Edwards Lifesciences (EW) 10-K risk factor changes: FY2025 vs FY2024

Please note that the headers and summary provided below are only intended to assist the reader in navigating the risk factors; some risks, present or future, may implicate multiple types of [removed: risks.* *Please read all risk factors in their entirety.*][added: risks.]

- [removed: Regulatory actions] [added: Risks] relating to animal-borne illnesses

Without [removed: the] timely innovation and [removed: development of products,] [added: development,] our products could be rendered obsolete or less competitive because of the introduction of a competitor's newer technologies or changing customer preferences.

Even if we timely innovate and develop products, our ability to successfully market them could be [removed: constrained] [added: limited] by a number of different factors, including competitive products and pricing, barriers in patient activation (including disease awareness, detection, and diagnosis), [added: restrictive requirements in] the [added: U.S. national coverage determination for transcatheter aortic valve replacement procedures, the] need for regulatory clearance, restrictions imposed on approved indications, [added: capacity constraints within hospital systems, including staffing shortages] and [added: the availability of catheterization laboratories, and] uncertainty over third-party reimbursement.

[removed: 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.

The manufacture and sterilization of many of our products [removed: is] [added: are] highly complex due in part to rigorous regulatory requirements.

Quality is extremely important [added: for many reasons, including] due to the serious and costly consequences of a product failure.

Problems can arise for a number of reasons, including disruption of facility utilities, equipment malfunction, failure to follow protocols and procedures, raw material [removed: problems,] [added: problems (including cost volatility and availability),] software problems, [removed: cyber] [added: cybersecurity] incidents, or human error.

If any of these manufacturing, logistics, or quality problems arise or if we or one of our suppliers or logistics partners otherwise fail to meet internal quality standards or those of the FDA or other applicable regulatory body, our reputation could be damaged, we could become subject to a safety alert or a [removed: recall,] [added: recall (whether voluntary or mandated),] we could incur product liability and other costs, product approvals and production could be delayed, and our business could otherwise be materially adversely affected.

See [removed: "*Competition*"] [added: “*Competition”*] under [removed: "*Business*"] [added: “*Business”*] in Part I, Item 1 included herein.

These physicians may assist us as researchers, marketing consultants, product trainers and consultants, inventors, and [removed: as] public speakers.

With multiple new technologies competing for these facilities, [added: 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 [added: products, or a decision to use a competitors’] products [removed: can] [added: instead of ours, has in the past and may continue in the future to] meaningfully adversely impact our ability to sell our [removed: products.][added: products,]

[removed: Those limitations] [added: Any of these events] could have a material adverse effect on our business, financial condition, and results of operations.

[removed: We] [added: We] are subject to risks associated with public health [removed: crises, including pandemics and epidemics, such as COVID-19.][added: crises.]

[removed: Other] [added: We are subject to risks associated with] public health crises, including [removed: any future epidemics or pandemics,] [added: pandemics and epidemics, the timing and effects of which] are highly uncertain and difficult to predict, and could [added: disrupt our business and the hospital systems and supply chains in which we operate and] result in material adverse impacts on our business, financial condition, and results of operations.

- [removed: Delays or] [added: Delays,] shortages [added: and price increases] due to trade or regulatory embargoes.

A change or addition to our vendors could require significant effort due to the rigorous regulations and requirements of the FDA and other regulatory authorities; it could be difficult to establish additional or replacement sources on a timely basis or at all, which could have a material adverse effect on our [removed: business.][added: business, financial condition, and results of operations.]

The operation of our business depends on our information technology [removed: systems.][added: systems and the information technology systems of certain of our service providers and suppliers.]

We rely on our information technology systems to, among other things, effectively manage sales and marketing data, accounting and financial functions, inventory [removed: management, product development tasks, clinical data, customer service and technical support functions.]

Our information technology systems are vulnerable to damage or interruption from earthquakes, fires, floods and other natural disasters, terrorist attacks, power losses, computer system or data network [removed: failures,] [added: failures or outages,] security breaches, and data corruption.

Further, cybersecurity threats and the techniques used in cybersecurity attacks change, develop, and evolve rapidly, including from emerging technologies, such as advanced forms of [removed: artificial intelligence ("AI")] [added: AI] and quantum computing.

See [removed: "*Human] [added: “*Human] Capital Management [removed: Strategy*"] [added: Strategy”*] under [removed: "*Business*"] [added: “*Business”*] in Part I, Item 1 included herein.

We [added: have also previously decided to, and] may [added: in the future decide to,] dispose of [removed: these] underperforming operations or products or voluntarily cease operations related to a [removed: product.]

In addition, we [added: have previously been required, and] may [added: in the future] be [removed: required] [added: 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.

We are subject to risks involved with transferring the Critical Care product group and [removed: operating] [added: functioning] under interim operating model arrangements, such as increased complexity of operations, including, but not limited to, those related to finance, quality, and information [added: 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.]

[removed: Domestic and Global Economic Conditions.] We [added: conduct extensive global operations and] have been impacted and may continue to be negatively impacted by general [removed: domestic and] global [removed: economic] [added: economic, political and social] conditions, although we cannot predict the extent to which such conditions may negatively impact our business.

These include, but are not limited to, conditions impacting inflation, credit and capital markets, interest rates, tax law, including tax rate and policy changes, factors affecting global economic stability, [added: tariffs] and the political environment relating to health care.

[removed: Health Care Legislation and Other Regulations.] We are subject to various federal and foreign laws that govern our domestic and international business practices.

For example, in the United States, continued implementation of the Affordable Care Act and the 21st Century Cures Act, or any future [removed: legislation under the new Administration and new Congress,] [added: legislation,] including deficit reduction legislation, could impact medical procedure volumes, reimbursement for our products, and demand for our products or the prices at which we sell our products.

[removed: Taxes. We are subject] [added: We face a number of risks related] to [removed: income] [added: our income] taxes in the United States as well as other [removed: jurisdictions.][added: jurisdictions.]

[removed: *•Provision] [added: *Provision] for Income Taxes.* Our provision for income taxes and our effective tax rate could fluctuate due to changes in the mix of earnings and losses in countries with differing statutory tax rates.

[removed: -] *Tax Reform*.

The effective dates of implementation, the interactions of tax reforms in multiple jurisdictions, [removed: and] uncertainty related to dispute resolution [removed: mechanisms] [added: 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.

[removed: -] *Tax Audits*.

[removed: -] *Tax Incentives*.

[removed: Other economic, political, and social risks. In addition to the factors enumerated above, we] [added: We] are from time to time impacted by a variety of [removed: other factors] [added: 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 [removed: surcharges;][added: 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);]

If government [removed: and] [added: 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.

The availability of reimbursement affects which products customers purchase and [removed: the prices they are willing to pay.][added: could impact pricing.]

Hospitals or physicians may respond to such cost-containment pressures by substituting lower cost products or other [removed: therapies.][added: therapies, to the extent they are available.]

Please read all risk factors in their entirety.*

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

Global Macroeconomic and Industry Risks

- Risks associated with global economic, political and social conditions

- Risks related to our international operations

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

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

Such clinical trials and procedures are inherently uncertain and there can be

We have in the past and are continuing to experience constrained procedure volumes and sales for our products because more products, including Edwards’ own products, are competing for the same facilities and staffing within hospitals.

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.

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

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.

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

Acquired businesses may have liabilities, or be subject to claims, litigation or investigations that we did not anticipate or which exceed our estimates at the time of the acquisition.

We have written down the value of certain acquired assets in the past, and may be required to do so in the future.

product.

We have also been, and may in the future be, party to disputes arising from divestitures or ceased operations related to certain products, which have previously and may in the future result in litigation, liability or reputational harm.

Global Macroeconomic and Industry Risks

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

Our international operations subject us to certain business risks.

- 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

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

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.

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

Additionally, the United States federal government has shut down several times in recent years, most recently on October 1, 2025, during which many government agencies, including the FDA, furloughed critical employees and stopped critical activities.

A prolonged government shutdown could significantly affect the FDA’s timely review of any regulatory filings or applications we submit, which could result in delays or failures to obtain or maintain regulatory approvals, clearances or to comply with regulatory requirements.

Further, we and our suppliers are subject to various United States and foreign regulations regarding environmental, social and governance matters.

Global Economic and Other External Risks

- Risks associated with international sales and operations

- Compliance with government regulations

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.

To the extent that the value of these assets decline, we may be required to write down the value of the assets.

Any of these events could adversely affect our results of 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.

Global Economic and Other External Risks

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

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, and other risks, including those listed below.

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 offense to fail to have procedures in place that prevent such payments.

Penalties resulting from any violation of these laws could adversely affect us and our business.

- differing labor regulations;

- military conflict, political unrest, or wars; and

Please see Note 20 to our *Consolidated Financial Statements* in this report for information regarding our legal proceedings.

If we are found not to be in compliance, we may be required to alter our practices or have sanctions imposed against us and our officers and employees, including substantial fines, imprisonment, and exclusion from participation in governmental health care programs.

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 variety of risks associated with international sales and operations.*"

Our products are often used in surgical and intensive care settings with seriously ill patients.

The following discussion and analysis presents the factors that had a material effect on our results of operations during the two years ended December 31, [removed: 2024.][added: 2025.]

Also discussed is our financial position as of December 31, [removed: 2024,] [added: 2025,] and our consolidated cash flows for [removed: 2024] [added: 2025] compared to [removed: 2023.][added: 2024.]

For a discussion related to the results of operations for [removed: 2023] [added: 2024] compared to [removed: 2022] [added: 2023] and a discussion related to our consolidated cash flows for [removed: 2023] [added: 2024] compared to [removed: 2022,] [added: 2023,] refer to Part II, Item 7, [removed: "*Management's] [added: “*Management's] Discussion and Analysis of Financial Condition and Results of [removed: Operations"*] [added: Operations”*] in our [removed: 2023] [added: 2024] Annual Report on Form 10–K filed with the Securities and Exchange Commission on February [removed: 12, 2024.][added: 28, 2025.]

