SEC EDGAR · 10-Q

10-Q – 2026-05-07 – gild-20260331.htm

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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 46
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 “ambition,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expe | 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 or outcomes 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
Revenues: | Product sales $ 6,946 $ 6,613 | Royalty, contract and other revenues 14 54
Purchases of marketable debt securities ( 525 ) — | Proceeds from sales of marketable debt securities 2,520 — | Proceeds from maturities of marketable debt securities 36 —
(in millions) U.S. Europe Rest of World Total U.S. Europe Rest of World Total | Product sales: | HIV
Odefsey 153 59 9 221 215 57 10 281 | Symtuza - Revenue share (1) | 107 28 3 138 82 29 3 114
Total Other 46 67 83 196 52 76 81 209 | Total product sales 4,926 1,137 883 6,946 4,631 1,073 909 6,613 | Royalty, contract and other revenues — 8 6 14 37 11 6 54
_______________________________ | (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 Ireland”). | (2) Includes Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, Truvada and Tybost.

Rörelseresultat

Total costs and expenses 4,374 4,430 | Operating income 2,586 2,237 | Interest expense 240 260

Periodens resultat

Income tax expense 559 334 | Net income $ 2,021 $ 1,315
(in millions) 2026 2025 | Net income $ 2,021 $ 1,315 | Other comprehensive income (loss), net of reclassifications and taxes:
Balance as of December 31, 2025 1,241 $ 1 $ 8,932 $ 39 $ 13,730 $ ( 84 ) $ 22,618 | Net income — — — — 2,021 — 2,021 | Other comprehensive income, net — — — 39 — — 39
Balance as of December 31, 2024 1,246 $ 1 $ 7,700 $ 132 $ 11,497 $ ( 84 ) $ 19,246 | Net income — — — — 1,315 — 1,315 | Other comprehensive loss, net — — — ( 40 ) — — ( 40 )
Operating Activities: | Net income $ 2,021 $ 1,315 | Adjustments to reconcile Net income to Net cash provided by operating activities:
Net income $ 2,021 $ 1,315 | Adjustments to reconcile Net income to Net cash provided by operating activities:
( 10 ) ( 10 ) 40 20 | (Gain) loss reclassified to net income, net of income tax benefit of $ 0 , $ 0 , and $( 3 ), respectively | — ( 2 ) 21 19
18 — ( 40 ) ( 22 ) | Gain reclassified to net income, net of income tax expense of $ 0 , $ 0 , and $ 3 , respectively | — — ( 18 ) ( 18 )

Resultat per aktie

Basic earnings per share $ 1.63 $ 1.06 | Diluted earnings per share $ 1.61 $ 1.04
Shares used in basic earnings per share calculation 1,242 1,246 | Shares used in diluted earnings per share calculation 1,254 1,259
11. EARNINGS PER SHARE | The following table shows the calculation of Basic and Diluted earnings per share:
Net income $ 2,021 $ 1,315 | Shares used in basic earnings per share calculation 1,242 1,246 | Dilutive effect of equity-based awards 12 13
Dilutive effect of equity-based awards 12 13 | Shares used in diluted earnings per share calculation 1,254 1,259
Potential shares of common stock excluded from the computation of Diluted earnings per share because their effect would have been antidilutive were 2 million for the three months ended March 31, 2026 and 2025. | 22
Net income $ 2,021 $ 1,315 54 % | Diluted earnings per share $ 1.61 $ 1.04 54 %
Total revenues increased 4% to $7.0 billion for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Veklury, as well as chronic hepatitis C virus (“HCV”) and Cell Therapy products. | Net income was $2.0 billion and diluted earnings per share was $1.61 for the three months ended March 31, 2026, compared to net income of $1.3 billion and diluted earnings per share of $1.04 for the same period in 2025. The increase was primarily due to: | • Net unrealized gains from equity securities compared to net unrealized losses in 2025;

Kassaflöde

Net loss on available-for-sale debt securities ( 12 ) — | Net gain (loss) on cash flow hedges 61 ( 58 ) | Other comprehensive income (loss), net 39 ( 40 )
The derivative instruments we use to mitigate our exposures for certain monetary assets and liabilities that are denominated in a non-functional currency are not designated as hedges. The derivative instruments we use to mitigate our exposures for forecasted product sales are designated as cash flow hedges and have maturities of 18 months or less. | We held foreign currency exchange contracts with outstanding notional amounts of $ 3.6 billion and $ 3.9 billion as of March 31, 2026 and December 31, 2025, respectively.
Approximately $ 2 million of pre-tax net losses related to the hedged forecasted transactions reported in Accumulated other comprehensive income as of March 31, 2026 are expected to be reclassified to Product sales within 12 months. There were no discontinuances of cash flow hedges for the three months ended March 31, 2026 and 2025. | 14
The cash flow effects of our derivative contracts for the three months ended March 31, 2026 and 2025 were included within Net cash provided by operating activities on our Condensed Consolidated Statements of Cash Flows.
(in millions) Foreign Currency Translation Available-for-Sale Debt Securities Cash Flow Hedges Total | Balance as of December 31, 2025 $ 74 $ 8 $ ( 43 ) $ 39
(in millions) Foreign Currency Translation Available-for-Sale Debt Securities Cash Flow Hedges Total | Balance as of December 31, 2024 $ 36 $ — $ 96 $ 132
(in millions) 2026 2025 Line Item Affected | Net (loss) gain related to cash flow hedges $ ( 24 ) $ 21 Product sales | Net gain related to available-for-sale debt securities $ ( 2 ) $ — Other (income) expense, net
Liquidity | Cash and cash equivalents were $7.6 billion and marketable debt securities were $997 million as of March 31, 2026. The table below summarizes our cash flow activities, followed by our analysis of changes and trends:

Likvida medel

Current assets: | Cash and cash equivalents $ 7,628 $ 7,564 | Short-term marketable debt securities 15 68
Net cash used in financing activities ( 4,239 ) ( 3,426 ) | Effect of exchange rate changes on cash and cash equivalents ( 11 ) 19 | Net change in cash and cash equivalents 65 ( 2,065 )
Effect of exchange rate changes on cash and cash equivalents ( 11 ) 19 | Net change in cash and cash equivalents 65 ( 2,065 ) | Cash and cash equivalents at beginning of period 7,564 9,991
Net change in cash and cash equivalents 65 ( 2,065 ) | Cash and cash equivalents at beginning of period 7,564 9,991 | Cash and cash equivalents at end of period $ 7,628 $ 7,926
Cash and cash equivalents at beginning of period 7,564 9,991 | Cash and cash equivalents at end of period $ 7,628 $ 7,926
Equity securities measured at fair value: | Cash and cash equivalents: | Money market funds $ 5,966 $ 6,150
Liquidity | Cash and cash equivalents were $7.6 billion and marketable debt securities were $997 million as of March 31, 2026. The table below summarizes our cash flow activities, followed by our analysis of changes and trends:
Financing activities (4,239) (3,426) 24 % | Effect of exchange rate changes on cash and cash equivalents (11) 19 NM | Net change in cash and cash equivalents $ 65 $ (2,065) NM

Nettoskuld

Net income $ 2,021 $ 1,315 | Adjustments to reconcile Net income to Net cash provided by operating activities:
Accrued and other liabilities ( 702 ) ( 244 ) | Net cash provided by operating activities 2,544 1,757 | Investing Activities:
Other investing activities, net ( 17 ) ( 23 ) | Net cash provided by (used in) investing activities 1,770 ( 415 ) | Financing Activities:
Other financing activities, net ( 179 ) ( 176 ) | Net cash used in financing activities ( 4,239 ) ( 3,426 ) | Effect of exchange rate changes on cash and cash equivalents ( 11 ) 19
5. DERIVATIVES | Our operations in foreign countries expose us to risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and various foreign currencies, primarily the Euro. To partially mitigate the impact of changes in currency exchange rates on net cash flows from our foreign currency denominated sales as well as outstanding monetary assets and liabilities, we enter into foreign currency exchange forward contracts. In general, the risk of foreign currency fluctuations related | 13
The cash flow effects of our derivative contracts for the three months ended March 31, 2026 and 2025 were included within Net cash provided by operating activities on our Condensed Consolidated Statements of Cash Flows.
(in millions, except percentages) 2026 2025 Change | Net cash provided by (used in): | Operating activities $ 2,544 $ 1,757 45 %
Operating Activities | Net cash provided by operating activities is our primary source of funds, driven mainly by collections on product sales, partially offset by operating spend. Changes in working capital balances, generally associated with the timing of collections and payments, as well as unanticipated payments related to litigation, taxes or other matters, may create some variation in any given year. Net cash provided by operating activities increased for the three months ended March 31, 2026, compared to the sa | Investing Activities

Eget kapital

Condensed Consolidated Statements of Stockholders’ Equity | 6
Total assets $ 56,278 $ 59,023 | Liabilities and Stockholders’ Equity | Current liabilities:
Stockholders’ equity: | Preferred stock, par value $ 0.001 per share; 5 shares authorized; no ne outstanding
Retained earnings 14,131 13,730 | Total Gilead stockholders’ equity 23,515 22,703 | Noncontrolling interest ( 84 ) ( 84 )
Noncontrolling interest ( 84 ) ( 84 ) | Total stockholders’ equity 23,431 22,618 | Total liabilities and stockholders’ equity $ 56,278 $ 59,023
Total stockholders’ equity 23,431 22,618 | Total liabilities and stockholders’ equity $ 56,278 $ 59,023
GILEAD SCIENCES, INC. | CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY | (unaudited)
Three Months Ended March 31, 2026 | (in millions, except per share amounts) Gilead Stockholders' Equity | Noncontrolling

Antal aktier

Yes ☐ No x | Number of shares outstanding of the issuer’s common stock, par value $0.001 per share, as of April 30, 2026: 1,241,569,874
In the first quarter of 2020, our Board of Directors authorized a $5.0 billion stock repurchase program (“2020 Program”) under which we started repurchases in December 2022. In the third quarter of 2025, our Board of Directors authorized a $6.0 billion stock repurchase program (“2025 Program”), which will commence upon the completion of the 2020 Program. | Both the 2020 Program and 2025 Program have no fixed expiration, and purchases under these programs may be made in the open market or in privately negotiated transactions, but the programs do not obligate us to repurchase any specific number of shares and may be amended, suspended or discontinued at any time. | The table below summarizes our stock repurchase activity for the three months ended March 31, 2026:
Total Number of Shares Purchased (in thousands) Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs (in thousands) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (in millions) | January 1 - January 31, 2026 1,485 $ 125.79 1,447 $ 6,620
_______________________________ | (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.

Antal anställda

Galapagos | In March 2026, we entered into an agreement (the “Framework Agreement”) with Galapagos, effective upon the closing of our definitive agreement to acquire Ouro, for a research and development collaboration on the acquired Ouro assets. Under the Framework Agreement, Galapagos will pay 50 % of the upfront cash consideration and 50 % of any contingent milestone payments payable to Ouro’s shareholders. Additionally, Galapagos will absorb substantially all of Ouro’s operating assets, retain its employ | LEO Pharma
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 subject to assumptions 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 | There also continues to be enhanced scrutiny of company-sponsored patient assistance programs, including co-pay assistance programs and manufacturer donations to third-party charities that provide such assistance. There has also been enhanced scrutiny by governments on reimbursement support offerings and other patient support offerings, clinical education programs and promotional speaker programs. Despite our training and compliance program, our internal control policies and procedures may not p | For a description of our government investigations and related litigation, see Note 10. Commitments and Contingencies of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
If we are found to 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 | Furthermore, we also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors. 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 kn | We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations.
Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases. | Actual or threatened outbreaks of epidemic, pandemic or contagious diseases, or other public health emergencies, may significantly disrupt our global operations and adversely affect our business, financial condition and results of operations. As seen during the COVID-19 pandemic, outbreaks can result in global supply chain and logistics disruptions and distribution constraints. The impact of an outbreak or other public health crisis on our results of operations and financial condition would depe | 41
• Interest Rates and Inflation: We have interest-generating assets and interest-bearing liabilities, including our senior unsecured notes, term loan facility and revolving credit facility. Fluctuations in interest rates could expose us to increased financial risk. In addition, high inflation, such as what we have seen in recent years, has adversely impacted and may in the future adversely impact our business and financial results. | • Anti-Bribery: We are subject to the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws that govern our international operations with respect to payments to government officials. Our international operations are heavily regulated and require significant interaction with foreign officials. We operate in parts of the world that have experienced governmental corruption to some degree. In certain circumstances, strict compliance with anti-bribery laws may conflict with local | Other risks inherent in conducting a global business include:
Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price. | We are subject to evolving and sometimes conflicting investor and other stakeholder expectations concerning corporate responsibility matters, such as environmental sustainability and climate change and related targets or performance. These expectations and standards are varied and evolving, and may be inconsistent with our current practices. It is not possible for our practices to satisfy all investors and stakeholders, and our reputation, our ability to attract or retain employees and our attra | We depend on relationships with third parties for sales and marketing performance, technology, development, logistics and commercialization of products. Failure to maintain these relationships, poor performance by these companies or disputes with these third parties could negatively impact our business.
workplace culture that is attractive to employees. In addition, competition for qualified personnel in the biopharmaceutical field is intense, and there is a limited pool of qualified potential employees to recruit. We face competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations. Furthermore, changes to immigration and work authorization laws and regulations could make it more difficult for employees to w | Information system service interruptions or breaches, including significant cybersecurity incidents, could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations.
Information system service interruptions or breaches, including significant cybersecurity incidents, could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations. | We are dependent upon information technology systems, infrastructure and data. For example, our Kite Konnect platform is critical to maintain chain of identity and chain of custody for our cell therapies. The multitude and complexity of our computer systems make them inherently vulnerable to service interruption or destruction, including those caused by failures during system upgrades or implementations, user error, network or hardware failure, malicious intrusion and ransomware attack. Likewise | Cybersecurity attacks and incidents are increasing in their frequency, sophistication and intensity. Malicious actors seek to steal money, gain unauthorized access to, destroy or manipulate data, and disrupt operations, and some of their attacks may not be recognized or discovered until after a significant period of time well after initial entry into the environment, such as novel or zero-day attacks that are launched before patches are available and defenses can be readied. Malicious actors are

