Sofosbuvir/Velpatasvir

Product Sales Excluding Veklury Increased 4% Year-Over-Year to $6.3 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.1 billion FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2025 results of operations. “Gilead had a strong start to the year driven by excellent commercial and clinical execution along with disciplined expense management,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Our base business grew 4% year-over-year, primarily led by Biktarvy’s continued strength, and we announced positive topline Phase 3 results for Trodelvy plus pembrolizumab in first line PD-L1+ metastatic triple negative breast cancer. With the upcoming June PDUFA date for lenacapavir for HIV prevention, and continued progress across our diverse pipeline, we look forward to building on our positive momentum throughout the year.” First Quarter 2025 Financial Results Total first quarter 2025 revenue of $6.7 billion remained flat compared to the same period in 2024, with lower Veklury® (remdesivir) and Oncology sales offset by higher HIV and Liver Disease sales. Diluted earnings (loss) per share (“EPS”) was $1.04 in the first quarter 2025 compared to $(3.34) in the same period in 2024. The increase was primarily driven by prior year charges that did not repeat, including the impact of a $3.9 billion acquired in-process research and development ("IPR&D") expense related to the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), as well as a pre-tax IPR&D impairment of $2.4 billion related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020. This increase was partially offset by higher tax expense and higher net unrealized losses on equity investments in the first quarter 2025. Non-GAAP diluted EPS was $1.81 in the first quarter 2025 compared to $(1.32) in the same period in 2024. The increase was primarily driven by the prior year IPR&D expense related to the CymaBay acquisition. As of March 31, 2025, Gilead had $7.9 billion of cash and cash equivalents compared to $10.0 billion as of December 31, 2024. During the first quarter 2025, Gilead generated $1.8 billion in operating cash flow. During the first quarter 2025, Gilead paid dividends of $1.0 billion and repurchased $730 million of common stock. In addition, Gilead repaid $1.8 billion of Senior Notes in February 2025. First Quarter 2025 Product Sales Total first quarter 2025 product sales decreased 1% to $6.6 billion compared to the same period in 2024. Total first quarter 2025 product sales excluding Veklury increased 4% to $6.3 billion compared to the same period in 2024, primarily due to higher HIV and Liver Disease sales, partially offset by lower Oncology sales. HIV product sales increased 6% to $4.6 billion in the first quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and demand. Biktarvy®(bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 7% to $3.1 billion in the first quarter 2025 compared to the same period in 2024, primarily driven by higher demand. Descovy®(FTC 200mg/TAF 25mg) sales increased 38% to $586 million in the first quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and higher demand. The Liver Disease portfolio sales increased 3% to $758 million in the first quarter 2025 compared to the same period in 2024. This was primarily driven by increased demand in products for primary biliary cholangitis (“PBC”), chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”), partially offset by lower average realized price for chronic hepatitis C virus (“HCV”) products. Veklury sales decreased 45% to $302 millionin the first quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19 related hospitalizations across regions. Cell Therapy product sales decreased 3% to $464 million in the first quarter 2025 compared to the same period in 2024. Yescarta® (axicabtagene ciloleucel) sales increased 2% to $386 million in the first quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and increased rest of world demand, partially offset by lower demand in the United States. Tecartus® (brexucabtagene autoleucel) sales decreased 22% to $78 million in the first quarter 2025 compared to the same period in 2024, primarily reflecting lower demand in the United States. Trodelvy® (sacituzumab govitecan-hziy) sales decreased 5% to $293 million in the first quarter 2025 compared to the same period in 2024, primarily driven by inventory dynamics and lower average realized price, partially offset by higher demand. First Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 76.7% in the first quarter 2025 compared to 76.6% in the same period in 2024. Non-GAAP product gross margin was 85.5% in the first quarter 2025 compared to 85.4% in the same period in 2024. Research and development (“R&D”) expenses were $1.4 billion in the first quarter 2025 compared to $1.5 billion in the same period in 2024, primarily due to lower clinical manufacturing activities and prior year CymaBay acquisition-related expenses that did not repeat. Non-GAAP R&D expenses were $1.3 billion in the first quarter 2025 compared to $1.4 billion in the same period in 2024, primarily due to lower clinical manufacturing activities. Acquired IPR&D expenses were $253 million in the first quarter 2025, primarily reflecting expenses related to the strategic partnership with LEO Pharma A/S (“LEO Pharma”) announced in January 2025. Selling, general and administrative (“SG&A”) expenses were $1.3 billion in the first quarter 2025 compared to $1.4 billion in the same period in 2024, primarily driven by prior year CymaBay acquisition-related expenses that did not repeat as well as lower corporate expenses, partially offset by incremental selling and marketing expenses in the United States. Non-GAAP SG&A expenses were $1.2 billion in the first quarter 2025 compared to $1.3 billion in the same period in 2024. This was primarily driven by lower corporate expenses, partially offset by incremental selling and marketing expenses in the United States. The effective tax rate (“ETR”) was 20.2% in the first quarter 2025 compared to 7.0% in the same period in 2024, and the non-GAAP ETR was 16.3% in the first quarter 2025 compared to (29.8)% in the same period in 2024. These changes primarily reflect the prior year non-deductible acquired IPR&D charge related to the CymaBay acquisition, and higher tax benefits from stock-based compensation. Guidance and Outlook For the full-year, Gilead expects: (in millions, except per share amounts) April 24, 2025 Guidance Low End High End Comparison to Prior Guidance Product sales $ 28,200 $ 28,600 Unchanged Product sales excluding Veklury $ 26,800 $ 27,200 Unchanged Veklury $ 1,400 $ 1,400 Unchanged Diluted EPS $ 5.65 $ 6.05 Previously $5.95 to $6.35 Non-GAAP diluted EPS $ 7.70 $ 8.10 Unchanged 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 FDA accepted New Drug Application submissions for twice-yearly lenacapavir for HIV prevention under priority review, with a PDUFA date of June 19, 2025. Announced the European Medicines Agency validated the Marketing