Exelixis (EXEL) risk factors, FY2024 10-K

Risks Related to the Commercialization of Our Products

1. 01Our ability to grow our company is dependent upon the commercial success of CABOMETYX in its approved indications and the continued clinical development, regulatory approval, clinical acceptance and commercial success of the cabozantinib franchise in additional indications
2. 02Our ability to grow revenues from sales of CABOMETYX depends upon the degree of market acceptance among physicians, patients, healthcare payers, and the medical community
3. 03Our competitors may develop products and technologies that impair the relative value of our marketed products and any current and future product candidates
4. 04If we are unable to maintain or increase our sales, marketing, market access and product distribution capabilities for our products, we may be unable to maximize product revenues, which could have a material adverse impact on our business, financial condition and results of operations
5. 05If we are unable to obtain or maintain coverage and reimbursement for our products from government and other third-party payers, our business will suffer
6. 06Lengthy regulatory pricing and reimbursement procedures and cost control initiatives imposed by governments outside the U.S. could delay the marketing of and/or result in downward pressure on the price of our approved products, resulting in a decrease in revenue

Risks Related to Growth of Our Product Portfolio and Research and Development

1. 07We may be unable to expand our discovery and development pipeline, which could limit our growth and revenue potential
2. 08and the length of time required to enroll eligible patients. Any delay could limit our ability to generate revenues, cause us to incur additional expenses and cause the market price of our common stock to decline significantly

Risks Related to Financial Matters

1. 09Our profitability could be negatively impacted if expenses associated with our drug discovery, clinical development, business development and commercialization activities grow more quickly than the revenues we generate

Risks Related to Our Relationships with Third Parties

1. 10We rely on Ipsen and Takeda for the commercial success of CABOMETYX in its approved indications outside of the U.S., and we are unable to control the amount or timing of resources expended by these collaboration partners in the commercialization of CABOMETYX in its approved indications outside of the U.S
2. 11Our clinical, regulatory and commercial collaborations with major companies make us reliant on those companies for their continued performance and investments, which subjects us to a number of risks
3. 12Our growth potential is dependent in part upon companies with which we have entered into research collaborations, in-licensing arrangements and similar business development relationships
4. 13If third parties, upon which we rely to perform clinical trials for cabozantinib in new indications and for other new product candidates, do not perform as contractually required or expected, additional regulatory approvals may be delayed or may not be possible
5. 14If third-party advisors we rely on to assist with our drug discovery and development efforts do not perform as expected, the expansion of our product pipeline may be delayed
6. 15We lack our own manufacturing and distribution capabilities necessary for us to produce materials required for certain preclinical activities and to produce and distribute our products for clinical development or for commercial sale, and our reliance on third parties for these services subjects us to various risks

Risks Related to Healthcare Regulatory and Other Legal Compliance Matters

1. 16We are subject to healthcare laws, regulations and enforcement; our failure to comply with those laws could have a material adverse impact on our business, financial condition and results of operations
2. 17We are subject to laws and regulations relating to privacy, data protection and the collection and processing of personal data. Failure to maintain compliance with these regulations could create additional liabilities for us

Risks Related to Our Information Technology and Intellectual Property

1. 18Data breaches and other cybersecurity incidents impacting our information technology operations and infrastructure could compromise our intellectual property or other sensitive information, damage our operations and cause significant harm to our business and reputation
2. 19If we are unable to adequately protect our intellectual property, third parties may be able to use our technology, which could adversely affect our ability to compete in the market
3. 20Litigation or third-party claims of intellectual property infringement could require us to spend substantial time and money and adversely affect our ability to develop and commercialize products

Risks Related to Our Operations, Managing Our Growth and Employee Matters

1. 21If we are unable to manage our human capital needs, there could be a material adverse impact on our business, financial condition and results of operations, and our prospects may be adversely affected
2. 22The loss of key personnel or the inability to retain or attract additional personnel could impair our ability to operate successfully

Risks Related to Environmental and Product Liability

1. 23We use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly
2. 24We face potential product liability exposure far in excess of our limited insurance coverage

Risks Related to Our Common Stock

1. 25Our stock price has been and may in the future be highly volatile
2. 26Our disclosures related to environmental, social and governance matters subjects us to risks, including risks to our market perception and stock price