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What changed in Gilead Sciences's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Gilead Sciences's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+363 added−348 removedSource: 10-K (2026-02-24) vs 10-K (2025-02-28)

Top changes in Gilead Sciences's 2025 10-K

363 paragraphs added · 348 removed · 264 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

82 edited+17 added−21 removed78 unchanged
Biggest changeOther • Trodelvy ® (sacituzumab govitecan-hziy), an injection for intravenous use, is a Trop-2 directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with (i) unresectable locally advanced or metastatic triple-negative breast cancer (“TNBC”) who have received two or more prior systemic therapies, at least one of them for metastatic disease, and (ii) unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Biggest changeOncology • Tecartus ® (brexucabtagene autoleucel), a suspension for intravenous infusion, is a chimeric antigen receptor (“CAR”) T-cell therapy for the treatment of adult patients with (i) relapsed or refractory mantle cell lymphoma (“MCL”) (1) and (ii) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”). • Trodelvy ® (sacituzumab govitecan-hziy), an injection for intravenous use, is a Trop-2 directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with (i) unresectable locally advanced or metastatic triple-negative breast cancer (“TNBC”) who have received two or more prior systemic therapies, at least one of them for metastatic disease, and (ii) unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. • Yescarta ® (axicabtagene ciloleucel), a suspension for intravenous infusion, is a CAR T-cell therapy for the treatment of adult patients with (i) large B-cell lymphoma (“LBCL”) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, (ii) relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse LBCL (“DLBCL”) not otherwise specified, primary mediastinal LBCL, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma (“FL”) and (iii) relapsed or refractory FL after two or more lines of systemic therapy (1) .
We also face significant competition from: (i) large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies to pursue the development of products and technologies that may be competitive with our existing products or research programs; (ii) academic institutions, government agencies and other public and private organizations conducting research who may seek patent protection or may establish collaborative arrangements for competitive products or programs; (iii) pricing pressures from private insurers and government payers as our products mature, which often result in a reduction of the net product prices; and (iv) new branded or generic products introduced into major markets, which may impact our ability to maintain pricing and market share.
We also face significant competition from: (i) large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies to pursue the development of products and technologies that may be competitive with our existing products or research programs; (ii) academic institutions, government agencies and other public and private organizations conducting research who may seek patent protection or may establish collaborative arrangements for competitive products or programs; (iii) pricing pressures from private insurers and government payers as our products mature, which often result in a reduction of our net product prices; and (iv) new branded or generic products introduced into major markets, which may impact our ability to maintain pricing and market share.
EU Viral Diseases: Lenacapavir 2037 2037 Bulevirtide 2030 2029 Oncology: Axicabtagene ciloleucel 2031 — (1) Anitocabtagene autoleucel (2) 2038 (2038) Sacituzumab govitecan-hziy 2028 (3) 2029 Zimberelimab (4) 2036 2036 Domvanalimab (4) 2037 (2037) (5) _______________________________ (1) The composition of matter patent has expired in the EU.
EU Viral Diseases: Lenacapavir 2037 2037 Bulevirtide 2030 2029 Oncology: Axicabtagene ciloleucel 2031 — (1) Anitocabtagene autoleucel (2) 2038 (2038) (3) Sacituzumab govitecan-hziy 2028 (4) 2029 Zimberelimab (5) 2036 2036 Domvanalimab (5) 2037 (2037) (3) _______________________________ (1) The composition of matter patent has expired in the EU.
Our portfolio (which varies by country and is subject to employee eligibility requirements and legal and regulatory requirements) includes but is not limited to: • Competitive base salary • Incentive compensation • Stock awards • Employee stock purchase plan • 401(k) savings plan with a company match that vests immediately • Health and wellbeing benefits • Flexible work arrangements • Flexible spending accounts • Paid time off • Paid family leave • Family support services, including family planning and reproductive health (e.g., fertility, adoption and surrogacy) • Mental health support, including complex care management • Health care navigation support • Cancer support services • Student loan repayment and tuition assistance • Employee assistance programs • Digital wellbeing platform • Global wellbeing reimbursement We are a pay-for-performance company and are committed to addressing pay equity.
Our portfolio (which varies by country and is subject to employee eligibility requirements and legal and regulatory requirements) includes but is not limited to: • Competitive base salary • Incentive compensation • Stock awards • Employee stock purchase plan • 401(k) savings plan with a company match that vests immediately • Health and wellbeing benefits • Flexible work arrangements • Flexible spending accounts • Paid time off • Paid family leave • Family support services, including family planning and reproductive health (e.g., fertility, adoption and surrogacy) • Mental health support, including complex care management • Health care navigation support • Cancer support services • Student loan repayment and tuition assistance • Employee assistance programs • Digital wellbeing platform • Global wellbeing reimbursement 10 We are a pay-for-performance company and are committed to addressing pay equity.
Risk Factors “Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price.” Seasonality of Operations Our worldwide product sales do not reflect any significant degree of seasonality in end-user demand. However, in the U.S., fluctuations in wholesaler inventory levels impact our product sales.
Risk Factors “Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price.” 11 Seasonality of Operations Our worldwide product sales do not reflect any significant degree of seasonality in end-user demand. However, in the U.S., fluctuations in wholesaler inventory levels impact our product sales.
The Corporate Responsibility Committee is responsible for reviewing ESG issues and, as appropriate, integrating them into our overall business strategy and operations. Additional information about this program and ESG highlights are available in Gilead’s 2023 ESG Impact Report on Gilead’s website at https://www.gilead.com/responsibility/esg. Our ESG goals are aspirational and may change.
The Corporate Responsibility Committee is responsible for reviewing ESG issues and, as appropriate, integrating them into our overall business strategy and operations. Additional information about this program and our corporate responsibility highlights are available in Gilead’s Responsible Business and Impact Report on Gilead’s website at https://www.gilead.com/responsibility/esg. Our ESG goals are aspirational and may change.
As part of our business strategy, we actively seek patent protection both in the U.S. and internationally and file additional patent applications, when appropriate, to cover improvements in our compounds, products and technology. 8 Patents covering certain of the active pharmaceutical ingredients (“API”) of some of our products are held by third parties.
As part of our business strategy, we actively seek patent protection both in the U.S. and internationally and file additional patent applications, when appropriate, to cover improvements in our compounds, products and technology. Patents covering certain of the active pharmaceutical ingredients (“API”) of some of our products are held by third parties.
FDA may grant Priority Review designation to a drug that would provide significant improvement in the safety or effectiveness of a treatment, diagnosis or prevention of a serious condition. 13 EU Drug Development In the EU, our products are subject to a variety of EU and EU member state regulations governing clinical trials, commercial sales and distribution.
FDA may grant Priority Review designation to a drug that would provide significant improvement in the safety or effectiveness of a treatment, diagnosis or prevention of a serious condition. EU Drug Development In the EU, our products are subject to a variety of EU and EU member state regulations governing clinical trials, commercial sales and distribution.
Similarly, in Europe, interactions between pharmaceutical companies and physicians are subject to strict laws, regulations, industry self‑regulation codes of conduct and physicians’ codes of professional conduct, as applicable, including the EU member states anti-corruption laws and the UK Bribery Act 2010. In addition, the U.S.
Similarly, in Europe, interactions between pharmaceutical companies and physicians are subject to strict laws, regulations, industry self‑regulation codes of conduct and physicians’ codes of professional conduct, as applicable, including the EU member states anti-corruption laws and the UK Bribery Act 2010. 14 In addition, the U.S.
We, our CMOs and our corporate partners are subject to current Good Manufacturing Practices (“cGMP”), which are extensive regulations governing manufacturing processes, stability testing, record keeping and quality standards as defined by FDA and EMA. Similar regulations are in effect in other jurisdictions.
We, our CMOs, our CTLs and our corporate partners are subject to current Good Manufacturing Practices (“cGMP”), which are extensive regulations governing manufacturing processes, stability testing, record keeping and quality standards as defined by FDA and EMA. Similar regulations are in effect in other jurisdictions.
We sell and distribute our products in Europe and countries outside the U.S. where the product is approved, either through our commercial teams, third-party distributors or corporate partners. Competition We operate in a highly competitive environment.
We sell and distribute our products in Europe and countries outside the U.S. where the product is approved, either through our commercial teams, third-party distributors or corporate partners. 4 Competition We operate in a highly competitive environment.
We acquired exclusive rights to these patents in the agreements we have with these parties. We often obtain patents for certain products many years before marketing approval is obtained.
We acquired exclusive rights to these patents in the agreements we have with these parties. 8 We often obtain patents for certain products many years before marketing approval is obtained.
Risk Factors “We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.” Drug development is inherently risky, and many product candidates and investigational therapies fail during the development process. In 2024, we continued to invest in and advance our R&D pipeline across our therapeutic areas.
Risk Factors “We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.” Drug development is inherently risky, and many product candidates and investigational therapies fail during the development process. In 2025, we continued to invest in and advance our R&D pipeline across our therapeutic areas.
For a description of our significant pending legal proceedings, see Note 13. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. Trade Secrets We also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation.
For a description of our significant pending legal proceedings, see Note 12. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. Trade Secrets We also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation.
For most of our products, including our HIV and HCV products, we use multiple CMOs so that we have both primary and back-up suppliers and manufacturing sites.
For most of our products, including our HIV products, we use multiple CMOs so that we have both primary and back-up suppliers and manufacturing sites.
For our future products, we continue to develop additional manufacturing capabilities and establish additional third-party suppliers to manufacture sufficient quantities of our product candidates to undertake clinical trials and to manufacture sufficient quantities of any product that is approved for commercial sale. For more information, see “Government Regulation” section below and Item 1A.
For our future products, we continue to develop additional manufacturing capabilities and establish additional third-party suppliers to manufacture and test sufficient quantities of our product candidates to undertake clinical trials and to manufacture and test sufficient quantities of any product that is approved for commercial sale. For more information, see the “Government Regulation” section below and Item 1A.
A significant portion of our sales of the majority of our products are subject to substantial discounts from their list prices, including rebates to Medicaid agencies or discounts to covered entities under Section 340B of the Public Health Service Act (“340B”).
A significant portion of our sales of the majority of our products are subject to substantial discounts from their list prices, including rebates to Medicare and Medicaid agencies or discounts to covered entities under Section 340B of the Public Health Service Act (“340B”).
Risk Factors “Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and discounts, and other pricing pressures” and “We face challenges in accurately forecasting sales because of the difficulties in predicting demand for our products and fluctuations in purchasing patterns or wholesaler inventories.” 14 Health Care Fraud and Abuse / Anti-Bribery Regulation We are subject to various U.S. federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claim laws.
Risk Factors “Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates” and “We face challenges in accurately forecasting sales because of the difficulties in predicting demand for our products and fluctuations in purchasing patterns or wholesaler inventories.” Health Care Fraud and Abuse / Anti-Bribery Regulation We are subject to various U.S. federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claim laws.
In addition to ongoing monitoring of key metrics (e.g., voluntary turnover), we conducted comprehensive reviews of the employee experience in 2023 and again in 2024 via surveys, focus groups and benchmarks. The resulting insights play a key role in determining the direction of our culture as well as the company’s broader response to emerging developments.
In addition to ongoing monitoring of key metrics (e.g., voluntary turnover), we conducted comprehensive reviews of the employee experience in 2025 via surveys, focus groups and benchmarks. The resulting insights play a key role in determining the direction of our culture as well as the company’s broader response to emerging developments.
Failure to comply with these requirements may lead to the imposition of civil, criminal or administrative sanctions, including suspension of marketing or manufacturing authorizations. Manufacturing Regulation The manufacturing process for pharmaceutical products is highly regulated and regulators may shut down manufacturing facilities that they observe are not complying with regulations.
Failure to comply with these requirements may lead to the imposition of civil, criminal or administrative sanctions, including suspension of marketing or manufacturing authorizations. Manufacturing Regulation The manufacturing process for pharmaceutical products is highly regulated, and regulators may shut down or impose severe restrictions on manufacturing facilities that they observe are not complying with regulations.
We are required to obtain a marketing authorization in the EU before we can market our medicinal products on the relevant market. The conduct of clinical trials in the EU is governed by, among others, Directive 2001/20/EC and Directive 2005/28/EC and the ICH Good Clinical Practice guidelines.
We are required to obtain a marketing authorization in the EU before we can market our medicinal products on the relevant market. The conduct of clinical trials in the EU is governed by, among others, Regulation (EU) No. 536/2014, Directive 2005/28/EC and the ICH Good Clinical Practice guidelines.
Phase 3 Lenacapavir combinations An oral combination of lenacapavir and bictegravir is being evaluated as an HIV treatment for virologically suppressed treatment-experienced and virologically suppressed people living with HIV. In combination with Merck & Co., Inc.
Bictegravir and lenacapavir An oral combination of bictegravir and lenacapavir is being evaluated as an HIV treatment for virologically suppressed treatment-experienced and virologically suppressed people living with HIV. Islatravir and lenacapavir In collaboration with Merck & Co., Inc.
We also conduct an annual pay equity review of employee compensation in an effort to strive to make our pay practices gender- and race-neutral. To promote employee productivity, we continue to address our employees’ needs by providing meaningful benefits and a flexible approach to work arrangements.
We also conduct an annual pay equity review of employee compensation in an effort to strive to make our pay practices gender- and race-neutral. To promote employee productivity, we continue to address our employees’ needs by providing meaningful benefits, such as wellness benefits that support physical and mental health, and a flexible approach to work arrangements.
Securities and Exchange Commission (“SEC”). SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with SEC. 15 Our website is www.gilead.com.
Therefore, we file periodic reports, proxy and information statements and other information with U.S. Securities and Exchange Commission (“SEC”). SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with SEC. Our website is www.gilead.com.
Environmental, social and governance (“ESG”) strategy and performance are overseen by the Nominating and Corporate Governance Committee of our Board of Directors and managed by a Corporate Responsibility Committee, which is comprised of leaders from key departments across our company.
Gilead’s corporate responsibility programs reflect this commitment to our stakeholders. Environmental, social and governance (“ESG”) strategy and performance are overseen by the Nominating and Corporate Governance Committee of our Board of Directors and managed by a Corporate Responsibility Committee, which is comprised of leaders from key departments across our company.
Food and Drug Administration (“FDA”) for a pre-exposure prophylaxis (“PrEP”) indication to reduce the risk of sexually acquired HIV-1 infection in certain at-risk patients. • Odefsey ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
Descovy is also approved by U.S. Food and Drug Administration (“FDA”) for a pre-exposure prophylaxis (“PrEP”) indication to reduce the risk of sexually acquired HIV-1 infection in certain at-risk patients. • Genvoya ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
We also utilize the La Verne facility for clinical manufacturing of our sterile drug products. • Oceanside, California: We utilize the facility for commercial retroviral vector manufacturing and clinical manufacturing and process development of our biologics candidates. • El Segundo, California: We utilize the facility for clinical and commercial manufacturing and processing of our cell therapy products. • Santa Monica, California: We utilize the facility for clinical manufacturing and processing of our cell therapy products. • Frederick, Maryland: We utilize the facility for clinical and commercial manufacturing and processing of our cell therapy products. • Cork and Dublin, Ireland: We utilize the Cork facility for commercial manufacturing, packaging and labeling of our products.
We have made investments in the La Verne facility to support the commercial manufacturing of sterile drug substances and other sterile drug products. • Oceanside, California: We utilize the facility for clinical and commercial retroviral vector manufacturing and process development of our biologics candidates. • El Segundo, California: We utilize the facility for clinical and commercial manufacturing and processing of our cell therapy products. • Santa Monica, California: We utilize the facility for clinical manufacturing and processing of our cell therapy products. • Frederick, Maryland: We utilize the facility for clinical and commercial manufacturing and processing of our cell therapy products. • Cork and Dublin, Ireland: We utilize the Cork facility for commercial manufacturing, packaging and labeling of our products.
EU Descovy 2031 (2) 2027 Vemlidy 2031 (2) 2027 Complera/Eviplera 2025 2026 Zydelig 2025 2029 Odefsey 2032 (2) 2027 Yescarta 2031 — (3) Stribild 2029 (4) 2028 Genvoya 2029 (4), (5) 2028 Harvoni 2030 2030 Epclusa 2033 2032 Biktarvy 2033 2033 Vosevi 2034 2033 Veklury 2036 (6) 2035 Tecartus 2027 — (3) Trodelvy 2028 (7) 2029 Hepcludex 2030 2029 Sunlenca 2037 2037 Livdelzi 2025 (8) — (9) _______________________________ (1) Where applicable, settlement and license agreements with generic manufacturers relating to the patents that protect our principal products are noted.
EU Descovy 2031 (2) 2027 Vemlidy 2031 (2) 2027 Odefsey 2032 (2) 2027 Yescarta 2031 — (3) Genvoya 2029 (4), (5) 2028 Epclusa 2033 2032 Biktarvy 2036 (6) 2033 Veklury 2036 (7) 2035 Tecartus 2027 — (3) Trodelvy 2028 (8) 2029 Sunlenca 2037 2037 Livdelzi 2025 (9) — (10) Yeztugo/Yeytuo 2037 2037 _______________________________ (1) Where applicable, settlement and license agreements with generic manufacturers relating to the patents that protect our principal products are noted.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, coronavirus disease 2019 (“COVID-19”), cancer and inflammation. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.
(“Arcus”) (1) , the combination of zimberelimab, an anti-PD-1 monoclonal antibody, and domvanalimab, an Fc-silent anti-TIGIT antibody, with chemotherapy is being evaluated as (i) a first-line treatment for NSCLC and (ii) a first-line treatment for upper gastrointestinal tract cancer. _______________________________ (1) For additional information regarding our collaborations with Merck, Arcellx and Arcus, see Note 7.
Domvanalimab and zimberelimab In collaboration with Arcus Biosciences, Inc. (“Arcus”) (1) , the combination of domvanalimab, an Fc-silent anti-TIGIT antibody, and zimberelimab, an anti-PD-1 monoclonal antibody, with chemotherapy, is being evaluated as a first-line treatment for metastatic NSCLC. _______________________________ (1) For additional information regarding our collaborations with Merck, Arcellx and Arcus, see Note 7.
Growing concern regarding climate change has resulted in an evolving legal and regulatory landscape, with new requirements enacted to prevent, mitigate or adapt to the implications of climate change.
The evolving legal and regulatory landscape around climate change has resulted in new requirements enacted to prevent, mitigate or adapt to the implications of climate change.
Our product development efforts are focused primarily on viral diseases, cancer and inflammatory diseases. Our team of research scientists is engaged in the discovery and development of new molecules and technologies that we hope will lead to the approval of innovative medicines and therapies that will transform care for people around the world.
Our team of research scientists is engaged in the discovery and development of new molecules and technologies that we hope will lead to the approval of innovative medicines and therapies that will transform care for people around the world.
The drug candidate is given to a small number of healthy human control subjects or patients suffering or at risk from the indicated disease, to test for safety, dose tolerance, pharmacokinetics, metabolism, distribution and excretion. • Phase 2.
