Gilead Sciences 10-Q 2024-06-30

`

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended June 30, 2024

or

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

For the transition period from ________ to ________

Commission File No. 0-19731

GILEAD SCIENCES, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware			94-3047598
(State or Other Jurisdiction of Incorporation or Organization)			(IRS Employer Identification No.)

333 Lakeside Drive, Foster City, California 94404

(Address of principal executive offices) (Zip Code)

650-574-3000

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

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

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer x Accelerated filer ¨ Non-accelerated filer ¨

Smaller reporting company ☐ Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No x

Number of shares outstanding of the issuer’s common stock, par value $0.001 per share, as of July 31, 2024: 1,244,992,081

GILEAD SCIENCES, INC.

INDEX

PART I.			FINANCIAL INFORMATION									3
			Item 1.			Condensed Consolidated Financial Statements						3
						Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023						3
						Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2024 and 2023						4
						Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Six Months Ended June 30, 2024 and 2023						5
						Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2024 and 2023						6
						Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023						8
						Notes to Condensed Consolidated Financial Statements						9
			Item 2.			Management’s Discussion and Analysis of Financial Condition and Results of Operations						25
			Item 3.			Quantitative and Qualitative Disclosures About Market Risk						33
			Item 4.			Controls and Procedures						33
PART II.			OTHER INFORMATION									34
			Item 1.			Legal Proceedings						34
			Item 1A.			Risk Factors						34
			Item 2.			Unregistered Sales of Equity Securities and Use of Proceeds						49
			Item 3.			Defaults Upon Senior Securities						49
			Item 4.			Mine Safety Disclosures						49
			Item 5.			Other Information						49
			Item 6.			Exhibits						49
SIGNATURES												54

We own or have rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, KITE™, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA®, TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. Other trademarks and trade names are the property of their respective owners.

Certain amounts and percentages in this Quarterly Report on Form 10-Q may not sum or recalculate due to rounding.

This Quarterly Report on Form 10-Q, including Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations and Part II, Item 1A. Risk Factors, 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. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “hope,” “intend,” “may,” “might,” “plan,” “project,” “seek,” “should,” “target” and 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; plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital; collaboration and licensing arrangements; patent protection and estimated loss of exclusivity for our products and product candidates*;* ongoing litigation and investigation matters; 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 in Part II, Item 1A. Risk Factors of this Quarterly Report on Form 10-Q. 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 unless otherwise specified. Except as required under federal securities laws and the rules and regulations of U.S. Securities and Exchange Commission, 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 Part II, Item 1A. Risk Factors of 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.

PART I. FINANCIAL INFORMATION

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in millions, except per share amounts)						June 30, 2024						December 31, 2023
Assets
Current assets:
Cash and cash equivalents						$	2,772					$	6,085
Short-term marketable debt securities						—						1,179
Accounts receivable, net						4,663						4,660
Inventories						2,026						1,787
Prepaid and other current assets						2,856						2,374
Total current assets						12,317						16,085
Property, plant and equipment, net						5,346						5,317
Long-term marketable debt securities						—						1,163
Intangible assets, net						22,832						26,454
Goodwill						8,314						8,314
Other long-term assets						4,770						4,792
Total assets						$	53,579					$	62,125
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable						$	537					$	550
Accrued rebates						3,923						3,802
Other current liabilities						4,510						5,130
Current portion of long-term debt and other obligations, net						1,810						1,798
Total current liabilities						10,781						11,280
Long-term debt, net						21,540						23,189
Long-term income taxes payable						738						2,039
Deferred tax liability						907						1,588
Other long-term obligations						1,418						1,280
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred stock, par value $0.001 per share; 5 shares authorized; none outstanding						—						—
Common stock, par value $0.001 per share; 5,600 shares authorized; 1,246 shares issued and outstanding						1						1
Additional paid-in capital						7,022						6,500
Accumulated other comprehensive income						93						28
Retained earnings						11,165						16,304
Total Gilead stockholders’ equity						18,281						22,833
Noncontrolling interest						(84)						(84)
Total stockholders’ equity						18,197						22,749
Total liabilities and stockholders’ equity						$	53,579					$	62,125

See accompanying notes.

