Edwards Lifesciences (EW) 10-K risk factor changes: FY2021 vs FY2020

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

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

These developments include, but are not limited to, the duration and spread of the outbreak (including new variants of COVID-19), its severity, the actions to contain the virus or address its impact, the timing, distribution, and efficacy of vaccines and other treatments, [removed: U.S.] [added: 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.

If preliminary clinical results are later contradicted, or if initial results cannot be [added: supported by actual long-term studies or clinical experience, our business could be adversely affected.]

Clinical trials or procedures may be delayed, suspended, or terminated by us, the FDA, or other regulatory authorities at any time if it is believed that the trial participants face unacceptable health risks or any other [removed: reasons.][added: 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 [removed: maintain working relationships] [added: work] with [added: leading global] physicians [removed: upon whom we rely to] [added: who] provide considerable knowledge and experience.

If new laws, regulations, or other developments limit our ability to appropriately engage these professionals or to continue to receive their advice and [removed: input,] [added: input or we are otherwise unsuccessful in maintaining strong working relationships with these physicians,] 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.

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

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

- The limitation or ban of certain [added: chemicals or other] materials used in the manufacture of our products; and

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

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

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

Cyber-based attacks can include, but are not limited to, computer viruses, [removed: computer] denial-of-service attacks, phishing attacks, ransomware attacks, [removed: worms,] and other [removed: malicious software programs or other attacks, covert] introduction of malware to computers and [removed: networks, impersonation] [added: networks; unauthorized access through the use] of [removed: authorized users, and efforts to discover and exploit any] [added: compromised credentials; exploitation of] design flaws, bugs, [removed: security vulnerabilities,] or security [removed: weaknesses, as well as] [added: vulnerabilities;] intentional or unintentional acts by employees or other insiders with access [removed: privileges,] [added: privileges; and] intentional acts of vandalism by third parties and sabotage.

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

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

[removed: The failure of] [added: Significant disruption in] either our or our service providers’ [added: or suppliers’] information technology [added: or the security of our products] could [removed: disrupt] [added: 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 sensitive or personal information, all of which could have a material adverse effect on our reputation, business, financial condition, and operating results.

These include, but are not limited to, credit and capital markets, interest rates, tax law, including tax rate and policy changes, factors affecting global economic stability, [added: and] the political environment relating to health [removed: care, and the potential implications of the U.K. “Brexit” or the withdrawal from the European Union of other member][added: care.]

For example, in the [removed: U.S.,] [added: United States,] the Affordable Care Act, the Medicare Access and CHIP Reauthorization Act of 2015, and the 21st Century Cures Act, or any future legislation, including deficit reduction legislation, could impact medical procedure volumes, reimbursement for our products, and demand for our products or the prices at which we sell our products.

For more information about these laws as they relate to our business, see the section entitled [removed: “*Health Care Legislation*” and] “*Government Regulation and Other Matter*s” in Part I, Item 1, “*Business*.”

Other economic, political, and social risks. [removed: Our future results could be harmed] [added: In addition to the factors enumerated above, we are from time to time impacted] by a variety of other factors associated with doing business internationally [removed: such as those enumerated in these risk factors as well as] [added: that can harm our future results, including] the following:

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

We sell our products and technologies to hospitals and other health care providers, nearly all of which receive reimbursement for the health care services provided to patients from third-party payors, such as government programs (both domestic and [removed: international),] [added: outside of the United States),] private insurance plans, and managed care programs.

We may be forced to defend against claims and legal actions alleging infringement of the intellectual property rights of others, and, if our defense is unsuccessful, [removed: Edwards] [added: we] could have significant liabilities to third parties or face injunctions that bar the sale of our products, or could require us to seek licenses from third parties.

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

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

Please note that the headers provided below are intended to assist the reader in navigating the risk factors; however, some risks, present or future, may implicate multiple types of risks.

In addition, our information technology infrastructure and products are vulnerable to cyber-based attacks.

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

We 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 California Consumer Privacy Act ("CCPA"), and the European Union’s General Data Protection Regulation ("GDPR").

The GDPR imposes stringent European Union data protection requirements and provides for significant penalties for noncompliance.

HIPAA also imposes stringent data privacy and security requirements and the regulatory authority has imposed

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

CCPA provides consumers with a private right of action against companies who have a security breach due to lack of appropriate security measures.

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

Additional risks related to government regulation are also described under "*Health Care Legislation and Other Regulations*" in the risk factor above titled "*Because we operate globally, our business is subject to a variety of risks associated with international sales and operations.*"

Climate change, or legal, regulatory or market measures to address climate change, may materially adversely affect our financial condition and business operations.

Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could present risks to our future operations from natural disasters and extreme weather conditions, such as hurricanes, tornadoes, seismic events, wildfires, or flooding.

Such extreme weather conditions could pose physical risks to our facilities and disrupt operation of our supply chain and may impact operational costs.

Concern over climate change could result in new legal or regulatory requirements designed to mitigate the effects of climate change on the environment.

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

We obtain bovine tissue

supported by actual long-term studies or clinical experience, our business could be adversely affected.

countries.

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: 2020.][added: 2021.]

Also discussed is our financial position as of December 31, [removed: 2020.][added: 2021.]

