Anitocabtagene autoleucel

Product Sales Excluding Veklury Increased 4% Year-Over-Year to $6.9 billion Biktarvy Sales Increased 9% Year-Over-Year to $3.5 billion FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its second quarter 2025 results of operations. “This was a very successful second quarter for Gilead, including the FDA approval for Yeztugo as the world’s first twice-yearly HIV prevention option,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Our strong growth this quarter was driven by Biktarvy, Descovy, Trodelvy and Livdelzi, reflecting the diversity of our portfolio. As we enter the third quarter, we are increasing revenue and earnings guidance for the year, and look forward to delivering continued innovation and growth across our core therapeutic areas.” Second Quarter 2025 Financial Results Total second quarter 2025 revenue increased 2% to $7.1 billion compared to the same period in 2024, driven by higher HIV, Livdelzi® (seladelpar) and Trodelvy® (sacituzumab govitecan-hziy) sales, partially offset by lower chronic hepatitis C virus (“HCV”) and Veklury® (remdesivir) sales. Diluted earnings per share (“EPS”) was $1.56 in the second quarter 2025 compared to $1.29 in the same period in 2024. The increase was primarily driven by net unrealized gains on securities compared to net unrealized losses in 2024 and higher product sales, partially offset by a pre-tax in-process research and development (“IPR&D”) impairment charge of $190 million related to assets acquired as part of the MYR GmbH (“MYR”) acquisition and higher research and development (“R&D”) expenses. Non-GAAP diluted EPS of $2.01 in the second quarter 2025 remained flat compared to the same period in 2024, with higher product sales offset by higher R&D expenses. As of June 30, 2025, Gilead had $7.1 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024. During the second quarter 2025, Gilead generated $827 million in operating cash flow, net of a final $1.3 billion transition tax payment associated with the Tax Cuts and Jobs Act of 2017. During the second quarter 2025, Gilead paid dividends of $994 million and repurchased $527 million of common stock. Second Quarter 2025 Product Sales Total second quarter 2025 product sales increased 2% to $7.1 billion compared to the same period in 2024. Total second quarter 2025 product sales excluding Veklury increased 4% to $6.9 billion compared to the same period in 2024, primarily due to higher HIV, Livdelzi and Trodelvy sales, partially offset by lower HCV sales. HIV product sales increased 7% to $5.1 billion in the second quarter 2025 compared to the same period in 2024, primarily driven by increased demand and higher average realized price. Biktarvy®(bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 9% to $3.5 billion in the second quarter 2025 compared to the same period in 2024, primarily driven by higher demand. Descovy®(FTC 200mg/TAF 25mg) sales increased 35% to $653 million in the second quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and demand. The Liver Disease portfolio sales decreased 4% to $795 million in the second quarter 2025 compared to the same period in 2024. This was primarily driven by lower HCV sales, partially offset by increased demand for Livdelzi, Hepcludex® (bulevirtide) and chronic hepatitis B virus (“HBV”) products. Veklury sales decreased 44% to $121 millionin the second quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations. Cell Therapy product sales decreased 7% to $485 million in the second quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds. Yescarta® (axicabtagene ciloleucel) sales decreased 5% to $393 million in the second quarter 2025 compared to the same period in 2024, primarily driven by lower demand, partially offset by higher average realized price. Tecartus® (brexucabtagene autoleucel) sales decreased 14% to $92 million in the second quarter 2025 compared to the same period in 2024, primarily reflecting lower demand, partially offset by higher average realized price. Trodelvy sales increased 14% to $364 million in the second quarter 2025 