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

						Three Months Ended												Six Months Ended
						June 30,												June 30,
(in millions, except per share amounts)						2024						2023						2024						2023
Revenues:
Product sales						$	6,912					$	6,564					$	13,559					$	12,870
Royalty, contract and other revenues						41						35						81						81
Total revenues						6,954						6,599						13,640						12,951
Costs and expenses:
Cost of goods sold						1,544						1,442						3,096						2,843
Research and development expenses						1,351						1,407						2,871						2,854
Acquired in-process research and development expenses						38						236						4,169						717
In-process research and development impairment						—						—						2,430						—
Selling, general and administrative expenses						1,377						1,849						2,752						3,168
Total costs and expenses						4,309						4,934						15,317						9,581
Operating income (loss)						2,644						1,665						(1,678)						3,370
Interest expense						237						230						491						459
Other (income) expense, net						355						(152)						265						22
Income (loss) before income taxes						2,053						1,588						(2,433)						2,888
Income tax expense						438						549						123						865
Net income (loss)						1,614						1,039						(2,556)						2,024
Net loss attributable to noncontrolling interest						—						(6)						—						(32)
Net income (loss) attributable to Gilead						$	1,614					$	1,045					$	(2,556)					$	2,055
Basic earnings (loss) per share attributable to Gilead						$	1.29					$	0.84					$	(2.05)					$	1.65
Shares used in basic earnings (loss) per share attributable to Gilead calculation						1,247						1,249						1,247						1,249
Diluted earnings (loss) per share attributable to Gilead						$	1.29					$	0.83					$	(2.05)					$	1.63
Shares used in diluted earnings (loss) per share attributable to Gilead calculation						1,251						1,258						1,247						1,260

See accompanying notes.

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(unaudited)

						Three Months Ended												Six Months Ended
						June 30,												June 30,
(in millions)						2024						2023						2024						2023
Net income (loss)

Showing the first 8K of 118K characters. Open the full section

The following discussion and analysis is intended to provide material information around events and uncertainties known to management that are relevant to an assessment of the financial condition and results of operations of Gilead and should therefore be read in conjunction with our audited Consolidated Financial Statements and the related notes thereto and other disclosures included as part of our Annual Report on Form 10-K for the year ended December 31, 2023 and our unaudited Condensed Consolidated Financial Statements for the three and six months ended June 30, 2024 and the related notes thereto and other disclosures (including the disclosures under Part II, Item 1A. Risk Factors) included in this Quarterly Report on Form 10-Q.

Management Overview

Gilead Sciences, Inc. (including its consolidated subsidiaries, referred to as “Gilead,” the “company,” “we,” “our” or “us”) is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, coronavirus disease 2019 (“COVID-19”) and cancer. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.

Key Business Updates

The following updates are based on select press releases issued since the filing of our Annual Report on Form 10-K for the year ended December 31, 2023. Readers are encouraged to review all press releases available on our website at www.gilead.com. The content on the referenced website does not constitute a part of and is not incorporated by reference into this Quarterly Report on Form 10-Q.

Virology

• Received approval from the U.S. Food and Drug Administration (“FDA”) to update Biktarvy’s label with additional data reinforcing the safety and efficacy profile to treat pregnant people with HIV-1 with suppressed viral loads.

• Received approval from FDA to expand Biktarvy’s label to include treatment of people with HIV who have suppressed viral loads with known or suspected M184V/I resistance.

• Received approval from FDA to expand the indication for Vemlidy to include treatment of chronic hepatitis B virus (“HBV”) in children six years and older who weigh at least 25 kg with compensated liver disease.

Oncology

• Announced a research collaboration, option and license agreement with Merus N.V. to discover novel antibody-based trispecific T-cell engagers in oncology.

• Entered into an exclusive license agreement with Xilio Therapeutics, Inc. (“Xilio”) to develop and commercialize Xilio’s tumor-activated IL-12 program, including investigational candidate XTX301 in advanced solid tumors.

Inflammation

• Entered into an amended license agreement featuring the buy-out of global seladelpar royalties from Janssen Pharmaceutica NV for $320 million. This transaction will be reflected in Gilead’s third quarter results.

