What the changes say
- Gilead adds execution risk around its planned $32 billion U.S. manufacturing and R&D investment through 2030.
- Intellectual-property risks now include trade-secret leakage and disputes over ownership of jointly developed inventions.
- Corporate responsibility scrutiny now specifically includes global patient access, while supplier qualification and administrative healthcare actions receive greater emphasis.
What changed since the prior 10-K
New
- NewRegulatory and Other Legal Risks
Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K
Trade secrets, internal know-how, technology, and invention ownership could be exposed or disputed, benefiting competitors and harming Gilead.
- NewStrategic and Financial Risks
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
Gilead’s planned $32 billion U.S. manufacturing and R&D investments could face delays, cost increases, regulatory problems, or fail to deliver expected benefits.
Dropped
- DroppedOperational Risks
The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations
Reworded
- 88% rewrittenOperational Risks
Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price
The risk shifts from achieving announced ESG goals to conflicting stakeholder expectations, employee attraction, investment appeal, and scrutiny over patient access.
- 53% rewrittenProduct and Commercialization Risks
Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently. We may be adversely impacted by any such legislative and regulatory actions, though it is difficult to predict the impact, if any, on the use and reimbursement of our products
The risk now covers increased administrative action alongside legislation affecting drug pricing, procurement, and reimbursement.
- 43% rewrittenProduct Development and Supply Chain Risks
We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption
No substantive change is visible in the provided text; it continues to emphasize unfavorable trial results, enrollment, safety, and delays.
- 41% rewrittenOperational Risks
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
No substantive change is visible; the risk continues to cover climate-related disasters, facility disruption, and mitigation measures.
Was: Climate change and natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations
- 39% rewrittenProduct Development and Supply Chain Risks
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
The oncology-drug shortage example was removed, while new supplier qualification requirements and possible approval delays were added.
- 37% rewrittenProduct and Commercialization Risks
Certain of our products subject us to additional or heightened risks
The specific TAF and nucleoside-treatment-paradigm example was removed, leaving the broader HIV revenue and competition risk.
- 33% rewrittenStrategic and Financial Risks
We are subject to risks associated with engaging in business acquisitions, licensing arrangements, collaborations, options, equity investments, asset divestitures and other strategic transactions
No substantive change is visible in the provided excerpt; it continues to cover execution and performance risks from strategic transactions.
- 28% rewrittenRegulatory and Other Legal Risks
We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry
The cited U.S. privacy-related action changed from an Executive Order to the Department of Justice Final Rule on bulk sensitive data access.
- 24% rewrittenProduct and Commercialization Risks
We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers
- 21% rewrittenProduct and Commercialization Risks
Our success depends on developing and commercializing new products or expanding the indications for existing products
All 23 risk factors
Headings as the filing states them, in filing order.
Product and Commercialization Risks
- 01Certain of our products subject us to additional or heightened risks37% rewritten
- 02Our success depends on developing and commercializing new products or expanding the indications for existing products21% rewritten
- 03We face challenges in accurately forecasting sales because of the difficulties in predicting demand for our products and fluctuations in purchasing patterns or wholesaler inventories
- 04We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers24% rewritten
- 05Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates
- 06Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently. We may be adversely impacted by any such legislative and regulatory actions, though it is difficult to predict the impact, if any, on the use and reimbursement of our products53% rewritten
- 07We 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
Product Development and Supply Chain Risks
- 08We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption43% rewritten
- 09We 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 revenues39% rewritten
Regulatory and Other Legal Risks
- 10We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry28% rewritten
- 11Our 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
- 12Contingencies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-KNew
- 13We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations
Operational Risks
- 14Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases
- 15We face risks associated with our global operations
- 16Climate change and related natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations41% rewritten
- 17Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price88% rewritten
- 18We 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
- 19Due to the specialized and technical nature of our business, the failure to attract, develop and retain highly qualified personnel could adversely impact us
- 20Information 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
Strategic and Financial Risks
- 21We are subject to risks associated with engaging in business acquisitions, licensing arrangements, collaborations, options, equity investments, asset divestitures and other strategic transactions33% rewritten
- 22Our U.S. manufacturing and R&D investments may not achieve their intended benefits and could adversely affect our business, results of operations and cash flowsNew
- 23Changes in our effective income tax rate could reduce our earnings
Other Gilead Sciences 10-Ks
- FY2024 10-K risk factors22 risks
HIV product revenue concentration makes maintaining market share and launching replacement therapies central business risks.
Filed Feb 28, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.