compared to the same period in 2024, primarily driven by higher demand and inventory dynamics. Second Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 78.7% in the second quarter 2025 compared to 77.7% in the same period in 2024. Non-GAAP product gross margin was 86.9% in the second quarter 2025 compared to 86.0% in the same period in 2024. The increases were primarily driven by product mix. R&D expenses were $1.5 billion in the second quarter 2025 compared to $1.4 billion in the same period in 2024, primarily due to increased clinical manufacturing and study expenses, as well as valuation adjustments to the MYR-related contingent consideration. Non-GAAP R&D expenses were $1.5 billion in the second quarter 2025 compared to $1.3 billion in the same period in 2024, primarily due to increased clinical manufacturing and study activities. Acquired IPR&D expenses were $61 million in the second quarter 2025, primarily reflecting expenses related to the strategic partnership with Kymera Therapeutics, Inc. (“Kymera”) announced in June 2025. Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses of $1.4 billion in the second quarter 2025 remained flat compared to the same period in 2024, with higher promotional expenses offset by lower corporate expenses. The effective tax rate (“ETR”) was 19.3% in the second quarter 2025 compared to 21.4% in the same period in 2024, primarily driven by lower non-taxable unrealized losses on securities, partially offset by a beneficial prior year settlement with a tax authority that did not repeat. The non-GAAP ETR was 18.8% in the second quarter 2025 compared to 17.8% in the same period in 2024, primarily reflecting the same non-recurring tax settlement in the prior year. Guidance and Outlook For the full-year, Gilead expects: August 7, 2025 Guidance Low End High End Comparison to Prior Guidance Product sales $ 28,300 $ 28,700 Previously $28,200 to $28,600 Product sales excluding Veklury $ 27,300 $ 27,700 Previously $26,800 to $27,200 Veklury $ 1,000 $ 1,000 Previously $1,400 Diluted EPS $ 5.85 $ 6.15 Previously $5.65 to $6.05 Non-GAAP diluted EPS $ 7.95 $ 8.25 Previously $7.70 to $8.10 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 Received U.S. Food and Drug Administration (“FDA”) approval for Yeztugo® (lenacapavir) for pre-exposure prophylaxis (“PrEP”) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg. Yeztugo is the first and only twice-yearly HIV PrEP option available in the United States. Received a positive opinion under accelerated review from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending lenacapavir for use as PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The recommendation will now be reviewed by the European Commission. Lenacapavir for HIV PrEP is not approved for use outside of the United States. Announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (“Global Fund”) to accelerate access, subject to regulatory approvals, to twice-yearly lenacapavir for HIV PrEP for up to two million people in primarily low- and lower-middle-income countries over three years, at no profit to Gilead. Presented new data at the International AIDS Society conference, including from the PURPOSE 1 and 2 trials evaluating twice-yearly lenacapavir for HIV PrEP in a broad range of populations, including pregnant and lactating women, adolescents, and young people. Announced that the World Health Organization released new guidelines recommending the use of twice-yearly lenacapavir for HIV PrEP, as well as new guidelines on HIV testing protocols for long-acting prevention medications. Announced that FDA had placed a clinical hold on the HIV treatment trials of GS-1720 and/or GS-4182, including the WONDERS-1 and WONDERS-2 trials. These drug candidates are investigational and not approved anywhere globally. Presented final data from the Phase 3 MYR301 study evaluating bulevirtide as a treatment for adults with chronic hepatitis delta virus (“HDV”) at the European Association for the Study of the Liver (“EASL”) Congress. Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S. Additionally, presented clinical and real-world data on HBV and HCV programs. Oncology Announced positive topline results from the Phase 3 ASCENT-03 trial evaluating Trodelvy in patients with 1L metastatic triple-negative breast cancer (“mTNBC”) who are not candidates for PD-1/PD-L1 checkpoint inhibitors. Additionally, presented results from the Phase 3 ASCENT-04 trial evaluating Trodelvy plus Keytruda® (pembrolizumab) in 1L PD-L1+ mTNBC at the American Society of Clinical Oncology (“ASCO”) meeting. Trodelvy is not approved in either of these settings. Presented new real-world data at ASCO supporting the use of Yescarta in outpatient care settings for patients with relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”), as well as other early-stage investigational CAR T data in glioblastoma and LBCL. Presented data in partnership with Arcellx, Inc. (“Arcellx”) at the European Hematology Association congress from the iMMagine-1 trial evaluating investigational anitocabtagene-autoleucel (“anito-cel”) in R/R multiple myeloma. Entered into an exclusive option and license agreement with Kymera to develop novel oral molecular glue CDK2 degraders with broad oncology treatment potential. Inflammation Presented new data from multiple analyses at EASL evaluating Livdelzi for the treatment of primary biliary cholangitis, including interim analysis from the open-label, long-term ASSURE study. Corporate The Board declared a quarterly dividend of $0.79 per share of common stock for the third quarter of 2025. The dividend is payable on September 29, 2025, to stockholders of record at the close of business on September 15, 2025. Future dividends will be subject to Board approval. The Board authorized a new $6.0 billion stock repurchase program, with no fixed expiration, which will commence upon the completion of the previously approved program. Reached a final settlement agreement with the U.S. Department of Justice resolving a legacy compliance matter. This settlement was accrued in 2024 and reported under SG&A expenses. Named by TIME as a 2025 Most Influential Company. 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 MYR, and the arrangements with Arcellx, Kymera and the Global Fund; patent protection and estimated loss of exclusivity for our products and product candidates; 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 Livdelzi, Trodelvy, Yescarta, Yeztugo (lenacapavir), anito-cel, bulevirtide, GS-1720, and GS-4182 (such as the ASCENT-03, ASCENT-04, ASSURE, iMMagine-1, MYR301, PURPOSE 1 PURPOSE 2, WONDERS-1, and WONDERS-2 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 the clinical hold on the GS-1720 and GS-4182 trials to the satisfaction of the FDA and the risk that FDA may not remove the clinical hold, 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; 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 June 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® and ZYDELIG®. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 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 Six Months Ended June 30, June 30, (in millions, except per share amounts) 2025 2024 2025 2024 Revenues: Product sales $ 7,054 $ 6,912 $ 13,668 $ 13,559 Royalty, contract and other revenues 27 41 81 81 Total revenues 7,082 6,954 13,749 13,640 Costs and expenses: Cost of goods sold 1,501 1,544 3,041 3,096 Research and development expenses 1,491 1,351 2,870 2,871 Acquired in-process research and development expenses 61 38 315 4,169 In-process research and development impairments 190 — 190 2,430 Selling, general and administrative expenses 1,365 1,377 2,623 2,752 Total costs and expenses 4,608 4,309 9,038 15,317 Operating income (loss) 2,474 2,644 4,711 (1,678 ) Interest expense 254 237 513 491 Other (income) expense, net (208 ) 355 120 265 Income (loss) before income taxes 2,429 2,053 4,077 (2,433 ) Income tax expense 468 438 802 123 Net income (loss) 1,960 1,614 3,275 (2,556 ) Net income attributable to noncontrolling interest — — — — Net income (loss) attributable to Gilead $ 1,960 $ 1,614 $ 3,275 $ (2,556 ) Basic earnings (loss) per share