AddedRisk Factors
•Use of, or failure to effectively and timely utilize, emerging technologies, including artificial intelligence (“AI”)
EWEdwards Lifesciences
Edwards Lifesciences Corporation is the leading global structural heart innovation company, driven by a passion to improve patient lives. 10-K, Item 1
- Employees
- 16,000
- Headquarters
- Irvine, CA
- CEO
- Bernard J. Zovighian
- Next results
- around Feb 9, 2027
10-K 0001099800-26-000009 (2026-02-25) vs 10-K 0001099800-25-000005 (2025-02-28)
| Section | Compared text | Words now | Changed |
|---|---|---|---|
| Risk Factors | Item 1A | 7,642 | 21.0% |
| MD&A | Item 7 | 6,371 | 24.3% |
| Legal Proceedings | Item 3, via Note 20 – COMMITMENTS AND CONTINGENCIES | 1,274 | 55.0% |
| Accounting Policies | Item 8, Note 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 5,040 | 11.4% |
The redline: what was cut and what was added
In each section, the paragraph that changed most, marked against last year's 10-K:
cut words struck through, new words highlighted and underlined.
Risk Factors 178 words changed in this paragraph; it is 48% similar to last year's version.
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. Unfavorable or inconsistent clinical data from current or future clinical trials or procedures conducted by us, our competitors, or third parties, or perceptions regarding these clinical data, could adversely affect our ability to obtain necessary approvals and the market's view of our future prospects. Such clinical trials and procedures are inherently uncertain and there can be 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 effect on our prospects. Clinical trials or procedures may experience significant setbacks even after earlier trials have shown promising results. Further, preliminary results from clinical trials or procedures may be contradicted by subsequent analyses. In addition, results from our clinical trials or procedures may not be supported by actual long-term studies or clinical experience. If preliminary clinical results are later contradicted, or if initial results cannot be supported by actual long-term studies or clinical experience, our business could be adversely affected. Clinical trials or procedures may be delayed, suspended, or terminated by us, the FDA, or other regulatory authorities at any time if it is believed that the trial participants face unacceptable health risks or any other reasons, and any such delay, suspension, or termination could have a material adverse effect on our prospects or the market's view of our future prospects.
Source: Item 1A, 10-K 0001099800-26-000009 vs Item 1A, 10-K 0001099800-25-000005
Legal Proceedings 167 words changed in this paragraph; it is 32% similar to last year's version.
On March 22, 2024, Fortis Advisors, LLC, in its capacity as the designated representative of the former stockholders of Harpoon Medical, Inc. February 16, 2026, Valtech Shareholder Representative LLC (“VT Shareholders”) filed suit a complaint against the Company in the Delaware Court of Chancery of the State of Delaware, alleging breach of the Agreement contract and Plan of Merger, dated December 8, 2015, by and between Harpoon Medical, Inc. and Edwards (the “Agreement”). Fortis seeks acceleration and payment of all contingent seeking accelerated milestone payments set forth in the Agreement. merger agreement in which the Company acquired transcatheter structural heart repair technology from Valtech Cardio Ltd. The trial complaint alleges the Company failed to exercise commercially reasonable efforts in the development and commercialization of such technology causing certain milestone payments to not come due. This suit is scheduled for December 2025. the second suit brought by VT Shareholders. The first, filed in 2023, was dismissed by the Court of Chancery on procedural grounds in July of 2024. The Company is unable to cannot predict the ultimate outcome of this matter the litigation or estimate a range of possible exposure; therefore, no amounts have been accrued. the potential impact on its financial statements. The Company is vigorously defending itself in this litigation.
Source: Item 3, via Note 20 – COMMITMENTS AND CONTINGENCIES, 10-K 0001099800-26-000009 vs Item 3, via Note 20 – LEGAL PROCEEDINGS, 10-K 0001099800-25-000005
MD&A 165 words changed in this paragraph; it is 37% similar to last year's version.