These three phases, which are subject to considerable regulation, are as follows: • Phase 1. The drug candidate is given to a small number of healthy human control subjects or patients suffering or at risk from the indicated disease, to test for safety, dose tolerance, pharmacokinetics, metabolism, distribution and excretion. • Phase 2.
In 2024, our products and collaboration products, with approved indications in the U.S., included the following: Virology HIV • Biktarvy ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
In 2025, our commercial portfolio included more than 25 therapies, including the following products and collaboration products with approved indications in the U.S.: HIV • Biktarvy ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
Biktarvy is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, bictegravir, emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”). • Genvoya ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
Biktarvy is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, bictegravir, emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”). • Descovy ® is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients. Descovy is a fixed-dose combination of our antiretroviral medications, FTC and TAF.
In addition, we have an authorized generic version of Harvoni distributed by our separate subsidiary, Asegua Therapeutics LLC. • Viread ® is an oral formulation of TDF dosed once a day for the treatment of chronic HBV infection in adults and pediatric patients 2 years of age and older and weighing at least 10 kg. • Livdelzi ® (seladelpar) is an oral formulation of a peroxisome proliferator-activated receptor delta agonist indicated for the treatment of primary biliary cholangitis (“PBC”) in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
In addition, we have an authorized generic version of Epclusa distributed by our separate subsidiary, Asegua Therapeutics LLC. • Livdelzi ® (seladelpar) is an oral formulation of a peroxisome proliferator-activated receptor delta agonist indicated for the treatment of primary biliary cholangitis (“PBC”) in combination with ursodeoxycholic acid (“UDCA”) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Risk Factors “Climate change and natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.” Other Information We are subject to the information requirements of the Securities Exchange Act of 1934 (“Exchange Act”). Therefore, we file periodic reports, proxy and information statements and other information with U.S.
For more information, see Item 1A. Risk Factors “Climate change and related natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.” Other Information We are subject to the information requirements of the Securities Exchange Act of 1934 (“Exchange Act”).
In collaboration with Merck, it is also being evaluated in combination with Merck’s pembrolizumab as (i) a first-line treatment for PD-L1 positive metastatic TNBC and (ii) an adjuvant treatment for early TNBC. In lung and thoracic cancer, sacituzumab govitecan-hziy is being evaluated in combination with Merck’s pembrolizumab as a first-line treatment for PD-L1 positive non-small cell lung cancer (“NSCLC”).
In lung and thoracic cancer, sacituzumab govitecan-hziy is being evaluated as a treatment for extensive stage small cell lung cancer. It is also being evaluated in combination with Merck’s pembrolizumab as a first-line treatment for PD-L1 positive metastatic non-small cell lung cancer (“NSCLC”). In gynecology, sacituzumab govitecan-hziy is being evaluated as a second-line treatment for metastatic endometrial cancer.
Product Candidates in Oncology Product Candidates Description Phase 3 Axicabtagene ciloleucel Axicabtagene ciloleucel, a CAR T-cell therapy, is being evaluated as (i) a second-line and later treatment for high-risk FL and (ii) a first-line treatment for high-risk LBCL. Anitocabtagene autoleucel In collaboration with Arcellx, Inc.
Phase 3 Axicabtagene ciloleucel Axicabtagene ciloleucel, a CAR T-cell therapy, is being evaluated as (i) a second-line and later treatment for high-risk FL and (ii) a first-line treatment for high-risk LBCL.
Sunlenca, in combination with other antiretroviral(s), is indicated as a twice-yearly treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. 3 Liver Disease • Epclusa ® is an oral formulation of a once-daily single-tablet regimen of sofosbuvir and velpatasvir for the treatment of chronic hepatitis C virus (“HCV”) infection in adults and pediatric patients 3 years of age and older with genotype 1, 2, 3, 4, 5 or 6: (i) without cirrhosis or with compensated cirrhosis or (ii) with decompensated cirrhosis for use in combination with ribavirin.
Liver Disease • Epclusa ® is an oral formulation of a once-daily single-tablet regimen of sofosbuvir and velpatasvir for the treatment of chronic hepatitis C virus (“HCV”) infection in adults and pediatric patients 3 years of age and older with genotype 1, 2, 3, 4, 5 or 6: (i) without cirrhosis or with compensated cirrhosis or (ii) with decompensated cirrhosis for use in combination with ribavirin.
Drug Development Preclinical Testing Before we can test a drug candidate in humans, we must study the drug in laboratory experiments and in animals to generate data to support the drug candidate’s potential benefits and safety.
Drug Development Preclinical Testing Before we can test a drug candidate in humans, we must study the drug in laboratory experiments and in animals to generate data to support the drug candidate’s potential benefits and safety. We submit this data to FDA in an Investigational New Drug (“IND”) application seeking its approval to test the compound in humans.
Genvoya is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, elvitegravir, cobicistat, FTC and TAF. • Descovy ® is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients. Descovy is a fixed-dose combination of our antiretroviral medications, FTC and TAF. Descovy is also approved by U.S.
Genvoya is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, elvitegravir, cobicistat, FTC and TAF. • Odefsey ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
We also perform quality control testing, labeling, packaging and final release of many of our products at the Cork facility, which are distributed to the EU and other international markets through our facility in Dublin. • Edmonton, Canada: We conduct process chemistry research and scale-up activities for our clinical development candidates, manufacture API for both investigational and commercial products and conduct chemical development activities to improve existing commercial manufacturing processes. • Hoofddorp, Netherlands: We utilize the facility for commercial manufacturing and processing of our cell therapy products. 9 We also depend on contract manufacturing organizations (“CMOs”), inside and outside of the U.S., to perform manufacturing activities for the majority of our API and drug products.
We have made investments in clinical drug product manufacturing at the Cork facility. • Edmonton, Canada: We conduct process development, analytical development and scale-up activities for our clinical development candidates, manufacture and quality control test API for clinical and commercial products, and conduct process development activities to improve existing commercial manufacturing processes. • Hoofddorp, Netherlands: We utilize the facility for commercial manufacturing and processing of our cell therapy products. 9 We also depend on contract manufacturing organizations (“CMOs”) and contract testing laboratories (“CTLs”), inside and outside of the U.S., to perform manufacturing and testing activities for the majority of our API and drug products.
(“Merck”) (1) , an oral combination of lenacapavir and Merck’s islatravir is being evaluated as a long-acting HIV treatment for virologically suppressed people living with HIV.
(“Merck”) (1) , an oral combination of Merck’s islatravir and lenacapavir is being evaluated as a long-acting HIV treatment for virologically suppressed people living with HIV. 5 Product Candidates in Oncology Product Candidates Description Regulatory Filings Anitocabtagene autoleucel In collaboration with Arcellx, Inc.
It is not uncommon for a drug candidate that appears promising in Phase 1 clinical trials to fail in the more rigorous and extensive Phase 2 clinical trials. • Phase 3. If a drug candidate appears to be effective and have an appropriate safety profile in Phase 2 clinical trials, Phase 3 clinical trials are commenced to confirm those results.
If a drug candidate appears to be effective and have an appropriate safety profile in Phase 2 clinical trials, Phase 3 clinical trials are commenced to confirm those results.
Stribild is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, elvitegravir, cobicistat, TDF and FTC. • Sunlenca ® is an HIV-1 capsid inhibitor in tablet form for oral use and as an injection for subcutaneous use.
Odefsey is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, FTC and TAF, and rilpivirine marketed by Janssen Products, LP of Johnson & Johnson Innovative Medicine (“Janssen”). • Sunlenca ® is an HIV-1 capsid inhibitor in tablet form for oral use and as an injection for subcutaneous use.
In 2023, we started a multi-year approach to support the development of all people leaders at Gilead, recognizing the complexity and challenges of their roles and supporting the impact they can have on the growth and development of all employees. Approximately 1,700 people leaders started their development journey in 2023, with an additional 3,500 in 2024.
This includes a multi-year approach to support the development of all people leaders at Gilead, recognizing the complexity and challenges of their roles and supporting the impact they can have on the growth and development of all employees.
This is in service to our mission to advance global health by providing innovative therapeutics in areas of unmet need in a way that is socially responsible and environmentally sustainable. Gilead’s corporate responsibility programs reflect this commitment to our stakeholders.
Corporate Responsibility Investing in corporate responsibility is core to our business strategy and reflects our values of accountability, inclusion, teamwork, excellence and integrity. This is in service to our mission to advance global health by providing innovative therapeutics in areas of unmet need in a way that is socially responsible and environmentally sustainable.
In the EU and the U.S., patent applications are pending relating to our proprietary manufacturing processes. (2) In collaboration with Arcellx. (3) Regulatory exclusivity in the U.S. expires in 2032. (4) In collaboration with Arcus.
In the EU and the U.S., patent applications are pending relating to our proprietary manufacturing processes. (2) In collaboration with Arcellx. (3) Dates in parentheses reflect the estimated expiration date of patents that may be issued from currently pending applications. (4) Regulatory exclusivity in the U.S. expires in 2032.
(5) Dates in parentheses reflect the estimated expiration date of patents that may be issued from currently pending applications. 7 The following table shows the actual or estimated expiration dates (including patent term extensions, supplementary protection certificates and/or pediatric exclusivity where granted) in the U.S. and the EU for the primary (typically compound) patents for our principal products.
(5) In collaboration with Arcus. 7 The following table shows the actual or estimated expiration dates (including patent term extensions, supplementary protection certificates and/or pediatric exclusivity where granted) in the U.S. and the EU for the primary (typically compound) patents for certain principal products as described above.
While costs related to compliance with environmental regulations cannot be predicted with certainty, we do not currently anticipate that these costs will have a material effect on our capital expenditures, earnings and competitive position. For more information, see Item 1A.
Our suppliers and third-party manufacturers and corporate partners face similar transition risks that could have an adverse effect on our business. While costs related to compliance with environmental regulations cannot be predicted with certainty, we do not currently anticipate that these costs will have a material effect on our capital expenditures, earnings and competitive position.
Drug Development Regulation A country’s regulatory agency, such as FDA in the U.S. and EMA and EC in the EU, as well as the national authorities of the EU member states, must approve a drug before it can be sold in the respective country or countries.
Risk Factors “Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.” Drug Development Regulation A country’s regulatory agency, such as FDA in the U.S. and EMA and EC in the EU, as well as the national authorities of the EU member states, must approve a drug before it can be sold in the respective country or countries.
Our strategic business development activity reflects our commitment to focus on transformative science, build a sustainable and diverse portfolio and position ourselves for the near-, medium- and long-term growth of our business.
Our strategic business development activity reflects our commitment to focus on transformative science, build a sustainable and diverse portfolio and position ourselves for the near-, medium- and long-term growth of our business. 6 Patents and Proprietary Rights U.S. and EU Patent Expiration We have a number of U.S. and foreign patents, patent applications and rights to patents related to our compounds, products and technology.
(1) COVID-19 • Veklury ® (remdesivir), an injection for intravenous use, is a nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19 in certain adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are (i) hospitalized or (ii) not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
Other • AmBisome ® (amphotericin B liposome for injection) is a proprietary liposomal formulation of amphotericin B, an antifungal agent, for the treatment of serious invasive fungal infections caused by various fungal species in adults. • Veklury ® (remdesivir), an injection for intravenous use, is a nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19 in certain adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are (i) hospitalized or (ii) not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. _______________________________ (1) This indication is approved under accelerated approval by FDA, and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Below is a summary of our product candidates that are in Phase 3 clinical trials or pending marketing authorization review by FDA or European Medicines Agency (“EMA”). 5 Product Candidates in Virology Product Candidates Description Regulatory Filings Lenacapavir A New Drug Application has been filed with FDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for the prevention of HIV as pre-exposure prophylaxis.
Below is a summary of our product candidates that are in Phase 3 clinical trials or pending marketing authorization review by FDA or European Medicines Agency (“EMA”). Product Candidates in Virology Product Candidates Description Regulatory Filings Bulevirtide A Biologics License Application has been filed with FDA for bulevirtide for the treatment of chronic hepatitis delta virus (“HDV”) infection.
(“Arcellx”) (1) , anitocabtagene autoleucel, a CAR T-cell therapy, is being evaluated in patients with relapsed and/or refractory multiple myeloma who have received one to three prior lines of therapy. Sacituzumab govitecan-hziy In breast cancer, sacituzumab govitecan-hziy is being evaluated as (i) a first-line treatment for PD-L1 negative metastatic TNBC and (ii) HR+/HER2- chemo-naive metastatic breast cancer.
Anitocabtagene autoleucel In collaboration with Arcellx (1) , anitocabtagene autoleucel is being evaluated in patients with relapsed and/or refractory multiple myeloma who have received one to three prior lines of therapy. Sacituzumab govitecan-hziy and combinations In breast cancer, sacituzumab govitecan-hziy is being evaluated in combination with Merck’s pembrolizumab as a treatment for high-risk adjuvant TNBC.
(8) Orphan exclusivity expires in 2031. (9) Ten years of regulatory/market exclusivity expected on approval. Patent and Trade Secret Strategy For a discussion of risks and challenges associated with our patent and trade secret strategy described below, see Item 1A.
Patent and Trade Secret Strategy For a discussion of risks and challenges associated with our patent and trade secret strategy described below, see Item 1A.
We generally grant our third-party distributors the exclusive right to promote our product in a territory for a specified period of time. Most of our agreements with these distributors provide for collaborative efforts between the distributor and Gilead in obtaining and maintaining regulatory approval for the product in the specified territory.
Most of our agreements with these distributors provide for collaborative efforts between the distributor and Gilead in obtaining and maintaining regulatory approval for the product in the specified territory. We sell and distribute most of our products in the U.S. exclusively through the wholesale channel.
Marketing authorization holders, manufacturers, importers, wholesalers and distributors of medicinal products placed on the market in the EU are required to comply with a number of regulatory requirements including pharmacovigilance, manufacturing compliance and the requirement to obtain manufacturing, import and/or distribution licenses issued by the competent authorities of the EU member states.
Regulation (EU) No. 536/2014, which entered into application in January 2022 and became fully applicable in January 2025, requires that clinical trial applications and related information and data be submitted through the Clinical Trials Information System, a coordinated system that supports submission, assessment and oversight of all clinical trials in the EU. 13 Marketing authorization holders, manufacturers, importers, wholesalers and distributors of medicinal products placed on the market in the EU are required to comply with a number of regulatory requirements including pharmacovigilance, manufacturing compliance and the requirement to obtain manufacturing, import and/or distribution licenses issued by the competent authorities of the EU member states.
As of the end of 2024, these facilities include: • Foster City, California: We conduct process chemistry research, analytical method development and formulation and device development activities, and manufacture API and drug product for our clinical trials. • La Verne, California: We manufacture AmBisome and also package and label the majority of our commercial products for distribution to the Americas and the Pacific Rim.
We also manufacture and perform quality control testing for API and drug product for our clinical trials. • La Verne, California: We manufacture AmBisome, perform quality control testing and package and label the majority of our commercial products for distribution to the Americas and the Pacific Rim.
Love, M.D. 65 Chair of Board of Directors, Biotechnology Innovation Organization Harish Manwani 71 Senior Operating Partner, Blackstone Inc. Javier J. Rodriguez 54 Chief Executive Officer, DaVita Inc. 16
Horning, M.D. 77 Retired Chief Medical Officer, Roche, Inc. Kelly A. Kramer 58 Retired Chief Financial Officer, Cisco Systems, Inc. Ted W. Love, M.D. 66 Former Chair of Board of Directors, Biotechnology Innovation Organization Harish Manwani 72 Senior Operating Partner, Blackstone Inc. Javier J. Rodriguez 55 Chief Executive Officer, DaVita Inc. 16
Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. • Truvada ® is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients. Truvada is a fixed-dose combination of our antiretroviral medications, TDF and FTC.
Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. • Yeztugo ® is an HIV-1 capsid inhibitor in tablet form for oral use and as an injection for subcutaneous use.
The Apotex/MSN agreement provides a non-exclusive license to those patents beginning on August 6, 2032, or earlier in certain circumstances. (6) In January 2024, FDA granted pediatric exclusivity for Veklury, which extends all non-expired exclusivities by six months, and which is reflected in the presently reported date. (7) Regulatory exclusivity in the U.S. expires in 2032.
(7) In January 2024, FDA granted pediatric exclusivity for Veklury, which extends all non-expired exclusivities by six months, and which is reflected in the presently reported date. (8) Regulatory exclusivity in the U.S. expires in 2032. (9) FDA Orphan Drug Exclusivity expires in 2031. (10) Ten years of regulatory/market exclusivity expected on approval.
We approach inclusion from the standpoint of it being a business imperative that is critical to hiring the very best talent, understanding the patients and communities we serve, and conducting science-based clinical trials focused on patient populations that represent the diseases being studied.
Gilead is an equal opportunity employer and is committed to inclusive practices, which are integral to Gilead’s culture and business. We believe it is a business imperative to hire the very best talent, understand the patients and communities we serve, and conduct science-based clinical trials focused on patient populations that represent the diseases being studied.
Commercialization and Distribution We have U.S. and international commercial sales operations, with marketing subsidiaries in more than 35 countries. Our products are marketed through our commercial teams and/or in conjunction with third-party wholesalers, distributors and corporate partners. Our commercial teams promote our products through direct field contact with physicians, hospitals, clinics and other healthcare providers.
Our products are marketed through our commercial teams and/or in conjunction with third-party wholesalers, distributors and corporate partners. Our commercial teams promote our products through direct field contact with physicians, hospitals, clinics and other healthcare providers. We generally grant our third-party distributors the exclusive right to promote our product in a territory for a specified period of time.
Revenues of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. Royalty, Contract and Other Revenues We also generate revenues from other activities, including royalties for outbound licenses of our intellectual property and other payments received from our collaborations with third-party partners.
Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
Our Executive Officers and Directors The following tables list our executive officers and directors as of the filing date of this Annual Report on Form 10-K: Executive Officers Name Age Position Daniel P. O’Day 60 Chairman and Chief Executive Officer Dietmar Berger 62 Chief Medical Officer Andrew D.
The content on the referenced websites does not constitute a part of and is not incorporated by reference into this Annual Report on Form 10-K. 15 Our Executive Officers and Directors The following tables list our executive officers and directors as of the filing date of this Annual Report on Form 10-K: Executive Officers Name Age Position Daniel P.
We own or lease manufacturing facilities to manufacture and distribute certain products and API for clinical and/or commercial uses.
We own or lease manufacturing facilities to manufacture and distribute certain products and API for clinical and/or commercial uses. As of the end of 2025, these facilities include: • Foster City, California: We conduct manufacturing process development, analytical method development and formulation and device development activities.