For a discussion related to the results of operations for [removed: 2019] [added: 2020] compared to [removed: 2018] [added: 2019] and a discussion related to our consolidated cash flows for [removed: 2019] [added: 2020] compared to [removed: 2018,] [added: 2019,] refer to Part II, Item 7, "*Management's Discussion and Analysis of Financial Condition and Results of Operations*" in our [removed: 2019] [added: 2020] Annual Report on Form 10–K filed with the Securities and Exchange Commission on February [removed: 14, 2020.][added: 12, 2021.]

We are the global leader in patient-focused medical innovations for structural heart [removed: disease, as well as] [added: disease and] critical care [removed: and surgical] monitoring.

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

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

[removed: ][added: ]

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

Our priority has been to [removed: support our clinician partners, protect the well-being of our employees, and] maintain [removed: continuous] access [added: for patients] to our life-saving technologies while [removed: offering] [added: providing continuous] front-line [removed: in-hospital support.][added: support to our clinician partners, and protecting the well-being of our employees.]

While we saw improvements to pre-COVID levels when we resumed enrollment, procedure volumes and enrollment in our clinical trials [removed: have since been] [added: were] negatively impacted [added: in late 2020] due to a resurgence of [removed: COVID-19 in late 2020.][added: COVID-19.]

[removed: In Critical Care, there was greater demand in Europe and the United States for our pressure monitoring products, but demand for] other Critical Care products began to decrease at the end of the first quarter of 2020 due to [added: decreased hospital spending related to] COVID-19, and that trend continued through the fourth quarter of 2020.

Despite the challenges associated with COVID-19, our net sales for [removed: 2020] [added: 2021] were [removed: $4.4] [added: $5.2] billion, representing an increase of [removed: $38.3] [added: $846.2] million over [removed: 2019,] [added: 2020,] driven by sales growth of our TAVR products.

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

In [removed: 2020,] [added: 2021,] we invested 17.3% of our net sales in research and development.

The following is a summary of important developments during [removed: 2020:][added: 2021:]

We are dedicated to generating robust clinical, economic, and [removed: quality of life] [added: quality-of-life] evidence increasingly expected by patients, clinicians, and payors in the current healthcare environment, with the goal of encouraging the adoption of innovative new medical therapies that demonstrate superior outcomes.

| Total net sales | | | $ | [removed: 4,386.3] [added: 5,232.5] | | | | | $ | [removed: 4,348.0] [added: 4,386.3] | | | | | | | | | | | $ | [removed: 38.3] [added: 846.2] | | | | | | | | | | | [removed: 0.9] [added: 19.3] | | % | | | | | | |

[removed: International net] [added: Net] sales [added: outside of the United States] include the impact of foreign currency exchange rate fluctuations.

| Transcatheter Aortic Valve Replacement | | | $ | [removed: 2,857.3] [added: 3,422.5] | | | | | $ | [removed: 2,737.9] [added: 2,857.3] | | | | | | | | | | | $ | [removed: 119.4] [added: 565.2] | | | | | | | | | | | [removed: 4.4] [added: 19.8] | | % | | | | | | |

| Transcatheter Mitral and Tricuspid Therapies | | | [removed: 41.8] [added: 86.0] | | | | | | [removed: 28.2] [added: 41.8] | | | | | | | | | | | | [removed: 13.6] [added: 44.2] | | | | | | | | | | | | [removed: 48.5] [added: 105.5] | | % | | | | | | |

| Surgical Heart Valve Therapy | | | [removed: 761.8] [added: 889.1] | | | | | | [removed: 841.7] [added: 761.8] | | | | | | | | | | | | [removed: (79.9)] [added: 127.3] | | | | | | | | | | | | [removed: (9.5)] [added: 16.7] | | % | | | | | | |

| Total net sales | | | $ | [removed: 4,386.3] [added: 5,232.5] | | | | | $ | [removed: 4,348.0] [added: 4,386.3] | | | | | | | | | | | $ | [removed: 38.3] [added: 846.2] | | | | | | | | | | | [removed: 0.9] [added: 19.3] | | % | | | | | | |

[removed: ][added: ]

[removed: ][added: ]

[removed: ][added: ]

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

[removed: ][added: ]

[removed: These decreases in net sales were partially offset by] [added: -] increased demand for our pressure monitoring [removed: products,] [added: products due to elevated COVID hospitalizations,] primarily in [removed: Europe and] the United [removed: States, as COVID-19 hospitalizations increased.][added: States;]

[removed: ][added: ]

[removed: Our] [added: The increase in] gross profit [removed: was higher] as a percentage of net sales in [removed: 2020] [added: 2021] compared to [removed: 2019.][added: 2020 was driven primarily by:]

[removed: ][added: ]

[removed: ][added: ]

We incurred intellectual property litigation expenses, including settlements and external legal costs, of [removed: $405.4] [added: $20.6] million and [removed: $33.4] [added: $405.4] million during [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.

[removed: See] [added: For further information, see] Note [removed: 18] [added: 3] to the "*Consolidated Financial [removed: Statements*" for additional information.][added: Statements.*"]

We made a one-time $100.0 million payment to Abbott in July 2020, and [removed: will make] [added: are making] quarterly payments in [removed: future] [added: subsequent] years.

The change in fair value of contingent consideration liabilities resulted in [removed: expense] [added: income] of [removed: $13.6] [added: $124.1] million in [removed: 2020] [added: 2021] and [removed: income] [added: expense] of [removed: $6.1] [added: $13.6] million in [removed: 2019.][added: 2020.]

