, we may be required to pay significant royalties on future sales if products related to these arrangements are commercialized. The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurrence.


7.	OTHER FINANCIAL INFORMATION

Inventories

~~Inventories are summarized as follows~~The following table summarizes our inventories (in millions):



	June 30, 2019		December 31, 2018
Raw materials	$	1,832	$	1,888
Work in process	265		235
Finished goods	498		507
Total	$	2,595	$	2,630

Reported as:
Inventories	$	884	$	814
Other long-term assets	1,711		1,816
Total	$	2,595	$	2,630

September 30, 2018 December 31, 2017
Raw materials $ 2,144
$ 1,880
Work in process 241
352
Finished goods 574
670
Total $ 2,959
$ 2,902

Reported as:
Inventories $ 816
$ 801
Other long-term assets 2,143
2,101
Total $ 2,959
$ 2,902

Amounts reported as other long-term assets primarily consisted of raw materials as of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017.~~2018.

Other Accrued Liabilities

The following table summarizes the components of other accrued liabilities ~~are summarized as follows~~ (in millions):



	June 30, 2019		December 31, 2018
Compensation and employee benefits	$	433	$	555
Accrued payment for marketing-related rights acquired from Japan Tobacco Inc.	175		365
Other accrued expenses	2,152		2,219
Total	$	2,760	$	3,139

September 30, 2018 December 31, 2017
Compensation and employee benefits $ 436
$ 455
Branded prescription drug fee 62
284
Income taxes payable 17
713
Other accrued expenses 1,818
1,918
Total $ 2,333
$ 3,370

~~Supplemental Disclosure of Cash Flow Information - Non-Cash Investing Activity~~

As of September 30, 2018, Prepaid and other current assets on our Condensed Consolidated Balance Sheets included $470 million of available-for-sale debt securities that were matured but unsettled. These available-for-sale debt securities were settled in October 2018 and will be reflected as cash from investing activities in the fourth quarter of 2018. As of December 31, 2017, available-for-sale debt securities that were matured but unsettled were not material.


8.	INTANGIBLE ASSETS

The following table summarizes our intangible assets, net (in millions):



	June 30, 2019										December 31, 2018
	Gross Carrying Amount		Accumulated Amortization			Foreign Currency Translation Adjustment			Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization			Foreign Currency Translation Adjustment			Net Carrying Amount
Finite-lived assets:
Intangible asset - sofosbuvir	$	10,720	$	(3,903	)	$	—		$	6,817	$	10,720	$	(3,554	)	$	—		$	7,166
Intangible asset - axicabtagene ciloleucel (DLBCL)	6,200		(588		)	—			5,612		6,200		(416		)	—			5,784
Intangible asset - Ranexa	688		(688		)	—			—		688		(678		)	—			10
Other	1,098		(415		)	(3		)	680		1,096		(359		)	(3		)	734
Total finite-lived assets	18,706		(5,594		)	(3		)	13,109		18,704		(5,007		)	(3		)	13,694
Indefinite-lived assets - In Process Research & Development	2,047		—			(4		)	2,043		2,047		—			(3		)	2,044
Total intangible assets	$	20,753	$	(5,594	)	$	(7	)	$	15,152	$	20,751	$	(5,007	)	$	(6	)	$	15,738

September 30, 2018 December 31, 2017

Gross
Carrying
Amount

Accumulated
Amortization
Foreign Currency Translation Adjustment Net Carrying Amount
Gross
Carrying
Amount

Accumulated
Amortization
Net Carrying Amount
Finite-lived intangible assets:
Intangible asset - sofosbuvir $ 10,720
$ (3,379 ) $ —
$ 7,341
$ 10,720
$ (2,855 ) $ 7,865
Intangible asset - axicabtagene ciloleucel (DLBCL) 6,200
(330 ) —
5,870
6,200
(72 ) 6,128
Intangible asset - Ranexa 688
(650 ) —
38
688
(566 ) 122
Other 546
(347 ) (1 ) 198
546
(311 ) 235
Total finite-lived intangible assets 18,154
(4,706 ) (1 ) 13,447
18,154
(3,804 ) 14,350
Indefinite-lived intangible assets - IPR&D 2,867
—
—
2,867
2,750
—
2,750
Total intangible assets $ 21,021
$ (4,706 ) $ (1 ) $ 16,314
$ 20,904
$ (3,804 ) $ 17,100

~~Amortization~~Aggregate amortization expense related to finite-lived intangible assets iswas $288 million and $587 million for the three and six months ended June 30, 2019, respectively, and $300 million and $601 million for the three and six months ended June 30, 2018, respectively, and was primarily included in Cost of goods sold on our Condensed Consolidated Statements of Income and totaled $301 million and $902 million for the three and nine months ended September 30, 2018, respectively, and $209 million and $629 million for the three and nine months ended September 30, 2017, respectively.Income.

~~As of September 30, 2018,~~

The following table summarizes the estimated future amortization expense associated with our finite-lived intangible assets is as ~~follows~~of June 30, 2019 (in millions):



Fiscal Year	Amount
2019 (remaining six months)	$	563
2020	1,125
2021	1,125
2022	1,125
2023	1,125
Thereafter	8,046
Total	$	13,109

Fiscal Year Amount
2018 (remaining three months) $ 301
2019 1,088
2020 1,064
2021 1,064
2022 1,064
Thereafter 8,866
Total $ 13,447


9.	DEBT AND CREDIT FACILITIES

The following table summarizes our borrowings under various financing arrangements (in millions):



				Carrying Amount
Type of Borrowing	Issue Date	Due Date	Interest Rate	June 30, 2019		December 31, 2018
Senior Unsecured	September 2017	March 2019	3-month LIBOR + 0.22%	$	—	$	750
Senior Unsecured	March 2014	April 2019	2.05%	—		500
Senior Unsecured	September 2017	September 2019	1.85%	999		999
Senior Unsecured	September 2017	September 2019	3-month LIBOR + 0.25%	500		499
Senior Unsecured	November 2014	February 2020	2.35%	500		499
Senior Unsecured	September 2015	September 2020	2.55%	1,997		1,996
Senior Unsecured	March 2011	April 2021	4.50%	998		997
Senior Unsecured	December 2011	December 2021	4.40%	1,248		1,247
Senior Unsecured	September 2016	March 2022	1.95%	498		498
Senior Unsecured	September 2015	September 2022	3.25%	997		997
Senior Unsecured	September 2016	September 2023	2.50%	746		746
Senior Unsecured	March 2014	April 2024	3.70%	1,744		1,744
Senior Unsecured	November 2014	February 2025	3.50%	1,745		1,745
Senior Unsecured	September 2015	March 2026	3.65%	2,733		2,731
Senior Unsecured	September 2016	March 2027	2.95%	1,245		1,245
Senior Unsecured	September 2015	September 2035	4.60%	990		990
Senior Unsecured	September 2016	September 2036	4.00%	741		740
Senior Unsecured	December 2011	December 2041	5.65%	995		995
Senior Unsecured	March 2014	April 2044	4.80%	1,734		1,734
Senior Unsecured	November 2014	February 2045	4.50%	1,731		1,730
Senior Unsecured	September 2015	March 2046	4.75%	2,217		2,216
Senior Unsecured	September 2016	March 2047	4.15%	1,725		1,724
Total debt, net				26,083		27,322
Less current portion				1,999		2,748
Total long-term debt, net				$	24,084	$	24,574

Carrying Amount
Type of Borrowing Issue Date Due Date Interest Rate September 30, 2018 December 31, 2017
Senior Unsecured September 2015 September 2018 1.85% $ —
$ 999
Senior Unsecured September 2017 September 2018 3-month LIBOR + 0.17% —
749
Term Loan October 2017 October 2018 Variable —
999
Senior Unsecured September 2017 March 2019 3-month LIBOR + 0.22% 749
748
Senior Unsecured March 2014 April 2019 2.05% 500
499
Senior Unsecured September 2017 September 2019 1.85% 998
997
Senior Unsecured September 2017 September 2019 3-month LIBOR + 0.25% 499
499
Senior Unsecured November 2014 February 2020 2.35% 499
499
Senior Unsecured September 2015 September 2020 2.55% 1,995
1,994
Term Loan October 2017 October 2020 Variable —
998
Senior Unsecured March 2011 April 2021 4.50% 996
995
Senior Unsecured December 2011 December 2021 4.40% 1,247
1,246
Senior Unsecured September 2016 March 2022 1.95% 498
497
Senior Unsecured September 2015 September 2022 3.25% 997
996
Term Loan October 2017 October 2022 Variable —
2,497
Senior Unsecured September 2016 September 2023 2.50% 745
745
Senior Unsecured March 2014 April 2024 3.70% 1,743
1,742
Senior Unsecured November 2014 February 2025 3.50% 1,745
1,744
Senior Unsecured September 2015 March 2026 3.65% 2,731
2,729
Senior Unsecured September 2016 March 2027 2.95% 1,245
1,244
Senior Unsecured September 2015 September 2035 4.60% 990
990
Senior Unsecured September 2016 September 2036 4.00% 740
740
Senior Unsecured December 2011 December 2041 5.65% 995
995
Senior Unsecured March 2014 April 2044 4.80% 1,734
1,733
Senior Unsecured November 2014 February 2045 4.50% 1,730
1,730
Senior Unsecured September 2015 March 2046 4.75% 2,216
2,215
Senior Unsecured September 2016 March 2047 4.15% 1,724
1,723
Total debt, net 27,316
33,542
Less current portion 2,746
2,747
Total long-term debt, net $ 24,570
$ 30,795

In ~~September 2018,~~March 2019, we repaid ~~$1.0 billion~~$750 million of our senior unsecured notes upon maturity that were issued in September ~~2015~~2017, and ~~$750~~in April 2019, we repaid $500 million of our senior unsecured notes upon maturity that were issued in ~~September 2017.~~

In March ~~2018, we fully repaid the $4.5 billion outstanding debt under our term loan facility credit agreement, at which time the term loan facility credit agreement terminated.~~2014.

We are required to comply with certain covenants under our credit agreement and note indentures governing our senior notes. As of ~~September~~June 30, ~~2018,~~2019, we were not in violation of any covenants. Additionally, as of ~~September~~June 30, 2019 and December 31, 2018, there were no amounts outstanding under our $2.5 billion five-year revolving credit ~~facility.~~facility agreement maturing in May 2021.


10.	LEASES

We lease facilities and equipment primarily related to administrative, research and development and sales and marketing activities under various non-cancelable operating leases in the United States and markets outside the United States. We determine if an arrangement contains a lease at inception. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of the lease payments over the lease term, which is the non-cancelable period stated in the contract adjusted for any options to extend or terminate when it is reasonably certain that we will exercise that option. Some of our leases include options to extend the terms for up to 15 years and some include options to terminate the lease within one year after the lease commencement date. Right-of-use assets include any prepaid lease payments and exclude lease incentives and initial direct costs incurred.

As of June 30, 2019, we do not have material finance leases. As most of our operating leases do not provide an implicit interest rate, we use a portfolio approach to determine a collateralized incremental borrowing rate based on the information available at the commencement date to determine the lease liability. Operating lease expense for the minimum lease payments is recognized on a straight-line basis over the lease term. Operating lease expenses including variable costs and short-term leases were $38 million and $74 million for the three and six months ended June 30, 2019, respectively.

The following table summarizes balance sheet and other information related to our operating leases as of June 30, 2019 (in millions, except weighted average data):



	Classification	Amount
Right-of-use assets, net	Other long-term assets	$	504
Lease liabilities - current	Other accrued liabilities	$	73
Lease liabilities - noncurrent	Other long-term obligations	$	481
Weighted average remaining lease term		9.5 years
Weighted average discount rate		3.60		%

The following table summarizes other supplemental information related to our operating leases (in millions):



	Three Months Ended		Six Months Ended
	June 30, 2019		June 30, 2019
Cash paid for amounts included in the measurement of lease liabilities	$	18	$	36
Right-of-use assets obtained in exchange for lease liabilities	$	70	$	100

The following table summarizes a maturity analysis of our operating lease liabilities showing the aggregate lease payments as of June 30, 2019 (in millions):



Fiscal Year	Amount
2019 (remaining six months)	$	47
2020	87
2021	83
2022	75
2023	66
Thereafter	305
Total undiscounted lease payments	663
Less: imputed interest	(109		)
Total discounted lease payments	$	554

The following table summarizes the aggregate undiscounted non-cancelable future minimum lease payments for operating leases under the prior leases standard as of December 31, 2018 (in millions):



Fiscal Year	Amount
2019	$	89
2020	78
2021	66
2022	60
2023	52
Thereafter	229
Total minimum lease payments	$	574


~~10.~~11.	COMMITMENTS AND CONTINGENCIES

We are a party to various legal actions. The most significant of these are described below. We recognize accruals for such actions to the extent that we conclude that a loss is both probable and reasonably estimable. We accrue for the best estimate of a

loss within a range; however, if no estimate in the range is better than any other, then we accrue the minimum amount in the range. If we determine that a loss is reasonably possible and the loss or range of loss can be estimated, we disclose the possible loss. Unless otherwise noted, 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.

We did not recognize any accruals for the actions described below in our Condensed Consolidated Balance Sheets as of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, as we did not believe losses were probable.

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 approval from U.S. Food and Drug Administration (FDA) for sofosbuvir, now known commercially as Sovaldi. Sofosbuvir is also included in all of our marketed HCV products. We have received a number of ~~contractual and intellectual property~~litigation 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 are aware of patents and patent applications owned by third parties that have been or may in the future be alleged by such parties to cover the use of our HCV products. If third parties obtain valid and enforceable patents, and successfully prove infringement of those patents by our HCV products, we could be required to pay significant monetary damages. We cannot predict the ultimate outcome of intellectual property claims related to our HCV products. We have spent, and will continue to spend, significant resources defending against these claims.

~~Interference Proceedings and~~ Litigation with Idenix Pharmaceuticals, Inc. (Idenix), Universita Degli Studi di Cagliari (UDSG), Centre National de la Recherche Scientifique and L’Universite Montpellier II

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 to determine who was the first to invent certain nucleoside compounds. In January 2014, the USPTO Patent Trial and Appeal Board (PTAB) determined that Pharmasset and not Idenix was the first to invent the compounds. Idenix was acquired by Merck & Co. Inc. (Merck) in August 2014. Idenix appealed the PTAB’s decisions to the U.S. District Court for the District of Delaware, and in September 2018, the District Court dismissed the First Idenix Interference with prejudice.

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. In March 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 Appeals for the Federal Circuit (CAFC). The CAFC heard oral arguments in September 2016 and affirmed the PTAB decision in June 2017. Idenix filed a Petition for Writ of Certiorari to the Supreme Court of the United States (U.S. Supreme Court) in March 2018. In April 2018, the U.S. Supreme Court denied certiorari; accordingly, the decision finding that Idenix is not entitled to the ‘600 patent is now final. All pending actions concerning the ‘600 patent have been dismissed.

We believe that 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. Idenix asserted that the commercialization of Sovaldi in Canada will infringe its ‘191 patent and that our Canadian Patent No. 2,527,657, corresponding to our ‘572 patent, is invalid. In November 2015, the Canadian court held that Idenix’s patent is invalid and that our patent is valid. Idenix appealed the decision to the Canadian Federal Court of Appeal in November 2015. In July 2017, the Canadian Federal Appeal Court affirmed the lower court’s decision in our favor. In September 2017, Idenix appealed the decision to the Supreme Court of Canada. In April 2018, the Supreme Court of Canada refused to hear Idenix’s appeal. The decision invalidating Idenix’s Canadian patent is now final.

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 infringes its Australian patent corresponding to the ‘600 patent. In March 2016, the Australian court revoked Idenix’s Australian patent. Idenix appealed this decision, and in December 2017, the Federal Court of Australia dismissed Idenix’s appeal. In January 2018, Idenix applied for Special Leave to Appeal to the High Court of Australia and, in April 2018, the High Court of Australia refused to hear Idenix’s appeal. The decision revoking Idenix’s Australian patent is now final.

In March 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. An opposition hearing was held in February 2016, and the EPO ruled in our favor and revoked the ‘489 patent. Idenix has appealed. In March 2014, Idenix also initiated infringement proceedings against us 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. 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. Idenix appealed. In November 2016, the appeals court affirmed the UK Court’s decision invalidating Idenix’s patent, and in April 2017, the UK Supreme Court refused Idenix’s application for permission to appeal. In March 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 hearing held by the EPO in February 2016. Idenix has not appealed this decision of the German court staying the proceedings. Upon Idenix’s request, the French proceedings have been stayed.

~~In December~~ 2013, Idenix, 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~~infringes U.S. Patent No. ~~8,415,322.~~7,608,600 (the ‘600 patent). 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~~infringes U.S. Patent Nos. 6,914,054 (the ‘054 patent) and 7,608,597 (the ‘597 patent). In ~~June~~ 2014, the court transferred the Massachusetts litigation to the U.S. District Court for the District of Delaware.

Prior to trial in ~~December~~ 2016, Idenix committed to give us a covenant not to sue with respect to any claims arising out of the ‘054 patent related to sofosbuvir and withdrew that patent from the trial. In addition, Idenix declined to litigate the ‘600 patent infringement action at trial in light of the appeal then pending at the CAFC. Since the U.S. Supreme Court denied Idenix’s petition for certiorari in the Second Idenix Interference, all pending actions concerning the ‘600 patent have been dismissed. A jury trial was held in ~~December~~ 2016 on the ‘597 ~~patent. In December 2016,~~patent, and the jury found that we willfully infringed the asserted claims of the ‘597 patent and awarded Idenix $2.54 billion in past damages. In ~~February~~ 2018, the judge invalidated Idenix’s ‘597 patent and vacated the jury’s award of $2.54 billion in past damages. Idenix ~~has~~ appealed this decision to the ~~CAFC.~~U.S. Court of Appeals for the Federal Circuit (CAFC), and oral argument took place in July 2019. No decision has been handed down yet. We believe the Delaware court’s decision correctly found that, as a matter of law, the ‘597 patent is invalid, and we remain confident in the merits of our case on appeal. We believe that the possibility of a material adverse outcome on this matter is remote.

~~Litigation with Merck~~

In ~~August 2013, Merck contacted us requesting that we pay royalties on~~2014, the ~~sales of sofosbuvir and obtain a license to U.S.~~European Patent Office (EPO) granted Idenix’s European Patent No. ~~7,105,499~~1 523 489 (the ~~‘499 patent) and U.S. Patent No. 8,481,712 (the ‘712~~‘489 patent), which ~~it co-owns with Ionis Pharmaceuticals, Inc.~~corresponds to the ‘600 patent. The ‘499 and ‘712 patents cover compounds which do not include, but may relate to, sofosbuvir. We filed a lawsuit in August 2013 in the U.S. District Court for the Northern District of California seeking a declaratory judgmentsame day that the ~~Merck patents are invalid~~‘489 patent was granted, we filed an opposition with the EPO seeking to revoke the ‘489 patent. An opposition hearing was held in 2016, and not infringed. Initially, in March 2016, a jury determined that we had not established that Merck’s patents are invalid for lack of written description or lack of enablement and awarded Merck $200 million in damages. However, in June 2016, the ~~court~~EPO ruled in our favor ~~on our defense~~and revoked the ‘489 patent.

Idenix has appealed. In 2014, Idenix also initiated infringement proceedings against us in Germany and France alleging that the commercialization of ~~unclean hands~~Sovaldi would infringe the German and French counterparts of the ‘489 patent. In 2015, the German court in Düsseldorf determined that ~~Merck may not recover any damages from us for~~ the ~~‘499~~Idenix patent was highly likely to be invalid and ~~‘712 patents. The judge has determined that Merck is required to pay our attorney’s fees due to~~stayed the ~~exceptional nature~~infringement proceedings pending the outcome of ~~this case. In July 2017,~~ the ~~court issued a decision setting the amount of attorney fees awarded to us.~~

Merck filed notices of appeal to the CAFC regarding the court’s decision on our defense of unclean hands and its award of attorney’s fees. In April 2018, the CAFC affirmed the court’s decision on unclean hands. Merck has filed a petition for reviewopposition hearing held by the ~~U.S. Supreme Court. If the~~EPO in 2016. Idenix has not appealed this decision on our defense of unclean hands is reversed subsequently and Merck’s patent is upheld, we may be required to pay damages and a royalty on sales of sofosbuvir-containing products following the appeal. In that event, the judge has indicated that she will determine the amount of the ~~royalty, if necessary, at~~German court staying the ~~conclusion of any appeal in this case.~~proceedings. Upon Idenix’s request, the French proceedings have been stayed.

Litigation with the University of Minnesota

The University of Minnesota (the University) has obtained Patent No. 8,815,830 (the ‘830 patent), which purports to broadly cover nucleosides with antiviral and anticancer activity. In ~~August~~ 2016, the University filed a lawsuit against us in the U.S. District Court for the District of Minnesota, alleging that the commercialization of sofosbuvir-containing products infringes the ‘830 patent. We believe the ‘830 patent is invalid and will not be infringed by the continued commercialization of sofosbuvir. In ~~October~~ 2017, the court granted our motion to transfer the case to California. We have also filed four petitions for inter partes review with the ~~PTAB~~USPTO Patent Trial and Appeal Board (PTAB) alleging that all asserted claims are invalid for anticipation and obviousness. In ~~March~~ 2018, the District Court stayed the litigation until after the PTAB rules on our petitions for inter partes review.

~~Petitions for Inter Partes Review filed by Initiative for Medicines, Access & Knowledge~~

In October 2017, we received notice that Initiative for Medicines, Access & Knowledge (I-MAK) submitted multiple petitions requesting inter partes review to the PTAB alleging that certain patents associated with sofosbuvir are invalid as either not novel or obvious. We strongly believe I-MAK’s petitions are without merit and that sofosbuvir, the only approved HCV drug of its kind, is both novel and not obvious. Accordingly, we defended against these allegations, and the PTAB declined to institute all ten of I-MAK’s petitions for inter partes review and denied I-MAK’s petitions for rehearing.

~~European Patent Claims~~

In February 2015, several parties filed oppositions in the EPO requesting revocation of one of our granted European patents covering sofosbuvir that expires in 2028. In October 2016, the EPO upheld the validity of certain claims of our sofosbuvir patent. We have appealed this decision, seeking to restore all of the original claims, and several of the original opposing parties have also appealed, requesting full revocation. The appeal process may take several years.

In April 2017, several parties filed oppositions in the EPO requesting revocation of our granted European patent relating to sofosbuvir that expires in 2024. The EPO conducted an oral hearing for this opposition in September 2018 and upheld the claims. The decision may be appealed.

In January 2016, several parties filed oppositions in the EPO requesting revocation of our granted European patent covering TAF that expires in 2021. In July 2017, the EPO upheld the validity of the claims of our TAF patent. Three parties have appealed this decision. The appeal process may take several years.

In July 2017, several parties filed oppositions in the EPO requesting revocation of our granted European patent relating to TAF hemifumarate that expires in 2032. We have responded to these oppositions. The EPO has not yet set a date for the oral hearing regarding this opposition.

In March 2016, three parties filed oppositions in the EPO requesting revocation of our granted European patent covering cobicistat that expires in 2027. In December 2017, the EPO upheld the validity of the claims of our cobicistat patent. The parties that filed the oppositions may appeal this decision. The appeal process may take several years.

While we are confident in the strength of our patents, we cannot predict the ultimate outcome of these oppositions. 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, TAF and cobicistat in the European Union could be substantially shortened or eliminated entirely. If our patents are revoked, and no other European patents are granted covering these compounds, our exclusivity may be based entirely on regulatory exclusivity granted by the European Medicines Agency. Sovaldi has been granted regulatory exclusivity that will prevent generic sofosbuvir from entering the European Union for 10 years following approval of Sovaldi, or January 2024. If we lose patent protection for sofosbuvir prior to 2028, our revenues and results of operations could be negatively impacted for the years including and succeeding the year in which such exclusivity is lost, which may cause our stock price to decline.

Litigation Related to Axicabtagene Ciloleucel

In October 2017, we acquired Kite, which is now our wholly-owned subsidiary. Through the acquisition, we acquired axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T cell therapy. In October 2017, we received approval from FDA for axicabtagene ciloleucel, now known commercially as Yescarta.

We own patents and patent applications that claim axicabtagene ciloleucel chimeric DNA segments. Third parties may have, or may obtain rights to, patents that allegedly could be used to prevent or attempt to prevent us from commercializing axicabtagene ciloleucel or to require us to obtain a license in order to commercialize axicabtagene ciloleucel. For example, we are aware that Juno Therapeutics, Inc. (Juno) has exclusively licensed Patent No. 7,446,190 (the ‘190 patent), which was issued to Sloan Kettering Cancer Center. In September 2017, Juno and Sloan Kettering Cancer Center filed a lawsuit against ~~Kite~~us in the U.S. District Court for the Central District of California, alleging that the commercialization of axicabtagene ciloleucel infringes the ‘190 patent. In October 2017, following FDA approval for Yescarta, Juno filed a second complaint alleging that axicabtagene ciloleucel infringes the ‘190 patent. Juno subsequently moved to dismiss the September 2017 complaint and has maintained the October 2017 complaint. The court has set a trial date of ~~October~~December 2019 for this lawsuit.

In August 2015, Kite filed a petition for inter partes review in the USPTO alleging that the asserted claims of the ‘190 patent are invalid as obvious. In December 2016, the PTAB determined that the claims of the ‘190 patent are not invalid due to obviousness. In February 2017, Kite filed a Notice of Appeal to the CAFC. In June 2018, the CAFC affirmed the PTAB’s determination that the ‘190 patent claims are not invalid due to obviousness.

We cannot predict the ultimate outcome of intellectual property claims related to axicabtagene ciloleucel. If Juno’s patent is upheld as valid and Juno successfully proves infringement of that patent by axicabtagene ciloleucel, we could be required to pay significant monetary damages or we could be prevented from selling Yescarta unless we were able to obtain a license to this patent. Such a license may not be available on commercially reasonable terms or at all.

Litigation Related to Bictegravir

In ~~February~~ 2018, ViiV Healthcare Company (ViiV) filed a lawsuit against us in the U.S. District Court of Delaware, alleging that the commercialization of bictegravir, ~~now known~~sold commercially in combination with tenofovir alafenamide and emtricitabine as Biktarvy, infringes ViiV’s U.S. Patent No. 8,129,385 (the ‘385 patent), which was issued to Shionogi & Co. Ltd. &and GlaxoSmithKline LLC. The ‘385 patent is the compound patent covering ViiV’s dolutegravir. Bictegravir is structurally different from dolutegravir, and we believe that bictegravir does not infringe the

claims of the ‘385 patent. To the extent that ViiV’s patent claims are interpreted to cover bictegravir, we believe those claims are invalid. The ~~USPTO~~U.S. Patent and Trademark Office (USPTO) has granted us patents covering bictegravir. The court has set a trial date of September 2020 for this lawsuit.

