Edwards Lifesciences (EW) 10-K risk factor changes: FY2022 vs FY2021

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

Please read the cautionary notice regarding forward-looking statements in Part I [removed: above.*][added: above.]

We are subject to risks associated with public health [removed: threats and epidemics,] [added: crises,] including the [removed: novel coronavirus ("COVID-19")] [added: COVID-19 pandemic] and [removed: any variants of COVID-19.][added: other pandemics or epidemics.]

We are subject to risks associated with public health [removed: threats and epidemics,] [added: crises,] including the global health concerns related to the COVID-19 pandemic.

The [removed: global] [added: 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.

- Significant volatility or reductions in demand for our [removed: products;][added: products.]

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

- 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 [removed: arrangements.][added: arrangements; or]

These [removed: developments] [added: factors] include, but are not limited to, the duration and spread of [removed: the outbreak (including new variants of COVID-19),] [added: any outbreak,] its severity, the actions to contain [removed: the virus] or address [removed: its impact,] the [added: impact of the outbreak, the] timing, distribution, and efficacy of vaccines and other treatments, United States and foreign government actions to respond to [removed: the reduction] [added: possible reductions] in global economic activity, and how quickly and to what extent normal economic and operating conditions can resume.

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

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

[removed: 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.

We face substantial competition and compete with [added: technologies of many types and] companies of all sizes on the basis of cost-effectiveness, technological innovations, product performance, brand name recognition, breadth of product offerings, real or perceived product advantages, pricing and availability and rate of reimbursement.

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

We work with leading global physicians [added: and research institutions] who provide considerable knowledge and experience.

If new laws, regulations, or other developments limit our ability to appropriately engage these professionals or [added: with the research institutions of which they are a part or] to continue to receive their advice and input or we are otherwise unsuccessful in maintaining strong working relationships with these [removed: physicians,] [added: physicians or their research institutions,] the development, marketing, and successful use of our products could suffer, which could have a material adverse effect on our business, financial condition, and results of operations.

We [removed: may] experience [added: from time to time, and may continue to experience,] supply interruptions due to a variety of factors, including:

- Vendors' election to no longer service [added: or supply] medical technology [removed: companies] [added: companies, including] due to the burdens of applicable quality requirements and [removed: regulations;][added: regulations or for no reason at all;]

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

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

Our business and results of operations may be adversely affected if we are unable to recruit and retain qualified [added: talent or are otherwise unsuccessful in the execution of our] management [removed: and other personnel.][added: succession plans.]

Our continued success depends, in large part, on our ability to hire and retain qualified people [removed: or otherwise have access to such qualified people globally] and [added: execute on our talent management and succession plans, and] if we are unable to do so, our business and operations may be impaired or disrupted.

Our extensive global operations and business activity as well as the fact that many of our manufacturing facilities and suppliers are outside of the United States [removed: are accompanied by] [added: exposes us to] certain financial, economic, political, and other risks, including those listed below.

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

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

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

- differing labor regulations; [removed: and]

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

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

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

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

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

HIPAA also imposes stringent data privacy and security requirements and the regulatory authority has imposed [added: significant fines and penalties on organizations found to be out of compliance.]

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

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

[added: We obtain bovine tissue] only from closely controlled sources within the United States and Australia.

Summary of Risk Factors

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.

The following summarizes the principal risks and uncertainties affecting our business, financial condition, and results of operations.

This summary should not be relied upon as an exhaustive summary of the material risks facing our business and you should read this summary together with the more detailed description of risks and uncertainties discussed below.

Business and Operating Risks

- Failure to successfully innovate and market products

- Unsuccessful clinical trials or procedures

- Manufacturing, logistics, or quality problems

- Public health crises, including pandemics and epidemics

- Competition

- Dependence on key physicians and research institutions

- Reliance on vendors, suppliers, and other third parties

- Damage, failure, or interruption of our information technology systems, including due to cyber-based attacks and breaches

- Failure to recruit and retain qualified talent or execute management succession plans

- Underperforming operations or unsuccessful business acquisitions or strategic alliances

Market and Other External Risks

- Risks associated with international sales and operations

- Inability to obtain government reimbursement or reductions in reimbursement levels

- Industry consolidation

Legal, Compliance and Regulatory Risks

- Inability to protect our intellectual property

- Inability to defend against intellectual property claims from third parties

- Compliance with government regulations

- Losses from product liability claims

- Use of products in unapproved circumstances

- Substantial costs from environmental, health and safety regulations

- Climate change

- Regulatory actions relating to animal borne illnesses

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

Other public health crises, including any future epidemics or pandemics, could result in similar adverse impacts on our business and markets.

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;

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.

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

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

The effective dates of implementation, the interactions of tax reforms in multiple jurisdictions, and uncertainty related to dispute resolution mechanisms could impact our provision for income taxes.

- military conflict, political unrest, or wars; and

affect the demand for and price levels of our products.

More specifically relating to the EU MDR which came into effect in May 2017 and became applicable in May 2021 with a staggered transition period, all regulated products must be assessed by notified bodies (organizations designated by EU member states) as to whether they meet the technical requirements of the EU MDR before entering the market in Europe.

In particular, we may experience material financial or operational impacts, including:

The extent to which the COVID-19 global pandemic and measures taken in response thereto impact our business, results

of operations, and financial condition will depend on future developments, which are highly uncertain and are difficult to

predict.

significant fines and penalties on organizations found to be out of compliance.

We obtain bovine tissue

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: 2021.][added: 2022.]

Also discussed is our financial position as of December 31, [removed: 2021.][added: 2022.]

For a discussion related to the results of operations for [removed: 2020] [added: 2021] compared to [removed: 2019] [added: 2020] and a discussion related to our consolidated cash flows for [removed: 2020] [added: 2021] compared to [removed: 2019,] [added: 2020,] refer to Part II, Item 7, "*Management's Discussion and Analysis of Financial Condition and Results of Operations*" in our [removed: 2020] [added: 2021] Annual Report on Form 10–K filed with the Securities and Exchange Commission on February [removed: 12, 2021.][added: 14, 2022.]

Financial Highlights and [removed: COVID-19][added: Market Update]

[removed: ][added: ]

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

[removed: In Critical Care, during 2020 there was greater] [added: - increased] demand [removed: in Europe and the United States] for our pressure monitoring products, [removed: but demand for][added: primarily in the United States; and]

Despite the challenges [removed: associated with COVID-19,] [added: to] our [added: business in 2022 due to COVID-19 and macroeconomic factors, our] net sales for [removed: 2021] [added: 2022] were [removed: $5.2] [added: $5.4] billion, representing an increase of [removed: $846.2] [added: $149.9] million over [removed: 2020,] [added: 2021,] driven by sales growth of our TAVR products.

Despite the challenges of the COVID-19 pandemic, our dedicated field teams [added: 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.

In [removed: 2021,] [added: 2022,] we invested [removed: 17.3%] [added: 17.6%] of our net sales in research and development.

