Gilead Sciences (GILD) risk factors: FY2025 10-K

Item 1A of the 10-K for the period ending 2025-12-31, filed 2026-02-24. 22 risk factor headings as filed. Read Item 1A in full · The whole 10-K · What changed since FY2024

1new since FY2024
2reworded
1removed
19unchanged

Headings mentioning a theme: Tariffs 0 · AI 0 · Cybersecurity 1 · China 0 · Interest rates 0. Compare across the S&P 500.

Product and Commercialization Risks

6
  1. Certain of our products subject us to additional or heightened risks.
  2. Our success depends on developing and commercializing new products or expanding the indications for existing products.
  3. We face challenges in accurately forecasting sales because of the difficulties in predicting demand for our products and fluctuations in purchasing patterns or wholesaler inventories.
  4. We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.
  5. Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.reworded
  6. We may experience adverse impacts resulting from the importation of our products from lower price markets or the distribution of illegally diverted or counterfeit versions of our products.

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Product Development and Supply Chain Risks

2
  1. We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.
  2. We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, or we may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners, which could limit our ability to generate revenues.

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Regulatory and Other Legal Risks

4
  1. Our operations depend on compliance with complex FDA and comparable international regulations. Failure to obtain broad approvals on a timely basis or to maintain compliance, including if significant safety issues arise for our marketed products or our product candidates, could delay or halt commercialization of our products.
  2. We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.
  3. Our success depends to a significant degree on our ability to obtain and defend our patents and other intellectual property rights both domestically and internationally, and to operate without infringing upon the patents or other proprietary rights of third parties.
  4. We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations.

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Operational Risks

7
  1. Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases.
  2. We face risks associated with our global operations.
  3. 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.reworded
  4. Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price.
  5. We depend on relationships with third parties for sales and marketing performance, technology, development, logistics and commercialization of products. Failure to maintain these relationships, poor performance by these companies or disputes with these third parties could negatively impact our business.
  6. Due to the specialized and technical nature of our business, the failure to attract, develop and retain highly qualified personnel could adversely impact us.
  7. 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

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Strategic and Financial Risks

3
  1. We are subject to risks associated with engaging in business acquisitions, licensing arrangements, collaborations, options, equity investments, asset divestitures and other strategic transactions.
  2. 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.new
  3. Changes in our effective income tax rate could reduce our earnings.

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No longer in Item 1A

1

Headings in the FY2024 10-K with no match this year.

  1. The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations.

Headings are the lines of Item 1A set wholly in bold or italics, as the parser reads them, without the introductory paragraph that opens the section. A heading is new when no heading in the prior 10-K matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. Source: the filing on sec.gov.