Tenofovir Alafenamide Fumarate

Product Sales Excluding Veklury Increased 8% Year-Over-Year to $26.8 billion for Full Year 2024 Biktarvy Sales Increased 13% Year-Over-Year to $13.4 billion for Full Year 2024 Oncology Sales Increased 12% Year-Over-Year to $3.3 billion for Full Year 2024 FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2024. “Gilead delivered another exceptionally strong full year and fourth quarter, with growth in our base business product sales of 8% for 2024 and 13% year-over-year for the fourth quarter,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “From this foundation of commercial strength, we are planning for the potential launch of lenacapavir for HIV PrEP in Summer 2025, with its unique opportunity to extend the reach of HIV prevention. This potential in HIV, along with our strong and diverse portfolio, and improved operational efficiencies, positions Gilead to deliver increasing patient impact and compelling shareholder returns in the years ahead.” Fourth Quarter 2024 Financial Results Total fourth quarter 2024 revenue increased 6% to $7.6 billion compared to the same period in 2023, primarily due to higher sales in HIV, as well as in Oncology and Liver Disease, partially offset by lower sales of Veklury® (remdesivir). Diluted Earnings Per Share (“EPS”) increased to $1.42 in the fourth quarter 2024 compared to $1.14 in the same period in 2023, primarily driven by lower costs of goods sold, higher product sales and lower acquired in-process research and development ("IPR&D") expenses, partially offset by higher operating expenses as well as unrealized losses on equity investments in 2024 compared to gains in 2023. Non-GAAP diluted EPS increased to $1.90 in the fourth quarter 2024 compared to $1.72 in the same period in 2023. The increase was primarily driven by higher product sales and lower acquired IPR&D expenses, partially offset by higher operating expenses. As of December 31, 2024, Gilead had $10.0 billion of cash, cash equivalents and marketable debt securities compared to $8.4 billion as of December 31, 2023. During the fourth quarter 2024, Gilead generated $3.0 billion in operating cash flow. During the fourth quarter 2024, Gilead issued senior unsecured notes in an aggregate principal amount of $3.5 billion, paid cash dividends of $973 million and utilized $350 million to repurchase common stock. Fourth Quarter 2024 Product Sales Total fourth quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total product sales excluding Veklury increased 13% to $7.2 billion compared to the same period in 2023, primarily due to higher sales in HIV, as well as in Oncology and Liver Disease. HIV product sales increased 16% to $5.5 billion in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favorable inventory dynamics. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 21% to $3.8 billion in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, favorable inventory dynamics and higher average realized price. Descovy® (FTC 200mg/TAF 25mg) sales increased 21% to $616 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favorable inventory dynamics. The Liver Disease portfolio sales increased 4% to $719 million in the fourth quarter 2024 compared to the same period in 2023. This was primarily driven by the launch of Livdelzi® (seladelpar) in primary biliary cholangitis (“PBC”), and increased demand in products for chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”), partially offset by lower demand and average realized price in products for chronic hepatitis C virus (“HCV”). Veklury sales decreased 53% to $337 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations, particularly in the United States. Cell Therapy product sales increased 5% to $488 million in the fourth quarter 2024 compared to the same period in 2023. Yescarta® (axicabtagene ciloleucel) sales increased 6% to $390 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher average realized price and increased demand outside of the United States, partially offset by lower demand in the United States. Tecartus® (brexucabtagene autoleucel) sales of $98 million in the fourth quarter 2024 were flat compared to the same period in 2023, reflecting increased demand outside of the United States, offset by lower demand in the United States. Trodelvy® (sacituzumab govitecan-hziy) sales increased 19% to $355 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by increased demand in all regions, as well as higher average realized price. Fourth Quarter 2024 Product Gross Margin, Operating Expenses and Tax Product gross margin was 79.0% in the fourth quarter 2024 compared to 70.4% in the same period in 2023, primarily driven by prior year restructuring expenses related to changes in our manufacturing strategy. Non-GAAP product gross margin was 86.7% in the fourth quarter 2024 compared to 86.1% in the same period in 2023. Research and development (“R&D”) expenses were $1.6 billion in the fourth quarter 2024 compared to $1.4 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio and the impact of a prior year valuation adjustment to the MYR-related contingent consideration that did not repeat. Non-GAAP R&D expenses were $1.6 billion in the fourth quarter 2024 compared to $1.5 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio. Acquired IPR&D expenses were $(11) million in the fourth quarter 2024, reflecting expenses related to the Terray Therapeutics, Inc. (“Terray”) and Tubulis GmbH (“Tubulis”) collaborations, offset by a favorable adjustment related to the CymaBay Therapeutics, Inc. (“CymaBay”) acquisition. Selling, general and administrative (“SG&A”) and non-GAAP SG&A expenses were $1.9 billion in the fourth quarter 2024 compared to $1.6 billion in the same period in 2023, primarily driven by a litigation accrual and higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV pre-exposure prophylaxis (“PrEP”) as well as for Livdelzi. The effective tax rate (“ETR”) was 17.8% in the fourth quarter 2024 compared to 14.3% in the same period in 2023, primarily due to prior year settlements with tax authorities and non-taxable unrealized gains and losses on equity investments. Non-GAAP ETR was 19.2% in the fourth quarter 2024 compared to 17.1% in the same period in 2023, primarily due to prior year settlements with tax authorities. Full Year 2024 Financial Results Total full year 2024 revenue increased 6% to $28.8 billion compared to 2023, primarily due to higher sales in HIV, Oncology and Liver Disease, partially offset by lower sales of Veklury. Diluted EPS decreased to $0.38 in the full year 2024 compared to $4.50 in 2023. The decrease was primarily driven by a pre-tax IPR&D impairment charge of $4.2 billion, or $2.49 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020, and acquired IPR&D charges of $3.9 billion, or $3.14 per share, in the first quarter 2024 related to the acquisition of CymaBay, partially offset by higher product sales. Non-GAAP diluted EPS decreased to $4.62 in the full year 2024 compared to $6.72 in 2023. This was primarily driven by higher acquired IPR&D expenses related to the CymaBay acquisition and higher income tax expense, partially offset by higher product sales. Full Year 2024 Product Sales Total full year 2024 product sales increased 6% to $28.6 billion compared to 2023. Total product sales excluding Veklury increased 8% to $26.8 billion in the full year 2024 compared to 2023, primarily driven by higher sales in HIV, Oncology and Liver Disease. HIV product sales increased 8% to $19.6 billion in the full year 2024 compared to 2023, primarily driven by higher demand, as well as the impact of higher average realized price. Biktarvy sales increased 13% to $13.4 billion in the full year 2024 compared to 2023, primarily driven by higher demand. Descovy sales increased 6% to $2.1 billion in the full year 2024 compared to 2023, primarily driven by higher demand, partially offset by lower average realized price. The Liver Disease portfolio sales increased 9% to $3.0 billion in the full year 2024 compared to 2023. The increase was primarily due to higher demand across all liver diseases. Veklury sales decreased 18% to $1.8 billion in the full year 2024 compared to 2023, primarily driven by lower rates of COVID-19 related hospitalizations. Cell Therapy product sales increased 6% to $2.0 billion in the full year 2024 compared to 2023. Yescarta sales increased 5% to $1.6 billion in the full year 2024 compared to 2023, primarily driven by increased demand outside of the United States and higher average realized price, partially offset by lower demand in the United States. Tecartus sales increased 9% to $403 million in the full year 2024 compared to 2023, primarily driven by increased demand outside of the United States, partially offset by lower demand in the United States. Trodelvy sales increased 24% to $1.3 billion in the full year 2024 compared to 2023, primarily driven by increased demand in all regions. Full Year 2024 Product Gross Margin, Operating Expenses and Tax Product gross margin was 78.2% in the full year 2024 compared to 75.9% in 2023, primarily driven by prior year restructuring expenses related to changes in our manufacturing strategy. Non-GAAP product gross margin was 86.2% in the full year 2024 compared to 86.3% in 2023. R&D expenses were $5.9 billion in the full year 2024 compared to $5.7 billion in 2023, primarily driven by restructuring costs and integration expenses related to the CymaBay acquisition. Non-GAAP R&D expenses of $5.7 billion in the full year 2024 were flat compared to 2023. Acquired IPR&D expenses were $4.7 billion in the full year 2024 compared to $1.2 billion in 2023, primarily reflecting the acquisition of CymaBay. SG&A expenses of $6.1 billion in the full year 2024 were flat compared to 2023, reflecting higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV PrEP as well as for Livdelzi, integration costs related to the acquisition of CymaBay, and restructuring expenses, offset by lower expenses related to legal matters. Non-GAAP SG&A expenses were $5.9 billion in the full year 2024 compared to $6.1 billion in 2023, primarily driven by lower expenses related to legal matters, partially offset by higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV PrEP as well as for Livdelzi. The ETR was 30.5% in the full year 2024 compared to 18.2% in 2023, primarily driven by the non-deductible acquired IPR&D charge for CymaBay and prior year decrease in tax reserves that did not repeat, partially offset by the tax impact of a legal entity restructuring and Immunomedics IPR&D impairment expense, as well as current year settlements with tax authorities and remeasurement of certain deferred tax liabilities. Non-GAAP ETR was 25.9% in the full year 2024 compared to 15.2% in 2023, primarily due to the non-deductible acquired IPR&D charge for CymaBay and a prior year decrease in tax reserves that did not repeat, partially offset by current year settlements with tax authorities. Guidance and Outlook For the full-year 2025, Gilead expects: (in millions, except per share amounts) February 11, 2025 Guidance Low End High End Product sales $ 28,200 $ 28,600 Product sales excluding Veklury $ 26,800 $ 27,200 Veklury $ 1,400 $ 1,400 Diluted EPS $ 5.95 $ 6.35 Non-GAAP diluted EPS $ 7.70 $ 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 Presented new HIV data at the International Congress on Drug Therapy in HIV Infection (“HIV Glasgow 2024”). This included full results from the Phase 3 PURPOSE 2 trial evaluating investigational twice-yearly lenacapavir for HIV prevention among cisgender men and gender-diverse people, with data published in theNew England Journal of Medicine. Additionally at HIV Glasgow 2024, presented new HIV treatment research data from Biktarvy, as well as for investigational regimens with once-daily, once-weekly and twice-yearly dosing frequencies. Completed the New Drug Application submissions to U.S. Food and Drug Administration (“FDA”), as well as a marketing authorization application and an EU-Medicines for All application to the European Medicines Agency (“EMA”), for twice-yearly lenacapavir for HIV prevention. Lenacapavir named by Science Magazine as its 2024 “Breakthrough of the Year,” based in part on the PURPOSE 1 and PURPOSE 2 trial results. Oncology Our partner, Arcellx, Inc. (“Arcellx”), presented new data evaluating investigational anitocabtagene autoleucel (“anito-cel”) in relapsed or refractory (“R/R”) multiple myeloma at the American Society of Hematology 2024 Annual Meeting (“ASH 2024”). This included preliminary data from the registrational Phase 2 iMMagine-1 trial, as well as updated Phase 1 data. Presented new data at ASH 2024 including long-term follow-up of Yescarta in R/R non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Yescarta in R/R large B-cell lymphoma and Tecartus in B-cell precursor adult acute lymphoblastic leukemia. Granted Breakthrough Therapy Designation by FDA to Trodelvy for the treatment of adult patients with extensive-stage small cell lung cancer (“ES-SCLC”) whose disease has progressed on or after platinum-based chemotherapy. The use of Trodelvy in ES-SCLC is investigational. Entered into a single-asset focused collaboration, license, and option agreement with Tubulis to develop an antibody-drug conjugate candidate for a solid tumor target using Tubulis’ Tubutecan and Alco5 platforms. Inflammation Received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use recommending 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. Received marketing authorization from the Medicines and Healthcare products Regulatory Agency in the UK for seladelpar for treatment of PBC, including pruritus, in adults in combination with UDCA who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Presented new data evaluating seladelpar in PBC at the American Association for the Study of Liver Diseases’ The Liver Meeting. This included longer-term follow-up data from the ASSURE trial, as well as additional analyses from the RESPONSE trial. Announced a strategic partnership to develop and commercialize the pre-clinical oral STAT6 program of LEO Pharma A/S (“LEO Pharma”) for the potential treatment of inflammatory diseases. Corporate Appointed Dietmar Berger, MD, PhD, as Chief Medical Officer effective January 2025. Entered into a strategic research collaboration with Terray to discover and develop novel, small molecule therapies across multiple targets using Terray’s artificial intelligence tNOVA platform. Reached a final settlement agreement with the U.S. Department of Justice and the U.S. Department of Health and Human Services on patents that the government alleged covered Truvada® (FTC 200mg/tenofovir disoproxil fumarate (“TDF”) 300mg) and Descovy for HIV PrEP. Issued $3.5 billion