Edwards Lifesciences (EW) Risk Factor Changes

hazardous substance releases, and emissions or discharges into the air or water.

We are required to comply with increasingly complex and changing legal and regulatory requirements that govern the collection, use, storage, security, transfer, disclosure, and other processing of personal data in the…

Tax Reform.

We face a number of risks related to our income taxes in the United States as well as other jurisdictions.

We are also subject to various United States and foreign laws pertaining to health care pricing, anti-competition, anti-corruption, and fraud and abuse, including prohibitions on kickbacks and the submission of false…

Regulatory agencies may refuse to grant approval or clearance, or review and disagree with our interpretation of approvals or clearances, or with our decision that regulatory approval is not required or has been maint…

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, a Mutual Recognition Agreement still under negotiation for the Medical Device Regulation may result in a lack of free movement of medical devices between the EU and Switzerland, may impact our access in t…

During recent years, we and our competitors have been involved in substantial litigation regarding patent and other intellectual property rights, which is typically costly and time-consuming.

We spend significant resources to protect and enforce our intellectual property rights, sometimes resulting in expensive and time-consuming litigation that is complex and may ultimately be unsuccessful.

Third-party payors may deny reimbursement if they determine that a device used in a procedure was not used in accordance with coverage requirements as determined by such third-party payors or was used for an unapprove…

We sell our products and technologies to hospitals and other health care providers, nearly all of which receive reimbursement for the health care services provided to patients from third-party payors, such as governme…

We are from time to time impacted by a variety of risks associated with doing business internationally that can harm our future results, including the following:

On September 3, 2024, we sold our Critical Care product group to Becton, Dickinson and Company.

From time to time, we identify operations and products that are underperforming or that do not fit with our longer-term business strategy, such as our recent divestiture of our Critical Care product group, or there ma…

As part of our strategy, we actively manage a portfolio of businesses, technologies, services, and products as well as enter into potential strategic alliances.

management, product development tasks, clinical data, customer service and technical support functions.

•Delays, shortages and price increases due to trade or regulatory embargoes.

We are subject to risks associated with public health crises, including pandemics and epidemics, the timing and effects of which are highly uncertain and difficult to predict, and could disrupt our business and the ho…

We work with leading global physicians and research institutions who provide considerable knowledge and experience.

We face substantial competition and compete with technologies of many types and companies of all sizes on the basis of cost-effectiveness, technological innovations, product performance, brand name recognition, breadt…

no assurance that these trials or procedures will be enrolled or completed in a timely or cost-effective manner or result in a commercially viable product or indication; failure to do so could have a material adverse…

Our continued growth and success depend on our ability to innovate and develop new and differentiated products in a timely manner and effectively market these products.

•Risks relating to animal-borne illnesses

Additional risks related to government regulation are also described under "Health Care Legislation and Other Regulations" in the risk factor above titled "Because we operate globally, our business is subject to a var…

•military conflict, political unrest, or wars; and

•trade protection measures, quotas, embargoes, import or export requirements, and duties, tariffs, or surcharges;

In addition, the United States Foreign Corrupt Practices Act, the United Kingdom Bribery Act, and similar laws in other jurisdictions contain prohibitions against bribery and other illegal payments, and make it an off…

Our 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, a…

Because we operate globally, our business is subject to a variety of risks associated with international sales and operations.

technology, diversion of management’s attention to our business, and additional related risks and costs which can have an adverse effect on our business, financial condition, and results of operations.

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.

•Compliance with government regulations

•Risks associated with international sales and operations

Global Economic and Other External Risks

Our operations are subject to environmental, health, and safety laws, and regulations concerning, among other things, the generation, handling, transportation, and disposal of hazardous substances or wastes, the clean…

We are, and may become, subject to various legal proceedings, investigations and claims that arise in or outside the ordinary course of business.

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, div…

measures.

We are subject to various federal and foreign laws that govern our domestic and international business practices.

Health care legislation and other regulations may adversely impact access to and demand for our products.

margins for our products, any of which could negatively affect our business, financial condition, and results of operations.

Additionally, the U.S.

•scrutiny from governmental bodies regarding the pricing of our products; and

•global regulations including those related to health care, labor and environmental, social and governance; military conflict, political unrest, or wars;

•trade protection measures, quotas, embargoes, import or export requirements, and duties, tariffs, or surcharges (including existing or potential future tariffs imposed by the U.S.

Our international operations subject us to certain business risks.

We may be adversely impacted by global economic, political and social conditions.

product.

The operation of our business depends on our information technology systems and the information technology systems of certain of our service providers and suppliers.

We use AI and other emerging technologies in various facets of our operations and our business.

Our use of, or our failure to effectively and timely utilize, emerging technologies, including AI, could adversely impact our business and financial results.

We are subject to risks associated with public health crises.

resulting in lower sales and revenue than we forecasted, which could have a material adverse effect on our business, financial condition, and results of operations.

The regulatory approval process for new products and new indications for existing products requires extensive clinical trials and procedures, including early clinical feasibility and regulatory studies.

•Risks related to domestic and foreign income and non-income taxes

•Reduced access and demand for our products as a result of, and compliance with, health care legislation and other government regulations

•Risks related to our international operations

•Risks associated with global economic, political and social conditions

•Use of, or failure to effectively and timely utilize, emerging technologies, including artificial intelligence (“AI”)