Darunavir

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

本周，多家药企财报密集发布。截至今日，创新转型药企“三剑客”2024年成绩单已集齐，在“A+H”新布局及“自研+BD”研发长线策略下，三家头部大药企集体表现出了韧劲和应对变化的灵敏度。数家创新药企发布财报，以云顶新耀、基石药业为代表的Biotech，凭以自身不错的商业化成果助力自身渐回高峰；以康宁杰瑞为代表的公司，则以BD交易寻找到了新的盈利增长点。然而，无论是大药企，还是创新药企，财报深处仍旧透露了他们各自为更好适应变化、快速穿越周期的压力和焦虑。CXO，作为创新药行业的晴雨表，侧面印证了过去一年整个行业还在破局的艰难探索路上。泰格医药，归母净利润约4.05亿元，同比下降79.99%；昭衍新药，归母净利润下降81.34%；博腾股份，年度净亏损2.88亿元……但要相信创新力量本身。本周，两起大额BD交易再次印证了中国新药之于国际舞台的重要性：联邦制药GLP-1/GIP/GCG授权给诺和诺德，交易总额最高约20亿美元；恒瑞也以近20亿美元将Lpa小分子抑制剂授权给了默沙东。一起看看本周都有什么大事发生？年报季复宏汉霖：2024年实现营业收入约人民币57.244亿元，较去年同期增长约6.1%，净利润达8.205亿元，同比增长50.3%。这是继2023年首次取得全年盈利之后，公司连续第二年实现全年盈利。核心产品商业化销售的持续扩大，成为业绩盈利的重要驱动力，产品销售收入合计约人民币49.335亿元，同比增长8.3%。云顶新耀：全年总收入大幅增长461%，达7.067亿元，超额完成7亿元既定目标；实现高毛利率83%，运营费用占收入比重大幅减少562%，非国际财务准则亏损总额显著收窄25%，现金储备达人民币16亿元，首次实现了年度商业化层面盈利。全球首个对因治疗IgA肾病药物耐赋康年内实现3.534亿元收入，同比增长1581%。全球首个氟环素类抗菌药物依嘉，实现收入3.528亿元，同比增长256%。康宁杰瑞：全年收入飙升至6.4亿元，同比增长192%，并实现净利润1.66亿元，成功扭亏为盈。许可费收入表现尤为亮眼，成为推动收入增长的主要动力。百利天恒：实现营业总收入58.23亿元，同比增长936.31%；归母净利润37.08亿元，同比扭亏为盈；经营活动产生的现金流量净额为40.59亿元。君实生物：实现营业收入19.48亿元，同比上升29.67%；归母净利润自上年同期亏损22.83亿元变为亏损12.81亿元。核心产品特瑞普利单抗获批适应证及纳入国家医保目录适应证增加，使得该药物的国内市场销售额同比大幅增长。科伦博泰：实现营业收入19.33亿元，同比增长25.5%；毛利达12.74亿元，增幅67.8%。调整后年度亏损同比大幅收窄73.7%至1.18亿元，经营效率显著优化。华北制药：公司实现营业收入98.70亿元，同比下滑2.48%；实现归母净利润1.27亿元，同比增长2496.8%。药明生物：2024年实现收入186.754亿元，同比增长9.6%；全年纯利为39.45亿元，同比增长10.5%。公司新增151个综合项目，综合项目总数高达817个，其中超过一半新增项目来自美国客户。政策动态2025版《药典》发布：3月25日，国家药监局、国家卫健委发出《关于2025年版《中华人民共和国药典》的公告》，根据《中华人民共和国药品管理法》，2025年版《中华人民共和国药典》将自2025年10月1日起施行。据观察，新版中国药典中有19种中成药被剔除。全国药政工作会议在京召开：会议强调，在研究完善国家药品制度、实施基层药品联动服务行动、巩固完善国家基本药物制度、整体提升全国短缺药品应对处置质效、深化药品使用监测和临床综合评价结果拓展应用、健全激励药师药学服务机制、持续提升特殊人群及特定疾病药品应用管理实效等方面，聚焦协同发展，强化治理转型，加快构建药品供应保障高质量发展新格局。北京将新设100亿元规模医药并购基金：3月26日，北京市医保局局长马继业3月26日在博鳌亚洲论坛期间透露，北京市充分发挥市级200亿元医药健康投资基金的作用，2024年，投决金额和撬动社会资本近100亿元。今年将再新设100亿元规模的医药并购基金，构建全周期接续支持、市区协同的医药健康产业基金体系。26省联盟启动带量采购：3月28日，山西省药械集中招标采购中心发布《关于做好二十六省联盟药品集中带量采购品种数据填报工作的通知》。此前，一份《关于填报二十六省联盟药品集中带量采购品种采购需求量的通知》在业内流传，文件共涉及50个药品，覆盖妇科及激素类、造影剂等重点品种。大型制药卫材出售雷贝拉唑钠中国权益：3 月 28 日，日本卫材制药宣布，将其质子泵抑制剂波利特（通用名：雷贝拉唑钠肠溶片）在中国的权利转让给康桥资本集团控制的北京顶峰生物医药。随着集采政策的推进和市场竞争的加剧，该产品市场表现面临一定挑战。此次交易标志着卫材制药在优化全球资源配置、聚焦核心业务领域的战略调整中迈出了重要一步。强生被判罚16.4亿美元：据行业媒体报道，强生旗下子公司在推广HIV药物Prezista和Intelence时，存在非法行为，根据判决，需向美国政府支付3.6亿美元，以弥补其违反联邦《虚假申报法》的过错。