About Gilead Sciences Inc

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) and cancer. The company operates in more than 35 countries worldwide. Business 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 2023, the company's 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. 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 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. 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. 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 current antiretroviral regimen due to resistance, intolerance or safety considerations. 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 have mild-to-moderate COVID-19, and is at high risk for progression to severe COVID-19, including hospitalization or death. 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: without cirrhosis or with compensated cirrhosis or 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 genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis, genotype 1 with decompensated cirrhosis, in combination with ribavirin, 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. 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 large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, 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 relapsed or refractory FL after two or more lines of systemic therapy. 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 have received two or more prior systemic therapies, at least one of them for metastatic disease, 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 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. Tecartus (brexucabtagene autoleucel), a suspension for intravenous infusion, is a CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)and relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 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. Revenue Share and Other Revenues The company also generates revenues from other activities, including revenue share from combination products, royalties for outbound licenses of its intellectual property and other payments received from its collaborations with third-party partners. For example, pursuant to its collaboration with Janssen, the company receives revenue share from cobicistat, FTC and TAF that are components of Symtuza (darunavir/cobicistat/FTC/TAF), a fixed-dose combination product commercialized by Janssen. The company includes its revenue share from Symtuza in its Product sales. 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 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 grants its third-party distributors the exclusive right to promote its product in a territory for a specified period of time. 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, 2023, approximately 91% of the company's product sales in the U.S. and approximately 66% of its total worldwide revenues were from three large wholesalers: Cencora, Inc., Cardinal Health, Inc. and McKesson Corporation. The company sells and distributes its products in Europe and countries outside the U.S. where the product is approved, either through its commercial teams, third-party distributors or corporate partners. Research and Development (R&D) In 2023, the company continued to invest in and advance its R&D pipeline across its therapeutic areas. Below is a summary of the company's product candidates that are in Phase 3 clinical trials or pending marketing authorization review by FDA or European Medicines Agency (EMA). Product Candidates in Viral Diseases 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. 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: Lenacapavir is being evaluated for an HIV PrEP indication. 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. 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 Sharpe & Dohme LLC (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 as a second- or third-line treatment for non-small cell lung cancer (NSCLC). It is also being evaluated in combination with Merck's pembrolizumab as a first-line treatment for PD-L1 positive NSCLC. Domvanalimab and Zimberelimab 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. 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 (ii) a first-line treatment for upper gastrointestinal tract cancer. In collaboration with Arcus, the combination of zimberelimab and domvanalimab is being evaluated as a first-line treatment for NSCLC. In January 2024, the company announced discontinuation of further enrollment in this study. In 2023, the company also received regulatory approvals or authorizations from FDA and European Commission (EC) for new products and expanded indications of its products, including: Veklury: FDA and EC approved an expanded 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. Hepcludex: EC granted full marketing authorization for Hepcludex for the treatment of adults with HDV and compensated liver disease. Hepcludex was initially granted conditional marketing authorization in July 2020. Bulevirtide remains the only approved treatment for HDV in the European Union (EU) and is not approved in the U.S. Yescarta: FDA approved a label update to Yescarta 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 LBCL versus standard of care. Trodelvy: FDA approved Trodelvy for the treatment of 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. EC approved Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the advanced setting. In addition, the company seeks to enhance its commercial portfolio and clinical pipeline across multiple therapeutic areas through strategic collaborations, in-licensing and acquisitions. In 2023, the company entered into multiple strategic transactions spanning its work in virology, oncology and inflammation, including: The company entered into new strategic collaborations, including with Assembly Biosciences, Inc. to advance the research and development of novel antiviral therapies, including for herpesviruses, HBV and HDV; Tentarix Biotherapeutics, Inc. (Tentarix) to discover and develop novel therapies across oncology and inflammation using Tentarix's proprietary Tentacles platform; and Arcellx, Inc. (Arcellx) to co-develop and co-commercialize Arcellx's CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma. The company expanded its existing collaborations with Arcellx to exercise an option for the ARC-SparX ACLX-001 program in multiple myeloma, expand the scope of the existing anito-cel collaboration to include lymphomas, and make an additional equity investment of $200 million; Arcus to include research programs in inflammatory diseases; and Nurix Therapeutics, Inc. to exercise an option to license investigational targeted protein degrader molecule NX-0479, which has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. The company entered into an exclusive license agreement with Compugen Ltd. 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. The company completed the acquisitions of XinThera, Inc. to add additional early pipeline assets in oncology and inflammation, including rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology as well as mK2 for inflammatory diseases; and Tmunity Therapeutics, Inc. to add next-generation CAR T-cell therapies and technologies, including an armored CAR T technology platform that has the potential to enhance anti-tumor activity and rapid manufacturing processes. Patents and Proprietary Rights U.S. and European Patent Expiration The company has a number of U.S. and foreign patents, patent applications and rights to patents related to its compounds, products and technology. For its product candidates that are fixed-dose combinations of single-tablet regimens, the estimated patent expiration date provided corresponds to the latest expiring compound patent for one of the active ingredients in the single-tablet regimen. For the company's products that are fixed-dose combinations or single-tablet regimens, the estimated patent expiration dates provided correspond to the latest expiring compound patent for one of the active ingredients in the single-tablet regimen. Seasonality of Operations However, in the U.S., fluctuations in wholesaler inventory levels impact 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 31, 2023). 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 manufacture its drugs for it. All of 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. 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. 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 it may be required to pay to Medicaid agencies or discounts it may be required to pay 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. The company, its third-party manufacturers and its 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. History Gilead Sciences, Inc. was founded in 1987. The company was incorporated in Delaware in 1987.