What changed in this filing

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Item 1. Business

2023-02-22 compared with 2022-02-23 · 211 added, 152 removed, 265 unchanged (58% of the section changed)

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We operate in more than 35 countries worldwide, with headquarters in Foster City, California.

Our innovative medicines represent advancements by offering first-in-class treatments, greater efficacy, enhanced modes of delivery, more convenient treatment regimens, improved resistance profiles and reduced side effects.

Our focus on innovation has allowed us to deliver marketed products across multiple therapeutic areas.

In 2021, our primary revenue-generating products and the approved indications in the United States were as follows:

We have 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.

Our 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 2022, our primary revenue-generating products and the approved indications in the U.S.

were as follows:

• Biktarvy ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.

Biktarvy is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, bictegravir, emtricitabine and tenofovir alafenamide (“TAF”).

Biktarvy is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, bictegravir, emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”).

• Genvoya ® is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients.

Genvoya is a single-tablet regimen of a fixed-dose combination of our antiretroviral medicines, elvitegravir, cobicistat, emtricitabine and TAF.

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

• Descovy ® is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients.

Descovy is a fixed-dose combination of our antiretroviral medications, emtricitabine and TAF.

Descovy is a fixed-dose combination of our antiretroviral medications, FTC and TAF.

Descovy is also approved by U.S.

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• 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 our antiretroviral medications, emtricitabine and TAF, and rilpivirine marketed by Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”).

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.

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.

Truvada is a fixed-dose combination of our antiretroviral medications, tenofovir disoproxil fumarate (“TDF”) and emtricitabine.

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.

• 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 United States as Complera and in Europe as Eviplera, is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, TDF and emtricitabine, and Janssen’s rilpivirine hydrochloride.

• 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 our antiretroviral medications, elvitegravir, cobicistat, TDF and emtricitabine.

• Atripla ® is an oral formulation indicated as a complete regimen for the treatment of HIV-1 infection in certain patients.

Atripla is a fixed-dose combination of our antiretroviral medications, TDF and emtricitabine, and Bristol-Myers Squibb Company (“BMS”)’s efavirenz.

• 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 children 12 years of age and older and weighing at least 88 pounds (40 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*.

*This indication received expedited approval by FDA in January 2022.

Liver Diseases

• 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 certain pediatric patients with genotype 1, 2, 3, 4, 5 or 6:

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.

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.

In addition, we have an authorized generic version of Epclusa distributed by our separate subsidiary, Asegua Therapeutics LLC.

• Harvoni ® is an oral formulation of a once-daily, single-tablet regimen of ledipasvir and sofosbuvir for the treatment of chronic HCV infection in:

(i) adults with genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis, (ii) adults with genotype 1 with decompensated cirrhosis, in combination with ribavirin, (iii) adults with genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin, or (iv) certain pediatric patients with genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis.

• 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, we have an authorized generic version of Harvoni distributed by our separate subsidiary, Asegua Therapeutics LLC.

• Vosevi ® is an oral formulation of a once-daily, single-tablet regimen of sofosbuvir, velpatasvir and voxilaprevir for the re-treatment of chronic HCV infection in adults:

(i) with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen or (ii) with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

• Vemlidy ® is an oral formulation of TAF dosed once a day for the treatment of chronic hepatitis B virus (“HBV”) infection in adults with compensated liver disease.

• Viread ® is an oral formulation of TDF dosed once a day for the treatment of chronic HBV infection in adults and certain pediatric patients.

Hematology/Oncology/Cell Therapy

• 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 relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (“DLBCL”) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma, and (ii) adult patients with relapsed or refractory follicular lymphoma (“FL”) after two or more lines of systemic therapy*.

*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.

• Tecartus ® (brexucabtagene autoleucel), a suspension for intravenous infusion, is a CAR T cell therapy for the treatment of (i) adult patients with relapsed or refractory mantle cell lymphoma (“MCL”) and (ii) adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”).

• Trodelvy ® (sacituzumab govitecan-hziy), an injection for intravenous use, is a Trop-2 directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of (i) 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, and (ii) adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (“PD-1”) or programmed death-ligand 1 (“PD-L1”) inhibitor*.

• 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.

• 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 (2) 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.

• 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”).

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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.

