Gilead Sciences (GILD) 10-K risk factor changes: FY2020 vs FY2019

*In evaluating our business, you should carefully consider the following [removed: risks] [added: discussion of material risks, events and uncertainties that make an investment] in [added: us speculative or risky in] addition to the other information in this Annual Report on Form 10-K.

[removed: It is not possible to predict or identify all such factors and, therefore,] [added: Therefore,] you should not consider the following risks to be a complete statement of all the potential risks or uncertainties that we face.*

During the [removed: year] [added: twelve months] ended December 31, [removed: 2019,] [added: 2020,] sales of our HIV products accounted for approximately [removed: 74% of our total product sales, and our HIV products account for a higher percentage] [added: 70%] of our total product [removed: sales in 2019 than in 2018.][added: sales.]

[removed: Most] [added: For example, most] of our HIV products contain tenofovir alafenamide [removed: (TAF),] [added: (“TAF”),] tenofovir disoproxil fumarate [removed: (TDF)] [added: (“TDF”)] and/or emtricitabine [removed: (FTC),] [added: (“FTC”),] which belong to the nucleoside class of antiviral [removed: therapeutics.][added: therapeutics, and any changes to the treatment paradigm for HIV may cause nucleoside-based therapeutics to fall out of favor.]

We may be unable to sustain or increase sales of our HIV products for any number of [removed: reasons including, but not limited to, the reasons discussed above and] [added: reasons, including market share gains by competitive products or] the [removed: following:][added: inability to introduce new HIV medications necessary to remain competitive.]

[removed: | • |] As our products mature, private insurers and government payers often reduce the amount they will reimburse patients for these products, which increases pressure on us to reduce prices. [removed: |]

[removed: | • | As new] [added: New] branded or generic products [removed: are introduced into] [added: entering] major [removed: markets,] [added: markets affects] our ability to maintain pricing and market [removed: share may be affected. |][added: share.]

The launch of commercially successful products is necessary to [added: grow our business,] cover our substantial R&D [removed: expenses] [added: expenses,] and [removed: to] offset revenue losses when [removed: our] existing products lose market share due to [removed: various] factors such as competition and loss of patent [removed: exclusivity, as well as to provide for the growth of our business.][added: exclusivity.]

[removed: For example, see “We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption, which may adversely affect our prospects for future revenue growth and our results of operations.”] We cannot state with certainty when or whether any of our product candidates under development will be approved or launched; whether we will be able to develop, license or acquire additional product candidates or products; or whether any products, once launched, will be commercially successful.

[removed: For example,] [added: Additionally,] the non-retail sector in the United States, which includes government institutions, including state AIDS Drug Assistance [removed: Programs (ADAPs),] [added: Programs,] the U.S. Department of Veterans Affairs, correctional facilities and large health maintenance organizations, tends to be less consistent in terms of buying patterns and often causes quarter-over-quarter fluctuations that do not necessarily mirror patient demand for our products.

We expect to continue to experience fluctuations in the purchasing patterns of our non-retail [removed: customers, which may result in fluctuations in our product sales, revenues and earnings in the future.][added: customers.]

We believe these measures have caused some government agencies and other purchasers to reduce inventory of our products in the distribution [removed: channels, which has decreased our revenues and caused fluctuations in our product sales and earnings.][added: channels.]

[removed: During] [added: For] the year ended December 31, [removed: 2019,] [added: 2020,] approximately [removed: 87%] [added: 92%] of our product sales in the United States were to three wholesalers, AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson Corporation.

[removed: We] [added: We] face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug [removed: manufacturers.][added: manufacturers.]

[removed: In addition, a] [added: A] number of companies are pursuing the development of technologies which are competitive with our existing products or research programs.

These competing companies include [removed: specialized pharmaceutical firms and] large pharmaceutical [added: and biotechnology] companies [added: and specialized pharmaceutical firms] acting either independently or together with other [removed: pharmaceutical] [added: such] companies.

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

[removed: If] [added: We may be adversely impacted if] any of these competitors gain market share as a result of new technologies, commercialization strategies or [removed: otherwise, it could adversely affect our results of operations and stock price.][added: otherwise.]

[removed: Adverse outcomes in ongoing litigation related to our Yescarta and Biktarvy products] [added: These matters] could require us to pay significant monetary [removed: damages and] [added: damages, including] royalty payments for past and future sales.

[removed: In] [added: For example, in] February 2018, ViiV filed a lawsuit against us in the U.S. District Court of Delaware, alleging that the commercialization of bictegravir, sold commercially in combination with TAF and FTC as Biktarvy, infringes on ViiV’s U.S. Patent No. 8,129,385 (the [removed: ‘385 patent),] [added: “’385 patent”),] covering ViiV’s dolutegravir.

The court has set a trial date of [removed: September 2020] [added: January 2022] for this lawsuit.

[removed: Among other pharmaceutical manufacturer industry-related proposals,] [added: For example,] Congress [removed: has] proposed bills to change the Medicare Part D benefit to impose an inflation-based rebate [removed: in Medicare Part D] [added: when list prices for drugs grow faster than inflation] and to [removed: alter the benefit structure to] increase manufacturer contributions in some or all [added: of the] benefit phases.

In addition, [removed: a majority of states] [added: many state legislatures are considering, or] have [removed: enacted] [added: already passed into law,] legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing, such as [removed: by] requiring [removed: biopharmaceutical] manufacturers to publicly report proprietary pricing [removed: information or] [added: information,] creating review boards for [removed: recommending price caps or other means for controlling] prices [removed: of pharmaceutical products purchased by] [added: to] state [removed: agencies.][added: agencies, and encouraging the use of generic drugs.]

Such initiatives and legislation may cause added pricing pressures on our [removed: products.][added: products, and the resulting impact on our business is uncertain.]

Changes to the [added: 340B program or the] Medicaid program at the federal or state level could [removed: also] have a material adverse effect on our business.

[removed: It] [added: We may be adversely impacted by any such legislative and regulatory actions, though it] is difficult to predict the impact, if any, [removed: of any such proposed legislative and regulatory actions or resulting state actions] on the use and reimbursement of our [removed: products in the United States, but such actions may adversely affect our results of operations.][added: products.]

Many countries outside the United States, including the European Union [removed: (EU) Member States,] [added: member states,] have established complex and lengthy procedures to obtain price approvals, coverage [added: reimbursement] and [removed: reimbursement.][added: periodically review their pricing and reimbursement decisions.]

The outcome of this review cannot be predicted and could have an adverse effect on the pricing and reimbursement of our medicinal products in the [removed: EU Member States.][added: European Union member states.]

Reductions in the pricing of our medicinal products in one [removed: EU Member State] [added: member state] could affect the price in other [removed: EU Member States] [added: member states] and have a negative impact on our financial results.

Our existing products are subject to reimbursement [added: pressures] from government agencies and other third parties, [removed: and we may be] required [removed: to provide] rebates and other discounts on our [removed: products, which may result in an adjustment to our product revenues.][added: products and other pricing pressures.]

Successful commercialization of our products depends, in part, on the availability of [removed: governmental and] third-party payer reimbursement for the cost of such products and related treatments [added: and medical services] in the markets where we sell our products.

A substantial portion of our product sales is subject to significant discounts from list price, including rebates that we may be required to pay [removed: certain governmental agencies.][added: state Medicaid agencies and discounts provided to 340B covered entities.]

Additionally, in the European Union, there are barriers to reimbursement in individual countries that could limit the uptake of [removed: Yescarta.][added: Yescarta and Tecartus.]

Actual claims and payments may vary significantly from our [removed: estimates which can cause an adjustment to our product][added: estimates.]

In the United States, these laws include anti-kickback and false claims laws, laws and regulations relating to the Medicare and Medicaid programs and other federal and state programs, the Medicaid Rebate Statute, individual state laws relating to pricing and sales and marketing practices, the Health Insurance Portability and Accountability Act [removed: (HIPAA)] and other federal and state laws relating to the privacy and security of health information.

[removed: Violations] [added: Actual or alleged violations] of these laws or any related regulations may be punishable by criminal and/or civil sanctions, including, in some instances, substantial fines, civil monetary penalties, exclusion from participation in federal and state health care programs, including Medicare, [removed: Medicaid,] [added: Medicaid and Department of] Veterans [removed: Administration health programs,] [added: Affairs] and [removed: federal employee] [added: Department of Defense] health [removed: benefit] programs, actions against executives overseeing our business and significant remediation [removed: measures.][added: measures, negative publicity or other consequences.]

[removed: In addition, these] [added: These] laws and regulations are broad in scope and [removed: they are] subject to [removed: change] [added: changing] and evolving interpretations, which could require us to incur substantial costs associated with compliance or to alter one or more of our sales or marketing practices.

[removed: Recently, there has been] [added: There also continues to be] enhanced scrutiny of company-sponsored patient assistance programs, including co-pay assistance programs, and manufacturer donations to third-party charities that provide such assistance.

If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal [removed: liability as described above.][added: liability.]

[removed: Yescarta,] [added: Advancing] a [removed: chimeric antigen receptor (CAR)] [added: novel and personalized therapy such as Yescarta, which is a Chimeric Antigen Receptor (“CAR”)] T cell therapy, [removed: represents a novel approach to cancer treatment that] creates significant [removed: challenges for us, which may impact our ability to increase sales of Yescarta.][added: challenges, including:]

A manifestation of any of the following risks and uncertainties could, in circumstances we may or may not be able to accurately predict, materially and adversely affect our business, growth, reputation (including the commercial or scientific reputation of our products), prospects, product pipeline and sales, operating and financial results, financial condition, cash flows, liquidity and stock price.

It is not possible to predict or identify all such factors; our operations could also be affected by factors, events or uncertainties that are not presently known to us or that we currently do not consider to present significant risks to our operations.

Product and Commercialization Risks

Certain of our products subject us to additional or heightened risks.

*HIV Products*

In such case, we may need to scale back our operations, including our future drug development and spending on research and development (“R&D”) efforts.

*Veklury (remdesivir)*

We face risks related to our significant investment in the rapid development, manufacturing and distribution of Veklury (remdesivir), which was approved by the U.S. Food and Drug Administration (“FDA”) in October 2020 as a treatment for hospitalized patients with COVID-19.

Given the severity and urgency of the COVID-19 pandemic, we committed significant capital and resources for clinical trials and the scale-up of the production of remdesivir.

We expect our investment will continue through 2021 and beyond, as we continue to manufacture large quantities of finished product and conduct additional studies of specific patient populations, develop and evaluate new formulations and delivery methods and combinations with other therapies.

While the utilization of remdesivir has largely tracked the level of infections, we are unable to accurately predict our revenues or supply needs over the short and long term due to the potential for new and better therapeutics, the availability and effectiveness of vaccines and fluctuating hospital utilization rates.

