8-K: Gilead Reports Strong 2025, Eyes 2026 Growth with New Launches

Gilead Sciences announced robust fourth quarter and full year 2025 financial results, driven by HIV and Liver Disease product growth, and provided optimistic 2026 guidance.

Summary

• Total fourth quarter 2025 revenues increased 5% to $7.9 billion compared to the same period in 2024.
• Full year 2025 revenues increased 2% to $29.4 billion compared to 2024.
• Diluted EPS was $1.74 in Q4 2025, up from $1.42 in Q4 2024, and $6.78 for full year 2025, significantly up from $0.38 in 2024.
• Non-GAAP diluted EPS was $1.86 in Q4 2025 (down from $1.90 in Q4 2024) and $8.15 for full year 2025 (up from $4.62 in 2024).
• Product sales excluding Veklury increased 7% to $7.7 billion in Q4 2025 and 4% to $28.0 billion for full year 2025.
• HIV product sales increased 6% to $5.8 billion in Q4 2025 and 6% to $20.8 billion for full year 2025.
• Biktarvy sales increased 5% to $4.0 billion in Q4 2025 and 7% to $14.3 billion for full year 2025.
• Descovy sales increased 33% to $819 million in Q4 2025 and 31% to $2.8 billion for full year 2025.
• Liver Disease portfolio sales increased 17% to $844 million in Q4 2025 and 6% to $3.2 billion for full year 2025.
• Veklury sales decreased 37% to $212 million in Q4 2025 and 49% to $911 million for full year 2025.
• Cell Therapy product sales decreased 6% to $458 million in Q4 2025 and 7% to $1.8 billion for full year 2025.
• Trodelvy sales increased 8% to $384 million in Q4 2025 and 6% to $1.4 billion for full year 2025.
• Gilead had $10.6 billion in cash, cash equivalents, and marketable debt securities as of December 31, 2025.
• Operating cash flow was $3.3 billion in Q4 2025 and $10.0 billion for full year 2025.
• The company paid $1.0 billion in dividends and repurchased $230 million of common stock in Q4 2025.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a strong positive report, driven by robust growth in core HIV and Liver Disease franchises, significant GAAP EPS improvement, and a promising pipeline with new launches. While Cell Therapy faces competitive pressures and some clinical trial setbacks occurred, the overall financial health and future outlook are solid.

Positives

• Total revenues increased 5% in Q4 2025 and 2% for full year 2025, reaching $7.9 billion and $29.4 billion respectively.
• GAAP diluted EPS saw significant growth, increasing from $1.42 to $1.74 in Q4 2025 and from $0.38 to $6.78 for full year 2025.
• Non-GAAP diluted EPS for full year 2025 increased 77% to $8.15.
• Product sales excluding Veklury showed strong growth, up 7% in Q4 2025 and 4% for the full year 2025.
• HIV product sales grew 6% in both Q4 and full year 2025, driven by higher demand for prevention and treatment.
• Biktarvy sales increased 5% in Q4 2025 and 7% for full year 2025, primarily due to higher demand.
• Descovy sales surged 33% in Q4 2025 and 31% for full year 2025, benefiting from higher average realized price and demand for HIV prevention.
• Liver Disease portfolio sales increased 17% in Q4 2025 and 6% for full year 2025, primarily due to higher demand for Livdelzi.
• Trodelvy sales increased 8% in Q4 2025 and 6% for full year 2025, driven by higher demand in breast cancer treatment.
• Cash, cash equivalents, and marketable debt securities increased to $10.6 billion as of December 31, 2025, from $10.0 billion in 2024.
• Operating cash flow was robust at $3.3 billion in Q4 2025 and $10.0 billion for full year 2025.
• SG&A expenses decreased in both Q4 and full year 2025 due to lower expenses related to legal matters and corporate initiatives.
• The effective tax rate was a benefit of (5.0)% in Q4 2025, driven by a tax benefit from a settlement with a tax authority and an IPR&D impairment charge.
• Successful U.S. launch of Yeztugo, the world's first twice-yearly HIV prevention therapy.
• Announced positive topline Phase 3 results for investigational daily oral single-tablet regimen BIC/LEN for HIV, demonstrating non-inferiority.
• New label update for Yescarta removes a limitation around Primary Central Nervous System Lymphoma, expanding its use.
• Presented new positive data for anitocabtagene autoleucel in multiple myeloma and new long-term data for Livdelzi in primary biliary cholangitis.