• Zydelig ® (idelalisib) is an oral formulation of a kinase inhibitor for the treatment of patients with relapsed chronic lymphocytic leukemia, in combination with rituximab, for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

• 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.

• Ranexa ® (ranolazine) is an oral formulation of an extended-release tablet of an antianginal for the treatment of chronic angina.

(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.

For information about our revenue-generating products, including the amount of revenue contributed by the products listed above, see Note 2.

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.

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

We also generate revenues from other activities, including revenue share from combination products, royalties for outbound licenses of our intellectual property and other payments received from our collaborations with third-party partners.

For example, pursuant to our collaboration with Janssen, we receive revenue share from cobicistat, emtricitabine and TAF that are components of Symtuza (darunavir/cobicistat/emtricitabine/TAF), a fixed-dose combination product commercialized by Janssen.

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.

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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 United States exclusively through the wholesale channel.

During the year ended December 31, 2021, approximately 91% of our product sales in the United States and approximately 65% of our total worldwide revenues were to three large wholesalers, AmerisourceBergen Corporation, Cardinal Health, Inc.

We sell and distribute most of our products in the U.S.

exclusively through the wholesale channel.

During the year ended December 31, 2022, approximately 89% of our product sales in the U.S.

and approximately 63% of our total worldwide revenues were from three large wholesalers:

AmerisourceBergen Corporation, Cardinal Health, Inc.

and McKesson Corporation.

We sell and distribute our products in Europe and countries outside the United States where the product is approved, either through our commercial teams, third-party distributors or corporate partners.

We sell and distribute our products in Europe and countries outside the U.S.

where the product is approved, either through our commercial teams, third-party distributors or corporate partners.

We operate in a highly competitive environment.

We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.

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.

As our products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices.

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.

These third parties include large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies.

Furthermore, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection or may establish collaborative arrangements for competitive products or programs.

In 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.

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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, inflammatory diseases and oncology.

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 advance the current standard of care and address unmet medical needs.

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

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 our ability to enroll patients in clinical trials, the possibility of unfavorable results of our clinical trials, the need to modify or delay our clinical trials, including on account of clinical holds placed by regulatory authorities, or to perform additional trials and the risk of failing to obtain regulatory approvals.

As a result, our product candidates and investigational therapies may never be successfully commercialized.

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.

In 2022, we continued to invest in and advance our R&D pipeline across our therapeutic areas.

Below is a summary of our product candidates that were in Phase 3 or registrational Phase 2 clinical trials or pending marketing authorization review by FDA or European Medicines Agency (“EMA”) as of the end of 2021.

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”).

Product Candidates in Viral Diseases

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Regulatory Filings

Lenacapavir A New Drug Application and a Marketing Authorization Application have been filed with FDA and EMA, respectively, for lenacapavir, an HIV capsid inhibitor, as a component of a long-acting regimen for the treatment of HIV infection in heavily treatment-experienced people living with HIV.

It has been granted Breakthrough Therapy designation 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.

Bulevirtide A Biologics License Application (“BLA”) 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.

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

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.

Program timeline is pending resolution of clinical hold placed by FDA on studies evaluating injectable lenacapavir.

Product Candidates in Inflammatory Diseases

Product Candidate

Cilofexor Cilofexor, an FXR agonist, is being evaluated for the treatment of primary sclerosing cholangitis.

Filgotinib Filgotinib, a JAK1 inhibitor, is being evaluated for the treatment of Crohn’s disease.

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

Product Candidates in Oncology

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Regulatory Filings

Yescarta (axicabtagene ciloleucel) A supplemental Biologics License Application and a Type II Variation Marketing Authorization Application have been filed with FDA and EMA, respectively, for axicabtagene ciloleucel, a CAR T cell therapy for the treatment of second-line DLBCL.

A Type II Variation Marketing Authorization Application has been filed with EMA for axicabtagene ciloleucel for the treatment of relapsed or refractory FL.

Yescarta has received accelerated approval by FDA for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.

Tecartus (brexucabtagene autoleucel) A Type II Variation Marketing Authorization Application has been filed with EMA for brexucabtagene autoleucel, a CAR T cell therapy, for the treatment of adult ALL.

Tecartus has received FDA approval for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.

Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy, a Trop-2 directed antibody and topoisomerase inhibitor conjugate, is being evaluated for (i) hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), metastatic breast cancer and (ii) non-small cell lung cancer (“NSCLC”) as a second-line or third-line treatment.