If we are unable to accurately forecast demand or manufacture Veklury at levels to meet actual demand, then this may result in shortages or excess inventory that may be written off.

We are subject to significant public attention and scrutiny over the complex decisions made regarding the clinical data, allocation, distribution and pricing of Veklury, all of which affects our corporate reputation.

*Yescarta*

Our success depends on developing and commercializing new products or expanding the indications for existing products.

If we are unable to launch commercially successful new products or new indications for existing products our business will be adversely impacted.

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 example, product demand may be adversely affected if physicians do not see the benefit of our products.

*Product Reimbursements*

For example, in September 2020, FDA issued a final rule implementing a pathway for the importation of certain prescription drugs from Canada.

This rule is subject to ongoing litigation.

In addition, in November 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued an interim final rule that would substantially alter the Medicare Part B reimbursement system for physician-administered medicines as of January 1, 2021.

This rule is subject to ongoing litigation and CMS has been preliminarily enjoined from implementing the rule.

*Product Pricing, Discounts and Rebates*

In the United States, the volume of drug pricing-related bills has dramatically increased in recent years.

For example, in December 2020, CMS issued a final rule that will make certain changes to the calculation of rebates under the Medicaid Drug Rebate Program.

Among other changes, effective January 1, 2023, the final rule will change the requirements for excluding manufacturer co-pay coupons from the Medicaid “best price.” If these changes go into effect, they could substantially increase our Medicaid rebate obligations and decrease the prices we charge 340B covered entities.

The continued growth of the 340B program also limits the prices we may charge to an increasing number of customers.

For example, beginning in fiscal year 2021, CMS established a new severity adjusted diagnosis related group (“DRG”) 018 for Medicare inpatient reimbursement of CAR T products such as Yescarta and Tecartus.

While the new DRG has a significantly higher base payment amount than the prior DRG 016, the payment available may not be sufficient to reimburse some hospitals for their cost of care for patients receiving Yescarta and Tecartus.

When reimbursement is not aligned well to account for treatment costs, Medicare beneficiaries may be denied access as this misalignment could impact the willingness of some hospitals to offer the therapy and of doctors to recommend the therapy.

For example, U.S. sales could also be affected if FDA permits importation of drugs from Canada.

Our actions to discourage the distribution and sale of counterfeit versions of our medicines around the world may not be successful, and we may be adversely affected as a result.

Product Development and Supply Chain Risks

We face numerous risks and uncertainties with our product candidates that could prevent completion of development of these product candidates.

In 2021, our key anticipated milestones for our product candidates include, among others, Phase 3 data readouts for (1) sacituzumab govitecan-hziy for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer patients and (2) axicabtagene ciloleucel for the treatment of second line diffuse large B cell lymphoma.

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

Any adverse developments affecting or resulting from our manufacturing operations or the operations of our third-party manufacturers and corporate partners may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the commercial supply of our products.

We may also need to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications and quality standards, undertake costly remediation efforts or seek more costly manufacturing alternatives.

Such developments could increase our manufacturing costs, cause us to lose revenues or market share and damage our reputation.

A manifestation of any of the following risks could materially and adversely affect our business, results of operations and financial condition.

A substantial portion of our revenues is derived from sales of our HIV products.

If we are unable to increase or maintain our HIV sales, then our results of operations may be adversely affected.

If the treatment paradigm for HIV changes, causing nucleoside-based therapeutics to fall out of favor, or if we are unable to maintain or increase our HIV product sales, our results of operations would likely suffer and we would likely need to scale back our operations, including our future drug development and spending on research and development (R&D) efforts.

In addition, future sales of our HIV products depend, in part, on the extent of reimbursement of our products by private and public payers.

We may continue to experience global pricing pressure that could result in larger discounts or rebates on our products or delayed reimbursement, which negatively impacts our product sales and results of operations.

Also, private and public payers can choose to exclude our products from their formulary coverage lists or limit the types of patients for whom coverage will be provided, which would negatively impact the demand for, and revenues of, our products.

Any change in the formulary coverage, reimbursement levels or discounts or rebates offered on our products to payers may impact our anticipated revenues.

If we are unable to achieve our forecasted HIV sales, our stock price could be adversely impacted.

| | |

| --- | --- |

| • | As our products are used over a longer period of time in many patients and in combination with other products, and additional studies are conducted, new issues with respect to safety, resistance and interactions with other drugs may arise, which could cause us to provide additional warnings or contraindications on our labels, narrow our approved indications or halt sales of a product, each of which could reduce our revenues. |

| • | If physicians do not see the benefit of our HIV products, the sales of our HIV products will be limited. |

If we fail to develop and commercialize new products or expand the indications for existing products, our prospects for future revenues and our results of operations may be adversely affected.

The success of our business depends on our ability to introduce new products as well as expand the indications for our existing products to address areas of unmet medical need.

Failure to launch commercially successful new products or new indications for existing products could have a material adverse effect on our future revenues, results of operations and long-term success.

Our inability to accurately predict demand for our products and fluctuations in purchasing patterns or wholesaler inventories makes it difficult for us to accurately forecast sales and may cause our forecasted revenues and earnings to fluctuate, which could adversely affect our financial results and stock price.

We face significant competition.

Our TAF-containing HIV products compete primarily with products from ViiV Healthcare Company (ViiV).

We also face competition from generic HIV products.

Generic versions of efavirenz, a component of Atripla, are available in the United States, Canada and Europe.

We have observed some pricing pressure related to the efavirenz component of our Atripla sales.

TDF, one of the active pharmaceutical ingredients in Truvada, Atripla, Complera/Eviplera and Stribild, faces generic competition in the European Union, the United States and certain other countries.

In addition, because FTC, the other active pharmaceutical ingredient of Truvada, faces generic competition in the European Union, Truvada also faces generic competition in the European Union and certain other countries outside of the United States.

Pursuant to a settlement agreement relating to patents that protect Truvada and Atripla, Teva Pharmaceuticals is permitted to launch generic fixed-dose combinations of FTC and TDF and generic fixed-dose combinations of FTC, TDF and efavirenz in the United States on September 30, 2020.

Our hepatitis C virus (HCV) products compete primarily with products marketed by AbbVie Inc. and Merck & Co., Inc.

Our hepatitis B virus (HBV) products face competition from existing therapies for treating patients with HBV as well as generic versions of TDF.

Our HBV products also compete with products marketed by Bristol-Myers Squibb Company and Novartis Pharmaceuticals Corporation (Novartis).

Yescarta competes with a CAR T cell therapy marketed by Novartis and a non-CAR T product marketed by Roche and is expected to compete with products from other companies developing advanced T cell therapies.

Yescarta and other commercial products also face competition from certain clinical trials that are enrolling CAR T eligible patients.

We may be required to pay significant damages and royalty payments as a result of ongoing litigation related to Yescarta and Biktarvy.

We cannot predict the ultimate outcome of these litigation matters, but the timing and magnitude of any such payments could have a material adverse impact on our results of operations, financial condition and stock price.

In October 2017, Juno Therapeutics, Inc. and Sloan Kettering Cancer Center (collectively, Juno) filed a lawsuit against us in the U.S. District Court for the Central District of California alleging that the commercialization of axicabtagene ciloleucel, sold commercially as Yescarta, infringes on U.S. Patent No. 7,446,190 (the ‘190 patent).

A jury trial was held on the ‘190 patent, and in December 2019, the jury found that the asserted claims of the ‘190 patent were valid, and that we willfully infringed the asserted claims of the ‘190 patent.

The jury also awarded Juno damages in amounts of $585 million in an up-front payment and a 27.6% running royalty from October 2017 through the date of the jury’s verdict.

The parties filed post-trial motions in January 2020 and will file further briefings during the first quarter of 2020, and we expect the judge to rule on these matters later in 2020.

Once the district court has issued these rulings and has entered judgment, the case may be appealed to the U.S. Court of Appeals for the Federal Circuit.

Although we cannot predict with certainty the ultimate outcome of this litigation, we believe the jury’s verdict to be in error, and we also believe that errors were made by the court with respect to certain rulings before and during trial.

If the jury’s verdict is not upheld on appeal, the loss will be zero, If the jury’s verdict is upheld in its entirety on appeal, we estimate the upper end of the range of possible loss through December 31, 2019 to be approximately $1.6 billion, which consists of (i) the $585 million up-front payment determined by the jury, (ii) approximately $200 million, which represents estimated royalties on our adjusted revenues from Yescarta from October 18, 2017 through December 31, 2019, and (iii) enhanced damages requested by Juno of up to two times the sum of (i) and (ii) above as a result of the jury’s finding of willfulness.

This sum excludes costs and pre-judgment interest.

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations [removed: (MD&A)] [added: (“MD&A”)] is intended to help the reader understand our results of operations and financial condition.

Additional information related to the comparison of our results of operations between the years [removed: 2018] [added: 2019] and [removed: 2017] [added: 2018] is included in *“*Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations*”* of our [removed: [2018] [added: [2019] Form [removed: 10-K](http://www.sec.gov/Archives/edgar/data/882095/000088209519000006/0000882095-19-000006-index.htm)] [added: 10-K](https://www.sec.gov/ix?doc=/Archives/edgar/data/882095/000088209520000006/a2019form10-k.htm#s11F232EE80B7FBB9B77B8F27BF3A0F35)] filed with the [removed: SEC] [added: U.S. Securities] and [added: Exchange Commission (the “SEC”), and] is incorporated by reference into this Annual Report on Form 10-K.

We [removed: have operations] [added: operate] in more than 35 countries worldwide, with headquarters in Foster City, California.

Our portfolio of marketed products includes AmBisome®, Atripla®, Biktarvy®, Cayston®, [removed: Complera®/Eviplera®,] [added: Complera®,] Descovy®, Descovy for PrEP®, Emtriva®, Epclusa®, [added: Eviplera®,] Genvoya®, Harvoni®, Hepsera®, [added: Jyseleca®,] Letairis®, Odefsey®, Ranexa®, Sovaldi®, Stribild®, [added: TecartusTM, Trodelvy®,] Truvada®, Truvada for PrEP®, Tybost®, [added: Veklury®,] Vemlidy®, Viread®, Vosevi®, Yescarta® and Zydelig®.