In ~~February~~ 2018, ViiV also filed a lawsuit against us in the Federal Court of Canada, alleging that our activities relating to our bictegravir ~~product~~compound have infringed ViiV’s Canadian Patent No. 2,606,282 (the ‘282 patent), which was issued to Shionogi & Co. Ltd. and ViiV. The ‘282 patent is the compound patent covering ViiV’s dolutegravir. We believe that bictegravir does not infringe the claims of the ‘282 patent. To the extent that ViiV’s patent claims are interpreted to cover bictegravir, we believe those claims are invalid.

We cannot predict the ultimate outcome of intellectual property claims related to bictegravir. If ViiV’s patents are upheld as valid and ViiV successfully proves infringement of those patents by bictegravir, we could be required to pay significant monetary damages.

Litigation with Generic Manufacturers

As part of the approval process for some of our products, 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 our products earlier than their patent expiration would have a significant negative

effect on our revenues and results of operations. To seek approval for a generic version of a product having NCE status, a generic company may submit its ANDA to FDA four years after the branded product’s approval.

Current legal proceedings of significance with generic manufacturers include:

HIV Products

In ~~February 2016,~~2018, we received notice that ~~Mylan~~Zydus Pharmaceuticals (USA) Inc. (Mylan) submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Tybost (cobicistat). In the notice, Mylan alleges that the patent covering cobicistat is invalid as obvious and that Mylan’s generic product cannot infringe an invalid claim. In March 2016, we filed lawsuits against Mylan in the U.S. District Court for the District of Delaware and U.S. District Court for the Northern District of West Virginia. The parties have agreed to dismiss the action in West Virginia, and the trial in Delaware was stayed. The patent in suit that covers Tybost is also listed in the Orange Book for Stribild and Genvoya. In November 2017, we received notice that Mylan submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Evotaz (atazanavir/cobicistat) and challenging the validity of our cobicistat compound patent, citing the arguments it has made in the ongoing litigation involving Tybost. In December 2017, we filed a lawsuit against Mylan in the U.S. District Court for the Northern District of West Virginia. In July 2018, we reached an agreement with Mylan to resolve all pending lawsuits. The settlement agreement has been filed with the Federal Trade Commission and Department of Justice as required by law.

~~In April and May 2018, we received notices that Aurobindo Pharma USA Inc. (Aurobindo)~~(Zydus) submitted an ANDA to FDA requesting permission to manufacture and market generic versions of Truvada at ~~low~~various dosage strengths. In the ~~May~~ notice, Aurobindo alleges that two patents associated with emtricitabine are invalid, unenforceable and/or will not be infringed by Aurobindo’s manufacture, use or sale of generic versions of Truvada at low dosage strengths. In May 2018, we filed a lawsuit against Aurobindo in the U.S. District Court for the District of Delaware for infringement of our patents. In October 2018, we reached an agreement with Aurobindo to resolve the lawsuit. The settlement agreement has been filed with the Federal Trade Commission and Department of Justice as required by law.

~~In May 2018, we received notice that Strides Pharma Inc. (Strides) submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Truvada. In the notice, Strides~~Zydus alleges that two patents associated with emtricitabine and four patents associated with the emtricitabine and tenofovir disoproxil fumarate fixed-dose combination are invalid, unenforceable and/or will not be infringed by ~~Strides’~~Zydus’ manufacture, use or sale of a generic ~~version~~versions of ~~Truvada.~~Truvada at various dosage strengths. In ~~June 2018,~~response, we filed a lawsuit against ~~Strides~~Zydus in the U.S. District Court for the District of New Jersey for infringement of our patents.

In 2018, we received notice that Mylan Pharmaceuticals Inc. (Mylan) submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Stribild. In the notice, Mylan alleges that one patent owned by Japan Tobacco Inc. (JT) and associated with elvitegravir is invalid, unenforceable and/or will not be infringed by Mylan’s manufacture, use or sale of a generic version of Stribild. In 2019, JT filed a lawsuit against Mylan in the U.S. District Court for the Northern District of West Virginia for infringement of its patent. In 2019, JT reached an agreement with Mylan to resolve the lawsuit, which has been dismissed.

HCV Products

In ~~February~~ 2018, we received notices from Natco Pharma Limited (Natco) and Teva Pharmaceuticals (Teva) that they have each submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Sovaldi. In Teva’s notice, it alleges that nine patents associated with sofosbuvir are invalid, unenforceable and/or will not be infringed by Teva’s manufacture, use or sale of generic versions of Sovaldi. In ~~March 2018,~~response, we filed lawsuits against Teva in the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Delaware for infringement of these patents. In Natco’s notice, it alleges that two patents associated with sofosbuvir are invalid, unenforceable and/or will not be infringed by Natco’s manufacture, use or sale of generic versions of Sovaldi. ~~Natco did not challenge all patents listed on the Orange Book for Sovaldi. In March 2018,~~

weWe also filed lawsuits against Natco in the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Delaware for infringement of these patents. In 2018, we reached an agreement with Teva to resolve the lawsuit, which has been dismissed. The settlement agreement has been filed with the Federal Trade Commission and Department of Justice as required by law. In 2019, we reached an agreement with Natco to resolve the lawsuit, which has been dismissed. The settlement agreement has been filed with the Federal Trade Commission and Department of Justice as required by law.

~~TAF Litigation~~European Patent Claims

In ~~January 2016, AIDS Healthcare Foundation, Inc. (AHF)~~2015, several parties filed a complaint with the U.S. District Court for the Northern District of California against Gilead, Japan Tobacco, Inc. and Japan Tobacco International, U.S.A. (together, JT), and Emory University. In April 2016, AHF amended its complaint to add Janssen and Johnson & Johnson Inc. (J&J) as defendants. AHF claims that U.S. Patent Nos. 7,390,791; 7,800,788; 8,754,065; 8,148,374; and 8,633,219 are invalid. In addition, AHF claims that Gilead, independently and together with JT, Akros, Janssen and J&J, is violating federal and state antitrust and unfair competition lawsoppositions in the ~~market for sales~~EPO requesting revocation of ~~TAF by offering TAF as part~~one of ~~a fixed-dose combination product with elvitegravir, cobicistat and emtricitabine (Genvoya), a fixed-dose combination product with emtricitabine and rilpivirine (Odefsey) and~~our granted European patents covering sofosbuvir that expires in ~~a fixed-dosed combination product with emtricitabine (Descovy). AHF sought a declaratory judgment~~2028. In 2016, the EPO upheld the validity of ~~invalidity against each~~certain claims of our sofosbuvir patent. We have appealed this decision, seeking to restore all of the ~~patents as well as monetary damages.~~ original claims, and several of the original opposing parties have also appealed, requesting full revocation. The appeal process may take several years.

In ~~May~~2017, several parties filed oppositions in the EPO requesting revocation of our granted European patent relating to sofosbuvir that expires in 2024. The EPO conducted an oral hearing for this opposition in 2018 and upheld the claims. Two of the original opposing parties have appealed, requesting full revocation. The appeal process may take several years.

In 2016, ~~we, JT, Janssen~~several parties filed oppositions in the EPO requesting revocation of our granted European patent covering TAF that expires in 2021. In 2017, the EPO upheld the validity of the claims of our TAF patent. Three parties have appealed this decision. The appeal process may take several years.

In 2017, several parties filed oppositions in the EPO requesting revocation of our granted European patent relating to TAF hemifumarate that expires in 2032. We responded to these oppositions, and ~~J&J filed motions to dismiss all of AHF’s claims, which AHF opposed. In June 2016,~~ a hearing was held onin February 2019. The patent was upheld at this hearing. Three parties have appealed this decision. The appeal process may take several years.

In 2016, three parties filed oppositions in the ~~motions to dismiss.~~EPO requesting revocation of our granted European patent covering cobicistat that expires in 2027. In ~~July 2016,~~2017, the ~~judge granted our and the other defendants’ motions and dismissed all of AHF’s claims. AHF subsequently appealed the court’s decision dismissing the challenge to~~EPO upheld the validity of the claims of our cobicistat patent. One of the original opposing parties has appealed this decision. The appeal process may take several years.

While we are confident in the strength of our patents, we cannot predict the ultimate outcome of these oppositions. 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, TAF, ~~patents. In May 2018,~~TAF hemifumarate and cobicistat in the ~~Federal Circuit affirmed the lower court’s decision dismissing AHF’s claims. In August 2018, AHF filed a petition for review~~European Union could be substantially shortened or eliminated entirely. If our patents are revoked, and no other European patents are granted covering these compounds, our exclusivity may be based entirely on regulatory exclusivity granted by the ~~U.S. Supreme Court~~European Medicines Agency. If we lose patent protection for any

of these compounds, our revenues and results of operations could be negatively impacted for the years including and succeeding the year in ~~October 2018, the U.S. Supreme Court denied AHF’s petition.~~which such exclusivity is lost, which may cause our stock price to decline.

Government Investigations and Related Litigation

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~~Also in 2014, the former employees served a First Amended ~~Complaint. In January 2015,~~Complaint, and the U.S. District Court for the Northern District of California 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, and ~~in June 2015,~~ the District Court issued an order granting our motion to dismiss the Second Amended Complaint. ~~In July 2015, the~~The plaintiffs then filed a notice of appeal in the U.S. Court of Appeals for the Ninth Circuit. In ~~July 2017, a three-judge panel of the Ninth Circuit reversed and remanded the case back to the District Court. In October~~ 2017, the Ninth Circuit granted our motion to stay the case pending an appeal to the U.S. Supreme ~~Court. In December 2017,~~Court, and we filed a Petition for a Writ of Certiorari to the U.S. Supreme Court. ~~We expect~~In 2018, the Solicitor General submitted a brief for the United States to the U.S. Supreme Court stating its intention to ~~decide whether it will hear~~file a motion to dismiss under the federal False Claims Act. In January 2019, the U.S. Supreme Court denied the petition and the case has been remanded to the District Court. In March 2019, the Department of Justice filed a motion to dismiss the Second Amended Complaint, which the District Court is expected to rule upon later this year.

In ~~February~~ 2016, we received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts requesting documents related to our support of 501(c)(3) organizations that provide financial assistance to patients and documents concerning our provision of financial assistance to patients for our HCV products. We are cooperating with this inquiry. In ~~October~~ 2017, we received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts requesting documents related to our copay coupon program and Medicaid price reporting methodology. We are cooperating with this inquiry.

In ~~September~~ 2017, we received a voluntary request for information from the U.S. Attorney’s Office for the Eastern District of Pennsylvania requesting information related to our reimbursement support offerings, clinical education programs and interactions with specialty pharmacies for Sovaldi and Harvoni. In ~~June~~ 2018, we received another voluntary request for information related to our speaker programs and advisory boards for our HCV and hepatitis B virus ~~(HBV)~~ products. We are cooperating with these voluntary requests.

In ~~October~~ 2017, we received a subpoena from the California Department of Insurance and the Alameda County District Attorney’s Office requesting documents related to our marketing activities, reimbursement support offerings, clinical education programs and interactions with specialty ~~pharmacies.~~pharmacies for Harvoni and Sovaldi. We are cooperating with this inquiry.

In November 2017, Health Choice Advocates LLC served us with a complaint in the United States District Court for the Eastern District of Texas alleging violations of the False Claims Act and similar state statutes through our marketing activities, reimbursement support offerings and clinical education programs for Sovaldi and Harvoni. The lawsuit was unsealed after the United States and 31 plaintiff-states declined to intervene in the action. In February 2018, we filed two motions to dismiss the complaint. In July 2018, the District Court entered an order dismissing the matter without prejudice as to all claims.

In November 2017, we received a subpoena from the U.S. Department of Health and Human Services requesting documents related to our Frontlines of Communities in the United States (FOCUS) program. We are cooperating with this inquiry.

~~In November~~ 2017, we also received a subpoena from the U.S. Attorney’s Office for the Southern District of New York requesting documents related to our promotional speaker programs for HIV. We are cooperating with this inquiry.

Product Liability

We have been named as a defendant in one class action lawsuit and various product liability lawsuits related to Viread, Truvada, Atripla, Complera and Stribild. Plaintiffs allege that Viread, Truvada, Atripla, Complera and/or Stribild caused them to suffer kidney and/or bone injuries. The lawsuits, all of which are pending in state or federal court in California, involve hundreds of plaintiffs. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss. We intend to vigorously defend ourselves in these actions. While we believe these cases are without merit, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages.

Antitrust and Consumer Protection

We (along with JT, Bristol-Myers Squibb Company and Johnson & Johnson, Inc.) have been named as defendants in a class action lawsuit filed in 2019 related to various drugs used to treat HIV, including drugs used in combination antiretroviral therapy. Plaintiffs allege that we (and the other defendants) engaged in various conduct to restrain competition in violation of federal and state antitrust laws and state consumer protection laws. The lawsuit, a consolidated action pending in the United States District Court for the Northern District of California, seeks to bring claims on behalf of a nationwide class of end-payor purchasers. Plaintiffs seek damages, permanent injunctive relief, and other relief. We intend to vigorously defend ourselves in this action. While we believe this action is without merit, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages or could be subject to permanent injunctive relief.

Other Matters

We are a party to various legal actions that arose 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.


~~11.~~12.	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, 2017 1,308
$ 1
$ 1,264
$ 165
$ 19,012
$ 59
$ 20,501
Change in noncontrolling interest —
—
—
—
—
82
82
Net income —
—
—
—
5,452
5
5,457
Other comprehensive income, net of tax —
—
—
164
—
—
164
Issuances under employee stock purchase plan 1
—
91
—
—
—
91
Issuances under equity incentive plans 12
—
167
—
—
—
167
Stock-based compensation —
—
667
—
—
—
667
Repurchases of common stock (27 ) —
(71 ) —
(1,996 ) —
(2,067 )
Dividends declared —
—
—
—
(2,245 ) —
(2,245 )
Cumulative effect from the adoption of new accounting standards —
—
—
(293 ) 483
—
190
Balance at September 30, 2018 1,294
$ 1
$ 2,118
$ 36
$ 20,706
$ 146
$ 23,007

~~Accumulated Other Comprehensive Income (Loss)~~

~~The following table summarizes the changes in AOCI by component, net of tax (in millions):~~

Foreign Currency Translation Unrealized Gains and Losses on Available-for-Sale Securities Unrealized Gains and Losses on Cash Flow Hedges Total
Balance at December 31, 2017 $ 85
$ 194
$ (114 ) $ 165
Reclassifications to retained earnings as a result of the adoption of new accounting standards —
(293 ) —
(293 )
Balance at January 1, 2018 85
(99 ) (114 ) (128 )
Net unrealized gain (loss) (17 ) 25
51
59
Reclassifications to net income —
4
101
105
Net current period other comprehensive income (loss) (17 ) 29
152
164
Balance at September 30, 2018 $ 68
$ (70 ) $ 38
$ 36

The amounts reclassified to net income for gains and losses on cash flow hedges are recorded as part of Product sales on our Condensed Consolidated Statements of Income. See Note 5, Derivative Financial Instruments, for additional information. The amounts reclassified to net income for gains and losses on available-for-sale debt securities are recorded as part of Other income (expense), net, on our Condensed Consolidated Statements of Income.

Stock Repurchase Program

In the first quarter of 2016, our Board of Directors authorized a $12.0 billion stock repurchase program (2016 Program) under which repurchases may be made in the open market or in privately negotiated transactions. We started repurchases under the 2016 Program in April 2016.

During the three and ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, we repurchased and retired 69 million and 2621 million shares of our common stock for ~~$449~~$588 million and ~~$1.9~~$1.4 billion, respectively, through open market transactions under the 2016 Program. During the three and six months ended June 30, 2018, we repurchased and retired 7 million and 20 million shares of our common stock for $450 million and $1.5 billion, respectively, through open market transactions under the 2016 Program. As of ~~September~~June 30, ~~2018,~~2019, the remaining authorized repurchase amount under the 2016 Program was ~~$6.1~~$3.7 billion.

Accumulated Other Comprehensive Income (Loss)

The following table summarizes the changes in AOCI by component, net of tax during the six months ended June 30, 2019 and 2018 (in millions):



	Foreign Currency Translation		Unrealized Gains and Losses on Available-for-Sale Debt Securities			Unrealized Gains and Losses on Cash Flow Hedges			Total
Balance at December 31, 2018	$	47	$	(52	)	$	85		$	80
Net unrealized gain	8		49			29			86
Reclassifications to net income	—		—			(64		)	(64		)
Net current period other comprehensive income (loss)	8		49			(35		)	22
Balance at June 30, 2019	$	55	$	(3	)	$	50		$	102



	Foreign Currency Translation			Unrealized Gains and Losses on Available-for-Sale Debt Securities			Unrealized Gains and Losses on Cash Flow Hedges			Total
Balance at December 31, 2017	$	85		$	194		$	(114	)	$	165
Reclassifications to retained earnings as a result of the adoption of new accounting standards	—			(293		)	—			(293		)
Balance at January 1, 2018	85			(99		)	(114		)	(128		)
Net unrealized gain (loss)	(18		)	(6		)	57			33
Reclassifications to net income	—			4			93			97
Net current period other comprehensive income (loss)	(18		)	(2		)	150			130
Balance at June 30, 2018	$	67		$	(101	)	$	36		$	2

The amounts reclassified to net income for gains and losses on cash flow hedges are recorded as part of Product sales on our Condensed Consolidated Statements of Income. See Note 5. Derivative Financial Instruments for additional information. The amounts reclassified to net income for gains and losses on available-for-sale debt securities are recorded as part of Other income (expense), net on our Condensed Consolidated Statements of Income. The income tax impact allocated to each component of other comprehensive income was not material for the periods presented.


~~12.~~13.	NET INCOME PER SHARE ATTRIBUTABLE TO GILEAD COMMON STOCKHOLDERS

Basic net income per share attributable to Gilead common stockholders is calculated based on the weighted-average number of shares of our common stock outstanding during the period. Diluted net income per share attributable to Gilead common stockholders is calculated based on the weighted-average number of shares of our common stock ~~outstanding~~ and other dilutive securities outstanding during the period. The potentially dilutive shares of our common stock resulting from the assumed exercise of outstanding stock options and equivalents were determined under the treasury stock method.

~~We have~~Potential shares of common stock excluded stock options and equivalents of 12 million and 13 million for the three and nine months ended September 30, 2018, respectively, and 9 million for both the three and nine months ended September 30, 2017 from the computation of diluted net income per share attributable to Gilead common ~~stockholders~~shareholders because their effect ~~was antidilutive.~~would have been antidilutive were 17 million and 14 million for the three and six months ended June 30, 2019, respectively, and 21 million and 16 million for the three and six months ended June 30, 2018, respectively.

The following table summarizes the calculation of basic and diluted net income per share attributable to Gilead common stockholders (in millions, except per share amounts):



	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2019		2018		2019		2018
Net income attributable to Gilead	$	1,880	$	1,817	$	3,855	$	3,355
Shares used in per share calculation - basic	1,270		1,298		1,273		1,302
Dilutive effect of stock options and equivalents	7		10		7		12
Shares used in per share calculation - diluted	1,277		1,308		1,280		1,314
Net income per share attributable to Gilead common stockholders - basic	$	1.48	$	1.40	$	3.03	$	2.58
Net income per share attributable to Gilead common stockholders - diluted	$	1.47	$	1.39	$	3.01	$	2.55

Three Months Ended Nine Months Ended
September 30, September 30,
2018 2017 2018 2017
Net income attributable to Gilead $ 2,097
$ 2,718
$ 5,452
$ 8,493
Shares used in per share calculation - basic 1,296
1,306
1,302
1,307
Dilutive effect of stock options and equivalents 11
13
11
12
Shares used in per share calculation - diluted 1,307
1,319
1,313
1,319
Net income per share attributable to Gilead common stockholders - basic $ 1.62
$ 2.08
$ 4.19
$ 6.50
Net income per share attributable to Gilead common stockholders - diluted $ 1.60
$ 2.06
$ 4.15
$ 6.44


~~13.~~14.	SEGMENT INFORMATION

We have one operating segment, which primarily focuses on the discovery, development and commercialization of innovative medicines in areas of unmet medical need. Therefore, our results of operations are reported on a consolidated basis consistent with internal management reporting reviewed by our chief operating decision maker, who is our chief executive officer.

See Note 2,2. Revenues for a summary of disaggregated revenues by product and geographic region.

The following table summarizes revenues from each of our customers who individually accounted for 10% or more of our total revenues (as a percentage of total revenues):



	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2019		2018		2019		2018
AmerisourceBergen Corp.	20	%	20	%	20	%	20	%
Cardinal Health, Inc.	21	%	20	%	21	%	20	%
McKesson Corp.	20	%	21	%	20	%	21	%

Three Months Ended Nine Months Ended
September 30, September 30,
2018 2017 2018 2017
AmerisourceBergen Corp. 20 % 21 % 20 % 20 %
Cardinal Health, Inc. 20 % 19 % 20 % 18 %
McKesson Corp. 22 % 25 % 21 % 23 %


~~14.~~15.	INCOME TAXES

On December 22, 2017, Tax Reform was signed into law making significant changes to the Internal Revenue Code of 1986, as amended. Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017, implementation of a modified territorial tax system and a repatriation tax on deemed repatriated earnings of foreign subsidiaries. We included a provisional estimate of the impact from Tax Reform in our 2017 income tax provision in accordance with our interpretation of Tax Reform and SAB 118.

We may refine our provisional estimates as further guidance is issued from the U.S. Treasury, the SEC and the FASB. Additionally, we are continuing to evaluate the accounting policy election required with regard to the tax on Global Intangible Low-Taxed Income (the Global Minimum Tax). The FASB allows companies to adopt a policy election to account for the Global Minimum Tax under one of two methods: (i) account for the Global Minimum Tax as a component of tax expense in the period in which a company is subject to the rules (the period cost method), or (ii) account for the Global Minimum Tax in a company’s measurement of deferred taxes (the deferred method). We have not elected a method and will only do so after our completion of the analysis of the Global Minimum Tax provisions. Our election method will depend, in part, on analyzing expected future U.S. taxable income inclusions related to Global Minimum Tax under both methodologies in order to determine the most appropriate method. Should we decide to elect the deferred method of accounting for the Global Minimum Tax, it is possible that our provisional

~~estimate for re-measuring our deferred taxes may materially change. We will finalize the analysis for the accounting policy election during the fourth quarter of 2018.~~

During the three and nine months ended September 30, 2018, we repatriated $500 million and $29.7 billion, respectively, of cash, cash equivalents and marketable securities to our parent company headquartered in the United States. Prior to the enactment of Tax Reform, these earnings were considered indefinitely reinvested and no U.S. taxes had been provided. In 2017, U.S. taxes were provided on these earnings through the accrual of the Tax Reform transition tax.

Our effective income tax rate of ~~21.2%~~22.2% for the three months ended ~~September~~June 30, ~~2018~~2019 differed from the U.S. federal statutory rate of 21% primarily due to the tax on Global ~~Minimum Tax and~~Intangible Low-Taxed Income, state taxes and our portion of the non-tax deductible Branded Prescription Drug (BPD) fee, partially offset by earnings from non-U.S. subsidiaries that operate in jurisdictions with lower tax rates than the United States.

Our effective income tax rate of ~~19.5%~~19.3% for the ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 differed from the U.S. federal statutory rate of 21% primarily due to a ~~$202~~$119 million tax benefit related to ~~settlement of a tax examination for an acquired entity~~settlements with taxing authorities and earnings from non-U.S. subsidiaries that operate in jurisdictions with lower tax rates than the United States, partially offset by the Global ~~Minimum Tax~~Intangible Low-Taxed Income, state taxes and our portion of the non-tax deductible BPD fee.

Our effective income tax rates of 12.8% and 18.5% for the three and six months ended June 30, 2018, respectively, differed from the U.S. federal statutory rate of 21% primarily due to tax benefits of $202 million and $153 million, respectively, related to settlements of tax examinations and earnings from non-U.S. subsidiaries that operate in jurisdictions with lower tax rates than the United States, partially offset by the Global Intangible Low-Taxed Income and state taxes.

We file federal, state and foreign income tax returns in the United States and in many foreign jurisdictions. For federal and California income tax purposes, the statute of limitations is open for 2013 and 2010 and onwards. For certain acquired entities, the statute of limitations is open for all years from inception due to our utilization of their net operating losses and credits carried over from prior years.

onwards, respectively. Our income tax returns are subject to audit by federal, state and foreign tax authorities. We are currently under examination by the IRS for the tax years from 2013 to 2015 and by various state and foreign jurisdictions. There are differing interpretations of tax laws and regulations, and as a result, significant disputes may arise with these tax authorities involving issues of the timing and amount of deductions and allocations of income among various tax jurisdictions. We ~~periodically~~regularly evaluate our exposures associated with our tax filing positions.

We record liabilities related to uncertain tax positions in accordance with the income tax guidance which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Resolution of one or more of these uncertain tax positions in any period may have a material impact on the results of operations for that period.

Our unrecognized tax benefits decreased by ~~$736~~$119 million during the ~~nine~~six months ended ~~September~~June 30, ~~2018 primarily~~2019 due to ~~a $706 million decrease for settlement of a tax examination.~~settlements with taxing authorities. As of ~~September~~June 30, ~~2018,~~2019, we believe that it is reasonably possible that our unrecognized tax benefits ~~will decrease by approximately $100 million~~may materially change in the next 12 months due to potential ~~settlements~~resolutions with a taxing ~~authorities.~~authority. An estimate of the range of the reasonably possible change cannot be determined at this time.

In June 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in Altera Corp. v. Commissioner reversing the prior decision of the United States Tax Court and requiring related parties in an intercompany cost-sharing arrangement to share expenses related to stock-based compensation. It is possible that there will be further judicial review of this issue; and as such, we believe the law to be unsettled and continue to recognize tax benefits for the exclusion of stock-based compensation from our cost-sharing arrangement. We will continue to monitor this issue and will reassess our evaluation of the financial reporting impact when more information becomes available.


16.	SUBSEQUENT EVENT

In July 2019, we entered into an Option, License and Collaboration Agreement (the Collaboration Agreement) with Galapagos NV (Galapagos), pursuant to which the parties entered into a global collaboration that covers Galapagos’ current and future product portfolio (other than filgotinib, an investigational, selective JAK1 inhibitor for inflammatory disease indications, which is already subject to the parties’ existing collaborative arrangement). Upon the closing of the Collaboration Agreement, we will make an up-front license and option fee payment of $3.95 billion and an equity investment in Galapagos of approximately $1.1 billion.