The following is a summary of important developments during [removed: 2021:][added: 2022:]

[removed: -] [added: During 2022,] we [removed: completed enrollment in] [added: continued to advance our] EARLY [removed: TAVR, a] [added: TAVR] pivotal [removed: trial] [added: trial,] studying the treatment of severe aortic stenosis patients before their symptoms develop, and [removed: CLASP IID, a] [added: our PROGRESS] pivotal [removed: trial] [added: trial,] studying [removed: *Edwards PASCAL* in patients with degenerative mitral regurgitation;][added: moderate aortic stenosis patients.]

| Outside of the United States | | | [removed: 2,269.4] [added: 2,249.8] | | | | | | [removed: 1,869.5] [added: 2,269.4] | | | | | | | | | | | | [removed: 399.9] [added: (19.6)] | | | | | | | | | | | | [removed: 21.4] [added: (0.9)] | | % | | | | | | |

| Total net sales | | | $ | [removed: 5,232.5] [added: 5,382.4] | | | | | $ | [removed: 4,386.3] [added: 5,232.5] | | | | | | | | | | | $ | [removed: 846.2] [added: 149.9] | | | | | | | | | | | [removed: 19.3] [added: 2.9] | | % | | | | | | |

| Transcatheter Aortic Valve Replacement | | | $ | [removed: 3,422.5] [added: 3,518.2] | | | | | $ | [removed: 2,857.3] [added: 3,422.5] | | | | | | | | | | | $ | [removed: 565.2] [added: 95.7] | | | | | | | | | | | [removed: 19.8] [added: 2.8] | | % | | | | | | |

| Transcatheter Mitral and Tricuspid Therapies | | | [removed: 86.0] [added: 116.1] | | | | | | [removed: 41.8] [added: 86.0] | | | | | | | | | | | | [removed: 44.2] [added: 30.1] | | | | | | | | | | | | [removed: 105.5] [added: 35.1] | | % | | | | | | |

| Surgical Heart Valve Therapy | | | [removed: 889.1] [added: 893.1] | | | | | | [removed: 761.8] [added: 889.1] | | | | | | | | | | | | [removed: 127.3] [added: 4.0] | | | | | | | | | | | | [removed: 16.7] [added: 0.4] | | % | | | | | | |

[removed: ][added: ]

- higher sales of the *Edwards SAPIEN* platform in [removed: 2021] [added: 2022, primarily the *Edwards SAPIEN 3 Ultra* valve] in the United States, Europe, and [removed: Japan driven by improved COVID-19 conditions compared to 2020.][added: Rest of World, the *Edwards SAPIEN 3 Ultra* *RESILIA* valve in the United States, and the *Edwards SAPIEN 3* in Japan;]

- foreign currency exchange rate fluctuations, which [removed: increased] [added: decreased] net sales outside of the United States by [removed: $33.9] [added: $140.2] million primarily due to the [removed: strengthening] [added: weakening] of the Euro [added: and the Japanese yen] against the United States dollar.

[removed: ][added: ]

The increase in net sales of TMTT products was due primarily to [removed: improved COVID-19 conditions compared to 2020 and] continued adoption of our *PASCAL* system in Europe.

[removed: ][added: ]

The increase in net sales of Surgical products was due primarily to [removed: improved COVID-19 conditions compared to 2020 and increased sales] [added: strong adoption] of the *INSPIRIS RESILIA* aortic [removed: valve] [added: valve, primarily in the United States] and [added: Europe, and] the [removed: *KONECT* aortic valved conduit,] [added: *MITRIS RESILIA* valve,] primarily in the United States.

[removed: addition,] [added: -] foreign currency exchange rate [removed: fluctuations increased] [added: fluctuations, which decreased] net sales outside of the United States by [removed: $13.1] [added: $39.5] million primarily due to the [removed: strengthening] [added: weakening] of the [added: Japanese yen and the] Euro against the United States dollar.

[removed: ][added: ]

- increased demand for our capital products, primarily [removed: *Hemosphere* platforms] [added: the *HemoSphere* monitoring platform] in the United [removed: States, as hospital capital spending continued to show signs of recovery;][added: States and Japan;]

- increased demand for our [removed: pressure monitoring products due to elevated COVID hospitalizations,] [added: enhanced surgical recovery products,] primarily in the United States;

[removed: -] [added: These increases were partially offset by the impact of] foreign currency exchange rate fluctuations, which [removed: increased] [added: decreased] net sales outside of the United States by [removed: $9.0] [added: $46.5] million primarily due to the [removed: strengthening] [added: weakening] of the Euro [added: and the Japanese yen] against the United States dollar.

[removed: ][added: ]

[removed: ][added: ]

[removed: ][added: ]

R&D expenses increased [added: marginally] in [removed: 2021] [added: 2022] compared to [removed: 2020] [added: 2021] due primarily to continued investments in our transcatheter [removed: innovations.][added: innovations, including increased clinical trial activity.]

In addition, we will incur royalty expenses through May 2024 totaling an estimated [removed: $100] [added: $70] million.

For further information, see Note [removed: 3] [added: 8] to the "*Consolidated Financial Statements.*"

The change in fair value of contingent consideration liabilities resulted in income of [removed: $124.1] [added: $35.8] million [removed: in 2021] and [removed: expense of $13.6] [added: $124.1] million in [removed: 2020.][added: in 2022 and 2021, respectively.]

The income in 2021 was [removed: driven by] [added: attributable to] changes in the projected [removed: probability and timing] [added: probabilities] of milestone achievements and the projected timing of cash [removed: inflows.][added: inflows from product sales.]

For information on special [removed: charges,] [added: charge,] see Note 4 to the "*Consolidated Financial Statements.*"

Interest expense was [removed: $18.4] [added: $19.2] million and [removed: $15.8] [added: $18.4] million in [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] respectively.

Interest income was [removed: $17.4] [added: $35.5] million and [removed: $23.4] [added: $17.4] million in [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] respectively.

*COVID-19 and Macroeconomic Uncertainties*

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.

In addition to the impacts described above, the global economy, including the financial and credit markets, has recently experienced extreme volatility and disruptions, including increases to inflation rates, rising interest rates, declines in consumer confidence, declines in economic growth, and uncertainty about economic stability.

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

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

*2022 Financial Highlights*

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.

- 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;

- we received CE Mark approval for the *PASCAL Precision* transcatheter valve repair system for patients suffering from mitral and tricuspid regurgitation, and FDA approval for *PASCAL Precision* for patients with degenerative mitral regurgitation; and

- we launched the *SAPIEN 3 Ultra RESILIA* valve following FDA approval.

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

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

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

| Total net sales | | | $ | 5,382.4 | | | | | $ | 5,232.5 | | | | | | | | | | | $ | 149.9 | | | | | | | | | | | 2.9 | | % | | | | | | |

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

and tricuspid regurgitation, and in September 2022, we received FDA approval for *PASCAL Precision* for patients with degenerative mitral regurgitation.

In mitral replacement, we continued to treat patients through the ENCIRCLE pivotal trial for *SAPIEN M3* and completed enrollment in the MISCEND early feasibility study for *EVOQUE Eos*.

We also continued to make progress in enrolling the 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.

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.

In early 2023, we began enrolling patients in our MOMENTS clinical study to demonstrate the durability of *RESILIA* tissue in the mitral position.

partially offset by:

The increase in gross profit as a percentage of net sales in 2022 compared to 2021 was driven primarily by a 3.6 percentage point increase from the impact of our foreign currency hedging program, which includes hedge contract gains and natural hedges (primarily the strengthening of the United States dollar against the Euro and the Japanese yen).

SG&A expenses increased in 2022 compared to 2021 due primarily to a resumption of in-person commercial activities following COVID-19 and higher field-based personnel-related costs, primarily TAVR and TMTT 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 2022 was 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.

Special Charge

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

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

TAVR and Surgical procedure volumes varied greatly since the middle of March 2020 by geography, and even by hospital, as patients and their physicians analyzed the trade-off between aortic stenosis and their concern for COVID-19.

In the last few weeks of the first quarter of 2020, procedure volumes related to our TAVR and Surgical products dropped significantly.

Beginning in the second quarter of 2020, procedure volumes improved.

