10-K: Gilead Reports Strong 2025 Growth, HIV Sales Up 6%

Gilead Sciences, Inc. reported a 2% increase in total revenues to $29.4 billion in 2025, driven by robust HIV product sales and significant R&D pipeline advancements, despite challenges in Veklury and Cell Therapy sales.

Summary

• Total revenues increased by 2% to $29.443 billion in 2025, up from $28.754 billion in 2024.
• Net income attributable to Gilead surged to $8.510 billion in 2025, compared to $480 million in 2024, primarily due to lower IPR&D expenses and impairment charges.
• Diluted earnings per share attributable to Gilead was $6.78 in 2025, a significant increase from $0.38 in 2024.
• HIV product sales grew by 6% to $20.752 billion, with Biktarvy sales up 7% and Descovy sales up 31%.
• Liver Disease product sales increased by 6% to $3.217 billion, driven by higher demand for Livdelzi and products for chronic hepatitis B and D viruses.
• Veklury product sales decreased by 49% to $911 million, attributed to lower COVID-19-related hospitalizations.
• Cell Therapy product sales declined by 7% to $1.839 billion due to ongoing competitive headwinds.
• Trodelvy product sales increased by 6% to $1.397 billion, primarily from higher demand in breast cancer treatment, partially offset by bladder cancer indication withdrawal.
• Royalty, contract, and other revenues significantly increased to $527 million from $144 million, largely due to $400 million from the sale of certain intellectual property.
• Acquired in-process R&D expenses decreased to $1.024 billion in 2025 from $4.663 billion in 2024, reflecting fewer large acquisitions.
• In-process R&D impairment charges were $590 million in 2025 (related to bulevirtide) compared to $4.180 billion in 2024 (related to the Trodelvy NSCLC program).
• Selling, general and administrative expenses decreased by 5% to $5.774 billion.
• Cash and cash equivalents stood at $7.564 billion as of December 31, 2025, down from $9.991 billion in 2024.
• Net cash provided by operating activities decreased by 7% to $10.019 billion.
• The company repaid $1.75 billion of senior unsecured notes due February 2025.
• A $6.0 billion stock repurchase program was authorized in Q3 2025, to commence upon completion of the existing $5.0 billion program.
• Settlement agreements for Biktarvy patent litigation were reached in October 2025, preventing generic entry before April 1, 2036, for the adult dose in the U.S.

Sentiment

Score: 7

Explanation: StockSavvy.ai views this as a moderately positive report. While core revenue growth is solid in key areas like HIV and Liver Disease, and patent settlements provide long-term clarity, the significant increase in net income is largely due to non-recurring items from the prior year, and pipeline setbacks in oncology and competitive pressures in cell therapy temper enthusiasm.

Positives

• Total revenues increased by 2% to $29.443 billion in 2025.
• Net income attributable to Gilead significantly increased to $8.510 billion in 2025 from $480 million in 2024.
• Diluted EPS rose to $6.78 in 2025 from $0.38 in 2024.
• HIV product sales grew by 6% to $20.752 billion, driven by Biktarvy (+7%) and Descovy (+31%).
• Liver Disease product sales increased by 6% to $3.217 billion, with strong demand for Livdelzi.
• Trodelvy sales increased by 6% to $1.397 billion due to higher demand in breast cancer treatment.
• Royalty, contract, and other revenues saw a substantial increase to $527 million, including $400 million from intellectual property sale.
• Lower acquired in-process R&D expenses and impairment charges contributed to improved profitability.
• Positive topline Phase 3 results for investigational oral BIC/LEN for HIV treatment, demonstrating non-inferiority.
• Biktarvy patent litigation settled, delaying generic entry in the U.S. until April 1, 2036, for the adult dose, extending exclusivity by over two years.
• Yeztugo (lenacapavir) received FDA approval and EC marketing authorization for HIV PrEP, offering the first and only twice-yearly option in the U.S.
• Partnership with the U.S. State Department and PEPFAR to deliver lenacapavir for HIV PrEP to up to two million people over three years.
• Lyvdelzi (seladelpar) received EC conditional marketing authorization for PBC.
• Agreement with the U.S. government in December 2025 to lower medicine costs, including a three-year pause on Section 232 tariffs for Gilead and MFN pricing in Medicaid for select products.
• Initiated a $32 billion investment in the U.S. through 2030, including a new Pharmaceutical Development and Manufacturing Technical Development Center in Foster City, California.
• Maintained a strong financial position with disciplined operating expense management and shareholder returns through dividends and share repurchases.