Collaboration Agreement

Under the Collaboration Agreement, we will acquire rights to participate in the development and commercialization of GLPG-1690, Galapagos’ Phase 3 candidate for idiopathic pulmonary fibrosis, and receive option rights to participate in the development and commercialization of GLPG-1972, a Phase 2b candidate for osteoarthritis, and Galapagos’ other current and future clinical programs that have entered clinical development during the first ten years of the collaboration. We may exercise our option to acquire a license to a program after the receipt of a data package from a completed, qualifying Phase 2 study for such program (or, in certain circumstances, the first Phase 3 study).

If GLPG-1690 receives marketing approval in the United States, we will pay Galapagos $325 million as well as tiered royalties. If we exercise our option to acquire a license to the GLPG-1972 program after the completion of Galapagos’ ongoing Phase 2 trial, we will pay a $250 million option exercise fee. In addition, following opt-in, Galapagos would be eligible to receive up to $750 million in development, regulatory and commercial milestones on GLPG-1972 as well as tiered royalties. With respect to all other products in Galapagos’ current and future pipeline, if we exercise our option to acquire a license to a program, we will pay a $150 million option exercise fee per program. In addition, Galapagos will receive tiered royalties ranging from 20% to 24% on net sales of all Galapagos products optioned by us as part of the Collaboration Agreement (including GLPG-1690 and GLPG-1972), subject to customary royalty terms and adjustments.

If we exercise our option rights for a program, we will share development costs and mutually agreed commercialization costs equally with Galapagos, subject to the ability of either party to conduct certain independent research or development activities and independent commercial activities in their respective territories. Galapagos will retain exclusive rights to commercialize products included in the optioned program in the European Union, Iceland, Norway, Lichtenstein and Switzerland, and we will have exclusive commercialization rights for such products for all other countries globally, except for GLPG-1972 where we will only acquire the U.S. rights as they are the only rights not subject to a license agreement between Galapagos and a third party.

For each program we opt-in to, we are required to use commercially reasonable efforts to obtain marketing approval in the United States and Japan and to market, promote, sell or distribute one product for one indication in the United States and Japan. We may terminate the collaboration in its entirety or on a program-by-program and country-by-country basis with advance notice as well as following other customary termination events.

Subscription Agreement

In July 2019, we entered into a Subscription Agreement (the Subscription Agreement) with Galapagos pursuant to which we agreed to purchase, subject to certain conditions, the number of ordinary shares of Galapagos, no par value (the Subscription Shares), sufficient to bring our aggregate ownership percentage in Galapagos at the closing of the Subscription Agreement to 20.1% on a fully diluted basis. The price per subscription share is equal to €140.59. In addition, subject to and upon Galapagos’ shareholders’ approval, we will be issued and will subscribe to warrants that confer the right to subscribe for a number of new shares to be issued by Galapagos sufficient to bring the number of shares owned by us to 29.9% of the issued and outstanding shares. We are subject to a 10-year standstill restricting our ability to acquire voting securities of Galapagos exceeding more than 29.9% of the then issued and outstanding voting securities of Galapagos.

We agreed not to, without the prior consent of Galapagos, dispose of any equity securities of Galapagos prior to the earlier of the second anniversary of the closing of the Subscription Agreement and the termination of the Subscription Agreement (if the closing does not occur). During the period running from the date that is two years following the closing of the Subscription Agreement until the date that is five years following the closing of the Subscription Agreement, we shall not, without the prior

consent of Galapagos, dispose of any equity securities of Galapagos if after such disposal we would own less than 20.1% of the then issued and outstanding voting securities of Galapagos.

We will have the right to have two designees appointed to Galapagos’ board of directors (the Galapagos Board) following the closing of the Subscription Agreement and the approval of Galapagos’ shareholders. In the event that our designees are not approved by Galapagos’ shareholders, our designees will be invited to the Galapagos Board as observers.

The closing of the Collaboration Agreement and Subscription Agreement are subject to a number of closing conditions, including antitrust clearances required by the U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder and receipt of merger control approval from the Austrian Federal Competition Authority.


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

This Quarterly Report on Form 10-Q contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. The forward-looking statements are contained principally in this section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Words such as “expect,” “anticipate,” “target,” “goal,” “project,” “hope,” “intend,” “plan,” “believe,” “seek,” “estimate,” “continue,” “may,” “could,” “should,” “might,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, any statements other than statements of historical fact are forward-looking statements, including statements regarding overall trends, operating cost and revenue trends, liquidity and capital needs, collaboration and licensing arrangements and other statements of expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions. We have based these forward-looking statements on our current expectations about future events. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Our actual results may differ materially from those suggested by these forward-looking statements for various reasons, including those identified below under “Risk Factors.” Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements included in this report are made only as of the date hereof. Except as required under federal securities laws and the rules and regulations of the Securities and Exchange Commission (SEC), we do not undertake and specifically decline any obligation to update any of these statements or to publicly announce the results of any revisions to any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise. In evaluating our business, you should carefully consider the risks described in the section entitled “Risk Factors” under Part II, Item 1A in addition to the other information in this Quarterly Report on Form 10-Q. Any of the risks contained herein could materially and adversely affect our business, results of operations and financial condition.

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our audited Consolidated Financial Statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended December 31, ~~2017~~2018 and our unaudited Condensed Consolidated Financial Statements for the ~~three and nine~~six months ended ~~September~~June 30, ~~2018~~2019 and other disclosures (including the disclosures under Part II, Item 1A, “Risk Factors”) included in this Quarterly Report on Form 10-Q. Our Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles and are presented in U.S. dollars.

Management Overview

Gilead Sciences, Inc. (Gilead, we, our or us), incorporated in Delaware on June 22, 1987, is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. WeWith each new discovery and investigational drug candidate, we strive to transform and simplify care for people with life-threatening illnesses around the world. We have operations in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead’s primary areas of focus include HIV/AIDS, liver diseases, hematology/oncology and inflammation/respiratory diseases. We seek to add to our existing portfolio of products through our internal discovery and clinical development programs, ~~and through~~ product acquisition, in-licensing and ~~in-licensing strategies.~~strategic collaborations.

Our portfolio of marketed products includes AmBisome^®, Atripla^®, Biktarvy^®, Cayston^®, Complera^®/Eviplera^®, Descovy^®, Emtriva^®, Epclusa^®, Genvoya^®, Harvoni^®, Hepsera^®, Letairis^®, Odefsey^®, Ranexa^®, Sovaldi^®, Stribild^®, Truvada^®, Tybost^®, Vemlidy^®, Viread^®, Vosevi^®, Yescarta^®and Zydelig^® ~~and Zydelig~~^®. We ~~have U.S.~~sell and ~~international commercial sales operations, with marketing subsidiaries~~distribute authorized generic versions of Epclusa and Harvoni in ~~over 35 countries. We also~~the United States through our separate subsidiary, Asegua Therapeutics LLC. In addition, we sell and distribute certain products through our corporate partners under ~~royalty-paying~~ collaborative agreements.

Business Highlights

During the ~~third~~second quarter of ~~2018,~~2019, we continued to advance our product pipeline across our therapeutic areas with the goal of delivering best-in-class drugs that advance the current standard of care and/or address unmet medical need. Recent key announcements include:

~~HIV~~

Collaborations:

Entry into a global research and ~~Liver Diseases Programs~~

~~The Hong Kong Department~~development collaboration with Galapagos NV (Galapagos). Upon closing of ~~Health approved Biktarvy for~~ the ~~treatment~~collaboration with Galapagos, we will make an up-front license and option fee payment of ~~HIV-1 infection~~$3.95 billion and an equity investment in ~~adults. Hong Kong is~~Galapagos of approximately $1.1 billion. Under the collaboration agreement, we have option rights to acquire an exclusive license to all current and future clinical programs of Galapagos being developed during the first ~~market in Asia~~ten years of the collaboration and, for those programs that entered clinical development prior to ~~approve Biktarvy.~~

~~We announced 96-week results from two Phase 3, randomized, double-blinded studies evaluating~~ the ~~safety and efficacy~~end of ~~Biktarvy~~the initial option term, for up to an additional three years thereafter. The closing of the ~~treatment of HIV-1 infection in treatment-naive adults. In the ongoing studies, Biktarvy was found to be statistically non-inferior~~collaboration with Galapagos is subject to a ~~regimen~~number of ~~dolutegravir~~closing conditions, including antitrust clearances required by the U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and ~~emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF)~~the rules and regulations promulgated thereunder and receipt of merger control approval from the Austrian Federal Competition Authority.

Entry into collaboration and/or license agreements with Renown Institute for Health Innovation, Novartis AG, Carna Biosciences Inc., Nurix Therapeutics, Inc., Humanigen, Inc. and Goldfinch Bio, Inc.

Product, Pipeline and Other Updates:

Presentation of data at the 10th International AIDS Society Conference on HIV Science, which included:


◦	Results from a sub-analysis of the DISCOVER trial evaluating an investigational use of Descovy for HIV pre-exposure prophylaxis (PrEP), which demonstrated that Descovy reached intracellular drug concentration levels above the estimated protective threshold significantly more quickly than Truvada and that these drug concentration levels persist longer than Truvada;


◦	Results from two studies of investigational toll-like receptor (TLR7) agonists as part of an HIV cure research program. The Phase 1 and preclinical study results demonstrate that TLR7 agonists have a potential role to play in scalable strategies for achieving sustained viral remission in humans;


◦	Results from two Phase 3 trials demonstrating the effectiveness of Biktarvy for the treatment of HIV in women and in virologically suppressed patients with known resistance; and


◦	Results from a Phase 1b study of GS-6207, an investigational, novel, selective capsid inhibitor, in people living with HIV. The Phase 1b data demonstrated the first proof of concept that HIV capsid inhibition can lead to significant declines in viral load in vivo and that resistance to GS-6207 in vitro did not lead to resistance to other classes of drugs used in the treatment of HIV.

Plans for a ~~regimen~~new 67,000-square foot facility in Oceanside, California, dedicated to the development and manufacturing of ~~abacavir/DTG/lamivudine (600/50/300mg) through 96 weeks of therapy.~~

~~We announced plans to launch authorized generic versions of Epclusa and Harvoni~~viral vectors, a critical starting material in the ~~United States through~~production of cell therapies.

Presentation of data at the 2019 American Society of Clinical Oncology Annual Meeting, which included:


◦	Results from a safety management analysis of early use of steroids from the ZUMA-1 trial of Yescarta in adult patients with diffuse large B-cel lymphoma (DLBCL);


◦	Results from a sub-population analysis from the ZUMA-1 trial of Yescarta in adult patients with DLBCL; and


◦	Results from the completed Phase 1 of the ZUMA-3 study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy. ZUMA-3 is a single-arm Phase 1/2 study in adult patients with relapsed or refractory acute lymphoblastic leukemia.

Intent to submit a ~~newly created subsidiary, Asegua Therapeutics LLC.~~

~~We entered into a strategic collaboration with Precision BioSciences (Precision)~~new drug application to ~~develop therapies targeting the~~ ~~in vivo~~ ~~elimination of hepatitis B virus (HBV) with Precision~~’~~s proprietary genome editing platform, ARCUS.~~

~~The China National~~U.S. Food and Drug Administration ~~approved Genvoya~~(FDA) for ~~the treatment of HIV-1 infection.~~

~~Oncology and Cell Therapy Programs~~

We announced a global strategic collaboration with Tango Therapeutics, Inc. (Tango) to discover, develop and commercialize a pipeline of targeted immuno-oncology treatments for patients with cancer. Under the multi-year collaboration, Tango will perform target discovery and validation and we will have options to worldwide rights on up to five targets emerging from Tango’s proprietary functional genomics-based discovery platform.

We entered into a research collaboration and license agreement with HiFiBiO Therapeutics to develop technology supporting the discovery of neoantigen-reactive T cell receptors for the potential treatment of various cancers, including solid tumors.

~~We entered into a license agreement with Trianni, Inc. (Trianni) that grants us the use of the Trianni transgenic human monoclonal antibody discovery platform to support our drug discovery efforts.~~

~~European Commission granted Marketing Authorization for Yescarta~~filgotinib this year, an investigational, oral, selective JAK1 inhibitor, as a treatment for ~~adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more lines~~rheumatoid arthritis (RA).

Presentation of ~~systemic therapy.~~

~~Inflammation Programs~~

~~We announced that detailed results from two clinical trials (EQUATOR and TORTUGA) evaluating filgotinib, an investigational, selective JAK 1 inhibitor, for~~data at the ~~treatment~~Annual European Congress of ~~psoriatic arthritis and ankylosing spondylitis (AS)~~Rheumatology 2019, which included data on filgotinib. Among the abstracts presented were ~~both published in~~ ~~The Lancet. The results of the EQUATOR and TORTUGA studies demonstrate that filgotinib improved~~

~~the signs and symptoms of patients with psoriatic arthritis whose disease had not responded to prior therapies and independently, for those with AS.~~

~~We announced detailed~~24 week interim results from the ongoing FINCH 1 and FINCH 3 Phase 3 ~~FINCH 2 clinical trial of~~studies evaluating filgotinib ~~an investigational, selective JAK1 inhibitor,~~ in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis. FINCH 2 achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response at week 12.RA.

We announced that the randomized, placebo-controlled Phase 2 TORTUGA study of filgotinib achieved its primary efficacy endpoint in adults with moderately to severely active AS. In the study, patients treated with filgotinib achieved significantly greater improvements in AS Disease Activity Score, the primary endpoint, at week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001).

•

The donation of Truvada for PrEP^® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) to the U.S. Centers for Disease Control and Prevention (CDC) in support of national efforts to help prevent HIV and end the epidemic. We will provide to CDC up to 2.4 million bottles of Truvada annually for uninsured Americans at risk for HIV. The donation, which extends until 2030, will transition to Descovy, if it is approved for use as prevention.

Financial Highlights

Total revenues ~~decreased~~increased by 1% to ~~$5.6~~$5.7 billion for the ~~third~~second quarter of ~~2018,~~2019, compared to ~~$6.5 billion for the third quarter of 2017, primarily due to lower product sales, which were $5.5 billion compared to $6.4~~$5.6 billion for the same period in ~~2017.~~2018, primarily due to higher product sales, which were $5.6 billion compared to $5.5 billion for the same period in 2018. The increase in product sales was primarily due to higher HIV product sales and $102 million higher net adjustments for government rebates and discounts related to sales made in prior years, partially offset by lower sales of Ranexa, Letairis and our HCV products.

Cost of goods sold decreased by 16% to $1.0 billion for the second quarter of 2019, compared to $1.2 billion for the same period in 2018, primarily due to lower royalty expenses, lower inventory reserves related to inventory and supply chain

rationalization and lower amortization expense related to the Ranexa intangible asset, which was fully amortized during the first quarter of 2019.

Research and development (R&D) expenses ~~increased~~decreased by 3% to ~~$939~~$1,160 million for the ~~third~~second quarter of ~~2018,~~2019, compared to ~~$789~~$1,192 million for the ~~third quarter~~same period in 2018, primarily due to the 2018 purchase of ~~2017.~~ an FDA Priority Review Voucher and lower stock-based compensation expense in 2019, largely offset by higher investments in 2019 to support our cell therapy programs.

Selling, general and administrative (SG&A) expenses increased by 12% to ~~$948~~$1.1 billion for the second quarter of 2019, compared to $980 million for the ~~third quarter of~~same period in 2018, ~~compared to $879 million for the third quarter of 2017. The increases in both R&D and SG&A expenses were~~ primarily due to higher ~~costs to support~~promotional expenses in the ~~growth~~United States and expenses associated with the expansion of our ~~business~~products in Japan and China, partially offset by lower stock-based compensation expense. Stock-based compensation expense was higher for the second quarter of 2018 following the acquisition of Kite Pharma Inc. ~~(Kite)~~

Net income attributable to Gilead increased to $1.9 billion, or $1.47 per diluted share, for the second quarter of 2019 from $1.8 billion, or $1.39 per diluted share, for the same period in 2018, primarily due to higher income from operations and ~~stock-based compensation expenses associated with~~net unrealized gains from changes in the fair value of our ~~acquisition~~equity securities, partially offset by a higher provision for income taxes. Net income attributable to Gilead for the second quarter of ~~Kite.~~2018 benefited from a $202 million, or $0.15 per diluted share, settlement of a tax examination.

As of ~~September~~June 30, ~~2018,~~2019, we had ~~$30.8~~$30.2 billion of cash, cash equivalents and marketable debt securities compared to ~~$31.7~~$31.5 billion as of ~~June 30,~~December 31, 2018. During the ~~third~~second quarter of ~~2018,~~2019, we generated $2.2 billion in operating cash flow, repaid ~~$1.8 billion~~$500 million of ~~our senior unsecured notes due in September 2018,~~debt, paid cash dividends of ~~$742~~$800 million and repurchased 69 million shares of our common stock for ~~$449~~$588 million through open market transactions.

Results of Operations

Total Revenues

The following table summarizes the period-over-period changes in our product sales and royalty, contract and other revenues:

Three Months Ended Nine Months Ended
September 30, September 30,
(In millions, except percentages) 2018 2017 Change 2018 2017 Change
Revenues:
Product sales $ 5,455
$ 6,402
(15 )% $ 15,996
$ 19,825
(19 )%
Royalty, contract and other revenues 141
110
28 % 336
333
1 %
Total revenues $ 5,596
$ 6,512
(14 )% $ 16,332
$ 20,158
(19 )%

On January 1, 2018, we adopted Accounting Standards Update No. 2014-09 (Topic 606) using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. As such, results for the three and nine months ended September 30, 2018 are presented under Topic 606, while the information for the three and nine months ended September 30, 2017 has not been adjusted and continues to be reported in accordance with our historical accounting under Topic 605 “Revenue Recognition” (Topic 605). See Note 1, Summary of Significant Accounting Policies, and Note 2, Revenues, of the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for further information.



	Three Months Ended						Six Months Ended
	June 30,						June 30,
(In millions, except percentages)	2019		2018		Change		2019		2018		Change
Revenues:
Product sales	$	5,607	$	5,540	1	%	$	10,807	$	10,541	3	%
Royalty, contract and other revenues	78		108		(28	)%	159		195		(18	)%
Total revenues	$	5,685	$	5,648	1	%	$	10,966	$	10,736	2	%

Product sales for the three months ended ~~September~~June 30, ~~2018~~2019

Total product sales ~~decreased~~increased by ~~15%~~1% to ~~$5.5~~$5.6 billion for the three months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$6.4~~$5.5 billion for the same period in ~~2017,~~2018, primarily due to higher HIV product sales and $102 million higher net adjustments for government rebates and discounts related to sales made in prior years, partially offset by lower sales of Ranexa, Letairis and our HCV ~~products, partially offset by increased sales of our HIV~~ products.

HIV product sales increased by ~~12%~~10% to ~~$3.7~~$4.0 billion for the three months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$3.3~~$3.7 billion for the same period in ~~2017,~~2018, primarily due to higher sales volume as a result of the continued uptake of ~~Descovy,~~Biktarvy and approximately $70 million of favorable adjustments for statutory rebates in Europe, partially offset by decreases in sales volume of Genvoya and ~~Odefsey~~our Truvada (emtricitabine (FTC) and ~~our launch of Biktarvy in 2018. Biktarvy was approved by FDA in February 2018 and the European Commission in June 2018.~~tenofovir disoproxil fumarate (TDF))-based products.

HCV product sales ~~which consist of Epclusa, Harvoni, Vosevi and Sovaldi,~~ decreased by ~~59%~~16% to ~~$902~~$842 million for the three months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$2.2~~$1.0 billion for the same period in ~~2017.~~2018, primarily due to competitive dynamics, including a decline in U.S. Medicare prices and lower patient starts. The decline was ~~primarily due to lower sales~~partially offset by approximately $80 million of ~~Harvoni, Epclusa and Sovaldi across all major markets as a result of increased competition.~~

~~In HCV, we expect a continued decline~~favorable adjustments for statutory rebates in product sales in the fourth quarter of 2018, compared to the same period in 2017, in major markets as a result of increased competition. HCV revenues are driven by four variables: patient starts, net pricing, market share and treatment duration. Treatment duration has stabilized as a variable and pricing has largely stabilized. We will continue to compete for market share across market segments and geographies. We anticipate patient starts to be more predictable with a continued slight decline moving forward.Europe.

Yescarta ~~which was launched in the United States in October 2017,~~ generated ~~$75~~$120 million in sales during the three months ended ~~September~~June 30, 2019, compared to $68 million for the same period in 2018. The increase was driven by an increase in the number of therapies provided to patients.

Other product sales, which include products from our HBV, cardiovascular, oncology and other categories inclusive of Vemlidy, Viread, Letairis, Ranexa, Zydelig, AmBisome and ~~AmBisome,~~Cayston, decreased by ~~14%~~25% to ~~$751~~$604 million for the three months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$874~~$807 million for the same period in ~~2017. Sales of Viread, which is~~2018. The decrease was primarily ~~used for treatment of chronic HBV, decreased~~ due to the ~~availability~~expected decline in sales of Ranexa and Letairis after the entry of generic versions ~~of the product. Letairis is expected to face generic competition~~ in the United States ~~because the U.S. patent for ambrisentan, the active pharmaceutical ingredient~~ in ~~Letairis, expired in July 2018. Ranexa is expected to face generic competition in the United States starting in the first quarter of~~ 2019. ~~We expect a decline in our Letairis and Ranexa sales in the United States after the generic entries.~~

Of our total product sales, ~~24%~~28% and 27% were generated outside the United States during the three months ended ~~September~~June 30, ~~2018.~~2019 and 2018, respectively. We faced exposure to movements in foreign currency exchange rates, primarily in the Euro. We used foreign currency exchange contracts to hedge a ~~percentage~~portion of our foreign currency exposure. Foreign currency exchange, net of

hedges, had an immaterial impact on our product sales for the three months ended ~~September~~June 30, ~~2018, compared to~~2019, based on a comparison using foreign currency exchange rates from the ~~same period in 2017.~~three months ended June 30, 2018.

Product sales in the United States decreased ~~by 9%~~slightly to ~~$4.1 billion~~$4,054 million for the three months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$4.5 billion~~$4,069 million for the same period in ~~2017.~~2018. The decrease was primarily due to lower sales of Ranexa and Letairis following the entry of generic versions in 2019 and lower sales of our HCV products, partially offset by higher sales of our HIV products. The decrease in sales of our HCV products was primarily due to lower average net selling price, ~~and~~including a decline in U.S. Medicare prices in 2019, lower sales volume as a result of ~~increased competition.~~a decrease in market share and fewer patient starts. The increase in sales of our HIV products was primarily ~~driven by~~due to the continued uptake of Biktarvy and increased ~~demand~~usage of Truvada for ~~our Descovy (FTC/TAF))-based products and to a lesser extent, higher average net selling price,~~PrEP, partially offset by ~~the decrease~~decreases in sales volume of ~~our Truvada (FTC~~Genvoya, Atripla, Stribild, Descovy and ~~tenofovir disoproxil fumarate (TDF))-based products, which include Atripla, Complera/Eviplera and Stribild.~~Complera.

Product sales in Europe ~~decreased~~increased by ~~27%~~4% to ~~$873~~$1,041 million for the three months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$1.2 billion~~$1,005 million for the same period in ~~2017. The decrease was primarily due to lower~~2018. Product sales for the second quarter of 2019 benefited from approximately $160 million of adjustments for statutory rebates. In addition, sales of ~~our HCV products~~Biktarvy and Odefsey were higher for the three months ended June 30, 2019 compared to the same period in 2018. The increases in product sales in Europe were partially offset by the broader availability of generic versions of Truvada, Atripla and Viread. The decrease in sales of our HCV products was primarily due to lower average net selling price and lower sales volume as a result of increased competition. The decrease was partially offset by the continued uptake of our Descovy (FTC/TAF)-based products. Foreign currency exchange, net of hedges, had an immaterial impact on our product sales in Europe for the three months ended ~~September~~June 30, ~~2018, compared to~~2019, based on a comparison using foreign currency exchange rates from the ~~same period in 2017.~~three months ended June 30, 2018.

Product sales in other locations ~~decreased~~increased by ~~32%~~10% to ~~$451~~$512 million for the three months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$663~~$466 million for the same period in ~~2017,~~2018, primarily due to higher HIV product sales in Japan as a result of acquiring the rights to certain products in our HIV portfolio in Japan effective January 1, 2019.

Product sales for the six months ended June 30, 2019

Total product sales increased by 3% to $10.8 billion for the six months ended June 30, 2019, compared to $10.5 billion for the same period in 2018, primarily due to higher HIV product sales and $296 million higher net adjustments for government rebates and discounts related to sales made in prior years. The increase was partially offset by lower sales of our HCV products, Ranexa and Letairis.

HIV product sales increased by 12% to $7.7 billion for the six months ended June 30, 2019, compared to $6.8 billion for the same period in 2018, driven by higher sales volume as a result of the continued uptake of Biktarvy and higher net adjustments for government rebates and discounts. The increase was partially offset by decreases in sales volume of Genvoya and our Truvada (FTC)/(TDF)-based products and lower average net selling prices.

HCV product sales decreased by 20% to $1.6 billion for the six months ended June 30, 2019, compared to $2.0 billion for the same period in 2018, primarily due to lower average net selling price, including a decline in U.S. Medicare prices in 2019, and lower patient starts. The decline was partially offset by higher net adjustments for government rebates and discounts.

Yescarta generated $216 million in sales ~~in Japan. Sales of our HCV products in Japan decreased to $45 million for~~during the ~~three~~six months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$170~~$108 million for the same period in ~~2017, primarily due~~2018. The increase was driven by an increase in the number of therapies provided to ~~lower market share as a result of increased competition.~~

~~Product sales for the nine months ended September 30, 2018~~

Total product sales decreased by 19% to $16.0 billion for the nine months ended September 30, 2018, compared to $19.8 billion for the same period in 2017, primarily due to lower sales of our HCV products, partially offset by increased sales of our HIV products.

HIV product sales increased by 10% to $10.6 billion for the nine months ended September 30, 2018, compared to $9.6 billion for the same period in 2017, primarily due to the continued uptake of Descovy, Genvoya and Odefsey and our launch of Biktarvy in 2018.

HCV product sales decreased by 61% to $2.9 billion for the nine months ended September 30, 2018, compared to $7.6 billion for the same period in 2017, primarily due to lower sales of Harvoni, Epclusa and Sovaldi across all major markets as a result of increased competition.

~~Yescarta generated $183 million in sales during the nine months ended September 30, 2018.~~patients.