Bruttomarginal

Cost of goods sold $ 1,445 $ 1,540 (6) % | Product gross margin 79.2 % 76.7 % 249 bps | Research and development expenses $ 1,372 $ 1,379 (1) %
Product Gross Margin | Product gross margin increased to 79.2% for the three months ended March 31, 2026, compared to the same period in 2025, primarily driven by the expiration of a royalty-related obligation and product mix.
Product Gross Margin | Product gross margin increased to 79.2% for the three months ended March 31, 2026, compared to the same period in 2025, primarily driven by the expiration of a royalty-related obligation and product mix. | Research and Development Expenses

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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 March 31, 2026
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. 000-19731
 

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 April 30, 2026: 1,241,569,874

GILEAD SCIENCES, INC.
INDEX

PART I.
FINANCIAL INFORMATION
3

Item 1.
Condensed Consolidated Financial Statements
3

Condensed Consolidated Balance Sheets
3

Condensed Consolidated Statements of Operations
4

Condensed Consolidated Statements of Comprehensive Income
5

Condensed Consolidated Statements of Stockholders’ Equity
6

Condensed Consolidated Statements of Cash Flows
7

Notes to Condensed Consolidated Financial Statements
8

Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
24

Item 3.
Quantitative and Qualitative Disclosures About Market Risk
31

Item 4.
Controls and Procedures
31

PART II.
OTHER INFORMATION
32

Item 1.
Legal Proceedings
32

Item 1A.
Risk Factors
32

Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
46

Item 3.
Defaults Upon Senior Securities
46

Item 4.
Mine Safety Disclosures
46

Item 5.
Other Information
46

Item 6.
Exhibits
46

SIGNATURES
51

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 ® , LIVDELZI ® /LYVDELZI ® , ODEFSEY ® , SOVALDI ® , STRIBILD ® , SUNLENCA ® , TECARTUS ® , TRODELVY ® , TRUVADA ® , TRUVADA FOR PREP ® , TYBOST ® , VEKLURY ® , VEMLIDY ® , VIREAD ® , VOSEVI ® , YESCARTA ® , YEZTUGO ® /YEYTUO ® 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 “ambition,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “hope,” “intend,” “may,” “might,” “outlook,” “plan,” “priority,” “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, product sales and revenue trends; liquidity and capital needs; plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections, strategic investments and the use of capital; expectations regarding the impact of the Inflation Reduction Act and the One Big Beautiful Bill Act, changes in U.S. regulatory policies, changes in U.S. trade policies, including tariffs, and U.S. government shutdowns; 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 or outcomes 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 under 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.
2

PART I.    FINANCIAL INFORMATION

Item 1.    CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)

(in millions, except per share amounts) March 31, 2026 December 31, 2025
Assets    
Current assets:    
Cash and cash equivalents $ 7,628   $ 7,564  
Short-term marketable debt securities 15   68  
Accounts receivable, net 4,741   4,913  
Inventories 1,914   1,774  
Prepaid and other current assets 4,342   4,024  
Total current assets 18,641   18,342  
Property, plant and equipment, net 5,638   5,606  
Long-term marketable debt securities 983   2,974  
Intangible assets, net 16,382   16,978  
Goodwill 8,314   8,314  
Deferred tax assets 1,767   1,964  
Other long-term assets 4,554   4,845  
Total assets $ 56,278   $ 59,023  
Liabilities and Stockholders’ Equity    
Current liabilities:    
Accounts payable $ 645   $ 715  
Accrued rebates 4,118   4,337  
Current portion of long-term debt, net 1,313   2,807  
Other current liabilities 3,399   3,953  
Total current liabilities 9,476   11,813  
Long-term debt, net 20,861   22,129  
Long-term income taxes payable 918   896  
Deferred tax liabilities 392   402  
Other long-term liabilities 1,200   1,165  
Commitments and contingencies (Note 10)

Stockholders’ equity:    
Preferred stock, par value $ 0.001 per share; 5 shares authorized; no ne outstanding
—   —  
Common stock, par value $ 0.001 per share; 5,600 shares authorized; 1,242 and 1,241 shares issued and outstanding, respectively
1   1  
Additional paid-in capital 9,305   8,932  
Accumulated other comprehensive income 78   39  
Retained earnings 14,131   13,730  
Total Gilead stockholders’ equity 23,515   22,703  
Noncontrolling interest ( 84 ) ( 84 )
Total stockholders’ equity 23,431   22,618  
Total liabilities and stockholders’ equity $ 56,278   $ 59,023  

See accompanying notes.
3

GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)

  Three Months Ended
March 31,
(in millions, except per share amounts) 2026 2025
Revenues:
Product sales $ 6,946   $ 6,613  
Royalty, contract and other revenues 14   54  
Total revenues 6,960   6,667  
Costs and expenses:
Cost of goods sold 1,445   1,540  
Research and development expenses 1,372   1,379  
Acquired in-process research and development expenses 107   253  
Selling, general and administrative expenses 1,451   1,258  
Total costs and expenses 4,374   4,430  
Operating income 2,586   2,237  
Interest expense 240   260  
Other (income) expense, net ( 235 ) 328  
Income before income taxes 2,580   1,649  
Income tax expense 559   334  
Net income $ 2,021   $ 1,315  

Basic earnings per share $ 1.63   $ 1.06  
Diluted earnings per share $ 1.61   $ 1.04  

Shares used in basic earnings per share calculation 1,242   1,246  
Shares used in diluted earnings per share calculation 1,254   1,259  

See accompanying notes.
4

GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)

Three Months Ended
March 31,
(in millions) 2026 2025
Net income $ 2,021   $ 1,315  
Other comprehensive income (loss), net of reclassifications and taxes:
Net (loss) gain on foreign currency translation ( 10 ) 18  
Net loss on available-for-sale debt securities ( 12 ) —  
Net gain (loss) on cash flow hedges 61   ( 58 )
Other comprehensive income (loss), net 39   ( 40 )
Comprehensive income, net $ 2,060   $ 1,275  

See accompanying notes.
5

GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)

Three Months Ended March 31, 2026
(in millions, except per share amounts) Gilead Stockholders' Equity 
Noncontrolling
Interest Total
Stockholders'
Equity

Common Stock 
Additional
Paid-In
Capital Accumulated Other Comprehensive Income Retained
Earnings
Shares Amount

Balance as of December 31, 2025 1,241   $ 1   $ 8,932   $ 39   $ 13,730   $ ( 84 ) $ 22,618  
Net income —  —  —  —  2,021   —  2,021  
Other comprehensive income, net —  —  —  39   —  —  39  
Issuances under employee stock purchase plan 1   —  86   —  —  —  86  
Issuances under equity incentive plans 5   —  81   —  —  —  81  
Stock-based compensation —  —  218   —  —  —  218  
Repurchases of common stock under repurchase programs ($ 136.54 average price per share)
( 3 ) —  ( 13 ) —  ( 406 ) —  ( 419 )
Repurchases of common stock for employee tax withholding under equity incentive plans and other ( 1 ) —  —  —  ( 179 ) —  ( 179 )
Dividends declared ($ 0.82 per share)
—  —  —  —  ( 1,035 ) —  ( 1,035 )
Balance as of March 31, 2026 1,242   $ 1   $ 9,305   $ 78   $ 14,131   $ ( 84 ) $ 23,431  

Three Months Ended March 31, 2025
(in millions, except per share amounts) Gilead Stockholders' Equity 
Noncontrolling
Interest Total
Stockholders'
Equity

Common Stock 
Additional
Paid-In
Capital Accumulated Other Comprehensive Income Retained
Earnings
Shares Amount

Balance as of December 31, 2024 1,246   $ 1   $ 7,700   $ 132   $ 11,497   $ ( 84 ) $ 19,246  
Net income —  —  —  —  1,315   —  1,315  
Other comprehensive loss, net —  —  —  ( 40 ) —  —  ( 40 )
Issuances under employee stock purchase plan 1   —  82   —  —  —  82  
Issuances under equity incentive plans 7   —  175   —  —  —  175  
Stock-based compensation —  —  211   —  —  —  211  
Repurchases of common stock under repurchase programs ($ 102.46 average price per share)
( 7 ) —  ( 29 ) —  ( 701 ) —  ( 730 )
Repurchases of common stock for employee tax withholding under equity incentive plans and other ( 2 ) —  —  —  ( 176 ) —  ( 176 )
Dividends declared ($ 0.79 per share)
—  —  —  —  ( 1,004 ) —  ( 1,004 )
Balance as of March 31, 2025 1,245   $ 1   $ 8,138   $ 92   $ 10,931   $ ( 84 ) $ 19,078  

See accompanying notes.
6

GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

Three Months Ended
March 31,
(in millions) 2026 2025
Operating Activities:
Net income $ 2,021   $ 1,315  
Adjustments to reconcile Net income to Net cash provided by operating activities:

Depreciation expense 93   97  
Amortization expense 596   599  
Stock-based compensation expense 218   209  
Deferred income taxes 179   ( 199 )
Net (gain) loss from equity securities ( 142 ) 426  
Acquired in-process research and development expenses 107   253  
Other, net 183   91  
Changes in operating assets and liabilities:
Accounts receivable, net 134   79  
Inventories ( 52 ) ( 223 )
Prepaid expenses and other 5   12  
Accounts payable ( 67 ) ( 105 )
Income tax assets and liabilities, net ( 29 ) ( 552 )
Accrued and other liabilities ( 702 ) ( 244 )
Net cash provided by operating activities 2,544   1,757  
Investing Activities:
Purchases of marketable debt securities ( 525 ) —  
Proceeds from sales of marketable debt securities 2,520   —  
Proceeds from maturities of marketable debt securities 36   —  
Acquisitions, including in-process research and development, net of cash acquired ( 109 ) ( 273 )
Purchases of equity securities ( 19 ) ( 16 )
Purchases of property, plant and equipment ( 117 ) ( 104 )
Other investing activities, net ( 17 ) ( 23 )
Net cash provided by (used in) investing activities 1,770   ( 415 )
Financing Activities:
Proceeds from issuances of common stock 166   252  
Repurchases of common stock under repurchase programs ( 419 ) ( 730 )
Repayments of debt and other obligations ( 2,766 ) ( 1,762 )
Payments of dividends ( 1,040 ) ( 1,010 )
Other financing activities, net ( 179 ) ( 176 )
Net cash used in financing activities ( 4,239 ) ( 3,426 )
Effect of exchange rate changes on cash and cash equivalents ( 11 ) 19  
Net change in cash and cash equivalents 65   ( 2,065 )
Cash and cash equivalents at beginning of period 7,564   9,991  
Cash and cash equivalents at end of period $ 7,628   $ 7,926  
    

See accompanying notes.
7

GILEAD SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)

1.     SUMMARY OF BUSINESS AND SIGNIFICANT ACCOUNTING POLICIES
The accompanying Condensed Consolidated Financial Statements and related Notes to Condensed Consolidated Financial Statements of Gilead Sciences, Inc. (“Gilead,” “we,” “our” or “us”) should be read in conjunction with the audited Consolidated Financial Statements and the related notes thereto for the year ended December 31, 2025, included in our Annual Report on Form 10-K filed with U.S. Securities and Exchange Commission. There have been no material changes to the summary of our business or significant accounting policies as disclosed in that filing.
These interim financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and include all adjustments consisting of normal recurring adjustments that the management of Gilead believes are necessary for a fair presentation of the periods presented and are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period. We have evaluated subsequent events through the report issuance date and determined that there are no further events or transactions to be disclosed other than those already disclosed elsewhere in the Notes to Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.
Certain amounts and percentages in these Condensed Consolidated Financial Statements and accompanying notes may not sum or recalculate due to rounding.
8

2.     REVENUES
Disaggregation of Revenues
The following table summarizes our Total revenues:

Three Months Ended March 31, 2026 Three Months Ended March 31, 2025
(in millions) U.S. Europe Rest of World Total U.S. Europe Rest of World Total
Product sales:
HIV
Biktarvy $ 2,573   $ 437   $ 352   $ 3,361   $ 2,474   $ 375   $ 301   $ 3,150  
Descovy 761   23   23   807   538   21   27   586  
Genvoya 215   33   16   264   305   40   19   364  
Odefsey 153   59   9   221   215   57   10   281  
Symtuza - Revenue share (1)
107   28   3   138   82   29   3   114  
Yeztugo 158   —   7   166   —   —   —   —  
Other HIV (2)
36   27   9   73   50   31   10   91  
Total HIV 4,004   607   419   5,030   3,664   553   370   4,587  

Liver Disease
Livdelzi 115   18   —   133   40   —   —   40  
Sofosbuvir/Velpatasvir (3)
141   60   82   283   166   80   99   346  
Vemlidy 91   13   132   237   100   12   140   252  
Other Liver Disease (4)
15   78   21   114   28   76   17   121  
Total Liver Disease 362   170   235   767   335   168   256   758  

Veklury 112   14   18   144   199   22   82   302  

Oncology
Cell Therapy
Tecartus 30   37   8   75   40   31   8   78  
Yescarta 120   146   67   332   160   149   77   386  
Total Cell Therapy 150   183   74   407   200   180   84   464  

Trodelvy 253   95   54   402   181   75   37   293  
Total Oncology 403   278   129   810   381   255   121   757  

Other
AmBisome 7   59   72   138   5   67   66   139  
Other (5)
39   8   11   58   47   9   14   70  
Total Other 46   67   83   196   52   76   81   209  
Total product sales 4,926   1,137   883   6,946   4,631   1,073   909   6,613  
Royalty, contract and other revenues —   8   6   14   37   11   6   54  
Total revenues $ 4,926   $ 1,144   $ 889   $ 6,960   $ 4,668   $ 1,084   $ 915   $ 6,667  

_______________________________
(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 Ireland”).
(2)     Includes Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, 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 and Zydelig.
9

Revenues Recognized from Performance Obligations Satisfied in Prior Years
The following table summarizes revenues recognized from performance obligations satisfied in prior years:

Three Months Ended
March 31,
(in millions) 2026 2025
Revenue share with Janssen Ireland and royalties for licenses of intellectual property $ 152   $ 157  
Changes in estimates $ 232   $ 214  

Contract Balances
The following table summarizes our contract balances:

(in millions) March 31, 2026 December 31, 2025
Contract assets $ 589   $ 629  
Contract liabilities (1)
$ 47   $ 48  

_______________________________
(1)     Future revenues recognized from contract liabilities are not expected to be material in any one year.

