Edwards Lifesciences Corp

Our business and assets are subject to varying degrees of risk and uncertainty that can be affected by a number of factors. An investor should carefully consider the risks described below, as well as those described under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31,2023. Additional risks not presently known to us or that we currently deem immaterial may also adversely affect our business. When any of these events or circumstances occurs, our business, financial condition, results of operations, or prospects could be materially harmed. In that case, the value of our securities could decline and an investor could lose part or all of his or her investment. In addition, forward-looking statements within the meaning of the federal securities laws that are contained in this Quarterly Report on Form 10-Q or in our other filings or statements may be subject to the risks described below and in our Annual Report on Form 10-K as well as other risks and uncertainties. Please read the cautionary notice regarding forward-looking statements.

In connection with us no longer pursuing a spin-off of our Critical Care product group, the risk factors titled “Assuming the spin-off is successfully completed, the newly spun-off Critical Care company as a standalone public company may not deliver the returns that we or the shareholders anticipate” and “We may not be able to complete the announced spin-off of our Critical Care product group at all, or within the timeframes we anticipate, or pursuant to the tax-free structure that we anticipate, and we may not realize some or all of the expected benefits of this transaction” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023 are no longer deemed material. In addition, the risk factor titled “If we identify underperforming operations or products or if there are unforeseen operating difficulties and expenditures in connection with business acquisitions or strategic alliances, we may be required, from time to time, to recognize charges, which could be substantial and which could adversely affect our results of operations” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023 is hereby replaced in its entirety with the risk factor titled “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,” as set forth below. Except as set forth herein and below, there have been no other material changes to the Company’s risk factors since the Annual Report on Form 10-K for the year ended December 31, 2023.

We may not be able to complete the announced sale of our Critical Care product group in a timely fashion or at all, and we may not realize some or all of the expected benefits of this transaction.

On June 3, 2024, we announced that we had entered into an agreement with Becton, Dickinson and Company (“Purchaser”) pursuant to which we agreed to sell our Critical Care product group to the Purchaser with the intention to close by the end of the third quarter of 2024 (the “Transaction”) and that we are no longer pursuing the previously announced spin-off of our Critical Care product group. In connection with the Transaction, we and the Purchaser must meet certain closing conditions, which include obtaining required regulatory approvals, among others. A failure to satisfy all closing conditions could result in the Transaction not closing in a timely manner or at all, which may adversely affect our business and the price of our common stock. In addition, the occurrence of an event, change, or other circumstance that could give rise to the termination of the agreement could have a material adverse effect on our business and operations. We have incurred, and we expect to continue to incur, significant costs associated with the Transaction, and the total costs may be significantly higher than projected. The Transaction has required, and we expect that it will continue to require, significant resources from us, including but not limited to management’s attention and employee resources. There is no assurance that the closing of the Transaction will occur at all or that we will be able to execute on ourstrategy or achieve our goals or other expectations after the closing of the Transaction. The Transaction may also have an adverse impact on our operating results and business generally. If we do not close in a timely manner or fail to realize some or all of the anticipated benefits of the Transaction, our business and financial condition may be adversely affected. Additionally, we plan to enter into transition services agreements in connection with the Transaction to provide certain support services, which could divert substantial attention and resources from the operation of our business and have an adverse effect on our business, results of operations, and financial condition.

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.

As part of our strategy we actively manage a portfolio of businesses, technologies, services, and products as well as enter into potential strategic alliances. If we are unable to acquire businesses or technologies or other transactions on a timely basis or at all, we will not be able to execute our strategy and our business and results of operations may be adversely impacted. The integration of acquired businesses and technologies may be costly and may divert significant amounts of resources, including management and employee time and attention, away from the development and commercialization of our other products. Our failure to successfully manage the integration and growth of acquired businesses and technologies and our existing structural heart therapies could have an adverse impact on our business. We may not receive the anticipated benefits of acquisitions despite such expenses and diversion of resources, and acquisitions may not prove to be profitable. Furthermore, we may face unforeseen challenges in executing our strategic plans to expand our products and therapies, which could cause our business and results of operations to suffer.

From time to time, we identify operations and products that are underperforming or that do not fit with our longer-term business strategy, or there may be unforeseen operating difficulties and significant expenditures during the integration of an acquired business, technology, service or product into our existing operations. To the extent that the value of these assets decline, we may be required to write down the value of the assets. We may dispose of these underperforming operations or products or voluntarily cease operations related to a product. In addition, we may be required to record charges or write-downs in connection with acquisitions and divestitures, including charges related to developed technology and/or in-process research and development assets. Any of these events could adversely affect our results of operations.