In addition, we have an authorized generic version of Epclusa distributed by our separate subsidiary, Asegua Therapeutics LLC. • Vemlidy ® is an oral formulation of TAF dosed once a day for the treatment of chronic hepatitis B virus (“HBV”) infection in adults and pediatric patients 12 years of age and older with compensated liver disease. • Harvoni ® is an oral formulation of a once-daily, single-tablet regimen of ledipasvir and sofosbuvir for the treatment of chronic HCV infection in adults and pediatric patients 3 years of age and older with: (i) genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis, (ii) genotype 1 with decompensated cirrhosis, in combination with ribavirin, (iii) genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
(1) 3 • Vemlidy ® is an oral formulation of TAF dosed once a day for the treatment of chronic hepatitis B virus (“HBV”) infection in adults and pediatric patients 12 years of age and older with compensated liver disease.
As of December 31, 2024, Gilead had approximately 17,600 employees. 10 Total Rewards Gilead’s Total Rewards portfolio is a competitive, robust benefits package that is designed to optimize our employees’ performance and support their wellbeing, allowing them to focus on mission-critical work.
Risk Factors “Due to the specialized and technical nature of our business, the failure to attract, develop and retain highly qualified personnel could adversely impact us.” Total Rewards Gilead’s Total Rewards portfolio is a competitive, robust package that is designed to optimize our employees’ performance and support their wellbeing, allowing them to focus on mission-critical work.
Some of these policy changes may be subject to litigation or other challenge, increasing the uncertainty of their effects on our business.
These tariffs and retaliatory measures taken by other nations in response may increase our costs and adversely impact the competitiveness of our products outside the U.S. Some of these policy changes may be subject to litigation or other challenge, increasing the uncertainty of their effects on our business. For more information, see Item 1A.
We sell and distribute most of our products in the U.S. exclusively through the wholesale channel. During the year ended December 31, 2024, approximately 91% of our product sales in the U.S. and approximately 65% of our total worldwide revenues were from three large wholesalers: Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation, and their specialty distributor affiliates.
Historically, approximately 90% of our gross product sales in the U.S. have been to three large wholesalers—Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation—and their specialty distributor affiliates.
These clinical trials involve three separate phases that often overlap, can take many years and are very expensive. These three phases, which are subject to considerable regulation, are as follows: • Phase 1.
Clinical Trials If FDA accepts the IND, the drug candidate can then be studied in human clinical trials to determine if the drug candidate is safe and effective. These clinical trials involve three separate phases that often overlap, can take many years and are very expensive.
Dickinson 55 Chief Financial Officer Johanna Mercier 55 Chief Commercial Officer Deborah H. Telman 60 Executive Vice President, Corporate Affairs and General Counsel Directors Name Age Principal Occupation or Employment Daniel P. O’Day, Chairman 60 Chairman and Chief Executive Officer of Gilead Sciences, Inc. Anthony Welters, Lead Independent Director 69 Chairman and Chief Executive Officer, CINQ Care Inc. Jacqueline K.
O’Day 61 Chairman and Chief Executive Officer Dietmar Berger 63 Chief Medical Officer Andrew D. Dickinson 56 Chief Financial Officer Johanna Mercier 56 Chief Commercial and Corporate Affairs Officer Keeley M. Cain Wettan 51 Executive Vice President, General Counsel, Legal and Compliance Directors Name Age Principal Occupation or Employment Daniel P.
Ultimately, a workforce with different lived experiences, perspectives and backgrounds is imperative to advancing health and delivering transformational medicines for patients worldwide. Our inclusion council (“Council”) is responsible for governance of our inclusion strategy and our efforts to promote a culture of inclusion and belonging in a sustainable and compliant way.
Our inclusion council (“Council”) is responsible for governance of our inclusion strategy and our efforts to promote a culture of inclusion, equal opportunity and belonging in a sustainable and compliant way. The Council includes senior executives and leaders from our employee resource groups (“ERGs”).
Barton, Ph.D. 72 Professor Emerita, California Institute of Technology Jeffrey A. Bluestone, Ph.D. 71 President and Chief Executive Officer, Sonoma Biotherapeutics, Inc. Sandra J. Horning, M.D. 76 Retired Chief Medical Officer, Roche, Inc. Kelly A. Kramer 57 Retired Chief Financial Officer, Cisco Systems, Inc. Ted W.
O’Day, Chairman 61 Chairman and Chief Executive Officer of Gilead Sciences, Inc. Anthony Welters, Lead Independent Director 70 Chairman and Chief Executive Officer, CINQ Care Inc. Jacqueline K. Barton, Ph.D. 73 Professor Emerita, California Institute of Technology Jeffrey A. Bluestone, Ph.D. 72 Former President and Chief Executive Officer, Sonoma Biotherapeutics, Inc. Sandra J.
President Trump also issued an executive order aimed at diversity, equity and inclusion initiatives and has pledged to impose tariffs on pharmaceuticals and other products, some of which have already started to be implemented. These tariffs and retaliatory measures taken by other nations in response may increase our costs and adversely impact the competitiveness of our products outside the U.S.
For example, the administration has taken a number of actions aimed at lowering U.S. drug prices and testing new Medicare and Medicaid payment models. President Trump also has pledged to impose tariffs on pharmaceuticals and other products, some of which have already started to be implemented.
For more information, see Item 1A. Risk Factors “We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.” Research and Development Our research and development (“R&D”) mission is to discover and develop transformational therapies in areas of high unmet medical need.
Research and Development Our research and development (“R&D”) mission is to discover and develop transformational therapies in areas of high unmet medical need. Our product development efforts are focused primarily on virology, oncology and inflammation.
The Council includes senior executives and leaders from our employee resource groups (“ERGs”). In addition, our ERGs, which are open to all, support employees and aim to raise awareness of different cultures within the workplace and cultivate the variety of lived experiences, perspectives and backgrounds as a business strength.
In addition, our ERGs, which are open to all, support employees and aim to raise awareness of different cultures within the workplace. Executive sponsors and leaders of our ERGs contribute to our inclusion efforts through annual planning and collaboration to support our communities inside and outside of Gilead. As of December 31, 2025, Gilead had approximately 17,000 employees.
Truvada is also approved by FDA for a PrEP indication to reduce the risk of sexually acquired HIV-1 infection in certain at-risk patients. • Stribild ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
Yeztugo is indicated for PrEP to reduce the risk of sexually acquired HIV-1 in certain adults and adolescents who are at risk for HIV-1 acquisition.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeFood and Drug Administration (“FDA”); • securing sufficient supply of other medications to manage side effects, such as tocilizumab and corticosteroids, which may not be available in sufficient quantities, may not adequately control the side effects and/or may have detrimental impacts on the efficacy of cell therapy; • developing and maintaining a robust and reliable process for engineering a patient’s T cells in our facilities and infusing them back into the patient; and • conditioning patients with chemotherapy in advance of administering our therapy, which may increase the risk of adverse side effects.
Biggest changeCell Therapy Advancing a novel and personalized therapy, such as Yescarta or Tecartus, which are chimeric antigen receptor (“CAR”) T-cell therapies, creates significant challenges, including: • developing and maintaining a robust and reliable process for engineering a patient’s T cells in our facilities and infusing them back into the patient; • conditioning patients with chemotherapy in advance of administering our therapy, which may increase the risk of adverse side effects; and • securing sufficient supply of other medications to manage side effects, such as tocilizumab and corticosteroids, which may not be available in sufficient quantities, may not adequately control the side effects and/or may have detrimental impacts on the efficacy of cell therapy.
For challenges related to the reimbursement of Yescarta and Tecartus, see also “ Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and discounts, and other pricing pressures.” We rely on third-party sites to collect patients’ white blood cells, known as apheresis centers, as well as shippers, couriers, and hospitals for the logistical collection of patients’ white blood cells and ultimate delivery of Yescarta and Tecartus to patients.
For challenges related to the reimbursement of Yescarta and Tecartus, see also “ Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.” We rely on third-party sites to collect patients’ white blood cells, known as apheresis centers, as well as shippers, couriers, and hospitals for the logistical collection of patients’ white blood cells and ultimate delivery of Yescarta and Tecartus to patients.
If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal liability. There also continues to be enhanced scrutiny of company-sponsored patient assistance programs, including co-pay assistance programs and manufacturer donations to third-party charities that provide such assistance.
If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal liability. 24 There also continues to be enhanced scrutiny of company-sponsored patient assistance programs, including co-pay assistance programs and manufacturer donations to third-party charities that provide such assistance.
As required by U.S. generally accepted accounting principles, we conduct annual impairment testing of our goodwill and other indefinite-lived intangible assets in the fourth quarter or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired.
As required by U.S. generally accepted accounting principles, we conduct annual impairment testing of our goodwill and other indefinite-lived intangible 29 assets in the fourth quarter or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired.
Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and discounts, and other pricing pressures. Successful commercialization of our products depends, in part, on the availability and amount of third-party payer reimbursement for our products and related treatments and medical services in the markets where we sell our products.
Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates. Successful commercialization of our products depends, in part, on the availability and amount of third-party payer reimbursement for our products and related treatments and medical services in the markets where we sell our products.
We cannot state with certainty when or whether any of our product candidates under development will be approved or launched; whether we will be able to develop, license or acquire additional product candidates or products; or whether any products, once launched, will be commercially successful. Further, how we manufacture and sell our products is subject to extensive regulation and review.
We cannot state with certainty when or whether any of our product candidates under development will be approved or launched; whether we will be able to develop, license or acquire additional product candidates or products; or whether any products, once launched, will be commercially successful. 23 Further, how we manufacture and sell our products is subject to extensive regulation and review.
We sell and distribute most of our products in the U.S. exclusively through the wholesaler/distributor channel. Historically, approximately 90% of our product sales in the U.S. have been to three wholesalers, Cardinal Health, Inc., Cencora, Inc., and McKesson Corporation, and their specialty distributor affiliates.
We sell and distribute most of our products in the U.S. exclusively through the wholesaler/distributor channel. Historically, approximately 90% of our gross product sales in the U.S. have been to three wholesalers—Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation—and their specialty distributor affiliates.
Some of our products and the materials that we utilize in our operations are manufactured by only one supplier or at only one facility, which we may not be able to replace in a timely manner and on commercially reasonable terms, or at all.
Some of our products and the materials that we utilize in our operations are manufactured and/or tested by only one supplier or at only one facility, which we may not be able to replace in a timely manner and on commercially reasonable terms, or at all.
For a description of our ANDA litigation, see Note 13. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. ANDA litigation and related settlement and license agreements, in some cases, may result in a loss of exclusivity for our patents sooner than we would otherwise expect.
For a description of our ANDA litigation, see Note 12. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. ANDA litigation and related settlement and license agreements, in some cases, may result in a loss of exclusivity for our patents sooner than we would otherwise expect.
For equity investments in our strategic partners, such as in connection with our collaborations with Arcus, Galapagos NV and Arcellx, Inc., the value of our equity investments may fluctuate and decline in value.
For equity investments in our strategic partners, such as in connection with our collaborations with Arcus Biosciences, Inc., Galapagos NV and Arcellx, Inc., the value of our equity investments may fluctuate and decline in value.
In the U.S., the European Union (“EU”) and other significant or potentially significant markets for our products and product candidates, government authorities and third-party payers are increasingly attempting to limit or regulate the price of medical products and services. The volume of drug pricing-related legislation has dramatically increased in recent years, including: • U.S.
In the U.S., the European Union (“EU”) and other significant or potentially significant markets for our products and product candidates, government authorities and third-party payers are increasingly attempting to limit or regulate the price of medical products and services. The volume of drug pricing-related legislation and administrative action has dramatically increased in recent years, including: • U.S.
We could be adversely affected if our trade secrets, internal know-how, technological innovation or confidential information become known or independently discovered by competitors or if we enter into disputes over ownership of inventions. We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations.
We could be adversely affected if our trade secrets, internal know-how, technological innovation or confidential information became known or independently discovered by competitors or if we enter into disputes over ownership of inventions. We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations.
We and our CMOs and corporate partners are subject to current Good Manufacturing Practices (“cGMP”), which are extensive regulations governing manufacturing processes, stability testing, recordkeeping and quality standards as defined by FDA and European Medicines Agency (“EMA”), as well as comparable regulations in other jurisdictions. Manufacturing operations are also subject to routine inspections by regulatory agencies.
We and our CMOs, CTLs and corporate partners are subject to current Good Manufacturing Practices (“cGMP”), which are extensive regulations governing manufacturing processes, release and stability testing, recordkeeping and quality standards as defined by FDA and European Medicines Agency (“EMA”), as well as comparable regulations in other jurisdictions. Manufacturing operations are also subject to routine inspections by regulatory agencies.
Such litigation and proceedings are unpredictable and expensive, and could divert management attention from other operations, such that, even if we are ultimately successful, we may be adversely impacted. Patents covering our existing compounds, products and processes, and those that we will likely file in the future, may not provide complete or adequate protection.
Such litigation and proceedings are unpredictable and expensive, and could divert management attention from other operations, such that, even if we are ultimately successful, we may be adversely impacted. Patents covering our existing compounds, products and technology, and those that we will likely file in the future, may not provide complete or adequate protection.
New branded or generic products entering major markets affects our ability to maintain pricing and market share. Our products compete with other available products based primarily on efficacy, safety, tolerability, acceptance by doctors, ease of patient compliance, ease of use, price, insurance and other reimbursement coverage, distribution and marketing.
New branded or generic products entering major markets affect our ability to maintain pricing and market share. Our products compete with other available products based primarily on efficacy, safety, tolerability, acceptance by doctors, ease of patient compliance, ease of use, price, insurance and other reimbursement coverage, distribution and marketing.
Climate change and natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.
Climate change and related natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.
For a description of our government investigations and related litigation, see Note 13. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
For a description of our government investigations and related litigation, see Note 12. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
For example, we enter into commitments to purchase materials and supplies in anticipation of the potential manufacture and sale of new product candidates, and in the event the development, approval or launch of these product candidates is delayed or otherwise unsuccessful, we may experience excess inventory that needs to be written down, losses on firm commitments to purchase inventory, or other costs and expenses resulting from such commitments.
For example, we enter into commitments to purchase materials and supplies in anticipation of the potential manufacture and sale of new product candidates, and if the development, approval or launch of these product candidates is delayed or otherwise unsuccessful, we may experience excess inventory that needs to be written down, losses on firm commitments to purchase inventory, or other related costs and expenses resulting from such commitments.
Such attacks and incidents include, for example, the deployment of harmful malware, exploitation of vulnerabilities, computer viruses, key loggers, ransomware, denial-of-service, social engineering and other means to affect service reliability and operations and threaten data confidentiality, integrity and availability. Recent developments in the threat landscape include the use of increasingly sophisticated and evolving artificial intelligence and machine learning tools.
Such attacks and incidents include, for example, the deployment of harmful malware, exploitation of vulnerabilities, computer viruses, key loggers, ransomware, denial-of-service, social engineering and other means to affect service reliability and operations and threaten data confidentiality, integrity and availability. Recent developments in the threat landscape include the use of increasingly sophisticated and evolving AI and machine learning tools.
For a description of our pending patent litigation, see Note 13. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. Furthermore, we also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation.
For a description of our pending patent litigation, see Note 12. Commitments and 25 Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. Furthermore, we also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation.
Congress has enacted the Inflation Reduction Act of 2022 (the “IRA”), which, among other changes, (1) requires the Department of Health and Human Services to “negotiate” Medicare prices for certain drugs (starting with 10 drugs in 2026, adding 15 drugs in 2027 and 2028, and adding 20 drugs in 2029 and subsequent years), which could also affect the Medicaid rebate obligations and the ceiling prices charged to covered entities under Section 340B of the Public Health Service Act (“340B”) if such prices are lower than the Medicaid Best Price; (2) imposes an inflation-based rebate on Medicare Part B utilization starting in 2023 and Part D utilization beginning October 1, 2022; and (3) restructures the Medicare Part D benefit to cap out-of-pocket expenses for Part D beneficiaries beginning in 2024 and, effective January 1, 2025, increases Part D plans’ contributions in the catastrophic coverage phase and increases manufacturers’ discount contributions across coverage phases such that manufacturers must pay a 10% discount in the initial coverage phase and a 20% discount in the catastrophic phase on drugs utilized by all Part D beneficiaries, including low income subsidy patients.
Congress has enacted the Inflation Reduction Act of 2022 (“IRA”), which, among other changes, (1) requires the Department of Health and Human Services to “negotiate” Medicare prices for certain drugs (starting with 10 drugs in 2026, adding 15 drugs in 2027 and 2028, and adding 20 drugs in 2029 and subsequent years), which could also affect the Medicaid rebate obligations and the ceiling prices charged to covered entities under Section 340B of the Public Health Service Act (“340B”) if such prices are lower than the Medicaid Best Price and reduce the Average Sales Price and associated Medicare reimbursement rate for products reimbursed under Medicare Part B; (2) imposes an inflation-based rebate on Medicare Part B utilization starting in 2023 and Part D utilization beginning October 1, 2022; and (3) restructures the Medicare Part D benefit to cap out-of-pocket expenses for Part D beneficiaries beginning in 2024 and, effective January 1, 2025, increases Part D plans’ contributions in the catastrophic coverage phase and increases manufacturers’ discount contributions across coverage phases such that manufacturers must pay a 10% discount in the initial coverage phase and a 20% discount in the catastrophic phase on drugs utilized by all Part D beneficiaries, including low income subsidy patients.
Department of Health and Human Services (“HHS”) asserting that those programs violate the 340B statute, have been referred to the HHS Office of Inspector General for assessment of civil monetary penalties, and have been subject to administrative dispute resolution proceedings brought on behalf of covered entities. Some of these manufacturers are challenging HHS’ position in litigation.
Department of Health and Human Services (“HHS”) asserting that those programs violate the 340B statute, have been referred to the HHS Office of Inspector General for assessment of civil monetary penalties, and have been subject to administrative dispute resolution proceedings brought on behalf of covered entities. Some of these manufacturers are challenging HHS’s position in litigation. The U.S.
Certain states have also enacted laws requiring manufacturers to provide 340B pricing through contract pharmacy arrangements, and additional states may adopt similar laws; we believe these laws, which are being challenged in ongoing litigation, are invalid but we have carved out covered entities in certain states from our integrity initiative while litigation challenging these laws proceeds.
A growing number of states have also enacted laws requiring manufacturers to provide 340B pricing through contract pharmacy arrangements, and additional states may adopt similar laws; we believe these laws, which are being challenged in ongoing litigation, are invalid but we have carved out covered entities in certain states from our integrity initiative while litigation challenging these laws proceeds.
These regulations, which can differ across jurisdictions, subject us to many transition risks, including, for example, new or expanded carbon pricing or taxes, increased compliance costs, restrictions on greenhouse gas emissions, investment in new technologies, increased carbon disclosure and transparency, investments in data gathering and reporting systems, upgrades of facilities to meet new building codes and the redesign of utility systems, which could increase the company’s operating costs, including the cost of electricity and energy.
These requirements, which can differ across jurisdictions, subject us to many transition risks, including, for example, new or expanded carbon pricing or taxes, increased compliance costs, restrictions on greenhouse gas emissions, investment in new technologies, increased sustainability disclosures and transparency, investments in data gathering and reporting systems, upgrades of facilities to meet new building codes and the redesign of utility systems, which could increase the company’s operating costs, including the cost of electricity and energy.
For example, see “Foreign Currency Exchange Impact” in Part II, Item 8 of this Annual Report on Form 10-K for a discussion of our exposure to movements in foreign currency exchange rates, primarily in the Euro, and the impacts from foreign currency exchange, net of hedges, for the year ended December 31, 2024. • Interest Rates and Inflation: We have interest-generating assets and interest-bearing liabilities, including our senior unsecured notes and credit facilities.
For example, see “Foreign Currency Exchange Impact” in Part II, Item 7 of this Annual Report on Form 10-K for a discussion of our exposure to movements in 26 foreign currency exchange rates, primarily in the Euro, and the impacts from foreign currency exchange, net of hedges, for the year ended December 31, 2025. • Interest Rates and Inflation: We have interest-generating assets and interest-bearing liabilities, including our senior unsecured notes and credit facilities.
In addition, multiple manufacturers and trade organizations have challenged the Medicare “negotiation” provisions of the IRA, and additional legal challenges may be filed in the future.
In addition, multiple manufacturers and trade organizations have challenged the Medicare negotiation provisions of the IRA, and additional legal challenges may be filed in the future.
Other risks inherent in conducting a global business include: • Restrictive government actions against our intellectual property and other assets such as nationalization, expropriation, the imposition of compulsory licenses or similar actions, including waiver of intellectual property protections. 26 • Changes in economic policies by the U.S. or foreign governments, which may result in trade protection measures, such as new or increased sanctions, tariffs, embargoes, import and export licensing requirements or other trade restrictions, or the threat of such restrictions. • Political instability or disruption in a geographic region where we operate, regardless of cause, including war, terrorism, social unrest and political changes, including in China, Russia, Ukraine, Israel and surrounding areas. • Increasing use of social media platforms and modern technologies present new risks and challenges, and inappropriate or unauthorized use of these platforms can result in exposure of sensitive data or information and damage our brand and reputation.
Other risks inherent in conducting a global business include: • Restrictive government actions against our intellectual property and other assets such as nationalization, expropriation, the imposition of compulsory licenses or similar actions, including waiver of intellectual property protections. • Changes in trade policies by the U.S. or foreign governments, which may result in protectionist measures, such as new or increased sanctions, tariffs (such as the country-specific tariffs and related retaliatory actions implemented by the U.S. and other countries), embargoes, import and export licensing requirements or other trade restrictions, or the threat of such restrictions. • Political instability or disruption in a geographic region where we operate, regardless of cause, including war, terrorism, social unrest and political changes, including in China, Russia, Ukraine, Israel and surrounding areas. • Increasing use of social media platforms and modern technologies present new risks and challenges, and inappropriate or unauthorized use of these platforms can result in exposure of sensitive data or information and damage our brand and reputation.
Likewise, data privacy or cybersecurity incidents or breaches by employees or others, including the unauthorized use of artificial intelligence tools, can result in the exposure of sensitive data, including our intellectual property or trade secrets or the personal information of our employees, patients, customers or other business partners to unauthorized persons or to the public.
Likewise, data privacy or cybersecurity incidents or breaches by employees or others, including the unauthorized use of AI tools, can result in the exposure of or misuse of sensitive data, including our intellectual property or trade secrets or the personal information of our employees, patients, customers or other business partners to unauthorized persons or to the public.
There are differing interpretations of tax laws and regulations and, as a result, significant disputes may arise with these tax authorities involving issues of the timing and amount of deductions and allocations of income among various tax jurisdictions. We may be adversely affected by the resolution of one or more of these exposures in any reporting period. 30
There are differing interpretations of tax laws and regulations and, as a result, significant disputes may arise with these tax authorities, including with respect to issues of the timing and amount of deductions and allocations of income among various tax jurisdictions. We may be adversely affected by the resolution of one or more of these exposures in any reporting period.
For example, in January 2024, we announced that our Phase 3 EVOKE-01 study evaluating sacituzumab govitecan-hziy did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer (“NSCLC”), which resulted in us recording an impairment charge during the three months ended March 31, 2024.
For example, in January 2024, we announced that our Phase 3 EVOKE-01 study evaluating sacituzumab govitecan-hziy (“SG”) did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer (“NSCLC”), which resulted in us recording an impairment charge during the three months ended March 31, 2024 (for more information, see Note 8.
A number of companies are pursuing the development of products and technologies that may be competitive with our existing products or research programs. These competing companies include large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies.
A number of companies, including large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies, are pursuing the development of products and technologies that may be competitive with our existing products or research programs.
Moreover, we estimate the rebates we will be required to pay in connection with sales during a particular quarter based on claims data from prior quarters. In the U.S., actual rebate claims are typically made by payers one to three quarters in arrears.
Moreover, we estimate the rebates we will be required to pay in connection with sales during a particular quarter based on claims data from prior quarters. In the U.S., actual rebate claims are typically made by payers one to three quarters in arrears. Actual claims and payments may vary significantly from our estimates.
Actual claims and payments may vary significantly from our estimates. 20 We may experience adverse impacts resulting from the importation of our products from lower price markets or the distribution of illegally diverted or counterfeit versions of our products. Prices for our products are based on local market economics and competition and sometimes differ from country to country.
We may experience adverse impacts resulting from the importation of our products from lower price markets or the distribution of illegally diverted or counterfeit versions of our products. Prices for our products are based on local market economics and competition and sometimes differ from country to country.
If any of their processes, methodologies or results were determined to be invalid or inadequate, our own clinical data and results and related regulatory approvals may be adversely affected.
If any of their processes, methodologies or results were determined to be invalid, inadequate or in violation of Good Clinical Practices and related regulations, our own clinical data and results and related regulatory approvals may be adversely affected.
There can be no assurance that we will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections.
There can be no assurance that we or our CMOs, CTLs or other corporate partners will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections.
Similarly, our pursuit of ESG practices, as well as our failure or perceived failure to pursue or fulfill our goals, targets and objectives, or to satisfy various reporting standards within the timelines we announce, or at all, could also have similar negative impacts and expose us to government enforcement actions, stakeholder criticism or negative campaigns, and private litigation.
Similarly, our pursuit of certain corporate responsibility practices, as well as our failure or perceived failure to pursue or fulfill our goals, targets and objectives, or to satisfy various reporting standards within the timelines we announce, or at all, could also similarly adversely impact us and expose us to government enforcement actions, stakeholder criticism or negative campaigns, and private litigation.
As we have seen with the COVID-19 pandemic, outbreaks can result in global supply chain and logistics disruptions and distribution constraints.
As seen during the COVID-19 pandemic, outbreaks can result in global supply chain and logistics disruptions and distribution constraints.
Additionally, recently proposed legislation in the U.S., such as the BIOSECURE Act (which, among other things, could prohibit U.S. executive agencies from contracting with, or expending loans or granting funds to, companies that use biotechnology equipment or services for certain activities from certain foreign-owned entities), has the potential to adversely impact our ability to receive equipment or services from such entities, including certain of which we use in connection with our clinical trials and our clinical and commercial manufacturing, which could increase the cost or limit the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials and regulatory submissions, delay the launch of commercial products and adversely affect our financial condition and business prospects.
For example, recently enacted and proposed legislation in the U.S., such as the BIOSECURE Act (which, among other things, prohibits U.S. executive agencies from contracting with, or expending loans or granting funds to, companies that use biotechnology equipment or services for certain activities from certain foreign-owned entities) and the ABC Safe Drug Act (which, among other things, could prohibit U.S. federal health care programs from purchasing drugs and drug ingredients manufactured in China), has the potential to adversely impact our ability to receive goods or services from such entities, including certain of which we use in connection with our clinical trials and our clinical and commercial manufacturing, which could increase the cost or limit the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials and regulatory submissions, delay the launch of commercial products and adversely affect our financial condition and business prospects.
Although we have business continuity plans and contingencies in place and conduct periodic assessments of our natural disaster risk as part of our overall enterprise risk management program, a major earthquake or other natural disaster can result in significant recovery time and a prolonged interruption to our operational and business activities.
Our business continuity plans and contingencies, including periodic assessments of our natural disaster risk as part of our overall enterprise risk management program, may be insufficient, and a major earthquake or other natural disaster can result in significant recovery time and a prolonged interruption to our operational and business activities.
The Centers for Medicare and Medicaid Services (“CMS”) has issued a number of guidance documents, but it remains unclear how certain provisions of the IRA will be implemented. Additional guidance, legislation or rulemaking may be issued that could change the scope or implementation of the IRA.
The Centers for Medicare and Medicaid Services (“CMS”) has issued a number of guidance documents governing certain aspects of the IRA, but it remains unclear how certain provisions of the IRA are being implemented due to lack of full transparency. Additional guidance, legislation or rulemaking may be issued that could change the scope or implementation of the IRA.
Further, we have in the past and we may in the future make a strategic decision to discontinue development of our product candidates, including but not limited to situations where we believe commercialization will be difficult relative to other opportunities in our pipeline. For example, in January 2024, we announced with our partner Arcus Biosciences, Inc.
Further, we have in the past and we may in the future make a strategic decision to discontinue development of our product candidates, including but not limited to situations where we believe commercialization will be difficult relative to other opportunities in our pipeline.
Our success depends on developing and commercializing new products or expanding the indications for existing products. If we are unable to launch commercially successful new products or new indications for existing products, including approval for earlier lines of therapy, our business will be adversely impacted.
If we are unable to launch commercially successful new products or new indications for existing products, including approval for earlier lines of therapy, our business will be adversely impacted.
Due to economic and political conditions, various countries are actively considering and have made changes to existing tax laws, and we cannot predict the form or timing of such changes.
We are subject to income taxes in the U.S. and various foreign jurisdictions. Due to economic and political conditions, various countries are actively considering and have made changes to existing tax laws, and we cannot predict the form or timing of such changes.
In March 2022, we implemented a contract pharmacy integrity initiative for our branded hepatitis C virus (“HCV”) products. This integrity initiative does not involve any products from Asegua Therapeutics LLC.
Detecting and remedying these program integrity violations is challenging. 20 In March 2022, we implemented a contract pharmacy integrity initiative for our branded hepatitis C virus (“HCV”) products. This integrity initiative does not involve any products from Asegua Therapeutics LLC.
It is not possible for our ESG practices to satisfy all investors and stakeholders, and our reputation, our ability to attract or retain employees and our attractiveness as an investment, business partner or acquiror could be negatively impacted.
These expectations and standards are varied and evolving, and may be inconsistent with our current practices. It is not possible for our practices to satisfy all investors and stakeholders, and our reputation, our ability to attract or retain employees and our attractiveness as an investment, business partner or acquiror could be negatively impacted.
For example, our Kite Konnect platform is critical to maintain chain of identity and chain of custody for our cell therapies. The multitude and complexity of our computer systems make them inherently vulnerable to service interruption or destruction, including those caused by failures during system upgrades or implementations, user error, network or hardware failure, malicious intrusion and ransomware attack.
The multitude and complexity of our computer systems make them inherently vulnerable to service interruption or destruction, including those caused by failures during system upgrades or implementations, user error, network or hardware failure, malicious intrusion and ransomware attack.
The healthcare industry is subject to various federal, state and international laws and regulations pertaining to drug approval, manufacturing, reimbursement, rebates, price reporting, healthcare fraud and abuse, and data privacy and security.
We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry. The healthcare industry is subject to various federal, state and international laws and regulations pertaining to drug approval, manufacturing, reimbursement, rebates, price reporting, healthcare fraud and abuse, and data privacy and security.
We have limited insurance for product liabilities that may arise and claims may exceed our coverage. For a description of our litigation, investigation and other dispute-related matters, see Note 13. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
For a description of our litigation, investigation and other dispute-related matters, see Note 12. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
Supreme Court decision to overrule the Chevron doctrine, any of which could require us to incur substantial costs associated with compliance, alter one or more of our sales or marketing practices, or impact our ability to obtain or maintain regulatory approvals. The resulting impact on our business is uncertain and could be material.
Supreme Court decision to overrule the Chevron doctrine, any of which could require us to incur substantial costs associated with compliance, alter one or more of our sales or marketing practices, adversely affect health insurance reimbursement of our products, or impact our ability to obtain or maintain regulatory approvals.
Such cybersecurity incidents can cause the loss of critical or sensitive information, including personal information, and could give rise to legal liability and regulatory action under data protection and privacy laws.
Such cybersecurity incidents can cause the loss of critical or sensitive information, including personal information, and could give rise to legal liability and regulatory action under data protection and privacy laws. Financial, legal, business, or reputational losses may result from a cybersecurity incident or breach of our information technology systems.
Further, there is risk that regulatory agencies in other countries where marketing applications are pending will undertake similar additional reviews or apply a heightened standard of review, which could delay the regulatory approvals for products in those countries. 22 Any adverse developments affecting or resulting from any single entity within our manufacturing operations or the operations of our CMOs and corporate partners can result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the development and commercial supply of our products, which may result in us not being able to generate sufficient quantities of clinical or commercial product to meet market demand and may cause delays in our clinical trials and applications for regulatory approval.
Any adverse developments affecting or resulting from any single entity within our manufacturing operations or the operations of our CMOs, CTLs and corporate partners can result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the development and commercial supply of our products, which may result in us not being able to generate sufficient quantities of clinical or commercial product to meet market demand and may cause delays in our clinical trials and applications for regulatory approval.
We expect these matters will continue to require a high level of internal and financial resources for the foreseeable future.
We expect these matters will continue to require a high level of internal and financial resources for the foreseeable future. These matters have reduced, and are expected to continue to reduce, our earnings and require significant management attention.
If there is any dispute or disruption in our relationships with our CROs, including as a result of legislative or regulatory actions, our clinical trials and regulatory submissions may be delayed and our costs may increase. Moreover, in our regulatory submissions, we rely on the quality and validity of the clinical work performed by our CROs.
If there is any dispute or disruption in our relationships with our CROs, including as a result of legislative or regulatory actions (such as the recently enacted BIOSECURE Act in the U.S.), our clinical trials and regulatory submissions may be delayed and our costs may increase.
A substantial portion of our product sales is subject to significant discounts from list price, including rebates that we may be required to pay state Medicaid agencies and discounts provided to covered entities under 340B. Changes to the 340B program or the Medicaid program at the federal or state level could have a material adverse effect on our business.
Some of these initiatives may be subject to litigation or other challenge, increasing the uncertainty of their effects on our business. A substantial portion of our product sales is subject to significant discounts from list price, including rebates that we may be required to pay state Medicaid agencies and discounts provided to covered entities under 340B.
In the U.S., these laws include anti-kickback and false claims laws, the Federal Food, Drug, and Cosmetic Act, laws and regulations relating to the Medicare and Medicaid programs and other federal and state programs, such as the Medicaid Rebate Statute and the 340B statute, laws that regulate written and verbal communications about our products, individual state laws relating to pricing and sales and marketing practices, the Health Insurance Portability and Accountability Act and other federal and state laws relating to the privacy and security of health information, including the Executive Order on Preventing Access to Americans’ Bulk Sensitive Personal Data, which may impact how and where clinical and other sensitive data is shared, accessed and analyzed, and United States Government-Related Data by Countries of Concern issued in February 2024.
In the U.S., these laws include anti-kickback and false claims laws, the Federal Food, Drug, and Cosmetic Act, laws and regulations relating to the Medicare and Medicaid programs and other federal and state programs, such as the Medicaid Rebate Statute and the 340B statute, laws that regulate written and verbal communications about our products, individual state laws relating to pricing and sales and marketing practices, the Health Insurance Portability and Accountability Act and other federal and state laws relating to the privacy and security of health information, including the Department of Justice Final Rule on Preventing Access to U.S.
Additionally, we periodically make adjustments, including to the size and composition of our workforce, to reflect our personnel needs in response to changing macroeconomic conditions, market opportunities, management changes, acquisitions, cost levels and other internal and external considerations, which may adversely impact our workplace culture and ability to retain and incentivize employees. 28 The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations.
Additionally, we periodically make adjustments, including to the size and composition of our workforce, to reflect our personnel needs in response to changing macroeconomic conditions, market opportunities, management changes, acquisitions, cost levels and other internal and external considerations, which may adversely impact our workplace culture and ability to retain and incentivize employees. 28 Information system service interruptions or breaches, including significant cybersecurity incidents, could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations.
These matters have reduced, and are expected to continue to reduce, our earnings and require significant management attention. 25 In addition, the testing, manufacturing, marketing and use of our commercial products, as well as product candidates in development, involve substantial risk of product liability claims. These claims may be made directly by consumers, healthcare providers, pharmaceutical companies or others.
In addition, the testing, manufacturing, marketing and use of our commercial products, as well as product candidates in development, involve substantial risk of product liability claims. These claims may be made directly by consumers, healthcare providers, pharmaceutical companies or others. We have limited insurance for product liabilities that may arise and claims may exceed our coverage.
While the new DRG has a significantly higher base payment amount than the prior DRG 016, the payment available may not be sufficient to reimburse some hospitals for their cost of care for patients receiving Yescarta and Tecartus.
For example, CMS established a severity-adjusted diagnosis-related group (“DRG”) 018 for Medicare inpatient reimbursement of CAR T-cell products such as Yescarta and Tecartus. While the DRG has a significantly higher base payment amount than the prior DRG 016, the payment available may not be sufficient to reimburse some hospitals for their cost of care for patients receiving Yescarta and Tecartus.
Suppliers of key components and materials must be named in the new drug application or marketing authorization application filed with the regulatory authority for any product candidate for which we are seeking marketing approval, and significant delays can occur if the qualification of a new supplier is required.
If we are unable to purchase enough of these materials and supplies or find suitable alternatives in a timely manner, our development efforts for our product candidates may be delayed or our ability to manufacture and sell our products could be limited. 22 Suppliers of key components and materials must be named in the new drug/biologics application or marketing authorization application filed with the regulatory authority for any product candidate for which we are seeking marketing approval, and significant delays can occur if the qualification of a new supplier is required.
Regulatory efforts, both internationally and in the U.S., are evolving, including the international alignment of such efforts, and we cannot determine what final regulations will be enacted, modified or reversed or what their ultimate impact on our business will be.
Regulatory efforts, both internationally and in the U.S., are evolving, including the international alignment of such efforts, and we cannot determine what final regulations will be enacted, modified or reversed or what their ultimate impact on our business will be. 27 Our suppliers and third-party manufacturers and corporate partners similarly face these risks that could have an adverse effect on our business, and any disruption to their operations could have an adverse effect on our manufacturing and supply chain.
For example, the continued growth of the 340B program limits the prices we may charge on an increasing percentage of sales. Changes to the calculation of rebates under the Medicaid program could substantially increase our Medicaid rebate obligations and decrease the prices we charge 340B-covered entities.