attributable to Gilead $ 1.57 $ 1.29 $ 2.63 $ (2.05 ) Diluted earnings (loss) per share attributable to Gilead $ 1.56 $ 1.29 $ 2.61 $ (2.05 ) Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,245 1,247 1,246 1,247 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,255 1,251 1,257 1,247 Supplemental Information: Cash dividends declared per share $ 0.79 $ 0.77 $ 1.58 $ 1.54 Product gross margin 78.7 % 77.7 % 77.7 % 77.2 % Research and development expenses as a % of revenues 21.1 % 19.4 % 20.9 % 21.0 % Selling, general and administrative expenses as a % of revenues 19.3 % 19.8 % 19.1 % 20.2 % Operating margin 34.9 % 38.0 % 34.3 % (12.3 )% Effective tax rate 19.3 % 21.4 % 19.7 % (5.1 )% GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Product sales: HIV $ 5,088 $ 4,745 7 % $ 9,675 $ 9,088 6 % Liver Disease 795 832 (4 )% 1,553 1,569 (1 )% Oncology 849 841 1 % 1,606 1,629 (1 )% Other 202 280 (28 )% 410 504 (19 )% Total product sales excluding Veklury 6,934 6,698 4 % 13,245 12,790 4 % Veklury 121 214 (44 )% 423 769 (45 )% Total product sales 7,054 6,912 2 % 13,668 13,559 1 % Royalty, contract and other revenues 27 41 (34 )% 81 81 1 % Total revenues $ 7,082 $ 6,954 2 % $ 13,749 $ 13,640 1 % GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Non-GAAP: Cost of goods sold $ 922 $ 965 (4 )% $ 1,883 $ 1,939 (3 )% Research and development expenses $ 1,450 $ 1,335 9 % $ 2,789 $ 2,738 2 % Acquired IPR&D expenses(2) $ 61 $ 38 61 % $ 315 $ 4,169 (92 )% Selling, general and administrative expenses $ 1,358 $ 1,351 — % $ 2,580 $ 2,646 (3 )% Other (income) expense, net $ (66 ) $ (37 ) 82 % $ (164 ) $ (141 ) 17 % Diluted earnings per share attributable to Gilead $ 2.01 $ 2.01 — % $ 3.82 $ 0.70 NM Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,255 1,251 — % 1,257 1,254 — % Product gross margin 86.9 % 86.0 % 89 bps 86.2 % 85.7 % 52 bps Research and development expenses as a % of revenues 20.5 % 19.2 % 128 bps 20.3 % 20.1 % 21 bps Selling, general and administrative expenses as a % of revenues 19.2 % 19.4 % -26 bps 18.8 % 19.4 % -64 bps Operating margin 46.5 % 47.0 % -49 bps 45.0 % 15.7 % NM Effective tax rate 18.8 % 17.8 % 96 bps 17.6 % 51.4 % 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. (2) Equal to GAAP financial information. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2025 2024 2025 2024 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,501 $ 1,544 $ 3,041 $ 3,096 Acquisition-related – amortization(1) (579 ) (579 ) (1,158 ) (1,158 ) Restructuring — — — 1 Non-GAAP cost of goods sold $ 922 $ 965 $ 1,883 $ 1,939 Product gross margin reconciliation: GAAP product gross margin 78.7 % 77.7 % 77.7 % 77.2 % Acquisition-related – amortization(1) 8.2 % 8.4 % 8.5 % 8.5 % Restructuring — % — % — % — % Non-GAAP product gross margin 86.9 % 86.0 % 86.2 % 85.7 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,491 $ 1,351 $ 2,870 $ 2,871 Acquisition-related – other costs(2) (35 ) (3 ) (37 ) (70 ) Restructuring (6 ) (13 ) (44 ) (63 ) Non-GAAP research and development expenses $ 1,450 $ 1,335 $ 2,789 $ 2,738 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 190 $ — $ 190 $ 2,430 IPR&D impairment (190 ) — (190 ) (2,430 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,365 $ 1,377 $ 2,623 $ 2,752 Acquisition-related – other costs(2) — (17 ) — (84 ) Restructuring (7 ) (8 ) (43 ) (22 ) Non-GAAP selling, general and administrative expenses $ 1,358 $ 1,351 $ 2,580 $ 2,646 Operating income (loss) reconciliation: GAAP operating income (loss) $ 2,474 $ 2,644 $ 4,711 $ (1,678 ) Acquisition-related – amortization(1) 579 579 1,158 1,158 Acquisition-related – other costs(2) 35 21 37 153 Restructuring 13 21 88 84 IPR&D impairment 190 — 190 2,430 Non-GAAP operating income $ 3,290 $ 3,265 $ 6,183 $ 2,148 Operating margin reconciliation: GAAP operating margin 34.9 % 38.0 % 34.3 % (12.3 )% Acquisition-related – amortization(1) 8.2 % 8.3 % 8.4 % 8.5 % Acquisition-related – other costs(2) 0.5 % 0.3 % 0.3 % 1.1 % Restructuring 0.2 % 0.3 % 0.6 % 0.6 % IPR&D impairment 2.7 % — % 1.4 % 17.8 % Non-GAAP operating margin 46.5 % 47.0 % 45.0 % 