[removed: 2019] [added: 2020] Business Highlights

[removed: Key corporate, product, pipeline] [added: *Key Product, Pipeline] and [removed: other updates included:][added: Corporate Updates(1)*]

[removed: *Viral Diseases*][added: | Corporate Development | | | | | | Viral Diseases | | |]

[removed: *Inflammatory and Fibrotic Diseases*][added: | | | | | | | Inflammatory Diseases | | |]

[removed: | • | Collaboration with Galapagos and equity investment in Galapagos to gain access to Galapagos’ current and future product portfolio. See Note 11. Collaborative and] Other [removed: Arrangements] [added: Financial Information] of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information. [removed: |]

[removed: *Oncology*][added: | | | | | | | Oncology | | |]

[removed: *Other*][added: | Other Products | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

[removed: 2019 Financial] [added: 2020 Financial] Highlights

[added: In 2020, cost of goods sold decreased by $103 million compared to 2019, primarily due to the 2019 inventory write-down charges of $649 million, of which $547 million was related to] slow moving and excess raw material and work in process inventory primarily due to lower long-term demand for our HCV products.

[removed: As of December 31, 2019, we had $25.8 billion of cash,] [added: Cash,] cash equivalents and marketable debt securities [removed: compared to $31.5 billion] as of December 31, [removed: 2018.][added: 2020, decreased by $17.9 billion, or 69%, compared to December 31, 2019.]

Strategy and [removed: Outlook 2020][added: Outlook 2021]

Our strategic ambitions [removed: define what success looks like over the next decade and] are [removed: summarized as] [added: to] (i) bring 10+ transformative therapies to patients by 2030; (ii) be the biotech employer and partner of choice; and (iii) deliver shareholder value in a sustainable and responsible manner.

Our [removed: progress] [added: ability to deliver] on [removed: all of these initiatives] [added: our strategy and 2021 objectives] is subject to a number of uncertainties, including, but not limited to, the [added: effects of the COVID-19 pandemic, which remains unpredictable; the continuation of an uncertain global macroeconomic environment; our ability to realize the potential benefits of our acquisitions, collaborations or licensing arrangements; our ability to initiate, progress or complete clinical trials within currently anticipated timeframes; the] possibility of unfavorable results from new and ongoing clinical trials; [removed: the continuation of an uncertain global macroeconomic environment;] additional pricing pressures from payers and competitors; [added: higher than anticipated effects of the loss of exclusivity from Truvada and Atripla;] slower than anticipated growth in [removed: our HIV] [added: Biktarvy, Trodelvy, Vemlidy and cell therapy] products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; market share and price erosion caused by the introduction of [removed: generic versions] [added: generics; loss] of [removed: products containing tenofovir disoproxil fumarate (TDF) outside the United States and Viread, Letairis and Ranexa in the United States;] [added: exclusivity of our products;] inaccuracies in our HCV patient start estimates; potential [removed: amendments to the Affordable Care Act or other] government [removed: action] [added: actions] that could have the effect of lowering prices; a larger-than anticipated shift in payer mix to more highly discounted payer segment; and volatility in foreign currency exchange rates.

| (In millions, except percentages) | | [removed: 2019] | | | | [added: 2020 | | | | | |] Change | | | [removed: 2018] | | | [added: 2019] | [added: | | | | |] Change | | | [removed: 2017] | | | [added: 2018 | | |]

| [removed: Product] [added: Total product] sales | | [removed: $] | [removed: 22,119] | | | [removed: 2] [added: 24,355] | [removed: %] | | [removed: $] | [removed: 21,677] | | [added: *10*] | [removed: (16] | [removed: )%] [added: *%*] | | [removed: $] | [removed: 25,662] | [added: 22,119] | [added: | | | | | *2* | | *%* | | | | 21,677 | | |]

| Royalty, contract and other revenues | | [removed: 330] | | | | [removed: (27] [added: 334] | [removed: )%] | | [removed: 450] | | | [added: *1*] | [removed: 1] | [removed: %] [added: *%*] | | [removed: 445] | | [added: 330] | [added: | | | | | *(27)* | | *%* | | | | 450 | | |]

| Total revenues | | [added: | | | |] $ | [removed: 22,449] [added: 24,689] | | | [removed: 1] | [removed: %] | [added: *10*] | [added: | *%* | | | |] $ | [removed: 22,127] [added: 22,449] | | | [removed: (15] | [removed: )%] | [added: *1*] | [added: | *%* | | | |] $ | [removed: 26,107] [added: 22,127] | |

[removed: Product Sales][added: | Product sales: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

[removed: *2019* *Compared to* *2018*][added: *2020 Compared to 2019*]

Other product sales, which include Vemlidy, Viread, Letairis, Ranexa, Zydelig, [removed: AmBisome] [added: AmBisome, Cayston] and [removed: Cayston,] [added: Jyseleca,] decreased by [removed: 26%] [added: 18%] to [removed: $2.3] [added: $1.9] billion in [removed: 2019,] [added: 2020,] compared to [removed: $3.1] [added: $2.3] billion in [removed: 2018,] [added: 2019,] primarily due to the expected [removed: decline] [added: declines] in sales of [removed: Ranexa and] Letairis [added: and Ranexa] after [removed: the entry of] generic [removed: versions] [added: entries] in the [removed: United States] [added: first half of 2019, partially offset by higher sales volume of Vemlidy] in [removed: early 2019.][added: other international locations.]

Of our total product sales, [added: 26% and] 25% were generated outside the United States in [removed: 2019.][added: 2020 and 2019, respectively.]

Foreign currency exchange, net of hedges, had an [removed: immaterial] [added: unfavorable] impact on our product sales [added: of $29 million] in [removed: 2019,] [added: 2020,] based on a comparison using foreign currency exchange rates from [removed: 2018.][added: 2019.]

We record product sales net of estimated government and other rebates and chargebacks, cash discounts for prompt payment, distributor [removed: fees] [added: fees, sales return provisions] and other related costs.

These deductions [added: to product sales] are generally referred to as gross-to-net [added: (“GTN”)] deductions, which totaled $15.3 billion, or [removed: 41%] [added: 39%] of gross product sales in [removed: 2019,] [added: 2020,] compared to [removed: $16.5] [added: $15.3] billion, or [removed: 43%] [added: 41%] of gross product sales in [removed: 2018.][added: 2019.]

Of the $15.3 billion in [removed: 2019, $13.5] [added: 2020, $13.0] billion or [removed: 36%] [added: 33%] of gross product sales [removed: in 2019] was related to government and other rebates and chargebacks, [removed: and $1.8] [added: $1.7] billion was related to cash discounts for prompt payment, distributor fees and other related [removed: costs.][added: costs and $572 million was related to sales return provisions.]

The decrease in sales of our HCV products was primarily due to lower [added: patient starts and] average net selling [removed: price, including a decline in U.S. Medicare prices in 2019.][added: price as discussed above.]

The decrease in [removed: sales of our] HCV [removed: products] [added: product sales in the United States and Europe in 2020 compared to 2019] was primarily due to lower patient [removed: starts] [added: starts, including declines attributable to a decrease in health care provider visits] and [added: screenings due to the COVID-19 pandemic as well as] lower average net selling price.

| [removed: Atripla] | | [removed: $] | [removed: 600] | | | [removed: (50] [added: 349] | [removed: )%] | | [removed: $] | [removed: 1,206] | | [added: *(42)*] | [removed: (33] | [removed: )%] [added: *%*] | | [removed: $] | [removed: 1,806] | [added: 600] | [added: | | | | | *(50)* | | *%* | | | | 1,206 | | |]

| [removed: Biktarvy] | | [removed: 4,738] | | | | [removed: *] [added: 7,259] | | | [removed: 1,184] | | | [added: *53*] | [removed: *] | [added: *%*] | | [removed: —] | | [added: 4,738] | [added: | | | | | *NM* | | | | | | 1,184 | | |]

| [removed: Descovy] | | [removed: 1,500] | | | | [removed: (5] [added: 1,861] | [removed: )%] | | [removed: 1,581] | | | [added: *24*] | [removed: 30] | [removed: %] [added: *%*] | | [removed: 1,218] | | [added: 1,500] | [added: | | | | | *(5)* | | *%* | | | | 1,581 | | |]

| [removed: Genvoya] | | [removed: 3,931] | | | | [removed: (15] [added: 3,338] | [removed: )%] | | [removed: 4,624] | | | [added: *(15)*] | [removed: 26] | [removed: %] [added: *%*] | | [removed: 3,674] | | [added: 3,931] | [added: | | | | | *(15)* | | *%* | | | | 4,624 | | |]

| [removed: Odefsey] | | [removed: 1,655] | | | | [removed: 4] [added: 1,672] | [removed: %] | | [removed: 1,598] | | | [added: *1*] | [removed: 44] | [removed: %] [added: *%*] | | [removed: 1,106] | | [added: 1,655] | [added: | | | | | *4* | | *%* | | | | 1,598 | | |]

| [removed: Stribild] | | [removed: 369] | | | | [removed: (43] [added: 196] | [removed: )%] | | [removed: 644] | | | [added: *(47)*] | [removed: (39] | [removed: )%] [added: *%*] | | [removed: 1,053] | | [added: 369] | [added: | | | | | *(43)* | | *%* | | | | 644 | | |]

| [removed: Truvada] | | [removed: 2,813] | | | | [removed: (6] [added: 1,448] | [removed: )%] | | [removed: 2,997] | | | [added: *(49)*] | [removed: (4] | [removed: )%] [added: *%*] | | [removed: 3,134] | | [added: 2,813] | [added: | | | | | *(6)* | | *%* | | | | 2,997 | | |]

| Other [removed: HIV(1)] [added: HIV(2) – U.S.] | | [removed: 47] | | | | [removed: (23] [added: 25] | [removed: )%] | | [removed: 61] | | | [added: *(17)*] | [removed: 5] | [removed: %] [added: *%*] | | [removed: 58] | | [added: 30] | [added: | | | | | *(25)* | | *%* | | | | 40 | | |]

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.

The approval status of Jyseleca varies worldwide, and Jyseleca is not approved in the United States.

Our financial performance was strong in 2020, despite the global impact of the COVID-19 pandemic, which is a clear reflection of the solid underlying fundamentals of our business driven by the HIV franchise and the increased demand we saw for Veklury amid the COVID-19 pandemic.

We also continued to expand and strengthen our commercial portfolio and clinical pipeline across various therapeutic areas to drive future growth potential.

- In April, we acquired Forty Seven, Inc. (“Forty Seven”) for approximately $4.7 billion, gaining an investigational drug candidate, magrolimab, which is currently in Phase 2/3 clinical studies for a number of hematological cancers, including myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin lymphoma and solid tumors.

- In October, we acquired Immunomedics, Inc. (“Immunomedics”) for approximately $20.6 billion and gained Trodelvy, a Trop-2-directed antibody-drug conjugate, which was granted accelerated approval by the U.S. Food and Drug Administration (“FDA”) for the treatment of adult patients with metastatic triple-negative breast cancer (“mTNBC”).