Changes to the 340B program or the Medicaid program at the federal or state level could have a material adverse effect on our business. For example, changes to the calculation of rebates under the Medicaid program could substantially increase our Medicaid rebate obligations and decrease the prices we charge 340B-covered entities.
Financial, legal, business, or reputational losses may result from a cybersecurity incident or breach of our information technology systems. 29 Regulators globally are also imposing data privacy and security requirements, such as EU’s General Data Protection Regulation (“GDPR”) and other domestic data privacy and security laws, such as the California Consumer Privacy Act and the California Privacy Rights Act.
Regulators globally are also imposing data privacy and security requirements, such as EU’s General Data Protection Regulation (“GDPR”) and other domestic data privacy and security laws, such as the California Consumer Privacy Act and the California Privacy Rights Act.
In such case, we may need to scale back our operations, including our future drug development and spending on research and development (“R&D”) efforts. For example, many of our HIV products contain tenofovir alafenamide (“TAF”), which belongs to the nucleoside class of antiviral therapeutics.
In such case, we may need to scale back our operations, including our future drug development and spending on research and development (“R&D”) efforts.
Quality, reliability and speed are critical in cell therapy manufacturing to quickly and safely deliver our cell therapies to patients. Any delays or quality issues with our manufacturing operations could adversely affect our business and damage our reputation. In addition, we may not be able to sufficiently increase manufacturing network capacity to meet growing demand.
Any delays or quality issues with our manufacturing operations could adversely affect our business and 17 damage our reputation. In addition, we may not be able to sufficiently increase manufacturing network capacity to meet growing demand. Our success depends on developing and commercializing new products or expanding the indications for existing products.
Our success depends to a significant degree on our ability to obtain patents and licenses to patent rights, enforce our patents and defend against infringement of our patents and efforts to invalidate them, operate without infringing on the intellectual property of others, and preserve trade secrets and internal know-how. 24 Our pending patent applications and the patent applications filed by our collaborative partners may not be able to prevent third parties from developing compounds or products that are closely related to those which we have developed or are developing.
Our success depends to a significant degree on our ability to obtain patents and licenses to patent rights, enforce our patents and defend against infringement of our patents and efforts to invalidate them, operate without infringing on the intellectual property of others, and preserve trade secrets and internal know-how.
Failure to comply with these or other requirements imposed by FDA could result in significant civil monetary penalties, fines, suspensions of regulatory approvals, product recalls, seizure of products and criminal prosecutions. 23 We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.
Safety information, without the appropriate context and expertise, may be misinterpreted and lead to misperception or legal action. Failure to comply with these or other requirements imposed by FDA could result in significant civil monetary penalties, fines, suspensions of regulatory approvals, product recalls, seizure of products and criminal prosecutions.
Our products, which are manufactured at our own facilities or by third-party contract manufacturing organizations (“CMOs”) and corporate partners, are the result of complex, highly regulated manufacturing processes. We depend on CMOs and corporate partners to perform manufacturing activities effectively and on a timely basis for the majority of our active pharmaceutical ingredients and drug products.
Our products, which are manufactured and tested at our own facilities or by third-party contract manufacturing organizations (“CMOs”), third-party contract testing laboratories (“CTLs”) and corporate partners, are the result of complex, highly regulated manufacturing processes.
While the full impact of the IRA on our business and the pharmaceutical industry remains uncertain at this time, we anticipate that the IRA will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results. 19 • Many state legislatures are considering, or have already passed into law, legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing, such as requiring manufacturers to publicly report proprietary pricing information, creating review boards for prices, establishing drug payment limits, and encouraging the use of generic drugs.
While the full impact of the IRA on our business and the pharmaceutical industry remains uncertain at this time, we anticipate that the IRA will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results. • U.S.
In addition, government price reporting and payment regulations are complex, and we are continually assessing the methods by which we calculate and report pricing in accordance with these obligations. Our methodologies for calculations are inherently subject to assumptions and may be subject to review and challenge by various government agencies, which may disagree with our interpretation.
Our methodologies for calculations are inherently subject to assumptions and may be subject to review and challenge by various government agencies, which may disagree with our interpretation.
The outcome of these reviews cannot be predicted and could have an adverse effect on the pricing and reimbursement of our medical products in the EU member states. Reductions in the pricing of our medical products in one member state could affect the price in other member states and have a negative impact on our financial results.
The outcome of these reviews is unpredictable and may adversely affect the pricing and reimbursement of our medical products in the EU. Price reductions in one EU member state could affect pricing in others and negatively impact our financial results. • U.S.
Based on trial results, it is possible that FDA and other regulatory authorities do not approve our product candidates, or that any market approvals include significant limitations on the products’ use. Additionally, products and indications approved under accelerated approval pathways may be subject to withdrawal where confirmatory studies are unsuccessful.
As a result, we may be unable to successfully complete our clinical trials on our anticipated timelines, or at all. Based on trial results, it is possible that FDA and other regulatory authorities do not approve our product candidates, or that any market approvals include significant limitations on the products’ use.
In addition, clinical trials involving our commercial products can raise new safety issues for our existing products, which could adversely impact our business.
Additionally, products and indications approved under accelerated approval pathways may be subject to withdrawal where confirmatory studies are unsuccessful. In addition, clinical trials involving our commercial products can raise new safety issues for our existing products, which could adversely impact our business.
Apheresis centers may also choose not to participate in our quality certification process, or we may be unable to complete such certification in a timely manner or at all, which could delay or constrain our manufacturing and commercialization efforts. 17 We also face risks related to our in-house CAR T-cell therapy manufacturing facilities in California, Maryland and the Netherlands, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.
Disruptions or difficulties at these vendors could result in product loss and regulatory action. Apheresis centers may also decline to participate in our quality certification process, or we may be unable to complete such certification in a timely manner or at all, which could delay or constrain our manufacturing and commercialization efforts.
Our investigation revealed that pharmaceutical distributors that are not authorized by Gilead to sell Gilead medicine sold purportedly genuine Gilead medicine sourced from an illegal counterfeiting scheme to independent pharmacies nationwide. Illegally diverted and counterfeit versions of Gilead-branded medicines exist and may pose a serious risk to patient health and safety.
For example, as part of a U.S. civil enforcement lawsuit, we seized thousands of bottles of Gilead-labeled medication with counterfeit supply chain documentation. Our investigation revealed that unauthorized pharmaceutical distributors sold counterfeit Gilead medicine to independent pharmacies nationwide. 21 Illegally diverted and counterfeit versions of Gilead-branded medicines exist and may pose a serious risk to patient health and safety.
These third parties are independent entities subject to their own unique operational and financial risks that are out of our control.
We depend on CMOs, CTLs and corporate partners to perform manufacturing and testing activities effectively and on a timely basis for the majority of our active pharmaceutical ingredients and drug products. These third parties are independent entities subject to their own unique operational and financial risks that are out of our control.
We may be required to incur significant costs to remedy the effects of such natural disasters and to resume or restore our operations, which could adversely impact us. Our suppliers and third-party manufacturers and corporate partners face similar risks, and any disruption to their operations could have an adverse effect on our manufacturing and supply chain.
We may be required to incur significant costs to remedy the effects of such natural disasters and to resume or restore our operations, which could adversely impact us. In addition, laws and regulations relating to climate change continue to evolve and may impose new or modified requirements on our operations.
These and any future marketing applications we file may not be approved by the regulatory authorities on a timely basis, or at all. For example, in October 2022, we announced that FDA issued a complete response letter for our Biologics License Application for bulevirtide for the treatment of adults with hepatitis delta virus infection.
These and any future marketing applications we file may not be approved by the regulatory authorities on a timely basis, or at all, and changes or disruptions at FDA or other regulatory agencies, including as a result of budget cuts and employee layoffs, could impair the ability of these agencies to timely review and process our applications.
We may be adversely impacted by any failure to overcome these additional risks. Changes in our effective income tax rate could reduce our earnings. We are subject to income taxes in the U.S. and various foreign jurisdictions.
We may be adversely impacted by any failure to overcome these additional risks. Our U.S. manufacturing and R&D investments may not achieve their intended benefits and could adversely affect our business, results of operations and cash flows.
Although none of our products were selected by the Department of Health and Human Services for “negotiation” in 2026 or 2027, there is no assurance that our products will not be selected in the future. We continue to evaluate the potential impact of the IRA on our business.
In January 2026, the Department of Health and Human Services selected Biktarvy for Medicare negotiation of Medicare prices that will be effective beginning in 2028, and more of our products may be selected in the future.
Removed
If there are any changes to the treatment or prevention paradigm for HIV, and nucleoside-based therapeutics do not remain the preferred regimen, our HIV product sales would be adversely impacted.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur IRP processes are tested in annual tabletop exercises to help identify strengths and areas for improvement. Under the IRP, cybersecurity incidents are escalated based on a defined incident severity to management as appropriate.
Biggest changeWe have an IRP designed to assist the company to prepare for and respond to cybersecurity incidents, and which also provides for escalation to management based on incident severity. Our IRP processes are regularly tested, including through tabletop exercises designed to help identify strengths and areas for improvement, and we update our IRP process as appropriate.
Our vendor security assessment process evaluates key vendors and, where appropriate, assesses vendor’s controls for IT security, privacy, business continuity and other third-party risks. Following an evaluation, the company determines and prioritizes risks based on their potential impact, which helps inform the appropriate level of additional due diligence and ongoing compliance monitoring.
Our vendor security assessment process evaluates key vendors and, where appropriate, assesses vendor controls for IT security, privacy, business continuity and other third-party risks. Following an evaluation, the company determines and prioritizes risks based on their potential impact, which helps inform the appropriate level of additional due diligence and ongoing compliance monitoring.
The CISO has over 30 years of IT and cybersecurity experience in large biopharmaceutical, life sciences, financial and technology industries, including over ten years with the company, and is responsible for managing the security architecture, engineering, technology operations, monitoring, incident response, risk, governance, quality and compliance at the company.
Our CISO has over 30 years of IT and cybersecurity experience in large biopharmaceutical, life sciences, financial and technology industries, including over ten years with the company, and is responsible for managing the security architecture, engineering, technology operations, monitoring, incident response, risk, governance, quality and compliance at the company.
ITEM 1C. CYBERSECURITY Cybersecurity Risk Management and Strategy Processes Used to Assess, Identify, and Manage Material Risks from Cybersecurity Threats Risk Assessment and Management We manage material risks from cybersecurity threats through a cross-functional and layered approach that is designed to detect, identify, respond to, recover from and protect from cybersecurity incidents and is informed by industry recognized standards.
ITEM 1C. CYBERSECURITY Cybersecurity Risk Management and Strategy Processes Used to Assess, Identify, and Manage Material Risks from Cybersecurity Threats Risk Assessment and Management We manage material risks from cybersecurity threats through a cross-functional and layered approach that is designed to detect, identify, respond to, recover from and protect against cybersecurity incidents, and which is informed by industry recognized standards.
Additionally, we assess our cybersecurity maturity annually and implement and maintain controls that are designed to evaluate and improve our cybersecurity program, such as vulnerability assessments and penetration tests, as needed. We also execute employee cybersecurity training and awareness programs around various key cybersecurity topics, including reporting incidents, phishing, ransomware, remote working, cloud security, privileged access and removable media.
Additionally, we assess our cybersecurity program’s maturity annually and implement and maintain controls that are designed to evaluate and improve our cybersecurity program, such as vulnerability assessments and penetration tests, as needed. We also maintain employee cybersecurity training and awareness programs around various cybersecurity topics, including reporting incidents, phishing, ransomware, remote working, cloud security, privileged access and removable media.
Management’s Role in Assessing and Managing Material Risks from Cybersecurity Threats Our CISO, supported by a cross-functional team, has primary responsibility for assessing and managing our cybersecurity program and the related risks. Details of the risk management and escalation processes are discussed in “Cybersecurity Risk Management and Strategy” above.
Management’s Role in Assessing and Managing Material Risks from Cybersecurity Threats Our CIO and CISO, supported by a cross-functional team, have primary responsibility for assessing and managing our cybersecurity program and the related risks. Details of the risk management and escalation processes are discussed in “Cybersecurity Risk Management and Strategy” above.
However, since the beginning of fiscal year 2024, the company has not identified risks from known cybersecurity threats or incidents that have materially affected us or are reasonably likely to materially affect us.
Since the beginning of fiscal year 2025, the company has not identified risks from known cybersecurity threats or incidents that have materially affected us or are reasonably likely to materially affect us.
We benefit from engaging third parties to provide specialized skills, knowledge, tools and resources. These third parties also help reduce costs, increase efficiency, improve quality, mitigate risks and review cybersecurity strategy, trends and threat landscape. Incident Response We have a dedicated Information Security team responsible for managing and coordinating incident response efforts.
We benefit from engaging third parties to provide specialized skills, knowledge, tools and resources. These third parties also help reduce costs, increase efficiency, improve quality, mitigate risks and review cybersecurity strategy, trends and threat landscape. Incident Response We have a dedicated Information Security team, whose duties include managing and coordinating incident response efforts.
The company’s Information Security function is comprised of teams that engage in a range of cybersecurity activities such as security operations, security engineering, data privacy controls, validation, compliance and audit readiness. Leaders of each team are expected to collaborate to help increase visibility of key issues and alignment with strategy.
The company’s Information Security group, which reports to the CISO, is comprised of teams that engage in a range of cybersecurity activities such as security operations, security engineering, data privacy controls, validation, compliance and audit readiness. Leaders of each team are expected to collaborate to help increase visibility of key issues and alignment with strategy.
When cybersecurity incidents are identified, our practice is to respond to and address them utilizing incident classifications and escalation protocols, in accordance with applicable governmental regulations and other legal requirements. Where necessary or appropriate, we also engage third-party advisors to assist in the incident response process. We have an IRP to prepare for and respond to cybersecurity incidents.
When cybersecurity incidents are identified, our practice is to respond to and address them utilizing incident classifications and escalation protocols, in accordance with applicable governmental regulations and other legal requirements. Where necessary or appropriate, we also engage third-party advisors to assist in the incident response process.
As noted above, the company’s IRP includes standard processes for escalating significant cybersecurity incidents to management, including the CISO. The company’s incident response team also coordinates with external legal advisors, cybersecurity forensic firms, communication specialists, and other outside advisors and experts, as appropriate.
As noted above, the company’s IRP includes standard processes for escalating significant cybersecurity incidents to management, including the CIO and CISO. The company engages external legal advisors, cybersecurity forensic firms, communication specialists and other third-party advisors, as appropriate, to assist and advise on cybersecurity program review, cybersecurity program testing and incident response. 32
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Our CIO has over 20 years of IT and cybersecurity experience in large biopharmaceutical and life sciences industries, having served in various roles of increasing leadership at a global biopharmaceutical company before joining the company in April 2025. In her current role, the CIO is responsible for implementing enterprise-wide IT and AI strategies for the company.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe also have administrative facilities in Raleigh, North Carolina; Parsippany, New Jersey; and Washington, D.C., and we have R&D facilities in Oceanside and Santa Monica, California; Frederick, Maryland; Philadelphia, Pennsylvania; Edmonton, Canada; Dublin, Ireland; and Cambridge and Oxford, United Kingdom.
Biggest changeOur other significant owned and leased properties are in the following locations: • Administrative facilities: Raleigh, North Carolina*; Parsippany, New Jersey*; Washington, D.C.*; and Cork, Ireland*; • R&D facilities: Oceanside, California; Santa Monica, California; Frederick, Maryland; Philadelphia, Pennsylvania*; Edmonton, Canada; Dublin, Ireland*; Cambridge, United Kingdom*; and Oxford, United Kingdom*; • Manufacturing facilities: El Segundo, California*; La Verne, California; Oceanside, California; Santa Monica, California; Frederick, Maryland; Edmonton, Canada; Cork, Ireland*; and Hoofddorp, Netherlands*.
ITEM 2. PROPERTIES Our corporate headquarters are located in Foster City, California, where we house our administrative, manufacturing and R&D activities.
ITEM 2. PROPERTIES Our corporate headquarters are located in Foster City, California, where we house administrative, R&D and manufacturing activities.
We believe that our existing properties, including both owned and leased sites, are adequate and suitable for the conduct of our business. We believe our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our expected long-term growth needs. 32
We believe our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our expected long-term growth needs.
Removed
Our principal manufacturing facilities are in El Segundo, La Verne, Oceanside and Santa Monica, California; Frederick, Maryland; Edmonton, Canada; Cork, Ireland and Hoofddorp, Netherlands. For more information about our manufacturing facilities, see Item 1. Business “Raw Materials and Manufacturing . ” Our global operations include offices in Europe, North America, Asia, South America, Africa, Australia and the Middle East.
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For more information about our manufacturing facilities, see the “Raw Materials and Manufacturing” section in Item 1. Business. _______________________________ * Leased property We believe that our existing properties, including both owned and leased sites, are adequate and suitable for the conduct of our business.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeITEM 3. LEGAL PROCEEDINGS For a description of our significant pending legal proceedings, see Note 13. Commitments and Contingencies - Legal Proceedings of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
Biggest changeITEM 3. LEGAL PROCEEDINGS For a description of our significant pending legal proceedings, see Note 12. Commitments and Contingencies - Legal Proceedings of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change(2) Shows the cumulative return on investment assuming an investment of $100 in our common stock, the NBI Index and the S&P 500 Index on December 31, 2019, and assuming that all dividends were reinvested. 35 Issuer Purchases of Equity Securities In the first quarter of 2020, our Board of Directors authorized a $5.0 billion stock repurchase program (“2020 Program”), with no fixed expiration.
Biggest change(2) Shows the cumulative return on investment assuming an investment of $100 in our common stock, the NBI Index and the S&P 500 Index on December 31, 2020, and assuming that all dividends were reinvested.
Dividends For the years ended December 31, 2024 and 2023 , we paid quarterly dividends. We expect to continue to pay quarterly dividends, although the amount and timing of any future dividends are subject to declaration by our Board of Directors.
Dividends For the years ended December 31, 2025 and 2024 , we paid quarterly dividends. We expect to continue to pay quarterly dividends, although the amount and timing of any future dividends are subject to declaration by our Board of Directors.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is traded on the Nasdaq Global Select Market under the symbol “GILD.” Holders As of February 21, 2025, we had approximately 1,339 stockholders of record of our common stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is traded on the Nasdaq Global Select Market under the symbol “GILD.” Holders As of February 13, 2026, we had approximately 1,305 stockholders of record of our common stock.
Securities Authorized For Issuance Under Equity Compensation Plans The following table provides certain information with respect to our equity compensation plans in effect as of December 31, 2024: (in millions, except exercise price) Number of Common Shares to be Issued Upon Exercise of Outstanding Options and Rights (1) Weighted-average Exercise Price of Outstanding Options and Rights (1) Number of Common Shares Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) Plan Category (a) (b) (c) Equity compensation plans approved by security holders: 2022 Equity Incentive Plan 34.7 $ 69.85 69.9 Employee Stock Purchase Plan (2) 23.8 Total equity compensation plans approved by security holders 34.7 $ 69.85 93.7 Equity compensation plans not approved by security holders — $ — — Total 34.7 $ 69.85 93.7 _______________________________ (1) Includes 23 million restricted stock units and performance share units.