Magrolimab Magrolimab, an anti-CD47, is being evaluated for (i) higher risk myelodysplastic syndrome (“MDS”) as a first-line treatment and (ii) acute myeloid leukemia (“AML”) as a first-line treatment.

Program timelines are pending resolution of partial clinical holds placed by FDA on studies evaluating magrolimab.

Zimberelimab* Zimberelimab, an anti-PD-1 monoclonal antibody, is being evaluated for NSCLC as a first-line treatment.

Domvanalimab* Domvanalimab, an Fc-silent anti-TIGIT antibody, is being evaluated for NSCLC as a first-line treatment.

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.

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 is being evaluated for the treatment of pediatric ALL.

*In collaboration with Arcus Biosciences, Inc.

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 additional information regarding this collaboration.

In 2021, we also received regulatory approvals or authorizations from FDA and the European Commission to expand the indications of our products, including:

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

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(1) For additional information regarding our collaborations with Merck and Arcus, see Note 10.

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:

Product Regulatory Approval or Authorization

Biktarvy FDA approved a new low-dose tablet dosage form of Biktarvy for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

Epclusa FDA approved an expansion of the pediatric indication of Epclusa for the treatment of chronic HCV infection to include pediatric patients 3 years of age and older, regardless of HCV genotype or liver disease severity.

Veklury European Commission approved a variation to the Conditional Marketing Authorization for Veklury to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.

Yescarta FDA granted accelerated approval of Yescarta for the treatment of adult patients with relapsed or refractory FL.

Tecartus FDA approved Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.

Trodelvy FDA granted full approval of Trodelvy for adult patients with unresectable locally advanced or metastatic TNBC.

FDA granted accelerated approval of Trodelvy for use in adult patients with locally advanced or metastatic UC.

European Commission granted marketing authorization for Trodelvy as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.

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.

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.

For example, in October 2021, we entered into a clinical trial collaboration with Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc.

(“Merck”), to evaluate Trodelvy in combination with Merck’s Keytruda in patients with first-line metastatic TNBC.

In November 2021, we expanded our research collaboration with Arcus and exercised our options to three programs in Arcus’s clinical-stage portfolio, including domvanalimab, which is in Phase 2 and 3 studies in NSCLC.

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.

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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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.

The following table shows the estimated expiration dates (including patent term extensions, supplementary protection certificates and/or pediatric exclusivity where granted) in the United States and the European Union 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.

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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Viral Diseases:

Lenacapavir 2037 2037

Bulevirtide 2030 2029

Inflammatory Diseases:

Cilofexor 2032 2032

Filgotinib 2030 2030

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Sacituzumab govitecan-hziy 2028 (2)

Magrolimab 2031 2031

Zimberelimab (3)

2036 (2036) (4)

Domvanalimab (3)

2037 (2037) (4)

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

In the European Union and the United States, patent applications are pending relating to proprietary manufacturing processes of Kite, a Gilead company (“Kite”).

(2) An application for patent term extension was filed in the United States that, if granted, would extend the U.S.

expiration date to at least 2028.

Regulatory exclusivity in the United States expires in 2032.

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.

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

(2) Regulatory exclusivity in the U.S.

expires in 2032.

(3) In collaboration with Arcus.

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 United States and the European Union for the primary (typically compound) patents for our principal products.

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

and the EU for the primary (typically compound) patents for our principal products.

For our 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.

Patent Expiration (1)

Descovy 2031 (2)

Vemlidy 2031 (2)

Complera/Eviplera 2025 2026

These estimated 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.

Odefsey 2032 (2)

Yescarta 2031

Stribild 2029 (4)

Genvoya 2029 (4)

Harvoni 2030 2030

Epclusa 2033 2032

Biktarvy 2033 2033

Vosevi 2034 2033

Veklury 2035 2035

Tecartus 2027 — (3)

Trodelvy 2028 (5)

Jyseleca 2030 2030

Hepcludex 2030 2029

Sunlenca 2037 2037

______________________________

(1) In 2013, Gilead and Lupin Limited reached an agreement to settle a patent litigation matter related to Ranexa.

(2) Applications for patent term extensions are pending in the United States and/or SPCs are pending in one or more countries in the European Union for these products.

