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What changed in Gilead Sciences's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Gilead Sciences's 2023 and 2024 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 2024 report.

+413 added−405 removedSource: 10-K (2025-02-28) vs 10-K (2024-02-23)

Top changes in Gilead Sciences's 2024 10-K

413 paragraphs added · 405 removed · 289 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

93 edited+32 added−37 removed56 unchanged
Biggest changeIn addition, as our products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices. Further, as new branded or generic products are introduced into major markets, our ability to maintain pricing and market share may be affected.
Biggest changeWe 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.
Oncology • Yescarta ® (axicabtagene ciloleucel), a suspension for intravenous infusion, is a chimeric antigen receptor (“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.
Oncology Cell Therapy • Yescarta ® (axicabtagene ciloleucel), a suspension for intravenous infusion, is a chimeric antigen receptor (“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.
Our employee salaries are informed by market research and market-based ranges and are assessed annually through performance reviews. Our policy is that compensation decisions are made without regard to personal characteristics such as gender, race, color, national or ethnic origin, age, disability, sexual orientation, gender identity or expression, genetic information, religion, or veteran status.
Our employee salaries are informed by market research, and market-based ranges and are assessed annually through performance reviews. Our policy is that compensation decisions are merit-based and made without regard to personal characteristics such as gender, race, color, national or ethnic origin, age, disability, sexual orientation, gender identity or expression, genetic information, religion or veteran status.
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.
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.
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, GMP compliance and the requirement to obtain manufacturing, import and/or distribution licenses issued by the competent authorities of the EU member states.
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.
We submit this data to FDA in an Investigational New Drug (“IND”) application seeking its approval to test the compound in humans. 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.
We submit this data to FDA in an Investigational New Drug (“IND”) application seeking its approval to test the compound in humans. 12 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.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, coronavirus disease 2019 (“COVID-19”) and cancer. 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, coronavirus disease 2019 (“COVID-19”), cancer and inflammation. We operate in more than 35 countries worldwide, with headquarters in Foster City, California.
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.” Health Care Fraud and Abuse Laws; Anti-Bribery Laws 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 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.
(4) 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) 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.
As of the end of 2023, 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.
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.
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 planned for 2024.
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.
As a result, the commercial value of the patent may be limited because the patent term is based on the date the patent application was filed, which may be prior to the regulatory approval and commercial sale of the related product. However, we may be able to apply for patent term extensions or supplementary protection certificates in some countries.
As a result, the commercial value of the patent may be limited because the patent term is based on the date the patent application was filed, which may be prior to the regulatory approval and commercial sale of the related product. However, we also apply for patent term extensions or supplementary protection certificates in some countries.
Our Manufacturing Facilities 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.
In the EU and the U.S., patent applications are pending relating to our proprietary manufacturing processes. (2) Regulatory exclusivity in the U.S. expires in 2032. (3) 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) Regulatory exclusivity in the U.S. expires in 2032. (4) In collaboration with Arcus.
We acquired exclusive rights to these patents in the agreements we have with these parties. We may 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. We often obtain patents for certain products many years before marketing approval is obtained.
Our human capital objective is to make Gilead an employer of choice for the best talent in our industry. Gilead’s key priorities for human capital management include inclusion and diversity, health and safety, total rewards, employee development and engagement. The Compensation and Talent Committee of our Board of Directors oversees our overall human capital management.
Our human capital objective is to make Gilead an employer of choice for the best talent in our industry. Gilead’s key priorities for human capital management include inclusion, total rewards, safety, and employee development and engagement initiatives and programs. The Compensation and Talent Committee of our Board of Directors oversees our overall human capital management.
The following table shows the 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 key product candidates as described above.
The following table shows the estimated expiration dates (including patent term extensions, supplementary protection certificates and/or pediatric exclusivity where granted) in the U.S. and the European Union (“EU”) for the primary (typically compound) patents for our key product candidates as described above.
Our portfolio (which varies by country and is subject to employee eligibility 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 • Family planning assistance (e.g., fertility, adoption and surrogacy) • Health care navigation for our LGBTQ+ community • 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 We are a pay-for-performance company and are committed to addressing pay equity.
A significant portion of our sales of the majority of our products are subject to substantial discounts from their list prices, including rebates we may be required to pay to Medicaid agencies or discounts we may be required to pay 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 Medicaid agencies or discounts to covered entities under Section 340B of the Public Health Service Act (“340B”).
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 Regulatory System and Approval Proce ss 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. 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.
For more information, see Item 1A. Risk Factors “We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.” Environment We are subject to a number of laws and regulations that require compliance with federal, state, and local regulations for the protection of the environment.
Risk Factors “We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.” Environmental Regulation We are subject to a number of laws and regulations that require compliance with federal, state and local regulations for the protection of the environment.
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.
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.
In collaboration with Merck Sharpe & Dohme LLC (“Merck”), (1) 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 as a second- or third-line treatment for non-small cell lung cancer (“NSCLC”).
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”).
The product, marketed in the U.S. as Complera and in Europe as Eviplera, is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, tenofovir disoproxil fumarate (“TDF”) and FTC, and Janssen’s rilpivirine hydrochloride. • Truvada ® is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients.
The product, marketed in the U.S. as Complera and in Europe as Eviplera, is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, tenofovir disoproxil fumarate (“TDF”) and FTC, and Janssen’s rilpivirine hydrochloride. • Symtuza ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
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 2022 ESG Impact Report on Gilead’s website at https://www.gilead.com/-/media/files/pdfs/yir-2022-pdfs/2022-environmental-social-governance-impact-report.pdf. 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 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.
In certain circumstances, strict compliance with anti-bribery laws may conflict with local customs and practices or may require us to interact with doctors and hospitals, some of which may be state controlled, in a manner that is different than local custom.
In certain circumstances, strict compliance with anti-bribery laws may conflict with local customs and practices or may require us to interact with doctors and hospitals, some of which may be state controlled, in a manner that is different than local custom. We have implemented trainings and programs geared toward compliance with these laws.
(1) • 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, (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 and (iii) locally advanced or metastatic urothelial cancer (“UC”) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (“PD-1”) or programmed death-ligand 1 (“PD-L1”) inhibitor.
Other • 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.
For example, extensions for the patents or supplementary protection certificates on many of our products have been granted in the U.S. and in a number of European countries, compensating in part for delays in obtaining marketing approval.
For example, extensions for the patents or supplementary protection certificates on many of our products have been granted in the U.S. and in a number of European countries, compensating in part for delays in obtaining marketing approval. From time to time, certain individuals or entities may challenge our patents.
Risk Factors “We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, which could limit our ability to generate revenues. ” Human Capital Gilead’s success depends on the work of its dedicated employees who embrace a shared sense of purpose and a culture of excellence.
Risk Factors “We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, or we may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners, which could limit our ability to generate revenues.” Human Capital Gilead’s success depends on the work of its dedicated employees who embrace a shared sense of purpose and a culture of excellence.
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. The general process for drug approval in the U.S. is summarized below.
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.
These raw materials are generally available from multiple sources, purchased worldwide and normally available in quantities adequate to meet the needs of our business. We attempt to manage the risks associated with our supply chain by inventory management, relationship management and evaluation of alternative sources when feasible. For more information, see Item 1A.
These raw materials are generally available from multiple sources and normally available in quantities adequate to meet the needs of our business. We attempt to manage the risks associated with our supply chain through inventory management, relationship management and the evaluation of alternative sources when feasible.
Truvada is a fixed-dose combination of our antiretroviral medications, TDF and FTC. 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.
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.
Odefsey is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, FTC and TAF, and rilpivirine marketed by Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”). • Complera ® /Eviplera ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
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”). • Complera ® /Eviplera ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
Barton, Ph.D. 71 Professor Emerita, California Institute of Technology Jeffrey A. Bluestone, Ph.D. 70 President and Chief Executive Officer, Sonoma Biotherapeutics, Inc.; Professor Emeritus, University of California San Francisco Sandra J. Horning, M.D. 75 Retired Chief Medical Officer, Roche, Inc. Kelly A. Kramer 56 Retired Chief Financial Officer, Cisco Systems, Inc. Ted W.
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.
In the U.S., the 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.
In the U.S., the EU and other significant or potentially significant markets for our products and product candidates, government authorities limit or regulate the price of medical products and services.
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 comprised of leaders from key departments across our company.
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.
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 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.
We, our third-party manufacturers and our corporate partners are subject to current Good Manufacturing Practices (“GMP”), 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. Our manufacturing operations are subject to routine inspections by regulatory agencies.
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.
(“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. In collaboration with Arcus, (1) the combination of zimberelimab and domvanalimab is being evaluated as a first-line treatment for NSCLC.
(“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.
Phase 3 Lenacapavir Lenacapavir is being evaluated for an HIV PrEP indication. 5 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.
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.
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 59 Chairman and Chief Executive Officer Andrew D. Dickinson 54 Chief Financial Officer Johanna Mercier 54 Chief Commercial Officer Merdad V.
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.
Additionally, we are required to maintain a complex chain of identity and custody with respect to patient material as such material moves to the manufacturing facilities, through the manufacturing process, and back to the patient. 10 Access to Raw Materials We need access to certain raw materials to conduct our clinical trials and manufacture our products.
