-Gilead Sciences, Inc. (Nasdaq: GILD) announced its results of operations for the fourth quarter and full year 2025.

“Our fourth quarter and full-year results close out a very strong year for Gilead overall, including the successful U.S. launch of Yeztugo, the world’s first twice-yearly HIV prevention therapy, and continued growth for Biktarvy and Descovy,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “In 2026, our potential new launches include two cancer therapies and an additional HIV treatment option, and we look forward to building on the launches of Yeztugo and Livdelzi for liver disease. As we continue to increase our positive impact on healthcare, Gilead is well positioned for continued growth in 2026 and beyond.”

Fourth Quarter 2025 Financial Results

• Total fourth quarter 2025 revenues increased 5% to $7.9 billion compared to the same period in 2024, primarily driven by higher sales of HIV and Liver Disease products, partially offset by lower sales of Veklury® (remdesivir).
• Diluted earnings per share (“EPS”) was $1.74 in the fourth quarter 2025 compared to $1.42 in the same period in 2024. The increase was primarily driven by higher income tax benefits, net unrealized gains from equity securities and higher product sales, as well as lower selling, general and administrative (“SG&A”) expenses. The increase was partially offset by higher acquired in-process research and development (“IPR&D”) expenses and an IPR&D impairment charge related to assets acquired as part of the MYR GmbH (“MYR”) acquisition.
• Non-GAAP diluted EPS of $1.86 in the fourth quarter 2025 compared to $1.90 in the same period in 2024. The decrease was primarily driven by higher acquired IPR&D expenses, partially offset by higher product sales and lower SG&A expenses.
• As of December 31, 2025, Gilead had $10.6 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024.
• During the fourth quarter 2025, Gilead generated $3.3 billion in operating cash flow.
• During the fourth quarter 2025, Gilead paid dividends of $1.0 billion and repurchased $230 million of common stock.

Fourth Quarter 2025 Product Sales

Total fourth quarter 2025 product sales increased 5% to $7.9 billion compared to the same period in 2024. Total fourth quarter 2025 product sales excluding Veklury increased 7% to $7.7 billion compared to the same period in 2024, primarily due to higher sales of HIV and Liver Disease products.

HIV product sales increased 6% to $5.8 billion in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand for HIV prevention and treatment.

• Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 5% to $4.0 billion in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price.
• Descovy® (FTC 200mg/TAF 25mg) sales increased 33% to $819 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and higher demand for HIV prevention.

The Liver Disease portfolio sales increased 17% to $844 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand for Livdelzi® (seladelpar).

Veklury sales decreased 37% to $212 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations.

Cell Therapy product sales decreased 6% to $458 million in the fourth quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds.

• Yescarta® (axicabtagene ciloleucel) sales decreased 6% to $368 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by in- and out-of-class competition.
• Tecartus® (brexucabtagene autoleucel) sales decreased 9% to $90 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by in-class competition.

Trodelvy® (sacituzumab govitecan-hziy) sales increased 8% to $384 million in the fourth quarter 2025 compared to the same period in 2024, primarily driven by higher demand in breast cancer treatment.

Fourth Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate

• Product gross margin remained relatively flat at 79.5% in the fourth quarter 2025 compared to 79.0% in the same period in 2024. Non-GAAP product gross margin was 86.8% in the fourth quarter 2025 compared to 86.7% in the same period in 2024.
• Research and development (“R&D”) expenses and non-GAAP R&D expenses were $1.6 billion in the fourth quarter 2025 and remained relatively flat compared to the same period in 2024.
• Acquired IPR&D expenses were $539 million in the fourth quarter 2025, primarily related to our acquisition of Interius BioTherapeutics, Inc. (“Interius”) and ongoing collaboration with Shenzhen Pregene Biopharma Co., Ltd. (“Pregene”).
• SG&A expenses were $1.8 billion in the fourth quarter 2025 compared to $1.9 billion in the same period in 2024, decreasing primarily due to lower expenses related to legal matters and corporate initiatives, partially offset by donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $1.7 billion in the fourth quarter 2025 compared to $1.9 billion in the same period in 2024, primarily due to lower expenses related to legal matters and corporate initiatives.
• The effective tax rate (“ETR”) was (5.0)% in the fourth quarter 2025 compared to 17.8% in the same period in 2024, primarily driven by a tax benefit from a settlement with a tax authority related to a prior year legal entity restructuring and a tax benefit from the IPR&D impairment charge related to assets acquired as part of the MYR acquisition. The non-GAAP ETR was 20.5% in the fourth quarter 2025 compared to 19.2% in the same period in 2024.

