Zimberelimab

Product Sales Excluding Veklury Increased 4% Year-Over-Year to $7.1 billion Biktarvy Sales Increased 6% Year-Over-Year to $3.7 billion FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its third quarter 2025 results of operations. “We continue to deliver on Gilead's robust portfolio with a strong start for Yeztugo, rapidly growing uptake of Biktarvy, Descovy and Livdelzi, and positive data for Trodelvy in 1L metastatic triple negative breast cancer,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “With multiple potential product launches in 2026, the strongest clinical pipeline in Gilead’s history, and no major loss of exclusivity expected until 2036, we are well-positioned to drive positive impact for patients and continued growth of our business.” Third Quarter 2025 Financial Results Total third quarter 2025 revenues increased 3% to $7.8 billion compared to the same period in 2024, broken down as follows: Total third quarter 2025 product sales decreased 2% to $7.3 billion compared to the same period in 2024, primarily driven by lower Veklury® (remdesivir) and Cell Therapy sales, partially offset by higher HIV and Livdelzi® (seladelpar) sales. Total third quarter 2025 royalty, contract and other revenues increased by approximately $400 million compared to the same period in 2024, primarily driven by revenue related to a previous sale of intellectual property not expected to reoccur. Diluted earnings per share (“EPS”) was $2.43 in the third quarter 2025 compared to $1.00 in the same period in 2024. The increase was primarily driven by a prior year pre-tax in-process research and development (“IPR&D”) impairment charge of $1.75 billion that did not repeat in the current period, as well as the $400 million increase in other revenue mentioned above, lower acquired IPR&D expenses and higher net unrealized gains on equity investments in the current period, partially offset by higher tax expense. Non-GAAP diluted EPS of $2.47 in the third quarter 2025 compared to $2.02 in the same period in 2024. The increase was primarily driven by the $400 million increase in other revenue mentioned above and lower acquired IPR&D expenses. As of September 30, 2025, Gilead had $9.4 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024. During the third quarter 2025, Gilead generated $4.1 billion in operating cash flow. During the third quarter 2025, Gilead paid dividends of $1.0 billion and repurchased $435 million of common stock. Total third quarter 2025 product sales decreased 2% to $7.3 billion compared to the same period in 2024, primarily driven by lower Veklury® (remdesivir) and Cell Therapy sales, partially offset by higher HIV and Livdelzi® (seladelpar) sales. Total third quarter 2025 royalty, contract and other revenues increased by approximately $400 million compared to the same period in 2024, primarily driven by revenue related to a previous sale of intellectual property not expected to reoccur. Third Quarter 2025 Product Sales Total third quarter 2025 product sales decreased 2% to $7.3 billion compared to the same period in 2024. Total third quarter 2025 product sales excluding Veklury increased 4% to $7.1 billion compared to the same period in 2024, primarily due to higher HIV and Livdelzi sales, partially offset by lower Cell Therapy sales. HIV product sales increased 4% to $5.3 billion in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price. Biktarvy®(bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 6% to $3.7 billion in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price. Descovy®(FTC 200mg/TAF 25mg) sales increased 20% to $701 million in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand. The Liver Disease portfolio sales increased 12% to $819 million in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand for Livdelzi. Veklury