Gilead Sciences (GILD) 10-K risk factor changes: FY2022 vs FY2021

[removed: *HIV Products*][added: HIV]

During [removed: 2021,] [added: the year ended December 31, 2022,] sales of our HIV products accounted for approximately [removed: 60%] [added: 64%] of our total product sales.

For example, many of our HIV products contain tenofovir alafenamide (“TAF”), which belongs to the nucleoside class of antiviral [removed: therapeutics, and any changes to the treatment paradigm for HIV may cause nucleoside-based therapeutics to fall out of favor.][added: therapeutics.]

[removed: *Veklury*][added: Veklury]

We face risks related to our supply and distribution of Veklury, which was approved by [removed: the] U.S. Food and Drug Administration (“FDA”) in October 2020 as a treatment for patients hospitalized with coronavirus disease 2019 [removed: (“COVID-19”) and] [added: (“COVID-19”),] in January 2022 as a treatment for non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or [added: death, and in April 2022 as a treatment for pediatric patients who are 28 days of age (and older), weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered at high risk for progression to severe COVID-19, including hospitalization or] death.

While [removed: the utilization of] Veklury [removed: has largely tracked] [added: sales generally reflect COVID-19 related] rates [added: and severity] of [removed: COVID-19] [added: infections and] hospitalizations, [added: as well as the availability, uptake and effectiveness of vaccines and alternative treatments for COVID-19,] we are unable to accurately predict our revenues or supply needs over the [removed: short] [added: short-] and [removed: long term] [added: long-term] due to the dynamic nature of the [removed: pandemic, including the availability, uptake and effectiveness of vaccines and alternative treatments for COVID-19, fluctuating hospital utilization rates, the emergence of new variants and timing of surges in infection.][added: COVID-19 pandemic.]

If we do not accurately forecast demand or manufacture Veklury at levels [removed: sufficient] to [removed: meet] [added: align with actual] demand, then we may experience product shortages or build excess inventory that may [added: need to] be written off.

[removed: *Cell Therapy*][added: Cell Therapy]

Advancing a novel and personalized therapy such as Yescarta or Tecartus, which are chimeric antigen receptor (“CAR”) [removed: T cell] [added: T-cell] therapies, creates significant challenges, including:

We rely on third-party sites to collect patients’ white blood cells, known as apheresis centers, as well as shippers, couriers, and hospitals for the logistical collection of patients’ white blood cells and ultimate delivery of Yescarta [removed: or] [added: and] Tecartus to patients.

[removed: As a result,] [added: In addition,] we may not be able to produce or otherwise obtain an amount of [added: viral vector] supply sufficient to satisfy demand for our [added: finished] products.

If we are unable to meet product demand, we will have difficulty meeting sales forecasts for [removed: products that we plan to manufacture at this facility.][added: our finished products.]

Additionally, the non-retail sector in the [removed: United States,] [added: U.S.,] which includes government institutions, including state AIDS Drug Assistance 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 [removed: necessarily] mirror [added: actual] patient demand for our products.

We sell and distribute most of our products in the [removed: United States] [added: U.S.] exclusively through the wholesale channel.

For the year ended December 31, [removed: 2021,] [added: 2022,] approximately [removed: 91%] [added: 89%] of our product sales in the [removed: United States] [added: U.S.] were to three wholesalers, AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson Corporation.

The U.S. wholesalers with whom we have entered into inventory management agreements make estimates to determine end-user demand and may not be [removed: completely effective] [added: accurate] in matching their inventory levels to actual end-user demand.

A number of companies are pursuing the development of [added: products and] technologies [removed: which are] [added: that may be] competitive with our existing products or research programs.

[removed: *Product Reimbursements*][added: Product Reimbursements]

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

[removed: *Product] [added: Product] Pricing, Discounts and [removed: Rebates*][added: Rebates]

In the [removed: United States,] [added: U.S.,] the European Union (“EU”) and other significant or potentially significant markets for our products and product candidates, government authorities and third-party payers are increasingly attempting to limit or regulate the price of medical products and services.

[removed: In the United States, the] [added: The] volume of drug pricing-related [removed: bills] [added: legislation] has dramatically increased in recent [removed: years.][added: years, including:]

[removed: For example,] [added: - U.S.] Congress has enacted laws requiring manufacturer refunds on certain amounts of discarded drug from single-use vials beginning in 2023 and eliminating the existing cap on Medicaid rebate amounts beginning in 2024.

[removed: In addition, many] [added: - Many] state legislatures are considering, or have already passed into law, legislation that seeks to indirectly or directly regulate pharmaceutical drug pricing, such as requiring manufacturers to publicly report proprietary pricing information, creating review boards for [removed: prices to state agencies,] [added: prices,] and encouraging the use of generic drugs.

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

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

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

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

A substantial portion of our product sales is subject to significant discounts from list price, including rebates that we may be required to pay state Medicaid agencies and discounts provided to [removed: 340B] covered [removed: entities.][added: entities under Section 340B of the Public Health Service Act (“340B”).]

[removed: If these changes go into effect, they] [added: Changes to the calculation of rebates under the Medicaid program] could substantially increase our Medicaid rebate obligations and decrease the prices we charge [removed: 340B covered] [added: 340B-covered] entities.

[removed: The] [added: For example, the] continued growth of the 340B program [removed: also] limits the prices we may charge on an increasing percentage of sales.

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

[removed: In addition,] [added: Moreover,] we estimate the rebates we will be required to pay in connection with sales during a particular quarter based on claims data from prior quarters.

In the [removed: United States,] [added: U.S.,] actual rebate claims are typically made by payers one to three quarters in arrears.

We have entered into agreements with generic drug manufacturers as well as licensing agreements with the Medicines Patent Pool, a United Nations-backed public health organization, which [removed: allows] [added: allow] generic drug manufacturers to manufacture generic versions of certain of our products for distribution in certain low- and middle-income countries.

We may be adversely affected if any generic versions of our products, whether or not produced and/or distributed under these agreements, are exported to the [removed: United States, Europe] [added: U.S., the EU] or markets with higher prices.

Purchases of our products in [removed: countries] [added: member states] where our selling prices are relatively low for resale in [removed: countries] [added: member states] in which our selling prices are relatively high can affect the inventory level held by our wholesalers and can cause the relative sales levels in the various countries to fluctuate from quarter to quarter and not reflect the actual consumer demand in any given quarter.

We are also aware of the existence of various suppliers around the world [removed: that] [added: that, without Gilead’s authorization, purport to] source our products and generic versions of our products [removed: without Gilead’s authorization] and sell them for use in countries where those products have not been approved.

As a result, patients may be at risk of taking unapproved medications that may not be what they purport to be, may not have the potency they claim to have or may contain harmful substances, which could [added: harm patients and] adversely impact us.

For example, as part of [removed: an ongoing investigation] [added: a U.S. civil enforcement lawsuit] in coordination with [removed: the U.S. Marshals and local] law enforcement, [removed: we recently executed court-ordered seizures at 17 locations across eight U.S. states] and [added: pursuant to court order, we] seized thousands of bottles of Gilead-labeled medication with counterfeit supply chain [removed: documentation, including bottles labeled as Biktarvy and Descovy.][added: documentation.]

If there are any changes to the treatment or prevention paradigm for HIV that cause nucleoside-based therapeutics to fall out of favor, our HIV product sales would be adversely impacted.

We operate a new automated CAR T-cell therapy manufacturing facility in Frederick, Maryland, which received FDA approval for commercial production in April 2022.

We have not previously manufactured our products in an automated facility on a commercial scale, and as a result, we may require additional time and resources in order to effectively increase manufacturing capacity.

We also operate a new retroviral vector manufacturing facility in Oceanside, California, which received FDA approval for commercial production in October 2022.

We also have not previously manufactured viral vectors on a commercial scale, and as a result, we may require additional time and resources in order to effectively increase manufacturing capacity.

- U.S. Congress has enacted the Inflation Reduction Act of 2022 (the “Act”), which, among other changes, (1) requires the Department of Health and Human Services to “negotiate” Medicare prices for certain drugs (starting with 10 drugs in 2026, adding 15 drugs in 2027 and 2028, and adding 20 drugs in 2029 and subsequent years), (2) imposes an inflation-based rebate on Medicare Part B utilization starting in 2023 and Part D utilization beginning October 1, 2022, and (3) restructures the Medicare Part D benefit to cap out-of-pocket expenses for Part D beneficiaries beginning in 2024 and, effective January 1, 2025, increases Part D plans’ contributions in the catastrophic coverage phase and increase manufacturers’ discount contributions across coverage phases such that manufacturers must pay a 10% discount in the initial coverage phase and a 20% discount in the catastrophic phase on drugs utilized by all Part D beneficiaries, including low income subsidy patients.

We continue to evaluate the impact of the Act on our business but expect the Act will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.

In addition, it is unclear how certain provisions of the Act will be implemented, there may be additional legislation or rulemaking related to the Act and select provisions may become subject to legal challenges in the future.

Therefore, the full impact of the Act on the profitability of our business and the pharmaceutical industry as a whole remains uncertain at this time.

We recently implemented a contract pharmacy integrity initiative for our branded hepatitis C virus (“HCV”) products.

This integrity initiative will not involve any products from Asegua Therapeutics LLC.

Our integrity initiative requires covered entities that enter into 340B bill to/ship to arrangements with contract pharmacies for our branded HCV products to provide claims level data for units dispensed from such contract pharmacies; covered entities without an in-house pharmacy that choose not to participate in the initiative can designate a single contract pharmacy for shipment.

Certain manufacturers that have implemented other contract pharmacy integrity programs have received enforcement letters from the U.S. Department of Health and Human Services (“HHS”) asserting that those programs violate the 340B statute, have been referred to the HHS Office of Inspector General for assessment of civil monetary penalties, and have been subject to administrative dispute resolution proceedings brought on behalf of covered entities.

These manufacturers are currently challenging HHS’ position in ongoing litigation.

Although we believe that our integrity initiative complies with the requirements of the 340B statute, additional legal or legislative developments with respect to the 340B program, including potential litigation with HHS, may negatively impact our ability to implement or continue our integrity initiative.

For example, in October 2022, we announced that FDA issued a complete response letter for our Biologics License Application for bulevirtide for the treatment of adults with hepatitis delta virus infection.

In addition, see Note 8.

Goodwill and Intangible Assets of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K for a discussion of the partial in-process research and development impairment charge that we recognized during the three months ended March 31, 2022 related to assets we acquired from Immunomedics, Inc. (“Immunomedics”) in 2020.

Patents covering our existing compounds, products and processes, and those that we will likely file in the future, may not provide complete or adequate protection.

Filing patent applications is a fact-intensive and complex process.

We may file patent applications that ultimately do not result in patents or have patents that do not provide adequate protection for the related product.

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

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

ANDA litigation and related settlement and license agreements, in some cases, may result in a loss of exclusivity for our patents sooner than we would otherwise expect.

In addition, loss of exclusivity may be earlier than expected under these settlement and license agreements under certain circumstances.

For example, settlement and license agreements with generic manufacturers typically include acceleration clauses that permit generic entry before the agreed-upon entry date in certain circumstances, and generic manufacturers may continue to challenge the patents protecting our products.

The impact of an outbreak or other public health crisis on our results of operations and financial condition would depend on numerous evolving factors, but could involve higher operating expenses, lower demand for our products as a result of governmental, business and individuals’ actions taken in response to such an event (including quarantines, travel restrictions and interruptions to healthcare services, which can impact enrollment in or operation of our clinical trials or limit patients’ ability or willingness to access and seek care), challenges associated with the safety of our employees and safe occupancy of our job sites, and financial market volatility and significant macroeconomic uncertainty in global markets.

For example, see Part II, Item 7 of this Annual Report on Form 10-K for a discussion of our exposure to movements in foreign currency exchange rates, primarily in the Euro, and the impacts from foreign currency exchange, net of hedges, for the year ended December 31, 2022.

In addition, high inflation, such as what we are seeing in the current economic environment, has adversely impacted and may continue to adversely impact our business and financial results.

In addition, regulatory authorities may impose mandatory disclosure requirements with respect to ESG matters.

For example, in March 2022, U.S. Securities and Exchange Commission (“SEC”) proposed rule changes that would require companies to make certain climate-related disclosures, including information about climate-related risks, greenhouse gas emissions and certain climate-related financial statement metrics.

In addition, enhancements to our processes and controls to reflect evolving reporting standards may be costly and require additional resources.

Malicious actors seek to steal money, gain unauthorized access to, destroy or manipulate data, and disrupt operations, and some of their attacks may not be recognized or discovered until launched or after initial entry into the environment, such as novel or zero-day attacks that are launched before patches are available and defenses can be readied.

Malicious actors are also increasingly developing methods to avoid prevention, detection and alerting capabilities, including employing counter-forensic tactics making response activities more difficult.

For example, as a result of an impairment analysis we conducted following our receipt of data in March 2022 from the Phase 3 TROPiCS-02 study evaluating Trodelvy in patients with hormone receptor-positive, human epidermal growth receptor 2-negative metastatic breast cancer, we recognized a partial in-process research and development impairment charge on our Consolidated Statements of Income during 2022.

We operate a new automated manufacturing facility in Frederick, Maryland.

The facility is pending FDA approval for commercial manufacturing and, even if we obtain such approval, we have not manufactured our products in an automated facility on a commercial scale.