Trodelvy has potential broader applicability for multiple tumor types, and is being studied as a monotherapy and combination agent for additional tumor types, including HR+/HER2- breast cancer, urothelial cancer, non-small cell lung cancer and other solid tumors.

- In December, we entered into a definitive agreement to acquire MYR GmbH.

Upon closing, which is subject to regulatory clearances and other conditions, the acquisition will provide us with Hepcludex® (bulevirtide), which was conditionally approved by the European Medicines Agency (“EMA”) for the treatment for chronic hepatitis delta virus (“HDV”) in July 2020.

- We significantly expanded our oncology portfolio through licensing, strategic collaboration as well as equity investments with our third-party collaboration partners.

Additional information is included in Note 11.

Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.

In addition to the assets we acquired pursuant to our strategic transactions, we developed several other therapies and treatments in our portfolio: Jyseleca, Tecartus and Veklury, the first FDA-approved antiviral therapy for COVID-19.

These efforts demonstrate our continued commitment to advancing innovative medicines in areas of unmet need.

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Category | | | | | | Therapeutic Area and Description | | |

| | | | | | | | | |

| Regulatory Approval & Submission | | | | | | Viral Diseases | | |

| | | | | | | •FDA, European Commission (“EC”) and Japanese Ministry of Health, Labour and Welfare (“JMHLW”) granted full approval, conditional marketing authorization and regulatory approval, respectively, to Veklury for the treatment of patients with COVID-19. | | |

| | | | | | | •FDA approved a supplemental New Drug Application for Epclusa for the treatment of children ages 6 and older (or weighing at least 17 kg) with hepatitis C virus (“HCV”). | | |

| | | | | | | | | |

| | | | | | | •FDA and EC granted accelerated approval and conditional marketing authorization, respectively, for Tecartus for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. | | |

| | | | | | | •We submitted a supplemental Biologics License Application (“sBLA”) to FDA for approval of Trodelvy as a treatment for adult patients with mTNBC based on the overall efficacy and safety results in the Phase 3 ASCENT trial. | | |

| | | | | | | •Kite Pharma, Inc. (“Kite”) submitted an sBLA to FDA for Yescarta for the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma. Kite also received EMA approval to implement a variation to the Yescarta Marketing Authorization for end-to-end manufacturing. | | |

| | | | | | | •FDA granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational, monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome. | | |

| | | | | | | | | |

| | | | | | | •EMA validated and is reviewing the application of Gilead and Galapagos NV (“Galapagos”) for a new indication to the approved license for filgotinib 200mg. The proposed indication is for the treatment of adults with moderately to severely active ulcerative colitis. | | |

| | | | | | | •JMHLW and EC granted regulatory approval and marketing authorization of Jyseleca, respectively, for the treatment of adults with moderate to severe active rheumatoid arthritis. | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | •Gilead and Vir Biotechnology, Inc. established a clinical collaboration related to hepatitis B virus in January 2021. | | |

| | | | | | | •Gilead and Gritstone Oncology, Inc. announced that the companies have entered into a collaboration, option and license agreement related to a curative treatment of HIV in February 2021. | | |

| | | | | | | | | |

| | | | | | | | | |

| Other | | | | | | •Veklury Distribution: ◦Beginning October 1, 2020, we started distributing Veklury in the United States upon conclusion of the previous distribution agreement with the U.S. Federal government. ◦Gilead and European Union signed a joint procurement agreement, which covers purchases of Veklury for a six-month period through April 2021 and has the option to be extended by the parties for additional six-month periods. | | |

| | | | | | | •Board Appointments: ◦Jeffrey A. Bluestone, Ph.D., the President and Chief Executive Officer (“CEO”) of Sonoma Biotherapeutics. ◦Sandra J. Horning, retired Chief Medical Officer and Global Head of Product Development for Roche. ◦Javier J. Rodriguez, the CEO of DaVita Inc. ◦Anthony Welters, retired Senior Advisor to the Office of the CEO of UnitedHealth Group, Inc. | | |

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

Gilead Sciences, Inc. (Gilead, we, our or us), incorporated in Delaware on June 22, 1987, is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

With each new discovery and investigational drug candidate, we strive to transform and simplify care for people with life-threatening illnesses around the world.

Gilead’s primary areas of focus include viral diseases, inflammatory and fibrotic diseases and oncology.

We seek to add to our existing portfolio of products through our internal discovery and clinical development programs, product acquisition, in-licensing and strategic collaborations.

Our financial performance in 2019 was solid, as growth across our HIV franchise continued to drive results.

We took several significant steps to position us for future growth, including an important research and development (R&D) collaboration, the introduction of a new corporate strategy and the hiring of key members of our executive leadership team.

In 2019:

- We developed a new, corporate strategy to guide our work as we seek to drive growth over the next decade, with the ambitious goal of launching 10 new, transformative therapies over the next 10 years.

- We continued to make progress with our pipeline.

We currently have 40 clinical-stage programs, with 14 programs either in registrational or in label-enabling studies.

Of these programs, four have already received Breakthrough Therapy designation from U.S. Food and Drug Administration (FDA).

- We achieved sales of $16.4 billion across our HIV franchise in 2019, an increase of 12% from 2018, reaching another all-time high.

The continued revenue growth of our HIV products was driven by the demand for Biktarvy and the increase in the number of individuals taking our products for pre-exposure prophylaxis (PrEP).

At the end of 2019, Biktarvy was available in most major markets and, in the United States, approximately 27% of individuals on PrEP were receiving Descovy.

- We entered into a transformative R&D collaboration with Galapagos NV (Galapagos) in July, building on an existing partnership, and effectively enabling us to double our R&D footprint and accelerate our development of novel treatments for inflammatory and fibrotic diseases.

We submitted a regulatory filing for filgotinib to FDA, and the compound is now under priority review for rheumatoid arthritis (RA).

We also submitted filgotinib for approval in Europe and Japan and actively prepared for competitive launches in all three regions.

We and Galapagos continued to advance the Phase 3 study of GLPG-1690 for the treatment of idiopathic pulmonary fibrosis.

With regard to nonalcoholic steatohepatitis (NASH), after the STELLAR and ATLAS studies failed to reach their primary endpoints, we continued to work to understand the results to determine appropriate next steps for these therapies, including the potential for combination therapeutic approaches.

- In cell therapy, Kite, a Gilead company (Kite), submitted KTE-X19 for regulatory approval in the United States and Europe as a treatment for relapsed or refractory mantle cell lymphoma (MCL).

If approved, Kite will be the first company with two cell therapies on the market.

We also continued to demonstrate the efficacy of Yescarta.

Data shared at the end of 2019 showed that approximately half of patients treated with Yescarta for refractory large B-cell lymphoma were still alive three years following treatment in the ZUMA-1 study, confirming Yescarta’s benefit/risk profile.

In addition to cell therapy, we continued to grow our research portfolio in immuno-oncology.

- Our business also expanded geographically, including in China, where eight products have been approved since 2017 and four products (Vemlidy, Epclusa, Harvoni and Genvoya) have been listed on the National Reimbursement Drug List effective in January 2020.

During 2019, we continued to advance our product pipeline across our therapeutic areas with the goal of delivering best-in-class drugs that have the potential to improve the lives of patients with serious illnesses.

| | |

| --- | --- |

| • | Licensing and collaboration agreements with The Rockefeller University, Novartis AG and Lyndra Therapeutics, Inc. |

| • | Approval of Vosevi and Biktarvy by the China National Medical Products Administration. |

| • | Approval of a PrEP indication for Descovy by FDA. |

| • | Approval of Biktarvy and Epclusa by Japan’s Ministry of Health, Labour and Welfare (MHLW). |

| • | Collaborations with Kyverna Therapeutics, Inc. Glympse Bio, Inc., Renown Institute for Health Innovation, Goldfinch Bio, Inc., Insitro, Inc., Novo Nordisk A/S and Yuhan Corporation. |

| • | Agreement with Eisai Co., Ltd. for the distribution and co-promotion of filgotinib in Japan, pending regulatory approval from Japan’s MHLW, for the treatment of RA. |

| • | Submission of a New Drug Application (NDA) under priority review to FDA and submission of a NDA to Japan’s MHLW for filgotinib. |

| • | Topline results from the Phase 2 ATLAS study of combination and monotherapy investigational treatments in patients with bridging fibrosis (F3) and compensated cirrhosis (F4) due to NASH. While the study did not meet its primary endpoint, we continued to analyze the ATLAS data to determine appropriate next steps for these therapies. |

| • | European Medicines Agency’s validation of the marketing authorization application for filgotinib; the application is now under evaluation by the Agency. |

| • | FDA’s acceptance of our Biologics License Application and granting Priority Review designation for KTE-X19 for the treatment of adult patients with relapsed or refractory MCL. |

| • | European Medicines Agency’s validation of the marketing authorization application for KTE-X19; the application is now under evaluation by the Agency. |

| • | Collaborations with Carna Biosciences Inc., Nurix Therapeutics, Inc., Humanigen, Inc. and Kiniksa Pharmaceuticals, Ltd. |

Approximately [removed: 25%] [added: 26%] of our product sales were denominated in foreign currencies during [removed: 2019.][added: 2020.]

As of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] we had open foreign currency forward contracts with notional amounts of [removed: $2.9] [added: $2.4] billion and [removed: $2.2] [added: $2.9] billion, respectively.

A hypothetical 10% adverse movement in foreign currency exchange rates compared with the U.S. dollar relative to exchange rates at December 31, [removed: 2019] [added: 2020] and [removed: December 31, 2018] [added: 2019] would have resulted in a reduction in fair value of these contracts of approximately [removed: $285] [added: $249] million and [removed: $218] [added: $285] million, respectively, on this date and, if realized, would negatively affect earnings over the remaining life of the contracts.

Our portfolio of available-for-sale debt securities and our [removed: fixed rate long-term debt] [added: senior unsecured notes] create an exposure to interest rate risk.