Securities Authorized For Issuance Under Equity Compensation Plans The following table provides certain information with respect to our equity compensation plans in effect as of December 31, 2025: (in millions, except exercise price) Number of Common Shares to be Issued Upon Exercise of Outstanding Options and Rights (1) Weighted-average Exercise Price of Outstanding Options and Rights (1) Number of Common Shares Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) Plan Category (a) (b) (c) Equity compensation plans approved by security holders: 2022 Equity Incentive Plan 27.2 $ 76.08 61.6 Employee Stock Purchase Plan (2) — $ — 21.8 Total equity compensation plans approved by security holders 27.2 $ 76.08 83.4 Equity compensation plans not approved by security holders — $ — — Total 27.2 $ 76.08 83.4 _______________________________ (1) Includes 18 million restricted stock units and performance share units.
Purchases under the 2020 Program may be made in the open market or in privately negotiated transactions, but the program does not obligate us to repurchase any specific number of shares and may be amended, suspended or discontinued at any time. We started repurchases under the 2020 Program in December 2022.
Both the 2020 Program and 2025 Program have no fixed expiration, and purchases under these programs may be made in the open market or in privately negotiated transactions, but the programs do not obligate us to repurchase any specific number of shares and may be amended, suspended or discontinued at any time.
The table below summarizes our stock repurchase activity for the three months ended December 31, 2024: Total Number of Shares Purchased (in thousands) Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs (in thousands) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (in millions) October 1 - October 31, 2024 509 $ 86.22 468 $ 3,034 November 1 - November 30, 2024 386 $ 91.54 334 $ 3,003 December 1 - December 31, 2024 3,444 $ 92.38 3,023 $ 2,724 Total (1) 4,339 $ 91.58 3,825 _______________________________ (1) The difference between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program is due to shares of common stock withheld by us from employee restricted stock awards in order to satisfy applicable tax withholding obligations.
The table below summarizes our stock repurchase activity for the three months ended December 31, 2025: Total Number of Shares Purchased (in thousands) Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs (in thousands) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (in millions) October 1 - October 31, 2025 1,235 $ 117.15 1,194 $ 6,892 November 1 - November 30, 2025 402 $ 121.26 362 $ 6,848 December 1 - December 31, 2025 818 $ 121.20 381 $ 6,802 Total (1) 2,456 $ 119.17 1,936 _______________________________ (1) The difference between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program is due to shares of common stock withheld by us from employee restricted stock awards in order to satisfy applicable tax withholding obligations.
Added
Issuer Purchases of Equity Securities In the first quarter of 2020, our Board of Directors authorized a $5.0 billion stock repurchase program (“2020 Program”), under which we started repurchases in December 2022.
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In the third quarter of 2025, our Board of Directors authorized a $6.0 billion stock repurchase program (“2025 Program”), which will commence upon the completion of the 2020 Program.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeEurope Rest of World Total Change Product sales: HIV Biktarvy $ 10,855 $ 1,509 $ 1,060 $ 13,423 $ 9,692 $ 1,253 $ 905 $ 11,850 13 % Descovy 1,902 100 110 2,113 1,771 100 114 1,985 6 % Genvoya 1,498 180 84 1,762 1,752 205 103 2,060 (14) % Odefsey 957 290 41 1,288 1,012 294 44 1,350 (5) % Symtuza - Revenue share (1) 450 130 12 592 382 133 13 529 12 % Other HIV (2) 257 129 48 434 238 116 47 401 8 % Total HIV 15,918 2,339 1,355 19,612 14,848 2,102 1,226 18,175 8 % Liver Disease Sofosbuvir/Velpatasvir (3) 922 299 374 1,596 859 323 355 1,537 4 % Vemlidy 486 44 428 959 410 38 414 862 11 % Other Liver Disease (4) 192 202 73 467 152 150 83 385 21 % Total Liver Disease 1,601 545 876 3,021 1,421 511 852 2,784 9 % Veklury 892 284 623 1,799 972 408 805 2,184 (18) % Oncology Cell Therapy Tecartus 234 138 31 403 245 110 15 370 9 % Yescarta 662 666 242 1,570 811 547 140 1,498 5 % Total Cell Therapy 896 804 274 1,973 1,055 658 156 1,869 6 % Trodelvy 902 294 119 1,315 777 217 68 1,063 24 % Total Oncology 1,798 1,098 393 3,289 1,833 875 224 2,932 12 % Other AmBisome 44 276 212 533 43 260 189 492 8 % Other (5) 255 34 68 356 261 40 66 367 (3) % Total Other 299 310 280 889 304 301 255 859 3 % Total product sales 20,508 4,576 3,526 28,610 19,377 4,197 3,361 26,934 6 % Royalty, contract and other revenues 82 58 4 144 62 114 7 182 (21) % Total revenues $ 20,591 $ 4,634 $ 3,529 $ 28,754 $ 19,438 $ 4,310 $ 3,368 $ 27,116 6 % _______________________________ (1) Represents our revenue from cobicistat (“C”), emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company (“Janssen”).
Biggest changeEurope Rest of World Total Change Product sales: HIV Biktarvy $ 11,467 $ 1,676 $ 1,190 $ 14,334 $ 10,855 $ 1,509 $ 1,060 $ 13,423 7 % Descovy 2,559 93 105 2,758 1,902 100 110 2,113 31 % Genvoya 1,281 148 69 1,498 1,498 180 84 1,762 (15) % Odefsey 881 246 40 1,167 957 290 41 1,288 (9) % Symtuza - Revenue share (1) 363 120 12 495 450 130 12 592 (16) % Other HIV (2) 352 109 40 500 257 129 48 434 15 % Total HIV 16,904 2,392 1,456 20,752 15,918 2,339 1,355 19,612 6 % Liver Disease Sofosbuvir/Velpatasvir (3) 636 292 344 1,272 922 299 374 1,596 (20) % Vemlidy 507 49 514 1,070 486 44 428 959 12 % Other Liver Disease (4) 476 330 69 874 192 202 73 467 87 % Total Liver Disease 1,619 671 927 3,217 1,601 545 876 3,021 6 % Veklury 470 151 290 911 892 284 623 1,799 (49) % Oncology Cell Therapy Tecartus 153 158 32 344 234 138 31 403 (15) % Yescarta 595 598 303 1,495 662 666 242 1,570 (5) % Total Cell Therapy 748 755 335 1,839 896 804 274 1,973 (7) % Trodelvy 877 347 173 1,397 902 294 119 1,315 6 % Total Oncology 1,626 1,102 508 3,236 1,798 1,098 393 3,289 (2) % Other AmBisome 20 267 221 509 44 276 212 533 (5) % Other (5) 177 32 81 290 255 34 68 356 (19) % Total Other 197 300 302 799 299 310 280 889 (10) % Total product sales 20,816 4,617 3,483 28,915 20,508 4,576 3,526 28,610 1 % Royalty, contract and other revenues 60 447 20 527 82 58 4 144 NM Total revenues $ 20,876 $ 5,064 $ 3,503 $ 29,443 $ 20,591 $ 4,634 $ 3,529 $ 28,754 2 % _______________________________ NM - Not Meaningful (1) Represents our revenue from cobicistat (“C”), emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company.
Based on our evaluation, and in connection with the preparation of the financial statements for the third quarter, we performed an interim impairment test and determined that the revised estimated fair value of the NSCLC IPR&D intangible asset was below its carrying value.
Based on our evaluation, and in connection with the preparation of the financial statements for the third quarter of 2024, we performed an interim impairment test and determined that the revised estimated fair value of the NSCLC IPR&D intangible asset was below its carrying value.
See Note 11. Debt and Credit Facilities of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information on our long-term debt and related interest rates.
See Note 10. Debt and Credit Facilities of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information on our long-term debt and related interest rates.
See Note 7. Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. (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”).
See Note 7. Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K. (2) Includes Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, Truvada, Tybost and Yeztugo/Yeytuo. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”).
Risk Factors). Additional information related to the comparison of our results of operations and liquidity and capital resources between the years 2023 and 2022 is included in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of our 2023 Form 10-K filed with U.S. Securities and Exchange Commission . Management Overview Gilead Sciences, Inc.
Risk Factors). Additional information related to the comparison of our results of operations and liquidity and capital resources between the years 2024 and 2023 is included in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of our 2024 Form 10-K filed with U.S. Securities and Exchange Commission . Management Overview Gilead Sciences, Inc.
We manage our R&D expenses by identifying the R&D activities we expect to be performed during a given period and then prioritizing efforts based on scientific data, probability of successful technical development and regulatory approval, market potential, available human and capital resources and other considerations.
We manage these expenses by identifying the R&D activities we expect to be performed during a given period and then prioritizing efforts based on scientific data, probability of successful technical development and regulatory approval, market potential, available human and capital resources and other considerations.
However, historical results are not indicative of future results. 46 Valuation of Intangible Assets Determining the fair values of intangible assets, whether as part of a business combination or impairment assessment, involves the use of a probability-weighted income approach that discounts expected future cash flows to present value and requires the use of critical estimated inputs, including: • identification of product candidates with sufficient substance requiring separate recognition; • estimates of projected future cash flows, including revenues and operating profits related to the products or product candidates, which, for example, include significant inputs such as addressable patient population, treatment duration and projected market share; • the probability of technical and regulatory success for unapproved product candidates considering their stages of development; • the time and resources needed to complete the development and approval of product candidates; • an appropriate discount rate based on the estimated weighted-average cost of capital for companies with profiles similar to our profile, representing the rate that market participants would use to value the intangible assets; • the life of the potential commercialized products and associated risks, including the inherent difficulties and uncertainties in developing a product candidate such as obtaining FDA and other regulatory approvals; and • risks related to the viability of and potential alternative treatments in any future target markets.
Valuation of Intangible Assets Determining the fair values of intangible assets, whether as part of a business combination or impairment assessment, involves the use of a probability-weighted income approach that discounts expected future cash flows to present value and requires the use of critical estimated inputs, including: • identification of product candidates with sufficient substance requiring separate recognition; • estimates of projected future cash flows, including revenues and operating profits related to the products or product candidates, which, for example, include significant inputs such as addressable patient population, treatment duration and projected market share; • the probability of technical and regulatory success for unapproved product candidates considering their stages of development; • the time and resources needed to complete the development and approval of product candidates; • an appropriate discount rate based on the estimated weighted-average cost of capital for companies with profiles similar to our profile, representing the rate that market participants would use to value the intangible assets; • the life of the potential commercialized products and associated risks, including the inherent difficulties and uncertainties in developing a product candidate such as obtaining FDA and other regulatory approvals; and • risks related to the viability of and potential alternative treatments in any future target markets.
While we are not aware of any trends at this time that are reasonably likely to materially impact our future cash requirements and sources of funds, such requirements and funds will depend on many factors, including but not limited to the following: • the commercial performance of our current and future products; • the progress and scope of our R&D efforts and those of our collaboration partners, including preclinical studies and clinical trials; • the cost, timing and outcome of regulatory reviews; • the expansion of our sales and marketing capabilities; 45 • the acquisition of additional manufacturing capabilities or office facilities on acceptable terms; • the acquisition of other companies or new products on acceptable terms; • the issuance of new debt or equity in the market on acceptable terms; • the favorability of repaying certain long-term debt obligations prior to maturity dates; • future dividends subject to declaration by our Board of Directors (see “Dividends” in Part II, Item 5 of this 10-K); • the favorability of repurchasing shares (see “Issuer Purchases of Equity Securities” in Part II, Item 5 of this 10-K); • the establishment of additional collaborative relationships with other companies on acceptable terms; and • costs associated with the defense, settlement and adverse results of government investigations and litigation (see Note 13.
Debt and Credit Facilities) and access other external capital through future debt or equity offerings. 45 While we are not aware of any trends at this time that are reasonably likely to materially impact our future cash requirements and sources of funds, such requirements and funds will depend on many factors, including but not limited to the following: • the commercial performance of our current and future products; • the progress and scope of our R&D efforts and those of our collaboration partners, including preclinical studies and clinical trials; • the cost, timing and outcome of regulatory reviews; • the expansion of our sales and marketing capabilities; • the acquisition of additional manufacturing capabilities or office facilities on acceptable terms; • the acquisition of other companies or new products on acceptable terms; • the issuance of new debt or equity in the market on acceptable terms; • the favorability of repaying certain long-term debt obligations prior to maturity dates; • future dividends subject to declaration by our Board of Directors (see “Dividends” in Part II, Item 5 of this 10-K); • the favorability of repurchasing shares (see “Issuer Purchases of Equity Securities” in Part II, Item 5 of this 10-K); • the establishment of additional collaborative relationships with other companies on acceptable terms; and • costs associated with the defense, settlement and adverse results of government investigations and litigation (see Note 12.
These inputs are subject to uncertainty due to potential changes in facts and circumstances, economic and political conditions, changes to existing tax laws and new regulations or interpretations by tax authorities. Changes in these conditions could have a material adverse impact on our results of operations and financial position. See Note 16.
These inputs are subject to uncertainty due to potential changes in facts and circumstances, economic and political conditions, changes to existing tax laws and new regulations or interpretations by tax authorities. Changes in these conditions could have a material adverse impact on our results of operations and financial position.
Based on our evaluation of the study results and all other data currently available, and in connection with the preparation of the financial statements for the first quarter, we performed an interim impairment test and determined that the revised estimated fair value of the NSCLC IPR&D intangible asset was below its carrying value.
Based on our evaluation of the study results and all other data available at the time, and in connection with the preparation of the financial statements for the first quarter of 2024, we performed an interim impairment test and determined that the revised estimated fair value of the NSCLC IPR&D intangible asset was below its carrying value.
Capital Resources As of December 31, 2024, our material cash requirements for the operations of our business consisted primarily of the current and long-term liabilities noted on our Consolidated Balance Sheets as well as other commitments, including the following notable items: • payments of outstanding borrowings, including interest on long-term debt (see Note 11.
Capital Resources As of December 31, 2025, our material cash requirements for the operations of our business consisted primarily of the current and long-term liabilities noted on our Consolidated Balance Sheets as well as other commitments, including the following notable items: • payments of outstanding borrowings, including interest on long-term debt (see Note 10.
The Organisation for Economic Co-operation and Development has a framework to implement a global minimum corporate tax of 15% for companies with global revenues and profits above certain thresholds (referred to as Pillar Two), with certain aspects effective January 1, 2024 and other aspects effective January 1, 2025.
The Organisation for Economic Co-operation and Development (“OECD”) has developed a framework to implement a global minimum corporate tax of 15% for companies with global revenues and profits above certain thresholds (referred to as “Pillar Two”), with certain aspects effective January 1, 2024 and other aspects effective January 1, 2025.
Income Taxes of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information. 47
See Note 15. Income Taxes of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information.
To arrive at the revised estimated fair value, we used a probability-weighted income approach that discounts expected future cash flows to present value, which requires the use of Level 3 fair value measurements and inputs, including critical estimated inputs, such as: revenues and operating profits related to the planned utilization of SG in NSCLC, which, include inputs such as addressable patient population, projected market share, treatment duration, and the life of the potential commercialized product; the probability of technical and regulatory success; the time and resources needed to complete the development and approval of SG in NSCLC; an appropriate discount rate based on the estimated weighted-average cost of capital for companies with profiles similar to our profile; and risks related to the viability of and potential alternative treatments in any future target markets.
To arrive at the revised estimated fair values as of June 30, 2025 and December 31, 2025, we used a probability-weighted income approach that discounts expected future cash flows to present value, which requires the use of Level 3 fair value measurements and inputs, including critical estimated inputs, such as: revenues and operating profits related to the planned utilization of bulevirtide outside of the European Union (“EU”), which includes inputs such as addressable patient population, projected market share, treatment duration, and the life of the potential commercialized product; the probability of technical and regulatory success; the time and resources needed to complete the development and approval of bulevirtide outside of the EU; an appropriate discount rate based on the estimated weighted-average cost of capital for companies with profiles similar to our profile; and risks related to the viability of and potential alternative treatments in any future target markets.
Based on our evaluation of our current position of liquidity, available capital resources and our material cash requirements, we believe that we can satisfy our capital needs for the next 12 months and the foreseeable future. Liquidity Cash and cash equivalents were $10.0 billion as of December 31, 2024.
Based on our evaluation of our current position of liquidity, available capital resources and our material cash requirements, we believe that we can satisfy our capital needs for the next 12 months and the foreseeable future. Liquidity Cash and cash equivalents were $7.6 billion and marketable debt securities were $3.0 billion as of December 31, 2025.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, coronavirus disease 2019 (“COVID-19”), cancer and inflammation. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.
Please refer to “Results of Operations” below for further information on 2024 results. Outlook As we look to 2025, we expect to see continued increases in demand for our products overall, bolstered by the growth of our HIV business.
Please refer to “Results of Operations” below for further information on 2025 results. Outlook As we look to 2026, we expect to see continued growth for our product sales overall, bolstered by increased demand in our HIV business.
For example, in the second quarter of 2023, we recorded an accrual of $525 million in Other current liabilities on our Consolidated Balance Sheets for settlements with certain plaintiffs in the HIV antitrust litigation, which we paid in the second half of 2023. Also, we accrued approximately $200 million for a potential settlement with the U.S.
For example, in the second quarter of 2023, we recorded an accrual of $525 million in Other current liabilities on our Consolidated Balance Sheets for settlements with certain plaintiffs in the HIV antitrust litigation, which we paid in the second half of 2023.
Also, on February 11, 2025, we announced that our Board of Directors declared a quarterly dividend of $0.79 per share of our common stock, with a payment date of March 28, 2025 to all stockholders of record as of the close of business on March 14, 2025. Future dividends are subject to declaration by our Board of Directors.
On February 10, 2026, we announced that our Board of Directors declared a quarterly dividend of $0.82 per share of our common stock, with a payment date of March 30, 2026 to all stockholders of record as of the close of business on March 13, 2026. Future dividends are subject to declaration by our Board of Directors.
Leases); • payments related to certain unconditional inventory purchase obligations and capital expenditures. There were no changes to such commitments in the current year that would have a material impact on our ability to meet short- or long-term cash requirements; • payments related to our acquisitions, including contingent consideration (see Notes 3. Fair Value Measurements and 6.
There were no changes to such commitments in the current year that would have a material impact on our ability to meet short- or long-term cash requirements; • payments related to our acquisitions, including contingent consideration (see Notes 3. Fair Value Measurements and 6. Acquisitions); and • milestone and other payments related to collaboration agreements (see Note 7.
Net income attributable to Gilead was $480 million and diluted earnings per share attributable to Gilead was $0.38 in 2024, compared to net income attributable to Gilead of $5.7 billion and $4.50 diluted earnings per share attributable to Gilead in 2023.