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

Congress has also proposed bills to require the Department of Health and Human Services to negotiate prices for certain drugs, impose an inflation-based rebate on Medicare Part B and D drugs when list prices for drugs grow faster than inflation, and increase manufacturer contributions in some or all of the Medicare Part D benefit phases.

For example, in December 2020, Centers for Medicare & Medicaid Services (“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.” These changes are subject to ongoing litigation.

We face numerous risks and uncertainties with our clinical trials that could result in delays or prevent completion of the development and approval of our product candidates.

For example, we recently announced clinical holds placed by FDA on clinical trials evaluating (1) injectable lenacapavir, (2) lenacapavir in combination with islatravir and (3) magrolimab, including in combination with azacitidine.

In 2022, we anticipate the continued expansion of our clinical pipeline, which includes multiple planned Phase 3 study initiations in oncology and virology.

A significant portion of the raw materials and intermediates used to manufacture our antiviral products are supplied by third-party manufacturers and corporate partners outside of the United States.

For example, a great deal of our liposomal manufacturing expertise, which is a key component of our liposomal technology, is not covered by patents but is instead protected as a trade secret.

For example, the COVID-19 pandemic has caused significant volatility and uncertainty in U.S. and international markets and has resulted in increased risks and adverse impacts to our operations, including as described below.

In addition to the developments discussed in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” we are monitoring a number of risks related to the pandemic, including the following:

For example, quarantines, shelter-in-place and other governmental orders and policies, travel restrictions, airline capacity and route reductions, safety guidelines and health impacts of the pandemic could impact the availability or productivity of products and personnel at manufacturers, distributors, freight carriers and other necessary components of our supply chain.

In addition, there may be unfavorable changes in the availability or cost of raw materials, intermediates and other materials necessary for production, which may result in higher costs, disruptions in our supply chain and interruptions in our distribution capabilities.

- Clinical Trials: The pandemic has adversely affected and may continue to adversely affect certain of our clinical trials, including our ability to initiate and complete our clinical trials within the anticipated timelines.

For ongoing trials, clinical trial sites have imposed restrictions on patient visits to limit risks of possible COVID-19 exposure, and we may experience issues with participant compliance with clinical trial protocols as a result of quarantines, travel restrictions and interruptions to healthcare services.

There is also a risk that closures at clinical sites may be necessary as the pandemic and related guidance and restrictions continue to evolve.

For the foregoing reasons, we have experienced delays with new subject enrollment for most clinical trials during the course of the pandemic, and may continue to experience overall delays in our clinical trials.

There is also the risk of biased data collection if only certain clinical trial sites remain open.

As a result of these challenges, our anticipated filing and marketing timelines for certain products may be adversely impacted.

- Regulatory Reviews: The operations of FDA, EMA or other regulatory agencies may be adversely affected.

We may also experience delays in necessary interactions with regulatory authorities around the world, including with respect to any anticipated filing, which, together with other factors resulting from the pandemic, may adversely impact our ability to launch new commercial products.

- Access to Healthcare Providers: The pandemic has limited patients’ ability or willingness to access and seek care from healthcare providers and initiate or continue therapies, which has resulted in lower demand for our products during the course of the pandemic, particularly with respect to hepatitis C virus (“HCV”) treatment and HIV treatment and prevention.

For example, we have observed lower levels of patient visits and testing volumes in HCV, resulting in fewer patient starts.

In addition, at times during the pandemic, we have seen lower levels of screening and diagnosis for HIV, resulting in fewer treatment initiations, as well as higher levels of discontinuations, resulting in a reduction in prescription refills.

With increased levels of unemployment at times during the pandemic, we have also experienced shifts in payer mix towards more government-funded coverage and the uninsured segment.

Our field personnel have also had reduced access to healthcare personnel during the pandemic, including fewer in-person interactions, which has adversely impacted and may continue to adversely impact our commercial activities.

- Employees: We face risks related to the health, safety, morale and productivity of our employees, including the safe occupancy of our sites during the pandemic.

In the fourth quarter of 2021, we transitioned to a return-to-site phase for our U.S. flexible location employees.

Our job site enhancements and risk protocols, which include health screenings and COVID-19 testing and vaccine requirements, do not guarantee that we can maintain the continued safe occupancy of our sites and may adversely impact employee recruitment and retention.

On-site employees testing positive for COVID-19 could lead to mandatory quarantines and potential site shutdowns.

- Financial: The pandemic has had, and may continue to have, an adverse financial impact in the short term and potentially beyond.

In particular, our HCV and HIV businesses have been and continue to be adversely impacted.

For example, we have observed reductions in the overall U.S. HCV treatment, HIV treatment and HIV pre-exposure prophylaxis (“PrEP”) volumes at times during the pandemic, and it is uncertain when these volumes will all return to pre-pandemic levels.

We may continue to experience fluctuating revenues as infection rates rise and fall and as pandemic restrictions are periodically tightened and eased.

We have also experienced, and may continue to experience, volatility in our short-term revenues due to fluctuations in inventory channel purchases during the pandemic.

We could also have additional unexpected expenses related to the pandemic, which could negatively affect our results of operations.

These factors together with the overall uncertainty and disruption caused by the pandemic could result in increased volatility and decreased predictability in our results of operations and volatility in our stock price.

The extent to which the pandemic impacts our business and results will depend on future developments, which are uncertain and cannot be predicted with confidence, including any potential future waves of the pandemic, new variants of the virus that impact the severity and duration of the pandemic, the development, distribution, effectiveness and public acceptance of vaccines, and any other ongoing and future actions taken to contain the pandemic.

[removed: MD&A is provided as a supplement to,] [added: to management relevant to an assessment of the financial condition] and [added: results of operations of Gilead and] should [added: therefore] be read in conjunction [removed: with,] [added: with] our audited Consolidated Financial Statements and the accompanying Notes to Consolidated Financial Statements and other disclosures included in this Annual Report on Form 10-K (including the disclosures under Part I, Item 1A.

Additional information related to the comparison of our results of operations between the years [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] is included in Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations of our [removed: [2020] [added: [2021] Form [removed: 10-K](https://www.sec.gov/ix?doc=/Archives/edgar/data/882095/000088209521000008/gild-20201231.htm)] [added: 10-K](http://www.sec.gov/ix?doc=/Archives/edgar/data/882095/000088209522000007/gild-20211231.htm)] filed with the U.S. Securities and Exchange Commission [removed: (the “SEC”).][added: (“SEC”).]

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

[removed: Cell Therapy][added: *Cell Therapy*]

The transaction closed in [removed: December 2021.][added: February 2023.]

- In [removed: September 2021, Health Canada] [added: February 2023, we announced that FDA has] approved Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic [removed: TNBC] [added: HR+/HER2- breast cancer] who have received [removed: two or more therapies,] [added: endocrine-based therapy and] at least [removed: one of them for] [added: two additional systemic therapies in the] metastatic [removed: disease.][added: setting.]

Readers are [removed: also] encouraged to review all [removed: other] press releases available on our website [removed: mentioned above.][added: at www.gilead.com.]

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

| (in millions, except percentages and per share amounts) | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | Change | | |

| Total revenues | | | | | | $ | [removed: 27,305] [added: 27,281] | | | | | $ | [removed: 24,689] [added: 27,305] | | | | | [removed: *11*] [added: *—*] | | *%* |

| Net income attributable to Gilead | | | | | | $ | [removed: 6,225] [added: 4,592] | | | | | $ | [removed: 123] [added: 6,225] | | | | | [removed: *NM*] [added: *(26)*] | | [added: *%*] |

| [removed: Net income] [added: Diluted earnings] per share attributable to Gilead [removed: common stockholders - diluted] | | | | | | $ | [removed: 4.93] [added: 3.64] | | | | | $ | [removed: 0.10] [added: 4.93] | | | | | [removed: *NM*] [added: *(26)*] | | [added: *%*] |

Net income attributable to Gilead was [removed: $6.2] [added: $4.6] billion or [removed: $4.93] [added: $3.64] diluted earnings per share [added: attributable to Gilead] in [removed: 2021,] [added: 2022,] compared to [removed: $123 million] [added: $6.2 billion] or [removed: $0.10] [added: $4.93] diluted earnings per share [added: attributable to Gilead] in [removed: 2020.][added: 2021.]

Strategy and [removed: Outlook 2022][added: Outlook]

[removed: Our] [added: Since 2019, our] strategic ambitions [removed: are] [added: have been] 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.

The following table summarizes the period-over-period changes in our [added: Total] revenues:

| | | | | | | Year Ended December 31, [removed: 2021] [added: 2022] | | | | | | | | | | | | | | | | | | | | | | | | Year Ended December 31, [removed: 2020] [added: 2021] | | | | | | | | | | | | | | | | | | | | | | | | | | |

| HBV/HDV | | | | | | [removed: 397] [added: 435] | | | | | | [removed: 104] [added: 112] | | | | | | [removed: 468] [added: 441] | | | | | | [removed: 969] [added: 988] | | | | | | [removed: 380] [added: 397] | | | | | | [removed: 71] [added: 104] | | | | | | [removed: 409] [added: 468] | | | | | | [removed: 860] [added: 969] | | | | | | [removed: *13*] [added: *2*] | | *%* |

| Cell Therapy | | | | | | [removed: 542] [added: 968] | | | | | | [removed: 293] [added: 430] | | | | | | [removed: 36] [added: 60] | | | | | | [removed: 871] [added: 1,459] | | | | | | [removed: 396] [added: 542] | | | | | | [removed: 201] [added: 293] | | | | | | [removed: 10] [added: 36] | | | | | | [removed: 607] [added: 871] | | | | | | [removed: *43*] [added: *68*] | | *%* |

| Trodelvy | | | | | | [removed: 370] [added: 525] | | | | | | [removed: 10] [added: 143] | | | | | | [removed: —] [added: 12] | | | | | | [removed: 380] [added: 680] | | | | | | [removed: 49] [added: 370] | | | | | | [removed: —] [added: 10] | | | | | | — | | | | | | [removed: 49] [added: 380] | | | | | | [removed: *NM*] [added: *79*] | | [added: *%*] |

| Total product sales | | | | | | [removed: 19,176] [added: 18,716] | | | | | | [removed: 4,678] [added: 4,342] | | | | | | [removed: 3,154] [added: 3,924] | | | | | | [removed: 27,008] [added: 26,982] | | | | | | [removed: 18,141] [added: 19,176] | | | | | | [removed: 3,894] [added: 4,678] | | | | | | [removed: 2,320] [added: 3,154] | | | | | | [removed: 24,355] [added: 27,008] | | | | | | [removed: *11*] [added: *—*] | | *%* |

| Royalty, contract and other revenues | | | | | | [removed: 91] [added: 168] | | | | | | [removed: 196] [added: 127] | | | | | | [removed: 10] [added: 4] | | | | | | [removed: 297] [added: 299] | | | | | | [removed: 76] [added: 91] | | | | | | [removed: 241] [added: 196] | | | | | | [removed: 17] [added: 10] | | | | | | [removed: 334] [added: 297] | | | | | | [removed: *(11)*] [added: *1*] | | *%* |

| Total revenues | | | | | | $ | [removed: 19,267] [added: 18,884] | | | | | $ | [removed: 4,874] [added: 4,469] | | | | | $ | [removed: 3,164] [added: 3,928] | | | | | $ | [removed: 27,305] [added: 27,281] | | | | | $ | [removed: 18,217] [added: 19,267] | | | | | $ | [removed: 4,135] [added: 4,874] | | | | | $ | [removed: 2,337] [added: 3,164] | | | | | $ | [removed: 24,689] [added: 27,305] | | | | | [removed: *11*] [added: *—*] | | *%* |

[removed: *Product Sales*][added: | % of gross product sales | | | | | | 35 | | % | | | | 35 | | % | | | | | | |]

Sales of Veklury [removed: are] generally [removed: affected by] [added: reflect] COVID-19 related rates [added: and severity] of [removed: infections, hospitalizations] [added: infections] and [removed: vaccinations] [added: hospitalizations,] as well as the availability, uptake and effectiveness of [added: vaccinations and] alternative treatments for COVID-19.

HCV product sales decreased by [removed: 9%] [added: 4%] to [removed: $1.9] [added: $1.8] billion in [removed: 2021,] [added: 2022,] compared to [removed: $2.1 billion in 2020,] [added: 2021,] primarily due to [removed: lower demand driven by] [added: unfavorable foreign currency exchange impact,] fewer patient starts [removed: worldwide due to the impact of the COVID-19 pandemic.][added: and unfavorable pricing dynamics.]

HBV and HDV product sales increased by [removed: 13%] [added: 2%] to [removed: $969] [added: $988] million in [removed: 2021,] [added: 2022,] compared to [removed: $860 million in 2020,] [added: 2021,] primarily due to higher [removed: Vemlidy product sales due to higher] demand [removed: in all geographies, partially offset by lower Viread product sales] [added: for Vemlidy and the continued adoption of Hepcludex] in [removed: Other international locations.][added: Europe.]

Of our total product sales, [removed: 29%] [added: 31%] and [removed: 26%] [added: 29%] were generated outside the [removed: United States] [added: U.S.] in [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] respectively.

Foreign currency exchange, net of hedges, had [removed: a favorable] [added: an unfavorable] impact on our total product sales of [removed: $141] [added: $608] million in [removed: 2021,] [added: 2022,] based on a comparison using foreign currency exchange rates from [removed: 2020, largely driven by Euro-based product sales.][added: 2021.]