[removed: | *•* |] [added: -] safety and preservation of principal and diversification of risk; [removed: |]

[removed: | • |] [added: -] liquidity of investments sufficient to meet cash flow requirements; and [removed: |]

[removed: | • |] [added: -] competitive after-tax rate of return. [removed: |]

The following table summarizes the expected maturities and average interest rates of our interest-generating assets and interest-bearing liabilities at December 31, [removed: 2019:][added: 2020:]

| | | | [added: | | | | | |] Expected Maturity | | | | | | | | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |] Total Fair Value | | [added: |]

| (In millions, except percentages) | | | [removed: 2020] | | | | [added: | |] 2021 | | | | [added: | | | | |] 2022 | | | | [added: | | | | |] 2023 | | | | [added: | | | | |] 2024 | | | | [added: | | | | | 2025 | | | | | | | | |] Thereafter | | | | [added: | | | | |] Total | | | | | | [added: | | | | | |]

| Assets | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Available-for-sale debt securities | | [added: | | | |] $ | [removed: 15,012] | | [added: 1,524] | [added: | | | | |] $ | [removed: 1,453] | | [added: 324] | [added: | | | | |] $ | [removed: 5] | | [added: 139] | [added: | | | | |] $ | [removed: 3] | | [added: 26] | [added: | | | | |] $ | [removed: 4] | | [added: 1] | [added: | | | | |] $ | [removed: 23] | | [added: 12] | [added: | | | | |] $ | [removed: 16,500] | | [added: 2,026] | [added: | | | | |] $ | [removed: 16,500] | | [added: 2,026 | | |]

| Liabilities | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [removed: Fixed] [added: Senior unsecured fixed] rate [removed: long-term debt,] [added: notes,] including current [removed: portion(1):] [added: portion(1)] | | [removed: $] | [removed: 2,500] | | | $ | [added: | |] 2,250 | | | [added: | | |] $ | [added: | |] 1,500 | | | [added: | | |] $ | [removed: 750] | | [added: 2,750] | [added: | | | | |] $ | [added: | |] 1,750 | | | [added: | | |] $ | [removed: 16,000] | | [added: 1,750] | [added: | | | | |] $ | [removed: 24,750] | | [added: 18,500] | [added: | | | | |] $ | [removed: 27,298] | | [added: 28,500 | | | | | | $ | | | 32,588 | | |]

| Average interest rate | | | [removed: 2.51] | [removed: %] | | | [added: | |] 4.44 | [added: |] % | | | [added: | | | |] 2.82 | [added: |] % | | | [removed: 2.50] | [added: | | | 1.23 | |] % | | | [added: | | | |] 3.70 | [added: |] % | | | [removed: 4.21] | [added: | | | 3.50 | |] % | | | | | | | [added: 3.81] | | [added: % | | | | | | | | | | | | | | | | | | |]

The fair value of these equity securities was approximately [removed: $3.8] [added: $2.4] billion and [removed: $881 million] [added: $3.8 billion] as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

A hypothetical 20% increase or decrease in the stock prices of these equity securities would increase or decrease their fair value at December 31, [removed: 2019] [added: 2020] and [removed: 2018] [added: 2019] by approximately [removed: $760] [added: $478] million and [removed: $176] [added: $760] million, respectively.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Average interest rate | | | | | | | | | 0.45 | | % | | | | | | | 0.27 | | % | | | | | | | 0.45 | | % | | | | | | | 0.49 | | % | | | | | | | 0.51 | | % | | | | | | | 0.23 | | % | | | | | | | | | | | | | | | | | | |

| Senior unsecured floating rate notes and term loan, including current portion | | | | | | $ | | | 500 | | | | | | $ | | | — | | | | | | $ | | | 1,500 | | | | | | $ | | | — | | | | | | $ | | | — | | | | | | $ | | | — | | | | | | $ | | | 2,000 | | | | | | $ | | | 2,002 | | |

| Average interest rate | | | | | | | | | 0.38 | | % | | | | | | | — | | % | | | | | | | 1.15 | | % | | | | | | | — | | % | | | | | | | — | | % | | | | | | | — | | % | | | | | | | | | | | | | | | | | | |

_______________________________

(1) Amounts represent principal balances.

In addition to the senior unsecured fixed rate notes, we have a $2.5 billion five-year revolving credit facility that matures in June 2025.

There were no amounts outstanding under the five-year revolving credit facility as of December 31, 2020.

See Note 12.

Debt and Credit Facilities of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information.

| | |

| --- | --- |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Average interest rate | | | 1.88 | % | | | 1.98 | % | | | 2.04 | % | | | 3.50 | % | | | 3.53 | % | | | 2.18 | % | | | | | | | | |

| _________________________________________ | |

| (1) | Amounts represent principal balances. In addition to the fixed rate long-term debt, we have a $2.5 billion five-year revolving credit facility that matures in May 2021. There were no amounts outstanding under the five-year revolving credit facility as of December 31, 2019. See Note 12. Debt and Credit Facilities of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information. |

We [removed: have operations] [added: operate] in more than 35 countries worldwide, with headquarters in Foster City, California.

We [added: also] seek to add to our [removed: existing] portfolio of products [removed: through our internal discovery] and [removed: clinical development programs,] product [removed: acquisition,] [added: candidates through acquisitions,] in-licensing and strategic collaborations.

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

Our focus on innovation has allowed us to deliver [removed: more than 24] marketed products across multiple therapeutic areas.

[removed: Our principal] [added: In 2020, our primary revenue-generating] products and the approved indications in the United States are as follows:

[removed: | • | 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 [removed: (TAF). |][added: (“TAF”).]

[removed: | • | Descovy® is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients.] Descovy is [removed: a fixed-dose combination of our antiretroviral medications, emtricitabine and TAF. Descovy is] also approved by U.S. Food and Drug Administration [removed: (FDA)] [added: (“FDA”)] for a pre-exposure prophylaxis [removed: (PrEP)] [added: (“PrEP”)] indication to reduce the risk of sexually acquired HIV-1 infection in certain at-risk patients. [removed: |]

[removed: | • | 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 [removed: UC,] [added: Unlimited Company,] one of the Janssen Pharmaceutical Companies of Johnson & Johnson [removed: (Janssen). |][added: (“Janssen”).]

[removed: | • | 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. [removed: |]

[removed: | • | 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, [removed: tenofovir disoproxil fumarate (TDF)] [added: TDF] and emtricitabine. [removed: |]

[removed: | • | 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, [removed: TDF] [added: tenofovir disoproxil fumarate (“TDF”)] and emtricitabine, and Janssen’s rilpivirine hydrochloride. [removed: |]

[removed: | • | 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 [removed: (BMS)’s] [added: (“BMS”)’s] efavirenz. [removed: |]

[removed: | • | Truvada®] [added: - Truvada®] is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in certain patients. [removed: It is a fixed-dose combination of our antiretroviral medications, TDF and emtricitabine. Truvada is also approved by FDA for a PrEP indication, in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in certain at-risk patients. |]

[removed: | • | Vosevi®] [added: - Vosevi®] is an oral formulation of a once-daily, single tablet regimen of sofosbuvir, velpatasvir and voxilaprevir for the re-treatment of chronic [removed: hepatitis C virus (HCV)] [added: 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. [removed: |]

[removed: | • | Epclusa®] [added: - Epclusa®] is an oral formulation of a once-daily single tablet regimen of sofosbuvir and velpatasvir for the treatment of chronic [removed: HCV] [added: hepatitis C virus (“HCV”)] infection in adults [added: and certain pediatric patients] 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. [removed: |]

[removed: | • | Harvoni®] [added: - 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 infection with decompensated cirrhosis, in combination with ribavirin, (iii) adults with genotype 1 or 4 [removed: |][added: 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.]

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

[removed: | • | Viread®] [added: - Viread®] is an oral formulation of TDF dosed once a day for the treatment of chronic HBV infection in adults and certain pediatric patients. [removed: |]

[removed: *Hematology/Oncology*][added: *Hematology/Oncology/Cell Therapy*]

[removed: | • | Yescarta®] [added: - Yescarta®] (axicabtagene [removed: ciloleucel)] [added: ciloleucel), a suspension for intravenous infusion,] is a chimeric antigen receptor [removed: (CAR)] [added: (“CAR”)] T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma [removed: (DLBCL)] [added: (“DLBCL”)] not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. [removed: |]

[removed: | • | Zydelig®] [added: - Zydelig®] (idelalisib) is an oral formulation of a kinase inhibitor for the treatment of patients with: (i) relapsed chronic lymphocytic leukemia [removed: (CLL),] [added: (“CLL”),] in combination with rituximab, for whom rituximab alone would be considered appropriate therapy due to other co-morbidities, (ii) relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies or (iii) relapsed small lymphocytic lymphoma who have received at least two prior systemic therapies. [removed: |]

[removed: | • | Letairis®] [added: - Letairis®] (ambrisentan) is an oral formulation of an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension [removed: (PAH)] [added: (“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. [removed: |]

[removed: | • | Ranexa®] [added: - Ranexa®] (ranolazine) is an oral formulation of an extended-release tablet of an antianginal for the treatment of chronic angina. [removed: |]

[removed: | • | AmBisome®] [added: - 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. [removed: |]

For information about our [removed: product revenues,] [added: revenue-generating products,] including the amount of revenue contributed by [removed: each of] the products listed [removed: above for each of the last three fiscal years,] [added: above,] see Note 2.

[removed: Our] [added: During the twelve months ended December 31, 2020, approximately 92% of our] product sales [added: in the United States and approximately 68% of our total worldwide revenues were] to three large wholesalers, AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson [removed: Corporation, each accounted for more than 10% of total revenues for each of the years ended December 31, 2019, 2018 and 2017.][added: Corporation.]

We intend to continue committing significant resources to internal R&D opportunities and external business development [removed: activity.][added: activity to drive innovation and growth of our business.]

Our product development efforts are focused primarily in viral diseases, inflammatory [removed: and fibrotic] diseases and oncology.

[removed: We have] [added: Our team of] research scientists [added: is] engaged in the discovery and development of new molecules and technologies that we hope will lead to the approval of [removed: new] [added: innovative] medicines [added: and therapies] that will advance the current standard of care and address unmet medical needs.

The development of [removed: our] product candidates [added: and investigational therapies in our pipeline] is subject to various risks and uncertainties.

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

Drug development is inherently [removed: risky] [added: risky,] and many product candidates [added: and investigational therapies] fail during the [removed: drug] development process.

In [removed: 2019,] [added: 2020,] we continued to invest in and advance our R&D pipeline across our therapeutic areas.

| Product Candidates | | [added: | | | |] Description | [added: | |]

| Phase [removed: 2] [added: 3 or Phase 2/3] | | | [added: | | | | | |]

| Phase [removed: 1] [added: 3] | | | [added: | | | | | |]

*Product Candidates in Inflammatory [removed: and Fibrotic] Diseases*

| Phase 3 | | | [added: | | | | | |]

| Filgotinib | | [removed: Filgotinib, a JAK1 inhibitor,] [added: | | | | Filgotinib] is being evaluated for the treatment of [removed: (i)] Crohn’s [removed: disease, (ii) ulcerative colitis and (iii) psoriatic arthritis.] [added: disease.] | [added: | |]

| Cilofexor | | [added: | | | |] Cilofexor, [removed: a] [added: an] FXR agonist, is being evaluated for the treatment of primary sclerosing cholangitis. | [added: | |]

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.

Our Business

*Products*

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

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

- 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.

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

It is a fixed-dose combination of our antiretroviral medications, TDF and emtricitabine.