15.7 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ (208 ) $ 355 $ 120 $ 265 Gain (loss) from equity securities, net 142 (392 ) (284 ) (405 ) Non-GAAP other (income) expense, net $ (66 ) $ (37 ) $ (164 ) $ (141 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 2,429 $ 2,053 $ 4,077 $ (2,433 ) Acquisition-related – amortization(1) 579 579 1,158 1,158 Acquisition-related – other costs(2) 35 21 37 153 Restructuring 13 21 88 84 IPR&D impairment 190 — 190 2,430 (Gain) loss from equity securities, net (142 ) 392 284 405 Non-GAAP income before income taxes $ 3,103 $ 3,065 $ 5,834 $ 1,798 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2025 2024 2025 2024 Income tax expense reconciliation: GAAP income tax expense $ 468 $ 438 $ 802 $ 123 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 120 121 241 242 Acquisition-related – other costs(2) — 7 — 37 Restructuring 2 7 15 16 IPR&D impairment 51 — 51 611 (Gain) loss from equity securities, net (11 ) 33 10 (6 ) Discrete and related tax charges(3) (48 ) (60 ) (90 ) (100 ) Non-GAAP income tax expense $ 583 $ 546 $ 1,029 $ 923 Effective tax rate reconciliation: GAAP effective tax rate 19.3 % 21.4 % 19.7 % (5.1 )% Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(3) (0.5 )% (3.5 )% (2.0 )% 56.4 % Non-GAAP effective tax rate 18.8 % 17.8 % 17.6 % 51.4 % Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,960 $ 1,614 $ 3,275 $ (2,556 ) Acquisition-related – amortization(1) 459 458 917 916 Acquisition-related – other costs(2) 35 14 37 117 Restructuring 11 14 72 68 IPR&D impairment 139 — 139 1,819 (Gain) loss from equity securities, net (131 ) 359 275 412 Discrete and related tax charges(3) 48 60 90 100 Non-GAAP net income attributable to Gilead $ 2,521 $ 2,519 $ 4,806 $ 874 Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.56 $ 1.29 $ 2.61 $ (2.05 ) Acquisition-related – amortization(1) 0.37 0.37 0.73 0.73 Acquisition-related – other costs(2) 0.03 0.01 0.03 0.09 Restructuring 0.01 0.01 0.06 0.05 IPR&D impairment 0.11 — 0.11 1.46 (Gain) loss from equity securities, net (0.10 ) 0.29 0.22 0.33 Discrete and related tax charges(3) 0.04 0.05 0.07 0.08 Non-GAAP diluted earnings per share $ 2.01 $ 2.01 $ 3.82 $ 0.70 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 579 $ 1,158 $ 1,157 Research and development expenses adjustments 41 16 81 133 IPR&D impairment adjustments 190 — 190 2,430 Selling, general and administrative expenses adjustments 7 26 43 106 Total non-GAAP adjustments to costs and expenses 817 620 1,472 3,826 Other (income) expense, net, adjustments (142 ) 392 284 405 Total non-GAAP adjustments before income taxes 675 1,012 1,757 4,231 Income tax effect of non-GAAP adjustments above (162 ) (168 ) (316 ) (900 ) Discrete and related tax charges(3) 48 60 90 100 Total non-GAAP adjustments to net income attributable to Gilead $ 560 $ 905 $ 1,530 $ 3,431 ________________________________ (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 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 77.0% - 78.0% 77.0% - 78.0% ~ 78.0% Acquisition-related expenses ~ 8.0% ~ 8.0% ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 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 Acquisition-related, IPR&D impairment and restructuring expenses ~ 2,500 ~ 2,500 ~ 2,700 Non-GAAP projected operating income $12,700 - $13,200 $12,700 - $13,200 $13,000 - $13,400 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 20% ~ 21% ~ 21% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 1%) (~ 2%) (~ 2%) Non-GAAP projected effective tax rate ~ 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 Acquisition-related, IPR&D impairment and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.75 ~ 2.05 ~ 2.10 Non-GAAP projected diluted EPS $7.70 - $8.10 $7.70 - $8.10 $7.95 - $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. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) June 30, December 31, (in millions) 2025 2024 Assets Cash, cash equivalents and marketable debt securities $ 7,126 $ 9,991 Accounts receivable, net 4,781 4,420 Inventories(1) 3,913 3,589 Property, plant and equipment, net 5,459 5,414 Intangible assets, net 18,566 19,948 Goodwill 8,314 8,314 Other assets 7,563 7,319 Total assets $ 55,721 $ 58,995 Liabilities and Stockholders’ Equity Current liabilities $ 11,189 $ 12,004 Long-term liabilities 24,942 27,744 Stockholders’ equity(2) 19,590 19,246 Total liabilities and stockholders’ equity $ 55,721 $ 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 June 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 Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 Net cash provided by operating activities $ 827 $ 1,325 $ 2,584 $ 3,544 Net cash used in investing activities (2,116 ) (307 ) (2,531 ) (2,514 ) Net cash used in financing activities (1,566 ) (2,953 ) (4,993 ) (4,314 ) Effect of exchange rate changes on cash and cash equivalents 73 (11 ) 92 (29 ) Net change in cash and cash equivalents (2,782 ) (1,947 ) (4,848 ) (3,313 ) Cash and cash equivalents at beginning of period 7,926 4,718 9,991 6,085 Cash and cash equivalents at end of period $ 5,144 $ 2,772 $ 5,144 $ 2,772 Three Months Ended Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 Net cash provided by operating activities $ 827 $ 1,325 $ 2,584 $ 3,544 Purchases of property, plant and equipment (107 ) (130 ) (211 ) (235 ) Free cash flow(1) $ 720 $ 1,195 $ 2,373 $ 3,309 ________________________________ (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 (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 HIV Biktarvy – U.S. $ 2,799 $ 2,585 $ 5,272 $ 4,900 Biktarvy – Europe 429 370 804 735 Biktarvy – Rest of World 302 277 603 542 3,530 3,232 6,679 6,177 Descovy – U.S. 601 434 1,139 805 Descovy – Europe 24 25 45 51 Descovy – Rest of World 28 26 55 55 653 485 1,239 911 Genvoya – U.S. 322 372 627 704 Genvoya – Europe 40 45 79 95 Genvoya – Rest of World 16 23 35 44 377 440 741 843 Odefsey – U.S. 221 233 436 457 Odefsey – Europe 66 72 123 148 Odefsey – Rest of World 11 10 20 21 298 315 579 626 Symtuza - Revenue share(1) – U.S. 88 131 170 236 Symtuza - Revenue share(1) – Europe 33 34 62 67 Symtuza - Revenue share(1) – Rest of World 3 3 6 6 124 168 238 309 Other HIV(2) – U.S. 65 65 115 125 Other HIV(2) – Europe 33 25 63 70 Other HIV(2) – Rest of World 9 15 19 27 107 105 198 222 Total HIV – U.S. 4,096 3,821 7,760 7,226 Total HIV – Europe 624 571 1,177 1,167 Total HIV – Rest of World 368 353 738 695 5,088 4,745 9,675 9,088 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 184 267 351 515 Sofosbuvir / Velpatasvir(3) – Europe 81 84 161 163 Sofosbuvir / Velpatasvir(3) – Rest of World 76 126 175 203 342 476 687 881 Vemlidy – U.S. 122 117 222 212 Vemlidy – Europe 13 11 24 22 Vemlidy – Rest of World 117 115 257 233 252 243 504 467 Other Liver Disease(4) – U.S. 106 47 175 89 Other Liver Disease(4) – Europe 76 47 152 94 Other Liver Disease(4) – Rest of World 19 19 35 38 201 113 362 221 Total Liver Disease – U.S. 413 431 748 816 Total Liver Disease – Europe 170 142 338 279 Total Liver Disease – Rest of World 211 259 467 474 795 832 1,553 1,569 Veklury Veklury – U.S. 51 76 250 391 Veklury – Europe 19 53 41 123 Veklury – Rest of World 50 85 132 255 121 214 423 769 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 Oncology Cell Therapy Tecartus – U.S. 41 63 82 118 Tecartus – Europe 41 37 72 73 Tecartus – Rest of World 9 7 17 16 92 107 171 207 Yescarta – U.S. 162 186 321 357 Yescarta – Europe 154 169 304 327 Yescarta – Rest of World 77 58 154 110 393 414 779 794 Total Cell Therapy – U.S. 203 250 403 475 Total Cell Therapy – Europe 196 206 376 400 Total Cell Therapy – Rest of World 86 66 171 126 485 521 949 1,001 Trodelvy Trodelvy – U.S. 224 224 405 429 Trodelvy – Europe 96 69 171 137 Trodelvy – Rest of World 44 26 81 62 364 320 657 628 Total Oncology – U.S. 427 474 808 904 Total Oncology – Europe 291 275 547 537 Total Oncology – Rest of World 131 92 252 188 849 841 1,606 1,629 Other AmBisome – U.S. 7 17 13 31 AmBisome – Europe 65 69 132 139 AmBisome – Rest of World 56 65 123 124 129 151 268 294 Other(5) – U.S. 44 98 91 156 Other(5) – Europe 8 8 16 18 Other(5) – Rest of World 21 24 35 36 73 130 143 209 Total Other – U.S. 52 115 104 188 Total Other – Europe 73 77 149 156 Total Other – Rest of World 77 88 158 160 202 280 410 504 Total product sales – U.S. 5,038 4,916 9,669 9,525 Total product sales – Europe 1,178 1,118 2,251 2,262 Total product sales – Rest of World 838 878 1,747 1,772 $ 7,054 $ 6,912 $ 13,668 $ 13,559 ________________________________ (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. (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

