GILD Gilead Sciences Inc.

Risks

• A substantial portion of our revenues is derived from sales of our HIV products. If we are unable to increase or maintain our HIV sales, then our results of operations may be adversely affected.
• If we fail to develop and commercialize new products or expand the indications for existing products, our prospects for future revenues and our results of operations may be adversely affected.
• Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases, including the recent coronavirus disease 2019 (“COVID-19”) outbreak.
• We face risks related to the development, manufacturing and distribution of remdesivir as a treatment for COVID-19, which has not been approved by FDA and has not been demonstrated to be safe or effective for any use.
• Our inability to accurately predict demand for our products and fluctuations in purchasing patterns or wholesaler inventories makes it difficult for us to accurately forecast sales and may cause our forecasted revenues and earnings to fluctuate, which could adversely affect our financial results and stock price.
• We face significant competition.
• We may be required to pay significant damages and royalty payments as a result of ongoing litigation related to Yescarta and Biktarvy.
• Our results of operations may be adversely affected by current and potential future healthcare legislative and regulatory actions.
• Our existing products are subject to reimbursement from government agencies and other third parties, and we may be required to provide rebates and other discounts on our products, which may result in an adjustment to our product revenues. Pharmaceutical pricing and reimbursement pressures may adversely affect our profitability and our results of operations.
• Laws and regulations applicable to the health care industry could impose new obligations on us, require us to change our business practices and restrict our operations in the future.
• Yescarta, a chimeric antigen receptor (“CAR”) T cell therapy, represents a novel approach to cancer treatment that creates significant challenges for us, which may impact our ability to increase sales of Yescarta.
• We have engaged in, and may in the future engage in, business acquisitions, licensing arrangements, collaborations, options, equity investments, disposals of our assets and other strategic transactions, which could cause us to incur significant expenses and could adversely affect our financial condition and results of operations.
• We face risks associated with our global operations, which may adversely affect our financial condition and results of operations.
• If significant safety issues arise for our marketed products or our product candidates, our reputation may be harmed and our future sales may be reduced, which could adversely affect our results of operations.
• 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 face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption, which may adversely affect our prospects for future revenue growth and our results of operations.
• 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.
• Our success depends to a significant degree on our ability to defend our patents and other intellectual property rights both domestically and internationally. We may not be able to obtain effective patents to protect our technologies from use by competitors.
• Our success depends in large part on our ability to operate without infringing upon the patents or other proprietary rights of third parties.
• Manufacturing problems, including at our third-party manufacturers and corporate partners, could cause inventory shortages and delay product shipments and regulatory approvals, which may adversely affect our results of operations.
• We may not be able to obtain materials or supplies necessary to conduct clinical trials or to manufacture and sell our products, which could limit our ability to generate revenues.
• Imports from countries where our products are available at lower prices and unapproved generic or counterfeit versions of our products could have a negative impact on our reputation and business.
• Expensive litigation and government investigations have increased our expenses which may continue to reduce our earnings.
• We may face significant liability resulting from our products and such liability could materially reduce our earnings.
• If we fail to attract, develop and retain highly qualified personnel, our business and operations may be adversely affected.
• We are dependent on information technology systems, infrastructure and data, which may be subject to cyberattacks, security breaches and legal claims.
• Changes in our effective income tax rate could reduce our earnings.
• There can be no assurance that we will continue to pay dividends or repurchase stock.