Negatives

• Veklury product sales decreased by 49% to $911 million due to lower COVID-19-related hospitalizations.
• Cell Therapy product sales decreased by 7% to $1.839 billion, reflecting ongoing competitive headwinds.
• Genvoya sales decreased by 15% and Odefsey sales decreased by 9%.
• Sofosbuvir/Velpatasvir sales decreased by 20%, partially due to lower average realized price and U.S. Medicare Part D program redesign impact.
• Phase 3 STAR-221 study (domvanalimab + zimberelimab + chemotherapy in first-line HER2advanced gastric and esophageal cancers) was discontinued due to an interim analysis recommendation.
• Phase 2 EDGE-Gastric study was also discontinued.
• Phase 3 ASCENT-07 study (Trodelvy for first-line HR+/HER2metastatic breast cancer) did not meet its primary endpoint of progression-free survival.
• FDA placed a clinical hold on HIV treatment trials of investigational drug candidates GS-1720 and/or GS-4182.
• In-process R&D impairment charges of $590 million were recognized in 2025 for bulevirtide due to a more competitive market.
• Net cash provided by operating activities decreased by 7% to $10.019 billion, primarily due to higher inventory build-up, increased income tax payments, and unfavorable timing of accounts receivable collections.
• Gross-to-net deductions as a percentage of gross product sales increased to 41% in 2025 from 38% in 2024, mainly due to the U.S. Medicare Part D program redesign impact.
• Cash and cash equivalents decreased to $7.564 billion from $9.991 billion year-over-year.

Risks

• Inability to sustain or increase sales of HIV products due to market share gains by competitive products, including generics, or failure to introduce new HIV medications.
• Significant challenges in developing and commercializing novel and personalized cell therapies like Yescarta and Tecartus, including manufacturing, managing side effects, and broad medical community acceptance.
• Risk of secondary T-cell malignancies in patients treated with CAR T-cell therapy, as indicated by the FDA's class labeling change in January 2024.
• Disruptions or difficulties at third-party apheresis centers, shippers, couriers, and hospitals could result in product loss and regulatory action for cell therapies.
• High rate of failure inherent in drug discovery and development, leading to potential inability to recoup significant R&D, clinical trial, and acquisition-related expenses.
• Challenges in accurately forecasting sales due to difficulties in predicting product demand and fluctuations in purchasing patterns or wholesaler inventories.
• Significant competition from global pharmaceutical and biotechnology companies, specialized firms, and generic drug manufacturers, impacting pricing and market share.
• Pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates, such as those imposed by the Inflation Reduction Act (IRA) and the One Big Beautiful Bill (OBBB) Act.
• Biktarvy has been selected for Medicare negotiation under the IRA, effective 2028, which is anticipated to result in substantially lower prices and increased rebate obligations.
• Expiration of enhanced premium subsidies for Affordable Care Act (ACA) health insurance exchange plans at the end of 2025 could decrease health insurance coverage for patients.
• Potential adverse impacts from the importation of products from lower-price markets or the distribution of illegally diverted or counterfeit versions of products.
• Risks in clinical trials, including unfavorable results, delays in anticipated timelines, and disruption, as demonstrated by the failure of the Phase 3 EVOKE-01 study for Trodelvy in NSCLC.
• Reliance on third-party contract research organizations (CROs) for clinical trial activities, with risks of disputes, disruptions, and potential invalidity of clinical data.
• Inability to obtain necessary raw materials or supplies, or manufacturing difficulties, delays, or interruptions, including at third-party manufacturers and corporate partners.
• Geopolitical or economic factors, including new trade regulations or compliance requirements (e.g., BIOSECURE Act, ABC Safe Drug Act), could limit supply of materials from outside the U.S.
• Failure to obtain broad regulatory approvals on a timely basis or to maintain compliance with complex FDA and international regulations.
• Evolving laws, regulations, and legislative actions applicable to the healthcare industry, including those related to healthcare fraud and abuse, anti-bribery, and data privacy and security.
• Potential significant liability and increased expenses from litigation and government investigations, including ongoing antitrust, product liability, and qui tam lawsuits.
• Adverse movements in foreign currency exchange rates, particularly the Euro, as a significant percentage of product sales are denominated in foreign currencies.
• Risks associated with engaging in business acquisitions, licensing arrangements, collaborations, and other strategic transactions, including failure to identify suitable transactions, integration challenges, and potential impairment charges.
• Significant multiyear capital investments in U.S. manufacturing and R&D ($32 billion through 2030) are subject to construction delays, cost inflation, supply chain constraints, and regulatory compliance risks.
• Changes in effective income tax rates due to economic and political conditions, changes in tax laws (e.g., Pillar Two), and disputes with tax authorities.