• Completed the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), for $4.3 billion in total equity value, or $3.9 billion net cash paid, adding investigational candidate seladelpar for the treatment of primary biliary cholangitis to Gilead’s Liver Disease portfolio. Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist with Orphan Drug Designation in the United States and Europe. PPARδ has been shown to regulate critical metabolic and liver disease pathways. FDA accepted the New Drug Application for seladelpar in February 2024 for priority review, with a Prescription Drug User Fee Act target action date of August 14, 2024.

Key Financial Results

						Three Months Ended																		Six Months Ended
						June 30,																		June 30,
(in millions, except percentages and per share amounts)						2024						2023						Change						2024						2023						Change
Total revenues						$	6,954					$	6,599					5		%				$	13,640					$	12,951					5		%
Net income (loss) attributable to Gilead						$	1,614					$	1,045					55		%				$	(2,556)					$	2,055					NM
Diluted earnings (loss) per share attributable to Gilead						$	1.29					$	0.83					55		%				$	(2.05)					$	1.63					NM

---

NM - Not Meaningful

Total revenues increased 5% to $7.0 billion and $13.6 billion for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily due to higher product sales in HIV, Oncology and Liver Disease.

Net income attributable to Gilead was $1.6 billion and diluted earnings per share attributable to Gilead was $1.29 for the three months ended June 30, 2024, compared to net income attributable to Gilead of $1.0 billion and diluted earnings per share attributable to Gilead of $0.83 for the same period in 2023. The increase was primarily driven by lower operating expenses, including a 2023 expense of $525 million for settlements with certain plaintiffs in HIV antitrust litigation which did not repeat in 2024, as well as higher revenues and lower income tax expense, partially offset by higher net unrealized losses on equity securities.

Net loss attributable to Gilead was $2.6 billion and diluted loss per share attributable to Gilead was $2.05 for the six months ended June 30, 2024, compared to net income attributable to Gilead of $2.1 billion and diluted earnings per share attributable to Gilead of $1.63 for the same period in 2023. The decrease was primarily driven by an acquired in-process research and development (“IPR&D”) charge of $3.9 billion related to the acquisition of CymaBay as well as a pre-tax IPR&D partial impairment charge of $2.4 billion related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020 and higher net unrealized losses on equity securities. The decrease was partially offset by higher revenues, lower operating expenses, including the aforementioned $525 million legal settlement, and lower income tax expense.

Results of Operations

Revenues

The following table summarizes the period-over-period changes in our Total revenues:

						Three Months Ended June 30, 2024																								Three Months Ended June 30, 2023
(in millions)						U.S.						Europe						Rest of World						Total						U.S.						Europe						Rest of World						Total						Change
Product sales:
HIV
Biktarvy						$	2,585					$	370					$	277					$	3,232					$	2,439					$	302					$	237					$	2,979					8		%
Descovy						434						25						26						485						460						25						31						516						(6)		%
Genvoya						372						45						23						440						455						56						29						540						(18)		%
Odefsey						233						72						10						315						267						74						11						351						(10)		%
Symtuza - Revenue share(1)						131						34						3						168						84						33						3						120						40		%
Other HIV(2)						65						25						15						105						74						31						15						120						(13)		%
Total HIV						3,821						571						353						4,745						3,778						521						326						4,626						3		%
Liver Disease
Sofosbuvir/Velpatasvir(3)						267						84						126						476						223						84						90						397						20		%
Vemlidy						117						11						115						243						96						10						113						219						11		%
Other Liver Disease(4)						47						47						19						113						37						37						21						95						19		%
Total Liver Disease						431						142						259						832						356						131						225						711						17		%
Veklury						76						53						85						214						97						52						107						256						(16)		%
Oncology
Cell Therapy
Tecartus						63						37						7						107						56						29						4						88						21		%
Yescarta						186						169						58						414						217						133						30						380						9		%
Total Cell Therapy						250						206						66						521						272						162						34						469						11		%
Trodelvy						224						69						26						320						189						53						17						260						23		%
Total Oncology						474						275						92						841						462						215						51						728						15		%
Other
AmBisome						17						69						65						151						20						69						61						151						—		%
Other(5)						98						8						24						130						64						10						17						92						41		%
Total Other						115						77						88						280						85						80						78						243						15		%
Total product sales						4,916						1,118						878						6,912						4,777						999						788						6,564						5		%
Royalty, contract and other revenues						25						15						1						41						6						28						1						35						18		%
Total revenues						$	4,941					$	1,133					$	879					$	6,954					$	4,784					$	1,027					$	789					$	6,599					5		%