Of our total product sales, 27% and 28% were generated outside the United States during the ~~nine~~six months ended ~~September~~June 30, ~~2018.~~2019 and 2018, respectively. We faced exposure to movements in foreign currency exchange rates, primarily in the Euro. We used foreign currency exchange

contracts to hedge a ~~percentage~~portion of our foreign currency exposure. Foreign currency exchange, net of hedges, had ~~a favorable~~an immaterial impact on our product sales ~~of $89 million~~ for the ~~nine~~six months ended ~~September~~June 30, ~~2018, compared to the same period in 2017.~~2019.

Product sales in the United States ~~decreased~~increased by ~~16%~~3% to ~~$11.7~~$7.9 billion for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$14.0~~$7.6 billion for the same period in ~~2017.~~2018. The ~~decrease~~increase was primarily due to higher sales of our HIV products and higher net adjustments for government rebates and discounts, partially offset by lower sales of our HCV products, ~~partially offset by higher~~and lower sales of Ranexa and Letairis following the entry of generic versions in 2019. The increase in sales of our HIV ~~products.~~products was primarily due to the continued uptake of Biktarvy and increased usage of Truvada for PrEP, partially offset by decreases in sales volume of Genvoya, Atripla, Stribild, Descovy and Complera. The decrease in sales of our HCV products was primarily due to lower average net selling price, ~~and~~including a decline in U.S. Medicare prices in 2019, lower sales volume as a result of ~~increased competition. The increase in the sales of our HIV products was primarily driven by higher demand for our Descovy (FTC/TAF)-based products and to~~ a ~~lesser extent, higher average net selling price, partially offset by the~~ decrease in ~~sales volume of our Truvada (FTC/TDF)-based products.~~market share and fewer patient starts.

Product sales in Europe decreased by ~~25%~~4% to ~~$2.9~~$1.9 billion for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, compared to ~~$3.9~~$2.0 billion for the same period in ~~2017.~~2018. The decrease was primarily due to ~~lower sales of our HCV products and~~ the broader availability of generic versions of Truvada, Atripla and ~~Viread. The decrease in sales of our HCV products was primarily due to~~Viread, lower ~~sales volume and~~ average net selling ~~price as a result of increased competition.~~prices and lower patient starts for our HCV products. The decrease was partially offset by the continued uptake of ~~our Descovy (FTC/TAF)-based products.~~Biktarvy and Odefsey and higher net adjustments for government rebates and discounts, primarily due to

approximately $160 million of favorable adjustments for statutory rebates. Foreign currency exchange, net of hedges, had ~~a favorable~~an immaterial impact on our product sales ~~of $62 million~~in Europe for the ~~nine~~six months ended ~~September~~June 30, ~~2018, compared to the same period in 2017.~~2019.

Product sales in other locations ~~decreased~~increased by ~~30%~~11% to ~~$1.4~~$1.0 billion for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, compared to $2.0 billion for the same period in 2017, primarily due to lower sales in Japan. Sales of our HCV products in Japan decreased to $124 million for the nine months ended September 30, 2018, compared to $556$935 million for the same period in ~~2017,~~2018, primarily due to ~~lower market share~~higher HIV product sales in Japan as a result of ~~increased competition.~~acquiring the rights to certain products in our HIV portfolio in Japan effective January 1, 2019.

The following table summarizes the period-over-period changes in our product sales by product:


	Three Months Ended						Nine Months Ended						Three Months Ended						Six Months Ended
	September 30,						September 30,						June 30,						June 30,
(In millions, except percentages)	2018		2017		Change		2018		2017		Change		2019		2018		Change		2019		2018		Change
Atripla	$	258	$	439	(41	)%	$	921	$	1,366	(33	)%	$	152	$	349	(56	)%	$	323	$	663	(51	)%
Biktarvy	386		—		*		606		—		*		1,116		185		*		1,909		220		*
Complera/Eviplera	139		237		(41	)%	528		744		(29	)%	123		199		(38	)%	238		389		(39	)%
Descovy	406		316		28	%	1,170		853		37	%	358		403		(11	)%	700		764		(8	)%
Genvoya	1,176		988		19	%	3,418		2,614		31	%	980		1,160		(16	)%	1,995		2,242		(11	)%
Odefsey	423		296		43	%	1,150		781		47	%	387		385		1	%	784		727		8	%
Stribild	146		229		(36	)%	507		831		(39	)%	108		187		(42	)%	204		361		(43	)%
Truvada	757		811		(7	)%	2,174		2,337		(7	)%	718		765		(6	)%	1,324		1,417		(7	)%
Other HIV⁽¹⁾	14		15		(7	)%	46		41		12	%	15		19		(21	)%	32		32		—	%
Revenue share - Symtuza⁽²⁾	22		—		*		42		—		*		84		13		*		150		20		*
Total HIV													4,041		3,665		10	%	7,659		6,835		12	%
AmBisome	102		92		11	%	312		276		13	%	105		103		2	%	198		210		(6	)%
Epclusa	477		882		(46	)%	1,513		2,945		(49	)%
Harvoni	311		973		(68	)%	990		3,726		(73	)%
Ledipasvir/Sofosbuvir⁽³⁾													193		331		(42	)%	418		679		(38	)%
Letairis	241		213		13	%	689		654		5	%	204		244		(16	)%	401		448		(10	)%
Ranexa	178		164		9	%	581		517		12	%	19		208		(91	)%	174		403		(57	)%
Sofosbuvir/Velpatasvir⁽⁴⁾													493		500		(1	)%	984		1,036		(5	)%
Vemlidy	87		37		*		221		70		*		116		76		53	%	217		134		62	%
Viread	70		274		(74	)%	249		834		(70	)%	75		82		(9	)%	147		179		(18	)%
Vosevi	103		123		(16	)%	319		123		*		75		109		(31	)%	138		216		(36	)%
Yescarta	75		—		*		183		—		*		120		68		76	%	216		108		100	%
Zydelig	20		40		(50	)%	92		110		(16	)%	26		39		(33	)%	53		72		(26	)%
Other⁽³⁾	64		273		(77	)%	285		1,003		(72	)%
Other⁽⁵⁾													140		115		22	%	202		221		(9	)%
Total product sales	$	5,455	$	6,402	(15	)%	$	15,996	$	19,825	(19	)%	$	5,607	$	5,540	1	%	$	10,807	$	10,541	3	%
_______________________

* ~~Percentage not meaningful~~

⁽¹⁾~~Includes Emtriva and Tybost~~



____________________
Notes:
*	Percentage is greater than 100%
(1)	Includes Emtriva and Tybost
(2)	Represents our revenue from cobicistat (C), emtricitabine (FTC) and tenofovir alafenamide (TAF) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland UC (Janssen)
(3)	Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by our separate subsidiary, Asegua Therapeutics LLC
(4)	Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by our separate subsidiary, Asegua Therapeutics LLC
(5)	Includes Cayston, Hepsera and Sovaldi. In Europe, the increase for both the three and six months ended June 30, 2019 was primarily due to favorable adjustments of approximately $80 million for statutory rebates related to sales of Sovaldi made in prior years

⁽²⁾~~Represents Gilead’s revenue from cobicistat (C), FTC and TAF in Symtuza~~^® ~~(darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen~~

⁽³⁾~~Includes Cayston, Hepsera and Sovaldi~~

The following is additional discussion of our results ~~by product:~~on certain products:

Descovy (FTC/TAF)-based products - Biktarvy, Descovy, Genvoya, Odefsey and ~~Odefsey~~Revenue Share - Symtuza

~~Product~~The following table summarizes the period-over-period changes in our sales of ~~our~~ Descovy (FTC/TAF)-based ~~products were $2.4 billion and $6.3 billion, and accounted for 44% and 40% of our total product sales for~~products:



	Three Months Ended								Six Months Ended
	June 30,								June 30,
(In millions, except percentages)	2019			2018			Change		2019			2018			Change
U.S.	$	2,323		$	1,701		37	%	$	4,347		$	3,142		38	%
Europe	459			377			22	%	898			703			28	%
Other International	143			68			110	%	293			128			129	%
Total	$	2,925		$	2,146		36	%	$	5,538		$	3,973		39	%
% of total product sales	52		%	39		%			51		%	38		%
% of HIV product sales	72		%	59		%			72		%	58		%

For both the three and ~~nine~~six months ended ~~September~~June 30, ~~2018, respectively. Product~~2019, the increases in U.S. sales were primarily due to the continued uptake of ~~our Descovy (FTC/TAF)-based products were $1.6 billion and $4.2 billion, and accounted for 25% and 21%~~Biktarvy, partially offset by decreases in sales volume of ~~our total product sales for the three and nine months ended September 30, 2017, respectively.~~

For the three months ended September 30, 2018, sales of our Descovy (FTC/TAF)-based products were $1.9 billion in the United States and $390 million in Europe, compared to $1.3 billion in the United States and $248 million in Europe for the same period in 2017.Genvoya. The increases in ~~all major markets~~sales in Europe were primarily ~~driven by~~due to higher sales volume ~~reflecting~~as a result of the ~~increased demand for Descovy, Genvoya~~continued uptake of Biktarvy and Odefsey, ~~and our launch of Biktarvy in 2018.~~

For the nine months ended September 30, 2018, sales of our Descovy (FTC/TAF)-based products were $5.1 billion in the United States and $1.1 billion in Europe, compared to $3.6 billion in the United States and $594 million in Europe for the same period in 2017. The increases in all major markets were primarily drivenpartially offset by ~~higher sales volume reflecting the increased demand for Descovy, Genvoya and Odefsey and our launch of Biktarvy in 2018.~~lower average net selling prices.

Truvada (FTC/TDF)-based products - Atripla, Complera/Eviplera, Stribild and Truvada

~~Product~~The following table summarizes the period-over-period changes in our sales of ~~our~~ Truvada (FTC/TDF)-based products were $1.3 billion and $4.1 billion, and accounted for 24% and 26% of our total product sales for the three and nine months ended September 30, 2018, respectively. Product sales of our Truvada (FTC/TDF)-based products were $1.7 billion and $5.3 billion, and accounted for 27% of our total product sales forproducts:



	Three Months Ended								Six Months Ended
	June 30,								June 30,
(In millions, except percentages)	2019			2018			Change		2019			2018			Change
U.S.	$	899		$	1,149		(22	)%	$	1,694		$	2,084		(19	)%
Europe	163			262			(38	)%	292			548			(47	)%
Other International	39			89			(56	)%	103			198			(48	)%
Total	$	1,101		$	1,500		(27	)%	$	2,089		$	2,830		(26	)%
% of total product sales	20		%	27		%			19		%	27		%

For both the three and ~~nine~~six months ended ~~September~~June 30, ~~2017, respectively.~~

~~For~~2019, the ~~three months ended September 30, 2018,~~decreases in U.S. sales were primarily due to lower sales volume as a result of ~~our~~patients switching to newer regimens containing FTC/TAF, partially offset by the increased usage of Truvada ~~(FTC/TDF)-based products were $1.1 billion~~for PrEP. The decreases in ~~the United States, $178 million~~sales in Europe and $64 million in other locations, compared to $1.2 billion in the United States, $406 million in Europe and $110 million in other locations for the same period in 2017. In the United States, the decrease waswere primarily due to lower sales volume as a result of the continued uptake of our Descovy (FTC/TAF)-based products, partially offset by the increased usage of Truvada for PrEP and higher average net selling price. In Europe, the decrease was primarily due to lower sales volume as a result of thebroader availability of generic versions of Truvada and Atripla and patients switching to newer regimens containing FTC/TAF.

HCV products - Epclusa, Harvoni, Sovaldi, Vosevi and Authorized Generics of Epclusa and Harvoni

The following table summarizes the ~~continued uptake of~~period-over-period changes in our ~~Descovy (FTC/TAF)-based products.~~

~~For the nine months ended September 30, 2018,~~ sales of our Truvada (FTC/TDF)-based products were $3.1 billion in the United States, $726 million in Europe and $262 million in other locations, compared to $3.6 billion in the United States, $1.3 billion in Europe and $390 million in other locations for the same period in 2017. In the United States, the decrease was primarily due to lower sales volume as a result of the continued uptake of our Descovy (FTC/TAF)-based products, partially offset by the increased usage of Truvada for PrEP and higher average net selling price. In Europe, the decrease was primarily due to lower sales volume as a result of the availability of generic versions of Truvada and Atripla and the continued uptake of our Descovy (FTC/TAF)-based products.HCV products:

~~Epclusa~~

Epclusa sales accounted for 9% of our total product sales for both the three and nine months ended September 30, 2018, respectively, and 14% and 15% of our total product sales for the three and nine months ended September 30, 2017, respectively.



	Three Months Ended								Six Months Ended
	June 30,								June 30,
(In millions, except percentages)	2019			2018			Change		2019			2018			Change
US	$	355		$	542		(35	)%	$	748		$	1,126		(34	)%
Europe	277			237			17	%	480			508			(6	)%
Other International	210			221			(5	)%	404			412			(2	)%
Total	$	842		$	1,000		(16	)%	$	1,632		$	2,046		(20	)%
% of total product sales	15		%	18		%			15		%	19		%

For the three months ended ~~September~~June 30, ~~2018, Epclusa product~~2019, the decrease in U.S. sales were $225 million in the United States and $136 million in Europe, compared to $543 million in the United States and $263 million in Europe for the same period in 2017. Sales of Epclusa decreased across all major marketswas primarily due to lower average net selling price, including a decline in U.S. Medicare prices in 2019, lower sales volume as a result of ~~increased competition.~~market share decline and fewer patient starts. The increase in sales in Europe was primarily due to approximately $80 million of favorable adjustments for statutory rebates related to sales of Sovaldi made in prior years.

For the ~~nine~~six months ended ~~September~~June 30, ~~2018, Epclusa product~~2019, the decrease in U.S. sales were $733 million in the United States and $502 million in Europe, compared to $2.1 billion in the United States and $649 million in Europe for the same period in 2017. Sales of Epclusa decreased across all major marketswas primarily due to lower average net selling price, asincluding a ~~result of increased competition.~~

~~Harvoni~~

Harvoni sales accounted for 6% of our total product sales for both the three and nine months ended September 30, 2018, and 15% and 19% of our total product sales for the three and nine months ended September 30, 2017, respectively.

~~For the three months ended September 30, 2018, Harvoni product sales were $185 million~~decline in ~~the United States, $38 million~~U.S. Medicare prices in ~~Europe and $88 million in other locations, compared to $718 million in the United States, $110 million in~~

~~Europe and $145 million in other locations for the same period in 2017. The decreases in all major markets were primarily due to~~2019, lower sales volume as a result of ~~increased competition.~~

~~For the nine months ended September 30, 2018, Harvoni product~~market share decline and fewer patient starts. The decrease in sales ~~were $649 million in the United States, $116 million~~ in Europe and $225 million in other locations, compared to $2.6 billion in the United States, $583 million in Europe and $515 million in other locations for the same period in 2017. The decreases in all major markets were primarilywas due to lower ~~sales volume as a result of increased competition.~~patient starts, partially offset by higher net adjustments for government rebates and discounts.

~~Other Products - Cayston, Hepsera and Sovaldi~~

Other product sales accounted for 1% and 2% of our total product sales for the three and nine months ended September 30, 2018 and 4% and 5% of our total product sales for the three and nine months ended September 30, 2017, respectively.

For the three months ended September 30, 2018, other product sales decreased to $64 million, compared to $273 million for the same period in 2017, primarily due to lower Sovaldi sales. Sales of Sovaldi decreased to $11 million for the three months ended September 30, 2018, compared to $219 million for the same period in 2017, primarily due to lower sales volume driven by a shift in the market from Sovaldi to Epclusa.

For the nine months ended September 30, 2018, other product sales decreased to $285 million, compared to $1.0 billion for the same period in 2017, primarily due to lower Sovaldi sales. Sales of Sovaldi decreased to $126 million for the nine months ended September 30, 2018, compared to $847 million for the same period in 2017, primarily due to lower sales volume driven by a shift in the market from Sovaldi to Epclusa.

Cost of Goods Sold and Product Gross Margin

The following table summarizes the period-over-period changes in our cost of goods sold and product gross margin:


	Three Months Ended								Nine Months Ended								Three Months Ended								Six Months Ended
	September 30,								September 30,								June 30,								June 30,
(In millions, except percentages)	2018			2017			Change		2018			2017			Change		2019			2018			Change		2019			2018			Change
Total product sales	$	5,455		$	6,402		(15	)%	$	15,996		$	19,825		(19	)%	$	5,607		$	5,540		1	%	$	10,807		$	10,541		3	%
Cost of goods sold	$	1,086		$	1,032		5	%	$	3,283		$	3,115		5	%	$	1,000		$	1,196		(16	)%	$	1,957		$	2,197		(11	)%
Product gross margin	80		%	84		%	(4	)%	79		%	84		%	(5	)%	82		%	78		%	4	%	82		%	79		%	3	%

~~Our cost~~Cost of goods sold for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018 increased~~2019 decreased by ~~$54~~$196 million and ~~$168~~$240 million, or 16% and 11%, respectively, compared to the same periods in 2018, primarily due to lower royalty expenses, lower inventory reserves related to inventory and supply chain rationalization and lower amortization expense related to the Ranexa intangible asset, which was fully amortized during the first quarter of 2019. Royalty expenses for the three and six months ended June 30, 2019 decreased by $77 million and $121 million, respectively, compared to the same periods in ~~2017,~~2018, primarily due to ~~$87 million and $263 million, respectively, in amortization expense related to the intangible assets acquired in connection with our acquisition of Kite. The increases were partially offset by~~ lower ~~costs of efavirenz, a component~~sales of Atripla, ~~as a result of the termination of a collaboration arrangement with Bristol-Myers Squibb Company on December 31, 2017.~~Ranexa, Letairis and products containing elvitegravir.

~~Our product~~Product gross margin for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018 decreased~~2019 increased by 4% and 5%3%, respectively, compared to the same periods in ~~2017,~~2018, primarily due to ~~changes in our~~ product mix and the factors noted ~~above.~~above relating to costs of goods sold.

~~Operating~~Research and Development Expenses

The following table summarizes the period-over-period changes in our R&D ~~expenses and SG&A~~ expenses:

Three Months Ended Nine Months Ended
September 30, September 30,
(In millions, except percentages) 2018 2017 Change 2018 2017 Change
Research and development expenses $ 939
$ 789
19 % $ 3,068
$ 2,584
19 %
Selling, general and administrative expenses $ 948
$ 879
8 % $ 2,925
$ 2,626
11 %

~~Research and Development Expenses~~



	Three Months Ended						Six Months Ended
	June 30,						June 30,
(In millions, except percentages)	2019		2018		Change		2019		2018		Change
Research and development expenses	$	1,160	$	1,192	(3	)%	$	2,217	$	2,129	4	%

R&D expenses consist primarily of clinical studies performed by contract research organizations, materials and supplies, licenses and fees, up-front and milestone payments under collaboration agreements, ~~milestone payments, in-process research and development (IPR&D) impairment charges,~~ personnel costs, including salaries, benefits and stock-based compensation, and overhead allocations consisting of various support and facilities-related costs. IPR&D assets capitalized in connection with acquisitions are tested for impairment in the fourth quarter of each year, or earlier if impairment indicators exist. No impairment charges were recorded for the three and nine months ended September 30, 2018 and 2017. For more information, refer to our critical accounting policies and estimates on valuation of intangible assets presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2017.

We do not track total R&D expenses by product candidate, therapeutic area or development phase. However, we manage our R&D expenses by identifying the R&D activities we anticipate will be performed during a given period and then prioritizing efforts based on scientific data, probability of successful development, market potential, available human and capital resources and other considerations. We continually review our R&D pipeline and the status of development and, as necessary, reallocate resources among the R&D portfolio that we believe will best support the future growth of our business.

R&D expenses for the three months ended ~~September~~June 30, ~~2018 increased~~2019 decreased by ~~$150~~$32 million, or ~~19%~~3%, compared to the same period in ~~2017,~~2018, primarily due to the 2018 purchase of an FDA Priority Review Voucher and lower stock-based compensation expense in 2019, largely offset by higher ~~costs~~investments in 2019 to support our cell therapy programs. Stock-based compensation expense for the ~~growth~~three months ended June 30, 2019 decreased by $22 million, compared to the same period in 2018, primarily due to the 2018 impact of ~~our business following the acquisition of Kite and~~ stock-based compensation ~~expenses~~expense associated with our acquisition of ~~Kite.~~Kite Pharma Inc.

R&D expenses for the ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 increased by ~~$484~~$88 million, or ~~19%~~4%, compared to the same period in ~~2017,~~2018, primarily due to $131 million higher ~~costs~~up-front collaboration expenses and higher investments to support our cell therapy programs, partially offset by the ~~growth~~2018 purchase of ~~our business following the acquisition of Kite,~~an FDA Priority Review Voucher and lower stock-based compensation ~~expenses~~expense. Stock-based compensation expense for the six months ended June 30, 2019 decreased by $64 million, compared to the same period in 2018, primarily due to the 2018 impact of stock-based compensation expense associated with our acquisition of Kite ~~and up-front collaboration payments related to our collaboration agreement with Sangamo Therapeutics,~~Pharma Inc.

Selling, General and Administrative Expenses

The following table summarizes the period-over-period changes in our SG&A expenses:



	Three Months Ended						Six Months Ended
	June 30,						June 30,
(In millions, except percentages)	2019		2018		Change		2019		2018		Change
Selling, general and administrative expenses	$	1,095	$	980	12	%	$	2,125	$	1,977	7	%

SG&A expenses relate to sales and marketing, finance, human resources, legal and other administrative activities. Expenses consist primarily of personnel costs, facilities and overhead costs, outside marketing, advertising and legal expenses and other general and administrative costs. SG&A expenses also include the ~~branded prescription drug~~Branded Prescription Drug (BPD) fee. In the United States,

we, along with other pharmaceutical manufacturers of branded drug products, are required to pay a portion of the BPD fee, which is estimated based on select government sales during the prior year as a percentage of total industry government sales and is trued-up upon receipt of invoices from the Internal Revenue ~~Service.~~Service (IRS).

SG&A expenses for the three ~~and nine~~ months ended ~~September~~June 30, ~~2018,~~2019 increased by ~~$69~~$115 million, or 8%12%, ~~and $299 million or 11%, respectively,~~ compared to the same ~~periods~~period in ~~2017,~~2018, primarily due to ~~increased~~higher promotional expenses ~~to support~~in the ~~growth~~United States and expenses associated with the expansion of our business ~~following the acquisition of Kite~~in Japan and China, partially offset by lower stock-based compensation ~~expenses~~expense. Stock-based compensation expense for the three months ended June 30, 2019 decreased by $48 million, compared to the same period in 2018, primarily due to the 2018 impact of stock-based compensation expense associated with our acquisition of Kite Pharma Inc.

SG&A expenses for the six months ended June 30, 2019 increased by $148 million, or 7%, compared to the same period in 2018, primarily due to higher promotional expenses in the United States and expenses associated with the expansion of our business in Japan, China and Europe, partially offset by lower stock-based compensation expense. Stock-based compensation expense for the six months ended June 30, 2019 decreased by $84 million, compared to the same period in 2018, primarily due to the 2018 impact of stock-based compensation expense associated with our acquisition of Kite Pharma Inc. BPD ~~fees.~~fee expense for the six months ended June 30, 2019 increased to $149 million from $126 million for the same period in 2018, primarily due to net adjustments based on IRS invoices.

Other Income (Expense), Net

Other income (expense), net ~~increased to $305~~was $228 million and ~~$547~~$595 million for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, respectively, compared to ~~$150~~$72 million and ~~$391~~$242 million ~~respectively,~~ for the ~~same periods in 2017.~~three and six months ended June 30, 2018, respectively. The increases ~~were~~in the three and six months ended June 30, 2019 related primarily ~~due~~ to higher net unrealized gains of $121 million and $273 million, respectively, from changes in the fair value of our ~~marketable equity securities. Starting in January 2018, we recorded unrealized gains (losses) from changes in the fair value of our marketable~~ equity securities ~~in Other~~and higher interest income ~~(expense), net on~~of $39 million and $87 million, respectively, due to our ~~Condensed Consolidated Statements of Income as~~cash, cash equivalents and marketable debt securities earning a result of the adoption of Accounting Standards Update No. 2016-01 “Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities”. See Note 1, Summary of Significant Accounting Policies, of the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for further information.higher yield.

Provision for Income Taxes

Our provision for income taxes was ~~$565~~$535 million and ~~$959~~$267 million for the three months ended ~~September~~June 30, ~~2018~~2019 and ~~2017,~~2018, respectively. Our effective tax rate ~~decreased~~increased to ~~21.2%~~22.2% for the three months ended ~~September~~June 30, 2018 compared to 26.1% for same period in 2017, primarily due to a reduction of the U.S. corporate tax rate as a result of the enactment of the Tax Cuts and Jobs Act (Tax Reform) in December 2017, partially offset by changes to the geographic mix of earnings and the Global Intangible Low-Taxed Income (the Global Minimum Tax).

Our provision for income taxes was $1.3 billion and $2.9 billion for the nine months ended September 30, 2018 and 2017, respectively. Our effective tax rate decreased to 19.5% for the nine months ended September 30, 2018 compared to 25.6%2019 from 12.8% for the same period in ~~2017,~~2018, primarily due to the 2018 impact of a ~~reduction of the U.S. corporate tax rate as a result of the enactment of Tax Reform in December 2017 and a~~$202 million tax benefit related to settlement of a tax ~~examination~~examination.

Our provision for ~~an acquired entity in~~income taxes was $917 million and $761 million for the ~~three~~six months ended June 30, 2019 and 2018, ~~partially offset by changes~~respectively. Our effective tax rate increased to 19.3% for the six months ended June 30, 2019 from 18.5% for the same period in 2018, primarily due to the ~~geographic mix~~impacts from tax settlements. We recorded net tax benefits of ~~earnings~~$119 million and $153 million related to settlements with taxing authorities during the ~~Global Minimum Tax.~~six months ended June 30, 2019 and 2018, respectively.

We calculated a provisional estimate of the impact from Tax Reform in our 2017 income tax provision in accordance with our interpretation of Tax Reform and the SEC Staff Accounting Bulletin 118. We expectcontinue to ~~finalize the provisional estimate during the fourth quarter of 2018.~~

~~We are evaluating~~evaluate certain changes to our legal entity structure in response to guidelines and requirements in various international tax jurisdictions where we conduct business. These changes may take multiple reporting periods to implement and may result in certain material, but non-recurring, adjustments to our deferred tax assets and/or liabilities, which will cause an offsetting increase or decrease to our tax provision. Estimates of these adjustments cannot be reasonably determined at this ~~time.~~time and are dependent on the changes actually implemented.

Liquidity and Capital Resources

We believe that our existing capital resources, supplemented by our cash flows generated from operating activities, will be adequate to satisfy our capital needs for the foreseeable future.