Future Outlook

Gilead anticipates continued growth in overall product sales for 2026, bolstered by increased demand in its HIV business. This growth is expected to be partially offset by the impact of various U.S. policy-related developments, a projected decrease in Veklury sales due to lower COVID-19 hospitalizations, and a decrease in Cell Therapy product sales reflecting ongoing competitive headwinds. The company plans to continue significant investment in its R&D pipeline, both internally and through external partnerships and business development, while maintaining disciplined operating expense management. Key updates are expected in 2026 on clinical trials and regulatory decisions, including FDA decisions for two first-line breast cancer therapies and an additional HIV treatment option.

Management Comments

• We delivered growth in our HIV product sales, introduced Yeztugo, the first and only twice-yearly HIV pre-exposure prophylaxis (PrEP) option available in the U.S., and expanded Livdelzis market share in the treatment of primary biliary cholangitis (PBC).
• We continued to invest in our business and research and development (R&D) pipeline through advancement of our portfolio and broadening of available therapies, including through acquisitions and collaborations.
• We maintained our financial position by lowering operating expenses, repaying senior notes coming due and providing shareholder returns through dividends and share repurchases.
• Our strategic ambitions are to (i) bring 10+ transformative therapies to patients by 2030 (tracking since 2020); (ii) be a biotech employer and partner of choice; and (iii) deliver shareholder value in a sustainable and responsible manner.
• Our strategic priorities, as refreshed in late 2025, to deliver on these ambitions include: (i) maximize impact of long-acting HIV therapies; (ii) accelerate our pipeline build in oncology and inflammation; (iii) adopt and scale artificial intelligence to transform how we work; (iv) prioritize investments for highest impact; and (v) strengthen collaboration to accelerate innovation.
• As part of our overall investment approach to fund the advancement of our pipeline and commercialization of our products, we will continue to focus on disciplined operating expense management.

Industry Context

StockSavvy.ai notes that Gilead's performance in 2025 reflects broader trends in the biopharmaceutical industry, where innovation in specialized therapeutic areas like HIV and oncology continues to drive growth, while demand for COVID-19 related treatments like Veklury is normalizing. The increasing regulatory and pricing pressures, particularly from the Inflation Reduction Act, are a significant industry-wide challenge, impacting net product prices and profitability for major players. The strategic focus on long-acting therapies and AI adoption aligns with industry efforts to enhance patient convenience and R&D efficiency. The competitive landscape in cell therapy and the high costs and risks associated with late-stage clinical trials remain critical factors for all biopharma companies.

Comparison to Industry Standards

• Gilead's Biktarvy patent settlement, extending U.S. exclusivity to April 1, 2036, for the adult dose, is a significant win compared to typical patent expiry challenges faced by pharmaceutical companies, providing a longer period of market protection than initially projected (December 2033).
• The FDA approval of Yeztugo as the first and only twice-yearly HIV PrEP option in the U.S. positions Gilead favorably against competitors offering daily or less frequent regimens, potentially capturing a larger market share for convenience-driven patients.
• The discontinuation of the Phase 3 STAR-221 study for domvanalimab and zimberelimab in gastric/esophageal cancers, and the failure of the Phase 3 ASCENT-07 study for Trodelvy in HR+/HER2metastatic breast cancer, highlight the inherent high-risk nature of late-stage oncology drug development, a common challenge across the biopharmaceutical industry, similar to setbacks experienced by companies like Bristol Myers Squibb or Merck in their respective pipelines.
• The selection of Biktarvy for Medicare price negotiation under the Inflation Reduction Act, effective 2028, places Gilead among the first cohort of drugs subject to these new pricing controls, a benchmark for future industry-wide impacts of the IRA, potentially setting a precedent for other high-revenue drugs.

Management Changes

Corporate Governance

Legal Proceedings

• Biktarvy patent litigation with Lupin Ltd., Laurus Labs Ltd., and Cipla Ltd. was settled in October 2025, preventing generic entry in the U.S. before April 1, 2036, for the adult dose and November 19, 2035 (or May 19, 2035 if pediatric exclusivity not granted) for the pediatric dose.
• A lawsuit was filed against Aspiro Pharma Ltd. in July 2025 in the U.S. District Court of New Jersey, challenging patents for Veklury.
• A lawsuit was filed against Cipla in February 2026 in the U.S. District Court of Delaware regarding a 505(b)(2) application for emtricitabine/tenofovir alafenamide tablets, referencing Descovy.
• Antitrust class action lawsuits (2019, 2020) against Gilead and other defendants related to HIV drugs are ongoing. Claims with direct purchaser class and retailer opt-out plaintiffs were settled for $525 million in May 2023. A jury returned a verdict in Gilead's favor on Phase I allegations (Truvada and Atripla) in June 2023, which is currently under appeal. The Aetna, Inc. lawsuit, with similar claims, is scheduled for trial in March 2027.
• Product liability lawsuits involving approximately 23,000 active plaintiffs allege kidney, bone, and/or tooth injuries from Viread, Truvada, Atripla, Complera, and Stribild. A federal court trial for the first bellwether is set for March 2027. A putative class action in Missouri had its class certification motion denied in January 2026, with an appeal pending.
• A qui tam lawsuit filed by a former sales employee in March 2017, alleging False Claims Act violations related to HCV sales/marketing and charitable donations, was dismissed via summary judgment in September 2025, but the relator has appealed.
• A new qui tam action by Health Choice Advocates, LLC (October 2023), with the Texas Attorney General intervening, asserts similar allegations to a previously dismissed case regarding TMFPA violations for clinical educator programs and patient support. Trial is scheduled for August 2026.

