Edwards Lifesciences (EW) risk factors, FY2024 10-K

Business and Operating Risks

1. 01Failure to successfully innovate and develop new and differentiated products in a timely manner and effectively market these products could have a material effect on our prospects
2. 02Unsuccessful clinical trials or procedures relating to products could have a material adverse effect on our prospects
3. 03If we or one of our suppliers or logistics partners encounters manufacturing, logistics, safety, or quality problems, our business could be materially adversely affected
4. 04We operate in highly competitive markets, and if we do not compete effectively, our business will be harmed
5. 05The success of many of our products depends upon certain key physicians, research institutions, and hospital systems
6. 06We are subject to risks associated with public health crises, particularly with respect to the pressures that such crises create on the hospital systems and supply chains in which we operate
7. 07We rely on third parties in the design, manufacture, and sterilization of our products. Any failure by or loss of a vendor could result in delays and increased costs, which may adversely affect our business
8. 08Failure to protect our information technology infrastructure and our products against cybersecurity attacks, network security breaches, service interruptions, or data corruption could materially disrupt our operations and adversely affect our business and operating results
9. 09Our business and results of operations may be adversely affected if we are unable to recruit and retain qualified talent or are otherwise unsuccessful in the execution of our management succession plans
10. 10Failure to successfully integrate acquired businesses, technologies or strategic alliances, or challenges related to the execution of acquisitions or divestitures, as well as liabilities or claims relating to such acquired businesses or divestitures, could adversely affect our business and results of operations
11. 11We are subject to risks associated with the sale of our Critical Care product group
12. 12Our extensive global operations and business activity as well as the fact that many of our manufacturing facilities and suppliers are outside of the United States expose us to certain financial, economic, political, and other risks, including those listed below
13. 13Taxes. We are subject to income taxes in the United States as well as other jurisdictions
14. 14If government and other third-party payors decline to reimburse our customers for our products or impose other cost containment measures to reduce reimbursement levels, our ability to profitably sell our products will be harmed
15. 15Continued consolidation in the health care industry could have an adverse effect on our sales and results of operations

Legal, Compliance, and Regulatory Risks

1. 16Our inability to protect our intellectual property or failure to maintain the confidentiality and integrity of data or other sensitive company information, by cyber-attack or other event, could have a material adverse effect on our business
2. 17Third parties may claim we are infringing their intellectual property, and we could suffer significant litigation or licensing expenses or be prevented from selling products
3. 18In addition, third parties could also obtain patents that may require us to either redesign products or negotiate licenses from such third parties, which may be costly, unavailable, or require us to exit a particular product offering
4. 19Failure to comply with data privacy and security laws could have a material adverse effect on our business
5. 20We may incur losses from product liability or other claims that could adversely affect our operating results
6. 21Use of our products in unapproved circumstances could expose us to liabilities
7. 22Our operations are subject to environmental, health, and safety regulations that could result in substantial costs
8. 23Climate change, or legal, regulatory or market measures to address climate change, may materially adversely affect our financial condition and business operations
9. 24We are subject to risks arising from concerns and/or regulatory actions relating to animal-borne illnesses, including "mad cow disease.”