The expense in 2020 was primarily driven by the accretion of interest due to the passage of time and adjustments to discount rates, partially offset by changes in the projected probability and timing of milestone [removed: achievements,] [added: achievements] and the projected timing of cash inflows.

Special [removed: Charges (Gain), net][added: Charges]

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

Interest expense was [removed: $15.8] [added: $18.4] million and [removed: $20.7] [added: $15.8] million in [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.

In Critical Care, during 2020 there was greater demand in Europe and the United States for our pressure monitoring products, but demand for

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

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

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

During the first 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.

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.

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

- we received United States Food and Drug Administration ("FDA") 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 completed enrollment in EARLY TAVR, a pivotal trial studying the treatment of severe aortic stenosis patients before their symptoms develop, and CLASP IID, a pivotal trial studying *Edwards PASCAL* in patients with degenerative mitral 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 | | % | | | | | | |

| Outside of the United States | | | 2,269.4 | | | | | | 1,869.5 | | | | | | | | | | | | 399.9 | | | | | | | | | | | | 21.4 | | % | | | | | | |

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

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

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

- higher sales of the *Edwards SAPIEN* platform in 2021 in the United States, Europe, and Japan driven by improved COVID-19 conditions compared to 2020.

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

- foreign currency exchange rate fluctuations, which increased net sales outside of the United States by $33.9 million primarily due to the strengthening of the Euro against the United States dollar.

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.

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

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.

hemodynamic monitoring during surgery or in intensive care.

On May 7, 2020, our Board of Directors declared a three-for-one stock split of our 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.

We 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 this “*Management’s Discussion and Analysis of Financial Condition and Results of Operations*” have been retroactively adjusted to give effect to this stock split.

In March 2020, the World Health Organization categorized the Coronavirus disease 2019 ("COVID-19") as a pandemic.

COVID-19 continues to spread throughout the United States and other countries across the world, and the duration and severity of its effects are currently unknown.

Even though health systems adapted to the challenge, the resurgence of COVID-19 late in 2020 continued to impact these patients who need care.

Our gross profit increase in 2020 was driven by a charge of $73.1 million recorded in 2019, primarily comprised of the write off of inventory related to strategic decisions regarding our TAVR portfolio, including the decision to discontinue our *CENTERA* program.

While some evidence collection was slowed due to the COVID-19 pandemic, we and the clinical community are committed to continuing our trials and generating robust evidence.

- in response to the urgent COVID-19 response around the globe, we temporarily paused new enrollments in our active pivotal clinical trials of transcatheter mitral and tricuspid therapies, which began resuming in the second quarter of 2020;

- we received CE Mark for the *Edwards PASCAL* transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation;

- we received Chinese regulatory approval for the *Edwards SAPIEN 3* transcatheter heart valve for the treatment of severe, symptomatic aortic stenosis patients at high risk for or unable to undergo open-heart surgery;

- we reached an agreement with Abbott to settle all outstanding patent disputes between the companies in cases related to transcatheter mitral and tricuspid repair products;

- we received FDA approval for the *KONECT RESILIA* aortic valved conduit, the first ready-to-implant solution for bio-Bentall procedures, a complex surgery that involves replacement of a patient's aortic valve, aortic root, and the ascending aorta.

- we treated our first patient in the RESTORE clinical trial, which will evaluate the safety and effectiveness of the investigational *HARPOON Beating Heart Mitral Valve Repair System* in the United States and Canada.

| | | | 2020 | | | | | | 2019 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| United States | | | $ | 2,516.8 | | | | | $ | 2,532.7 | | | | | | | | | | | $ | (15.9) | | | | | | | | | | | (0.6) | | % | | | | | | |

| Europe | | | 973.6 | | | | | | 941.2 | | | | | | | | | | | | 32.4 | | | | | | | | | | | | 3.4 | | % | | | | | | |

| Japan | | | 460.1 | | | | | | 444.7 | | | | | | | | | | | | 15.4 | | | | | | | | | | | | 3.5 | | % | | | | | | |

| Rest of World | | | 435.8 | | | | | | 429.4 | | | | | | | | | | | | 6.4 | | | | | | | | | | | | 1.5 | | % | | | | | | |

| International | | | 1,869.5 | | | | | | 1,815.3 | | | | | | | | | | | | 54.2 | | | | | | | | | | | | 3.0 | | % | | | | | | |

| | | | 2020 | | | | | | 2019 | | | | | | | | | | | | $ | | | | | | | | | | | | % | | | | | | | | |

| Critical Care | | | 725.4 | | | | | | 740.2 | | | | | | | | | | | | (14.8) | | | | | | | | | | | | (2.0) | | % | | | | | | |

The increase in net sales of TAVR products was due primarily to higher sales of the *Edwards SAPIEN 3 Ultra System* following its regulatory approval in the United States (December 2018) and in Europe (November 2018).

The adoption of the *Edwards SAPIEN 3 Ultra System* continued to be very positive in 2020.

However, our sales in 2020 were negatively impacted by the COVID-19 pandemic, and these challenges have continued in early 2021.

Our procedure volumes dropped significantly beginning in March 2020 due to COVID-19, and began to steadily improve beginning in May 2020.