						Six Months Ended June 30, 2024																								Six Months Ended June 30, 2023																					**
(in millions)						U.S.						Europe						Rest of World						Total						U.S.						Europe						Rest of World						Total						Change
Product sales:
HIV
Biktarvy						$	4,900					$	735					$	542					$	6,177					$	4,600					$	606					$	449					$	5,656					9		%
Descovy						805						51						55						911						855						50						60						965						(6)		%
Genvoya						704						95						44						843						872						111						58						1,041						(19)		%
Odefsey						457						148						21						626						497						149						22						668						(6)		%
Symtuza - Revenue share(1)						236						67						6						309						182						70						7						259						19		%
Other HIV(2)						125						70						27						222						136						63						28						228						(2)		%
Total HIV						7,226						1,167						695						9,088						7,142						1,049						624						8,816						3		%
Liver Disease
Sofosbuvir/Velpatasvir(3)						515						163						203						881						427						174						181						782						13		%
Vemlidy						212						22						233						467						183						19						216						418						12		%
Other Liver Disease(4)						89						94						38						221						64						78						44						186						18		%
Total Liver Disease						816						279						474						1,569						674						271						441						1,386						13		%
Veklury						391						123						255						769						349						163						317						829						(7)		%
Oncology
Cell Therapy
Tecartus						118						73						16						207						114						56						6						177						17		%
Yescarta						357						327						110						794						427						254						58						739						7		%
Total Cell Therapy						475						400						126						1,001						542						310						65						916						9		%
Trodelvy						429						137						62						628						351						107						23						482						30		%
Total Oncology						904						537						188						1,629						893						417						88						1,398						17		%
Other
AmBisome						31						139						124						294						27						129						111						267						10		%
Other(5)						156						18						36						209						127						22						26						175						20		%
Total Other						188						156						160						504						153						152						137						442						14		%
Total product sales						9,525						2,262						1,772						13,559						9,211						2,052						1,607						12,870						5		%
Royalty, contract and other revenues						49						30						2						81						25						54						3						81						(1)		%
Total revenues						$	9,574					$	2,292					$	1,774					$	13,640					$	9,236					$	2,106					$	1,610					$	12,951					5		%

---

(1) 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 Unlimited Company (“Janssen”).

(2) Includes Atripla, Complera/Eviplera, Emtriva, Sunlenca, Stribild, Truvada and Tybost.

(3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”).

(4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Sovaldi, Viread and Vosevi.

(5) Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.

HIV

HIV product sales increased 3% to $4.7 billion and $9.1 billion for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily driven by higher demand across treatment and prevention, partially offset by lower average realized price. In particular, Biktarvy sales increased primarily reflecting higher demand, including patients switching from Genvoya and other Gilead HIV products, partially offset by lower average realized price. Descovy sales decreased primarily driven by lower average realized price, partially offset by higher demand.

Liver Disease

Liver Disease product sales increased 17% and 13% to $832 million and $1.6 billion for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily driven by higher average realized price due to channel mix in the United States as well as higher demand in products for chronic hepatitis C virus (“HCV”), HBV and, in Europe, chronic hepatitis D virus (“HDV”).

Veklury

Veklury product sales decreased 16% and 7% to $214 million and $769 million for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily driven by lower rates of COVID-19 related hospitalizations.

Oncology

Cell Therapy

Cell Therapy product sales increased 11% and 9% to $521 million and $1.0 billion for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily due to increased Yescarta demand for the treatment of relapsed or refractory (“R/R”) large B-cell lymphoma outside the United States and increased Tecartus demand for the treatment of R/R adult acute lymphoblastic leukemia and R/R mantle cell lymphoma, mostly in Europe.

Trodelvy

Trodelvy product sales increased 23% and 30% to $320 million and $628 million for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily due to higher demand in second-line metastatic triple negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer.

Other

Other product sales increased 15% and 14% to $280 million and $504 million for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily due to increased sales of Letairis related to a temporary shortage of generics in the market. The increase for the six months ended June 30, 2024 also included higher demand for AmBisome.