In the second quarter of 2020, we also started to progressively resume patient enrollment in all clinical trials that were voluntarily paused or slowed at the end of the first quarter of 2020.

While we saw improvements to pre-COVID levels when we resumed enrollment, procedure volumes and enrollment in our clinical trials were negatively impacted in late 2020 due to a resurgence of COVID-19.

other Critical Care products began to decrease at the end of the first quarter of 2020 due to decreased hospital spending related to COVID-19, and that trend continued through the fourth quarter of 2020.

During the first half of 2021, United States TAVR procedures began to grow as COVID-19 hospitalizations decreased and vaccinations increased.

However, TAVR sales were negatively impacted in the second half of 2021 as United States procedures declined due to the significant impact the Delta and Omicron variants had on hospital resources.

Surgical sales grew during 2021 due to increased adoption of our premium high-value technologies around the world and rebounding surgical aortic treatment rates in the United States.

We also saw an increased demand for our Critical Care products in 2021 as hospital capital spending continued to show signs of recovery and elevated COVID hospitalizations in the United States and Europe increased demand for our pressure monitoring devices.

Our gross profit increase in 2021 was driven by our sales growth and lower incremental costs associated with COVID-19.

The increase in our diluted earnings per share in 2021 was driven by our gross profit increase and an after-tax charge of $305.1 million in 2020 to settle certain patent litigation related to transcatheter mitral and tricuspid repair products.

We are closely monitoring the impact of COVID-19 on all aspects of our business and geographies, including its impact on our customers, employees, suppliers, vendors, business partners and distribution channels.

The extent to which COVID-19 and measures taken in response thereto impact our business, results of operations, and financial condition will depend on future developments, which are highly uncertain and are difficult to predict.

These developments include, but are not limited to, the duration and spread of the outbreak (including new and more contagious variants of COVID-19), its severity, the actions to contain the virus or address its impact, the timing, distribution, public acceptance and efficacy of vaccines and other treatments, United States and foreign government actions to respond to the reduction in global economic activity, and how quickly and to what extent normal economic and operating conditions can resume.

Even after the COVID-19 outbreak has subsided, we may continue to experience materially adverse impacts on our financial condition and results of operations.

- we received United States Food and Drug Administration ("FDA") clearance for the *Acumen Hypotension Prediction Index* software with the *Acumen IQ* finger cuff.

This is the first noninvasive solution that uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure;

- we received FDA approval for the use of the *Edwards SAPIEN 3* transcatheter valve with the *Alterra* adaptive prestent for patients with severe pulmonary regurgitation;

- we received CE Mark approval to begin treating patients with a previously repaired or replaced valve in the pulmonic position;

- we received regulatory approval in Japan for our *MITRIS* valve, a new mitral valve incorporating *RESILIA* technology; and

- we received FDA approval for our ALLIANCE pivotal trial to study our next generation TAVR technology, *SAPIEN X4.*

| | | | 2021 | | | | | | 2020 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| United States | | | $ | 2,963.1 | | | | | $ | 2,516.8 | | | | | | | | | | | $ | 446.3 | | | | | | | | | | | 17.7 | | % | | | | | | |

| Europe | | | 1,190.3 | | | | | | 973.6 | | | | | | | | | | | | 216.7 | | | | | | | | | | | | 22.3 | | % | | | | | | |

| Japan | | | 528.9 | | | | | | 460.1 | | | | | | | | | | | | 68.8 | | | | | | | | | | | | 15.0 | | % | | | | | | |

| Rest of World | | | 550.2 | | | | | | 435.8 | | | | | | | | | | | | 114.4 | | | | | | | | | | | | 26.3 | | % | | | | | | |

| Critical Care | | | 834.9 | | | | | | 725.4 | | | | | | | | | | | | 109.5 | | | | | | | | | | | | 15.1 | | % | | | | | | |

Sales, however, were negatively impacted in the second half of 2021 as United States procedures declined due to the significant impact COVID had on hospital resources; and

In the second quarter of 2021, we (1) received approval for a United States pivotal trial for TAVR in moderate aortic stenosis patients, (2) received approval in Japan to begin treating low-risk patients with *SAPIEN 3*, and (3) received *SAPIEN 3* CE Mark approval to begin treating patients with a previously repaired or replaced valve in the pulmonic position.

In the fourth quarter of 2021, we (1) completed enrollment of our EARLY TAVR pivotal trial, which is focused on the treatment of asymptomatic aortic stenosis patients, (2) initiated enrollment in our PROGRESS pivotal trial for moderate aortic stenosis patients, (3) received FDA approval for our ALLIANCE pivotal trial to study our next generation TAVR device, *SAPIEN X4*, and (4) received FDA approval for the use of the *Edwards SAPIEN 3* transcatheter valve with the *Alterra* adaptive prestent for congenital heart patients.

The *Alterra* prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the *SAPIEN 3* valve.

In the fourth quarter of 2021, we completed enrollment of our CLASP IID pivotal trial studying *Edwards PASCAL* in patients with degenerative mitral regurgitation.

We continued to treat patients with both of our transcatheter mitral replacement therapies through the ENCIRCLE trial for *SAPIEN M3* and the MISCEND study for *EVOQUE Eos.* The MISCEND study will evaluate the safety and performance of *EVOQUE Eos*, which is designed to advance the treatment of patients with mitral regurgitation with a low-profile valve delivered through a sub 30 French transfemoral delivery system.

We also began treating patients with *EVOQUE* in the TRISCEND II pivotal trial.

This study will evaluate the safety and effectiveness of the *EVOQUE* tricuspid valve replacement system for patients with severe tricuspid regurgitation.

In

In January 2021, we received regulatory approval in Japan for our *MITRIS* valve, a new mitral valve incorporating *RESILIA* technology, which was launched in Japan during the second quarter of 2021.

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

In June 2021, we received FDA clearance for the *Acumen Hypotension Prediction Index* software with the *Acumen IQ* finger cuff.

As of December 31, [removed: 2021,] [added: 2022,] we had [removed: $2.3] [added: $1.6] billion of investments in debt securities which had an average remaining term to maturity of [removed: 1.29] [added: 0.98] years.

[removed: 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: 2021] [added: 2022] would have resulted in a [removed: $15.3] [added: $7.8] million to [removed: $30.6] [added: $15.5] million decrease in the fair value of these investments.

As of December 31, [removed: 2021,] [added: 2022,] 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 [removed: London interbank offered rate ("LIBOR").][added: Secured Overnight Financing Rate ("SOFR").]

As of December 31, [removed: 2021,] [added: 2022,] there were no borrowings outstanding under the Credit Agreement.

Based on our December 31, [removed: 2021] [added: 2022] 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: 2021,] [added: 2022,] a hypothetical 1.0% absolute increase in market interest rates would decrease the fair value of the fixed-rate debt by approximately [removed: $36.0] [added: $26.7] million.

The total notional amount of our derivative financial instruments entered into for foreign currency management purposes at December 31, [removed: 2021] [added: 2022] was [removed: $1.8] [added: $2.0] billion.

A hypothetical 10% [removed: increase/decrease] [added: increase (or decrease)] in the value of the United States dollar against all hedged currencies would [removed: increase/decrease] [added: increase (or decrease)] the fair value of these derivative contracts by [removed: $134.9] [added: $158.2] million.

At December 31, [removed: 2021,] [added: 2022,] all derivative financial instruments were with bank counterparties assigned investment grade ratings by national rating agencies.

In [removed: 2021,] [added: 2022,] we had no customers that represented 10% or more of our total net sales or accounts receivable, net.