Negatives

• Non-GAAP diluted EPS decreased 2% in Q4 2025 to $1.86, primarily due to higher acquired IPR&D expenses.
• Veklury sales decreased significantly by 37% in Q4 2025 and 49% for full year 2025, driven by lower COVID-19-related hospitalizations.
• Cell Therapy product sales decreased 6% in Q4 2025 and 7% for full year 2025, reflecting ongoing competitive headwinds.
• Yescarta sales decreased 6% in Q4 2025 and 5% for full year 2025, primarily due to inand out-of-class competition.
• Tecartus sales decreased 9% in Q4 2025 and 15% for full year 2025, primarily driven by in-class competition.
• Trodelvy's indication in bladder cancer treatment was withdrawn, partially offsetting breast cancer demand growth.
• Acquired IPR&D expenses were $539 million in Q4 2025 and $1.0 billion for full year 2025, contributing to lower non-GAAP EPS in Q4.
• An IPR&D impairment charge related to assets acquired as part of the MYR GmbH acquisition impacted Q4 2025 GAAP EPS.
• The Phase 3 ASCENT-07 study for Trodelvy in first-line HR+/HER2metastatic breast cancer did not meet its primary endpoint of progression-free survival.
• Discontinuation of the Phase 3 STAR-221 study and Phase 2 EDGE-Gastric study for domvanalimab plus zimberelimab and chemotherapy in gastric and esophageal cancers due to interim analysis recommendations.

Risks

• Ability to achieve full year 2026 financial guidance, including uncertainty of Veklury revenues, impact from Medicare Part D pricing reform, expiration of Affordable Care Act subsidies, and most-favored-nation pricing agreement with the U.S. government.
• Changes in U.S. regulatory or legislative policies and U.S. trade policies, including tariffs.
• Ability to accelerate or sustain revenues for virology, oncology, inflammation, and other programs.
• Ability to realize potential benefits of acquisitions, collaborations, or licensing arrangements.
• Risk that U.S. manufacturing and R&D investment may not achieve intended benefits.
• Patent protection and estimated loss of exclusivity for products and product candidates.
• Ability to initiate, progress, or complete clinical trials within anticipated timeframes or at all, and the possibility of unfavorable results from ongoing and additional clinical trials.
• Risk that safety and efficacy data from clinical trials may not warrant further development of product candidates.
• Ability to resolve issues cited by the FDA in pending clinical holds and the risk that FDA may not remove such holds in a timely manner or at all.
• Ability to submit new drug applications for new product candidates or expanded indications in anticipated timelines.
• Ability to receive or maintain regulatory approvals in a timely manner or at all, and the risk that approvals may be subject to significant limitations or withdrawal.
• Ability to successfully commercialize products.
• Risk of potential disruptions to the manufacturing and supply chain of 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.
• Risk that physicians and patients may not see advantages of Gilead's products over other therapies.
• Ability to effectively manage the access strategy relating to lenacapavir for HIV PrEP.

Future Outlook

Gilead expects full year 2026 product sales to be between $29.6 billion and $30.0 billion, with product sales excluding Veklury projected at $29.0 billion to $29.4 billion. Veklury sales are expected to be $600 million. Diluted EPS is guided to be between $6.75 and $7.15, while non-GAAP diluted EPS is projected to be $8.45 to $8.85. The company anticipates potential new launches in 2026, including two cancer therapies and an additional HIV treatment option, and plans to build on the recent launches of Yeztugo and Livdelzi.

Management Comments

• Daniel O'Day, Chairman and CEO, stated: "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."
• Daniel O'Day also commented: "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."

