Gilead Sciences (GILD) 10-K risk factor changes: FY2023 vs FY2022
The 2023-12-31 10-K against the 2022-12-31 one, compared heading by heading and sentence by sentence.
Item 1A50 rewritten57 added14 removed292 unchanged
All filing items941 rewritten590 added489 removed1,935 unchanged
Summary
counted, not written
- Item 1A lists 24 risk factor headings: 2 new, 3 reworded and 19 unchanged since FY2022. 0 headings from FY2022 no longer appear.
- Sentence by sentence, 590 added, 489 removed, 941 rewritten and 1,935 unchanged across 16 items that differ.
- New this year: Item 1C. CYBERSECURITY.
New Item 1A headings (2)
- Climate change and related natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.
- The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations.
Removed Item 1A headings (0)
Every FY2022 risk factor heading is still here, word for word or reworded.
Reworded Item 1A headings (3)
- Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and
[removed: other discounts on our products][added: discounts,] and other pricing pressures. - Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious
[removed: diseases, including the ongoing COVID-19 pandemic.][added: diseases.] [removed: Significant][added: Information system service interruptions or breaches, including significant] cybersecurity[removed: incidents][added: incidents,] could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations.
A heading is new when no FY2022 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2023; struck-through words were in FY2022. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
50 rewritten, 57 added, 14 removed, 292 unchanged
During the year ended December 31, [removed: 2022,] [added: 2023,] sales of our HIV products accounted for approximately [removed: 64%] [added: 67%] of our total product sales.
If there are any changes to the treatment or prevention paradigm for [removed: HIV that cause] [added: HIV, and] nucleoside-based therapeutics [removed: to fall out of favor,] [added: do not remain the preferred regimen,] our HIV product sales would be adversely impacted.
We face risks related to our supply and [removed: distribution] [added: sale] of Veklury, which was approved by U.S. Food and Drug Administration (“FDA”) [removed: in October 2020] as a treatment for patients [removed: hospitalized] with coronavirus disease 2019 [removed: (“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 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.][added: (“COVID-19”).]
[removed: While] Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccines and alternative treatments for [removed: COVID-19, we are unable to accurately predict our revenues or supply needs over the short- and long-term due to the dynamic nature of the COVID-19 pandemic.][added: COVID-19.]
For challenges related to the reimbursement of Yescarta and Tecartus, see also “Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and [removed: other discounts on our products] [added: discounts,] and other pricing pressures.”
For the year ended December 31, [removed: 2022,] [added: 2023,] approximately [removed: 89%] [added: 91%] of our product sales in the U.S. were to three wholesalers, [added: Cencora, Inc. (formerly known as] AmerisourceBergen [removed: Corporation,] [added: Corporation),] Cardinal Health, Inc. and McKesson Corporation.
In addition, we have observed that strong wholesaler and sub-wholesaler purchases of our products in the [removed: fourth quarter] [added: second half of the year] typically results in inventory draw-down by wholesalers and sub-wholesalers in the subsequent first quarter.
Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and [removed: other discounts on our products] [added: discounts,] and other pricing pressures.
- U.S. Congress has enacted laws requiring manufacturer refunds on certain amounts of discarded drug from single-use vials [removed: beginning in 2023] and eliminating the existing cap on Medicaid rebate amounts beginning in 2024.
- 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 [removed: increase] [added: increases] 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.
[removed: We continue to evaluate] [added: While] the [added: full] impact of the Act on our business [removed: but expect] [added: and] the [added: pharmaceutical industry remains uncertain at this time, we anticipate that the] Act will increase our payment obligations under the redesigned Part D discount program, limit the prices we can [removed: charge,] [added: charge for our products,] and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.
- 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 prices, [added: establishing drug payment limits,] and encouraging the use of generic drugs.
These initiatives and such other legislation may cause added pricing pressures on our products, and the resulting impact on our business is [removed: uncertain.][added: uncertain at this time.]
[removed: We recently] [added: In March 2022, we] implemented a contract pharmacy integrity initiative for our branded hepatitis C virus (“HCV”) products.
This integrity initiative [removed: will] [added: does] not involve any products from Asegua Therapeutics LLC.
[removed: Although we believe that our integrity initiative complies with the requirements of the 340B statute,] [added: However,] additional legal or legislative developments with respect to the 340B program, including potential litigation with [removed: HHS,] [added: HHS or other stakeholders,] may negatively impact our ability to implement or continue our integrity initiative.
[removed: For example,] U.S. sales could also be affected if FDA permits importation of drugs from Canada.
These diverted products may be handled, shipped and stored inappropriately, which may affect the [added: quality and/or] efficacy of the products and could harm patients and adversely impact us.
Further, we [added: have in the past and we] may [added: in the future] make a strategic decision to discontinue development of our product [removed: candidates if, for example,] [added: candidates, including but not limited to situations where] we believe commercialization will be difficult relative to other opportunities in our pipeline.
We expect to [removed: expend] [added: spend] significant time and resources on our clinical trial activities without any assurance that we will recoup our investments or that our efforts will be commercially successful.
We rely on independent third-party contract research organizations (“CROs”) to perform most of our clinical studies, including document preparation, site identification, screening and preparation, pre-study visits, training, program management, patient enrollment, ongoing monitoring, site management and [removed: bioanalytical analysis.][added: bioanalysis.]
We have incurred, and will continue to incur, inventory write-off charges and other expenses for products that fail to meet specifications and quality [removed: standards,] [added: standards as well as changes we may adopt in our manufacturing strategy,] and we may need to undertake costly remediation efforts or seek more costly manufacturing alternatives.
In addition, if deliveries of materials from our suppliers are interrupted for any reason, [added: including as a result of natural disasters or extreme weather conditions,] we may be unable to ship certain of our products for commercial supply or to supply our product candidates in development for clinical trials.
Problems with any of the single suppliers or facilities we depend on, including in the event of a disaster, such as an earthquake, [added: flood or fire,] equipment failure or other difficulty, may negatively impact our development and commercialization efforts.
The healthcare industry is subject to various federal, state and international laws and regulations pertaining to drug [added: approval,] reimbursement, rebates, price reporting, healthcare fraud and abuse, and data privacy and security.
In the U.S., these laws include anti-kickback and false claims laws, [added: Federal Food, Drug, and Cosmetic Act,] laws and regulations relating to the Medicare and Medicaid programs and other federal and state programs, such as the Medicaid Rebate Statute and the 340B statute, laws that regulate written and verbal communications about our products, individual state laws relating to pricing and sales and marketing practices, the Health Insurance Portability and Accountability Act and other federal and state laws relating to the privacy and security of health information.
These laws and regulations are broad in scope and subject to changing and evolving interpretations, which could require us to incur substantial costs associated with [removed: compliance or to] [added: compliance,] alter one or more of our sales or marketing [removed: practices.][added: practices, or impact our ability to obtain or maintain regulatory approvals.]
Any such issues may require changes to our product labels, such as additional warnings, contraindications or even narrowed indications, or [removed: to] [added: the] halt [removed: sales] of [removed: a product.][added: product sales.]
[removed: These] [added: From time to time, these] matters [removed: could] require us to pay significant monetary amounts, including royalty payments for past and future sales.
Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious [removed: diseases, including the ongoing COVID-19 pandemic.][added: diseases.]
[removed: - Foreign Currency Exchange: For the year ended December 31, 2022, approximately 31% of our product sales were outside the U.S.] Because a significant percentage of our product sales is denominated in foreign currencies, primarily the Euro, we face exposure to adverse movements in foreign currency exchange rates.
For example, see [added: “Foreign Currency Exchange Impact” in] 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, [removed: 2022.][added: 2023.]
Fluctuations in interest rates, including the U.S. Federal Reserve’s recent increases in interest [removed: rates,] [added: rates and anticipated decreases in 2024,] could expose us to increased financial risk.
- Restrictive government actions against our intellectual property and other [removed: foreign] assets such as nationalization, expropriation, the imposition of compulsory licenses or similar actions, including waiver of intellectual property protections.
- Protective economic policies taken by [removed: foreign] governments, such as trade protection measures and import and export licensing requirements, which may result in the imposition of trade sanctions or similar restrictions by the U.S. or other governments.
[removed: - Business interruptions stemming from] [added: Many of our operations and facilities, including those essential to our manufacturing, R&D and commercialization/distribution activities, are located in regions subject to] natural or man-made disasters, such as climate change, earthquakes, hurricanes, [added: rising sea levels and] flooding, fires, extreme heat, drought or [removed: actual or threatened public health emergencies,] [added: other extreme weather conditions,] or efforts taken by third parties to prevent or mitigate such disasters, such as public safety power shutoffs and facility [removed: shutdowns, for which we may not have sufficient insurance.][added: shutdowns.]
[removed: For example,] [added: Additionally,] our corporate headquarters in Foster City and certain R&D and manufacturing facilities are located in California, a seismically active region.
- Political instability or disruption in a geographic region where we operate, regardless of cause, including war, terrorism, social unrest and political changes, including in China, [removed: Russia] [added: Russia, Ukraine, Israel] and [removed: Ukraine.][added: surrounding areas.]
[removed: Additionally,] [added: Furthermore,] changes to [removed: U.S.] immigration and work authorization laws and regulations could make it more difficult for employees to work in or transfer to one of the jurisdictions in which we operate.
[removed: Significant] [added: Information system service interruptions or breaches, including significant] cybersecurity [removed: incidents] [added: incidents,] could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations.
In May 2023, the World Health Organization declared the end of COVID-19 as a public health emergency of international concern.
Future sales of Veklury in the short- and long-term remain uncertain.
In November 2023, FDA announced that it is investigating the risk of T-cell malignancies in patients who received treatment with CAR T-cell therapy, noting that the overall benefits of CAR T-cell therapy products continue to outweigh their potential risks for their approved uses.
In January 2024, FDA determined that safety labeling issues were needed for approved CAR T-cell therapies, including a “boxed warning” about the possible risk of T-cell malignancies in patients treated with CAR T-cell therapy.
Additionally, FDA requested continued monitoring and reporting of cases of secondary cancers.
We also face risks related to our in-house CAR T-cell therapy manufacturing facilities in California, Maryland and the Netherlands, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.
Quality, reliability and speed are critical in cell therapy manufacturing to quickly and safely deliver our cell therapies to patients.
Any delays or quality issues with our manufacturing operations could adversely affect our business and damage our reputation.
In addition, we may not be able to sufficiently increase manufacturing network capacity to meet growing demand.
In January 2024, FDA authorized Florida’s proposed program to import prescription drugs from Canada, although Florida must meet certain additional requirements before it can begin shipments of prescription drugs into the U.S. from Canada.
The list of the specific prescription drugs that Florida intends to import has not been made public.
We continue to evaluate the potential impact of the Act on our business.
Centers for Medicare & Medicaid Services (“CMS”) has issued a number of guidance documents, but it remains unclear how certain provisions will be implemented.
Additional guidance, legislation or rulemaking may be issued that could reflect the government’s evolving views.
In addition, multiple manufacturers and trade organizations have challenged the Medicare “negotiation” provisions of the Act, and additional legal challenges may be filed in the future.
For example, in August 2023, the Colorado Prescription Drug Affordability Review Board selected Genvoya for an affordability review, and it is possible the board may designate an upper limit on the amount certain purchasers and payors can pay for Genvoya.
Certain states have also enacted laws requiring manufacturers to provide 340B pricing through contract pharmacy arrangements; we believe these laws, which are being challenged in ongoing litigation, are invalid.
We also believe that our integrity initiative complies with the requirements of the 340B statute.
In January 2024, we announced that our Phase 3 EVOKE-01 study evaluating sacituzumab govitecan-hziy did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer (“NSCLC”).
We believe that this represents an indicator of potential impairment in the first quarter of 2024, which could result in us being required to record an impairment charge during the three months ended March 31, 2024.
Any such impairment charge, which we are unable to reasonably estimate at this time, could have a material impact on our results of operations (for more information, see Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations “Results of Operations - In-Process Research and Development Impairments”).
In addition, in February 2024, we announced a full clinical hold placed by FDA on all magrolimab studies in myelodysplastic syndromes and acute myeloid leukemia, and that we will not pursue further development of magrolimab in hematologic cancers.
For example, in February 2024, we announced a full clinical hold placed by FDA on all magrolimab studies in myelodysplastic syndromes and acute myeloid leukemia, and based on these results and data from other clinical studies, we will not pursue further development of magrolimab in hematologic cancers.
In addition, in January 2024, we announced with our partner Arcus Biosciences, Inc. (“Arcus”) the discontinuation of further enrollment in the Phase 3 ARC-10 study evaluating domvanalimab plus zimberelimab in first-line locally advanced or metastatic, PD-L1-high NSCLC based on strategic prioritization to advance and potentially accelerate other Phase 3 studies in our collaboration with Arcus.
For example, see Note 10.
Other Financial Information 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 certain charges we incurred related to changes in our manufacturing strategy.
For example, in the U.S., there has been a shortage of certain cancer drugs that are the backbone of standard-of-care treatments, such as carboplatin and cisplatin, which are also used in R&D and clinical trials.
While we have observed minimal impacts to our oncology clinical trials to date, if these shortages continue or increase in magnitude, our ongoing and future oncology clinical trials may be delayed, halted or adversely impacted.
- Foreign Currency Exchange: For the year ended December 31, 2023, approximately 26% of our product sales were denominated in foreign currencies.
- Increasing use of social media platforms and modern technologies present new risks and challenges, and inappropriate or unauthorized use of these platforms can result in exposure of sensitive data or information and damage our brand and reputation.
Climate change and related natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.
The severity and frequency of weather-related events has been amplified, and is expected to continue to be amplified, by climate change.
Such natural disasters have caused, and in the future may cause, damage to and/or disrupt our operations, which may result in a material adverse effect on our business and financial results.
For example, our facility in Cork, Ireland, where we conduct commercial manufacturing, packaging and labeling and perform quality control testing and final release of many of our products, temporarily suspended on-site operations as a result of the flooding caused by Storm Babet in October 2023.
Although we have business continuity plans and contingencies in place and conduct periodic assessments of our natural disaster risk as part of our overall enterprise risk management program, a major earthquake or other natural disaster can result in significant recovery time and a prolonged interruption to our operational and business activities.
We may be required to incur significant costs to remedy the effects of such natural disasters and to resume or restore our operations, which could adversely impact us.
Our suppliers and third-party manufacturers and corporate partners face similar risks, and any disruption to their operations could have an adverse effect on our manufacturing and supply chain.
Also, see risks under the headings “We may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners” and “We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, which could limit our ability to generate revenues.
In addition, growing concern regarding climate change has resulted in an evolving legal and regulatory landscape, with new requirements enacted to prevent, mitigate or adapt to the implications of climate change.
We also remain subject to significant public attention and scrutiny over the complex decisions made regarding clinical data, supply, allocation, distribution and pricing of Veklury, all of which affects our corporate reputation.
