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)--Apr. 24, 2025-- 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:

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).

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Investors:
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investor_relations@gilead.com

Media:
Ashleigh Koss
public_affairs@gilead.com

Source: Gilead Sciences, Inc.