Sentences and paragraphs of GILD's Risk Factors and MD&A, 10-K 2026-02-24 against 10-K 2025-02-28.
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AddedRisk Factors
A significant portion of the raw materials and intermediates in the manufacturing of our products and product candidates are supplied by third-party suppliers, manufacturers and corporate partners outside of the U.S. As a result, any geopolitical or economic factors in a specific country or region, including any new, or changes in or interpretations of existing law, trade regulations, or compliance requirements (such as the recently enacted BIOSECURE Act) or tax that would limit or prevent third parties outside of the U.S. from supplying these materials could adversely affect our ability to manufacture and supply our products to meet market needs and have a material and adverse effect on our operating results. Such factors may also negatively impact our ability to supply our clinical trials and commercial product, which may result in the delay of our clinical trials and regulatory submissions, and could lead to regulatory delays, increased costs, and/or lost revenue.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedRisk Factors
foreign currency exchange rates, primarily in the Euro, and the impacts from foreign currency exchange, net of hedges, for the year ended December 31, 2025.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedRisk Factors
Our suppliers and third-party manufacturers and corporate partners similarly face these risks that could have an adverse effect on our business, and any disruption to their operations could have an adverse effect on our manufacturing and supply chain.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedRisk Factors
Our U.S. manufacturing and R&D investments may not achieve their intended benefits and could adversely affect our business, results of operations and cash flows.
Read it in 10-K 2026-02-24 at sec.gov ↗
RemovedRisk Factors
•educating and certifying medical personnel regarding the procedures and the potential side effects, such as cytokine release syndrome and neurologic toxicities, in compliance with the Risk Evaluation and Mitigation Strategy program required by the U.S. Food and Drug Administration (“FDA”);
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedRisk Factors
Some institutional and individual investors continue to use environmental, social and governance (“ESG”) screening criteria to determine whether Gilead qualifies for inclusion in their investment portfolios. We are frequently asked by investors and other stakeholders to set ambitious ESG goals and provide new and more robust disclosure on goals, progress toward goals and other matters of interest to ESG stakeholders. In response, we have adapted the tracking and reporting of our corporate responsibility program to various evolving ESG frameworks, and we have established and announced goals and other objectives related to ESG matters. These goal statements reflect our current plans and aspirations and are not guarantees that we will be able to achieve them. Our efforts to accomplish and accurately report on these goals and objectives present numerous operational, reputational, financial, legal and other risks, any of which could have a material negative impact, including on our reputation and stock price.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedRisk Factors
Our ability to achieve any corporate responsibility goal or objective is subject to numerous risks, many of which are outside of our control. Examples of such risks include: (1) the availability and cost of low- or non-carbon-based energy sources and technologies, (2) evolving regulatory requirements affecting ESG standards or disclosures, (3) the availability of suppliers that can meet our corporate responsibility and related standards, (4) our ability to recruit, develop and retain qualified talent in our labor markets and (5) the impact of our organic growth and acquisitions or dispositions of businesses or operations.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedRisk Factors
The standards for tracking and reporting on ESG matters are relatively new, have not been harmonized and continue to evolve. Our selection of disclosure frameworks that seek to align with various reporting standards may change from time to time and may result in a lack of consistent or meaningful comparative data from period to period. In addition, regulatory authorities have begun to impose mandatory disclosure requirements with respect to ESG matters, such as regulations proposed or adopted by federal agencies related to climate-related disclosures, claims, practices or initiatives, the EU’s Corporate Sustainability Reporting Directive, and California’s Climate-Related Financial Risk Act and the Climate Corporate Data Accountability Act. Our processes and controls may not reflect evolving standards for identifying, measuring and reporting ESG matters, immediately or at all, our interpretation of reporting standards may differ from those of others, and such standards may change over time, any of which could result in significant revisions to our goals or reported progress in achieving such goals. In addition, enhancements to our processes and controls to reflect evolving reporting standards may be costly and require additional resources.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedRisk Factors
The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedRisk Factors
We periodically implement or upgrade new or enhanced enterprise resource planning (“ERP”) and other information systems in order to better manage our business operations, align our global organizations and enable future growth. Implementation or upgrade of new business processes and information systems requires the commitment of significant personnel, training and financial resources, and entails risks to our business operations. If we do not successfully implement ERP and other information systems improvements, or if there are delays or difficulties in implementing these systems, we may not realize anticipated productivity improvements or cost efficiencies, and we may experience operational difficulties and challenges in effectively managing our business, all of which could result in quality issues, reputational harm, lost market and revenue opportunities, and otherwise adversely affect our business, financial condition and results of operations.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedRisk Factors
