Gilead Sciences, Inc. operates as a biopharmaceutical company.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, coronavirus disease 2019 (‘COVID-19’), cancer and inflammation. The company operates in more than 35 countries worldwide.
Products
The company has transformed care for people around the world by discovering, developing and delivering innovative medicines to address unmet medical needs in virolo...
Gilead Sciences, Inc. operates as a biopharmaceutical company.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, coronavirus disease 2019 (‘COVID-19’), cancer and inflammation. The company operates in more than 35 countries worldwide.
Products
The company has transformed care for people around the world by discovering, developing and delivering innovative medicines to address unmet medical needs in virology, oncology and other therapeutic areas. The company’s innovative medicines represent advancements by offering first-in-class therapies, greater efficacy, enhanced modes of delivery, more convenient treatment and prevention regimens, improved resistance profiles and reduced side effects.
In 2024, the company’s 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. Biktarvy is a single-tablet regimen of a fixed-dose combination of the company’s antiretroviral medications, bictegravir, emtricitabine (‘FTC’) and tenofovir alafenamide (‘TAF’).
Genvoya is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients. Genvoya is a single-tablet regimen of a fixed-dose combination of the company’s antiretroviral medications, elvitegravir, cobicistat, FTC and TAF.
Descovy is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients. Descovy is a fixed-dose combination of the company’s antiretroviral medications, FTC and TAF. Descovy is also approved by U.S. Food and Drug Administration (‘FDA’) for a pre-exposure prophylaxis (‘PrEP’) indication to reduce the risk of sexually acquired HIV-1 infection in certain at-risk patients.
Odefsey 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 the company’s 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. 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 the company’s 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. Symtuza is a single-tablet regimen of a fixed-dose combination of the company’s antiretroviral medications, cobicistat, FTC and TAF, and Janssen’s darunavir. Symtuza is commercialized by Janssen, and the company receives a share in revenue for the components that it contributes.
Truvada is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients. Truvada is a fixed-dose combination of the company’s 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. Stribild is a single-tablet regimen of a fixed-dose combination of the company’s antiretroviral medications, elvitegravir, cobicistat, TDF and FTC.
Sunlenca is an HIV-1 capsid inhibitor in tablet form for oral use and as an injection for subcutaneous use. Sunlenca, in combination with other antiretroviral(s), is indicated as a twice-yearly treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their antiretroviral regimen due to resistance, intolerance or safety considerations.
Liver Disease
Epclusa is an oral formulation of a once-daily single-tablet regimen of sofosbuvir and velpatasvir for the treatment of chronic hepatitis C virus (‘HCV’) infection in adults and pediatric patients 3 years of age and older with genotype 1, 2, 3, 4, 5 or 6: (i) without cirrhosis or with compensated cirrhosis or (ii) with decompensated cirrhosis for use in combination with ribavirin. In addition, the company has an authorized generic version of Epclusa distributed by its separate subsidiary, Asegua Therapeutics LLC.
Vemlidy is an oral formulation of TAF dosed once a day for the treatment of chronic hepatitis B virus (‘HBV’) infection in adults and pediatric patients 12 years of age and older with compensated liver disease.
Harvoni is an oral formulation of a once-daily, single-tablet regimen of ledipasvir and sofosbuvir for the treatment of chronic HCV infection in adults and pediatric patients 3 years of age and older with: (i) genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis, (ii) genotype 1 with decompensated cirrhosis, in combination with ribavirin, (iii) genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin. In addition, the company has an authorized generic version of Harvoni distributed by its 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 has an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
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 hospitalized or not hospitalized and has mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
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.
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’) and (ii) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (‘ALL’).
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 unresectable locally advanced or metastatic triple-negative breast cancer (‘TNBC’) who has received two or more prior systemic therapies, at least one of them for metastatic disease, and unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who has received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
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) to improve exercise capacity and delay clinical worsening or in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
Royalty, Contract and Other Revenues
The company also generates revenues from other activities, including royalties for outbound licenses of its intellectual property and other payments received from its collaborations with third-party partners.