The following table summarizes the period-over-period changes in our [removed: product sales:][added: Income tax expense:]

| [removed: | | | | | | Year Ended December 31, 2021 | | | | | | | | | | | | | | | | | | | | | | | | Year Ended] [added: Year ended] December 31, [removed: 2020 | | | | | | | | | | | |] [added: 2022:] | | | | | | | | | | | | | | | | | | | | | | | | | | |

[removed: | Other HIV(2) | | | | | | 15 | | | | | | 18 | | | | | | 17 | | | | | | 50 | | | | | | 25 | | | | | | 5 | | | | | | 28 | | | | | | 58 | | | | | | *(14)* | | *%* | | | | | | | | | | | | |][added: *Other*]

| [removed: (In] [added: (in] millions, except percentages) | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | Change | | |

| Cost of goods sold | | | | | | $ | [removed: 6,601] [added: 5,657] | | | | | $ | [removed: 4,572] [added: 6,601] | | | | | [removed: *44*] [added: *(14)*] | | *%* |

| Product gross margin | | | | | | [removed: 75.6] [added: 79.0] | | % | | | | [removed: 81.2] [added: 75.6] | | % | | | | [removed: *\-560] [added: *347] bps* | | |

[removed: |] Research and [removed: development (“R&D”) expenses | | | | | | $ | 5,363 | | | | | $ | 5,039 | | | | | *6* | | *%* |][added: Development Expenses]

| Selling, general and administrative [removed: (“SG&A”)] expenses | | | | | | $ | [removed: 5,246] [added: 5,673] | | | | | $ | [removed: 5,151] [added: 5,246] | | | | | [removed: *2*] [added: *8*] | | *%* |

[removed: *Product] [added: Product] Gross [removed: Margin*][added: Margin]

[removed: *Research] [added: | Research] and [removed: Development Expenses*][added: development expenses | | | | | | $ | 4,977 | | | | | $ | 4,601 | | | | | *8* | | *%* |]

The following discussion and analysis is intended to provide material information around events and uncertainties known

Risk Factors) where other material events and uncertainties not otherwise discussed below are disclosed.

Certain amounts and percentages herein may not sum or recalculate due to rounding.

Our strategic priorities for 2023 and beyond, reflecting how we plan to deliver those ambitions, are: (i) maximize near-term revenue growth; (ii) maximize impact of long-active HIV; (iii) expand and deliver on oncology programs; (iv) champion an environment of inclusion and employee growth; and (v) remove barriers to speed in execution.

We plan to provide consistent execution on a portfolio with quality, depth and breadth, including continued growth in our leading HIV portfolio, which is poised to shape the long-acting market following our first lenacapavir approvals, as well as strong commercial performance and clinical momentum for our fast-growing oncology business.

Key Business Updates

During 2022, we continued to advance our portfolio, receiving approvals across various therapeutic areas, indications and geographies.

We ended the year with Sunlenca receiving its first approval in the U.S. for heavily-treatment experienced individuals, following the first European market approval by the European Commission (“EC”).

This is the first twice-yearly, subcutaneous HIV medicine to be approved.

We also continued to broaden therapies available in oncology, receiving approvals for additional indications of Yescarta and Tecartus, and the 2023 approval of Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

In terms of capital resources, we continued to invest in our business and research and development (“R&D”) pipeline through acquisitions and collaborations.

We also continued to provide shareholder returns in the form of dividends and share repurchases.

The following highlights are taken from press releases recently issued.

Virology

- In December 2022, we announced U.S. Food and Drug Administration (“FDA”) approval of Sunlenca, in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.

- In November 2022, we announced the EC authorized an extended indication and line extension for a low-dosage tablet form of Biktarvy for the treatment of HIV in virologically suppressed children who are at least 2 years of age and weigh at least 14 kg.

- In November 2022, we announced FDA approval of Vemlidy for the treatment of chronic hepatitis B virus (“HBV”) infection in pediatric patients 12 years and older with compensated liver disease.

- In October 2022, we announced that Merck & Co., Inc. (“Merck”) and Gilead plan to resume their Phase 2 study under an amended protocol.

The study will evaluate an investigational once-weekly oral combination treatment regimen of Merck’s islatravir at a lower weekly dose and Gilead’s lenacapavir.

- In August 2022, we announced that EC has granted marketing authorization for Sunlenca (lenacapavir) for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.

- In July 2022, we received a positive opinion from European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) for Veklury to be granted full marketing authorization for the treatment of coronavirus disease 2019 (“COVID-19”) in adults and adolescents with pneumonia requiring supplemental oxygen and adults who do not require supplemental oxygen and are at increased risk of developing severe COVID-19.

- In May 2022, we announced FDA lifted the clinical hold placed on the Investigational New Drug Application to evaluate injectable lenacapavir for HIV treatment and pre-exposure prophylaxis following the agency’s review of the storage and compatibility data of lenacapavir injection with an alternate vial made from aluminosilicate glass.

- In April 2022, FDA approved a supplemental new drug application for Veklury for the treatment of pediatric patients under 12 years of age for the treatment of COVID-19.

- In December 2022, we entered into an agreement to acquire Tmunity Therapeutics Inc. (“Tmunity”), a clinical stage private biotech company, which will provide us with preclinical and clinical programs, including an “armored” CAR T technology platform that has the potential to be applied to a variety of CAR Ts to enhance anti-tumor activity, as well as rapid manufacturing processes.

- In December 2022, we entered into a strategic collaboration with Arcellx, Inc. (“Arcellx”) to co-develop and co-commercialize CART-ddBCMA, a late-stage clinical asset in development for the treatment of multiple myeloma.

The transaction closed in January 2023.

- In December 2022, we announced the transfer of the marketing authorization for Yescarta in Japan from Daiichi Sankyo Co., Ltd. to Gilead K.K. in 2023.

- In December 2022, we received approval from the Ministry of Health, Labour and Welfare in Japan for Yescarta for the initial treatment of relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”).

- In October 2022, we received European marketing authorization for Yescarta use in adults with second-line diffuse LBCL.

Additionally, EC granted marketing authorization for Tecartus for the treatment of adult R/R B-cell precursor acute lymphoblastic leukemia (“ALL”), and in Canada, we received conditional marketing authorization for Yescarta for R/R follicular lymphoma (“FL”) after two or more lines of systemic therapy.

- In July 2022, we received a positive opinion from EMA’s CHMP for Tecartus for the treatment of adult patients 26 years of age and above with R/R B-cell precursor ALL.

- In June 2022, EC approved Yescarta for the treatment of adult patients with R/R FL after three or more lines of systemic therapy.

- In April 2022, FDA approved commercial production at our new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

- In April 2022, FDA granted approval to Yescarta as initial treatment for adults with LBCL that is refractory to or relapses within 12 months of first-line chemoimmunotherapy.

- In January 2023, we announced that EMA has validated a Type II variation of the Marketing Authorization Application for Trodelvy for the treatment of adult patients unresectable or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

- In December 2022, we acquired the remaining rights to GS-1811, an anti-CCR8 antibody developed by Jounce Therapeutics, Inc. (“Jounce”) for the treatment of solid tumors.

- In October 2022, we announced a strategic collaboration with MacroGenics, Inc. (“MacroGenics”) to develop bispecific antibodies to treat various cancers.

The agreement includes an upfront payment by us of $60 million to MacroGenics and an exclusive option granted to us on MGD024, an investigational CD123 and CD3 bispecific.

- In August 2022, we announced an agreement with Everest Medicines (“Everest”) to transfer all development and commercialization rights to Gilead for Trodelvy in Greater China, South Korea, and other Asian markets.

- In April 2022, we entered into a strategic research collaboration agreement with Dragonfly Therapeutics, Inc. (“Dragonfly”) to develop natural killer cell engager-based immunotherapies for oncology and inflammation indications.

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

Risk Factors).

Our Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles and are presented in U.S. dollars.

Our portfolio of marketed products includes AmBisome®, Atripla®, Biktarvy®, Cayston®, Complera®, Descovy®, Descovy for PrEP®, Emtriva®, Epclusa®, Eviplera®, Genvoya®, Harvoni®, Hepcludex® (bulevirtide), Hepsera®, Jyseleca® (filgotinib), Letairis®, Odefsey®, Ranexa®, Sovaldi®, Stribild®, Tecartus®, Trodelvy®, Truvada®, Truvada for PrEP®, Tybost®, Veklury®, Vemlidy®, Viread®, Vosevi®, Yescarta® and Zydelig®.

The approval status of Hepcludex and Jyseleca vary worldwide, and Hepcludex and Jyseleca are not approved in the United States.

We also sell and distribute authorized generic versions of Epclusa and Harvoni in the United States through our separate subsidiary, Asegua Therapeutics, LLC.

In addition, we sell and distribute certain products through our corporate partners under collaborative agreements.

Business Highlights(1)

We delivered strong financial performance in 2021.

Veklury continued to play a critical role in addressing the coronavirus disease 2019 (“COVID-19”) pandemic.

Veklury’s performance helped mitigate the impacts of COVID-19 on other parts of the business, including on our HIV and chronic hepatitis C virus (“HCV”) franchises, and the impacts of the October 2020 loss of exclusivity of Truvada and Atripla in the United States.

Despite these transitory headwinds, underlying demand for our virology portfolio remained strong, led by the continued growth of our Biktarvy franchise.

We also received increased contributions from our oncology franchise, experiencing growth in Trodelvy, as well as our Cell Therapy franchise.

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

During 2021, we announced an additional six filings for regulatory approval.

In addition to investing in our internal pipeline programs, we also continued to enter into and leverage our existing strategic collaborations and partnerships, including opting into four additional pipeline assets from our collaboration with Arcus Biosciences, Inc. (“Arcus”) to further develop the foundation for a more sustainable and diversified business.

*Viral Diseases*

- In October 2021, U.S. Food and Drug Administration (“FDA”) approved a new low-dose tablet dosage form of Biktarvy for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

- In August 2021, our Marketing Authorization Application for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, was fully validated and is now under evaluation with the European Medicines Agency (“EMA”).

- In June 2021, FDA granted approval of a new oral pellet formulation of Epclusa, expanding the pediatric indication to treat children as young as 3 years of age with chronic HCV.

- In June 2021, we submitted a New Drug Application to FDA for lenacapavir, an investigational, long-acting agent in development for the treatment of HIV-1 in people with limited therapy options.

- In March 2021, we entered into an agreement with Merck Sharp & Dohme Corp. (“Merck”), a subsidiary of Merck & Co., Inc., to jointly develop and commercialize long-acting investigational treatments in HIV that combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir.

- In March 2021, we completed the acquisition of MYR GmbH (“MYR”).

The acquisition provides us with Hepcludex, which is conditionally approved by EMA for the treatment of chronic hepatitis delta virus (“HDV”) in adults with compensated liver disease.

*COVID-19*

- In January 2022, FDA granted expedited approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death.

- In December 2021, the European Commission granted approval to expand the indication for Veklury for use in the earlier stages of the disease in adult patients who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.

- In April 2021, we announced that we will (i) provide assistance and support for expansion of local manufacturing capacity of remdesivir in India and will donate the active pharmaceutical ingredient and (ii) donate a minimum of 450,000 vials of Veklury (remdesivir) to the government of India.

- In January 2022, FDA approved an update to the prescribing information for Yescarta to include the use of prophylactic corticosteroids across all approved indications.

Yescarta is now the first and only chimeric antigen receptor (“CAR”) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects.

- In October 2021, FDA approved Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”).

Tecartus is the first and only CAR T cell therapy approved for adults with ALL.

*•*In September 2021, Kite, a Gilead company (“Kite”) submitted a supplemental Biologics License Application to FDA for Yescarta to expand its current indication to include the treatment of adults with relapsed or refractory large B-cell lymphoma (“LBCL”) in the second-line setting.

- In August 2021, Kite and Appia Bio, Inc. entered into a collaboration and license agreement to research and develop hematopoietic stem cell derived cell therapies directed toward hematological malignancies.

- In June 2021, Kite entered into a research collaboration and license agreement with Shoreline Biosciences, Inc. to develop novel allogeneic cell therapies across a variety of cancer targets.

*•*In June 2021, Fosun Kite Biotechnology Co. Ltd, a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd, received approval from the China National Medical Products Administration for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory LBCL in China.

*•*In March 2021, FDA granted accelerated approval of Yescarta for the treatment of adult patients with relapsed or refractory follicular lymphoma (“FL”).

- In January 2022, we entered into a clinical trial collaboration agreement with Merck to evaluate Trodelvy in combination with Merck’s anti-programmed death receptor-1 (“PD-1”) therapy, Keytruda, in a first-line setting for patients with non-small cell lung cancer (“NSCLC”).

- In November 2021, the European Commission granted marketing authorization for Trodelvy for treatment of metastatic triple-negative breast cancer (“TNBC”) in adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.

- In November 2021, we exercised options to three programs in the clinical-stage portfolio of Arcus, including anti-TIGIT molecules domvanalimab and AB308, as well as clinical candidates etrumadenant (dual adenosine A2a/A2b receptor antagonist) and quemliclustat (small molecule CD73 inhibitor).

We are exposed to market risks that may result from changes in foreign currency exchange rates, interest [removed: rates, credit risks] [added: rates] and [removed: market] [added: credit, and equity] prices.