Many countries are implementing some or all of the Organisation for Economic Co-operation and Development’s Base Erosion and Profit Shifting Pillar Two (“Pillar Two”) rules ("Pillar Two") that impose a global minimum tax of 15%. Under Pillar Two, a company is required to determine a combined effective tax rate for all entities located in a jurisdiction. If the jurisdictional effective tax rate is less than 15%, a top-up tax will be due to bring the jurisdictional effective tax rate up to 15%. We are continuing to monitor the implementation of 15% on reported profits. Although Pillar Two by individual provides a framework for applying the minimum tax, countries may enact Pillar Two differently than the model rules and on different timelines and may adjust domestic tax incentives in response to Pillar Two. In addition, in January 2025, the United States issued an executive order announcing opposition to aspects of these rules. As countries continue to enact and refine the Pillar Two rules, we will evaluate the potential effects of Pillar Two on our effective tax rate. The In 2025, the Pillar Two provisions may have a material impact on our consolidated financial statements resulted in 2025 and future years, depending on future legislation, regulatory guidance, and business events. additional tax expense of approximately $19.1 million.
Source: Item 7, 10-K 0001099800-26-000009 vs Item 7, 10-K 0001099800-25-000005
Accounting Policies 124 words changed in this paragraph; it is 33% similar to last year's version.
In March 2023, November 2024, the FASB issued an amendment ASU 2024-03 on income statement presentation to require disclosure, in the notes to the accounting guidance on investments financial statements, of disaggregated information about certain costs and expenses, including purchases of inventory, employee compensation, and depreciation and amortization included in tax credit structures to allow entities to elect to account for their tax equity investments, regardless of the tax credit program from which the income tax credits are received, using the proportional amortization method if certain conditions are met. each relevant expense caption within continuing operations. The guidance was is effective for fiscal years beginning after December 15, 2023, including 2026, and interim periods within those fiscal years. beginning after December 15, 2027. The Company adopted this is currently evaluating the impact the guidance will have on January 1, 2024. The adoption of this guidance did not have a material impact on the Company's its consolidated financial statements.
Source: Item 8, Note 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, 10-K 0001099800-26-000009 vs Item 8, Note 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, 10-K 0001099800-25-000005
Every change, by type
Sentences and paragraphs of EW's Risk Factors and MD&A, 10-K 2026-02-25 against 10-K 2025-02-28. Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier
(may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, would
AddedRisk Factors
•Reduced access and demand for our products as a result of, and compliance with, health care legislation and other government regulations
AddedRisk Factors
Our use of, or our failure to effectively and timely utilize, emerging technologies, including AI, could adversely impact our business and financial results.
AddedRisk Factors
We use AI and other emerging technologies in various facets of our operations and our business. The legal and regulatory landscape surrounding AI technologies is rapidly evolving and uncertain. The rapid advancement of these technologies entails risks, including potential deficiencies in AI-generated information and increased regulatory, cybersecurity, privacy, intellectual property and data-related risks. Another risk may arise if we are unable to timely utilize AI for technological innovation and business operation efficiency in a manner that is faster and more effective than our competitors. In addition, compliance with new or changing laws, regulations or industry standards relating to AI may impose significant costs on us and limit our ability to effectively develop, deploy or use AI technologies. Furthermore, if we are unable to effectively manage the use of AI technologies by our employees and service providers, our confidential information, intellectual property and reputation could be put at risk. Failure to appropriately respond to this evolving landscape may result in reputational, competitive and business harm as well as litigation and regulatory action and fines, penalties and expenses related thereto.
AddedRisk Factors
We may be adversely impacted by global economic, political and social conditions.
AddedRisk Factors
•global regulations including those related to health care, labor and environmental, social and governance; military conflict, political unrest, or wars;
AddedRisk Factors
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
AddedRisk Factors
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.
AddedRisk Factors
Health care legislation and other regulations may adversely impact access to and demand for our products.