The following table summarizes our cash, cash equivalents and marketable debt securities and working capital:


(In millions)	September 30, 2018		December 31, 2017		June 30, 2019		December 31, 2018
Cash, cash equivalents and marketable securities	$	30,844	$	36,694
Cash, cash equivalents and marketable debt securities					$	30,234	$	31,512
Working capital	$	24,802	$	20,188	$	24,766	$	25,231

Cash, Cash Equivalents and Marketable Debt Securities

Cash, cash equivalents and marketable debt securities ~~totaled $30.8~~decreased by $1.3 billion, ~~as of September 30, 2018, a decrease of $5.9 billion~~or 4%, compared to ~~$36.7 billion as of~~ December 31, ~~2017.~~2018. During the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, we generated ~~$6.1~~$3.7 billion in operating cash ~~flow. We~~flow, repaid ~~$1.8~~$1.3 billion of ~~our senior unsecured notes due in September 2018, repaid $4.5 billion of term loans borrowed in connection with our acquisition of Kite,~~debt, paid cash dividends of ~~$2.2~~$1.6 billion and ~~utilized $1.9~~repurchased 21 million shares of our common stock for $1.4 billion through open market transactions. In the second half of 2019, we expect a significant decrease to our cash, cash equivalents and marketable debt securities upon closing of a collaboration with Galapagos under which we are obligated to make a $3.95 billion up-front payment and an equity investment of approximately $1.1 billion. See Note 16. Subsequent Event of the Notes to Condensed Consolidated Financial Statements included in Part 1, Item 1 of this Quarterly Report on ~~stock repurchases.~~Form 10-Q for additional information.

Working Capital

Working capital ~~was $24.8 billion as of September 30, 2018,~~decreased by $465 million, or 2%, compared to ~~$20.2 billion as of~~ December 31, ~~2017. The increase of $4.6 billion was~~2018, primarily ~~driven by~~due to a ~~shift~~decrease in ~~the duration of our~~cash, cash equivalents and short-term marketable ~~securities portfolio to reduce interest rate risk.~~debt securities.

Cash Flows

The following table summarizes our cash flow activities:


	Nine Months Ended						Six Months Ended
	September 30,						June 30,
(In millions)	2018			2017			2019			2018
Cash provided by (used in):
Operating activities	$	6,055		$	9,145		$	3,665		$	3,843
Investing activities	$	11,620		$	(6,053	)	$	(6,153	)	$	9,595
Financing activities	$	(10,648	)	$	46		$	(4,223	)	$	(7,747	)


PART II.	OTHER INFORMATION


Item 1.	LEGAL PROCEEDINGS

For a description of our significant pending legal proceedings, please see Note ~~10,~~11. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item I of this Quarterly Report on Form 10-Q.


Item 1A.	RISK FACTORS

In evaluating our business, you should carefully consider the following risks in addition to the other information in this Quarterly Report on Form 10-Q. A manifestation of any of the following risks could materially and adversely affect our business, results of operations and financial condition. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. It is not possible to predict or identify all such factors and, therefore, you should not consider the following risks to be a complete statement of all the potential risks or uncertainties that we face.

A substantial portion of our revenues is derived from sales of products to treat HIV and HCV. If we are unable to increase HIV sales or if HCV sales decrease more than anticipated, then our results of operations may be adversely affected.

We receive a substantial portion of our revenue from sales of our products for the treatment of HIV ~~infection, which include Genvoya, Truvada, Odefsey, Descovy, Biktarvy, Atripla, Stribild and Complera/Eviplera.~~infection. During the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, sales of our HIV products accounted for approximately ~~66%~~71% of our total product sales, and we expect our HIV products to account for a higher percentage of our total product sales in ~~2018~~2019 than in ~~2017.~~2018. Most of our HIV products contain tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF) and/or emtricitabine, which belong to the nucleoside class of antiviral therapeutics. If the treatment paradigm for HIV changes, causing nucleoside-based therapeutics to fall out of favor, or if we are unable to maintain or increase our HIV product sales, our results of operations would likely suffer and we would likely need to scale back our operations, including our future drug development and spending on research and development (R&D) efforts.

During the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, sales of ~~Epclusa, Harvoni, Vosevi and Sovaldi~~our products for the treatment of ~~HCV~~chronic hepatitis C virus (HCV) infection accounted for approximately ~~18%~~15% of our total product sales. Our HCV revenues have declined, and we expect a further decline in product sales in ~~2018,~~2019, compared to ~~2017,~~2018, in major ~~markets as a result of increased competition. However, we believe that the overall HCV market and our HCV revenues have begun to stabilize in 2018.~~markets. The drivers of our HCV product revenues are patient starts, net pricing, market share and treatment duration. With treatment duration stabilizing and pricing largely stabilizing, ~~in 2018,~~ we expect to continue to compete for market share across market segments and geographies. ~~While the number of new patient starts has diminished, we~~We anticipate patient starts to continue to steadily decline and be more ~~predictable with a continued slight decline moving forward.~~predictable. Any unexpected and adverse changes to these drivers, including any larger than anticipated shifts, may adversely impact our HCV product revenues.

In addition, future sales of our HIV and HCV products ~~depends,~~depend, in part, on the extent of reimbursement of our products by private and public payers. We may continue to experience global pricing pressure ~~which~~that could result in larger discounts or rebates on our products or delayed reimbursement, which negatively impacts our product sales and results of operations. Also, private and public payers can choose to exclude our products from their formulary coverage lists or limit the types of patients for whom coverage will be provided, which would negatively impact the demand for, and revenues of, our products. Any change in the formulary coverage, reimbursement levels or discounts or rebates offered on our products to payers may impact our anticipated revenues. If we are unable to achieve our forecasted HIV and HCV sales, our stock price could be adversely impacted.

We may be unable to sustain or increase sales of our HIV or HCV products for any number of reasons including, but not limited to, the reasons discussed above and the following:

As our products are used over a longer period of time in many patients and in combination with other products, and additional studies are conducted, new issues with respect to safety, resistance and interactions with other drugs may arise, which could cause us to provide additional warnings or contraindications on our labels, narrow our approved indications or halt sales of a product, each of which could reduce our revenues.

As our products mature, private insurers and government payers often reduce the amount they will reimburse patients for these products, which increases pressure on us to reduce prices.

If physicians do not see the benefit of our HIV or HCV products, the sales of our HIV or HCV products will be limited.

As new branded or generic products are introduced into major markets, our ability to maintain pricing and market share may be affected. For example, TDF, one of the active pharmaceutical ingredients in Truvada, Atripla, Complera/Eviplera and Stribild, faces generic competition in the European Union, the United States and certain other countries. In addition, because emtricitabine, the other active pharmaceutical ingredient of Truvada, faces generic competition in the European Union, Truvada faces generic competition in the European Union and certain other countries outside

~~of the United States. This has had, and is expected to continue to have, a negative impact on our business and results of operations.~~

If we fail to develop and commercialize new products or expand the indications for existing products, our prospects for future revenues and our results of operations may be adversely affected.

~~If we do not~~The success of our business depends on our ability to introduce new products ~~or increase sales of~~as well as expand the indications for our existing products to address areas of unmet medical need. The launch of commercially successful products is necessary to cover our substantial research and development expenses and to offset revenue losses when our existing products lose market share due to

various factors such as competition and loss of patent exclusivity, as well as to provide for the growth of our business. There are many difficulties and uncertainties inherent in drug development and the introduction of new products. The product development cycle is characterized by significant investments of resources, long lead times and unpredictable outcomes due to the nature of developing medicines for human use. We expend significant time and resources on our product pipeline without any assurance that we will ~~not~~recoup our investments or that our efforts will be commercially successful. A high rate of failure is inherent in the discovery and development of new products, and failure can occur at any point in the process, including late in the process after substantial investment. For example, see “We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption, which may adversely affect our prospects for future revenue growth and our results of operations.” We cannot state with certainty when or whether any of our product candidates under development will be approved or launched; whether we will be able to ~~increase~~develop, license or ~~maintain our total revenues nor continue to expand our R&D efforts. Drug development is inherently risky and many~~acquire additional product candidates ~~fail during the drug development process. For example, during 2018, we terminated~~or products; or whether any products, once launched, will be commercially successful. Failure to launch commercially successful new products or new indications for existing products could have a material adverse effect on our Phase 3 study of andecaliximab for the treatment of gastric cancer. We may decide to terminate product development after expending significant resources and effort. In addition, if we are unable to obtain regulatory approval for product candidates from our recent acquisition of Kite Pharma, Inc. (Kite) and effectively commercialize Kite’s product candidates, we may not be able to realize the anticipated benefits from our acquisition of Kite, including any expected future revenues, ~~from Kite’s product candidates.~~

Further, any future marketing applications we file may not be approved by the regulatory authorities on a timely basis, or at all. Even if marketing approval is granted, there may be significant limitations on their use.results of operations and long-term success.

Our inability to accurately predict demand for our products ~~uptake of new products or~~and fluctuations in ~~customer~~purchasing patterns or wholesaler inventories makes it difficult for us to accurately forecast sales and may cause our forecasted revenues and earnings to fluctuate, which could adversely affect our financial results and ~~our~~ stock price.

We may be unable to accurately predict demand for our products, including the uptake of new products, as demand ~~is dependent~~depends on a number of factors. For example, the non-retail sector in the United States, which includes government institutions, including state AIDS Drug Assistance Programs (ADAPs), the U.S. Department of Veterans Affairs, correctional facilities and large health maintenance organizations, tends to be ~~even~~ less consistent in terms of buying patterns and often causes quarter-over-quarter fluctuations that do not necessarily mirror patient demand for our products. Federal and state budget pressures, as well as the annual grant cycles for federal and state funds, may cause purchasing patterns to not reflect patient demand of our products. For example, in the first quarters of 2018 and certain prior years, we observed large non-retail purchases of our HIV products by a number of state ADAPs that exceeded patient demand. We believe such purchases were driven by the grant cycle for federal ADAP funds. We expect to continue to experience fluctuations in the purchasing patterns of our non-retail customers, which may result in fluctuations in our product sales, revenues and earnings in the future. In light of the budget crises faced by many European countries, we have observed variations in purchasing patterns induced by cost containment measures in Europe. We believe these measures have caused some government agencies and other purchasers to reduce inventory of our products in the distribution channels, which has decreased our revenues and caused fluctuations in our product sales and earnings. We may continue to see this trend in the future.

We sell and distribute most of our products in the United States exclusively through the wholesale channel. During the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, approximately 86% of our product sales in the United States were to three wholesalers, AmerisourceBergen Corp., Cardinal Health, Inc. and McKesson Corp. The U.S. wholesalers with whom we have entered into inventory management agreements make estimates to determine end user demand and may not be completely effective in matching their inventory levels to actual end user demand. As a result, changes in inventory levels held by those wholesalers can cause our operating results to fluctuate unexpectedly if our sales to these wholesalers do not match end user demand. In addition, inventory is held at retail pharmacies and other non-wholesaler locations with whom we have no inventory management agreements and no control over buying patterns. Adverse changes in economic conditions, increased competition or other factors may cause retail pharmacies to reduce their inventories of our products, which would reduce their orders from wholesalers and, consequently, the wholesalers’ orders from us, even if end user demand has not changed. ~~For example, during the fourth quarter of 2017,~~In addition, we have observed that strong wholesaler and sub-wholesaler purchases of our products ~~resulted~~in the fourth quarter typically results in inventory draw-down by wholesalers and sub-wholesalers in the subsequent first ~~quarter of 2018.~~quarter. As inventory in the distribution channel fluctuates from quarter to quarter, we may continue to see fluctuations in our earnings and a mismatch between prescription demand for our products and our revenues.

Further, because our HCV products represent a cure and competitors’ HCV products have entered the market, revenues from our HCV products are difficult for us and investors to estimate. See a discussion of the primary drivers of our HCV product revenues and the factors that can negatively impact such revenues in the risk factor entitled “A substantial portion of our revenues is derived from sales of products to treat HIV and HCV. If we are unable to increase HIV sales or if HCV sales decrease more than anticipated, then our results of operations may be adversely affected” starting on page 37. In addition, we estimate the rebates we will be required to pay in connection with sales during a particular quarter based on claims data from prior quarters. In the United States, actual rebate claims are typically made by payers one to three quarters in arrears. Actual claims may vary significantly from our estimates which can cause an adjustment to our product revenues. Because HCV product revenues are difficult to predict, investors may have widely varying expectations that may be materially higher or lower than our actual or anticipated revenues. To the extent our actual or anticipated HCV product revenues exceed or fall short of these expectations, our stock price could be adversely impacted.

Yescarta, a chimeric antigen receptor (CAR) T cell therapy, represents a novel approach to cancer treatment that creates significant challenges for ~~us.~~us, which may impact our ability to increase sales of Yescarta.

Yescarta, a CAR T cell therapy, involves (i) harvesting T cells from the patient’s blood, (ii) engineering T cells to express cancer-specific receptors, (iii) increasing the number of engineered T cells and (iv) infusing the functional cancer-specific T cells back into the patient. Advancing this novel and personalized therapy creates significant challenges, including:

educating and certifying medical personnel regarding the procedures and the potential side effect profile of our therapy, such as the potential adverse side effects related to cytokine release syndrome and neurologic toxicities, in compliance with the Risk Evaluation and Mitigation Strategy ~~(REMS)~~ program required by ~~FDA~~U.S. Food and Drug Administration (FDA) for Yescarta;

using medicines to manage adverse side effects of our therapy, such as tocilizumab and corticosteroids, which may not be available in sufficient quantities, may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment;

~~sourcing clinical and commercial supplies for the materials used to manufacture and process Yescarta;~~

developing a robust and reliable process, while limiting contamination risks, for engineering a patient’s T cells ex vivo and infusing the engineered T cells back into the patient; and

conditioning patients with chemotherapy in advance of administering our therapy, which may increase the risk of adverse side effects.

The use of engineered T cells as a potential cancer treatment is a recent development and may not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community. We may not be able to establish or demonstrate into the medical community or commercial or governmental payers the safety and efficacy of Yescarta and the potential advantages ~~and side effects~~ compared to existing and future therapeutics. If we fail to overcome these significant challenges, our sales of Yescarta, results of operations and stock price could be adversely affected.

We face significant competition.

We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers. Our products compete with other available products based primarily on efficacy, safety, tolerability, acceptance by doctors, ease of patient compliance, ease of use, price, insurance and other reimbursement coverage, distribution and marketing.

Our TAF-containing HIV products compete primarily with products from ViiV Healthcare Company (ViiV), which markets fixed-dose combination products that compete with Genvoya, Truvada, Descovy, Odefsey, Atripla, Complera/Eviplera, Stribild and Biktarvy. For example, products marketed by ViiV, including Tivicay (dolutegravir), Triumeq (abacavir/dolutegravir/lamivudine) and Juluca (dolutegravir/rilpivirine), compete with our HIV products. For Tybost, we compete with ritonavir marketed by AbbVie Inc. (AbbVie).

We also face competition from generic HIV products. ~~Generic versions of lamivudine and Combivir (lamivudine and zidovudine) are available in the United States and certain other countries.~~ Generic versions of efavirenz, a component of Atripla, are available in the United States, Canada and Europe. We have observed some pricing pressure related to the efavirenz component of our Atripla sales. TDF, one of the active pharmaceutical ingredients in Truvada, Atripla, Complera/Eviplera and Stribild, faces generic competition in the European Union, the United States and certain other countries. In addition, because emtricitabine, the other active pharmaceutical ingredient of Truvada, faces generic competition in the European Union, Truvada also faces generic competition in the European Union and certain other countries outside of the United States. Pursuant to a settlement agreement relating to patents that protect Truvada and Atripla, Teva Pharmaceuticals will be able to launch generic fixed-dose combinations of emtricitabine and TDF and generic fixed-dose combinations of emtricitabine, TDF and efavirenz in the United States on September 30, 2020.

Our HCV products ~~Epclusa, Harvoni, Sovaldi and Vosevi,~~ compete primarily with ~~Mavyret (glecaprevir/pibrentasvir)~~products marketed by AbbVie Inc. and ~~Zepatier (elbasvir and grazoprevir) marketed by Merck.~~Merck & Co., Inc.

Our HBV products ~~Viread, Vemlidy and Hepsera,~~ face competition from existing therapies for treating patients with ~~HBV. Our~~ HBV ~~products face competition from~~as well as generic versions of TDF. Our HBV products also compete with ~~Baraclude (entecavir), an oral nucleoside analog~~products marketed by Bristol-Myers Squibb Company ~~as well as generic entecavir,~~ and ~~Tyzeka/Sebivo (telbivudine), an oral nucleoside analog marketed by~~ Novartis Pharmaceuticals Corporation (Novartis).

Yescarta competes with ~~Kymriah,~~ a CAR T cell therapy ~~for the treatment of relapsed or refractory diffuse large B-cell lymphoma,~~ marketed by Novartis and is expected to compete with products from other companies developing advanced T cell therapies.

Letairis competes with ~~Tracleer (bosentan) and Opsumit (macitentan)~~products marketed by Actelion Pharmaceuticals US, Inc. ~~and also with Adcirca (tadalafil) marketed by~~, United Therapeutics Corporation and Pfizer Inc. ~~Because the U.S. patent for ambrisentan, the active pharmaceutical ingredient in~~ Letairis ~~expired in July 2018,~~also faces competition from manufacturers of generic versions of Letairis ~~is expected to face generic competition~~ in the United States.

Ranexa competes predominantly with generic compounds from three distinct classes of drugs for the treatment of chronic angina in the United States, including generic and/or branded beta-blockers, calcium channel blockers and long-acting nitrates. Ranexa ~~is expected to face~~also faces competition from manufacturers of generic ~~competition~~versions of Ranexa in the United ~~States starting in the first quarter of 2019.~~States.

In addition, a number of companies are pursuing the development of technologies which are competitive with our existing products or research programs. These competing companies include specialized pharmaceutical firms and large pharmaceutical companies acting either independently or together with other pharmaceutical companies. Furthermore, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection and may establish collaborative arrangements for competitive products or programs. If any of these competitors gain market share as a result of new technologies, commercialization strategies or otherwise, it could adversely affect our results of operations and stock price.

Our results of operations may be adversely affected by current and potential future healthcare ~~reforms.~~legislative and regulatory actions.

Legislative and regulatory ~~changes to~~actions affecting government prescription drug procurement and reimbursement programs occur relatively ~~frequently in the United States and foreign jurisdictions.~~frequently. In the United States, we, along with other pharmaceutical manufacturers of branded drug products, are required to pay a portion of an industry fee (also known as the branded prescription drug (BPD) fee), calculated based on select government sales during the prior year as a percentage of total industry government sales. The amount of the annual BPD fee imposed on the pharmaceutical industry as a whole is $4.1 billion in 2018 and $2.8 billion in 2019 and thereafter. Our BPD fee expenses were $385 million in 2017, $270 million in 2016 and $414 million in 2015. The BPD fee is not tax deductible.

~~Since the November 2016 U.S. election, President Trump and the U.S. Congress have made numerous efforts to repeal or amend~~ the Affordable Care Act (the ACA) was enacted in 2010 to expand healthcare coverage. Since then, numerous efforts have been made to repeal, amend or administratively limit the ACA in whole or in part. In May 2017, the U.S. House of Representatives voted to pass the American Health Care Act (the AHCA), which would repeal many provisions of the Affordable Care Act. Although the U.S. Senate considered but failed to pass the AHCA and other comparable measures, the U.S. Congress may consider further legislation to repeal or replace elements of the Affordable Care Act. In addition,For example, the Tax Cuts and Jobs Act, ~~which President Trump~~ signed into law by President Trump in ~~December~~ 2017, ~~repeals~~repealed the ~~Affordable Care Act’s~~ individual health insurance mandate, which is considered a key component of the ~~Affordable Care Act.~~ACA. In December 2018, a Texas federal district court struck down the ACA on the grounds that the individual health insurance mandate is unconstitutional, although this ruling has been stayed pending appeal. The ongoing challenges to the ACA and new legislative proposals have resulted in uncertainty regarding the ACA's future ~~stability~~viability and destabilization of the ~~Affordable Care Act~~health insurance market. The resulting impact on our business is uncertain and could be material.

Efforts to control prescription drug prices could also have a material adverse effect on our business. For example, in 2018, President Trump and the Secretary of the U.S. Department of Health and Human Services (HHS) released the "American Patients First Blueprint" and have begun implementing certain portions. The initiative includes proposals to increase generic drug and biosimilar competition, enable the Medicare program to negotiate drug prices more directly and improve transparency regarding

drug prices and ways to lower consumers' out-of-pocket costs. The Trump administration also proposed to establish an “international pricing index” that would be used as a benchmark to determine the costs and potentially limit the reimbursement of drugs under Medicare Part B. Among other pharmaceutical manufacturer industry-related proposals, Congress has proposed bills to change the Medicare Part D benefit to impose an inflation-based rebate in Medicare Part D and to alter the benefit structure to increase manufacturer contributions in the catastrophic phase. The volume of drug pricing-related bills has dramatically increased under the current Congress, and the resulting impact on our business is ~~thus~~ uncertain and could be material.

In addition, many states have proposed or enacted legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing, such as by requiring biopharmaceutical manufacturers to publicly report proprietary pricing information or to place a maximum price ceiling on pharmaceutical products purchased by state agencies. ~~If such proposed legislation is passed, we may experience additional pricing pressures on our products.~~ For example, in ~~October~~ 2017, California’s governor signed a prescription drug price transparency state bill into law, requiring prescription drug manufacturers to provide advance notice and explanation for price increases of certain drugs that exceed a specified threshold. ~~Similar~~Both Congress and state legislatures are considering various bills ~~have been previously introduced~~that would reform drug purchasing and price negotiations, allow greater use of utilization management tools to limit Medicare Part D coverage, facilitate the import of lower-priced drugs from outside the United States and encourage the use of generic drugs. Such initiatives and legislation may cause added pricing pressures on our products.

Changes to the Medicaid program at the federal or state level could also have a material adverse effect on our business. Proposals that could impact coverage and the Trump administration has focused attention on proposed efforts to curb prescription drug prices. In May 2018, President Trump and the Health and Human Services (HHS) Secretary released the American Patients First blueprint, which included measures to increase generic drug and biosimilar competition, the abilityreimbursement of the Medicare program to negotiate drug prices, public transparency regarding drug prices and information available to beneficiaries regarding ways to lower out-of-pocket costs. The Trump Administration has begun implementing many of these measures, and in October 2018, President Trump proposed a demonstration project to establish an “international pricing index” that would be used as a benchmark in deciding how much to pay for Medicare Part B drugs. The potential effect of health insurance market destabilization during ongoing repeal and replace discussions, as well as the impact of potential changes to the way the Medicaid program is financed, will likely affect patients’ sources of insurance and resultant drug coverage. In addition to the Trump Administration’s proposals, discussions continue at the federal level regarding policies that would require manufacturers to pay higher rebates in Medicare Part D, giveour products, including giving states more flexibility onto manage drugs ~~that are~~ covered under the Medicaid program ~~permit~~and permitting the re-importation of prescription medications from Canada or other countries, ~~and other policy proposals that~~ could ~~impact reimbursement for~~have a material adverse effect by limiting our ~~products. It is difficult to predict the impact, if any, of any such legislation, executive actions or Medicaid flexibility on the~~products’ use and ~~reimbursement of our products in the United States, including the potential for the importation of generic versions of our products.~~

~~In addition,~~coverage. Furthermore, state Medicaid programs could request additional supplemental rebates on our products as a result of ~~the~~an increase in the federal base Medicaid rebate. ~~Private~~To the extent that private insurers or managed care programs follow Medicaid coverage and payment developments, they could ~~also~~ use the enactment of these increased rebates to exert pricing pressure on our products, and ~~to the extent that private insurers or managed care programs follow Medicaid coverage and payment developments,~~ the adverse effects may be magnified by ~~private insurers adopting~~their adoption of lower payment schedules.

Other proposed regulatory actions affecting manufacturers could have a material adverse effect on our business. It is difficult to predict the impact, if any, of any such proposed legislative and regulatory actions or resulting state actions on the use and reimbursement of our products in the United States, but our results of operations may be adversely affected.

Our existing products are subject to reimbursement from government agencies and other third ~~parties.~~parties, and we may be required to provide rebates and other discounts on our products, which may result in an adjustment to our product revenues. Pharmaceutical pricing and reimbursement pressures may ~~reduce profitability.~~adversely affect our profitability and our results of operations.

Successful commercialization of our products depends, in part, on the availability of governmental and third-party payer reimbursement for the cost of such products and related treatments in the markets where we sell our products. Government health authorities, private health insurers and other organizations generally provide reimbursement. In the United States, the European

Union and other significant or potentially significant markets for our products and product candidates, government authorities and third-party payers are increasingly attempting to limit or regulate the price of medical products and services. A ~~significant~~substantial portion of ~~our~~ sales ~~of the majority~~ of our products ~~are~~is subject to significant discounts from list ~~price.~~price, including rebates that we may be required to pay certain governmental agencies. In addition, standard reimbursement structures may not adequately reimburse for innovative therapies. For example, Yescarta is typically administered on an in-patient basis. Reimbursement through federal programs like Medicare and Medicaid is challenging and may be insufficient to cover the complete cost associated with the therapy.

For example, effective October 1, 2018, the Centers for Medicare and Medicaid Services (CMS) established inpatient reimbursement for patients receiving Yescarta. The reimbursement includes payment for a severity adjusted diagnosis related group (DRG) 016, a new technology add-on payment (NTAP) for Yescarta that at most will cover one half the cost of Yescarta and may cover less than that, and, in some cases, an outlier payment. Taken together, the total payment may not be sufficient to reimburse hospitals for their cost of care for patients receiving Yescarta. ~~Furthermore, this~~This payment methodology is likely to be in effect until at least September 2020. Limited payments such as this could impact the willingness of some hospitals to offer the therapy and of doctors to recommend the therapy and could lessen the attractiveness of our therapy to patients, which could have an adverse effect on sales of Yescarta and on our results of operations. CMS has also ~~opened~~proposed a National Coverage ~~Analysis~~Decision on CAR T ~~cells~~cell therapy and ~~may~~would impose certain coverage limitations on that therapy. These coverage limitations would apply to the entire Medicare program and ~~could include,~~includes, among other things, a requirement for patients to be enrolled in a clinical trial or registry in order for the hospital and physician to be paid for CAR T cell therapy. Further, commercial payers may follow Medicare coverage policies and could impose similar limitations. ~~Lastly,~~Additionally, in the European Union, there ~~could be~~are barriers to reimbursement in individual countries that could limit the uptake of Yescarta.