aggregate principal amount of senior unsecured notes in a registered offering. The Board declared a quarterly dividend of $0.79 per share of common stock for the first quarter of 2025. The dividend is payable on March 28, 2025, to stockholders of record at the close of business on March 14, 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; 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 arrangements with Arcellx, LEO Pharma, Terray and Tubulis; 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, Tecartus, Trodelvy, Yescarta, anito-cel, lenacapavir and seladelpar (such as the ASSURE, iMMagine-1, PURPOSE 1 and 2, and RESPONSE 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 submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines, including for lenacapavir for HIV PrEP and seladelpar for PBC; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, 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; 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 December 31, 2024 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. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITETM , AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LIVDELZI®, 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 Twelve Months Ended December 31, December 31, (in millions, except per share amounts) 2024 2023 2024 2023 Revenues: Product sales $ 7,536 $ 7,070 $ 28,610 $ 26,934 Royalty, contract and other revenues 33 45 144 182 Total revenues 7,569 7,115 28,754 27,116 Costs and expenses: Cost of goods sold 1,581 2,090 6,251 6,498 Research and development expenses 1,641 1,408 5,907 5,718 Acquired in-process research and development expenses (11 ) 347 4,663 1,155 In-process research and development impairments — 50 4,180 50 Selling, general and administrative expenses 1,906 1,608 6,091 6,090 Total costs and expenses 5,118 5,503 27,092 19,511 Operating income 2,451 1,612 1,662 7,605 Interest expense 248 252 977 944 Other (income) expense, net 35 (293 ) (6 ) (198 ) Income before income taxes 2,168 1,653 690 6,859 Income tax expense 385 236 211 1,247 Net income 1,783 1,417 480 5,613 Net loss attributable to noncontrolling interest — (12 ) — (52 ) Net income attributable to Gilead $ 1,783 $ 1,429 $ 480 $ 5,665 Basic earnings per share attributable to Gilead $ 1.43 $ 1.15 $ 0.38 $ 4.54 Shares used in basic earnings per share attributable to Gilead calculation 1,248 1,248 1,247 1,248 Diluted earnings per share attributable to Gilead $ 1.42 $ 1.14 $ 0.38 $ 4.50 Shares used in diluted earnings per share attributable to Gilead calculation 1,259 1,256 1,255 1,258 Supplemental Information: Cash dividends declared per share $ 0.77 $ 0.75 $ 3.08 $ 3.00 Product gross margin 79.0 % 70.4 % 78.2 % 75.9 % Research and development expenses as a % of revenues 21.7 % 19.8 % 20.5 % 21.1 % Selling, general and administrative expenses as a % of revenues 25.2 % 22.6 % 21.2 % 22.5 % Operating margin 32.4 % 22.7 % 5.8 % 28.0 % Effective tax rate 17.8 % 14.3 % 30.5 % 18.2 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Product sales: HIV $ 5,452 $ 4,693 16% $ 19,612 $ 18,175 8% Liver Disease 719 691 4% 3,021 2,784 9% Oncology 843 765 10% 3,289 2,932 12% Other 184 201 (8)% 889 859 3% Total product sales excluding Veklury 7,198 6,350 13% 26,811 24,750 8% Veklury 337 720 (53)% 1,799 2,184 (18)% Total product sales 7,536 7,070 7% 28,610 26,934 6% Royalty, contract and other revenues 33 45 (26)% 144 182 (21)% Total revenues $ 7,569 $ 7,115 6% $ 28,754 $ 27,116 6% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2024 2023 Change 2024 2023 Change Non-GAAP: Cost of goods sold $ 1,002 $ 980 2% $ 3,936 $ 3,697 6% Research and development expenses $ 1,612 $ 1,452 11% $ 5,732 $ 5,720 —% Acquired IPR&D expenses(2) $ (11 ) $ 347 NM $ 4,663 $ 1,155 NM Selling, general and administrative expenses $ 1,852 $ 1,597 16% $ 5,903 $ 6,060 (3)% Other (income) expense, net $ (91 ) $ (104 ) (13)% $ (279 ) $ (365 ) (24)% Diluted EPS $ 1.90 $ 1.72 10% $ 4.62 $ 6.72 (31)% Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,259 1,256 —% 1,255 1,258 —% Product gross margin 86.7 % 86.1 % 56 bps 86.2 % 86.3 % -3 bps Research and development expenses as a % of revenues 21.3 % 20.4 % 89 bps 19.9 % 21.1 % -116 bps Selling, general and administrative expenses as a % of revenues 24.5 % 22.4 % 203 bps 20.5 % 22.3 % -182 bps Operating margin 41.1 % 38.5 % 265 bps 29.6 % 38.7 % -903 bps Effective tax rate 19.2 % 17.1 % 210 bps 25.9 % 15.2 % 1075 bps 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 Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,581 $ 2,090 $ 6,251 $ 6,498 Acquisition-related – amortization(1) (579 ) (580 ) (2,316 ) (2,271 ) Restructuring — (479 ) — (479 ) Other(2) — (51 ) — (51 ) Non-GAAP cost of goods sold $ 1,002 $ 980 $ 3,936 $ 3,697 Product gross margin reconciliation: GAAP product gross margin 79.0 % 70.4 % 78.2 % 75.9 % Acquisition-related – amortization(1) 7.7 % 8.2 % 8.1 % 8.4 % Restructuring — % 6.8 % (— )% 1.8 % Other(2) — % 0.7 % — % 0.2 % Non-GAAP product gross margin 86.7 % 86.1 % 86.2 % 86.3 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,641 $ 1,408 $ 5,907 $ 5,718 Acquisition-related – other costs(3) — 59 (78 ) 22 Restructuring (30 ) (15 ) (98 ) (20 ) Non-GAAP research and development expenses $ 1,612 $ 1,452 $ 5,732 $ 5,720 IPR&D impairment reconciliation: GAAP IPR&D impairment $ — $ 50 $ 4,180 $ 50 IPR&D impairment — (50 ) (4,180 ) (50 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,906 $ 1,608 $ 6,091 $ 6,090 Acquisition-related – other costs(3) (8 ) — (97 ) (2 ) Restructuring (46 ) (11 ) (91 ) (28 ) Non-GAAP selling, general and administrative expenses $ 1,852 $ 1,597 $ 5,903 $ 6,060 Operating income reconciliation: GAAP operating income $ 2,451 $ 1,612 $ 1,662 $ 7,605 Acquisition-related – amortization(1) 579 580 2,316 2,271 Acquisition-related – other costs(3) 8 (59 ) 174 (20 ) Restructuring 76 505 188 527 IPR&D impairment — 50 4,180 50 Other(2) — 51 — 51 Non-GAAP operating income $ 3,114 $ 2,739 $ 8,520 $ 10,484 Operating margin reconciliation: GAAP operating margin 32.4 % 22.7 % 5.8 % 28.0 % Acquisition-related – amortization(1) 7.6 % 8.1 % 8.1 % 8.4 % Acquisition-related – other costs(3) 0.1 % (0.8 )% 0.6 % (0.1 )% Restructuring 1.0 % 7.1 % 0.7 % 1.9 % IPR&D impairment — % 0.7 % 14.5 % 0.2 % Other(2) — % 0.7 % — % 0.2 % Non-GAAP operating margin 41.1 % 38.5 % 29.6 % 38.7 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ 35 $ (293 ) $ (6 ) $ (198 ) (Loss) gain from equity securities, net (126 ) 189 (274 ) (167 ) Non-GAAP other (income) expense, net $ (91 ) $ (104 ) $ (279 ) $ (365 ) GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Income before income taxes reconciliation: GAAP income before income taxes $ 2,168 $ 1,653 $ 690 $ 6,859 Acquisition-related – amortization(1) 579 580 2,316 2,271 Acquisition-related – other costs(3) 8 (59 ) 174 (20 ) Restructuring 76 505 188 527 IPR&D impairment — 50 4,180 50 Loss (gain) from equity securities, net 126 (189 ) 274 167 Other(2) — 51 — 51 Non-GAAP income before income taxes $ 2,956 $ 2,591 $ 7,822 $ 9,905 Income tax expense reconciliation: GAAP income tax (benefit) expense $ 385 $ 236 $ 211 $ 1,247 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 121 119 484 466 Acquisition-related – other costs(3) 2 1 41 9 Restructuring 16 90 37 95 IPR&D impairment — 15 1,051 15 Loss (gain) from equity securities, net 13 (18 ) (39 ) (14 ) Discrete and related tax charges(4) 29 (12 ) 243 (326 ) Other(2) — 11 — 11 Non-GAAP income tax expense $ 566 $ 442 $ 2,028 $ 1,503 Effective tax rate reconciliation: GAAP effective tax rate 17.8 % 14.3 % 30.5 % 18.2 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(4) 1.4 % 2.8 % (4.6 )% (3.0 )% Non-GAAP effective tax rate 19.2 % 17.1 % 25.9 % 15.2 % Net income attributable to Gilead reconciliation: GAAP net income attributable to Gilead $ 1,783 $ 1,429 $ 480 $ 5,665 Acquisition-related – amortization(1) 458 460 1,832 1,805 Acquisition-related – other costs(3) 6 (59 ) 134 (29 ) Restructuring 59 414 151 431 IPR&D impairment — 35 3,129 35 Loss (gain) from equity securities, net 113 (171 ) 313 180 Discrete and related tax charges(4) (29 ) 12 (243 ) 326 Other(2) — 40 — 40 Non-GAAP net income attributable to Gilead $ 2,390 $ 2,161 $ 5,795 $ 8,454 Diluted earnings per share reconciliation: GAAP diluted earnings per share $ 1.42 $ 1.14 $ 0.38 $ 4.50 Acquisition-related – amortization(1) 0.36 0.37 1.46 1.43 Acquisition-related – other costs(3) — (0.05 ) 0.11 (0.02 ) Restructuring 0.05 0.33 0.12 0.34 IPR&D impairment — 0.03 2.49 0.03 Loss (gain) from equity securities, net 0.09 (0.14 ) 0.25 0.14 Discrete and related tax charges(4) (0.02 ) 0.01 (0.19 ) 0.26 Other(2) — 0.03 — 0.03 Non-GAAP diluted earnings per share $ 1.90 $ 1.72 $ 4.62 $ 6.72 Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2024 2023 2024 2023 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 1,110 $ 2,315 $ 2,801 Research and development expenses adjustments 29 (44 ) 176 (2 ) IPR&D impairment adjustments — 50 4,180 50 Selling, general and administrative expenses adjustments 54 11 188 30 Total non-GAAP adjustments to costs and expenses 663 1,127 6,858 2,879 Other (income) expense, net, adjustments 126 (189 ) 274 167 Total non-GAAP adjustments before income taxes 789 938 7,132 3,046 Income tax effect of non-GAAP adjustments above (152 ) (218 ) (1,574 ) (583 ) Discrete and related tax charges(4) (29 ) 12 (243 ) 326 Total non-GAAP adjustments to net income attributable to Gilead $ 607 $ 732 $ 5,315 $ 2,789 (1) Relates to amortization of acquired intangibles. (2) Relates to a write-off of an intangible asset related to the restructuring of our collaboration with Galapagos NV during the fourth quarter of 2023. (3) Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s recent acquisitions. (4) Represents 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. RECONCILIATION