For example, we are currently in the process of implementing new ERP and other information systems to help us manage our operations and financial reporting. Costs and risks inherent in this transition may include disruptions to business continuity, administrative and technical problems, interruptions or delays in sales, manufacturing or R&D processes, expenditure overruns, delays in paying our suppliers and employees, and data migration issues. If we do not properly address or mitigate these issues, this could result in increased costs and diversion of resources, negatively impacting our operating results and ability to effectively manage our business. Additionally, if we do not effectively implement the ERP system as planned, or the ERP system does not operate as intended, the effectiveness of our internal control over financial reporting could be negatively affected.
Read it in 10-K 2025-02-28 at sec.gov ↗
RewordedRisk Factors
In the U.S., these laws include anti-kickback and false claims laws, the 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, including the Executive Order Department of Justice Final Rule on Preventing Access to Americans’ Bulk Sensitive Personal Data, which may impact how and where clinical and other sensitive data is shared, accessed and analyzed, and United States Government-Related Data by Countries of Concern issued in February 2024. U.S.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
Additionally, For example, recently enacted and proposed legislation in the U.S., such as the BIOSECURE Act (which, among other things, could prohibit prohibits U.S. executive agencies from contracting with, or expending loans or granting funds to, companies that use biotechnology equipment or services for certain activities from certain foreign-owned entities), entities) and the ABC Safe Drug Act (which, among other things, could prohibit U.S. federal health care programs from purchasing drugs and drug ingredients manufactured in China), has the potential to adversely impact our ability to receive equipment goods or services from such entities, including certain of which we use in connection with our clinical trials and our clinical and commercial manufacturing, which could increase the cost or limit the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials and regulatory submissions, delay the launch of commercial products and adversely affect our financial condition and business prospects.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
These and any future marketing applications we file may not be approved by the regulatory authorities on a timely basis, or at all. all, and changes or disruptions at FDA or other regulatory agencies, including as a result of budget cuts and employee layoffs, could impair the ability of these agencies to timely review and process our applications.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
As such, there is an increasing expectation for For example, many nations, particularly in the health sector to implement commitments EU, have communicated plans to decarbonize their healthcare systems and achieve net zero emissions by 2050, and we which may be required require us to incur material costs in order to do so.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
For example, see “Foreign Currency Exchange Impact” in Part II, Item 8 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, 2024.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
As required by U.S. generally accepted accounting principles, we conduct annual impairment testing of our goodwill and other indefinite-lived intangible assets in the fourth quarter or more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
Congress has enacted the Inflation Reduction Act of 2022 (the “IRA”), (“IRA”), 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), which could also affect the Medicaid rebate obligations and the ceiling prices charged to covered entities under Section 340B of the Public Health Service Act (“340B”) if such prices are lower than the Medicaid Best Price; Price and reduce the Average Sales Price and associated Medicare reimbursement rate for products reimbursed under Medicare Part B;
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
Reductions in the pricing of our medical products Price reductions in one EU member state could affect the price pricing in other member states others and have a negative negatively impact on our financial results.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
Our investigation revealed that unauthorized pharmaceutical distributors that are not authorized by Gilead to sell sold counterfeit Gilead medicine sold purportedly genuine Gilead medicine sourced from an illegal counterfeiting scheme to independent pharmacies nationwide.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
The Centers for Medicare and Medicaid Services (“CMS”) has issued a number of guidance documents, documents governing certain aspects of the IRA, but it remains unclear how certain provisions of the IRA will be implemented. are being implemented due to lack of full transparency.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
A number of companies, including large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies, are pursuing the development of products and technologies that may be competitive with our existing products or research programs.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedRisk Factors
The outcome of these reviews cannot be predicted is unpredictable and could have an adverse effect on may adversely affect the pricing and reimbursement of our medical products in the EU member states. EU.