[added: On December 18, 2025, we completed the sale of a business that is not focused on implantable] medical innovations for structural heart [removed: disease, we have committed to a plan to sell a non-core] [added: disease (the “non-core] product [removed: group, with the sale][added: group”).]

[added: As such, the historical] financial condition and results of the discontinued product groups have been reflected as discontinued operations in our [added: consolidated financial statements.]

Our discussion and analysis of our results of [added: operations is reflective of our continuing operations.]

See Note 5 to the *Consolidated Financial [removed: Statements*.][added: Statements* for further information.]

[removed: ][added: ]

Our net sales for [removed: 2024] [added: 2025] were [removed: $5.4] [added: $6.1] billion, representing an increase of [removed: $429.5] [added: $628.1] million over [removed: 2023,] [added: 2024,] driven [added: primarily] by sales growth of our TAVR and TMTT products.

Our gross profit increased in [removed: 2024,] [added: 2025,] driven by our sales growth.

Gross profit as a percentage of sales decreased primarily due to [removed: the impact of foreign currency exchange rate fluctuations.][added: higher operational expenses.]

[removed: See] [added: For further information, see] Note [removed: 3] [added: 4] to the *Consolidated Financial Statements*.

In [removed: 2024,] [added: 2025,] we invested [removed: 19%] [added: 18%] of our net sales in research and development.

The following is a summary of important developments since January 1, [removed: 2024:][added: 2025:]

- we received United States Food and Drug Administration [removed: ("FDA")] [added: (“FDA”)] approval [removed: and launched the *EVOQUE* tricuspid valve replacement system] for the [removed: treatment of tricuspid regurgitation in the United States;][added: *SAPIEN 3* platform for severe aortic stenosis patients without symptoms;]

- we completed enrollment in the CLASP [removed: II TR] [added: IIF] trial for the *PASCAL* [removed: tricuspid implant;][added: transcatheter valve repair system;]

[removed: -] [added: On September 3, 2024,] we sold our Critical Care product group [added: (“Critical Care”)] to Becton, Dickinson and Company [removed: in an all-cash transaction for $4.2 billion.][added: (“BD”).]

| Outside of the United States | | | [removed: 2,233.5] [added: 2,524.5] | | | | | | [removed: 2,062.1] [added: 2,233.5] | | | | | | | | | | | | [removed: 171.4] [added: 291.0] | | | | | | | | | | | | [removed: 8.3] [added: 13.0] | | % | | | | | | |

| Total net sales | | | $ | [removed: 5,439.5] [added: 6,067.6] | | | | | $ | [removed: 5,010.0] [added: 5,439.5] | | | | | | | | | | | $ | [removed: 429.5] [added: 628.1] | | | | | | | | | | | [removed: 8.6] [added: 11.5] | | % | | | | | | |

| Transcatheter Aortic Valve Replacement | | | $ | [removed: 4,106.1] [added: 4,487.7] | | | | | $ | [removed: 3,879.8] [added: 4,106.1] | | | | | | | | | | | $ | [removed: 226.3] [added: 381.6] | | | | | | | | | | | [removed: 5.8] [added: 9.3] | | % | | | | | | |

| Transcatheter Mitral and Tricuspid Therapies | | | [removed: 352.1] [added: 550.6] | | | | | | [removed: 197.6] [added: 352.1] | | | | | | | | | | | | [removed: 154.5] [added: 198.5] | | | | | | | | | | | | [removed: 78.2] [added: 56.4] | | % | | | | | | |

| Surgical Structural Heart | | | [removed: 981.3] [added: 1,029.3] | | | | | | [removed: 932.6] [added: 981.3] | | | | | | | | | | | | [removed: 48.7] [added: 48.0] | | | | | | | | | | | | [removed: 5.2] [added: 4.9] | | % | | | | | | |

[removed: ][added: ]

[removed: -] [added: Net sales of TAVR products increased in 2025, driven by] higher sales of the [removed: *Edwards SAPIEN*] [added: Edwards *SAPIEN*] platform in [removed: 2024,] [added: 2025,] primarily due to [added: higher] sales of the [removed: *Edwards SAPIEN 3 Ultra* *RESILIA* valve] [added: Edwards *SAPIEN 3* *Ultra RESILIA v*alve] in the United [removed: States, Europe,] [added: States] and [removed: Japan;][added: Europe.]

[removed: -] [added: In addition,] foreign currency exchange rate [removed: fluctuations, which decreased] [added: fluctuations increased] net sales outside of the United States by [removed: $13.6] [added: $26.7] million primarily due to the [removed: weakening of the Japanese yen against the United States dollar, partially offset by the] strengthening of the Euro against the United States dollar.

[removed: ][added: ]

The increase in net sales [added: in 2025] of TMTT products was [removed: due] primarily [added: due] to higher sales of our *PASCAL* transcatheter edge-to-edge repair system and [removed: our continued launch of the] *EVOQUE* tricuspid valve replacement system in the United States and Europe.

[removed: ][added: ]

Net sales of Surgical products increased in [removed: 2024] [added: 2025] primarily due to higher sales of the [removed: *INSPIRIS RESILIA*] [added: INSPIRIS RESILIA] aortic valve [removed: in the United States] and [removed: Europe,] the [removed: *KONECT RESILIA* tissue valved conduit] [added: MITRIS RESILIA] in the United States, [added: Europe] and [added: Rest of World, and] the [removed: *MITRIS RESILIA* valve] [added: KONECT RESILIA tissue valved conduit] in the United States.

[removed: ][added: ]

Our gross profit increased in [added: 2025 compared to] 2024, driven by our sales growth discussed above.

[removed: ][added: ]

SG&A expenses increased in [removed: 2024] [added: 2025] compared to [removed: 2023] [added: 2024] primarily due to (a) higher field-based personnel-related costs in support of our growth strategy initiatives, primarily in the United [removed: States and Europe,] [added: States,] (b) [removed: costs associated with our recent business combinations and] [added: increased marketing expenses primarily related to TAVR,] (c) [added: increased performance-based compensation expenses, and (d) increased] professional services costs to support [removed: a] [added: the] transition services agreement.

[removed: ][added: ]

We incurred certain expenses related to [added: legal settlement and contingency,] intellectual property [removed: litigation] [added: litigation,] and tax litigation of [removed: $40.4] [added: $325.4] million and [removed: $203.5] [added: $40.4] million during [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] respectively.

For [removed: more] [added: further] information, see Note [removed: 3] [added: 9] to the *Consolidated Financial Statements*.

The change in fair value of contingent consideration liabilities resulted in gains of [removed: $26.2] [added: $12.5] million during [removed: 2023,] [added: 2025,] primarily due to changes in projected probabilities of milestone [removed: achievement.][added: achievements.]

In [removed: September] [added: 2025 and] 2024, we recorded [removed: an expense] [added: expenses] of [removed: $32.9] [added: $13.1] million [removed: primarily] [added: and $32.9 million, respectively,] related to severance [removed: expenses] associated with [removed: a global workforce] realignment [removed: impacting approximately 360 employees.][added: initiatives.]

In [removed: the fourth quarter of] [added: 2025 and] 2024, we [added: also] recorded expenses of [added: $8.5 million and] $19.0 million, [added: respectively,] primarily related to costs incurred for [removed: consulting, legal, tax, and other] professional advisory services associated with the [removed: sale.][added: sale of Critical Care to BD.]

For [removed: more] [added: further] information, see Note [removed: 4] [added: 3] to the *Consolidated Financial Statements*.

We are the leading global structural heart disease innovation company, driven by a passion to improve patient lives.

Through breakthrough technologies, world-class evidence, and meaningful partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

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”).

The decrease in our net income and diluted earnings per share in 2025 was driven primarily by increases in personnel-related costs, one-time charges related to impairments on our investments, and increased certain litigation expenses.

- 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;

- 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;

- 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;

- we announced ENCIRCLE pivotal trial results demonstrating successful patient outcomes supporting our portfolio of mitral and tricuspid therapies;

- we announced seven-year data from the PARTNER 3 trial, reaffirming the early and sustained patient benefits of Edwards TAVR; and

- 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.

| | | | 2025 | | | | | | 2024 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| United States | | | $ | 3,543.1 | | | | | $ | 3,206.0 | | | | | | | | | | | $ | 337.1 | | | | | | | | | | | 10.5 | | % | | | | | | |

| Europe | | | 1,517.5 | | | | | | 1,321.7 | | | | | | | | | | | | 195.8 | | | | | | | | | | | | 14.8 | | % | | | | | | |

| Japan | | | 354.7 | | | | | | 339.8 | | | | | | | | | | | | 14.9 | | | | | | | | | | | | 4.4 | | % | | | | | | |

| Rest of World | | | 652.3 | | | | | | 572.0 | | | | | | | | | | | | 80.3 | | | | | | | | | | | | 14.0 | | % | | | | | | |

| | | | 2025 | | | | | | 2024 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| Total net sales | | | $ | 6,067.6 | | | | | $ | 5,439.5 | | | | | | | | | | | $ | 628.1 | | | | | | | | | | | 11.5 | | % | | | | | | |

Gross profit as a percentage of net sales decreased in 2025, primarily driven by higher operational expenses.

R&D expenses increased in 2025 compared to 2024 primarily due to increased investments in implantable heart failure management innovations.

Intangible Assets Impairment Charges

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.

Other operating income, net of $67.2 million in 2025 primarily included income from the transition services agreement relating to the sale of Critical Care of $63.7 million.

Loss on Impairment

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.

| | | | 2025 | | | | | | 2024 | | | | | | $ | | | | | | % | | | | | | | | |

Our effective tax rate for 2025 increased in comparison to 2024 primarily due to the impact of Pillar Two (see below), other local tax increases, and certain non-deductible litigation expenses.

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.

In 2025, the Pillar Two provisions resulted in additional tax expense of approximately $19.1 million.

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.

The final installment of $78.5 million was paid in the second quarter of 2025.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law.

The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the 2017 Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions.

The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through

2027.

The OBBBA did not have a material impact to our tax expense in 2025 and is not expected to have a material impact on future periods.

NOPA.

We are the global leader in patient-focused medical innovations for structural heart disease.

Driven by a passion to help patients, we partner with the world's leading clinicians and researchers and invest in research and development to transform care for those impacted by structural heart disease.

On June 3, 2024, we entered into a definitive agreement to sell our Critical Care product group ("Critical Care") to

Becton, Dickinson and Company ("BD") in an all cash-transaction for $4.2 billion, subject to certain customary adjustments as set forth in the agreement.

We completed the sale of Critical Care on September 3, 2024.

We believe that the sale will enable us to pursue expanded opportunities for TAVR, TMTT, and Surgical patients, as well as new investments in interventional heart

failure technologies.

In addition, as a next step in our disposal plan to exit businesses that are not focused on implantable

expected to occur in 2025.

We analyzed the quantitative and qualitative factors relevant to the divestiture of

Critical Care and the aforementioned non-core product group (collectively, the "discontinued product groups"), including its

significance to our overall net income and total assets, and determined that, when considered together, the conditions for

discontinued operations presentation with respect to the discontinued product groups had been met.

As such, the historical

consolidated financial statements, including a $3.3 billion pre-tax gain on the sale of Critical Care.

Prior period

amounts have been adjusted to reflect the discontinued operations presentation.

operations is reflective of our continuing operations.

The increase in our net income and diluted earnings per share in 2024 was driven primarily by the aforementioned increase in net sales and a one-time after-tax charge of $134.9 million in 2023 related to an intellectual property agreement.

- we launched the *Edwards SAPIEN 3 Ultra RESILIA* valve in Europe;

- we announced results from the EARLY TAVR trial, the first randomized, controlled trial designed to study the best strategy for the treatment of asymptomatic severe aortic stenosis ("AS") patients and demonstrate the benefits of early intervention with TAVR;

- we announced results from the TRISCEND II trial, a randomized pivotal trial designed to study the *EVOQUE* system and which demonstrated superiority compared to medical therapy alone for the one-year primary endpoint;

- we completed enrollment in PROGRESS, a pivotal trial studying the treatment of moderate AS patients;

The sale will enable us to pursue expanded opportunities for TAVR, TMTT, and Surgical patients, as well as new investments in interventional heart failure technologies;

- we completed the acquisition of Endotronix, Inc., a leader in heart failure management solutions;

- we completed the acquisition of Innovalve Bio Medical Ltd., an early-stage transcatheter mitral replacement company; and

- we completed the acquisition of JC Medical, Inc., an early-stage company developing a TAVR technology for patients with aortic regurgitation.

| | | | 2024 | | | | | | 2023 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| United States | | | $ | 3,206.0 | | | | | $ | 2,947.9 | | | | | | | | | | | $ | 258.1 | | | | | | | | | | | 8.8 | | % | | | | | | |

| Europe | | | 1,321.7 | | | | | | 1,180.2 | | | | | | | | | | | | 141.5 | | | | | | | | | | | | 12.0 | | % | | | | | | |

| Japan | | | 339.8 | | | | | | 350.8 | | | | | | | | | | | | (11.0) | | | | | | | | | | | | (3.1) | | % | | | | | | |

| Rest of World | | | 572.0 | | | | | | 531.1 | | | | | | | | | | | | 40.9 | | | | | | | | | | | | 7.7 | | % | | | | | | |

The increase in net sales of TAVR products was driven by:

partially offset by:

While our global competitive position and pricing remained stable during 2024, we experienced some regional sales pressure and a reduction in procedures with certain hospital centers in the United States related to a variety of factors including, but not limited to, resources and priorities.

In January 2024, we completed patient enrollment in our PROGRESS pivotal trial, studying the treatment of moderate AS patients, and we received CE Mark approval for the *Edwards SAPIEN 3 Ultra RESILIA* valve in Europe.

In September 2024, we received CE mark for the *Edwards SAPIEN 3* transcatheter pulmonary valve system with *Alterra* adaptive prestent for use in the management of patients with severe pulmonary regurgitation.

We have completed enrollment in the United States and Canada of patients in our MOMENTIS clinical study to demonstrate the durability of *RESILIA* tissue in the mitral position.

The decrease in gross profit as a percentage of net sales in 2024 compared to 2023 was driven by a 0.6 percentage point impact from foreign currency rate fluctuations, including the settlement of foreign currency hedging contracts.

R&D expenses increased in 2024 compared to 2023 primarily due to continued investments in our aortic transcatheter valve innovations, including increased clinical trial activity, higher personnel-related costs in support of our growth strategy initiatives, and costs associated with our recent business combinations.

We invest in a variety of debt securities, primarily time deposits, commercial paper, United States [removed: and foreign] government and agency securities, asset-backed securities, corporate debt securities, and municipal debt securities.

As of December 31, [removed: 2024,] [added: 2025,] we had [removed: $1.1] [added: $1.3] billion of investments in debt securities which had an average remaining term to maturity of [removed: 0.16] [added: 0.28] years.

Taking into consideration the average maturity of our debt securities, a hypothetical 0.5% to 1.0% absolute increase in interest rates at December 31, [removed: 2024] [added: 2025] would have resulted in a [removed: $1.8] [added: $1.9] million to [removed: $3.5] [added: $3.8] million decrease in the fair value of these investments.

For [removed: more] [added: further] information related to investments, see Note 8 to the *Consolidated Financial Statements.*

As of December 31, [removed: 2024,] [added: 2025,] we had $600.0 million of 2018 Notes outstanding that carry a fixed rate, and also had available a $750.0 million Credit Agreement that carries a variable interest rate based on the Secured Overnight Financing Rate [removed: ("SOFR").][added: (“SOFR”).]

As of December 31, [removed: 2024,] [added: 2025,] there were no borrowings outstanding under the Credit Agreement.

Based on our December 31, [removed: 2024] [added: 2025] variable debt levels, a hypothetical 1.0% absolute increase in floating market interest rates would not have impacted our interest expense since we had no variable debt outstanding during the year.

As of December 31, [removed: 2024,] [added: 2025,] a hypothetical 1.0% absolute increase in market interest rates would decrease the fair value of the fixed-rate debt by approximately [removed: $18.2] [added: $13.3] million.

For [removed: more] [added: further] information related to outstanding debt obligations, see Note 12 to the *Consolidated Financial Statements.*

Our objective is to minimize the volatility of our exposure to these risks through a combination of normal operating and financing activities and the use of derivative financial instruments in the form of foreign currency forward exchange contracts and [removed: cross currency] [added: cross-currency] swap contracts.

The total notional amount of our derivative financial instruments entered into for foreign currency management purposes at December 31, [removed: 2024] [added: 2025] was [removed: $2.2] [added: $2.4] billion.

A hypothetical 10% increase (or decrease) in the value of the United States dollar against all hedged currencies would increase (or decrease) the fair value of these derivative contracts by [removed: $105.2] [added: $159.8] million.

For [removed: more] [added: further] information related to outstanding foreign exchange contracts, see Note 2 and Note 14 to the *Consolidated Financial Statements.*

At December 31, [removed: 2024,] [added: 2025,] all derivative financial instruments were with bank counterparties assigned investment grade ratings by national rating agencies.

In [removed: 2024,] [added: 2025,] we had no customers that represented 10% or more of our total net sales or accounts receivable, net.

As of December 31, [removed: 2024,] [added: 2025,] we had [removed: $1.1] [added: $1.3] billion of investments in debt securities of various companies, of which [removed: $148.5] [added: $51.3] million were long-term.

In addition, we had [removed: $159.4] [added: $227.3] million of investments in equity instruments.

[removed: See] [added: For further information, see] Note 8 to the *Consolidated Financial [removed: Statements* for additional information.][added: Statements.*]

Through breakthrough technologies, world-class [removed: evidence] [added: evidence,] and [added: meaningful] partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to [removed: structural heart patients] [added: those] who need them most.

Since our founder, Miles [removed: Lowell] [added: “Lowell”] Edwards, first dreamed of using engineering to address diseases of the human heart, we have steadily built a company on the premise of imagining, building, and realizing a better future for patients.

In addition, our unique portfolio of repair and replacement technologies for [removed: both mitral and] [added: aortic, mitral,] tricuspid [added: and pulmonic] heart valves provides a broad set of treatment options to serve the many diverse and complex patients in need.

Edwards remains committed to its strategy of transformative product innovation, [removed: robust and expanding] [added: high-quality, expansive] clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes.

[added: In the U.S. alone, one cardiovascular patient dies every 34 seconds.1] Cardiovascular disease is progressive in that it tends to worsen over time and often affects the structure of an individual's heart.

Our future growth opportunities include offering solutions for treating patients with both valvular and non-valvular structural heart disease, such as heart failure, which is a natural progression of the disease for many patients suffering from aortic [removed: stenosis and] [added: stenosis,] mitral and tricuspid regurgitation [added: and aortic regurgitation.]

Alternatively, [removed: a clinician (typically] an interventional [removed: cardiologist)] [added: cardiologist or cardiac surgeon] may implant an Edwards transcatheter valve or repair system via a catheter-based approach that does not require traditional open-heart surgery and can be done while the heart continues to beat.

For more information on net sales from these three main groups, see [removed: "*Net] [added: “*Net] Sales by Product [removed: Group*"] [added: Group”*] in Part II, Item 7 [removed: "*Management's] [added: “*Management's] Discussion and Analysis of Financial Condition and Results of [removed: Operations*."][added: Operations*.”]

The [removed: *SAPIEN 3*] [added: *SAPIEN*] valves are delivered while the heart is still beating.

The majority of these procedures are conducted without the use of general anesthesia and patients are discharged home within one to [removed: two days.]

Transcatheter aortic valve replacement with the [removed: *SAPIEN 3*] [added: *SAPIEN*] family of valves enables patients to recover more quickly and return to a better quality of life sooner than patients receiving traditional open heart surgical therapies.

[added: Edwards' transcatheter aortic heart valves] were first commercialized in Europe in 2007, in the United States in 2011, and in Japan in 2013.

Edwards has partnered with the physician community to generate [removed: optimistic] [added: robust] data that has expanded access to patients [added: regardless] of [removed: all] risk [removed: profiles.][added: profiles or symptom status.]

In 2024, [removed: *EARLY TAVR*] [added: EARLY TAVR] trial data [removed: were presented, demonstrating] [added: demonstrated] the superiority of early TAVR intervention in severe asymptomatic aortic stenosis patients with the *SAPIEN 3* platform versus clinical [removed: surveillance.][added: surveillance.2 The *SAPIEN 3* platform was the world’s first transcatheter heart valve with a transcatheter heart valve in the transcatheter heart valve (“THV-in-THV”) indication for patients assessed at high-risk for surgical replacement, offering patients the ability to have a second minimally invasive procedure.]

Sales of our TAVR products represented [added: 74%,] 75%, [removed: 77%,] and [removed: 79%] [added: 77%] of our net sales in [added: 2025,] 2024, [removed: 2023,] and [removed: 2022,] [added: 2023,] respectively.

[removed: While several technologies are in the development and clinical phases, the *PASCAL Precision*] [added: The *PASCAL*] transcatheter repair system (in Europe, the United States, and Japan), *EVOQUE* tricuspid valve replacement system (in Europe and the United States), and [removed: *Cardioband* tricuspid] [added: *SAPIEN M3* mitral] valve [removed: reconstruction] [added: replacement] system (in [removed: Europe)] [added: Europe and the United States)] are commercially available.

The [removed: *PASCAL Precision*] [added: *PASCAL*] system addresses the needs of patients with mitral or tricuspid regurgitation through leaflet [removed: approximation, while the *Cardioband* system enables clinicians to reduce the size of a valve's annulus to lower regurgitation.][added: approximation.]

Our [added: differentiated] *RESILIA* [removed: tissue,] [added: tissue technology,] with published clinical data showing [added: over] 99% freedom from structural valve deterioration through [removed: seven years1,] [added: eight years,3] has set the new standard for tissue valve durability.

Our flagship *INSPIRIS RESILIA* aortic [removed: valve,] [added: valve] offers *RESILIA* tissue and *VFit* technology.

[removed: Sales of our surgical therapies in the United States also continue to gain traction with] [added: Our] *KONECT [removed: RESILIA*,] [added: RESILIA* aortic valved conduit,] the first pre-assembled, ready to implant, tissue valved conduit for complex combined [removed: procedures.][added: procedures, continues to gain strong adoption in the United States and was launched in Europe in 2025.]

Our [removed: latest innovation, the] *MITRIS RESILIA* [removed: valve,] [added: valve] is commercially available in the United States, Europe, [added: Japan] and [removed: Japan,] [added: China,] as well as other geographies, where it has been widely adopted by surgeons as the leading product in our mitral valve portfolio.

Sales of our surgical tissue heart valve products represented [added: 17%,] 18%, [removed: 19%,] and 19% of our net sales in [added: 2025,] 2024, [removed: 2023,] and [removed: 2022,] [added: 2023,] respectively.

We also compete with both established and newer technologies that [removed: target] [added: address] the patients served by our products.

Our strategy is to develop and produce safe and effective therapies supported by [removed: rigorous] [added: high-quality] clinical studies with extensive data and with innovative features that can enhance patient benefits and product performance and reliability, as well as benefit healthcare systems.

[removed: Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.][added: Propensity-matched 8-year Outcomes Following Surgical Aortic Valve Replacement With Novel Calcificationresistant Versus Contemporary Tissue Bioprostheses.]

The ability to provide products and technologies that demonstrate value [removed: and improve] [added: while improving] clinical outcomes is becoming increasingly important for medical technology manufacturers.

In TAVR, our primary competitors include Medtronic plc [removed: ("Medtronic"),] [added: (“Medtronic”) and] Abbott Laboratories [removed: ("Abbott"), and Boston Scientific Corporation.][added: (“Abbott”).]

In Surgical, our primary competitors include [removed: Medtronic, Abbott,] [added: Medtronic] and [removed: Artivion, Inc (formerly CryoLife).][added: Abbott.]

We are not dependent on any single customer and no single customer accounted for 10% or more of our net sales in [removed: 2024.][added: 2025.]

Field clinical specialists routinely attend procedures where Edwards' products are being used in order to provide guidance on the use of our [removed: devices,] [added: therapies,] thereby enabling physicians and staff to reach expert proficiency and deliver [removed: positive] [added: differentiated] patient outcomes.

Also, [removed: for certain of our product lines and] where appropriate, our corporate sales team actively pursues approval of Edwards Lifesciences as a qualified supplier for hospital group purchasing organizations [removed: ("GPOs")] [added: (“GPOs”)] that negotiate contracts with suppliers of medical products.

In [removed: 2024, 59%] [added: 2025, 58%] of our net sales were derived from sales to customers in the United States.

Outside of the United States. In [removed: 2024, 41%] [added: 2025, 42%] of our net sales were derived outside of the United States through our direct sales forces and independent distributors.

Of the total sales outside of the United States, [removed: 59%] [added: 60%] were in Europe, [removed: 15%] [added: 14%] were in Japan, and 26% were in Rest of World.

We sell our products in approximately 100 countries, including Germany, Japan, France, United [removed: Kingdom,] [added: Kingdom (“U.K.”),] Italy, Canada, [added: China,] and [removed: China.][added: Spain.]

A majority of the sales and marketing approach outside of the United States is direct [removed: sales,] [added: sales and sales of products under consignment arrangements,] although it varies depending on each country's size and state of development.

We manufacture our TAVR, TMTT, and Surgical products primarily in the United States, Singapore, Costa Rica, and [removed: Ireland.][added: Ireland, to ensure continuity of care for patients in these regions and also worldwide.]

We comply with [removed: all] current global guidelines regarding risks for products incorporating animal tissue intended to be implanted in humans.

We follow rigorous sourcing and manufacturing procedures intended to safeguard humans from potential [added: risks associated with diseases such as bovine spongiform encephalopathy (“BSE”).]

We are committed to providing [removed: quality] [added: high-quality] products to patients and have implemented modern quality systems and concepts throughout the organization.

The *Edwards SAPIEN* family of valves remains a best-in-class therapy for lifetime management of patients with severe aortic stenosis.

1 National Center for Health Statistics.

Multiple Cause of Death 2018–2023 on CDC WONDER Database.

Accessed February 1, 2025.

two days.

*SAPIEN* is the most studied valve in the world, with more than 15 years of distinguished clinical trials involving over 10,000 patients, 10 New England Journal of Medicine publications and 1.2 million patients treated around the world.

Edwards’ leadership strategy of differentiated innovation, world-class evidence generation and indication expansion is driving guideline and policy evolution and improved patient access and long-term adoption of the *SAPIEN* platform.

Edwards continues to deliver the most predictable, durable and trusted TAVR therapy.

We continue to make significant progress addressing the complex unmet needs of patients with mitral and tricuspid disease with a differentiated portfolio comprised of repair and replacement technologies.

The company has successfully commercialized a unique portfolio of therapies, including the *PASCAL, EVOQUE and SAPIEN M3* systems, transforming care by enabling personalized therapy.

We remain committed to our strategy of transformative product innovation, robust and expanding clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes.

Sales of our TMTT products represented 9%, 7%, and 4% of our net sales in 2025, 2024, and 2023, respectively.

We continue to advance our leadership in surgical therapies and transforming patients’ lives globally with leading surgical innovations.

We are focused on identifying and solving critical unmet needs in cardiac surgery to help patients live longer, healthier and more active lives.

2 Généreux, P., A.

Schwartz, J.B. Oldemeyer, et al.

“Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis.” The New England Journal of Medicine, 28 Oct.

2024.

3 Kaneko, T, Johnston D, Bavaria JE, et al.

Presented at the Heart Valve Society Annual Scientific Meeting, April 2025.

Even following the United Kingdom’s exit from the European Union, the United Kingdom continues to recognize the validity of EU CE mark certificates for the supply of medical devices in the United Kingdom.

The UK allows both UK Conformity Assessed (“UKCA”) and CE-marked medical devices to access the Great Britain (GB) market.

Currently, the UK’s medical device legislation states that the access for CE-marked medical devices will end on June 30, 2030; however, the UK’s regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced it will consult on extending the recognition of CE-marked products indefinitely.

In addition, the UK government has put in place legislation to clarify and strengthen the post-market surveillance requirements for medical devices in Great Britain.

These measures became effective on June 16, 2025, and aim to facilitate greater traceability of incidents and trends, and to allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues to reduce harm.

In addition, strict regulations and management standards exist under the “Pharmaceuticals and Medical Devices Act (PMD Act)” and “Ordinance for execution of PMD Act” to ensure the quality and safety of imported medical devices.

In addition to myVoice, we also conduct onboarding and exit surveys to help us better understand the broader employee experience at Edwards.

We believe that good health is the foundation for great performance, both at work and at home.

That is why we offer a comprehensive benefits and well-being program designed to support the whole person.

Our offerings include health and wellness insurance, health savings accounts, family support services, and site-specific programs tailored to local needs.

We continuously review and enhance our benefits to stay competitive, comply with evolving legislation, and meet the unique needs of our workforce.

As part of this commitment, we have identified five key areas of health where focused support can have the greatest impact:

- Mind+ (Mental Well-being)

- Metabolic Health

- Heart Health

- Musculoskeletal Health

- Cancer Care and Prevention

Our programs include education, resources, and tools to help employees maintain and improve their health in these areas, such as screenings, early detection initiatives, and guidance for managing chronic conditions.

Mental well-being remains a cornerstone of our approach.

Through Mind+, we offer a wide range of mental health resources and foster an environment where employees feel comfortable discussing mental health and accessing support.

Overview

Edwards Lifesciences Corporation is the leading global structural heart innovation company, driven by a passion to improve patient lives.

Edwards Lifesciences has been a leader in our field for over six decades.

Our innovative work encompasses both surgical and transcatheter therapies.

Cardiovascular disease is the number-one cause of death in the world and is the top disease in terms of health care spending in nearly every country.

In the U.S. alone, one cardiovascular patient dies every 33 seconds.

Our vision is to transform patient care where patients are diagnosed earlier, treated in a routine fashion, live longer, and enjoy a better quality of life.

Patients undergoing treatment for cardiovascular disease can be treated with a number of our medical technologies, which are designed to address individual patient needs with respect to disease process, comorbidities, and health status.

For example, an individual with a heart valve disorder may have a faulty valve that is affecting the function of his or her heart or blood flow throughout his or her body.

A cardiac surgeon may elect to remove the valve and replace it with one of our bioprosthetic surgical tissue heart valves or surgically re-shape and repair the faulty valve with an Edwards annuloplasty ring.

We are the global leader in transcatheter heart valve replacement technologies designed for the minimally-invasive replacement of aortic heart valves.

The *Edwards SAPIEN* family of valves, including the *Edwards SAPIEN 3*, the *Edwards SAPIEN 3 Ultra*, and the *Edwards SAPIEN 3 Ultra RESILIA* systems, are catheter-based approaches for treating patients who have severe aortic stenosis.

Edwards' transcatheter aortic heart valves

The *SAPIEN 3* platform remains the only transcatheter heart valve with a THV-in-THV indication for patients assessed at high-risk for surgical replacement, offering patients the ability to have a second minimally invasive procedure.

The *SAPIEN* family of valves are the most widely implanted transcatheter heart valves in the world with over one million patient lives impacted since launch.

We continue to make significant investments in the development of transcatheter heart valve repair and replacement technologies designed to treat mitral and tricuspid valve diseases.

In addition to these therapies, we are pursuing a transcatheter mitral replacement strategy which we believe would position us for leadership in the mid-to-long term.

We believe both transcatheter repair and replacement are necessary to unlock the full mitral and tricuspid opportunity.

We continue to invest in bringing innovations to cardiac surgery patients.

1 Beaver T, Bavaria JE, Griffith B, et al.

Presented at the 103rd Annual Meeting of the American Association for Thoracic Surgery, May 2023.

risks associated with diseases such as bovine spongiform encephalopathy ("BSE").

In May 2017, the EU implemented a new regulatory scheme for medical devices under the Medical Device Regulation ("MDR").

The MDR became effective on May 26, 2021, and brought significant new requirements for many medical devices, including enhanced requirements for clinical evidence and documentation, increased focus on device identification and traceability, new definitions and registration of economic operators throughout the distribution chain, and additional post-market surveillance and vigilance.

Compliance with the MDR requires re-certification of many of our products to the enhanced standards, and has resulted in and will continue to result in substantial additional expense.

In addition, importation of medical devices into Japan is subject to the "Good Import Practices" regulations.

that are tied to our Key Operating Drivers ("KODs").

We understand that good health leads to better performance.

We offer competitive employee benefits and well-being packages that include, among other things, health and wellness insurance, health savings accounts, family support services, and a variety of site-specific programs.

We regularly evaluate our benefits package to make modifications that are aligned with the competitive landscape, legislative changes, and the unique needs of our population.

As part of our regular evaluation and commitment to putting employees first, we determined our employees could benefit from support in four main areas related to health: Mind+, metabolic, heart, and musculoskeletal health.

We offer a variety of programs and education to support employees in these areas.

In recent years, mental well-being has become a central topic for organizations worldwide.

Mind+ offers a wide variety of mental well-being programs for our employees.

This commitment extends to creating a work environment where employees can feel confident speaking about mental well-being with their managers and know how best to access the tools and resources available to support them.

We believe there are strong benefits when employees are feeling their best.

We are subject to various environmental laws and regulations both within and outside of the United States.

Our operations, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes.

While it is difficult to quantify the potential impact of continuing compliance with environmental protection laws, management believes that such compliance will not have a material impact on our financial results.

Our threshold for disclosing material environmental legal proceedings involving a governmental authority where potential monetary sanctions are involved is $1 million.

For the Fiscal Year Ended December 31, [removed: 2024][added: 2025]

Yes [removed: ý] No ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit [removed: report ☒.][added: report.]

Yes ☐ No [removed: ý][added: ☒]

The aggregate market value of the registrant's common stock held by non-affiliates as of June [removed: 28, 2024] [added: 30, 2025] (the last trading day of the registrant's most recently completed second quarter): [removed: $55,525,009,946] [added: $45,899,189,298] based on the closing price of the registrant's common stock on the New York Stock Exchange.

The number of shares outstanding of the registrant's common stock, $1.00 par value, as of January 31, [removed: 2025,] [added: 2026,] was [removed: 587.9] [added: 580.8] million.

Portions of the registrant's proxy statement for the [removed: 2025] [added: 2026] Annual Meeting of Stockholders (to be filed within 120 days of December 31, [removed: 2024)] [added: 2025)] are incorporated by reference into Part III, as indicated herein.

Form 10-K Annual [removed: Report—2024][added: Report—2025]

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*This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the [removed: "Securities Act"),] [added: “Securities Act”),] and Section 21E of the Securities Exchange Act of 1934, as amended (the [removed: "Exchange Act"] [added: “Exchange Act”] and together with the Securities Act, the [removed: "Acts")..][added: “Acts”).]

Statements regarding past performance, efforts, or results about which inferences or assumptions may be made can also be forward-looking statements and are not indicative of future performance or results; these statements can be identified by the use of words such as [removed: "preliminary," "initial," "potential," "possible," "diligence," "industry-leading," "compliant," "indications," "early feedback,"] [added: “preliminary,” “initial,” “potential,” “possible,” “early feedback,”] or other forms of these words or similar words or expressions or the negatives thereof.

These risks and uncertainties include, but are not limited to: [removed: our ability] [added: risks related] to [removed: realize] the [removed: anticipated benefits of the sale of our Critical Care product group; our ability] [added: failure] to [removed: develop new products and avoid manufacturing] [added: successfully innovate] and [removed: quality issues; risks or challenges related to integrating acquired businesses;] [added: market our products; unsuccessful] clinical [removed: trial] [added: trials] or [removed: commercial results] [added: procedures; manufacturing, logistics] or [removed: new product approvals and therapy adoption; the impact of domestic and global conditions;] [added: quality issues; competition;] dependence on [added: key] physicians, research [removed: institutions,] [added: institutions] and hospital systems; [removed: competition in the markets in which we operate; our] [added: public health crises;] reliance on vendors, suppliers, and other third parties; [removed: damage,] [added: use of, or] failure [added: to effectively and timely utilize, emerging technologies, including artificial intelligence; damage, failure,] or interruption of our information technology [removed: systems;] [added: systems, including due to cybersecurity attacks and breaches; failure to recruit and retain qualified talent or execute management succession plans; failure to integrate acquired businesses; risks associated with] the [removed: impact] [added: sale] of [removed: public health crises; consolidation in the healthcare industry;] our [removed: ability] [added: Critical Care product group; risks associated with global, economic, political and social conditions; risks related] to [added: our international operations; inability to obtain governmental reimbursement or reductions in reimbursement levels; industry consolidation; inability to] protect our intellectual property; [added: inability to defend against intellectual property claims from third parties; reduced access and demand for] our [added: products as a result of, and] compliance [removed: with applicable] [added: with, health care legislation and other government] regulations; [removed: our exposure] [added: risks related] to [added: domestic and foreign income and non-income taxes; risks related to data privacy and security laws; losses from] product liability claims; use of [removed: our] products in unapproved circumstances; [removed: changes to reimbursement for our products; the impact of currency exchange rates; unanticipated actions by the United States Food] [added: substantial costs from environmental, health] and [removed: Drug Administration] [added: safety regulations; climate change;] and [removed: other regulatory agencies; changes] [added: risks relating] to [removed: tax laws; unexpected impacts or expenses of litigation or internal or government investigations;] [added: animal-borne illnesses;] and other risks detailed under [removed: "Risk Factors"] [added: “Risk Factors”] in Part I, Item 1A below, as such risks and uncertainties may be amended, supplemented or superseded from time to time by our subsequent reports on Forms 10-Q and 8-K we file with the United States Securities and Exchange Commission.

| [PART I](#i5345f2a169804576827ac231f9dcd449_10) | | | | | | | | |

| [PART II](#i5345f2a169804576827ac231f9dcd449_37) | | | | | | | | |

| [PART III](#i5345f2a169804576827ac231f9dcd449_181) | | | | | | | | |

| [PART IV](#i5345f2a169804576827ac231f9dcd449_199) | | | | | | | | |

| | | | [Signatures](#i5345f2a169804576827ac231f9dcd449_208) | | | [113](#i5345f2a169804576827ac231f9dcd449_208) | | |

| [PART I](#ife1ed5cd84d945f99b0f6c7065fc6e7b_10) | | | | | | | | |

| [PART II](#ife1ed5cd84d945f99b0f6c7065fc6e7b_37) | | | | | | | | |

| [PART III](#ife1ed5cd84d945f99b0f6c7065fc6e7b_172) | | | | | | | | |

| [PART IV](#ife1ed5cd84d945f99b0f6c7065fc6e7b_190) | | | | | | | | |

| | | | [Signatures](#ife1ed5cd84d945f99b0f6c7065fc6e7b_199) | | | [109](#ife1ed5cd84d945f99b0f6c7065fc6e7b_199) | | |

[removed: *Risk] [added: Risk] Management and [removed: Strategy*][added: Strategy]

Our Information Security team manages Edwards’ Information Security Program, which is focused on assessing, [removed: identifying,] [added: identifying] and managing cybersecurity risk and information security threats.

Through these channels and others, we work to proactively identify potential vulnerabilities in our information security [removed: system.][added: system and continually enhance our processes.]

[removed: *Governance*][added: Governance]

Our Senior Vice President [removed: ("SVP"),] [added: (“SVP”),] Enterprise Risk [removed: Management] [added: Management,] presents to our Board of Directors and our Audit Committee at least once a year on our significant enterprise-wide risks as well as our enterprise-wide risk program.

In addition, our Chief Information Security Officer (“CISO”) [removed: meets regularly with the Audit Committee] [added: provides a report] on [removed: risks related to] cybersecurity and information [removed: security.][added: security matters to the Audit Committee at each regularly scheduled meeting, minimally once a quarter.]

Finally, management has instituted our Information Security Council and Enterprise Risk Management [removed: Council] [added: Council,] both of which are made up of senior leaders of the Company.

This council serves as an escalation point for issues requiring concerted [removed: action, and] [added: action and,] in turn, informs executive management regarding information security and cybersecurity risks and issues.

We conduct information security training as part of our compliance program that occurs at least annually and is mandatory for all new employees.

We also administer a cybersecurity training program for the Board of Directors.

We also maintain insurance policies that may cover damages as a result of a cybersecurity incident.

Our Information Security Program is designed to align with industry standards such as the National Institute of Standards and Technology Cybersecurity Framework, Center for Internet Security Framework and Open Web Application Security Project Top 10, among others.

We leverage these frameworks to build security controls that are both specific to Edwards and aligned with

best practices.

In addition to tracking best practice frameworks, we also work with trusted third parties to help us assess and audit our cybersecurity program and annually audit our systems and test our IT infrastructure.

As part of our efforts to track and shape industry best practices, the Information Security team is an affiliated member and active contributor of the Health Information Sharing and Analysis Center (“H-ISAC”).

We also conduct regular cybersecurity awareness and training campaigns for existing employees.

We also periodically engage external partners to conduct annual audits of our systems and test our IT infrastructure.

| | | | | | | | | | | | |

| Valencia, Spain | | | (3) | | | | | | Manufacturing | | |

(3) Under construction.

On January 31, [removed: 2025,] [added: 2026,] there were [removed: 7,197] [added: 6,691] stockholders of record of our common stock.

| Period | | | | | | | | | | | | Total Number of Shares Purchased | | | | | | Average Price Paid per Share | | | | | | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | | | | | | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs (in millions) [removed: (a) (b) | | |] [added: (a)] | | |

The cumulative total return listed below assumes an initial investment of $100 at the market close on December 31, [removed: 2019] [added: 2020] and reinvestment of dividends.

[removed: ][added: ]

| | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2024] [added: 2025] | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| October 1, 2025 through October 31, 2025 | | | | | | | | | | | | 425,194 | | | | | | $ | 73.82 | | | | | 425,194 | | | | | | $ | 2,022.1 | |

| November 1, 2025 through November 30, 2025 | | | | | | | | | | | | 17,885 | | | | | | 84.22 | | | | | | 17,885 | | | | | | 2,020.6 | | |

| December 1, 2025 through December 31, 2025 | | | | | | | | | | | | 81,464 | | | | | | 84.76 | | | | | | 81,464 | | | | | | 2,013.7 | | |

| Total | | | | | | | | | | | | 524,543 | | | | | | 75.88 | | | | | | 524,543 | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

In September 2025, the Board of Directors approved up to an additional $1.5 billion of repurchases under this program.

| Edwards Lifesciences | | | $ | 142.00 | | | | | $ | 81.78 | | | | | $ | 83.58 | | | | | $ | 81.15 | | | | | $ | 93.45 | |

| S&P 500 | | | 128.71 | | | | | | 105.40 | | | | | | 133.10 | | | | | | 166.40 | | | | | | 196.16 | | |

| S&P 500 Health Care Equipment | | | 119.35 | | | | | | 96.84 | | | | | | 105.60 | | | | | | 117.15 | | | | | | 126.87 | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| October 1, 2024 through October 31, 2024 | | | | | | | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 1,398.5 | | | | |

| November 1, 2024 through November 30, 2024 | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,398.5 | | | | | |

| December 1, 2024 through December 31, 2024 | | | | | | | | | | | | 1,704,349 | | | | | | 66.60 | | | | | | 1,704,349 | | | | | | 1,398.5 | | | | | |

| Total | | | | | | | | | | | | 1,704,349 | | | | | | 66.60 | | | | | | 1,704,349 | | | | | | | | | | | |

(b) In August 2024, we entered into a $500.0 million accelerated share repurchase ("ASR") agreement and received, on September 5, 2024, an initial delivery of 5.8 million shares of our common stock, representing approximately 80 percent of the total contract value.

The ASR concluded on December 27, 2024 and we received an additional 1.7 million shares.

Shares purchased pursuant to the ASR agreement are presented in the table above in the periods in which they were received.

| Edwards Lifesciences | | | $ | 117.32 | | | | | $ | 166.60 | | | | | $ | 95.95 | | | | | $ | 98.05 | | | | | $ | 95.20 | |

| S&P 500 | | | 118.40 | | | | | | 152.39 | | | | | | 124.79 | | | | | | 157.59 | | | | | | 197.02 | | |

| S&P 500 Health Care Equipment | | | 117.63 | | | | | | 140.40 | | | | | | 113.92 | | | | | | 124.22 | | | | | | 137.81 | | |

[removed: DECEMBER] [added: | | | | December] 31, [added: 2025 | | | | | | | | | | | | | | | | | | | | | | | | December 31,] 2024 [added: | | | | | | | | | | | | | | | | | | | | |]

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#ife1ed5cd84d945f99b0f6c7065fc6e7b_73) 238[)](#ife1ed5cd84d945f99b0f6c7065fc6e7b_73)] [added: ID](#i5345f2a169804576827ac231f9dcd449_73) 238[)](#i5345f2a169804576827ac231f9dcd449_73)] | | | [removed: [42](#ife1ed5cd84d945f99b0f6c7065fc6e7b_73)] [added: [44](#i5345f2a169804576827ac231f9dcd449_73)] | | |

| [Consolidated Balance Sheets as of December [removed: 31,](#ife1ed5cd84d945f99b0f6c7065fc6e7b_76)] [added: 31,](#i5345f2a169804576827ac231f9dcd449_76) 2025 [and](#i5345f2a169804576827ac231f9dcd449_76)] 2024 [removed: [and](#ife1ed5cd84d945f99b0f6c7065fc6e7b_76) 2023] | | | [removed: [45](#ife1ed5cd84d945f99b0f6c7065fc6e7b_76)] [added: [46](#i5345f2a169804576827ac231f9dcd449_76)] | | |

| For the Years Ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022:] [added: 2023:] | | | | | |

| [Consolidated Statements of [removed: Operations](#ife1ed5cd84d945f99b0f6c7065fc6e7b_79)] [added: Operations](#i5345f2a169804576827ac231f9dcd449_79)] | | | [removed: [46](#ife1ed5cd84d945f99b0f6c7065fc6e7b_79)] [added: [47](#i5345f2a169804576827ac231f9dcd449_79)] | | |

| [Consolidated Statements of Comprehensive [removed: Income](#ife1ed5cd84d945f99b0f6c7065fc6e7b_82)] [added: Income](#i5345f2a169804576827ac231f9dcd449_82)] | | | [removed: [47](#ife1ed5cd84d945f99b0f6c7065fc6e7b_82)] [added: [48](#i5345f2a169804576827ac231f9dcd449_82)] | | |

| [Consolidated Statements of Cash [removed: Flows](#ife1ed5cd84d945f99b0f6c7065fc6e7b_85)] [added: Flows](#i5345f2a169804576827ac231f9dcd449_85)] | | | [removed: [48](#ife1ed5cd84d945f99b0f6c7065fc6e7b_85)] [added: [49](#i5345f2a169804576827ac231f9dcd449_85)] | | |

| [Consolidated Statements of Stockholders' [removed: Equity](#ife1ed5cd84d945f99b0f6c7065fc6e7b_88)] [added: Equity](#i5345f2a169804576827ac231f9dcd449_88)] | | | [removed: [49](#ife1ed5cd84d945f99b0f6c7065fc6e7b_88)] [added: [50](#i5345f2a169804576827ac231f9dcd449_88)] | | |

| [Notes to Consolidated Financial [removed: Statements](#ife1ed5cd84d945f99b0f6c7065fc6e7b_91)] [added: Statements](#i5345f2a169804576827ac231f9dcd449_91)] | | | [removed: [50](#ife1ed5cd84d945f99b0f6c7065fc6e7b_91)] [added: [51](#i5345f2a169804576827ac231f9dcd449_91)] | | |

We have audited the accompanying consolidated balance sheets of Edwards Lifesciences Corporation and its subsidiaries (the “Company”) as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the related consolidated statements of operations, of comprehensive income, of stockholders’ equity and of cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] including the related notes (collectively referred to as the “consolidated financial statements”).

We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2024] [added: 2025] in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

[added: A company’s internal control over financial reporting includes those policies and procedures] that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable [removed: assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.]

The critical audit [removed: matters] [added: matter] communicated below [removed: are matters] [added: is a matter] arising from the current period audit of the consolidated financial statements that [removed: were] [added: was] communicated or required to be communicated to the audit committee and that (i) [removed: relate] [added: relates] to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matters] [added: matter] below, providing [added: a] separate [removed: opinions] [added: opinion] on the critical audit [removed: matters] [added: matter] or on the accounts or disclosures to which [removed: they relate.][added: it relates.]