Additionally, we are required to maintain a complex chain of identity and custody with respect to patient material as such material moves to the manufacturing facilities, through the manufacturing process, and back to the patient.
Risk Factors “Our success depends to a significant degree on our ability to obtain and defend our patents and other intellectual property rights both domestically and internationally, and to operate without infringing upon the patents or other proprietary rights of third parties.” Trade Secrets We also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation.
Risk Factors “Our success depends to a significant degree on our ability to obtain and defend our patents and other intellectual property rights both domestically and internationally, and to operate without infringing upon the patents or other proprietary rights of third parties.” Patents Patents and other proprietary rights are very important to our business.
EU Descovy 2031 (2) 2026 Vemlidy 2031 (2) 2026 Complera/Eviplera 2025 2026 Zydelig 2025 2029 Odefsey 2032 (2) 2026 Yescarta 2031 — (3) Stribild 2029 (4) 2028 Genvoya 2029 (4) 2028 Harvoni 2030 2030 Epclusa 2033 2032 Biktarvy 2033 2033 Vosevi 2034 2033 Veklury 2036 (5) 2035 Tecartus 2027 — (3) Trodelvy 2028 (6) 2029 Hepcludex 2030 2029 Sunlenca 2037 2037 The listed expiration dates do not include any potential additional exclusivity (e.g., patent term extensions, supplementary protection certificates or pediatric exclusivity) that has not yet been granted. ______________________________ (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 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.
In 2023, our primary revenue-generating products and the approved indications in the U.S. were as follows: HIV • Biktarvy ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.
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.
Many other countries, including countries in the EU (and the EU under a centralized procedure), have similar regulatory structures. 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.
For our cell therapy products, we have established clinical and commercial manufacturing facilities for cell processing activities. 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 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.
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. 3 Viral Hepatitis • 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.
(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.
(1) • Tecartus ® (brexucabtagene autoleucel), a suspension for intravenous infusion, is a 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”). ________________________________ (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.
(1) • Tecartus ® (brexucabtagene autoleucel), a suspension for intravenous infusion, is a 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”).
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.
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.
For more information about these risks and uncertainties, see Item 1A. 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.
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.
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. • Letairis ® (ambrisentan) is an oral formulation of an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension (“PAH”) (WHO Group I) (i) to improve exercise capacity and delay clinical worsening or (ii) in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
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. • Letairis ® (ambrisentan) is an oral formulation of an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension (“PAH”) (WHO Group I) (i) to improve exercise capacity and delay clinical worsening or (ii) in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. _______________________________ (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. 4 For the disaggregated revenue amounts contributed by the products listed above as well as the total product sales that include our other approved products, see Note 2.
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.
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.
Gilead offers a number of internal and external professional, management and leadership development training programs to help our employees develop technical, cross-functional and leadership skills and tools to grow their careers.
Employee Development and Engagement Employee development maximizes the potential and performance of each member of our workforce and is critical to achieving our business goals. Gilead offers a number of internal and external professional, management and leadership development training programs to help our employees develop technical, cross-functional and leadership skills and tools to advance their careers.
Pricing and Reimbursement Successful commercialization of our products depends, in part, on the availability of third-party payer reimbursement for the cost of such products and related treatments and medical services in the markets where we sell our products. Government health authorities, private health insurers and other organizations generally provide reimbursement.
Pricing and Reimbursement Regulation Health insurers, including government health authorities, generally provide reimbursement for the cost of our products and related treatments and medical services in the markets where we sell.
As a result, the price increases we implement from time to time on certain products may have a limited effect on our net product sales in certain markets.
As a result, the price increases we implement from time to time on certain products may have a limited effect on our net product sales in certain markets. In addition, standard reimbursement structures may not adequately reimburse for innovative therapies. For more information, see Item 1A.
It is not unusual, however, for FDA to decline to approve an application because it believes that the drug candidate is not safe enough or efficacious enough (i.e., does not have an appropriate benefit-risk profile) or because it does not believe that the data submitted is reliable or conclusive. 13 At any point in this process, the development of a drug candidate can be stopped for a number of reasons, including safety concerns, lack of treatment benefit or manufacturing issues.
It is not unusual, however, for FDA to decline to approve an application because it believes that the drug candidate is not safe enough or efficacious enough (i.e., does not have an appropriate benefit-risk profile) or because it does not believe that the data submitted is reliable or conclusive.
In the case of employees, the agreements provide that all inventions made by an individual while employed by us will be our exclusive property.
In the case of employees, the agreements provide that all inventions made by an individual while employed by us will be our exclusive property. Raw Materials and Manufacturing We need access to certain raw materials to conduct our clinical trials and manufacture our products.
Product Candidates in Viral Diseases 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. It has been granted both Orphan Drug and Breakthrough Therapy designations by FDA for this indication.
Bulevirtide A Biologics License Application has been filed with FDA for bulevirtide for the treatment of chronic hepatitis delta virus (“HDV”) infection. It has been granted both Orphan Drug and Breakthrough Therapy designations by FDA for this indication. Approval is pending resolution of certain manufacturing and delivery concerns cited in a complete response letter issued by FDA in October 2022.
Any such changes could also impact the voluntary licensing patent programs that we establish for our products to support access to medicines. 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.
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.
During the year ended December 31, 2023, approximately 91% of our product sales in the U.S. and approximately 66% of our total worldwide revenues were from three large wholesalers: Cencora, Inc. (formerly known as AmerisourceBergen Corporation), Cardinal Health, Inc. and McKesson Corporation.
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.
Our products compete with other commercially 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. We also face significant competition as third parties pursue the development of products and technologies that may be competitive with our existing products or research programs.
Our products compete with other commercially 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.
In January 2024, we announced discontinuation of further enrollment in this study. ________________________________ (1) For additional information regarding our collaborations with Merck and Arcus, 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.
For information on some of our notable recent transactions, see Notes 6. Acquisitions and 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.
Violations can also lead to the imposition of a Corporate Integrity Agreement or similar government oversight program, even if we disagree with the government’s perspective that we have violated any rules or guidance. Any similar violations by our competitors could also negatively impact the reputation of our industry and increase governmental and public scrutiny over our business and our products.
Violations can also lead to the imposition of a Corporate Integrity Agreement or similar government oversight program, even if we disagree with the government’s perspective that we have violated any rules or guidance. For more information, see Item 1A.
Parsey, M.D., Ph.D. 61 Chief Medical Officer Deborah H. Telman 59 Executive Vice President, Corporate Affairs and General Counsel Directors Name Age Principal Occupation or Employment Daniel P. O’Day, Chairman 59 Chairman and Chief Executive Officer of Gilead Sciences, Inc. Kevin E. Lofton, Lead Independent Director 69 Retired Chief Executive Officer, Common Spirit Health Jacqueline K.
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.
We depend on third parties to perform manufacturing activities for the majority of our API and drug products. For most of our products, including our HIV and HCV products, we use multiple third-party contract manufacturers so that we have primary and back-up suppliers and manufacturing sites.
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.
In addition to ongoing internal and external data collection and benchmarking, we conducted comprehensive reviews of the employee experience in 2022 and again in 2023, including through the use of employee surveys. The results of these surveys 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 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.
(5) 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. (6) Regulatory exclusivity in the U.S. expires in 2032. Patent Protection and Certain Challenges Patents and other proprietary rights are very important to our business.
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.
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.
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.
To promote employee productivity, we continue to address our employees’ needs by providing meaningful benefits and a flexible approach to work arrangements. We believe our flexible work program positions us to be competitive for talent and support employee safety and wellbeing while also creating the collaborative environment and connections that fuel innovation.
We believe our flexible work program positions us to be competitive for talent and support employee wellbeing while also creating the collaborative environment and connections that fuel innovation. Safety We have a workplace safety, training and security program that focuses on preventing work-related injuries and illnesses and providing a safe and secure environment for our employees.
Patents and Proprietary Rights U.S. and European 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, but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents.
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.
EU Viral Diseases: Lenacapavir 2037 2037 Bulevirtide 2030 2029 Oncology: Axicabtagene ciloleucel 2031 — (1) Sacituzumab govitecan-hziy 2028 (2) 2029 Zimberelimab (3) 2036 (2036) (4) Domvanalimab (3) 2037 (2037) (4) The listed expiration dates do not include any potential additional exclusivity (e.g., patent term extensions, supplementary protection certificates or pediatric exclusivity) that has not yet been granted. _______________________________ (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) 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.
Love, M.D. 64 Chair of Board of Directors, Biotechnology Innovation Organization Harish Manwani 70 Senior Operating Partner, Blackstone Inc.; Retired Chief Operating Officer, Unilever Group Javier J. Rodriguez 53 Chief Executive Officer, DaVita Inc. Anthony Welters 68 Chairman and Chief Executive Officer, CINQ Care Inc.; Retired Senior Advisor to the Office of CEO, UnitedHealth Group 16
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
For example, pursuant to our collaboration with Janssen, we receive revenue share from cobicistat, FTC and TAF that are components of Symtuza (darunavir/cobicistat/FTC/TAF), a fixed-dose combination product commercialized by Janssen. We include our revenue share from Symtuza in our Product sales. For a description of our collaborations with Janssen and other partners, see Note 7.