Full Year 2025 Financial Results

• Total full year 2025 revenues increased 2% to $29.4 billion compared to 2024, broken down as follows:
  • Total full year 2025 product sales increased 1% to $28.9 billion compared to 2024, primarily driven by higher sales of HIV and Liver Disease products, partially offset by lower sales of Veklury.
  • Total full year 2025 royalty, contract and other revenues increased by approximately $383 million compared to 2024, primarily driven by revenue related to a previous sale of intellectual property not expected to reoccur.
• Diluted EPS was $6.78 in the full year 2025 compared to $0.38 in 2024. The increase was primarily driven by lower acquired IPR&D expenses, lower IPR&D impairments, higher net unrealized gains on equity investments, higher revenues and lower SG&A expenses, partially offset by higher tax expense.
• Non-GAAP diluted EPS was $8.15 in the full year 2025 compared to $4.62 in 2024. The increase was primarily driven by lower acquired IPR&D expenses, higher revenues, and lower SG&A expenses.

Full Year 2025 Product Sales

Total full year 2025 product sales increased 1% to $28.9 billion compared to 2024. Total full year 2025 product sales excluding Veklury increased 4% to $28.0 billion compared to 2024, primarily due to higher sales of HIV and Liver Disease products.

HIV product sales increased 6% to $20.8 billion in the full year 2025 compared to 2024, primarily driven by higher demand for HIV treatment and prevention.

• Biktarvy sales increased 7% to $14.3 billion in the full year 2025 compared to 2024, primarily driven by higher demand, partially offset by lower average realized price.
• Descovy sales increased 31% to $2.8 billion in the full year 2025 compared to 2024, primarily driven by higher demand and average realized price.

The Liver Disease portfolio sales increased 6% to $3.2 billion in the full year 2025 compared to 2024, primarily driven by higher demand for Livdelzi and products for chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”), partially offset by lower average realized price in products for chronic hepatitis C virus (“HCV”).

Veklury sales decreased 49% to $911 million in the full year 2025 compared to 2024, primarily driven by lower COVID-19-related hospitalizations.

Cell Therapy product sales decreased 7% to $1.8 billion in the full year 2025 compared to 2024, reflecting ongoing competitive headwinds.

• Yescarta sales decreased 5% to $1.5 billion in the full year 2025 compared to 2024, primarily driven by in- and out-of-class competition.
• Tecartus sales decreased 15% to $344 million in the full year 2025 compared to 2024, primarily driven by in-class competition.

Trodelvy sales increased 6% to $1.4 billion in the full year 2025 compared to 2024, primarily driven by higher demand in breast cancer treatment, partially offset by the indication withdrawal in bladder cancer treatment.

Full Year 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate

• Product gross margin remained relatively flat at 78.4% in the full year 2025 compared to 78.2% in 2024. Non-GAAP product gross margin was 86.4% in the full year 2025 compared to 86.2% in 2024.
• R&D expenses were $5.8 billion in the full year 2025 compared to $5.9 billion in 2024, decreasing primarily due to lower acquisition-related integration expenses and restructuring costs, as well as lower study-related and clinical manufacturing expenses. Non-GAAP R&D expenses were $5.7 billion in the full year 2025, decreasing slightly compared to 2024 due to lower study-related and clinical manufacturing expenses.
• Acquired IPR&D expenses were $1.0 billion in the full year 2025, primarily related to the acquisition of Interius and collaborations with LEO Pharma A/S and Pregene.
• SG&A expenses were $5.8 billion in the full year 2025 compared to $6.1 billion in 2024, decreasing primarily due to lower corporate, legal, acquisition-related integration and restructuring expenses, partially offset by higher HIV promotional expenses and donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $5.6 billion in the full year 2025 compared to $5.9 billion in 2024, decreasing primarily due to lower expenses related to corporate initiatives and legal matters, partially offset by higher HIV promotional expenses.
• The ETR was 13.1% in the full year 2025 compared to 30.5% in 2024, primarily driven by the impact of the prior year non-deductible acquired IPR&D charge for the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), partially offset by the tax impact of the prior year higher IPR&D impairment charges. The non-GAAP ETR was 18.3% in the full year 2025 compared to 25.9% in 2024, primarily driven by the prior year non-deductible acquired IPR&D charge for the acquisition of CymaBay.