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.

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

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

*COVID-19*

- Veklury® (remdesivir), an injection for intravenous use, is a nucleotide analog RNA polymerase inhibitor indicated for certain patients for the treatment of coronavirus disease 2019 (“COVID-19”) requiring hospitalization.

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

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

- Tecartus™ (brexucabtagene autoleucel), a suspension for intravenous infusion, is a CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

- 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 metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

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.

*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.

We include our revenue share from Symtuza in our Product sales.

For a description of our collaborations with Janssen and other partners, see Note 11.

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.

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

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

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Remdesivir (injection) | | | | | | Remdesivir for injection is being evaluated for the outpatient treatment of COVID-19 (expanded indication). | | |

| Lenacapavir | | | | | | Lenacapavir, an HIV capsid inhibitor, is being evaluated 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(1) | | | | | | Bulevirtide is being evaluated for the treatment of chronic hepatitis delta virus (“HDV”) infection. It has been granted both Orphan Drug and Breakthrough Therapy designations by FDA for chronic HDV infection. It has also been granted Breakthrough Therapy designation and PRIority MEdicines (“PRIME”) scheme eligibility by the European Commission for chronic HDV infection. | | |

________________________________

(1) In December 2020, we entered into a definitive agreement to acquire MYR GmbH.

Upon closing, which is subject to regulatory clearances and other conditions, the acquisition will provide us with Hepcludex® (bulevirtide), which was conditionally approved by the European Commission for the treatment for chronic HDV infection in July 2020.

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Product Candidates | | | | | | Description | | |

Gilead Sciences, Inc. (Gilead, we, our or us), incorporated in Delaware on June 22, 1987, is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

With each new discovery and investigational drug candidate, we strive to transform and simplify care for people with life-threatening illnesses around the world.

Gilead’s primary areas of focus include viral diseases, inflammatory and fibrotic diseases and oncology.

Our Principal Products

| | |

| --- | --- |

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.

On a combined basis, in 2019, these wholesalers accounted for approximately 87% of our product sales in the United States and approximately 64% of our total worldwide revenues.

For a description of our competitors, see Item 1A.

Risk Factors “We face significant competition.”

Our research and development (R&D) philosophy and strategy are to develop best-in-class drugs that improve safety or efficacy for unmet medical needs.

At the end of 2019, our R&D pipeline included 104 active clinical studies, of which 27 were Phase 3 clinical trials.

Below is a summary of our key product candidates and their corresponding current stages of development.

| | | |

| --- | --- | --- |

| GS-6207 | | GS-6207, a capsid inhibitor, is being evaluated for the treatment of HIV infection. |

| Selgantolimod | | Selgantolimod, a TLR-8 agonist, is being evaluated for the treatment of chronic HBV infection. |

| Vesatolimod | | Vesatolimod, a TLR-7 agonist, is being evaluated as a potential cure for HIV infection. |

| Elipovimab | | Elipovimab, a broadly neutralizing antibody, is being evaluated as a potential cure for HIV infection. |

| GS-4224 | | GS-4224, a PD-L1 inhibitor, is being evaluated for the treatment of chronic HBV infection. |

| GLPG-1690(2) | | GLPG-1690, an autotaxin inhibitor, is being evaluated for the treatment of idiopathic pulmonary fibrosis. |

| Filgotinib | | Filgotinib is being evaluated for the treatment of (i) ankylosing spondylitis and (ii) uveitis. |

| GS-4875 | | GS-4875, a TPL2 inhibitor, is being evaluated for the treatment of ulcerative colitis. |

| GLPG-1972(1) | | GLPG-1972, an ADAMTS-5 inhibitor, is being evaluated for the treatment of osteoarthritis. |

| Selonsertib | | Selonsertib, an ASK-1 inhibitor, is being evaluated for the treatment of diabetic kidney disease. |

| Cilofexor, firsocostat and selonsertib combinations | | Cilofexor, firsocostat (an ACC inhibitor) and selonsertib combinations are being evaluated for the treatment of nonalcoholic steatohepatitis (NASH). |

| GLPG-1690(2) | | GLPG-1690 is being evaluated for the treatment of systemic sclerosis. |

| GLPG-1205(1) | | GLPG-1205, a GPR84 inhibitor, is being evaluated for the treatment of idiopathic pulmonary fibrosis. |

| GLPG-0555(1) | | GLPG-0555 is being evaluated for the treatment of inflammatory diseases. |

| GLPG-3312(1) | | GLPG-3312 is being evaluated for the treatment of inflammatory diseases. |

| GLPG-3970(1) | | GLPG-3970 is being evaluated for the treatment of inflammatory diseases. |

| GLPG-3667(1) | | GLPG-3667 is being evaluated for the treatment of inflammatory diseases. |

| Axicabtagene ciloleucel | | Axicabtagene ciloleucel is being evaluated for the treatment of indolent non-Hodgkin lymphoma. Axicabtagene ciloleucel is also being evaluated for the treatment of (i) first line DLBCL and (ii) DLBCL in combination with either rituximab or lenalidomide. |

| Axicabtagene ciloleucel | | Axicabtagene ciloleucel is being evaluated for the treatment of DLBCL in combination with utomilumab. |

| KITE-718 | | KITE-718, a MAGE A3/A6, is being evaluated for the treatment of solid tumors. |

| KITE-439 | | KITE-439, an HPV E7, is being evaluated for the treatment of solid tumors. |

| GS-1423 | | GS-1423, a bi-specific antibody, is being evaluated for the treatment of solid tumors. |

| GS-4224 | | GS-4224, an oral PD-L1 inhibitor, is being evaluated for the treatment of solid tumors. |

| AGEN1223(1) | | AGEN1223, a bi-specific mAb, is being evaluated for the treatment of multiple indications in oncology. |

| AGEN2373(1) | | AGEN2373, an anti-CD137 mAb, is being evaluated for the treatment of multiple indications in oncology. |

Commitments and Contingencies - Legal Proceedings of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form [removed: 10-K, which is incorporated herein by reference.][added: 10-K.]

| | |

| --- | --- |

[removed: FORM 10-K][added: FORM 10-K]

| ☒ | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

For the fiscal year [removed: ended December] [added: ended December] 31, [removed: 2019][added: 2020]

| ☐ | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

Commission File [removed: No. 0-19731][added: No. 0-19731]

| Delaware | [added: | |] 94-3047598 | [added: | |]

| (State or Other Jurisdiction of Incorporation) | [added: | |] (IRS Employer Identification No.) | [added: | |]

333 Lakeside [removed: Drive, Foster City, California 94404][added: Drive, Foster City, California 94404]

[removed: 650\-574-3000][added: 650-574-3000]

| Title of each class | | [added: | | | |] Trading Symbol(s) | | [added: | | | |] Name of each exchange on which registered | [added: | |]

| Common Stock, par value, $0.001 per share | | [added: | | | |] GILD | | [added: | | | |] The Nasdaq Global Select Market | [added: | |]

Yes [removed: x] [added: ☒] No ¨

Yes ¨ No [removed: x][added: ☒]

Large accelerated filer [removed: x] [added: ☒] Accelerated filer ¨ Non-accelerated filer ¨

Yes [removed: ☐] [added: ☒] No [removed: x][added: ¨]

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant based upon the closing price of its Common Stock on the Nasdaq Global Select Market on June [removed: 28, 2019] [added: 30, 2020] was [removed: $66.4] [added: $69.9] billion.*

The number of shares outstanding of the registrant’s Common Stock on February 18, [removed: 2020] [added: 2021] was [removed: 1,263,636,656.][added: 1,256,593,156]

Specified portions of the registrant’s proxy statement, which will be filed with the Commission pursuant to Regulation 14A in connection with the registrant’s [removed: 2020] [added: 2021] Annual Meeting of Stockholders, to be held on May [removed: 6, 2020,] [added: 12, 2021,] are incorporated by reference into Part III of this Report.

* Based on a closing price of [removed: $67.56] [added: $76.94] per share on June [removed: 28, 2019.][added: 30, 2020.]

Excludes [removed: 284,647,252] [added: 346,304,310] shares of the registrant’s Common Stock held by executive officers, directors and any stockholders whose ownership exceeds 5% of registrant’s common stock outstanding at June [removed: 28, 2019.][added: 30, 2020.]

[removed: 2019 Form] [added: 2020 Form] 10-K Annual Report

| PART I | | | [added: | | | | | |]

| Item 1 | [removed: [Business](#s7141EC9E5ECF108F98A48F27BF3ADA45)] | [removed: [3](#s7141EC9E5ECF108F98A48F27BF3ADA45)] | [added: [Business](#ib93766b38a794f83a6a283fa0a85c17d_13) | | | [3](#ib93766b38a794f83a6a283fa0a85c17d_13) | | |]

| Item 1A | [added: | |] [Risk [removed: Factors](#s76B4F2A417E427538CBB8F280B7FEEBD)] [added: Factors](#ib93766b38a794f83a6a283fa0a85c17d_16)] | [removed: [13](#s76B4F2A417E427538CBB8F280B7FEEBD)] | [added: | [16](#ib93766b38a794f83a6a283fa0a85c17d_16) | | |]

| Item 1B | [added: | |] [Unresolved Staff [removed: Comments](#sD4127B25FFB67BE59BA08F280BA2EC1E)] [added: Comments](#ib93766b38a794f83a6a283fa0a85c17d_19)] | [removed: [26](#sD4127B25FFB67BE59BA08F280BA2EC1E)] | [added: | [28](#ib93766b38a794f83a6a283fa0a85c17d_19) | | |]

| Item 2 | [removed: [Properties](#s11F232EE80B7FBB9B77B8F27BF3A0F35)] | [removed: [26](#s11F232EE80B7FBB9B77B8F27BF3A0F35)] | [added: [Properties](#ib93766b38a794f83a6a283fa0a85c17d_22) | | | [28](#ib93766b38a794f83a6a283fa0a85c17d_22) | | |]

| Item 3 | [added: | |] [Legal [removed: Proceedings](#s0162E6D9FE88AA291A698F280BF400DB)] [added: Proceedings](#ib93766b38a794f83a6a283fa0a85c17d_25)] | [removed: [26](#s0162E6D9FE88AA291A698F280BF400DB)] | [added: | [28](#ib93766b38a794f83a6a283fa0a85c17d_25) | | |]

| Item 4 | [added: | |] [Mine Safety [removed: Disclosures](#sFD19A1271C74BCC0AAA18F280C32ED88)] [added: Disclosures](#ib93766b38a794f83a6a283fa0a85c17d_28)] | [removed: [26](#sFD19A1271C74BCC0AAA18F280C32ED88)] | [added: | [28](#ib93766b38a794f83a6a283fa0a85c17d_28) | | |]