Symtuza is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, cobicistat, FTC and TAF, and Janssen’s darunavir. Symtuza is commercialized by Janssen, and we receive a share in revenue for the components that we contribute. See Note 7.
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.
(“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.
It is also being evaluated in combination with Merck’s pembrolizumab as a first-line treatment for PD-L1 positive NSCLC. In genitourinary cancer, sacituzumab govitecan-hziy is being evaluated as a second-line treatment for metastatic UC. FDA granted accelerated approval for Trodelvy in second-line metastatic UC in April 2021. Domvanalimab and zimberelimab In collaboration with Arcus Biosciences, Inc.
In gynecology, sacituzumab govitecan-hziy is being evaluated as a second-line treatment for metastatic endometrial cancer. Domvanalimab and zimberelimab In collaboration with Arcus Biosciences, Inc.
We have committed significant resources to internal R&D opportunities and external business development activity to drive innovation and growth of our business. The development of product candidates and investigational therapies in our pipeline is subject to various risks and uncertainties that could result in delays or prevent completion of the development and approval of our product candidates.
The development of product candidates and investigational therapies in our pipeline is subject to various risks and uncertainties that could result in delays or prevent completion of the development and approval of our product candidates. For more information about these risks and uncertainties, see Item 1A.
Failure to comply with these requirements may lead to the imposition of civil, criminal or administrative sanctions, including suspension of marketing or manufacturing authorizations.
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.
Third-Party Manufacturers We believe the technology we use to manufacture our products is proprietary. For products manufactured by our third-party contract manufacturers, we have disclosed all necessary aspects of this technology to enable them to manufacture the products for us.
For products manufactured by our third-party contract manufacturers, we have disclosed all necessary aspects of these technologies to enable them to manufacture the products for us. We protect these rights mainly through confidentiality agreements with third-party manufacturers, corporate partners, employees, consultants and vendors.
In addition to internal development, employees can receive reimbursement for tuition expenses incurred while pursuing undergraduate, graduate or certificate courses at an accredited college or university. As we strive to be the employer of choice in our industry, our listening strategy gathers input from our employees to shape our engagement strategies and programs and measure our progress.
As we strive to be an employer of choice in our industry, our listening strategy gathers input from our internal and external talent to shape our engagement strategies and programs and measure our progress.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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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: • educating and certifying medical personnel regarding the procedures and the potential side effects, such as cytokine release syndrome and neurologic toxicities, in compliance with the Risk Evaluation and Mitigation Strategy program required by 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. 17 The use of engineered T cells as a potential cancer treatment is a recent development and may not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community.
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.
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. 25 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 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.
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.
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
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. We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.
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.
As inventory in the distribution channel fluctuates from quarter to quarter, we may continue to see fluctuations in our earnings and a mismatch between prescription demand for our products and our revenues. We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.
As inventory in the distribution channel fluctuates from quarter to quarter, we may continue to see fluctuations in our earnings and a mismatch between prescription demand for our products and our revenues. 18 We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.
Because patent applications are confidential for a period of time after filing, we may not know if our competitors have filed applications for technology covered by our pending applications or if we were the first to invent or first to file an application directed toward the technology that is the subject of our patent applications.
Because patent applications are confidential for a period of time after filing, we may not know if our competitors have filed applications for technology covered by our pending applications or if we were the first to file an application directed toward the technology that is the subject of our patent applications.
Our business and technology partners face similar risks and any security breach of their systems could adversely affect our security posture. 29 Like many companies, we have experienced and expect to continue to be the target of cybersecurity incidents, including data breaches and temporary service interruptions.
Our business and technology partners face similar risks, and any security breach of their systems could adversely affect our security posture. Like many companies, we have experienced and expect to continue to be the target of cybersecurity incidents, including data breaches and temporary service interruptions.
Also, 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 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.
The U.S. wholesalers with whom we have entered into inventory management agreements make estimates to determine end-user demand and may not be accurate in matching their inventory levels to actual end-user demand.
The U.S. wholesalers and distributors with whom we have entered into inventory management agreements make estimates to determine end-user demand and may not be accurate in matching their inventory levels to actual end-user demand.
Congress has enacted laws requiring manufacturer refunds on certain amounts of discarded drug from single-use vials and eliminating the existing cap on Medicaid rebate amounts beginning in 2024. 19 • U.S.
Congress has enacted laws requiring manufacturer refunds on certain amounts of discarded drug from single-use vials and eliminating the existing cap on Medicaid rebate amounts beginning in 2024. • U.S.
While the full impact of the Act on our business and the pharmaceutical industry remains uncertain at this time, we anticipate that the Act 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. • 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. 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.
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 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.
The healthcare industry is subject to various federal, state and international laws and regulations pertaining to drug approval, reimbursement, rebates, price reporting, healthcare fraud and abuse, and data privacy and security.
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.
Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and discounts, and other pricing pressures. Product Reimbursements 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 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.
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.
Climate change and natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.
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 subjective and may be subject to review and challenge by various government agencies, which may disagree with our interpretation.
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.
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. These manufacturers are currently challenging HHS’ position in ongoing 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’ position in litigation.
In addition, we have observed that strong wholesaler and sub-wholesaler purchases of our products in the second half of the year typically results in inventory draw-down by wholesalers and sub-wholesalers in the subsequent first quarter.
In addition, we have observed that strong wholesaler/distributor and sub-wholesaler/distributor purchases of our products in the second half of the year typically results in inventory draw-down by wholesalers/distributors and sub-wholesalers/distributors in the subsequent first quarter.
We need access to certain supplies and products to conduct our clinical trials and to manufacture and sell our products.
We need access to certain materials and supplies to conduct our clinical trials and to manufacture and sell our products.
These regulations, which can differ across jurisdictions, subject Gilead to many transitional 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 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.
Adverse changes in economic conditions, increased competition or other factors may cause retail pharmacies to reduce their inventories of our products, which would reduce their orders from wholesalers and, consequently, the wholesalers’ orders from us, even if end-user demand has not changed.
Adverse changes in economic conditions, increased competition or other factors may cause retail and specialty pharmacies to reduce their inventories of our products, which would reduce their orders from wholesalers and distributors and, consequently, the wholesalers’ and distributors’ orders from us, even if end-user demand has not changed.
Therefore, our product candidates may never be successfully commercialized, and we may be unable to recoup the significant R&D and clinical trial expenses incurred. We expect to spend significant time and resources on our clinical trial activities without any assurance that we will recoup our investments or that our efforts will be commercially successful.
Therefore, our product candidates may never be successfully commercialized, and we may be unable to recoup the significant R&D, clinical trial, acquisition-related and other expenses incurred. We expect to spend significant time and resources on our clinical trial activities without any assurance that we will recoup our investments or that our efforts will be commercially successful.
We rely on independent third-party contract research organizations (“CROs”) to perform most of our clinical studies, including document preparation, site identification, screening and preparation, pre-study visits, training, program management, patient enrollment, ongoing monitoring, site management and bioanalysis. Many important aspects of the services performed for us by the CROs are out of our direct control.
We rely on third-party contract research organizations (“CROs”) to perform most of our clinical studies, including document preparation, site identification, screening and preparation, pre-study visits, training, program management, patient enrollment, ongoing monitoring, site management and bioanalysis. Many important aspects of the services performed for us by the CROs are not within our direct control.
For equity investments in our strategic partners, such as in connection with our collaborations with Arcus Biosciences, Inc. and Galapagos NV, 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, Galapagos NV and Arcellx, Inc., the value of our equity investments may fluctuate and decline in value.
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. • Protective economic policies taken by governments, such as trade protection measures and import and export licensing requirements, which may result in the imposition of trade sanctions or similar restrictions by the U.S. or other governments. • 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. 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.
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. We may be unable to accurately predict demand for our products, including the uptake of new products, as demand depends on a number of factors.
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. We may be unable to accurately predict demand for our products as demand depends on a number of factors.
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 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.
Product Pricing, Discounts and Rebates In the U.S., the European Union (“EU”) and other significant or potentially significant markets for our products and pro duct 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 has dramatically increased in recent years, including: • U.S.
If we are unable to purchase enough of these materials or find suitable alternative materials 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.
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.
In addition, multiple manufacturers and trade organizations have challenged the Medicare “negotiation” provisions of the Act, 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.
We have incurred, and will continue to incur, inventory write-off charges and other expenses for products that fail to meet specifications and quality standards as well as changes we may adopt in our manufacturing strategy, and we may need to undertake costly remediation efforts or seek more costly manufacturing alternatives. For example, see Note 10.
We have incurred, and will continue to incur, inventory write-off charges and other expenses for products that fail to meet specifications and quality standards as well as changes we may adopt in our manufacturing strategy, and we may need to undertake costly remediation efforts or seek more costly manufacturing alternatives.
Likewise, data privacy or cybersecurity incidents or breaches by employees or others 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 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.
Our products, which are manufactured at our own facilities or by third-party manufacturers and corporate partners, are the result of complex, highly regulated manufacturing processes. We depend on third-party manufacturers 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 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.