Industry Context

StockSavvy.ai notes that Gilead's strong performance in HIV and Liver Disease products aligns with ongoing demand in these therapeutic areas, particularly with the successful launch of innovative prevention therapies like Yeztugo. The significant decline in Veklury sales reflects the broader industry trend of decreasing COVID-19-related hospitalizations and the evolving pandemic landscape. The competitive headwinds faced by Cell Therapy products (Yescarta, Tecartus) highlight the increasing intensity and innovation within the oncology and CAR-T space, requiring continuous R&D and differentiation. The strategic acquisitions and collaborations, such as with Interius BioTherapeutics and Shenzhen Pregene Biopharma, indicate a proactive approach to pipeline diversification and addressing competitive pressures.

Comparison to Industry Standards

• The filing notes that Cell Therapy product sales decreased due to 'ongoing competitive headwinds' and 'inand out-of-class competition' for Yescarta and 'in-class competition' for Tecartus. This suggests that while Gilead's CAR-T therapies remain significant, the market is becoming more crowded with other players and alternative treatment modalities.
• The discontinuation of the Phase 3 STAR-221 study and Phase 2 EDGE-Gastric study for domvanalimab plus zimberelimab in gastric and esophageal cancers, based on an Independent Data Monitoring Committee recommendation, indicates the high bar for efficacy in competitive oncology indications and the challenges of developing novel immunotherapies.
• The positive topline Phase 3 results for BIC/LEN in HIV, demonstrating non-inferiority to existing regimens and Biktarvy, position Gilead to maintain its leadership in the HIV market against other established and emerging treatments.

Management Changes

Corporate Governance

Legal Proceedings

• Lower expenses related to legal matters contributed to decreased SG&A expenses in Q4 and full year 2025.
• A tax benefit from a settlement with a tax authority related to a prior year legal entity restructuring positively impacted the effective tax rate in Q4 2025.

Stakeholder Impact

• Shareholders: Benefited from a declared quarterly dividend of $0.82 per share and $230 million in common stock repurchases in Q4 2025, reflecting strong capital allocation.
• Patients: Will benefit from the successful launch of Yeztugo (HIV prevention) and Livdelzi (liver disease), as well as potential new therapies in cancer and HIV in 2026. The agreement with the U.S. government aims to lower medicine costs for Americans.
• Employees: The appointment of Keeley Cain Wettan to a key executive role signifies leadership stability and strategic direction in legal and compliance.
• U.S. Government: Engaged in an agreement to lower medicine costs, aligning with public health objectives and potentially influencing future regulatory and pricing discussions.
• Creditors: Strong cash position of $10.6 billion and robust operating cash flow of $10.0 billion for FY 2025 indicate solid financial health and ability to meet obligations.

Next Steps

• Potential new launches in 2026, including two cancer therapies and an additional HIV treatment option.
• Building on the launches of Yeztugo and Livdelzi for liver disease.
• Payment of a quarterly dividend of $0.82 per share on March 30, 2026, to stockholders of record on March 13, 2026.
• Continued clinical development and potential regulatory submissions for investigational programs like anitocabtagene autoleucel, BIC/LEN, ABI-1179, ABI-5366, KITE-753, and KITE-363.

Key Dates

Recommendation

Gilead's strong financial performance in 2025, particularly the significant increase in GAAP EPS and robust growth in core HIV and Liver Disease franchises, positions the company favorably. Despite competitive pressures in Cell Therapy and some clinical setbacks, the successful launch of new products like Yeztugo and a promising pipeline with multiple potential launches in 2026 indicate sustained growth momentum. The healthy cash flow and commitment to shareholder returns further enhance its investment appeal, making it a compelling 'buy' for long-term investors.

Keywords

Gilead Sciences, GILD, Biopharmaceutical, HIV, Oncology, Liver Disease, Cell Therapy, Financial Results, Earnings, EPS, Revenue, Biktarvy, Descovy, Veklury, Trodelvy, Yescarta, Livdelzi, Yeztugo, Clinical Trials, Drug Development, Pharmaceuticals, Biotech