Commercialization and Distribution
The company has the U.S. and international commercial sales operations, with marketing subsidiaries in more than 35 countries. The company’s products are marketed through its commercial teams and/or in conjunction with third-party wholesalers, distributors and corporate partners. The company’s commercial teams promote its products through direct field contact with physicians, hospitals, clinics and other healthcare providers. The company generally grant its third-party distributors the exclusive right to promote the company’s product in a territory for a specified period. Most of the company’s 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.
The company sells and distributes most of its products in the U.S. exclusively through the wholesale channel. During the year ended December 31, 2024, approximately 91% of the company’s product sales in the U.S. and approximately 65% of its total worldwide revenues were from three large wholesalers: Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation, and their specialty distributor affiliates. The company sells and distributes its products in Europe and countries outside the U.S. where the product is approved, either through the company’s commercial teams, third-party distributors, or corporate partners.
Product Candidates in Virology
Regulatory Filings
Lenacapavir: A New Drug Application has been filed with FDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for the prevention of HIV as pre-exposure prophylaxis.
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.
Phase 3
Lenacapavir Combinations: An oral combination of lenacapavir and bictegravir is being evaluated as an HIV treatment for virologically suppressed treatment-experienced and virologically suppressed people living with HIV. In combination with Merck & Co., Inc. (‘Merck’), an oral combination of lenacapavir and Merck’s islatravir is being evaluated as a long-acting HIV treatment for virologically suppressed people living with HIV.
Product Candidates in Oncology
Phase 3
Axicabtagene ciloleucel: Axicabtagene ciloleucel, a CAR T-cell therapy, is being evaluated as a second line and later treatment for high-risk FL and a first-line treatment for high-risk LBCL.
Anitocabtagene autoleucel: In collaboration with Arcellx, Inc. (‘Arcellx’), anitocabtagene autoleucel, a CAR T-cell therapy, is being evaluated in patients with relapsed and/or refractory multiple myeloma who has received one to three prior lines of therapy.
Sacituzumab govitecan-hziy: In breast cancer, sacituzumab govitecan-hziy is being evaluated as a first-line treatment for PD-L1 negative metastatic TNBC and HR+/HER2- chemo-naive metastatic breast cancer. In collaboration with Merck, it is also being evaluated in combination with Merck’s pembrolizumab as a first-line treatment for PD-L1 positive metastatic TNBC and an adjuvant treatment for early TNBC. In lung and thoracic cancer, sacituzumab govitecan-hziy is being evaluated in combination with Merck’s pembrolizumab as a first-line treatment for PD-L1 positive non-small cell lung cancer (‘NSCLC’). In 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. (‘Arcus’), the combination of zimberelimab, an anti-PD-1 monoclonal antibody, and domvanalimab, an Fc-silent anti-TIGIT antibody, with chemotherapy is being evaluated as a first-line treatment for NSCLC and a first-line treatment for upper gastrointestinal tract cancer.
In 2024, the company also received regulatory approvals or authorizations from FDA for new products and expanded indications of its products, including:
Livdelzi: FDA granted accelerated approval of Livdelzi for the treatment of PBC in combination with UDCA in adults who has an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Accelerated approval was based primarily on data from the Phase 3 RESPONSE study, which achieved a reduction of alkaline phosphatase values, a cholestatic marker that is a predictor of risk for liver transplant and death.
Trodelvy: FDA granted Breakthrough Therapy designation to Trodelvy for the treatment of adult patients with extensive-stage small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. Breakthrough Therapy designation is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, has the potential to substantially improve clinical outcomes compared to available therapy. This is the second Breakthrough Therapy designation for Trodelvy.
Biktarvy: FDA approved an expanded indication for Biktarvy to treat people with HIV who has suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. FDA also approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy to treat pregnant people with HIV-1 with suppressed viral loads.
Vemlidy: FDA approved an expanded indication for Vemlidy as a once-daily treatment for chronic HBV infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.