此外，还需承担12.8亿美元的民事罚款。恒瑞医药Lpa小分子抑制剂授权给默沙东：3月25日，恒瑞医药宣布将Lpa小分子抑制剂HRS-5346的大中华区以外全球权益授权给默沙东。根据协议，默沙东将支付2亿美元预付款，17.7亿美元里程碑金额，以及一定比例的销售分成。联邦制药GLP-1/GIP/GCG授权给诺和诺德：3月24日，联邦制药宣布将GLP-1/GIP/GCG受体激动剂UBT251的大中华区外全球权益授权给诺和诺德，诺和诺德支付2亿美元预付款、18亿美元里程碑金额，以及一定比例的销售分成。UBT251为联邦制药自主研发的GLP-1/GIP/GCG受体激动剂，目前处于糖尿病、减重II期的临床试验阶段。阿斯利康呼吸领域首款生物制剂在华正式商业上市：阿斯利康宣布，其重度嗜酸粒细胞性哮喘（SEA）创新靶向生物制剂本瑞利珠单抗注射液（商品名：凡舒卓）在中国正式商业上市，用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘的维持治疗。本瑞利珠单抗是精准靶向嗜酸性粒细胞（EOS）的抗IL-5R创新生物制剂，也是阿斯利康在呼吸领域的首款生物制剂。罗氏制药与默克达成战略合作，推进中国肺癌精准治疗：3月26日，罗氏制药和默克共同宣布双方正式签订协议，就特泊替尼在中国大陆市场的商业化达成合作。特泊替尼是全球首个获批上市的MET抑制剂，于2023年12月在中国获批上市，通过靶向METex 14跳跃突变等特定靶点，用于非小细胞肺癌患者的精准治疗。赛诺菲血友病新药获FDA批准：赛诺菲和Alnylam联合开发的潜在重磅siRNA疗法Qfitlia（fitusiran）于近期获美国FDA批准，该疗法通过抑制肝脏中抗凝血酶的生产，有望成为一种革命性的预防手段。这是美国批准的第六款Alnylam发现的RNAi治疗药物，也是唯一一种降低抗凝血酶的治疗药物。生物科技基石药业向欧洲递交舒格利单抗治疗III期非小细胞肺癌的新适应证申请：3月24日，基石药业宣布已向欧洲药品管理局（EMA）提交舒格利单抗的新适应证申请，用于治疗同步或序贯放化疗（CRT）后未出现疾病进展的、不可切除的III期非小细胞肺癌（NSCLC）患者。这是继2024年该药物首次获EMA批准用于转移性鳞状和非鳞状NSCLC一线治疗后，基石药业在欧洲市场推进的第二项适应证。三叶草生物陷2.24亿美元纠纷：3月24日，三叶草生物发布公告，全资附属子公司三叶草生物制药（香港）有限公司收到全球疫苗免疫联盟（GAVI）的书面通知，称其单方面终止预购协议，并要求三叶草香港退还预付款项2.24亿美元。而三叶草生物方面表示，公司拒绝有关退款的要求，认为基于预购协议条款该等要求缺乏依据，并将全力以赴、严正有力地维护自身权益。全球首创阿尔茨海默病新药III期研究再次失败：3月25日，Cassava Sciences公司宣布其Simufilam治疗轻度至中度阿尔茨海默病（AD）的III期REFOCUS-ALZ研究未达到主要终点。此前，该研究因III期RETHINK-ALZ研究失败在2024年11月25日终止开展。资本市场上海莱士拟收购南岳生物：3月26日，上海莱士宣布拟以42亿元收购南岳生物100%股权，南岳生物是湖南省唯一拥有GMP证照的血液制品生产企业，其生产基地的设计产能达500吨、目前旗下在运营的单采血浆站共9家，2024年采浆量达278吨。本次收购旨在进一步拓展公司血浆资源和优质生产基地，与上海莱士现有优势资源形成协同与互补。香雪制药将被ST：近日，香雪制药发布公告，称收到中国证监会发出的《行政处罚事先告知书》，经查明，公司2019年年度报告存在虚假记载；未按规定披露关联方非经营性资金占用，2016年至2020年年度报告存在重大遗漏。香雪制药、公司实控人王永辉，时任董事和高管卢锋、陈炳华、黄滨、徐力、郝世明被警告及罚款15万元到1000万元不等，另外，王永辉被实施5年证券市场禁入措施。智飞生物斥资近6亿增资控股宸安生物：近日，智飞生物发布公告，称将以现金5.93亿元人民币对重庆宸安生物制药有限公司进行增资，取得后者51%的股权。早在2023年11月，智飞生物就与宸安生物原股东就智飞生物拟以现金形式收购宸安生物股权达成初步意向并签署了《股权收购意向性协议》，此次公告意味着该交易真正落地。基因检测公司23andMe申请破产：在多年努力寻找可持续的商业模式却未能成功后，23andMe于近日申请第11章破产保护，以便推动公司出售。在宣布破产的一份声明中，该公司称其首席执行官Anne Wojcicki已立即辞职，不过她将继续留在公司董事会。丽珠生物获10亿元增资：丽珠集团发布公告，称拟使用自有资金10亿元向珠海市丽珠生物医药科技有限公司增资。丽珠生物为公司与控股股东健康元药业集团股份有限公司共同投资的企业，本次交易构成关联交易。增资完成后，丽珠生物的注册资本将从10.95亿元增加至13.02亿元，公司持股比例将提升至66.54%。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册