Read it in 10-K 2026-02-24 at sec.gov ↗
Quiet changesRisk Factors
Apheresis centers may also choose not decline to participate in our quality certification process, or we may be unable to complete such certification in a timely manner or at all, which could delay or constrain our manufacturing and commercialization efforts.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Announced positive topline Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trial, evaluating our investigational daily oral single-tablet regimen of bictegravir 75mg and lenacapavir 50mg (“BIC/LEN”) for virologically suppressed adults with HIV. BIC/LEN met its primary endpoint, demonstrating non-inferiority to baseline multi-tablet antiviral regimens (ARTISTRY-1) and Biktarvy (ARTISTRY-2).
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Announced settlement agreements to resolve Biktarvy patent litigation with generic manufacturers Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd. Under the agreements, the earliest date the three generic manufacturers can market a generic version of full dose Biktarvy in the U.S. is April 1, 2036, subject to standard acceleration provisions. This is more than two years later than our previous loss of exclusivity projection for Biktarvy (December 2033).
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Received a strong recommendation for the use of twice-yearly injectable Yeztugo (lenacapavir) for HIV PrEP in the new U.S. Centers for Disease Control and Prevention guidelines.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Announced a partnership with the U.S. State Department and the U.S. President’s Emergency Plan for AIDS Relief (“PEPFAR”) to deliver lenacapavir for HIV PrEP for up to two million people over three years in countries supported by both PEPFAR and the Global Fund.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Received European Commission (“EC”) marketing authorization for Yeytuo (lenacapavir) for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Received U.S. Food and Drug Administration (“FDA”) approval for Yeztugo (lenacapavir) for PrEP to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Announced that FDA had placed a clinical hold on the HIV treatment trials of GS-1720 and/or GS-4182, including the WONDERS-1 and WONDERS-2 trials. These drug candidates are investigational and not approved anywhere globally.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Announced that we entered into a definitive agreement to acquire all of the outstanding common stock of Arcellx, Inc. (“Arcellx”), providing us with full control of its leading pipeline candidate, anitocabtagene autoleucel, an investigational BCMA-directed CAR-T cell therapy for patients with relapsed and/or refractory multiple myeloma. This transaction is anticipated to close during the second quarter of 2026, subject to the satisfaction or waiver of customary closing conditions.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Announced the discontinuation of the Phase 3 STAR-221 study, in partnership with Arcus Biosciences, Inc. (“Arcus”), evaluating the anti-TIGIT antibody domvanalimab (“dom”) plus zimberelimab (“zim”) and chemotherapy in first-line HER2- advanced gastric and esophageal cancers. The decision was based on the recommendation of the Independent Data Monitoring Committee, following review of data from a pre-specified interim analysis. Additionally, Gilead and Arcus will discontinue the Phase 2 EDGE-Gastric study evaluating dom and zim regimens in upper gastrointestinal cancers. Dom and zim are investigational products and are not approved anywhere globally.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Announced that our Phase 3 ASCENT-07 study of Trodelvy evaluating sacituzumab govitecan-hziy (“SG”) as a first-line treatment post-endocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative (“HR+/HER2-”) metastatic breast cancer patients did not meet the primary endpoint of progression-free survival. Overall survival is a key secondary endpoint and was not mature at the time of the primary analysis; however, an early trend was observed favoring patients treated with Trodelvy compared to chemotherapy.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Presented Phase 3 ASCENT-03 data for Trodelvy in 1L metastatic triple-negative breast cancer (“mTNBC”) patients who are not candidates for PD-1/PD-L1 checkpoint inhibitors at the 2025 European Society for Medical Oncology Congress. Trodelvy is not approved in this setting.