To reduce certain of these risks, we enter into various types of foreign currency [removed: or interest rate] derivative hedging transactions, follow investment guidelines and monitor outstanding receivables as part of our risk management program.

Foreign Currency Exchange [added: Rate] Risk

Conversely, when the U.S. dollar weakens against these currencies, the relative value of such sales [removed: increase.][added: increases.]

Approximately [removed: 26%] [added: 29%] of our product sales were denominated in foreign currencies during [removed: 2021.][added: 2022.]

To partially mitigate the impact of changes in currency exchange rates on net cash flows from our foreign currency denominated sales, we [removed: may] enter into foreign currency exchange forward [removed: or option] contracts.

As of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] we had open foreign currency forward contracts with notional amounts of [removed: $2.9] [added: $3.0] billion and [removed: $2.4] [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 as of December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] would have resulted in a reduction in fair value of these contracts of approximately [removed: $333] [added: $299] million and [removed: $249] [added: $333] million, respectively, and if realized, would have negatively affected earnings over the remaining life of the contracts.

Interest Rate [added: and Credit] Risk

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

The following table summarizes the expected maturities and average interest rates of our interest-generating assets and interest-bearing liabilities as of December 31, [removed: 2021:][added: 2022:]

| (in millions, except percentages) | | | | | | | | | [removed: 2022] [added: 2023] | | | | | | | | | [removed: 2023] [added: 2024] | | | | | | | | | [removed: 2024] [added: 2025] | | | | | | | | | [removed: 2025] [added: 2026] | | | | | | | | | [removed: 2026] [added: 2027] | | | | | | | | | Thereafter | | | | | | | | | Total | | | | | | | | | | | |

| Senior unsecured fixed rate notes, including current portion(1) | | | | | | $ | | | [removed: 1,500] [added: 2,250] | | | | | | $ | | | [removed: 2,250] [added: 1,750] | | | | | | $ | | | 1,750 | | | | | | $ | | | [removed: 1,750] [added: 2,750] | | | | | | $ | | | [removed: 2,750] [added: 2,000] | | | | | | $ | | | [removed: 15,750] [added: 13,750] | | | | | | $ | | | [removed: 25,750] [added: 24,250] | | | | | | $ | | | [removed: 28,599] [added: 21,872] | | |

| Average interest rate | | | | | | | | | [removed: 2.82] [added: 1.33] | | % | | | | | | | [removed: 1.33] [added: 3.70] | | % | | | | | | | [removed: 3.70] [added: 3.50] | | % | | | | | | | [removed: 3.50] [added: 3.65] | | % | | | | | | | [removed: 3.65] [added: 2.29] | | % | | | | | | | [removed: 3.84] [added: 4.07] | | % | | | | | | | | | | | | | | | | | | |

There were no amounts outstanding under the five-year revolving credit facility as of December 31, [removed: 2021.][added: 2022.]

See Note [removed: 12.][added: 11.]

[removed: Market] [added: Equity] Price Risk

The fair value of these equity securities was approximately [removed: $1.8] [added: $1.2] billion and [removed: $2.4] [added: $1.8] billion as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] respectively.

A hypothetical 20% increase or decrease in the stock prices of these equity securities would have increased or decreased their fair value as of December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] by approximately [removed: $364] [added: $239] million and [removed: $478] [added: $364] million, respectively.

We may also enter into other transactions, such as interest rate derivative hedges, as needed.

| Available-for-sale debt securities | | | | | | $ | | | 1,048 | | | | | | $ | | | 830 | | | | | | $ | | | 382 | | | | | | $ | | | 19 | | | | | | $ | | | 4 | | | | | | $ | | | 9 | | | | | | $ | | | 2,293 | | | | | | $ | | | 2,293 | | |

| Average interest rate | | | | | | | | | 2.55 | | % | | | | | | | 3.41 | | % | | | | | | | 3.83 | | % | | | | | | | 5.09 | | % | | | | | | | 2.42 | | % | | | | | | | 2.07 | | % | | | | | | | | | | | | | | | | | | |

| Available-for-sale debt securities | | | | | | $ | | | 1,188 | | | | | | $ | | | 599 | | | | | | $ | | | 643 | | | | | | $ | | | 37 | | | | | | $ | | | 7 | | | | | | $ | | | 23 | | | | | | $ | | | 2,497 | | | | | | $ | | | 2,497 | | |

| Average interest rate | | | | | | | | | 0.46 | | % | | | | | | | 0.61 | | % | | | | | | | 0.60 | | % | | | | | | | 1.09 | | % | | | | | | | 0.57 | | % | | | | | | | 0.60 | | % | | | | | | | | | | | | | | | | | | |

[removed: *Products*][added: Products]

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

In [removed: 2021,] [added: 2022,] our primary revenue-generating products and the approved indications in the [removed: United States] [added: U.S.] were as follows:

[removed: *HIV/AIDS*][added: HIV]

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

Genvoya is a single-tablet regimen of a fixed-dose combination of our antiretroviral [removed: medicines,] [added: medications,] elvitegravir, cobicistat, [removed: emtricitabine] [added: FTC] and TAF.

Descovy is a fixed-dose combination of our antiretroviral medications, [removed: emtricitabine] [added: FTC] and TAF.

Odefsey is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, [removed: emtricitabine] [added: FTC] and TAF, and rilpivirine marketed by Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”).

Truvada is a fixed-dose combination of our antiretroviral medications, [removed: tenofovir disoproxil fumarate (“TDF”)] [added: TDF] and [removed: emtricitabine.][added: FTC.]

The product, marketed in the [removed: United States] [added: U.S.] 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 [removed: emtricitabine,] [added: FTC,] and Janssen’s rilpivirine hydrochloride.

Stribild is a single-tablet regimen of a fixed-dose combination of our antiretroviral medications, elvitegravir, cobicistat, TDF and [removed: emtricitabine.][added: FTC.]

[removed: *COVID-19*][added: COVID-19]

- Veklury® (remdesivir), an injection for intravenous use, is a nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (“COVID-19”) in certain adults and [removed: children 12 years] [added: pediatric patients (28 days] of age and older and weighing at least [removed: 88 pounds (40] [added: 3] kg) who are (i) hospitalized or (ii) not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or [removed: death*.][added: death.]

[removed: *This] [added: (2) This] indication received [removed: expedited approval by] FDA [added: approval] in [removed: January 2022.][added: February 2023.]

- Epclusa® is an oral formulation of a once-daily single-tablet regimen of sofosbuvir and velpatasvir for the treatment of chronic hepatitis C virus (“HCV”) infection in adults and [removed: certain] pediatric patients [added: 3 years of age and older] with genotype 1, 2, 3, 4, 5 or 6: (i) without cirrhosis or with compensated cirrhosis or (ii) with decompensated cirrhosis for use in combination with ribavirin.

- Harvoni® is an oral formulation of a once-daily, single-tablet regimen of ledipasvir and sofosbuvir for the treatment of chronic HCV infection [removed: in: (i)] [added: in] adults [removed: with] [added: and pediatric patients 3 years of age and older with: (i)] genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis, (ii) [removed: adults with] genotype 1 with decompensated cirrhosis, in combination with ribavirin, (iii) [removed: adults with] genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with [removed: ribavirin, or (iv) certain pediatric patients with genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis.][added: ribavirin.]

- Vemlidy® is an oral formulation of TAF dosed once a day for the treatment of chronic hepatitis B virus (“HBV”) infection in adults [added: and pediatric patients 12 years of age and older] with compensated liver disease.

- Viread® is an oral formulation of TDF dosed once a day for the treatment of chronic HBV infection in adults and [removed: certain] pediatric [removed: patients.][added: patients 2 years of age and older and weighing at least 10 kg.]

- Yescarta® (axicabtagene ciloleucel), a suspension for intravenous infusion, is a chimeric antigen receptor (“CAR”) T-cell therapy for the treatment of (i) adult patients with [removed: relapsed or refractory] large B-cell lymphoma [added: (“LBCL”) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, (ii) adult patients with relapsed or refractory LBCL] after two or more lines of systemic therapy, including diffuse [removed: large B-cell lymphoma] [added: LBCL] (“DLBCL”) not otherwise specified, primary mediastinal [removed: large B-cell lymphoma,] [added: LBCL,] high-grade B-cell lymphoma and DLBCL arising from follicular [removed: lymphoma,] [added: lymphoma (“FL”),] and [removed: (ii)] [added: (iii)] adult patients with relapsed or refractory [removed: follicular lymphoma (“FL”)] [added: FL] after two or more lines of systemic [removed: therapy*.][added: therapy.(1)]

[removed: *This] [added: (1) This] indication is approved under accelerated approval by FDA, and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

- Tecartus® (brexucabtagene autoleucel), a suspension for intravenous infusion, is a CAR [removed: T cell] [added: T-cell] therapy for the treatment of [removed: (i)] adult patients with [added: (i)] relapsed or refractory mantle cell lymphoma [removed: (“MCL”)] [added: (“MCL”)(1)] and (ii) [removed: adult patients with] relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”).

- Trodelvy® (sacituzumab govitecan-hziy), an injection for intravenous use, is a Trop-2 directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of [removed: (i)] adult patients with [added: (i)] unresectable locally advanced or metastatic triple-negative breast cancer (“TNBC”) who have received two or more prior systemic therapies, at least one of them for metastatic disease, [removed: and] (ii) [removed: adult patients with] [added: unresectable] locally advanced or metastatic [added: hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting(2) and (iii) locally advanced or metastatic] urothelial cancer [added: (“UC”)] who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (“PD-1”) or programmed death-ligand 1 (“PD-L1”) [removed: inhibitor*.][added: inhibitor.(1)]

[removed: *Other*][added: Other]

For [removed: information about our revenue-generating products, including] the [removed: amount of] [added: disaggregated] revenue [added: amounts] contributed by the products listed [removed: above,] [added: above as well as the total product sales that include our other approved products,] see Note 2.

[removed: *Revenue] [added: Revenue] Share and Other [removed: Revenues*][added: Revenues]

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

For a description of our collaborations with Janssen and other partners, see Note [removed: 11.][added: 10.]

We sell and distribute most of our products in the [removed: United States] [added: U.S.] exclusively through the wholesale channel.

During the year ended December 31, [removed: 2021,] [added: 2022,] approximately [removed: 91%] [added: 89%] of our product sales in the [removed: United States] [added: U.S.] and approximately [removed: 65%] [added: 63%] of our total worldwide revenues were [removed: to] [added: from] three large [removed: wholesalers,] [added: wholesalers:] AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson Corporation.

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

[removed: As] [added: In addition, as] our products mature, pricing pressures from private insurers and government payers often result in a reduction of the net product prices.

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

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

These risks and uncertainties include [added: challenges in clinical trial protocol design,] our ability to enroll patients in clinical trials, the possibility of unfavorable [added: or inadequate trial] results [added: to support further development] of our [added: product candidates, including failure to meet a trial’s primary endpoint, safety issues arising from our] clinical trials, [added: and] the need to modify or delay our clinical [removed: trials, including on account of clinical holds placed by regulatory authorities,] [added: trials] or to perform additional [removed: trials and the risk of failing to obtain regulatory approvals.][added: trials.]

In [removed: 2021,] [added: 2022,] we continued to invest in and advance our R&D pipeline across our therapeutic areas.

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

[removed: *Product] [added: Product] Candidates in Viral [removed: Diseases*][added: Diseases]

| Bulevirtide | | | | | | A Biologics License Application [added: (“BLA”)] has been filed with FDA for bulevirtide for the treatment of chronic hepatitis delta virus (“HDV”) infection. It has been granted both Orphan Drug and Breakthrough Therapy designations by FDA for this indication. [added: Approval is pending resolution of certain manufacturing and delivery concerns cited in a complete response letter issued by FDA in October 2022.] In Europe, Hepcludex® (bulevirtide) has been granted Conditional Marketing Authorization by the European Commission [added: (“EC”)] and PRIority MEdicines [removed: (PRIME)] [added: (“PRIME”)] scheme eligibility by the EMA as the first approved treatment in adults with chronic HDV infection with compensated liver disease. | | |

[removed: *Product Candidates in Inflammatory Diseases*][added: | Inflammatory Diseases: | | | | | | | | | | | | | | | | | | | | | | | | | | |]

[removed: *Product] [added: Product] Candidates in [removed: Oncology*][added: Oncology]

We have transformed care for people around the world by discovering, developing and delivering innovative medicines to address unmet medical needs in virology, oncology and other therapeutic areas.

Viral Hepatitis

________________________________

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

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

We also face significant competition as third parties pursue the development of products and technologies that may be competitive with our existing products or research programs.

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

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

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

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

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

Therefore, our product candidates may never be successfully commercialized, and we may be unable to recoup the significant R&D and clinical trial expenses incurred.