Reliance on collaborative relationships poses a number of risks, including the risk that: • we are unable to control the resources our corporate partners devote to our programs or products; • disputes may arise with respect to the ownership of rights to technology developed with our corporate partners; • disagreements with our corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration; • contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform; • our corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors; • our corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and • our distributors and our corporate partners may be unable to pay us. 28 Given these risks, there is a great deal of uncertainty regarding the success of our current and future collaborative efforts.
Reliance on collaborative relationships poses a number of risks, including the risk that: • we are unable to control the resources our corporate partners devote to our programs or products; • disputes may arise with respect to the ownership of rights to technology developed with our corporate partners; • disagreements with our corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration; • contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform; • our corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors; • our corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and • our distributors and our corporate partners may be unable to pay us.
Even successfully completed large-scale clinical trials may not result in marketable products. 21 We face numerous risks and uncertainties with our clinical trials that could result in delays or prevent completion of the development and approval of our product candidates, including challenges in clinical trial protocol design, our ability to enroll patients in clinical trials, the possibility of unfavorable or inadequate trial results to support further development of our product candidates, including failure to meet a trial’s primary endpoint, safety issues arising from our clinical trials, and the need to modify or delay our clinical trials or to perform additional trials.
We face numerous risks and uncertainties with our clinical trials that could result in delays or prevent completion of the development and approval of our product candidates, including challenges in clinical trial protocol design, our ability to enroll patients in clinical trials, the possibility of unfavorable or inadequate trial results to support further development of our product candidates, including failure to meet a trial’s primary endpoint, safety issues arising from our clinical trials, and the need to modify or delay our clinical trials or to perform additional trials.
Our hedging program does not eliminate our exposure to currency fluctuations. We may be adversely impacted if the U.S. dollar appreciates significantly against certain currencies and our hedging program does not sufficiently offset the effects of such appreciation.
We may be adversely impacted if the U.S. dollar appreciates significantly against certain currencies and our hedging program does not sufficiently offset the effects of such appreciation.
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 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 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 foreign currency exchange rates, primarily in the Euro, and the impacts from foreign currency exchange, net of hedges, for the year ended December 31, 2023. 26 • Interest Rates and Inflation: We hold interest-generating assets and interest-bearing liabilities, including our available-for-sale debt securities and our senior unsecured notes and credit facilities.
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.
Institutional and individual investors are increasingly using ESG screening criteria to determine whether Gilead qualifies for inclusion in their investment portfolios. We are frequently asked by investors and other stakeholders to set ambitious ESG goals and provide new and more robust disclosure on goals, progress toward goals and other matters of interest to ESG stakeholders.
Some institutional and individual investors continue to use environmental, social and governance (“ESG”) screening criteria to determine whether Gilead qualifies for inclusion in their investment portfolios. We are frequently asked by investors and other stakeholders to set ambitious ESG goals and provide new and more robust disclosure on goals, progress toward goals and other matters of interest to ESG stakeholders.
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.
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. We are dependent upon information technology systems, infrastructure and data.
Additionally, our corporate headquarters in Foster City and certain R&D and manufacturing facilities are located in California, a seismically active region.
Additionally, our corporate headquarters in Foster City and certain R&D and manufacturing facilities are located in California, a region that is seismically active and prone to wildfires.
Similarly, 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 and private litigation.
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.
Congress has enacted the Inflation Reduction Act of 2022 (the “Act”), 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), (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 (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.
However, additional legal or legislative developments with respect to the 340B program, including potential litigation with HHS or other stakeholders, may negatively impact our ability to implement or continue our integrity initiative. In addition, standard reimbursement structures may not adequately reimburse for innovative therapies.
We also believe that our integrity initiative complies with the requirements of the 340B statute. However, additional legal or legislative developments with respect to the 340B program, including potential litigation with HHS or other stakeholders, may negatively impact our ability to implement or continue our integrity initiative. In addition, standard reimbursement structures do not always adequately reimburse for innovative therapies.
For example, in the U.S., there has been a shortage of certain cancer drugs that are the backbone of standard-of-care treatments, such as carboplatin and cisplatin, which are also used in R&D and clinical trials.
For example, in the U.S., there have been ongoing or recent shortages of certain cancer drugs that are the backbone of standard-of-care treatments, such as carboplatin and cisplatin, which are also used in R&D and clinical trials.
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.
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.
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.
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.
Even if marketing approval is granted for these products, there may be significant limitations on their use.
Even if marketing approval is granted for our product candidates, there may be significant limitations on their use.
During the year ended December 31, 2023, sales of our HIV products accounted for approximately 67% of our total product sales. We may be unable to sustain or increase sales of our HIV products for any number of reasons, including market share gains by competitive products, including generics, or the inability to introduce new HIV medications necessary to remain competitive.
We may be unable to sustain or increase sales of our HIV products for any number of reasons, including market share gains by competitive products, including generics, or the inability to introduce new HIV medications necessary to remain competitive.
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.
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.
If there is any dispute or disruption in our relationship with our CROs, our clinical trials may be delayed. Moreover, in our regulatory submissions, we rely on the quality and validity of the clinical work performed by third-party CROs.
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.
When reimbursement is not aligned well to account for treatment costs, Medicare beneficiaries may be denied access as this misalignment could impact the willingness of some hospitals to offer the therapy and of doctors to recommend the therapy.
When reimbursement is not aligned well to account for treatment costs, Medicare beneficiaries may be denied access as this misalignment could impact the willingness of some hospitals to offer the therapy and of doctors to recommend the therapy. Additionally, in the EU, there are barriers to reimbursement in individual countries that could limit the uptake of Yescarta and Tecartus.
Our efforts to accomplish and accurately report on these goals and objectives present numerous operational, reputational, financial, legal and other risks, any of which could have a material negative impact, including on our reputation and stock price.
Our efforts to accomplish and accurately report on these goals and objectives present numerous operational, reputational, financial, legal and other risks, any of which could have a material negative impact, including on our reputation and stock price. Our ability to achieve any corporate responsibility goal or objective is subject to numerous risks, many of which are outside of our control.
As our products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices. Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently. For example, in September 2020, FDA issued a final rule implementing a pathway for the importation of certain prescription drugs from Canada.
As our products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices. Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently.
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.
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.
If we do not accurately forecast demand or manufacture Veklury at levels to align with actual demand, then we may experience product shortages or build excess inventory that may need to be written off.
If we do not accurately forecast demand or manufacture products at levels to align with actual demand, then we may experience product shortages or build excess inventory that may need to be written off. For example, product demand may be adversely affected if physicians do not see the benefit of our products.
Our international operations are heavily regulated and require significant interaction with foreign officials. We operate in parts of the world that have experienced governmental corruption to some degree.
Foreign Corrupt Practices Act and similar worldwide anti-bribery laws that govern our international operations with respect to payments to government officials. Our international operations are heavily regulated and require significant interaction with foreign officials. We operate in parts of the world that have experienced governmental corruption to some degree.
The results from these studies do not always accurately predict results in later, large-scale clinical trials.
The results from these studies do not always accurately predict results in later, large-scale clinical trials. Even successfully completed large-scale clinical trials may not result in marketable products.
There are many difficulties and uncertainties inherent in drug development and the introduction of new products. The product development cycle is characterized by significant investments of resources, long lead times and unpredictable outcomes due to the nature of developing medicines for human use.
The product development cycle is characterized by significant investments of resources, long lead times and unpredictable outcomes due to the nature of developing medicines for human use.
Filing patent applications is a fact-intensive and complex process. We may file patent applications that ultimately do not result in patents or have patents that do not provide adequate protection for the related product.
Filing patent applications is a fact-intensive and complex process. We may file patent applications that ultimately do not result in patents or have patents that do not provide adequate protection for the related product. Patent term extensions may be available for products we are developing, but we cannot be certain we will obtain them.
Examples of such risks include: (1) the availability and cost of low- or non-carbon-based energy sources and technologies, (2) evolving regulatory requirements affecting ESG standards or disclosures, (3) the availability of suppliers that can meet our sustainability, diversity and other standards, (4) our ability to recruit, develop and retain diverse talent in our labor markets and (5) the impact of our organic growth and acquisitions or dispositions of businesses or operations.
Examples of such risks include: (1) the availability and cost of low- or non-carbon-based energy sources and technologies, (2) evolving regulatory requirements affecting ESG standards or disclosures, (3) the availability of suppliers that can meet our corporate responsibility and related standards, (4) our ability to recruit, develop and retain qualified talent in our labor markets and (5) the impact of our organic growth and acquisitions or dispositions of businesses or operations. 27 The standards for tracking and reporting on ESG matters are relatively new, have not been harmonized and continue to evolve.
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.
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.
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”).
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.
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. Veklury We face risks related to our supply and sale of Veklury, which was approved by U.S.
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.
We and our third-party manufacturers and corporate partners are subject to Good Manufacturing Practices (“GMP”), which are extensive regulations governing manufacturing processes, stability testing, record keeping and quality standards as defined by FDA and European Medicines Agency (“EMA”), as well as comparable regulations in other jurisdictions.
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.
Department of Veterans Affairs, correctional facilities and large health maintenance organizations, tends to be less consistent in terms of buying patterns and often causes quarter-over-quarter fluctuations that do not mirror actual patient demand for our products.