sales decreased 60% to $277 millionin the third quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations. Cell Therapy product sales decreased 11% to $432 million in the third quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds. Yescarta® (axicabtagene ciloleucel) sales decreased 10% to $349 million in the third quarter 2025 compared to the same period in 2024, primarily driven by lower demand. Tecartus® (brexucabtagene autoleucel) sales decreased 15% to $83 million in the third quarter 2025 compared to the same period in 2024, primarily reflecting lower demand. Trodelvy® (sacituzumab govitecan-hziy) sales increased 7% to $357 million in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand. Third Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin remained relatively flat at 78.6% in the third quarter 2025 compared to 79.1% in the same period in 2024. Non-GAAP product gross margin also remained relatively flat at 86.5% in the third quarter 2025 compared to 86.8% in the same period in 2024. Research and development (“R&D”) expenses and non-GAAP R&D expenses were $1.3 billion in the third quarter 2025 compared to $1.4 billion in the same period in 2024, decreasing primarily due to lower study-related and clinical manufacturing expenses. Acquired IPR&D expenses were $170 million in the third quarter 2025, primarily related to a $120 million upfront payment related to our collaboration with Shenzhen Pregene Biopharma Co., Ltd. (“Pregene”). Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses of $1.4 billion in the third quarter 2025 remained relatively flat compared to the same period in 2024, with lower corporate expenses being largely offset by higher HIV promotional expenses. The effective tax rate (“ETR”) was 16.2% in the third quarter 2025 compared to (31.1)% in the same period in 2024, primarily driven by the prior year impact of a legal entity restructuring and the aforementioned IPR&D impairment charge that did not repeat in the current period. The non-GAAP ETR was 17.5% in both the third quarter 2025 and the same period in 2024. Guidance and Outlook For the full-year, Gilead expects: (in millions, except per share amounts) October 30, 2025 Guidance Low End High End Comparison to Prior Guidance Product sales $ 28,400 $ 28,700 Previously $28,300 to $28,700 Product sales excluding Veklury $ 27,400 $ 27,700 Previously $27,300 to $27,700 Veklury $ 1,000 $ 1,000 Unchanged Diluted EPS $ 6.65 $ 6.85 Previously $5.85 to $6.15 Non-GAAP diluted EPS $ 8.05 $ 8.25 Previously $7.95 to $8.25 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Announced settlement agreements to resolve Biktarvy patent litigation with generic manufacturers Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd. Under the agreements, the earliest date the three generic manufacturers can market a generic version of full dose Biktarvy in the U.S. is April 1, 2036, subject to standard acceleration provisions. This is more than two years later than our previous loss of exclusivity projection for Biktarvy (December 2033). Received a strong recommendation for the use of twice-yearly injectable Yeztugo® (lenacapavir) for HIV pre-exposure prophylaxis (“PrEP”) in the new U.S. Centers for Disease Control and Prevention guidelines. Announced a partnership with the U.S. State Department and the U.S. President’s Emergency Plan for AIDS Relief (“PEPFAR”) to deliver lenacapavir for HIV PrEP for up to two million people over three years in countries supported by both PEPFAR and the Global Fund. Received European Commission marketing authorization for Yeytuo® (lenacapavir) for use as PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. Oncology Presented Phase 3 ASCENT-03 data for Trodelvy® in 1L metastatic triple-negative breast cancer (“mTNBC”) patients who are not candidates for PD-1/PD-L1 checkpoint