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

In the European Union and the United States, patent applications are pending relating to proprietary manufacturing processes of Kite.

(1) Where applicable, settlement and license agreements with generic manufacturers relating to the patents that protect our principal products are noted.

The nature and timing of loss of exclusivity for these products depends on a multitude of factors, and loss of exclusivity may be earlier under certain circumstances.

For more information, see Item 1A.

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.”

(2) In September 2022, Gilead and five generic manufacturers (Lupin Ltd., Apotex Inc., Macleods Pharma Ltd., Hetero Labs Ltd., and Cipla Ltd.) reached agreements to settle the U.S.

patent litigation concerning patents that protect TAF in our Descovy, Vemlidy and Odefsey products.

(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.

(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) An application for patent term extension was filed in the United States that, if granted, would extend the U.S.

expiration date to at least 2028.

Regulatory exclusivity in the United States expires in 2032.

(5) Regulatory exclusivity in the U.S.

expires in 2032.

Patent Protection and Certain Challenges

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If we have a properly drafted and enforceable patent, it can be more difficult for our competitors to use our technology to create competitive products and more difficult for our competitors to obtain a patent that prevents us from using technology we create.

As part of our business strategy, we actively seek patent protection both in the United States 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 most of our HIV products as well as cell therapy products are held by third parties.

As part of our business strategy, we actively seek patent protection both in the U.S.

and internationally and file additional patent applications, when appropriate, to cover improvements in our compounds, products and technology.

Patents covering certain of the active pharmaceutical ingredients (“API”) of some of our products are held by third parties.

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.

Because patents have a limited life that may begin to run prior to the commercial sale of the related product, the commercial value of the patent may be limited.

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.

For example, extensions for the patents or supplementary protection certificates on many of our products have been granted in the United States 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.

Similar patent term extensions may be available for other products we are developing, but we cannot be certain we will obtain them in some countries.

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If we fail to obtain these licenses or alternative technologies, we may be unable to develop or commercialize some or all of our products.

For example, we are aware of patents and patent applications owned by other parties that such parties may claim to cover the use of sofosbuvir, axicabtagene ciloleucel, brexucabtagene autoleucel, tenofovir disoproxil, tenofovir alafenamide and bictegravir.

Because patent applications are confidential for a period of time until a patent is issued, we may not know if our competitors have filed patent 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.

Competitors may have filed patent applications or received patents and may obtain additional patents and proprietary rights that block or compete with our products.

For example, we are aware of patents and patent applications owned by other parties that such parties may claim to cover the use of our products and research activities.

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.

Competitors may have filed patent applications or received patents and proprietary rights that block or compete with our products.

In addition, if competitors file patent applications covering our technology, we may have to participate in litigation, post-grant proceedings before the U.S.

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Patents relating to pharmaceutical, biopharmaceutical and biotechnology products, compounds and processes such as those that cover our existing compounds, products and processes and those that we will likely file in the future, do not always provide complete or adequate protection.

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.

Future litigation or other proceedings regarding the enforcement or validity of our existing patents or any future patents could result in the invalidation of our patents or substantially reduce their protection.

From time to time, certain individuals or entities may challenge our patents.

Our pending patent applications and the patent applications filed by our collaborative partners may not result in the issuance of any patents or may result in patents that do not provide adequate protection.

As a result, we may not be able to prevent third parties from developing compounds or products that are closely related to those which we have developed or are developing.

Our pending patent applications and the patent applications filed by our collaborative partners may not be able to prevent third parties from developing compounds or products that are closely related to those which we have developed or are developing.

In addition, certain countries do not provide effective enforcement of our patents, and third-party manufacturers may be able to sell generic versions of our products in those countries.

We may face criticism as a result of our legitimate use of the patent systems to protect our investments in new and useful innovations in medicine.

Further, incentives and exclusivities relating to our products and product candidates may change in the future.

We are aware that several countries are considering changes to support sharing how to make and use new inventions that could impact the current patent systems and protections for innovation.

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.

See also Item 1A 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.”

See also Item 1A.

Trade Secrets

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We own or lease manufacturing facilities to manufacture and distribute certain products and API for clinical and/or commercial uses.

These facilities include:

As of the end of 2022, these facilities include:

• Foster City, California:

We conduct process chemistry research and formulation development activities, manufacture API and drug product for our clinical trials and oversee our third-party contract manufacturers.