As of December 31, [removed: 2021,] [added: 2022,] we had [removed: $2.3] [added: $1.6] billion of investments in debt securities of various companies, of which [removed: $1.7] [added: $1.1] billion were long-term.

In addition, we had [removed: $92.5] [added: $108.3] million of investments in equity instruments.

Should these companies experience a decline in financial performance, financial condition or credit capacity, or fail to meet certain development milestones, [removed: including as] a [removed: result of the impact from COVID-19 on their business or operations or otherwise, a] decline in the investments' value may occur, resulting in unrealized or realized losses.

Taking into consideration the

Driven by a passion to help patients, we partner with the world’s leading clinicians and researchers and invest in research and development to transform care for those impacted by structural heart disease or who require hemodynamic monitoring [added: during surgery or] in [removed: the hospital setting.][added: intensive care.]

Edwards Lifesciences has been a leader in [removed: these areas] [added: our field] for over six decades.

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

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

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

The *Edwards SAPIEN* family of valves*,* including *Edwards SAPIEN XT,* the *Edwards SAPIEN 3,* [added: the *Edwards SAPIEN 3 Ultra,*] and the *Edwards SAPIEN 3 [removed: Ultra*] [added: Ultra RESILIA*] transcatheter heart valves, and their respective delivery systems, are used to treat heart valve disease using catheter-based approaches for patients who have severe symptomatic aortic stenosis and certain [added: patients with congenital heart disease.]

[removed: Delivered while the heart is beating, these valves] can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies.

Sales of our transcatheter aortic valve replacement products represented [removed: 65%, 65%, and 63%] [added: 65%] of our net sales in [added: each of 2022,] 2021, [removed: 2020,] and [removed: 2019,] [added: 2020,] respectively.

While many of these technologies are in development and clinical phases, the [removed: *PASCAL*] [added: *PASCAL PRECISION*] and *Cardioband* transcatheter valve repair systems are commercially available in Europe for mitral and tricuspid valve repair.

The [removed: *PASCAL*] [added: *PASCAL PRECISION*] system [removed: provides a differentiated, minimally-invasive therapy to address] [added: addresses] the needs of patients with mitral or tricuspid regurgitation through leaflet approximation, while the *Cardioband* system enables clinicians to reduce the valve's annulus [removed: to restore a patient’s mitral or tricuspid valve to a more functional state] and lower regurgitation.

In addition to transcatheter repair, we believe transcatheter replacement is key to unlocking the full mitral and tricuspid [removed: opportunity, given the complex and diverse patient population.][added: opportunity.]

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

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

Our *RESILIA* tissue, [removed: now] with [removed: five years of] published clinical data showing 0% structural valve deterioration through five years1, is helping us redefine tissue durability standards.

Our latest innovation, the *INSPIRIS RESILIA* aortic valve, is built on our *PERIMOUNT* [removed: platform and offers] [added: platform, offering] *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, aortic tissue valved [removed: conduit, for patients who require replacement of the valve, root, and ascending aorta.][added: conduit.]

We believe the demand for surgical structural heart therapies is growing [removed: worldwide] [added: worldwide,] and that our innovation strategy will continue to [removed: extend] [added: strengthen] our leadership and [removed: patient impact.][added: positive impact on patients.]

Sales of our surgical tissue heart valve products represented 15%, [removed: 16%,] [added: 15%,] and [removed: 17%] [added: 16%] of our net sales in [added: 2022,] 2021, [removed: 2020,] and [removed: 2019,] [added: 2020,] respectively.

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

Edwards’ complete hemodynamic portfolio helps clinicians make proactive clinical decisions that can improve patient [removed: outcomes.][added: recovery.]

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

We also support clinical needs with our well-established *Swan-Ganz* [removed: line of] pulmonary artery catheters and arterial pressure monitoring products.

Compatible with our portfolio of sensors and catheters, the *HemoSphere* monitoring platform displays valuable physiological [removed: information in an easy to understand and actionable manner.][added: information.]

Our first predictive algorithm, *Acumen Hypotension Prediction Index* software, alerts clinicians in advance of a patient developing dangerously low blood [removed: pressure and amplifies the clinical need for our *Acumen IQ* and *HemoSphere* monitoring solutions.][added: pressure.]

We compete with [removed: many companies, including] divisions of [removed: companies much] larger [removed: than us and] [added: companies as well as] smaller companies that [removed: compete in specific] [added: offer competitive] product lines [removed: or] [added: in] certain [removed: geographies.][added: geographies in which we operate.]

[removed: Furthermore, new] [added: New] product development and technological change characterize the areas in which we compete.

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

We are not dependent on any single customer and no single customer accounted for 10% or more of our net sales in [removed: 2021.][added: 2022.]

In [removed: 2021, 57%] [added: 2022, 58%] of our net sales were derived from sales to customers in the United States.

Outside of the United States. In [removed: 2021, 43%] [added: 2022, 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: 53%] [added: 52%] were in Europe, [removed: 23%] [added: 21%] were in Japan, and [removed: 24%] [added: 27%] were in Rest of World.

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

We manufacture our Critical Care products primarily in [removed: Puerto Rico and] the Dominican [removed: Republic.][added: Republic and Puerto Rico.]

Most of our replacement heart valves are manufactured from natural tissues harvested from animal [removed: tissue,] [added: tissue] as well as fabricated materials.

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

The quality system is intended to design quality into the products and [removed: utilizes] [added: uses] continuous improvement concepts, including Lean/Six Sigma principles, throughout the product lifecycle.

In [removed: 2021,] [added: 2022,] 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: 19%] [added: 5%] year over year, representing [removed: 17%] [added: 18%] of [removed: 2021] [added: 2022] sales.

The regulatory regime in the European Union [added: ("EU")] for medical devices became mandatory in June 1998.

National laws conforming to the [removed: European Union's] [added: EU's] legislation regulate our products under the medical devices regulatory system.

Delivered while the heart is beating, these valves

As of 2022, the *PASCAL PRECISION* system is also commercially available in the U.S. for degenerative mitral regurgitation patients.

*SAPIEN M3* is based on the proven *SAPIEN* valve while *EVOQUE Eos* is designed specifically for mitral patients.

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.

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

We also compete with both established and newer technologies that target the patients served by our products.

Our Board of Directors also annually approves the strategic talent imperatives that are tied to our Key Operating Drivers ("KODs").

The strategic talent imperatives are developed to identify talent related initiatives that support achievement of the KODs.

This has enabled us to build 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.

We track our performance regularly.

Diversity, Inclusion, and Belonging

We have established a Diversity, Inclusion, and Belonging strategy that includes our four focus areas of Business, People, Communication, and Community, and whose overriding priority is "The Patient." As a practice, all employees receive unconscious bias training as a foundational aspect of our culture.

Employee Listening

The CEO and Executive Leadership Team hold themselves accountable to act on the results of the survey, and these results are reviewed by management with our Board of Directors.

Total Well-being

Edwards has established a long-term aspiration to grow and develop talent significantly, centering our efforts around critical leadership and technical skills for the present and future needs of the business.

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.

Edwards Lifesciences Corporation was incorporated in Delaware on September 10, 1999.

patients with congenital heart disease.

*SAPIEN M3* is based on the proven *SAPIEN* valve, paired with a novel docking system.

*EVOQUE Eos* is our next generation transcatheter replacement system, designed specifically for mitral patients.

Both *SAPIEN M3* and *EVOQUE Eos* are implanted with transfemoral delivery systems that are sub 30-French, which has benefits for femoral puncture and septal crossing, contributing to ease of use, and patient safety.

We are pioneering more resilient surgical therapies that help patients and can improve the quality of their lives.