In addition, we estimate the rebates we will be required to pay in connection with sales during a particular quarter based on claims data from prior quarters. In the United States, actual rebate claims are typically made by payers one to three quarters in arrears. Actual claims and payments may vary significantly from our estimates which can cause an adjustment to our product revenues. To the extent our actual or anticipated product revenues fall short of investors’ expectations, our stock price could be adversely impacted.

Laws and regulations applicable to the health care industry could impose new obligations on us, require us to change our business practices and restrict our operations in the future.

The health care industry is subject to various federal, state and international laws and regulations pertaining to drug reimbursement, rebates, price reporting, health care fraud and abuse, and data privacy and security. In the United States, these laws include anti-kickback and false claims laws, laws and regulations relating to the Medicare and Medicaid programs and other federal and state programs, the Medicaid Rebate Statute, individual state laws relating to pricing and sales and marketing practices, the Health Insurance Portability and Accountability Act (HIPAA) and other federal and state laws relating to the privacy and security of health information. ~~In addition, while not specific to the health care industry, we may be subject to additional data privacy and security laws, such as the California Consumer Privacy Act of 2018.~~

Violations of these laws or any related regulations may be punishable by criminal and/or civil sanctions, including, in some instances, substantial fines, civil monetary penalties, exclusion from participation in federal and state health care programs, including Medicare, Medicaid, Veterans Administration health programs, and federal employee health benefit programs, actions against executives overseeing our business and burdensome remediation measures. In addition, these laws and regulations are broad in scope and they are subject to change and evolving interpretations, which could require us to incur substantial costs associated with compliance or to alter one or more of our sales or marketing practices. Violations of these laws, or allegations of such violations, could also result in negative publicity or other consequences that could harm our reputation, disrupt our business or adversely affect our results of operations. If any or all of these events occur, our business and stock price could be materially and adversely affected.

Recently, there has been enhanced scrutiny of company-sponsored patient assistance programs, including insurance premium and co-pay assistance programs and donations to third-party charities that provide such assistance. There has also been enhanced scrutiny by governments on reimbursement support offerings, clinical education programs and promotional speaker programs. If we, or our agents, vendors or donation recipients, are deemed to have failed to comply with laws, regulations or government guidance in any of these areas, we could be subject to criminal or civil sanctions. Any similar violations by our competitors could also negatively impact our industry reputation and increase scrutiny over our business and our products.

~~See~~In addition, government price reporting and payment regulations are complex and we are continually assessing the methods by which we calculate and report pricing in accordance with these obligations. Our methodologies for calculations are inherently subjective and may be subject to review and challenge by various government agencies, which may disagree with our interpretation. If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal liability as described above.

For a description of our government investigations and related litigation, insee Note ~~10,~~11. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

We have engaged in, and may in the future engage in, business acquisitions, licensing arrangements, ~~strategic~~ collaborations, or disposal of our assets and other strategic transactions, which could cause us to incur significant expenses and could adversely affect our financial condition and results of operations.

We have engaged in, and may in the future engage in, business acquisitions, licensing arrangements, ~~strategic~~ collaborations, or disposal of our assets and other transactions, as part of our business strategy. We may not identify suitable transactions in the future and, if we do, we may not complete such transactions in a timely manner, on a cost-effective basis, or at all, and may not realize the expected benefits. IfFor example, if we are successful in making an acquisition, the products and technologies that are acquired may not be successful or may require significantly greater resources and investments than originally anticipated. We also may not be able to integrate acquisitions successfully into our existing business and could incur or assume significant debt and unknown or contingent liabilities. We have also acquired, and may in the future acquire, equity investments in our strategic transactions, such as in connection with our collaboration with Galapagos NV, and the value of our equity investments may fluctuate and decline in value. Further, we conduct annual impairment testing of our goodwill and other indefinite lived intangible assets in the fourth quarter, or earlier if impairment indicators exist, as required under U.S. generally accepted accounting ~~principles.~~principles, which may result in an impairment charge. If we fail to overcome these risks, it could cause us to incur significant expenses and negatively affect profitability, which could have an adverse effect on our results of operations. We could also experience negative effects on our reported results of operations from acquisition or disposition-related charges, amortization of expenses related to intangibles and charges for impairment of long-term assets.

Approximately 27% of our product sales occur outside the United States, and currency fluctuations and hedging expenses may cause our earnings to fluctuate, which could adversely affect our stock price.

Because a significant percentage of our product sales are denominated in foreign currencies, primarily the Euro, we face exposure to adverse movements in foreign currency exchange rates. When the U.S. dollar strengthens against these foreign currencies, the relative value of sales made in the respective foreign currency decreases. Conversely, when the U.S. dollar weakens against these currencies, the relative value of such sales increases. Overall, we are a net receiver of foreign currencies and, therefore, benefit from a weaker U.S. dollar and are adversely affected by a stronger U.S. dollar.

We use foreign currency exchange forward and option contracts to hedge a ~~percentage~~portion of our forecasted international sales, primarily those denominated in the Euro. We also hedge certain monetary assets and liabilities denominated in foreign currencies, which reduces but does not eliminate our exposure to currency fluctuations between the date a transaction is recorded and the date cash is collected or paid. Foreign currency exchange, net of hedges, had ~~a favorable~~an immaterial impact on our product sales ~~of $89 million~~ for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, compared to the same period in ~~2017.~~2018.

We cannot predict future fluctuations in the foreign currency exchange rates of the U.S. dollar. If the U.S. dollar appreciates significantly against certain currencies and our hedging program does not sufficiently offset the effects of such appreciation, our results of operations will be adversely affected and our stock price may decline.

Additionally, the expenses that we recognize in relation to our hedging activities can also cause our earnings to fluctuate. The level of hedging expenses that we recognize in a particular period is impacted by the changes in interest rate spreads between the foreign currencies that we hedge and the U.S. dollar.

If significant safety issues arise for our marketed products or our product candidates, our reputation may be harmed and our future sales may be reduced, which ~~would~~could adversely affect our results of operations.

The data supporting the marketing approvals for our products and forming the basis for the safety warnings in our product labels were obtained in controlled clinical trials of limited duration and, in some cases, from post-approval use. As our products are used over longer periods of time by ~~many~~ patients with underlying health problems ~~taking numerous~~or other medicines, we expect to continue ~~to find~~finding new issues ~~such as~~related to safety, resistance or drug ~~interaction~~interactions. Any such issues ~~which~~ may require uschanges to ~~provide~~our product labels, such as additional warnings, contraindications or ~~contraindications on our labels or narrow our approved indications, each~~even narrowed indications. If any of ~~which~~these were to occur, it could reduce the market acceptance and sales of ~~these~~our products.

Regulatory authorities have been moving towards more active and transparent pharmacovigilance and are making greater amounts of stand-alone safety information and clinical trial data directly available to the public through websites and other means, such as periodic safety update report summaries, risk management plan summaries and various adverse event data. Safety information, without the appropriate context and expertise, may be misinterpreted and lead to misperception or legal action which may potentially cause our product sales or stock price to decline.

For Yescarta, a novel CAR T cell therapy, treatment-related adverse effects may not be appropriately recognized and managed by the treating medical staff, as toxicities resulting from personalized T cell therapy are not typically encountered in the general patient population and by medical personnel. Common medicines that may be used at academic medical centers and hospitals to help manage adverse side effects of Yescarta, such as tocilizumab and corticosteroids, may not be available in sufficient quantities, may not adequately control such adverse side effects and/or may have a detrimental impact on the efficacy of the treatment. We have trained and expect to continue to train medical personnel to understand the side effect profile of Yescarta in compliance with the REMS program required by FDA for Yescarta, although we can give no assurances on the efficacy of our training efforts.

Inadequate training in recognizing or managing the potential adverse effects of Yescarta, or the disregard or modification of our training by medical staff, could result in more severe or prolonged toxicities or even patient deaths.

Further, if serious safety, resistance or drug interaction issues arise with our marketed products, sales of these products could be limited or halted by us or by regulatory authorities and our results of operations ~~would~~could be adversely affected.

Our operations depend on compliance with complex FDA and comparable international regulations. Failure to obtain broad approvals on a timely basis or to maintain compliance could delay or halt commercialization of our products.

The products we develop must be approved for marketing and sale by regulatory authorities and, once approved, are subject to extensive regulation by FDA, the European Medicines Agency (EMA) and comparable regulatory agencies in other countries. We are continuing clinical trials for many of our products for currently approved and additional uses. We anticipate that we will file for marketing approval in additional countries and for additional indications and products over the next several years. These products may fail to receive such marketing approvals on a timely basis, or at all.

Further, how we manufacture and sell our products is subject to extensive regulation and review. Discovery of previously unknown problems with our marketed products or problems with our manufacturing, safety reporting or promotional activities may result in restrictions on our products, including withdrawal of the products from the market. If we fail to comply with applicable regulatory requirements, including those related to promotion and manufacturing, we could be subject to penalties including fines, suspensions of regulatory approvals, product recalls, seizure of products and criminal prosecution.

For example, under FDA rules, we are often required to conduct post-approval clinical studies to assess a known serious risk, signals of serious risk or to identify an unexpected serious ~~risk and~~risk. In certain circumstances, we may be required to implement a ~~REMS~~Risk Evaluation and Mitigation Strategy program for our products, which could include a medication guide, patient package insert, a communication plan to healthcare providers, restrictions on distribution or use of a product and other elements as FDA deems ~~are~~ necessary to assure safe use of the ~~drug, which could include imposing certain restrictions on the distribution or use of a product.~~drug. Failure to comply with these or other requirements imposed by FDA could result in significant civil monetary penalties and our operating results may be adversely affected.

~~The results and anticipated timelines of~~We face risks in our clinical trials, ~~are uncertain~~including the potential for unfavorable results, delays in anticipated timelines and ~~may not support continued development of a product candidate,~~disruption, which ~~would~~may adversely affect our prospects for future revenue ~~growth.~~growth and our results of operations.

We are required to demonstrate the safety and efficacy of products that we develop for each intended use through extensive preclinical studies and clinical trials. The results from preclinical and early clinical studies do not always accurately predict results in later, large-scale clinical trials. Even successfully completed large-scale clinical trials may not result in marketable products. For example, ~~during 2018,~~ we ~~terminated~~recently announced that our ~~Phase 3 study of andecaliximab~~KITE-585 program, an anti-B cell maturation antigen being evaluated for the treatment of ~~gastric cancer, after determining~~multiple myeloma, will not be moving forward. We also recently announced that ~~study data showed insufficient evidence~~STELLAR-3 and STELLAR-4, Phase 3 studies evaluating the safety and efficacy of selonsertib for the treatment ~~benefit.~~of nonalcoholic steatohepatitis (NASH), did not meet the pre-

specified week 48 primary endpoints. If any of our product candidates fails to achieve its primary endpoint in clinical trials, if safety issues arise or if the results from our clinical trials are otherwise inadequate to support regulatory approval of our product candidates, commercialization of that product candidate could be delayed or halted. In addition, we may also face challenges in clinical trial protocol design.

If the clinical trials for any of the product candidates in our pipeline are delayed or terminated, our prospects for future revenue growth ~~would~~and our results of operations may be adversely impacted. For example, we face numerous risks and uncertainties with our product candidates, including Descovy for pre-exposure prophylaxis (PrEP); selonsertib for the treatment of ~~nonalcoholic steatohepatitis (NASH);~~NASH; axicabtagene ciloleucel for the treatment of second line diffuse large B-cell lymphoma; and filgotinib for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis, each currently in Phase 3 clinical trials, that could prevent completion of development of these product candidates. These risks include our ability to enroll patients in clinical trials, the possibility of unfavorable results of our clinical trials, the need to modify or delay our clinical trials or to perform additional trials and the risk of failing to obtain FDA and other regulatory body approvals. As a result, our product candidates may never be successfully commercialized. For example, FDA has requested that we conduct a safety study of filgotinib in men with moderately to severely active inflammatory bowel disease (MANTA study) as a post-marketing requirement. Further, we may make a strategic decision to discontinue development of our product candidates if, for example, we believe commercialization will be difficult relative to other opportunities in our pipeline. If these programs and others in our pipeline cannot be completed on a timely basis or at all, then our prospects for future revenue growth and our results of operations may be adversely impacted. In addition, clinical trials involving our commercial products could raise new safety issues for our existing products, which could in turn ~~decrease~~adversely affect our ~~revenues~~results of operations and harm our business.

~~Due to our reliance on third-party contract research organizations to conduct our clinical trials,~~In addition, we ~~are unable to directly control the timing, conduct, expense and quality of our clinical trials.~~

We extensively outsource our clinical trial activities and usually perform only a small portion of the start-up activities in-house. We rely on independent third-party contract research organizations (CROs) to perform most of our clinical studies, including document preparation, site identification, screening and preparation, pre-study visits, training, program management, patient enrollment, ongoing monitoring, site management and bioanalytical analysis. Many important aspects of the services performed for us by the CROs are out of our direct control. If there is any dispute or disruption in our relationship with our CROs, our clinical trials may be delayed. Moreover, in our regulatory submissions, we rely on the quality and validity of the clinical work performed

by third-party CROs. If any of our CROs’ processes, methodologies or results were determined to be invalid or inadequate, our own clinical data and results and related regulatory approvals ~~could~~may be adversely affected.

We depend on relationships with ~~other companies~~third parties for sales and marketing performance, technology, development, logistics and commercialization of ~~product candidates and revenues.~~products. Failure to maintain these relationships, poor performance by these companies or disputes with these ~~companies~~third parties could negatively impact our business.

We rely on a number of collaborative relationships with ~~major pharmaceutical companies~~third parties for our sales and marketing performance in certain territories. For example, we have collaboration arrangements with Janssen Sciences Ireland UC for Odefsey, Complera/Eviplera and Symtuza. In some countries, we rely on international distributors for sales of certain of our products. Some of these relationships also involve the clinical development of these products by our partners. Reliance on collaborative relationships poses a number of risks, including the risk that:

we are unable to control the resources our corporate partners devote to our programs or products;

disputes may arise with respect to the ownership of rights to technology developed with our corporate partners;

disagreements with our corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration;

contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform;

our corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors;

our corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and

our distributors and our corporate partners may be unable to pay us.

Given these risks, there is a great deal of uncertainty regarding the success of our current and future collaborative efforts. If these efforts fail, our product development or commercialization of new products could be delayed or revenues from products could decline.

Yescarta is available only through a REMS program, which is required by FDA to mitigate the potential risks of the product. Only hospitals and their associated clinics certified in the REMS program are permitted to dispense Yescarta. All relevant staff involved in the prescribing, dispensing or administering of Yescarta must be trained on the REMS program requirements and must successfully complete a REMS program knowledge assessment. Failure of hospitals and clinics to enroll in the Yescarta REMS program or to successfully complete and comply with the program requirements may result in regulatory action from FDA or decreased sales of Yescarta, which could harm our business and our reputation.

For Yescarta, we rely on technology partners to assist in the development and maintenance of the Kite Konnect platform. This platform is critical to ensure positive prescriber and patient experience, as well as chain of identity and chain of custody of Yescarta. If the technology platform is incomplete, insufficiently maintained or develops technological issues, we may experience a disruption to the sales and logistics of our Yescarta business, which could extend for a significant period of time, and we may need to expend considerable resources and time to repair or improve the platform in cooperation with our partners. In addition, we rely on third-party sites to collect ~~patient~~patients’ white blood cells, known as apheresis centers, shippers, couriers, and hospitals for the logistical collection of ~~patient’s~~patients’ white blood cells and ultimate delivery of Yescarta to patients. Any disruption or difficulties incurred by any of these vendors could result in product loss and regulatory action and harm our Yescarta business and our reputation.

~~In addition, to~~ To ensure that any apheresis center is prepared to ship cells to our manufacturing facilities, we plan to conduct quality certifications of each apheresis center. However, apheresis centers may choose not to participate in the certification process

or we may be unable to complete certification in a timely manner or at all, which could delay or restrain our manufacturing and commercialization efforts. As a result, our sales of Yescarta may be limited which could harm our results of operations.

Our success depends to a significant degree on our ability to defend our patents and other intellectual property rights both domestically and internationally. We may not be able to obtain effective patents to protect our technologies from use by ~~competitors and patents of other companies could require us to stop using or pay for the use of required technology.~~competitors.

Patents and other proprietary rights are very important to our business. Our success depends to a significant degree on our ability to:

obtain patents and licenses to patent rights;

preserve trade secrets and internal know-how;

defend against infringement of our patents and efforts to invalidate ~~our patents;~~them; and

operate without infringing on the intellectual property of others.

If we have a properly drafted and enforceable patent, it can be more difficult for our competitors to use our technology to create competitive products and more difficult for our competitors to obtain a patent that prevents us from using technology we create. As part of our business strategy, we actively seek patent protection both in the United States and internationally and file additional patent applications, when appropriate, to cover improvements in our compounds, products and technology.

We have a number of U.S. and foreign patents, patent applications and rights to patents related to our compounds, products and technology, but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents. Patent applications are confidential for a period of time before a patent is issued. As a result, we may not know if our competitors filed patent applications for technology covered by our pending applications or if we were the first to invent or first to file an application directed toward the technology that is the subject of our patent applications. ~~Competitors may have filed patent applications or received patents and may obtain additional patents and proprietary rights that block or compete with our products.~~ In addition, if competitors file patent applications covering our technology, we may have to participate in litigation, ~~interference~~post-grant proceedings before the U.S. Patent and Trademark Office or other proceedings to determine the right to a patent or validity of any patent granted. Litigation, ~~interference~~post-grant proceedings before the U.S. Patent and Trademark Office or other proceedings are unpredictable and expensive, and could divert management attention from other operations, such that, even if we are ultimately successful, our results of operations may be adversely affected by such events.

For example, TDF, one of the active pharmaceutical ingredients in Truvada, Atripla, Complera/Eviplera and Stribild, and the main active pharmaceutical ingredient in Viread, faces generic competition in the European Union, the United States and certain other countries. In addition, because emtricitabine, the other active pharmaceutical ingredient of Truvada, faces generic competition in the European Union, Truvada also faces generic competition in the European Union and certain other countries outside of the United States. Because the U.S. patent for ambrisentan, the active pharmaceutical ingredient in Letairis, expired in July 2018, Letairis is expected to face generic competition in the United States. Further, Ranexa is also expected to face generic competition in the United States starting in the first quarter of 2019. The entry of these generic products may lead to market share and price erosion and have a negative impact on our business and results of operations. In addition, we do not own any patents covering ranolazine, the active ingredient of Ranexa. Instead, when it was discovered that only a sustained-release formulation of ranolazine would achieve therapeutic plasma levels, we obtained patents on those formulations and the characteristic plasma levels they achieve. For Yescarta, the composition of matter patent has expired in the European Union. In the European Union and the United States, patent applications are pending related to Kite’s proprietary manufacturing processes. We own a granted patent in the United States and pending applications in the United States and European Union relating to Kite’s proprietary pre-conditioning methods.

We may obtain patents for certain products many years before marketing approval is obtained for those products. Because patents have a limited life, which may begin to run prior to the commercial sale of the related product, the commercial value of the patent may be limited. However, we may be able to apply for patent term extensions or supplementary protection certificates in some countries.

Generic manufacturers have sought, and may continue to seek, FDA approval to market generic versions of our products through an abbreviated new drug application (ANDA), the application ~~form~~process typically used by manufacturers seeking approval of a generic drug. ~~See~~For a description of our ANDA litigation, in see Note ~~10,~~11. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form ~~10-Q and risk factor entitled “Litigation with generic manufacturers has increased our expenses which may continue to reduce our earnings. If we are unsuccessful in all or some~~10-Q. The entry of ~~these lawsuits, some or all of our claims in the patents may be narrowed or invalidated and~~ generic versions of our products ~~could be launched prior~~has, and may in the future, lead to market share and price erosion and have a negative impact on our ~~patent expiry” beginning on page 49.~~business and results of operations.

Our success depends in large part on our ability to operate without infringing upon the patents or other proprietary rights of third parties.

If we infringe the valid patents of third parties, we may be required to pay significant monetary damages or we may be prevented from commercializing products or may be required to obtain licenses from these third parties. We may not be able to obtain alternative technologies or any required license on commercially reasonable terms or at all. If we fail to obtain these licenses or alternative technologies, we may be unable to develop or commercialize some or all of our products. For example, we are aware of patents and patent applications owned by third parties that such parties may claim cover the use of sofosbuvir, axicabtagene ciloleucel and bictegravir. See also a description of our litigation regarding sofosbuvir, axicabtagene ciloleucel and bictegravir in Note ~~10,~~11, Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q and the risk factors entitled “If any of our HCV products is proven to infringe the patents of any third party, we may be required to pay significant monetary damages, which could adversely affect our financial results” beginning on page 46 and “If any party is successful in establishing exclusive rights to axicabtagene ciloleucel, our anticipated revenues and earnings from the sale of that product could be adversely affected” beginning on page 47.10-Q. We are also aware of U.S. Patent Nos. 9,044,509, 9,579,333, 9,937,191 and ~~9,937,191~~10,335,423 assigned to the U.S. Department of Health and Human Services that purport to claim a process of protecting a primate host from infection by an immunodeficiency retrovirus by administering a

combination of emtricitabine and tenofovir or TDF prior to exposure of the host to the immunodeficiency retrovirus. We have been in contact with the U.S. Department of Health and Human Services about the scope and relevance of the patents and have explained that we do not believe that these patents are valid because the patent office was not given the most relevant prior art and because physicians and patients were using the claimed methods years before the Centers for Disease Control and Prevention filed the applications for the patents.

Furthermore, we also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation. For example, a great deal of our liposomal manufacturing expertise, which is a key component of our liposomal technology, is not covered by patents but is instead protected as a trade secret. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors. These agreements provide that all confidential information developed or made known to an individual during the course of their relationship with us will be kept confidential and will not be used or disclosed to third parties except in specified circumstances. In the case of employees, the agreements provide that all inventions made by an individual while employed by us will be our exclusive property. We cannot be certain that these parties will comply with these confidentiality agreements, that we have adequate remedies for any breach or that our trade secrets, internal know-how or technological innovation will not otherwise become known or be independently discovered by our competitors. Under some of our R&D agreements, inventions become jointly owned by us and our corporate partner and in other cases become the exclusive property of one party. In certain circumstances, it can be difficult to determine who owns a particular invention and disputes could

arise regarding those inventions. If our trade secrets, internal know-how, technological innovation or confidential information become known or independently discovered by competitors or if we enter into disputes over ownership of inventions, our business and results of operations could be adversely affected.

~~If any of our HCV products is proven to infringe the patents of any third party, we may be required to pay significant monetary damages, which could adversely affect our financial results.~~

We own patents and patent applications that claim sofosbuvir (Sovaldi) as a chemical entity and its metabolites and the fixed-dose combinations of sofosbuvir and velpatasvir (Epclusa), ledipasvir and sofosbuvir (Harvoni) and sofosbuvir, velpatasvir and voxilaprevir (Vosevi). We are aware of patents and patent applications owned by third parties that have been or may in the future be alleged by such parties to cover the use of our HCV products. If third parties obtain valid and enforceable patents, and successfully prove infringement of those patents by our HCV products, we could be required to pay significant monetary damages.

~~Current legal proceedings of significance related to sofosbuvir include:~~

~~Litigation with Idenix Pharmaceuticals, Inc. (Idenix)~~

See the risk factor entitled “We may be required to pay material damages to Merck if the court’s decision invalidating a patent owned by Merck’s Idenix subsidiary is overturned on appeal” beginning on page 47. See also a description of our Idenix litigation in ~~Note 10, Commitments and Contingencies~~ ~~of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.~~

~~Litigation with Merck & Co., Inc. (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 No. 7,105,499 (the ‘499 patent) and U.S. Patent No. 8,481,712 (the ‘712 patent), which it co-owns with Ionis Pharmaceuticals, Inc. The ‘499 and ‘712 patents cover compounds which do not include, but may relate to, sofosbuvir. We filed a lawsuit in August 2013 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. Initially, in March 2016, a jury determined that we had not established that Merck’s patents are invalid for lack of written description or lack of enablement and awarded Merck $200 million in damages. However, in June 2016, the court ruled in our favor on our defense of unclean hands and determined that Merck may not recover any damages from us for the ‘499 and ‘712 patents. The judge has determined that Merck is required to pay our attorney’s fees due to the exceptional nature of this case. In July 2017, the court issued a decision setting the amount of attorney fees awarded to us.

Merck filed notices of appeal to the CAFC regarding the court’s decision on our defense of unclean hands and its award of attorney’s fees. In April 2018, the CAFC affirmed the court’s decision on unclean hands. Merck has filed a petition for review by the U.S. Supreme Court. If the decision on our defense of unclean hands is reversed subsequently and Merck’s patent is upheld, we may be required to pay damages and a royalty on sales of sofosbuvir-containing products following the appeal. In that event, the judge has indicated that she will determine the amount of the royalty, if necessary, at the conclusion of any appeal in this case.

~~Litigation with the University of Minnesota~~

We believe the ‘830 patent is invalid and will not be infringed by the continued commercialization of sofosbuvir. In October 2017, the court granted our motion to transfer the case to California. We have also filed four petitions for inter partes review with the U.S. Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB) alleging that all asserted claims are invalid for anticipation and obviousness. In March 2018, the District Court stayed the litigation until after the PTAB rules on our petitions for inter partes review.

~~Petitions for Inter Partes Review filed by Initiative for Medicines, Access & Knowledge~~

In October 2017, we received notice that Initiative for Medicines, Access & Knowledge (I-MAK) submitted multiple petitions requesting inter partes review to the USPTO PTAB alleging that certain patents associated with sofosbuvir are invalid as either not novel or obvious. We strongly believe I-MAK’s petitions are without merit and that sofosbuvir, the only approved HCV drug of its kind, is both novel and not obvious. Accordingly, we defended against these allegations, and the PTAB declined to institute all ten of I-MAK’s petitions for inter partes review as well as all of I-MAK’s petitions for rehearing.

~~European Patent Claims~~

We cannot predict the ultimate outcome of intellectual property claims related to our HCV products, and we have spent, and will continue to spend, significant resources defending against these claims. If we are unsuccessful in all or some of these lawsuits, we could be required to pay significant monetary damages, which could have a significant negative effect on our financial results.

~~We may be required to pay material damages to Merck if the court~~’~~s decision invalidating a patent owned by Merck~~’~~s Idenix subsidiary is overturned on appeal.~~

In December 2013, Idenix, 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 Universita Degli Studi di Cagliari 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 (the ‘054 patent) and 7,608,597 (the ‘597 patent). In June 2014, the court transferred the Massachusetts litigation to the U.S. District Court for the District of Delaware. Idenix was acquired by Merck in August 2014.