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.
In addition, we may not be able to produce or otherwise obtain an amount of viral vector supply sufficient to satisfy demand for our finished products.
If we are unable to meet product demand, we will have difficulty meeting sales forecasts for our finished products.
This rule is subject to ongoing litigation.
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.
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.
For example, on February 1, 2022, we reached an agreement with ViiV Healthcare Company and related parties (collectively, “ViiV”) for a global resolution of all claims related to our sales of Biktarvy, pursuant to which (1) Gilead agreed to make a one-time payment of $1.25 billion and an ongoing royalty at a rate of 3% on future sales of Biktarvy and the bictegravir component of bictegravir-containing products in the U.S. until October 5, 2027, and (2) ViiV granted Gilead a broad worldwide license and covenant not to sue relating to any past, present or future development or commercialization of bictegravir.
In the event of a major earthquake, we may not carry sufficient earthquake insurance, and significant recovery time could be required to resume operations.
An excerpt. Shown here: 40 of 50 rewritten, 40 of 57 added and all 14 removed. The counts are complete. For every sentence, read Item 1A. RISK FACTORS in the FY2023 filing and the FY2022 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
71 rewritten, 136 added, 92 removed, 126 unchanged
[added: The following discussion and analysis is intended] to [added: provide material information around events and uncertainties known to] management [added: that are] relevant to an assessment of the financial condition and results of operations of Gilead and should therefore be read in conjunction with our audited Consolidated Financial Statements and the [removed: accompanying Notes to Consolidated Financial Statements] [added: related notes thereto] and other disclosures included [removed: in] [added: as part of] 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: 2021] [added: 2022] and [removed: 2020] [added: 2021] is included in Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations of our [removed: [2021 Form] [added: 2022 [Form] 10-K](http://www.sec.gov/ix?doc=/Archives/edgar/data/882095/000088209522000007/gild-20211231.htm) filed with [removed: the] U.S. Securities and Exchange [removed: Commission (“SEC”).][added: Commission.]
Gilead Sciences, Inc. [removed: (“Gilead,”] [added: (including its consolidated subsidiaries, referred to as “Gilead,” the “company,”] “we,” “our” or “us”) is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral [removed: hepatitis] [added: hepatitis, coronavirus disease 2019 (“COVID-19”)] and cancer.
[removed: We also continued to broaden therapies available in oncology, receiving approvals for additional indications of Yescarta and Tecartus, and the 2023] [added: - Received EC] approval [removed: of] [added: for] Trodelvy [added: as monotherapy] for the treatment of adult patients with unresectable [removed: locally advanced] or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) breast cancer who have received endocrine-based [removed: therapy] [added: therapy,] and at least two additional systemic therapies in the [removed: metastatic] [added: advanced] setting.
We also continued to provide shareholder returns [removed: in the form of] [added: through] dividends and share repurchases.
[removed: - 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] [added: This includes] 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.
- [removed: In December 2022, we entered] [added: 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 [added: patients with relapsed or refractory] multiple [removed: myeloma.][added: myeloma, and later announced expansion of the Arcellx collaboration to include exercising an option for the ARC-SparX ACLX-001 program in multiple myeloma, expanding the scope of the existing anito-cel collaboration to include lymphomas, and a further equity investment.]
- [removed: In December 2022, we announced] [added: Completed] the transfer of [removed: the] [added: Yescarta’s] marketing authorization [removed: for Yescarta] in Japan from Daiichi Sankyo Co., Ltd. to Gilead [added: Sciences] K.K. [removed: in 2023.]
[removed: *Other*][added: Other]
- [removed: In February 2023, we announced that] [added: Received] FDA [removed: has approved] [added: approval of] Trodelvy for the treatment of adult patients with 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.
| (in millions, except percentages and per share amounts) | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | Change | | |
| Total revenues | | | | | | $ | [removed: 27,281] [added: 27,116] | | | | | $ | [removed: 27,305] [added: 27,281] | | | | | [removed: *—*] [added: *(1)*] | | *%* |
| Net income attributable to Gilead | | | | | | $ | [removed: 4,592] [added: 5,665] | | | | | $ | [removed: 6,225] [added: 4,592] | | | | | [removed: *(26)*] [added: *23*] | | *%* |
| Diluted earnings per share attributable to Gilead | | | | | | $ | [removed: 3.64] [added: 4.50] | | | | | $ | [removed: 4.93] [added: 3.64] | | | | | [removed: *(26)*] [added: *24*] | | *%* |
Net income attributable to Gilead was [removed: $4.6] [added: $5.7] billion [removed: or $3.64] [added: and] diluted earnings per share attributable to Gilead [added: was $4.50] in [removed: 2022,] [added: 2023,] compared to [removed: $6.2] [added: $4.6] billion [removed: or $4.93] [added: and $3.64] diluted earnings per share attributable to Gilead in [removed: 2021.][added: 2022.]
| | | | | | | Year Ended December 31, [removed: 2022] [added: 2023] | | | | | | | | | | | | | | | | | | | | | | | | Year Ended December 31, [removed: 2021] [added: 2022] | | | | | | | | | | | | | | | | | | | | | | | | | | |
| [removed: HBV/HDV] [added: *HBV / HDV*] | | | | | | [removed: 435] [added: *418*] | | | | | | [removed: 112] [added: *133*] | | | | | | [removed: 441] [added: *466*] | | | | | | [removed: 988] [added: *1,017*] | | | | | | [removed: 397] [added: *435*] | | | | | | [removed: 104] [added: *112*] | | | | | | [removed: 468] [added: *441*] | | | | | | [removed: 969] [added: *988*] | | | | | | [removed: *2*] [added: *3*] | | *%* |
| [removed: Cell Therapy] [added: *Cell Therapy*] | | | | | | [removed: 968] [added: *1,055*] | | | | | | [removed: 430] [added: *658*] | | | | | | [removed: 60] [added: *156*] | | | | | | [removed: 1,459] [added: *1,869*] | | | | | | [removed: 542] [added: *968*] | | | | | | [removed: 293] [added: *430*] | | | | | | [removed: 36] [added: *60*] | | | | | | [removed: 871] [added: *1,459*] | | | | | | [removed: *68*] [added: *28*] | | *%* |
| [removed: Trodelvy] [added: *Trodelvy*] | | | | | | [removed: 525] [added: *777*] | | | | | | [removed: 143] [added: *217*] | | | | | | [removed: 12] [added: *68*] | | | | | | [removed: 680] [added: *1,063*] | | | | | | [removed: 370] [added: *525*] | | | | | | [removed: 10] [added: *143*] | | | | | | [removed: —] [added: *12*] | | | | | | [removed: 380] [added: *680*] | | | | | | [removed: *79*] [added: *56*] | | *%* |
| Total product sales | | | | | | [removed: 18,716] [added: 19,377] | | | | | | [removed: 4,342] [added: 4,197] | | | | | | [removed: 3,924] [added: 3,361] | | | | | | [removed: 26,982] [added: 26,934] | | | | | | [removed: 19,176] [added: 18,716] | | | | | | [removed: 4,678] [added: 4,342] | | | | | | [removed: 3,154] [added: 3,924] | | | | | | [removed: 27,008] [added: 26,982] | | | | | | *—* | | *%* |
| Royalty, contract and other revenues | | | | | | [removed: 168] [added: 62] | | | | | | [removed: 127] [added: 114] | | | | | | [removed: 4] [added: 7] | | | | | | [removed: 299] [added: 182] | | | | | | [removed: 91] [added: 168] | | | | | | [removed: 196] [added: 127] | | | | | | [removed: 10] [added: 4] | | | | | | [removed: 297] [added: 299] | | | | | | [removed: *1*] [added: *(39)*] | | *%* |
| Total revenues | | | | | | $ | [removed: 18,884] [added: 19,438] | | | | | $ | [removed: 4,469] [added: 4,310] | | | | | $ | [removed: 3,928] [added: 3,368] | | | | | $ | [removed: 27,281] [added: 27,116] | | | | | $ | [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: *—*] [added: *(1)*] | | *%* |
Cell [removed: therapy] [added: Therapy] product [removed: sales, which include Yescarta and Tecartus,] [added: sales] increased [removed: by 68%] [added: 28%] to [removed: $1.5] [added: $1.9] billion in [removed: 2022,] [added: 2023,] compared to [removed: 2021,] [added: 2022,] primarily due to [removed: higher] [added: increased Yescarta] demand for [removed: Yescarta in] [added: the treatment of] R/R LBCL [removed: in the U.S.] and [removed: Europe, as well as for] [added: increased] Tecartus [removed: in] [added: demand for the treatment of] R/R [removed: ALL] [added: adult acute lymphoblastic leukemia] and [added: R/R] mantle cell lymphoma.
[removed: Trodelvy][added: *Trodelvy*]
Other product sales decreased [removed: by 8%] [added: 9%] to [removed: $946] [added: $859] million in [removed: 2022, as] [added: 2023,] compared to [removed: 2021,] [added: 2022,] primarily due to [removed: lower demand for AmBisome and] loss of exclusivity for Letairis.
The following table summarizes the period-over-period changes in [removed: gross-to-net deductions:][added: Income tax expense:]
| (in millions, except percentages) | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | Change | | |
Foreign currency exchange, net of hedges, had an unfavorable impact on our total product sales of [removed: $608] [added: $224] million in [removed: 2022,] [added: 2023,] based on a comparison using foreign currency exchange rates from [removed: 2021.][added: 2022.]
| Cost of goods sold | | | | | | $ | [removed: 5,657] [added: 6,498] | | | | | $ | [removed: 6,601] [added: 5,657] | | | | | [removed: *(14)*] [added: *15*] | | *%* |
| Product gross margin | | | | | | [removed: 79.0] [added: 75.9] | | % | | | | [removed: 75.6] [added: 79.0] | | % | | | | [removed: *347] [added: *\-316] bps* | | |
| Research and development expenses | | | | | | $ | [removed: 4,977] [added: 5,718] | | | | | $ | [removed: 4,601] [added: 4,977] | | | | | [removed: *8*] [added: *15*] | | *%* |
| Acquired in-process research and development expenses | | | | | | $ | [removed: 944] [added: 1,155] | | | | | $ | [removed: 939] [added: 944] | | | | | [removed: *1*] [added: *22*] | | *%* |
| In-process research and development [removed: impairment] [added: impairments] | | | | | | $ | [removed: 2,700] [added: 50] | | | | | $ | [removed: —] [added: 2,700] | | | | | [removed: *NM*] [added: *(98)*] | | [added: *%*] |
| Selling, general and administrative expenses | | | | | | $ | [removed: 5,673] [added: 6,090] | | | | | $ | [removed: 5,246] [added: 5,673] | | | | | [removed: *8*] [added: *7*] | | *%* |
Acquired in-process research and development expenses [removed: of] [added: were] $944 million in [removed: 2022 were] [added: 2022,] primarily [removed: related to a] [added: comprised of] $389 million [removed: charge] associated with [removed: our] [added: the] acquisition of [removed: MiroBio, a] [added: MiroBio Ltd,] $315 million [removed: charge] associated with the [added: collaboration with] Dragonfly [removed: collaboration, an] [added: Therapeutics, Inc.,] $82 million [removed: charge] associated with the [removed: Jounce] collaboration [added: with Jounce Therapeutics, Inc.] and acquisition of GS-1811, and [removed: a] $60 million [removed: charge] associated with the [removed: MacroGenics collaboration.][added: collaboration with MacroGenics, Inc. See Note 6.]
See Note [removed: 6.][added: 7.]
Acquisitions and Note [removed: 10.][added: 7.]
In-Process Research and Development [removed: Impairment][added: Impairments]
Risk Factors).
During 2023, we continued to advance our portfolio and broaden available therapies while delivering continued growth in our HIV and Oncology product sales.
The following updates are based on press releases issued since our last annual report.
- Announced that the Phase 3 OAKTREE trial of obeldesivir in non-hospitalized participants without risk factors for developing severe COVID-19 did not meet its primary endpoint of improvement in time to symptom alleviation.
Obeldesivir was well-tolerated in this large study population.
- Received U.S. Food and Drug Administration (“FDA”) and European Commission (“EC”) approval to extend the use of Veklury to treat COVID-19 in appropriate patients with mild to severe hepatic impairment as well as people with severe renal impairment, including those on dialysis.
- Announced a collaboration with Assembly Biosciences, Inc. (“Assembly”) to advance the research and development of novel antiviral therapies, including for herpesviruses, chronic hepatitis B virus (“HBV”) and chronic hepatitis delta virus (“HDV”).
- Received full marketing authorization from EC for Hepcludex (bulevirtide) for the treatment of adults with HDV and compensated liver disease.
Hepcludex was initially granted conditional marketing authorization in July 2020.
Bulevirtide remains the only approved treatment for HDV in the European Union (“EU”) and is not approved in the U.S.
- Announced a full clinical hold placed by FDA on all magrolimab studies in myelodysplastic syndromes and acute myeloid leukemia, and that we will not pursue further development of magrolimab in hematologic cancers.
- Announced that the Phase 3 EVOKE-01 study of Trodelvy versus docetaxel in previously treated metastatic non-small cell lung cancer did not meet its primary endpoint of overall survival.
While not statistically powered, we observed an encouraging trend in a subgroup of patients non-responsive to prior anti-PD-(L)1 immunotherapy, that we may potentially explore further.
- Received FDA approval of Yescarta’s label update to include overall survival data from the Phase 3 ZUMA-7 study, which showed a statistically significant overall survival improvement for Yescarta in second-line relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) versus standard of care.
- Received FDA approval of a manufacturing process change resulting in reduced median turnaround time for Yescarta in the U.S. to an anticipated 14 days (from 16 days previously).
- Announced an exclusive license agreement with Compugen Ltd. (“Compugen”) for later-stage development and commercialization of novel pre-clinical anti-IL18 binding protein antibodies, including COM503, that have the potential to treat various tumor types.
- Announced a collaboration with Tentarix Biotherapeutics Inc. (“Tentarix”) to discover and develop novel therapies across oncology and inflammation, using Tentarix’s proprietary Tentacles platform.
- Announced, through Fosun Kite Biotechnology Co., Ltd., a joint venture between us and Shanghai Fosun Pharmaceutical (Group) Co., Ltd., the approval of axicabtagene ciloleucel (under the trade name Yikaida®) by the China National Medical Products Administration for the treatment of adult patients with R/R LBCL who failed first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy.
- Announced the acquisition of XinThera, Inc. (“XinThera”), adding additional pipeline assets including rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology as well as MK2 for inflammatory diseases.
- Completed the acquisition of Tmunity Therapeutics, Inc. (“Tmunity”), a clinical stage private biotech company, which provides preclinical and clinical programs.
- Announced that we entered into a definitive agreement to acquire all of the outstanding common stock of CymaBay Therapeutics, Inc. (“CymaBay”) and its lead product candidate, seladelpar, which is an investigational treatment for primary biliary cholangitis.