In the first quarter of 2020, to ensure the safety of our employees and clinician partners from the threat of COVID-19, we decided to pause proctoring at centers that were not already trained on the *Edwards SAPIEN 3 Ultra System*.

In the second quarter of 2020, we resumed proctoring.

The increase in net sales of TMTT products was due primarily to sales in Europe of the *Edwards PASCAL* transcatheter valve repair system, which received CE Mark in February 2019.

Our sales in 2020 were negatively impacted by the COVID-19 pandemic.

Our procedure volumes for *PASCAL* dropped significantly in March 2020 due to COVID-19, and began to improve beginning in May 2020.

At the end of March 2020, we temporarily paused new enrollments in our active pivotal clinical trials of transcatheter

mitral and tricuspid therapies in response to the COVID-19 response around the globe.

In the second quarter of 2020, we began

resuming enrollments.

However, due to a resurgence of COVID-19 in late 2020, we are experiencing a negative impact to clinical trial enrollment.

In May 2020, we received CE Mark for the *PASCAL Ace* implant system for mitral and tricuspid repair.

The decrease in net sales of Surgical products was due primarily to decreased sales of aortic tissue valves, primarily in the United States and Europe, due to the impact of COVID-19.

The ongoing adoption of TAVR also contributed to the decrease in United States surgical aortic valve sales.

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

As of December 31, [removed: 2020,] [added: 2021,] we had [removed: $985.9 million] [added: $2.3 billion] of investments in debt securities which had an average remaining term to maturity of [removed: approximately 1.56] [added: 1.29] years.

Taking into consideration the average maturity of our debt securities, a hypothetical 0.5% to 1.0% absolute increase in interest rates at December 31, [removed: 2020] [added: 2021] would have resulted in a [removed: $7.8] [added: $15.3] million to [removed: $15.6] [added: $30.6] million decrease in the fair value of these investments.

As of December 31, [removed: 2020,] [added: 2021,] we had $600.0 million of [added: 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 London interbank offered rate ("LIBOR").

As of December 31, [removed: 2020,] [added: 2021,] there were no borrowings outstanding under the Credit Agreement.

Based on our December 31, [removed: 2020] [added: 2021] 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: 2020,] [added: 2021,] a hypothetical 1.0% absolute increase in market interest rates would decrease the fair value of the fixed-rate debt by approximately [removed: $43.2] [added: $36.0] million.

The total notional amount of our derivative financial instruments entered into for foreign currency management purposes at December 31, [removed: 2020] [added: 2021] was $1.8 billion.

A hypothetical 10% increase/decrease in the value of the United States dollar against all hedged currencies would increase/decrease the fair value of these derivative contracts by [removed: $141.5] [added: $134.9] million.

At December 31, [removed: 2020,] [added: 2021,] all derivative financial instruments were with bank counterparties assigned investment grade ratings by national rating agencies.

In [removed: 2020,] [added: 2021,] we had no customers that represented 10% or more of our total net sales or accounts receivable, net.

As of December 31, [removed: 2020,] [added: 2021,] we had [removed: $985.9 million] [added: $2.3 billion] of investments in debt securities of various companies, of which [removed: $766.5 million] [added: $1.7 billion] were long-term.

In addition, we had $92.5 million of investments in equity instruments.

In addition, we had $35.1 million of investments in equity instruments of public and private companies.

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 [removed: during surgery or] in [removed: intensive care.][added: the hospital setting.]

Cardiovascular disease is the number-one cause of death in the [removed: world,] [added: world] and is the top disease in terms of health care spending in nearly every country.

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] [added: minimally-] invasive technologies.

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

The *Edwards SAPIEN* family of valves*,* including *Edwards SAPIEN XT,* the *Edwards SAPIEN 3,* and the *Edwards SAPIEN 3 Ultra* transcatheter [removed: aortic] 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 [removed: patients]

[added: patients] with congenital heart disease.

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

Sales of our transcatheter aortic valve replacement products represented 65%, [removed: 63%,] [added: 65%,] and [removed: 61%] [added: 63%] of our net sales in [added: 2021,] 2020, [removed: 2019,] and [removed: 2018,] [added: 2019,] respectively.

We [removed: are making] [added: continue to make] significant investments in the development of transcatheter heart valve repair and replacement technologies designed to treat mitral and tricuspid valve diseases.

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

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

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

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

*INSPIRIS* is [removed: now] the leading aortic surgical valve in the world.

[removed: In 2020, we] [added: Our recently] launched [removed: the] *HARPOON Beating Heart Mitral Valve Repair [removed: System*, which] [added: System*] can help transform care for many patients with degenerative mitral regurgitation.

Sales of our surgical tissue heart valve products represented [added: 15%,] 16%, [removed: 17%,] and [removed: 18%] [added: 17%] of our net sales in [added: 2021,] 2020, [removed: 2019,] and [removed: 2018,] [added: 2019,] respectively.

We are a world leader in [added: 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, and includes the minimally invasive *FloTrac* system, the noninvasive *ClearSight* system, and *ForeSight,* the noninvasive tissue oximetry system.][added: outcomes.]

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

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

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

Sales of our [removed: core] hemodynamic products represented [removed: 9%,] [added: 8%,] 9%, and 10% of our net sales in [added: 2021,] 2020, [removed: 2019,] and [removed: 2018,] [added: 2019,] respectively.