| PART II | | | [added: | | | | | |]

| Item 5 | [added: | |] [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#s278EAFD5A8E3CF0001E18F27E4497576)] [added: Securities](#ib93766b38a794f83a6a283fa0a85c17d_34)] | [removed: [27](#s278EAFD5A8E3CF0001E18F27E4497576)] | [added: | [29](#ib93766b38a794f83a6a283fa0a85c17d_34) | | |]

| Item 6 | [added: | |] [Selected Financial [removed: Data](#sF107E3FEF21B612187E58F27D851BFC8)] [added: Data](#ib93766b38a794f83a6a283fa0a85c17d_37)] | [removed: [29](#sF107E3FEF21B612187E58F27D851BFC8)] | [added: | [31](#ib93766b38a794f83a6a283fa0a85c17d_37) | | |]

| Item 7 | [added: | |] [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#sA2E20D6F7B7E4CA775488F280CCD0CFA)] [added: Operations](#ib93766b38a794f83a6a283fa0a85c17d_40)] | [removed: [30](#sA2E20D6F7B7E4CA775488F280CCD0CFA)] | [added: | [32](#ib93766b38a794f83a6a283fa0a85c17d_40) | | |]

| Item 7A | [added: | |] [Quantitative and Qualitative Disclosures about Market [removed: Risk](#s4C53EA5EB6CDB5ECFCD18F27D6E1CE2D)] [added: Risk](#ib93766b38a794f83a6a283fa0a85c17d_64)] | [removed: [43](#s4C53EA5EB6CDB5ECFCD18F27D6E1CE2D)] | [added: | [48](#ib93766b38a794f83a6a283fa0a85c17d_64) | | |]

| Item 8 | [added: | |] [Financial Statements and Supplementary [removed: Data](#sBC321EEC0111E64228848F280EC0A037)] [added: Data](#ib93766b38a794f83a6a283fa0a85c17d_67)] | [removed: [45](#sBC321EEC0111E64228848F280EC0A037)] | [added: | [51](#ib93766b38a794f83a6a283fa0a85c17d_67) | | |]

| Item 9 | [added: | |] [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#sBAE4358D005D90EBDB948F2815645AAD)] [added: Disclosure](#ib93766b38a794f83a6a283fa0a85c17d_193)] | [removed: [90](#sBAE4358D005D90EBDB948F2815645AAD)] | [added: | [103](#ib93766b38a794f83a6a283fa0a85c17d_193) | | |]

| Item 9A | [added: | |] [Controls and [removed: Procedures](#s25E0A78CCE46D81C768F8F2815A26D92)] [added: Procedures](#ib93766b38a794f83a6a283fa0a85c17d_196)] | [removed: [90](#s25E0A78CCE46D81C768F8F2815A26D92)] | [added: | [105](#ib93766b38a794f83a6a283fa0a85c17d_196) | | |]

| Item 9B | [added: | |] [Other [removed: Information](#sCA75AB7F1163CA6353158F2815F6EF8D)] [added: Information](#ib93766b38a794f83a6a283fa0a85c17d_202)] | [removed: [92](#sCA75AB7F1163CA6353158F2815F6EF8D)] | [added: | [106](#ib93766b38a794f83a6a283fa0a85c17d_202) | | |]

| PART III | | | [added: | | | | | |]

| Item 10 | [added: | |] [Directors, Executive Officers and Corporate [removed: Governance](#s0153DABEC48F17820A998F281649A55D)] [added: Governance](#ib93766b38a794f83a6a283fa0a85c17d_208)] | [removed: [92](#s0153DABEC48F17820A998F281649A55D)] | [added: | [106](#ib93766b38a794f83a6a283fa0a85c17d_208) | | |]

| Item 11 | [added: | |] [Executive [removed: Compensation](#s06B613B84B99FC125A198F28165FE983)] [added: Compensation](#ib93766b38a794f83a6a283fa0a85c17d_211)] | [removed: [92](#s06B613B84B99FC125A198F28165FE983)] | [added: | [106](#ib93766b38a794f83a6a283fa0a85c17d_211) | | |]

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Yes ☒ No ¨

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

Yes ☐ No ☒

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| [SIGNATURES](#ib93766b38a794f83a6a283fa0a85c17d_235) | | | | | | [111](#ib93766b38a794f83a6a283fa0a85c17d_235) | | |

TAMIFLU® is a registered trademark of Hoffmann-La Roche Inc. HEPCLUDEX® is a registered trademark of MYR GmbH.

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| [SIGNATURES](#sDA2568D24163CD5FFF278F2817AC24AF) | | [96](#sDA2568D24163CD5FFF278F2817AC24AF) |

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We also have R&D facilities in Emeryville, Oceanside and Santa Monica, California; Gaithersburg, Maryland; Seattle, Washington; [added: Morris Plains, New Jersey;] Edmonton, Canada; and [removed: Amsterdam, Netherlands.][added: Dublin, Ireland.]

Our principal manufacturing facilities are in El Segundo, La Verne, Oceanside and San Dimas, California; [added: Morris Plains, New Jersey;] Edmonton, Canada; Cork, Ireland; and Hoofddorp, Netherlands.

For more information about our manufacturing facilities, see Item 1 - Business [removed: “Our] [added: “*Our] Manufacturing [removed: Facilities.”] [added: Facilities.*”] Our global operations include offices in Europe, North America, Asia, South America, Africa, Australia and the Middle East.

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As of February 18, [removed: 2020,] [added: 2021,] we had approximately [removed: 473] [added: 1,402] stockholders of record of our common stock.

[removed: *Performance Graph* *(1)*][added: Performance Graph(1)]

The following graph compares our cumulative total stockholder return for the past five years to two indices: the Standard & Poor’s 500 Stock Index [removed: (S&P] [added: (“S&P] 500 [removed: Index)] [added: Index”)] and the Nasdaq Biotechnology Index [removed: (NBI Index).][added: (“NBI Index”).]

[removed: ][added: ]

[removed: |] (1) [removed: |] This section is not “soliciting material,” is not deemed “filed” with the SEC and is not to be incorporated by reference in any of our filings under the Securities Act or the Exchange Act whether made before or after the date hereof and irrespective of any general incorporation language in any such filing. [removed: |]

[removed: |] (2) [removed: |] Shows the cumulative return on investment assuming an investment of $100 in our common stock, the NBI Index and the S&P 500 Index on December 31, [removed: 2014,] [added: 2015,] and assuming that all dividends were reinvested. [removed: |]

[removed: *Equity] [added: Equity] Compensation Plan [removed: Information*][added: Information]

The following table provides certain information with respect to our equity compensation plans in effect as of December 31, [removed: 2019 (in millions, except per share amounts):][added: 2020:]

| [added: (in millions, except per share amounts)] | | [added: | | | |] Number of Common Shares to be Issued Upon Exercise of Outstanding Options, Warrants and [removed: Rights] [added: Rights(1)] | | | [added: | | |] Weighted-average Exercise Price of Outstanding Options, Warrants and Rights(1) | | | | [added: | |] Number of Common Shares Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) | | [added: |]

| Plan Category | | [added: | | | |] (a) | | | [added: | | |] (b) | | | | [added: | |] (c) | | [added: |]

| Equity Compensation plans approved by security holders: | | | | | | | | | | | [added: | | | | | | | | | |]

| 2004 Equity Incentive [removed: Plan] [added: Plan(2)] | | [removed: 19.5] | | | [added: | 16.1 | | | | | |] $ | [removed: 61.35] [added: 69.43] | | | [removed: 79.2] | | [added: 85.9 | | |]

| Employee Stock Purchase [removed: Plan(2)] [added: Plan(3)] | | | | | | | | | [removed: 8.9] | | [added: | | | | | | | 7.1 | | |]

| Total equity compensation plans approved by security holders | | [removed: 19.5] | | | [added: | 16.1 | | | | | |] $ | [removed: 61.35] [added: 69.43] | | | [removed: 88.1] | | [added: 93.0 | | |]

| Equity Compensation plans not approved by security [removed: holders] [added: holders(4)] | | [removed: —] | | | [removed: —] | [added: 0.5] | | | [removed: —] | | [added: | $ | 68.57 | | | | | 10.3 | | |]

[removed: |] (1) [removed: |] Does not take into account [removed: 18] [added: 20] million restricted stock units, performance share awards or units and phantom shares, which have no exercise price and were granted under our 2004 [added: and 2018] Equity Incentive [removed: Plan. |][added: Plans.]

[removed: | (2) |] [added: (3)] Under our Employee Stock Purchase Plan, participants are permitted to purchase our common stock at a discount on certain dates through payroll deductions within a pre-determined purchase period. [removed: Accordingly, these numbers are not determinable. |]

[removed: *Issuer] [added: Issuer] Purchases of Equity [removed: Securities*][added: Securities]

In the first quarter of 2016, our Board of Directors authorized a $12.0 billion [removed: share] [added: stock] repurchase program [removed: (2016 Program)] [added: (“2016 Program”)] under which repurchases may be made in the open market or in privately negotiated transactions.

During [removed: 2019,] [added: 2020,] we repurchased and retired [removed: 26] [added: 22] million shares of our common stock for [removed: $1.7] [added: $1.6] billion through open market transactions under the 2016 Program.

The table below summarizes our stock repurchase activity for the three months ended December 31, [removed: 2019 (in thousands, except per share amounts):][added: 2020:]

| | | [added: | | | |] Total [removed: Number of Shares Purchased] [added: Number of Shares Purchased (in thousands)] | | | [removed: Average Price Paid per Share] | | | [added: Average Price Paid per Share (in dollars)] | [added: | | | | |] Total Number [removed: of Shares Purchased as] [added: of Shares Purchased as] Part of a [removed: Publicly Announced Program] [added: Publicly Announced Program (in thousands)] | | | [added: | | |] Maximum [removed: Fair Value] [added: Fair Value] of [removed: Shares that] [added: Shares that] May Yet [removed: Be Purchased Under the Program] [added: Be Purchased Under the Programs (in millions)] | | |

In the first quarter of 2020, our Board of Directors authorized a new $5.0 billion stock repurchase program [removed: (2020 Program),] [added: (“2020 Program”),] which will commence upon the completion of the 2016 Program.

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| Total | | | | | | 16.6 | | | | | | $ | 69.40 | | | | | 103.3 | | |

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(2) Includes awards and shares previously issuable under The Immunomedics, Inc. Amended and Restated 2014 Long-Term Incentive Plan (the “Immunomedics Plan”), which was assumed in connection with our acquisition of Immunomedics, Inc. and subsequently merged into the 2004 Equity Incentive Plan.

Accordingly, these numbers are not determinable.