Prior to trial in December 2016, Idenix committed to give us a covenant not to sue with respect to any claims arising out of the ‘054 patent related to sofosbuvir and withdrew that patent from the trial. In addition, Idenix declined to litigate the ‘600 patent infringement action at trial in light of the appeal then pending at the U.S. Court of Appeals for the Federal Circuit (CAFC). Since the U.S. Supreme Court denied Idenix’s petition for certiorari in the appeal of the interference decision on the ‘600 patent, all pending actions concerning the ‘600 patent have been dismissed. A jury trial was held in December 2016 on the ‘597 patent. In December 2016, the jury found that we willfully infringed the asserted claims of the ‘597 patent and awarded Idenix $2.54 billion in past damages. In February 2018, the judge invalidated Idenix’s ‘597 patent and vacated the jury’s award of $2.54 billion in past damages. Idenix has appealed this decision to the CAFC. We believe the Delaware court’s decision correctly found that, as a matter of law, the ‘597 patent is invalid, and we remain confident in the merits of our case on appeal.

If the court’s decision invalidating Idenix’s patent is overturned on appeal, the amount we could be required to pay could be material. The timing and magnitude of the amount of any such payment could have a material adverse impact on our results of operations and stock price.

~~If any party is successful in establishing exclusive rights to axicabtagene ciloleucel, our anticipated revenues and earnings from the sale of that product could be adversely affected.~~

In October 2017, we acquired Kite, which is now our wholly-owned subsidiary. Through the acquisition, we acquired axicabtagene ciloleucel, a CAR T cell therapy. In October 2017, we received approval from FDA for axicabtagene ciloleucel, now known commercially as Yescarta.

Juno Therapeutics, Inc. (Juno) has exclusively licensed Patent No. 7,446,190 (the ‘190 patent) which was issued to Sloan Kettering Cancer Center. In September 2017, Juno and Sloan Kettering Cancer Center filed a lawsuit against Kite in the U.S. District Court for the Central District of California, alleging that the commercialization of axicabtagene ciloleucel infringes the ‘190 patent. In October 2017, following FDA approval for Yescarta, Juno filed a second complaint alleging that axicabtagene ciloleucel infringes the ‘190 patent. Juno subsequently moved to dismiss the September 2017 complaint and has maintained the October 2017 complaint. The court has set a trial date of October 2019 for this lawsuit.

Manufacturing problems, including at our third-party manufacturers and corporate partners, could cause inventory shortages and delay product shipments and regulatory approvals, which may adversely affect our results of operations.

In order to generate revenue from our products, we must be able to produce sufficient quantities of our products to satisfy demand. Many of our products are the result of complex manufacturing processes. The manufacturing process for pharmaceutical products is also highly regulated and regulators may shut down manufacturing facilities that they believe do not comply with regulations.

Our products are either manufactured at our own facilities or by third-party manufacturers or corporate partners. We depend on third parties to perform manufacturing activities effectively and on a timely basis for the majority of our solid dose products. We, our third-party manufacturers and our corporate partners are subject to Good Manufacturing Practices (GMP), which are extensive regulations governing manufacturing processes, stability testing, record keeping and quality standards as defined by FDA and EMA. Similar regulations are in effect in other jurisdictions.

Our third-party manufacturers and corporate partners are independent entities ~~who are~~ subject to their own unique operational and financial risks ~~which~~that are out of our control. If we or any of these third-party manufacturers or corporate partners fail to perform as required, this could impair our ability to deliver our products on a timely basis or receive royalties or could cause delays in our clinical trials and applications for regulatory approval. Further, we may have to ~~write-off~~write off the costs of manufacturing any batch that fails to pass quality inspection or meet regulatory approval. In addition, we, our third-party manufacturers and our corporate partners may only be able to produce some of our products at one or a limited number of facilities and, therefore, have limited manufacturing capacity for certain products, and we may not be able to locate additional or replacement facilities on a reasonable basis or at all. Our sales of such products could also be adversely impacted by our reliance on such limited number of facilities. To the extent these risks materialize and affect their performance obligations to us, our financial results may be adversely affected.

Our manufacturing operations are subject to routine inspections by regulatory agencies. If we are unable to remedy any deficiencies cited by FDA in these inspections, our currently marketed products and the timing of regulatory approval of products in development could be adversely affected. Further, there is risk that regulatory agencies in other countries where marketing applications are pending will undertake similar additional reviews or apply a heightened standard of review, which could delay the regulatory approvals for products in those countries. If approval of any of our product candidates were delayed or if production of our marketed products was interrupted, our anticipated revenues and our stock price ~~would~~may be adversely affected.

We have limited experience managing the T cell engineering process, and our processes may be more difficult or more expensive than the approaches taken by our current and future competitors. We cannot be sure that the manufacturing processes employed by us will result in engineered T cells that will be safe and effective. In addition, we may encounter difficulties in production, particularly in scaling up and validating initial production to meet patient demand and ensuring the absence of contamination. These problems could include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Further, if contaminants are discovered in our supply of Yescarta or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination, which could require substantial resources and management attention. We cannot assure you that any stability or other issues relating to the manufacture of Yescarta will not occur in the future or that any such issues may be remedied on a timely basis or at all. In addition, we may fail to manage the logistics of collecting and shipping patient material to the manufacturing site and shipping Yescarta back to the patient. Logistical and shipment delays and problems caused by us, our vendors or other factors not in our control, such as weather and natural disasters, could prevent or delay the delivery of our products and product candidates to patients. Additionally, we are required to maintain a complex chain of identity and custody with respect to patient

material as such material moves to the manufacturing facilities, through the manufacturing process, and back to the patient. Failure to maintain chain of identity and custody could result in patient death, loss of product or regulatory action, which could have an adverse effect on us, our reputation and our stock price.

We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, which ~~would~~could limit our ability to generate revenues.

We need access to certain supplies and products to conduct our clinical trials and to manufacture and sell our products. If we are unable to purchase sufficient quantities of these materials or find suitable ~~alternate~~alternative materials in a timely manner, our development efforts for our product candidates may be delayed or our ability to manufacture our products ~~would~~could be limited, which ~~would~~could limit our ability to generate revenues.

Suppliers of key components and materials must be named in the new drug application or ~~MAA~~marketing authorization application filed with ~~FDA, EMA or other~~the regulatory authority for any product candidate for which we are seeking marketing approval, and significant delays can occur if the qualification of a new supplier is required. Even after a manufacturer is qualified by the regulatory authority, the manufacturer must continue to expend time, money and effort in the area of production and quality control to ensure full compliance with GMP. Manufacturers are subject to regular periodic inspections by ~~the~~ regulatory authorities following initial approval. If, as a result of these inspections, a regulatory authority determines that the equipment, facilities, laboratories or processes do not comply with applicable regulations and conditions of product approval, the regulatory authority may suspend the manufacturing operations. If the manufacturing operations of any of the single suppliers for our products are suspended, we may be unable to generate sufficient quantities of commercial or clinical supplies of product to meet market demand, which ~~would~~could in turn decrease our revenues and harm our business. In addition, if ~~delivery~~deliveries of ~~material~~materials from our suppliers were interrupted for any reason, we may be unable to ship certain of our products for commercial supply or to supply our ~~products~~product candidates in development for clinical trials. In addition, some of our products and the materials that we utilize in our operations are ~~made~~manufactured at only one facility, which we may not be able to replace in a timely manner and on commercially reasonable terms, or at all. Problems with any of the single suppliers we depend on, including in the event of a disaster, such as an earthquake, equipment failure or other difficulty, may negatively impact our development and commercialization efforts.

A significant portion of the raw materials and intermediates used to manufacture our antiviral products are supplied by third-party manufacturers and corporate partners outside of the United States. As a result, any political or economic factors in a specific country or region, including any changes in or interpretations of trade regulations, compliance requirements or tax legislation, that would limit or prevent third parties outside of the United States from supplying these materials ~~would~~could adversely affect our ability

to manufacture and supply our antiviral products to meet market needs and have a material and adverse effect on our operating results.

If we were to encounter any of these difficulties, our ability to ~~provide our products and~~conduct clinical trials on product candidates and to ~~patients would be jeopardized.~~

Litigation with generic manufacturers has increased our expenses which may continue to reduce our earnings. If we are unsuccessful in all or some of these lawsuits, some or all of our claims in the patents may be narrowed or invalidatedmanufacture and ~~generic versions of~~sell our products could be ~~launched prior to our patent expiry.~~

~~As part of the approval process for some of our products, FDA granted us a New Chemical Entity (NCE) exclusivity period during~~impaired, 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~~could 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 ANDA, the application form typically used by manufacturers seeking approval of a generic drug. To seek approval for a generic version of a product having NCE status, a generic manufacturer may submit its ANDA to FDA four years after the branded product’s approval.

~~Current legal proceedings of significance with generic manufacturers include:~~

~~Mylan~~

In February 2016, we received notice that Mylan Pharmaceuticals, Inc. (Mylan) submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Tybost (cobicistat). In the notice, Mylan alleges that the patent covering cobicistat is invalid as obvious and that Mylan’s generic product cannot infringe an invalid claim. In March 2016, we filed lawsuits against Mylan in the U.S. District Court for the District of Delaware and U.S. District Court for the Northern District of West Virginia. The parties have agreed to dismiss the action in West Virginia, and the trial in Delaware was stayed. The patent in suit that covers Tybost is also listed in the Orange Book for Stribild and Genvoya. In November 2017, we received notice that Mylan submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Evotaz (atazanavir/cobicistat) and challenging the validity of our cobicistat compound patent, citing the arguments it has made in the ongoing litigation involving Tybost. In December 2017, we filed a lawsuit against Mylan in the U.S. District Court for the Northern District of West Virginia.

In July 2018, we reached an agreement with Mylan to resolve all pending lawsuits. The settlement agreement has been filed with the Federal Trade Commission and Department of Justice as required by law.

~~Aurobindo~~

In April and May 2018, we received notices that Aurobindo Pharma USA Inc. (Aurobindo) submitted an ANDA to FDA requesting permission to manufacture and market generic versions of Truvada at low dosage strengths. In the May notice, Aurobindo alleges that two patents associated with emtricitabine are invalid, unenforceable and/or will not be infringed by Aurobindo’s manufacture, use or sale of generic versions of Truvada at low dosage strengths. In May 2018, we filed a lawsuit against Aurobindo in the U.S. District Court for the District of Delaware for infringement of our patents. In October 2018, we reached an agreement with Aurobindo to resolve the lawsuit. The settlement agreement has been filed with the Federal Trade Commission and Department of Justice as required by law.

~~Strides~~

In May 2018, we received notice that Strides Pharma Inc. (Strides) submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Truvada. In the notice, Strides alleges that two patents associated with emtricitabine and four patents associated with the emtricitabine and tenofovir disoproxil fumarate (TDF) fixed-dose combination are invalid, unenforceable and/or will not be infringed by Strides’ manufacture, use or sale of a generic version of Truvada. In June 2018, we filed a lawsuit against Strides in the U.S. District Court for the District of New Jersey for infringement of our patents.

~~Natco and Teva~~

In February 2018, we received notices from Natco Pharma Limited (Natco) and Teva Pharmaceuticals (Teva) that they have each submitted an ANDA to FDA requesting permission to manufacture and market a generic version of Sovaldi. In Teva’s notice, it alleges that nine patents associated with sofosbuvir are invalid, unenforceable and/or will not be infringed by Teva’s manufacture, use or sale of generic versions of Sovaldi. In March 2018, we filed lawsuits against Teva in the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Delaware for infringement of these patents. In Natco’s notice, it alleges that two patents associated with sofosbuvir are invalid, unenforceable and/or will not be infringed by Natco’s manufacture, use or sale of generic versions of Sovaldi. Natco did not challenge all patents listed on the Orange Book for Sovaldi. In March 2018, we filed lawsuits against Natco in the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Delaware for infringement of these patents.

We cannot predict the ultimate outcome of the foregoing actions and other litigation with generic manufacturers, and we may spend significant resources enforcing and defending these patents. If we are unsuccessful in these lawsuits, some or all of our original claims in the patents may be narrowed or invalidated and the patent protection for these products could be substantially shortened. Further, if all of the patents covering one or more products are invalidated, FDA could approve the requests to manufacture a generic version of such products in the United States prior to the expiration date of those patents. The sale of generic versions of these products earlier than their patent expiration would have a significant negativeadverse effect on our ~~revenues and results of operations.~~business.

Imports from countries where our products are available at lower prices and unapproved generic or counterfeit versions of our products could have a negative impact on our reputation and business.

Prices for our products are based on local market economics and competition and sometimes differ from country to country. Our sales in countries with relatively higher prices may be reduced if products can be imported into those or other countries from lower price markets. If our HIV, HBV and HCV products, which we have agreed to make available at substantially reduced prices to certain low- and middle-income countries participating in our Gilead Access Program, are re-exported from these low- and middle-income countries into the United States, Europe or other higher price markets, our revenues ~~would~~could be adversely affected. In addition, we have entered into voluntary licensing agreements with generic drug companies in India, South Africa and China, as well as a licensing agreement with the Medicines Patent Pool, a United Nations-backed public health organization, which allows generic drug companies to manufacture generic versions of HIV and HBV products incorporating our licensed compounds, TAF, cobicistat, elvitegravir and bictegravir, for distribution in certain low- and middle-income countries. We have also entered into ~~licensing~~ agreements with generic manufacturers in India, Egypt and Pakistan allowing them to produce ~~and~~and/or distribute generic versions of our HCV products in certain low- and middle-income countries. If generic versions of our HIV, HBV and HCV products produced and/or distributed under these ~~licenses~~agreements are then re-exported to the United States, Europe or other markets outside of these low- and middle-income countries, our revenues ~~would~~could be adversely affected.

In addition, purchases of our products in countries where our selling prices are relatively low for resale in countries in which our selling prices are relatively high may adversely impact our revenues and gross margin and may cause our sales to fluctuate from quarter to quarter. ~~For example,~~Additionally, use of these diverted products could occur in countries where they have not been approved and patients could source the product outside the legitimate supply chain. Therefore, the products may be handled, shipped and stored inappropriately, which may affect the efficacy of the product and could harm patients, our brands or the commercial or scientific reputation of our products.

In the European Union, we are required to permit products purchased in one ~~country~~EU member state to be sold in another ~~country.~~EU member state. Purchases of our products in countries where our selling prices are relatively low for resale in countries

in which our selling prices are relatively high can affect the inventory level held by our wholesalers and can cause the relative sales levels in the various countries to fluctuate from quarter to quarter and not reflect the actual consumer demand in any given quarter. These quarterly fluctuations may impact our earnings, which could adversely affect our stock price and harm our business.

We are also aware of the existence of various “Buyers Clubs” around the world that promote the personal importation of generic versions of our HCV and HIV products that have not been approved for use in the countries into which they are imported. As a result, patients may be at risk of taking unapproved medications which may not be what they purport to be, may not have the potency they claim to have or may contain harmful substances. To the extent patients take unapproved generic versions of one or more of our medications and are injured ~~or not cured~~ by these generic products, our ~~brand~~brands or the commercial or scientific reputation of our HCV and HIV products could be harmed.

Further, third parties may illegally distribute and sell counterfeit versions of our products, which do not meet the rigorous quality standards of our manufacturing and supply chain. For example, in 2017 and 2018, there were reports that a product labeled as Epclusa was available in multiple countries, which we determined was not an authentic product based on sample analysis and the lot number. We have cooperated and continue to cooperate with regulatory authorities to investigate this matter. We actively take actions to discourage the distribution and sale of counterfeits of our products around the world, including working with local regulatory and legal authorities to enforce laws against counterfeit drugs, raising public awareness of the dangers of counterfeit drugs and promoting public policies to hinder the sale and availability of counterfeit drugs. Counterfeit drugs pose a serious risk to patient health and ~~safety.~~safety and may raise the risk of product recalls. Our reputation and business could suffer as a result of counterfeit drugs sold under our brand ~~name.~~names.

Expensive litigation and government investigations have increased our expenses which may continue to reduce our earnings.

We are involved in a number of litigation, investigation and other dispute-related matters that require us to expend substantial internal and financial resources. We expect these matters will continue to require a high level of internal and financial resources for the foreseeable future. These matters have reduced and will continue to reduce our earnings and require significant management attention. ~~Please see~~For a description of our litigation, ~~investigation~~investigations and other dispute-related matters, in see Note ~~10,~~11. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q. The outcome of such legal proceedings or any other legal proceedings that may be brought against us, the investigations or any other investigations that may be initiated and any other dispute-related matters, are inherently uncertain, and adverse developments or outcomes can result in significant expenses, monetary damages, penalties or injunctive relief against us that could significantly reduce our earnings and cash flows and harm our ~~business.~~business and reputation.

~~In some countries, governments may grant compulsory licenses for our products or our patents may not be enforced.~~

In a number of developing countries, government officials and other interested groups have suggested that pharmaceutical companies should make drugs for HIV or HCV infection available at low cost. Alternatively, governments in those developing countries could issue compulsory licenses or government use licenses to allow competitors to manufacture and sell their own versions of our products, thereby reducing our product sales. For example, there is growing attention on the availability of HCV therapies and some activists are advocating for the increased availability of HCV therapies through other means including compulsory licenses. The government of Malaysia has exercised Government Rights under Section 84 of the Malaysian Patents Act to practice the patented invention of sofosbuvir for a period of three years for use only in government hospitals and clinics. In the past, certain offices of the government of Brazil have expressed concern over the affordability of our HIV products and declared that they were considering issuing compulsory licenses to permit the manufacture of otherwise patented products for HIV infection. If compulsory licenses permit generic manufacturing to override our product patents for our HIV, HCV or other products, or if compulsory licenses or government use licenses are issued for these products, it could reduce our earnings and cash flows and harm our business.

In addition, certain countries do not permit enforcement of our patents, or permit our patents to issue, and third-party manufacturers are able to sell generic versions of our products in those countries. For example, in 2017, the Brazilian Health Regulatory Agency rejected our patent applications related to sofosbuvir and our HCV products. We successfully appealed those decisions, and those applications are now under examination at the Brazilian Patent and Trademark Office. Sales of generic versions of our products could significantly reduce our sales and adversely affect our results of operations, particularly if generic versions of our products are imported into territories where we have existing commercial sales.

We may face significant liability resulting from our products and such liability could materially reduce our earnings.

The testing, manufacturing, marketing and use of our commercial products, as well as product candidates in development, involve substantial risk of product liability claims. These claims may be made directly by consumers, healthcare providers, pharmaceutical companies or others. We have limited insurance for product liabilities that may arise. If ~~we do not maintain adequate coverage or if~~ claims exceed our coverage, our financial condition will be adversely affected. In addition, negative publicity associated with any claims, regardless of their merit, may decrease the future demand for our products and impair our financial condition.

For a description of our product liability matters, see Note 11. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

If we fail to attract and retain highly qualified personnel, we may be unable to successfully develop new product candidates, conduct our clinical trials and commercialize our product candidates.

Our future success will depend in large part on our continued ability to attract and retain highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing, governmental regulation and commercialization. In July 2018, we announced that John F. Milligan will step down as our President and Chief Executive Officer after a 28-year career with the company. While our Board of Directors conducts a search to identify a successor, Dr. Milligan will remain in his current position through the end of the year, or if earlier, when his successor is named and commences in the role. We face competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations. Competition for qualified personnel in the biopharmaceutical field is intense, and there is a limited pool of qualified potential employees to recruit. We may not be able to attract and retain quality personnel on acceptable terms. Additionally, changes to U.S. immigration and work authorization laws and regulations could make it more difficult for employees to work in or transfer to jurisdictions in which we have operations and could impair our ability to attract and retain qualified personnel. If we are unsuccessful in our recruitment and retention efforts, our business may be harmed. ~~Further,~~

We have recently announced changes to our senior leadership team. In April 2019, we announced that Robin L. Washington plans to retire from her position as our Executive Vice President and Chief Financial Officer, effective March 2020, or if earlier, when a successor is named and commences in the role. Should a successor be named and commences in the role prior to March 2020, Ms. Washington has agreed to remain in an advisory capacity through the completion of our reporting of 2019 financial results. In July 2019, we also announced that John G. McHutchison, A.O., M.D., our Chief Scientific Officer and Head of Research and Development, has decided to leave the company, effective August 2019. We have commenced a search for his successor. If there are delays with the selection of a new Chief ~~Executive~~Financial Officer and Chief Scientific Officer, or if we do not successfully manage ~~the transition,~~these transitions, our business may be negatively impacted.

Business disruptions from natural or man-made disasters may ~~harm~~adversely affect our ~~future revenues.~~revenues and materially reduce our earnings.

Our worldwide operations, third-party manufacturers or corporate partners could be subject to business interruptions stemming from natural or man-made disasters, including those related to climate change, for which we or they may be uninsured or inadequately insured. Our corporate headquarters in Foster City and our Santa Monica location, which together house a majority of our R&D activities, and our San Dimas, La Verne, Oceanside and El Segundo manufacturing facilities are located in California, a seismically active region. As we may not carry adequate earthquake insurance and significant recovery time could be required to resume operations, our financial condition and operating results could be materially adversely affected in the event of a major earthquake. In addition, our Yescarta business is also reliant on our ability to manage the logistics of collecting and shipping patient material to our manufacturing facilities and shipping Yescarta back to the patient. Any logistical and shipment delays caused by such natural or man-made disasters could prevent or delay the delivery of our products to patients and could harm our Yescarta business.

We are dependent on information technology systems, infrastructure and ~~data.~~data, which may be subject to cyberattacks and security breaches.

We are dependent upon information technology systems, infrastructure and data, including our ~~new~~ Kite Konnect ~~platform.~~platform, which is critical to ensure chain of identity and chain of custody of Yescarta. The multitude and complexity of our computer systems make them inherently vulnerable to service interruption or destruction, malicious intrusion and random attack. Likewise, data privacy or security breaches by employees or others ~~may~~ pose a risk that sensitive data, including our intellectual property or trade secrets or the personal information of our employees, patients, customers or other business partners may be exposed to unauthorized persons or to the public. Cyberattacksare increasing in their frequency, sophistication and intensity. Cyberattacks could include the deployment of harmful malware, denial-of-service, social engineering and other means to affect service reliability and threaten data confidentiality, integrity and availability. Our business and technology partners face similar risks and any security breach of their systems could adversely affect our security posture. While we have invested, and continue to invest, in the protection of our data and information technology infrastructure, there can be no assurance that our efforts, or the efforts of our partners and vendors, will prevent service interruptions or identify breaches in our ~~systems, that~~systems. Such interruptions or breaches could adversely affect our business and operations and/or ~~result in~~cause the loss of critical or sensitive information, which could result in financial, legal, business or reputational harm to us. In addition, our ~~liability~~ insurance may not be sufficient in type or amount to cover ~~us against claims related to security breaches, cyberattacks and other related breaches.~~the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.

Regulators globally are also imposing new data security requirements, including greater monetary fines for privacy violations. For example, ~~in 2016, the European Union adopted a new law governing data practices and privacy called~~ the General Data Protection Regulation (GDPR)~~, which~~ that became effective in ~~May 2018. The law~~Europe in 2018 established new ~~requirements~~regulations regarding the handling of personal data, and non-compliance with the GDPR may result in monetary penalties of up to 4% four percent

of worldwide revenue. In addition, we may be subject to additional data privacy and security laws, such as the California Consumer Privacy Act of 2018. The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, ~~such as~~including healthcare data or other personal information, could greatly increase our cost of providing our products and services or even prevent us from offering certain services in jurisdictions ~~that~~in which we operate.

Changes in our effective income tax rate could reduce our earnings.

We are subject to income taxes in the United States and various foreign jurisdictions including Ireland. Due to economic and political conditions, various countries are actively considering and have made changes to existing tax laws. We cannot predict the form or timing of potential legislative and regulatory changes that could have a material adverse impact on our results of operations. For example, the United States ~~recently~~ enacted significant tax reform, and certain provisions of the new law are complex and will continue to significantly affect us. The accounting for these changes is currently considered provisional and may change materially during the measurement period due to the issuance of anticipated guidance and finalization of certain accounting method elections. See ~~Note 14, Income Taxes, of the~~

~~Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional details.~~

In addition, significant judgment is required in determining our worldwide provision for income taxes. Various factors may have favorable or unfavorable effects on our income tax rate including, but not limited to, changes in forecasted demand for our HCV products, our portion of the non-tax deductible annual ~~BPD~~branded prescription drug fee, the accounting for stock options and other share-based awards, mergers and acquisitions, the ability to manufacture product in our Cork, Ireland facility, the amortization of certain acquisition related intangibles for which we receive no tax benefit, future levels of R&D spending, changes in the mix of earnings in the various tax jurisdictions in which we operate, changes in overall levels of pre-tax earnings, ~~and~~ resolution of federal, state and foreign income tax ~~audits.~~audits, and potential changes to our legal entity structure. The impact on our income tax provision resulting from the above mentioned factors may be significant and could have a negative impact on our consolidated results of operations.

Our income tax returns are subject to audit by federal, state and foreign tax authorities. We are currently under examination by the Internal Revenue Service for the tax years from 2013 to 2015 and by various state and foreign jurisdictions. There are differing interpretations of tax laws and regulations and, as a result, significant disputes may arise with these tax authorities involving issues of the timing and amount of deductions and allocations of income among various tax jurisdictions. Resolution of one or more of these exposures in any reporting period could have a material impact on the results of operations for that period.

There can be no assurance that we will pay dividends or continue to repurchase stock.

Our Board of Directors authorized a dividend program under which we intend to pay quarterly dividends of ~~$0.57~~$0.63 per share, subject to quarterly declarations by our Board of Directors. Our Board of Directors also approved the repurchase of up to $12.0 billion of our common stock, of which ~~$6.1~~$3.7 billion is available for repurchase as of ~~September~~June 30, ~~2018.~~2019. Any future declarations, amount and timing of any dividends and/or the amount and timing of such stock repurchases are subject to capital availability and determinations by our Board of Directors that cash dividends and/or stock repurchases are in the best interest of our stockholders and are in compliance with all respective laws and our agreements applicable to the declaration and payment of cash dividends and the repurchase of stock. Our ability to pay dividends and/or repurchase stock will depend upon, among other factors, our cash balances and potential future capital requirements for strategic transactions, including acquisitions, debt service requirements, results of operations, financial condition and other factors beyond our control that our Board of Directors may deem relevant. A reduction in or elimination of our dividend payments, our dividend program and/or stock repurchases could have a negative effect on our stock price.


Item 2.	UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Issuer Purchases of Equity Securities

In the first quarter of 2016, our Board of Directors authorized a $12.0 billion share repurchase program (2016 Program) under which repurchases may be made in the open market or in privately negotiated transactions. We started repurchases under the 2016 Program in April 2016.

