What changed in this filing

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Item 1. Business

2024-02-23 compared with 2023-02-22 · 132 added, 102 removed, 374 unchanged (38% of the section changed)

Gilead Sciences, Inc.

(“Gilead,” “we,” “our” or “us”) is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

(including its consolidated subsidiaries, referred to as “Gilead,” the “company,” “we,” “our” or “us”) is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

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.

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Stribild is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, elvitegravir, cobicistat, TDF and FTC.

• Veklury ® (remdesivir), an injection for intravenous use, is a nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (“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.

• 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.

• 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.

Viral Hepatitis

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• 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.

• Yescarta ® (axicabtagene ciloleucel), a suspension for intravenous infusion, is a chimeric antigen receptor (“CAR”) T-cell therapy for the treatment of (i) 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, (ii) adult patients with 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) adult patients with relapsed or refractory FL after two or more lines of systemic 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.

• 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.

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(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.

(2) This indication received FDA approval in February 2023.

• 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.

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Revenues of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.

In December 2022, we received FDA approval for Sunlenca ® (lenacapavir), a HIV-1 capsid inhibitor in tablet form for oral use and as an injection for subcutaneous use.

Sunlenca, in combination with other antiretrovirals, is approved as a twice-yearly treatment option for HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection.

Revenue Share and Other Revenues

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and approximately 66% of our total worldwide revenues were from three large wholesalers:

AmerisourceBergen Corporation, Cardinal Health, Inc.

Cencora, Inc.

(formerly known as AmerisourceBergen Corporation), Cardinal Health, Inc.

and McKesson Corporation.

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Our research and development (“R&D”) mission is to discover and develop transformational therapies in areas of high unmet medical need.

Our product development efforts are focused primarily in viral diseases, oncology and inflammatory diseases.

Our product development efforts are focused primarily on viral diseases, oncology 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 intend to continue committing 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.

These risks and uncertainties include 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.

As a result, we may be unable to successfully complete our clinical trials on our anticipated timelines, or at all.

Based on trial results, it is possible that FDA and other regulatory authorities do not approve our product candidates, or that any market approvals include significant limitations on the products’ use.

Further, we may make a strategic decision to discontinue development of our product candidates if, for example, we believe commercialization will be difficult relative to other opportunities in our pipeline.

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 expend significant time and resources on our R&D activities without any assurance that we will recoup our investments or that our efforts will be commercially successful.

Drug development is inherently risky, and many product candidates and investigational therapies fail during the development process.

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.

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.

In 2023, we continued to invest in and advance our R&D pipeline across our therapeutic areas.

Below is a summary of our product candidates that are in Phase 3 or registrational Phase 2 clinical trials or pending marketing authorization review by FDA or European Medicines Agency (“EMA”).

Below is a summary of our product candidates that are in Phase 3 clinical trials or pending marketing authorization review by FDA or European Medicines Agency (“EMA”).

Product Candidates in Viral Diseases

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Regulatory Filings

Bulevirtide A Biologics License Application (“BLA”) has been filed with FDA for bulevirtide for the treatment of chronic hepatitis delta virus (“HDV”) infection.

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.

In Europe, Hepcludex ® (bulevirtide) has been granted Conditional Marketing Authorization by the European Commission (“EC”) and PRIority MEdicines (“PRIME”) scheme eligibility by the EMA as the first approved treatment in adults with chronic HDV infection with compensated liver disease.

Lenacapavir Lenacapavir is being evaluated for an HIV PrEP indication.

GS-5245 GS-5245, a novel oral COVID-19 nucleoside, is being evaluated for the treatment of COVID-19 infection.

Product Candidates in Oncology

Product Candidates Description

Regulatory Filings

Sacituzumab govitecan-hziy A Type II variation Marketing Authorization Application has been filed with EMA for sacituzumab govitecan-hziy, a Trop-2 directed antibody and topoisomerase inhibitor conjugate, 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 metastatic setting.

This indication received FDA approval in February 2023.