Foreign Currency Exchange Impact

We generally face exposure to movements in foreign currency exchange rates, primarily in the Euro. We use foreign currency exchange contracts to hedge a portion of our foreign currency exposures.

Approximately 26% and 25% of our product sales were denominated in foreign currencies during the three months ended June 30, 2024 and 2023, respectively. Foreign currency exchange, net of hedges, had an unfavorable impact on our total product sales of $69 million for the three months ended June 30, 2024, based on a comparison using foreign currency exchange rates from the three months ended June 30, 2023.

Approximately 28% and 26% of our product sales were denominated in foreign currencies during the six months ended June 30, 2024 and 2023, respectively. Foreign currency exchange, net of hedges, had an unfavorable impact on our total product sales of $116 million for the six months ended June 30, 2024, based on a comparison using foreign currency exchange rates from the six months ended June 30, 2023.

Costs and Expenses

The following table summarizes the period-over-period changes in our costs and expenses:

						Three Months Ended																		Six Months Ended
						June 30,																		June 30,
(in millions, except percentages)						2024						2023						Change						2024						2023						Change
Cost of goods sold						$	1,544					$	1,442					7		%				$	3,096					$	2,843					9		%
Product gross margin						77.7		%				78.0		%				-36 bps						77.2		%				77.9		%				-74 bps
Research and development expenses						$	1,351					$	1,407					(4)		%				$	2,871					$	2,854					1		%
Acquired in-process research and development expenses						$	38					$	236					(84)		%				$	4,169					$	717					NM
In-process research and development impairment						$	—					$	—					NM						$	2,430					$	—					NM
Selling, general and administrative expenses						$	1,377					$	1,849					(26)		%				$	2,752					$	3,168					(13)		%

---

NM - Not Meaningful

Product Gross Margin

Product gross margin was 77.7% and 77.2% for the three and six months ended June 30, 2024, respectively, and remained relatively flat compared to the same periods in 2023.

Research and Development Expenses

Research and development (“R&D”) expenses consist primarily of personnel costs including salaries, benefits and stock-based compensation expense, infrastructure, materials and supplies and other support costs, research and clinical studies performed by contract research organizations and our collaboration partners and other outside services.

We manage our R&D expenses by identifying the R&D activities we expect to be performed during a given period and then prioritizing efforts based on scientific data, probability of successful technical development and regulatory approval, market potential, available human and capital resources and other considerations. We regularly review our R&D activities based on unmet medical need and, as necessary, reallocate resources among our internal R&D portfolio and external opportunities that we believe will best support the long-term growth of our business. We do not track total R&D expenses by product candidate, therapeutic area or development phase.

The following table provides a breakout of expenses by major cost type:

						Three Months Ended												Six Months Ended
						June 30,												June 30,
(in millions)						2024						2023						2024						2023
Personnel, infrastructure and other support costs						$	830					$	788					$	1,793					$	1,606
Clinical studies and other costs						520						619						1,077						1,248
Total						$	1,351					$	1,407					$	2,871					$	2,854

Research and development expenses were $1.4 billion and $2.9 billion for the three and six months ended June 30, 2024, respectively, and remained relatively flat compared to the same periods in 2023. Personnel, infrastructure and other support costs increased for the three months ended June 30, 2024 primarily due to higher compensation expenses and restructuring expenses. Personnel, infrastructure and other support costs increased for the six months ended June 30, 2024 primarily due to stock-based compensation expenses of $67 million and other integration costs related to the acquisition of CymaBay, higher compensation expenses and restructuring expenses. Clinical studies and other costs decreased during both periods in 2024, compared to the same periods in 2023, primarily due to timing of clinical activities, including the wind-down of studies for magrolimab and obeldesivir for treatment of COVID-19 and higher R&D reimbursements.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development expenses are recorded when incurred and reflect costs of externally-developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront and milestone payments related to various collaborations and the costs of rights to IPR&D projects.

Acquired in-process research and development expenses were $38 million and $4.2 billion for the three and six months ended June 30, 2024, respectively, with the expenses in the six month period primarily comprised of $3.9 billion related to the CymaBay acquisition in March 2024 and $100 million related to the Arcus Biosciences, Inc. collaboration amendment in January 2024. Acquired in-process research and development expenses were $236 million and $717 million for the three and six months ended June 30, 2023, respectively, primarily comprised of $170 million related to the XinThera, Inc. acquisition in May 2023, $244 million related to the Tmunity Therapeutics, Inc. acquisition in February 2023 and $212 million related to the Arcellx, Inc. collaboration entered into in January 2023. See Note 6. Acquisitions, Collaborations and Other Arrangements of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information.

