What dominates the section
- HIV product revenue concentration makes maintaining market share and launching replacement therapies central business risks.
- Pricing, reimbursement and generic competition threaten net prices and market share across major markets.
- Clinical development, manufacturing supply and intellectual-property challenges could delay or prevent future product growth.
The risks most specific to Gilead Sciences
Certain of our products subject us to additional or heightened risks
A substantial share of revenue comes from HIV products, which could lose sales to competitors or generics without new medicines.
Our success depends on developing and commercializing new products or expanding the indications for existing products
Failed launches or delayed approvals for new products and expanded indications could leave Gilead unable to grow or replace declining products.
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
Unpredictable demand and wholesaler inventories could cause HIV and other products to run short or create excess inventory write-offs.
We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers
Branded, generic and biotechnology competitors could reduce Gilead’s pricing and market share based on efficacy, safety, convenience and reimbursement.
Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and discounts, and other pricing pressures
Government and private-payer rebates, discounts and reimbursement limits could reduce net prices as products mature.
We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption
Unfavorable or delayed clinical-trial results could prevent product candidates from demonstrating safety and efficacy or reaching market.
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
Material shortages or manufacturing interruptions at Gilead, third-party manufacturers or partners could delay trials and limit product sales.
- Regulatory and Other Legal Risks
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
Patent losses, inability to defend intellectual property or infringement claims could weaken product exclusivity and increase costs.
- Operational Risks
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
Poor performance or disputes involving distributors, collaborators and other partners could disrupt development, logistics, sales or commercialization.
- Operational Risks
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 incidents or system outages could disrupt operations, trigger privacy-law liability and compromise Kite Konnect’s cell-therapy chain-of-identity and custody data.
All 22 risk factors
Headings as the filing states them, in filing order.
Other
- 01Certain of our products subject us to additional or heightened risks
- 02Our success depends on developing and commercializing new products or expanding the indications for existing products
- 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 manufacturers
- 05Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and discounts, and other pricing pressures
- 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 products
- 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
- 08We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption
- 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 revenues
Regulatory and Other Legal Risks
- 10We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry
- 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
- 12We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations
Operational Risks
- 13Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases
- 14We face risks associated with our global operations
- 15Climate change and natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations
- 16Our aspirations, goals and disclosures related to corporate responsibility matters expose us to numerous risks, including risks to our reputation and stock price
- 17We 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
- 18Due to the specialized and technical nature of our business, the failure to attract, develop and retain highly qualified personnel could adversely impact us
- 19The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations
- 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 transactions
- 22Changes in our effective income tax rate could reduce our earnings
Other Gilead Sciences 10-Ks
- 2026 10-K risk factors
24 risks. Gilead faces heavy revenue concentration in HIV products alongside intense generic and competitive pressure. Substantial R&D and manufacturing investments carry execution and regulatory risks. Global operations expose the company to pricing, reimbursement, and foreign currency pressures.
Filed Feb 24, 2026
About this page
Item 1A of the 10-K on EDGAR was split into its risk factors and, where the company's previous 10-K is on file, each heading was matched to last year's and the text compared word for word. The headings are the filing's own. The one-line readings and the overview were written by a language model from the text of the new, dropped, and rewritten risks; they refer to risks by position and cannot misquote a heading.