Additionally, the non-retail sector in the U.S., which includes government institutions, including state AIDS Drug Assistance Programs, the U.S. Department of Veterans Affairs, correctional facilities and large health maintenance organizations, tends to be less consistent in terms of buying patterns and often causes quarter-over-quarter fluctuations that do not mirror actual patient demand for our products.
Therefore, you should not consider the following risks to be a complete statement of all the potential risks or uncertainties that we face. Product and Commercialization Risks Certain of our products subject us to additional or heightened risks. HIV We receive a substantial portion of our revenue from sales of our products for the treatment and prevention of HIV infection.
Product and Commercialization Risks Certain of our products subject us to additional or heightened risks. HIV We receive a substantial portion of our revenue from sales of our products for the treatment and prevention of HIV infection.
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.
We expect these matters will continue to require a high level of internal and financial resources for the foreseeable future.
In addition, domestic data privacy and security laws, such as the California Consumer Privacy Act and the California Privacy Rights Act and other laws that have been or may be passed, similarly introduce requirements with respect to personal information, and non-compliance with such laws may result in liability through private actions (subject to statutorily defined damages in the event of certain data breaches) and enforcement.
These and other similar types of laws and regulations that have been or may be passed, often include requirements with respect to personal information, and non-compliance with such laws may result in liability through private actions (subject to statutorily defined damages in the event of certain data breaches) and government enforcement.
These laws and regulations are broad in scope and subject to changing and evolving interpretations, 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, or impact our ability to obtain or maintain regulatory approvals. The resulting impact on our business is uncertain and could be material.
Even after a manufacturer is qualified by the regulatory authority, the manufacturer must continue to expend time, money and effort in the area of production and quality control to maintain full compliance with GMP. Manufacturers are subject to regular periodic inspections by regulatory authorities following initial approval.
Even after a supplier is qualified by the regulatory authority, the supplier must continue to expend time, money and effort in the area of production and quality control to maintain full compliance with cGMP.
If we are unable to launch commercially successful new products or new indications for existing products, our business will be adversely impacted. The launch of commercially successful products is necessary to grow our business, cover our substantial R&D expenses, and offset revenue losses when existing products lose market share due to factors such as competition and loss of patent exclusivity.
The launch of commercially successful products is necessary to grow our business, cover our substantial R&D expenses, and offset revenue losses when existing products lose market share due to factors such as competition and loss of patent exclusivity. There are many difficulties and uncertainties inherent in drug development and the introduction of new products.
Safety information, without the appropriate context and expertise, may be misinterpreted and lead to misperception or legal action. Our success depends to a significant degree on our ability to obtain and defend our patents and other intellectual property rights both domestically and internationally, and to operate without infringing upon the patents or other proprietary rights of third parties.
Our success depends to a significant degree on our ability to obtain and defend our patents and other intellectual property rights both domestically and internationally, and to operate without infringing upon the patents or other proprietary rights of third parties. Patents and other proprietary rights are very important to our business.
The standards for tracking and reporting on ESG matters are relatively new, have not been harmonized and continue to evolve. Our selection of disclosure frameworks that seek to align with various reporting standards may change from time to time and may result in a lack of consistent or meaningful comparative data from period to period.
Our selection of disclosure frameworks that seek to align with various reporting standards may change from time to time and may result in a lack of consistent or meaningful comparative data from period to period.
The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations. We periodically implement or upgrade new or enhanced enterprise resource planning (“ERP”) and other information systems in order to better manage our business operations, align our global organizations and enable future growth.
We periodically implement or upgrade new or enhanced enterprise resource planning (“ERP”) and other information systems in order to better manage our business operations, align our global organizations and enable future growth. Implementation or upgrade of new business processes and information systems requires the commitment of significant personnel, training and financial resources, and entails risks to our business operations.
In addition, in February 2024, we announced a full clinical hold placed by FDA on all magrolimab studies in myelodysplastic syndromes and acute myeloid leukemia, and that we will not pursue further development of magrolimab in hematologic cancers. As a result, we may be unable to successfully complete our clinical trials on our anticipated timelines, or at all.
In addition, following results and data from several magrolimab studies as well as corresponding FDA clinical holds, we announced in February 2024 that we would not pursue further development of magrolimab in hematologic cancers. 21 As a result, we may be unable to successfully complete our clinical trials on our anticipated timelines, or at all.
Additionally, we periodically make adjustments 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.
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.
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 Section 340B of the Public Health Service Act (“340B”).
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.
In the U.S., these laws include anti-kickback and false claims laws, 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.
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 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.
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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeLeaders of each team are expected to collaborate to help increase visibility of key issues and alignment with strategy. As noted above, the company’s IRP includes standard processes for escalating significant cybersecurity incidents to management, including the CISO.
Biggest changeThe 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.
Risks related to cybersecurity events are provided to the Board on an annual basis as part of an overall ERM update. In addition to this regular reporting, significant cybersecurity risks may also be escalated on an as-needed basis through the company’s organizational structure in accordance with the IRP.
Updates related to cybersecurity are provided to the Board on an annual basis as part of an overall ERM update. In addition to this regular reporting, significant cybersecurity events may also be escalated on an as-needed basis through the company’s organizational structure in accordance with the IRP.
We have a robust enterprise risk management (“ERM”) program that plays an important role in seeking to manage and address existing and emerging risks, including cybersecurity risks, which are critical to our overall business goals and objectives.
Our process for assessing, identifying and managing material risks from cybersecurity threats is integrated into our overall risk management process. We have a robust enterprise risk management (“ERM”) program that plays an important role in seeking to manage and address existing and emerging risks, including cybersecurity risks, which are critical to our overall business goals and objectives.
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. 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. We have an IRP to prepare for and respond to cybersecurity incidents.
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. 32 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.
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 Board of Directors has established an oversight structure for monitoring the effectiveness of and risks related to the cybersecurity program. Designated by the Board to oversee cybersecurity and information technology risks, the Audit Committee receives quarterly cybersecurity updates from our CISO, and the chair of the Audit Committee meets with the CISO individually on a quarterly basis.
Our Board of Directors has established an oversight structure for monitoring the effectiveness of and risks related to the cybersecurity program. The Audit Committee has been designated by the Board to oversee cybersecurity and information technology risks.
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 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.
These third parties also help reduce costs, increase efficiency, improve quality, mitigate risks, and review cybersecurity strategy, trends, and threat landscape. Third-Party Service Provider Risk Management We have a process in place to oversee and identify risks from cybersecurity threats associated with our use of key third-party service providers during the course of engagement.
Third-Party Service Provider Risk Management We have a process in place to oversee and identify risks from cybersecurity threats associated with our use of key third-party service providers during the course of engagement. The company uses an external risk management software program to identify, assess, monitor and mitigate risks associated with third-party relationships, including cybersecurity risks.
Following an evaluation, the company determines and prioritizes risks based on their potential impact, which help inform the appropriate level of additional due diligence and ongoing compliance monitoring. The third-party risk assessment is a cross-functional effort involving our end-user, Legal, Privacy, and Information Security teams.
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.
Additionally, we assess our cybersecurity maturity annually using the NIST framework and implement and maintain controls that are designed to evaluate and improve our cybersecurity program, such as vulnerability assessments and penetration tests, as needed.
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.
CYBERSECURITY Cybersecurity Risk Management and Strategy Processes Used to Assess, Identify, and Manage Material Risks from Cybersecurity Threats Risk Assessment and Management Our approach to managing material risks from cybersecurity threats, which is informed in part by the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework (though we do not imply that we meet any particular technical standards, specifications or requirements), is designed to detect, identify, respond to, recover from and protect from cybersecurity incidents.
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.
Material Risks from Cybersecurity Threats The company has not identified any risks from cybersecurity threats that have materially affected us. We do not believe that risks from cybersecurity threats are reasonably likely to materially affect us, including our business strategy, results of operations or financial condition, over the long term.
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.
Management’s Role in Assessing and Managing Materials Risks from Cybersecurity Threats Under the IRP, cybersecurity incidents are escalated based on a defined incident severity to management as appropriate. Management, including the CIO and CISO, is involved in assessing and managing our cybersecurity risks.
Our 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.
The ERM team updates our CEO and his leadership team on cybersecurity risks as well as their potential impact, likelihood, potential mitigation plan, and status. Incident Response We have a dedicated Information Security team responsible for managing and coordinating incident response efforts.
The ERM team updates our Chief Executive Officer (“CEO”) and his leadership team on cybersecurity risks as well as their potential impact, likelihood, potential mitigation plan and status. Engagement of Third-Party Advisors We engage third-party advisors, including assessors and cybersecurity consultants, to assess, validate and enhance our cybersecurity program.
Like many companies, we have experienced cybersecurity incidents, including data breaches and temporary service interruptions. However, as of the end of 2023, known cybersecurity incidents, individually or in aggregate, have not had a material impact.
The third-party risk assessment is a cross-functional effort involving our end-user, Legal, Privacy and Information Security teams. 31 Material Risks from Cybersecurity Threats Like many companies, we face cybersecurity threats and have experienced cybersecurity incidents, including data breaches and temporary service interruptions.
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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. Our process for assessing, identifying, and managing material risks from cybersecurity threats is integrated into our overall risk management process.
Added
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.