Net income attributable to Gilead was $8.5 billion and diluted earnings per share attributable to Gilead was $6.78 in 2025, compared to net income attributable to Gilead of $480 million and $0.38 diluted earnings per share attributable to Gilead in 2024.
Financing Activities Net cash used in financing activities in 2024 was primarily the result of $2.0 billion for debt repayments, $3.9 billion for dividend payments and $1.2 billion for common stock repurchases, partially offset by $3.5 billion in net proceeds from the issuance of senior unsecured notes in November 2024.
In 2024, we utilized cash of $3.9 billion for dividend payments, $2.0 billion for repayment of debt and other obligations, and $1.2 billion for common stock repurchases, partially offset by $3.5 billion in net proceeds from the issuance of senior unsecured notes in November 2024.
The table below summarizes our cash flow activities, followed by our analysis of changes and trends: Year Ended December 31, (in millions) 2024 2023 Net cash provided by (used in): Operating activities $ 10,828 $ 8,006 Investing activities (3,449) (2,265) Financing activities (3,433) (5,125) Effect of exchange rate changes on cash and cash equivalents (40) 57 Net change in cash and cash equivalents $ 3,906 $ 673 Operating Activities Net cash provided by operating activities is our primary source of funds, driven mainly by collections on product sales, partially offset by operating spend.
The table below summarizes our cash flow activities, followed by our analysis of changes and trends: Year Ended December 31, (in millions, except percentages) 2025 2024 Change Net cash provided by (used in): Operating activities $ 10,019 $ 10,828 (7) % Investing activities (4,793) (3,449) 39 % Financing activities (7,745) (3,433) NM Effect of exchange rate changes on cash and cash equivalents 92 (40) NM Net change in cash and cash equivalents $ (2,428) $ 3,906 NM 44 Operating Activities Net cash provided by operating activities is our primary source of funds, driven mainly by collections on product sales, partially offset by operating spend.
The following table summarizes our key financial results for the year and period-over-period changes: Year Ended December 31, (in millions, except percentages and per share amounts) 2024 2023 Change Total revenues $ 28,754 $ 27,116 6 % Net income attributable to Gilead $ 480 $ 5,665 (92) % Diluted earnings per share attributable to Gilead $ 0.38 $ 4.50 (92) % Total revenues increased 6% to $28.8 billion in 2024, compared to 2023, primarily due to higher sales in HIV, Oncology and Liver Disease, partially offset by lower sales of Veklury.
The following table summarizes our key financial results for the year and period-over-period changes: Year Ended December 31, (in millions, except percentages and per share amounts) 2025 2024 Change Total revenues $ 29,443 $ 28,754 2 % Net income attributable to Gilead $ 8,510 $ 480 NM Diluted earnings per share attributable to Gilead $ 6.78 $ 0.38 NM _______________________________ NM - Not Meaningful 37 Total revenues increased 2% to $29.4 billion in 2025, compared to 2024, primarily due to: • Higher product sales primarily driven by HIV and Liver Disease products, partially offset by lower sales of Veklury; and • Higher royalty, contract and other revenues.
Foreign Currency Exchange Impact We generally face exposure to movements in foreign currency exchange rates, primarily in the Euro. We use foreign currency exchange contracts to hedge a portion of our foreign currency exposures. Approximately 27% and 26% of our product sales were denominated in foreign currencies during 2024 and 2023, respectively.
We use foreign currency exchange contracts to hedge a portion of our foreign currency exposures. Approximately 26% and 27% of our product sales were denominated in foreign currencies during 2025 and 2024, respectively.
The following represents a summary of notable business updates and events during 2024, including certain items from our press releases, which readers are encouraged to review in full as available on our website at www.gilead.com. The content on the referenced website does not constitute a part of and is not incorporated by reference into this Annual Report on Form 10-K.
The following represents a summary of notable business updates and events since the filing of our Annual Report on Form 10-K for the year ended December 31, 2024, including certain items from our press releases, which readers are encouraged to review in full as available on our website at www.gilead.com.
The following table summarizes our Selling, general and administrative expenses and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2024 2023 Change Selling and marketing expenses $ 3,453 $ 3,272 6 % General and administrative expenses 2,638 2,818 (6) % Selling, general and administrative expenses $ 6,091 $ 6,090 — % Selling, general and administrative expenses were $6.1 billion and remained relatively flat in 2024, compared to 2023.
The following table summarizes our Selling, general and administrative expenses and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2025 2024 Change Selling and marketing expenses $ 3,522 $ 3,453 2 % General and administrative expenses 2,252 2,638 (15) % Selling, general and administrative expenses $ 5,774 $ 6,091 (5) % Selling, general and administrative expenses decreased 5% to $5.8 billion in 2025, compared to 2024.
Attorney’s Office for the Southern District of New York, on our Consolidated Balance Sheets as of December 31, 2024. Income Taxes We are subject to income taxes in the U.S. and various foreign jurisdictions, including Ireland.
Also, as of December 31, 2024, we accrued approximately $200 million on our Consolidated Balance Sheets for a potential settlement with the U.S. Attorney’s Office for the Southern District of New York, which we eventually entered into in April 2025 and subsequently paid. Income Taxes We are subject to income taxes in the U.S. and various foreign jurisdictions, including Ireland.
Changes in working capital balances, generally associated with the timing of collections and payments, as well as unanticipated payments related to litigation, taxes or other matters, may create some variation in any given year. Net cash provided by operating activities increased in 2024 mainly due to higher collections on sales and lower income tax and operating payments.
Changes in working capital balances, generally associated with the timing of collections and payments, as well as unanticipated payments related to litigation, taxes or other matters, may create some variation in any given year.
In particular: • Biktarvy sales increased primarily due to higher demand, including patients switching from Genvoya and other Gilead HIV products.
In particular: • Biktarvy sales increased 7% primarily due to higher demand, including patients switching from Genvoya and other Gilead HIV products, partially offset by lower average realized price due to the U.S.
Critical inputs to the accruals recorded and disclosures provided in relation to these matters include the probability of a certain outcome of the case, the determination as to whether an exposure is reasonably estimable and the amount of potential exposure.
Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K. 47 Critical inputs to the accruals recorded and disclosures provided in relation to these matters include the probability of a certain outcome of the case, the determination as to whether an exposure is reasonably estimable and the amount of potential exposure.
Our R&D portfolio includes over 100 pre-clinical and clinical-stage programs across our core therapeutic areas. We plan to continue investing in our business and R&D pipeline both internally and externally through partnerships and select business development transactions.
We plan to continue investing in our business and R&D pipeline both internally and externally through partnerships and select business development transactions.
Net cash used in financing activities may vary in any given year depending primarily on the timing of debt repayments and proceeds from debt offerings and the amount of common stock repurchases. Subsequently, in February 2025, we repaid $1.75 billion of principal balance related to our senior unsecured notes due February 2025.
Net cash used in financing activities may vary in any given year depending primarily on the timing of debt repayments and proceeds from debt offerings and the amount of common stock repurchases.
Acquired In-Process Research and Development Expenses Acquired in-process research and development expenses are recorded when incurred and reflect costs of externally-developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront and pre-commercialization milestone payments related to various collaborations and the costs of rights to IPR&D projects. 41 Acquired in-process research and development expenses were $4.7 billion in 2024, primarily related to the following transactions: • $3.8 billion CymaBay acquisition; • $320 million Janssen Pharmaceutica NV future royalty obligation extinguishment related to seladelpar; • $100 million Arcus Biosciences, Inc. collaboration continuation fee; • $68 million Arcellx, Inc.
Acquired In-Process Research and Development Expenses Acquired in-process research and development expenses are recorded when incurred and reflect costs of externally-developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront and pre-commercialization milestone payments related to various collaborations and the costs of rights to IPR&D projects.
Unfavorable movements in Other (income) expense, net in 2024, compared to 2023, primarily related to higher net losses from equity securities and lower interest income due to lower average cash balances. 43 Income Taxes The following table summarizes our Income tax expense and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2024 2023 Change Income before income taxes $ 690 $ 6,859 $ (6,169) Income tax expense $ 211 $ 1,247 $ (1,036) Effective tax rate 30.5 % 18.2 % 12.4 % Our effective tax rate increased in 2024, compared to 2023, primarily due to: • The non-deductible acquired IPR&D expense recorded in connection with our first quarter 2024 acquisition of CymaBay; • A decrease in unrecognized tax benefits as a result of reaching agreement with a tax authority on certain tax positions in 2023; partially offset by • A non-recurring tax benefit associated with a legal entity restructuring; • A decrease in state deferred tax liabilities associated with the $4.2 billion NSCLC IPR&D intangible asset impairment charge; • Settlements with tax authorities in 2024; and • Remeasurement of certain deferred tax liabilities related to acquired intangible assets.
Favorable movements in Other (income) expense, net in 2025, compared to 2024, primarily related to net unrealized gains from equity securities compared to net unrealized losses in 2024, as well as higher interest income. 43 Income Taxes The following table summarizes our Income tax (benefit) expense and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2025 2024 Change Income before income taxes $ 9,796 $ 690 $ 9,106 Income tax expense $ 1,286 $ 211 $ 1,075 Effective tax rate 13.1 % 30.5 % NM _______________________________ NM - Not Meaningful Our effective tax rate decreased in 2025, compared to 2024, primarily due to: • The non-deductible acquired IPR&D expense recorded in connection with our acquisition of CymaBay in 2024, which did not repeat in 2025; • A settlement with a tax authority related to a prior year legal entity restructuring; and • Favorable changes in the fair value of our equity securities that are non-taxable for income tax purposes; partially offset by • A tax benefit associated with a legal entity restructuring in 2024; and • A decrease in state deferred tax liabilities associated with the $4.2 billion NSCLC IPR&D intangible asset impairment charge in 2024.
Interest Expense and Other (Income) Expense, Net The following table summarizes our Interest expense and Other (income) expense, net and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2024 2023 Change Interest expense $ 977 $ 944 3 % Other (income) expense, net $ (6) $ (198) (97) % Loss from equity securities, net $ 274 $ 167 64 % Interest income $ (281) $ (376) (25) % Other, net $ 2 $ 11 (84) % Interest expense increased 3% to $977 million in 2024, compared to 2023, primarily due to a higher average interest rate on long-term debt.
Interest Expense and Other (Income) Expense, Net The following table summarizes our Interest expense and Other (income) expense, net and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2025 2024 Change Interest expense $ 1,024 $ 977 5 % Other (income) expense, net $ (798) $ (6) NM (Gain) loss from equity securities, net $ (451) $ 274 NM Interest income $ (349) $ (281) 24 % Other, net $ 1 $ 2 (41) % _______________________________ NM - Not Meaningful Interest expense increased 5% to $1.0 billion in 2025, compared to 2024, primarily due to higher debt balances and a higher weighted-average interest rate on the debt.
Meanwhile, we maintained our financial position through repayment of senior notes coming due and the issuance of new senior notes, and provided shareholder returns through dividends and share repurchases.
Meanwhile, we maintained our financial position by lowering operating expenses, repaying senior notes coming due and providing shareholder returns through dividends and share repurchases.
Rebates and chargebacks are based on contractual arrangements or statutory requirements and include amounts due to payers and healthcare providers under various programs. These amounts may vary by product, payer and individual plans. Rebates and chargebacks are estimated primarily based on product sales, and expected payer mix and discount rates, which require significant estimates and judgment.
Rebates and Chargebacks Rebates and chargebacks include amounts due to payers and healthcare providers under various programs based on contractual arrangements or statutory requirements, which may vary by product, payer and individual plans and may not be known at the time of sale.
Year in Review During 2024, we delivered growth in our HIV, Oncology and Liver Disease product sales and 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.
As evidenced by various late-stage clinical trial updates in HIV and oncology, 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.
Personnel, infrastructure and other support costs increased mainly due to higher compensation expenses, increases in restructuring costs, and stock-based compensation expenses and other integration costs related to the acquisition of CymaBay.
Personnel, infrastructure and other support costs decreased primarily due to the impact of stock-based compensation expenses and other integration costs related to the acquisition of CymaBay in 2024, which did not repeat in 2025, as well as lower restructuring costs.
Acquisitions); and • milestone and other payments related to collaboration agreements (see Note 7. Collaborations and Other Arrangements). We are contractually obligated to make payments to our collaboration partners upon the achievement of various development, regulatory and commercial milestones as well as royalty payments.
Collaborations and Other Arrangements). We are contractually obligated to make payments to our collaboration partners upon the achievement of various development, regulatory and commercial milestones as well as royalty payments. These payments are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring.
In January 2024, we received data from our Phase 3 EVOKE-01 study of Trodelvy evaluating sacituzumab govitecan-hziy (“SG”) indicating that the study did not meet its primary endpoint of overall survival in previously treated metastatic NSCLC, thus triggering a review for potential impairment of the NSCLC IPR&D intangible asset.
Our revised discounted cash flows for the June 30, 2025 and December 31, 2025 fair value estimations primarily reflected the updated expectations for bulevirtide’s potential market share outside of the EU. 2024 Impairments In January 2024, we received data from our Phase 3 EVOKE-01 study of Trodelvy evaluating SG indicating that the study did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer (“NSCLC”), thus triggering a review for potential impairment of the NSCLC IPR&D intangible asset.
Liquidity and Capital Resources We regularly analyze our ability to generate and obtain adequate amounts of cash to meet our short-term and long-term requirements and plans.
We do not expect Pillar Two, including the side-by-side framework, to have a material impact on our results of operations, liquidity or capital resources. Liquidity and Capital Resources We regularly analyze our ability to generate and obtain adequate amounts of cash to meet our short-term and long-term requirements and plans.
The following table summarizes the consolidated activities and ending balances in our rebates and chargebacks accounts, including adjustments made relating to previous years’ sales as a result of changes in estimates: (in millions) Balance at Beginning of Year Decrease/(Increase) to Product Sales Payments Balance at End of Year Year ended December 31, 2024: Activity related to 2024 sales $ — $ 15,808 $ (11,508) $ 4,300 Activity related to sales prior to 2024 4,493 (350) (3,797) 345 Total $ 4,493 $ 15,458 $ (15,305) $ 4,646 Year ended December 31, 2023: Activity related to 2023 sales $ — $ 14,577 $ (10,389) $ 4,187 Activity related to sales prior to 2023 4,028 (302) (3,421) 306 Total $ 4,028 $ 14,275 $ (13,810) $ 4,493 We assess and update our estimates each reporting period to reflect actual claims and other current information.
In developing our estimates of rebates and chargebacks, we consider the following: • product sales, including product mix and pricing; • historical and estimated payer mix; • statutory discount requirements and contractual terms; • historical claims experience and processing time lags; • estimated patient population; • known market events or trends; • market research; • channel inventory data obtained from our major U.S. wholesalers; and • other pertinent internal or external information. 46 The following table summarizes the consolidated activities and ending balances in our rebates and chargebacks accounts, including adjustments made relating to previous years’ sales as a result of changes in estimates: (in millions) Balance at Beginning of Year Decrease/(Increase) to Product Sales Payments Balance at End of Year Year ended December 31, 2025: Activity related to 2025 sales $ — $ 17,880 $ (13,064) $ 4,816 Activity related to sales prior to 2025 4,646 (378) (3,903) 365 Total $ 4,646 $ 17,503 $ (16,967) $ 5,181 Year ended December 31, 2024: Activity related to 2024 sales $ — $ 15,808 $ (11,508) $ 4,300 Activity related to sales prior to 2024 4,493 (350) (3,797) 345 Total $ 4,493 $ 15,458 $ (15,305) $ 4,646 We assess and update our estimates each reporting period to reflect actual claims and other current information.
(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. HIV HIV product sales increased 8% to $19.6 billion in 2024, compared to 2023, primarily due to higher demand and higher average realized price.
(4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Livdelzi/Lyvdelzi, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis and Zydelig.
General and administrative expenses decreased mainly due to lower expenses related to legal matters, partially offset by stock-based compensation expenses and other integration costs related to the acquisition of CymaBay, and higher restructuring costs.
General and administrative expenses decreased primarily due to lower expenses related to corporate initiatives and legal matters, as well as the impact of stock-based compensation expenses and other integration costs related to the acquisition of CymaBay in 2024, which did not repeat in 2025, partially offset by donations of equity securities made to the Gilead Foundation.
To a lesser extent, the increase was also due to higher average realized price. • Descovy sales increased primarily due to higher demand, partially offset by lower average realized price. 39 Liver Disease Liver Disease product sales increased 9% to $3.0 billion in 2024, compared to 2023, primarily due to higher demand in products for chronic hepatitis C virus, HBV and, in Europe, chronic hepatitis delta virus, as well as the launch of Livdelzi for treatment of PBC.
Medicare Part D program redesign; and • Descovy sales increased 31% primarily due to higher demand and average realized price. 39 Liver Disease Liver Disease product sales increased 6% to $3.2 billion in 2025, compared to 2024, primarily due to higher demand for Livdelzi and products for chronic hepatitis B virus and chronic hepatitis D virus, partially offset by lower average realized price across all Liver Disease products, most notably for chronic hepatitis C virus, inclusive of the U.S.
Investing Activities Net cash used in investing activities was notably higher in 2024 primarily related to the $3.9 billion net cash payment for the CymaBay acquisition, partially offset by proceeds from the liquidation of marketable debt securities to fund that acquisition.
In 2025, we utilized cash primarily for purchases of marketable debt securities and payments related to the Interius acquisition and various collaborations. In 2024, we utilized cash primarily for the $3.9 billion CymaBay acquisition and purchases of equity securities, partially offset by cash received from the liquidation of marketable debt securities.
The following table provides a breakout of expenses by major cost type: Year Ended December 31, (in millions) 2024 2023 Personnel, infrastructure and other support costs $ 3,555 $ 3,204 Clinical studies and other costs 2,352 2,514 Total $ 5,907 $ 5,718 Research and development expenses increased 3% to $5.9 billion in 2024, compared to 2023.
The following table summarizes our Research and development expenses and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2025 2024 Change Personnel, infrastructure and other support costs $ 3,427 $ 3,555 (4) % Clinical studies and other costs 2,372 2,352 1 % Research and development expenses $ 5,799 $ 5,907 (2) % Research and development expenses decreased 2% to $5.8 billion in 2025, compared to 2024.
Gross-to-Net Deductions A substantial portion of our product sales is subject to significant discounts from list price, including government and commercial rebates and chargebacks, as well as other deductions, including patient co-pay assistance, cash discounts for prompt payment, distributor fees, and sales return provisions.
Gross-to-Net Deductions Product sales are recorded n et of estimated gross-to-net deductions, including rebates and chargebacks, patient co-pay assistance, prompt pay discounts, distributor fees, sales return provisions and other related deductions.