Authorization Application and EU-Medicines for All application for twice-yearly lenacapavir for HIV prevention, which will undergo parallel reviews under an Accelerated Assessment timeline. Presented initial Phase 1 data evaluating investigational once-yearly lenacapavir for HIV prevention at the Conference on Retroviruses and Opportunistic Infections (“CROI”), and announced plans to launch a Phase 3 study in the second half of 2025. Presented HIV treatment research data at CROI, including long-term outcomes evaluating the use of Biktarvy in people with HIV/HBV coinfection and the primary results of a Phase 2 study evaluating the investigational combination regimen of lenacapavir and broadly neutralizing antibodies teropavimab and zinlirvimab. Oncology Announced Trodelvy plus Keytruda® (pembrolizumab) demonstrated a statistically significant and clinically meaningful improvement in progression free survival in patients with previously untreated PD-L1+ unresectable locally advanced or metastatic triple-negative breast cancer in the Phase 3 ASCENT-04 trial. The use of Trodelvy plus Keytruda is investigational in this setting. Inflammation Received conditional marketing authorization from the European Commission for seladelpar for the treatment of PBC in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Corporate The Board declared a quarterly dividend of $0.79 per share of common stock for the second quarter of 2025. The dividend is payable on June 27, 2025, to stockholders of record at the close of business on June 13, 2025. Future dividends will be subject to Board approval. 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 CymaBay and Immunomedics, and the arrangement with LEO Pharma; 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 Biktarvy, Trodelvy, lenacapavir, teropavimab and zinlirvimab, 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 submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines, including for lenacapavir for HIV PrEP; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, including for lenacapavir for 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 Livdelzi/Lyvdelzi; 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 March 31, 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® and ZYDELIG®. 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 March 31, (in millions, except per share amounts) 2025 2024 Revenues: Product sales $ 6,613 $ 6,647 Royalty, contract and other revenues 54 39 Total revenues 6,667 6,686 Costs and expenses: Cost of goods sold 1,540 1,552 Research and development expenses 1,379 1,520 Acquired in-process research and development expenses 253 4,131 In-process research and development impairments — 2,430 Selling, general and administrative expenses 1,258 1,375 Total costs and expenses 4,430 11,008 Operating income (loss) 2,237 (4,322 ) Interest expense 260 254 Other (income) expense, net 328 (91 ) Income (loss) before income taxes 1,649 (4,486 ) Income tax expense (benefit) 334 (315 ) Net income (loss) 1,315 (4,170 ) Net income attributable to noncontrolling interest — — Net income (loss) attributable to Gilead $ 1,315 $ (4,170 ) Basic earnings (loss) per share attributable to Gilead $ 1.06 $ (3.34 ) Diluted earnings (loss) per share attributable to Gilead $ 1.04 $ (3.34 ) Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,246 1,247 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,259 1,247 Supplemental Information: Cash dividends declared per share $ 0.79 $ 0.77 Product gross