- Announced an amendment expanding the collaboration agreement with Arcus Biosciences, Inc. (“Arcus”), including research programs in inflammatory diseases, an update to the domvanalimab collaboration program, and an additional equity investment.
- Exercised an option to license investigational targeted protein degrader molecule NX‑0479 (“GS-6791”) from Nurix Therapeutics, Inc. GS-6791 is a potent, selective, oral IRAK4 degrader with potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases.
- Issued $2.0 billion aggregate principal amount of senior unsecured notes in a registered offering, comprised of $1.0 billion principal amount of 5.25% senior notes due in 2033 and $1.0 billion principal amount of 5.55% senior notes due in 2053, and repaid debt of $2.25 billion.
Total revenues decreased 1% to $27.1 billion in 2023, compared to 2022, driven by lower Veklury sales, largely offset by higher HIV and Oncology sales.
The increase was primarily due to lower in-process research and development (“IPR&D”) impairment expenses, lower net unrealized losses on equity investments and higher interest income, partially offset by higher costs of goods sold and operating expenses, and lower revenues.
| HIV | | | | | | $ | 14,848 | | | | | $ | 2,102 | | | | | $ | 1,226 | | | | | $ | 18,175 | | | | | $ | 13,820 | | | | | $ | 2,219 | | | | | $ | 1,155 | | | | | $ | 17,194 | | | | | *6* | | *%* |
| Oncology | | | | | | 1,833 | | | | | | 875 | | | | | | 224 | | | | | | 2,932 | | | | | | 1,494 | | | | | | 573 | | | | | | 73 | | | | | | 2,139 | | | | | | *37* | | *%* |
| Liver Disease | | | | | | 1,421 | | | | | | 511 | | | | | | 852 | | | | | | 2,784 | | | | | | 1,440 | | | | | | 525 | | | | | | 833 | | | | | | 2,798 | | | | | | *(1)* | | *%* |
| *HCV* *(1)* | | | | | | *1,002* | | | | | | *378* | | | | | | *386* | | | | | | *1,767* | | | | | | *1,005* | | | | | | *413* | | | | | | *392* | | | | | | *1,810* | | | | | | *(2)* | | *%* |
| Veklury | | | | | | 972 | | | | | | 408 | | | | | | 805 | | | | | | 2,184 | | | | | | 1,575 | | | | | | 702 | | | | | | 1,628 | | | | | | 3,905 | | | | | | *(44)* | | *%* |
| Other | | | | | | 304 | | | | | | 301 | | | | | | 255 | | | | | | 859 | | | | | | 388 | | | | | | 323 | | | | | | 235 | | | | | | 946 | | | | | | *(9)* | | *%* |
(1) Chronic hepatitis C virus (“HCV”)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | Year Ended December 31, 2023 | | | | | | | | | | | | | | | | | | | | | | | | Year Ended December 31, 2022 | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (in millions, except percentages) | | | | | | U.S. | | | | | | Europe | | | | | | Other International | | | | | | Total | | | | | | U.S. | | | | | | Europe | | | | | | Other International | | | | | | Total | | | | | | Change | | |
| Biktarvy | | | | | | $ | 9,692 | | | | | $ | 1,253 | | | | | $ | 905 | | | | | $ | 11,850 | | | | | $ | 8,510 | | | | | $ | 1,103 | | | | | $ | 777 | | | | | $ | 10,390 | | | | | *14* | | *%* |
| Complera/Eviplera | | | | | | 47 | | | | | | 70 | | | | | | 12 | | | | | | 129 | | | | | | 74 | | | | | | 113 | | | | | | 13 | | | | | | 200 | | | | | | *(35)* | | *%* |
| Descovy | | | | | | 1,771 | | | | | | 100 | | | | | | 114 | | | | | | 1,985 | | | | | | 1,631 | | | | | | 118 | | | | | | 123 | | | | | | 1,872 | | | | | | *6* | | *%* |
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.
Strategy and Outlook
Since 2019, our strategic ambitions 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.
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.
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.
The following highlights are taken from press releases recently issued.
- 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.
The transaction closed in February 2023.
The transaction closed in January 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.
- In March 2022, we announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- mBC who received prior endocrine therapy, cyclin-dependent kinase (“CDK”) 4/6 inhibitors and two to four lines of chemotherapy.
- In January 2023, we announced a collaboration and licensing agreement with EVOQ Therapeutics, Inc. (“EVOQ”) to advance EVOQ’s proprietary NanoDisc technology for the treatment of rheumatoid arthritis and lupus.
- In September 2022, we completed the acquisition of MiroBio Ltd. (“MiroBio”) for $414 million in cash.
MiroBio is a U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors.
| | | | | | | | | | | | | | | | | | | | | |
An excerpt. Shown here: 40 of 71 rewritten, 40 of 136 added and 40 of 92 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS in the FY2023 filing and the FY2022 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
9 rewritten, 11 added, 15 removed, 23 unchanged
We are exposed to market risks that may result from changes in foreign currency exchange rates, interest rates and [removed: credit,] [added: credit] and equity prices.
Approximately [removed: 29%] [added: 26%] of our product sales were denominated in foreign currencies during [removed: 2022.][added: 2023.]
As of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] we had open foreign currency forward contracts with notional amounts of [removed: $3.0] [added: $2.5] billion and [removed: $2.9] [added: $3.0] 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: 2022] [added: 2023] and [removed: 2021] [added: 2022] would have resulted in a reduction in fair value of these contracts of approximately [removed: $299] [added: $328] million and [removed: $333] [added: $299] million, respectively, and if realized, would have negatively affected earnings over the remaining life of the contracts.
Our portfolio of available-for-sale debt securities and our [removed: senior unsecured notes create an exposure] [added: long-term borrowings are exposed] to interest rate and credit risk.
[removed: In addition to the senior unsecured fixed rate notes,] [added: Additionally,] we have a $2.5 billion five-year revolving credit facility that matures in June 2025.
There were no amounts outstanding under the [removed: five-year] revolving credit facility as of December 31, [removed: 2022.][added: 2023.]
The fair value of these equity securities was approximately [removed: $1.2] [added: $1.5] billion and [removed: $1.8] [added: $1.2] billion as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] 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: 2022] [added: 2023] and [removed: 2021] [added: 2022] by approximately [removed: $239] [added: $292] million and [removed: $364] [added: $239] million, respectively.
The fair value of our available-for-sale debt securities is subject to change as a result of potential changes in market interest rates.
The fair value of our portfolio of available-for-sale debt securities would not be significantly affected by either a 10% increase or decrease in interest rates primarily due to the short-term nature of the portfolio.
We do not believe that the future market risks related to our securities will have a material adverse impact on our financial position, results of operations, or liquidity.
Our senior unsecured notes have fixed interest rates.
As such, there is no financial interest rate exposure.
The fair value of these senior unsecured notes and our liability related to future royalties as part of our 2020 acquisition of Immunomedics, Inc. are exposed to fluctuations in interest rates.
The current fair value of our debt portfolio and liability related to future royalties are $22.6 billion and $1.2 billion, respectively.
The fair value will decrease as interest rates increase.
The fair value will increase as interest rates decrease.
Loans under our revolving credit facility bear interest at either (i) the Term Secured Overnight Financing Rate plus the Applicable Percentage, or (ii) the Base Rate plus the Applicable Percentage, each as defined in the revolving credit facility agreement.
As such, there is currently no financial interest rate exposure.
The following table summarizes the expected maturities and average interest rates of our interest-generating assets and interest-bearing liabilities as of December 31, 2022:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | | Expected Maturity | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Total Fair Value | | |
| (in millions, except percentages) | | | | | | | | | 2023 | | | | | | | | | 2024 | | | | | | | | | 2025 | | | | | | | | | 2026 | | | | | | | | | 2027 | | | | | | | | | Thereafter | | | | | | | | | Total | | | | | | | | | | | |
| Assets | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | | % | | | | | | | | | | | | | | | | | | |
| Liabilities | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Senior unsecured fixed rate notes, including current portion(1) | | | | | | $ | | | 2,250 | | | | | | $ | | | 1,750 | | | | | | $ | | | 1,750 | | | | | | $ | | | 2,750 | | | | | | $ | | | 2,000 | | | | | | $ | | | 13,750 | | | | | | $ | | | 24,250 | | | | | | $ | | | 21,872 | | |
| Average interest rate | | | | | | | | | 1.33 | | % | | | | | | | 3.70 | | % | | | | | | | 3.50 | | % | | | | | | | 3.65 | | % | | | | | | | 2.29 | | % | | | | | | | 4.07 | | % | | | | | | | | | | | | | | | | | | |
_______________________________
(1) Amounts represent principal balances.
See Note 11.
Debt and Credit Facilities of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information.
Item 1. BUSINESS
56 rewritten, 49 added, 37 removed, 340 unchanged
Gilead Sciences, Inc. [removed: (“Gilead,”] [added: (including its consolidated subsidiaries, referred to as “Gilead,” the “company,”] “we,” “our” or “us”) is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral [removed: hepatitis] [added: hepatitis, coronavirus disease 2019 (“COVID-19”)] and cancer.
In [removed: 2022,] [added: 2023,] our primary revenue-generating products and the approved indications in the U.S. were as follows:
- Veklury® (remdesivir), an injection for intravenous use, is a nucleotide analog RNA polymerase inhibitor indicated for the treatment of [removed: coronavirus disease 2019 (“COVID-19”)] [added: COVID-19] in certain adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are (i) hospitalized or (ii) not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
- Yescarta® (axicabtagene ciloleucel), a suspension for intravenous infusion, is a chimeric antigen receptor (“CAR”) T-cell therapy for the treatment of [removed: (i)] adult patients with [added: (i)] large B-cell lymphoma (“LBCL”) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, (ii) [removed: adult patients with] relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse LBCL (“DLBCL”) not otherwise specified, primary mediastinal LBCL, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma [removed: (“FL”),] [added: (“FL”)] and (iii) [removed: adult patients with] relapsed or refractory FL after two or more lines of systemic therapy.(1)
- Trodelvy® (sacituzumab govitecan-hziy), an injection for intravenous use, is a Trop-2 directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with (i) unresectable locally advanced or metastatic triple-negative breast cancer (“TNBC”) who have received two or more prior systemic therapies, at least one of them for metastatic disease, (ii) unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic [removed: setting(2)] [added: setting] and (iii) locally advanced or metastatic urothelial cancer (“UC”) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (“PD-1”) or programmed death-ligand 1 (“PD-L1”) inhibitor.(1)
[removed: In December 2022, we received FDA approval for Sunlenca® (lenacapavir), a] [added: - Sunlenca® is an] HIV-1 capsid inhibitor in tablet form for oral use and as an injection for subcutaneous use.
Sunlenca, in combination with other [removed: antiretrovirals,] [added: antiretroviral(s),] is [removed: approved] [added: indicated] as a twice-yearly treatment [removed: option for] [added: of] HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 [removed: infection.][added: infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations.]
For a description of our collaborations with Janssen and other partners, see Note [removed: 10.][added: 7.]
During the year ended December 31, [removed: 2022,] [added: 2023,] approximately [removed: 89%] [added: 91%] of our product sales in the U.S. and approximately [removed: 63%] [added: 66%] of our total worldwide revenues were from three large wholesalers: [added: Cencora, Inc. (formerly known as] AmerisourceBergen [removed: Corporation,] [added: Corporation),] Cardinal Health, Inc. and McKesson Corporation.
Our product development efforts are focused primarily [removed: in] [added: on] viral diseases, oncology and inflammatory diseases.
We [removed: intend to continue committing] [added: have committed] significant resources to internal R&D opportunities and external business development activity to drive innovation and growth of our business.
The development of product candidates and investigational therapies in our pipeline is subject to various risks and [removed: uncertainties.][added: uncertainties that could result in delays or prevent completion of the development and approval of our product candidates.]
[added: Risk Factors “We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.”] Drug development is inherently risky, and many product candidates and investigational therapies fail during the development process.
In [removed: 2022,] [added: 2023,] we continued to invest in and advance our R&D pipeline across our therapeutic areas.
Below is a summary of our product candidates that are in Phase 3 [removed: or registrational Phase 2] clinical trials or pending marketing authorization review by FDA or European Medicines Agency (“EMA”).
| Bulevirtide | | | | | | A Biologics License Application [removed: (“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. Approval is pending resolution of certain manufacturing and delivery concerns cited in a complete response letter issued by FDA in October 2022. [removed: In Europe, Hepcludex® (bulevirtide) has been granted Conditional Marketing Authorization by the European Commission (“EC”) and PRIority MEdicines (“PRIME”) scheme eligibility by the EMA as the first approved treatment in adults with chronic HDV infection with compensated liver disease.] | | |
| [removed: Sacituzumab govitecan-hziy] [added: Trodelvy] | | | | | | [removed: A Type II variation Marketing Authorization Application has been filed with EMA] [added: FDA approved Trodelvy] for [removed: sacituzumab govitecan-hziy, a Trop-2 directed antibody] [added: the treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy] and [removed: topoisomerase inhibitor conjugate,] [added: at least two additional systemic therapies in the metastatic setting. EC approved Trodelvy as monotherapy] for the treatment of adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the [removed: metastatic] [added: advanced] setting. [removed: This indication received FDA approval in February 2023.] | | |
| Axicabtagene ciloleucel | | | | | | Axicabtagene ciloleucel, a CAR T-cell therapy, is being evaluated as [added: (i)] a second-line and later treatment for high-risk [removed: follicular lymphoma.] [added: FL and (ii) a first-line treatment for high risk LBCL.] | | |
| Sacituzumab govitecan-hziy | | | | | | [removed: Sacituzumab] [added: In breast cancer, sacituzumab] govitecan-hziy is being evaluated as (i) a [removed: second- or third-line treatment for non-small cell lung cancer (“NSCLC”); (ii) a] first-line treatment for PD-L1 negative metastatic [removed: triple-negative breast cancer (“TNBC”);] [added: TNBC] and [removed: (iii) a second-line treatment for] [added: (ii) HR+/HER2- chemo-naive] metastatic [removed: urothelial] [added: breast] cancer. In collaboration with Merck [removed: Sharp] [added: Sharpe] & Dohme LLC (“Merck”),(1) [removed: sacituzumab govitecan-hziy] [added: it] is [added: also] being evaluated in combination with Merck’s pembrolizumab as (i) a first-line treatment for PD-L1 positive metastatic TNBC and (ii) [removed: a first-line] [added: an adjuvant] treatment for [removed: NSCLC. Sacituzumab] [added: early TNBC. In lung and thoracic cancer, sacituzumab] govitecan-hziy is [added: being evaluated as a second- or third-line treatment for non-small cell lung cancer (“NSCLC”). It is] also being evaluated in combination with [added: Merck’s] pembrolizumab as a [added: first-line] treatment for [removed: adjuvant TNBC.] [added: PD-L1 positive NSCLC. In genitourinary cancer, sacituzumab govitecan-hziy is being evaluated as a second-line treatment for metastatic UC. FDA granted accelerated approval for Trodelvy in second-line metastatic UC in April 2021.] | | |
| Domvanalimab and [removed: Zimberelimab] [added: 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, [removed: is being evaluated as a first-line treatment for NSCLC. In collaboration] with [removed: Arcus,(1) the combination of zimberelimab and domvanalimab with] chemotherapy is [removed: 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 [removed: Arcus(1) and AstraZeneca,] [added: Arcus,(1)] the combination of [removed: domvanalimab] [added: zimberelimab] and [removed: durvalumab] [added: domvanalimab] is being evaluated [removed: for the] [added: as a first-line] treatment [removed: of Stage 3] [added: for] NSCLC. [added: In January 2024, we announced discontinuation of further enrollment in this study.] | | |
(1) For additional information regarding our collaborations with Merck and Arcus, see Note [removed: 10.][added: 7.]
