Gilead Sciences (GILD)

Risks

• Certain of our products subject us to additional or heightened risks.
• Our success depends on developing and commercializing new products or expanding the indications for existing 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.
• We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.
• Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and other discounts on our products and other pricing pressures.
• 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.
• We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.
• We may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners.
• 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 could delay or halt commercialization of our products.
• We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the health care industry.
• We are subject to risks if significant safety issues arise for our marketed products or our product candidates.
• 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.
• We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations.
• Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases, including the ongoing COVID-19 pandemic.
• We face risks associated with our global operations.
• Our aspirations, goals and disclosures related to environmental, social and governance (“ESG”) matters expose us to numerous risks, including risks to our reputation and stock price.
• 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.
• Due to the specialized and technical nature of our business, the failure to attract, develop and retain highly qualified personnel could adversely impact us.
• 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.
• We are subject to risks associated with engaging in business acquisitions, licensing arrangements, collaborations, options, equity investments, asset divestitures and other strategic transactions.
• Changes in our effective income tax rate could reduce our earnings.