3.     FAIR VALUE MEASUREMENTS
Recurring Fair Value Measurements
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:

March 31, 2026 December 31, 2025
(in millions) Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total
Assets:
Available-for-sale debt securities:
U.S. treasury securities $ 298   $ —   $ —   $ 298   $ 1,224   $ —   $ —   $ 1,224  
U.S. government agencies securities —   —   —   —   —   15   —   15  

Corporate debt securities —   555   —   555   —   1,398   —   1,398  
Residential mortgage and asset-backed securities —   144   —   144   —   407   —   407  
Equity securities:
Money market funds 5,966   —   —   5,966   6,150   —   —   6,150  
Publicly traded equity securities 2,147   —   —   2,147   1,961   —   —   1,961  
Deferred compensation plan 405   —   —   405   406   —   —   406  
Foreign currency derivative contracts —   73   —   73   —   56   —   56  
Total $ 8,817   $ 772   $ —   $ 9,589   $ 9,741   $ 1,875   $ —   $ 11,616  
Liabilities:
Contingent consideration liability $ —   $ —   $ 275   $ 275   $ —   $ —   $ 278   $ 278  
Deferred compensation plan 405   —   —   405   406   —   —   406  
Foreign currency derivative contracts —   30   —   30   —   72   —   72  
Total $ 405   $ 30   $ 275   $ 710   $ 406   $ 72   $ 278   $ 757  

Level 2 Inputs
Available-for-Sale Debt Securities
For our available-for-sale debt securities, we estimate the fair values by reviewing trading activity and pricing as of the measurement date and 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.
10

Foreign Currency Derivative Contracts
Our foreign currency derivative contracts have maturities of 18 months or less 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 utilizing 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, Secured Overnight Financing Rate (“SOFR”) and swap rates. These inputs, where applicable, are observable at commonly quoted intervals.
Level 3 Inputs
Contingent Consideration Liability
In connection with our first quarter 2021 acquisition of MYR GmbH, we are subject to a potential contingent consideration payment of up to € 300 million, subject to customary adjustments, which is revalued each reporting period using probability-weighted scenarios for U.S. Food and Drug Administration (“FDA”) approval of bulevirtide until the related contingency is resolved.
The following table summarizes the change in fair value of our contingent consideration liability:

Three Months Ended
March 31,
(in millions) 2026 2025
Beginning balance $ 278   $ 206  
Changes in valuation assumptions (1)
3   2  
Effect of foreign exchange remeasurement (2)
( 6 ) 7  
Ending balance (3)
$ 275   $ 216  

________________________________
(1)     Included in Research and development expenses on our Condensed Consolidated Statements of Operations.
(2)     Included in Other (income) expense, net on our Condensed Consolidated Statements of Operations.
(3)     Included in Other current liabilities on our Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025.
Fair Value Level Transfers
There were no transfers between Level 1, Level 2 and Level 3 in the periods presented.
Other Fair Value Disclosures
Senior Unsecured Notes
The following table summarizes the total estimated fair value and carrying value of our senior unsecured notes, determined using Level 2 inputs based on their quoted market values:

(in millions) March 31, 2026 December 31, 2025
Fair value $ 19,178   $ 22,342  
Carrying value $ 21,080   $ 23,827  

Liability Related to Future Royalties
We recorded a liability related to future royalties as part of our 2020 acquisition of Immunomedics, Inc., which is subsequently amortized using the effective interest method over the remaining estimated life. The fair value of the liability related to future royalties, determined using Level 3 inputs, was approximately $ 0.8 billion as of March 31, 2026 and December 31, 2025, and the carrying value was $ 1.1 billion as of March 31, 2026 and December 31, 2025.
11

4.      INVESTMENTS
Available-for-Sale Debt Securities
The following table summarizes our available-for-sale debt securities:

March 31, 2026 December 31, 2025
(in millions) 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 $ 300   $ —   $ ( 1 ) $ 298   $ 1,222   $ 3   $ —   $ 1,224  
U.S. government agencies securities —   —   —   —   15   —   —   15  
Corporate debt securities 557   —   ( 2 ) 555   1,392   7   —   1,398  
Residential mortgage and asset-backed securities 144   —   —   144   405   2   —   407  
Total $ 1,000   $ 1   $ ( 4 ) $ 997   $ 3,033   $ 11   $ ( 1 ) $ 3,044  

The total gross unrealized losses in the table above relate to available-for-sale debt securities, primarily corporate debt securities and U.S. treasury securities, with an estimated fair value of approximately $ 669 million and $ 724 million that have been in a continuous unrealized loss position for less than 12 months as of March 31, 2026 and December 31, 2025, respectively. No allowance for credit losses was recognized for investments with unrealized losses as of March 31, 2026 as the unrealized losses were primarily driven by broader change in interest rates with no adverse conditions identified that would prevent the issuer from making scheduled principal and interest payments. In April 2026, we sold all remaining securities.
The following table summarizes the classification of our available-for-sale debt securities on our Condensed Consolidated Balance Sheets:

(in millions) March 31, 2026
Short-term marketable debt securities $ 15  
Long-term marketable debt securities 983  
Total $ 997  

The following table summarizes our available-for-sale debt securities by contractual maturity:

March 31, 2026
(in millions) Amortized Cost Fair Value
Within one year $ 15   $ 15  
After one year through five years 982   979  
After five years through ten years 4   4  
Total $ 1,000   $ 997  

12

Equity Securities
The following table summarizes the classification of our equity securities on our Condensed Consolidated Balance Sheets, including certain equity method investments for which we elected and applied the fair value option as we believe it best reflects the underlying economics of these investments:

(in millions) March 31, 2026 December 31, 2025
Equity securities measured at fair value:
Cash and cash equivalents:
Money market funds $ 5,966   $ 6,150  
Prepaid and other current assets:
Equity method investment in Galapagos NV (“Galapagos”) – fair value option 504   551  
Equity method investment in Arcus Biosciences, Inc. – fair value option 679   749  
Other equity method investments – fair value option (1)
155   183  
Other 836   499  
Other long-term assets 379   386  
Equity method investments and other equity securities without readily determinable fair values:
Other long-term assets (2)
308   393  
Total $ 8,827   $ 8,909  

________________________________
(1)     Mostly comprised of our equity interest in Assembly Biosciences, Inc. (“Assembly”), which was approximately 29 % of outstanding Assembly stock at the time of our latest purchase of shares.
(2)     Mostly comprised of equity interests in certain collaboration partners and investment funds that are considered to be variable interest entities (“VIEs”) for which we are not the primary beneficiary. Our maximum exposure to loss as a result of our involvement in these VIEs is limited to the value of our investment.
The following table summarizes net unrealized gains and losses related to equity securities still held as of the respective ending balance sheet dates for the periods below, included in Other (income) expense, net on our Condensed Consolidated Statements of Operations:

Three Months Ended
March 31,
(in millions) 2026 2025
Unrealized loss, net, related to fair value option investments $ 146   $ 276  
Unrealized (gain) loss, net, related to all other equity investments ( 277 ) 160  
Total unrealized (gain) loss, net $ ( 131 ) $ 436  

Related Party Transaction
During the three months ended March 31, 2026, we donated certain equity securities to the Gilead Foundation, a California nonprofit public benefit corporation for which certain of our officers serve as directors, and recorded a related expense of $ 63 million in Selling, general and administrative expenses on our Condensed Consolidated Statements of Operations.

5.      DERIVATIVES
Our operations in foreign countries expose us to risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and various foreign currencies, primarily the Euro. To partially mitigate the impact of changes in currency exchange rates on net cash flows from our foreign currency denominated sales as well as outstanding monetary assets and liabilities, we enter into foreign currency exchange forward contracts. In general, the risk of foreign currency fluctuations related to our operations is offset by corresponding gains and losses from our derivative instruments. By working only with major banks and closely monitoring current market conditions, we seek to limit the credit risk that counterparties to these contracts may be unable to perform. We enter into contracts that permit net settlement at maturity. In addition, our overall risk of loss in the event of counterparty default is limited to the amount of any net unrealized gains on outstanding contracts (i.e., including the impact of offsetting unrealized losses). We do not enter into derivative contracts for trading purposes.
13

The derivative instruments we use to mitigate our exposures for certain monetary assets and liabilities that are denominated in a non-functional currency are not designated as hedges. The derivative instruments we use to mitigate our exposures for forecasted product sales are designated as cash flow hedges and have maturities of 18 months or less.
We held foreign currency exchange contracts with outstanding notional amounts of $ 3.6 billion and $ 3.9 billion as of March 31, 2026 and December 31, 2025, respectively.
While all our derivative contracts allow us the right to offset assets and liabilities, we have presented amounts on our Condensed Consolidated Balance Sheets on a gross basis. Further, our contracts generally do not require financial collateral. The following table summarizes the classification and fair values of derivative instruments, including the potential effect of offsetting:

March 31, 2026
(in millions) Prepaid and other current assets Other long-term assets Total Derivative Assets Other current liabilities Other long-term liabilities Total Derivative Liabilities
Foreign currency exchange contracts designated as hedges $ 45   $ 7   $ 52   $ 28   $ 1   $ 29  
Foreign currency exchange contracts not designated as hedges 21   —   21   1   —   1  
Total derivatives presented gross on the Condensed Consolidated Balance Sheets $ 73   $ 30  
Total derivatives not offset on the Condensed Consolidated Balance Sheets ( 24 ) ( 24 )
Net amount (legal offset) $ 49   $ 6  

December 31, 2025
(in millions) Prepaid and other current assets Other long-term assets Total Derivative Assets Other current liabilities Other long-term liabilities Total Derivative Liabilities
Foreign currency exchange contracts designated as hedges $ 18   $ 2   $ 20   $ 62   $ 3   $ 65  
Foreign currency exchange contracts not designated as hedges 36   —   36   7   —   7  
Total derivatives presented gross on the Condensed Consolidated Balance Sheets $ 56   $ 72  
Total derivatives not offset on the Condensed Consolidated Balance Sheets ( 40 ) ( 40 )
Net amount (legal offset) $ 16   $ 32  

The following table summarizes the effect of our derivative contracts on our Condensed Consolidated Financial Statements:

Three Months Ended
  March 31,
(in millions) 2026 2025
Derivatives designated as hedges:
Net gain (loss) recognized in Accumulated other comprehensive income $ 45   $ ( 45 )
Net (loss) gain reclassified from Accumulated other comprehensive income into Product sales $ ( 24 ) $ 21  
Derivatives not designated as hedges:
Net gain (loss) recognized in Other (income) expense, net $ 3   $ ( 5 )

Approximately $ 2 million of pre-tax net losses related to the hedged forecasted transactions reported in Accumulated other comprehensive income as of March 31, 2026 are expected to be reclassified to Product sales within 12 months. There were no discontinuances of cash flow hedges for the three months ended March 31, 2026 and 2025.
14

The cash flow effects of our derivative contracts for the three months ended March 31, 2026 and 2025 were included within Net cash provided by operating activities on our Condensed Consolidated Statements of Cash Flows.