In [removed: 2022,] [added: 2023,] we also received regulatory approvals or authorizations from FDA and [removed: EC] [added: European Commission (“EC”)] for new products and expanded indications of our products, including:
In addition, we seek to enhance our commercial portfolio and clinical pipeline across multiple therapeutic areas through [removed: acquisitions,] [added: strategic collaborations,] in-licensing and [removed: strategic collaborations.][added: acquisitions.]
The following table shows the estimated expiration dates (including patent term extensions, supplementary protection certificates and/or pediatric exclusivity where granted) in the U.S. and the [removed: European Union (“EU”)] [added: EU] for the primary (typically compound) patents for our key product candidates as described above.
In the EU and the U.S., patent applications are pending relating to [added: our] proprietary manufacturing [removed: processes of Kite, a Gilead company (“Kite”).][added: processes.]
(4) Dates in parentheses reflect the estimated expiration date of patents [removed: which] [added: that] may [removed: issue] [added: be issued] from currently pending applications.
| Veklury | | | | | | | | | [removed: 2035] [added: 2036] | | | [added: (5)] | | | | | | | | | 2035 | | | | | |
| Trodelvy | | | | | | | | | 2028 | | | [removed: (5)] [added: (6)] | | | | | | | | | 2029 | | | | | |
In the EU and the U.S., patent applications are pending relating to [added: our] proprietary manufacturing [removed: processes of Kite.][added: processes.]
[removed: (5)] [added: (6)] Regulatory exclusivity in the U.S. expires in 2032.
As of the end of [removed: 2022,] [added: 2023,] these facilities include:
- [removed: San Dimas and] La Verne, California: We manufacture AmBisome and also package and label the majority of our commercial products for distribution to the Americas and the Pacific Rim.
Risk Factors “We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, which could limit our ability to generate [removed: revenues.”][added: revenues.]
The Global Inclusion and Diversity Council is chaired by our Chairman and Chief Executive Officer [added: (“CEO”)] and includes members of our leadership team.
[added: In 2020,] Gilead [removed: also] implemented multiple programs to train managers on inclusion and diversity [removed: topics,] [added: topics] and created strategies and initiatives focused on attracting, developing and retaining diverse talent and driving an inclusive culture in our workplace, which organizational leaders [removed: were] [added: have been] required to regularly review [removed: starting in] [added: since] 2021.
In addition, our employee resource groups (“ERGs”) support diverse employees and aim to raise awareness of different cultures within the workplace, cultivate diversity as a business strength and support Gilead’s talent acquisition strategy to [added: promote equal opportunities and to] source, attract and recruit diverse candidates.
Executive sponsors and leaders of our ERGs contribute to the advancement of our inclusion and diversity commitments through [removed: service on] [added: annual planning and collaborative efforts to support] our [removed: Global Inclusion] [added: communities inside] and [removed: Diversity Council.][added: outside of Gilead.]
As of December 31, [removed: 2022,] [added: 2023,] Gilead had approximately [removed: 17,000] [added: 18,000] employees, and Gilead’s global workforce was approximately 53% female.
In the U.S., based on our employees’ voluntary self-identification, our workforce was 38% White, 37% Asian, 13% Hispanic, 8% Black and [removed: 4%] [added: 3%] Other.
For more information about these risks and uncertainties, see Item 1A.
| Veklury | | | | | | FDA and EC approved an expanded use of Veklury to treat COVID-19 in appropriate patients with mild to severe hepatic impairment as well as people with severe renal impairment, including those on dialysis. | | |
| Hepcludex | | | | | | EC granted full marketing authorization for Hepcludex for the treatment of adults with HDV and compensated liver disease. Hepcludex was initially granted conditional marketing authorization in July 2020. Bulevirtide remains the only approved treatment for HDV in the European Union (“EU”) and is not approved in the U.S. | | |
| Yescarta | | | | | | FDA approved a label update to Yescarta to include overall survival data from the Phase 3 ZUMA-7 study, which showed a statistically significant overall survival improvement for Yescarta in second-line relapsed or refractory LBCL versus standard of care. | | |
In 2023, we entered into multiple strategic transactions spanning our work in virology, oncology and inflammation, including:
- We entered into new strategic collaborations, including with (i) Assembly Biosciences, Inc. to advance the research and development of novel antiviral therapies, including for herpesviruses, HBV and HDV; (ii) Tentarix Biotherapeutics, Inc. (“Tentarix”) to discover and develop novel therapies across oncology and inflammation using Tentarix’s proprietary Tentacles platform; and (iii) Arcellx, Inc. (“Arcellx”) to co-develop and co-commercialize Arcellx’s CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma.
- We expanded our existing collaborations with (i) Arcellx to exercise an option for the ARC-SparX ACLX-001 program in multiple myeloma, expand the scope of the existing anito-cel collaboration to include lymphomas, and make an additional equity investment of $200 million; (ii) Arcus to include research programs in inflammatory diseases; and (iii) Nurix Therapeutics, Inc. to exercise an option to license investigational targeted protein degrader molecule NX-0479, which has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases.
- We entered into an exclusive license agreement with Compugen Ltd. for later-stage development and commercialization of novel pre-clinical anti-IL18 binding protein antibodies, including COM503, that have the potential to treat various tumor types.
- We completed the acquisitions of (i) XinThera, Inc. to add additional early pipeline assets in oncology and inflammation, including rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology as well as mK2 for inflammatory diseases; and (ii) Tmunity Therapeutics, Inc. to add next-generation CAR T-cell therapies and technologies, including an “armored” CAR T technology platform that has the potential to enhance anti-tumor activity and rapid manufacturing processes.
Our strategic business development activity reflects our commitment to focus on transformative science, build a sustainable and diverse portfolio and position ourselves for the near-, medium- and long-term growth of our business.
(5) In January 2024, FDA granted pediatric exclusivity for Veklury, which extends all non-expired exclusivities by six months, and which is reflected in the presently reported date.
We also utilize the La Verne facility for clinical manufacturing of our sterile drug products.
- Santa Monica, California: We utilize the facility for clinical manufacturing and processing of our cell therapy products.
Gilead is an equal opportunity employer and is committed to inclusive practices, creating internal and external pipelines for diverse talent, as well as building awareness, capabilities and accountability among our people managers.
We provide a competitive benefits package to support the health and wellbeing of our employees — see “Total Rewards” below.
To promote employee productivity, we continue to address our employees’ needs by providing meaningful benefits and a flexible approach to work arrangements.
In 2023, in response to employee feedback, we also implemented multiple enterprise initiatives to address areas of opportunity to improve efficiency and remove barriers to speed of execution.
Gilead’s Total Rewards portfolio is designed to optimize our employees’ performance and support their wellbeing, allowing them to focus on mission-critical work.
Our portfolio (which varies by country and is subject to employee eligibility requirements) includes but is not limited to:
| | | | | | |
| --- | --- | --- | --- | --- | --- |
In 2023, we started a multi-year approach to support the development of all People Leaders at Gilead, recognizing the complexity and challenges of their roles and supporting the impact they can have on the growth and development of all employees.
Approximately 1,700 people leaders started their development journey in 2023, with an additional 3,500 planned for 2024.
Corporate Responsibility
Our Executive Officers and Directors
The following tables list our executive officers and directors as of the filing date of this Annual Report on Form 10-K:
Executive Officers
| | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Name | | | | | | Age | | | | | | Position | | |
| Daniel P. O’Day | | | | | | 59 | | | | | | Chairman and Chief Executive Officer | | |
| Andrew D. Dickinson | | | | | | 54 | | | | | | Chief Financial Officer | | |
| Johanna Mercier | | | | | | 54 | | | | | | Chief Commercial Officer | | |
| Merdad V. Parsey, M.D., Ph.D. | | | | | | 61 | | | | | | Chief Medical Officer | | |
| Deborah H. Telman | | | | | | 59 | | | | | | Executive Vice President, Corporate Affairs and General Counsel | | |
Directors
| | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Name | | | | | | Age | | | | | | Principal Occupation or Employment | | |
| Daniel P. O’Day, Chairman | | | | | | 59 | | | | | | Chairman and Chief Executive Officer of Gilead Sciences, Inc. | | |
(2) This indication received FDA approval in February 2023.
These risks and uncertainties include challenges in clinical trial protocol design, our ability to enroll patients in clinical trials, the possibility of unfavorable or inadequate trial results to support further development of our product candidates, including failure to meet a trial’s primary endpoint, safety issues arising from our clinical trials, and the need to modify or delay our clinical trials or to perform additional trials.
As a result, we may be unable to successfully complete our clinical trials on our anticipated timelines, or at all.
Based on trial results, it is possible that FDA and other regulatory authorities do not approve our product candidates, or that any market approvals include significant limitations on the products’ use.
Further, we may make a strategic decision to discontinue development of our product candidates if, for example, we believe commercialization will be difficult relative to other opportunities in our pipeline.
Therefore, our product candidates may never be successfully commercialized, and we may be unable to recoup the significant R&D and clinical trial expenses incurred.
We expect to expend significant time and resources on our R&D activities without any assurance that we will recoup our investments or that our efforts will be commercially successful.
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Regulatory Filings | | | | | | | | |
| GS-5245 | | | | | | GS-5245, a novel oral COVID-19 nucleoside, is being evaluated for the treatment of COVID-19 infection. | | |
| 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. | | |
| Registrational Phase 2 | | | | | | | | |
| Brexucabtagene autoleucel | | | | | | Brexucabtagene autoleucel, a CAR T-cell therapy, is being evaluated for the treatment of pediatric acute lymphoblastic leukemia. | | |
| Sunlenca | | | | | | FDA and EC approved Sunlenca, a first-in-class, long-acting HIV capsid inhibitor, for the treatment of HIV infection, in combination with other antiretrovirals, in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is a new, twice-yearly treatment option for adults with HIV infection that is not adequately controlled by their current treatment regimen. | | |
| Yescarta | | | | | | FDA approved Yescarta for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta is the first FDA-approved CAR T-cell therapy for the initial treatment of relapsed or refractory LBCL. EC approved Yescarta for the treatment of adult patients with DLBCL and high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Yescarta is the first CAR T-cell therapy approved for patients in Europe who do not respond to first-line treatment for DLBCL and high-grade B-cell lymphoma. EC also approved Yescarta for the treatment of adult patients with relapsed or refractory FL after three or more lines of systemic therapy. | | |
| Tecartus | | | | | | EC approved Tecartus for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor ALL. | | |
| Veklury | | | | | | FDA approved an expanded use of Veklury for the treatment of non-hospitalized patients who are at high risk of progression to severe COVID-19, including hospitalization and death. FDA also expanded the approval of Veklury to include pediatric patients 28 days of age and older and weighing at least 3 kg. | | |
| Biktarvy | | | | | | EC approved a low-dose tablet dosage form of Biktarvy and an extension of the indication for Biktarvy to treat HIV infection in virologically suppressed children who are at least two years of age and weigh at least 14 kg. | | |
| Vemlidy | | | | | | FDA approved an expanded use of Vemlidy for the treatment of chronic HBV infection in pediatric patients 12 years of age and older with compensated liver disease. | | |
| Trodelvy | | | | | | FDA approved Trodelvy for the treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. This indication received FDA approval in February 2023. | | |
In 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.
| Inflammatory Diseases: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cilofexor | | | | | | | | | 2032 | | | | | | | | | | | | 2032 | | | | | |
| Filgotinib | | | | | | | | | 2030 | | | | | | | | | | | | 2030 | | | | | |
| Brexucabtagene autoleucel | | | | | | | | | 2027 | | | | | | | | | | | | — | | | (1) | | |
| Magrolimab | | | | | | | | | 2031 | | | | | | | | | | | | 2031 | | | | | |
| Jyseleca | | | | | | | | | 2030 | | | | | | | | | | | | 2030 | | | | | |
In 2020, we introduced our Advancing Black Leadership Strategy, a multi-year initiative that outlines our commitments to create internal and external pipelines for diverse talent and to build awareness, capabilities and accountability among our people managers.
As part of this strategy, we set clear targets for representation within our overall workforce and executive populations, including goals to increase the percentage of female, Black and Hispanic employees with well-defined annual targets through 2025.
We routinely train and educate our employees on workplace safety and security.
In response to the COVID-19 pandemic, we implemented job site enhancements and risk protocols, including health screenings, COVID-19 testing and vaccine requirements, reconfiguration of work and common spaces to allow for physical distancing, in our effort to support the safe occupancy of our sites.
Gilead also maintains a robust contact tracing and notification process for any employee who reports COVID-19 infection.
Gilead’s compensation and benefits programs are designed to help attract, develop and retain the industry’s most talented workforce.
For example, in response to the COVID-19 pandemic, we provided meaningful benefits to employees and refined our approach to flexible work arrangements.
Environmental, Social and Governance (“ESG”)
An excerpt. Shown here: 40 of 56 rewritten, 40 of 49 added and all 37 removed. The counts are complete. For every sentence, read Item 1. BUSINESS in the FY2023 filing and the FY2022 filing.
Cover and table of contents
35 rewritten, 9 added, 6 removed, 68 unchanged
For the fiscal year ended December 31, [removed: 2022][added: 2023]
Indicate by check mark whether [added: the] registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
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: 2022] [added: 2023] was [removed: $55.9] [added: $67.0] billion.*
The number of shares outstanding of the registrant’s Common Stock on February [removed: 17, 2023] [added: 16, 2024] was [removed: 1,247,105,154][added: 1,245,774,616.]
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: 2023] [added: 2024] Annual Meeting of [removed: Stockholders, to be held on May 3, 2023,] [added: Stockholders] are incorporated by reference into Part III of this Report.
* Based on a closing price of [removed: $61.81] [added: $77.07] per share on June 30, [removed: 2022.][added: 2023.]