In addition, the company seeks to enhance its commercial portfolio and clinical pipeline across multiple therapeutic areas through strategic collaborations, in-licensing and acquisitions.
The company’s strategic business development activity reflects its commitment to focus on transformative science, build a sustainable and diverse portfolio and position itself for the near-, medium- and long-term growth of its business.
Patents
As part of the company’s business strategy, it actively seeks patent protection both in the U.S. and internationally and files additional patent applications, when appropriate, to cover improvements in its compounds, products and technology.
Trademarks
The company owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD, GILEAD SCIENCES, KITE, AMBISOME, ATRIPLA, BIKTARVY, CAYSTON, COMPLERA, DESCOVY, DESCOVY FOR PREP, EMTRIVA, EPCLUSA, EVIPLERA, GENVOYA, HARVONI, HEPCLUDEX, HEPSERA, JYSELECA, LETAIRIS, LIVDELZI, ODEFSEY, SOVALDI, STRIBILD, SUNLENCA, TECARTUS, TRODELVY, TRUVADA, TRUVADA FOR PREP, TYBOST, VEKLURY, VEMLIDY, VIREAD, VOSEVI, YESCARTA and ZYDELIG.
Seasonality
In the U.S., fluctuations in wholesaler inventory levels impacts the company’s product sales. In recent years, the company has observed strong wholesaler and sub-wholesaler purchases of its products in the second half of the year, resulting in inventory draw-down by wholesalers and sub-wholesalers in the subsequent first quarter (year ended December 2024).
Government Regulation
In addition to obtaining FDA approval for each drug, the company obtains FDA approval of the manufacturing facilities for any drug it sells, including those of companies who manufactures its drugs for the company. All these facilities are subject to periodic inspections by FDA. FDA must also approve foreign establishments that manufacture products to be sold in the U.S. and these facilities are subject to periodic regulatory inspection. The company’s manufacturing facilities located in California also must be licensed by the State of California in compliance with local regulatory requirements. The company’s manufacturing facilities in Canada, Ireland and Netherlands also must obtain local licenses and permits in compliance with local regulatory requirements.
In the EU, the company’s products are subject to a variety of EU and EU member state regulations governing clinical trials, commercial sales and distribution. The company is required to obtain a marketing authorization in the EU before it can market its medicinal products on the relevant market. The conduct of clinical trials in the EU is governed by, among others, Directive 2001/20/EC and Directive 2005/28/EC and the ICH Good Clinical Practice guidelines. These impose legal and regulatory obligations that are similar to those provided in applicable U.S. laws. The conduct of clinical trials in the EU must be approved by the competent authorities of each EU member states in which the clinical trials take place, and a positive opinion must be obtained from the relevant Ethics Committee in the relevant member state. In 2014, the EU legislator adopted Regulation (EU) No 536/2014 to replace Directive 2001/20/EC and to introduce a coordinated procedure for authorization of clinical trials. This Regulation entered into application in January 2022.
The company’s CMOs and its corporate partners are subject to Good Manufacturing Practices (‘cGMP’), which are extensive regulations governing manufacturing processes, stability testing, record keeping, and quality standards as defined by FDA and EMA.
A significant portion of the company’s sales of the majority of its 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’).
The company is subject to various U.S. federal and state laws pertaining to health care ‘fraud and abuse’, including anti-kickback laws and false claim laws. In addition, FDA regulates written and verbal communications about the company’s products. In addition to federal law, states also have consumer protection and false claims laws.
In addition, the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments for the purpose of obtaining or retaining business. The company’s policies mandate compliance with these anti-bribery laws.
The company is subject to the information requirements of the Securities Exchange Act of 1934 (‘Exchange Act’). Therefore, the company’s file periodic reports, proxy and information statements and other information with U.S. Securities and Exchange Commission (‘SEC’).
Research and Development
The company’s research and development expenses were $5.9 billion in 2024.
History
Gilead Sciences, Inc. was founded in 1987. The company was incorporated in 1987.