In 2021, we also received regulatory approval with reimbursement in Japan for our *MITRIS RESILIA* valve, a new mitral valve incorporating our newest tissue technology.

In addition to our replacement valves, we are the worldwide leader in surgical heart valve repair therapies.

Our recently launched *HARPOON Beating Heart Mitral Valve Repair System* can help transform care for many patients with degenerative mitral regurgitation.

Hemodynamic monitoring plays an important role in enhancing surgical recovery.

Sales of our hemodynamic products represented 8%, 9%, and 10% of our net sales in 2021, 2020, and 2019, respectively.

We must continue to develop and commercialize new products and technologies to remain competitive in the cardiovascular medical technology industry.

Attracting, developing, and retaining talent is fundamental to our success.

The T&O Strategy framework takes a comprehensive approach which includes envisioning the future of our work (the "what" and "how" we deliver our patient focused strategy), planning our workforce (the "who" joining our community of trusted partners), and designing our workplace (the "where" and "when" work gets done).

Our HCM governance includes a global talent development review ("TDR") process as well as an HCM dashboard.

Our HCM dashboard is generated quarterly and provides insights on key metrics related to areas such as attraction and growth rates, retention trends, diversity, and employee sentiment.

We have established a Diversity, Inclusion, and Belonging strategy that incorporates the four pillars of Business, People, Communication, and Community.

programs for our employees.

In addition to our robust TDR process and tuition reimbursement programs, we provide a variety of leadership, technical, and professional development programs around the globe.

For the Fiscal Year Ended December 31, [removed: 2021][added: 2022]

The aggregate market value of the registrant's common stock held by non-affiliates as of June 30, [removed: 2021] [added: 2022] (the last trading day of the registrant's most recently completed second quarter): [removed: $64,028,235,982] [added: $58,453,646,002] 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: 2022,] [added: 2023,] was [removed: 623,207,437.][added: 608,313,396.]

Portions of the registrant's proxy statement for the [removed: 2022] [added: 2023] Annual Meeting of Stockholders (to be filed within 120 days of December 31, [removed: 2021)] [added: 2022)] are incorporated by reference into Part III, as indicated herein.

Form 10-K Annual [removed: Report—2021][added: Report—2022]

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| [PART [removed: III](#i8e6404ebd98d416daa7f88f48159b601_163)] [added: III](#i7911ec8fe8cb4553848d1b6fe0ac94b3_163)] | | | | | | | | |

| [Item [removed: 10.](#i8e6404ebd98d416daa7f88f48159b601_166)] [added: 10.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_166)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#i8e6404ebd98d416daa7f88f48159b601_166)] [added: Governance](#i7911ec8fe8cb4553848d1b6fe0ac94b3_166)] | | | [removed: [91](#i8e6404ebd98d416daa7f88f48159b601_166)] [added: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_166)] | | |

| [Item [removed: 11.](#i8e6404ebd98d416daa7f88f48159b601_169)] [added: 11.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_169)] | | | [Executive [removed: Compensation](#i8e6404ebd98d416daa7f88f48159b601_169)] [added: Compensation](#i7911ec8fe8cb4553848d1b6fe0ac94b3_169)] | | | [removed: [91](#i8e6404ebd98d416daa7f88f48159b601_169)] [added: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_169)] | | |

| [Item [removed: 12.](#i8e6404ebd98d416daa7f88f48159b601_172)] [added: 12.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_172)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i8e6404ebd98d416daa7f88f48159b601_172)] [added: Matters](#i7911ec8fe8cb4553848d1b6fe0ac94b3_172)] | | | [removed: [91](#i8e6404ebd98d416daa7f88f48159b601_172)] [added: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_172)] | | |

| [Item [removed: 13.](#i8e6404ebd98d416daa7f88f48159b601_175)] [added: 13.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_175)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i8e6404ebd98d416daa7f88f48159b601_175)] [added: Independence](#i7911ec8fe8cb4553848d1b6fe0ac94b3_175)] | | | [removed: [91](#i8e6404ebd98d416daa7f88f48159b601_175)] [added: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_175)] | | |

| [Item [removed: 14.](#i8e6404ebd98d416daa7f88f48159b601_178)] [added: 14.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_178)] | | | [Principal Accounting Fees and [removed: Services](#i8e6404ebd98d416daa7f88f48159b601_178)] [added: Services](#i7911ec8fe8cb4553848d1b6fe0ac94b3_178)] | | | [removed: [91](#i8e6404ebd98d416daa7f88f48159b601_178)] [added: [89](#i7911ec8fe8cb4553848d1b6fe0ac94b3_178)] | | |

| [PART [removed: IV](#i8e6404ebd98d416daa7f88f48159b601_181)] [added: IV](#i7911ec8fe8cb4553848d1b6fe0ac94b3_181)] | | | | | | | | |

| [Item [removed: 15.](#i8e6404ebd98d416daa7f88f48159b601_184)] [added: 15.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_184)] | | | [Exhibits and Financial Statement [removed: Schedules](#i8e6404ebd98d416daa7f88f48159b601_184)] [added: Schedules](#i7911ec8fe8cb4553848d1b6fe0ac94b3_184)] | | | [removed: [92](#i8e6404ebd98d416daa7f88f48159b601_184)] [added: [90](#i7911ec8fe8cb4553848d1b6fe0ac94b3_184)] | | |

| [Item [removed: 16.](#i8e6404ebd98d416daa7f88f48159b601_187)] [added: 16.](#i7911ec8fe8cb4553848d1b6fe0ac94b3_187)] | | | [Form 10-K [removed: Summary](#i8e6404ebd98d416daa7f88f48159b601_187)] [added: Summary](#i7911ec8fe8cb4553848d1b6fe0ac94b3_187)] | | | [removed: [93](#i8e6404ebd98d416daa7f88f48159b601_187)] [added: [91](#i7911ec8fe8cb4553848d1b6fe0ac94b3_187)] | | |

| | | | [removed: [Signatures](#i8e6404ebd98d416daa7f88f48159b601_190)] [added: [Signatures](#i7911ec8fe8cb4553848d1b6fe0ac94b3_190)] | | | [removed: [94](#i8e6404ebd98d416daa7f88f48159b601_190)] [added: [92](#i7911ec8fe8cb4553848d1b6fe0ac94b3_190)] | | |

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

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

These statements include, among other things, the [removed: continued] [added: expected] impact of COVID-19 on our business, [added: 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 [added: 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.

These risks and uncertainties include, but are not limited to: [removed: uncertainties regarding the severity and duration of the COVID-19 pandemic and its impact on] our [removed: business] [added: success in developing new products] and [removed: the economy generally,] [added: avoiding manufacturing and quality issues;] clinical trial or commercial results or new product approvals and therapy adoption; [removed: inability] [added: the impact of public health crises, including the COVID-19 pandemic; the impact of domestic and global economic conditions; competitive dynamics in the markets in which we operate; our reliance on vendors, suppliers, and other third parties; damage, failure,] or [removed: failure] [added: interruption of our information technology systems; consolidation in the healthcare industry; our ability] to [removed: comply] [added: protect our intellectual property; our compliance] with applicable regulations; [removed: unpredictability of] [added: our exposure to] product [removed: launches; competitive dynamics;] [added: liability claims; use of our products in unapproved circumstances;] changes to reimbursement for [removed: the company's] [added: our] products; the [removed: company’s success in developing new products and avoiding manufacturing and quality issues; the] impact of currency exchange rates; [removed: the timing or results of research and development and clinical trials;] unanticipated actions by the United States Food and Drug Administration and other regulatory agencies; [added: changes to tax laws;] unexpected impacts or expenses [removed: resulting from] [added: 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 [removed: U.S.] [added: United States] Securities and Exchange Commission.