Excludes [removed: 350,109,572] [added: 376,696,796] shares of the registrant’s Common Stock held by executive officers, directors and any stockholders whose ownership exceeds 5% of [added: the] registrant’s common stock outstanding at June 30, [removed: 2022.][added: 2023.]
[removed: 2022] [added: 2023] FORM 10-K ANNUAL REPORT
| [Item [removed: 1](#i6d96c727bd3e4a10969bbf6a84d64ce7_13)] [added: 1](#i1a21f79537ba4f149055dfe665e667c1_13)] | | | [removed: [Business](#i6d96c727bd3e4a10969bbf6a84d64ce7_13)] [added: [Business](#i1a21f79537ba4f149055dfe665e667c1_13)] | | | [removed: [3](#i6d96c727bd3e4a10969bbf6a84d64ce7_13)] [added: [3](#i1a21f79537ba4f149055dfe665e667c1_13)] | | |
| [Item [removed: 1A](#i6d96c727bd3e4a10969bbf6a84d64ce7_16)] [added: 1A](#i1a21f79537ba4f149055dfe665e667c1_16)] | | | [Risk [removed: Factors](#i6d96c727bd3e4a10969bbf6a84d64ce7_16)] [added: Factors](#i1a21f79537ba4f149055dfe665e667c1_16)] | | | [removed: [17](#i6d96c727bd3e4a10969bbf6a84d64ce7_16)] [added: [17](#i1a21f79537ba4f149055dfe665e667c1_16)] | | |
| [Item [removed: 1B](#i6d96c727bd3e4a10969bbf6a84d64ce7_19)] [added: 1B](#i1a21f79537ba4f149055dfe665e667c1_19)] | | | [Unresolved Staff [removed: Comments](#i6d96c727bd3e4a10969bbf6a84d64ce7_19)] [added: Comments](#i1a21f79537ba4f149055dfe665e667c1_19)] | | | [removed: [29](#i6d96c727bd3e4a10969bbf6a84d64ce7_19)] [added: [31](#i1a21f79537ba4f149055dfe665e667c1_19)] | | |
| [Item [removed: 2](#i6d96c727bd3e4a10969bbf6a84d64ce7_22)] [added: 2](#i1a21f79537ba4f149055dfe665e667c1_22)] | | | [removed: [Properties](#i6d96c727bd3e4a10969bbf6a84d64ce7_22)] [added: [Properties](#i1a21f79537ba4f149055dfe665e667c1_22)] | | | [removed: [30](#i6d96c727bd3e4a10969bbf6a84d64ce7_22)] [added: [33](#i1a21f79537ba4f149055dfe665e667c1_22)] | | |
| [Item [removed: 3](#i6d96c727bd3e4a10969bbf6a84d64ce7_25)] [added: 3](#i1a21f79537ba4f149055dfe665e667c1_25)] | | | [Legal [removed: Proceedings](#i6d96c727bd3e4a10969bbf6a84d64ce7_25)] [added: Proceedings](#i1a21f79537ba4f149055dfe665e667c1_25)] | | | [removed: [30](#i6d96c727bd3e4a10969bbf6a84d64ce7_25)] [added: [33](#i1a21f79537ba4f149055dfe665e667c1_25)] | | |
| [Item [removed: 4](#i6d96c727bd3e4a10969bbf6a84d64ce7_28)] [added: 4](#i1a21f79537ba4f149055dfe665e667c1_28)] | | | [Mine Safety [removed: Disclosures](#i6d96c727bd3e4a10969bbf6a84d64ce7_28)] [added: Disclosures](#i1a21f79537ba4f149055dfe665e667c1_28)] | | | [removed: [30](#i6d96c727bd3e4a10969bbf6a84d64ce7_28)] [added: [33](#i1a21f79537ba4f149055dfe665e667c1_28)] | | |
| [Item [removed: 5](#i6d96c727bd3e4a10969bbf6a84d64ce7_34)] [added: 5](#i1a21f79537ba4f149055dfe665e667c1_34)] | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i6d96c727bd3e4a10969bbf6a84d64ce7_34)] [added: Securities](#i1a21f79537ba4f149055dfe665e667c1_34)] | | | [removed: [31](#i6d96c727bd3e4a10969bbf6a84d64ce7_34)] [added: [34](#i1a21f79537ba4f149055dfe665e667c1_34)] | | |
| [Item [removed: 6](#i6d96c727bd3e4a10969bbf6a84d64ce7_37)] [added: 6](#i1a21f79537ba4f149055dfe665e667c1_37)] | | | [removed: [\[Reserved\]](#i6d96c727bd3e4a10969bbf6a84d64ce7_37)] [added: [\[Reserved\]](#i1a21f79537ba4f149055dfe665e667c1_37)] | | | [removed: [33](#i6d96c727bd3e4a10969bbf6a84d64ce7_37)] [added: [36](#i1a21f79537ba4f149055dfe665e667c1_37)] | | |
| [Item [removed: 7](#i6d96c727bd3e4a10969bbf6a84d64ce7_40)] [added: 7](#i1a21f79537ba4f149055dfe665e667c1_40)] | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i6d96c727bd3e4a10969bbf6a84d64ce7_40)] [added: Operations](#i1a21f79537ba4f149055dfe665e667c1_40)] | | | [removed: [34](#i6d96c727bd3e4a10969bbf6a84d64ce7_40)] [added: [37](#i1a21f79537ba4f149055dfe665e667c1_40)] | | |
| [Item [removed: 7A](#i6d96c727bd3e4a10969bbf6a84d64ce7_58)] [added: 7A](#i1a21f79537ba4f149055dfe665e667c1_55)] | | | [Quantitative and Qualitative Disclosures about Market [removed: Risk](#i6d96c727bd3e4a10969bbf6a84d64ce7_58)] [added: Risk](#i1a21f79537ba4f149055dfe665e667c1_55)] | | | [removed: [43](#i6d96c727bd3e4a10969bbf6a84d64ce7_58)] [added: [47](#i1a21f79537ba4f149055dfe665e667c1_55)] | | |
| [Item [removed: 8](#i6d96c727bd3e4a10969bbf6a84d64ce7_61)] [added: 8](#i1a21f79537ba4f149055dfe665e667c1_58)] | | | [Financial Statements and Supplementary [removed: Data](#i6d96c727bd3e4a10969bbf6a84d64ce7_61)] [added: Data](#i1a21f79537ba4f149055dfe665e667c1_58)] | | | [removed: [45](#i6d96c727bd3e4a10969bbf6a84d64ce7_61)] [added: [49](#i1a21f79537ba4f149055dfe665e667c1_58)] | | |
| [Item [removed: 9](#i6d96c727bd3e4a10969bbf6a84d64ce7_145)] [added: 9](#i1a21f79537ba4f149055dfe665e667c1_142)] | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i6d96c727bd3e4a10969bbf6a84d64ce7_145)] [added: Disclosure](#i1a21f79537ba4f149055dfe665e667c1_142)] | | | [removed: [94](#i6d96c727bd3e4a10969bbf6a84d64ce7_145)] [added: [96](#i1a21f79537ba4f149055dfe665e667c1_142)] | | |
| [Item [removed: 9A](#i6d96c727bd3e4a10969bbf6a84d64ce7_151)] [added: 9A](#i1a21f79537ba4f149055dfe665e667c1_148)] | | | [Controls and [removed: Procedures](#i6d96c727bd3e4a10969bbf6a84d64ce7_151)] [added: Procedures](#i1a21f79537ba4f149055dfe665e667c1_148)] | | | [removed: [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_151)] [added: [98](#i1a21f79537ba4f149055dfe665e667c1_148)] | | |
| [Item [removed: 9B](#i6d96c727bd3e4a10969bbf6a84d64ce7_154)] [added: 9B](#i1a21f79537ba4f149055dfe665e667c1_151)] | | | [Other [removed: Information](#i6d96c727bd3e4a10969bbf6a84d64ce7_154)] [added: Information](#i1a21f79537ba4f149055dfe665e667c1_151)] | | | [removed: [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_154)] [added: [98](#i1a21f79537ba4f149055dfe665e667c1_151)] | | |
| [Item [removed: 9C](#i6d96c727bd3e4a10969bbf6a84d64ce7_157)] [added: 9C](#i1a21f79537ba4f149055dfe665e667c1_154)] | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#i6d96c727bd3e4a10969bbf6a84d64ce7_157)] [added: Inspections](#i1a21f79537ba4f149055dfe665e667c1_154)] | | | [removed: [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_157)] [added: [98](#i1a21f79537ba4f149055dfe665e667c1_154)] | | |
| [Item [removed: 10](#i6d96c727bd3e4a10969bbf6a84d64ce7_163)] [added: 10](#i1a21f79537ba4f149055dfe665e667c1_160)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#i6d96c727bd3e4a10969bbf6a84d64ce7_163)] [added: Governance](#i1a21f79537ba4f149055dfe665e667c1_160)] | | | [removed: [96](#i6d96c727bd3e4a10969bbf6a84d64ce7_163)] [added: [99](#i1a21f79537ba4f149055dfe665e667c1_160)] | | |
| [Item [removed: 11](#i6d96c727bd3e4a10969bbf6a84d64ce7_166)] [added: 11](#i1a21f79537ba4f149055dfe665e667c1_163)] | | | [Executive [removed: Compensation](#i6d96c727bd3e4a10969bbf6a84d64ce7_166)] [added: Compensation](#i1a21f79537ba4f149055dfe665e667c1_163)] | | | [removed: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_166)] [added: [99](#i1a21f79537ba4f149055dfe665e667c1_163)] | | |
| [Item [removed: 12](#i6d96c727bd3e4a10969bbf6a84d64ce7_169)] [added: 12](#i1a21f79537ba4f149055dfe665e667c1_166)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i6d96c727bd3e4a10969bbf6a84d64ce7_169)] [added: Matters](#i1a21f79537ba4f149055dfe665e667c1_166)] | | | [removed: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_169)] [added: [99](#i1a21f79537ba4f149055dfe665e667c1_166)] | | |
| [Item [removed: 13](#i6d96c727bd3e4a10969bbf6a84d64ce7_172)] [added: 13](#i1a21f79537ba4f149055dfe665e667c1_169)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i6d96c727bd3e4a10969bbf6a84d64ce7_172)] [added: Independence](#i1a21f79537ba4f149055dfe665e667c1_169)] | | | [removed: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_172)] [added: [99](#i1a21f79537ba4f149055dfe665e667c1_169)] | | |
| [Item [removed: 14](#i6d96c727bd3e4a10969bbf6a84d64ce7_175)] [added: 14](#i1a21f79537ba4f149055dfe665e667c1_172)] | | | [Principal Accountant Fees and [removed: Services](#i6d96c727bd3e4a10969bbf6a84d64ce7_175)] [added: Services](#i1a21f79537ba4f149055dfe665e667c1_172)] | | | [removed: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_175)] [added: [99](#i1a21f79537ba4f149055dfe665e667c1_172)] | | |
| [Item [removed: 15](#i6d96c727bd3e4a10969bbf6a84d64ce7_181)] [added: 15](#i1a21f79537ba4f149055dfe665e667c1_178)] | | | [Exhibits and Financial Statement [removed: Schedules](#i6d96c727bd3e4a10969bbf6a84d64ce7_181)] [added: Schedules](#i1a21f79537ba4f149055dfe665e667c1_178)] | | | [removed: [97](#i6d96c727bd3e4a10969bbf6a84d64ce7_181)] [added: [99](#i1a21f79537ba4f149055dfe665e667c1_178)] | | |
We own or have rights to various [removed: trademarks] [added: trademarks, copyrights] and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, KITE™, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, [removed: RANEXA®,] SOVALDI®, STRIBILD®, SUNLENCA®, TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®.
[removed: This report also refers to trademarks, service marks] [added: Other trademarks] and trade names [removed: of other companies, which] are the property of their respective owners.
*This Annual Report on Form 10-K, including Part [removed: II,] [added: I,] Item [removed: 7.][added: 1A.]
Management’s Discussion and Analysis of Financial Condition and Results of 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 [removed: amended (the “Securities Act”),] [added: amended,] and the Securities Exchange Act of 1934, as [removed: amended (the “Exchange Act”).][added: amended.]
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; [added: expectations regarding any impairment charges related to our Phase 3 EVOKE-01 study;] collaboration and licensing arrangements; patent protection and estimated loss of exclusivity for our products and product candidates; ongoing litigation and investigation matters; [removed: statements regarding the anticipated future impact on our business of the coronavirus disease 2019 (“COVID-19”)] and [removed: related public health measures; and] other statements of expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions.*
Except as required under federal securities laws and the rules and regulations of U.S. Securities and Exchange [removed: Commission (“SEC”),] [added: Commission,] 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.
| [PART I](#i1a21f79537ba4f149055dfe665e667c1_10) | | | | | | | | |
| [Item 1C](#i1a21f79537ba4f149055dfe665e667c1_549755815402) | | | [Cybersecurity](#i1a21f79537ba4f149055dfe665e667c1_549755815402) | | | [29](#i1a21f79537ba4f149055dfe665e667c1_549755815402) | | |
| [PART II](#i1a21f79537ba4f149055dfe665e667c1_31) | | | | | | | | |
| [PART III](#i1a21f79537ba4f149055dfe665e667c1_157) | | | | | | | | |
| [PART IV](#i1a21f79537ba4f149055dfe665e667c1_175) | | | | | | | | |
| [Item 16](#i1a21f79537ba4f149055dfe665e667c1_184) | | | [Form 10-K Summary](#i1a21f79537ba4f149055dfe665e667c1_184) | | | [103](#i1a21f79537ba4f149055dfe665e667c1_184) | | |
| [SIGNATURES](#i1a21f79537ba4f149055dfe665e667c1_187) | | | | | | [104](#i1a21f79537ba4f149055dfe665e667c1_187) | | |
Certain amounts and percentages in this Annual Report on Form 10-K may not sum or recalculate due to rounding.
Risk Factors and Part II, Item 7.
| [PART I](#i6d96c727bd3e4a10969bbf6a84d64ce7_10) | | | | | | | | |
| [PART II](#i6d96c727bd3e4a10969bbf6a84d64ce7_31) | | | | | | | | |
| [PART III](#i6d96c727bd3e4a10969bbf6a84d64ce7_160) | | | | | | | | |
| [PART IV](#i6d96c727bd3e4a10969bbf6a84d64ce7_178) | | | | | | | | |
| [Item 16](#i6d96c727bd3e4a10969bbf6a84d64ce7_187) | | | [Form 10-K Summary](#i6d96c727bd3e4a10969bbf6a84d64ce7_187) | | | [100](#i6d96c727bd3e4a10969bbf6a84d64ce7_187) | | |
| [SIGNATURES](#i6d96c727bd3e4a10969bbf6a84d64ce7_190) | | | | | | [101](#i6d96c727bd3e4a10969bbf6a84d64ce7_190) | | |
Item 1C. CYBERSECURITY
0 rewritten, 54 added, 0 removed, 0 unchanged
New section this year
Cybersecurity Risk Management and Strategy
Processes Used to Assess, Identify, and Manage Material Risks from Cybersecurity Threats
Risk Assessment and Management
Our approach to managing material risks from cybersecurity threats, which is informed in part by the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework (though we do not imply that we meet any particular technical standards, specifications or requirements), is designed to detect, identify, respond to, recover from and protect from cybersecurity incidents.