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:

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

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

• Oceanside, California:

We utilize the facility for clinical manufacturing and process development of our biologics candidates.

We utilize the facility for commercial retroviral vector manufacturing and clinical manufacturing and process development of our biologics candidates.

• El Segundo, California:

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• Frederick, Maryland:

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

• Morris Plains, New Jersey:

We utilize the facility for manufacturing for monoclonal antibody intermediate and process optimization of our antibody drug conjugate products.

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

• Cork and Dublin, Ireland:

We utilize the Cork facility for commercial manufacturing, packaging and labeling of our products.

We also perform quality control testing, labeling, packaging and final release of many of our products at the Cork facility, which are distributed to the European Union and other international markets through our facility in Dublin.

We utilize our other facility in central Dublin as a drug development hub for our pediatric programs where we perform clinical development, safety, quality, biostatistics and data sciences, regulatory and compliance functions.

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:

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We have agreements with these third-party manufacturers that are intended to restrict them from using or revealing this technology, but we cannot be certain that these third-party manufacturers will comply with these restrictions.

For more information about our third-party manufacturers, see Item 1A Risk Factors “We may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners.”

For more information about our third-party manufacturers, see Item 1A.

Risk Factors “We may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners.”

Regulation of Manufacturing Process

The manufacturing process for pharmaceutical products is highly regulated and regulators may shut down manufacturing facilities that they observe do not comply with regulations.

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 the EMA.

The manufacturing process for pharmaceutical products is highly regulated and regulators may shut down manufacturing facilities that they observe are not complying with regulations.

Similar regulations are in effect in other jurisdictions.

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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 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.”

For more information, see Item 1A.

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.

Our human capital objective is to make Gilead the employer of choice for the best talent in our industry.

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.

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Gilead’s commitment to equal employment opportunity furthers its efforts to cultivate and celebrate an equitable culture of belonging.

As of December 31, 2021, Gilead had approximately 14,400 employees, and Gilead’s global workforce was approximately 52% female and 48% male.

As of December 31, 2022, Gilead had approximately 17,000 employees, and Gilead’s global workforce was approximately 53% female.

Additionally, women represented 36% of Gilead’s leadership (defined as vice president level and above).

In the United States, based on our employees’ voluntary self-identification, our workforce was 40% White, 38% Asian, 11% Hispanic, 7% Black and 4% Other.

In the U.S., based on our employees’ voluntary self-identification, our workforce was 38% White, 37% Asian, 13% Hispanic, 8% Black and 4% Other.

Health and Safety

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

In response to the COVID-19 pandemic, most Gilead sites required flexible location employees to work from home, while employees who needed to be physically present for their positions (such as laboratory technicians) continued to work at Gilead sites.

In the fourth quarter of 2021, Gilead transitioned to a return-to-site phase for our U.S.

flexible location employees.

During the 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.

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.

We continue to monitor the state of the pandemic and we remain committed to maintaining a work environment that promotes the health, safety and productivity of our workforce.

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, global wellbeing reimbursement and tuition assistance, among many others.

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.

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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.

In addition to ongoing internal and external data collection, we conducted a large-scale review of the employee experience in 2021 with an employee survey.

The results of this survey played a key role in determining the direction of our culture as well as the company’s broader response to the continuing COVID-19 pandemic, including the meaningful benefits we provided to employees and our approach to flexible work arrangements.

In addition to ongoing internal and external data collection and benchmarking, we conducted comprehensive reviews of the employee experience in 2021 and again in 2022, 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.

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.

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

ESG strategy and performance are overseen by the Nominating and Corporate Governance Committee of its 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 material ESG issues and integrating them into our overall business strategy and operations.

Additional information about this program and ESG highlights are available in Gilead’s 2020 year in review under Gilead’s website at www.gilead.com/news-and-press/annual-report/year-in-review-2020.

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.

Our ESG goals are aspirational and may change.

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Our worldwide product sales do not reflect any significant degree of seasonality in end-user demand.

However, in the United States, fluctuations in wholesaler inventory levels impact our product sales.

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.

Several other factors, including government budgets, annual grant cycles for federal and state funds, the COVID-19 pandemic, and other buying patterns, also could impact the product sales recorded in a particular quarter.