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

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

We are not dependent on any single customer and no single customer accounted for 10% or more of our net sales in [removed: 2020.][added: 2021.]

In [removed: 2020,] [added: 2021,] 57% of our net sales were derived from sales to customers in the United States.

[removed: International.] [added: Outside of the United States.] In [removed: 2020,] [added: 2021,] 43% of our net sales were derived [removed: internationally] [added: outside of the United States] through our direct sales forces and independent distributors.

Of the total [removed: international sales, 52%] [added: sales outside of the United States, 53%] were in Europe, [removed: 25%] [added: 23%] were in Japan, and [removed: 23%] [added: 24%] were in Rest of World.

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

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

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

In [removed: 2020,] [added: 2021,] 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: 1%] [added: 19%] year over [removed: year to] [added: year, representing] 17% of [removed: 2020] [added: 2021] sales.

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

A considerable portion of our research and development investment includes clinical trials and the collection of evidence that provide data for use in regulatory submissions, and required post-market approval studies involving applications of our [added: products.]

In Transcatheter Aortic Valve Replacement, we are developing new products to further improve and streamline transcatheter aortic heart valve replacement [removed: procedures, and developing pulmonic platforms to expand therapies for congenital heart disease patients.][added: procedures.]

We own or have rights to a substantial number of patents and have patent applications pending both in the [removed: U.S.] [added: United States] and in foreign countries.

We continue to innovate and file new patent applications to protect [removed: the full range of] our [added: new] products and technologies.

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

We undertake reasonable measures to protect our patent rights, including monitoring the products of our competitors for possible infringement of our [removed: owned and licensed] patents.

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

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

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

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

Sales of our surgical therapies in the United States also continue to gain traction with *KONECT RESILIA*, the first pre-assembled, aortic tissue valved conduit, for patients who require replacement of the valve, root, and ascending aorta.

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.

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

1 Bavaria, et al.

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

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

Final 5-year outcomes following aortic valve replacement with *RESILIA* tissue bio prosthesis.

European Journal of Cardio-Thoracic Surgery, 2020.

As we scale to reach more patients around the world, we have integrated our Talent & Organization (“T&O”) Strategy with our Edwards Strategic Planning process.

The purpose of our T&O Strategy is to anticipate dynamic global trends related to our workforce, develop our talent to meet future organizational needs, and enable us to be well-poised for ongoing market success.

The T&O Strategy enables us to explore external workforce signals, share insights, and identify and build emerging capabilities across our organization.

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).

This consistent and scalable approach looks across all our product groups, regions, and significant functions to align and elevate priorities, critical capabilities, and organizational evolutions in line with our strategic plan.

This integrated approach informs our yearly objectives and fuels our talent roadmap across the strategic horizon.

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

Speak-Up is a resource available to all employees to bring forth compliance related concerns; a key element of our compliance program is that each employee is accountable for maintaining ethical business practices.

In recent years, mental wellness has become a central topic for organizations worldwide.

As part of our regular evaluation and commitment to putting employees first, we launched a new program, Mind+, which offers a wide variety of mental health benefits and wellness

programs for our employees.

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

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

Employees who are mentally healthy are more innovative, resilient, better decision-makers, and able to build stronger relationships.

We also believe that prioritizing and promoting Mind+ allows us to help patients around the world to live longer, healthier, and more productive lives and supports employees to be their best self at home and at work.

We are also continuing to advance our *EVOQUE* platform for both mitral and tricuspid replacement.

The core of our surgical tissue heart valve product line is the *Carpentier-Edwards PERIMOUNT* pericardial valve platform, including the line of *PERIMOUNT Magna Ease* pericardial valves for aortic and mitral surgical valve replacement.

With more long-term clinical publications on durability and performance than any other surgical valve, *PERIMOUNT* valves are the most widely implanted surgical tissue heart valves in the world.

We are also a global leader in cardiac cannula devices and offer a variety of procedure-enabling innovations that advance minimally invasive surgery.

products.

regulations or amendments to existing regulations to make them more stringent could have such an effect in the future.

To assist in our

Speak-Up is a resource available to all employees to bring forth compliance related concerns.

For the Fiscal Year Ended December 31, [removed: 2020][added: 2021]

The aggregate market value of the registrant's common stock held by non-affiliates as of June 30, [removed: 2020] [added: 2021] (the last trading day of the registrant's most recently completed second quarter): [removed: $42,640,586,293] [added: $64,028,235,982] 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: 2021,] [added: 2022,] was [removed: 624,518,873.][added: 623,207,437.]

Portions of the registrant's proxy statement for the [removed: 2021] [added: 2022] Annual Meeting of Stockholders (to be filed within 120 days of December 31, [removed: 2020)] [added: 2021)] are incorporated by reference into Part III, as indicated herein.