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

| Lenacapavir | | | | | | Lenacapavir is being evaluated for an HIV PrEP indication. | | |

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

| Sacituzumab govitecan-hziy | | | | | | A Type II variation Marketing Authorization Application has been filed with EMA for sacituzumab govitecan-hziy, a Trop-2 directed antibody and topoisomerase inhibitor conjugate, for the treatment of adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. This indication received FDA approval in February 2023. | | |

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

| Sacituzumab govitecan-hziy | | | | | | Sacituzumab govitecan-hziy is being evaluated as (i) a second- or third-line treatment for non-small cell lung cancer (“NSCLC”); (ii) a first-line treatment for PD-L1 negative metastatic triple-negative breast cancer (“TNBC”); and (iii) a second-line treatment for metastatic urothelial cancer. In collaboration with Merck Sharp & Dohme LLC (“Merck”),(1) sacituzumab govitecan-hziy is being evaluated in combination with Merck’s pembrolizumab as (i) a first-line treatment for PD-L1 positive metastatic TNBC and (ii) a first-line treatment for NSCLC. Sacituzumab govitecan-hziy is also being evaluated in combination with pembrolizumab as a treatment for adjuvant TNBC. | | |

| Magrolimab | | | | | | Magrolimab, an anti-CD47 monoclonal antibody, is being evaluated in combination with azacitidine as a first-line treatment for higher risk myelodysplastic syndrome (“MDS”). It has been granted Breakthrough Therapy designation by FDA and PRIME scheme eligibility for this indication. Magrolimab is also being evaluated in combination with azacitidine as a first-line treatment for TP53m acute myeloid leukemia (“AML”). Magrolimab is also being evaluated in combination with venetoclax and azacitidine as a first-line treatment for unfit AML. | | |

| Domvanalimab and Zimberelimab | | | | | | In collaboration with Arcus Biosciences, Inc. (“Arcus”),(1) the combination of zimberelimab, an anti-PD-1 monoclonal antibody, and domvanalimab, an Fc-silent anti-TIGIT antibody, is being evaluated as a first-line treatment for NSCLC. In collaboration with Arcus,(1) the combination of zimberelimab and domvanalimab with chemotherapy is also being evaluated as (i) a first-line treatment for NSCLC and (ii) a first-line treatment for upper gastrointestinal tract cancer. In collaboration with Arcus(1) and AstraZeneca, the combination of domvanalimab and durvalumab is being evaluated for the treatment of Stage 3 NSCLC. | | |

________________________________

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

| Sunlenca | | | | | | FDA and EC approved Sunlenca, a first-in-class, long-acting HIV capsid inhibitor, for the treatment of HIV infection, in combination with other antiretrovirals, in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is a new, twice-yearly treatment option for adults with HIV infection that is not adequately controlled by their current treatment regimen. | | |

| Yescarta | | | | | | FDA approved Yescarta for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta is the first FDA-approved CAR T-cell therapy for the initial treatment of relapsed or refractory LBCL. EC approved Yescarta for the treatment of adult patients with DLBCL and high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Yescarta is the first CAR T-cell therapy approved for patients in Europe who do not respond to first-line treatment for DLBCL and high-grade B-cell lymphoma. EC also approved Yescarta for the treatment of adult patients with relapsed or refractory FL after three or more lines of systemic therapy. | | |

| Veklury | | | | | | FDA approved an expanded use of Veklury for the treatment of non-hospitalized patients who are at high risk of progression to severe COVID-19, including hospitalization and death. FDA also expanded the approval of Veklury to include pediatric patients 28 days of age and older and weighing at least 3 kg. | | |

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

| Trodelvy | | | | | | FDA approved Trodelvy for the treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. This indication received FDA approval in February 2023. | | |

In 2022, we announced multiple strategic collaborations, including (i) a research collaboration with Dragonfly Therapeutics, Inc. to develop natural killer cell engager-based immunotherapies in oncology and inflammation; (ii) a global strategic collaboration with Arcellx, Inc. to co-develop and co-commercialize Arcellx’s lead late-stage product candidate, CART-ddBCMA, for the treatment of relapsed or refractory multiple myeloma; and (iii) an oncology collaboration with MacroGenics, Inc. to develop bispecific antibodies, including Gilead’s exclusive option to license MGD024, a potential treatment for certain blood cancers.

We also announced the acquisitions of (i) MiroBio, a private U.K.-based biotech company focused on restoring immune balance with agonists targeting immune inhibitory receptors; (ii) Tmunity Therapeutics, a clinical-stage, private biotech company focused on next-generation CAR T-cell therapies and technologies; and (iii) all remaining rights to GS-1811, an anti-CCR8 antibody in development as a potential treatment for solid tumors, from Jounce Therapeutics, Inc. Our strategic business development activity reflects our commitment to focus on transformative science, build a sustainable and diverse portfolio and position ourselves for the near-, medium- and long-term growth of our business.

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

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

| Oncology: | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

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

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

| | | | | | | U.S. | | | | | | | | | | | | EU | | | | | | | | |

| Sunlenca | | | | | | | | | 2037 | | | | | | | | | | | | 2037 | | | | | |

| *The listed expiration dates do not include any potential additional exclusivity (e.g., patent term extensions, supplementary protection certificates or pediatric exclusivity) that has not yet been granted.* | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

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

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

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

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

*Liver Diseases*

- Vosevi® is an oral formulation of a once-daily, single-tablet regimen of sofosbuvir, velpatasvir and voxilaprevir for the re-treatment of chronic HCV infection in adults: (i) with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen or (ii) with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

*Hematology/Oncology/Cell Therapy*

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

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

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

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

| Lenacapavir | | | | | | A New Drug Application and a Marketing Authorization Application have been filed with FDA and EMA, respectively, for lenacapavir, an HIV capsid inhibitor, as a component of a long-acting regimen for the treatment of HIV infection in heavily treatment-experienced people living with HIV. It has been granted Breakthrough Therapy designation by FDA for this indication. | | |

| Phase 3 | | | | | | | | |

| Lenacapavir | | | | | | Lenacapavir is being evaluated for an HIV PrEP indication. Program timeline is pending resolution of clinical hold placed by FDA on studies evaluating injectable lenacapavir. | | |

| Product Candidate | | | | | | Description | | |

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

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

| Yescarta (axicabtagene ciloleucel) | | | | | | A supplemental Biologics License Application and a Type II Variation Marketing Authorization Application have been filed with FDA and EMA, respectively, for axicabtagene ciloleucel, a CAR T cell therapy for the treatment of second-line DLBCL. A Type II Variation Marketing Authorization Application has been filed with EMA for axicabtagene ciloleucel for the treatment of relapsed or refractory FL. Yescarta has received accelerated approval by FDA for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy. | | |

| Tecartus (brexucabtagene autoleucel) | | | | | | A Type II Variation Marketing Authorization Application has been filed with EMA for brexucabtagene autoleucel, a CAR T cell therapy, for the treatment of adult ALL. Tecartus has received FDA approval for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. | | |

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

| Magrolimab | | | | | | Magrolimab, an anti-CD47, is being evaluated for (i) higher risk myelodysplastic syndrome (“MDS”) as a first-line treatment and (ii) acute myeloid leukemia (“AML”) as a first-line treatment. Program timelines are pending resolution of partial clinical holds placed by FDA on studies evaluating magrolimab. | | |

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

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

*In collaboration with Arcus Biosciences, Inc. (“Arcus”).

See Note 11.

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

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

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

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

For example, in October 2021, we entered into a clinical trial collaboration with Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc. (“Merck”), to evaluate Trodelvy in combination with Merck’s Keytruda in patients with first-line metastatic TNBC.

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

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

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

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

| Inflammatory Diseases: | | | | | | | | | | | | | | | | | | | | |

(2) An application for patent term extension was filed in the United States that, if granted, would extend the U.S. expiration date to at least 2028.

| Ranexa | | | | | | 2019 | | | (1) | | | | | | 2023 | | | | | |

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

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

(5) An application for patent term extension was filed in the United States that, if granted, would extend the U.S. expiration date to at least 2028.

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

For a description of our significant pending legal proceedings, see Note [removed: 14.][added: 13.]

For the fiscal year ended December 31, [removed: 2021][added: 2022]

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 30, [removed: 2021] [added: 2022] was [removed: $62.6] [added: $55.9] billion.*

The number of shares outstanding of the registrant’s Common Stock on February [removed: 18, 2022] [added: 17, 2023] was [removed: 1,253,886,724][added: 1,247,105,154]

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: 2022] [added: 2023] Annual Meeting of Stockholders, to be held on May [removed: 4, 2022,] [added: 3, 2023,] are incorporated by reference into Part III of this Report.

* Based on a closing price of [removed: $68.86] [added: $61.81] per share on June 30, [removed: 2021.][added: 2022.]

Excludes [removed: 344,972,966] [added: 350,109,572] 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 30, [removed: 2021.][added: 2022.]

[removed: 2021 Form] [added: 2022 FORM] 10-K [removed: Annual Report][added: ANNUAL REPORT]

| [removed: PART I] [added: [PART I](#i6d96c727bd3e4a10969bbf6a84d64ce7_10)] | | | | | | | | |

| [removed: Item 1] [added: [Item 1](#i6d96c727bd3e4a10969bbf6a84d64ce7_13)] | | | [removed: [Business](#i72faa4a0a4974dcca6db2bf491b63d7a_13)] [added: [Business](#i6d96c727bd3e4a10969bbf6a84d64ce7_13)] | | | [removed: [3](#i72faa4a0a4974dcca6db2bf491b63d7a_13)] [added: [3](#i6d96c727bd3e4a10969bbf6a84d64ce7_13)] | | |

| [removed: Item 1A] [added: [Item 1A](#i6d96c727bd3e4a10969bbf6a84d64ce7_16)] | | | [Risk [removed: Factors](#i72faa4a0a4974dcca6db2bf491b63d7a_16)] [added: Factors](#i6d96c727bd3e4a10969bbf6a84d64ce7_16)] | | | [removed: [17](#i72faa4a0a4974dcca6db2bf491b63d7a_16)] [added: [17](#i6d96c727bd3e4a10969bbf6a84d64ce7_16)] | | |

| [removed: Item 1B] [added: [Item 1B](#i6d96c727bd3e4a10969bbf6a84d64ce7_19)] | | | [Unresolved Staff [removed: Comments](#i72faa4a0a4974dcca6db2bf491b63d7a_19)] [added: Comments](#i6d96c727bd3e4a10969bbf6a84d64ce7_19)] | | | [removed: [29](#i72faa4a0a4974dcca6db2bf491b63d7a_19)] [added: [29](#i6d96c727bd3e4a10969bbf6a84d64ce7_19)] | | |

| [removed: Item 2] [added: [Item 2](#i6d96c727bd3e4a10969bbf6a84d64ce7_22)] | | | [removed: [Properties](#i72faa4a0a4974dcca6db2bf491b63d7a_22)] [added: [Properties](#i6d96c727bd3e4a10969bbf6a84d64ce7_22)] | | | [removed: [29](#i72faa4a0a4974dcca6db2bf491b63d7a_22)] [added: [30](#i6d96c727bd3e4a10969bbf6a84d64ce7_22)] | | |

| [removed: Item 3] [added: [Item 3](#i6d96c727bd3e4a10969bbf6a84d64ce7_25)] | | | [Legal [removed: Proceedings](#i72faa4a0a4974dcca6db2bf491b63d7a_25)] [added: Proceedings](#i6d96c727bd3e4a10969bbf6a84d64ce7_25)] | | | [removed: [30](#i72faa4a0a4974dcca6db2bf491b63d7a_25)] [added: [30](#i6d96c727bd3e4a10969bbf6a84d64ce7_25)] | | |

| [removed: Item 4] [added: [Item 4](#i6d96c727bd3e4a10969bbf6a84d64ce7_28)] | | | [Mine Safety [removed: Disclosures](#i72faa4a0a4974dcca6db2bf491b63d7a_28)] [added: Disclosures](#i6d96c727bd3e4a10969bbf6a84d64ce7_28)] | | | [removed: [30](#i72faa4a0a4974dcca6db2bf491b63d7a_28)] [added: [30](#i6d96c727bd3e4a10969bbf6a84d64ce7_28)] | | |

| [removed: PART II] [added: [PART II](#i6d96c727bd3e4a10969bbf6a84d64ce7_31)] | | | | | | | | |

| [removed: Item 5] [added: [Item 5](#i6d96c727bd3e4a10969bbf6a84d64ce7_34)] | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i72faa4a0a4974dcca6db2bf491b63d7a_34)] [added: Securities](#i6d96c727bd3e4a10969bbf6a84d64ce7_34)] | | | [removed: [31](#i72faa4a0a4974dcca6db2bf491b63d7a_34)] [added: [31](#i6d96c727bd3e4a10969bbf6a84d64ce7_34)] | | |

| [removed: Item 6] [added: [Item 6](#i6d96c727bd3e4a10969bbf6a84d64ce7_37)] | | | [removed: [\[Reserved\]](#i72faa4a0a4974dcca6db2bf491b63d7a_1662)] [added: [\[Reserved\]](#i6d96c727bd3e4a10969bbf6a84d64ce7_37)] | | | [removed: [33](#i72faa4a0a4974dcca6db2bf491b63d7a_1662)] [added: [33](#i6d96c727bd3e4a10969bbf6a84d64ce7_37)] | | |

| [removed: Item 7] [added: [Item 7](#i6d96c727bd3e4a10969bbf6a84d64ce7_40)] | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i72faa4a0a4974dcca6db2bf491b63d7a_40)] [added: Operations](#i6d96c727bd3e4a10969bbf6a84d64ce7_40)] | | | [removed: [33](#i72faa4a0a4974dcca6db2bf491b63d7a_40)] [added: [34](#i6d96c727bd3e4a10969bbf6a84d64ce7_40)] | | |