AddedRisk Factors
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.
AddedRisk Factors
We are, and may become, subject to various legal proceedings, investigations and claims that arise in or outside the ordinary course of business. The outcome of these legal proceedings cannot be predicted with certainty. We purchase and maintain business insurance for certain liabilities; however, we cannot determine whether our existing business insurance program would be sufficient to cover the costs or potential losses related to our lawsuits and legal proceedings or otherwise be excluded under the terms of any insurance policy. Regardless of merit, litigation may be time-consuming and disruptive to our operations and cause significant legal costs (including settlements, judgments, legal fees and other related defense costs) and diversion of management attention. We could also be subject to governmental investigations in connection with some of these claims. If we do not prevail in these legal proceedings, we may be faced with significant monetary damages or injunctive relief against us that could have a material adverse effect on our business, financial condition, or results of operations. In addition, even if we believe that we have meritorious defenses, from time to time, we engage in settlement discussions and mediation and consider settlements taking into account various factors including, among other things, developments in such legal proceedings and the resulting risks and uncertainties.
RemovedRisk Factors
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RewordedRisk Factors
With multiple new technologies competing for these facilities, including technologies we develop and introduce in both our TAVR and TMTT product groups, a decision by a hospital system, particularly a large hospital system, not to adequately staff or provide facilities necessary to perform procedures using our products, or a decision to use a competitors’ products can instead of ours, has in the past and may continue in the future to meaningfully adversely impact our ability to sell our products. products,
RewordedRisk Factors
RewordedRisk Factors
We are subject to risks involved with transferring the Critical Care product group and operating functioning under interim operating model arrangements, such as increased complexity of operations, including, but not limited to, those related to finance, quality, and information 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.
RewordedRisk Factors
Even if we timely innovate and develop products, our ability to successfully market them could be constrained limited by a number of different factors, including competitive products and pricing, barriers in patient activation (including disease awareness, detection, and diagnosis), restrictive requirements in the U.S. national coverage determination for transcatheter aortic valve replacement procedures, the need for regulatory clearance, restrictions imposed on approved indications, capacity constraints within hospital systems, including staffing shortages and the availability of catheterization laboratories, and uncertainty over third-party reimbursement.
RewordedRisk Factors
We believe or have demonstrated through studies or analyses that many of our existing products are cost-effective, even though the one-time cost may be significant, because they are intended to improve quality of life and can reduce overall health care costs over a long period of time. in the short- and long-term.
RewordedRisk Factors
These laws are global and broad in scope scope, are rapidly increasing and are subject to evolving interpretation, constantly evolving, which could require us to incur substantial costs and utilize internal resources to monitor compliance. the regulations and to comply.
RewordedRisk Factors
The effective dates of implementation, the interactions of tax reforms in multiple jurisdictions, and uncertainty related to dispute resolution mechanisms mechanisms, and any ultimate agreement regarding treatment of the U.S. tax regime as a qualified side-by-side Pillar Two system, could impact our provision for income taxes.
RewordedRisk Factors
The operation of our business depends on our information technology systems. systems and the information technology systems of certain of our service providers and suppliers.
RewordedRisk Factors
We have also previously decided to, and may in the future decide to, dispose of these underperforming operations or products or voluntarily cease operations related to a product.
RewordedRisk Factors
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 and develop products that are compatible with these regulations.
RewordedRisk Factors
We rely on our information technology systems to, among other things, effectively manage sales and marketing data, accounting and financial functions, inventory management, product development tasks, clinical data, customer service and technical support functions.
RewordedRisk Factors
Any of these events could adversely affect have a material adverse effect on our business, financial condition, and results of operations.
Quiet changesRisk Factors
Quality is extremely important for many reasons, including due to the serious and costly consequences of a product failure.