Foreign currency exchange, net of hedges, had an unfavorable impact on our total product sales of $163 million in 2024, based on a comparison using foreign currency exchange rates from 2023. 40 Costs and Expenses The following table summarizes our costs and expenses and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2024 2023 Change Cost of goods sold $ 6,251 $ 6,498 (4) % Product gross margin 78.2 % 75.9 % 228 bps Research and development expenses $ 5,907 $ 5,718 3 % Acquired in-process research and development expenses $ 4,663 $ 1,155 NM In-process research and development impairments $ 4,180 $ 50 NM Selling, general and administrative expenses $ 6,091 $ 6,090 — % _______________________________ NM - Not Meaningful Product Gross Margin Product gross margin increased to 78.2% in 2024, compared to 2023, primarily due to prior year restructuring expenses related to changes in our manufacturing strategy, which resulted in write-offs of certain manufacturing facilities, related inventories and other costs totaling $479 million.
Royalty, Contract and Other Revenues Royalty, contract and other revenues increased to $527 million in 2025, compared to 2024, primarily due to recognition of $400 million of previously constrained revenues from the sale of certain intellectual property. 40 Costs and Expenses The following table summarizes our costs and expenses and period-over-period changes: Year Ended December 31, (in millions, except percentages) 2025 2024 Change Cost of goods sold $ 6,234 $ 6,251 — % Product gross margin 78.4 % 78.2 % 29 bps Research and development expenses $ 5,799 $ 5,907 (2) % Acquired in-process research and development expenses $ 1,024 $ 4,663 (78) % In-process research and development impairments $ 590 $ 4,180 (86) % Selling, general and administrative expenses $ 5,774 $ 6,091 (5) % Product Gross Margin Product gross margin was 78.4% in 2025 and remained relatively flat compared to 2024.
Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information. In-Process Research and Development Impairments As of December 31, 2023, our indefinite-lived IPR&D intangible asset related to Trodelvy for metastatic NSCLC was approximately $5.9 billion.
See Note 6. Acquisitions and Note 7. Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information.
For example, we entered into an agreement with LEO Pharma A/S in early 2025 to develop and commercialize their pre-clinical oral signal transducer and activator of transcription 6 programs for the potential treatment of inflammatory diseases.
Inflammation • Received conditional marketing authorization from the EC 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. • Entered into a strategic partnership with LEO Pharma A/S (“LEO Pharma”) to develop and commercialize their pre-clinical oral signal transducer and activator of transcription 6 programs for the potential treatment of inflammatory diseases.
Our anticipated sources of funds to satisfy the above material cash requirements for the short- and long-term include our current balances of cash and cash equivalents as well as future cash flows from operations. If needed, we also have the ability to utilize our $2.5 billion revolving credit facility (see Note 11.
As such, these obligations are not recorded on our Consolidated Balance Sheets until the events triggering milestone payments occur. Our anticipated sources of funds to satisfy the above material cash requirements for the short- and long-term include our current balances of cash and cash equivalents as well as future cash flows from operations.
As a result, we recognized a partial impairment charge of $1.8 billion in In-process research and development impairments on our Consolidated Statements of Operations during the third quarter of 2024.
As a result, we recognized partial impairment charges of $190 million and $400 million in In-process research and development impairments on our Consolidated Statements of Operations for the second and fourth quarters of 2025, respectively, for a total of $590 million for the year ended December 31, 2025.
Debt and Credit Facilities); • income tax payments, including the remaining obligations for the one-time repatriation transition tax from the Tax Cuts and Jobs Act, as well as potential payments related to uncertain tax positions (see Note 16. Income Taxes); • payments of operating lease obligations (see Note 12.
Debt and Credit Facilities); • income tax payments, including potential payments related to uncertain tax positions (see Note 15. Income Taxes); • payments of operating lease obligations (see Note 11. Leases); • payments related to certain unconditional inventory purchase obligations and capital expenditures.
Legal Contingencies We are a party to various legal actions. Certain significant matters are described in Note 13. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.
Legal Contingencies We are a party to various legal actions. Certain significant matters are described in Note 12.
Trodelvy Trodelvy product sales increased 24% to $1.3 billion in 2024, compared to 2023, primarily due to higher demand across all regions.
Trodelvy Trodelvy product sales increased 6% to $1.4 billion in 2025, compared to 2024, primarily due to higher demand in breast cancer treatment, partially offset by the indication withdrawal in bladder cancer treatment.
In addition, 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. Our ability to deliver on our strategy and 2025 objectives is subject to a number of uncertainties. Please refer to Part I, Item 1A.
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. 38 Results of Operations Revenues The following table summarizes our Total revenues and period-over-period changes: Year Ended December 31, 2025 Year Ended December 31, 2024 (in millions, except percentages) U.S.
These payments are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring. If milestones for multiple products covered by these arrangements happen to be reached in the same reporting period, the aggregate cash requirement could be material.
If milestones for multiple products covered by these arrangements happen to be reached in the same reporting period, the aggregate cash requirement could be material. It is not possible to predict with reasonable certainty whether these milestones will be achieved or the timing for achievement.
Veklury Veklury product sales decreased 18% to $1.8 billion in 2024, compared to 2023, primarily due to decreased rates of COVID-19-related hospitalizations.
Medicare Part D program redesign impact. Veklury Veklury product sales decreased 49% to $911 million in 2025, compared to 2024, primarily due to lower COVID-19-related hospitalizations. Oncology Cell Therapy Cell Therapy product sales decreased 7% to $1.8 billion in 2025, compared to 2024, primarily due to lower demand reflecting ongoing competitive headwinds.
Oncology Cell Therapy Cell Therapy product sales increased 6% to $2.0 billion in 2024, compared to 2023, primarily due to increased demand outside the U.S. for Yescarta and Tecartus and higher average realized price, partially offset by lower demand in the U.S.
HIV HIV product sales increased 6% to $20.8 billion in 2025, compared to 2024, primarily due to higher demand for treatment and prevention, with average realized price being relatively flat despite the U.S. Medicare Part D program redesign impact.
We anticipate that strong, demand-led volume growth in 2025 will be offset by: (i) the effects of the Inflation Reduction Act, which is expected to increase our payment obligations under the redesigned Medicare Part D discount program; (ii) an expected decrease in our Veklury product sales reflecting lower rates of COVID-19-related hospitalizations; and (iii) the impact of the U.S. dollar strengthening against major foreign currencies.
We anticipate that such growth will be partially offset by the impact of various policy-related developments in the U.S., as well as an expected decrease in our Veklury product sales due to lower rates of COVID-19-related hospitalizations and an expected decrease in our Cell Therapy product sales reflecting ongoing competitive headwinds.
Our strategic priorities to deliver on these ambitions include: (i) maximize near-term revenue growth; (ii) maximize impact of long-acting HIV therapies; and (iii) expand and deliver on oncology programs.
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.
Our revised discounted cash flows for the September 30, 2024 fair value estimation primarily reflected the removal of cash flows associated with second-line plus patients. There were no IPR&D impairment charges in the three months ended December 31, 2024.
Our revised discounted cash flows for the September 30, 2024 fair value estimation primarily reflected the removal of cash flows associated with second-line plus patients, and the remaining carrying value as of that date reflects Trodelvy’s opportunity as a combination therapy in first-line metastatic NSCLC patients supported by its ongoing Phase 3 clinical trial in this patient population.
Rebates and Chargebacks Rebates and chargebacks are determined using a complex estimation process which requires significant judgment by management in part due to the lag between the date of the product sales and the date the related rebates or chargeback claims are settled.
As a result, our recorded amounts for rebates and chargebacks are determined using a complex estimation process that requires significant management judgment.
Certain countries in which we operate have adopted Pillar Two legislation and other countries are in the process of introducing legislation to implement Pillar Two. We do not expect Pillar Two to have a material impact on our results of operations, liquidity or capital resources.
Certain countries in which we operate have enacted Pillar Two legislation, and other countries are in the process of introducing legislation to implement Pillar Two. In January 2026, the OECD announced additional administrative guidance, including a “side-by-side” framework intended to coordinate the application of Pillar Two with existing minimum tax regimes in certain jurisdictions.
In 2023, we utilized cash of $2.3 billion for debt repayments, $3.8 billion for dividend payments and $1.0 billion for common stock repurchases, partially offset by $2.0 billion in net proceeds from the issuance of senior unsecured notes in September 2023. The year-over-year changes were due mostly to higher cash provided by new debt issuances.
In 2025, we utilized cash of $4.0 billion for dividend payments, $1.9 billion for common stock repurchases and $1.8 billion for repayment of debt.
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Virology • Completed the New Drug Application submissions to U.S. Food and Drug Administration (“FDA”) for twice-yearly lenacapavir for HIV prevention. • Announced results of PURPOSE 2, the second Phase 3 study of twice-yearly lenacapavir for HIV prevention, with data presented at the HIV Research for Prevention Conference.
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Year in Review During 2025, 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 Livdelzi’s market share in the treatment of primary biliary cholangitis (“PBC”).
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In the lenacapavir group, 99.9% of participants did not acquire HIV infection, with two incident cases among 2,179 participants. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence in cisgender men and gender-diverse people, and additionally demonstrated superiority to daily Truvada (89% relative risk reduction). Lenacapavir was generally well-tolerated and no significant or new safety concerns were identified.
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The content on the referenced website does not constitute a part of and is not incorporated by reference into this Annual Report on Form 10-K. Virology • Announced positive topline Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trial, evaluating our investigational daily oral single-tablet regimen of bictegravir 75mg and lenacapavir 50mg (“BIC/LEN”) for virologically suppressed adults with HIV.
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The use of lenacapavir for the prevention of HIV is investigational. Oncology • Received Breakthrough Therapy Designation from 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.
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BIC/LEN met its primary endpoint, demonstrating non-inferiority to baseline multi-tablet antiviral regimens (ARTISTRY-1) and Biktarvy (ARTISTRY-2). • Announced settlement agreements to resolve Biktarvy patent litigation with generic manufacturers Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd.
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The use of Trodelvy in ES-SCLC is investigational. • Announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy for use in pre-treated adult patients with locally advanced or metastatic urothelial cancer, following the results of the Phase 3 TROPiCS-04 trial announced in May 2024. • Incurred partial impairment charges related to in-process research and development (“IPR&D”) assets acquired by Gilead from Immunomedics, Inc. in 2020 as a result of our evaluation of the Phase 3 EVOKE-01 study data and a strategic decision to discontinue our clinical development program in metastatic non-small cell lung cancer (“NSCLC”) for Trodelvy in the second-line indication (see further information in “Results of Operations; In-Process Research and Development Impairments” below). 37 Inflammation • Received a positive opinion from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use recommending seladelpar for the treatment of primary biliary cholangitis (“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 accelerated approval from FDA for Livdelzi for the treatment of primary biliary cholangitis in combination with UDCA in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. • Entered into an amended license agreement featuring the buy-out of global seladelpar royalties from Janssen Pharmaceutica NV for $320 million. • Completed the acquisition of CymaBay Therapeutics, Inc.
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Under the agreements, the earliest date the three generic manufacturers can market a generic version of full dose Biktarvy in the U.S. is April 1, 2036, subject to standard acceleration provisions.
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(“CymaBay”) for $4.3 billion in total equity value, or $3.9 billion net cash paid, adding investigational candidate seladelpar for the treatment of primary biliary cholangitis to Gilead’s Liver Disease portfolio. Other • Announced the appointment of Dietmar Berger, MD, PhD, as Chief Medical Officer effective January 2025.
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This is more than two years later than our previous loss of exclusivity projection for Biktarvy (December 2033). • Received a strong recommendation for the use of twice-yearly injectable Yeztugo (lenacapavir) for HIV PrEP in the new U.S. Centers for Disease Control and Prevention guidelines. • Announced a partnership with the U.S. State Department and the U.S.
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The decrease was primarily due to: • A pre-tax IPR&D partial impairment charge of $4.2 billion related to Trodelvy IPR&D assets; and • Higher acquired IPR&D expenses, primarily $3.8 billion related to the acquisition of CymaBay; partially offset by • Higher product sales; and • Lower income tax expense.
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President’s Emergency Plan for AIDS Relief (“PEPFAR”) to deliver lenacapavir for HIV PrEP for up to two million people over three years in countries supported by both PEPFAR and the Global Fund. • Received European Commission (“EC”) marketing authorization for Yeytuo (lenacapavir) for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. • Received U.S.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

14 edited+1 added−2 removed5 unchanged
Biggest changeWe also hedge certain monetary assets and liabilities denominated in foreign currencies, which reduces but does not eliminate our exposure to currency fluctuations between the date a transaction is recorded and the date that cash is collected or paid. In general, the market risks of these contracts are offset by corresponding gains and losses on the transactions being hedged.
Biggest changeOverall, we are a net receiver of foreign currencies and, therefore, we benefit from a weaker U.S. dollar and are adversely affected by a stronger U.S. dollar. Additionally, our monetary assets and liabilities denominated in foreign currencies expose us to currency fluctuations between the date a transaction is recorded and the date that cash is collected or paid.
Interest Rate Risk We occasionally invest in available-for-sale debt securities, adhering to a policy that requires us to limit invested amounts based on credit rating, maturity, industry group and investment type and issuer, except for securities issued by the U.S. government.
Interest Rate Risk We invest in available-for-sale debt securities, adhering to a policy that requires us to limit invested amounts based on credit rating, maturity, industry group and investment type and issuer, except for securities issued by the U.S. government.
There were no amounts outstanding under the revolving credit facility as of December 31, 2024. As such, there is currently no financial interest rate exposure. Equity Price Risk We hold shares of common stock of certain publicly traded biotechnology companies primarily in connection with license and collaboration agreements.
There were no amounts outstanding under the revolving credit facility as of December 31, 2025. As such, there is currently no financial interest rate exposure. Equity Price Risk We hold shares of common stock of certain publicly traded biotechnology companies primarily in connection with license and collaboration agreements.
To reduce certain of these risks, we enter into various types of foreign currency derivative hedging transactions, follow investment guidelines and monitor outstanding receivables as part of our risk management program. Foreign Currency Exchange Rate Risk We have operations in more than 35 countries worldwide.
To reduce certain of these risks, we enter into various types of foreign currency derivative transactions, follow our investment policy guidelines and monitor outstanding receivables as part of our risk management program. Foreign Currency Exchange Rate Risk We have operations in more than 35 countries worldwide.
A hypothetical 10% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2024 and 2023 would have resulted in a reduction in fair value of these contracts of approximately $364 million and $328 million, respectively, and if realized, would have negatively affected earnings over the remaining life of the contracts.
A hypothetical 10% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2025 and 2024 would have resulted in a reduction in fair value of these contracts of approximately $439 million and $364 million, respectively, and if realized, would have negatively affected earnings over the remaining life of the contracts.
The current fair value of our debt portfolio and liability related to future royalties are $23.3 billion and $0.9 billion, respectively. The fair value will decrease as interest rates increase. The fair value will increase as interest rates decrease. Additionally, we have a $2.5 billion five-year revolving credit facility that matures in June 2029.
The current fair value of our debt portfolio and liability related to future royalties are $22.3 billion and $0.8 billion, respectively. The fair value will decrease as interest rates increase and will increase as interest rates decrease. Additionally, we have a $2.5 billion five-year revolving credit facility that matures in June 2029.
A hypothetical 20% increase or decrease in the stock prices of these equity securities would have increased or decreased their fair value as of December 31, 2024 and 2023 by approximately $312 million and $292 million, respectively. 49
A hypothetical 20% increase or decrease in the stock prices of these equity securities would have increased or decreased their fair value as of December 31, 2025 and 2024 by approximately $392 million and $312 million, respectively. 49
The goals of our investment policy, in order of priority, are as follows: • safety and preservation of principal and diversification of risk; • liquidity of investments sufficient to meet cash flow requirements; and • a competitive after-tax rate of return.
The goals of our investment policy, in order of priority, are (1) safety and preservation of principal and diversification of risk, (2) liquidity of investments sufficient to meet cash flow requirements and (3) a competitive after-tax rate of return.
As such, there is no financial interest rate exposure. The fair value of these senior unsecured notes and our liability related to future royalties as part of our 2020 acquisition of Immunomedics, Inc. are exposed to fluctuations in interest rates.
As such, there is no financial interest rate exposure. The fair values of both our senior unsecured notes as well as our liability related to future royalties as part of our 2020 acquisition of Immunomedics, Inc. are exposed to fluctuations in interest rates.
As of December 31, 2024 and 2023, we had open foreign currency forward contracts with notional amounts of $2.9 billion and $2.5 billion, respectively.
As of December 31, 2025 and 2024, we had open foreign currency forward contracts with notional amounts of $3.9 billion and $2.9 billion, respectively.
These equity securities are measured at fair value with any changes in fair value recognized in earnings. 48 The fair value of these equity securities was approximately $1.6 billion and $1.5 billion as of December 31, 2024 and 2023, respectively.
These equity securities are measured at fair value with any changes in fair value recognized in earnings. The fair value of these equity securities was approximately $2.0 billion and $1.6 billion as of December 31, 2025 and 2024, respectively.
However, primarily due to the typically short-term nature of our portfolio, we do not believe that future market risks, including a hypothetical 10% increase or decrease in interest rates related to any securities, would have a material adverse impact on our financial position, results of operations, or liquidity. Our senior unsecured notes have fixed interest rates.
However, primarily due to the contractual maturity typically being less than five years, we do not believe that future market risks, including a hypothetical 10% increase or decrease in interest rates related to any securities, would have a material adverse impact on our financial position, results of operations, or liquidity. Our senior unsecured notes have fixed interest rates.
To partially mitigate the impact of changes in currency exchange rates on net cash flows from our foreign currency denominated sales, we enter into foreign currency exchange forward contracts.
To partially mitigate the impact of changes in currency exchange rates on net cash flows from our foreign currency denominated sales as well as outstanding monetary assets and liabilities, we enter into foreign currency exchange forward contracts. In general, the risk of foreign currency fluctuations related to our operations is offset by corresponding gains and losses from our derivative instruments.
Our operating results are exposed to changes in foreign currency exchange rates between the U.S. dollar and various foreign currencies, the most significant of which is the Euro. When the U.S. dollar strengthens against these currencies, the relative value of sales made in the respective foreign currency decreases.
When the U.S. dollar strengthens against these currencies, the relative value of sales made in the respective foreign currency decreases. Conversely, when the U.S. dollar weakens against these currencies, the relative value of such sales increases.
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As a result, our financial results could be significantly affected by factors such as changes in foreign currency exchange rates or weak economic conditions in the foreign markets in which we distribute our products.
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As such, certain of our monetary assets and liabilities and approximately 26% of our 2025 product sales are denominated in foreign currencies. Our operations in foreign countries expose us to risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and various foreign currencies, primarily the Euro.
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Conversely, when the U.S. dollar weakens against these currencies, the relative value of such sales increases. Overall, we are a net receiver of foreign currencies and, therefore, we benefit from a weaker U.S. dollar and are adversely affected by a stronger U.S. dollar. Approximately 27% of our product sales were denominated in foreign currencies during 2024.

Other GILD 10-K year-over-year comparisons