In-Process Research and Development Impairment

As of December 31, 2023, approximately $5.9 billion was assigned to an indefinite-lived IPR&D intangible asset related to Trodelvy for metastatic non-small cell lung cancer (“NSCLC”). In addition to NSCLC, Trodelvy is being explored for potential investigational use in a range of tumor types where Trop-2 is highly expressed. Gilead’s clinical development program in metastatic NSCLC includes ongoing Phase 2 and registrational Phase 3 studies for Trodelvy as a first- or second-line indication.

In January 2024, we received data from our Phase 3 EVOKE-01 study of Trodelvy evaluating sacituzumab govitecan-hziy (“SG”) indicating that the study did not meet its primary endpoint of overall survival in previously treated metastatic NSCLC, thus triggering a review for potential impairment of the NSCLC IPR&D impairment asset.

Based on our evaluation of the study results and all other data currently available, and in connection with the preparation of the financial statements for the first quarter, we performed an interim impairment test and determined that the revised estimated fair value of the NSCLC IPR&D intangible asset was below its carrying value. As a result, we recognized a partial impairment charge of $2.4 billion in In-process research and development impairment on our Condensed Consolidated Statements of Operations for the three months ended March 31, 2024.

To arrive at the revised estimated fair value, we used a probability-weighted income approach that discounts expected future cash flows to present value, which requires the use of Level 3 fair value measurements and inputs, and requires the use of critical estimated inputs, including: revenues and operating profits related to the planned utilization of SG in NSCLC, which, include inputs such as addressable patient population, projected market share, treatment duration, and the life of the potential commercialized product; the probability of technical and regulatory success; the time and resources needed to complete the development and approval of SG in NSCLC; an appropriate discount rate based on the estimated weighted-average cost of capital for companies with profiles similar to our profile; and risks related to the viability of and potential alternative treatments in any future target markets. Our revised discounted cash flows primarily reflect the smaller addressable market that Trodelvy could serve among metastatic NSCLC patients and a delay in expected launch timing for second-line plus patients. The revised estimated fair value of the NSCLC IPR&D intangible asset was $3.5 billion as of March 31, 2024.

If future events result in adverse changes in the key assumptions used in determining fair value, including the timing of product launches, information on the competitive landscape of treatments in this indication, changes to the probability of technical or regulatory success, failure to obtain anticipated regulatory approval or discount rate, among others, additional impairments may be recorded and could be material to our financial statements.

No IPR&D impairment charges were recorded during the three months ended June 30, 2024 and three and six months ended June 30, 2023.

Selling, General and Administrative Expenses

Selling, general and administrative expenses are recorded when incurred and consist primarily of personnel costs, facilities and overhead costs, outside marketing, advertising and legal expenses, and other general and administrative costs related to sales and marketing, finance, human resources, legal and other administrative activities.

Selling, general and administrative expenses decreased 26% and 13% to $1.4 billion and $2.8 billion for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, primarily due to a 2023 expense of $525 million for settlements with certain plaintiffs in HIV antitrust litigation which did not repeat in 2024 as well as a decrease in our allocation of the branded prescription drug fee, partially offset by stock-based compensation and other integration expenses related to the acquisition of CymaBay.

Interest Expense and Other (Income) Expense, Net

The following table summarizes the period-over-period changes in Interest expense and Other (income) expense, net:

						Three Months Ended																		Six Months Ended
						June 30,																		June 30,
(in millions, except percentages)						2024						2023						Change						2024						2023						Change
Interest expense						$	237					$	230					3		%				$	491					$	459					7		%
Other (income) expense, net						$	355					$	(152)					NM						$	265					$	22					NM
Loss (gain) from equity securities, net						$	392					$	(69)					NM						$	405					$	187					NM
Interest income						$	(35)					$	(90)					(61)		%				$	(144)					$	(168)					(15)		%
Other, net						$	(1)					$	7					NM						$	3					$	3					(4)		%

---

NM - Not Meaningful

Interest expense increased 3% and 7% to $237 million and $491 million for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023, due to a higher average interest rate on long-term debt, partially offset by lower debt balances. See Note 9. Debt and Credit Facilities of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information on our long-term debt and related interest rates.