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

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

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

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

WEBSITE REFERENCES

In this Annual Report on Form 10-K, we make references to our website at www.edwards.com.

References to our website through this Form 10-K are provided for convenience only and the content of our website does not constitute a part of, and shall not be deemed incorporated by reference into, this Annual Report on Form 10-K.

| [PART I](#i8e6404ebd98d416daa7f88f48159b601_10) | | | | | | | | |

| [PART II](#i8e6404ebd98d416daa7f88f48159b601_34) | | | | | | | | |

The Draper, Utah lease expires in 2031; the Dominican Republic lease expires in 2022; the Puerto Rico property has two leases that expire in 2023; the Costa Rica lease expires in 2026; the Prague, Czech Republic lease expires in 2026; the Shannon, Ireland lease expires in 2024; the Tokyo, Japan lease expires in 2024; the Shanghai, China lease expires in 2024; Singapore has one land lease that expires in 2036 and one that expires in 2041; and the Caesarea, Israel lease expires in 2030.

On January 31, [removed: 2022,] [added: 2023,] there were [removed: 8,413] [added: 8,019] stockholders of record of our common stock.

(b) On May [removed: 8, 2019,] [added: 4, 2021,] the Board of Directors approved a stock repurchase program [removed: authorizing us to purchase] [added: providing for] up to $1.0 billion of [added: repurchases of] our common stock.

[removed: On May 4, 2021,] [added: In July 2022,] the Board of Directors approved [removed: a new stock repurchase program providing for] an additional [removed: $1.0] [added: $1.5] billion of repurchases of our common [removed: stock.][added: stock under this program, effective July 28, 2022.]

Repurchases under the [removed: programs] [added: program] may be made on the open market, including pursuant to a Rule 10b5-1 plan, and in privately negotiated transactions.

[removed: These] [added: The] repurchase [removed: programs do] [added: program does] not have an expiration date.

The cumulative total return listed below assumes an initial investment of $100 at the market close on December 31, [removed: 2016] [added: 2017] and reinvestment of dividends.

[removed: ][added: ]

| | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | |

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

| 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 | | |

| October 1, 2021 through October 31, 2021 | | | | | | | | | | | | — | | | | | | $ | — | | | | | — | | | | | | $ | 1,222.7 | | | | |

| November 1, 2021 through November 30, 2021 | | | | | | | | | | | | 458,862 | | | | | | 114.46 | | | | | | 456,745 | | | | | | 1,170.4 | | | | | |

| December 1, 2021 through December 31, 2021 | | | | | | | | | | | | 401,444 | | | | | | 109.58 | | | | | | 401,444 | | | | | | 1,126.4 | | | | | |

| Total | | | | | | | | | | | | 860,306 | | | | | | 112.18 | | | | | | 858,189 | | | | | | | | | | | |

| Edwards Lifesciences | | | $ | 120.29 | | | | | $ | 163.47 | | | | | $ | 248.98 | | | | | $ | 292.09 | | | | | $ | 414.78 | |

| S&P 500 | | | 121.83 | | | | | | 116.49 | | | | | | 153.17 | | | | | | 181.35 | | | | | | 233.41 | | |

| S&P 500 Health Care Equipment | | | 130.90 | | | | | | 152.15 | | | | | | 196.77 | | | | | | 231.46 | | | | | | 276.26 | | |

[removed: DECEMBER] [added: | December] 31, 2021 [added: | | | | | | | | | | | | | | | | | | | | | | | |]

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#i8e6404ebd98d416daa7f88f48159b601_67) 238[)](#i8e6404ebd98d416daa7f88f48159b601_67)] [added: ID](#i7911ec8fe8cb4553848d1b6fe0ac94b3_67) 238[)](#i7911ec8fe8cb4553848d1b6fe0ac94b3_67)] | | | [removed: [40](#i8e6404ebd98d416daa7f88f48159b601_67)] [added: [40](#i7911ec8fe8cb4553848d1b6fe0ac94b3_67)] | | |

| [Consolidated Balance Sheets as of December [removed: 31,](#i8e6404ebd98d416daa7f88f48159b601_70)] [added: 31,](#i7911ec8fe8cb4553848d1b6fe0ac94b3_70) 2022 [and](#i7911ec8fe8cb4553848d1b6fe0ac94b3_70)] 2021 [removed: [and](#i8e6404ebd98d416daa7f88f48159b601_70) 2020] | | | [removed: [43](#i8e6404ebd98d416daa7f88f48159b601_70)] [added: [42](#i7911ec8fe8cb4553848d1b6fe0ac94b3_70)] | | |

| For the Years Ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019:] [added: 2020:] | | | | | |

| [Consolidated Statements of [removed: Operations](#i8e6404ebd98d416daa7f88f48159b601_73)] [added: Operations](#i7911ec8fe8cb4553848d1b6fe0ac94b3_73)] | | | [removed: [44](#i8e6404ebd98d416daa7f88f48159b601_73)] [added: [43](#i7911ec8fe8cb4553848d1b6fe0ac94b3_73)] | | |

| [Consolidated Statements of Comprehensive [removed: Income](#i8e6404ebd98d416daa7f88f48159b601_76)] [added: Income](#i7911ec8fe8cb4553848d1b6fe0ac94b3_76)] | | | [removed: [45](#i8e6404ebd98d416daa7f88f48159b601_76)] [added: [44](#i7911ec8fe8cb4553848d1b6fe0ac94b3_76)] | | |

| [Consolidated Statements of Cash [removed: Flows](#i8e6404ebd98d416daa7f88f48159b601_79)] [added: Flows](#i7911ec8fe8cb4553848d1b6fe0ac94b3_79)] | | | [removed: [46](#i8e6404ebd98d416daa7f88f48159b601_79)] [added: [45](#i7911ec8fe8cb4553848d1b6fe0ac94b3_79)] | | |

| [Consolidated Statements of Stockholders' [removed: Equity](#i8e6404ebd98d416daa7f88f48159b601_82)] [added: Equity](#i7911ec8fe8cb4553848d1b6fe0ac94b3_82)] | | | [removed: [47](#i8e6404ebd98d416daa7f88f48159b601_82)] [added: [46](#i7911ec8fe8cb4553848d1b6fe0ac94b3_82)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i8e6404ebd98d416daa7f88f48159b601_85)] [added: Statements](#i7911ec8fe8cb4553848d1b6fe0ac94b3_85)] | | | [removed: [48](#i8e6404ebd98d416daa7f88f48159b601_85)] [added: [47](#i7911ec8fe8cb4553848d1b6fe0ac94b3_85)] | | |

We have audited the accompanying consolidated balance sheets of Edwards Lifesciences Corporation and its subsidiaries (the “Company”) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] 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: 2021,] [added: 2022,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

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

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

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

As described in Note 17 to the consolidated financial statements, the Company had an uncertain gross tax position liability balance of [removed: $358.4] [added: $475.3] million as of December 31, [removed: 2021,] [added: 2022,] of which a majority is related to intercompany transfer pricing.

