Edwards Lifesciences (EW) risk factors: FY2025 10-K

1. Failure 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. Unsuccessful clinical trials or procedures relating to products could have a material adverse effect on our prospects.
3. If we or one of our suppliers or logistics partners encounters manufacturing, logistics, safety, or quality problems, our business could be materially adversely affected.
4. We operate in highly competitive markets, and if we do not compete effectively, our business will be harmed.
5. The success of many of our products depends upon certain key physicians, research institutions, and hospital systems.
6. We are subject to risks associated with public health crises.new
7. We 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. Our use of, or our failure to effectively and timely utilize, emerging technologies, including AI, could adversely impact our business and financial results.newAI
9. Failure 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.Cybersecurity
10. Our 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.
11. Failure 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.
12. We are subject to risks associated with the sale of our Critical Care product group.

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1. We may be adversely impacted by global economic, political and social conditions.new
2. Our international operations subject us to certain business risks.new
3. If government or 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.reworded
4. Continued consolidation in the health care industry could have an adverse effect on our sales and results of operations.

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1. Our 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.Cybersecurity
2. Third 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. Health care legislation and other regulations may adversely impact access to and demand for our products.new
4. We and our customers are subject to healthcare legislation and other rigorous governmental regulations and we may incur significant expenses to comply with these regulations. In addition, failure to comply with these regulations could subject us to substantial sanctions and may impact our ability to sell our products in certain countries which could adversely affect our business, financial condition, and results of operations.reworded
5. We face a number of risks related to our income taxes in the United States as well as other jurisdictions.new
6. Provision for Income Taxes.new
7. Failure to comply with data privacy and security laws could have a material adverse effect on our business.
8. We may incur losses from product liability or other claims that could adversely affect our operating results.
9. We are subject to litigation, investigations, and other legal proceedings relating to our products, customers, competitors, and government regulators that could materially adversely affect our financial condition, divert management’s attention, and harm our business.new
10. Use of our products in unapproved circumstances could expose us to liabilities.
11. Our operations are subject to environmental, health, and safety regulations that could result in substantial costs.
12. Climate change, or legal, regulatory or market measures to address climate change, may materially adversely affect our financial condition and business operations.
13. We are subject to risks arising from concerns and/or regulatory actions relating to animal-borne illnesses, including “mad cow disease.”

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Headings in the FY2024 10-K with no match this year.

1. We 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.
2. Because we operate globally, our business is subject to a variety of risks associated with international sales and operations.
3. Domestic and Global Economic Conditions.
4. Other economic, political, and social risks.