Unfavorable movements in Other (income) expense, net for the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily related to higher net losses from equity securities and lower interest income due to lower average cash balances.

Income Taxes

The following table summarizes the period-over-period changes in Income tax expense:

						Three Months Ended																		Six Months Ended
						June 30,																		June 30,
(in millions, except percentages)						2024						2023						Change						2024						2023						Change
Income (loss) before income taxes						$	2,053					$	1,588					$	465					$	(2,433)					$	2,888					$	(5,321)
Income tax expense						$	438					$	549					$	(110)					$	123					$	865					$	742
Effective tax rate						21.4		%				34.6		%				(13.2)		%				(5.1)		%				29.9		%				(35.0)		%

Our effective tax rate decreased for the three months ended June 30, 2024, compared to the same period in 2023, primarily due to the remeasurement of certain deferred tax liabilities related to acquired intangible assets recorded in the three months ended June 30, 2023 and a settlement with a tax authority in the three months ended June 30, 2024.

Our effective tax rate decreased for the six months ended June 30, 2024, compared to the same period in 2023, primarily due to the non-deductible acquired IPR&D expense recorded in connection with our first quarter 2024 acquisition of CymaBay.

Liquidity and Capital Resources

We regularly evaluate our liquidity and capital resources, including our access to external capital, so that we can adequately and efficiently finance our operations.

Liquidity

Cash, cash equivalents and marketable debt securities were $2.8 billion and $8.4 billion as of June 30, 2024 and December 31, 2023, respectively. During the three months ended March 31, 2024, we sold all of our marketable debt securities and used the proceeds to partially fund our acquisition of CymaBay.

Cash and cash equivalents decreased by $3.3 billion from December 31, 2023 to June 30, 2024 due to the following cash flow activities:

						Six Months Ended
(in millions)						June 30, 2024
Net cash provided by (used in):
Operating activities						$	3,544
Investing activities						$	(2,514)
Financing activities						$	(4,314)
Effect of exchange rate changes on cash and cash equivalents						$	(29)

Operating Activities

Net cash provided by operating activities for the six months ended June 30, 2024 consisted of our net loss of $2.6 billion adjusted for non-cash and non-operating expenses of $8.1 billion primarily related to our acquisition of CymaBay, impairment charges and amortization expenses, partially offset by a $1.2 billion transition tax payment associated with the Tax Cuts and Jobs Acts of 2017.

Investing Activities

Net cash used in investing activities primarily relates to the $3.9 billion net cash payment for the CymaBay acquisition and purchases of equity securities, partially offset by proceeds from the liquidation of marketable debt securities.

Financing Activities

Net cash used in financing activities primarily relates to $2.0 billion for dividend payments, $1.85 billion for repayment of debt and other obligations, and $500 million for common stock repurchases.

Capital Resources and Material Cash Requirements

We believe our existing capital resources, including cash and cash equivalents and our revolving credit facility, supplemented by cash flows generated from our operations, will be adequate to satisfy our capital needs for the foreseeable future. A summary of our capital resources and material cash requirements is presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023. Other than as disclosed in the Liquidity section above and in Notes 4. Available-For-Sale Debt Securities and Equity Securities, 6. Acquisitions, Collaborations and Other Arrangements, 9. Debt and Credit Facilities, 10. Commitments and Contingencies and 12. Income Taxes of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, there were no material changes to our capital resources and material cash requirements during the six months ended June 30, 2024.

Subsequently, in August 2024, we announced that our Board of Directors declared a quarterly dividend of $0.77 per share of common stock for the third quarter of 2024. The dividend is payable on September 27, 2024, to stockholders of record at the close of business on September 13, 2024. Future dividends will be subject to Board approval.

Critical Accounting Estimates

A summary of our critical accounting estimates is presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023. Other than as disclosed in Notes 2. Revenues, 7. Intangible Assets, 10. Commitments and Contingencies and 12. Income Taxes of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, there were no material changes to our critical accounting estimates during the six months ended June 30, 2024.