inhibitors at the 2025 European Society for Medical Oncology (“ESMO”) Congress. Trodelvy is not approved in this setting. Presented overall survival results at ESMO from Arm A1 of the Phase 2 EDGE-Gastric study evaluating combination treatment of the Fc-silent anti-TIGIT domvanalimab plus the anti-PD-1 zimberelimab and chemo in people with advanced gastric or esophageal cancer that has spread or cannot be removed with surgery. Domvanalimab and zimberelimab are investigational and not approved in this setting. Cell Therapy Announced the acquisition of Interius BioTherapeutics, Inc. (“Interius”), a privately held biotechnology company developing in vivo therapeutics. Corporate The Board declared a quarterly dividend of $0.79 per share of common stock for the fourth quarter of 2025. The dividend is payable on December 30, 2025, to stockholders of record at the close of business on December 15, 2025. Future dividends will be subject to Board approval. Moody’s has affirmed Gilead’s A3 senior unsecured rating and upgraded the company’s outlook to positive from stable, citing the momentum in the product pipeline. Announced ground-breaking on a new Pharmaceutical Development and Manufacturing Technical Development Center in Foster City, California as part of a planned $32 billion investment in the U.S. through 2030. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with such exclusions as well as changes in tax-related laws and guidelines, transfers of intangible assets between certain legal entities, and legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation.Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. 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. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its full year 2025 financial guidance, including as a result of the uncertainty of the amount and timing of Veklury revenues, the impact of the Inflation Reduction Act, changes in U.S. regulatory or legislative policies, and changes in U.S. trade policies, including tariffs; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the acquisitions of Interius, and the arrangements with Pregene and PEPFAR; the risk that Gilead’s U.S. manufacturing and R&D investment may not achieve their intended benefits; patent protection and estimated loss of exclusivity for our products and product candidates, including with respect to Biktarvy; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Trodelvy, domvanalimab and zimberelimab (such as the ASCENT-03, and EDGE-Gastric studies), and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to resolve the issues cited by the FDA in pending clinical holds to the satisfaction of the FDA and the risk that FDA may not remove such clinical holds, in whole or in part, in a timely manner or at all; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, including for additional approvals for lenacapavir for HIV PrEP, and the risk that any such approvals, if granted, may be subject to significant limitations on use and may be subject to withdrawal or other adverse actions by the applicable regulatory authority; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies and may therefore be reluctant to prescribe the products, including Yeztugo/Yeytuo; Gilead’s ability to effectively manage the access strategy relating to lenacapavir for HIV PrEP, subject to necessary regulatory approvals; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended September 30, 2025 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Additional information is available on our Investor Relations 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 (10) days after the end of each quarter. Gilead owns or has rights to various trademarks, copyrights and trade names used in its 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®, LIVDELZI®/LYVDELZI®, LETAIRIS®, 