For more information, see Item 1A Risk 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.”

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.

For more information, see Item 1A.

Risk 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.”

Government Regulation

Our operations and activities are subject to extensive regulation by numerous government authorities in the United States, the European Union and other countries, including laws and regulations governing the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of our products.

Our operations and activities are subject to extensive regulation by numerous government authorities in the U.S., the EU and other countries, including laws and regulations governing the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of our products.

As a result of these regulations, product development and product approval processes are very expensive and time consuming, which has a significant impact on our capital expenditures and results of operations.

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Any legal and regulatory changes may impact our operations in the future.

A country’s regulatory agency, such as FDA in the United States and the EMA and European Commission for the European Union, as well as the national authorities of the European Union 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 United States is summarized below.

Many other countries, including countries in the European Union (and the European Union under a centralized procedure), have similar regulatory structures.

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.

Many other countries, including countries in the EU (and the EU under a centralized procedure), have similar regulatory structures.

Preclinical Testing

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This committee makes a recommendation to FDA that is not binding but is generally followed by FDA.

If FDA agrees that the drug has met the required level of safety and efficacy for a particular use, it will approve the application and allow us to sell the drug in the United States for that use.

If FDA agrees that the drug has met the required level of safety and efficacy for a particular use, it will approve the application and allow us to sell the drug in the U.S.

for that use.

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.

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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 United States and these facilities are subject to periodic regulatory inspection.

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.

Our manufacturing facilities located in California also must be licensed by the State of California in compliance with local regulatory requirements.

Our manufacturing facilities in Canada, Ireland and Netherlands also must obtain local licenses and permits in compliance with local regulatory requirements.

FDA may employ one of several tools to facilitate and expedite the development and review of a drug, including fast track designation, Breakthrough Therapy designation, accelerated approval and Priority Review designation.

FDA may employ one of several tools to facilitate and expedite the development and review of a drug, including Fast Track designation, Breakthrough Therapy designation, Accelerated Approval designation and Priority Review designation.

Fast Track designation is designed to facilitate the development and review of a drug that treats a serious condition and fills an unmet medical need.

Breakthrough Therapy designation is designed to expedite the development and review of a drug that treats a serious condition and preliminary clinical evidence demonstrates substantial improvement over available therapies.

Breakthrough Therapy designation is designed to expedite the development and review of a drug that treats a serious condition where preliminary clinical evidence demonstrates substantial improvement over available therapies.

Accelerated Approval of a drug may be granted by FDA where the drug treats a serious condition, fills an unmet medical need and has been studied for safety and efficacy.

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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.

European Union Regulatory System and Approval Process

In the European Union (“EU”), our products are subject to a variety of EU and EU Member State regulations governing clinical trials, commercial sales and distribution.

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.

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

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Government health authorities, private health insurers and other organizations generally provide reimbursement.

In the United States, the European Union 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.

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 340B covered entities.

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.

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.

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Further, as new branded or generic products are introduced into major markets, our ability to maintain pricing and market share may be affected.

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.”

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.”

Health Care Fraud and Abuse Laws;

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False claims laws generally prohibit anyone from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment by federal and certain state payers (including Medicare and Medicaid), or knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim.

In addition, the FDA regulates written and verbal communications about our products.

In addition, FDA regulates written and verbal communications about our products.

In addition to federal law, states also have consumer protection and false claims laws.

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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.

Healthcare Reform

federal and state governments continue to propose and pass legislation designed to regulate the healthcare industry, including legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing.

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.”

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.”

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.

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We are subject to the information requirements of the Securities Exchange Act of 1934 (“Exchange Act”).

Therefore, we file periodic reports, proxy and information statements and other information with the SEC.

The SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC.

Therefore, we file periodic reports, proxy and information statements and other information with U.S.

Securities and Exchange Commission (“SEC”).

SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with SEC.

Our website is www.gilead.com.

Through a link on the “Investors” page of our website (under the “SEC Filings” section), we make available the following filings free of charge as soon as reasonably practicable after they are electronically filed with or furnished to the SEC:

Through a link on the “Investors” page of our website (under the “Financials - SEC Filings” section), we make available the following filings free of charge as soon as reasonably practicable after they are electronically filed with or furnished to SEC:

our Annual Reports on Form 10-K;

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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