Axicabtagene ciloleucel Axicabtagene ciloleucel, a CAR T-cell therapy, is being evaluated as a second-line and later treatment for high-risk follicular lymphoma.

Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy is being evaluated as (i) a second- or third-line treatment for non-small cell lung cancer (“NSCLC”);

(ii) a first-line treatment for PD-L1 negative metastatic triple-negative breast cancer (“TNBC”);

and (iii) a second-line treatment for metastatic urothelial cancer.

In collaboration with Merck Sharp & Dohme LLC (“Merck”), (1) sacituzumab govitecan-hziy is being evaluated in combination with Merck’s pembrolizumab as (i) a first-line treatment for PD-L1 positive metastatic TNBC and (ii) a first-line treatment for NSCLC.

Sacituzumab govitecan-hziy is also being evaluated in combination with pembrolizumab as a treatment for adjuvant TNBC.

Magrolimab Magrolimab, an anti-CD47 monoclonal antibody, is being evaluated in combination with azacitidine as a first-line treatment for higher risk myelodysplastic syndrome (“MDS”).

It has been granted Breakthrough Therapy designation by FDA and PRIME scheme eligibility for this indication.

Magrolimab is also being evaluated in combination with azacitidine as a first-line treatment for TP53m acute myeloid leukemia (“AML”).

Magrolimab is also being evaluated in combination with venetoclax and azacitidine as a first-line treatment for unfit AML.

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.

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.

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”).

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.

(“Arcus”), (1) the combination of zimberelimab, an anti-PD-1 monoclonal antibody, and domvanalimab, an Fc-silent anti-TIGIT antibody, is being evaluated as a first-line treatment for NSCLC.

In collaboration with Arcus, (1) the combination of zimberelimab and domvanalimab with chemotherapy is also 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) and AstraZeneca, the combination of domvanalimab and durvalumab is being evaluated for the treatment of Stage 3 NSCLC.

Registrational Phase 2

Brexucabtagene autoleucel Brexucabtagene autoleucel, a CAR T-cell therapy, is being evaluated for the treatment of pediatric acute lymphoblastic leukemia.

(“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.

In January 2024, we announced discontinuation of further enrollment in this study.

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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.

In 2022, we also received regulatory approvals or authorizations from FDA and EC for new products and expanded indications of our products, including:

In 2023, we also received regulatory approvals or authorizations from FDA and European Commission (“EC”) for new products and expanded indications of our products, including:

Product Regulatory Approval or Authorization

Sunlenca FDA and EC approved Sunlenca, a first-in-class, long-acting HIV capsid inhibitor, for the treatment of HIV infection, in combination with other antiretrovirals, in adults with multi-drug resistant HIV who are heavily treatment-experienced.

Sunlenca is a new, twice-yearly treatment option for adults with HIV infection that is not adequately controlled by their current treatment regimen.

Yescarta FDA approved Yescarta for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

Yescarta is the first FDA-approved CAR T-cell therapy for the initial treatment of relapsed or refractory LBCL.

EC approved Yescarta for the treatment of adult patients with DLBCL and high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Yescarta is the first CAR T-cell therapy approved for patients in Europe who do not respond to first-line treatment for DLBCL and high-grade B-cell lymphoma.

EC also approved Yescarta for the treatment of adult patients with relapsed or refractory FL after three or more lines of systemic therapy.

Tecartus EC approved Tecartus for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor ALL.

Veklury FDA approved an expanded use of Veklury for the treatment of non-hospitalized patients who are at high risk of progression to severe COVID-19, including hospitalization and death.

FDA also expanded the approval of Veklury to include pediatric patients 28 days of age and older and weighing at least 3 kg.

Biktarvy EC approved a low-dose tablet dosage form of Biktarvy and an extension of the indication for Biktarvy to treat HIV infection in virologically suppressed children who are at least two years of age and weigh at least 14 kg.

Vemlidy FDA approved an expanded use of Vemlidy for the treatment of chronic HBV infection in pediatric patients 12 years of age and older with compensated liver disease.

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.

This indication received FDA approval in February 2023.