Form 10-K Annual [removed: Report—2020][added: Report—2021]

| [Item [removed: 1.](#if12725e820b640d3be478e9249641078_16)] [added: 1.](#i8e6404ebd98d416daa7f88f48159b601_16)] | | | [removed: [Business](#if12725e820b640d3be478e9249641078_16)] [added: [Business](#i8e6404ebd98d416daa7f88f48159b601_16)] | | | [removed: [2](#if12725e820b640d3be478e9249641078_16)] [added: [2](#i8e6404ebd98d416daa7f88f48159b601_16)] | | |

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| [Item [removed: 1B.](#if12725e820b640d3be478e9249641078_22)] [added: 1B.](#i8e6404ebd98d416daa7f88f48159b601_22)] | | | [Unresolved Staff [removed: Comments](#if12725e820b640d3be478e9249641078_22)] [added: Comments](#i8e6404ebd98d416daa7f88f48159b601_22)] | | | [removed: [17](#if12725e820b640d3be478e9249641078_22)] [added: [19](#i8e6404ebd98d416daa7f88f48159b601_22)] | | |

| [Item [removed: 2.](#if12725e820b640d3be478e9249641078_25)] [added: 2.](#i8e6404ebd98d416daa7f88f48159b601_25)] | | | [removed: [Properties](#if12725e820b640d3be478e9249641078_25)] [added: [Properties](#i8e6404ebd98d416daa7f88f48159b601_25)] | | | [removed: [18](#if12725e820b640d3be478e9249641078_25)] [added: [19](#i8e6404ebd98d416daa7f88f48159b601_25)] | | |

| [Item [removed: 3.](#if12725e820b640d3be478e9249641078_28)] [added: 3.](#i8e6404ebd98d416daa7f88f48159b601_28)] | | | [Legal [removed: Proceedings](#if12725e820b640d3be478e9249641078_28)] [added: Proceedings](#i8e6404ebd98d416daa7f88f48159b601_28)] | | | [removed: [18](#if12725e820b640d3be478e9249641078_28)] [added: [19](#i8e6404ebd98d416daa7f88f48159b601_28)] | | |

| [Item [removed: 4.](#if12725e820b640d3be478e9249641078_31)] [added: 4.](#i8e6404ebd98d416daa7f88f48159b601_31)] | | | [Mine Safety [removed: Disclosures](#if12725e820b640d3be478e9249641078_31)] [added: Disclosures](#i8e6404ebd98d416daa7f88f48159b601_31)] | | | [removed: [18](#if12725e820b640d3be478e9249641078_31)] [added: [19](#i8e6404ebd98d416daa7f88f48159b601_31)] | | |

| [Item [removed: 5.](#if12725e820b640d3be478e9249641078_37)] [added: 5.](#i8e6404ebd98d416daa7f88f48159b601_37)] | | | [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#if12725e820b640d3be478e9249641078_37)] [added: Securities](#i8e6404ebd98d416daa7f88f48159b601_37)] | | | [removed: [19](#if12725e820b640d3be478e9249641078_37)] [added: [20](#i8e6404ebd98d416daa7f88f48159b601_37)] | | |

| [Item [removed: 7.](#if12725e820b640d3be478e9249641078_43)] [added: 7.](#i8e6404ebd98d416daa7f88f48159b601_43)] | | | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#if12725e820b640d3be478e9249641078_43)] [added: Operations](#i8e6404ebd98d416daa7f88f48159b601_43)] | | | [removed: [21](#if12725e820b640d3be478e9249641078_43)] [added: [21](#i8e6404ebd98d416daa7f88f48159b601_43)] | | |

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| [Item [removed: 8.](#if12725e820b640d3be478e9249641078_61)] [added: 8.](#i8e6404ebd98d416daa7f88f48159b601_61)] | | | [Financial Statements and Supplementary [removed: Data](#if12725e820b640d3be478e9249641078_61)] [added: Data](#i8e6404ebd98d416daa7f88f48159b601_61)] | | | [removed: [38](#if12725e820b640d3be478e9249641078_61)] [added: [39](#i8e6404ebd98d416daa7f88f48159b601_61)] | | |

| [Item [removed: 9.](#if12725e820b640d3be478e9249641078_166)] [added: 9.](#i8e6404ebd98d416daa7f88f48159b601_154)] | | | [Changes in and Disagreements With Accountants on Accounting and Financial [removed: Disclosure](#if12725e820b640d3be478e9249641078_166)] [added: Disclosure](#i8e6404ebd98d416daa7f88f48159b601_154)] | | | [removed: [91](#if12725e820b640d3be478e9249641078_166)] [added: [89](#i8e6404ebd98d416daa7f88f48159b601_154)] | | |

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| [Item [removed: 9B.](#if12725e820b640d3be478e9249641078_172)] [added: 9B.](#i8e6404ebd98d416daa7f88f48159b601_160)] | | | [Other [removed: Information](#if12725e820b640d3be478e9249641078_172)] [added: Information](#i8e6404ebd98d416daa7f88f48159b601_160)] | | | [removed: [92](#if12725e820b640d3be478e9249641078_172)] [added: [90](#i8e6404ebd98d416daa7f88f48159b601_160)] | | |

| [Item [removed: 10.](#if12725e820b640d3be478e9249641078_178)] [added: 10.](#i8e6404ebd98d416daa7f88f48159b601_166)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#if12725e820b640d3be478e9249641078_178)] [added: Governance](#i8e6404ebd98d416daa7f88f48159b601_166)] | | | [removed: [93](#if12725e820b640d3be478e9249641078_178)] [added: [91](#i8e6404ebd98d416daa7f88f48159b601_166)] | | |

| [Item [removed: 11.](#if12725e820b640d3be478e9249641078_181)] [added: 11.](#i8e6404ebd98d416daa7f88f48159b601_169)] | | | [Executive [removed: Compensation](#if12725e820b640d3be478e9249641078_181)] [added: Compensation](#i8e6404ebd98d416daa7f88f48159b601_169)] | | | [removed: [93](#if12725e820b640d3be478e9249641078_181)] [added: [91](#i8e6404ebd98d416daa7f88f48159b601_169)] | | |