6.     ACQUISITIONS, COLLABORATIONS AND OTHER ARRANGEMENTS
We enter into acquisitions, licensing and strategic collaborations and other similar arrangements with third parties for the research, development and commercialization of certain products and product candidates. The collaborations involve two or more parties who are active participants in the operating activities of the collaboration and are exposed to significant risks and rewards depending on the commercial success of the activities. The financial terms of these arrangements may include non-refundable upfront payments, expense reimbursements, 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.
Acquisitions
Arcellx
In April 2026, we closed an agreement to acquire Arcellx, Inc. (“Arcellx”), a public biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases. Under the terms of the agreement, we successfully completed our tender offer for all outstanding shares of Arcellx other than those already owned by Gilead for approximately $ 7.1 billion in cash consideration. As a result, Arcellx became our wholly-owned subsidiary. We will also pay one non-transferable contingent value right of $ 5 per share upon the achievement of at least $ 6.0 billion in cumulative global net sales of anitocabtagene autoleucel (“anito-cel”) from launch through year-end 2029.
Prior to the acquisition, we had been engaged in a global strategic collaboration with Arcellx to co-develop and co-commercialize Arcellx’s lead late-stage product candidate, anito-cel, an investigational BCMA-directed chimeric antigen receptor T-cell therapy for patients with relapsed and/or refractory multiple myeloma. In conjunction with the collaboration, we obtained licenses to develop and manufacture certain products, including anito-cel, and to commercialize those products outside the U.S. and to co-commercialize those products in the U.S. with Arcellx. We also made various purchases of Arcellx shares. Under the agreement, Arcellx was eligible to receive performance-based development and regulatory milestone payments, with further commercial milestone payments, profit split payments on co-promoted products and royalties on at least a portion of worldwide net sales, depending on whether Arcellx opted in to co-promote the future products.
We expect to account for this transaction as an asset acquisition in the second quarter of 2026 since the acquired intellectual property rights related to anito-cel represent substantially all of the fair value of the gross assets acquired.
Tubulis
In April 2026, we entered into a definitive agreement to acquire Tubulis GmbH (“Tubulis”), a private Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates (“ADC”), for approximately $ 3.2 billion in upfront cash consideration, subject to customary adjustments, payable at closing, and up to $ 1.9 billion in contingent milestone payments. The closing of the transaction is subject to the expiration or termination of certain regulatory filings and other customary conditions. Upon closing, Tubulis will become our wholly-owned subsidiary.
We expect to account for this transaction as an asset acquisition in the second quarter of 2026 since the lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor ADC currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer (“NSCLC”), represents substantially all of the fair value of the gross assets acquired.
Ouro Medicines
In March 2026, we entered into a definitive agreement to acquire Ouro Medicines, LLC (“Ouro”), a privately held biotechnology company focused on developing T cell engager (“TCE”) therapies for autoimmune diseases, for approximately $ 1.7 billion in upfront cash consideration, subject to customary adjustments, payable at closing, and up to $ 500 million in contingent milestone payments. The closing of the transaction is subject to the expiration or termination of certain regulatory filings and other customary conditions. Upon closing, which is anticipated in the second quarter of 2026, Ouro will become our wholly-owned subsidiary.
We expect to account for this transaction as an asset acquisition in the second quarter of 2026 since the lead asset, OM336 (gamgertamig), a clinical-stage BCMAxCD3 TCE, represents substantially all of the fair value of the gross assets acquired.
15

Collaborations and Other Arrangements
Galapagos
In March 2026, we entered into an agreement (the “Framework Agreement”) with Galapagos, effective upon the closing of our definitive agreement to acquire Ouro, for a research and development collaboration on the acquired Ouro assets. Under the Framework Agreement, Galapagos will pay 50 % of the upfront cash consideration and 50 % of any contingent milestone payments payable to Ouro’s shareholders. Additionally, Galapagos will absorb substantially all of Ouro’s operating assets, retain its employees and be responsible for all development costs prior to registrational studies for gamgertamig, with later clinical development costs being shared equally between Gilead and Galapagos. Gilead will retain commercialization rights and pay Galapagos royalties of 20 % to 23 % of net sales of gamgertamig products.
LEO Pharma
In January 2025, we entered into a strategic partnership with LEO Pharma A/S (“LEO Pharma”) to accelerate the development and commercialization of LEO Pharma’s small molecule oral signal transducer and activator of transcription 6 (“STAT6”) programs for the potential treatment of patients with inflammatory diseases. Gilead acquired global rights to develop, manufacture, and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to potentially co-commercialize oral programs for dermatology outside the U.S. LEO Pharma will hold exclusive global rights to STAT6 topical formulations in dermatology. We made a $ 250 million upfront payment to LEO Pharma, which was charged to Acquired in-process research and development expenses on our Condensed Consolidated Statements of Operations in 2025. In addition, LEO Pharma is eligible to receive up to approximately $ 1.5 billion in additional milestone payments and may also receive tiered royalties on sales of oral STAT6 products.

7.      INTANGIBLE ASSETS
The following table summarizes our Intangible assets, net:

  March 31, 2026 December 31, 2025
(in millions) 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   $ ( 8,623 ) $ —   $ 2,097   $ 10,720   $ ( 8,448 ) $ —   $ 2,272  
Intangible asset – axicabtagene ciloleucel
7,110   ( 3,229 ) —   3,881   7,110   ( 3,127 ) —   3,983  
Intangible asset – Trodelvy
11,730   ( 4,434 ) —   7,296   11,730   ( 4,164 ) —   7,566  
Intangible asset – Hepcludex
845   ( 437 ) —   408   845   ( 415 ) —   430  
Other 1,458   ( 1,059 ) —   400   1,483   ( 1,056 ) —   428  
Total finite-lived assets 31,863   ( 17,782 ) —   14,082   31,888   ( 17,211 ) —   14,678  
Indefinite-lived assets – IPR&D (1)
2,300   —  —   2,300   2,300   —  —   2,300  
Total intangible assets $ 34,163   $ ( 17,782 ) $ —   $ 16,382   $ 34,188   $ ( 17,211 ) $ —   $ 16,978  

_______________________________
(1)     The Indefinite-lived assets – IPR&D balance as of March 31, 2026 was comprised of $ 1.75 billion related to sacituzumab govitecan-hziy for NSCLC and $ 550 million related to bulevirtide.
Impairment Assessments
No indicators of impairment resulting in an adjustment to the carrying value of intangible assets were identified for the three months ended March 31, 2026 and 2025.
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8.      OTHER FINANCIAL INFORMATION
Accounts Receivable, Net
The following table summarizes our Accounts receivable, net:

(in millions) March 31, 2026 December 31, 2025
Accounts receivable (1)
$ 5,544   $ 5,895  
Less: allowances for chargebacks 661   843  
Less: allowances for cash discounts and other 98   97  
Less: allowances for credit losses 44   41  
Accounts receivable, net $ 4,741   $ 4,913  
_______________________________
(1)     As of March 31, 2026, the majority of our Accounts receivable balance arises from product sales in the U.S. and Europe and approximately 60 % relates to three wholesalers—Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation—and their specialty distributor affiliates.
Inventories
The following table summarizes our Inventories:

(in millions) March 31, 2026 December 31, 2025
Raw materials $ 1,357   $ 1,414  
Work in process 1,276   1,306  
Finished goods 1,706   1,647  
Total $ 4,339   $ 4,368  
Reported as:
Inventories $ 1,914   $ 1,774  
Other long-term assets (1)
2,424   2,594  
Total $ 4,339   $ 4,368  

_______________________________
(1)     As of March 31, 2026, this amount primarily consists of raw materials and work in process.
As of March 31, 2026, we held approximately $ 638  million of pre-commercial Trodelvy inventory for which the manufacturing process has not yet been approved by FDA.
Property, Plant and Equipment, Net
The following table summarizes our Property, plant and equipment, net:

(in millions) March 31, 2026 December 31, 2025
Property, plant and equipment $ 8,422   $ 8,302  
Less: accumulated depreciation 2,784   2,696  
Property, plant and equipment, net $ 5,638   $ 5,606  

The following table summarizes Depreciation expense:

Three Months Ended
March 31,
(in millions) 2026 2025
Depreciation expense $ 93   $ 97  

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Accumulated Other Comprehensive Income
The following tables summarize the changes in Accumulated other comprehensive income by component, net of tax:

(in millions) Foreign Currency Translation Available-for-Sale Debt Securities Cash Flow Hedges Total
Balance as of December 31, 2025 $ 74   $ 8   $ ( 43 ) $ 39  
Net unrealized (loss) gain, net of income tax expense (benefit) of $ 0 , $( 3 ), and $ 6 , respectively
( 10 ) ( 10 ) 40   20  
(Gain) loss reclassified to net income, net of income tax benefit of $ 0 , $ 0 , and $( 3 ), respectively
—   ( 2 ) 21   19  
Other comprehensive (loss) income, net ( 10 ) ( 12 ) 61   39  
Balance as of March 31, 2026 $ 64   $ ( 3 ) $ 18   $ 78  

(in millions) Foreign Currency Translation Available-for-Sale Debt Securities Cash Flow Hedges Total
Balance as of December 31, 2024 $ 36   $ —   $ 96   $ 132  
Net unrealized gain (loss), net of income tax benefit of $ 0 , $ 0 , and $( 6 ), respectively
18   —   ( 40 ) ( 22 )
Gain reclassified to net income, net of income tax expense of $ 0 , $ 0 , and $ 3 , respectively
—   —   ( 18 ) ( 18 )
Other comprehensive income (loss), net 18   —   ( 58 ) ( 40 )
Balance as of March 31, 2025 $ 54   $ —   $ 38   $ 92  

The following table summarizes the reclassifications out of Accumulated other comprehensive income and into Net income, including the affected line items from our Condensed Consolidated Statements of Operations:

Three Months Ended
March 31,
(in millions) 2026 2025 Line Item Affected
Net (loss) gain related to cash flow hedges $ ( 24 ) $ 21   Product sales
Net gain related to available-for-sale debt securities $ ( 2 ) $ —   Other (income) expense, net
Income tax (benefit) expense $ ( 3 ) $ 3   Income tax expense

Restructuring
During the three months ended March 31, 2026 and 2025, we incurred restructuring charges primarily related to severance costs resulting from reductions in our workforce.
The following table summarizes the affected line items from our Condensed Consolidated Statements of Operations:

Three Months Ended
March 31,
(in millions) 2026 2025
Research and development expenses $ 14   $ 38  
Selling, general and administrative expenses 25   36  
Restructuring charges $ 40   $ 74  

As of March 31, 2026, we had a remaining liability of $ 73 million on our Condensed Consolidated Balance Sheets associated with restructuring charges, a majority of which we anticipate will be paid in the next 12 months.
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Other (Income) Expense, Net
The following table summarizes the components of Other (income) expense, net:

Three Months Ended
March 31,
(in millions) 2026 2025
(Gain) loss from equity securities, net $ ( 142 ) $ 426  
Interest income ( 95 ) ( 94 )
Other, net 2   ( 4 )
Other (income) expense, net $ ( 235 ) $ 328  

9 .     DEBT AND CREDIT FACILITIES
The following table summarizes the carrying amount of our borrowings under various financing arrangements:

(in millions) Carrying Amount
Type of Borrowing Issue Date Maturity Date Interest Rate March 31, 2026 December 31, 2025
Senior Unsecured September 2015 March 2026 3.65 % —   2,750  
Senior Unsecured September 2016 March 2027 2.95 % 1,249   1,249  
Senior Unsecured September 2020 October 2027 1.20 % 749   749  
Senior Unsecured November 2024 November 2029 4.80 % 747   747  
Senior Unsecured September 2020 October 2030 1.65 % 996   996  
Senior Unsecured September 2023 October 2033 5.25 % 994   994  
Senior Unsecured November 2024 June 2035 5.10 % 992   992  
Senior Unsecured September 2015 September 2035 4.60 % 994   994  
Senior Unsecured September 2016 September 2036 4.00 % 744   744  
Senior Unsecured September 2020 October 2040 2.60 % 990   990  
Senior Unsecured December 2011 December 2041 5.65 % 997   997  
Senior Unsecured March 2014 April 2044 4.80 % 1,738   1,738  
Senior Unsecured November 2014 February 2045 4.50 % 1,736   1,736  
Senior Unsecured September 2015 March 2046 4.75 % 2,225   2,225  
Senior Unsecured September 2016 March 2047 4.15 % 1,731   1,731  
Senior Unsecured September 2020 October 2050 2.80 % 1,480   1,480  
Senior Unsecured September 2023 October 2053 5.55 % 989   989  
Senior Unsecured November 2024 November 2054 5.50 % 989   989  
Senior Unsecured November 2024 November 2064 5.60 % 739   739  
Total senior unsecured notes 21,080   23,827  
Liability related to future royalties 1,094   1,110  
Total debt, net 22,174   24,937  
Less: Current portion of long-term debt, net 1,313   2,807  
Total Long-term debt, net $ 20,861   $ 22,129  

Senior Unsecured Notes
We are required to comply with certain covenants under our note indentures governing our senior unsecured notes. As of March 31, 2026, we were not in violation of any covenants. In March 2026, we repaid $ 2.75 billion of principal balance related to our senior unsecured notes due March 2026.
Term Loan Facility
In April 2026, we entered into a term loan facility credit agreement (the “Term Loan Facility”) with a group of institutional lenders to provide for a one-year senior unsecured term loan facility in an aggregate principal amount of $ 4.7 billion. Pursuant to the Term Loan Facility, we borrowed an aggregate principal amount of $ 1.1 billion.
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The Term Loan Facility contains customary representations, warranties, affirmative and negative covenants and events of default. The Term Loan Facility bears interest at either (i) Term SOFR plus the Applicable Margin or (ii) Base Rate plus the Applicable Margin, each as defined in the Term Loan Facility. We may prepay or reduce the amount borrowed under the Term Loan Facility in whole or in part at any time without premium or penalty.
Revolving Credit Facility
As of March 31, 2026 and December 31, 2025, there were no amounts outstanding under our $ 2.5 billion revolving credit facility maturing in June 2029, and we were in compliance with all covenants.