In addition, we seek to enhance our commercial portfolio and clinical pipeline across multiple therapeutic areas through acquisitions, in-licensing and strategic collaborations.

In 2022, we announced multiple strategic collaborations, including (i) a research collaboration with Dragonfly Therapeutics, Inc.

to develop natural killer cell engager-based immunotherapies in oncology and inflammation;

(ii) a global strategic collaboration with Arcellx, Inc.

to co-develop and co-commercialize Arcellx’s lead late-stage product candidate, CART-ddBCMA, for the treatment of relapsed or refractory multiple myeloma;

and (iii) an oncology collaboration with MacroGenics, Inc.

to develop bispecific antibodies, including Gilead’s exclusive option to license MGD024, a potential treatment for certain blood cancers.

We also announced the acquisitions of (i) MiroBio, a private U.K.-based biotech company focused on restoring immune balance with agonists targeting immune inhibitory receptors;

(ii) Tmunity Therapeutics, a clinical-stage, private biotech company focused on next-generation CAR T-cell therapies and technologies;

and (iii) all remaining rights to GS-1811, an anti-CCR8 antibody in development as a potential treatment for solid tumors, from Jounce Therapeutics, Inc.

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, we seek to enhance our commercial portfolio and clinical pipeline across multiple therapeutic areas through strategic collaborations, in-licensing and acquisitions.

In 2023, we entered into multiple strategic transactions spanning our work in virology, oncology and inflammation, including:

• We entered into new strategic collaborations, including with (i) Assembly Biosciences, Inc.

to advance the research and development of novel antiviral therapies, including for herpesviruses, HBV and HDV;

(ii) Tentarix Biotherapeutics, Inc.

(“Tentarix”) to discover and develop novel therapies across oncology and inflammation using Tentarix’s proprietary Tentacles platform;

and (iii) Arcellx, Inc.

(“Arcellx”) to co-develop and co-commercialize Arcellx’s CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma.

• We expanded our existing collaborations with (i) 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;

(ii) Arcus to include research programs in inflammatory diseases;

and (iii) 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.

• We 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.

• We completed the acquisitions of (i) 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 (ii) 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.

Our strategic business development activity reflects our commitment to focus on transformative science, build a sustainable and diverse portfolio and position ourselves for the near-, medium- and long-term growth of our business.

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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.

and the EU for the primary (typically compound) patents for our key product candidates as described above.

For our 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.

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Bulevirtide 2030 2029

Inflammatory Diseases:

Cilofexor 2032 2032

Filgotinib 2030 2030

Axicabtagene ciloleucel 2031 — (1)

Brexucabtagene autoleucel 2027 — (1)

Sacituzumab govitecan-hziy 2028 (2)

Magrolimab 2031 2031

Zimberelimab (3)

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(1) The composition of matter patent has expired in the EU.

In the EU and the U.S., patent applications are pending relating to proprietary manufacturing processes of Kite, a Gilead company (“Kite”).

In the EU and the U.S., patent applications are pending relating to our proprietary manufacturing processes.

(2) Regulatory exclusivity in the U.S.

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(3) In collaboration with Arcus.

(4) Dates in parentheses reflect the estimated expiration date of patents which may issue from currently pending applications.

(4) Dates in parentheses reflect the estimated expiration date of patents that may be issued from currently pending applications.

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.

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Trodelvy 2028 (6)

Jyseleca 2030 2030

Hepcludex 2030 2029

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(3) The composition of matter patent has expired in the EU.

In the EU and the U.S., patent applications are pending relating to proprietary manufacturing processes of Kite.

In the EU and the U.S., patent applications are pending relating to our proprietary manufacturing processes.

(4) In 2018, Gilead and Mylan Pharmaceuticals reached an agreement to settle the patent litigation concerning patents that protect cobicistat in our Stribild and Genvoya products.

(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.

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We conduct process chemistry research, analytical method development and formulation and device development activities, and manufacture API and drug product for our clinical trials.