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The process is tested in annual tabletop exercises to help identify strengths and areas for improvement. 31 Engagement of Third Party Advisors We engage third party advisors, including assessors, cybersecurity consultants, and auditors to assess, validate, and enhance our cybersecurity program. We benefit from engaging third parties to provide specialized skills, knowledge, tools, and resources.
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The Audit Committee receives quarterly cybersecurity updates from our CISO, and the chair of the Audit Committee meets with the CISO individually on a quarterly basis.
Removed
The company uses an external risk management software program to identify, assess, monitor and mitigate risks associated with third-party relationships, including cybersecurity risks. 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.
Added
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.
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The CISO reports to the CIO (who in turn reports to our Chief Financial Officer, who in turn reports to the CEO), and both the CIO and CISO participate in global leadership team meetings.
Removed
With over 26 years of experience, including over three years with the company, the CIO has been recognized externally for his leadership in technology innovation in the industry, and provides strategic leadership for the company’s IT organization.

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 Emeryville, Oceanside and Santa Monica, California; Seattle, Washington; Frederick, Maryland; Edmonton, Canada; Dublin, Ireland; Cambridge and Oxford, United Kingdom.
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.
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.
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
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 “Our Manufacturing Facilities . ” Our global operations include offices in Europe, North America, Asia, South America, Africa, Australia and the Middle East.
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.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeWe started repurchases under the 2020 Program in December 2022. 35 The table below summarizes our stock repurchase activity for the three months ended December 31, 2023: 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, 2023 863 $ 76.86 808 $ 3,962 November 1 - November 30, 2023 800 $ 76.57 738 $ 3,905 December 1 - December 31, 2023 709 $ 79.37 391 $ 3,874 Total (1) 2,371 $ 77.51 1,937 ______________________________________________________ (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.
Biggest changeThe 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.
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.
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.
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 16, 2024, we had approximately 1,396 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 21, 2025, we had approximately 1,339 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, 2023: (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 38.0 $ 69.38 82.3 Employee Stock Purchase Plan (2) 26.0 Total equity compensation plans approved by security holders 38.0 $ 69.38 108.3 Equity compensation plans not approved by security holders — $ — — Total 38.0 $ 69.38 108.3 ______________________________________________________ (1) Includes 24 million restricted stock units, performance share units and phantom shares.
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.
Dividends For the years ended December 31, 2023 and 2022 , 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. Additional information is included in Consolidated Statements of Stockholders' Equity and in Note 17.
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.
(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, 2018, and assuming that all dividends were reinvested.
(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.
Subsequent Events of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.
Additional information is included in Consolidated Statements of Stockholders’ Equity of Part II, Item 8 of this Annual Report on Form 10-K and “Liquidity and Capital Resources” of Part II, Item 7 of this Annual Report on Form 10-K.
Removed
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.

Item 7. Management's Discussion & Analysis

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

38 edited+53 added−41 removed22 unchanged
Biggest changeOther income (expense), net in 2022 included $657 million of net unrealized losses on equity investments, partially offset by $106 million of interest income. 42 Income Taxes The following table summarizes the period-over-period changes in Income tax expense: Year Ended December 31, (in millions, except percentages) 2023 2022 Change Income before income taxes $ 6,859 $ 5,814 $ 1,045 Income tax expense $ (1,247) $ (1,248) $ 2 Effective tax rate 18.2 % 21.5 % (3.3) % Our effective tax rate decreased in 2023, compared to 2022, primarily due to a decrease in unrecognized tax benefits as a result of reaching agreement with a tax authority on certain tax positions in 2023.
Biggest changeUnfavorable 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.
Selling, General and Administrative Expenses Selling, general and administrative expenses are recorded when incurred and consist primarily of personnel costs, facilities and overhead costs, and sales, marketing and advertising expenses, as well as other general and administrative costs related to finance, human resources, legal and other administrative activities.
Selling, General and Administrative Expenses Selling, general and administrative expenses are recorded when incurred and consist primarily of personnel costs, facilities and overhead costs, and selling, marketing and advertising expenses, as well as other general and administrative costs related to finance, human resources, legal and other administrative activities.
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.
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.
Research and Development Expenses Research and development (“R&D”) expenses consist primarily of personnel costs including salaries, benefits and stock-based compensation expense, infrastructure, materials and supplies and other support costs, research and clinical studies performed by contract research organizations and our collaboration partners and other outside services.
Research and Development Expenses Research and development expenses consist primarily of personnel costs including salaries, benefits and stock-based compensation expense, infrastructure, materials and supplies and other support costs, research and clinical studies performed by contract research organizations and our collaboration partners and other outside services.
Income Taxes of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information. 46
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
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 26% and 29% of our product sales were denominated in foreign currencies during 2023 and 2022, respectively.
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.
Risk Factors). Additional information related to the comparison of our results of operations between the years 2022 and 2021 is included in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of our 2022 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 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.
Organization and Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for information about our significant accounting policies and how estimates are involved in the preparation of our financial statements.
Commitments and Contingencies). Critical Accounting Estimates See Note 1. Summary of Business and Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for information about our significant accounting policies and how estimates are involved in the preparation of our financial statements.
The following table provides a breakout of expenses by major cost type: Year Ended December 31, (in millions) 2023 2022 Personnel, infrastructure and other support costs $ 3,204 $ 2,811 Clinical studies and other costs 2,514 2,166 Total $ 5,718 $ 4,977 Research and development expenses increased $741 million in 2023, compared to 2022.
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 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: 44 (in millions) Balance at Beginning of Year Decrease/(Increase) to Product Sales Payments Balance at End of Year 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 Year ended December 31, 2022: Activity related to 2022 sales $ — $ 13,040 $ (9,442) $ 3,598 Activity related to sales prior to 2022 3,915 (418) (3,067) 430 Total $ 3,915 $ 12,622 $ (12,509) $ 4,028 We assess and update our estimates each reporting period to reflect actual claims and other current information.
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.
Historically, our actual rebates and chargebacks claimed for prior years have varied by less than 5% from our estimates. However, historical results are not indicative of future results.
Historically, our actual rebates and chargebacks claimed for prior years have varied by less than 5% from our estimates.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, coronavirus disease 2019 (“COVID-19”) and cancer. We operate in more than 35 countries worldwide, with headquarters in Foster City, California. During 2023, we continued to advance our portfolio and broaden available therapies while delivering continued growth in our HIV and Oncology product sales.
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.
Readers are encouraged to review all press releases 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 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.
These were partially offset by $2.0 billion in proceeds from the issuance of senior unsecured notes in September 2023, net of issuance costs. In 2022, we utilized cash of $1.5 billion for debt repayments, $3.7 billion for dividend payments, and $1.4 billion for common stock repurchases.
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.
Acquired in-process research and development expenses were $1.2 billion in 2023, primarily comprised of $313 million associated with the Arcellx collaboration, $269 million associated with the Tmunity acquisition, $218 million associated with the XinThera acquisition, $97 million associated with the Assembly collaboration and $60 million associated with the Compugen licensing agreement.
Acquired in-process research and development expenses were $1.2 billion in 2023, primarily related to the following transactions: • $313 million Arcellx collaboration; • $269 million Tmunity acquisition; • $218 million XinThera, Inc. acquisition; • $97 million Assembly Biosciences, Inc. collaboration; and • $60 million Compugen Ltd. licensing agreement. See Note 6. Acquisitions and Note 7.
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. 45 Income Taxes We are subject to income taxes in the U.S. and various foreign jurisdictions, including Ireland.
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.
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 13. Commitments and Contingencies of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.
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. Other income (expense), net in 2023 included $376 million of interest income, partially offset by $167 million of net unrealized losses on equity investments.
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 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. (2) Includes Atripla, Emtriva, Sunlenca and Tybost.
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”).
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 milestone payments related to various collaborations and the costs of rights to IPR&D projects.
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.
Key Financial Results Year Ended December 31, (in millions, except percentages and per share amounts) 2023 2022 Change Total revenues $ 27,116 $ 27,281 (1) % Net income attributable to Gilead $ 5,665 $ 4,592 23 % Diluted earnings per share attributable to Gilead $ 4.50 $ 3.64 24 % Total revenues decreased 1% to $27.1 billion in 2023, compared to 2022, driven by lower Veklury sales, largely offset by higher HIV and Oncology sales. 38 Net income attributable to Gilead was $5.7 billion and diluted earnings per share attributable to Gilead was $4.50 in 2023, compared to $4.6 billion and $3.64 diluted earnings per share attributable to Gilead in 2022.
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.
Of the $14.6 billion in 2022, $12.6 billion or 30% of gross product sales was related to rebates and chargebacks, $2.0 billion or 5% was primarily related to patient co-pay assistance, cash discounts for prompt payment, distributor fees, and sales return provisions. Current year gross-to-net deductions as a percent of gross product sales may not be indicative of future results.
Of the $16.4 billion in 2023, $14.3 billion, or 33%, of gross product sales was related to rebates and chargebacks, and $2.2 billion, or 5%, was related to other gross-to-net deductions. Current year gross-to-net deductions as a percent of gross product sales may not be indicative of future results.