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. For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except per share amounts) 2025 2024 2025 2024 Revenues: Product sales $ 7,345 $ 7,515 $ 21,013 $ 21,074 Royalty, contract and other revenues 424 30 505 111 Total revenues 7,769 7,545 21,518 21,185 Costs and expenses: Cost of goods sold 1,569 1,574 4,610 4,670 Research and development expenses 1,346 1,395 4,215 4,266 Acquired in-process research and development expenses 170 505 485 4,674 In-process research and development impairments — 1,750 190 4,180 Selling, general and administrative expenses 1,357 1,433 3,980 4,184 Total costs and expenses 4,442 6,657 13,480 21,975 Operating income (loss) 3,327 888 8,038 (790 ) Interest expense 256 238 769 728 Other (income) expense, net (569 ) (306 ) (449 ) (41 ) Income (loss) before income taxes 3,641 956 7,718 (1,477 ) Income tax expense (benefit) 589 (297 ) 1,391 (174 ) Net income (loss) 3,052 1,253 6,327 (1,303 ) Net income attributable to noncontrolling interest — — — — Net income (loss) attributable to Gilead $ 3,052 $ 1,253 $ 6,327 $ (1,303 ) Basic earnings (loss) per share attributable to Gilead $ 2.46 $ 1.00 $ 5.08 $ (1.04 ) Diluted earnings (loss) per share attributable to Gilead $ 2.43 $ 1.00 $ 5.04 $ (1.04 ) Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,243 1,247 1,245 1,247 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,254 1,254 1,256 1,247 Supplemental Information: Cash dividends declared per share $ 0.79 $ 0.77 $ 2.37 $ 2.31 Product gross margin 78.6 % 79.1 % 78.1 % 77.8 % Research and development expenses as a % of revenues 17.3 % 18.5 % 19.6 % 20.1 % Selling, general and administrative expenses as a % of revenues 17.5 % 19.0 % 18.5 % 19.8 % Operating margin 42.8 % 11.8 % 37.4 % (3.7 )% Effective tax rate 16.2 % (31.1 )% 18.0 % 11.8 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Product sales: HIV $ 5,277 $ 5,073 4 % $ 14,952 $ 14,160 6 % Liver Disease 819 733 12 % 2,372 2,302 3 % Oncology 788 816 (3 )% 2,395 2,446 (2 )% Other 184 201 (8 )% 594 705 (16 )% Total product sales excluding Veklury 7,068 6,823 4 % 20,313 19,613 4 % Veklury 277 692 (60 )% 700 1,461 (52 )% Total product sales 7,345 7,515 (2 )% 21,013 21,074 — % Royalty, contract and other revenues 424 30 NM 505 111 NM Total revenues $ 7,769 $ 7,545 3 % $ 21,518 $ 21,185 2 % GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Non-GAAP: Cost of goods sold $ 992 $ 995 — % $ 2,875 $ 2,933 (2 )% Research and development expenses $ 1,334 $ 1,382 (3 )% $ 4,123 $ 4,120 — % Acquired IPR&D expenses $ 170 $ 505 (66 )% $ 485 $ 4,674 (90 )% Selling, general and administrative expenses $ 1,351 $ 1,405 (4 )% $ 3,931 $ 4,051 (3 )% Other (income) expense, net $ (87 ) $ (48 ) 80 % $ (251 ) $ (189 ) 33 % Diluted earnings per share attributable to Gilead $ 2.47 $ 2.02 22 % $ 6.29 $ 2.72 NM Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,254 1,254 — % 1,256 1,254 — % Product gross margin 86.5 % 86.8 % -27 bps 86.3 % 86.1 % 24 bps Research and development expenses as a % of revenues 17.2 % 18.3 % -115 bps 19.2 % 19.4 % -29 bps Selling, general and administrative expenses as a % of revenues 17.4 % 18.6 % -123 bps 18.3 % 19.1 % -85 bps Operating margin 50.5 % 43.2 % 729 bps 47.0 % 25.5 % NM Effective tax rate 17.5 % 17.5 % -2 bps 17.6 % 30.0 % NM NM - Not Meaningful (1) Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables below. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages and per share amounts) 2025 2024 2025 2024 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,569 $ 1,574 $ 4,610 $ 4,670 Acquisition-related – amortization(1) (577 ) (579 ) (1,735 ) (1,737 ) Restructuring — — — 1 Non-GAAP cost of goods sold $ 992 $ 995 $ 2,875 $ 2,933 Product gross margin reconciliation: GAAP product gross margin 78.6 % 79.1 % 78.1 % 77.8 % Acquisition-related – amortization(1) 7.9 % 7.7 % 8.3 % 8.2 % Restructuring — % — % — % — % Non-GAAP product gross margin 86.5 % 86.8 % 86.3 % 86.1 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,346 $ 1,395 $ 4,215 $ 4,266 Acquisition-related – other costs(2) (4 ) (9 ) (41 ) (78 ) Restructuring (8 ) (5 ) (52 ) (68 ) Non-GAAP research and development expenses $ 1,334 $ 1,382 $ 4,123 $ 4,120 IPR&D impairment reconciliation: GAAP IPR&D impairment $ — $ 1,750 $ 190 $ 4,180 IPR&D impairment — (1,750 ) (190 ) (4,180 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,357 $ 1,433 $ 3,980 $ 4,184 Acquisition-related – other costs(2) — (5 ) — (88 ) Restructuring (5 ) (23 ) (49 ) (45 ) Non-GAAP selling, general and administrative expenses $ 1,351 $ 1,405 $ 3,931 $ 4,051 Operating income (loss) reconciliation: GAAP operating income (loss) $ 3,327 $ 888 $ 8,038 $ (790 ) Acquisition-related – amortization(1) 577 579 1,735 1,737 Acquisition-related – other costs(2) 4 13 41 167 Restructuring 14 28 101 112 IPR&D impairment — 1,750 190 4,180 Non-GAAP operating income $ 3,921 $ 3,258 $ 10,104 $ 5,406 Operating margin reconciliation: GAAP operating margin 42.8 % 11.8 % 37.4 % (3.7 )% Acquisition-related – amortization(1) 7.4 % 7.7 % 8.1 % 8.2 % Acquisition-related – other costs(2) — % 0.2 % 0.2 % 0.8 % Restructuring 0.2 % 0.4 % 0.5 % 0.5 % IPR&D impairment — % 23.2 % 0.9 % 19.7 % Non-GAAP operating margin 50.5 % 43.2 % 47.0 % 25.5 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ (569 ) $ (306 ) $ (449 ) $ (41 ) Gain (loss) from equity securities, net 483 258 198 (148 ) Non-GAAP other (income) expense, net $ (87 ) $ (48 ) $ (251 ) $ (189 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 3,641 $ 956 $ 7,718 $ (1,477 ) Acquisition-related – amortization(1) 577 579 1,735 1,737 Acquisition-related – other costs(2) 4 13 41 167 Restructuring 14 28 101 112 IPR&D impairment — 1,750 190 4,180 (Gain) loss from equity securities, net (483 ) (258 ) (198 ) 148 Non-GAAP income before income taxes $ 3,752 $ 3,068 $ 9,586 $ 4,866 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions, except percentages and per share amounts) 2025 2024 2025 2024 Income tax expense (benefit) reconciliation: GAAP income tax expense (benefit) $ 589 $ (297 ) $ 1,391 $ (174 ) Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 120 121 360 363 Acquisition-related – other costs(2) — 2 — 39 Restructuring 3 4 18 21 IPR&D impairment — 440 51 1,051 Gain from equity securities, net (43 ) (46 ) (33 ) (52 ) Discrete and related tax charges(3) (11 ) 314 (101 ) 214 Non-GAAP income tax expense $ 657 $ 538 $ 1,686 $ 1,461 Effective tax rate reconciliation: GAAP effective tax rate 16.2 % (31.1 )% 18.0 % 11.8 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(3) 1.3 % 48.6 % (0.4 )% 18.2 % Non-GAAP effective tax rate 17.5 % 17.5 % 17.6 % 30.0 % Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 3,052 $ 1,253 $ 6,327 $ (1,303 ) Acquisition-related – amortization(1) 457 458 1,374 1,374 Acquisition-related – other costs(2) 4 11 41 128 Restructuring 11 24 83 92 IPR&D impairment — 1,310 139 3,129 (Gain) loss from equity securities, net (440 ) (212 ) (165 ) 200 Discrete and related tax charges(3) 11 (314 ) 101 (214 ) Non-GAAP net income attributable to Gilead $ 3,095 $ 2,531 $ 7,901 $ 3,405 Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 2.43 $ 1.00 $ 5.04 $ (1.04 ) Acquisition-related – amortization(1) 0.36 0.37 1.09 1.10 Acquisition-related – other costs(2) — 0.01 0.03 0.10 Restructuring 0.01 0.02 0.07 0.07 IPR&D impairment — 1.04 0.11 2.51 (Gain) loss from equity securities, net (0.35 ) (0.17 ) (0.13 ) 0.16 Discrete and related tax charges(3) 0.01 (0.25 ) 0.08 (0.17 ) Difference in shares used for GAAP vs. Non-GAAP $ — $ — $ — $ (0.01 ) Non-GAAP diluted earnings per share $ 2.47 $ 2.02 $ 6.29 $ 2.72 