| [Item [removed: 12.](#if12725e820b640d3be478e9249641078_184)] [added: 12.](#i8e6404ebd98d416daa7f88f48159b601_172)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#if12725e820b640d3be478e9249641078_184)] [added: Matters](#i8e6404ebd98d416daa7f88f48159b601_172)] | | | [removed: [93](#if12725e820b640d3be478e9249641078_184)] [added: [91](#i8e6404ebd98d416daa7f88f48159b601_172)] | | |

| [Item [removed: 13.](#if12725e820b640d3be478e9249641078_187)] [added: 13.](#i8e6404ebd98d416daa7f88f48159b601_175)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#if12725e820b640d3be478e9249641078_187)] [added: Independence](#i8e6404ebd98d416daa7f88f48159b601_175)] | | | [removed: [93](#if12725e820b640d3be478e9249641078_187)] [added: [91](#i8e6404ebd98d416daa7f88f48159b601_175)] | | |

| [Item [removed: 14.](#if12725e820b640d3be478e9249641078_190)] [added: 14.](#i8e6404ebd98d416daa7f88f48159b601_178)] | | | [Principal Accounting Fees and [removed: Services](#if12725e820b640d3be478e9249641078_190)] [added: Services](#i8e6404ebd98d416daa7f88f48159b601_178)] | | | [removed: [93](#if12725e820b640d3be478e9249641078_190)] [added: [91](#i8e6404ebd98d416daa7f88f48159b601_178)] | | |

| [Item [removed: 15.](#if12725e820b640d3be478e9249641078_196)] [added: 15.](#i8e6404ebd98d416daa7f88f48159b601_184)] | | | [Exhibits and Financial Statement [removed: Schedules](#if12725e820b640d3be478e9249641078_196)] [added: Schedules](#i8e6404ebd98d416daa7f88f48159b601_184)] | | | [removed: [94](#if12725e820b640d3be478e9249641078_196)] [added: [92](#i8e6404ebd98d416daa7f88f48159b601_184)] | | |

| [Item [removed: 16.](#if12725e820b640d3be478e9249641078_199)] [added: 16.](#i8e6404ebd98d416daa7f88f48159b601_187)] | | | [Form 10-K [removed: Summary](#if12725e820b640d3be478e9249641078_199)] [added: Summary](#i8e6404ebd98d416daa7f88f48159b601_187)] | | | [removed: [96](#if12725e820b640d3be478e9249641078_199)] [added: [93](#i8e6404ebd98d416daa7f88f48159b601_187)] | | |

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

These statements include, among other things, the [removed: expected] [added: continued] impact of COVID-19 on our business, any predictions, opinions, expectations, plans, strategies, objectives and any statements of assumptions underlying any of the foregoing relating to [removed: the company's] [added: 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: uncertainties regarding the severity and duration of the COVID-19 pandemic and its impact on our business and the economy generally, clinical trial or commercial results or new product approvals and therapy adoption; inability or failure to comply with [added: applicable] regulations; unpredictability of product launches; competitive dynamics; changes to reimbursement for the company's products; the company’s success in developing new products and avoiding manufacturing and quality issues; the impact of currency exchange rates; the timing or results of research and development and clinical trials; unanticipated actions by the [removed: U.S.] [added: United States] Food and Drug Administration and other regulatory agencies; unexpected [removed: litigation] impacts or [removed: expenses;] [added: expenses resulting from 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 [added: U.S.] Securities and Exchange Commission.

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

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

| [Item 6.](#i8e6404ebd98d416daa7f88f48159b601_40) | | | [\[Reserved\]](#i8e6404ebd98d416daa7f88f48159b601_40) | | | [21](#i8e6404ebd98d416daa7f88f48159b601_40) | | |

| [Item 9C.](#i8e6404ebd98d416daa7f88f48159b601_1709) | | | [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](#i8e6404ebd98d416daa7f88f48159b601_1709) | | | [90](#i8e6404ebd98d416daa7f88f48159b601_1709) | | |

| [PART III](#i8e6404ebd98d416daa7f88f48159b601_163) | | | | | | | | |

| [PART IV](#i8e6404ebd98d416daa7f88f48159b601_181) | | | | | | | | |

| | | | [Signatures](#i8e6404ebd98d416daa7f88f48159b601_190) | | | [94](#i8e6404ebd98d416daa7f88f48159b601_190) | | |

| [PART I](#if12725e820b640d3be478e9249641078_10) | | | | | | | | |

| [PART II](#if12725e820b640d3be478e9249641078_34) | | | | | | | | |

| [Item 6.](#if12725e820b640d3be478e9249641078_40) | | | [Selected Financial Data](#if12725e820b640d3be478e9249641078_40) | | | [21](#if12725e820b640d3be478e9249641078_40) | | |

| [PART III](#if12725e820b640d3be478e9249641078_175) | | | | | | | | |

| [PART IV](#if12725e820b640d3be478e9249641078_193) | | | | | | | | |

| | | | [Signatures](#if12725e820b640d3be478e9249641078_202) | | | [97](#if12725e820b640d3be478e9249641078_202) | | |

| Shannon, Limerick, Ireland | | | (1),(2) | | | | | | Manufacturing [removed: (under construction)] | | |