(4) Includes awards and shares issuable under the Forty Seven, Inc. 2018 Equity Incentive Plan, which was assumed in connection with our acquisition of Forty Seven, Inc. (“Forty Seven”) and subsequently amended and restated as our 2018 Equity Incentive Plan.

*Material Features of the Gilead Sciences, Inc. 2018 Equity Incentive Plan*

The Forty Seven, Inc. 2018 Equity Incentive Plan was originally established by Forty Seven in June 2018.

In connection with Gilead’s acquisition of Forty Seven in April 2020, Gilead assumed the Forty Seven, Inc. 2018 Equity Incentive Plan, and amended and restated it as the Gilead Sciences, Inc. 2018 Equity Incentive Plan (the “2018 Plan”).

The 2018 Plan is intended to help the Company secure and retain the services of eligible award recipients, provide incentives for such persons to exert maximum efforts for the success of the Company and any affiliate, and provide a means by which the eligible recipients may benefit from increases in value of Gilead common stock.

From and after April 7, 2020, only employees and consultants of Forty Seven as of immediately prior to such date and employees and consultants of Gilead hired on or following such date are eligible to receive grants of new awards under the 2018 Plan.

The 2018 Plan provides for the award of incentive stock options and Nonstatutory stock options, each of which must generally have an exercise price equal to at least the fair market value of our common stock on the date of grant; stock appreciation rights; restricted stock awards; restricted stock unit awards; performance stock awards; other stock awards; and performance cash awards.

As of April 7, 2020, the aggregate number of shares of common stock issuable under the 2018 Plan (from and after such date) was 12,069,378.

From and after April 7, 2020, Gilead has granted restricted stock units and stock options under the 2018 Plan, and these are the only types of equity awards outstanding under the plan.

As of December 31, 2020, 10.3 million shares of Gilead common stock remained available for issuance under the 2018 Plan.

We made repurchases under the 2016 Program starting in April 2016.

As of December 31, 2020, the remaining authorized repurchase amount from both programs was $6.8 billion.

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| October 1 - October 31, 2020 | | | | | | 27 | | | | | | $ | 63.84 | | | | | — | | | | | | $ | 6,816 | |

| November 1 - November 30, 2020 | | | | | | 171 | | | | | | $ | 60.49 | | | | | — | | | | | | $ | 6,816 | |

| December 1 - December 31, 2020 | | | | | | 34 | | | | | | $ | 59.82 | | | | | — | | | | | | $ | 6,816 | |

| Total | | | | | | 232 | | | (1) | | | $ | 60.78 | | | | | — | | | (1) | | | | | |

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(1) A total of 232 thousand shares were transferred to us from employees in satisfaction of minimum tax withholding obligations associated with the vesting of restricted stock units during the period.

We did not purchase any shares of our common stock in the open market pursuant to our repurchase program.

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| Total | | 19.5 | | | $ | 61.35 | | | 88.1 | |

| _________________________________________ | | | | | | | | | | |

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| October 1 - October 31, 2019 | | 712 | | | $ | 63.84 | | | 688 | | | $ | 3,459 | |

| November 1 - November 30, 2019 | | 768 | | | $ | 65.14 | | | 557 | | | $ | 3,423 | |

| December 1 - December 31, 2019 | | 393 | | | $ | 66.59 | | | 372 | | | $ | 3,398 | |

| Total | | 1,873 | | (1) | $ | 64.95 | | | 1,617 | | (1) | | | |

| _________________________________________ | | | | | | | | | | | | | | |

| (1) | The difference between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program is due to shares of common stock withheld by us from employee restricted stock unit awards in order to satisfy applicable tax withholding obligations. |

[added: |] (in millions, except per share amounts) [added: | | | | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |]

| | [added: | | | | |] Year Ended December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| [added: (in millions)] | [added: | | | | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| CONSOLIDATED STATEMENT OF INCOME [removed: DATA(1):] [added: DATA(1):] | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | |]

| Total revenues [removed: (2)] | [added: | | | | |] $ | [removed: 22,449] [added: 24,689] | | | [added: | |] $ | [removed: 22,127] [added: 22,449] | | | [added: | |] $ | [removed: 26,107] [added: 22,127] | | | [added: | |] $ | [removed: 30,390] [added: 26,107] | | | [added: | |] $ | [removed: 32,639] [added: 30,390] | |

| Total costs and [removed: expenses] [added: expenses(2)] | [added: | | | | |] $ | [removed: 18,162] [added: 20,618] | | | [added: | |] $ | [removed: 13,927] [added: 18,162] | | | [added: | |] $ | [removed: 11,983] [added: 13,927] | | | [added: | |] $ | [removed: 12,757] [added: 11,983] | | | [added: | |] $ | [removed: 10,446] [added: 12,757] | |

| Income from [removed: operations(2)] [added: operations] | [added: | | | | |] $ | [removed: 4,287] [added: 4,071] | | | [added: | |] $ | [removed: 8,200] [added: 4,287] | | | [added: | |] $ | [removed: 14,124] [added: 8,200] | | | [added: | |] $ | [removed: 17,633] [added: 14,124] | | | [added: | |] $ | [removed: 22,193] [added: 17,633] | |

| Net [removed: income(2)(3)(4)] [added: income(2)(3)] | [added: | | | | |] $ | [removed: 5,364] [added: 89] | | | [added: | |] $ | [removed: 5,460] [added: 5,364] | | | [added: | |] $ | [removed: 4,644] [added: 5,460] | | | [added: | |] $ | [removed: 13,488] [added: 4,644] | | | [added: | |] $ | [removed: 18,106] [added: 13,488] | |

| Net income attributable to [removed: Gilead(2)(3)(4)] [added: Gilead(2)(3)] | [added: | | | | |] $ | [removed: 5,386] [added: 123] | | | [added: | |] $ | [removed: 5,455] [added: 5,386] | | | [added: | |] $ | [removed: 4,628] [added: 5,455] | | | [added: | |] $ | [removed: 13,501] [added: 4,628] | | | [added: | |] $ | [removed: 18,108] [added: 13,501] | |

| Net income per share attributable to Gilead common stockholders - [removed: basic(2)(3)(4)] [added: basic(2)(3)] | [added: | | | | |] $ | [removed: 4.24] [added: 0.10] | | | [added: | |] $ | [removed: 4.20] [added: 4.24] | | | [added: | |] $ | [removed: 3.54] [added: 4.20] | | | [added: | |] $ | [removed: 10.08] [added: 3.54] | | | [added: | |] $ | [removed: 12.37] [added: 10.08] | |

| Shares used in per share calculation - basic | [added: | | | | | 1,257 | | | | | |] 1,270 | | | | [added: | |] 1,298 | | | | [removed: 1,307] | | [added: 1,307] | | [removed: 1,339] | | | | [removed: 1,464] [added: 1,339] | | |

| Net income per share attributable to Gilead common stockholders - [removed: diluted(2)(3)(4)] [added: diluted(2)(3)] | [added: | | | | |] $ | [removed: 4.22] [added: 0.10] | | | [added: | |] $ | [removed: 4.17] [added: 4.22] | | | [added: | |] $ | [removed: 3.51] [added: 4.17] | | | [added: | |] $ | [removed: 9.94] [added: 3.51] | | | [added: | |] $ | [removed: 11.91] [added: 9.94] | |

| Shares used in per share calculation - diluted | [added: | | | | | 1,263 | | | | | |] 1,277 | | | | [added: | |] 1,308 | | | | [removed: 1,319] | | [added: 1,319] | | [removed: 1,358] | | | | [removed: 1,521] [added: 1,358] | | |

| Cash dividends declared per share | [added: | | | | |] $ | [removed: 2.52] [added: 2.72] | | | [added: | |] $ | [removed: 2.28] [added: 2.52] | | | [added: | |] $ | [removed: 2.08] [added: 2.28] | | | [added: | |] $ | [removed: 1.84] [added: 2.08] | | | [added: | |] $ | [removed: 1.29] [added: 1.84] | |

| | [added: | | | | |] December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| CONSOLIDATED BALANCE SHEET [removed: DATA(1):] [added: DATA(1):] | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | |]

| Cash, cash equivalents and marketable debt [removed: securities(5)] [added: securities(4)(5)] | [added: | | | | |] $ | [removed: 25,840] [added: 7,910] | | | [added: | |] $ | [removed: 31,512] [added: 25,840] | | | [added: | |] $ | [removed: 36,694] [added: 31,512] | | | [added: | |] $ | [removed: 32,380] [added: 36,694] | | | [added: | |] $ | [removed: 26,208] [added: 32,380] | |

| Working [removed: capital(3)(4)(5)(6)] [added: capital(3)(4)(5)] | [added: | | | | |] $ | [removed: 20,537] [added: 4,599] | | | [added: | |] $ | [removed: 25,231] [added: 20,537] | | | [added: | |] $ | [removed: 20,188] [added: 25,231] | | | [added: | |] $ | [removed: 10,370] [added: 20,188] | | | [added: | |] $ | [removed: 14,044] [added: 10,370] | |

| Total [removed: assets(5)(6)] [added: assets(4)(5)] | [added: | | | | |] $ | [removed: 61,627] [added: 68,407] | | | [added: | |] $ | [removed: 63,675] [added: 61,627] | | | [added: | |] $ | [removed: 70,283] [added: 63,675] | | | [added: | |] $ | [removed: 56,977] [added: 70,283] | | | [added: | |] $ | [removed: 51,716] [added: 56,977] | |

| Other long-term [removed: obligations(6)] [added: obligations] | [added: | | | | |] $ | [removed: 1,009] [added: 5,128] | | | [added: | |] $ | [removed: 1,040] [added: 1,009] | | | [added: | |] $ | [removed: 558] [added: 1,040] | | | [added: | |] $ | [removed: 297] [added: 558] | | | [added: | |] $ | [removed: 395] [added: 297] | |

| Long-term debt, including current [removed: portion(5)] [added: portion(4)] | [added: | | | | |] $ | [removed: 24,593] [added: 31,402] | | | [added: | |] $ | [removed: 27,322] [added: 24,593] | | | [added: | |] $ | [removed: 33,542] [added: 27,322] | | | [added: | |] $ | [removed: 26,346] [added: 33,542] | | | [added: | |] $ | [removed: 22,055] [added: 26,346] | |

| Retained [removed: earnings(2)(3)(4)(6)] [added: earnings(3)] | [added: | | | | |] $ | [removed: 19,388] [added: 14,381] | | | [added: | |] $ | [removed: 19,024] [added: 19,388] | | | [added: | |] $ | [removed: 19,012] [added: 19,024] | | | [added: | |] $ | [removed: 18,154] [added: 19,012] | | | [added: | |] $ | [removed: 18,001] [added: 18,154] | |