Quiet changesRisk Factors
AddedMD&A
On December 18, 2025, we completed the sale of a business that is not focused on implantable medical innovations for structural heart disease (the “non-core product group”). On September 3, 2024, we sold our Critical Care product group (“Critical Care”) to Becton, Dickinson and Company (“BD”). We concluded that the non-core product group met the criteria to be classified as held-for-sale in September 2024 and the Critical Care met the criteria to be classified as held-for-sale in June 2024. We determined that, when considered together, the conditions for discontinued operations presentation had been met with respect to each of Critical Care and the non-core product group (collectively, the “discontinued product groups”). As such, the historical financial condition and results of the discontinued product groups have been reflected as discontinued operations in our consolidated financial statements. Our discussion and analysis of our results of operations is reflective of our continuing operations. See Note 5 to the Consolidated Financial Statements for further information.
AddedMD&A
•we received FDA and CE Mark approval for the SAPIEN M3 mitral valve replacement system, launching in both Europe and the U.S. the first transcatheter therapy utilizing a transseptal approach for treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation who are deemed unsuitable for surgery or transcatheter edge-to-edge therapy;
AddedMD&A
•we received a CE Mark for and launched in Europe the KONECT RESILIA aortic valved conduit, the first ready-to-implant solution with RESILIA tissue specifically designed for bio-Bentall procedures;
AddedMD&A
•we announced new eight-year data showing that patients receiving aortic surgical valves treated with our proprietary RESILIA tissue technology have significantly improved long-term outcomes compared to those receiving non-RESILIA tissue bioprosthetic valves;
AddedMD&A
•we announced ENCIRCLE pivotal trial results demonstrating successful patient outcomes supporting our portfolio of mitral and tricuspid therapies;
AddedMD&A
•we announced seven-year data from the PARTNER 3 trial, reaffirming the early and sustained patient benefits of Edwards TAVR; and
AddedMD&A
•we announced our founding sponsorship of the American Heart Association’s Heart Valve Initiative, a national effort to improve care and outcomes for the more than 28 million people living with heart valve disease worldwide.
AddedMD&A
R&D expenses increased in 2025 compared to 2024 primarily due to increased investments in implantable heart failure management innovations.
AddedMD&A
Intangible assets impairment loss of $40.0 million in 2025 related to certain developed technology assets. There were no intangible assets impairment charges recognized in 2024.
AddedMD&A
Loss on impairment of $146.9 million in 2025 related to our investment in a promissory note and our determination to not exercise an option to acquire one of our VIE investments. For further information, see Note 9 to the Consolidated Financial Statements.
AddedMD&A
Many countries are implementing some or all of the Organisation for Economic Co-operation and Development’s Base Erosion and Profit Shifting Pillar Two (“Pillar Two”) rules that impose a global minimum tax of 15% on reported profits. Although Pillar Two provides a framework for applying the minimum tax, countries may enact Pillar Two differently than the model rules and on different timelines and may adjust domestic tax incentives in response to Pillar Two. In addition, in January 2025, the United States issued an executive order announcing opposition to aspects of these rules. As countries continue to enact and refine the Pillar Two rules, we will evaluate the potential effects of Pillar Two on our effective tax rate. In 2025, the Pillar Two provisions resulted in additional tax expense of approximately $19.1 million.
AddedMD&A
In December 2017, the Tax Cuts and Jobs Act of 2017 (the "2017 Act") was signed into law. The 2017 Act required companies to pay a one-time mandatory deemed repatriation tax on the cumulative earnings of certain foreign subsidiaries that were previously tax deferred. We elected to pay the repatriation tax in installments over eight years. As of December 31, 2024, we had a remaining tax obligation of $78.5 million related to the deemed repatriation. The final installment of $78.5 million was paid in the second quarter of 2025.