Our security governance function, which includes key employees who work in Information Security, Legal, and Privacy teams such as our Chief Information Officer (“CIO”) and Chief Information Security Officer (“CISO”), are responsible for establishing and implementing cybersecurity policies and procedures, which includes developing and updating our enterprise incident response plan (“IRP”), managing incident response, and overseeing any policy exceptions and potential compensating controls.
Additionally, we assess our cybersecurity maturity annually using the NIST framework and implement and maintain controls that are designed to evaluate and improve our cybersecurity program, such as vulnerability assessments and penetration tests, as needed.
We also execute employee cybersecurity training and awareness programs around various key cybersecurity topics including reporting incidents, phishing, ransomware, remote working, cloud security, privileged access, and removable media.
Our process for assessing, identifying, and managing material risks from cybersecurity threats is integrated into our overall risk management process.
We have a robust enterprise risk management (“ERM”) program that plays an important role in seeking to manage and address existing and emerging risks, including cybersecurity risks, which are critical to our overall business goals and objectives.
The ERM team updates our CEO and his leadership team on cybersecurity risks as well as their potential impact, likelihood, potential mitigation plan, and status.
Incident Response
We have a dedicated Information Security team responsible for managing and coordinating incident response efforts.
This team collaborates closely with other teams within the company, including teams within information technology (“IT”), Legal and Privacy, in identifying, analyzing, and responding to cybersecurity incidents, which includes tracking cybersecurity incidents to help identify any related incidents.
When cybersecurity incidents are identified, our practice is to respond to and address them utilizing incident classifications and escalation protocols, in accordance with applicable governmental regulations and other legal requirements.
We have an IRP to prepare for and respond to cybersecurity incidents.
The process is tested in annual tabletop exercises to help identify strengths and areas for improvement.
Engagement of Third Party Advisors
We engage third party advisors, including assessors, cybersecurity consultants, and auditors to assess, validate, and enhance our cybersecurity program.
We benefit from engaging third parties to provide specialized skills, knowledge, tools, and resources.
These third parties also help reduce costs, increase efficiency, improve quality, mitigate risks, and review cybersecurity strategy, trends, and threat landscape.
Third-Party Service Provider Risk Management
We have a process in place to oversee and identify risks from cybersecurity threats associated with our use of key third-party service providers during the course of engagement.
The company uses an external risk management software program to identify, assess, monitor and mitigate risks associated with third-party relationships, including cybersecurity risks.
Our vendor security assessment process evaluates key vendors and, where appropriate, assesses vendor’s controls for IT security, privacy, business continuity, and other third-party risks.
Following an evaluation, the company determines and prioritizes risks based on their potential impact, which help inform the appropriate level of additional due diligence and ongoing compliance monitoring.
The third-party risk assessment is a cross-functional effort involving our end-user, Legal, Privacy, and Information Security teams.
Material Risks from Cybersecurity Threats
The company has not identified any risks from cybersecurity threats that have materially affected us.
We do not believe that risks from cybersecurity threats are reasonably likely to materially affect us, including our business strategy, results of operations or financial condition, over the long term.
Like many companies, we have experienced cybersecurity incidents, including data breaches and temporary service interruptions.
However, as of the end of 2023, known cybersecurity incidents, individually or in aggregate, have not had a material impact.
Nevertheless, there can be no assurance that our efforts in response to cybersecurity incidents, as well as our investments to protect our IT infrastructure and data, will shield us from significant losses, brand and reputational harm and potential liability or prevent any future interruption or breach of our systems.
Such cybersecurity incidents can cause the loss of critical or sensitive information, including personal information, and could give rise to legal liability and regulatory action under data protection and privacy laws.
For additional information on cybersecurity risks we face, see Part I, Item 1A.
Risk Factors of this Annual Report on Form 10-K under the heading “Information system service interruptions or breaches, including significant cybersecurity incidents, could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations.”
Cybersecurity Governance
Board Oversight of Risks from Cybersecurity Threats
Our Board of Directors plays an important role in overseeing cybersecurity risks.
Our Board of Directors has established an oversight structure for monitoring the effectiveness of and risks related to the cybersecurity program.
Designated by the Board to oversee cybersecurity and information technology risks, the Audit Committee receives quarterly cybersecurity updates from our CISO, and the chair of the Audit Committee meets with the CISO individually on a quarterly basis.
An excerpt. Shown here: all 0 rewritten, 40 of 54 added and all 0 removed. The counts are complete. For every sentence, read Item 1C. CYBERSECURITY in the FY2023 filing.
Item 2. PROPERTIES
2 rewritten, 0 added, 0 removed, 5 unchanged
We also have administrative facilities in Raleigh, North [removed: Carolina] [added: Carolina; Parsippany, New Jersey;] and Washington, D.C., and we have R&D facilities in Emeryville, Oceanside and Santa Monica, California; Seattle, Washington; Frederick, Maryland; [removed: Morris Plains, New Jersey;] Edmonton, Canada; [removed: and] Dublin, [removed: Ireland.][added: Ireland; Cambridge and Oxford, United Kingdom.]
Our principal manufacturing facilities are in El Segundo, La Verne, Oceanside and [removed: San Dimas,] [added: Santa Monica,] California; [added: Frederick, Maryland;] Edmonton, Canada; Cork, Ireland and Hoofddorp, Netherlands.
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
16 rewritten, 8 added, 10 removed, 24 unchanged
As of February [removed: 17, 2023,] [added: 16, 2024,] we had approximately [removed: 1,452] [added: 1,396] stockholders of record of our common stock.
For the years ended December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] we paid quarterly dividends.
[removed: Stockholders’ Equity] [added: Subsequent Events] of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.
The following table provides certain information with respect to our equity compensation plans in effect as of December 31, [removed: 2022:][added: 2023:]
| (in millions, except [removed: per share amounts)] [added: exercise price)] | | | | | | Number of Common Shares to be Issued Upon Exercise of Outstanding Options and Rights(1) | | | | | | Weighted-average Exercise Price of Outstanding Options and Rights(1) | | | | | | Number of Common Shares Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) | | |
| 2022 Equity Incentive Plan | | | | | | [removed: 39.1] [added: 38.0] | | | | | | $ | [removed: 67.69] [added: 69.38] | | | | | [removed: 100.5] [added: 82.3] | | |
| Employee Stock Purchase Plan(2) | | | | | | | | | | | | | | | | | | [removed: 3.1] [added: 26.0] | | |
| Total equity compensation plans approved by security holders | | | | | | [removed: 39.1] [added: 38.0] | | | | | | $ | [removed: 67.69] [added: 69.38] | | | | | [removed: 103.7] [added: 108.3] | | |
(1) Includes [removed: 25] [added: 24] million restricted stock units, performance share units and phantom shares.
[removed: ][added: ]
(1) This section is not “soliciting material,” is not deemed “filed” with [removed: the] [added: U.S.] Securities and Exchange Commission [removed: (“SEC”)] and is not to be incorporated by reference in any of our filings under the Securities Act of 1933, as amended [removed: (the “Securities Act”)] or the Securities Exchange Act of [removed: 1934 (“Exchange Act”)] [added: 1934, as amended,] whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
(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: 2017,] [added: 2018,] and assuming that all dividends were reinvested.
In the first quarter of 2020, our Board of Directors authorized a [removed: new] $5.0 billion stock repurchase program (“2020 Program”), with no fixed expiration.
Purchases under the 2020 Program may be made in the open market or in privately negotiated [removed: transactions.][added: transactions, but the program does not obligate us to repurchase any specific number of shares and may be amended, suspended or discontinued at any time.]
The table below summarizes our stock repurchase activity for the three months ended December 31, [removed: 2022:][added: 2023:]
| | | | | | | Total Number of Shares Purchased (in thousands) | | | | | | Average Price Paid per Share | | | | | | Total Number of Shares Purchased as Part of [removed: a] Publicly Announced [removed: Program] [added: Programs] (in thousands) | | | | | | [removed: Maximum Fair Value of Shares that May Yet Be Purchased Under the 2016 Program (in millions) | | | | | | Maximum Fair] [added: Approximate Dollar] Value of Shares that May Yet Be Purchased Under the [removed: 2020 Program] [added: Programs] (in millions) | | |
Additional information is included in Consolidated Statements of Stockholders' Equity and in Note 17.
| Total | | | | | | 38.0 | | | | | | $ | 69.38 | | | | | 108.3 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 1 - October 31, 2023 | | | | | | 863 | | | | | | $ | 76.86 | | | | | 808 | | | | | | $ | 3,962 | |
| November 1 - November 30, 2023 | | | | | | 800 | | | | | | $ | 76.57 | | | | | 738 | | | | | | $ | 3,905 | |
| December 1 - December 31, 2023 | | | | | | 709 | | | | | | $ | 79.37 | | | | | 391 | | | | | | $ | 3,874 | |
| Total(1) | | | | | | 2,371 | | | | | | $ | 77.51 | | | | | 1,937 | | | | | | | | |
Additional information is included in Note 14.
| Total | | | | | | 39.1 | | | | | | $ | 67.69 | | | | | 103.7 | | |
The $12.0 billion stock repurchase program authorized by our Board of Directors in the first quarter of 2016 (“2016 Program”) was completed in the fourth quarter of 2022.
As of December 31, 2022, the remaining authorized repurchase amount under the 2020 Program was $4.9 billion.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | | | | | | | | | | | | | | |
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
553 rewritten, 250 added, 308 removed, 863 unchanged
Years [removed: ended] [added: Ended] December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020][added: 2021]
| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID:](#i6d96c727bd3e4a10969bbf6a84d64ce7_67) 42[)](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] [added: ID:](#i1a21f79537ba4f149055dfe665e667c1_64) 42[)](#i1a21f79537ba4f149055dfe665e667c1_64)] | | | | | | [removed: [46](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] [added: [50](#i1a21f79537ba4f149055dfe665e667c1_64)] | | |
| [Audited Consolidated Financial [removed: Statements:](#i6d96c727bd3e4a10969bbf6a84d64ce7_70)] [added: Statements:](#i1a21f79537ba4f149055dfe665e667c1_67)] | | | | | | | | |
| [Consolidated Balance [removed: Sheets](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] [added: Sheets](#i1a21f79537ba4f149055dfe665e667c1_70)] | | | | | | [removed: [48](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] [added: [52](#i1a21f79537ba4f149055dfe665e667c1_70)] | | |
| [Consolidated Statements of [removed: Income](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] [added: Income](#i1a21f79537ba4f149055dfe665e667c1_73)] | | | | | | [removed: [49](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] [added: [53](#i1a21f79537ba4f149055dfe665e667c1_73)] | | |
[removed: | [Consolidated Statements of Comprehensive Income (Loss)](#i6d96c727bd3e4a10969bbf6a84d64ce7_79) | | | | | | [50](#i6d96c727bd3e4a10969bbf6a84d64ce7_79) | | |][added: CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME]
| [Consolidated Statements of Stockholders’ [removed: Equity](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] [added: Equity](#i1a21f79537ba4f149055dfe665e667c1_79)] | | | | | | [removed: [51](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] [added: [55](#i1a21f79537ba4f149055dfe665e667c1_79)] | | |
| [Consolidated Statements of Cash [removed: Flows](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] [added: Flows](#i1a21f79537ba4f149055dfe665e667c1_82)] | | | | | | [removed: [52](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] [added: [56](#i1a21f79537ba4f149055dfe665e667c1_82)] | | |
| [Notes to Consolidated Financial [removed: Statements](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] [added: Statements](#i1a21f79537ba4f149055dfe665e667c1_85)] | | | | | | [removed: [53](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] [added: [57](#i1a21f79537ba4f149055dfe665e667c1_85)] | | |
[removed: To] [added: To] the Stockholders and the Board of Directors of Gilead Sciences, [removed: Inc.][added: Inc.]
We have audited the accompanying consolidated balance sheets of Gilead Sciences, Inc. (the Company) as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] 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: 2022,] [added: 2023,] 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: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] 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: 2022,] [added: 2023,] based on criteria established in Internal [removed: Control-Integrated] [added: Control—Integrated] Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 [removed: framework)] [added: framework),] and our report dated February [removed: 22, 2023,] [added: 23, 2024] expressed an unqualified opinion thereon.
Critical Audit [removed: Matters][added: Matter]
The critical audit [removed: matters] [added: matter] communicated below [removed: are matters] [added: is a matter] arising from the current period audit of the financial statements that [removed: were] [added: was] communicated or required to be communicated to the audit committee and that: (1) [removed: relate] [added: relates] to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, [removed: subjective,] [added: subjective] or complex judgments.