| [removed: Item 7A] [added: [Item 7A](#i6d96c727bd3e4a10969bbf6a84d64ce7_58)] | | | [Quantitative and Qualitative Disclosures about Market [removed: Risk](#i72faa4a0a4974dcca6db2bf491b63d7a_64)] [added: Risk](#i6d96c727bd3e4a10969bbf6a84d64ce7_58)] | | | [removed: [47](#i72faa4a0a4974dcca6db2bf491b63d7a_64)] [added: [43](#i6d96c727bd3e4a10969bbf6a84d64ce7_58)] | | |

| [removed: Item 8] [added: [Item 8](#i6d96c727bd3e4a10969bbf6a84d64ce7_61)] | | | [Financial Statements and Supplementary [removed: Data](#i72faa4a0a4974dcca6db2bf491b63d7a_67)] [added: Data](#i6d96c727bd3e4a10969bbf6a84d64ce7_61)] | | | [removed: [49](#i72faa4a0a4974dcca6db2bf491b63d7a_67)] [added: [45](#i6d96c727bd3e4a10969bbf6a84d64ce7_61)] | | |

| [removed: Item 9] [added: [Item 9](#i6d96c727bd3e4a10969bbf6a84d64ce7_145)] | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i72faa4a0a4974dcca6db2bf491b63d7a_157)] [added: Disclosure](#i6d96c727bd3e4a10969bbf6a84d64ce7_145)] | | | [removed: [98](#i72faa4a0a4974dcca6db2bf491b63d7a_157)] [added: [94](#i6d96c727bd3e4a10969bbf6a84d64ce7_145)] | | |

| [removed: Item 9A] [added: [Item 9A](#i6d96c727bd3e4a10969bbf6a84d64ce7_151)] | | | [Controls and [removed: Procedures](#i72faa4a0a4974dcca6db2bf491b63d7a_163)] [added: Procedures](#i6d96c727bd3e4a10969bbf6a84d64ce7_151)] | | | [removed: [100](#i72faa4a0a4974dcca6db2bf491b63d7a_163)] [added: [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_151)] | | |

| [removed: Item 9C] [added: [Item 9C](#i6d96c727bd3e4a10969bbf6a84d64ce7_157)] | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#i72faa4a0a4974dcca6db2bf491b63d7a_1732)] [added: Inspections](#i6d96c727bd3e4a10969bbf6a84d64ce7_157)] | | | [removed: [100](#i72faa4a0a4974dcca6db2bf491b63d7a_1732)] [added: [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_157)] | | |

| [removed: PART III] [added: [PART III](#i6d96c727bd3e4a10969bbf6a84d64ce7_160)] | | | | | | | | |

| [removed: Item 10] [added: [Item 10](#i6d96c727bd3e4a10969bbf6a84d64ce7_163)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#i72faa4a0a4974dcca6db2bf491b63d7a_172)] [added: Governance](#i6d96c727bd3e4a10969bbf6a84d64ce7_163)] | | | [removed: [100](#i72faa4a0a4974dcca6db2bf491b63d7a_172)] [added: [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_163)] | | |

| [removed: Item 12] [added: [Item 12](#i6d96c727bd3e4a10969bbf6a84d64ce7_169)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i72faa4a0a4974dcca6db2bf491b63d7a_178)] [added: Matters](#i6d96c727bd3e4a10969bbf6a84d64ce7_169)] | | | [removed: [101](#i72faa4a0a4974dcca6db2bf491b63d7a_178)] [added: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_169)] | | |

| [removed: Item 13] [added: [Item 13](#i6d96c727bd3e4a10969bbf6a84d64ce7_172)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i72faa4a0a4974dcca6db2bf491b63d7a_181)] [added: Independence](#i6d96c727bd3e4a10969bbf6a84d64ce7_172)] | | | [removed: [101](#i72faa4a0a4974dcca6db2bf491b63d7a_181)] [added: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_172)] | | |

| [removed: Item 14] [added: [Item 14](#i6d96c727bd3e4a10969bbf6a84d64ce7_175)] | | | [Principal Accountant Fees and [removed: Services](#i72faa4a0a4974dcca6db2bf491b63d7a_184)] [added: Services](#i6d96c727bd3e4a10969bbf6a84d64ce7_175)] | | | [removed: [101](#i72faa4a0a4974dcca6db2bf491b63d7a_184)] [added: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_175)] | | |

| [removed: Item 15] [added: [Item 15](#i6d96c727bd3e4a10969bbf6a84d64ce7_181)] | | | [Exhibits and Financial Statement [removed: Schedules](#i72faa4a0a4974dcca6db2bf491b63d7a_190)] [added: Schedules](#i6d96c727bd3e4a10969bbf6a84d64ce7_181)] | | | [removed: [101](#i72faa4a0a4974dcca6db2bf491b63d7a_190)] [added: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_181)] | | |

We own or have rights to various [removed: trademarks, copyrights] [added: trademarks] and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, [added: KITE™,] AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, [removed: HEPCLUDEX® (BULEVIRTIDE),] [added: HEPCLUDEX®,] HEPSERA®, [removed: JYSELECA® (FILGOTINIB),] [added: JYSELECA®,] LETAIRIS®, ODEFSEY®, RANEXA®, SOVALDI®, STRIBILD®, [added: SUNLENCA®,] TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®.

This report also refers to trademarks, service marks and trade names of other [removed: companies.][added: companies, which are the property of their respective owners.]

[removed: *This Annual Report on Form 10-K, including the section entitled “Management’s] [added: Management’s] Discussion and Analysis of Financial Condition and Results of [removed: Operations,”] [added: Operations,] contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

In addition, any statements other than statements of historical fact are forward-looking statements, including statements regarding overall trends; operating cost and revenue trends; liquidity and capital needs; plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital; collaboration and licensing arrangements; [added: patent protection and estimated loss of exclusivity for our products and product candidates;] ongoing litigation and investigation matters; statements regarding the anticipated future impact on our business of the [removed: ongoing] coronavirus disease 2019 (“COVID-19”) and related public health measures; and other statements of expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions.*

Our actual results may differ materially from those suggested by these forward-looking statements for various reasons, including those identified in Part I, Item [removed: 1A of this Annual Report on Form 10-K under the heading “Risk Factors.” Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements.][added: 1A.]

Except as required under federal securities laws and the rules and regulations of [removed: the] [added: U.S.] Securities and Exchange Commission (“SEC”), we do not undertake, and specifically decline, any obligation to update any of these statements or to publicly announce the results of any revisions to any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.

In evaluating our business, you should carefully consider the risks described [removed: in the section entitled “Risk Factors”] under Part I, Item [removed: 1A of this Annual Report on Form 10-K.][added: 1A.]

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

| [Item 9B](#i6d96c727bd3e4a10969bbf6a84d64ce7_154) | | | [Other Information](#i6d96c727bd3e4a10969bbf6a84d64ce7_154) | | | [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_154) | | |

| [Item 11](#i6d96c727bd3e4a10969bbf6a84d64ce7_166) | | | [Executive Compensation](#i6d96c727bd3e4a10969bbf6a84d64ce7_166) | | | [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_166) | | |

| [PART IV](#i6d96c727bd3e4a10969bbf6a84d64ce7_178) | | | | | | | | |

| [Item 16](#i6d96c727bd3e4a10969bbf6a84d64ce7_187) | | | [Form 10-K Summary](#i6d96c727bd3e4a10969bbf6a84d64ce7_187) | | | [100](#i6d96c727bd3e4a10969bbf6a84d64ce7_187) | | |

| [SIGNATURES](#i6d96c727bd3e4a10969bbf6a84d64ce7_190) | | | | | | [101](#i6d96c727bd3e4a10969bbf6a84d64ce7_190) | | |

*This Annual Report on Form 10-K, including Part II, Item 7.

Risk Factors* *of this Annual Report on Form 10-K.

Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements.

Risk Factors of this Annual Report on Form 10-K.

| Item 9B | | | [Other Information](#i72faa4a0a4974dcca6db2bf491b63d7a_166) | | | [100](#i72faa4a0a4974dcca6db2bf491b63d7a_166) | | |

| Item 11 | | | [Executive Compensation](#i72faa4a0a4974dcca6db2bf491b63d7a_175) | | | [101](#i72faa4a0a4974dcca6db2bf491b63d7a_175) | | |

| PART IV | | | | | | | | |

| Item 16 | | | [Form 10-K Summary](#i72faa4a0a4974dcca6db2bf491b63d7a_196) | | | [104](#i72faa4a0a4974dcca6db2bf491b63d7a_196) | | |

| [SIGNATURES](#i72faa4a0a4974dcca6db2bf491b63d7a_199) | | | | | | [105](#i72faa4a0a4974dcca6db2bf491b63d7a_199) | | |

We also have [added: administrative facilities in Raleigh, North Carolina and Washington, D.C., and we have] R&D facilities in Emeryville, Oceanside and Santa Monica, California; Seattle, Washington; [added: Frederick, Maryland;] Morris Plains, New Jersey; [removed: Frederick, Maryland;] Edmonton, Canada; and Dublin, Ireland.

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.

As of February [removed: 18, 2022,] [added: 17, 2023,] we had approximately [removed: 1,456] [added: 1,452] stockholders of record of our common stock.

Comparison of Cumulative Total Return on Investment for the Past Five [removed: Years (2)][added: Years(2)]

[removed: ][added: ]

(2) 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: 2016,] [added: 2017,] and assuming that all dividends were reinvested.

The following table provides certain information with respect to our equity compensation plans in effect as of December 31, [removed: 2021:][added: 2022:]

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

| Employee Stock Purchase [removed: Plan(3)] [added: Plan(2)] | | | | | | | | | | | | | | | | | | [removed: 5.1] [added: 3.1] | | |

| [removed: Total equity] [added: Equity] compensation plans [added: not] approved by security holders | | | | | | [removed: 15.2] [added: —] | | | | | | $ | [removed: 70.95] [added: —] | | | | | [removed: 80.0] [added: —] | | |

| [removed: Equity] [added: Total equity] compensation plans [removed: not] approved by security [removed: holders(4)] [added: holders] | | | | | | [removed: 1.6] [added: 39.1] | | | | | | $ | [removed: 67.28] [added: 67.69] | | | | | [removed: 6.7] [added: 103.7] | | |

[removed: (3)] [added: (2)] 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: In the first quarter of 2016, our Board of Directors authorized a] [added: The] $12.0 billion stock repurchase program [removed: (the “2016 Program”) under which repurchases may be made] [added: authorized by our Board of Directors] in the [removed: open market or] [added: first quarter of 2016 (“2016 Program”) was completed] in [removed: privately negotiated transactions.][added: the fourth quarter of 2022.]

In the first quarter of 2020, our Board of Directors authorized a new $5.0 billion stock repurchase program [removed: (the “2020] [added: (“2020] Program”), [removed: which will commence upon the completion of the 2016 Program.][added: with no fixed expiration.]

As of December 31, [removed: 2021,] [added: 2022,] the remaining authorized repurchase amount [removed: from both programs] [added: under the 2020 Program] was [removed: $6.3] [added: $4.9] billion.

The table below summarizes our stock repurchase activity for the three months ended December 31, [removed: 2021:][added: 2022:]

| | | | | | | Total Number of Shares Purchased (in thousands) | | | | | | Average Price Paid per [removed: Share (in dollars)] [added: Share] | | | | | | Total Number of Shares Purchased as Part of a Publicly Announced Program (in thousands) | | | | | | Maximum Fair Value of Shares that May Yet Be Purchased Under the [removed: Programs] [added: 2016 Program] (in millions) | | | [added: | | | Maximum Fair Value of Shares that May Yet Be Purchased Under the 2020 Program (in millions) | | |]

[removed: *Dividends*][added: Dividends]

For the years ended December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] we paid quarterly dividends.

Market Information

Holders

Additional information is included in Note 14.

Stockholders’ Equity of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.

Securities Authorized For Issuance Under Equity Compensation Plans

| 2022 Equity Incentive Plan | | | | | | 39.1 | | | | | | $ | 67.69 | | | | | 100.5 | | |

| Total | | | | | | 39.1 | | | | | | $ | 67.69 | | | | | 103.7 | | |

(1) Includes 25 million restricted stock units, performance share units and phantom shares.

These awards have no exercise price and are not included in the weighted-average exercise price of outstanding awards.

We started repurchases under the 2020 Program in December 2022.

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

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

| October 1 - October 31, 2022 | | | | | | 282 | | | | | | $ | 66.91 | | | | | 241 | | | | | | $ | 649 | | | | | $ | 5,000 | |

| November 1 - November 30, 2022 | | | | | | 5,788 | | | | | | $ | 82.94 | | | | | 5,729 | | | | | | $ | 174 | | | | | $ | 5,000 | |

| December 1 - December 31, 2022 | | | | | | 3,581 | | | | | | $ | 88.02 | | | | | 3,404 | | | | | | $ | — | | | | | $ | 4,874 | |

| Total(1) | | | | | | 9,651 | | | | | | $ | 84.35 | | | | | 9,374 | | | | | | | | | | | | | | |

Equity Compensation Plan Information

| 2004 Equity Incentive Plan(2) | | | | | | 15.2 | | | | | | $ | 70.95 | | | | | 74.9 | | |

| Total | | | | | | 16.8 | | | | | | $ | 70.60 | | | | | 86.7 | | |

(1) Does not take into account 22 million restricted stock units, performance share awards or units and phantom shares, which have no exercise price and were granted under our 2004 and 2018 Equity Incentive Plans.

