Cooper Companies (COO) risk factors, FY2024 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 could make it more difficult or costly for us to conduct our operations or achieve our business objectives
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 business
8. 08loss of confidential or protected data which could disrupt our business, force us to incur excessive costs or cause reputational harm
9. 09We 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
10. 10Pricing 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
11. 11We rely on independent suppliers 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 disruption
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 obtained
2. 25uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices (including IVDs) and ensure a high level of safety and health while supporting innovation
3. 26Our products are subject to reporting requirements and recalls, even after receiving regulatory clearance, approval or certification, which could harm our reputation and business
4. 27If 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 suffer
5. 28requirements on CooperVision and CooperSurgical that could increase the costs of compliance or otherwise create competition that may negatively affect our business
6. 29Our failure to comply with regulatory requirements or to receive regulatory clearance, approval or certification for our products or operations could adversely affect our business
7. 30Development 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
8. 31Increased 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 services
9. 32If 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 business
10. 33Embryology Association (HFEA) regulating IVF. Our laboratories are located in Japan, the United Kingdom and United States, and we must maintain the requisite licenses in each jurisdiction
11. 34Our HCT/P products are subject to extensive government regulation and our failure to comply with these requirements could cause our business to suffer
12. 35States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities
13. 36Ethical, 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
14. 37The 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
15. 38Changes 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
16. 39These 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
17. 40Laws 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. 41Exchange rate fluctuations and foreign currency hedges could adversely affect our financial results
2. 42We are vulnerable to interest rate risk with respect to our debt
3. 43We have now and expect to continue to have a significant amount of indebtedness
4. 44Volatility in the securities markets, interest rates, and other factors could substantially increase our defined benefit plan costs

Risks Relating to Taxes

1. 45Changes in tax laws, examinations by tax authorities, and changes in our geographic composition of income could adversely affect our financial results