Cooper Companies (COO) risk factors, FY2025 10-K

Risks Relating to Our Business

1. 01Current market conditions and recessionary pressures in one or more of our markets could impact our ability to grow our business
2. 02Inflation could materially adversely affect our business
3. 03Our substantial and expanding international operations are subject to uncertainties which could affect our business
4. 04THE COOPER COMPANIES, INC. AND SUBSIDIARIES
5. 05Economic and trade sanctions, including tariff and import/export regulations by the U.S. and foreign governments, could make it more difficult or costly for us to conduct our operations or achieve our business objectives41% rewritten
6. 06Acquisitions and other strategic transactions that we have made and may make in the future involve numerous risks
7. 07We face risks associated with disruption of our manufacturing, distribution and storage operations, including possible failure to develop necessary manufacturing processes, or constrained, idle or excess capacity, which could adversely affect our business54% rewritten
8. 08We manage our businesses utilizing multiple complex integrated software and hardware information technology operating systems that are regularly maintained and upgraded; an interruption or disruption to these systems could disrupt our business or force us to incur excessive costs
9. 09Pricing pressure from our competitors, customers and changes in third-party coverage and reimbursement may adversely affect demand for our products and negatively impact our operating results
10. 10We rely on independent suppliers and third-party logistics providers in our supply chain for raw materials, packaging materials and components, mechanical equipment and some finished goods; we could experience inventory shortages if any of these suppliers encounter a manufacturing or distribution disruption27% rewritten
11. 11Our supply chain and our cost of goods also may be negatively impacted by unanticipated price increases due to factors such as inflation, including wage inflation, or to supply restrictions beyond our control or the control of our suppliersNew
12. 12If we fail to protect our intellectual property adequately, our business could suffer
13. 13Our products or processes could be subject to claims of infringement of the intellectual property of others
14. 14We could experience losses from product liability claims or legal claims relating to our service offerings, including such claims and other losses resulting from sales of counterfeit and other infringing products
15. 15If our products or services are not accepted by the market, we will not be able to sustain or expand our business
16. 16We operate in the highly competitive health care industry, and we cannot be assured that we will be able to compete successfully
17. 17To a lesser extent, CooperVision also competes with manufacturers of eyeglasses and providers of other forms of vision correction including ophthalmic surgery
18. 18New medical and technological developments may reduce the need for our products
19. 19Product innovations are important in the industry in which we operate, and we face the risk of product obsolescence if we are unable to develop new products or gain regulatory approvals or certifications or if our competitors introduce new products
20. 20We face risks related to environmental, social and governance matters
21. 21Environmental, social and corporate governance issues, including those related to climate change and sustainability, may have an adverse effect on our business and damage our reputation
22. 22If we do not retain our key personnel and attract and retain other highly skilled employees, our business could suffer
23. 23Provisions of our governing documents and Delaware law may have anti-takeover effects

Risks Relating to Government Regulation of Manufacture and Sale of Our Products and Services

1. 24Legislative or regulatory reforms in the United States, Europe or other countries may make it more difficult and costly for us to obtain regulatory clearances, approvals or certifications for our products or to manufacture, market or distribute our products after clearance or approval is obtained37% rewritten
2. 25Our products are subject to reporting requirements and recalls, even after receiving regulatory clearance, approval or certification, which could harm our reputation and business
3. 26If our manufacturing operations fail to comply with applicable regulations, our manufacturing could be delayed or disrupted, our products could be subject to recall, and sales and profitability could suffer59% rewritten
4. 27Our failure to comply with regulatory requirements or to receive regulatory clearance, approval or certification for our products or operations could adversely affect our business
5. 28Development and marketing of our products are subject to strict governmental regulation by foreign regulatory agencies, and failure to receive, or delay in receiving, foreign qualifications or certifications could have a material adverse effect on our business
6. 29Increased regulatory scrutiny of genetic testing may adversely affect our business through increased costs and risks associated with gaining marketing approvals or certifications and potential impact on demand for our genetic testing services36% rewritten
7. 30If we fail to comply with applicable federal, state, local and foreign laboratory licensing requirements, we could lose the ability to perform our genetic tests or experience disruptions to our business57% rewritten
8. 31Our HCT/P products are subject to extensive government regulation and our failure to comply with these requirements could cause our business to suffer23% rewritten
9. 32Ethical, legal and social concerns related to the use of genetic information, sperm and egg selection services and stem cells could reduce demand for our service offerings
10. 33The costs of complying with the requirements of federal, state and foreign laws pertaining to the privacy and security of personal information, including health related information and the potential liability associated with failure to do so could materially adversely affect our business
11. 34Changes in legislation and government regulation of the health care industry both in the United States and internationally, as well as third-party payors' efforts to control the costs of health care could materially adversely affect our business
12. 35These measures could result in decreased net revenues or increased expenses from our fertility, office and surgical portfolios and decrease potential returns from our development efforts
13. 36Laws pertaining to health care fraud and abuse could materially adversely affect our business

Risks Relating to Interest and Foreign Exchange Rates, Debt and Equity

1. 37Exchange rate fluctuations and foreign currency hedges could adversely affect our financial results
2. 38We are vulnerable to interest rate risk with respect to our debt
3. 39We have now and expect to continue to have a significant amount of indebtedness
4. 40Volatility in the securities markets, interest rates, and other factors could substantially increase our defined benefit plan costs

Risks Relating to Taxes

1. 41Changes in tax laws, examinations by tax authorities, and changes in our geographic composition of income could adversely affect our financial results