RemovedMD&A
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RewordedMD&A
Payments Due by Period Contractual Obligations Total Year 1 Years 2-3 Years 4-5 After 5 Years Debt $ 600.0 $ — $ 600.0 $ — $ 600.0 $ — Operating leases 114.2 26.4 42.4 21.6 23.8 130.9 28.3 41.5 20.1 41.0 Interest on debt 78.1 19.8 39.3 19.0 — Transition tax on unremitted foreign earnings and profits (a) 78.5 78.5 — 49.1 20.3 28.8 — — Litigation settlement obligation (minimum payments) 62.5 50.0 12.5 50.0 — — — Pension obligations (b) 2.6 2.6 (a) 2.9 2.9 — — — Purchase and other commitments (c) 93.1 41.3 51.8 — (b) 97.1 43.2 39.9 14.0 — Total contractual cash obligations (d), (e) (c), (d) $ 1,029.0 930.0 $ 218.6 144.7 $ 146.0 710.2 $ 640.6 34.1 $ 23.8 41.0
RewordedMD&A
The increase decrease in our net income and diluted earnings per share in 2024 2025 was driven primarily by the aforementioned increase increases in net sales and a personnel-related costs, one-time after-tax charge of $134.9 million in 2023 charges related to an intellectual property agreement. impairments on our investments, and increased certain litigation expenses.
RewordedMD&A
SG&A expenses increased in 2024 2025 compared to 2023 2024 primarily due to (a) higher field-based personnel-related costs in support of our growth strategy initiatives, primarily in the United States States, (b) increased marketing expenses primarily related to TAVR, (c) increased performance-based compensation expenses, and Europe, (b) costs associated with our recent business combinations and (c) (d) increased professional services costs to support a the transition services agreement.
RewordedMD&A
RewordedMD&A
Net sales of Surgical products increased in 2024 2025 primarily due to higher sales of the INSPIRIS RESILIA aortic valve and the MITRIS RESILIA in the United States States, Europe and Europe, Rest of World, and the KONECT RESILIA tissue valved conduit in the United States, and the MITRIS RESILIA valve in the United States.
RewordedMD&A
In the fourth quarter of 2025 and 2024, we also recorded expenses of $8.5 million and $19.0 million, respectively, primarily related to costs incurred for consulting, legal, tax, and other professional advisory services associated with the sale. sale of Critical Care to BD.
RewordedMD&A
The effective rates for 2025 and 2024 and 2023 were lower than the federal statutory rate of 21% primarily due to (1) foreign earnings taxed at lower rates, (2) United States federal and California research and development credits, and (3) the tax benefit from foreign-derived intangible income.
RewordedMD&A
We plan to file filed a formal appeal of the second assessment in the first quarter of 2025 and, if necessary, expect to defend our position through judicial proceedings. 2025.
RewordedMD&A
Net cash used in financing activities of $711.0 $956.8 million in 2023 2025 consisted primarily of purchases of treasury stock of $879.6 $893.4 million and purchase of the remaining noncontrolling interest in a subsidiary of $233.7 million, partially offset by proceeds from stock plans of $169.9 $174.1 million.
RewordedMD&A
For a discussion related to the results of operations for 2023 2024 compared to 2022 2023 and a discussion related to our consolidated cash flows for 2023 2024 compared to 2022, 2023, refer to Part II, Item 7, "Management's “Management's Discussion and Analysis of Financial Condition and Results of Operations" Operations” in our 2023 2024 Annual Report on Form 10–K filed with the Securities and Exchange Commission on February 12, 2024. 28, 2025.
RewordedMD&A
We incurred certain expenses related to legal settlement and contingency, intellectual property litigation litigation, and tax litigation of $325.4 million and $40.4 million during 2025 and $203.5 million during 2024 and 2023, 2024, respectively.
RewordedMD&A
During 2024, 2025, under the Board of Directors authorized repurchase program, we repurchased a total of 16.7 11.7 million shares at an aggregate cost of $1.2 billion, $884.7 million, including pursuant to a $500.0 $750.0 million of accelerated share repurchase agreement. agreements executed during the period.
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