iStock/ Natalya Kosarevich Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.” FDA leaders Marty Makary and Vinay Prasad have struck a tone of urgency when it comes to bringing innovative medicines to the U.S. market, launching a new priority review voucher program for certain drugs and vowing to “rapidly make available” rare disease therapies. Last week, the agency took another step in this direction, removing guardrails around six CAR T cell therapies. Specifically, the FDA removed the Risk Evaluation and Mitigation Strategies (REMS) that had been in place for BCMA- and CD19-directed CAR T therapies for multiple myeloma and certain types of leukemia and lymphoma, made by Bristol Myers Squibb, Johnson & Johnson, Gilead/Kite and others. REMS had been in place to address the two syndromes most often associated with the therapies: cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). But the FDA has now determined that “established management guidelines” and the “extensive experience” of the medical and hematology community are sufficient to diagnose and manage these risks, BMS said in a press release Thursday, adding that the change is “likely to help further accelerate cell therapy into the community center setting.” In a statement Friday, Prasad, director of the Center for Biologics Evaluation and Research (CBER), called the move a “bold step,” adding that dropping REMS “expedites the delivery of potentially curative treatments to patients and reduces burden on providers.” Analysts and cell therapy groups lauded the move. “Overall, we view the removal of the REMS program for CAR-T cell therapies as a positive development for the space, as it supports the notion that the FDA is working to minimize red tape and increase access to potentially curative treatments for patients,” William Blair said in a note to investors on Friday. The FDA also significantly shortened the length of time patients must wait after treatment before driving from eight to two weeks and cut the requirement to stay near a healthcare facility from four to two weeks. In an emailed statement to BioSpace , Stephen Majors, vice president of global communications at The Alliance for Regenerative Medicine, added that the change is a “patient friendly move that will significantly reduce the burden on patients seeking transformative treatments for deadly blood cancers.” He added that the move “reflects the agency’s thoughtful consideration of real-world evidence and evolving understanding of CAR-T cell therapies, based on recent dialogue with ARM and our members.” Meanwhile, Benjamin McLeod, founder of Convey Bio wrote on LinkedIn , “Regulatory trust has finally caught up with clinical practice.” Increased Patient Access a Boon for CAR T Developers CAR T cell therapy—which involves the extraction of a patient’s own T cells and adding a chimeric antigen receptor (CAR) that directs them to target and kill cancer cells before expanding and reinfusing those T cells back into the patient’s bloodstream—can be lifesaving. However, only about 2 in 10 patients receive this treatment, according to BMS, due to “the confluence of complex logistical and geographic barriers affecting patients and providers.” The FDA’s new requirements should lower that burden, experts agree. In a note to investors on Friday, Leerink Partners wrote, “We believe the reduction in CAR-T burden for patients and caregivers, enabled by FDA’s new monitoring and driving requirements, will drive expansion of the US cell therapy market.” Leerink relayed one KOL’s belief that if the FDA reduced monitoring requirements and driving restrictions to 14 days, “he would expect rates