Read it in 10-K 2026-02-24 at sec.gov ↗
AddedMD&A
•Entered into a collaboration with Shenzhen Pregene Biopharma Co., Ltd. (“Pregene”) to develop next-generation in vivo therapies.
Read it in 10-K 2026-02-24 at sec.gov ↗
RemovedMD&A
•Completed the New Drug Application submissions to U.S. Food and Drug Administration (“FDA”) for twice-yearly lenacapavir for HIV prevention.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•Announced results of PURPOSE 2, the second Phase 3 study of twice-yearly lenacapavir for HIV prevention, with data presented at the HIV Research for Prevention Conference. In the lenacapavir group, 99.9% of participants did not acquire HIV infection, with two incident cases among 2,179 participants. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence in cisgender men and gender-diverse people, and additionally demonstrated superiority to daily Truvada (89% relative risk reduction). Lenacapavir was generally well-tolerated and no significant or new safety concerns were identified. The use of lenacapavir for the prevention of HIV is investigational.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•Received Breakthrough Therapy Designation from FDA to Trodelvy for the treatment of adult patients with extensive-stage small cell lung cancer (“ES-SCLC”) whose disease has progressed on or after platinum-based chemotherapy. The use of Trodelvy in ES-SCLC is investigational.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•Announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy for use in pre-treated adult patients with locally advanced or metastatic urothelial cancer, following the results of the Phase 3 TROPiCS-04 trial announced in May 2024.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•Incurred partial impairment charges related to in-process research and development (“IPR&D”) assets acquired by Gilead from Immunomedics, Inc. in 2020 as a result of our evaluation of the Phase 3 EVOKE-01 study data and a strategic decision to discontinue our clinical development program in metastatic non-small cell lung cancer (“NSCLC”) for Trodelvy in the second-line indication (see further information in “Results of Operations; In-Process Research and Development Impairments” below).
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•Entered into an amended license agreement featuring the buy-out of global seladelpar royalties from Janssen Pharmaceutica NV for $320 million.
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RemovedMD&A
•Completed the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”) for $4.3 billion in total equity value, or $3.9 billion net cash paid, adding investigational candidate seladelpar for the treatment of primary biliary cholangitis to Gilead’s Liver Disease portfolio.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•Announced the appointment of Dietmar Berger, MD, PhD, as Chief Medical Officer effective January 2025.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•A pre-tax IPR&D partial impairment charge of $4.2 billion related to Trodelvy IPR&D assets; and
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
•Higher acquired IPR&D expenses, primarily $3.8 billion related to the acquisition of CymaBay; partially offset by
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
Our ability to deliver on our strategy and 2025 objectives is subject to a number of uncertainties. Please refer to Part I, Item 1A. Risk Factors of this Annual Report on Form 10-K for a listing of risk factors that could materially and adversely affect our results of operations and financial condition.
Read it in 10-K 2025-02-28 at sec.gov ↗
RemovedMD&A
A substantial portion of our product sales is subject to significant discounts from list price, including government and commercial rebates and chargebacks, as well as other deductions, including patient co-pay assistance, cash discounts for prompt payment, distributor fees, and sales return provisions. These deductions to product sales are generally referred to as gross-to-net deductions and are primarily a function of product sales volume, product mix, contractual or statutory discounts and estimated payer mix.
