Regeneron Pharmaceuticals (REGN) risk factors, FY2024 10-K

Other

1. 01We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent
2. 02If we or our collaborators are unable to continue to successfully commercialize our products, our business, prospects, operating results, and financial condition will be materially harmed
3. 03More detailed information about the risks related to the commercialization of our marketed products is provided in the risk factors below
4. 04Sales of our marketed products are dependent on the availability and extent of coverage and reimbursement from third-party payors
5. 05Changes to product reimbursement and coverage policies and practices may materially harm our business, prospects, operating results, and financial condition
6. 06We rely on our collaborations with Bayer and Sanofi for commercializing some of our marketed products
7. 07Sales of our marketed products recorded by us and our collaborators could be reduced by imports from countries where such products may be available at lower prices
8. 08We may be unsuccessful in continuing the commercialization of our marketed products or in commercializing our product candidates or new indications for our marketed products, if approved, which would materially and adversely affect our business, profitability, and future prospects
9. 09We are dependent upon a small number of customers for a significant portion of our revenue, and the loss of or significant reduction in sales to these customers would adversely affect our results of operations
10. 10If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected
11. 11Successful development of our current and future product candidates is uncertain
12. 12Many of our products are intended to be used and, if approved, our product candidates may be used in combination with drug-delivery devices, which may result in additional regulatory, commercialization, and other risks

Risks Related to Intellectual Property and Market Exclusivity

1. 13For purposes of this subsection, references to our intellectual property (including patents, trademarks, copyrights, and trade secrets) include that of our collaborators and licensees, unless otherwise stated or required by the context
2. 14If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our business and competitive position will be harmed
3. 15We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights
4. 16Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, have in the past reduced and could reduce in the future the duration of market exclusivity for our products
5. 17A number of jurisdictions outside the United States have also established abbreviated pathways for regulatory approval of biological products that are biosimilar to earlier versions of biological products. For example, the EU has had an established regulatory pathway for biosimilars since 2005

Risks Related to Manufacturing and Supply

1. 18We rely on limited internal and contracted manufacturing and supply chain capacity, which could adversely affect our ability to commercialize our marketed products and, if approved, our product candidates and to advance our clinical pipeline
2. 19Our ability to manufacture products may be impaired if any of our or our collaborators' manufacturing activities, or the activities of other third parties involved in our manufacture and supply chain, are found to infringe patents of others
3. 20If sales of our marketed products do not meet the levels currently expected, or if the launch of any of our product candidates is delayed or unsuccessful, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators

Other Regulatory and Litigation Risks

1. 21If the testing or use of our products harms people, or is perceived to harm them even when such harm is unrelated to our products, we could be subject to costly and damaging product liability claims
2. 22Our business activities have been, and may in the future be, challenged under U.S. federal or state and foreign healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties
3. 23The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor
4. 24We have obligations to report the average sales price for certain of our drugs to the Medicare program. Statutory or regulatory changes or CMS guidance could affect the average sales price calculations for our products and the resulting Medicare payment rate, and could negatively impact our results of operations
5. 25Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition
6. 26Our operations are subject to environmental, health, and safety laws and regulations, including those governing the use of hazardous materials. Compliance with these laws and regulations is costly, and we may incur substantial liability arising from our activities involving the use of hazardous materials
7. 27Changes in laws, regulations, and policies affecting the healthcare industry could adversely affect our business
8. 28Risks associated with our operations outside the United States could adversely affect our business
9. 29We may incur additional tax liabilities related to our operations
10. 30We face risks related to the personal data we collect, process, and share
11. 31Increasing use of social media and artificial intelligence-based platforms could give rise to liability, breaches of data security and privacy laws, or reputational damage

Risks Related to Our Reliance on or Transactions with Third Parties

1. 32If our collaboration with Bayer for EYLEA HD and EYLEA is terminated, or Bayer materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to continue to commercialize EYLEA HD and EYLEA outside the United States would be materially harmed
2. 33Our collaborators and service providers may fail to perform adequately in their efforts to support the development, manufacture, and commercialization of our drug candidates and current and future products
3. 34We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions could adversely affect our business, operating results, and financial condition
4. 35We are dependent on our key personnel and if we cannot recruit and retain leaders in our research, development, manufacturing, and commercial organizations, our business will be harmed
5. 36Significant disruptions of information technology systems or breaches of data security could adversely affect our business
6. 37Public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) have adversely affected and may in the future adversely affect our business
7. 38Our indebtedness could adversely impact our business
8. 39Changes in foreign currency exchange rates could have a material adverse effect on our operating results
9. 40Our investments are subject to risks and other external factors that may result in losses or affect the liquidity of these investments

Risks Related to Our Common Stock

1. 41Our stock price is extremely volatile
2. 42Future sales of our Common Stock by our significant shareholders or us may depress our stock price and impair our ability to raise funds in new share offerings
3. 43There can be no assurance that we will continue to repurchase shares of our Common Stock or continue to declare cash dividends
4. 44Our existing shareholders may be able to exert substantial influence over matters requiring shareholder approval and over our management