Related Party Transactions

• In 2025, Gilead donated certain equity securities at fair value to the Gilead Foundation, a California nonprofit public benefit corporation for which certain officers serve as directors, recording an expense of $89 million in Selling, general and administrative expenses.

Stakeholder Impact

• Shareholders: Benefited from increased net income and diluted EPS, continued quarterly dividends, and ongoing share repurchase programs. However, the significant increase in net income was largely due to non-recurring items, and pipeline setbacks could impact future growth.
• Employees: The company maintains a competitive Total Rewards portfolio, including competitive base salary, incentive compensation, stock awards, and comprehensive health and wellbeing benefits. The termination of Deborah Telman as EVP and General Counsel, though without cause, represents a change in senior leadership. The company's commitment to inclusion and employee development is highlighted.
• Customers/Patients: Benefited from the introduction of Yeztugo as the first twice-yearly HIV PrEP option and expanded market share for Livdelzi. However, pricing pressures from government policies (IRA, OBBB Act) and potential impacts on access to medicines are noted. The discontinuation of certain clinical trials means some patient populations will not have access to those investigational therapies.
• Suppliers/Partners: Collaborations with Arcellx, LEO Pharma, Pregene, Merck, and Arcus Biosciences continue to be strategic for pipeline development. The acquisition of Interius BioTherapeutics strengthens the CAR T-cell therapy pipeline. However, risks related to third-party manufacturing and supply chain disruptions, potentially exacerbated by legislation like the BIOSECURE Act, could impact these relationships.
• Creditors: The company repaid $1.75 billion in senior unsecured notes and maintains a $2.5 billion revolving credit facility with no outstanding amounts, indicating sound liquidity and capital management, which is positive for creditors.

Next Steps

• Continue investing in the R&D pipeline, both internally and externally through partnerships and business development transactions.
• Focus on disciplined operating expense management to fund pipeline advancement and product commercialization.
• Await updates in 2026 on various clinical trials and certain regulatory filing submissions and decisions.
• Anticipate FDA decisions related to two first-line breast cancer therapies and an additional HIV treatment option in 2026.
• Close the acquisition of Arcellx, Inc. during the second quarter of 2026.
• Continue to evaluate the potential impact of the Inflation Reduction Act on the business, particularly the Medicare negotiation for Biktarvy effective 2028.
• Prepare for the implementation of most policies of the One Big Beautiful Bill (OBBB) Act in 2027.
• Continue to defend against ongoing antitrust and product liability lawsuits, with trials scheduled for March 2027 for the Aetna lawsuit and the first bellwether product liability trial.
• Continue to defend against the appealed qui tam lawsuit and the newly filed action by Health Choice Advocates, LLC with trial scheduled for August 2026.
• Continue phased deployment of a new enterprise resource planning system (ERP) and other related systems over the next few years.

Key Dates

Recommendation

Gilead's 2025 performance shows solid revenue growth in its core HIV and Liver Disease segments, and the Biktarvy patent settlement provides significant long-term exclusivity. The substantial increase in net income and EPS is largely attributable to the non-recurrence of prior-year IPR&D expenses and impairments, rather than a dramatic improvement in underlying operational profitability. While the pipeline has seen some positive developments like Yeztugo's approval, there have also been notable setbacks in oncology clinical trials (Trodelvy's ASCENT-07 failure, STAR-221 discontinuation). The company faces ongoing competitive pressures in cell therapy and significant regulatory/pricing headwinds from the IRA and other government policies. Given the mixed bag of strong core business performance, strategic pipeline advancements, but also clinical trial failures and regulatory challenges, a 'hold' recommendation is appropriate. Investors should monitor pipeline execution, the impact of pricing reforms, and competitive dynamics in key therapeutic areas.

Keywords

Biopharmaceutical, HIV, Oncology, Viral Hepatitis, COVID-19, CAR T-cell therapy, Drug Development, SEC Filing, 10-K, Financial Results, Biktarvy, Trodelvy, Yeztugo, Livdelzi, Veklury, Patent Litigation, R&D Pipeline, Acquisitions, Collaborations, Regulatory Approval, Healthcare Policy, Inflation Reduction Act, Corporate Governance, Risk Management, Cybersecurity