Our future capital requirements 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, including preclinical studies and clinical trials; • the cost, timing and outcome of regulatory reviews; • the expansion of our sales and marketing capabilities; • the possibility of acquiring additional manufacturing capabilities or office facilities; • the possibility of acquiring other companies or new products; • debt service requirements; • future dividends subject to declaration by our Board of Directors; • the establishment of additional collaborative relationships with other companies; and • costs associated with the defense, settlement and adverse results of government investigations and litigation.
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.
Trodelvy Trodelvy product sales increased 56% to $1.1 billion in 2023, compared to 2022, primarily due to higher demand in new and existing geographies.
Trodelvy Trodelvy product sales increased 24% to $1.3 billion in 2024, compared to 2023, primarily due to higher demand across all regions.
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. 41 In-Process Research and Development Impairments In-process research and development impairments included $50 million in 2023 related to a partial impairment charge on our bulevirtide IPR&D intangible asset due to a change in assumptions primarily around probability and timing of regulatory approval, and $2.7 billion in 2022 related to a partial impairment charge on our HR+/HER2- IPR&D intangible asset.
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.
Financing Activities Net cash used in financing activities was $5.1 billion in 2023, compared to $6.5 billion in 2022. 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.
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.
Gilead’s clinical development program in metastatic NSCLC includes multiple ongoing registrational Phase 3 studies and several ongoing Phase 2 studies for Trodelvy as a first- or second-line indication. In January 2024, we announced that our Phase 3 EVOKE-01 study of Trodelvy evaluating sacituzumab govitecan-hziy (“SG”) did not meet its primary endpoint of overall survival (“OS”) in previously treated NSCLC.
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.
The following table summarizes our cash flow activities: Year Ended December 31, (in millions) 2023 2022 Net cash provided by (used in): Operating activities $ 8,006 $ 9,072 Investing activities $ (2,265) $ (2,466) Financing activities $ (5,125) $ (6,469) Effect of exchange rate changes on cash and cash equivalents $ 57 $ (63) Operating Activities Net cash provided by operating activities is derived by adjusting our net income for non-cash items and changes in operating assets and liabilities.
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.
Our gross-to-net deductions totaled $16.4 billion, or 38% of gross product sales in 2023, compared to $14.6 billion, or 35% of gross product sales in 2022.
Our gross-to-net deductions totaled $17.8 billion, or 38%, of gross product sales in 2024, compared to $16.4 billion, or 38%, of gross product sales in 2023. Of the $17.8 billion in 2024, $15.5 billion, or 33%, of gross product sales was related to rebates and chargebacks, and $2.3 billion, or 5%, was related to other gross-to-net deductions.
Royalty, Contract and Other Revenues Royalty, contract and other revenues decreased 39% to $182 million in 2023, compared to 2022, primarily due to higher milestone payments received in 2022 and lower royalty revenues in 2023 due to the impact of generic launches. 40 Costs and Expenses The following table summarizes the period-over-period changes in our costs and expenses: Year Ended December 31, (in millions, except percentages) 2023 2022 Change Cost of goods sold $ 6,498 $ 5,657 15 % Product gross margin 75.9 % 79.0 % -316 bps Research and development expenses $ 5,718 $ 4,977 15 % Acquired in-process research and development expenses $ 1,155 $ 944 22 % In-process research and development impairments $ 50 $ 2,700 (98) % Selling, general and administrative expenses $ 6,090 $ 5,673 7 % Product Gross Margin Product gross margin decreased to 75.9% in 2023, compared to 2022, primarily driven by higher intangible asset amortization expenses related to the pretreated HR+/HER2- metastatic breast cancer indication for Trodelvy following its approval in February 2023, 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, and product mix, partially offset by higher amortization of inventory step-up charges in 2022.
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.
We enter into certain unconditional purchase obligations, capital expenditure projects and other commitments in the normal course of business. There have been no changes to these commitments during the year that would have a material impact on the company’s ability to meet either short-term or long-term cash requirements.
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.
HIV product sales increased 6% to $18.2 billion in 2023, compared to 2022, primarily due to higher demand across treatment and prevention, in addition to higher average realized price and favorable channel inventory dynamics. In particular, Biktarvy sales increased primarily reflecting higher demand, including patients switching from other Gilead HIV products, as well as higher average realized price.
In particular: • Biktarvy sales increased primarily due to higher demand, including patients switching from Genvoya and other Gilead HIV products.
Veklury Veklury product sales decreased 44% to $2.2 billion in 2023, compared to 2022, primarily due to lower demand driven by lower rates of COVID-19 related hospitalizations in all regions. Other Other product sales decreased 9% to $859 million in 2023, compared to 2022, primarily due to loss of exclusivity for Letairis.
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.
Results of Operations Revenues The following table summarizes the period-over-period changes in our Total revenues: Year Ended December 31, 2023 Year Ended December 31, 2022 (in millions, except percentages) U.S. Europe Other International Total U.S.
Risk Factors of this Annual Report on Form 10-K for a listing of risk factors that could materially and adversely affect our results of operations and financial condition. 38 Results of Operations Revenues The following table summarizes our Total revenues and period-over-period changes: Year Ended December 31, 2024 Year Ended December 31, 2023 (in millions) U.S.
Interest Expense and Other Income (Expense), Net The following table summarizes the period-over-period changes in Interest expense and Other income (expense), net: Year Ended December 31, (in millions, except percentages) 2023 2022 Change Interest expense $ (944) $ (935) 1 % Other income (expense), net $ 198 $ (581) NM _______________________________ NM - Not Meaningful Interest expense remained relatively flat in 2023 compared to 2022.
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.
Investing Activities Net cash used in investing activities was $2.3 billion in 2023, compared to $2.5 billion in 2022. The change was primarily due to a decrease in acquisition spend, including acquired IPR&D, and capital expenditures, partially offset by higher net purchases of marketable debt and equity securities.
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.
As of December 31, 2023, approximately $5.9 billion was assigned to an indefinite-lived IPR&D intangible asset related to Trodelvy for metastatic non-small cell lung cancer (“NSCLC”). In addition to NSCLC, Trodelvy is being explored for potential investigational use in a range of tumor types where Trop-2 is highly expressed.
In addition to NSCLC, Trodelvy is being explored for potential investigational use in a range of tumor types where Trop-2 is highly expressed. Gilead’s clinical development program in metastatic NSCLC includes ongoing Phase 2 and registrational Phase 3 studies for Trodelvy as a first- or second-line indication.
Also, Descovy sales increased primarily driven by favorable channel inventory dynamics and higher demand. 39 Oncology Cell Therapy Cell Therapy product sales increased 28% to $1.9 billion in 2023, compared to 2022, primarily due to increased Yescarta demand for the treatment of R/R LBCL and increased Tecartus demand for the treatment of R/R adult acute lymphoblastic leukemia and R/R mantle cell lymphoma.
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.
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In terms of capital resources, we continued to invest in our business and research and development (“R&D”) pipeline through acquisitions and collaborations. We also continued to provide shareholder returns through dividends and share repurchases. Key Business Updates The following updates are based on press releases issued since our last annual report.
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Our strategic ambitions are to (i) bring 10+ transformative therapies to patients by 2030 (tracking since 2020); (ii) be a biotech employer and partner of choice; and (iii) deliver shareholder value in a sustainable and responsible manner.
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Virology • Announced that the Phase 3 OAKTREE trial of obeldesivir in non-hospitalized participants without risk factors for developing severe COVID-19 did not meet its primary endpoint of improvement in time to symptom alleviation. Obeldesivir was well-tolerated in this large study population. • Received U.S.
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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.
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Food and Drug Administration (“FDA”) and European Commission (“EC”) approval to extend the use of Veklury to treat COVID-19 in appropriate patients with mild to severe hepatic impairment as well as people with severe renal impairment, including those on dialysis. • Announced a collaboration with Assembly Biosciences, Inc.
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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.
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(“Assembly”) to advance the research and development of novel antiviral therapies, including for herpesviruses, chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”). • Received full marketing authorization from EC for Hepcludex (bulevirtide) for the treatment of adults with HDV and compensated liver disease. Hepcludex was initially granted conditional marketing authorization in July 2020.
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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.
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Bulevirtide remains the only approved treatment for HDV in the European Union (“EU”) and is not approved in the U.S.
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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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Oncology • Announced a full clinical hold placed by FDA on all magrolimab studies in myelodysplastic syndromes and acute myeloid leukemia, and that we will not pursue further development of magrolimab in hematologic cancers. • Announced that the Phase 3 EVOKE-01 study of Trodelvy versus docetaxel in previously treated metastatic non-small cell lung cancer did not meet its primary endpoint of overall survival.
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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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While not statistically powered, we observed an encouraging trend in a subgroup of patients non-responsive to prior anti-PD-(L)1 immunotherapy, that we may potentially explore further. • Received FDA approval of Yescarta’s label update to include overall survival data from the Phase 3 ZUMA-7 study, which showed a statistically significant overall survival improvement for Yescarta in second-line relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) versus standard of care. • Received FDA approval of a manufacturing process change resulting in reduced median turnaround time for Yescarta in the U.S. to an anticipated 14 days (from 16 days previously). 37 • Entered into a strategic collaboration with Arcellx, Inc.