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

[removed: *Fair Value] [added: | Change in fair value] of [removed: Contingent Consideration Liabilities*][added: contingent consideration liabilities, net | | | 35.8 | | | | | | 124.1 | | | | | | (13.6) | | |]

These inputs [added: as of December 31, 2022] include (1) the discount rate used to present value the projected cash [removed: flows,] [added: flows (ranging from 3.8% to 12.8%; weighted average of 4.1%),] (2) the probability of milestone [removed: achievement,] [added: achievement (ranging from 0% to 50%; weighted average of 39.6%), and] (3) the projected payment [removed: dates, and (4) the volatility of future sales.][added: dates (2026).]

| | | | [added: 2022 | | | | | |] 2021 | | | | | | 2020 | | |

| Cash and cash equivalents | | | $ | [added: 769.0 | | | | | $ |] 862.8 | | | | | $ | 1,183.2 | |

| Short-term investments (Note 7) | | | [removed: 604.0] [added: 446.3] | | | | | | [removed: 219.4] [added: 604.0] | | |

| Accounts receivable, net of allowances of [removed: $9.3] [added: $7.9] and [removed: $9.6,] [added: $9.3,] respectively | | | [removed: 582.2] [added: 643.0] | | | | | | [removed: 514.6] [added: 582.2] | | |

| Other receivables | | | [removed: 82.7] [added: 56.1] | | | | | | [removed: 88.2] [added: 82.7] | | |

| Inventories (Note 5) | | | [removed: 726.7] [added: 875.5] | | | | | | [removed: 802.3] [added: 726.7] | | |

| Prepaid expenses | | | [removed: 85.2] [added: 110.0] | | | | | | [removed: 75.1] [added: 85.2] | | |

| Other current assets | | | [removed: 237.1] [added: 195.9] | | | | | | [removed: 208.2] [added: 237.1] | | |

| Total current assets | | | [removed: 3,180.7] [added: 3,095.8] | | | | | | [removed: 3,091.0] [added: 3,180.7] | | |

| Long-term investments (Note 7) | | | [removed: 1,834.2] [added: 1,239.0] | | | | | | [removed: 801.6] [added: 1,834.2] | | |

| Property, plant, and equipment, net (Note 5) | | | [removed: 1,546.6] [added: 1,632.8] | | | | | | [removed: 1,395.2] [added: 1,546.6] | | |

| Operating lease right-of-use assets (Note 6) | | | [removed: 92.1] [added: 92.3] | | | | | | [removed: 94.2] [added: 92.1] | | |

| Goodwill (Note 9) | | | [removed: 1,167.9] [added: 1,164.3] | | | | | | [removed: 1,173.2] [added: 1,167.9] | | |

| Other intangible assets, net (Note 9) | | | [removed: 323.6] [added: 285.2] | | | | | | [removed: 331.4] [added: 323.6] | | |

| Deferred income taxes | | | [removed: 246.7] [added: 484.0] | | | | | | [removed: 230.9] [added: 246.7] | | |

| Other assets | | | [removed: 110.8] [added: 299.1] | | | | | | [removed: 119.6] [added: 110.8] | | |

| Total assets | | | $ | [removed: 8,502.6] [added: 8,292.5] | | | | | $ | [removed: 7,237.1] [added: 8,502.6] | |

| Accounts payable | | | $ | [removed: 204.5] [added: 201.9] | | | | | $ | [removed: 196.5] [added: 204.5] | |

| Accrued and other liabilities (Note 5) | | | [removed: 802.3] [added: 795.0] | | | | | | [removed: 670.2] [added: 802.3] | | |

| Operating lease liabilities (Note 6) | | | 25.5 | | | | | | [removed: 27.2] [added: 25.5] | | |

DECEMBER 31, 2022

February 13, 2023

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

| Special charge (Note 4) | | | 60.7 | | | | | | — | | | | | | — | | |

| Net income | | | $ | 1,521.9 | | | | | $ | 1,503.1 | | | | | $ | 823.4 | |

| Net income | | | $ | 1,521.9 | | | | | $ | 1,503.1 | | | | | $ | 823.4 | |

| Loss (gain) on investments, net | | | 51.5 | | | | | | (36.8) | | | | | | (21.2) | | |

| Other | | | 7.8 | | | | | | 9.4 | | | | | | 17.7 | | |

| BALANCE AT DECEMBER 31, 2022 | | | 646.3 | | | | | | $ | 646.3 | | | | | 38.0 | | | | | | $ | (4,144.0) | | | | | $ | 1,969.3 | | | | | $ | 7,590.0 | | | | | $ | (254.9) | | | | | $ | 5,806.7 | |

Businesses that the Company acquires are included in its results of operations as of the acquisition date.

The purchase price is allocated to the assets acquired and liabilities assumed based on their estimated fair values.

The excess of the purchase price over the fair values of identifiable assets and liabilities is recorded as goodwill.

Acquisition-related expenses are recognized separately from the business combination and are expensed as incurred.

Contingent consideration obligations incurred in connection with a business combination are recorded at their fair values on the acquisition date and remeasured on a quarterly basis, with changes in their fair value recorded as an adjustment to earnings, until the related contingencies have been resolved.

When the assets acquired do not meet the definition of a business combination, the transactions is accounted for as an asset acquisition.

In an asset acquisition, the cost of the acquisition is allocated to the assets acquired and liabilities assumed based on their relative fair values.

Upfront payments related to in-process research and development projects with no alternative future use are expensed upon acquisition.

For further information, see Note 4.

| Net income | | | $ | 1,521.9 | | | | | $ | 1,503.1 | | | | | $ | 823.4 | |

| Net income | | | $ | 1,521.9 | | | | | $ | 1,503.1 | | | | | $ | 823.4 | |

| Weighted-average shares outstanding | | | 619.0 | | | | | | 623.3 | | | | | | 622.6 | | |

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

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.

SPECIAL CHARGE

In September 2022, the Company decided to exit its *HARPOON* surgical mitral repair system program.

As a result, the Company recorded a charge to its United States segment of $62.3 million, of which $60.7 million was included in "*Special Charge*" and $1.6 million was included in "*Cost of Sales*" on the consolidated statements of operations.

The charge primarily related to the full impairment of intangible assets associated with the technology for $52.7 million (see Note 8 and Note 9) and other related exit costs.

The Company believes that no additional contingent consideration is due and, in September 2022, recorded an $11.7 million contingent consideration gain associated with the exit (see Note 11).

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

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

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

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

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

| | | | 2022 | | | | | | 2021 | | | | | | 2020 | | |

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

| 2023 | | | $ | 27.0 | |

| 2024 | | | 18.5 | | |

| 2025 | | | 12.5 | | |

| 2026 | | | 10.5 | | |

| | | | | | |

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

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

As described in Note 11 to the consolidated financial statements, certain of the Company’s acquisitions involve contingent consideration arrangements.

As of December 31, 2021, the Company had a contingent consideration liability of $62.0 million.

These contingent consideration liabilities are measured by management at estimated fair value using either a probability weighted discounted cash flow analysis or a Monte Carlo simulation model, both of which consider significant unobservable inputs.

The principal considerations for our determination that performing procedures relating to the fair value of contingent consideration liabilities is a critical audit matter are the significant judgment by management when estimating the fair value of

these contingent consideration liabilities, including a high degree of estimation uncertainty in evaluating the discount rate, the probability of milestone achievement, the projected payment dates, and the volatility of future sales.

This in turn led to a high degree of auditor judgment, effort, and subjectivity in performing procedures to evaluate the fair value of contingent consideration liabilities.

These procedures included testing the effectiveness of controls relating to management’s process for estimating the fair value of contingent consideration liabilities, including controls over the determination of the significant unobservable inputs selected by management.

These procedures also included, among others (i) testing management’s process for estimating the fair value of these contingent consideration liabilities and (ii) testing management’s probability weighted discounted cash flow analysis or Monte Carlo simulation model used to estimate the fair value of the contingent consideration liabilities.

Testing management’s process included evaluating the appropriateness of the valuation methods used and the reasonableness of the significant assumptions related to the discount rate, the probability of milestone achievement, the projected payment dates, and the volatility of future sales.