• San Dimas and La Verne, California:

• La Verne, California:

We manufacture AmBisome and also package and label the majority of our commercial products for distribution to the Americas and the Pacific Rim.

We also utilize the La Verne facility for clinical manufacturing of our sterile drug products.

• Oceanside, California:

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We utilize the facility for clinical and commercial manufacturing and processing of our cell therapy products.

• Santa Monica, California:

We utilize the facility for clinical manufacturing and processing of our cell therapy products.

• Frederick, Maryland:

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Our Global Inclusion and Diversity Council is responsible for governance of these matters, tracking progress on our goals and promoting a culture of inclusion.

The Global Inclusion and Diversity Council is chaired by our Chairman and Chief Executive Officer and includes members of our leadership team.

In 2020, we introduced our Advancing Black Leadership Strategy, a multi-year initiative that outlines our commitments to create internal and external pipelines for diverse talent and to build awareness, capabilities and accountability among our people managers.

As part of this strategy, we set clear targets for representation within our overall workforce and executive populations, including goals to increase the percentage of female, Black and Hispanic employees with well-defined annual targets through 2025.

Gilead also implemented multiple programs to train managers on inclusion and diversity topics, and created strategies and initiatives focused on attracting, developing and retaining diverse talent and driving an inclusive culture in our workplace, which organizational leaders were required to regularly review starting in 2021.

In addition, our employee resource groups (“ERGs”) support diverse employees and aim to raise awareness of different cultures within the workplace, cultivate diversity as a business strength and support Gilead’s talent acquisition strategy to source, attract and recruit diverse candidates.

Executive sponsors and leaders of our ERGs contribute to the advancement of our inclusion and diversity commitments through service on our Global Inclusion and Diversity Council.

The Global Inclusion and Diversity Council is chaired by our Chairman and Chief Executive Officer (“CEO”) and includes members of our leadership team.

Gilead is an equal opportunity employer and is committed to inclusive practices, creating internal and external pipelines for diverse talent, as well as building awareness, capabilities and accountability among our people managers.

In 2020, Gilead implemented multiple programs to train managers on inclusion and diversity topics and created strategies and initiatives focused on attracting, developing and retaining diverse talent and driving an inclusive culture in our workplace, which organizational leaders have been required to regularly review since 2021.

Executive sponsors and leaders of our ERGs contribute to the advancement of our inclusion and diversity commitments through annual planning and collaborative efforts to support our communities inside and outside of Gilead.

We believe Gilead’s inclusive and diverse workforce is the foundation for innovation and productivity.

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In the U.S., based on our employees’ voluntary self-identification, our workforce was 38% White, 37% Asian, 13% Hispanic, 8% Black and 3% Other.

Health and Safety

Gilead is committed to providing a workplace for its employees that promotes health, safety, wellness and productivity.

We have a workplace safety, training and security program together with various compliance protocols to support this commitment.

We routinely train and educate our employees on workplace safety and security.

In response to the COVID-19 pandemic, we implemented job site enhancements and risk protocols, including health screenings, COVID-19 testing and vaccine requirements, reconfiguration of work and common spaces to allow for physical distancing, in our effort to support the safe occupancy of our sites.

Gilead also maintains a robust contact tracing and notification process for any employee who reports COVID-19 infection.

Health, Safety and Productivity

Gilead is committed to providing a workplace for its employees that promotes health and wellbeing, safety and productivity.

We provide a competitive benefits package to support the health and wellbeing of our employees — see “Total Rewards” below.

We have a workplace safety, training and security program together with various compliance protocols designed to support the safety of our employees, and we routinely train and educate our employees on workplace safety and security.

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.

In 2023, in response to employee feedback, we also implemented multiple enterprise initiatives to address areas of opportunity to improve efficiency and remove barriers to speed of execution.

Total Rewards

Gilead’s compensation and benefits programs are designed to help attract, develop and retain the industry’s most talented workforce.