(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.

(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 Gilead secure and retain the services of eligible award recipients, provide incentives for such persons to exert maximum efforts for the success of Gilead 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 non-qualified 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, performance share awards or 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, 2021, 6.7 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.

During 2021, we repurchased and retired 8 million shares of our common stock for $546 million through open market transactions under the 2016 Program.

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

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

| October 1 - October 31, 2021 | | | | | | 309 | | | | | | $ | 67.47 | | | | | 283 | | | | | | $ | 6,299 | |

| November 1 - November 30, 2021 | | | | | | 372 | | | | | | $ | 67.66 | | | | | 281 | | | | | | $ | 6,280 | |

| December 1 - December 31, 2021 | | | | | | 195 | | | | | | $ | 70.37 | | | | | 155 | | | | | | $ | 6,269 | |

| Total | | | | | | 876 | | | (1) | | | $ | 68.19 | | | | | 719 | | | (1) | | | | | |

Additional information is included in Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations to the Consolidated Financial Statements.

Years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019][added: 2020]

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID:](#i72faa4a0a4974dcca6db2bf491b63d7a_73) 42[)](#i72faa4a0a4974dcca6db2bf491b63d7a_73)] [added: ID:](#i6d96c727bd3e4a10969bbf6a84d64ce7_67) 42[)](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] | | | | | | [removed: [50](#i72faa4a0a4974dcca6db2bf491b63d7a_73)] [added: [46](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] | | |

| [Audited Consolidated Financial [removed: Statements:](#i72faa4a0a4974dcca6db2bf491b63d7a_76)] [added: Statements:](#i6d96c727bd3e4a10969bbf6a84d64ce7_70)] | | | | | | | | |

| [Consolidated Balance [removed: Sheets](#i72faa4a0a4974dcca6db2bf491b63d7a_79)] [added: Sheets](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] | | | | | | [removed: [52](#i72faa4a0a4974dcca6db2bf491b63d7a_79)] [added: [48](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] | | |

| [Consolidated Statements of [removed: Income](#i72faa4a0a4974dcca6db2bf491b63d7a_82)] [added: Income](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] | | | | | | [removed: [53](#i72faa4a0a4974dcca6db2bf491b63d7a_82)] [added: [49](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] | | |

| [Consolidated Statements of Comprehensive Income [removed: (Loss)](#i72faa4a0a4974dcca6db2bf491b63d7a_85)] [added: (Loss)](#i6d96c727bd3e4a10969bbf6a84d64ce7_79)] | | | | | | [removed: [54](#i72faa4a0a4974dcca6db2bf491b63d7a_85)] [added: [50](#i6d96c727bd3e4a10969bbf6a84d64ce7_79)] | | |

| [Consolidated Statements of Stockholders’ [removed: Equity](#i72faa4a0a4974dcca6db2bf491b63d7a_88)] [added: Equity](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] | | | | | | [removed: [55](#i72faa4a0a4974dcca6db2bf491b63d7a_88)] [added: [51](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] | | |

| [Consolidated Statements of Cash [removed: Flows](#i72faa4a0a4974dcca6db2bf491b63d7a_91)] [added: Flows](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] | | | | | | [removed: [56](#i72faa4a0a4974dcca6db2bf491b63d7a_91)] [added: [52](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i72faa4a0a4974dcca6db2bf491b63d7a_94)] [added: Statements](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] | | | | | | [removed: [57](#i72faa4a0a4974dcca6db2bf491b63d7a_94)] [added: [53](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] | | |

We have audited the accompanying consolidated balance sheets of Gilead Sciences, Inc. (the Company) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the [removed: Company’s] [added: Company's] internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February [removed: 23, 2022] [added: 22, 2023,] expressed an unqualified opinion thereon.

| | | | | | | Valuation of in-process research and development intangible [removed: assets acquired from Immunomedics, Inc.] [added: asset] | | |

| *Description of the Matter* | | | | | | [removed: At December 31, 2021,] [added: During 2022,] the [removed: Company’s] [added: Company recognized a $2.7 billion impairment charge related to its] in-process research and development (IPR&D) intangible [removed: assets acquired in connection] [added: asset related to Trodelvy for treatment of patients] with [removed: the 2020 acquisition] [added: hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. At December 31, 2022, this intangible asset had a remaining carrying value] of [removed: Immunomedics, Inc. were $14.7] [added: $6.1] billion. As discussed in Note 1, intangible assets with indefinite useful lives related to [removed: purchased] IPR&D projects [added: acquired in a business combination] are measured at their respective fair values as of the acquisition date and are considered indefinite-lived until the completion or abandonment of the associated R&D efforts. The Company tests indefinite-lived intangible assets for impairment on an annual basis and in between annual tests if they become aware of any events or changes that would indicate the fair values of the assets are below their carrying amounts. [removed: Auditing] [added: An impairment charge is recognized to] the [added: degree the carrying value exceeds the fair value. As discussed in Note 8, the Company estimated the fair value of the IPR&D intangible asset related to Trodelvy for patients with HR+/HER2- breast cancer in connection with both an interim] impairment [removed: test] [added: assessment as] of [added: March 31, 2022, and an annual impairment assessment as of October 1, 2022. Auditing] the [added: fair values of this] IPR&D intangible [removed: assets acquired from Immunomedics] [added: asset] was complex due to the significant judgment required in estimating [removed: their] [added: the] fair values. In particular, the fair value estimates required the use of [added: a] valuation [removed: methodologies] [added: methodology] that [removed: were] [added: was] sensitive to significant assumptions (e.g., discount rate, probability of technical and regulatory success, addressable patient population, treatment duration and projected market share), which were affected by expected future market or economic conditions. | | |

| *How We Addressed the Matter in Our Audit* | | | | | | We evaluated and tested the design and operating effectiveness of the Company’s internal controls over the determination of the estimated fair value of the IPR&D intangible [removed: assets acquired from Immunomedics.] [added: asset related to Trodelvy for patients with HR+/HER2- breast cancer for both the interim and annual impairment assessments.] For example, we tested controls over management's review of the valuation [removed: methodologies] [added: methodology] and the significant assumptions used to develop the fair value estimates. We also tested management's controls to validate that the data used in the fair value estimates were complete and accurate. To test the estimated fair value of [added: this asset at both] the [removed: Company's IPR&D intangible assets acquired from Immunomedics,] [added: interim and annual assessment dates,] our audit procedures, among others, included evaluating the Company's use of [added: an] appropriate valuation [removed: methodologies] [added: methodology] with assistance from a valuation specialist, evaluating sensitivity analyses to determine which assumptions had the greatest impact on the [removed: overall determination of value,] [added: fair value determination,] and testing the completeness and accuracy of the underlying data. Our audit procedures over the most significant assumptions included comparing the assumptions to current industry, market and economic trends, to historical results of the Company's business and other guideline companies within the same industry and to other relevant factors. For example, we evaluated the probability of technical and regulatory success by considering the phase of development of the clinical [removed: projects,] [added: projects] and the Company's history of obtaining regulatory approval. In addition, we evaluated the expected addressable patient populations by comparing the Company’s estimates to external industry forecasts. | | |

| (in millions, except per share amounts) | | | | | | [added: 2022 | | | | | |] 2021 | | | | | | 2020 | | |

| Cash and cash equivalents | | | | | | $ | [removed: 5,338] [added: 5,412] | | | | | $ | [removed: 5,997] [added: 5,338] | |

| Short-term marketable debt securities | | | | | | [removed: 1,182] [added: 973] | | | | | | [removed: 1,411] [added: 1,182] | | |

| Accounts receivable, net | | | | | | [removed: 4,493] [added: 4,777] | | | | | | [removed: 4,892] [added: 4,493] | | |

| Inventories | | | | | | [removed: 1,618] [added: 1,507] | | | | | | [removed: 1,683] [added: 1,618] | | |

| Prepaid and other current assets | | | | | | [removed: 2,141] [added: 1,774] | | | | | | [removed: 2,013] [added: 2,141] | | |

| Total current assets | | | | | | [removed: 14,772] [added: 14,443] | | | | | | [removed: 15,996] [added: 14,772] | | |

| Property, plant and equipment, net | | | | | | [removed: 5,121] [added: 5,475] | | | | | | [removed: 4,967] [added: 5,121] | | |

| Long-term marketable debt securities | | | | | | [removed: 1,309] [added: 1,245] | | | | | | [removed: 502] [added: 1,309] | | |

| Intangible assets, net | | | | | | [removed: 33,455] [added: 28,894] | | | | | | [removed: 33,126] [added: 33,455] | | |

| Goodwill | | | | | | [removed: 8,332] [added: 8,314] | | | | | | [removed: 8,108] [added: 8,332] | | |

| Other long-term assets | | | | | | [removed: 4,963] [added: 4,800] | | | | | | [removed: 5,708] [added: 4,963] | | |

| Total assets | | | | | | $ | [removed: 67,952] [added: 63,171] | | | | | $ | [removed: 68,407] [added: 67,952] | |

| Accounts payable | | | | | | $ | [removed: 705] [added: 905] | | | | | $ | [removed: 844] [added: 705] | |

| [removed: Accrued and other] [added: Other] current liabilities | | | | | | [removed: 6,145] [added: 4,580] | | | | | | [removed: 4,336] [added: 6,145] | | |

| Current portion of long-term debt and other obligations, net | | | | | | [removed: 1,516] [added: 2,273] | | | | | | [removed: 2,757] [added: 1,516] | | |

| Total current liabilities | | | | | | [removed: 11,610] [added: 11,237] | | | | | | [removed: 11,397] [added: 11,610] | | |

| Long-term debt, net | | | | | | [removed: 25,179] [added: 22,957] | | | | | | [removed: 28,645] [added: 25,179] | | |

| Long-term income taxes payable | | | | | | [removed: 4,767] [added: 3,916] | | | | | | [removed: 5,016] [added: 4,767] | | |

| Deferred tax liability | | | | | | [removed: 4,356] [added: 2,673] | | | | | | [removed: 3,914] [added: 4,356] | | |

| Other long-term obligations | | | | | | [removed: 976] [added: 1,179] | | | | | | [removed: 1,214] [added: 976] | | |

| Commitments and contingencies (Note [removed: 14)] [added: 13)] | | | | | | | | | | | | | | |

| Common stock, par value $0.001 per share; 5,600 authorized; [added: 1,247 and] 1,254 shares issued and [removed: outstanding as of December 31, 2021 and 2020] [added: outstanding, respectively] | | | | | | 1 | | | | | | 1 | | |

| Additional paid-in capital | | | | | | [removed: 4,661] [added: 5,550] | | | | | | [removed: 3,880] [added: 4,661] | | |

| Accumulated other comprehensive income [removed: (loss)] | | | | | | [removed: 83] [added: 2] | | | | | | [removed: (60)] [added: 83] | | |

February 22, 2023

| (in millions, except per share amounts) | | | | | | 2022 | | | | | | 2021 | | |

| Accrued rebates | | | | | | 3,479 | | | | | | 3,244 | | |

| Operating income | | | | | | 7,330 | | | | | | 9,918 | | | | | | 4,071 | | |

| Reclassifications to net income, net of tax impact of $25, $(9) and $6, respectively | | | | | | (171) | | | | | | 58 | | | | | | (41) | | |

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

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

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

| Balance as of December 31, 2022 | | | | | | 1,247 | | | | | | $ | 1 | | | | | $ | 5,550 | | | | | $ | 2 | | | | | $ | 15,687 | | | | | $ | (31) | | | | | $ | 21,209 | |

| Net income | | | | | | $ | 4,566 | | | | | $ | 6,201 | | | | | $ | 89 | |

| In-process research and development impairment | | | | | | 2,700 | | | | | | — | | | | | | — | | |

| Other | | | | | | 780 | | | | | | 576 | | | | | | 178 | | |

1.

Organization

Certain amounts and percentages herein may not sum or recalculate due to rounding.

Beginning in the second quarter of 2022, expenses related to development milestones and other collaboration payments made prior to regulatory approval of a developed product were reclassified from Research and development expenses to Acquired in-process research and development expenses on our Consolidated Statements of Income.

Concurrently, we reclassified the cash payments related to these expenses from Other to Acquisitions, including in-process research and development, net of cash acquired within Investing Activities in the Consolidated Statements of Cash Flows.

We believe this presentation assists users of the financial statements to better understand the total costs incurred to acquire in-process research and development (“IPR&D”) projects.

Prior periods have been revised to reflect this classification, resulting in a reduction of previously-reported Research and development expenses of $762 million and $112 million for the years ended December 31, 2021 and 2020, respectively.

Rebates and chargebacks are based on contractual arrangements or statutory requirements and include amounts due to payers and healthcare providers under various programs.

These amounts may vary by product, payer and individual plans.

Providers qualified under certain programs can purchase our products through wholesalers or other distributors at a discount.

The wholesalers or distributors then charge the discount back to us.

Contract and other revenues are recognized when the performance obligation is satisfied.

Advertising expenses within Selling, general and administrative expenses, including promotional expenses, are recorded when incurred and were $778 million, $735 million and $795 million for the years ended December 31, 2022, 2021 and 2020, respectively.