Evaluating the reasonableness of the probability of milestone achievement and projected payment dates involved consideration of information obtained from the Company’s product engineers, clinical trial data, and third-party industry data.

The reasonableness of the discount rate was evaluated by considering the cost of capital of comparable businesses and other industry factors.

Professionals with specialized skill and knowledge were used to assist in the evaluation of the reasonableness of significant assumptions related to the discount rate and volatility of future sales.

February 14, 2022

EDWARDS LIFESCIENCES CORPORATION

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

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

| Special charges (Note 4) | | | — | | | | | | — | | | | | | 64.6 | | |

| Inventory write off (Note 2) | | | — | | | | | | — | | | | | | 73.1 | | |

| Other | | | (23.4) | | | | | | (3.5) | | | | | | (2.8) | | |

| Acquisition (Note 8) | | | — | | | | | | — | | | | | | (100.2) | | |

| BALANCE AT DECEMBER 31, 2018 | | | 215.2 | | | | | | $ | 215.2 | | | | | 7.5 | | | | | | $ | (1,015.4) | | | | | $ | 1,384.4 | | | | | $ | 2,694.7 | | | | | $ | (138.5) | | | | | $ | 3,140.4 | |

Stock Split

On May 7, 2020, the Company’s Board of Directors declared a three-for-one stock split of the Company's outstanding shares of common stock effected in the form of a stock dividend, distributed on May 29, 2020 to stockholders of record on May 18, 2020.

The Company distributed two newly issued shares of common stock to holders of record of each share of common stock to effect the stock split.

All applicable share and per-share amounts in the consolidated financial statements and the notes to consolidated financial statements have been retroactively adjusted to reflect this stock split.

The consolidated statement of stockholders' equity for the year ended December 31, 2019 has not been retroactively adjusted to reflect the stock split.

In particular, the COVID-19 pandemic has adversely impacted, and may further adversely impact, nearly all aspects of the Company's business and markets, including its workforce and the operations of its customers, suppliers, and business partners.

The full extent to which the pandemic will directly or indirectly impact the Company's business, results of operations, and financial condition, including sales, expenses, manufacturing, clinical trials, research and development costs, reserves and allowances, fair value measurements, asset impairment charges, contingent consideration obligations, and the effectiveness of the Company's hedging instruments, will depend on future developments that are highly uncertain and difficult to predict.

These developments include, but are not limited to, the duration and spread of the outbreak (including new and more contagious variants of COVID-19), its severity, the actions to contain the virus or address its impact, the timing, distribution, public acceptance and efficacy of vaccines and other treatments, United States and foreign government actions to respond to the reduction in global economic activity, and how quickly and to what extent normal economic and operating conditions can resume.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

Equity method investments are considered impaired when

In 2019, the Company recorded a $73.1 million charge to "*Cost of Sales*," primarily comprised of the write off of inventory related to strategic decisions regarding its transcatheter aortic valve portfolio, including the decision to discontinue its *CENTERA* program.

An impairment

In addition, the

SPECIAL CHARGES

*Impairment of Long-lived Assets*

These assets were acquired as part of the acquisition of Valtech Cardio Ltd. ("Valtech") in 2017.

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) [removed: and] [added: or] 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of December 31, [removed: 2021.][added: 2022.]

Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of December 31, [removed: 2021] [added: 2022] 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: 2021.][added: 2022.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] 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: 2021] [added: 2022] that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.

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: 2022] [added: 2023] Annual Meeting of Stockholders (the "Proxy Statement") (which Proxy Statement will be filed with the SEC within 120 days of December 31, [removed: 2021).][added: 2022).]

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

| 4.2 | | | [Description of Edwards Lifesciences Corporation's Capital [removed: Stock](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-4210xkq42021.htm)] [added: 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 by reference to Exhibit 4.2 in Edwards Lifesciences' report on Form 10-K](https://www.sec.gov/ix?doc=/Archives/edgar/data/1099800/000109980022000005/ew-20211231.htm) [for the fiscal year ended December 31, 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)] | | |

| 10.1 | | | [Five-Year Credit Agreement, dated as of [removed: April 30, 2018,] [added: July 15, 2022,] among Edwards Lifesciences Corporation and certain of its subsidiaries, as Borrowers, the lenders signatory thereto, Bank of America, N.A., as Administrative [removed: Agent, JPMorgan Chase Bank, N.A., as Syndication Agent, and Morgan Stanley MUFG Loan Partners, LLC, Deutsche Bank Securities Inc., HSBC Bank USA, National Association, and Wells Fargo Bank, National Association, as Co-Documentation Agents] [added: Agent] (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 8-K filed on [removed: April 30, 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000119312518143174/d579000dex101.htm)] [added: July 21, 2022)](https://www.sec.gov/Archives/edgar/data/1099800/000119312522199173/d383535dex101.htm)] | | |

| *10.11 | | | [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Nonqualified Stock Option Award Agreement for awards granted beginning May [removed: 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101110xkq42021.htm)] [added: 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)] | | |

| *10.12 | | | [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Restricted Stock Unit Award Agreement for awards granted beginning May 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101210xkq42021.htm) [added: [(incorporated by reference to Exhibit 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 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)] | | |

| *10.13 | | | [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Performance-Based Restricted Stock Unit Award Agreement for awards granted beginning May 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101310xkq42021.htm) [added: [(incorporated by reference to Exhibit 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 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)] | | |

| *10.15 | | | [Edwards Lifesciences Corporation 2020 Nonemployee Directors Stock Incentive Program](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm) [added: [](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm)[(incorporated by reference to Exhibit 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 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)] | | |

| *10.16 | | | [Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related Nonemployee Directors Stock Incentive Program Nonqualified Stock Option Award Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm) [added: [](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm)[(incorporated by reference to Exhibit 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 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)] | | |

| *10.17 | | | [Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program Restricted Stock Units Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm) [added: [](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm)[(incorporated by reference to Exhibit 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 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)] | | |

| *10.18 | | | [Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program Restricted Stock Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101810xkq42021.htm) [added: [(incorporated by reference to Exhibit 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 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)] | | |

| 21.1 | | | [Subsidiaries of Edwards Lifesciences [removed: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-21110xkq42021.htm)] [added: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-21110xkq42022.htm)] | | |

| 23 | | | [Consent of Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-2310xkq42021.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-2310xkq42022.htm)] | | |

| 31.1 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-31110xkq42021.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-31110xkq42022.htm)] | | |

| 31.2 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-31210xkq42021.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-31210xkq42022.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/1099800/000109980022000005/ex-3210xkq42021.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980023000005/ex-3210xkq42022.htm)] | | |

| February [removed: 14, 2022] [added: 13, 2023] | | | By: | | | | | | /s/ MICHAEL A. MUSSALLEM | | |

| /s/ MICHAEL A. MUSSALLEM | | | Chairman of the Board and Chief Executive Officer | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ SCOTT B. ULLEM | | | Corporate Vice President, Chief Financial Officer | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ ROBERT W.A. SELLERS | | | [added: Senior] Vice President, Corporate Controller | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ KIERAN T. GALLAHUE | | | Director | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ LESLIE S. HEISZ | | | Director | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ PAUL A. LAVIOLETTE | | | Director | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ STEVEN R. LORANGER | | | Director | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ MARTHA H. MARSH | | | Director | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ RAMONA SEQUEIRA | | | Director | | | February [removed: 14, 2022] [added: 13, 2023] | | |

| /s/ NICHOLAS J. VALERIANI | | | Director | | | February [removed: 14, 2022] [added: 13, 2023] | | |