margin 76.7 % 76.6 % Research and development expenses as a % of revenues 20.7 % 22.7 % Selling, general and administrative expenses as a % of revenues 18.9 % 20.6 % Operating margin 33.6 % (64.6 )% Effective tax rate 20.2 % 7.0 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended March 31, (in millions, except percentages) 2025 2024 Change Product sales: HIV $ 4,587 $ 4,342 6% Liver Disease 758 737 3% Oncology 757 789 (4)% Other 209 224 (7)% Total product sales excluding Veklury 6,311 6,092 4% Veklury 302 555 (45)% Total product sales 6,613 6,647 (1)% Royalty, contract and other revenues 54 39 37% Total revenues $ 6,667 $ 6,686 —% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended March 31, (in millions, except percentages) 2025 2024 Change Non-GAAP: Cost of goods sold $ 961 $ 974 (1)% Research and development expenses $ 1,338 $ 1,403 (5)% Acquired IPR&D expenses(2) $ 253 $ 4,131 (94)% Selling, general and administrative expenses $ 1,222 $ 1,295 (6)% Other (income) expense, net $ (98 ) $ (104 ) (6)% Diluted earnings (loss) per share attributable to Gilead $ 1.81 $ (1.32 ) NM Shares used in non-GAAP diluted earnings (loss) per share attributable to Gilead calculation 1,259 1,247 1% Product gross margin 85.5 % 85.4 % 12 bps Research and development expenses as a % of revenues 20.1 % 21.0 % -91 bps Selling, general and administrative expenses as a % of revenues 18.3 % 19.4 % -104 bps Operating margin 43.4 % (16.7 )% NM Effective tax rate 16.3 % (29.8 )% NM (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 March 31, (in millions, except percentages and per share amounts) 2025 2024 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,540 $ 1,552 Acquisition-related – amortization(1) (579 ) (579 ) Non-GAAP cost of goods sold $ 961 $ 974 Product gross margin reconciliation: GAAP product gross margin 76.7 % 76.6 % Acquisition-related – amortization(1) 8.8 % 8.7 % Non-GAAP product gross margin 85.5 % 85.4 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,379 $ 1,520 Acquisition-related – other costs(2) (2 ) (66 ) Restructuring (38 ) (50 ) Non-GAAP research and development expenses $ 1,338 $ 1,403 IPR&D impairment reconciliation: GAAP IPR&D impairment $ — $ 2,430 IPR&D impairment — (2,430 ) Non-GAAP IPR&D impairment $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,258 $ 1,375 Acquisition-related – other costs(2) — (67 ) Restructuring (36 ) (13 ) Non-GAAP selling, general and administrative expenses $ 1,222 $ 1,295 Operating income (loss) reconciliation: GAAP operating income (loss) $ 2,237 $ (4,322 ) Acquisition-related – amortization(1) 579 579 Acquisition-related – other costs(2) 2 133 Restructuring 74 63 IPR&D impairment — 2,430 Non-GAAP operating income (loss) $ 2,893 $ (1,117 ) Operating margin reconciliation: GAAP operating margin 33.6 % (64.6 )% Acquisition-related – amortization(1) 8.7 % 8.7 % Acquisition-related – other costs(2) — % 2.0 % Restructuring 1.1 % 0.9 % IPR&D impairment — % 36.3 % Non-GAAP operating margin 43.4 % (16.7 )% Other (income) expense, net reconciliation: GAAP other (income) expense, net $ 328 $ (91 ) Loss from equity securities, net (426 ) (14 ) Non-GAAP other (income) expense, net $ (98 ) $ (104 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 1,649 $ (4,486 ) Acquisition-related – amortization(1) 579 579 Acquisition-related – other costs(2) 2 133 Restructuring 74 63 IPR&D impairment — 2,430 Loss from equity securities, net 426 14 Non-GAAP income (loss) before income taxes $ 2,731 $ (1,267 ) GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended March 31, (in millions, except percentages and per share amounts) 2025 2024 Income tax expense (benefit) reconciliation: GAAP income tax expense (benefit) $ 334 $ (315 ) Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 120 121 Acquisition-related – other costs(2) — 30 Restructuring 14 10 IPR&D impairment — 611 Loss (gain) from equity securities, net 20 (39 ) Discrete and related tax charges(3) (42 ) (39 ) Non-GAAP income tax expense $ 446 $ 379 Effective tax rate reconciliation: GAAP effective tax rate 20.2 % 7.0 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(3) (3.9 )% (36.8 )% Non-GAAP effective tax rate 16.3 % (29.8 )% Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,315 $ (4,170 ) Acquisition-related – amortization(1) 459 458 Acquisition-related – other costs(2) 2 103 Restructuring 61 54 IPR&D impairment — 1,819 Loss from equity securities, net 406 53 Discrete and related tax charges(3) 42 39 Non-GAAP net income (loss) attributable to Gilead $ 2,285 $ (1,644 ) Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.04 $ (3.34 ) Acquisition-related – amortization(1) 0.36 0.37 Acquisition-related – other costs(2) — 0.08 Restructuring 0.05 0.04 IPR&D impairment — 1.46 Loss from equity securities, net 0.32 0.04 Discrete and related tax charges(3) 0.03 0.03 Non-GAAP diluted earnings (loss) per share $ 1.81 $ (1.32 ) Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 579 Research and development expenses adjustments 40 117 IPR&D impairment adjustments — 2,430 Selling, general and administrative expenses adjustments 36 80 Total non-GAAP adjustments to costs and expenses 656 3,205 Other (income) expense, net, adjustments 426 14 Total non-GAAP adjustments before income taxes 1,082 3,219 Income tax effect of non-GAAP adjustments above (154 ) (732 ) Discrete and related tax charges(3) 42 39 Total non-GAAP adjustments to net income attributable to Gilead $ 970 $ 2,526 (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 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 77.0% - 78.0% 77.0% - 78.0% Acquisition-related expenses ~ 8.0% ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $10,200 - $10,700 $10,200 - $10,700 Acquisition-related and restructuring expenses ~ 2,500 ~ 2,500 Non-GAAP projected operating income $12,700 - $13,200 $12,700 - $13,200 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 20% ~ 21% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 1%) (~ 2%) Non-GAAP projected effective tax rate ~ 19% ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.95 - $6.35 $5.65 - $6.05 Acquisition-related and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.75 ~ 2.05 Non-GAAP projected diluted EPS $7.70 - $8.10 $7.70 - $8.10 (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) March 31, December 31, (in millions) 2025 2024 Assets Cash and cash equivalents $ 7,926 $ 9,991 Accounts receivable, net 4,388 4,420 Inventories 3,778 3,589 Property, plant and equipment, net 5,421 5,414 Intangible assets, net 19,355 19,948 Goodwill 8,314 8,314 Other assets 7,253 7,319 Total assets $ 56,434 $ 58,995 Liabilities and Stockholders’ Equity Current liabilities $ 12,344 $ 12,004 Long-term liabilities 25,012 27,744 Stockholders’ equity(1) 19,078 19,246 Total liabilities and stockholders’ equity $ 56,434 $ 58,995 (1) As of March 31, 2025 and December 31, 2024, there were 1,245 and 1,246 shares of common stock issued and outstanding, respectively. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended March 31, (in millions) 2025 2024 Net cash provided by operating activities $ 1,757 $ 2,219 Net cash used in investing activities (415 ) (2,207 ) Net cash used in financing activities (3,426 ) (1,361 ) Effect of exchange rate changes on cash and cash equivalents 19 (18 ) Net change in cash and cash equivalents (2,065 ) (1,367 ) Cash and cash equivalents at beginning of period 9,991 6,085 Cash and cash equivalents at end of period $ 7,926 $ 4,718 Three Months Ended March 31, (in millions) 2025 2024 Net cash provided by operating activities $ 1,757 $ 2,219 Purchases of property, plant and equipment (104 ) (105 ) Free cash flow(1) $ 1,653 $ 2,114 (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 March 31, (in millions) 2025 2024 HIV Biktarvy – U.S. $ 2,474 $ 2,315 Biktarvy – Europe 375 365 Biktarvy – Rest of World 301 265 3,150 2,946 Descovy – U.S. 538 371 Descovy – Europe 21 26 Descovy – Rest of World 27 29 586 426 Genvoya – U.S. 305 332 Genvoya – Europe 40 49 Genvoya – Rest of World 19 21 364 403 Odefsey – U.S. 215 223 Odefsey – Europe 57 76 Odefsey – Rest of World 10 11 281 310 Symtuza - Revenue share(1) – U.S. 82 104 Symtuza - Revenue share(1) – Europe 29 33 Symtuza - Revenue share(1) – Rest of World 3 3 114 141 Other HIV(2) – U.S. 50 60 Other HIV(2) – Europe 31 45 Other HIV(2) – Rest of World 10 12 91 117 Total HIV – U.S. 3,664 3,405 Total HIV – Europe 553 596 Total HIV – Rest of World 370 342 4,587 4,342 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 166 248 Sofosbuvir / Velpatasvir(3) – Europe 80 79 Sofosbuvir / Velpatasvir(3) – Rest of World 99 78 346 405 Vemlidy – U.S. 100 95 Vemlidy – Europe 12 11 Vemlidy – Rest of World 140 119 252 225 Other Liver Disease(4) – U.S. 68 42 Other Liver Disease(4) – Europe 76 47 Other Liver Disease(4) – Rest of World 17 19 161 107 Total Liver Disease – U.S. 335 385 Total Liver Disease – Europe 168 137 Total Liver Disease – Rest of World 256 215 758 737 Veklury Veklury – U.S. 199 315 Veklury – Europe 22 70 Veklury – Rest of World 82 169 302 555 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended March 31, (in millions) 2025 2024 Oncology Cell Therapy Tecartus – U.S. 40 55 Tecartus – Europe 31 36 Tecartus – Rest of World 8 8 78 100 Yescarta – U.S. 160 170 Yescarta – Europe 149 158 Yescarta – Rest of World 77 52 386 380 Total Cell Therapy – U.S. 200 225 Total Cell Therapy – Europe 180 195 Total Cell Therapy – Rest of World 84 60 464 480 Trodelvy Trodelvy – U.S. 181 206 Trodelvy – Europe 75 68 Trodelvy – Rest of World 37 36 293 309 Total Oncology – U.S. 381 431 Total Oncology – Europe 255 262 Total Oncology – Rest of World 121 96 757 789 Other AmBisome – U.S. 5 14 AmBisome – Europe 67 70 AmBisome – Rest of World 66 60 139 144 Other(5) – U.S. 47 59 Other(5) – Europe 9 9 Other(5) – Rest of World 14 12 70 80 Total Other – U.S. 52 73 Total Other – Europe 76 79 Total Other – Rest of World 81 71 209 224 Total product sales – U.S. 4,631 4,609 Total product sales – Europe 1,073 1,144 Total product sales – Rest of World 909 894 $ 6,613 $ 6,647 (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 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, 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