of CAR-T infusion to double.” In its press release last week, BMS wrote that label changes “reinforce [the company’s] continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.” In an interview with BioSpace , Lynelle Hoch, president of the cell therapy organization at BMS, noted that with CAR T cell therapies moving into earlier lines of treatment, patients tend to have jobs and childcare responsibilities, “and the idea of being at an academic center, potentially hours away from home for four weeks with a caregiver, and then not being able to drive, really impedes their ability to get these CAR Ts.” Additionally, Hoch said it is “well documented” that because CAR T therapies are delivered at “a select set of academic centers” and come with logistical barriers, there are “significant socioeconomic and racial disparities” in terms of patient access to these medicines. Hoch pointed to recently published research showing that individuals with an income of less than $40,000 were nearly 60% less likely to receive a CAR T therapy than those with an income greater than $100,000 thousand, and that Black and Hispanic patients are only half as likely to receive a CAR T than other patient populations. In terms of infrastructure, sites might be ready to accommodate these additional patients. The two KOLs Leerink consulted said their centers “now have excess capacity and could absorb increases in demand.” Hoch added that with the label changes, some of the infrastructure requirements—including the need for community hospitals to have a contractual relationship with an affiliated adverse event hospital—have now been reduced. Such increased uptake should fuel further CAR T development. At a recent investor dinner hosted by William Blair, BMS management “cited community uptake as a key driver of CAR-T market expansion and Breyanzi growth,” the firm wrote. Breyanzi, a CD19-directed CAR T cell therapy, is approved for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma, while a second BMS CAR T, BCMA-directed Abecma, is marketed for patients with relapsed or refractory multiple myeloma. A representative for Gilead/Kite told BioSpace in an email that the labels for Yescarta (FDA-approved for relapsed or refractory (R/R) large B-cell lymphoma and R/R follicular lymphoma) and Tecartus (R/R B-cell precursor acute lymphoblastic leukemia and R/R mantle cell lymphoma) have been updated to reflect the recent FDA changes. While Hoch wouldn’t speculate on any specific near-term sales projections for Breyanzi and Abecma, she said “there is no question that this was an important step forward in being able to increase the number of patients that are eligible for CAR T to receive a CAR T.” Beyond the potential for market expansion for approved CAR T therapies, William Blair noted possible readthrough benefits for those in development, such as such as Arcellx and Gilead’s anito-cel, whose positive neurotoxicity profile could help it compete against J&J and Legend’s Carvykti in relapsed or refractory multiple myeloma. “This update also suggests that we may not see REMS requirements for CD19 and BCMA autologous CAR-T cell therapies approved in the future, such as Arcellx’s anito-cel,” the firm wrote. Further, William Blair said the news is a “positive signal” to companies developing CAR T therapies for autoimmune diseases, including BMS, Autolus and Cabaletta Bio, “given that the safety pro more tolerable than in oncology.” This is a field that is currently exploding, as evidenced by AbbVie’s $2.1 billion buyout of Capstan Therapeutics and its in vivo edited CAR T therapy for B cell–mediated autoimmune diseases on Monday. From a regulatory standpoint, Hoch agreed that last week’s CAR T label changes are indicative of the FDA’s broader thinking around the cell and gene therapy space. “I think the FDA’s decision signals an increase in confidence in the safety pro therapy. It’s also reflective of making a data-driven decision,” she said, noting that over 30,000 patients have been treated with CAR T therapies. “To us, it shows a very strong signal from the FDA.”