Edwards Lifesciences (EW) 10-K risk factor changes: FY2024 vs FY2023

- Damage, failure, or interruption of our information technology systems, including due to [removed: cyber-based] [added: cybersecurity] attacks and breaches

- Risks [removed: related to] [added: associated with] the [removed: spin-off] [added: sale] of our Critical Care product group

[removed: Market] [added: Global Economic] and Other External Risks

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

Unfavorable or inconsistent clinical data from current or future clinical trials or procedures conducted by us, our competitors, or third parties, or perceptions regarding [removed: this] [added: these] clinical data, could adversely affect our ability to obtain necessary approvals and the market's view of our future prospects.

Other public health crises, including any future epidemics or pandemics, are highly uncertain and difficult to predict, and could result in material adverse impacts on our [removed: business and] [added: business,] financial [removed: condition.][added: condition, and results of operations.]

The success of many of our products depends upon certain key [removed: physicians and] [added: physicians,] research [removed: institutions.][added: institutions, and hospital systems.]

Additionally, any significant increases in the cost of raw materials, whether due to inflationary pressure, supply constraints, [added: the imposition of tariffs,] regulatory changes, or otherwise, could adversely impact our operating results.

Failure to protect our information technology infrastructure and our products against [removed: cyber-based] [added: cybersecurity] attacks, network security breaches, service interruptions, or data corruption could materially disrupt our operations and adversely affect our business and operating results.

In addition, our information technology infrastructure and products are vulnerable to [removed: cyber-based] [added: cybersecurity] attacks.

[removed: Cyber-based] [added: Cybersecurity] attacks can include, but are not limited to, computer viruses, denial-of-service attacks, phishing attacks, ransomware attacks, and other introduction of malware to computers and networks; [added: social engineering or other] unauthorized access through the use of compromised credentials; exploitation of design flaws, bugs, or security vulnerabilities; intentional or unintentional acts by employees or other insiders with access privileges; and intentional acts of vandalism by third parties and sabotage.

In addition, we rely upon technology suppliers, including cloud‑based data management applications hosted by third‑party service providers, whose [removed: security] [added: cybersecurity] and information technology systems are subject to similar risks.

Significant disruption in either our or our service providers’ or suppliers’ information technology or the security of our products could impede our operations or result in decreased sales, result in liability claims or regulatory penalties, [added: impact patient safety] or lead to increased overhead costs, product shortages, loss or misuse of proprietary or confidential information, intellectual property, or sensitive or personal information, all of which could have a material adverse effect on our reputation, business, financial condition, and [removed: operating results.][added: results of operations.]

[removed: We] [added: As part of our strategy, we] actively manage a portfolio of [removed: research and development products, and we regularly explore potential acquisitions of complementary] businesses, technologies, services, [removed: or products,] [added: and products] as well as [added: enter into] potential strategic alliances.

From time to time, we identify operations and products that are [removed: underperforming,] [added: underperforming or that] do not fit with our longer-term business [removed: strategy] [added: strategy, such as our recent divestiture of our Critical Care product group,] or there may be unforeseen operating difficulties and significant expenditures during the integration of an acquired business, technology, [removed: service,] [added: service] or product into our existing operations.

[removed: If we cannot] [added: We may] dispose of [removed: an operation] [added: these underperforming operations] or [removed: product on acceptable terms, we may] [added: products or] voluntarily cease operations related to [removed: that] [added: a] product.

In addition, we may be required to [removed: take] [added: record] charges or write-downs in connection with acquisitions and [removed: divestitures.][added: divestitures, including charges related to developed technology and/or in-process research and development assets.]

Any of these events could [removed: result in charges, which could be substantial and which could] adversely affect our results of operations.

[removed: Market] [added: Global Economic] and Other External Risks

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 [removed: exposes] [added: expose] us to certain financial, economic, political, and other risks, including those listed below.

For example, in the United States, [added: continued implementation of] the Affordable Care [removed: Act, the Medicare Access and CHIP Reauthorization] Act [removed: of 2015,] and the 21st Century Cures Act, or any future [removed: legislation,] [added: legislation under the new Administration and new Congress,] 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.

In addition, a Mutual Recognition Agreement still under negotiation for the Medical Device Regulation [removed: can] [added: may] result in a lack of free movement of medical devices between the [removed: European Union] [added: EU] and Switzerland, [removed: can] [added: may] impact our access in the [removed: European Union] [added: EU] and [removed: can,] [added: may,] ultimately, have a material effect on our business, financial condition, and results of operations.

For example, many countries are aligning their international tax rules with the Organisation for Economic Co-operation and Development’s Base Erosion and Profit Shifting [added: Pillar Two] recommendations and action plans that aim to [added: standardize and modernize international corporate tax policy, including changes to cross-border taxes, transfer pricing documentation rules, nexus-based tax practices, and taxation of digital activities.]

Please [removed: review] [added: see] Note [removed: 18 (Income Taxes)] [added: 19] to our [removed: "*Consolidated] [added: *Consolidated] Financial [removed: Statements*"] [added: Statements*] in this report for information regarding our current audits and disputes with tax authorities.

Although we regularly assess the likely outcomes of [removed: the] [added: such] audits and record reserves for potential tax payments, the calculation of tax liabilities involves the application of complex tax laws, and our estimates could be different than the amounts for which we are ultimately liable.

In addition, we [added: have challenged in the past and] may decide [added: in the future] to challenge any assessments, if made, and may exercise our right to appeal, which could result in expensive and time-consuming litigation that may ultimately be unsuccessful.

In addition, third parties could also obtain patents that may require us to either redesign [removed: products,] [added: products or] negotiate licenses from such third parties, which may be costly, [removed: unavailable] [added: unavailable,] or require us to exit a particular product offering.

In addition, failure to comply with these regulations could subject us to substantial sanctions which could adversely affect our business, [added: financial condition, and] results of [removed: operations, and financial condition.][added: operations.]

The medical technologies we create, study, manufacture, and market globally are subject to rigorous regulation and scrutiny by the FDA and various other federal, state, and foreign governmental authorities, including the European Union's European Commission [added: (the "Commission")] who promulgated the European Medical Device Regulation ("EU MDR").

Switzerland is not a member state of the EU, but is linked to the EU through bilateral treaties; therefore, the free movement of goods, including medical devices, between the EU and Switzerland after implementation of the EU MDR [removed: requires] [added: required] a revised MRA.

Our failure to comply with these regulatory requirements of the FDA, the [removed: European] Commission, or other applicable regulatory requirements in the United States or elsewhere might subject us to administratively or judicially imposed sanctions.

These sanctions [added: may] include, among others, warning letters, fines, civil penalties, criminal penalties, injunctions, debarment, product seizure or detention, product recalls and total or partial suspension of production, sale and/or promotion.

Any of the foregoing actions could result in decreased sales including as a result of negative publicity and product liability claims, and could have a material adverse effect on our [added: business,] financial condition, results of operations, and prospects.

In addition to the sanctions for noncompliance described above, commencement of an enforcement proceeding, inspection, or investigation could divert substantial management attention from the operation of our business and have an adverse effect on our business, [added: financial condition, and] results of [removed: operations, and financial condition.][added: operations.]

We are also subject to various United States and foreign laws pertaining to health care pricing, anti-competition, anti-corruption, and fraud and abuse, including prohibitions on kickbacks and the submission of false claims laws and restrictions on [added: relationships with physicians and other referral sources.]

We are required to comply with increasingly complex and changing legal and regulatory requirements that govern the collection, use, storage, security, transfer, [removed: disclosure] [added: disclosure,] and other processing of personal data in the United States and in other countries, which may include, but are not limited to, [removed: The] [added: the] Health Insurance Portability and Accountability [removed: Act,] [added: Act (“HIPPA”),] as amended [removed: ("HIPAA"), The] [added: by the] Health Information Technology for Economic and Clinical Health [removed: Act,] [added: Act of 2009,] the [removed: CCPA,] [added: General Data Protection Regulation ("GDPR") adopted by] the [removed: CRPA,] [added: EU] and the [removed: GDPR.][added: California Privacy Rights Act ("CRPA") and the California Consumer Privacy Act, as amended by the CRPA (the “CCPA”).]

The GDPR imposes stringent [removed: European Union] [added: EU] data protection requirements and provides for significant penalties for noncompliance.

The CCPA and the CRPA provides consumers with a private right of action against companies [removed: who] [added: that] have a security breach due to lack of appropriate security measures.

Component failures, manufacturing and assembly flaws, design defects, software defects, medical procedure errors, or inadequate disclosure of product-related risks or information could result in an unsafe [removed: condition,] [added: condition for,] injury to, or death [removed: of,] [added: of] patients.

We have incurred and may incur in the future expenditures in connection with environmental, [removed: health] [added: health,] and safety [removed: laws,] [added: laws] and regulations.

- Dependence on key physicians.

research institutions, and hospital systems

- Failure to integrate acquired businesses

- Risks related to data privacy and security laws

In addition, we rely on hospital systems to be able to hire staff and have available facilities, including catheterization laboratories, to perform procedures using our products.

With multiple new technologies competing for these facilities, a decision by a hospital system, particularly a large hospital system, not to adequately staff or provide facilities necessary to perform procedures using our products can meaningfully adversely impact our ability to sell our products.

Those limitations could have a material adverse effect on our business, financial condition, and results of operations.

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

While we are not aware of any cybersecurity attacks that have materially affected our business, financial condition, or operations, the preventative measures we have implemented to date may not be sufficient to prevent, mitigate, or offset a future incident that may materially and adversely impact us.

Failure to successfully integrate acquired businesses, technologies or strategic alliances, or challenges related to the execution of acquisitions or divestitures, as well as liabilities or claims relating to such acquired businesses or divestitures, could adversely affect our business and results of operations.

If we are unable to acquire businesses or technologies or other transactions on a timely basis or at all, we will not be able to execute our strategy and our business and results of operations may be adversely impacted.

The integration of acquired businesses and technologies may be costly and may divert significant amounts of resources, including management and employee time and attention, away from the development and commercialization of our other products.

Our failure to successfully manage the integration and growth of acquired businesses and technologies and our existing structural heart therapies could have an adverse impact on our business.

We may not receive the anticipated benefits of acquisitions despite such expenses and diversion of resources, and acquisitions may not prove to be profitable.

Furthermore, we may face unforeseen challenges in executing our strategic plans to expand our products and therapies, which could cause our business and results of operations to suffer.

We are subject to risks associated with the sale of our Critical Care product group.

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

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

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

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

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

Failure to comply with data privacy and security laws could have a material adverse effect on our business.

These laws affect how we collect and use data of our employees, customers, and other parties, including patients treated with our products, and they may further restrict our transfer and use of such data, and can expose us to investigations and enforcement actions by regulatory authorities and claims from individuals potentially resulting in penalties and significant legal liability, if our efforts to protect such confidential personal information are inadequate.

These laws, as well as similar laws being enacted by other states and countries, impose substantial requirements that involve the expenditure of significant resources and the investment of significant time and effort to comply.

We also rely on third parties to host or otherwise process some of this data, who are subject to similar risks, and any failure by such third parties to comply with data privacy and security laws or protect such confidential information, could harm our reputation and have a material adverse effect on our business.

- Dependence on key physicians and research institutions

- Underperforming operations or unsuccessful business acquisitions or strategic alliances

Without the timely innovation and development of products, our products

In addition, United States federal and state laws and regulations, and the laws and regulations of jurisdictions outside of the United States, such as the General Data Protection Regulation ("GDPR") adopted by the European Union and the California Privacy Rights Act ("CRPA") and the California Consumer Privacy Act, as amended by the CRPA (the "CCPA"), can expose us to investigations and enforcement actions by regulatory authorities and claims from individuals potentially resulting in penalties and significant legal liability, if our information technology security efforts are inadequate.

If we identify underperforming operations or products or if there are unforeseen operating difficulties and expenditures in connection with business acquisitions or strategic alliances, we may be required, from time to time, to recognize charges, which could be substantial and which could adversely affect our results of operations.

We may seek to dispose of these underperforming operations or products, and we may also seek to dispose of other operations or products for strategic or other business reasons.

In particular, acquisitions of businesses engaged in the development of new products may give rise to developed technology and/or in-process research and development assets.

Also, in connection with certain asset acquisitions, we may be required to take an immediate charge related to acquired in-process research and development assets.

We may not be able to complete the announced spin-off of our Critical Care product group at all, or within the timeframes we anticipate, or pursuant to the tax-free structure that we anticipate, and we may not realize some or all of the expected benefits of this transaction.

On December 7, 2023, we announced our intention to complete a tax-free spin-off of our Critical Care product group at the end of 2024.

We also announced our intention to submit a Form 10 with the SEC in mid-year 2024.

In connection with this spin-off and the separation of the Critical Care product group from the rest of Edwards, we will be required to satisfy all necessary governance, contractual, and regulatory conditions, among other, including those required by third parties.

A failure to satisfy all necessary conditions could delay or prevent the spin-off from occurring or could result in us completing the spin-off on terms less than favorable to us.

In addition, we will incur significant costs associated with the spin-off, which may be significantly higher than projected.

Our intention is to complete the spin-off on a tax-free basis, however, there is no assurance that the spin-off will qualify tax-free as intended, which may result in a significant tax liability.

Lastly, preparing and structuring the spin-off requires significant resources from Edwards, including but not limited to management’s attention, financial support for the new company, and the collective employee effort to separate the Critical Care product group from the rest of Edwards while continuing to operate in the normal course of business.

There is no assurance that the spin-off will occur at all or that the execution, timing, and structure of the spin-off will proceed as intended.

There may be a sudden or unpredictable reaction to the spin-off by the investors and financial institutions, which would affect our stock market price.

If we don’t realize some or all of the benefits of the spin-off, our business and financial condition and those of the newly spun-off company will be materially adversely affected.

Assuming the spin-off is successfully completed, the newly spun-off Critical Care company as a standalone public company may not deliver the returns that we or the shareholders anticipate.

The Company plans to spin-off the Critical Care product group into a successful independent public company to be able to increase focus and flexibility to build upon its global leadership position in advanced patient monitoring, transforming care through AI-enabled smart monitoring solutions while expanding its reach to millions of patients around the world.

The intention for the newly spun-off company is to retain its Chief Executive Officer and other senior leaders, however, there is no assurance that we or the newly spun-off company will be able to do so, which may materially impact the operations of the newly spun-off company.

In addition, the new spin-off will result in a smaller, less diversified standalone company than it was as part of Edwards, which may make it more susceptible to macroeconomic trends, geopolitical risks, financial volatility, and changing market and regulatory conditions, any of which could have a material adverse effect on its financial condition and operations.

The newly spun-off company will incur ongoing costs related to the separation and its public listing, and its transition to a standalone public company, if executed at all, may not be executed as anticipated.

Lastly, we cannot predict whether the market value of our stock and the stock of the spun-off company after the completion of the transaction, will be, in the aggregate, less than, equal to, or greater than the market value of our stock prior to the spin-off.

There is no assurance that the newly spun-off company will be successful as a standalone public company, and if it is not successful, that would have a material adverse impact on the operations and financial condition of the newly spun-off company.

standardize and modernize international corporate tax policy, including changes to cross-border taxes, transfer pricing documentation rules, nexus-based tax practices, and taxation of digital activities.

relationships with physicians and other referral sources.

In addition, as a global company, we are subject to global data privacy and security laws, regulations and codes of conduct that apply to our businesses.

We or our third-party providers and business partners may also be subjected to audits or investigations by one or more domestic or foreign government agencies relating to compliance with information security and privacy laws and regulations, and noncompliance with the laws and regulations could result in substantial and material fines or class action litigation.

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: 2023.][added: 2024.]

Also discussed is our financial position as of December 31, [removed: 2023] [added: 2024,] and our consolidated cash flows for [removed: 2023] [added: 2024] compared to [removed: 2022.][added: 2023.]

For a discussion related to the results of operations for [removed: 2022] [added: 2023] compared to [removed: 2021] [added: 2022] and a discussion related to our consolidated cash flows for [removed: 2022] [added: 2023] compared to [removed: 2021,] [added: 2022,] refer to Part II, Item 7, "*Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations*"] [added: Operations"*] in our [removed: 2022] [added: 2023] Annual Report on Form 10–K filed with the Securities and Exchange Commission on February [removed: 13, 2023.][added: 12, 2024.]

We are the global leader in patient-focused medical innovations for structural heart [removed: disease and critical care monitoring.][added: 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 [removed: disease or who require hemodynamic monitoring during surgery or in intensive care.][added: disease.]

Our products are categorized into the following groups: Transcatheter Aortic Valve Replacement ("TAVR"), Transcatheter Mitral and Tricuspid Therapies ("TMTT"), [added: and] Surgical Structural Heart [removed: ("Surgical"), and Critical Care.][added: ("Surgical").]

The [removed: planned separation] [added: sale] will enable us to pursue expanded opportunities for TAVR, TMTT, and Surgical patients, as well as new investments in interventional heart failure [removed: technologies.][added: technologies;]

[removed: ][added: ]

[removed: Despite the challenges to our business due to COVID-19 and macroeconomic headwinds, our] [added: Our] net sales for [removed: 2023] [added: 2024] were [removed: $6.0] [added: $5.4] billion, representing an increase of [removed: $622.4] [added: $429.5] million over [removed: 2022,] [added: 2023,] driven by sales growth of our TAVR [added: and TMTT] products.

Our gross profit increased in [removed: 2023,] [added: 2024,] driven by our sales growth.

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

See Note [removed: 3] [added: 15] to the [removed: "*Consolidated] [added: *Consolidated] Financial [removed: Statements*"] [added: Statements*] for further information.

We are committed to developing new technologies and [removed: providing innovative patient care,] [added: innovations,] and we are committed to defending our intellectual property in support of those developments.

In [removed: 2023,] [added: 2024,] we invested [removed: 17.8%] [added: 19%] of our net sales in research and development.

The following is a summary of important developments since January 1, [removed: 2023:][added: 2024:]

- we launched the *Edwards SAPIEN 3 Ultra RESILIA* valve in [removed: Japan;][added: Europe;]

- we received [removed: CE Mark approval for the *EVOQUE* tricuspid valve replacement system for the transcatheter treatment of eligible patients with tricuspid regurgitation and] United States Food and Drug Administration ("FDA") approval [added: and launched the *EVOQUE* tricuspid valve replacement system] for the treatment of tricuspid [removed: regurgitation, making it] [added: regurgitation in] the [removed: world's first transcatheter valve replacement therapy to receive regulatory approval to treat tricuspid regurgitation;][added: United States;]

- we completed enrollment in PROGRESS, a pivotal trial studying the treatment of moderate [removed: aortic stenosis] [added: AS] patients;

[removed: The planned separation] [added: We believe that the sale] will enable [removed: sharpened focus as we] [added: us to] pursue expanded opportunities for TAVR, TMTT, and Surgical patients, as well as new investments in interventional heart [removed: failure technologies.]

Net sales outside of the United States include the impact of foreign currency exchange rate [removed: fluctuations.][added: fluctuations, as further detailed in the discussion below.]

For more information, see [removed: *"Quantitative] [added: "*Quantitative] and Qualitative Disclosures About Market [removed: Risk."*][added: Risk"* in Part II, Item 7A*.*]

| Transcatheter Aortic Valve Replacement | | | $ | [removed: 3,879.8] [added: 4,106.1] | | | | | $ | [removed: 3,518.2] [added: 3,879.8] | | | | | | | | | | | $ | [removed: 361.6] [added: 226.3] | | | | | | | | | | | [removed: 10.3] [added: 5.8] | | % | | | | | | |

| Transcatheter Mitral and Tricuspid Therapies | | | [removed: 197.6] [added: 352.1] | | | | | | [removed: 116.1] [added: 197.6] | | | | | | | | | | | | [removed: 81.5] [added: 154.5] | | | | | | | | | | | | [removed: 70.1] [added: 78.2] | | % | | | | | | |

[removed: ][added: ]

- higher sales of the *Edwards SAPIEN* platform in [removed: 2023,] [added: 2024,] primarily [added: due to sales of] the *Edwards SAPIEN 3 Ultra* *RESILIA* valve in the United [removed: States and Japan, and the *Edwards SAPIEN 3 Ultra* valve in Europe] [added: States, Europe,] and [removed: Rest of World;][added: Japan;]

- foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by [removed: $11.3] [added: $13.6] million primarily due to the weakening of the Japanese yen against the United States dollar, partially offset by the strengthening of the Euro against the United States dollar.

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

[removed: ][added: ]

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

[removed: ][added: ]

Net sales of Surgical products increased in [removed: 2023] [added: 2024] primarily due to [added: higher] sales of the *INSPIRIS RESILIA* aortic valve in the United States and Europe, [added: the *KONECT RESILIA* tissue valved conduit in the United States,] and the *MITRIS RESILIA* valve in the United States.

We [removed: are continuing to enroll] [added: 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.

[removed: ][added: ]

[removed: ][added: ]

The decrease in gross profit as a percentage of net sales in [removed: 2023] [added: 2024] compared to [removed: 2022] [added: 2023] was driven [removed: primarily] by a [removed: 2.5] [added: 0.6] percentage point [removed: decrease from the] impact [removed: of] [added: from] foreign currency [removed: exchange] rate fluctuations, [removed: primarily the weakening of the United States dollar against multiple currencies, partially offset by] [added: including] the [removed: strengthening] [added: settlement] of [removed: the United States dollar against the Japanese yen.][added: foreign currency hedging contracts.]

[removed: ][added: ]

SG&A expenses increased in [removed: 2023] [added: 2024] compared to [removed: 2022 due] [added: 2023] primarily [added: due] to [removed: higher performance-based compensation and] [added: (a)] higher field-based personnel-related costs in support of our growth strategy [removed: and patient activation] initiatives, primarily [removed: related to TAVR and TMTT] in the United States and [removed: Europe.][added: Europe, (b) costs associated with our recent business combinations and (c) professional services costs to support a transition services agreement.]

[removed: ][added:   ]

R&D expenses increased in [removed: 2023] [added: 2024] compared to [removed: 2022 due] [added: 2023] primarily [added: due] to continued investments in our [added: aortic] transcatheter [added: valve] innovations, including increased clinical trial [removed: activity.][added: activity, higher personnel-related costs in support of our growth strategy initiatives, and costs associated with our recent business combinations.]

Intellectual Property Agreement and [added: Certain] Litigation [removed: Expense][added: Expenses]

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.

failure technologies.

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

medical innovations for structural heart disease, we have committed to a plan to sell a non-core product group, with the sale

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

financial condition and results of the discontinued product groups have been reflected as discontinued operations in our

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.

Our discussion and analysis of our results of

operations is reflective of our continuing operations.

See Note 5 to the *Consolidated Financial Statements*.

See Note 3 to the *Consolidated Financial Statements*.

- 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 the CLASP II TR trial for the *PASCAL* tricuspid implant;

- we sold our Critical Care product group to Becton, Dickinson and Company in an all-cash transaction for $4.2 billion.

- 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 | | % | | | | | | |

| Outside of the United States | | | 2,233.5 | | | | | | 2,062.1 | | | | | | | | | | | | 171.4 | | | | | | | | | | | | 8.3 | | % | | | | | | |

| Total net sales | | | $ | 5,439.5 | | | | | $ | 5,010.0 | | | | | | | | | | | $ | 429.5 | | | | | | | | | | | 8.6 | | % | | | | | | |

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

| Surgical Structural Heart | | | 981.3 | | | | | | 932.6 | | | | | | | | | | | | 48.7 | | | | | | | | | | | | 5.2 | | % | | | | | | |

| Total net sales | | | $ | 5,439.5 | | | | | $ | 5,010.0 | | | | | | | | | | | $ | 429.5 | | | | | | | | | | | 8.6 | | % | | | | | | |

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 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.

Our gross profit increased in 2024, driven by our sales growth discussed above.

On December 7, 2023, we announced our intention to complete a tax-free spin-off of our Critical Care product group around the end of 2024.

*COVID-19 and Macroeconomic Uncertainties*

While conditions related to the COVID-19 pandemic have improved compared to 2022, we have continued to experience the impacts of the COVID-19 pandemic in 2023, particularly in Japan and disruptions related to staffing shortages in the United States and Europe.

We continued to remain fully committed to our patient-focused innovation strategy, and our teams were relentless in doing the right things for patients.

Our priority has been to maintain access for patients to our life-saving technologies while providing continuous front-line support to our clinician partners, and protecting the well-being of our employees.

We expect to continue to experience adverse effects related to COVID-19 for some time, particularly as hospital systems continue experiencing budget constraints and staffing shortages, the supply chains continue to adjust to the market, and medical procedure rates and demand for our products continue to fluctuate as the medical system rebalances its infrastructure and resources in a post-COVID-19 market.

In addition to the impacts described above, the global economy, including the financial and credit markets, continues to experience volatility and disruptions, including conditions impacting inflation, credit and capital markets, interest rates, and factors affecting global economic stability and the political environment relating to health care.

The severity and duration of the impact of these conditions on our business cannot be predicted.

See Item 1A, "*Risk Factors*," for additional information.

- we received CE Mark approval for the *Edwards SAPIEN 3 Ultra RESILIA* valve in Europe;

- we received approval in Japan for *PASCAL Precision* to treat patients with degenerative mitral regurgitation;

- we received CE Mark approval for our *MITRIS RESILIA* surgical mitral valve;

- we completed enrollment in the ENCIRCLE Trial, the first pivotal trial for our transfemoral mitral replacement therapy, *SAPIEN M3*;

- we received FDA approval for a *SAPIEN M3* continued access program;

- we restarted enrollment in our pivotal trial, ALLIANCE, designed to study our next generation TAVR technology, *SAPIEN X4*;

- we completed the enrollment of the full cohort of the TRISCEND II pivotal trial of the *EVOQUE* replacement system; and

- we announced our intention to complete a tax-free spin-off of our Critical Care product group around the end of 2024.

| | | | 2023 | | | | | | 2022 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| United States | | | $ | 3,508.7 | | | | | $ | 3,132.6 | | | | | | | | | | | $ | 376.1 | | | | | | | | | | | 12.0 | | % | | | | | | |

| Europe | | | 1,334.5 | | | | | | 1,174.8 | | | | | | | | | | | | 159.7 | | | | | | | | | | | | 13.6 | | % | | | | | | |

| Japan | | | 452.4 | | | | | | 473.6 | | | | | | | | | | | | (21.2) | | | | | | | | | | | | (4.5) | | % | | | | | | |

| Rest of World | | | 709.2 | | | | | | 601.4 | | | | | | | | | | | | 107.8 | | | | | | | | | | | | 17.9 | | % | | | | | | |

| Outside of the United States | | | 2,496.1 | | | | | | 2,249.8 | | | | | | | | | | | | 246.3 | | | | | | | | | | | | 10.9 | | % | | | | | | |

| Total net sales | | | $ | 6,004.8 | | | | | $ | 5,382.4 | | | | | | | | | | | $ | 622.4 | | | | | | | | | | | 11.6 | | % | | | | | | |

| Surgical Heart Valve Therapy | | | 999.3 | | | | | | 893.1 | | | | | | | | | | | | 106.2 | | | | | | | | | | | | 11.9 | | % | | | | | | |

| Critical Care | | | 928.1 | | | | | | 855.0 | | | | | | | | | | | | 73.1 | | | | | | | | | | | | 8.5 | | % | | | | | | |

partially offset by:

In March 2023, we launched the *Edwards SAPIEN 3 Ultra RESILIA* valve in Japan.

In July 2023, we announced the restart of enrollment in our pivotal trial, ALLIANCE, designed to study our next generation TAVR technology, *SAPIEN X4*.

During 2023, we continued to enroll the CLASP IIF pivotal trial with *PASCAL* for patients with functional mitral regurgitation.

In mitral replacement, we completed enrollment in the ENCIRCLE pivotal trial for *SAPIEN M3* and, in January 2024, we received FDA approval for a S*APIEN M3* continued access program*.* In tricuspid, we completed the enrollment of the full cohort of the TRISCEND II pivotal trial of the *EVOQUE* replacement system.

In October 2023, we received CE Mark approval in Europe for *EVOQUE* and in February 2024 we received FDA approval for *EVOQUE* for the treatment of tricuspic regurgitation.

In October 2023, we also received approval in Japan for *PASCAL Precision* to treat patients with degenerative mitral regurgitation.

In addition, enrollment continued in the CLASP IITR pivotal trial with the *PASCAL* repair system in patients with symptomatic, severe tricuspid regurgitation.

These increases were partially offset by the impact of foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by $6.4 million, primarily due to the weakening of the Japanese yen against the United States dollar, partially offset by the strengthening of the Euro against the United States dollar.

In October 2023, we received CE Mark approval for our *MITRIS RESILIA* mitral valve and have begun its launch in several European countries.

Critical Care

The increase in net sales of Critical Care products was driven by:

- increased demand for our enhanced surgical recovery products and pressure monitoring products, primarily in the United States;

- foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by $10.3 million primarily due to the weakening of the Japanese yen against the United States dollar.

[removed: million] [added: As] of [added: December 31, 2024, we had $1.1 billion of] investments in debt securities which had an average remaining term to maturity of [removed: 0.53] [added: 0.16] 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: 2023] [added: 2024] would have resulted in a [removed: $3.2] [added: $1.8] million to [removed: $6.5] [added: $3.5] million decrease in the fair value of these investments.

For more information related to investments, see Note [removed: 7] [added: 8] to the [removed: "*Consolidated] [added: *Consolidated] Financial [removed: Statements.*"][added: Statements.*]

As of December 31, [removed: 2023,] [added: 2024,] 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 ("SOFR").

As of December 31, [removed: 2023,] [added: 2024,] there were no borrowings outstanding under the Credit Agreement.

Based on our December 31, [removed: 2023] [added: 2024] 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: 2023,] [added: 2024,] a hypothetical 1.0% absolute increase in market interest rates would decrease the fair value of the fixed-rate debt by approximately [removed: $23.1] [added: $18.2] million.

For more information related to outstanding debt obligations, see Note [removed: 11] [added: 12] to the [removed: "*Consolidated] [added: *Consolidated] Financial [removed: Statements.*"][added: Statements.*]

The total notional amount of our derivative financial instruments entered into for foreign currency management purposes at December 31, [removed: 2023] [added: 2024] was [removed: $2.1] [added: $2.2] 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: $165.5] [added: $105.2] million.

For more information related to outstanding foreign exchange contracts, see Note 2 and Note [removed: 13] [added: 14] to the [removed: "*Consolidated] [added: *Consolidated] Financial [removed: Statements.*"][added: Statements.*]

At December 31, [removed: 2023,] [added: 2024,] all derivative financial instruments were with bank counterparties assigned investment grade ratings by national rating agencies.

In [removed: 2023,] [added: 2024,] we had no customers that represented 10% or more of our total net sales or accounts receivable, net.

As of December 31, [removed: 2023,] [added: 2024,] we had [removed: $963.2 million] [added: $1.1 billion] of investments in debt securities of various companies, of which [removed: $462.7] [added: $148.5] million were long-term.

In addition, we had [removed: $121.2] [added: $159.4] million of investments in equity instruments.

See Note [removed: 7] [added: 8] to the [removed: *"Consolidated] [added: *Consolidated] Financial [removed: Statements"*] [added: Statements*] for additional information.

As of December 31, 2023, we had $963.2

Since our founder, [added: Miles] 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.

Our innovative work [removed: in heart valves] encompasses both surgical and transcatheter [removed: therapies for heart valve replacement and repair.][added: therapies.]

Our vision is to transform patient care where patients are diagnosed earlier, treated in a routine fashion, [removed: living longer] [added: live longer,] and [removed: enjoying] [added: enjoy] a better quality of life.

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 [removed: Lifesciences] annuloplasty ring.

Alternatively, a clinician (typically an interventional cardiologist) may implant an Edwards [removed: Lifesciences] 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.

Our products [removed: and technologies] are categorized into [removed: four main] [added: the following] groups: Transcatheter Aortic Valve [removed: Replacement,] [added: Replacement ("TAVR"),] Transcatheter Mitral and Tricuspid [removed: Therapies,] [added: Therapies ("TMTT"), and] Surgical Structural [removed: Heart, and Critical Care.][added: Heart ("Surgical").]

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

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

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

[removed: 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: groundbreaking] [added: optimistic] data that has expanded access to patients of all risk profiles.

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

Additionally, the [removed: Edwards] [added: *Edwards*] *SAPIEN 3* system and *Alterra* system offer a minimally invasive option for pulmonary valve replacement for patients with congenital heart disease.

Sales of our [removed: transcatheter aortic] [added: surgical tissue heart] valve [removed: replacement] products represented [removed: 65%] [added: 18%, 19%, and 19%] of our net sales in [removed: each of] [added: 2024,] 2023, [removed: 2022,] and [removed: 2021.][added: 2022, respectively.]

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

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

[removed: In addition to transcatheter repair, we] [added: We] believe [added: both] transcatheter [added: repair and] replacement [removed: is key] [added: are necessary] to [removed: unlocking] [added: unlock] the full mitral and tricuspid opportunity.

[removed: We believe our] [added: In addition to these therapies, we are pursuing a transcatheter] mitral replacement strategy [removed: positions] [added: which we believe would position] us for leadership in the mid-to-long term.

[added: The] *SAPIEN M3* [added: transcatheter mitral valve replacement system] is based on the proven *SAPIEN* valve and is designed specifically for mitral patients.

The *EVOQUE* [removed: system is] [added: system,] the world's first transcatheter [added: tricuspid] valve replacement therapy to receive regulatory [removed: approval to treat] [added: approval, addresses] tricuspid [removed: regurgitation.][added: valve regurgitation by replacing the native valve with a bioprosthetic valve.]

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

Sales of our [removed: surgical tissue heart valve] [added: TAVR] products represented [removed: 16%, 15%,] [added: 75%, 77%,] and [removed: 16%] [added: 79%] of our net sales in [added: 2024,] 2023, [removed: 2022,] and [removed: 2021,] [added: 2022,] respectively.

1 [removed: Bavaria,] [added: Beaver T, Bavaria JE, Griffith B,] et al.

[removed: Final 5-year] [added: Seven-year] outcomes following aortic valve replacement with [removed: *RESILIA*] [added: a novel] tissue [removed: bio prosthesis.][added: bioprosthesis.]

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

In [removed: Transcatheter Aortic Valve Replacement,] [added: TAVR,] our primary competitors include Medtronic [removed: PLC,] [added: plc ("Medtronic"),] Abbott Laboratories ("Abbott"), and Boston Scientific Corporation.

In [removed: Transcatheter Mitral and Tricuspid Therapies,] [added: TMTT,] our primary competitor is Abbott, and there are a considerable number of large and small companies with development efforts in these fields.

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

We have a number of product lines that require sales and marketing strategies [added: that are] tailored to deliver high-quality, cost-effective products and technologies to customers worldwide.

We are not dependent on any single customer and no single customer accounted for 10% or more of our net sales in [removed: 2023.][added: 2024.]

[added: In addition to working closely with] physicians, nurses, and other clinical personnel, our customers include decision makers such as service line leaders, material managers, biomedical staff, hospital administrators and executives, purchasing managers, and ministries of health.

In [removed: 2023, 58%] [added: 2024, 59%] of our net sales were derived from sales to customers in the United States.

Outside of the United States. In [removed: 2023, 42%] [added: 2024, 41%] 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: 53%] [added: 59%] were in Europe, [removed: 18%] [added: 15%] were in Japan, and [removed: 28%] [added: 26%] were in Rest of World.

We sell our products in approximately 100 countries, including [removed: Japan,] Germany, [added: Japan,] France, United Kingdom, Italy, [removed: China,] [added: Canada,] and [removed: Canada.][added: China.]

We manufacture our [removed: Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid technologies,] [added: TAVR, TMTT,] and [removed: Structural] Surgical [removed: Heart] products primarily in the United [removed: States (California and Utah),] [added: States,] Singapore, Costa Rica, and Ireland.

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

Our operations are frequently inspected by the many regulators that oversee medical device manufacturing, including the [removed: FDA,] [added: United States Food and Drug Administration ("FDA"),] European Notified Bodies, and other regulatory entities.

These regulatory approvals and ISO certifications can be obtained only after a successful audit of a company's quality system has been conducted by regulatory [added: or independent outside auditors.]

In order to measure performance, we monitor and report on a number of metrics, including regulated and non-regulated waste disposal, energy usage, water consumption, air [removed: toxic] emissions, and injuries from our production activities.

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

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

In addition, our unique portfolio of repair and replacement technologies for both mitral and tricuspid 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, robust and expanding clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes.

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 stenosis and mitral and tricuspid regurgitation

Edwards' transcatheter aortic heart valves

In 2024, *EARLY TAVR* trial data were presented, demonstrating the superiority of early TAVR intervention in severe asymptomatic aortic stenosis patients with the *SAPIEN 3* platform versus clinical surveillance.

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").

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 stenosis and mitral and tricuspid regurgitation.

Overview

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

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

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

Since our founder, Miles 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.

Our innovative work encompasses both surgical and transcatheter therapies.

In addition, our unique portfolio of repair and replacement technologies for both mitral and tricuspid 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, robust and expanding clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes.

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.

Cardiovascular disease is progressive in that it tends to worsen over time and often affects the structure of an individual's heart.

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.

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 stenosis and mitral and tricuspid regurgitation.

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.

Alternatively, a clinician (typically an interventional cardiologist) 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.

These entities confirm our compliance with the various laws and regulations governing the development, testing, manufacturing, labeling, marketing, and distribution of our products.

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

We are proud of our patient-focused culture, and the way we work together globally to bring life-saving innovations to patients in need.

We recognize the need for diverse perspectives and experiences, and we foster inclusion, belonging, and collaboration across Edwards.

We believe this commitment can be best achieved by always selecting the best candidate and building a culture that celebrates excellence.

We aim to deliver this by centering our decisions on the following focus areas whose overriding priority is "The Patient" - Business, People, Communication, and Community.

Edwards Lifesciences Corporation is the global leader in patient-focused medical innovations for structural heart disease and critical care monitoring.

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 or who require hemodynamic monitoring during surgery or in intensive care.

A pioneer in the development of heart valve therapies, we are the world's leading manufacturer of heart valve systems and repair products used to replace or repair a patient's diseased or defective heart valve.

In addition, our robust pipeline of future technologies is focused on the less invasive repair or replacement of the mitral and tricuspid valves of the heart, which are more complex and more challenging to treat than the aortic valve.

We are also a global leader in hemodynamic and noninvasive brain and tissue oxygenation monitoring systems used to measure a patient's cardiovascular function in the hospital setting.

Patients in the hospital setting, including high-risk patients in the operating room or intensive care unit, are candidates for having their cardiac function or fluid levels monitored by our Critical Care products through multiple monitoring options, including noninvasive and minimally-invasive technologies.

These technologies enable proactive clinical decisions while also providing the opportunity for improving diagnoses and developing individualized therapeutic management plans for patients.

have severe symptomatic aortic stenosis.

In 2023, The *PARTNER 3* Trial, which demonstrated a 99% freedom from stroke or mortality at 1 year, had 5-year data presented with a 90% freedom from all-cause mortality.

As of 2023, the *PASCAL PRECISION* system is also commercially available in the U.S. and Japan for degenerative mitral regurgitation patients.

For tricuspid valve replacement, our *EVOQUE* system is delivered through a low-profile transfemoral sub 30-French system, and available in a variety of valve sizes to enable treatment in a wide range of patient anatomies.

In 2023, the *EVOQUE* system received CE Mark approval for the transcatheter treatment of eligible patients with tricuspid regurgitation.

More recently, in February 2024, the *EVOQUE* system received United States Food and Drug Administration ("FDA") approval for the treatment of tricuspid regurgitation.

This development will give a wide range of U.S. patients access to a treatment option that not only has the potential to improve quality-of-life, but also showed favorable clinical trends in all-cause mortality, re-intervention, and heart failure hospitalizations.

Five-year Outcomes of the COMMENCE trial investigating Aortic Valve Replacement with a Bioprosthetic Valve with a Novel Tissue.

The Society of Thoracic Surgeons 2021 Annual Meeting; Bartus, et al.

European Journal of Cardio-Thoracic Surgery, 2020.

Critical Care

We are the world leader in advanced hemodynamic monitoring systems used to measure a patient's heart function and fluid status in surgical and intensive care settings.

Edwards’ complete hemodynamic portfolio helps clinicians make proactive clinical decisions that can improve patient recovery.

The portfolio includes the minimally-invasive *FloTrac* and *Acumen IQ* sensors, the noninvasive *ClearSight* and *Acumen IQ* cuffs, and the *ForeSight* noninvasive tissue oximetry sensor.

We also support clinical needs with our well-established *Swan-Ganz* pulmonary artery catheters and arterial pressure monitoring products.

Compatible with our portfolio of sensors and catheters, the *HemoSphere* monitoring platform displays valuable physiological information.

Our first predictive algorithm, *Acumen Hypotension Prediction Index* software, alerts clinicians in advance of a patient developing dangerously low blood pressure.

Our latest algorithm, *Acumen Assisted Fluid Management* software, provides patient-specific fluid suggestions to help keep patients in an optimal range during surgery.

On December 7, 2023, we announced plans for a tax-free spin-off of our Critical Care product group as a separate publicly traded company to Edwards Lifesciences' shareholders.

While we expect to complete the Critical Care spin-off around the end of 2024, we remain committed to supporting strong momentum and growth during the transition period.

The team will advance innovative advanced patient monitoring solutions, with the goal of improving the quality of care for millions of patients annually.

Critical Care is currently integrating a full range of smart monitoring technologies into the seventh generation of its *HemoSphere* platform, creating a unique offering of enhanced recovery tools.

In Critical Care, we compete primarily with a variety of companies in specific product lines including ICU Medical, Inc., PULSION Medical Systems SE, a subsidiary of Getinge AB, Cheetah Medical, Inc., a subsidiary of Baxter International, and LiDCO Group PLC, a subsidiary of Masimo Corporation.

In addition to working closely with

We manufacture our Critical Care products primarily in the Dominican Republic and Puerto Rico.

or independent outside auditors.

In our Critical Care product line, we are pursuing the development of a variety of decision support solutions for our clinicians.

This includes next-generation noninvasive and minimally-invasive hemodynamic monitoring systems, and a next-generation monitor platform.

We are also developing a decision support software suite with advanced algorithms for proactive hemodynamic management, including a semi-closed loop system for standardized management of patient fluid levels.

Lastly, we are developing a connectivity platform that will offer clinicians additional clinical support, remote monitoring capability, analytics, and insights for their patients’ hemodynamic status.

FDA review may involve substantial delays that adversely affect the marketing and sale of our products.

If an MRA covering the MDR is not put in place, then non-EU manufacturers may be required to make significant changes, including replacement of Swiss economic operators with operators based in EU member states, and changes will need to be made to our device labeling and/or packaging to satisfy MDR requirements.

If these measures are unable to be taken, it may no longer be possible to place such devices on the EU market.

Please see Note 20 to our *Consolidated Financial Statements* in this Annual Report for a description of our legal proceedings, which is incorporated by reference herein.

In 2021, we initiated an internal review and investigation into whether business activities in Japan and other markets violated certain provisions of the Foreign Corrupt Practices Act ("FCPA").

We voluntarily notified the United States Securities and Exchange Commission ("SEC") and the United States Department of Justice ("DOJ") during 2021 that we engaged outside counsel to conduct this review and investigation.

We have provided status updates to the SEC and DOJ since that time.

Any determination that our operations or activities are not in compliance with existing laws, including the FCPA, could result in the imposition of fines, penalties, and equitable remedies.

We cannot currently predict the final outcome of the investigation or any potential impact on our financial statements.

On September 28, 2021, Aortic Innovations LLC, a non-practicing entity, filed a lawsuit against Edwards Lifesciences Corporation and certain of its subsidiaries (“Edwards”) in the United States District Court for the District of Delaware, alleging that Edwards’ *SAPIEN 3 Ultra* product infringes certain of its patents.

We are unable to predict the ultimate outcome of this matter or estimate a range of possible exposure; therefore, no amount has been accrued.

We intend to vigorously defend ourselves in this litigation.

The European Commission (the "Commission") is investigating certain business practices of Edwards including its unilateral pro-innovation (anti-copycat) policy and patent practices.

We are committed to healthy competition and are cooperating with the Commission.

We cannot predict the outcome of the investigation or the potential impact on its financial statements.

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: 2023][added: 2024]

Indicate by check mark whether any of those error corrections are restatements that required a [removed: recover] [added: recovery] analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b).

The aggregate market value of the registrant's common stock held by non-affiliates as of June [removed: 30, 2023] [added: 28, 2024] (the last trading day of the registrant's most recently completed second quarter): [removed: $56,849,824,065] [added: $55,525,009,946] 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: 2024,] [added: 2025,] was [removed: 601.3] [added: 587.9] million.

Portions of the registrant's proxy statement for the [removed: 2024] [added: 2025] Annual Meeting of Stockholders (to be filed within 120 days of December 31, [removed: 2023)] [added: 2024)] are incorporated by reference into Part III, as indicated herein.

Form 10-K Annual [removed: Report—2023][added: Report—2024]

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

These statements can sometimes be identified by the use of the forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "goal," "continue," "seek," "pro forma," "forecast," "intend," "guidance," "optimistic," "aspire," "confident," [added: or] other forms of these words or similar words or expressions or the negatives thereof.

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 "preliminary," "initial," "potential," "possible," "diligence," "industry-leading," "compliant," "indications," [removed: or] "early [removed: feedback"] [added: 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: [added: our ability to realize] the [removed: spin-off] [added: anticipated benefits] of [added: the sale of] our [removed: critical care] [added: Critical Care] product [removed: group,] [added: group;] our ability to develop new products and avoid manufacturing and quality issues; [added: risks or challenges related to integrating acquired businesses;] clinical trial or commercial results or new product approvals and therapy adoption; the impact of domestic and global [removed: economic] conditions; [added: dependence on physicians, research institutions, and hospital systems;] competition in the markets in which we operate; our reliance on vendors, suppliers, and other third parties; damage, [removed: failure,] [added: failure] or interruption of our information technology systems; the impact of public health crises; consolidation in the healthcare industry; our ability to protect our intellectual property; our compliance with applicable regulations; our exposure to product liability claims; use of our products in unapproved circumstances; changes to reimbursement for our products; the impact of currency exchange rates; unanticipated actions by the United States Food and Drug Administration and other regulatory agencies; changes to tax laws; unexpected impacts or expenses of litigation or internal or government investigations; and other risks detailed under "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.

These forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the [removed: statement.][added: statement, except as required by law.]

If we do update or correct one or more of these statements, investors and others should not conclude that we will make additional updates or [removed: corrections.*][added: corrections, except as required by law.*]

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

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

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

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

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

| [PART I](#i439731ebbdd84c3bbb0be09a4bcbe5ab_10) | | | | | | | | |

| [PART II](#i439731ebbdd84c3bbb0be09a4bcbe5ab_34) | | | | | | | | |

| [PART III](#i439731ebbdd84c3bbb0be09a4bcbe5ab_160) | | | | | | | | |

| [PART IV](#i439731ebbdd84c3bbb0be09a4bcbe5ab_178) | | | | | | | | |

| | | | [Signatures](#i439731ebbdd84c3bbb0be09a4bcbe5ab_187) | | | [98](#i439731ebbdd84c3bbb0be09a4bcbe5ab_187) | | |

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

We evaluate cybersecurity risk on an ongoing basis, and it is a risk monitored through our overall enterprise risk management program, including by the executive leadership and the [removed: board] [added: Board] of [removed: directors,] [added: Directors,] described below under [removed: "*Governance*."][added: *Governance*.]

We also periodically engage external partners to conduct annual audits of our [removed: systems,] [added: systems] and test our IT infrastructure.

[added: To minimize the risk and vulnerabilities to our own systems stemming] from such use, our Information Security team identifies and addresses known cybersecurity threats and incidents at third-party service providers on a continuous basis.

Our risks associated with cybersecurity threats are set forth under [removed: “*Risk Factors*”] [added: "*Risk Factors"*] in Part I, Item 1A in this report.

Our [removed: SVP,] [added: Senior Vice President ("SVP"),] Enterprise Risk 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 [removed: Officer (“CIO”) and our Chief Information] Security Officer (“CISO”) [removed: present to the Audit Committee at each] [added: meets] regularly [removed: scheduled] [added: with the] Audit Committee [removed: meeting] on [removed: information technology infrastructure as well as] risks related to cybersecurity and information security.

This council is responsible for [removed: assessing,] [added: assessing] and providing input [removed: into,] [added: into] the enterprise risks that are presented to the Board of Directors.

Based on information known to us, we do not believe any risks from cybersecurity threats, including as a result of previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition.

To minimize the risk and vulnerabilities to our own systems stemming

We have not had previous cybersecurity incidents that have materially affected us.

| Cartago, Costa Rica | | | (1),(2) | | | | | | [removed: Manufacturing] [added: Manufacturing, Administration] | | |

| Naperville, Illinois | | | (2) | | | | | | Manufacturing, Administration | | |

| Haina, Dominican Republic | | | (1),(2) | | | | | | Manufacturing | | |

| Añasco, Puerto Rico | | | (2) | | | | | | Manufacturing | | |

On January 31, [removed: 2024,] [added: 2025,] there were [removed: 7,599] [added: 7,197] 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 | | | | | | [removed: Approximate Dollar] [added: Approximate Dollar] Value [removed: of Shares that May] [added: of Shares that May] Yet [removed: Be Purchased Under] [added: Be Purchased Under] the [removed: Plans or Programs (in millions) (a),] [added: Plans or Programs (in millions) (a)] (b) | | | | | |

(a) In [removed: July 2022,] [added: August 2024,] the Board of Directors approved a stock repurchase program providing for up to $1.5 billion of repurchases of our common [removed: stock, effective July 28, 2022.][added: stock.]

(b) In [removed: December 2023,] [added: August 2024,] we entered into a [removed: $400.0] [added: $500.0] million accelerated share repurchase ("ASR") agreement and received, on [removed: December 12, 2023,] [added: September 5, 2024,] an initial delivery of [removed: 4.6] [added: 5.8] million shares of our common stock, representing approximately 80 percent of the total contract value.

The ASR concluded [removed: and] on December [removed: 29, 2023] [added: 27, 2024 and] we received an additional [removed: 0.7] [added: 1.7] million shares.

The cumulative total return listed below assumes an initial investment of $100 at the market close on December 31, [removed: 2018] [added: 2019] and reinvestment of dividends.

[removed: ][added: ]

| | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2023] [added: 2024] | | |

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

| 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 | | |

| October 1, 2023 through October 31, 2023 | | | | | | | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 492.8 | | | | |

| November 1, 2023 through November 30, 2023 | | | | | | | | | | | | 649,918 | | | | | | 64.76 | | | | | | 649,918 | | | | | | 450.7 | | | | | |

| December 1, 2023 through December 31, 2023 | | | | | | | | | | | | 5,333,315 | | | | | | 75.41 | | | | | | 5,333,315 | | | | | | 1,048.5 | | | | | |

| Total | | | | | | | | | | | | 5,983,233 | | | | | | 74.25 | | | | | | 5,983,233 | | | | | | | | | | | |

In December 2023, the Board of Directors approved an additional $1.0 billion of repurchases under this program.

| Edwards Lifesciences | | | $ | 152.31 | | | | | $ | 178.68 | | | | | $ | 253.74 | | | | | $ | 146.13 | | | | | $ | 149.34 | |

| S&P 500 | | | 131.49 | | | | | | 155.68 | | | | | | 200.37 | | | | | | 164.08 | | | | | | 207.21 | | |

| S&P 500 Health Care Equipment | | | 129.32 | | | | | | 152.12 | | | | | | 181.56 | | | | | | 147.32 | | | | | | 160.64 | | |

[removed: DECEMBER] [added: | Balance at December] 31, [removed: 2023][added: 2023 | | | $ | — | | | | |]

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#i439731ebbdd84c3bbb0be09a4bcbe5ab_67) 238[)](#i439731ebbdd84c3bbb0be09a4bcbe5ab_67)] [added: ID](#ife1ed5cd84d945f99b0f6c7065fc6e7b_73) 238[)](#ife1ed5cd84d945f99b0f6c7065fc6e7b_73)] | | | [removed: [44](#i439731ebbdd84c3bbb0be09a4bcbe5ab_67)] [added: [42](#ife1ed5cd84d945f99b0f6c7065fc6e7b_73)] | | |

| [Consolidated Balance Sheets as of December [removed: 31,](#i439731ebbdd84c3bbb0be09a4bcbe5ab_70)] [added: 31,](#ife1ed5cd84d945f99b0f6c7065fc6e7b_76) 2024 [and](#ife1ed5cd84d945f99b0f6c7065fc6e7b_76)] 2023 [removed: [and](#i439731ebbdd84c3bbb0be09a4bcbe5ab_70) 2022] | | | [removed: [46](#i439731ebbdd84c3bbb0be09a4bcbe5ab_70)] [added: [45](#ife1ed5cd84d945f99b0f6c7065fc6e7b_76)] | | |

| For the Years Ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021:] [added: 2022:] | | | | | |

| [Consolidated Statements of [removed: Operations](#i439731ebbdd84c3bbb0be09a4bcbe5ab_73)] [added: Operations](#ife1ed5cd84d945f99b0f6c7065fc6e7b_79)] | | | [removed: [47](#i439731ebbdd84c3bbb0be09a4bcbe5ab_73)] [added: [46](#ife1ed5cd84d945f99b0f6c7065fc6e7b_79)] | | |

| [Consolidated Statements of Comprehensive [removed: Income](#i439731ebbdd84c3bbb0be09a4bcbe5ab_76)] [added: Income](#ife1ed5cd84d945f99b0f6c7065fc6e7b_82)] | | | [removed: [48](#i439731ebbdd84c3bbb0be09a4bcbe5ab_76)] [added: [47](#ife1ed5cd84d945f99b0f6c7065fc6e7b_82)] | | |

| [Consolidated Statements of Cash [removed: Flows](#i439731ebbdd84c3bbb0be09a4bcbe5ab_79)] [added: Flows](#ife1ed5cd84d945f99b0f6c7065fc6e7b_85)] | | | [removed: [49](#i439731ebbdd84c3bbb0be09a4bcbe5ab_79)] [added: [48](#ife1ed5cd84d945f99b0f6c7065fc6e7b_85)] | | |

| [Consolidated Statements of Stockholders' [removed: Equity](#i439731ebbdd84c3bbb0be09a4bcbe5ab_82)] [added: Equity](#ife1ed5cd84d945f99b0f6c7065fc6e7b_88)] | | | [removed: [50](#i439731ebbdd84c3bbb0be09a4bcbe5ab_82)] [added: [49](#ife1ed5cd84d945f99b0f6c7065fc6e7b_88)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i439731ebbdd84c3bbb0be09a4bcbe5ab_85)] [added: Statements](#ife1ed5cd84d945f99b0f6c7065fc6e7b_91)] | | | [removed: [51](#i439731ebbdd84c3bbb0be09a4bcbe5ab_85)] [added: [50](#ife1ed5cd84d945f99b0f6c7065fc6e7b_91)] | | |

| [removed: All other] [added: Financial statement] schedules [removed: are] [added: not included in this Form 10-K have been] omitted [removed: as] [added: because] they are not applicable or [added: because] the required information is [removed: furnished] [added: shown] in the [removed: Consolidated Financial Statements] [added: consolidated financial statements] or [added: the] notes thereto. | | | | | |

We have audited the accompanying consolidated balance sheets of Edwards Lifesciences Corporation and its subsidiaries (the “Company”) as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] 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: 2023,] [added: 2024,] 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: 2023,] [added: 2024,] 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: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] 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: 2023,] [added: 2024,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

[removed: 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 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.

Critical Audit [removed: Matter][added: Matters]

The critical audit [removed: matter] [added: matters] communicated below [removed: is a matter] [added: are matters] arising from the current period audit of the consolidated financial statements that [removed: was] [added: were] communicated or required to be communicated to the audit committee and that (i) [removed: relates] [added: relate] 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: matter] [added: matters] below, providing [removed: a] separate [removed: opinion] [added: opinions] on the critical audit [removed: matter] [added: matters] or on the accounts or disclosures to which [removed: it relates.][added: they relate.]

As described in Note [removed: 18] [added: 19] to the consolidated financial statements, the Company had an uncertain gross tax [removed: position liability] [added: positions] balance of [removed: $583.9] [added: $678.8] million as of December 31, [removed: 2023,] [added: 2024,] of which a majority is related to intercompany transfer pricing.

The principal considerations for our determination that performing procedures relating to [added: the] uncertain tax positions related to intercompany transfer pricing is a critical audit matter are [added: (i)] the significant judgment by management when [removed: determining] [added: recognizing and evaluating the] uncertain tax positions related to intercompany transfer [removed: pricing, including] [added: pricing; (ii)] a high degree of [removed: estimation uncertainty] [added: auditor judgment, subjectivity, and effort] in [removed: estimating] [added: performing procedures and evaluating management's measurement of] the [removed: ultimate resolution] [added: uncertain tax positions related] to intercompany [removed: pricing controversies between countries when there are numerous possible outcomes.][added: transfer pricing; 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 [removed: intercompany transfer pricing,] [added: the recognition] and [removed: controls over measurement] [added: evaluation] of [removed: the liability.][added: uncertain tax positions related to intercompany transfer pricing.]

These procedures also included, among [removed: others,] [added: others] (i) testing the information used in the calculation of the [removed: liability for] uncertain tax positions related to intercompany transfer pricing, including [removed: US] [added: United States] federal filing [removed: positions,] [added: positions] and the related final income tax returns; (ii) testing the calculation of the [removed: liability for] uncertain tax positions related to intercompany transfer pricing, by jurisdiction, including management’s assessment of the technical merits of tax positions and estimates of the amount of tax benefit expected to be sustained; (iii) testing management’s assessment of possible outcomes of uncertain tax positions related to intercompany transfer pricing controversies between countries; and (iv) [removed: evaluating] [added: evaluating, for uncertain tax positions related to intercompany transfer pricing,] the status and results of income tax audits with the relevant tax authorities.

Professionals with specialized skill and knowledge were used to assist in [removed: the evaluation of] [added: evaluating (i)] the [removed: accurate] measurement of the Company’s uncertain tax positions related to intercompany transfer pricing, including evaluating the reasonableness of management’s assessment of whether tax positions are more-likely-than not to be sustained and the amount of potential tax benefit to be [removed: realized,] [added: realized] and [added: (ii)] the application of relevant tax laws.

| | | | [added: 2024 | | | | | |] 2023 | | | | | | 2022 | | |

| Cash and cash equivalents | | | $ | [removed: 1,144.0] [added: 3,045.2] | | | | | $ | [removed: 769.0] [added: 1,132.3] | |

| Short-term investments (Note [removed: 7)] [added: 8)] | | | [removed: 500.5] [added: 930.7] | | | | | | [removed: 446.3] [added: 500.5] | | |

| Accounts receivable, net of allowances of [removed: $8.3] [added: $11.6] and [removed: $7.9,] [added: $8.2,] respectively | | | [removed: 775.1] [added: 609.1] | | | | | | [removed: 643.0] [added: 771.5] | | |

| Other receivables | | | [removed: 61.8] [added: —] | | | | | | [removed: 56.1] [added: 5.2] | | |

| Other current assets | | | [removed: 239.3] [added: —] | | | | | | [removed: 195.9] [added: 14.4] | | |

| Total current assets | | | [removed: 4,035.7] [added: 6,285.4] | | | | | | [removed: 3,095.8] [added: 4,035.7] | | |

| Long-term investments (Note [removed: 7)] [added: 8)] | | | [removed: 583.9] [added: 307.9] | | | | | | [removed: 1,239.0] [added: 583.9] | | |

| Property, plant, and equipment, net (Note [removed: 5)] [added: 6)] | | | [removed: 1,749.4] [added: 1,686.0] | | | | | | [removed: 1,632.8] [added: 1,591.0] | | |

| Operating lease right-of-use assets (Note [removed: 6)] [added: 7)] | | | [removed: 94.0] [added: 98.2] | | | | | | [removed: 92.3] [added: 84.4] | | |

| Other intangible assets, net (Note [removed: 10)] [added: 11)] | | | [removed: 428.4] [added: 1,176.6] | | | | | | [removed: 285.2] [added: 399.4] | | |

| Deferred income taxes | | | [removed: 754.6] [added: —] | | | | | | [removed: 484.0] [added: 5.2] | | |

| [removed: Other assets] [added: Other assets] | | | [removed: 463.7] | | | | | | [removed: 299.1] | | |

| Total assets | | | $ | [removed: 9,363.2] [added: 13,055.3] | | | | | $ | [removed: 8,292.5] [added: 9,363.2] | |

| Accounts payable | | | $ | [removed: 201.4] [added: —] | | | | | $ | [removed: 201.9] [added: 14.8] | |

| Accrued and other liabilities (Note [removed: 5)] [added: 6)] | | | [removed: 969.1] [added: 1,282.4] | | | | | | [removed: 795.0] [added: 856.4] | | |

| Operating lease liabilities (Note [removed: 6)] [added: 7)] | | | [removed: 24.9] [added: 23.4] | | | | | | [removed: 25.5] [added: 22.9] | | |

DECEMBER 31, 2024

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

*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.

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

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.

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 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.

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

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.

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.

February 28, 2025

| | | | 2024 | | | | | | 2023 | | |

| Other receivables | | | 118.3 | | | | | | 56.6 | | |

| Inventories (Note 6) | | | 1,086.7 | | | | | | 903.5 | | |

| Prepaid expenses | | | 121.0 | | | | | | 128.8 | | |

| Other current assets | | | 347.6 | | | | | | 224.9 | | |

| Current assets of discontinued operations (Note 5) | | | 26.8 | | | | | | 317.6 | | |

| Goodwill (Note 11) | | | 1,776.7 | | | | | | 1,145.1 | | |

| Deferred income taxes | | | 992.1 | | | | | | 749.4 | | |

| Other assets | | | 721.6 | | | | | | 463.2 | | |

| Non-current assets of discontinued operations (Note 5) | | | 10.8 | | | | | | 311.1 | | |

| Accounts payable | | | $ | 197.4 | | | | | $ | 186.6 | |

| Current liabilities of discontinued operations (Note 5) | | | 2.0 | | | | | | 129.5 | | |

This in turn led to a high degree of auditor judgment, effort, and subjectivity in performing procedures to evaluate the accurate measurement of uncertain tax positions related to intercompany transfer pricing.

In addition, the audit effort involved the use of professionals with specialized skill and knowledge.

February 12, 2024

| Inventories (Note 5) | | | 1,168.2 | | | | | | 875.5 | | |

| Prepaid expenses | | | 146.8 | | | | | | 110.0 | | |

| Goodwill (Note 10) | | | 1,253.5 | | | | | | 1,164.3 | | |

| Net sales | | | $ | 6,004.8 | | | | | $ | 5,382.4 | | | | | $ | 5,232.5 | |

| Gross profit | | | 4,625.0 | | | | | | 4,302.0 | | | | | | 3,983.6 | | |

| Operating income | | | 1,534.1 | | | | | | 1,748.5 | | | | | | 1,690.3 | | |

| Basic | | | $ | 2.31 | | | | | $ | 2.46 | | | | | $ | 2.41 | |

| Diluted | | | $ | 2.30 | | | | | $ | 2.44 | | | | | $ | 2.38 | |

| Proceeds from issuance of debt | | | — | | | | | | — | | | | | | 5.2 | | |

| Payments on debt and finance lease obligations | | | (0.3) | | | | | | (0.2) | | | | | | (7.0) | | |

| Other | | | (1.0) | | | | | | (3.6) | | | | | | (0.3) | | |

| BALANCE AT DECEMBER 31, 2020 | | | 636.4 | | | | | | $ | 636.4 | | | | | 12.1 | | | | | | $ | (1,904.1) | | | | | $ | 1,438.1 | | | | | $ | 4,565.0 | | | | | $ | (161.1) | | | | | $ | 4,574.3 | | | | | $ | — | | | | | $ | 4,574.3 | |

| Other comprehensive loss, net of tax | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 12.1 | | | | | | 12.1 | | | | | | | | | | | | 12.1 | | |

On December 7, 2023, the Company announced its intention to complete a tax-free spin-off of its Critical Care product group around the end of 2024.

The planned separation will enable the Company to pursue expanded opportunities for TAVR, TMTT, and Surgical patients, as well as new investments in interventional heart failure technologies.

In addition, the Company

The Company sells separately priced service contracts, which range from 12 to 36 months, to owners of its hemodynamic monitors.

The Company invoices the customer the total amount of consideration at the inception of the contract and recognizes revenue ratably over the term of the contract.

As of December 31, 2023 and 2022, $13.3 million and $10.6 million, respectively, of deferred revenue associated with outstanding service contracts was recorded in “*Accrued and Other Liabilities*” and "*Other Liabilities.*" During 2023, the Company recognized as revenue $7.6 million that was included in the balance of deferred revenue as of December 31, 2022, and during 2022, the Company recognized as revenue $7.2 million that was included in the balance of deferred revenue as of December 31, 2021.

Acquisitions

respectively, were not included in the computation of diluted earnings per share because the effect would have been anti-dilutive.

| Cost of sales | | | $ | 23.6 | | | | | $ | 22.8 | | | | | $ | 20.4 | |

| Income tax benefit | | | (24.1) | | | | | | (21.6) | | | | | | (18.9) | | |

The Company recorded a prepaid royalty asset of $124.0 million in April

SPECIAL CHARGE AND SEPARATION COSTS

On December 7, 2023, the Company announced its intention to complete a spin-off of its Critical Care product group as a separate publicly traded company to Edwards Lifesciences' shareholders.

The proposed spin-off is intended to be a tax-free transaction for U.S. federal income tax purposes and is expected to be completed around the end of 2024, subject to the satisfaction of customary conditions including final approval by the Company's board of directors, receipt of a favorable opinion and Internal Revenue Service ruling with respect to the tax-free nature of the transaction, and the effectiveness of a registration statement on Form 10.

| Raw materials | | | $ | 252.6 | | | | | $ | 156.4 | |

| Work in process | | | 220.1 | | | | | | 177.4 | | |

| Finished products | | | 695.5 | | | | | | 541.7 | | |

| | | | $ | 1,168.2 | | | | | $ | 875.5 | |

| Land | | | $ | 116.4 | | | | | $ | 116.3 | |

| Equipment with customers | | | 37.9 | | | | | | 37.4 | | |

| Software | | | 87.2 | | | | | | 87.5 | | |

| Construction in progress | | | 355.3 | | | | | | 255.2 | | |

| | | | 2,606.8 | | | | | | 2,383.2 | | |

| Accumulated depreciation | | | (857.4) | | | | | | (750.4) | | |

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: 2023.][added: 2024.]

Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of December 31, [removed: 2023] [added: 2024] 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: 2023.][added: 2024.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] 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: 2023] [added: 2024] 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.

[removed: On December 14, 2023, Donald Bobo, Jr., Corporate Vice President, Strategy & Corporate Development,] [added: Zovighian, Chief Executive Officer and Director,] entered into a 10b5-1 trading plan (the “Plan”) intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended.

The Plan provides for the potential sale of [removed: 70,500] [added: 14,925] shares of the Company’s stock commencing [removed: May] [added: March] 10, [removed: 2024.][added: 2025.]

The Plan terminates on the earlier of [removed: April 14,] [added: May 16,] 2025 or the date all shares are sold.

On December 6, 2024, Bernard J.

Certain information required by this Item will be set forth under the headings "Board of Directors Matters—Proposal 1 - Election of Directors—Board of Director Nominees," [removed: "Board of Directors Matters—Corporate] [added: "Corporate] Governance Policies and Practices," and "Executive Compensation and Other Information—Executive Officers" in the definitive proxy statement to be filed in connection with the Company's [removed: 2024] [added: 2025] Annual Meeting of Stockholders (the "Proxy Statement") (which Proxy Statement will be filed with the SEC within 120 days of December 31, [removed: 2023).][added: 2024).]

The code of ethics [removed: (business] [added: (our "business] practice [removed: standards)] [added: standards")] is posted on the Company's website, which is found at https://ir.edwards.com under "Governance & [removed: Sustainability—Corporate Responsibility & Sustainability—Corporate Responsibility—Global Integrity Program."] [added: Corporate Impact—Corporate Compliance."] To the extent required by applicable rules of the SEC and the New York Stock Exchange, the Company intends to disclose on its website any amendments to, or waivers from, any provision of its code of ethics that apply to the Company's directors and executive officers, including the principal executive officer, principal financial [added: officer, principal accounting] officer or [removed: controller] [added: controller,] or persons performing similar functions.

The information contained under the heading "Other [removed: Matters and Business—Related] [added: Information—Related] Persons Transactions" and under the heading "Board of Directors Matters—Corporate Governance Policies and Practices—Director Independence" in the Proxy Statement is incorporated herein by reference.

| 3.1 | | | [Amended and Restated Certificate of Incorporation of Edwards Lifesciences Corporation, dated May 16, 2013 (incorporated by reference to Exhibit 3.1 in Edwards Lifesciences' report on Form 8-K filed on May 17, [removed: 2013)](http://www.sec.gov/Archives/edgar/data/1099800/000110465913042912/a13-12753_1ex3d1.htm)] [added: 2013)](https://www.sec.gov/Archives/edgar/data/1099800/000110465913042912/a13-12753_1ex3d1.htm)] | | |

| 3.4 | | | [Bylaws of Edwards Lifesciences Corporation, as amended and restated as [removed: of](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm) [February 16,](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm) [202](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)[3](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm) [(incorporated] [added: of February 16, 2023 (incorporated] by reference to Exhibit 3.1 in Edwards Lifesciences' report on Form 8-K filed [removed: on](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm) [February](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm) [](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)[2](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)[1](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)[, 202](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)[3](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)[)](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)] [added: on February 21, 2023)](https://www.sec.gov/Archives/edgar/data/1099800/000119312523043538/d452156dex31.htm)] | | |

| 4.1 | | | [Specimen form of certificate representing Edwards Lifesciences Corporation common stock (incorporated by reference to Exhibit 4.1 in Edwards Lifesciences' Registration Statement on Form 10 (File No. 001-15525) filed on March 15, [removed: 2000)](http://www.sec.gov/Archives/edgar/data/1099800/000095013100001782/0000950131-00-001782.txt)] [added: 2000)](https://www.sec.gov/Archives/edgar/data/1099800/000095013100001782/0000950131-00-001782.txt)] | | |

| 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: 2022)](https://www.sec.gov/ix?doc=/Archives/edgar/data/1099800/000109980022000005/ew-20211231.htm)] [added: 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)] | | |

| 4.3 | | | [Indenture, dated as of September 6, 2013, between Edwards Lifesciences Corporation and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.5 in Edwards Lifesciences' Registration Statement on Form S-3 (File No. 333-191022) filed on September 6, 2013) (the [removed: "Indenture")](http://www.sec.gov/Archives/edgar/data/1099800/000104746913008896/a2216567zex-4_5.htm)] [added: "Indenture")](https://www.sec.gov/Archives/edgar/data/1099800/000104746913008896/a2216567zex-4_5.htm)] | | |

| 4.4 | | | [Second Supplemental Indenture, dated as of June 15, 2018, to the Indenture (incorporated by reference to Exhibit 4.2 in Edwards Lifesciences' report on Form 8-K filed on June 15, 2018) ("Second Supplemental [removed: Indenture")](http://www.sec.gov/Archives/edgar/data/1099800/000119312518194499/d609576dex42.htm)] [added: Indenture")](https://www.sec.gov/Archives/edgar/data/1099800/000119312518194499/d609576dex42.htm)] | | |

| 4.5 | | | [Form of Global Note for the 4.300% Senior Notes due 2028 (incorporated by reference to Exhibit A in the Second Supplemental Indenture filed as Exhibit 4.2 in Edwards Lifesciences' report on Form 8-K filed on June 15, [removed: 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000119312518194499/d609576dex42.htm)] [added: 2018)](https://www.sec.gov/Archives/edgar/data/1099800/000119312518194499/d609576dex42.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, Bank] [added: 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] 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) | | |

| *10.2 | | | [Edwards Lifesciences Corporation Form of Employment Agreement (incorporated by reference to Exhibit 10.8 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended March 31, [removed: 2003)](http://www.sec.gov/Archives/edgar/data/1099800/000104746903018615/a2110800zex-10_8.htm)] [added: 2003)](https://www.sec.gov/Archives/edgar/data/1099800/000104746903018615/a2110800zex-10_8.htm)] | | |

| *10.3 | | | [Edwards Lifesciences Corporation Form of Employment [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-10310xkq42023.htm)] [added: Agreement (incorporated by reference to Exhibit 10.3 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2023)](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-10310xkq42023.htm)] | | |

| [removed: *10.4] [added: *10.6] | | | [Edwards Lifesciences Corporation [removed: Amended and Restated Employment] [added: Form of Change-in-Control Severance] Agreement [removed: for Michael A. Mussallem, dated March 30, 2009] (incorporated by reference to Exhibit 10.2 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended [removed: March 31, 2009)](http://www.sec.gov/Archives/edgar/data/1099800/000104746909005269/a2192784zex-10_2.htm)] [added: September 30, 2012)](https://www.sec.gov/Archives/edgar/data/1099800/000104746912010132/a2211501zex-10_2.htm)] | | |

| [removed: *10.5] [added: *10.13] | | | [Edwards Lifesciences Corporation [removed: Amended] [added: Nonemployee Directors Stock Incentive Program, as amended] and [removed: Restated Chief Executive Officer Change-in-Control Severance Agreement, dated October 9, 2012] [added: restated as of February 25, 2016] (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended [removed: September 30, 2012)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912010132/a2211501zex-10_1.htm)] [added: March 31, 2016)](https://www.sec.gov/Archives/edgar/data/1099800/000109980016000053/ex-10110xqq12016.htm)] | | |

| [removed: *10.6] [added: *10.19] | | | [Edwards Lifesciences Corporation Form of [removed: Change-in-Control Severance] [added: Indemnification] Agreement (incorporated by reference to Exhibit [removed: 10.2] [added: 10.20] in Edwards Lifesciences' report on Form [removed: 10-Q] [added: 10-K] for the [removed: quarterly period] [added: fiscal year] ended [removed: September 30, 2012)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912010132/a2211501zex-10_2.htm)] [added: December 31, 2011)](https://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_20.htm)] | | |

| *10.7 | | | [Edwards Lifesciences Corporation 2018 Edwards Incentive Plan (incorporated by reference to Exhibit 10.7 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, [removed: 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm)] [added: 2018)](https://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm)] | | |

| *10.8 | | | [Edwards Lifesciences Corporation Long-Term Stock Incentive Compensation Program, as amended and restated [removed: as of May 7, 2020] [added: on February 22, 2024] (incorporated by reference to Exhibit 10.1 in Edwards [removed: Lifesciences'] [added: Lifesciences’] report on Form 10-Q for the quarterly period ended June 30, [removed: 2020)](https://www.sec.gov/Archives/edgar/data/1099800/000109980020000019/ex-10110xqq22020.htm)] [added: 2024)](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000078/ex10110-qq22024.htm)] | | |

| *10.9 | | | [Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related Long-Term Stock Program Global Nonqualified Stock Option Award Agreement for awards granted prior to May 2015 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended March 31, [removed: 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746911004794/a2203819zex-10_1.htm)] [added: 2011)](https://www.sec.gov/Archives/edgar/data/1099800/000104746911004794/a2203819zex-10_1.htm)] | | |

| *10.18 | | | [Edwards Lifesciences Corporation Executive Deferred Compensation Plan, as amended and restated effective as of November 9, 2011 (incorporated by reference to Exhibit 10.7 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, [removed: 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_7.htm)] [added: 2011)](https://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_7.htm)] | | |

| [removed: *10.19] [added: 97.1] | | | [Edwards Lifesciences [removed: Corporation Officer Perquisite Program Guidelines, as] [added: Corporation's Policy for Recovery] of [removed: February 20, 2013] [added: Erroneously Awarded Compensation] (incorporated by reference to Exhibit [removed: 10.25] [added: 97.1] in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, [removed: 2012)](http://www.sec.gov/Archives/edgar/data/1099800/000104746913001954/a2213019zex-10_25.htm)] [added: 2023)](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-97110xkq42023.htm)] | | |

| 21.1 | | | [Subsidiaries of Edwards Lifesciences [removed: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-21110xkq42023.htm)] [added: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-21110xkq42024.htm)] | | |

| 23 | | | [Consent of Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-2310xkq42023.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-2310xkq42024.htm)] | | |

| 31.1 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-31110xkq42023.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-31110xkq42024.htm)] | | |

| 31.2 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-31210xkq42023.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-31210xkq42024.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/1099800/000109980024000004/ex-3210xkq42023.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-3210xkq42024.htm)] | | |

| [removed: 97.1] [added: 19.1] | | | [Edwards Lifesciences Corporation's [removed: Policy for Recovery of Erroneously Awarded Compensation](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-97110xkq42023.htm)] [added: Insider Trading Policy](https://www.sec.gov/Archives/edgar/data/1099800/000109980025000005/ex-19110xkq42024.htm)] | | |

| | | | | | |

| *10.13 | | | [Edwards Lifesciences Corporation Nonemployee Directors Stock Incentive Program, as amended and restated as of February 25, 2016 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended March 31, 2016)](http://www.sec.gov/Archives/edgar/data/1099800/000109980016000053/ex-10110xqq12016.htm) | | |

| *10.20 | | | [Edwards Lifesciences Corporation Form of Indemnification Agreement (incorporated by reference to Exhibit 10.20 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_20.htm) | | |

# Pursuant to a request for confidential treatment, confidential portions of this exhibit have been redacted and have been filed separately with the Securities and Exchange Commission

| February [removed: 12, 2024] [added: 28, 2025] | | | By: | | | | | | /s/ BERNARD J. ZOVIGHIAN | | |

| /s/ BERNARD J. ZOVIGHIAN | | | Director and Chief Executive Officer | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ SCOTT B. ULLEM | | | Corporate Vice President, Chief Financial Officer | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ [removed: MICHAEL A. MUSSALLEM] [added: NICHOLAS J. VALERIANI] | | | Chairman of the Board | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ KIERAN T. GALLAHUE | | | Director | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ LESLIE S. HEISZ | | | Director | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ PAUL A. LAVIOLETTE | | | Director | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ STEVEN R. LORANGER | | | Director | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ RAMONA SEQUEIRA | | | Director | | | February [removed: 12, 2024] [added: 28, 2025] | | |

| /s/ ANDREW M. DAHL | | | Senior Vice President, Corporate Controller | | | February 28, 2025 | | |

| Andrew M. Dahl | | | (Principal Accounting Officer) | | | | | |

| /s/ LESLIE C. DAVIS | | | Director | | | February 28, 2025 | | |

| Leslie C. Davis | | | | | | | | |

| /s/ DAVID T. FEINBERG | | | Director | | | February 28, 2025 | | |

| David T. Feinberg | | | | | | | | |

| /s/ ROBERT W.A. SELLERS | | | Senior Vice President, Principal Accounting Officer | | | February 12, 2024 | | |

| Robert W.A. Sellers | | | (Principal Accounting Officer) | | | | | |

| Michael A. Mussallem | | | | | | | | |

| /s/ MARTHA H. MARSH | | | Director | | | February 12, 2024 | | |

| Martha H. Marsh | | | | | | | | |

| /s/ NICHOLAS J. VALERIANI | | | Director | | | February 12, 2024 | | |