Our Total Rewards program (which varies by country) includes competitive base salary and incentive compensation, stock awards, an employee stock purchase plan, a 401(k) savings plan with a company match that vests immediately, health and welfare and other valuable benefits, such as flexible work arrangements, flexible spending accounts, paid time off, family leave, family care resources, fertility, adoption and surrogacy assistance, student loan repayment and tuition assistance, employee assistance programs and global wellbeing reimbursement, among many others.

Each year, we reassess our Total Rewards package to confirm whether it offers benefits and incentives that align with our total reward philosophy.

Gilead’s Total Rewards portfolio is designed to optimize our employees’ performance and support their wellbeing, allowing them to focus on mission-critical work.

Each year, we reassess our Total Rewards package to confirm whether it offers benefits and incentives that align with our total rewards philosophy.

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 employee salaries are informed by market-based ranges and are assessed annually through performance and career development reviews.

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.

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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.

In addition, employees can receive reimbursement for tuition expenses incurred while pursuing undergraduate, graduate or certificate courses at an accredited college or university.

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 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.

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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.

For example, in response to the COVID-19 pandemic, we provided meaningful benefits to employees and refined our approach to flexible work arrangements.

We believe our flexible work program positions us to be competitive for talent and support employee well-being while also creating the collaborative environment and connections that fuel innovation.

Environmental, Social and Governance (“ESG”)

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.

Gilead’s ESG programs reflect this commitment to our stakeholders.

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.

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.

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 2021 year in review on Gilead’s website at https://www.gilead.com/-/media/files/pdfs/yir-2021-pdfs/2021-gilead-yir_desktop.pdf.

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.

3 unchanged sentences

However, in the U.S., fluctuations in wholesaler inventory levels impact our product sales.

We typically observe strong wholesaler and sub-wholesaler purchases of our products in the fourth quarter, resulting in inventory draw-down by wholesalers and sub-wholesalers in the subsequent first quarter.

In recent years, we have observed strong wholesaler and sub-wholesaler purchases of our products in the second half of the year, resulting in inventory draw-down by wholesalers and sub-wholesalers in the subsequent first quarter.

Several other factors, including government budgets, annual grant cycles for federal and state funds, adverse changes in economic conditions, increased competition and other buying patterns, also could impact the product sales recorded in a particular quarter.

53 unchanged sentences

We are required to obtain a marketing authorization in the EU before we can market our medicinal products on the relevant market.

The conduct of clinical trials in the EU is governed by, among others, Directive 2001/20/EC and Directive 2005/28/EC and the EU (ICH) Good Clinical Practice rules.

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.

14 unchanged sentences

For more information, see Item 1A.

Risk Factors “Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and other discounts on our products 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.”

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;

19 unchanged sentences

For more information, see Item 1A.

Risk Factors “We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the health care industry.”

Risk Factors “We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.”

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.

16 unchanged sentences

The content on the referenced websites does not constitute a part of and is not incorporated by reference into this Annual Report on Form 10-K.

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

O’Day 59 Chairman and Chief Executive Officer

Dickinson 54 Chief Financial Officer

Johanna Mercier 54 Chief Commercial Officer

Parsey, M.D., Ph.D.

61 Chief Medical Officer

Telman 59 Executive Vice President, Corporate Affairs and General Counsel

Name Age Principal Occupation or Employment

O’Day, Chairman 59 Chairman and Chief Executive Officer of Gilead Sciences, Inc.

Lofton, Lead Independent Director 69 Retired Chief Executive Officer, Common Spirit Health

Jacqueline K.

Barton, Ph.D.

71 Professor Emerita, California Institute of Technology

Bluestone, Ph.D.

70 President and Chief Executive Officer, Sonoma Biotherapeutics, Inc.;

Professor Emeritus, University of California San Francisco

Horning, M.D.

75 Retired Chief Medical Officer, Roche, Inc.

Kramer 56 Retired Chief Financial Officer, Cisco Systems, Inc.

64 Chair of Board of Directors, Biotechnology Innovation Organization

Harish Manwani 70 Senior Operating Partner, Blackstone Inc.;

Retired Chief Operating Officer, Unilever Group

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

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business