10 .     COMMITMENTS AND CONTINGENCIES
Legal Proceedings
We are a party to various legal actions. Certain significant matters 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 material loss is reasonably possible and the loss or range of loss can be estimated, we disclose the possible loss. Unless otherwise noted, the outcome of these matters either is not expected to be material or is not possible to determine such that we cannot reasonably estimate the maximum potential exposure or the range of possible loss. As of March 31, 2026 and December 31, 2025, we did not have any material accruals for the matters described herein.
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 products 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 prior to 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.
In June 2025, we received a letter from Aspiro Pharma Ltd. (“Aspiro”), indicating that it had submitted an ANDA to FDA to request permission to market and manufacture a generic version of Veklury. Aspiro challenges six of the sixteen patents listed in the Orange Book for Veklury as not valid or not infringed by Aspiro’s proposed ANDA product. In July 2025, we filed a lawsuit against Aspiro in the U.S. District Court of New Jersey. In March 2026, this lawsuit was dismissed after Gilead and Aspiro entered into a settlement agreement, which grants a license to Aspiro to sell a generic version of Veklury starting in May 2041.
In January 2026, we received a letter from Cipla Ltd. (“Cipla”) indicating that it has submitted a new drug application under §505(b)(2) of the Federal Food, Drug, and Cosmetic Act (“505(b)(2) application”) for emtricitabine/tenofovir alafenamide tablets. The 505(b)(2) application references Descovy as the listed drug product. The 505(b)(2) application also includes a paragraph IV certification challenging two Orange Book patents for Descovy. In February 2026, we filed a lawsuit against Cipla in the U.S. District of Court of Delaware. We intend to enforce and defend our intellectual property.
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Antitrust and Consumer Protection
We, along with Bristol-Myers Squibb Company (“BMS”), Johnson & Johnson, Inc. (“Johnson & Johnson”) and Teva Pharmaceutical Industries Ltd. (“Teva”) have been named as defendants in class action lawsuits filed in 2019 and 2020 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 lawsuits, which have been consolidated, are pending in the U.S. District Court for the Northern District of California. The lawsuits seek to bring claims on behalf of direct purchasers consisting largely of wholesalers and indirect or end-payor purchasers, including health insurers and individual patients. Plaintiffs seek damages, permanent injunctive relief and other relief. In the second half of 2021 and first half of 2022, several plaintiffs consisting of retail pharmacies, individual health plans and United Healthcare, filed separate lawsuits effectively opting out of the class action cases, asserting claims that are substantively the same as the classes. These cases have been coordinated with the class actions. In March 2023, the District Court granted our motion to hold separate trials as to (i) the allegations against us and Teva seeking monetary damages relating to Truvada and Atripla (“Phase I”) and (ii) the allegations against us and, in part, Johnson & Johnson, seeking monetary damages and injunctive relief relating to Complera (“Phase II”). In May 2023, we settled claims with the direct purchaser class and the retailer opt-out plaintiffs for $ 525 million, which we paid in the second half of 2023. The settlement agreements are not an admission of liability or fault by us. In June 2023, the jury returned a complete verdict in Gilead’s favor on the remaining plaintiffs’ Phase I allegations. In November 2023, the court denied plaintiffs’ motion to set aside the verdict, and in February 2024, the court entered final judgment on the Phase I verdict and certain summary judgment rulings. In September 2024, plaintiffs filed their opening appellate briefs challenging the Phase I verdict and those summary judgment rulings. We filed our responsive briefs in January 2025. Plaintiffs filed their reply briefs in March 2025. Oral argument took place in October 2025. The court has stayed Phase II pending the appeal of Phase I. While we intend to vigorously oppose the appeal and defend against the Phase II claims, we cannot predict the ultimate outcome. If plaintiffs are successful in their appeal or Phase II claims, we could be required to pay monetary damages or could be subject to permanent injunctive relief in favor of plaintiffs.
In January 2022, we, along with BMS and Janssen Products, L.P., were named as defendants in a lawsuit filed in the Superior Court of the State of California, County of San Mateo, by Aetna, Inc. on behalf of itself and its affiliates and subsidiaries that effectively opts the Aetna plaintiffs out of the above class actions. The allegations are substantively the same as those in the class actions. The Aetna plaintiffs seek damages, permanent injunctive relief and other relief. In March 2024, the court denied our motion for judgment on the pleadings to preclude Aetna from re-litigating claims that were dismissed at summary judgment in the above class action cases. We filed a writ petition appealing the denial of our motion for judgment on the pleadings, which the appellate court denied in May 2024. In April 2024, the court granted our motion to bifurcate the case to adjudicate the issue of preclusion before litigating the merits of the case. In July 2024, Aetna filed a request to voluntarily dismiss two of its claims with prejudice, which the court subsequently granted, leaving only the claims related to Truvada and Atripla. In September 2024, Aetna filed an amended complaint with respect to these claims. In October 2024, we filed a demurrer and motion to strike plaintiff’s claims. In April 2025, the court overruled the demurrer and stated in its order that an immediate appeal is warranted. In June 2025, we filed a writ petition to the Court of Appeal, which was denied in August 2025. Trial has been scheduled for January 2027.
We intend to vigorously defend ourselves in these actions, however, 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 awarded in favor of plaintiffs, which may result in a material, adverse effect on our results of operations and financial condition, including in a particular reporting period in which any such outcome becomes probable and estimable.
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Product Liability
We have been named as a defendant in one putative 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 experience kidney, bone and/or tooth injuries. The lawsuits, which are pending in state or federal court in California and Missouri, involve approximately 23,000 active plaintiffs. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss. The first bellwether trial in California state court was scheduled to begin in October 2022 but is currently stayed pending the conclusion of appellate proceedings in the California Supreme Court. In the California federal case, Gilead agreed to make a one-time payment of approximately $ 39 million to a group of plaintiffs (approximately 2,470 plaintiffs). The federal court set a trial date of March 2027 for the first bellwether trial of the remaining cases. In the putative class action pending in Missouri, the district court issued an order in January 2026 denying, among other things, plaintiffs’ motion for class certification. The U.S. Court of Appeals for the Eighth Circuit then denied Plaintiff’s request for interlocutory appellate review of the district court’s decision to deny class certification. We intend to vigorously defend ourselves in these actions, however, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages, which may result in a material, adverse effect on our results of operations and financial condition, including in a particular reporting period in which any such outcome becomes probable and estimable.
Qui Tam Litigation
A former sales employee filed a qui tam lawsuit against Gilead in March 2017 in U.S. District Court for the Eastern District of Pennsylvania. Following the government’s decision not to intervene in the suit, the case was unsealed in December 2020. The lawsuit alleges that certain of Gilead’s hepatitis C virus (“HCV”) sales and marketing activities and donations to an independent charitable foundation violated the federal False Claims Act and various state false claims acts. The lawsuit seeks all available relief under these statutes. In September 2025, the court granted Gilead’s motion for summary judgment and dismissed the case. Relator has appealed the court’s ruling.
Health Choice Advocates, LLC (“Health Choice”) filed a qui tam lawsuit against Gilead in May 2020 in Texas state court. The lawsuit alleged that Gilead violated the Texas Medicare Fraud Prevention Act (“TMFPA”) through our clinical educator programs for Sovaldi and Harvoni and our HCV and HIV patient support programs. The lawsuit sought all available relief under the TMFPA. Health Choice voluntarily dismissed the case without prejudice in August 2023, and commenced a new action in October 2023, asserting largely identical allegations and claims. In the newly filed action, the Texas Attorney General has intervened as a plaintiff. Trial has been scheduled for December 2026.
We intend to vigorously defend ourselves in these actions, however, we cannot predict the ultimate outcomes. If any of these plaintiffs are successful in their claims, we could be required to pay significant monetary damages, which may result in a material, adverse effect on our results of operations and financial condition, including in a particular reporting period in which any such outcome becomes probable and estimable.
Other Matters
We are a party to various legal actions that arose in the ordinary course of our business. We do not believe that it is probable or reasonably possible that these other legal actions will have a material adverse impact on our consolidated financial position, results of operations or cash flows.

11.      EARNINGS PER SHARE
The following table shows the calculation of Basic and Diluted earnings per share:

  Three Months Ended
March 31,
(in millions, except per share amounts) 2026 2025
Net income $ 2,021   $ 1,315  
Shares used in basic earnings per share calculation 1,242   1,246  
Dilutive effect of equity-based awards 12   13  
Shares used in diluted earnings per share calculation 1,254   1,259  

Basic earnings per share $ 1.63   $ 1.06  
Diluted earnings per share $ 1.61   $ 1.04  

Potential shares of common stock excluded from the computation of Diluted earnings per share because their effect would have been antidilutive were 2  million for the three months ended March 31, 2026 and 2025.
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12.      INCOME TAXES
The following table summarizes our Income tax expense:

Three Months Ended
March 31,
(in millions, except percentages) 2026 2025
Income before income taxes $ 2,580   $ 1,649  
Income tax expense $ 559   $ 334  
Effective tax rate 21.7   % 20.2   %

Our effective income tax rate of 21.7 % for the three months ended March 31, 2026 was generally consistent with the U.S. federal statutory rate of 21%.
Our effective income tax rate of 20.2 % for the three months ended March 31, 2025 differed from the U.S. federal statutory rate of 21% primarily due to tax benefits from stock-based compensation and provision to return adjustments, partially offset by fair value losses on our equity investments that are non-deductible for income tax purposes.

13.     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. See Note 2. Revenues for disaggregation of our revenues by major products and by geography. Our Chief Executive Officer, as the chief operating decision-maker (“CODM”), uses Net income as the primary measure to evaluate performance, allocate resources to the operations of our company on an entity-wide basis and forecast future financial results. Managing and allocating resources on an entity-wide basis enables our CODM to assess the overall level of resources available and how to best deploy these resources across functions and research and development (“R&D”) projects based on unmet medical need, scientific data, probability of technical and regulatory successful development, market potential and other considerations, and, as necessary, reallocate resources among our internal R&D portfolio and external opportunities to best support the long-term growth of our business. Our CODM is regularly provided with entity-wide expense categories similar to those found on our Condensed Consolidated Statements of Operations, as well as the following:

Three Months Ended
March 31,
(in millions) 2026 2025
Selling and marketing expenses $ 898   $ 753  
General and administrative expenses 553   505  
Selling, general and administrative expenses $ 1,451   $ 1,258  

Asset information is not regularly provided to the CODM for assessing performance and allocating resources other than consolidated cash, cash equivalents and marketable debt securities, which can be found on our Condensed Consolidated Balance Sheets.
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Item 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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, 2025 and our unaudited Condensed Consolidated Financial Statements for the three months ended March 31, 2026 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, COVID-19 and cancer. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.
Key Business Updates
The following represents a summary of notable business updates and events since the filing of our Annual Report on Form 10-K for the year ended December 31, 2025, including certain items from our press releases, which readers are encouraged to review in full as 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
• Announced U.S. Food and Drug Administration (“FDA”) accepted New Drug Application for bictegravir and lenacapavir (“BIC/LEN”) for virologically suppressed people with HIV under priority review, with a Prescription Drug User Fee Act (“PDUFA”) date of August 27, 2026.
• Presented late-breaking Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials at the 2026 Conference on Retroviruses and Opportunistic Infections (CROI), evaluating the investigational daily oral single-tablet regimen of BIC/LEN for virologically suppressed people with HIV. BIC/LEN maintained high levels of virologic suppression, demonstrating comparable efficacy to complex regimens and to Biktarvy at Week 48 in people with HIV who switched antiretroviral therapy. These data support global regulatory filings.
Oncology
• Completed the acquisition of Arcellx, Inc. (“Arcellx”) for $115 per share, or an implied equity value of $7.8 billion, and one contingent value right of $5 per share. This acquisition builds on an existing collaboration agreement with Arcellx for the development of anitocabtagene autoleucel (“anito-cel”) in relapsed or refractory (“R/R”) multiple myeloma (“MM”), and also adds Arcellx’s D-Domain BCMA binder that has the potential to strengthen Gilead’s portfolio in oncology and inflammation.
• Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.
• Announced a definitive agreement to acquire Tubulis GmbH (“Tubulis”) a private clinical-stage biotechnology company developing next-generation antibody-drug conjugates (“ADC”), including lead asset TUB-040, a NaPi2b-directed topoisomerase-I inhibitor ADC currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.
• Received FDA full approval for Tecartus in adult patients with R/R mantle cell lymphoma, following an accelerated approval in this setting in July 2020. Tecartus’ label now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor-naïve.
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Inflammation
• Announced a definitive agreement to acquire Ouro Medicines, LLC (“Ouro”), a private clinical-stage biotechnology company developing T cell engager (“TCE”) therapies for autoimmune diseases. This acquisition adds Ouro’s lead asset, OM336 (gamgertamig), a BCMAxCD3 TCE, to Gilead’s portfolio. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. Gilead has entered into a framework agreement with Galapagos NV in relation to this acquisition, which includes equally splitting the $1.675 billion upfront payment and up to $500 million in milestone payments, among other terms.
Key Financial Results
The following table summarizes our key financial results for the period and period-over-period changes:

Three Months Ended
March 31,
(in millions, except percentages and per share amounts) 2026 2025 Change
Total revenues $ 6,960  $ 6,667  4  %
Net income $ 2,021  $ 1,315  54  %
Diluted earnings per share $ 1.61  $ 1.04  54  %

Total revenues increased 4% to $7.0 billion for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Veklury, as well as chronic hepatitis C virus (“HCV”) and Cell Therapy products.
Net income was $2.0 billion and diluted earnings per share was $1.61 for the three months ended March 31, 2026, compared to net income of $1.3 billion and diluted earnings per share of $1.04 for the same period in 2025. The increase was primarily due to:
• Net unrealized gains from equity securities compared to net unrealized losses in 2025;
• Higher product sales; and
• Lower acquired in-process research and development (“IPR&D”) expenses; partially offset by
• Higher income tax expense; and
• Higher selling, general and administrative expenses.
Please refer to “Results of Operations” below for further information on results for the three months ended March 31, 2026.
Outlook Update
As a result of the recent acquisitions completed or announced above, we expect to record related charges of approximately $11.5 billion to Acquired in-process research and development expenses in the second quarter of 2026, which we expect to result in a net loss for the second quarter and full year 2026.
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Results of Operations
Revenues
The following table summarizes our Total revenues and period-over-period changes:

Three Months Ended March 31, 2026 Three Months Ended March 31, 2025
(in millions, except percentages) U.S. Europe Rest of World Total U.S. Europe Rest of World Total Change
Product sales:
HIV
Biktarvy $ 2,573  $ 437  $ 352  $ 3,361  $ 2,474  $ 375  $ 301  $ 3,150  7  %
Descovy 761  23  23  807  538  21  27  586  38  %
Genvoya 215  33  16  264  305  40  19  364  (28) %
Odefsey 153  59  9  221  215  57  10  281  (21) %
Symtuza - Revenue share (1)
107  28  3  138  82  29  3  114  21  %
Yeztugo 158  —  7  166  —  —  —  —  NM
Other HIV (2)
36  27  9  73  50  31  10  91  (20) %
Total HIV 4,004  607  419  5,030  3,664  553  370  4,587  10  %

Liver Disease
Livdelzi 115  18  —  133  40  —  —  40  NM
Sofosbuvir/Velpatasvir (3)
141  60  82  283  166  80  99  346  (18) %
Vemlidy 91  13  132  237  100  12  140  252  (6) %
Other Liver Disease (4)
15  78  21  114  28  76  17  121  (6) %
Total Liver Disease 362  170  235  767  335  168  256  758  1  %

Veklury 112  14  18  144  199  22  82  302  (52) %

Oncology
Cell Therapy
Tecartus 30  37  8  75  40  31  8  78  (4) %
Yescarta 120  146  67  332  160  149  77  386  (14) %
Total Cell Therapy 150  183  74  407  200  180  84  464  (12) %

Trodelvy 253  95  54  402  181  75  37  293  37  %
Total Oncology 403  278  129  810  381  255  121  757  7  %

Other
AmBisome 7  59  72  138  5  67  66  139  (1) %
Other (5)
39  8  11  58  47  9  14  70  (17) %
Total Other 46  67  83  196  52  76  81  209  (6) %
Total product sales 4,926  1,137  883  6,946  4,631  1,073  909  6,613  5  %
Royalty, contract and other revenues —  8  6  14  37  11  6  54  (75) %
Total revenues $ 4,926  $ 1,144  $ 889  $ 6,960  $ 4,668  $ 1,084  $ 915  $ 6,667  4  %

_______________________________
NM - Not Meaningful
(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.
(2)     Includes Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, 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 and Zydelig.
HIV
HIV product sales increased 10% to $5.0 billion for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher demand and average realized price, partially offset by unfavorable inventory dynamics. In particular:
• Biktarvy sales increased 7% primarily due to higher demand, including patients switching from Genvoya and other Gilead HIV products, and average realized price, partially offset by unfavorable inventory dynamics; and
• Descovy sales increased 38% primarily due to higher average realized price and demand.
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Liver Disease
Liver Disease product sales increased 1% to $767 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher demand for Livdelzi, partially offset by unfavorable inventory dynamics and lower sales for HCV products.
Veklury
Veklury product sales decreased 52% to $144 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower rates of COVID-19-related hospitalizations.
Oncology
Cell Therapy
Cell Therapy product sales decreased 12% to $407 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower demand reflecting ongoing competitive headwinds.
Trodelvy
Trodelvy product sales increased 37% to $402 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to higher demand, favorable inventory dynamics and higher average realized price.
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.
Approximat ely 27% and 28% of our product sales were denominated in foreign currencies during the three months ended March 31, 2026 and 2025, respectively. Foreign currency exchange, net of hedges, had a favorable impact on our total product sales of $112 million for the three months ended March 31, 2026, based on a comparison using foreign currency exchange rates from the three months ended March 31, 2025.
Costs and Expenses
The following table summarizes our costs and expenses and period-over-period changes:

Three Months Ended
March 31,
(in millions, except percentages) 2026 2025 Change
Cost of goods sold $ 1,445  $ 1,540  (6) %
Product gross margin 79.2  % 76.7  % 249 bps
Research and development expenses $ 1,372  $ 1,379  (1) %
Acquired in-process research and development expenses $ 107  $ 253  (58) %
Selling, general and administrative expenses $ 1,451  $ 1,258  15  %

Product Gross Margin
Product gross margin increased to 79.2% for the three months ended March 31, 2026, compared to the same period in 2025, primarily driven by the expiration of a royalty-related obligation and product mix.
Research and Development Expenses
Research and development 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 these expenses by identifying the research and development (“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.
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The following table summarizes our Research and development expenses and period-over-period changes:

Three Months Ended
March 31,
(in millions, except percentages) 2026 2025 Change
Personnel, infrastructure and other support costs $ 861  $ 854  1  %
Clinical studies and other costs 510  524  (3) %
Research and development expenses $ 1,372  $ 1,379  (1) %

Research and development expenses remained relatively flat at $1.4 billion for the three months ended March 31, 2026, compared to the same period in 2025. Personnel, infrastructure and other support costs remained relatively flat with higher compensation largely offset by lower restructuring costs. Clinical studies and other costs decreased slightly primarily due to lower oncology clinical study activity, partially offset by higher investment in virology clinical manufacturing.
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 pre-commercialization milestone payments related to various collaborations and the costs of rights to IPR&D projects.
Acquired in-process research and development expenses were $107 million for the three months ended March 31, 2026, primarily related to $80 million associated with the Suzhou Genhouse Bio Co., Ltd. collaboration upfront payment.
Acquired in-process research and development expenses were $253 million for the three months ended March 31, 2025, primarily related to $250 million associated with the LEO Pharma A/S collaboration upfront payment.
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. Also, refer to the “Outlook Update” section above regarding significant Acquired in-process research and development expenses expected for the second quarter of 2026.
Selling, General and Administrative Expenses
Selling, general and administrative expenses are recorded when incurred and consist primarily of personnel costs, facilities and overhead costs, and selling, marketing and advertising expenses, as well as other general and administrative costs related to finance, human resources, legal and other administrative activities.
The following table summarizes our Selling, general and administrative expenses and period-over-period changes:
Three Months Ended
March 31,
(in millions, except percentages) 2026 2025 Change
Selling and marketing expenses $ 898  $ 753  19  %
General and administrative expenses 553  505  9  %
Selling, general and administrative expenses $ 1,451  $ 1,258  15  %

Selling, general and administrative expenses increased 15% to $1.5 billion for the three months ended March 31, 2026, compared to the same period in 2025. Selling and marketing expenses increased primarily due to higher HIV promotional expenses. General and administrative expenses increased primarily due to donations of equity securities made to the Gilead Foundation.
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Interest Expense and Other (Income) Expense, Net
The following table summarizes our Interest expense and Other (income) expense, net and period-over-period changes:

Three Months Ended
March 31,
(in millions, except percentages) 2026 2025 Change
Interest expense $ 240  $ 260  (8) %
Other (income) expense, net $ (235) $ 328  NM
(Gain) loss from equity securities, net $ (142) $ 426  NM
Interest income $ (95) $ (94) 1  %
Other, net $ 2  $ (4) NM

_______________________________
NM - Not Meaningful
Interest expense decreased 8% to $240 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower debt balances.
Favorable movements in Other (income) expense, net for the three months ended March 31, 2026, compared to the same period in 2025, primarily related to net unrealized gains from equity securities compared to net unrealized losses in 2025.
Income Taxes
The following table summarizes our Income tax expense and period-over-period changes:

Three Months Ended
March 31,
(in millions, except percentages) 2026 2025 Change
Income before income taxes $ 2,580  $ 1,649  56  %
Income tax expense $ 559  $ 334  67  %
Effective tax rate 21.7  % 20.2  % 141 bps

Our effective tax rate increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to provision to return adjustments that occurred in the three months ended March 31, 2025.
The Organisation for Economic Co-operation and Development (“OECD”) has developed a framework to implement a global minimum corporate tax of 15% for companies with global revenues and profits above certain thresholds (referred to as “Pillar Two”), with certain aspects effective January 1, 2024 and other aspects effective January 1, 2025. Certain countries in which we operate have enacted Pillar Two legislation, and other countries are in the process of introducing legislation to implement Pillar Two. In January 2026, the OECD announced additional administrative guidance, including a “side-by-side” framework intended to coordinate the application of Pillar Two with existing minimum tax regimes in certain jurisdictions. We do not expect Pillar Two, including the side-by-side framework, to have a material impact on our results of operations, liquidity or capital resources.

Liquidity and Capital Resources
We regularly analyze our ability to generate and obtain adequate amounts of cash to meet our short-term and long-term requirements and plans. Our capital priorities include: (i) investing in our business and R&D pipeline, (ii) continuing select partnerships and business development transactions, (iii) growing our dividend over time and (iv) repurchasing shares to offset dilution and opportunistically reduce share count. Based on our evaluation of our current position of liquidity, available capital resources and our material cash requirements, we believe that we can satisfy our capital needs for the next 12 months and the foreseeable future.
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Liquidity
Cash and cash equivalents were $7.6 billion and marketable debt securities were $997 million as of March 31, 2026. The table below summarizes our cash flow activities, followed by our analysis of changes and trends:

Three Months Ended
March 31,
(in millions, except percentages) 2026 2025 Change
Net cash provided by (used in):
Operating activities $ 2,544  $ 1,757  45  %
Investing activities 1,770  (415) NM
Financing activities (4,239) (3,426) 24  %
Effect of exchange rate changes on cash and cash equivalents (11) 19  NM
Net change in cash and cash equivalents $ 65  $ (2,065) NM

_______________________________
NM - Not Meaningful
Operating Activities
Net cash provided by operating activities is our primary source of funds, driven mainly by collections on product sales, partially offset by operating spend. Changes in working capital balances, generally associated with the timing of collections and payments, as well as unanticipated payments related to litigation, taxes or other matters, may create some variation in any given year. Net cash provided by operating activities increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower income tax payments and lower inventory spend.
Investing Activities
The change in Net cash provided by (used in) investing activities for the three months ended March 31, 2026, compared to the same period in 2025, was primarily due to a partial liquidation of our marketable securities portfolio in 2026. Net cash provided by (used in) investing activities may vary in any given year depending on the favorability of strategic opportunities for the business.
Financing Activities
The change in Net cash used in financing activities for the three months ended March 31, 2026, compared to the same period in 2025, was primarily due to higher debt repayments, partially offset by lower common stock repurchases. Net cash used in financing activities may vary in any given year depending primarily on the timing of debt repayments and proceeds from debt offerings and the amount of common stock repurchases.
In April 2026, we received cash of $1.1 billion related to a borrowing under a term loan facility credit agreement with a group of institutional lenders. 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.
In May 2026, we announced that our Board of Directors declared a quarterly dividend of $0.82 per share of our common stock, with a payment date of June 29, 2026 to all stockholders of record as of the close of business on June 15, 2026. Future dividends are subject to declaration by our Board of Directors.
Capital Resources
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, 2025. Other than as disclosed in the Liquidity section above and in Notes 4. Investments, 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 three months ended March 31, 2026.

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, 2025. 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 three months ended March 31, 2026.
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Information Available on Our Website
Our company website is www.gilead.com. We routinely post important information for investors in the “Investors” section of our website, https://investors.gilead.com. Among other things, an estimate of Acquired IPR&D expenses is expected to be made available on the Quarterly Results page within the first ten days after the end of each quarter. The content on the referenced websites does not constitute a part of and is not incorporated by reference into this Quarterly Report on Form 10-Q.

Item 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Information about our market risk is presented in Part II, Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2025. Other than as disclosed in Notes 3. Fair Value Measurements, 4. Investments, 5. Derivatives and 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, there were no material changes to these disclosures.