The communication of [added: the] critical audit [removed: matters] [added: matter] does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matters] [added: matter] below, providing [added: a] separate [removed: opinions] [added: opinion] on the critical audit [removed: matters] [added: matter] or on the accounts or disclosures to which [removed: they relate.][added: it relates.]
| [added: In-process research and development impairments] | | | | | | [removed: Valuation of in-process research and development intangible asset] [added: 50] | | | [added: | | | 2,700 | | | | | | — | | |]
San [removed: Jose,] [added: Mateo,] California
| (in millions, except per share amounts) | | | | | | [added: 2023 | | | | | |] 2022 | | | | | | 2021 | | |
| Cash and cash equivalents | | | | | | $ | [removed: 5,412] [added: 6,085] | | | | | $ | [removed: 5,338] [added: 5,412] | |
| Short-term marketable debt securities | | | | | | [removed: 973] [added: 1,179] | | | | | | [removed: 1,182] [added: 973] | | |
| Accounts receivable, net | | | | | | [removed: 4,777] [added: 4,660] | | | | | | [removed: 4,493] [added: 4,777] | | |
| Inventories | | | | | | [removed: 1,507] [added: 1,787] | | | | | | [removed: 1,618] [added: 1,507] | | |
| Prepaid and other current assets | | | | | | [removed: 1,774] [added: 2,374] | | | | | | [removed: 2,141] [added: 1,774] | | |
| Total current assets | | | | | | [removed: 14,443] [added: 16,085] | | | | | | [removed: 14,772] [added: 14,443] | | |
| Property, plant and equipment, net | | | | | | [removed: 5,475] [added: 5,317] | | | | | | [removed: 5,121] [added: 5,475] | | |
| Long-term marketable debt securities | | | | | | [removed: 1,245] [added: 1,163] | | | | | | [removed: 1,309] [added: 1,245] | | |
| Intangible assets, net | | | | | | [removed: 28,894] [added: 26,454] | | | | | | [removed: 33,455] [added: 28,894] | | |
| Goodwill | | | | | | 8,314 | | | | | | [removed: 8,332] [added: 8,314] | | |
| Other long-term assets | | | | | | [removed: 4,800] [added: 4,792] | | | | | | [removed: 4,963] [added: 4,800] | | |
| Total assets | | | | | | $ | [removed: 63,171] [added: 62,125] | | | | | $ | [removed: 67,952] [added: 63,171] | |
| Accounts payable | | | | | | $ | [removed: 905] [added: 550] | | | | | $ | [removed: 705] [added: 905] | |
| Accrued rebates | | | | | | [removed: 3,479] [added: 3,802] | | | | | | [removed: 3,244] [added: 3,479] | | |
| Other current liabilities | | | | | | [removed: 4,580] [added: 5,130] | | | | | | [removed: 6,145] [added: 4,580] | | |
| Current portion of long-term debt and other obligations, net | | | | | | [removed: 2,273] [added: 1,798] | | | | | | [removed: 1,516] [added: 2,273] | | |
| Total current liabilities | | | | | | [removed: 11,237] [added: 11,280] | | | | | | [removed: 11,610] [added: 11,237] | | |
| Long-term debt, net | | | | | | [removed: 22,957] [added: 23,189] | | | | | | [removed: 25,179] [added: 22,957] | | |
| Long-term income taxes payable | | | | | | [removed: 3,916] [added: 2,039] | | | | | | [removed: 4,767] [added: 3,916] | | |
| Deferred tax liability | | | | | | [removed: 2,673] [added: 1,588] | | | | | | [removed: 4,356] [added: 2,673] | | |
| Other long-term obligations | | | | | | [removed: 1,179] [added: 1,280] | | | | | | [removed: 976] [added: 1,179] | | |
February 23, 2024
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Repurchases of common stock under repurchase programs ($66.58 average price per share) | | | | | | (8) | | | | | | — | | | | | | (28) | | | | | | — | | | | | | (518) | | | | | | — | | | | | | (546) | | |
| Repurchases of common stock for employee tax withholding under equity incentive plans and other | | | | | | (3) | | | | | | — | | | | | | — | | | | | | — | | | | | | (146) | | | | | | — | | | | | | (146) | | |
| Repurchases of common stock under repurchase programs ($73.77 average price per share) | | | | | | (19) | | | | | | — | | | | | | (65) | | | | | | — | | | | | | (1,331) | | | | | | — | | | | | | (1,396) | | |
| Repurchases of common stock for employee tax withholding under equity incentive plans and other | | | | | | (3) | | | | | | — | | | | | | — | | | | | | | | | | | | (173) | | | | | | | | | | | | (173) | | |
| Repurchases of common stock under repurchase programs ($79.52 average price per share) | | | | | | (13) | | | | | | — | | | | | | (45) | | | | | | — | | | | | | (955) | | | | | | — | | | | | | (1,000) | | |
| Repurchases of common stock for employee tax withholding under equity incentive plans and other | | | | | | (4) | | | | | | — | | | | | | — | | | | | | — | | | | | | (279) | | | | | | — | | | | | | (279) | | |
| Balance as of December 31, 2023 | | | | | | 1,246 | | | | | | $ | 1 | | | | | $ | 6,500 | | | | | $ | 28 | | | | | $ | 16,304 | | | | | $ | (84) | | | | | $ | 22,749 | |
| Net income | | | | | | $ | 5,613 | | | | | $ | 4,566 | | | | | $ | 6,201 | |
| Acquired in-process research and development expenses | | | | | | 1,155 | | | | | | 944 | | | | | | 939 | | |
Beginning in the first quarter of 2023, we reclassified changes in income taxes prepaid and receivable from Prepaid expenses and other to combine them with changes in income taxes payable as Income tax assets and liabilities, net within Operating Activities on our Consolidated Statements of Cash Flows.
*Patient Co-Pay Assistance*
Co-pay assistance represents financial assistance to qualified patients, assisting them with prescription drug co-payments required by insurance.
Our accrual for copay is based on an estimate of claims and the cost per claim that we expect to receive associated with inventory that exists in the distribution channel at period end.
Under the par value method, we record the par value of the shares repurchased to Common stock and the historical issuance cost over par value of the shares repurchased to Additional paid-in capital.
The excess of the cost of the shares repurchased over these two amounts is then recorded to Retained earnings.
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2023, Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07 “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” ASU 2023-07 requires incremental annual and quarterly disclosures about segment measures of profit or loss as well as significant segment expenditures.
It also requires public entities with a single reportable segment to provide all segment disclosures required by the amendments in the update and all existing segment disclosures in Topic 280.
This guidance will be applied retrospectively, and we plan to adopt it beginning with our 2024 annual report to be filed in early 2025 and all quarterly and annual reports thereafter.
As we have a single reportable segment, we expect the adoption of this standard to result in increased disclosures in our Notes to Consolidated Financial Statements.
In December 2023, FASB issued ASU No. 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” ASU 2023-09 requires incremental annual disclosures around income tax rate reconciliations, income taxes paid and other related disclosures.
This guidance requires prospective application and permits retrospective application to prior periods presented.
We plan to adopt it beginning with our 2025 annual report to be filed in early 2026.
We expect the adoption of this standard to result in increased disclosures in our Notes to Consolidated Financial Statements.
| Oncology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Total Oncology | | | | | | 1,833 | | | | | | 875 | | | | | | 224 | | | | | | 2,932 | | | | | | 1,494 | | | | | | 573 | | | | | | 73 | | | | | | 2,139 | | | | | | 912 | | | | | | 303 | | | | | | 36 | | | | | | 1,251 | | | | | | | | | | | | | | |
| Liver Disease | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Total Liver Disease | | | | | | 1,421 | | | | | | 511 | | | | | | 852 | | | | | | 2,784 | | | | | | 1,440 | | | | | | 525 | | | | | | 833 | | | | | | 2,798 | | | | | | 1,415 | | | | | | 525 | | | | | | 910 | | | | | | 2,850 | | | | | | | | | | | | | | |
| Cencora, Inc. (formerly known as AmerisourceBergen Corporation) | | | | | | 19 | | % | | | | 18 | | % | | | | 23 | | % |
| | | | | | | | | |
| *Description of the Matter* | | | | | | During 2022, the Company recognized a $2.7 billion impairment charge related to its in-process research and development (IPR&D) intangible asset related to Trodelvy for treatment of patients with 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 $6.1 billion. As discussed in Note 1, intangible assets with indefinite useful lives related to IPR&D projects 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. An impairment charge is recognized to the 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 assessment as of March 31, 2022, and an annual impairment assessment as of October 1, 2022. Auditing the fair values of this IPR&D intangible asset was complex due to the significant judgment required in estimating the fair values. In particular, the fair value estimates required the use of a valuation methodology that 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 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 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 this asset at both the interim and annual assessment dates, our audit procedures, among others, included evaluating the Company's use of an appropriate valuation methodology with assistance from a valuation specialist, evaluating sensitivity analyses to determine which assumptions had the greatest impact on the 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 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. | | |
February 22, 2023
| Balance as of December 31, 2019 | | | | | | 1,266 | | | | | | $ | 1 | | | | | $ | 3,051 | | | | | $ | 85 | | | | | $ | 19,388 | | | | | $ | 125 | | | | | $ | 22,650 | |
| Cumulative effect from the adoption of new accounting standard | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (7) | | | | | | — | | | | | | (7) | | |
| Change in noncontrolling interest | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (72) | | | | | | (72) | | |
| Repurchases of common stock | | | | | | (11) | | | | | | — | | | | | | (28) | | | | | | — | | | | | | (664) | | | | | | — | | | | | | (692) | | |
| Repurchases of common stock | | | | | | (22) | | | | | | — | | | | | | (65) | | | | | | — | | | | | | (1,504) | | | | | | — | | | | | | (1,569) | | |
| Income taxes payable | | | | | | (568) | | | | | | (364) | | | | | | (778) | | |
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.
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
_______________________________
| AmerisourceBergen Corporation | | | | | | 18 | | % | | | | 23 | | % | | | | 27 | | % |
| Equity investment in Galapagos NV (“Galapagos”)(1) | | | | | | 736 | | | | | | — | | | | | | — | | | | | | 736 | | | | | | 931 | | | | | | — | | | | | | — | | | | | | 931 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Equity investment in Arcus Biosciences, Inc. (“Arcus”)(1) | | | | | | 286 | | | | | | — | | | | | | — | | | | | | 286 | | | | | | 559 | | | | | | — | | | | | | — | | | | | | 559 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
The contingent consideration was estimated using probability-weighted scenarios for U.S. Food and Drug Administration (“FDA”) approval of Hepcludex.
| Additions | | | | | | — | | | | | | 341 | | | | | |
The fair values of the liability related to future royalties were $1.1 billion and $1.3 billion as of December 31, 2022 and 2021, respectively, and the carrying value was $1.1 billion as of December 31, 2022 and 2021.
Debt and Credit Facilities for additional information.
Goodwill and Intangible Assets for additional information.
There were no indicators of impairment noted during 2021.
| Certificates of deposit | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
| Total | | | | | | $ | (4) | | | | | $ | 2,022 | | | | | $ | — | | | | | $ | 10 | | | | | $ | (4) | | | | | $ | 2,032 | |
| Total | | | | | | $ | 2,325 | | | | | $ | 2,293 | |
| Total | | | | | | $ | 5,248 | | | | | $ | 5,743 | |
Our investment in Galapagos is classified in Other long-term assets due to certain lock-up provisions in our amended subscription agreement with them, which extend to August 2024.
Other Equity Securities
These amounts were included in Other long-term assets on our Consolidated Balance Sheets.
Net unrealized losses recognized on equity securities were $657 million, $610 million and $1.7 billion for the years ended December 31, 2022, 2021 and 2020, respectively, and were included in Other income (expense), net on our Consolidated Statements of Income.
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
As of December 31, 2021, the fair value of the liability was $317 million and was included in Other current liabilities on our Consolidated Balance Sheets.
As of December 31, 2022, the fair value of the liability was $275 million and was included in Other long-term obligations.
| (in millions) | | | | | | Amount | | |
| Intangible assets: | | | | | | | | |
*Intangible Assets*
An excerpt. Shown here: 40 of 553 rewritten, 40 of 250 added and 40 of 308 removed. The counts are complete. For every sentence, read Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA in the FY2023 filing and the FY2022 filing.
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
4 rewritten, 1 added, 1 removed, 18 unchanged
We have audited Gilead Sciences, Inc.’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 [removed: framework)] [added: 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: 2022,] [added: 2023,] 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: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] 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: 2022,] [added: 2023,] and the related notes and our report dated February [removed: 22, 2023] [added: 23, 2024] expressed an unqualified opinion thereon.
San [removed: Jose,] [added: Mateo,] California
February 23, 2024
February 22, 2023
Item 9A. CONTROLS AND PROCEDURES
5 rewritten, 3 added, 0 removed, 8 unchanged
An evaluation as of December 31, [removed: 2022] [added: 2023] 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: 2022.][added: 2023.]
Based on our evaluation, we concluded that our internal control over financial reporting was effective as of December 31, [removed: 2022.][added: 2023.]
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: 2022.][added: 2023.]
Our management, including our Chief Executive Officer and Chief Financial Officer, has evaluated any changes in our internal control over financial reporting [removed: that occurred] during the quarter ended December 31, [removed: 2022, and has concluded that there was no] [added: 2023, to identify any] change [removed: during such quarter] that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
In August 2023, we began deploying a new enterprise resource planning system (“ERP”) as well as other related systems.
We have made changes to our internal control over financial reporting to address the related processes and systems.
We will continue to evaluate any further changes in our internal control over financial reporting over the course of the implementation of the new ERP and other related systems, which is scheduled to occur in phases over the next few years.
Item 9B. OTHER INFORMATION
0 rewritten, 2 added, 1 removed, 0 unchanged
On November 9, 2023, Merdad V.
Parsey, M.D., PhD., our Chief Medical Officer, adopted a trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell, subject to certain conditions, through November 8, 2024: (a) up to 29,393 shares of our common stock; (b) the total number of shares of our common stock sufficient to cover costs and fees and to satisfy applicable withholding taxes in connection with the exercise of 64,376 stock options; and (c) 25% of net shares of our common stock to be issued to Dr. Parsey after the satisfaction of applicable withholding taxes following the potential vesting and settlement of up to 56,624 performance shares.
Not applicable.
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
2 rewritten, 0 added, 0 removed, 1 unchanged
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: 2023] [added: 2024] 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 “Governance - Governance [removed: Documents”] [added: 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.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is incorporated by reference to the sections of the Proxy Statement under the headings “The Gilead Board of [removed: Directors,”] [added: Directors”] and “Board Processes.”