Guidance and Outlook

For the full year 2026, Gilead expects:

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 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 positive topline Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials, evaluating our investigational daily oral single-tablet regimen of bictegravir 75mg and lenacapavir 50mg (“BIC/LEN”) for virologically suppressed adults with HIV. BIC/LEN met its primary endpoints demonstrating non-inferiority to baseline multi-tablet antiviral regimens (ARTISTRY-1) and Biktarvy (ARTISTRY-2).
• Exercised option to license investigational herpes simplex virus helicase-primase inhibitor programs ABI-1179 and ABI-5366 from Assembly Biosciences, Inc. (“Assembly”).
• Announced the first delivery of lenacapavir for PrEP in sub-Saharan African countries Eswatini and Zambia through the U.S. President’s Emergency Plan for AIDS Relief.

Oncology

• Announced that the Phase 3 ASCENT-07 study evaluating the investigational use of Trodelvy versus chemotherapy in first-line post-endocrine HR+/HER2- metastatic breast cancer did not meet its primary endpoint of progression-free survival as assessed by Blinded Independent Central Review. Overall survival, a secondary endpoint, was not mature at the time of the primary analysis, however, a favorable early trend compared to chemotherapy was observed in the Trodelvy arm. In addition, no new safety signals were identified in this patient population. The results from this study were presented at the 2025 San Antonio Breast Cancer Symposium.
• Announced the discontinuation of the Phase 3 STAR-221 study, in partnership with Arcus Biosciences, Inc. (“Arcus”), evaluating the anti-TIGIT antibody domvanalimab (“dom”) plus zimberelimab (“zim”) and chemotherapy in first-line HER2- advanced gastric and esophageal cancers. The decision was based on the recommendation of the Independent Data Monitoring Committee, following review of data from a pre-specified interim analysis. Additionally, Gilead and Arcus will discontinue the Phase 2 EDGE-Gastric study evaluating dom and zim regimens in upper gastrointestinal cancers. Dom and zim are investigational products and are not approved anywhere globally.

Cell Therapy

• Announced a new label update for Yescarta that removes a limitation around Primary Central Nervous System Lymphoma, an ultra-rare cancer affecting a highly vulnerable patient population. Yescarta is the only CAR-T therapy in relapsed or refractory large B-cell lymphoma (“R/R LBCL”) to have this limitation removed.
• Presented new positive data, with our partner Arcellx, Inc. (“Arcellx”), from the pivotal Phase 2 iMMagine-1 trial evaluating the investigational CAR T-cell therapy anitocabtagene autoleucel in 4L+ R/R multiple myeloma at the 2025 American Society of Hematology (“ASH”).
• Presented initial Phase 1 data for KITE-753 and KITE-363, evaluating two investigational bicistronic CAR T-cell therapies in patients with R/R LBCL at ASH 2025.
• Presented a new analysis of Yescarta from the Phase 3 ZUMA-7 and Phase 2 ALYCANTE study in patients with R/R LBCL at ASH 2025. The data demonstrated consistent benefits of Yescarta among patients with R/R LBCL, including those ineligible for previous standard of care chemotherapy and stem cell transplant.

Inflammation

• Presented new long-term data from the Phase 3 ASSURE study for Livdelzi, which reinforce the safety and efficacy of Livdelzi for people living with primary biliary cholangitis over 3 years, including data on switching from obeticholic acid. The data were presented at the American Association for the Study of Liver Diseases meeting.

Corporate

• The Board declared a quarterly dividend of $0.82 per share of common stock for the first quarter of 2026. The dividend is payable on March 30, 2026, to stockholders of record at the close of business on March 13, 2026. Future dividends will be subject to Board approval.
• Appointed Keeley Cain Wettan as Executive Vice President, General Counsel, Legal and Compliance.
• Announced an agreement with the U.S. government to lower the cost of medicines for Americans, reinforcing a commitment to U.S.-based innovation, affordability and global health leadership.

Certain amounts and percentages in this press release may not sum or recalculate due to rounding.