During the ~~third quarter of 2018,~~three months ended June 30, 2019, we repurchased and retired 69 million shares of our common stock for ~~$449~~$588 million through open market transactions under the 2016 Program. The table below summarizes our stock repurchase activity ~~under the 2016 Program~~ for the three months ended ~~September~~June 30, ~~2018:~~2019:

Total Number
of Shares
Purchased
(in thousands) Average
Price Paid
per Share
(in dollars) Total Number of Shares Purchased as Part of Publicly Announced Program
(in thousands) Maximum Fair Value of Shares that May Yet Be Purchased Under the Program
(in millions)
July 1 - July 31, 2018 870
$ 75.35
653
$ 6,508
August 1 - August 31, 2018 3,292
$ 75.80
3,026
$ 6,279
September 1 - September 30, 2018 2,328
$ 73.96
2,300
$ 6,109
Total 6,490
⁽¹⁾
$ 75.08
5,979
⁽¹⁾

_________________________________________



	Total Number of Shares Purchased (in thousands)		Average Price Paid per Share (in dollars)		Total Number of Shares Purchased as Part of Publicly Announced Program (in thousands)		Maximum Fair Value of Shares that May Yet Be Purchased Under the Program (in millions)
April 1 - April 30, 2019	3,130		$	65.22	3,103		$	4,111
May 1 - May 31, 2019	3,274		$	65.47	3,236		$	3,899
June 1 - June 30, 2019	2,629		$	66.65	2,601		$	3,726
Total	9,033	⁽¹⁾	$	65.73	8,940	⁽¹⁾
_________________________________________


⁽¹⁾	The difference between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program is due to shares of common stock withheld by us from employee restricted stock awards in order to satisfy applicable tax withholding obligations.


Item 3.	DEFAULTS UPON SENIOR SECURITIES

Not applicable.


Item 4.	MINE SAFETY DISCLOSURES

Not applicable.


Item 5.	OTHER INFORMATION

Not applicable.


Item 6.	EXHIBITS

Reference is made to the Exhibit Index included herein.

Exhibit Index

Exhibit
Footnote
Exhibit Number Description of Document
(1) 3.1
Restated Certificate of Incorporation of Registrant

(2) 3.2
Amended and Restated Bylaws of Registrant

4.1 Reference is made to Exhibit 3.1 and Exhibit 3.2

(3) 4.2
Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee

(3) 4.3
First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes)

(4) 4.4
Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2014 Note, Form of 2016 Note, Form of 2021 Note, Form of 2041 Note)

(5) 4.5
Third Supplemental Indenture related to Senior Notes, dated as of March 7, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2019 Note, Form of 2024 Note, Form of 2044 Note)

(6) 4.6
Fourth Supplemental Indenture related to Senior Notes, dated as of November 17, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2020 Note, Form of 2025 Note, Form of 2045 Note)

(7) 4.7
Fifth Supplemental Indenture, dated as of September 14, 2015, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of 2018 Note, Form of 2020 Note, Form of 2022 Note, Form of 2026 Note, Form of 2035 Note and Form of 2046 Note)

(8) 4.8
Sixth Supplemental Indenture, dated as of September 20, 2016, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of 2022 Note, Form of 2023 Note, Form of 2027 Note, Form of 2036 Note and Form of 2047 Note)

(9) 4.9
Seventh Supplemental Indenture, dated as of September 21, 2017, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of Fixed Rate Note, Form of Form of September 2018 Note, Form of March 2019 Note and Form of September 2019 Note)

*(10) 10.1
Gilead Sciences, Inc. 2004 Equity Incentive Plan, as amended and restated May 10, 2017

*(11) 10.2
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants made February 2008 through April 2009)

*(12) 10.3
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in May 2009)

*(13) 10.4
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in February 2010)

*(14) 10.5
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for 2011 and subsequent year grants)

*(12) 10.6
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants commencing in May 2009 and through May 2012)

*(15) 10.7
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2013)

*(15) 10.8
Form of non-employee director option agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants made in May 2013)

*(16) 10.9
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in and after May 2014)

*(15) 10.10
Form of restricted stock unit issuance agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2013)

*(17) 10.11
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals (US) in 2016)

*(17) 10.12
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals (US) with Director Retirement Provisions in 2016 )

*(17) 10.13
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals (US) in 2016)

*(17) 10.14
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals (US) with Director Retirement Provisions in 2016)

*(18) 10.15
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals - Non-US in 2015)

*(17) 10.16
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals -Non-US in 2016)

*(18) 10.17
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals - Non-US in 2015)

*(17) 10.18
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals - Non-US in 2016)

*(14) 10.19
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in 2011)

*(19) 10.20
Gilead Sciences, Inc. Employee Stock Purchase Plan, restated on January 22, 2015

*(20) 10.21
Gilead Sciences, Inc. Deferred Compensation Plan-Basic Plan Document

*(20) 10.22
Gilead Sciences, Inc. Deferred Compensation Plan-Adoption Agreement



Exhibit Footnote	Exhibit Number	Description of Document
(1)	3.1	Restated Certificate of Incorporation of Registrant

(1)	3.2	Amended and Restated Bylaws of Registrant

	4.1	Reference is made to Exhibit 3.1 and Exhibit 3.2

(2)	4.2	Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee

(2)	4.3	First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes)

(3)	4.4	Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2021 Note, Form of 2041 Note)

(4)	4.5	Third Supplemental Indenture related to Senior Notes, dated as of March 7, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2024 Note, Form of 2044 Note)

(5)	4.6	Fourth Supplemental Indenture related to Senior Notes, dated as of November 17, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2020 Note, Form of 2025 Note, Form of 2045 Note)

(6)	4.7	Fifth Supplemental Indenture, dated as of September 14, 2015, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of 2020 Note, Form of 2022 Note, Form of 2026 Note, Form of 2035 Note and Form of 2046 Note)

(7)	4.8	Sixth Supplemental Indenture, dated as of September 20, 2016, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of 2022 Note, Form of 2023 Note, Form of 2027 Note, Form of 2036 Note and Form of 2047 Note)

(8)	4.9	Seventh Supplemental Indenture, dated as of September 21, 2017, between Registrant and Wells Fargo Bank, National Association, as Trustee (including Form of Fixed Rate Note, Form of Form of September 2018 Note, Form of March 2019 Note and Form of September 2019 Note)

*(9)	10.1	Gilead Sciences, Inc. 2004 Equity Incentive Plan, as amended and restated May 10, 2017

*(10)	10.2	Form of employee stock option agreement under 2004 Equity Incentive Plan (for grants made in 2010)

*(11)	10.3	Form of employee stock option agreement under 2004 Equity Incentive Plan (for grants made in 2011 through 2018)

*	10.4***	Form of employee stock option agreement under 2004 Equity Incentive Plan (for grants commencing in 2019)

*(12)	10.5	Form of non-employee director stock option agreement under 2004 Equity Incentive Plan (for grants made in 2009 through 2012)

*(13)	10.6	Form of non-employee director stock option agreement (U.S.) under 2004 Equity Incentive Plan (for grants made in 2013)

*(13)	10.7	Form of non-employee director stock option agreement (non-U.S.) under 2004 Equity Incentive Plan (for grants made in 2013)

*(14)	10.8	Form of non-employee director stock option agreement under 2004 Equity Incentive Plan (for grants made in 2014 through 2018)

*	10.9***	Form of non-employee director stock option agreement under 2004 Equity Incentive Plan (for grants commencing in 2019)

*(15)	10.10	Form of performance share award agreement - TSR Goals (U.S.) with Director Retirement Provisions under 2004 Equity Incentive Plan (for grants made in 2016 through 2018)

*(15)	10.11	Form of performance share award agreement - TSR Goals (non-US) under 2004 Equity Incentive Plan (for grants made in 2016 through 2018)

*	10.12***	Form of performance share award agreement - TSR Goals (U.S.) under 2004 Equity Incentive Plan (for grants commencing in 2019)

*(15)	10.13	Form of performance share award agreement - Revenue Goals (U.S.) under 2004 Equity Incentive Plan (for grants made in 2016 through 2018)

*(15)	10.14	Form of performance share award agreement - Revenue Goals (U.S.) with Director Retirement Provisions under 2004 Equity Incentive Plan (for grants made in 2016 through 2018)

*	10.15***	Form of performance share award agreement - Revenue Goals (U.S.) under 2004 Equity Incentive Plan (for grants commencing in 2019)

*(11)	10.16	Form of employee restricted stock unit issuance agreement under 2004 Equity Incentive Plan (for grants made in 2011 through 2018)

*	10.17***	Form of employee restricted stock unit issuance agreement under 2004 Equity Incentive Plan (for grants commencing in 2019)

*	10.18***	Form of non-employee director restricted stock unit issuance agreement under 2004 Equity Incentive Plan (for grants commencing in 2019)

*(16)	10.19	Gilead Sciences, Inc. Employee Stock Purchase Plan, as amended and restated January 22, 2015

*	10.20***	Gilead Sciences, Inc. 2005 Deferred Compensation Plan, as amended and restated April 19, 2016

*(17)	10.21	Gilead Sciences, Inc. Severance Plan, as amended on March 8, 2016

*(18)	10.22	Gilead Sciences, Inc. Corporate Bonus Plan, amended and restated effective as of January 1, 2019

*(19)	10.23	Gilead Sciences, Inc. Retention Program for Executive Officers



*(20)	~~10.23~~10.24	~~Addendum to the Gilead Sciences, Inc. Deferred Compensation Plan~~Offer Letter dated April 16, 2008 between Registrant and Robin Washington

*(21)	~~10.24~~10.25	~~Gilead Sciences, Inc. 2005 Deferred Compensation~~Offer Letter dated November 30, 2018 between Registrant and Daniel O’Day

*	10.26***	Offer Letter dated May 21, 2019 between Registrant and Johanna Mercier

*	10.27***	Stock option agreement for Daniel O’Day under 2004 Equity Incentive Plan ~~as amended and restated on October 23, 2008~~

*	10.28***	Performance share award agreement for Daniel O’Day (for TSR Goals in 2019) under 2004 Equity Incentive Plan

*	10.29***	Performance share award agreement for Daniel O’Day (for Revenue Goals in 2019) under 2004 Equity Incentive Plan

*	10.30***	Form of restricted stock unit issuance agreement for Daniel O’Day (in 2019) under 2004 Equity Incentive Plan

*(22)	~~10.25~~	~~Gilead Sciences, Inc. Severance Plan, as amended on March 8, 2016~~

*(23)	~~10.26~~	~~Gilead Sciences, Inc. Corporate Bonus Plan, as amended and restated on January 1, 2019~~

*(24)	~~10.27~~	~~Amended and Restated Gilead Sciences, Inc. Code Section 162(m) Bonus Plan~~

*	~~10.28~~	~~Gilead Sciences, Inc. Retention Program for Executive Officers~~

*(25)	~~10.29~~	~~2018 Base Salaries for the Named Executive Officers~~

*(26)	~~10.30~~	~~Offer Letter dated April 16, 2008 between Registrant and Robin Washington~~

*(27)	10.31	~~Separation Agreement and Release dated August 6, 2018 between Registrant and John F. Milligan, Ph.D.~~

*(28)	~~10.32~~	Form of Indemnity Agreement entered into between Registrant and its directors and executive officers

*~~(28)~~(22)	~~10.33~~10.32	Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees

*~~(29)~~(23)	~~10.34~~10.33	Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees (revised in September 2006)

~~+(30)~~+(24)	~~10.35~~10.34	Amendment Agreement, dated October 25, 1993, between Registrant, the Institute of Organic Chemistry and Biochemistry (IOCB) and Rega Stichting v.z.w. (REGA), together with the following exhibits: the License Agreement, dated December 15, 1991, between Registrant, IOCB and REGA (the 1991 License Agreement), the License Agreement, dated October 15, 1992, between Registrant, IOCB and REGA (the October 1992 License Agreement) and the License Agreement, dated December 1, 1992, between Registrant, IOCB and REGA (the December 1992 License Agreement)

~~+(31)~~+(25)	~~10.36~~10.35	Amendment Agreement between Registrant and IOCB/REGA, dated December 27, 2000 amending the 1991 License Agreement and the December 1992 License Agreement

~~+(32)~~+(26)	~~10.37~~10.36	Sixth Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated August 18, 2006 amending the October 1992 License Agreement and the December 1992 License Agreement

~~+(33)~~+(27)	~~10.38~~10.37	Seventh Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant dated July 1, 2013 amending the October 1992 License Agreement and the December 1992 License Agreement

~~+(34)~~+(28)	~~10.39~~10.38	Exclusive License Agreement between Registrant (as successor to Triangle Pharmaceuticals, Inc.), Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome Inc. and Emory University, dated May 6, 1999

~~+(35)~~+(29)	~~10.40~~10.39	Royalty Sale Agreement by and among Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 18, 2005

~~+(35)~~+(29)	~~10.41~~10.40	Amended and Restated License Agreement between Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 21, 2005

~~+(36)~~++(30)	~~10.42~~10.41	Amended and Restated EVG License Agreement between Japan Tobacco Inc., and Registrant, dated ~~March 22, 2005~~November 29, 2018

~~+(37)~~++(30)	~~10.43~~10.42	~~First Amendment to License~~Master Agreement by and between Registrant, Gilead Sciences K.K. and Japan Tobacco Inc. ~~and Registrant,~~, dated ~~May 19, 2005~~

~~+(37)~~	~~10.44~~	~~Second Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 17, 2010~~

~~+(38)~~	~~10.45~~	~~Third Amendment (Revised) to License Agreement between Japan Tobacco Inc. and Registrant, dated June 10, 2015~~

~~+(37)~~	~~10.46~~	~~Fourth Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011~~

~~+(39)~~	~~10.47~~	~~Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated October 10, 2013~~

~~+(40)~~	~~10.48~~	~~Fifth Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated September~~November 29, ~~2014~~2018

+~~(41)~~(31)	~~10.49~~10.43	Amended and Restated Collaboration Agreement by and among Registrant, Gilead Sciences Ireland UC (formerly Gilead Sciences Limited) and Janssen R&D Ireland, dated December 23, 2014

+~~(42)~~(32)	~~10.50~~10.44	License Agreement by and among Kite Pharma, Inc., Cabaret Biotech Ltd. and Dr. Zelig Eshhar, dated December 12, 2013

	~~31.1~~31.1***	Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended

	~~31.2~~31.2***	Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended

	32.1** 32üü	Certifications of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)

	101.INS***	XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

	101.SCH***	XBRL Taxonomy Extension Schema Document

	101.CAL***	XBRL Taxonomy Extension Calculation Linkbase Document

	101.DEF***	XBRL Taxonomy Extension Definition Linkbase Document

	101.LAB***	XBRL Taxonomy Extension Label Linkbase Document



	101.PRE***			XBRL Taxonomy Extension Presentation Linkbase Document

	104			The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, formatted in Inline XBRL


(1)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on May ~~8, 2014,~~9, 2019, and incorporated herein by reference.


(2)	~~Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on December 23, 2015, and incorporated herein by reference.~~


~~(3)~~	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on April 1, 2011, and incorporated herein by reference.


~~(4)~~(3)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on December 13, 2011, and incorporated herein by reference.


~~(5)~~(4)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on March 7, 2014, and incorporated herein by reference.


~~(6)~~(5)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on November 17, 2014, and incorporated herein by reference.


~~(7)~~(6)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on September 14, 2015, and incorporated herein by reference.


~~(8)~~(7)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on September 20, 2016, and incorporated herein by reference.


~~(9)~~(8)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on September 21, 2017, and incorporated herein by reference.


~~(10)~~(9)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on May 12, 2017, and incorporated herein by reference.


~~(11)~~(10)	Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, ~~2007,~~2009, and incorporated herein by reference.


(11)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and incorporated herein by reference.


(12)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and incorporated herein by reference.


(13)	Filed as an exhibit to Registrant’s ~~Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and incorporated herein by reference.~~


~~(14)~~	~~Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and incorporated herein by reference.~~


~~(15)~~	~~Filed as an exhibit to Registrant’s~~ Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, and incorporated herein by reference


~~(16)~~(14)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, and incorporated herein by reference.


~~(17)~~(15)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, and incorporated herein by reference.


~~(18)~~	~~Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, and incorporated herein by reference.~~


~~(19)~~(16)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on May 8, 2015, and incorporated herein by reference.


~~(20)~~(17)	Filed as an exhibit to ~~Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and incorporated herein by reference.~~


~~(21)~~	~~Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.~~


~~(22)~~	~~Filed as an exhibit to Registrant’s~~Registrant's Current Report on Form 8-K filed on March 11, 2016, and incorporated herein by reference.


~~(23)~~(18)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, and incorporated herein by reference.


~~(24)~~(19)	Filed as an exhibit to Registrant’s ~~Current~~Quarterly Report on Form ~~8-K filed on May 17, 2016, and incorporated herein by reference.~~


~~(25)~~	~~Filed on Registrant’s Current Report on Form 8-K filed on February 5,~~10-Q for the quarter ended September 30, 2018, and incorporated herein by reference.


~~(26)~~(20)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, and incorporated herein by reference.


~~(27)~~(21)	Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on ~~August 7,~~December 10, 2018, and incorporated herein by reference.


~~(28)~~(22)	Filed as an exhibit to Registrant’s Registration Statement on Form S-1 (No. 33-55680), as amended, and incorporated herein by reference.


~~(29)~~(23)	Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006, and incorporated herein by reference.


~~(30)~~(24)	Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the fiscal year ended March 31, 1994, and incorporated herein by reference.


~~(31)~~(25)	Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2000, and incorporated herein by reference.


~~(32)~~(26)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, and incorporated herein by reference.


~~(33)~~(27)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, and incorporated herein by reference.


~~(34)~~(28)	Filed as an exhibit to Triangle Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q/A filed on November 3, 1999, and incorporated herein by reference.


~~(35)~~(29)	Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, and incorporated herein by reference.


~~(36)~~(30)	Filed as an exhibit to Registrant’s ~~Quarterly~~Amendment No. 1 to Annual Report on Form ~~10-Q for the quarter ended March 31, 2005,~~10-K/A filed on April 18, 2019, and incorporated herein by reference.


~~(37)~~	~~Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, and incorporated herein by reference.~~


~~(38)~~	~~Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, and incorporated herein by reference.~~


~~(39)~~	~~Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013, and incorporated herein by reference.~~


~~(40)~~	~~Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, and incorporated herein by reference.~~


~~(41)~~(31)	Filed as an exhibit to Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014, and incorporated herein by reference.


~~(42)~~(32)	Filed as an exhibit to Kite Pharma, Inc.’s Registration Statement on Form S-1/A (No. 333-196081) filed on June 17, 2014, and incorporated herein by reference.


*	Management contract or compensatory plan or arrangement.

***

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.Filed herewith.


~~***~~üü	~~XBRL information is filed~~Furnished herewith.


+	Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the Securities and Exchange Commission without the Mark pursuant to Registrant’s Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


++	Certain confidential portions of this Exhibit were omitted by means of marking such portions with the Mark because the identified confidential portions are (i) not material and (ii) would be competitively harmful if publicly disclosed.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.



		GILEAD SCIENCES, INC.
		(Registrant)

Date:	~~November~~August 6, ~~2018~~2019	/s/ J~~OHN~~ ~~F. MILLIGAN~~ DANIEL P. O’DAY
		~~John F. Milligan, Ph.D.~~Daniel P. O’Day ~~President~~Chairman and Chief Executive Officer (Principal Executive Officer)

Date:	~~November~~August 6, ~~2018~~2019	/s/ R~~OBIN~~ROBIN L. W~~ASHINGTON~~ WASHINGTON
		Robin L. Washington Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)

5853



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)~~



Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value, $0.001 per share	GILD	Nasdaq Global Select Market



ý☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	~~For the quarterly period ended September 30, 2018~~



o☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	~~For the transition period from ________ to ________~~



PART I.	FINANCIAL INFORMATION		2

	Item 1.	Condensed Consolidated Financial Statements	2

		Condensed Consolidated Balance Sheets at ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017~~2018 (unaudited)	2

		Condensed Consolidated Statements of Income for the Three and ~~Nine~~Six Months Ended ~~September~~June 30, 2019 and 2018 ~~and 2017~~ (unaudited)	3

		Condensed Consolidated Statements of Comprehensive Income for the Three and ~~Nine~~Six Months Ended ~~September~~June 30, 2019 and 2018 ~~and 2017~~ (unaudited)	4

		Condensed Consolidated Statements of ~~Cash Flows~~Stockholders’ Equity for the ~~Nine~~Three and Six Months Ended ~~September~~June 30, 2019 and 2018 ~~and 2017~~ (unaudited)	5

		Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2019 and 2018 (unaudited)	7

		Notes to Condensed Consolidated Financial Statements (unaudited)	68

	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2627

	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	36

	Item 4.	Controls and Procedures	36

PART II.	OTHER INFORMATION		37

	Item 1.	Legal Proceedings	37

	Item 1A.	Risk Factors	37

	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	5349

	Item 3.	Defaults Upon Senior Securities	5349

	Item 4.	Mine Safety Disclosures	5349

	Item 5.	Other Information	5449

	Item 6.	Exhibits	5449

SIGNATURES			5853



	December 31, 2017		Adjustments Due to Topic 606			January 1, 2018
Prepaid and other current assets	$	1,661	$	96		$	1,757
Other long-term assets	$	2,722	$	10		$	2,732
Other accrued liabilities	$	3,370	$	(115	)	$	3,255
Other long-term obligations	$	558	$	31		$	589
Retained earnings	$	19,012	$	190		$	19,202



	Three Months Ended September 30, 2018								Three Months Ended September 30, 2017
(In millions)	U.S.		Europe		Other International		Total		U.S.		Europe		Other International		Total
Product sales:
Atripla	$	221	$	29	$	8	$	258	$	324	$	79	$	36	$	439
Biktarvy	375		11		—		386		—		—		—		—
Complera/Eviplera	61		67		11		139		91		133		13		237
Descovy	310		81		15		406		241		65		10		316
Genvoya	921		203		52		1,176		810		146		32		988
Odefsey	323		95		5		423		255		37		4		296
Stribild	111		20		15		146		181		40		8		229
Truvada	665		62		30		757		604		154		53		811
Other HIV⁽¹⁾	10		2		2		14		13		2		—		15
Revenue share - Symtuza⁽²⁾	8		14		—		22		—		—		—		—
AmBisome	9		59		34		102		9		51		32		92
Epclusa	225		136		116		477		543		263		76		882
Harvoni	185		38		88		311		718		110		145		973
Letairis	241		—		—		241		213		—		—		213
Ranexa	178		—		—		178		164		—		—		164
Vemlidy	66		2		19		87		34		2		1		37
Viread	17		10		43		70		137		55		82		274
Vosevi	78		21		4		103		117		5		1		123
Yescarta	75		—		—		75		—		—		—		—
Zydelig	15		4		1		20		18		22		—		40
Other⁽³⁾	37		19		8		64		70		33		170		273
Total product sales	4,131		873		451		5,455		4,542		1,197		663		6,402
Royalty, contract and other revenues	20		102		19		141		21		74		15		110
Total revenues	$	4,151	$	975	$	470	$	5,596	$	4,563	$	1,271	$	678	$	6,512



	Nine Months Ended September 30, 2018								Nine Months Ended September 30, 2017
(In millions)	U.S.		Europe		Other International		Total		U.S.		Europe		Other International		Total
Product Sales:
Atripla	$	723	$	119	$	79	$	921	$	974	$	259	$	133	$	1,366
Biktarvy	593		13		—		606		—		—		—		—
Complera/Eviplera	210		279		39		528		315		385		44		744
Descovy	895		234		41		1,170		682		149		22		853
Genvoya	2,678		596		144		3,418		2,189		358		67		2,614
Odefsey	905		230		15		1,150		688		87		6		781
Stribild	388		83		36		507		632		161		38		831
Truvada	1,821		245		108		2,174		1,635		527		175		2,337
Other HIV⁽¹⁾	30		6		10		46		34		5		2		41
Revenue share - Symtuza⁽²⁾	8		34		—		42		—		—		—		—
AmBisome	40		170		102		312		26		153		97		276
Epclusa	733		502		278		1,513		2,142		649		154		2,945
Harvoni	649		116		225		990		2,628		583		515		3,726
Letairis	689		—		—		689		654		—		—		654
Ranexa	581		—		—		581		517		—		—		517
Vemlidy	172		8		41		221		66		3		1		70
Viread	40		72		137		249		395		202		237		834
Vosevi	250		57		12		319		117		5		1		123
Yescarta	183		—		—		183		—		—		—		—
Zydelig	46		44		2		92		52		57		1		110
Other⁽³⁾	93		75		117		285		228		279		496		1,003
Total product sales	11,727		2,883		1,386		15,996		13,974		3,862		1,989		19,825
Royalty, contract and other revenues	54		233		49		336		62		226		45		333
Total revenues	$	11,781	$	3,116	$	1,435	$	16,332	$	14,036	$	4,088	$	2,034	$	20,158

____________________
⁽¹⁾ Includes Emtriva and Tybost
⁽²⁾Represents Gilead’s revenue from cobicistat (C), emtricitabine (FTC) and tenofovir alafenamide (TAF) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen
⁽³⁾ Includes Cayston, Hepsera and Sovaldi



Cash and cash equivalents	$	652
Identifiable intangible assets:
Indefinite-lived intangible assets - in-process research and development (IPR&D)	8,950
Outlicense acquired	91
Deferred income taxes	(1,564		)
Other assets acquired (liabilities assumed), net	81
Total identifiable net assets	8,210
Goodwill	2,945
Total consideration transferred	$	11,155



Fiscal Year	Amount
2018 (remaining three months)	$	301
2019	1,088
2020	1,064
2021	1,064
2022	1,064
Thereafter	8,866
Total	$	13,447



	Gilead Stockholders’ Equity													Noncontrolling Interest		Total Stockholders’ Equity
	Common Stock				Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
	Shares		Amount		Additional Paid-In Capital			Accumulated Other Comprehensive Income (Loss)			Retained Earnings
Balance at December 31, 2017	1,308		$	1	$	1,264		$	165		$	19,012		$	59	$	20,501
Change in noncontrolling interest	—		—		—			—			—			82		82
Net income	—		—		—			—			5,452			5		5,457
Other comprehensive income, net of tax	—		—		—			164			—			—		164
Issuances under employee stock purchase plan	1		—		91			—			—			—		91
Issuances under equity incentive plans	12		—		167			—			—			—		167
Stock-based compensation	—		—		667			—			—			—		667
Repurchases of common stock	(27	)	—		(71		)	—			(1,996		)	—		(2,067		)
Dividends declared	—		—		—			—			(2,245		)	—		(2,245		)
Cumulative effect from the adoption of new accounting standards	—		—		—			(293		)	483			—		190
Balance at September 30, 2018	1,294		$	1	$	2,118		$	36		$	20,706		$	146	$	23,007