Item 4.    CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
An evaluation as of March 31, 2026 was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our “disclosure controls and procedures,” which are defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as controls and other procedures of a company that are designed to ensure that the information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in U.S. Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2026.
Changes in Internal Control over Financial Reporting
Our management, including our Chief Executive Officer and Chief Financial Officer, has evaluated any changes in our internal control over financial reporting during the quarter ended March 31, 2026, to identify any change that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We have an ongoing deployment of a new enterprise resource planning system (“ERP”) as well as other related systems. We have made changes to our internal control over financial reporting to address the related processes and systems. We will continue to evaluate any further changes in our internal control over financial reporting over the course of the implementation of the new ERP and other related systems, which is scheduled to occur in phases over the next few years.
Limitations on the Effectiveness of Controls
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our Chief Executive Officer and Chief Financial Officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.
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PART II.    OTHER INFORMATION

Item 1.      LEGAL PROCEEDINGS
For a description of our significant pending legal proceedings, please see 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.

Item 1A.     RISK FACTORS
In evaluating our business, you should carefully consider the following discussion of material risks, events and uncertainties that make an investment in us speculative or risky in addition to the other information in this Quarterly Report on Form 10-Q. A manifestation of any of the following risks and uncertainties could, in circumstances we may or may not be able to accurately predict, materially and adversely affect our business and operations, growth, reputation (including the commercial or scientific reputation of our products), prospects, product pipeline and sales, operating and financial results, financial condition, cash flows, liquidity and stock price. 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; our operations could also be affected by factors, events or uncertainties that are not presently known to us or that we currently do not consider to present significant risks to our operations. Therefore, you should not consider the following risks to be a complete statement of all the potential risks or uncertainties that we face. Moreover, some of the factors, events and contingencies discussed below may have occurred in the past, but the disclosures below are not representations as to whether or not the factors, events or contingencies have occurred in the past, and instead reflect our beliefs and opinions as to the factors, events or contingencies that could materially and adversely affect us in the future.
Product and Commercialization Risks
Certain of our products subject us to additional or heightened risks.
HIV
We receive a substantial portion of our revenue from sales of our products for the treatment and prevention of HIV infection. We may be unable to sustain or increase sales of our HIV products for any number of reasons, including market share gains by competitive products, including generics, or the inability to introduce new HIV medications necessary to remain competitive. In such case, we may need to scale back our operations, including our future drug development and spending on research and development (“R&D”) efforts.
Cell Therapy
Advancing a novel and personalized therapy, such as Yescarta or Tecartus, which are chimeric antigen receptor (“CAR”) T-cell therapies, creates significant challenges, including:
• developing and maintaining a robust and reliable process for engineering a patient’s T cells in our facilities and infusing them back into the patient;
• conditioning patients with chemotherapy in advance of administering our therapy, which may increase the risk of adverse side effects; and
• securing sufficient supply of other medications to manage side effects, such as tocilizumab and corticosteroids, which may not be available in sufficient quantities, may not adequately control the side effects and/or may have detrimental impacts on the efficacy of cell therapy.
In addition, future cell therapy products may be subject to a Risk Evaluation and Mitigation Strategy (“REMS”), which is a drug safety program that the U.S. Food and Drug Administration (“FDA”) may require for certain drugs. For example, until June 2025, Yescarta and Tecartus were subject to a REMS requirement to manage the risks of cytokine release syndrome and neurologic toxicities, which required a certification process for hospitals and clinics that dispense the products.
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. For example, in January 2024, FDA instituted a class labeling change for all approved CAR T-cell therapies, including a “boxed warning” about the possible risk of secondary T-cell malignancies in patients treated with CAR T-cell therapy. For challenges related to the reimbursement of Yescarta and Tecartus, see also “ Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.”
We rely on third-party sites to collect patients’ white blood cells, known as apheresis centers, as well as shippers, couriers, and hospitals for the logistical collection of patients’ white blood cells and ultimate delivery of Yescarta and Tecartus to patients. Disruptions or difficulties at these vendors could result in product loss and regulatory action. Apheresis centers may
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also decline to participate in our quality certification process, or we may be unable to complete such certification in a timely manner or at all, which could delay or constrain our manufacturing and commercialization efforts.
We also face risks related to our in-house CAR T-cell therapy manufacturing facilities in California, Maryland and the Netherlands, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. Quality, reliability and speed are critical in cell therapy manufacturing to quickly and safely deliver our cell therapies to patients. Any delays or quality issues with our manufacturing operations could adversely affect our business and damage our reputation. In addition, we may not be able to sufficiently increase manufacturing network capacity to meet growing demand.
Our success depends on developing and commercializing new products or expanding the indications for existing products.
If we are unable to launch commercially successful new products or new indications for existing products, including approval for earlier lines of therapy, our business will be adversely impacted. The launch of commercially successful products is necessary to grow our business, cover our substantial R&D expenses, and offset revenue losses when existing products lose market share due to factors such as competition and loss of patent exclusivity. 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 as well as on preparations for potential commercial launch without any assurance that we will 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. Such failures have had, and may have in the future, a negative impact on our business and financial results, including as a result of our inability to recover R&D, clinical trial, acquisition-related and other expenses incurred in connection with the development of and launch preparations for our product candidates. For example, we enter into commitments to purchase materials and supplies in anticipation of the potential manufacture and sale of new product candidates, and if the development, approval or launch of these product candidates is delayed or otherwise unsuccessful, we may experience excess inventory that needs to be written down, losses on firm commitments to purchase inventory, or other related costs and expenses resulting from such commitments.
Additionally, we face public attention and scrutiny related to the complex decisions we make concerning the pricing, global supply and distribution, allocation and intellectual property of our commercialized products as well as other factors that may contribute to patient access to our medicines, all of which may adversely affect our business and our corporate reputation.
We face challenges in accurately forecasting sales because of the difficulties in predicting demand for our products and fluctuations in purchasing patterns or wholesaler inventories.
We may be unable to accurately predict demand for our products as demand depends on a number of factors. If we do not accurately forecast demand or manufacture products at levels to align with actual demand, then we may experience product shortages or build excess inventory that may need to be written off. For example, product demand may be adversely affected if physicians do not see the benefit of our products. Additionally, uptake of new products may not materialize as expected, or at all in the case of unsuccessful product candidates. For example, Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccines and alternative treatments for COVID-19, and future sales remain uncertain.
Additionally, the non-retail sector in the U.S., which includes government institutions such as state AIDS Drug Assistance Programs (“ADAPs”), the U.S. Department of Veterans Affairs, correctional facilities and large health maintenance organizations, tends to exhibit less predictable purchasing patterns, which results in quarter-over-quarter fluctuations that do not mirror actual patient demand for our products. Federal and state budget pressures, as well as the annual grant cycles for federal and state funds, may continue to contribute to variability in purchasing patterns. For example, in March 2026, the Florida ADAP implemented certain cost-containment measures, including removing Biktarvy from the formulary and imposing additional restrictions on access to Descovy. Other state ADAPs may also implement similar measures, including restricting eligibility and using waiting lists, which could adversely impact patient access and product sales. We expect to continue to experience fluctuations in the purchasing patterns of our non-retail customers. We have also observed variability in purchasing patterns in Europe as a result of cost containment measures in response to budgetary pressures. We believe these measures have caused some government agencies and other purchasers to reduce inventory of our products in the distribution channels, and we may continue to see this trend in the future.
We sell and distribute most of our products in the U.S. exclusively through the wholesaler/distributor channel. Historically, approximately 90% of our gross product sales in the U.S. have been to three wholesalers—Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation—and their specialty distributor affiliates. The U.S. wholesalers and distributors with whom we have entered into inventory management agreements make estimates to determine end-user demand and may not be accurate in matching their inventory levels to actual end-user demand. As a result, changes in inventory levels held by those wholesalers and distributors can cause our operating results to fluctuate unexpectedly if our sales to these wholesalers and
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distributors do not match end-user demand. In addition, inventory is held at retail and specialty pharmacies and other non-wholesaler/distributor 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 and specialty pharmacies to reduce their inventories of our products, which would reduce their orders from wholesalers and distributors and, consequently, the wholesalers’ and distributors’ orders from us, even if end-user demand has not changed. In addition, we have observed that strong wholesaler/distributor and sub-wholesaler/distributor purchases of our products in the second half of the year typically results in inventory draw-down by wholesalers/distributors and sub-wholesalers/distributors in the subsequent first 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.
We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.
New branded or generic products entering major markets affect our ability to maintain pricing and market share. 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. A number of companies, including large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies, are pursuing the development of products and technologies that may be competitive with our existing products or research programs. Furthermore, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection or may establish collaborative arrangements for competitive products or programs. We may be adversely impacted if any of these competitors gain market share as a result of new technologies, commercialization strategies or otherwise.
Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.
Successful commercialization of our products depends, in part, on the availability and amount of third-party payer reimbursement for our products and related treatments and medical services in the markets where we sell our products. As our products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices.
Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently. We may be adversely impacted by any such legislative and regulatory actions, though it is difficult to predict the impact, if any, on the use and reimbursement of our products.
In the U.S., the European Union (“EU”) 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. The volume of drug pricing-related legislation and administrative action has dramatically increased in recent years, including:
• U.S. Congress has enacted the Inflation Reduction Act of 2022 (“IRA”), which, among other changes, (1) requires the Department of Health and Human Services to “negotiate” Medicare prices for certain drugs (starting with 10 drugs in 2026, adding 15 drugs in 2027 and 2028, and adding 20 drugs in 2029 and subsequent years), which could also affect the Medicaid rebate obligations and the ceiling prices charged to covered entities under Section 340B of the Public Health Service Act (“340B”) if such prices are lower than the Medicaid Best Price and reduce the Average Sales Price and associated Medicare reimbursement rate for products reimbursed under Medicare Part B; (2) imposes an inflation-based rebate on Medicare Part B utilization starting in 2023 and Part D utilization beginning October 1, 2022; and (3) restructures the Medicare Part D benefit to cap out-of-pocket expenses for Part D beneficiaries beginning in 2024 and, effective January 1, 2025, increases Part D plans’ contributions in the catastrophic coverage phase and increases manufacturers’ discount contributions across coverage phases such that manufacturers must pay a 10% discount in the initial coverage phase and a 20% discount in the catastrophic phase on drugs utilized by all Part D beneficiaries, including low income subsidy patients. In January 2026, the Department of Health and Human Services selected Biktarvy for Maximum Fair Price determination under Medicaid, effective beginning in 2028, and more of our products may be selected in the future. We continue to evaluate the potential impact of the IRA on our business, but we anticipate that the negotiated Medicare price will be substantially lower than the price we currently charge in Medicare and may also lead to increased rebates to Medicaid agencies and potentially other segments and reduced ceiling prices charged to 340B covered entities. The Centers for Medicare and Medicaid Services (“CMS”) has issued a number of guidance documents and regulations governing certain aspects of the IRA, but it remains unclear how certain provisions of the IRA are being implemented due to lack of full transparency. Additional guidance, legislation or rulemaking may be issued that could change the scope or implementation of the IRA. In addition, multiple manufacturers and trade organizations have challenged the Medicare negotiation provisions of the IRA, and additional legal challenges may be filed in the future. While the full impact of the IRA on our business and the pharmaceutical
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industry remains uncertain at this time, we anticipate that the IRA will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.
• In July 2025, U.S. Congress enacted the One Big Beautiful Bill (“OBBB”) Act, which made several changes to the Medicaid program, such as imposing Medicaid work requirements and stricter eligibility and enrollment standards. Most of these policies will take effect in 2027. In addition, as of the end of 2025, enhanced subsidies for patient premiums are no longer available for Affordable Care Act (“ACA”) health insurance exchange plans, which has already contributed, and may continue to contribute, to decreases in patient enrollment in ACA exchange plans. These changes to Medicaid and ACA plans, individually or in combination, have reduced, and may continue to decrease, health insurance coverage for patients taking our medicines, potentially disrupting access to our medicines for some individuals and adversely impacting our financial results.
• The current U.S. Presidential administration has indicated that it plans to pursue additional policies aimed at lowering prescription drug costs. The administration has issued multiple executive orders and statements that illustrate the intent to require pharmaceutical manufacturers to offer U.S. prices based on most-favored-nation (“MFN”) lowest prices and that direct specified agency heads to take certain actions if significant progress towards such MFN prices is not achieved. In July 2025, the President sent letters to Gilead and other pharmaceutical manufacturers outlining the steps the President believes pharmaceutical manufacturers must take to bring down the prices of prescription drugs in the U.S. to match the MFN price offered in other developed nations. In December 2025, Gilead reached an agreement with the administration to (1) exclude Gilead branded pharmaceutical products and associated pharmaceutical ingredients from tariffs under Section 232 of the Trade Expansion Act of 1962, as amended (“Section 232”), for three years, provided Gilead further invests in manufacturing in the United States, (2) implement MFN prices in Medicaid for select existing products through the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model and MFN prices in the U.S. market for future launched products, (3) set a new direct-to-patient price for Epclusa and (4) return a portion of increased international revenues to the U.S. if the U.S. government is successful in increasing drug prices abroad. In addition, the administration announced several demonstration projects that would implement MFN pricing for certain Medicare Part B and Part D drugs through manufacturer inflation rebates on utilization by a portion of Medicare enrollees. The administration also recently called on Congress to enact legislation codifying MFN pricing. The specifics of these proposals and policies are evolving, and as a result, there is uncertainty as to how these and other potential legal and regulatory changes may impact our business.