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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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(“Arcellx”) to co-develop and co-commercialize CART-ddBCMA, a late-stage clinical asset in development for the treatment of patients with relapsed or refractory multiple myeloma, and later announced expansion of the Arcellx collaboration to include exercising an option for the ARC-SparX ACLX-001 program in multiple myeloma, expanding the scope of the existing anito-cel collaboration to include lymphomas, and a further equity investment. • Announced an exclusive license agreement with Compugen 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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(“Compugen”) for later-stage development and commercialization of novel pre-clinical anti-IL18 binding protein antibodies, including COM503, that have the potential to treat various tumor types. • Announced a collaboration with Tentarix Biotherapeutics Inc.
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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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(“Tentarix”) to discover and develop novel therapies across oncology and inflammation, using Tentarix’s proprietary Tentacles platform. • Received EC approval for Trodelvy as monotherapy for the treatment of adult patients with unresectable 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 advanced setting. • Announced, through Fosun Kite Biotechnology Co., Ltd., a joint venture between us and Shanghai Fosun Pharmaceutical (Group) Co., Ltd., the approval of axicabtagene ciloleucel (under the trade name Yikaida ® ) by the China National Medical Products Administration for the treatment of adult patients with R/R LBCL who failed first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy. • Completed the transfer of Yescarta’s marketing authorization in Japan from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K. • Announced the acquisition of XinThera, Inc.
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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.
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(“XinThera”), adding additional pipeline assets including rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology as well as MK2 for inflammatory diseases. • Completed the acquisition of Tmunity Therapeutics, Inc. (“Tmunity”), a clinical stage private biotech company, which provides preclinical and clinical programs.
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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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This includes an “armored” CAR T technology platform that has the potential to be applied to a variety of CAR Ts to enhance anti-tumor activity, as well as rapid manufacturing processes. • Received FDA approval of Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
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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.
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Inflammation • Announced that we entered into a definitive agreement to acquire all of the outstanding common stock of CymaBay Therapeutics, Inc. (“CymaBay”) and its lead product candidate, seladelpar, which is an investigational treatment for primary biliary cholangitis. • Announced an amendment expanding the collaboration agreement with Arcus Biosciences, Inc.
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We look forward to the regulatory decisions for twice-yearly lenacapavir for HIV prevention in the U.S. under priority review as well as in the EU where we submitted a marketing authorization application in early 2025.
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(“Arcus”), including research programs in inflammatory diseases, an update to the domvanalimab collaboration program, and an additional equity investment. • Exercised an option to license investigational targeted protein degrader molecule NX‑0479 (“GS-6791”) from Nurix Therapeutics, Inc. GS-6791 is a potent, selective, oral IRAK4 degrader with potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases.
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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.
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Other • Issued $2.0 billion aggregate principal amount of senior unsecured notes in a registered offering, comprised of $1.0 billion principal amount of 5.25% senior notes due in 2033 and $1.0 billion principal amount of 5.55% senior notes due in 2053, and repaid debt of $2.25 billion.
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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.
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The increase was primarily due to lower in-process research and development (“IPR&D”) impairment expenses, lower net unrealized losses on equity investments and higher interest income, partially offset by higher costs of goods sold and operating expenses, and lower revenues.
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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.
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Europe Other International Total Change Product sales: HIV $ 14,848 $ 2,102 $ 1,226 $ 18,175 $ 13,820 $ 2,219 $ 1,155 $ 17,194 6 % Oncology 1,833 875 224 2,932 1,494 573 73 2,139 37 % Cell Therapy 1,055 658 156 1,869 968 430 60 1,459 28 % Trodelvy 777 217 68 1,063 525 143 12 680 56 % Liver Disease 1,421 511 852 2,784 1,440 525 833 2,798 (1) % HCV (1) 1,002 378 386 1,767 1,005 413 392 1,810 (2) % HBV / HDV 418 133 466 1,017 435 112 441 988 3 % Veklury 972 408 805 2,184 1,575 702 1,628 3,905 (44) % Other 304 301 255 859 388 323 235 946 (9) % Total product sales 19,377 4,197 3,361 26,934 18,716 4,342 3,924 26,982 — % Royalty, contract and other revenues 62 114 7 182 168 127 4 299 (39) % Total revenues $ 19,438 $ 4,310 $ 3,368 $ 27,116 $ 18,884 $ 4,469 $ 3,928 $ 27,281 (1) % ________________________________ See Note 2.
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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.
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Revenues of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for further disaggregation of revenue by product. (1) Chronic hepatitis C virus (“HCV”) HIV The following table summarizes the period-over-period changes in our HIV product sales: Year Ended December 31, 2023 Year Ended December 31, 2022 (in millions, except percentages) U.S.
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Europe 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”).
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Europe Other International Total Change Biktarvy $ 9,692 $ 1,253 $ 905 $ 11,850 $ 8,510 $ 1,103 $ 777 $ 10,390 14 % Complera/Eviplera 47 70 12 129 74 113 13 200 (35) % Descovy 1,771 100 114 1,985 1,631 118 123 1,872 6 % Genvoya 1,752 205 103 2,060 1,983 284 136 2,404 (14) % Odefsey 1,012 294 44 1,350 1,058 364 47 1,469 (8) % Stribild 72 21 8 101 88 29 10 127 (20) % Truvada 82 13 19 114 113 15 18 147 (22) % Revenue share - Symtuza (1) 382 133 13 529 348 168 14 530 — % Other HIV (2) 37 12 7 56 15 24 17 57 (1) % Total HIV $ 14,848 $ 2,102 $ 1,226 $ 18,175 $ 13,820 $ 2,219 $ 1,155 $ 17,194 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”).
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(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.
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Liver Disease Liver Disease product sales decreased 1% to $2.8 billion in 2023, compared to 2022, primarily due to unfavorable HCV pricing dynamics and foreign exchange rates, partially offset by higher demand across HCV, HDV and HBV products.
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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.
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The increase to 38% was primarily due to changes in product mix, where decreases in Veklury product sales in all regions were offset by increased sales in HIV and oncology products, and changes in payer mix.
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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.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeWe do not believe that the future market risks related to our securities will have a material adverse impact on our financial position, results of operations, or liquidity. Our senior unsecured notes have fixed interest rates. As such, there is no financial interest rate exposure.
Biggest changeHowever, 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.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We are exposed to market risks that may result from changes in foreign currency exchange rates, interest rates and credit and equity prices.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We are exposed to market risks that may result from changes in foreign currency exchange rates, interest rates and equity prices.
A hypothetical 10% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates as of December 31, 2023 and 2022 would have resulted in a reduction in fair value of these contracts of approximately $328 million and $299 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, 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.
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 26% of our product sales were denominated in foreign currencies during 2023.
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.
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. We may also enter into other transactions, such as interest rate derivative hedges, as needed. 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 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.
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, 2023 and 2022 by approximately $292 million and $239 million, respectively. 48
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
As of December 31, 2023 and 2022, we had open foreign currency forward contracts with notional amounts of $2.5 billion and $3.0 billion, respectively.
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.
Loans under our revolving credit facility bear interest at either (i) the Term Secured Overnight Financing Rate plus the Applicable Percentage, or (ii) the Base Rate plus the Applicable Percentage, each as defined in the revolving credit facility agreement. There were no amounts outstanding under the revolving credit facility as of December 31, 2023.
Loans under our revolving credit facility bear interest at either (i) Term Secured Overnight Financing Rate plus the Applicable Percentage, (ii) the Alternative Currency Term Rate plus the Applicable Percentage, or (iii) the Base Rate plus the Applicable Percentage, each as defined in the revolving credit facility agreement.
With respect to our investment portfolio, we adhere to an investment policy that requires us to limit amounts invested in securities 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 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.
The fair value of these equity securities was approximately $1.5 billion and $1.2 billion as of December 31, 2023 and 2022, respectively. Changes in fair value of these equity securities are impacted by the volatility of the stock market and changes in general economic conditions, among other factors.
Changes in fair value of these equity securities are impacted by the volatility of the stock market and changes in general economic conditions, among other factors.
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. The current fair value of our debt portfolio and liability related to future royalties are $22.6 billion and $1.2 billion, respectively.
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.
The analysis does not consider the impact that hypothetical changes in foreign currency exchange rates would have on anticipated transactions that these foreign currency sensitive instruments were designed to offset. Interest Rate and Credit Risk Our portfolio of available-for-sale debt securities and our long-term borrowings are exposed to interest rate and credit risk.
The analysis does not consider the impact that hypothetical changes in foreign currency exchange rates would have on anticipated transactions that these foreign currency sensitive instruments were designed to offset.
As such, there is currently no financial interest rate exposure. 47 Equity Price Risk We hold shares of common stock of certain publicly traded biotechnology companies primarily in connection with license and collaboration agreements. These equity securities are measured at fair value with any changes in fair value recognized in earnings.
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.
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 2025.
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 fair value of our available-for-sale debt securities is subject to change as a result of potential changes in market interest rates. The fair value of our portfolio of available-for-sale debt securities would not be significantly affected by either a 10% increase or decrease in interest rates primarily due to the short-term nature of the portfolio.
The fair value of any available-for-sale debt securities is subject to change as a result of potential changes in market interest rates.
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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.

Other GILD 10-K year-over-year comparisons