Edwards Lifesciences Corporation: 10-K Risk Factor Changes

2026 vs 2025  ·  SEC EDGAR  ·  2026-07-05
✓ Deterministic extraction — no AI-generated data

Classification is based on semantic text similarity scoring and may include approximations. “No match” means no high-confidence textual match was found — not necessarily that a section was removed.

5
New Risks
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Removed
6
Modified
18
Unchanged
🟢 New in Current Filing Severity10/10Det 10

Our international operations subject us to certain business risks.

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

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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: •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. on goods from other countries and tariffs imposed by other countries on U.S. goods); •cultural or other local factors affecting financial terms with customers; •global regulations including those related to health care, labor and environmental, social and governance; military conflict, political unrest, or wars; •scrutiny from governmental bodies regarding the pricing of our products; and •currency exchange rate fluctuations; that is, decreases in the value of the United States dollar to the Euro or the Japanese yen, as well as other currencies in which we transact business, have the effect of increasing our reported sales even when the volume of sales outside of the United States has remained constant. Increases in the value of the United States dollar relative to the Euro or the Japanese yen, as well as other currencies, have the opposite effect. Significant increases or decreases in the value of the United States dollar could have a material adverse effect on our sales, cost of sales, or results of operations. Additionally, the U.S. Department of Commerce recently initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, into (among other things) imports of personal protective equipment, medical consumables and medical equipment (including devices), to determine whether they threaten U.S. national security, which further creates policy uncertainty in terms of tariffs. The current tariff environment is dynamic, as the U.S. government has imposed, modified and paused tariffs multiple times since the beginning of 2025. Changes to tariffs and other trade restrictions can be announced at any time with little or no notice. We cannot predict with certainty the future trade policy of the U.S. or other countries. We are monitoring recent judicial developments and executive branch responses related to U.S. tariffs; however, the impact, if any, cannot be reasonably estimated at this time. Tariffs may cause (i) increases in manufacturing costs, (ii) disruptions or delays to our supply chain, (iii) limitations on our ability to sell our products domestically or abroad, and (iv) reductions in sales volumes and gross 17 17 17 Table of Contents Table of Contents margins for our products, any of which could negatively affect our business, financial condition, and results of operations. The ultimate impact of any existing or new tariffs or other changes in international trade policies on our business, financial condition, results of operations and cash flows is subject to a number of factors, including, but not limited to, the duration of such tariffs, changes in tariff rates, the amount, scope and nature of the tariffs, the results of the Section 232 investigation referenced above, any countermeasures that target countries may take or any mitigating actions that may become available.

🟢 New in Current Filing Our use of, or our failure to effectively and timely utilize, emerging technologies, including AI, could adversely impact our business and financial results. 🔒
🟢 New in Current Filing We may be adversely impacted by global economic, political and social conditions. 🔒
🟢 New in Current Filing Health care legislation and other regulations may adversely impact access to and demand for our products. 🔒
🟢 New in Current Filing 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. 🔒
🟡 Modified We face a number of risks related to our income taxes in the United States as well as other jurisdictions. 🔒
🟡 Modified Summary of Risk Factors 🔒
🟡 Modified 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. 🔒
🟡 Modified We are subject to risks associated with public health crises. 🔒
🟡 Modified The success of many of our products depends upon certain key physicians, research institutions, and hospital systems. 🔒
🟡 Modified We operate in highly competitive markets, and if we do not compete effectively, our business will be harmed. 🔒
10 more changes in this filing

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