OF GAAP TO NON-GAAP 2025 FULL YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 11, 2025 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 77.0% - 78.0% Acquisition-related expenses ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $10,200 - $10,700 Acquisition-related and restructuring expenses ~ 2,500 Non-GAAP projected operating income $12,700 - $13,200 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 20% Income tax effect of above non-GAAP adjustments, and discrete and related tax adjustments (~ 1%) Non-GAAP projected effective tax rate ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.95 - $6.35 Acquisition-related and restructuring expenses, and discrete and related tax adjustments ~ 1.75 Non-GAAP projected diluted EPS $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) December 31, (in millions) 2024 2023 Assets Cash, cash equivalents and marketable debt securities $ 9,991 $ 8,428 Accounts receivable, net 4,420 4,660 Inventories 3,589 3,366 Property, plant and equipment, net 5,414 5,317 Intangible assets, net 19,948 26,454 Goodwill 8,314 8,314 Other assets 7,319 5,586 Total assets $ 58,995 $ 62,125 Liabilities and Stockholders’ Equity Current liabilities $ 12,004 $ 11,280 Long-term liabilities 27,744 28,096 Stockholders’ equity(1) 19,246 22,749 Total liabilities and stockholders’ equity $ 58,995 $ 62,125 (1) As of December 31, 2024 and 2023, there were 1,246 shares of common stock issued and outstanding. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 2,975 $ 2,168 $ 10,828 $ 8,006 Net cash used in investing activities (225 ) (726 ) (3,449 ) (2,265 ) Net cash used in financing activities 2,260 (1,100 ) (3,433 ) (5,125 ) Effect of exchange rate changes on cash and cash equivalents (55 ) 37 (40 ) 57 Net change in cash and cash equivalents 4,954 380 3,906 673 Cash and cash equivalents at beginning of period 5,037 5,705 6,085 5,412 Cash and cash equivalents at end of period $ 9,991 $ 6,085 $ 9,991 $ 6,085 Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 Net cash provided by operating activities $ 2,975 $ 2,168 $ 10,828 $ 8,006 Capital expenditures (147 ) (214 ) (523 ) (585 ) Free cash flow(1) $ 2,828 $ 1,954 $ 10,305 $ 7,421 (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 Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 HIV Biktarvy – U.S. $ 3,129 $ 2,588 $ 10,855 $ 9,692 Biktarvy – Europe 400 333 1,509 1,253 Biktarvy – Rest of World 246 188 1,060 905 3,774 3,109 13,423 11,850 Descovy – U.S. 563 457 1,902 1,771 Descovy – Europe 25 25 100 100 Descovy – Rest of World 28 28 110 114 616 509 2,113 1,985 Genvoya – U.S. 410 447 1,498 1,752 Genvoya – Europe 42 48 180 205 Genvoya – Rest of World 18 22 84 103 470 517 1,762 2,060 Odefsey – U.S. 252 258 957 1,012 Odefsey – Europe 74 71 290 294 Odefsey – Rest of World 11 11 41 44 336 340 1,288 1,350 Symtuza - Revenue share(1) – U.S. 112 104 450 382 Symtuza - Revenue share(1) – Europe 30 32 130 133 Symtuza - Revenue share(1) – Rest of World 3 3 12 13 144 139 592 529 Other HIV(2) – U.S. 67 46 257 238 Other HIV(2) – Europe 33 25 129 116 Other HIV(2) – Rest of World 11 9 48 47 111 79 434 401 Total HIV – U.S. 4,532 3,899 15,918 14,848 Total HIV – Europe 603 533 2,339 2,102 Total HIV – Rest of World 317 261 1,355 1,226 5,452 4,693 19,612 18,175 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 185 216 922 859 Sofosbuvir / Velpatasvir(3) – Europe 69 74 299 323 Sofosbuvir / Velpatasvir(3) – Rest of World 75 89 374 355 330 378 1,596 1,537 Vemlidy – U.S. 148 115 486 410 Vemlidy – Europe 11 10 44 38 Vemlidy – Rest of World 100 92 428 414 260 217 959 862 Other Liver Disease(4) – U.S. 58 39 192 152 Other Liver Disease(4) – Europe 54 38 202 150 Other Liver Disease(4) – Rest of World 18 19 73 83 130 96 467 385 Total Liver Disease – U.S. 391 370 1,601 1,421 Total Liver Disease – Europe 134 121 545 511 Total Liver Disease – Rest of World 194 200 876 852 719 691 3,021 2,784 Veklury Veklury – U.S. 108 364 892 972 Veklury – Europe 80 181 284 408 Veklury – Rest of World 150 175 623 805 337 720 1,799 2,184 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2024 2023 2024 2023 Oncology Cell Therapy Tecartus – U.S. 53 66 234 245 Tecartus – Europe 36 27 138 110 Tecartus – Rest of World 10 5 31 15 98 98 403 370 Yescarta – U.S. 161 187 662 811 Yescarta – Europe 156 140 666 547 Yescarta – Rest of World 72 42 242 140 390 368 1,570 1,498 Total Cell Therapy – U.S. 213 253 896 1,055 Total Cell Therapy – Europe 193 167 804 658 Total Cell Therapy – Rest of World 82 46 274 156 488 466 1,973 1,869 Trodelvy Trodelvy – U.S. 247 226 902 777 Trodelvy – Europe 77 48 294 217 Trodelvy – Rest of World 31 24 119 68 355 299 1,315 1,063 Total Oncology – U.S. 461 479 1,798 1,833 Total Oncology – Europe 269 216 1,098 875 Total Oncology – Rest of World 113 70 393 224 843 765 3,289 2,932 Other AmBisome – U.S. 7 4 44 43 AmBisome – Europe 66 68 276 260 AmBisome – Rest of World 36 39 212 189 109 111 533 492 Other(5) – U.S. 51 64 255 261 Other(5) – Europe 8 9 34 40 Other(5) – Rest of World 16 17 68 66 76 90 356 367 Total Other – U.S. 59 68 299 304 Total Other – Europe 74 77 310 301 Total Other – Rest of World 52 56 280 255 184 201 889 859 Total product sales – U.S. 5,550 5,180 20,508 19,377 Total product sales – Europe 1,160 1,128 4,576 4,197 Total product sales – Rest of World 826 762 3,526 3,361 $ 7,536 $ 7,070 $ 28,610 $ 26,934 (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, Stribild, Sunlenca, Truvada and Tybost. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”). (4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Livdelzi, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig. Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com

RAHWAY, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in adults with HIV-1 infection that is virologically suppressed on different antiretroviral therapy regimens [baseline antiretroviral therapy (bART)]; MK-8591A-051 or bictegravir/emtricitabine/tenofovir alafenamide i [BIC/FTC/TAF (50 mg/200 mg/25 mg)]; MK-8591A-052 . The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48, was met in both trials. DOR/ISL was demonstrated to be non-inferior to bART in open-label trial MK-8591A-051 and non-inferior to BIC/FTC/TAF in double-blind trial MK-8591A-052. The superiority criteria were not met in trial MK-8591A-052. Primary safety objectives of both trials were also met. The company is planning to present detailed findings from these trials at a future scientific congress and will also plan to file these data with regulatory authorities. In the U.S., doravirine is approved for the treatment of adults with HIV-1 in combination with other antiretrovirals, as a single agent (PIFELTRO) and a component of a single-tablet regimen [DELSTRIGO; doravirine, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF)]. “ We are encouraged by the results from these Phase 3 trials evaluating a once-daily, oral, two-drug, single-tablet regimen of doravirine and islatravir,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “ We are committed to advancing our clinical programs for islatravir in combination with other antiretrovirals as potential options to help address the needs of people living with HIV.” Islatravir (MK-8591), Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), exhibits both transcriptase and translocation inhibition (which prevents nucleotide binding and incorporation to the DNA chain, resulting in immediate chain termination) and delayed chain termination (which prevents nucleotide incorporation even in the event of translocation). Islatravir is being evaluated in multiple early and late-stage clinical trials in combination with other antiretroviral therapies for the treatment of HIV-1. In addition to the MK-8591A-051 and MK-8591A-052 trials, ongoing Phase 3 trials of DOR/ISL include MK-8591A-053 in people with HIV who had not previously received treatment (treatment-naïve), and MK-8591A-054 evaluating open-label DOR/ISL (100 mg/0.25 mg) in individuals who participated in earlier Phase 3 trials of DOR/ISL (100 mg/0.75 mg). About MK-8591A-051 ( NCT05631093 ) MK-8591A-051 is a Phase 3, randomized, active-controlled, open-label clinical trial evaluating a switch to investigational, oral, once-daily DOR/ISL (100 mg/0.25 mg) in adults with HIV-1 infection that has been virologically suppressed using ART. Participants (n=551) were randomized 2:1 to either switch to investigational DOR/ISL or continue with their current bART regimen through Week 48. After Week 48, all participants receive DOR/ISL through Week 144 of the trial. After Week 144, eligible participants may continue on DOR/ISL and continue trial treatment until Week 240 or when DOR/ISL becomes commercially accessible (whichever comes first). The primary efficacy (percentage of participants with HIV-1 RNA levels ≥50 copies/mL) and safety (number of participants experiencing adverse events (AEs) and discontinuing trial intervention due to AEs) endpoints were assessed at Week 48. About MK-8591A-052 ( NCT05630755 ) MK-8591A-052 is a Phase 3, randomized, active-controlled, double-blind clinical trial evaluating a switch to investigational, oral, once-daily DOR/ISL (100mg /0.25mg) in adults with HIV-1 infection that has been virologically suppressed using BIC/FTC/TAF (50 mg/200 mg/25 mg). Participants (n=513) were randomized 2:1 to either switch to DOR/ISL or continue on BIC/FTC/TAF through Week 144. After Week 144, eligible participants may continue on DOR/ISL and continue trial treatment until Week 240 or when DOR/ISL becomes commercially accessible (whichever comes first). The primary efficacy (percentage of participants with HIV-1 RNA levels ≥50 copies/mL) and safety (number of participants experiencing AEs and discontinuing trial intervention due to AEs) endpoints were assessed at Week 48. Indications and usage for PIFELTRO and DELSTRIGO in the