• In April 2025, the U.S. Department of Commerce initiated an investigation pursuant to Section 232 to assess whether imports of pharmaceuticals and pharmaceutical ingredients into the United States pose a national security risk. Following this investigation, in April 2026, the U.S. President issued a Proclamation imposing 100% tariffs on patented pharmaceutical products and associated pharmaceutical ingredients, with such tariffs expected to take effect in the second half of 2026. The impact on Gilead remains uncertain at this time because the imposition of tariffs is subject to certain exemptions, as well as potential modifications to timing, scope and duration, and could be affected by broader tariffs and trade actions both within and outside the pharmaceutical industry. Even if it is determined that Gilead currently qualifies for an exemption, there can be no assurance that these or other tariffs will not apply to us in the future. Any such tariffs and related trade actions could increase our manufacturing costs, disrupt our supply chain and adversely affect our business competitiveness.
• Actions by the current U.S. Presidential administration to reorganize federal health agencies or reduce or pause funding for domestic and international HIV treatment and prevention programs and grants may adversely impact our business. Some of these initiatives may be subject to litigation or other challenge, increasing the uncertainty of their effects on our business.
• Many state legislatures are considering, or have already enacted, legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing, such as requiring manufacturers to publicly report proprietary pricing information, creating drug affordability review boards, establishing drug payment limits, and encouraging the use of generic drugs. A finding that one of our products is unaffordable could lead to legislative action to designate an upper limit on the amount certain purchasers and payors can pay for our products. These initiatives and such other legislation may cause added pricing pressures on our products, and the resulting impact on our business is uncertain at this time.
• Many countries outside the U.S., including the EU member states, have established complex and lengthy procedures to obtain price approvals and coverage reimbursement and periodically review their pricing and reimbursement decisions. The outcome of these reviews is unpredictable and may adversely affect the pricing and reimbursement of our medical products in the EU. Price reductions in one EU member state could affect pricing in other member states, or in the U.S. pursuant to MFN pricing initiatives, and negatively impact our financial results.
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A substantial portion of our product sales is subject to significant discounts from list price, including rebates that we may be required to pay state Medicaid agencies and discounts provided to covered entities under 340B. Changes to the 340B program or the Medicaid program at the federal or state level could have a material adverse effect on our business. For example, changes to the calculation of rebates under the Medicaid program could substantially increase our Medicaid rebate obligations and decrease the prices we charge 340B-covered entities. In addition, the continued growth of the 340B program has had the unintended consequence of an increasingly out of scope percentage of sales at deeply discounted 340B prices due, in part, to pervasive violations of the program’s diversion and duplicate discount prohibitions. Detecting and remedying these program integrity violations is challenging.
In March 2022, we implemented a contract pharmacy integrity initiative for our branded hepatitis C virus (“HCV”) products. This integrity initiative does not involve any products from Asegua Therapeutics LLC. Our integrity initiative requires covered entities that enter into 340B bill to/ship to arrangements with contract pharmacies for our branded HCV products to provide claims level data for units dispensed from such contract pharmacies; covered entities without an in-house pharmacy that choose not to participate in the initiative can designate a single contract pharmacy for shipment. Certain manufacturers that have implemented other contract pharmacy integrity programs have received enforcement letters from the U.S. Department of Health and Human Services (“HHS”) asserting that those programs violate the 340B statute, have been referred to the HHS Office of Inspector General for assessment of civil monetary penalties, and have been subject to administrative dispute resolution proceedings brought on behalf of covered entities. Some of these manufacturers are challenging HHS’s position in litigation. The U.S. Courts of Appeals for the Third Circuit and the District of Columbia Circuit have held that HHS’s enforcement actions are unlawful, and a decision by the U.S. Court of Appeals for the Seventh Circuit is pending. A growing number of states have also enacted laws requiring manufacturers to provide 340B pricing through contract pharmacy arrangements, and additional states may adopt similar laws; we believe these laws, which are being challenged in ongoing litigation, are invalid but we have carved out covered entities in certain states from our integrity initiative while litigation challenging these laws proceeds. We also believe that our integrity initiative complies with the requirements of the 340B statute. However, additional legal or legislative developments with respect to the 340B program, including potential litigation with HHS or other stakeholders, may negatively impact our ability to implement or continue our integrity initiative.
In addition, standard reimbursement structures do not always adequately reimburse for innovative therapies. For example, CMS established a severity-adjusted diagnosis-related group (“DRG”) 018 for Medicare inpatient reimbursement of CAR T-cell products such as Yescarta and Tecartus. While the DRG has a significantly higher base payment amount than the prior DRG 016, the payment available may not be sufficient to reimburse some hospitals for their cost of care for patients receiving Yescarta and Tecartus. When reimbursement is not aligned well to account for treatment costs, Medicare beneficiaries may be denied access as this misalignment could impact the willingness of some hospitals to offer the therapy and of doctors to recommend the therapy. Additionally, in the EU, there are barriers to reimbursement in individual countries that could limit the uptake of Yescarta and Tecartus.
Moreover, 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 U.S., actual rebate claims are typically made by payers one to three quarters in arrears. Actual claims and payments may vary significantly from our estimates.
We may experience adverse impacts resulting from the importation of our products from lower price markets or the distribution of illegally diverted or counterfeit versions of our products.
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 and resold into those countries from lower price markets. For example, in January 2024, FDA authorized Florida’s proposed program to import prescription drugs from Canada, subject to additional requirements, and U.S. sales may be adversely affected if Florida or other jurisdictions are able to implement such programs under the applicable regulatory framework. We have entered into agreements with generic drug manufacturers as well as licensing agreements with the Medicines Patent Pool, a United Nations-backed public health organization, which allow generic drug manufacturers to manufacture generic versions of certain of our products for distribution in certain low- and middle-income countries. We may be adversely affected if any generic versions of our products, whether or not produced and/or distributed under these agreements, are exported to the U.S., the EU or markets with higher prices.
In the EU, we are required to permit products purchased in one EU member state to be sold in another member state. Purchases of our products in member states where our selling prices are relatively low for resale in member states 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.
Additionally, diverted products may be used in countries where they have not been approved and patients may source the diverted products outside the legitimate supply chain. These diverted products may be handled, shipped and stored improperly, which may adversely affect the quality and/or efficacy of the products and could harm patients and adversely impact us.
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We are also aware of the existence of various suppliers around the world that, without Gilead’s authorization, purport to source our products and generic versions of our products and sell them for use in countries where those products have not been approved. As a result, patients may be at risk of taking unapproved medications that may not be what they purport to be, may not have the potency they claim to have or may contain harmful substances, which could harm patients and adversely impact us.
Further, third parties have illegally distributed and sold, and may continue to illegally distribute and sell, illegally diverted and counterfeit versions of our medicines, which do not meet the rigorous quality standards of our manufacturing and supply chain. For example, as part of a U.S. civil enforcement lawsuit, we seized thousands of bottles of Gilead-labeled medication with counterfeit supply chain documentation. Our investigation revealed that unauthorized pharmaceutical distributors sold counterfeit Gilead medicine to independent pharmacies nationwide.
Illegally diverted and counterfeit versions of Gilead-branded medicines exist and may pose a serious risk to patient health and safety. Our actions to stop or prevent the distribution and sale of illegally diverted and counterfeit versions of our medicines around the world may be costly and unsuccessful, which may adversely affect patients and our reputation and business, including our product revenues and financial results.
Product Development and Supply Chain Risks
We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.
We are required to demonstrate the safety and efficacy of product candidates that we develop for each intended use through extensive preclinical studies and clinical trials. The results from these 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.
We face numerous risks and uncertainties with our clinical trials that could result in delays or prevent completion of the development and approval of our product candidates, including challenges in clinical trial protocol design, our ability to enroll patients in clinical trials, the possibility of unfavorable or inadequate trial results to support further development of our product candidates, including failure to meet a trial’s primary endpoint, safety issues arising from our clinical trials, and the need to modify or delay our clinical trials or to perform additional trials. For example, in January 2024, we announced that our Phase 3 EVOKE-01 study evaluating sacituzumab govitecan-hziy (“SG”) did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer (“NSCLC”), which resulted in us recording an impairment charge during the three months ended March 31, 2024 (for more information, see Note 7. Intangible Assets of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q). In November 2025, we also announced that our Phase 3 ASCENT-07 study evaluating SG as a first-line treatment post-endocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) metastatic breast cancer patients did not meet the primary endpoint of progression-free survival. While this information did not result in an impairment of the associated finite-lived intangible asset related to Trodelvy, potential future adverse changes in estimated Trodelvy revenues could negatively impact our results of operations and result in impairment charges in future periods.
As a result, we may be unable to successfully complete our clinical trials on our anticipated timelines, or at all. Based on trial results, it is possible that FDA and other regulatory authorities do not approve our product candidates, or that any market approvals include significant limitations on the products’ use. Additionally, products and indications approved under accelerated approval pathways may be subject to withdrawal where confirmatory studies are unsuccessful. In addition, clinical trials involving our commercial products can raise new safety issues for our existing products, which could adversely impact our business. Further, we have in the past and we may in the future make a strategic decision to discontinue development of our product candidates, including but not limited to situations where we believe commercialization will be difficult relative to other opportunities in our pipeline. Therefore, our product candidates may never be successfully commercialized, and we may be unable to recoup the significant R&D, clinical trial, acquisition-related and other expenses incurred. We expect to spend significant time and resources on our clinical trial activities without any assurance that we will recoup our investments or that our efforts will be commercially successful.
There are also risks associated with the use of third parties in our clinical trial activities. We extensively outsource our clinical trial activities and usually perform only a small portion of the start-up activities in-house. We rely on 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 bioanalysis. Many important aspects of the services performed for us by the CROs are not within our direct control. If there is any dispute or disruption in our relationships with our CROs, including as a result of legislative or regulatory actions (such as the recently enacted BIOSECURE Act in the U.S.), our clinical trials and regulatory submissions may be delayed and our costs may increase. Moreover, in our regulatory submissions, we rely on the quality and validity of the clinical work performed by our CROs and investigators at the clinical trial sites. If any of their processes, methodologies or results were determined to be invalid, inadequate or in violation of Good Clinical Practices and related regulations, our own clinical data and results and related regulatory approvals may be adversely affected.
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We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, or we may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners, which could limit our ability to generate revenues.
We need access to certain materials and supplies to conduct our clinical trials and to manufacture and sell our products. If we are unable to purchase enough of these materials and supplies or find suitable alternatives in a timely manner, our development efforts for our product candidates may be delayed or our ability to manufacture and sell our products could be limited.
Suppliers of key components and materials must be named in the new drug/biologics application or marketing authorization application filed with 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. Our products, which are manufactured and tested at our own facilities or by third-party contract manufacturing organizations (“CMOs”), third-party contract testing laboratories (“CTLs”) and corporate partners, are the result of complex, highly regulated manufacturing processes. We depend on CMOs, CTLs and corporate partners to perform manufacturing and testing activities effectively and on a timely basis for the majority of our active pharmaceutical ingredients and drug products. These third parties are independent entities subject to their own unique operational and financial risks that are out of our control. Some of our products and the materials that we utilize in our operations are manufactured and/or tested by only one supplier or at only one facility, which we may not be able to replace in a timely manner and on commercially reasonable terms, or at all. We and our CMOs, CTLs and corporate partners are subject to current Good Manufacturing Practices (“cGMP”), which are extensive regulations governing manufacturing processes, release and stability testing, recordkeeping and quality standards as defined by FDA and European Medicines Agency (“EMA”), as well as comparable regulations in other jurisdictions. Manufacturing operations are also subject to routine inspections by regulatory agencies. Even after a supplier is qualified by the regulatory authority, the supplier must continue to expend time, money and effort in the area of production and quality control to maintain full compliance with cGMP. 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. There can be no assurance that we or our CMOs, CTLs or other corporate partners will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections. 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.
A significant portion of the raw materials and intermediates in the manufacturing of our products and product candidates are supplied by third-party suppliers, manufacturers and corporate partners outside of the U.S. As a result, any geopolitical or economic factors in a specific country or region, including any new, or changes in or interpretations of existing law, trade regulations, or compliance requirements (such as the recently enacted BIOSECURE Act) or tax that would limit or prevent third parties outside of the U.S. from supplying these materials could adversely affect our ability to manufacture and supply our products to meet market needs and have a material and adverse effect on our operating results. Such factors may also negatively impact our ability to supply our clinical trials and commercial product, which may result in the delay of our clinical trials and regulatory submissions, and could lead to regulatory delays, increased costs, and/or lost revenue.
Any adverse developments affecting or resulting from any single entity within our manufacturing operations or the operations of our CMOs, CTLs and corporate partners can result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the development and commercial supply of our products, which may result in us not being able to generate sufficient quantities of clinical or commercial product to meet market demand and may cause delays in our clinical trials and applications for regulatory approval. We have incurred, and will continue to incur, inventory write-off charges and other expenses for products that fail to meet specifications and quality standards as well as changes we may adopt in our manufacturing strategy, and we may need to undertake costly remediation efforts or seek more costly manufacturing alternatives. Such developments could increase our manufacturing costs, cause us to lose revenues or market share and damage our reputation. Our business may be adversely affected if approval of any of our product candidates were delayed or if production of our products were interrupted.
Regulatory and Other Legal Risks
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, including if significant safety issues arise for our marketed products or our product candidates, 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, EMA and comparable regulatory agencies in other countries. We have filed, and anticipate that we will continue to file, for marketing approval in additional countries and for additional indications and products. These and any future marketing applications we file may not be approved by the regulatory authorities on a timely basis, or at all, and changes or disruptions at FDA or other regulatory agencies, including as a result of budget cuts and
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