▎药明康德内容团队报道 3月26日-30日，备受瞩目的第34届亚太肝病学会年会（APASL 2025）在北京举行。本次大会上，吉利德科学（Gilead Sciences）将以壁报和口头报告的形式公布31项肝病领域的最新研究成果，包括慢性乙型肝炎（CHB）领域富马酸丙酚替诺福韦（TAF）的3期临床研究中国队列随访8年的有效性和安全性数据，原发性胆汁性胆管炎（PBC）领域Seladelpar在亚裔PBC患者中的有效性和安全性数据，乙型肝炎病毒合并丙型肝炎病毒感染患者的抗病毒治疗的真实世界数据等。 吉利德科学新闻稿介绍，这些研究成果不仅将为加速消除病毒性肝炎提供重要的临床数据支持，还将进一步推动包括原发性胆汁性胆管炎在内的广泛肝病领域的科研发展。 中国CHB患者的8年随访数据显示TAF有效性和安全性良好 本次APASL会议上，南方医科大学南方医院感染内科主任侯金林教授将口头报告TAF在中国人群中为期8年的3期临床研究结果，该研究证实了TAF具有良好的有效性和安全性。 TAF在中国人群中的3期临床研究共纳入了334名CHB患者，在随机（2：1）接受TAF （25 mg，n=227）或富马酸替诺福韦酯（TDF，300 mg，n=107）双盲治疗三年后，接受TAF开放标签治疗至第8年。研究的有效性终点为治疗384周时，两组患者（即TAF→TAF组和TDF→TAF组）的病毒学抑制率；研究的安全性终点为不良事件（AEs）、各项骨肾安全性指标的变化，其中骨密度（BMD）的变化采用双能X射线吸收测定法（DXA）对髋骨和脊柱进行检测。 在334名CHB患者中，有311名进入开放标签阶段，其中 TAF-TAF组 212名，TDF-TAF组99名。第384周时，采用缺失即失败（M=F）的统计方法的结果显示，TAF-TAF组与TDF-TAF组的病毒学抑制率分别为79.3%（180/227）和78.5%（84/107）（P=0.8517），而通过缺失即排除（M=E）统计方法的结果显示，两组病毒学抑制率为95.2%（180/189）和95.5%（84/88）（P=0.9407）。两组患者在第384周的ALT复常率均较高（TAF-TAF组87.8% vs. TDF-TAF组84.9%，M=E分析，P=0.5514；M=F分析亦呈相似趋势）。此外，TAF-TAF组的血清学反应比例较高；在有基线Fibro Test评分的患者中，TAF-TAF组的肝纤维化状态改善、无变化及恶化的比例分别为26.1%、71.7%和2.2%，而TDF-TAF组为28.9%、61.4%和9.6%。且8年随访时间内，尚未发现对TAF的基因型耐药。 总体安全性数据显示，TAF治疗8年具有良好的安全性。3级及以上的不良事件发生率均较低，TAF-TAF组为5.7%（12/212）和TDF-TAF组为6.1%（6/99），未出现因不良事件导致中止的情况。在双盲阶段观察到的两组患者肾功能和骨参数之间的差异，在接受开放标签TAF治疗后逐渐缩小，至第384周，两组eGFR中位数较基线变化小且相当（-1.3 mL/min vs -2.0 mL/min，P=0.9233）。此外，双盲阶段观察到的两组之间RBP:Cr与ꞵ2M:Cr中位百分比变化的差异，在接受开放标签TAF治疗后也明显缩小，且使用TDF时出现的髋部和脊柱骨密度轻微下降现象在转换成TAF治疗后也有所改善。 该研究随访8年的有效性数据表明：无论是持续使用TAF还是由TDF转为TAF治疗，都能保持良好的抗病毒治疗效果；安全性数据表明：长期接受TAF治疗具有良好的安全性且耐受性良好，骨肾安全性得到有效维持，从TDF转换成TAF治疗的患者在骨肾安全性得到改善。 TAF在中国开展的3期临床研究随访至8年的有效性及安全性的结果，进一步支持TAF作为一线口服抗病毒药物之一在CHB中长期使用的有效性及安全性。 Seladelpar在PBC亚裔患者中展现出高有效性及安全性 Seladelpar是一种用于治疗原发性胆汁性胆管炎（PBC）的新型选择性过氧化物酶体增殖物激活受体δ（PPARδ）激动剂。该产品目前已经在美国、欧盟和英国获批，用于联合熊去氧胆酸治疗对熊去氧胆酸应答不佳或不耐受的原发性胆汁性胆管炎患者。 RESPONSE研究是一项随机、安慰剂对照、国际多中心3期试验，探索Seladelpar在PBC患者中的疗效和安全性。同时，Seladelpar长期安全性和耐受性正在一项开放标签试验ASSURE研究中被评估。在今年的APASL上，报告了RESPONSE研究和ASSURE研究中亚裔患者为期12个月的试验结果。 RESPONSE研究纳入对熊去氧胆酸（UDCA）应答不佳或不耐受的PBC患者，碱性磷酸酶（ALP）≥1.67倍正常值上限（ULN）且总胆红素（TB）≤2倍ULN的患者。患者每日口服10mg Seladelpar或安慰剂（2:1随机分组），持续12个月。根据ALP和瘙痒数值评定量表（NRS; 0-10）进行分层。主要终点是第12个月时的复合应答（定义为ALP＜1.67倍ULN，ALP下降≥15%且TB≤ULN）。关键次要终点是第12个月时ALP正常化以及第6个月时NRS的变化。ASSURE研究纳入既往参与Seladelpar研究的PBC患者，随访5年以评估Seladelpar的长期安全性和有效性，主要终点是治疗期间不良事件和生化及血液结果。 在RESPONSE研究的193名PBC患者中，有11名为亚裔患者（其中7例接受Seladelpar治疗，4例接受安慰剂治疗），其余182名为非亚裔患者。治疗第 12 个月时，亚裔患者中接受Seladelpar治疗的复合应答率为100%（7/7），安慰剂组为0%（0/4）；非亚裔患者中接受Seladelpar治疗的复合应答率为59.5%(72/121)；安慰剂组为21.3%（13/61）。在ASSURE研究的174名PBC患者中，有13名为亚裔患者，其余161名为非亚裔患者。8名亚裔患者以及140名非亚裔患者有第12个月时的随访数据，结果显示接受Seladelpar 10mg治疗的亚裔和非亚裔患者复合应答率分别为75%（6/8）和70%（98/140）。 在ALP复常方面，RESPONSE研究第12个月，接受Seladelpar治疗的亚裔患者，71.4%（5/7）患者实现了ALP复常，非亚裔患者有 22.3%（27/121）实现 ALP复常 ，安慰剂组中无患者实现 ALP 复常。ASSURE研究第12个月，接受Seladelpar治疗的亚裔患者ALP复常率为 25%（2/8），非亚裔患者ALP复常率为37.9%（53/140）。所有接受 Seladelpar的患者，无论是亚裔患者还是非亚裔患者，ALP 水平均有类似程度的降低。亚裔患者中接受Seladelpar治疗和接受安慰剂治疗不良事件发生率相似，无严重不良事件发生。 RESPONSE及ASSURE研究均表明Seladelpar能有效降低亚裔或非亚裔PBC患者的胆汁淤积相关生物标志物，且具有良好的安全性及耐受性。 索磷布韦维帕他韦联合预防性使用TAF在HBV/HCV合并感染患者中展现出高安全性和有效性 本次大会上还展示了一项来自中国16个中心，前瞻性，单臂，开放标签，为期12周，接续12/48周的观察性临床研究。该研究共纳入105例乙型肝炎病毒（HBV）/丙型肝炎病毒（HCV）GT1-6合并感染的成人患者。其中，83例非肝硬化患者被纳入第1组，22例代偿期肝硬化患者被纳入第2组。所有患者均接受抗HBV和HCV的治疗。具体治疗方案为：富马酸丙酚替诺福韦（TAF）单药治疗4周，随后TAF联合索磷布韦维帕他韦（SOF/VEL）治疗12周。非肝硬化患者继续每日一次TAF单药治疗12周，代偿期肝硬化患者继续每日一次TAF单药治疗48周。 研究结果显示，SOF/VEL治疗结束时，持续性病毒学应答率（SVR）为97.6%，其中，第2组的SVR率达到100%。所有患者HCV RNA和HBV DNA水平均显著下降（p＜0.001）。与治疗前相比，第1组治疗至12周时，丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、总胆红素（TBIL）水平均显著下降（p＜0.05），白蛋白（ALB）水平显著上升（p＜0.001）。第2组治疗至48周时，ALT、AST水平显著下降（p＜0.001），ALB、血小板（PLT）水平显著上升（p＜0.05），肝脏硬度值（LSM）、天门冬氨酸氨基转移酶血小板比值（APRI）和FIB-4指数（FIB-4）均显著下降（p＜0.05）。第1组中仅1例GT3型患者出现HBV再激活。本研究未观察到与药物相关的不良事件。 该研究结果表明SOF/VEL可显著降低HBV/HCV合并感染患者的HCV RNA水平，改善肝功能，且安全性较高。抗病毒治疗后，代偿期肝硬化患者的肝功能指标显著改善。此外，HBV/HCV合共感染患者中预防性使用TAF在一定程度上可预防HBV再激活。 参考资料： [1]吉利德科学新闻稿. 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。