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
124 rewritten, 5 added, 5 removed, 119 unchanged
| [Report of Independent Registered Public Accounting Firm (PCAOB ID: [removed: 42)](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] [added: 42)](#i1a21f79537ba4f149055dfe665e667c1_64)] | | | [removed: [46](#i6d96c727bd3e4a10969bbf6a84d64ce7_67)] [added: [50](#i1a21f79537ba4f149055dfe665e667c1_64)] | | |
| [Audited Consolidated Financial [removed: Statements:](#i6d96c727bd3e4a10969bbf6a84d64ce7_70)] [added: Statements:](#i1a21f79537ba4f149055dfe665e667c1_67)] | | | | | |
| [Consolidated Balance [removed: Sheets](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] [added: Sheets](#i1a21f79537ba4f149055dfe665e667c1_70)] | | | [removed: [48](#i6d96c727bd3e4a10969bbf6a84d64ce7_73)] [added: [52](#i1a21f79537ba4f149055dfe665e667c1_70)] | | |
| [Consolidated Statements of [removed: Income](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] [added: Income](#i1a21f79537ba4f149055dfe665e667c1_73)] | | | [removed: [49](#i6d96c727bd3e4a10969bbf6a84d64ce7_76)] [added: [53](#i1a21f79537ba4f149055dfe665e667c1_73)] | | |
| [Consolidated Statements of Comprehensive [removed: Income (Loss)](#i6d96c727bd3e4a10969bbf6a84d64ce7_79)] [added: Income](#i1a21f79537ba4f149055dfe665e667c1_76)] | | | [removed: [50](#i6d96c727bd3e4a10969bbf6a84d64ce7_79)] [added: [54](#i1a21f79537ba4f149055dfe665e667c1_76)] | | |
| [Consolidated Statements of Stockholders’ [removed: Equity](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] [added: Equity](#i1a21f79537ba4f149055dfe665e667c1_79)] | | | [removed: [51](#i6d96c727bd3e4a10969bbf6a84d64ce7_82)] [added: [55](#i1a21f79537ba4f149055dfe665e667c1_79)] | | |
| [Consolidated Statements of Cash [removed: Flows](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] [added: Flows](#i1a21f79537ba4f149055dfe665e667c1_82)] | | | [removed: [52](#i6d96c727bd3e4a10969bbf6a84d64ce7_85)] [added: [56](#i1a21f79537ba4f149055dfe665e667c1_82)] | | |
| [Notes to Consolidated Financial [removed: Statements](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] [added: Statements](#i1a21f79537ba4f149055dfe665e667c1_85)] | | | [removed: [53](#i6d96c727bd3e4a10969bbf6a84d64ce7_88)] [added: [57](#i1a21f79537ba4f149055dfe665e667c1_85)] | | |
| [removed: (1)] [added: (2)] | | | 3.2 | | | | | | | | | [Amended and Restated Bylaws of Registrant](http://www.sec.gov/Archives/edgar/data/882095/000110465923011167/tm235492d1_ex3-1.htm) | | |
| [removed: (2)] [added: (3)] | | | 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: (2)] [added: (3)] | | | 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: (3)] [added: (4)] | | | 4.4 | | | | | | | | | [Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2041 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312511339157/d269235dex41.htm) | | |
| [removed: (4)] [added: (5)] | | | 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 Note and Form of 2044 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312514089047/d688498dex41.htm) | | |
| [removed: (5)] [added: (6)] | | | 4.6 | | | | | | | | | [Fourth Supplemental Indenture related to Senior Notes, dated as of November 17, 2014, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2025 Note and Form of 2045 Note)](http://www.sec.gov/Archives/edgar/data/882095/000119312514415184/d821656dex41.htm) | | |
| [removed: (6)] [added: (7)] | | | 4.7 | | | | | | | | | [Fifth Supplemental Indenture, dated as of September 14, 2015, between Registrant and Wells Fargo Bank, National Association, as Trustee (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: (7)] [added: (8)] | | | 4.8 | | | | | | | | | [Sixth Supplemental Indenture, dated as of September 20, 2016, between Registrant and Wells Fargo Bank, National Association, as Trustee [removed: (including Form of 2023 Note, Form] [added: (including](http://www.sec.gov/Archives/edgar/data/882095/000119312516714926/d259911dex41.htm) [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: (8)] [added: (9)] | | | 4.9 | | | | | | | | | [Eighth Supplemental Indenture, dated as of September 30, 2020, between the Registrant and Wells Fargo Bank, National Association, as Trustee [removed: (including form] [added: (](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm)[including](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm) [Form] of [removed: notes)](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm)] [added: 2027 Note, Form of 2030 Note, Form of 2040 Note, and Form of 2050 Note)](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm)[)](http://www.sec.gov/Archives/edgar/data/882095/000110465920110185/tm2031940d2_ex4-1.htm)] | | |
| [removed: (9)] [added: (11)] | | | [removed: 4.10] [added: 4.11] | | | | | | | | | [Description of Registrant’s Securities](http://www.sec.gov/Archives/edgar/data/882095/000088209520000006/gild2019form10-kex49.htm) | | |
| [removed: (10)] [added: (12)] | | | 10.1* | | | | | | | | | [Gilead Sciences, Inc. 2004 Equity Incentive Plan, amended and restated May 10, 2017](http://www.sec.gov/Archives/edgar/data/882095/000119312517168672/d396034dex101.htm) | | |
| [removed: (11)] [added: (13)] | | | 10.2* | | | | | | | | | [Amendment No. 1 to Gilead Sciences, Inc. 2004 Equity Incentive Plan, amended and restated May 10, 2017](http://www.sec.gov/Archives/edgar/data/882095/000088209521000008/gild20ormex102amendmentto2.htm) | | |
| [removed: (12)] [added: (14)] | | | 10.3* | | | | | | | | | [Gilead Sciences, Inc. 2022 Equity Incentive Plan](http://www.sec.gov/Archives/edgar/data/882095/000110465922056435/tm2213708d1_ex10-1.htm) | | |
| [removed: (13)] [added: (15)] | | | 10.4* | | | | | | | | | [Form of employee stock option agreement under 2004 Equity Incentive Plan (for grants made in 2011 through 2018)](http://www.sec.gov/Archives/edgar/data/882095/000119312511132405/dex1042.htm) | | |
| [removed: (14)] [added: (16)] | | | 10.5* | | | | | | | | | [Form of employee stock option agreement under 2004 Equity Incentive Plan (for grants made in 2019)](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex104.htm) | | |
| [removed: (15)] [added: (17)] | | | 10.6* | | | | | | | | | [Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for grants made in 2019)](http://www.sec.gov/Archives/edgar/data/882095/000088209519000027/gildq32019ex105.htm) | | |
| [removed: (16)] [added: (18)] | | | 10.7* | | | | | | | | | [Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for grants made in 2020)](http://www.sec.gov/Archives/edgar/data/882095/000088209520000013/gildq12020ex105.htm) | | |
| [removed: (17)] [added: (19)] | | | 10.8* | | | | | | | | | [Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for [removed: grants](https://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex1072021employe.htm) [made](https://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex1072021employe.htm) [in] [added: grants made in] 2021)](https://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex1072021employe.htm) | | |
| [removed: (18)] [added: (20)] | | | 10.9* | | | | | | | | | [Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for certain grants made in 2022)](http://www.sec.gov/Archives/edgar/data/882095/000088209522000013/gildq12022ex1082022employe.htm) | | |
| [removed: (19)] [added: (21)] | | | 10.10* | | | | | | | | | [Form of global employee stock option agreement under 2004 Equity Incentive Plan (4 year vest) (for certain [removed: grants commencing in 202](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10102022employ.htm)[2](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10102022employ.htm)[)](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10102022employ.htm)] [added: grants](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10102022employ.htm) [made](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10102022employ.htm) [in 2022)](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10102022employ.htm)] | | |
| [removed: (20)] [added: (16)] | | | [removed: 10.11*] [added: 10.13*] | | | | | | | | | [Form of non-employee director stock option agreement under 2004 Equity Incentive Plan (for [removed: grants made in 2009 through 2012)](http://www.sec.gov/Archives/edgar/data/882095/000119312509165506/dex1019.htm)] [added: grants](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex109.htm) [made](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex109.htm) [in 2019)](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex109.htm)] | | |
| [removed: (21)] [added: (23)] | | | 10.12* | | | | | | | | | [Form of non-employee director stock option agreement [removed: (U.S.)] under 2004 Equity Incentive Plan (for grants made in [removed: 2013)](http://www.sec.gov/Archives/edgar/data/882095/000088209513000038/gildq21310-qex1043.htm)] [added: 2014 through 2018)](http://www.sec.gov/Archives/edgar/data/882095/000088209514000038/ex1045-stockoptionagreement.htm)] | | |
| [removed: (21)] [added: (24)] | | | [removed: 10.13*] [added: 10.14*] | | | | | | | | | [Form of non-employee director stock option agreement [removed: (non-U.S.)] under 2004 Equity Incentive Plan (for grants made in [removed: 2013)](http://www.sec.gov/Archives/edgar/data/882095/000088209513000038/gildq21310-qex1044.htm)] [added: 2020 and 2021)](http://www.sec.gov/Archives/edgar/data/882095/000088209520000019/gildq22020ex10262020no.htm)] | | |
| [removed: (22)] [added: (21)] | | | [removed: 10.14*] [added: 10.15*] | | | | | | | | | [Form of non-employee director stock option agreement under [removed: 2004] [added: 2022] Equity Incentive Plan (for grants made in [removed: 2014 through 2018)](http://www.sec.gov/Archives/edgar/data/882095/000088209514000038/ex1045-stockoptionagreement.htm)] [added: 2022)](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10172022non-ee.htm)] | | |
| [removed: (14)] [added: (16)] | | | [removed: 10.15*] [added: 10.25*] | | | | | | | | | [Form of [removed: non-employee director] [added: employee restricted] stock [removed: option] [added: unit issuance] agreement under 2004 Equity Incentive Plan (for [removed: grants](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex109.htm) [made](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex109.htm) [in 2019)](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex109.htm)] [added: grants made in 2019)](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex1017.htm)] | | |
| [removed: (23)] [added: (25)] | | | 10.16* | | | | | | | | | [Form of non-employee director stock option agreement under [removed: 2004] [added: 2022] Equity Incentive Plan (for [removed: grants](http://www.sec.gov/Archives/edgar/data/882095/000088209520000019/gildq22020ex10262020no.htm) [made](http://www.sec.gov/Archives/edgar/data/882095/000088209520000019/gildq22020ex10262020no.htm) [in 2020](http://www.sec.gov/Archives/edgar/data/882095/000088209520000019/gildq22020ex10262020no.htm) [and 2021](http://www.sec.gov/Archives/edgar/data/882095/000088209520000019/gildq22020ex10262020no.htm)[)](http://www.sec.gov/Archives/edgar/data/882095/000088209520000019/gildq22020ex10262020no.htm)] [added: grants commencing in 2023)](http://www.sec.gov/Archives/edgar/data/882095/000088209523000025/gildq22023ex10162023non-ee.htm)] | | |
| [removed: (19)] [added: (25)] | | | [removed: 10.17*] [added: 10.32*] | | | | | | | | | [Form of non-employee director [added: restricted] stock [removed: option] [added: unit] agreement under [removed: 2004] [added: 2022] Equity Incentive Plan (for grants commencing in [removed: 2022)](http://www.sec.gov/Archives/edgar/data/882095/000088209522000019/gildq22022ex10172022non-ee.htm)] [added: 2023)](http://www.sec.gov/Archives/edgar/data/882095/000088209520000019/gildq22020ex10112020no.htm)] | | |
| [removed: (14)] [added: (19)] | | | 10.18* | | | | | | | | | [Form of performance share award agreement - TSR Goals (U.S.) under 2004 Equity Incentive Plan (for grants made in [removed: 2019)](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex1012.htm)] [added: 2021)](http://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex10162021psuagr.htm)] | | |
| [removed: (16)] [added: (18)] | | | [removed: 10.19*] [added: 10.17*] | | | | | | | | | [Form of performance share award agreement - TSR Goals (U.S.) under 2004 Equity Incentive Plan (for grants made in 2020)](http://www.sec.gov/Archives/edgar/data/882095/000088209520000013/gildq12020ex1013.htm) | | |
| [removed: (17)] [added: (19)] | | | [removed: 10.20*] [added: 10.22*] | | | | | | | | | [Form of performance share award agreement - [removed: TSR] [added: Revenue] Goals (U.S.) under 2004 Equity Incentive Plan (for [removed: grants](http://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex10162021psuagr.htm) [made](http://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex10162021psuagr.htm) [in 2021)](http://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex10162021psuagr.htm)] [added: grants made in 2021)](http://www.sec.gov/Archives/edgar/data/882095/000088209521000013/gildq12021ex10192021psuagr.htm)] | | |
| [removed: (18)] [added: (20)] | | | [removed: 10.21*] [added: 10.19*] | | | | | | | | | [Form of performance share award agreement - TSR Goals (U.S.) under 2004 Equity Incentive Plan (for grants commencing in 2022)](http://www.sec.gov/Archives/edgar/data/882095/000088209522000013/gildq12022ex10182022psuagr.htm) | | |
| [removed: (14)] [added: (18)] | | | [removed: 10.22*] [added: 10.21*] | | | | | | | | | [Form of performance share award agreement - Revenue Goals (U.S.) under 2004 Equity Incentive Plan (for grants made in [removed: 2019)](http://www.sec.gov/Archives/edgar/data/882095/000088209519000020/gildq22019ex1015.htm)] [added: 2020)](http://www.sec.gov/Archives/edgar/data/882095/000088209520000013/gildq12020ex1017.htm)] | | |
| (10) | | | 4.10 | | | | | | | | | [Ninth Supplemental Indenture, dated as of September 14, 2023, between the Registrant and Computershare Trust Company, National Association, as successor to Wells Fargo Bank, National Association, as Trustee (including Form of 2033 Note and Form of 2053 Note)](http://www.sec.gov/Archives/edgar/data/882095/000110465923100638/tm2324696d5_ex4-2.htm) | | |
| | | | 97.1 | | | | | | | | | [Gilead Sciences, Inc. Compensation Recovery Policy](https://www.sec.gov/Archives/edgar/data/882095/000088209524000007/gild2023formex971compensat.htm) | | |
(2) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on February 6, 2023, and incorporated herein by reference.
(10) Filed as an exhibit to Registrant’s Current Report on Form 8-K filed on September 14, 2023, and incorporated herein by reference.
(27) Filed as an exhibit to Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and incorporated herein by reference.
| | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (16) | | | 10.48* | | | | | | | | | [Restricted stock unit issuance agreement for Johanna Mercier (for Performance Objectives in 2019-2020) under 2004 Equity Incentive Plan](http://www.sec.gov/Archives/edgar/data/882095/000088209520000013/gildq12020ex1041.htm) | | |
| (16) | | | 10.51* | | | | | | | | | [Global stock option agreement for Merdad Parsey (in 2019) under 2004 Equity Incentive Plan](http://www.sec.gov/Archives/edgar/data/882095/000088209520000013/gildq12020ex1044.htm) | | |
| (16) | | | 10.52* | | | | | | | | | [Global restricted stock unit issuance agreement for Merdad Parsey (in 2019) under 2004 Equity Incentive Plan](http://www.sec.gov/Archives/edgar/data/882095/000088209520000013/gildq12020ex1045.htm) | | |
An excerpt. Shown here: 40 of 124 rewritten, all 5 added and all 5 removed. The counts are complete. For every sentence, read Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES in the FY2023 filing and the FY2022 filing.
Item 16. FORM 10-K SUMMARY
13 rewritten, 5 added, 0 removed, 37 unchanged
Telman, and each of them, as his [added: or her] true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities, to sign any and all amendments to this Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he [added: or she] might or could do in person, hereby ratifying and confirming that all said attorneys-in-fact and agents, or any of them or their or his [added: or her] substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
| /s/ DANIEL P. O’DAY | | | | | | Chairman and Chief Executive Officer | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ ANDREW D. DICKINSON | | | | | | Chief Financial Officer | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ [removed: DIANE E. WILFONG] [added: SANDRA PATTERSON] | | | | | | Senior Vice President and Chief Accounting Officer | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| [removed: Diane E. Wilfong] [added: Sandra Patterson] | | | | | | *(Principal Accounting Officer)* | | | | | | | | |
| /s/ JACQUELINE K. BARTON | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ JEFFREY A. BLUESTONE | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ SANDRA J. HORNING | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ KELLY A. KRAMER | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ KEVIN E. LOFTON | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ HARISH MANWANI | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ JAVIER J. RODRIGUEZ | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| /s/ ANTHONY WELTERS | | | | | | Director | | | | | | February [removed: 22, 2023] [added: 23, 2024] | | |
| | | | | | |
| Date: | | | February 23, 2024 | | |
| /s/ TED W. LOVE | | | | | | Director | | | | | | February 23, 2024 | | |
| Ted W. Love, M.D. | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |