Edwards Lifesciences (EW) 10-K risk factor changes: FY2023 vs FY2022

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

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

Even if we timely innovate and develop products, our ability to successfully market them could be constrained by a number of different factors, including competitive products and pricing, barriers in [removed: patients' treatment pathway] [added: patient activation] (including disease awareness, detection, and diagnosis), the need for regulatory clearance, restrictions imposed on approved indications, and uncertainty over third-party reimbursement.

[added: Clinical trials or procedures may be delayed, suspended, or terminated by us, the FDA, or other regulatory authorities at any time if it is believed] that the trial participants face unacceptable health risks or any other reasons, and any such delay, suspension, or termination could have a material adverse effect on our prospects or the market's view of our future prospects.

If we or one of our suppliers or logistics partners encounters manufacturing, logistics, [added: safety,] or quality problems, our business could be materially adversely affected.

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

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

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, or lead to increased overhead costs, product shortages, loss or misuse of proprietary or confidential information, intellectual property, or [added: sensitive or personal information, all of which could have a material adverse effect on our reputation, business, financial condition, and operating results.]

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 recommendations and action plans that aim to [removed: 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.]

Tax authorities [added: have disagreed and] may disagree with certain positions we have taken and assess additional [removed: taxes.][added: taxes that could be material.]

*•*currency exchange rate fluctuations; that is, decreases in the value of the United States dollar to the Euro or the Japanese yen, as well as other currencies in which we transact business, have the effect of increasing our reported [removed: revenues] [added: sales] even when the volume of sales outside of the United States has remained constant.

Significant increases or decreases in the value of the United States dollar could have a material adverse effect on our [removed: revenues,] [added: sales,] cost of sales, or results of operations.

Additionally, future legislation, regulation, or reimbursement policies of third-party payors may otherwise adversely [added: affect the demand for and price levels of our products.]

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

New laws and regulations, violations of these laws or regulations, stricter enforcement of existing requirements, or the discovery of previously unknown contamination could require us to incur costs or could become the basis for [added: litigation or] new or increased liabilities that could be material.

If such laws or regulations are more stringent than current legal or regulatory requirements, we may experience increased compliance burdens and costs to [added: meet the regulatory obligations, and it may adversely affect our raw material sourcing, manufacturing operations, and the distribution of our products.]

We are subject to risks arising from concerns and/or regulatory actions relating to [removed: animal borne] [added: animal-borne] illnesses, including “mad cow disease.”

Concerns relating to the potential transmission of [removed: animal borne] [added: animal-borne] illnesses, including BSE, commonly known as "mad cow disease," from cows to humans may result in reduced acceptance of products containing bovine materials.

- Risks related to the spin-off of our Critical Care product group

Without the timely innovation and development of products, our products

Safety is also critically important.

We are subject to risks associated with public health crises, particularly with respect to the pressures that such crises create on the hospital systems and supply chains in which we operate.

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.

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

In addition, we may decide 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.

relationships with physicians and other referral sources.

We group our risk factors into three principal sections: (1) Business and Operating Risks; (2) Market and Other External Risks and (3) Legal, Compliance and Regulatory Risks.

Clinical trials or procedures may be delayed, suspended, or terminated by us, the FDA, or other regulatory authorities at any time if it is believed

We are subject to risks associated with public health crises, including the global health concerns related to the COVID-19 pandemic.

The COVID-19 pandemic has adversely impacted and is likely to further adversely impact nearly all aspects of our business and markets, including our workforce and operations and the operations of our customers, suppliers, and business partners.

Financial or operational impacts that we have experienced in connection with the COVID-19 pandemic and may experience as a result of future COVID-19 outbreaks or other public health crises include:

- Staffing shortages at hospitals which can add to the barriers along the patient treatment pathway;

- Impacts and delays to clinical trials, our pipeline milestones, or regulatory clearances and approvals;

- The inability to meet our customers’ needs or other obligations due to disruptions to our operations or the operations of our third-party partners, suppliers, contractors, logistics partners, or customers including disruptions to production, development, manufacturing, administrative, and supply operations and arrangements; or

- Significant volatility or reductions in demand for our products.

Depending on the severity of the financial and operational impacts, our business, financial condition, and results of operations may be materially adversely impacted.

The extent to which the COVID-19 pandemic or other future public health crises may impact our business, results of operations, and financial condition depends on many factors which are highly uncertain and are difficult to predict.

These factors include, but are not limited to, the duration and spread of any outbreak, its severity, the actions to contain or address the impact of the outbreak, the timing, distribution, and efficacy of vaccines and other treatments, United States and foreign government actions to respond to possible reductions in global economic activity, and how quickly and to what extent normal economic and operating conditions can resume.

sensitive or personal information, all of which could have a material adverse effect on our reputation, business, financial condition, and operating results.

affect the demand for and price levels of our products.

meet the regulatory obligations, and it may adversely affect our raw material sourcing, manufacturing operations, and the distribution of our products.

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: 2022.][added: 2023.]

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

For a discussion related to the results of operations for [removed: 2021] [added: 2022] compared to [removed: 2020] [added: 2021] and a discussion related to our consolidated cash flows for [removed: 2021] [added: 2022] compared to [removed: 2020,] [added: 2021,] refer to Part II, Item 7, "*Management's Discussion and Analysis of Financial Condition and Results of Operations*" in our [removed: 2021] [added: 2022] Annual Report on Form 10–K filed with the Securities and Exchange Commission on February [removed: 14, 2022.][added: 13, 2023.]

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

[removed: ][added: ]

In addition to the impacts described above, the global economy, including the financial and credit markets, [removed: has recently experienced extreme] [added: continues to experience] volatility and disruptions, including [removed: increases to inflation rates, rising] [added: conditions impacting inflation, credit and capital markets,] interest rates, [removed: declines in consumer confidence, declines in economic growth,] and [removed: uncertainty about] [added: factors affecting global] economic [removed: stability.][added: stability and the political environment relating to health care.]

[removed: *2022 Financial] [added: *Financial] Highlights*

Despite the challenges to our business [removed: in 2022] due to COVID-19 and macroeconomic [removed: factors,] [added: headwinds,] our net sales for [removed: 2022] [added: 2023] were [removed: $5.4] [added: $6.0] billion, representing an increase of [removed: $149.9] [added: $622.4] million over [removed: 2021,] [added: 2022,] driven by sales growth of our TAVR products.

In [removed: 2022,] [added: 2023,] we invested [removed: 17.6%] [added: 17.8%] of our net sales in research and development.

The following is a summary of important developments [removed: during 2022:][added: since January 1, 2023:]

- we received [removed: CE Mark] approval [removed: for the *PASCAL Precision* transcatheter valve repair system for patients suffering from mitral and tricuspid regurgitation, and FDA approval] [added: in Japan] for *PASCAL Precision* [removed: for] [added: to treat] patients with degenerative mitral regurgitation; [removed: and]

- we launched the [removed: *SAPIEN] [added: *Edwards SAPIEN] 3 Ultra RESILIA* valve [removed: following FDA approval.][added: in Japan;]

| Outside of the United States | | | [removed: 2,249.8] [added: 2,496.1] | | | | | | [removed: 2,269.4] [added: 2,249.8] | | | | | | | | | | | | [removed: (19.6)] [added: 246.3] | | | | | | | | | | | | [removed: (0.9)] [added: 10.9] | | % | | | | | | |

| Total net sales | | | $ | [removed: 5,382.4] [added: 6,004.8] | | | | | $ | [removed: 5,232.5] [added: 5,382.4] | | | | | | | | | | | $ | [removed: 149.9] [added: 622.4] | | | | | | | | | | | [removed: 2.9] [added: 11.6] | | % | | | | | | |

| Transcatheter Aortic Valve Replacement | | | $ | [removed: 3,518.2] [added: 3,879.8] | | | | | $ | [removed: 3,422.5] [added: 3,518.2] | | | | | | | | | | | $ | [removed: 95.7] [added: 361.6] | | | | | | | | | | | [removed: 2.8] [added: 10.3] | | % | | | | | | |

| Transcatheter Mitral and Tricuspid Therapies | | | [removed: 116.1] [added: 197.6] | | | | | | [removed: 86.0] [added: 116.1] | | | | | | | | | | | | [removed: 30.1] [added: 81.5] | | | | | | | | | | | | [removed: 35.1] [added: 70.1] | | % | | | | | | |

| Surgical Heart Valve Therapy | | | [removed: 893.1] [added: 999.3] | | | | | | [removed: 889.1] [added: 893.1] | | | | | | | | | | | | [removed: 4.0] [added: 106.2] | | | | | | | | | | | | [removed: 0.4] [added: 11.9] | | % | | | | | | |

[removed: ][added: ]

- higher sales of the *Edwards SAPIEN* platform in [removed: 2022,] [added: 2023,] primarily the *Edwards SAPIEN 3 Ultra* [added: *RESILIA*] valve in the United [removed: States, Europe,] [added: States] and [removed: Rest of World,] [added: Japan, and] the *Edwards SAPIEN 3 Ultra* [removed: *RESILIA*] valve in [removed: the United States,] [added: Europe] and [removed: the *Edwards SAPIEN 3* in Japan;][added: Rest of World;]

- foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by [removed: $140.2] [added: $10.3] million primarily due to the weakening of the [removed: Euro and the] Japanese yen against the United States dollar.

[removed: ][added: ]

The increase in net sales of TMTT products was due primarily to [removed: continued adoption] [added: the launch] of our *PASCAL* system in [added: the United States and its continued adoption in] Europe.

[removed: and tricuspid regurgitation, and in September 2022,] [added: In October 2023,] we [added: also] received [removed: FDA] approval [added: in Japan] for *PASCAL Precision* [removed: for] [added: to treat] patients with degenerative mitral regurgitation.

[removed: In mitral replacement,] [added: -] we [removed: continued to treat patients through] [added: completed enrollment in] the ENCIRCLE [added: Trial, the first] pivotal trial for [added: our transfemoral mitral replacement therapy,] *SAPIEN [removed: M3* and completed enrollment in the MISCEND early feasibility study for *EVOQUE Eos*.][added: M3*;]

[removed: We also] [added: In addition, enrollment] continued [removed: to make progress] in [removed: enrolling] the [removed: TRISCEND II pivotal trial of the *EVOQUE* replacement system and the] CLASP IITR pivotal trial with the *PASCAL* repair system in patients with symptomatic, severe tricuspid regurgitation.

[removed: ][added: ]

[removed: The increase in net] [added: Net] sales of Surgical products [removed: was due] [added: increased in 2023] primarily [added: due] to [removed: strong adoption] [added: sales] of the *INSPIRIS RESILIA* aortic [removed: valve, primarily] [added: valve] in the United States and Europe, and the *MITRIS RESILIA* [removed: valve, primarily] [added: valve] in the United States.

These increases were partially offset by the impact of foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by [removed: $46.5 million] [added: $6.4 million,] primarily due to the weakening of the [removed: Euro and the] Japanese yen against the United States [added: dollar, partially offset by the strengthening of the Euro against the United States] dollar.

[removed: In early 2023, we began enrolling] [added: We are continuing to enroll] patients in our [removed: MOMENTS] [added: MOMENTIS] clinical study to demonstrate the durability of *RESILIA* tissue in the mitral position.

[removed: ][added: ]

- increased demand for our [removed: capital] [added: enhanced surgical recovery products and pressure monitoring] products, primarily [removed: the *HemoSphere* monitoring platform] in the United [removed: States and Japan;][added: States;]

- foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by [removed: $39.5] [added: $11.3] million primarily due to the weakening of the Japanese yen [removed: and] [added: against] the [added: United States dollar, partially offset by the strengthening of the] Euro against the United States dollar.

[removed: ][added: ]

The [removed: increase] [added: decrease] in gross profit as a percentage of net sales in [removed: 2022] [added: 2023] compared to [removed: 2021] [added: 2022] was driven primarily by a [removed: 3.6] [added: 2.5] percentage point [removed: increase] [added: decrease] from the impact of [removed: our] foreign currency [removed: hedging program, which includes hedge contract gains and natural hedges (primarily] [added: exchange rate fluctuations, primarily] the [removed: strengthening] [added: weakening] of the United States dollar against [added: multiple currencies, partially offset by] the [removed: Euro and] [added: strengthening of] the [added: United States dollar against the] Japanese [removed: yen).][added: yen.]

[removed: ][added: ]

SG&A expenses increased in [removed: 2022] [added: 2023] compared to [removed: 2021] [added: 2022] due primarily to [removed: a resumption of in-person commercial activities following COVID-19] [added: higher performance-based compensation] and higher field-based personnel-related [removed: costs,] [added: costs in support of our growth strategy and patient activation initiatives,] primarily [added: related to] TAVR and TMTT in the United [removed: States.][added: States and Europe.]

[removed: ][added: ]

R&D expenses increased [removed: marginally] in [removed: 2022] [added: 2023] compared to [removed: 2021] [added: 2022] due primarily to continued investments in our transcatheter innovations, including increased clinical trial activity.

The change in fair value of contingent consideration liabilities resulted in [removed: income] [added: gains] of [removed: $35.8] [added: $26.2] million and [removed: $124.1] [added: $35.8] million [removed: in in 2022] [added: during 2023] and [removed: 2021,] [added: 2022,] respectively.

The [removed: income] [added: gains] in 2022 [removed: was] [added: were] due to changes in projected probabilities of milestone achievement and our decision in the third quarter of 2022 to exit our *HARPOON* surgical mitral repair system program.

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.

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

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.

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.

Our gross profit increased in 2023, driven by our sales growth.

Gross profit as a percentage of sales decreased primarily due to the impact of foreign currency exchange rate fluctuations.

The decrease in our net income and diluted earnings per share in 2023 was driven primarily by an after-tax charge of $134.9 million related to an intellectual property agreement.

Our vision for growth is to treat 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.

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

- we received 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 for the treatment of tricuspid regurgitation, making it the world's first transcatheter valve replacement therapy to receive regulatory approval to treat tricuspid regurgitation;

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

- 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 enrollment in PROGRESS, a pivotal trial studying the treatment of moderate aortic stenosis patients;

- 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.

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

Net Sales by Geographic Region

| | | | 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 | | % | | | | | | |

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

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

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

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*.

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

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

Intellectual Property Agreement and Litigation Expense

We incurred intellectual property agreement and litigation expenses of $203.5 million and $15.8 million during 2023 and 2022, respectively.

On April 12, 2023, we entered into an Intellectual Property Agreement (the "Intellectual Property Agreement") with Medtronic, Inc. ("Medtronic") and recorded a $37.0 million charge in March 2023 and a $139.0 million charge in April 2023.

For more information, see Note 3 to the "*Consolidated Financial Statements*."

The gains in 2023 were primarily due to changes in projected probabilities of milestone achievement.

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

The COVID-19 pandemic has adversely impacted, and may further adversely impact, nearly all aspects of our business and markets, including our workforce and the operations of our customers, suppliers, and business partners.

Our manufacturing operations have continued to respond to impacts related to COVID-19, and we have been able to supply our technologies around the world.

Across the organization, we are proactively managing inventory, assessing alternative logistics options, and closely monitoring the supply of components to address potential supply constraints.

During the first quarter of 2021, COVID-19 stressed the global healthcare system during the winter months.

However, we saw strong recovery beginning in the second quarter of 2021 as widespread vaccine adoption contributed to an increased number of patients.

However, the Delta variant had a significant impact on hospital resources during the last two months of the third quarter of 2021, and the Omicron variant had a significant impact during December 2021, especially in the United States.

During the first quarter of 2022, the Omicron variant had a pronounced impact on hospital capacity, resources, and

procedure volumes in January 2022, especially in the United States.

Our 2022 sales were also impacted by slower than expected improvement in United States hospital staffing shortages and foreign currency headwinds.

In the second half of 2022, we faced COVID-19 headwinds in Japan, which created significant strain on hospital capacity.

Our gross profit increase in 2022 was driven by our sales growth and the positive impact of our foreign currency hedging program.

The increase in our diluted earnings per share in 2022 was driven by a) the aforementioned increase in our gross profit and b) a decrease in our diluted weighted-average shares outstanding, driven by our increased share repurchase activity.

This increase was partially offset by a) changes in the fair value of our contingent consideration liabilities, which resulted in a $121.6 million after tax gain in 2021 compared to a $35.0 million after tax gain in 2022, b) an after-tax charge of $47.0 million in 2022, primarily related to the impairment of intangible assets resulting from our decision to exit our *HARPOON* surgical mitral repair system program, and c) increased sales and marketing and research and development expenses in 2022.

Despite the challenges of the COVID-19 pandemic, our dedicated field teams have found creative ways to support physicians, our engineers continued to advance innovation, and our colleagues worked diligently to keep our clinical trials on track.

- we received United States Food and Drug Administration ("FDA") approval for the *MITRIS RESILIA* valve, a tissue valve replacement specifically designed for the heart's mitral position;

Net Sales by Major Regions

| | | | 2022 | | | | | | 2021 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| United States | | | $ | 3,132.6 | | | | | $ | 2,963.1 | | | | | | | | | | | $ | 169.5 | | | | | | | | | | | 5.7 | | % | | | | | | |

| Europe | | | 1,174.8 | | | | | | 1,190.3 | | | | | | | | | | | | (15.5) | | | | | | | | | | | | (1.3) | | % | | | | | | |

| Japan | | | 473.6 | | | | | | 528.9 | | | | | | | | | | | | (55.3) | | | | | | | | | | | | (10.4) | | % | | | | | | |

| Rest of World | | | 601.4 | | | | | | 550.2 | | | | | | | | | | | | 51.2 | | | | | | | | | | | | 9.3 | | % | | | | | | |

| Critical Care | | | 855.0 | | | | | | 834.9 | | | | | | | | | | | | 20.1 | | | | | | | | | | | | 2.4 | | % | | | | | | |

During 2022, we continued to advance our EARLY TAVR pivotal trial, studying the treatment of severe aortic stenosis patients before their symptoms develop, and our PROGRESS pivotal trial, studying moderate aortic stenosis patients.

During the second quarter of 2022, we began treating patients in our ALLIANCE pivotal trial, studying our next-generation TAVR technology, *SAPIEN X4*, and during the fourth quarter of 2022, we began the introduction of the *SAPIEN 3 Ultra Resilia* valve in the United States.

During August 2022, we received European regulatory approval for *PASCAL Precision* for patients suffering from mitral

In March 2022, we received FDA approval for the *MITRIS RESILIA* valve and initiated the product launch in the United States in April 2022.

*MITRIS RESILIA* is a tissue valve replacement specifically designed for the heart's mitral position and incorporates our advanced *RESILIA* technology.

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

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

Foreign

currency exchange rate fluctuations decreased expenses by $63.1 million due primarily to the strengthening of the United States dollar against the Euro and the Japanese yen.

The income in 2021 was attributable to changes in the projected probabilities of milestone achievements and the projected timing of cash inflows from product sales.

(in millions)

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

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

| | | | Years Ended December 31, | | | | | | | | | | | | | | |

| | | | 2022 | | | | | | 2021 | | | | | | | | |

| Foreign exchange losses (gains), net | | | $ | 1.2 | | | | | $ | (5.0) | | | | | | | |

| Gain on insurance settlement | | | (3.8) | | | | | | — | | | | | | | | |

| Loss (gain) on investments | | | 1.1 | | | | | | (5.8) | | | | | | | | |

[removed: As of December 31, 2022, we had $1.6 billion] [added: million] of investments in debt securities which had an average remaining term to maturity of [removed: 0.98] [added: 0.53] years.

[added: 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: 2022] [added: 2023] would have resulted in a [removed: $7.8] [added: $3.2] million to [removed: $15.5] [added: $6.5] million decrease in the fair value of these investments.

As of December 31, [removed: 2022,] [added: 2023,] 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: 2022,] [added: 2023,] there were no borrowings outstanding under the Credit Agreement.

Based on our December 31, [removed: 2022] [added: 2023] 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: 2022,] [added: 2023,] a hypothetical 1.0% absolute increase in market interest rates would decrease the fair value of the fixed-rate debt by approximately [removed: $26.7] [added: $23.1] million.

For more information related to outstanding debt obligations, see Note [removed: 10] [added: 11] to the "*Consolidated Financial Statements.*"

These risks include the translation of local currency balances and results of our non-United States subsidiaries into United States dollars, currency gains and losses related to intercompany and third-party transactions denominated in currencies other than a subsidiary's functional currency, and currency gains and losses associated with [added: global] intercompany [removed: loans.][added: receivable and payable balances.]

The total notional amount of our derivative financial instruments entered into for foreign currency management purposes at December 31, [removed: 2022] [added: 2023] was [removed: $2.0] [added: $2.1] 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: $158.2] [added: $165.5] million.

Any gains or losses on the fair value of derivative contracts would generally be offset by gains and losses on the underlying [removed: transactions,] [added: transactions and the net investment,] so the net impact would not be significant to our financial condition or results of operations.

For more information related to outstanding foreign exchange contracts, see Note 2 and Note [removed: 12] [added: 13] to the "*Consolidated Financial Statements.*"

At December 31, [removed: 2022,] [added: 2023,] all derivative financial instruments were with bank counterparties assigned investment grade ratings by national rating agencies.

We invest excess cash in a variety of debt securities, and diversify the investments [removed: between] [added: amongst] financial institutions.

In [removed: 2022,] [added: 2023,] we had no customers that represented 10% or more of our total net sales or accounts receivable, net.

As of December 31, [removed: 2022,] [added: 2023,] we had [removed: $1.6 billion] [added: $963.2 million] of investments in debt securities of various companies, of which [removed: $1.1 billion] [added: $462.7 million] were long-term.

In addition, we had [removed: $108.3] [added: $121.2] million of investments in equity instruments.

As of December 31, 2023, we had $963.2

See Note 7 to the *"Consolidated Financial Statements"* for additional information.

Taking into consideration the

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 [removed: valve that is currently the focus of many of our commercially approved valve technologies.][added: valve.]

The following discussion summarizes the main [removed: areas] [added: groups] of products and technologies we offer to treat advanced cardiovascular disease.

Our products and technologies are categorized into four main [removed: areas:] [added: groups:] Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid Therapies, Surgical Structural Heart, and Critical Care.

For more information on net sales from these four main [removed: areas,] [added: groups,] see *"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 valves*,* including [removed: *Edwards SAPIEN XT,*] the *Edwards SAPIEN 3,* the *Edwards SAPIEN 3 Ultra,* and the *Edwards SAPIEN 3 Ultra RESILIA* [removed: transcatheter heart valves, and their respective delivery] systems, are [removed: used to treat heart valve disease using] catheter-based approaches for [added: treating] patients who [removed: have severe symptomatic aortic stenosis and certain patients with congenital heart disease.]

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

[removed: We began offering our] [added: Edwards'] transcatheter aortic heart valves [removed: to patients commercially] [added: were first commercialized] in Europe in 2007, in the United States in 2011, and in Japan in 2013.

Sales of our transcatheter aortic valve replacement products represented 65% of our net sales in each of [added: 2023,] 2022, [removed: 2021,] and [removed: 2020, respectively.][added: 2021.]

As of [removed: 2022,] [added: 2023,] the *PASCAL PRECISION* system is also commercially available in the U.S. [added: and Japan] for degenerative mitral regurgitation patients.

We believe our [removed: two-platform] mitral replacement strategy positions us for leadership in the mid-to-long term.

*SAPIEN M3* is based on the proven *SAPIEN* valve [removed: while *EVOQUE Eos*] [added: and] is designed specifically for mitral patients.

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

Our *RESILIA* tissue, with published clinical data showing [removed: 0%] [added: 99% freedom from] structural valve deterioration through [removed: five] [added: seven] years1, [removed: is helping us redefine] [added: has set the new standard for] tissue [removed: durability standards.][added: valve durability.]

Our [removed: latest innovation, the] [added: flagship] *INSPIRIS RESILIA* aortic valve, [removed: is built on our *PERIMOUNT* platform, offering] [added: offers] *RESILIA* tissue and *VFit* technology.

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

Sales of our surgical tissue heart valve products represented [removed: 15%,] [added: 16%,] 15%, and 16% of our net sales in [added: 2023,] 2022, [removed: 2021,] and [removed: 2020,] [added: 2021,] respectively.

We believe we hold leadership positions because we develop and produce safe and effective therapies supported by rigorous clinical studies with extensive data and with innovative features that [added: can] enhance patient [removed: benefit, product performance,] [added: benefit] and [removed: reliability; these superior clinical outcomes are in part due to the level of customer] [added: product performance] and [removed: clinical support we provide.][added: reliability, as well as benefit healthcare systems.]

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

We are not dependent on any single customer and no single customer accounted for 10% or more of our net sales in [removed: 2022.][added: 2023.]

To [removed: ensure] [added: achieve] optimal outcomes for patients, we conduct educational symposia and best practices training for our physician, hospital executive, service line leadership, nursing, and clinical-based customers.

[removed: Our customers include] physicians, nurses, and other clinical personnel, [removed: but can also] [added: 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: 2022,] [added: 2023,] 58% of our net sales were derived from sales to customers in the United States.

Outside of the United States. In [removed: 2022,] [added: 2023,] 42% of our net sales were derived outside of the United States through our direct sales forces and independent distributors.

Of the total sales outside of the United States, [removed: 52%] [added: 53%] were in Europe, [removed: 21%] [added: 18%] were in Japan, and [removed: 27%] [added: 28%] were in Rest of World.

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

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

The medical technology industry is highly regulated and our facilities and operations are designed to comply with all applicable quality systems standards, including the International Organization for Standardization ("ISO") [removed: 13485.][added: 13485:2016.]

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 [removed: or independent outside auditors.]

In [removed: 2022,] [added: 2023,] we made significant investments in research and development as we worked to develop therapies that we believe have the potential to change the practice of medicine.

Research and development spending increased [removed: 5%] [added: 13%] year over year, representing 18% of [removed: 2022] [added: 2023] sales.

This increase was primarily the result of significant investments in our transcatheter structural heart programs, including an increase in clinical research for our [removed: mitral] [added: mitral, aortic,] and tricuspid therapies.

Additionally, we are a party to license agreements [added: and other arrangements] with various third parties pursuant to which we have obtained, for varying terms, the exclusive or non-exclusive rights to certain patents held by such third parties in consideration for cross-licensing rights and/or royalty payments.

We are also governed by federal, state, local, and international laws of general applicability, including, but not limited to, those regulating employee health and safety, labor, competition, [added: securities, privacy, anti-corruption,] trade secret, and the protection of the environment.

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

Our quarterly [removed: net] sales are influenced by many factors, including new product introductions, acquisitions, regulatory approvals, patient and physician holiday schedules, and other factors.

[removed: Net sales] [added: Sales] in the third quarter are typically lower than other quarters of the year due to the seasonality of the United States and European markets, where summer vacation schedules normally result in fewer medical procedures.

The primary goals of our talent management strategy are to [removed: attract] [added: attract, develop] and [removed: maintain] [added: retain] a motivated, professional workforce and to ensure alignment on our patient-focused innovation strategy.

The purpose of our T&O Strategy is to anticipate [removed: dynamic] global trends related to our workforce, develop our talent to meet future organizational needs, and enable us to be well-poised to meet these needs.

[removed: This has enabled us to build] [added: We have also developed] a comprehensive succession planning process that allows us to build strong talent from within while we pursue an aggressive recruiting process to fill any gaps with highly qualified external talent.

Our HCM governance includes a global talent development review ("TDR") process to align our [removed: business strategy with] talent [removed: strategies,] [added: strategies with our business strategy,] assess talent against future organizational needs, evaluate critical talent populations, and enhance the strength of our succession planning.

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

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

have severe symptomatic aortic stenosis.

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

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

Edwards has partnered with the physician community to generate groundbreaking data that has expanded access to patients of all risk profiles.

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.

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

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

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

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.

The *EVOQUE* system is the world's first transcatheter valve replacement therapy to receive regulatory approval to treat tricuspid regurgitation.

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

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

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.

The benefits associated with our products are in part due to the level of customer and clinical support we provide.

In addition to working closely with

or independent outside auditors.

We undertake reasonable measures to protect our intellectual property rights.

Import Practices" regulations.

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

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

Developing talent around the globe is critical to achieving our mission at Edwards.

Edwards provides in-depth learning and development resources for employees at all levels, including blended learning opportunities such as in-person, virtual, and online courses, capability assessments, coaching, and developmental experiences.

We are committed to enabling our employees to have long-term careers at Edwards by encouraging each employee to take ownership of their professional development, engage in the significant resources available, and leverage the performance management and feedback process to be on a journey of continuous growth.

We also encourage managers to be involved in helping their employees develop enhanced personal, professional, and leadership skills.

Our learning and development strategy aims to have a balanced focus on building leadership and technical capabilities, with resources dedicated to building learning and development for global leaders, such as our course on ethical decision making for managers, and developing technical skills and capabilities for unique talent segments.

Our learning and development initiatives are designed to support and sustain Edwards’ values and unique culture, inspiring our employees to collaborate, innovate, and grow, ultimately enabling us to better serve our patients.

can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies.

Supported by extensive customer training and service, and a growing body of compelling clinical evidence, our *SAPIEN* family of transcatheter aortic heart valves are the most widely prescribed transcatheter heart valves in the world.

We are innovating in the field of cardiac surgical therapies to improve the quality of life for patients.

The *MITRIS RESILIA* valve, our newest mitral valve incorporating our latest tissue technology, is now commercially available in both the U.S. and Japan.

In addition to our internally developed programs, we have made investments in several companies that are independently developing minimally-invasive technologies to treat structural heart diseases.

We undertake reasonable measures to protect our patent rights, including monitoring the products of our competitors for possible infringement of our patents.

Our learning and development structure and processes strive to meet the internal demand to develop our talent in such a way that demonstrates impact at scale and delivered to our workforce through optimized learning modalities.

This includes leadership training programs, including our ethical decision making training program for managers.

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 a description of our material pending legal proceedings, please see Note 18 to the "*Consolidated Financial Statements*" of this Annual Report on Form 10-K, which is incorporated by reference.

For the Fiscal Year Ended December 31, [removed: 2022][added: 2023]

The aggregate market value of the registrant's common stock held by non-affiliates as of June 30, [removed: 2022] [added: 2023] (the last trading day of the registrant's most recently completed second quarter): [removed: $58,453,646,002] [added: $56,849,824,065] 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: 2023,] [added: 2024,] was [removed: 608,313,396.][added: 601.3 million.]

Portions of the registrant's proxy statement for the [removed: 2023] [added: 2024] Annual Meeting of Stockholders (to be filed within 120 days of December 31, [removed: 2022)] [added: 2023)] are incorporated by reference into Part III, as indicated herein.

Form 10-K Annual [removed: Report—2022][added: Report—2023]

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| [Item [removed: 9A.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_154)] [added: 9A.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_151)] | | | [Controls and [removed: Procedures](#i7911ec8fe8cb4553848d1b6fe0ac94b3_154)] [added: Procedures](#i439731ebbdd84c3bbb0be09a4bcbe5ab_151)] | | | [removed: [88](#i7911ec8fe8cb4553848d1b6fe0ac94b3_154)] [added: [94](#i439731ebbdd84c3bbb0be09a4bcbe5ab_151)] | | |

| [Item [removed: 9B.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_157)] [added: 9B.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_154)] | | | [Other [removed: Information](#i7911ec8fe8cb4553848d1b6fe0ac94b3_157)] [added: Information](#i439731ebbdd84c3bbb0be09a4bcbe5ab_154)] | | | [removed: [88](#i7911ec8fe8cb4553848d1b6fe0ac94b3_157)] [added: [94](#i439731ebbdd84c3bbb0be09a4bcbe5ab_154)] | | |

| [Item [removed: 9C.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_160)] [added: 9C.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_157)] | | | [Disclosure Regarding Foreign Jurisdictions That Prevent [removed: Inspections](#i7911ec8fe8cb4553848d1b6fe0ac94b3_160)] [added: Inspections](#i439731ebbdd84c3bbb0be09a4bcbe5ab_157)] | | | [removed: [88](#i7911ec8fe8cb4553848d1b6fe0ac94b3_160)] [added: [94](#i439731ebbdd84c3bbb0be09a4bcbe5ab_157)] | | |

| [Item [removed: 10.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_166)] [added: 10.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_163)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#i7911ec8fe8cb4553848d1b6fe0ac94b3_166)] [added: Governance](#i439731ebbdd84c3bbb0be09a4bcbe5ab_163)] | | | [removed: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_166)] [added: [95](#i439731ebbdd84c3bbb0be09a4bcbe5ab_163)] | | |

| [Item [removed: 11.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_169)] [added: 11.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_166)] | | | [Executive [removed: Compensation](#i7911ec8fe8cb4553848d1b6fe0ac94b3_169)] [added: Compensation](#i439731ebbdd84c3bbb0be09a4bcbe5ab_166)] | | | [removed: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_169)] [added: [95](#i439731ebbdd84c3bbb0be09a4bcbe5ab_166)] | | |

| [Item [removed: 12.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_172)] [added: 12.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_169)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i7911ec8fe8cb4553848d1b6fe0ac94b3_172)] [added: Matters](#i439731ebbdd84c3bbb0be09a4bcbe5ab_169)] | | | [removed: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_172)] [added: [95](#i439731ebbdd84c3bbb0be09a4bcbe5ab_169)] | | |

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| [Item [removed: 15.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_184)] [added: 15.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_181)] | | | [Exhibits and Financial Statement [removed: Schedules](#i7911ec8fe8cb4553848d1b6fe0ac94b3_184)] [added: Schedules](#i439731ebbdd84c3bbb0be09a4bcbe5ab_181)] | | | [removed: [90](#i7911ec8fe8cb4553848d1b6fe0ac94b3_184)] [added: [96](#i439731ebbdd84c3bbb0be09a4bcbe5ab_181)] | | |

| [Item [removed: 16.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_187)] [added: 16.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_184)] | | | [Form 10-K [removed: Summary](#i7911ec8fe8cb4553848d1b6fe0ac94b3_187)] [added: Summary](#i439731ebbdd84c3bbb0be09a4bcbe5ab_184)] | | | [removed: [91](#i7911ec8fe8cb4553848d1b6fe0ac94b3_187)] [added: [97](#i439731ebbdd84c3bbb0be09a4bcbe5ab_184)] | | |

Statements other than statements of historical or current fact in this report or referred to or incorporated by reference into this report are "forward-looking statements" for purposes of these [removed: sections.][added: safe harbor provisions.]

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," other forms of these words or similar words or expressions or the [removed: negative] [added: negatives] thereof.

Statements [removed: of] [added: 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," [removed: diligence,"] [added: "potential," "possible," "diligence,"] "industry-leading," "compliant," "indications," or "early feedback" or other forms of these words or similar words or expressions or the [removed: negative] [added: negatives] thereof.

These risks and uncertainties include, but are not limited to: [added: the spin-off of] our [removed: success in developing] [added: critical care product group, our ability to develop] new products and [removed: avoiding] [added: avoid] manufacturing and quality issues; clinical trial or commercial results or new product approvals and therapy adoption; the impact of [removed: public health crises, including the COVID-19 pandemic; the impact of] domestic and global economic conditions; [removed: competitive dynamics] [added: competition] in the markets in which we operate; our reliance on vendors, suppliers, and other third parties; damage, failure, or interruption of our information technology systems; [added: 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.

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

| [Item 1C.](#i439731ebbdd84c3bbb0be09a4bcbe5ab_1747) | | | [Cybersecurity](#i439731ebbdd84c3bbb0be09a4bcbe5ab_1747) | | | [21](#i439731ebbdd84c3bbb0be09a4bcbe5ab_1747) | | |

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

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

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

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

| [PART I](#i7911ec8fe8cb4553848d1b6fe0ac94b3_10) | | | | | | | | |

| [PART II](#i7911ec8fe8cb4553848d1b6fe0ac94b3_34) | | | | | | | | |

| [PART III](#i7911ec8fe8cb4553848d1b6fe0ac94b3_163) | | | | | | | | |

| [PART IV](#i7911ec8fe8cb4553848d1b6fe0ac94b3_181) | | | | | | | | |

| | | | [Signatures](#i7911ec8fe8cb4553848d1b6fe0ac94b3_190) | | | [92](#i7911ec8fe8cb4553848d1b6fe0ac94b3_190) | | |

These statements include, among other things, the expected impact of COVID-19 on our business, the expected impact of macroeconomic conditions on our business, any predictions, opinions, expectations, plans, strategies, objectives and any statements of assumptions underlying any of the foregoing relating to the our current and future business and operations, including, but not limited to, financial matters, development activities, clinical trials and regulatory matters, manufacturing and supply operations, and product sales and demand.

*Risk Management and Strategy*

Our Information Security team manages Edwards’ Information Security Program, which is focused on assessing, identifying, and managing cyber 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 board of directors, described below under "*Governance*."

To proactively manage cybersecurity risk in our organization, our management team has instituted an Edwards Information Technology Security Policy that is available to all employees through the employee handbook and on our intranet.

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

Internal and external stakeholders can access the Edwards Integrity Helpline 24/7 online or by phone, to report any security incidents for escalation.

We also disclose information about our product security and provide relevant contact information for our stakeholders to report any product vulnerabilities.

To proactively identify, mitigate, and prepare for potential cybersecurity incidents, we maintain both a business continuity plan and cyber incident response plan with formalized workflows and playbooks.

We periodically conduct simulation exercises involving employees at various levels of the organization.

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

Through these channels and others, we work to proactively identify potential vulnerabilities in our information security system.

We recognize that we are exposed to cybersecurity threats associated with our use of third-party service providers.

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.

In addition, we strive to minimize cybersecurity risks when we first select or renew a vendor by including cybersecurity risk as part of our overall vendor evaluation and due diligence process.

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

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

*Governance*

Our Board of Directors and our Audit Committee oversee our enterprise-wide risk management, including with respect to cybersecurity.

Our Chief Financial Officer presents information on our enterprise-wide risks to the Board of Directors at each of its regularly scheduled meetings.

Our 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 Officer (“CIO”) and our Chief Information Security Officer (“CISO”) present to the Audit Committee at each regularly scheduled Audit Committee meeting on information technology infrastructure as well as risks related to cybersecurity and information security.

The oversight of our cybersecurity program at the management level rests with the Executive Leadership Team (“ELT”) who has designated the CISO to lead and execute on the cybersecurity program.

The CISO provides regular updates to the executive leadership team, including the CEO, on our cybersecurity program and cybersecurity risks.

Our cybersecurity leaders have extensive experience in cybersecurity, including in consulting and corporate roles at Forbes 100 companies and experience leading security incident detection and response, security architecture, and strategy programs.

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

The Information Security Council is tasked with overseeing information security matters at Edwards, including cybersecurity.

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

The Enterprise Risk Management Council is tasked with proactive management of our enterprise-wide risks, including information security risks that also include cybersecurity.

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

On January 31, [removed: 2023,] [added: 2024,] there were [removed: 8,019] [added: 7,599] stockholders of record of our common stock.

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

[removed: (b) On May 4, 2021,] [added: (a) In July 2022,] the Board of Directors approved a stock repurchase program providing for up to [removed: $1.0] [added: $1.5] billion of repurchases of our common [removed: stock.][added: stock, effective July 28, 2022.]

In [removed: July 2022,] [added: December 2023,] the Board of Directors approved an additional [removed: $1.5] [added: $1.0] billion of repurchases [removed: of our common stock] under this [removed: program, effective July 28, 2022.][added: program.]

The cumulative total return listed below assumes an initial investment of $100 at the market close on December 31, [removed: 2017] [added: 2018] and reinvestment of dividends.

[removed: ][added: ]

| | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | |

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

(b) In December 2023, we entered into a $400.0 million accelerated share repurchase ("ASR") agreement and received, on December 12, 2023, an initial delivery of 4.6 million shares of our common stock, representing approximately 80 percent of the total contract value.

The ASR concluded and on December 29, 2023 we received an additional 0.7 million shares.

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

| Edwards Lifesciences | | | $ | 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 | | |

| October 1, 2022 through October 31, 2022 | | | | | | | | | | | | 1,381,903 | | | | | | $ | 83.66 | | | | | 1,381,903 | | | | | | $ | 1,666.0 | | | | |

| November 1, 2022 through November 30, 2022 | | | | | | | | | | | | 8,284,153 | | | | | | 72.91 | | | | | | 8,283,860 | | | | | | 1,061.6 | | | | | |

| December 1, 2022 through December 31, 2022 | | | | | | | | | | | | 2,003,416 | | | | | | 72.91 | | | | | | 2,003,416 | | | | | | 915.6 | | | | | |

| Total | | | | | | | | | | | | 11,669,472 | | | | | | 74.18 | | | | | | 11,669,179 | | | | | | | | | | | |

(a) The difference between the total number of shares (or units) purchased and the total number of shares (or units) purchased as part of publicly announced plans or programs is due to shares withheld by us to satisfy tax withholding obligations in connection with the vesting of restricted stock units issued to employees.

| Edwards Lifesciences | | | $ | 135.90 | | | | | $ | 206.98 | | | | | $ | 242.83 | | | | | $ | 344.82 | | | | | $ | 198.59 | |

| S&P 500 | | | 95.62 | | | | | | 125.72 | | | | | | 148.85 | | | | | | 191.58 | | | | | | 156.89 | | |

| S&P 500 Health Care Equipment | | | 116.24 | | | | | | 150.32 | | | | | | 176.83 | | | | | | 211.05 | | | | | | 171.25 | | |

[removed: DECEMBER] [added: | December] 31, 2022 [added: | | | | | | | | | | | | | | | | | | | | | | | |]

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#i7911ec8fe8cb4553848d1b6fe0ac94b3_67) 238[)](#i7911ec8fe8cb4553848d1b6fe0ac94b3_67)] [added: ID](#i439731ebbdd84c3bbb0be09a4bcbe5ab_67) 238[)](#i439731ebbdd84c3bbb0be09a4bcbe5ab_67)] | | | [removed: [40](#i7911ec8fe8cb4553848d1b6fe0ac94b3_67)] [added: [44](#i439731ebbdd84c3bbb0be09a4bcbe5ab_67)] | | |

| [Consolidated Balance Sheets as of December [removed: 31,](#i7911ec8fe8cb4553848d1b6fe0ac94b3_70)] [added: 31,](#i439731ebbdd84c3bbb0be09a4bcbe5ab_70) 2023 [and](#i439731ebbdd84c3bbb0be09a4bcbe5ab_70)] 2022 [removed: [and](#i7911ec8fe8cb4553848d1b6fe0ac94b3_70) 2021] | | | [removed: [42](#i7911ec8fe8cb4553848d1b6fe0ac94b3_70)] [added: [46](#i439731ebbdd84c3bbb0be09a4bcbe5ab_70)] | | |

| For the Years Ended December 31, [added: 2023,] 2022, [removed: 2021,] and [removed: 2020:] [added: 2021:] | | | | | |

| [Consolidated Statements of [removed: Operations](#i7911ec8fe8cb4553848d1b6fe0ac94b3_73)] [added: Operations](#i439731ebbdd84c3bbb0be09a4bcbe5ab_73)] | | | [removed: [43](#i7911ec8fe8cb4553848d1b6fe0ac94b3_73)] [added: [47](#i439731ebbdd84c3bbb0be09a4bcbe5ab_73)] | | |

| [Consolidated Statements of Comprehensive [removed: Income](#i7911ec8fe8cb4553848d1b6fe0ac94b3_76)] [added: Income](#i439731ebbdd84c3bbb0be09a4bcbe5ab_76)] | | | [removed: [44](#i7911ec8fe8cb4553848d1b6fe0ac94b3_76)] [added: [48](#i439731ebbdd84c3bbb0be09a4bcbe5ab_76)] | | |

| [Consolidated Statements of Cash [removed: Flows](#i7911ec8fe8cb4553848d1b6fe0ac94b3_79)] [added: Flows](#i439731ebbdd84c3bbb0be09a4bcbe5ab_79)] | | | [removed: [45](#i7911ec8fe8cb4553848d1b6fe0ac94b3_79)] [added: [49](#i439731ebbdd84c3bbb0be09a4bcbe5ab_79)] | | |

| [Consolidated Statements of Stockholders' [removed: Equity](#i7911ec8fe8cb4553848d1b6fe0ac94b3_82)] [added: Equity](#i439731ebbdd84c3bbb0be09a4bcbe5ab_82)] | | | [removed: [46](#i7911ec8fe8cb4553848d1b6fe0ac94b3_82)] [added: [50](#i439731ebbdd84c3bbb0be09a4bcbe5ab_82)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i7911ec8fe8cb4553848d1b6fe0ac94b3_85)] [added: Statements](#i439731ebbdd84c3bbb0be09a4bcbe5ab_85)] | | | [removed: [47](#i7911ec8fe8cb4553848d1b6fe0ac94b3_85)] [added: [51](#i439731ebbdd84c3bbb0be09a4bcbe5ab_85)] | | |

We have audited the accompanying consolidated balance sheets of Edwards Lifesciences Corporation and its subsidiaries (the “Company”) as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] 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: 2022,] [added: 2023,] 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: 2022,] [added: 2023,] 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: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] 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: 2022,] [added: 2023,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

As described in Note [removed: 17] [added: 18] to the consolidated financial statements, the Company had an uncertain gross tax position liability balance of [removed: $475.3] [added: $583.9] million as of December 31, [removed: 2022,] [added: 2023,] of which a majority is related to intercompany transfer pricing.

| | | | [added: 2023 | | | | | |] 2022 | | | | | | 2021 | | |

| Cash and cash equivalents | | | $ | [added: 1,144.0 | | | | | $ |] 769.0 | | | | | $ | 862.8 | |

| Short-term investments (Note 7) | | | [removed: 446.3] [added: 500.5] | | | | | | [removed: 604.0] [added: 446.3] | | |

| Accounts receivable, net of allowances of [removed: $7.9] [added: $8.3] and [removed: $9.3,] [added: $7.9,] respectively | | | [removed: 643.0] [added: 775.1] | | | | | | [removed: 582.2] [added: 643.0] | | |

| Other receivables | | | [removed: 56.1] [added: 61.8] | | | | | | [removed: 82.7] [added: 56.1] | | |

| Inventories (Note 5) | | | [removed: 875.5] [added: 1,168.2] | | | | | | [removed: 726.7] [added: 875.5] | | |

| Prepaid expenses | | | [removed: 110.0] [added: 146.8] | | | | | | [removed: 85.2] [added: 110.0] | | |

| Other current assets | | | [removed: 195.9] [added: 239.3] | | | | | | [removed: 237.1] [added: 195.9] | | |

| Total current assets | | | [removed: 3,095.8] [added: 4,035.7] | | | | | | [removed: 3,180.7] [added: 3,095.8] | | |

| Long-term investments (Note 7) | | | [removed: 1,239.0] [added: 583.9] | | | | | | [removed: 1,834.2] [added: 1,239.0] | | |

| Property, plant, and equipment, net (Note 5) | | | [removed: 1,632.8] [added: 1,749.4] | | | | | | [removed: 1,546.6] [added: 1,632.8] | | |

| Operating lease right-of-use assets (Note 6) | | | [removed: 92.3] [added: 94.0] | | | | | | [removed: 92.1] [added: 92.3] | | |

| Goodwill (Note [removed: 9)] [added: 10)] | | | [removed: 1,164.3] [added: 1,253.5] | | | | | | [removed: 1,167.9] [added: 1,164.3] | | |

| Other intangible assets, net (Note [removed: 9)] [added: 10)] | | | [removed: 285.2] [added: 428.4] | | | | | | [removed: 323.6] [added: 285.2] | | |

| Deferred income taxes | | | [removed: 484.0] [added: 754.6] | | | | | | [removed: 246.7] [added: 484.0] | | |

| Other assets | | | [removed: 299.1] [added: 463.7] | | | | | | [removed: 110.8] [added: 299.1] | | |

| Total assets | | | $ | [removed: 8,292.5] [added: 9,363.2] | | | | | $ | [removed: 8,502.6] [added: 8,292.5] | |

| Accounts payable | | | $ | [removed: 201.9] [added: 201.4] | | | | | $ | [removed: 204.5] [added: 201.9] | |

| Accrued and other liabilities (Note 5) | | | [removed: 795.0] [added: 969.1] | | | | | | [removed: 802.3] [added: 795.0] | | |

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

| Total current liabilities | | | [removed: 1,022.4] [added: 1,195.4] | | | | | | [removed: 1,032.3] [added: 1,022.4] | | |

| Long-term debt (Note [removed: 10)] [added: 11)] | | | [removed: 596.3] [added: 597.0] | | | | | | [removed: 595.7] [added: 596.3] | | |

| Contingent consideration liabilities [removed: (Notes 8 and 11)] [added: (Note 12)] | | | [removed: 26.2] [added: —] | | | | | | [removed: 62.0] [added: 26.2] | | |

| Taxes payable (Note [removed: 17)] [added: 18)] | | | [removed: 143.4] [added: 80.6] | | | | | | [removed: 190.0] [added: 143.4] | | |

| Operating lease liabilities (Note 6) | | | [removed: 69.5] [added: 73.0] | | | | | | [removed: 69.1] [added: 69.5] | | |

| Uncertain tax positions (Note [removed: 17)] [added: 18)] | | | [removed: 267.5] [added: 339.3] | | | | | | [removed: 259.0] [added: 267.5] | | |

DECEMBER 31, 2023

February 12, 2024

| | | | 2023 | | | | | | 2022 | | |

| Total Edwards Lifesciences Corporation stockholders' equity | | | 6,650.0 | | | | | | 5,806.7 | | |

| Noncontrolling interest (Note 9) | | | 69.4 | | | | | | — | | |

| Net loss attributable to noncontrolling interest (Note 9) | | | (3.0) | | | | | | — | | | | | | — | | |

| Net income attributable to Edwards Lifesciences Corporation. | | | $ | 1,402.4 | | | | | $ | 1,521.9 | | | | | $ | 1,503.1 | |

| Comprehensive loss attributable to noncontrolling interest | | | (3.0) | | | | | | — | | | | | | — | | |

| Comprehensive income attributable to Edwards Lifesciences Corporation | | | $ | 1,414.5 | | | | | $ | 1,424.7 | | | | | $ | 1,506.5 | |

| Net income | | | $ | 1,399.4 | | | | | $ | 1,521.9 | | | | | $ | 1,503.1 | |

| Change in fair value of contingent consideration liabilities (Note 12) | | | (26.2) | | | | | | (35.8) | | | | | | (124.1) | | |

| Intellectual property agreement accrual | | | (33.0) | | | | | | (45.0) | | | | | | (29.2) | | |

| Long-term prepaid royalties (Note 3) | | | (109.9) | | | | | | — | | | | | | — | | |

| Business combination, net of cash (Note 9) | | | (95.2) | | | | | | — | | | | | | — | | |

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

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

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

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

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

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

| Net income (loss) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1,402.4 | | | | | | | | | | | | 1,402.4 | | | | | | (3.0) | | | | | | 1,399.4 | | |

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

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

| Changes to noncontrolling interest (Note 9) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | — | | | | | | 72.4 | | | | | | 72.4 | | |

| BALANCE AT DECEMBER 31, 2023 | | | 650.5 | | | | | | $ | 650.5 | | | | | 49.4 | | | | | | $ | (5,024.5) | | | | | $ | 2,274.4 | | | | | $ | 8,992.4 | | | | | $ | (242.8) | | | | | $ | 6,650.0 | | | | | $ | 69.4 | | | | | $ | 6,719.4 | |

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.

The Company attributes the net income or losses of its consolidated variable interest entities to controlling and noncontrolling interests using the hypothetical liquidation at book value method.

In addition, the Company

| Net income attributable to Edwards Lifesciences Corporation | | | $ | 1,402.4 | | | | | $ | 1,521.9 | | | | | $ | 1,503.1 | |

| Net income attributable to Edwards Lifesciences Corporation | | | $ | 1,402.4 | | | | | $ | 1,521.9 | | | | | $ | 1,503.1 | |

| Weighted-average shares outstanding | | | 606.7 | | | | | | 619.0 | | | | | | 623.3 | | |

In December 2023, the Financial Accounting Standards Board ("FASB") issued an amendment to the accounting guidance on income taxes which requires entities to provide additional information in the rate reconciliation and additional disaggregated disclosures about income taxes paid.

This guidance requires public entities to disclose in their rate reconciliation table additional categories of information about federal, state, and foreign income taxes and to provide more details about the reconciling items in some categories if the items meet a quantitative threshold.

The Company does not expect the adoption of this guidance to impact its financial statements, but the guidance will impact its income tax disclosures.

The amendments require disclosure of significant segment expenses and other segment items and requires entities to provide in interim periods all disclosures about a reportable segment's profit or loss and assets that are currently required annually.

The amendment also requires disclosure of the title and position of the chief operating decision maker ("CODM") and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources.

The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.

Retrospective application is required, and early adoption is permitted.

| | | | | | |

February 13, 2023

| Reclassification of net realized investment loss to earnings | | | 18.8 | | | | | | 8.6 | | | | | | 0.3 | | |

| Litigation settlement accrual | | | (45.0) | | | | | | (29.2) | | | | | | 270.5 | | |

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

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

| BALANCE AT DECEMBER 31, 2019 | | | 218.1 | | | | | | $ | 218.1 | | | | | 9.0 | | | | | | $ | (1,278.7) | | | | | $ | 1,623.3 | | | | | $ | 3,741.6 | | | | | $ | (156.0) | | | | | $ | 4,148.3 | |

| Stock issued to effect stock split | | | 413.8 | | | | | | 413.8 | | | | | | | | | | | | | | | | | | (413.8) | | | | | | | | | | | | | | | | | | — | | |

Based on the Company's analysis, it determined it is not the primary beneficiary of any material VIEs; however, future events may require VIEs to be consolidated if the Company becomes the primary beneficiary.

The guidance requires certain disclosures about transactions with a government that are accounted for by applying a grant or contribution model.

INTELLECTUAL PROPERTY LITIGATION EXPENSES, NET

On July 12, 2020, the Company reached an agreement with Abbott Laboratories and its direct and indirect subsidiaries ("Abbott") to, among other things, settle all outstanding patent disputes between the companies (the “Settlement Agreement”) in cases related to transcatheter mitral and tricuspid repair products.

The Settlement Agreement resulted in the Company recording an estimated $367.9 million pre-tax charge and related liability in June 2020 related to past damages.

In addition, the Company will incur royalty expenses through May 2024 totaling an estimated $70 million.

The Company made a one-time $100.0 million payment to Abbott in July 2020, and is making quarterly payments in subsequent years.

As of December 31, 2022, $53.3 million was accrued in "*Accrued and other liabilities*" and $143.0 million was accrued in "*Litigation*

*settlement accrual*" on the consolidated balance sheet.

| | | | $ | 875.5 | | | | | $ | 726.7 | |

| | | | 2,383.2 | | | | | | 2,201.2 | | |

| | | | $ | 1,632.8 | | | | | $ | 1,546.6 | |

| | | | $ | 795.0 | | | | | $ | 802.3 | |

| Operating cash flows from operating leases | | | $ | 28.1 | | | | | $ | 31.9 | | | | | $ | 29.7 | |

Restricted cash as of December 31, 2020 also included funds restricted for construction.

| 2023 | | | $ | 27.0 | |

| 2024 | | | 18.5 | | |

| 2025 | | | 12.5 | | |

| 2026 | | | 10.5 | | |

| 2027 | | | 8.2 | | |

| Thereafter | | | 26.0 | | |

| Bank time deposits | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | 2.5 | | | | | $ | — | | | | | $ | — | | | | | $ | 2.5 | |

| Commercial paper | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 127.7 | | | | | | — | | | | | | — | | | | | | 127.7 | | |

| | | | $ | 1,549.1 | | | | | $ | — | | | | | $ | (68.1) | | | | | $ | 1,481.0 | | | | | $ | 2,192.7 | | | | | $ | 2.9 | | | | | $ | (11.9) | | | | | $ | 2,183.7 | |

| Due in 1 year or less | | | $ | 91.5 | | | | | $ | 91.5 | | | | | $ | 362.0 | | | | | $ | 354.8 | |

| | | | $ | 96.0 | | | | | $ | 96.0 | | | | | $ | 1,549.1 | | | | | $ | 1,481.0 | |

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

| | | | $ | 1,632.5 | | | | | $ | (11.9) | | | | | $ | — | | | | | $ | — | | | | | $ | 1,632.5 | | | | | $ | (11.9) | |

During 2021, the Company recorded an upward adjustment of $4.2 million based on observable price changes.

ACQUISITIONS AND OTHER ARRANGEMENTS

ACQUISITIONS AND OTHER ARRANGEMENTS (Continued)

Certain of the Company's business acquisitions involve contingent consideration arrangements.

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: 2022.][added: 2023.]

Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of December 31, [removed: 2022] [added: 2023] 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: 2022.][added: 2023.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2022] [added: 2023] 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: 2022] [added: 2023] that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.

*Rule 10b5-1 Trading Plans*

On December 14, 2023, Donald Bobo, Jr., Corporate Vice President, Strategy & Corporate Development, 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 70,500 shares of the Company’s stock commencing May 10, 2024.

The Plan terminates on the earlier of April 14, 2025 or the date all shares are sold.

None.

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," "Board of Directors Matters—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: 2023] [added: 2024] Annual Meeting of Stockholders (the "Proxy Statement") (which Proxy Statement will be filed with the SEC within 120 days of December 31, [removed: 2022).][added: 2023).]

| [removed: 3.3] [added: 3.4] | | | [Bylaws of Edwards Lifesciences Corporation, as amended and restated as [removed: of July 15, 2021 (incorporated] [added: 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] by reference to Exhibit 3.1 in Edwards Lifesciences' report on Form 8-K filed [removed: on July 15, 2021)](https://www.sec.gov/Archives/edgar/data/0001099800/000119312521216533/d111792dex31.htm)] [added: 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)] | | |

| 4.2 | | | [Description of Edwards Lifesciences Corporation's Capital [removed: Stock](https://www.sec.gov/ix?doc=/Archives/edgar/data/1099800/000109980022000005/ew-20211231.htm) [](https://www.sec.gov/ix?doc=/Archives/edgar/data/1099800/000109980022000005/ew-20211231.htm)[(incorporated] [added: Stock (incorporated] by reference to Exhibit 4.2 in Edwards Lifesciences' report on Form [removed: 10-K](https://www.sec.gov/ix?doc=/Archives/edgar/data/1099800/000109980022000005/ew-20211231.htm) [for] [added: 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)[)](https://www.sec.gov/ix?doc=/Archives/edgar/data/1099800/000109980022000005/ew-20211231.htm)] [added: 2022)](https://www.sec.gov/ix?doc=/Archives/edgar/data/1099800/000109980022000005/ew-20211231.htm)] | | |

| [removed: #10.2] [added: *10.2] | | | [removed: [Settlement Agreement, dated May 19, 2014, between Edwards] [added: [Edwards] Lifesciences Corporation [removed: and Medtronic, Inc.] [added: Form of Employment Agreement] (incorporated by reference to Exhibit [removed: 10.2] [added: 10.8] in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended [removed: June 30, 2014)](http://www.sec.gov/Archives/edgar/data/1099800/000104746914006621/a2220912zex-10_2.htm)] [added: March 31, 2003)](http://www.sec.gov/Archives/edgar/data/1099800/000104746903018615/a2110800zex-10_8.htm)] | | |

| [removed: *10.3] [added: *10.20] | | | [Edwards Lifesciences Corporation Form of [removed: Employment] [added: Indemnification] Agreement (incorporated by reference to Exhibit [removed: 10.8] [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: March] [added: December] 31, [removed: 2003)](http://www.sec.gov/Archives/edgar/data/1099800/000104746903018615/a2110800zex-10_8.htm)] [added: 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_20.htm)] | | |

| *10.7 | | | [removed: [Description of Severance Benefits for Mr. Jean-Luc Lemercier] [added: [Edwards Lifesciences Corporation 2018 Edwards Incentive Plan] (incorporated by reference to Exhibit [removed: 10.1] [added: 10.7] in Edwards [removed: Lifesciences](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000012/ex-10110xqq12021.htm)['](http://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm) [report] [added: Lifesciences' report] on Form [removed: 10-Q] [added: 10-K] for the [removed: quarterly period] [added: fiscal year] ended [removed: March] [added: December] 31, [removed: 2021)](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000012/ex-10110xqq12021.htm)] [added: 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm)] | | |

| [removed: *10.8] [added: *10.18] | | | [Edwards Lifesciences Corporation [removed: 2018 Edwards Incentive Plan] [added: 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: 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm)] [added: 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_7.htm)] | | |

| [removed: *10.9] [added: *10.8] | | | [Edwards Lifesciences Corporation Long-Term Stock Incentive Compensation Program, as amended and restated as of May 7, 2020 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended June 30, 2020)](https://www.sec.gov/Archives/edgar/data/1099800/000109980020000019/ex-10110xqq22020.htm) | | |

| [removed: *10.10] [added: *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, 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746911004794/a2203819zex-10_1.htm) | | |

| [removed: *10.11] [added: *10.10] | | | [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Nonqualified Stock Option Award Agreement for awards granted beginning May 2015 (incorporated by reference to Exhibit 10.11 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101110xkq42021.htm) | | |

| [removed: *10.12] [added: *10.11] | | | [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Restricted Stock Unit Award Agreement for awards granted beginning May [removed: 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101210xkq42021.htm) [(incorporated] [added: 2015 (incorporated] by reference to Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101210xkq42021.htm)[2](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101210xkq42021.htm) [in] [added: 10.12 in] Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101210xkq42021.htm) | | |

| [removed: *10.13] [added: *10.12] | | | [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Performance-Based Restricted Stock Unit Award Agreement for awards granted beginning May [removed: 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101310xkq42021.htm) [(incorporated] [added: 2015 (incorporated] by reference to Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101310xkq42021.htm)[3](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101310xkq42021.htm) [in] [added: 10.13 in] Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101310xkq42021.htm) | | |

| [removed: *10.14] [added: *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) | | |

| [removed: *10.15] [added: *10.14] | | | [Edwards Lifesciences Corporation 2020 Nonemployee Directors Stock Incentive [removed: Program](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm) [](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm)[(incorporated] [added: Program (incorporated] by reference to Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm)[5](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm) [in] [added: 10.15 in] Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm) | | |

| [removed: *10.16] [added: *10.15] | | | [Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related Nonemployee Directors Stock Incentive Program Nonqualified Stock Option Award [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm) [](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm)[(incorporated] [added: Agreement (incorporated] by reference to Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm)[6](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm) [in] [added: 10.16 in] Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm) | | |

| [removed: *10.17] [added: *10.16] | | | [Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program Restricted Stock Units [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm) [](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm)[(incorporated] [added: Agreement (incorporated] by reference to Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm)[7](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm) [in] [added: 10.17 in] Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm) | | |

| [removed: *10.18] [added: *10.17] | | | [Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program Restricted Stock [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101810xkq42021.htm) [(incorporated] [added: Agreement (incorporated] by reference to Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101810xkq42021.htm)[8](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101810xkq42021.htm) [in] [added: 10.18 in] Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101810xkq42021.htm) | | |

| *10.19 | | | [Edwards Lifesciences Corporation [removed: Executive Deferred Compensation Plan, as amended and restated effective] [added: Officer Perquisite Program Guidelines,] as of [removed: November 9, 2011] [added: February 20, 2013] (incorporated by reference to Exhibit [removed: 10.7] [added: 10.25] 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: 2012)](http://www.sec.gov/Archives/edgar/data/1099800/000104746913001954/a2213019zex-10_25.htm)] | | |

| 21.1 | | | [Subsidiaries of Edwards Lifesciences [removed: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-21110xkq42022.htm)] [added: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-21110xkq42023.htm)] | | |

| 23 | | | [Consent of Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-2310xkq42022.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-2310xkq42023.htm)] | | |

| 31.1 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-31110xkq42022.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-31110xkq42023.htm)] | | |

| 31.2 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-31210xkq42022.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-31210xkq42023.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/1099800/000109980023000005/ex-3210xkq42022.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-3210xkq42023.htm)] | | |

| 3.3 | | | [Certificate of Amendment of Amended and Restated Certificate of Incorporation of Edwards Lifesciences Corporation, dated May 11, 2023 (incorporated by reference to Exhibit 3.1 in Edwards Lifesciences' report on Form 8-K filed on May 15, 2023)](https://www.sec.gov/Archives/edgar/data/1099800/000119312523144564/d427364dex31.htm) | | |

| *10.3 | | | [Edwards Lifesciences Corporation Form of Employment Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980024000004/ex-10310xkq42023.htm) | | |

| | | | | | |

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

| *10.20 | | | [Edwards Lifesciences Corporation Officer Perquisite Program Guidelines, as of February 20, 2013 (incorporated by reference to Exhibit 10.25 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2012)](http://www.sec.gov/Archives/edgar/data/1099800/000104746913001954/a2213019zex-10_25.htm) | | |

| *10.21 | | | [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) | | |

| [removed: February 13, 2023 | | | By:] [added: Michael A. Mussallem] | | | | | | [removed: /s/ MICHAEL A. MUSSALLEM] | | |

| [removed: | | | | | |] [added: /s/ MICHAEL A. MUSSALLEM] | | | [removed: Michael A. Mussallem *Chairman] [added: Chairman] of the Board [removed: and* *Chief Executive Officer*] | | | [added: February 12, 2024 | | |]

| [removed: Michael A. Mussallem] [added: Bernard J. Zovighian] | | | (Principal Executive Officer) | | | | | |

| /s/ SCOTT B. ULLEM | | | Corporate Vice President, Chief Financial Officer | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ ROBERT W.A. SELLERS | | | Senior Vice President, [removed: Corporate Controller] [added: Principal Accounting Officer] | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ KIERAN T. GALLAHUE | | | Director | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ LESLIE S. HEISZ | | | Director | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ PAUL A. LAVIOLETTE | | | Director | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ STEVEN R. LORANGER | | | Director | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ MARTHA H. MARSH | | | Director | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ RAMONA SEQUEIRA | | | Director | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| /s/ NICHOLAS J. VALERIANI | | | Director | | | February [removed: 13, 2023] [added: 12, 2024] | | |

| February 12, 2024 | | | By: | | | | | | /s/ BERNARD J. ZOVIGHIAN | | |

| | | | | | | | | | Bernard J. Zovighian *Director and* *Chief Executive Officer* | | |

| /s/ BERNARD J. ZOVIGHIAN | | | Director and Chief Executive Officer | | | February 12, 2024 | | |

| | | | | | | | | |

| /s/ MICHAEL A. MUSSALLEM | | | Chairman of the Board and Chief Executive Officer | | | February 13, 2023 | | |