Estimated inputs to that model include (i) expected volatility, based on a blend of historical volatility of our common stock price along with implied volatility for traded options on our common stock, (ii) expected term in years, based on the weighted-average period awards are expected to remain outstanding using historical cancellation and exercise data, contractual terms and vesting terms of the award, (iii) risk-free interest rate, based on observed interest rates appropriate for the term of the stock-based awards, and (iv) expected dividend yield, based on our history and expectation of dividend payments.

Earnings Per Share

Accounts Receivable

See “Impairment of Long-Lived Assets” for additional information.

We determine if an arrangement contains a lease at inception and classify each lease as operating or financing.

Acquisitions, including Goodwill, Intangible Assets and Contingent Consideration

See “Impairment of Long-Lived Assets” for additional information.

In determining the initial fair value of an intangible asset, or when quantitative analysis is required to determine any impairment, we use a probability-weighted income approach that discounts expected future cash flows to present value using a discount rate that is based on the estimated weighted-average cost of capital for companies with profiles similar to ours and represents the rate that market participants would use to value the intangible assets.

These cash flow models require the use of Level 3 fair value measurements and inputs, including estimated revenues, which, for example, include significant inputs such as addressable patient population, treatment duration, projected market share, assessment of the asset’s life cycle, and competitive trends impacting the asset; costs and probability of technical and regulatory success, among other factors.

February 23, 2022

| Accrued government and other rebates | | | | | | 3,244 | | | | | | 3,460 | | |

| Income from operations | | | | | | 9,918 | | | | | | 4,071 | | | | | | 4,287 | | |

| Balance as of December 31, 2018 | | | | | | 1,282 | | | | | | $ | 1 | | | | | $ | 2,282 | | | | | $ | 80 | | | | | $ | 19,024 | | | | | $ | 147 | | | | | $ | 21,534 | |

| Cumulative effect from the adoption of new accounting standards | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | 8 | | |

| Write-downs for slow-moving and excess raw material and work in process inventory | | | | | | 121 | | | | | | 40 | | | | | | 547 | | |

| Other | | | | | | 1,217 | | | | | | 250 | | | | | | 279 | | |

| Other | | | | | | (163) | | | | | | (171) | | | | | | (434) | | |

Overview

The approval status of Hepcludex and Jyseleca vary worldwide, and Hepcludex and Jyseleca are not approved in the United States.

We assess whether we are the primary beneficiary of a variable interest entity (“VIE”) at the inception of the arrangement and at each reporting date.

Certain reclassifications have been made to prior periods in the Consolidated Financial Statements and accompanying notes to conform with the current presentation.

Our Consolidated Statements of Income for the year ended December 31, 2019 was conformed to separately present acquired IPR&D expenses.

Segment Information

Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the impact that the coronavirus disease (“COVID-19”) could have on our significant accounting estimates.

Revenues from product sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to-net deductions is subsequently resolved.

Government and other rebates and chargebacks include amounts payable to payers and healthcare providers under various programs, and may vary by product, by payer and individual payer plans.

Rebates and chargebacks are based on contractual arrangements or statutory requirements which may vary by product, payer and individual payer plans.

For qualified programs that can purchase our products through wholesalers or other distributors at a lower contractual price, the wholesalers or distributors charge back to us the difference between their acquisition cost and the lower contractual price.

Additionally, in developing our estimates, we consider: historical and estimated payer mix; statutory discount requirements and contractual terms; historical claims experience and processing time lags; estimated patient population; known market events or trends; market research; channel inventory data obtained from our major U.S. wholesalers; and other pertinent internal or external information.

*Shipping and Handling*

Milestone payments made to third-party collaborators are expensed as incurred up to the point of regulatory approval.

Milestone payments made upon regulatory approval are capitalized and amortized over the remaining useful life of the related product.

We charge R&D costs, including clinical study costs, to expense when incurred.

The acquired IPR&D is expensed on acquisition date.

Future costs to develop these IPR&D projects are recorded in Research and development expenses on our Consolidated Statements of Income as incurred.

SG&A expenses consist primarily of personnel costs, facilities and overhead costs, outside marketing, advertising and legal expenses, and other general and administrative costs.

SG&A expenses also include the Branded Prescription Drug (“BPD”) fee.

In the United States, we, along with other pharmaceutical manufacturers of branded drug products, are required to pay a portion of the BPD fee, which is estimated based on select government sales during the prior year as a percentage of total industry government sales.

We expense the costs of advertising, including promotional expenses, as incurred.

We have elected the fair value option to account for our equity investments in Arcus Biosciences, Inc. (“Arcus”) and Galapagos NV (“Galapagos”) over which we have significant influence.

We believe the fair value option best reflects the underlying economics of these investments.

Equity securities without readily determinable fair values are recorded using the measurement alternative of cost less impairment, if any, adjusted for observable price changes in orderly transactions for identical or similar investments of the same issuer.

Certain investments in equity securities of non-public companies are accounted for using the equity method based on our ownership percentage and other factors that indicate we have significant influence over the investee.

Concentrations of Risk

We are subject to credit risk from our portfolio of cash equivalents and marketable securities.

Under our investment policy, we limit amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government.

We are not exposed to any significant concentrations of credit risk from these financial instruments.

The goals of our investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return.

We are also subject to credit risk from our accounts receivable related to our product sales.

We have audited Gilead Sciences, Inc.’s internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Gilead Sciences, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] and the related notes and our report dated February [removed: 23, 2022] [added: 22, 2023] expressed an unqualified opinion thereon.

February 22, 2023

February 23, 2022

An evaluation as of December 31, [removed: 2021] [added: 2022] was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our “disclosure controls and procedures,” which are defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as controls and other procedures of a company that are designed to ensure that the information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to the company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, [removed: 2021.][added: 2022.]

Based on our evaluation, we concluded that our internal control over financial reporting was effective as of December 31, [removed: 2021.][added: 2022.]

Our independent registered public accounting firm, Ernst & Young LLP, has audited our Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K and have issued a report on our internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]

Our management, including our Chief Executive Officer and Chief Financial Officer, has evaluated any changes in our internal control over financial reporting that occurred during the quarter ended December 31, [removed: 2021,] [added: 2022,] and has concluded that there was no change during such quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

The information required by this Item concerning our directors and executive officers is incorporated by reference to the sections of our Definitive Proxy Statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A in connection with our [removed: 2022] [added: 2023] Annual Meeting of Stockholders (the “Proxy Statement”) under the headings “The Gilead Board of Directors - Nominees,” “Board Structure,” “Executive Officers,” and, if applicable, “Delinquent Section 16(a) Reports.”

The Code of Ethics is available on our website at www.gilead.com in the “Investors” section under [removed: “Corporate Governance.”] [added: “Governance - Governance Documents”] We intend to disclose future amendments to certain provisions of the Code of Ethics, and waivers of the Code of Ethics granted to executive officers and directors, on the website within four business days following the date of the amendment or waiver.

The information required by this Item is incorporated by reference to Item 5 of our Annual Report on Form 10-K under the heading [removed: “Equity] [added: “Securities Authorized For Issuance Under Equity] Compensation [removed: Plan Information”] [added: Plans”] and the section of the Proxy Statement under the heading “Security Ownership of Certain Beneficial Owners and Management.”

| [Report of Independent Registered Public Accounting Firm (PCAOB ID: [removed: 42)](#i72faa4a0a4974dcca6db2bf491b63d7a_73)] [added: 42)](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] | | | [removed: [50](#i72faa4a0a4974dcca6db2bf491b63d7a_73)] [added: [46](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] | | |

| [Audited Consolidated Financial [removed: Statements:](#i72faa4a0a4974dcca6db2bf491b63d7a_76)] [added: Statements:](#i6d96c727bd3e4a10969bbf6a84d64ce7_70)] | | | | | |

| [Consolidated Balance [removed: Sheets](#i72faa4a0a4974dcca6db2bf491b63d7a_79)] [added: Sheets](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] | | | [removed: [52](#i72faa4a0a4974dcca6db2bf491b63d7a_79)] [added: [48](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] | | |

| [Consolidated Statements of [removed: Income](#i72faa4a0a4974dcca6db2bf491b63d7a_82)] [added: Income](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] | | | [removed: [53](#i72faa4a0a4974dcca6db2bf491b63d7a_82)] [added: [49](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] | | |

| [Consolidated Statements of Comprehensive Income [removed: (Loss)](#i72faa4a0a4974dcca6db2bf491b63d7a_85)] [added: (Loss)](#i6d96c727bd3e4a10969bbf6a84d64ce7_79)] | | | [removed: [54](#i72faa4a0a4974dcca6db2bf491b63d7a_85)] [added: [50](#i6d96c727bd3e4a10969bbf6a84d64ce7_79)] | | |

| [Consolidated Statements of Stockholders’ [removed: Equity](#i72faa4a0a4974dcca6db2bf491b63d7a_88)] [added: Equity](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] | | | [removed: [55](#i72faa4a0a4974dcca6db2bf491b63d7a_88)] [added: [51](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] | | |

| [Consolidated Statements of Cash [removed: Flows](#i72faa4a0a4974dcca6db2bf491b63d7a_91)] [added: Flows](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] | | | [removed: [56](#i72faa4a0a4974dcca6db2bf491b63d7a_91)] [added: [52](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i72faa4a0a4974dcca6db2bf491b63d7a_94)] [added: Statements](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] | | | [removed: [57](#i72faa4a0a4974dcca6db2bf491b63d7a_94)] [added: [53](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] | | |

| [removed: (3)] [added: (1)] | | | 3.1 | | | | | | | | | [Restated Certificate of Incorporation of Registrant](http://www.sec.gov/Archives/edgar/data/882095/000110465919028215/a19-9678_1ex3d2.htm) | | |

| [removed: (3)] [added: (1)] | | | 3.2 | | | | | | | | | [Amended and Restated Bylaws of [removed: Registrant](http://www.sec.gov/Archives/edgar/data/882095/000110465919028215/a19-9678_1ex3d3.htm)] [added: Registrant](http://www.sec.gov/Archives/edgar/data/882095/000110465923011167/tm235492d1_ex3-1.htm)] | | |

| [removed: (4)] [added: (2)] | | | [removed: 4.1] [added: 4.2] | | | | | | | | | [Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee](http://www.sec.gov/Archives/edgar/data/882095/000119312511086814/dex41.htm) | | |

| [removed: (4)] [added: (2)] | | | [removed: 4.2] [added: 4.3] | | | | | | | | | [First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes)](http://www.sec.gov/Archives/edgar/data/882095/000119312511086814/dex42.htm) | | |

| [removed: (5)] [added: (3)] | | | [removed: 4.3] [added: 4.4] | | | | | | | | | [Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee [removed: (including](http://www.sec.gov/Archives/edgar/data/882095/000119312511339157/d269235dex41.htm) [Form] [added: (including Form] of 2041 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312511339157/d269235dex41.htm) | | |

| [removed: (6)] [added: (4)] | | | [removed: 4.4] [added: 4.5] | | | | | | | | | [Third Supplemental Indenture related to Senior Notes, dated as of March 7, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2024 [removed: Note](http://www.sec.gov/Archives/edgar/data/882095/000119312514089047/d688498dex41.htm) [a](http://www.sec.gov/Archives/edgar/data/882095/000119312514089047/d688498dex41.htm)[nd](http://www.sec.gov/Archives/edgar/data/882095/000119312514089047/d688498dex41.htm) [Form] [added: Note and Form] of 2044 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312514089047/d688498dex41.htm) | | |

| [removed: (7)] [added: (5)] | | | [removed: 4.5] [added: 4.6] | | | | | | | | | [Fourth Supplemental Indenture related to Senior Notes, dated as of November 17, 2014, between Registrant and Wells Fargo, National Association, as Trustee [removed: (including](http://www.sec.gov/Archives/edgar/data/882095/000119312514415184/d821656dex41.htm) [Form] [added: (including Form] of 2025 [removed: Note](http://www.sec.gov/Archives/edgar/data/882095/000119312514415184/d821656dex41.htm) [and](http://www.sec.gov/Archives/edgar/data/882095/000119312514415184/d821656dex41.htm) [Form] [added: Note and Form] of 2045 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312514415184/d821656dex41.htm) | | |

| [removed: (8)] [added: (6)] | | | [removed: 4.6] [added: 4.7] | | | | | | | | | [Fifth Supplemental Indenture, dated as of September 14, 2015, between Registrant and Wells Fargo Bank, National Association, as Trustee [removed: (including](http://www.sec.gov/Archives/edgar/data/882095/000119312515319560/d68529dex41.htm) [Form] [added: (including Form] of 2026 Note, Form of 2035 Note and Form of 2046 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312515319560/d68529dex41.htm) | | |

| [removed: (9)] [added: (7)] | | | [removed: 4.7] [added: 4.8] | | | | | | | | | [Sixth Supplemental Indenture, dated as of September 20, 2016, between Registrant and Wells Fargo Bank, National Association, as Trustee [removed: (including](http://www.sec.gov/Archives/edgar/data/882095/000119312516714926/d259911dex41.htm) [Form] [added: (including Form] of 2023 Note, Form of 2027 Note, Form of 2036 Note and Form of 2047 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312516714926/d259911dex41.htm) | | |

| [removed: (10)] [added: (8)] | | | [removed: 4.8] [added: 4.9] | | | | | | | | | [Eighth Supplemental Indenture, dated as of September 30, 2020, between [removed: the](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm) [Registrant](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm) [and] [added: the Registrant and] Wells Fargo Bank, National Association, as Trustee (including form of notes)](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm) | | |