As described in Note 19 to the consolidated financial statements, the Company had an uncertain gross tax positions balance of [removed: $678.8] [added: $767.4] million as of December 31, [removed: 2024,] [added: 2025,] of which a majority is related to intercompany transfer pricing.

| | | | [added: | | | | | |] 2024 | | | | | | 2023 | | |

| Cash and cash equivalents | | | $ | [added: 2,938.0 | | | | | $ |] 3,045.2 | | | | | $ | 1,132.3 | |

| Short-term investments (Note 8) | | | [removed: 930.7] [added: 1,288.3] | | | | | | [removed: 500.5] [added: 930.7] | | |

| Accounts receivable, net of allowances of [removed: $11.6] [added: $15.0] and [removed: $8.2,] [added: $11.6,] respectively | | | [removed: 609.1] [added: 659.6] | | | | | | [removed: 771.5] [added: 609.1] | | |

| Other receivables | | | [removed: 118.3] [added: 252.5] | | | | | | [removed: 56.6] [added: 118.3] | | |

| Inventories (Note 6) | | | [removed: 1,086.7] [added: 1,126.2] | | | | | | [removed: 903.5] [added: 1,086.7] | | |

| Prepaid expenses | | | [removed: 121.0] [added: 135.0] | | | | | | [removed: 128.8] [added: 121.0] | | |

| Other current assets | | | [removed: 347.6] [added: 339.3] | | | | | | [removed: 224.9] [added: 347.6] | | |

| Current assets of discontinued operations (Note 5) | | | [removed: 26.8] [added: —] | | | | | | [removed: 317.6] [added: 26.8] | | |

| Total current assets | | | [removed: 6,285.4] [added: 6,738.9] | | | | | | [removed: 4,035.7] [added: 6,285.4] | | |

| Long-term investments (Note 8) | | | [removed: 307.9] [added: 278.6] | | | | | | [removed: 583.9] [added: 307.9] | | |

| Property, plant, and equipment, net (Note 6) | | | [removed: 1,686.0] [added: 1,811.9] | | | | | | [removed: 1,591.0] [added: 1,686.0] | | |

| Operating lease right-of-use assets (Note 7) | | | [removed: 98.2] [added: 102.7] | | | | | | [removed: 84.4] [added: 98.2] | | |

| Goodwill (Note 11) | | | [removed: 1,776.7] [added: 1,768.6] | | | | | | [removed: 1,145.1] [added: 1,776.7] | | |

| Other intangible assets, net (Note 11) | | | [removed: 1,176.6] [added: 1,128.2] | | | | | | [removed: 399.4] [added: 1,176.6] | | |

| Deferred income taxes | | | [removed: 992.1] [added: 1,138.1] | | | | | | [removed: 749.4] [added: 992.1] | | |

| Other assets | | | [removed: 721.6] [added: 730.2] | | | | | | [removed: 463.2] [added: 721.6] | | |

| Non-current assets of discontinued operations (Note 5) | | | [removed: 10.8] [added: —] | | | | | | [removed: 311.1] [added: 10.8] | | |

| Total assets | | | $ | [removed: 13,055.3] [added: 13,697.2] | | | | | $ | [removed: 9,363.2] [added: 13,055.3] | |

| Accounts payable | | | $ | [removed: 197.4] [added: 227.5] | | | | | $ | [removed: 186.6] [added: 197.4] | |

| Accrued and other liabilities (Note 6) | | | [removed: 1,282.4] [added: 1,561.7] | | | | | | [removed: 856.4] [added: 1,282.4] | | |

| Operating lease liabilities (Note 7) | | | [removed: 23.4] [added: 24.5] | | | | | | [removed: 22.9] [added: 23.4] | | |

| Current liabilities of discontinued operations (Note 5) | | | [removed: 2.0] [added: —] | | | | | | [removed: 129.5] [added: 2.0] | | |

assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

February 25, 2026

| Commitments and contingencies (Note 7, Note 12, and Note 20) | | | | | | | | | | | |

| Intangible assets impairment charges | | | 40.0 | | | | | | — | | | | | | — | | |

| Loss on impairment | | | 146.9 | | | | | | — | | | | | | — | | |

| Change in fair value of contingent consideration liabilities (Note 13) | | | (12.5) | | | | | | — | | | | | | (26.2) | | |

| Loss on impairment and intangible assets impairment charges (Note 11 and Note 9) | | | 186.9 | | | | | | — | | | | | | — | | |

| Other | | | 7.7 | | | | | | 13.2 | | | | | | 8.5 | | |

| Investments in unconsolidated entities (Note 8) | | | (64.8) | | | | | | (60.3) | | | | | | (15.8) | | |

| Payment for working capital adjustment and proceeds from sale of Critical Care (Note 5) | | | (36.3) | | | | | | 3,927.4 | | | | | | — | | |

| Other | | | (7.4) | | | | | | (12.6) | | | | | | 3.3 | | |

| Purchase of remaining noncontrolling interest in subsidiary (Note 9) | | | (233.7) | | | | | | — | | | | | | — | | |

| Net income (loss) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1,073.5 | | | | | | | | | | | | 1,073.5 | | | | | | (4.1) | | | | | | 1,069.4 | | |

| Changes to noncontrolling interest (Note 9) | | | | | | | | | | | | | | | | | | | | | | | | | | | (173.3) | | | | | | | | | | | | | | | | | | (173.3) | | | | | | (60.4) | | | | | | (233.7) | | |

| BALANCE AT DECEMBER 31, 2025 | | | 658.7 | | | | | | $ | 658.7 | | | | | 78.0 | | | | | | $ | (7,091.7) | | | | | $ | 2,768.4 | | | | | $ | 14,240.5 | | | | | $ | (238.3) | | | | | $ | 10,337.6 | | | | | $ | — | | | | | $ | 10,337.6 | |

On December 18, 2025, the Company sold a business that was not focused on implantable medical innovations for structural heart diseases (the “non-core product group”) and on September 3, 2024, the Company sold its Critical Care product group ("Critical Care").

Certain reclassifications have been made to prior period financial statements to conform to classifications used in the current period.

performance obligation is satisfied upon delivery of the product.

For further information, see Note 11.

| Continuing operations | | | $ | 1.81 | | | | | $ | 2.34 | | | | | $ | 2.02 | |

| Continuing operations | | | $ | 1.81 | | | | | $ | 2.34 | | | | | $ | 2.01 | |

| | | | 2025 | | | | | | 2024 | | | | | | 2023 | | |

each period based upon the change in the fair value of the derivative financial instrument.

For further information, see Note 19.

In September 2025, the FASB issued ASU 2025-07 on derivatives and hedging and revenue from contracts with customers.

The amendment provides clarity on application of derivative accounting to certain nonexchange-traded contracts with features based on operations or activities of one of the parties to the contract.

In September 2025, the FASB issued ASU 2025-06 on internal-use software related to accounting for internal-use software costs.

The amendment in this update improve the operability of the guidance by clarifying the criteria for capitalization, which begins when both of the following occur: (1) management has authorized and committed to funding the software project and (2) it is probable that the project will be completed and the software will be used to perform the function intended.

Early adoption is permitted.

The guidance can be applied on a fully prospective basis, a modified basis for in-process projects, or a full retrospective basis.

The Company is currently evaluating the impact the guidance will have on its consolidated financial statements.

The

In December 2025, the Company recorded an expense of $13.1 million related to severance associated with a realignment initiative.

| Restructuring charges | | | 13.1 | | |

| Payments | | | (19.9) | | |

| Balance at December 31, 2025 | | | $ | 13.3 | |

On December 18, 2025, the Company completed the sale of its non-core product group for $81.8 million up-front consideration (net cash proceeds of $78.8 million), resulting in a gain of $36.9 million (included in *Income from* *Discontinued Operations, net of tax)*.

The transaction included additional potential earnouts of up to $40 million.

In connection with the sale of its non-core product group, the Company entered into a transition services agreement (“TSA”) to provide certain support services for up to one year from the closing date of the sale (with certain extension rights as provided therein), the impact of which is not expected to be material.

The assets and liabilities associated with

As described in Management’s Report on Internal Control Over Financial Reporting, management has excluded Innovalve Bio Medical Ltd., Endotronix Inc., and J.C. Medical, Inc. from its assessment of internal control over financial reporting as of December 31, 2024 because they were acquired by the Company in purchase business combinations during 2024.

We have also excluded Innovalve Bio Medical Ltd., Endotronix Inc., and J.C. Medical, Inc. from our audit of internal control over financial reporting.

Innovalve Bio Medical Ltd., Endotronix Inc., and J.C. Medical, Inc. are wholly-owned subsidiaries whose total assets and total revenues excluded from management’s assessment and our audit of internal control over financial reporting collectively represent less than 1%, respectively, of the related consolidated financial statement amounts as of and for the year ended December 31, 2024.

A company’s internal control over financial reporting includes those policies and procedures

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.

*Acquisition of Endotronix, Inc. – Valuation of the Developed Technology*

As described in Note 10 to the consolidated financial statements, on August 19, 2024, the Company acquired all the remaining outstanding shares of Endotronix, Inc. for total purchase consideration, net of cash acquired, of $798.8 million.

Of the acquired intangible assets, $388.9 million of developed technology was recorded.

Fair value of the developed technology was determined by management using an income approach.

As disclosed by management, the determination of fair value involves the use of estimates and assumptions, such as projected revenues, projected gross margins, and discount rate.

The principal considerations for our determination that performing procedures relating to the valuation of the developed technology acquired in the acquisition of Endotronix, Inc. is a critical audit matter are (i) the significant judgment by management when developing the fair value estimate of the developed technology acquired; (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to projected revenues, projected gross margins, and discount rate; and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.

These procedures included testing the effectiveness of controls relating to the acquisition accounting, including controls over management’s valuation of the developed technology acquired.

These procedures also included, among others (i) reading the purchase agreement; (ii) testing management’s process for developing the fair value estimate of the developed technology acquired; (iii) evaluating the appropriateness of the income approach used by management; (iv) testing the completeness and accuracy of the underlying data used in the income approach; and (v) evaluating the reasonableness of the significant assumptions used by management related to projected revenues, projected gross margins, and discount rate.

Evaluating management’s assumptions related to projected revenues and projected gross margins involved considering (i) the current and past performance of the Endotronix, Inc. business; (ii) the consistency with external market and industry data; and (iii) whether the assumptions were consistent with evidence obtained in other areas of the audit.

Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the income approach and (ii) the reasonableness of the discount rate assumption.

*Acquisition of Innovalve Bio Medical Ltd. – Valuation of the IPR&D*

As described in Note 10 to the consolidated financial statements, on October 1, 2024, the Company acquired all the remaining outstanding shares of Innovalve Bio Medical Ltd. for total purchase consideration, net of cash acquired, of $380.9 million.