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 577 $ 579 $ 1,735 $ 1,736 Research and development expenses adjustments 12 13 93 146 IPR&D impairment adjustments — 1,750 190 4,180 Selling, general and administrative expenses adjustments 5 28 49 133 Total non-GAAP adjustments to costs and expenses 594 2,370 2,067 6,196 Other (income) expense, net, adjustments (483 ) (258 ) (198 ) 148 Total non-GAAP adjustments before income taxes 112 2,113 1,868 6,343 Income tax effect of non-GAAP adjustments above (79 ) (521 ) (396 ) (1,421 ) Discrete and related tax charges(3) 11 (314 ) 101 (214 ) Total non-GAAP adjustments to net income attributable to Gilead $ 43 $ 1,278 $ 1,573 $ 4,708 (1) Relates to amortization of acquired intangibles. (2) Adjustments include integration expenses and contingent consideration fair value adjustments associated with Gilead’s recent acquisitions. (3) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2025 FULL-YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 11, 2025 Updated April 24, 2025 Updated August 7, 2025 Updated October 30, 2025 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 77.0% - 78.0% 77.0% - 78.0% ~ 78.0% ~ 78.0% Acquisition-related expenses ~ 8.0% ~ 8.0% ~ 8.0% ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% ~ 86.0% ~ 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $10,200 - $10,700 $10,200 - $10,700 $10,300 - $10,700 $10,300 - $10,600 Acquisition-related, IPR&D impairment and restructuring expenses ~ 2,500 ~ 2,500 ~ 2,700 ~ 2,800 Non-GAAP projected operating income $12,700 - $13,200 $12,700 - $13,200 $13,000 - $13,400 $13,100 - $13,400 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate(2) ~ 20% ~ 21% ~ 21% ~ 16% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments(2) (~ 1%) (~ 2%) (~ 2%) ~ 3% Non-GAAP projected effective tax rate ~ 19% ~ 19% ~ 19% ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.95 - $6.35 $5.65 - $6.05 $5.85 - $6.15 $6.65 - $6.85 Acquisition-related, IPR&D impairment and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments(2) ~ 1.75 ~ 2.05 ~ 2.10 ~ 1.40 Non-GAAP projected diluted EPS $7.70 - $8.10 $7.70 - $8.10 $7.95 - $8.25 $8.05 - $8.25 (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. (2) GAAP projected effective tax rate and tax adjustments for the October 30, 2025 update include an October 2025 settlement with a tax authority related to a prior year legal entity restructuring. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) September 30, December 31, (in millions) 2025 2024 Assets Cash, cash equivalents and marketable debt securities $ 9,354 $ 9,991 Accounts receivable, net 5,095 4,420 Inventories(1) 4,387 3,589 Property, plant and equipment, net 5,500 5,414 Intangible assets, net 17,970 19,948 Goodwill 8,314 8,314 Other assets 7,914 7,319 Total assets $ 58,533 $ 58,995 Liabilities and Stockholders’ Equity Current liabilities $ 12,298 $ 12,004 Long-term liabilities 24,780 27,744 Stockholders’ equity(2) 21,456 19,246 Total liabilities and stockholders’ equity $ 58,533 $ 58,995 (1) Includes current and long-term inventories, which are disclosed separately in the notes to our financial statements in Form 10-K and Form 10-Q. (2) As of September 30, 2025 and December 31, 2024, there were 1,242 and 1,246 shares of common stock issued and outstanding, respectively. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2025 2024 2025 2024 Net cash provided by operating activities $ 4,109 $ 4,309 $ 6,692 $ 7,853 Net cash used in investing activities (427 ) (710 ) (2,958 ) (3,224 ) Net cash used in financing activities (1,490 ) (1,379 ) (6,482 ) (5,693 ) Effect of exchange rate changes on cash and cash equivalents (5 ) 44 87 15 Net change in cash and cash equivalents 2,187 2,265 (2,661 ) (1,049 ) Cash and cash equivalents at beginning of period 5,144 2,772 9,991 6,085 Cash and cash equivalents at end of period $ 7,330 $ 5,037 $ 7,330 $ 5,037 Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2025 2024 2025 2024 Net cash provided by operating activities $ 4,109 $ 4,309 $ 6,692 $ 7,853 Purchases of property, plant and equipment (147 ) (140 ) (358 ) (376 ) Free cash flow(1) $ 3,962 $ 4,169 $ 6,335 $ 7,478 (1) Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above. GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2025 2024 2025 2024 HIV Biktarvy – U.S. $ 2,940 $ 2,826 $ 8,212 $ 7,726 Biktarvy – Europe 427 375 1,231 1,110 Biktarvy – Rest of World 320 272 922 814 3,686 3,472 10,366 9,649 Descovy – U.S. 652 534 1,791 1,339 Descovy – Europe 23 24 67 75 Descovy – Rest of World 25 28 81 82 701 586 1,939 1,496 Genvoya – U.S. 323 384 950 1,088 Genvoya – Europe 34 44 114 138 Genvoya – Rest of World 19 21 54 66 377 449 1,118 1,292 Odefsey – U.S. 206 248 642 705 Odefsey – Europe 61 69 184 217 Odefsey – Rest of World 10 9 30 30 277 326 857 952 Symtuza - Revenue share(1) – U.S. 95 103 265 338 Symtuza - Revenue share(1) – Europe 26 33 88 101 Symtuza - Revenue share(1) – Rest of World 3 3 9 9 124 139 362 448 Other HIV(2) – U.S. 82 65 198 190 Other HIV(2) – Europe 22 26 85 96 Other HIV(2) – Rest of World 9 9 28 36 112 100 310 322 Total HIV – U.S. 4,299 4,161 12,059 11,386 Total HIV – Europe 592 570 1,769 1,737 Total HIV – Rest of World 386 342 1,124 1,038 5,277 5,073 14,952 14,160 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 146 222 497 737 Sofosbuvir / Velpatasvir(3) – Europe 65 67 227 230 Sofosbuvir / Velpatasvir(3) – Rest of World 97 96 273 299 309 385 996 1,266 Vemlidy – U.S. 136 126 358 338 Vemlidy – Europe 12 11 36 33 Vemlidy – Rest of World 132 95 389 328 280 232 783 699 Other Liver Disease(4) – U.S. 132 45 307 134 Other Liver Disease(4) – Europe 81 54 233 148 Other Liver Disease(4) – Rest of World 17 17 53 55 231 116 593 337 Total Liver Disease – U.S. 414 393 1,162 1,210 Total Liver Disease – Europe 158 132 496 411 Total Liver Disease – Rest of World 247 207 714 682 819 733 2,372 2,302 Veklury Veklury – U.S. 140 393 390 784 Veklury – Europe 43 81 84 204 Veklury – Rest of World 93 219 225 473 277 692 700 1,461 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2025 2024 2025 2024 Oncology Cell Therapy Tecartus – U.S. 40 63 122 181 Tecartus – Europe 35 29 107 102 Tecartus – Rest of World 8 6 25 22 83 98 254 305 Yescarta – U.S. 123 145 444 502 Yescarta – Europe 151 182 455 509 Yescarta – Rest of World 75 60 228 170 349 387 1,127 1,181 Total Cell Therapy – U.S. 163 208 566 683 Total Cell Therapy – Europe 186 211 562 611 Total Cell Therapy – Rest of World 83 66 253 192 432 485 1,381 1,485 Trodelvy Trodelvy – U.S. 221 226 626 655 Trodelvy – Europe 89 80 259 217 Trodelvy – Rest of World 47 26 128 88 357 332 1,013 960 Total Oncology – U.S. 384 433 1,192 1,338 Total Oncology – Europe 275 291 821 828 Total Oncology – Rest of World 129 92 381 280 788 816 2,395 2,446 Other AmBisome – U.S. 2 6 15 37 AmBisome – Europe 69 71 201 210 AmBisome – Rest of World 52 52 175 176 123 130 391 424 Other(5) – U.S. 34 47 125 203 Other(5) – Europe 7 8 23 26 Other(5) – Rest of World 20 16 55 52 61 71 204 281 Total Other – U.S. 36 53 140 241 Total Other – Europe 76 80 225 236 Total Other – Rest of World 72 68 230 228 184 201 594 705 Total product sales – U.S. 5,274 5,433 14,943 14,958 Total product sales – Europe 1,144 1,154 3,395 3,416 Total product sales – Rest of World 928 928 2,674 2,700 $ 7,345 $ 7,515 $ 21,013 $ 21,074 (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and 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, Sunlenca, Stribild, Truvada, Tybost and Yeztugo/Yeytuo. (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, Livdelzi/Lyvdelzi, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis and Zydelig. Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com