U.S. PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. Selected Safety Information Warning: Posttreatment Acute Exacerbation of Hepatitis B (HBV) All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in people with concomitant HIV-1 and HBV who have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted. Contraindications PIFELTRO and DELSTRIGO are contraindicated when coadministered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO. DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Warnings and Precautions Severe Skin Reactions Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during the postmarketing experience with doravirine-containing regimens. Discontinue PIFELTRO or DELSTRIGO, and other medications known to be associated with severe skin reactions, immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Clinical status should be closely monitored, and appropriate therapy should be initiated. New or Worsening Renal Impairment Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in people living with HIV with risk factors for renal dysfunction who appeared stable on TDF. Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min. Bone Loss and Mineralization Defects In clinical trials in adults living with HIV, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF. Immune Reconstitution Syndrome Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment. Drug Interactions Because DELSTRIGO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. Coadministration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended. If DELSTRIGO is coadministered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO. If PIFELTRO is coadministered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart). Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions. Dosage and Administration/Specific Populations Renal Impairment Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min. Adverse Reactions The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%). By week 96 in DRIVE-FORWARD, 2% of adult participants in the PIFELTRO group and 3% in the darunavir+ritonavir (DRV+r) group had adverse events leading to discontinuation of study medication. By week 96 in DRIVE-AHEAD, 3% of adult participants in the DELSTRIGO group and 7% in the efavirenz (EFV)/emtricitabine (FTC)/TDF group had adverse events leading to discontinuation of study medication. In DRIVE-FORWARD, mean changes from baseline at week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, mean changes from baseline at week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated. In DRIVE-SHIFT, mean changes from baseline at week 24 in LDL-C and non-HDL-C were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL in the DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult participants in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium. The safety of DELSTRIGO in virologically-suppressed adults was based on week 48 data from participants in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult participants was similar to that in participants with no ARV treatment history. Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of participants in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of participants had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of participants in the delayed switch group experienced ALT and AST elevations of greater than 1.25 X ULN through 24 weeks on their baseline regimen. Pregnancy/Breastfeeding There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO or DELSTRIGO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Inform individuals with HIV-1 infection of the potential risks of breastfeeding, including: (1) HIV-1 transmission (in HIV-1–negative infants), (2) developing viral resistance (in HIV-1–positive infants), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults. About Islatravir (MK-8591) and Merck’s HIV Research Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1. Studies with islatravir are designed to offer different dosing options as potential daily and once-weekly treatments. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here . Merck’s Commitment to HIV For more than 35 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has been pioneering in the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We want to ensure people are not defined by HIV and our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at the goal of helping to end the HIV epidemic for everyone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf and Patient Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf Please see Prescribing Information for DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf and Patient Information for DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate) https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.pdf i bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY) is a registered trademark of Gilead Sciences, Inc.