Of the acquired intangible assets, $218.4 million of in-process research and development (IPR&D) was recorded.

Fair value of the IPR&D was determined by management using an income approach.

The principal considerations for our determination that performing procedures relating to the valuation of the IPR&D acquired in the acquisition of Innovalve Bio Medical Ltd. is a critical audit matter are (i) the significant judgment by management when developing the fair value estimate of the IPR&D acquired; (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to projected revenues, projected gross margins, and discount rate; and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.

These procedures included testing the effectiveness of controls relating to the acquisition accounting, including controls over management’s valuation of the IPR&D acquired.

These procedures also included, among others (i) reading the purchase agreement; (ii) testing management’s process for developing the fair value estimate of the IPR&D acquired; (iii) evaluating the appropriateness of the income approach used by management; (iv) testing the completeness and accuracy of the underlying data used in the income approach; and (v) evaluating the reasonableness of the significant assumptions used by management related to projected revenues, projected gross margins, and discount rate.

Evaluating management’s assumptions related to projected revenues and projected gross margins involved considering (i) the current and past performance of the Innovalve Bio Medical Ltd. business; (ii) the consistency with external market and industry data; and (iii) whether the assumptions were consistent with evidence obtained in other areas of the audit.

February 28, 2025

| | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Taxes payable (Note 19) | | | 1.3 | | | | | | 80.6 | | |

| Other liabilities | | | 357.5 | | | | | | 251.3 | | |

| Non-current liabilities of discontinued operations (Note 5) | | | — | | | | | | 25.1 | | |

| Impairment charges (Note 4) | | | — | | | | | | — | | | | | | 55.1 | | |

| (Gain) loss on investments, net | | | (5.2) | | | | | | 0.1 | | | | | | 51.5 | | |

| Other | | | 18.4 | | | | | | 8.4 | | | | | | 7.8 | | |

| Collections of notes receivable | | | — | | | | | | — | | | | | | 18.0 | | |

| Other | | | (72.9) | | | | | | (12.5) | | | | | | (28.8) | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| BALANCE AT DECEMBER 31, 2021 | | | 642.0 | | | | | | $ | 642.0 | | | | | 17.9 | | | | | | $ | (2,416.9) | | | | | $ | 1,700.4 | | | | | $ | 6,068.1 | | | | | $ | (157.7) | | | | | $ | 5,835.9 | | | | | $ | — | | | | | $ | 5,835.9 | |

| Net income | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1,521.9 | | | | | | | | | | | | 1,521.9 | | | | | | | | | | | | 1,521.9 | | |

On September 3, 2024, the Company sold its Critical Care product group ("Critical Care").

In addition, as a next step in the Company's disposal plan to exit businesses that are not focused on implantable medical innovations for structural heart disease, the historical results of a small non-core product group that the Company plans to sell are also included in discontinued operations.

2.

Evaluation of Disclosure Controls and Procedures. The Company's management, including the Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of the Company's disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of December 31, [removed: 2024.][added: 2025.]

Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of December 31, [removed: 2024] [added: 2025] that the Company's disclosure controls and procedures are designed at a reasonable assurance level and are effective in providing reasonable assurance that the information required to be disclosed by the Company in the reports it files or submits under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to the Company's management, including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Based on that evaluation, the Company's management concluded that its internal control over financial reporting was effective as of December 31, [removed: 2024.][added: 2025.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2024] [added: 2025] has been audited by PricewaterhouseCoopers LLP, the independent registered public accounting firm that audited the financial statements included in this Annual Report on Form 10-K, as stated in their report which appears herein.

Changes in Internal Control Over Financial Reporting. There have been no changes in the Company's internal control over financial reporting that occurred during the Company's fourth fiscal quarter of [removed: 2024] [added: 2025] that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.

The Company excluded Innovalve Bio Medical Ltd., Endotronix, Inc., and J.C. Medical, Inc. from its assessment of internal control over financial reporting as of December 31, 2024, because they were acquired by the Company in business combinations during 2024.

The total assets and total revenues of the acquired entities collectively represented approximately less than 1%, of the related consolidated financial statement amounts as of and for the year ended December 31, 2024.

On December [removed: 6, 2024,] [added: 12, 2025,] Bernard J.

The Plan provides for the potential sale of [removed: 14,925] [added: 25,350] shares of the Company’s stock commencing [removed: March 10, 2025.][added: May 12, 2026.]

[removed: The] [added: Mr. Bobo's] Plan terminates on the earlier of May [removed: 16, 2025] [added: 6, 2027,] or the date all shares are sold.

The Plan terminates on the earlier of June 16, 2026 or the date all shares are sold.

On February 12, 2026, Donald E.

Bobo, Jr., Corporate Vice President, Strategy & Corporate Development, entered into a Plan providing for the potential sale of 48,900 shares of the Company’s stock commencing June 2, 2026.

On February 13, 2026, Daniel J.

Lippis, Corporate Vice President, Transcatheter Aortic Valve Replacement (TAVR), entered into a Plan providing for the potential sale of 6,810 shares of the Company’s stock commencing May 18, 2026.

Mr. Lippis's Plan terminates on the earlier of May 5, 2027, or the date all shares are sold.

Certain information required by this Item will be set forth under the headings [removed: "Board] [added: “Board] of Directors Matters—Proposal 1 - Election of Directors—Board of Director [removed: Nominees," "Corporate] [added: Nominees,” “Corporate] Governance Policies and [removed: Practices,"] [added: Practices,”] and [removed: "Executive] [added: “Executive] Compensation and Other Information—Executive [removed: Officers"] [added: Officers”] in the definitive proxy statement to be filed in connection with the Company's [removed: 2025] [added: 2026] Annual Meeting of Stockholders (the [removed: "Proxy Statement")] [added: “Proxy Statement”)] (which Proxy Statement will be filed with the SEC within 120 days of December 31, [removed: 2024).][added: 2025).]

The information contained under the headings [removed: "Security] [added: “Security] Ownership of Certain Beneficial [removed: Owners] [added: Owners” “Stock Ownership of Directors] and [removed: Management"] [added: Officers”] and [removed: "Equity] [added: “Equity] Compensation Plan [removed: Information"] [added: Information”] in the Proxy Statement is incorporated herein by reference.

| 4.2 | | | [Description of Edwards Lifesciences Corporation's Capital Stock (incorporated by reference to Exhibit 4.2 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, [removed: 202](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-4210xkq42021.htm)[1](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-4210xkq42021.htm)[)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-4210xkq42021.htm)] [added: 2021)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-4210xkq42021.htm)] | | |

| 10.1 | | | [Five-Year Credit Agreement, dated as of July 15, 2022, among Edwards Lifesciences Corporation and certain of its subsidiaries, as Borrowers, the lenders signatory [removed: thereto,](https://www.sec.gov/Archives/edgar/data/1099800/000119312522199173/d383535dex101.htm) [and](https://www.sec.gov/Archives/edgar/data/1099800/000119312522199173/d383535dex101.htm) [Bank] [added: thereto, and Bank] of America, N.A., as Administrative Agent (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 8-K filed on July 21, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000119312522199173/d383535dex101.htm) | | |

| 19.1 | | | [Edwards Lifesciences Corporation's Insider Trading [removed: Policy](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-19110xkq42024.htm)] [added: Policy (incorporated by reference to Exhibit 19.1 in Edwards Lifesciences’ report on Form 10-K filed on February 28, 2025).](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-19110xkq42024.htm)] | | |

| 21.1 | | | [Subsidiaries of Edwards Lifesciences [removed: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-21110xkq42024.htm)] [added: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/ex-21110xkq42025.htm)] | | |

| 23 | | | [Consent of Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-2310xkq42024.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/ex-2310xkq42025.htm)] | | |

| 31.1 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-31110xkq42024.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/ex-31110xkq42025.htm)] | | |

| 31.2 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-31210xkq42024.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/ex-31210xkq42025.htm)] | | |

| +32 | | | [Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-3210xkq42024.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/ex-3210xkq42025.htm)] | | |

| *10.20 | | | [Edwards Encore Agreement, dated November 4, 2025, by and between Edwards Lifesciences LLC and Scott B. Ullem (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q filed on November 5, 2025)](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000062/ex-101encoreagreement.htm) | | |

| 10.21 | | | [Edwards Lifesciences Corporation 2001 Employee Stock Purchase Plan for United States Employees, as amended and restated February 13, 2025 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q filed on August 5, 2025)](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000048/ex-1012001usesppplan.htm) | | |

| 10.22 | | | [Edwards Lifesciences Corporation 2001 Employee Stock Purchase Plan for International Employees, as amended and restated February 13, 2025 (incorporated by reference to Exhibit 10.2 in Edwards Lifesciences' report on Form 10-Q filed on August 5, 2025)](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000048/ex-1022001internationalesp.htm) | | |

| | | | | | |

| --- | --- | --- | --- | --- | --- |

| Exhibit No. | | | Description | | |

| February [removed: 28, 2025] [added: 25, 2026] | | | By: | | | | | | /s/ BERNARD J. ZOVIGHIAN | | |

| /s/ BERNARD J. ZOVIGHIAN | | | Director and Chief Executive Officer | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ SCOTT B. ULLEM | | | Corporate Vice President, Chief Financial Officer | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ ANDREW M. DAHL | | | Senior Vice President, Corporate Controller | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ LESLIE C. DAVIS | | | Director | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ DAVID T. FEINBERG | | | Director | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ KIERAN T. GALLAHUE | | | Director | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ LESLIE S. HEISZ | | | Director | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ PAUL A. LAVIOLETTE | | | Director | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ STEVEN R. LORANGER | | | Director | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ RAMONA SEQUEIRA | | | Director | | | February [removed: 28, 2025] [added: 25, 2026] | | |

| /s/ NICHOLAS J. VALERIANI | | | Chairman of the Board | | | February [removed: 28, 2025] [added: 25, 2026] | | |