Read it in 10-K 2025-02-28 at sec.gov ↗
RewordedMD&A
General and administrative expenses decreased mainly primarily due to lower expenses related to corporate initiatives and legal matters, partially offset by as well as the impact of stock-based compensation expenses and other integration costs related to the acquisition of CymaBay, and higher restructuring costs. CymaBay in 2024, which did not repeat in 2025, partially offset by donations of equity securities made to the Gilead Foundation.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
Net In 2024, we utilized cash used in investing activities was notably higher in 2024 primarily related to for the $3.9 billion net cash payment for the CymaBay acquisition, acquisition and purchases of equity securities, partially offset by proceeds cash received from the liquidation of marketable debt securities to fund that acquisition. securities.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
Our revised discounted cash flows for the September 30, 2024 fair value estimation primarily reflected the removal of cash flows associated with second-line plus patients. patients, and the remaining carrying value as of that date reflects Trodelvy’s opportunity as a combination therapy in first-line metastatic NSCLC patients supported by its ongoing Phase 3 clinical trial in this patient population.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
Year Ended December 31, (in millions, except percentages) 2025 2024 2023 Change Interest expense $ 977 $944 3% 1,024 $977 5% Other (income) expense, net $ (6) $(198) (97)% Loss (798) $(6) NM (Gain) loss from equity securities, net $ 274 $167 64% (451) $274 NM Interest income $ (281) $(376) (25)% (349) $(281) 24% Other, net $ 2 $11 (84)% 1 $2 (41)%
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RewordedMD&A
As a result, we recognized a partial impairment charge charges of $1.8 billion $190 million and $400 million in In-process research and development impairments on our Consolidated Statements of Operations during for the third quarter second and fourth quarters of 2024. 2025, respectively, for a total of $590 million for the year ended December 31, 2025.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
To arrive at the revised estimated fair value, values as of June 30, 2025 and December 31, 2025, we used a probability-weighted income approach that discounts expected future cash flows to present value, which requires the use of Level 3 fair value measurements and inputs, including critical estimated inputs, such as: revenues and operating profits related to the planned utilization of SG in NSCLC, which, include bulevirtide outside of the European Union (“EU”), which includes inputs such as addressable patient population, projected market share, treatment duration, and the life of the potential commercialized product; the probability of technical and regulatory success; the time and resources needed to complete the development and approval of SG in NSCLC; bulevirtide outside of the EU; an appropriate discount rate based on the estimated weighted-average cost of capital for companies with profiles similar to our profile; and risks related to the viability of and potential alternative treatments in any future target markets.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
Based on our evaluation, evaluation of the data, and in connection with the preparation of the financial statements for the third quarter, second quarter of 2025 and again for the year ended December 31, 2025, we performed an interim impairment test tests and determined that the revised estimated fair value of the NSCLC bulevirtide IPR&D intangible asset was below its carrying value. value in both periods.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
Unfavorable Favorable movements in Other (income) expense, net in 2024, 2025, compared to 2023, 2024, primarily related to higher net losses unrealized gains from equity securities and lower compared to net unrealized losses in 2024, as well as higher interest income due to lower average cash balances. income.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
Net In 2024, we utilized cash used in financing activities in 2024 was primarily the result of $2.0 billion for debt repayments, $3.9 billion for dividend payments payments, $2.0 billion for repayment of debt and other obligations, and $1.2 billion for common stock repurchases, partially offset by $3.5 billion in net proceeds from the issuance of senior unsecured notes in November 2024.
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RewordedMD&A
Net cash provided by operating activities increased decreased in 2024 mainly 2025, compared to 2024, primarily due to higher collections on sales inventory build-up and lower higher income tax and operating payments. payments, as well as unfavorable timing of accounts receivable collections.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
Our revised discounted cash flows for the September June 30, 2024 2025 and December 31, 2025 fair value estimation estimations primarily reflected the removal updated expectations for bulevirtide’s potential market share outside of cash flows associated with second-line plus patients. the EU.
Read it in 10-K 2026-02-24 at sec.gov ↗
RewordedMD&A
During 2024, As evidenced by various late-stage clinical trial updates in HIV and oncology, we delivered growth in our HIV, Oncology and Liver Disease product sales and continued to invest in our business and research and development (“R&D”) pipeline through advancement of our portfolio and broadening of available therapies, including through acquisitions and collaborations.
Read it in 10-K 2026-02-24 at sec.gov ↗