The [added: 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 [removed: 2021;] [added: 2026;] the Prague, Czech Republic lease expires in 2026; the Shannon, Ireland lease expires in 2024; the Tokyo, Japan lease expires in [removed: 2021;] [added: 2024;] the Shanghai, China lease expires in [removed: 2021;] [added: 2024;] Singapore has one land lease that expires in 2036 and one that expires in 2041; [removed: Caesarea, Israel has one lease that expires in 2021] and [removed: one that expires in 2030; and] the [removed: Or Yehuda,] [added: Caesarea,] Israel lease expires in [removed: 2023.][added: 2030.]

| Or Yehuda, Israel | | | (2) | | | | | | Research and Development | | |

On January 31, [removed: 2021,] [added: 2022,] there were [removed: 8,876] [added: 8,413] stockholders of record of our common stock.

[added: (b)] On May 8, 2019, the Board of Directors approved a stock repurchase program authorizing us to purchase [removed: on the open market, including pursuant to a Rule 10b5-1 plan and in privately negotiated transactions,] up to $1.0 billion of our common stock.

[removed: The] [added: These] repurchase [removed: program does] [added: programs do] 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: 2015] [added: 2016] and reinvestment of dividends.

[removed: ][added: ]

| | | | [removed: 2016] [added: 2017] | | | | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | |

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

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

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

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

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

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

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

On May 4, 2021, the Board of Directors approved a new stock repurchase program providing for an additional $1.0 billion of repurchases of our common stock.

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

| 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 | | |

We did not purchase any of our common stock during the fourth quarter of 2020 and, as of December 31, 2020, we had remaining authority to purchase $625.0 million of common stock.

| Edwards Lifesciences | | | $ | 118.64 | | | | | $ | 142.71 | | | | | $ | 193.94 | | | | | $ | 295.38 | | | | | $ | 346.53 | |

| S&P 500 | | | 111.96 | | | | | | 136.40 | | | | | | 130.42 | | | | | | 171.49 | | | | | | 203.04 | | |

| S&P 500 Health Care Equipment | | | 106.48 | | | | | | 139.38 | | | | | | 162.02 | | | | | | 209.52 | | | | | | 246.47 | | |

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

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

| | | | | | | As of or for the Years Ended December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |

| | | | | | | (in millions, except per share data) | | | | | | | | | | | | | | | | | | | | | | | | | | |

| OPERATING RESULTS | | | Net sales | | | $ | 4,386.3 | | | | | $ | 4,348.0 | | | | | $ | 3,722.8 | | | | | $ | 3,435.3 | | | | | $ | 2,963.7 | |

| | | | Gross profit | | | 3,305.7 | | | | | | 3,233.6 | | | | | | 2,783.4 | | | | | | 2,560.0 | | | | | | 2,166.3 | | |

| | | | Operating income (a) | | | 897.6 | | | | | | 1,146.8 | | | | | | 748.2 | | | | | | 1,089.4 | | | | | | 751.2 | | |

| | | | Net income (a) | | | 823.4 | | | | | | 1,046.9 | | | | | | 722.2 | | | | | | 583.6 | | | | | | 569.5 | | |

| COMMON STOCK INFORMATION | | | Net income per common share (a) (c): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | Basic | | | $ | 1.32 | | | | | $ | 1.68 | | | | | $ | 1.15 | | | | | $ | 0.92 | | | | | $ | 0.89 | |

| | | | Diluted | | | 1.30 | | | | | | 1.64 | | | | | | 1.13 | | | | | | 0.90 | | | | | | 0.87 | | |

| | | | Cash dividends declared per common share | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| BALANCE SHEET DATA | | | Total assets | | | $ | 7,237.1 | | | | | $ | 6,488.1 | | | | | $ | 5,323.7 | | | | | $ | 5,666.4 | | | | | $ | 4,518.5 | |

| | | | Long-term debt (b) | | | 595.0 | | | | | | 594.4 | | | | | | 593.8 | | | | | | 438.4 | | | | | | 822.3 | | |

_______________________________________________________________________________

(a) The above results for 2020 include a $367.9 million pre-tax charge ($305.1 million, net of tax) related to a litigation settlement.

The above results for 2019 include special charges of $64.6 million ($58.7 million, net of tax), primarily the impairment of certain assets and the acquisition of early-stage intellectual property.

The above results for 2018 include special charges of $109.1 million ($103.0 million, net of tax), primarily the impairment of intangible assets and a $180.0 million ($137.5 million, net of tax) charge related to a litigation settlement.

The above results for 2017 include a $112.5 million ($70.3 million, net of tax) gain for a litigation payment received in 2017 and a $262.0 million tax expense related to the implementation of U.S. tax law changes.

See Part II, Item 7, *"Management's Discussion and Analysis of Financial Condition and Results of Operations*" and Note 3, Note 4, and Note 17 to the *"Consolidated Financial Statements"* for additional information.

(b) In October 2013, we issued $600.0 million of 2.875% fixed-rate unsecured senior notes due October 15, 2018 (the "2013 Notes").

At December 31, 2017, the 2013 Notes were classified as short-term obligations as these obligations were due within one year.

These 2013 Notes were paid in October 2018.

In June 2018, we issued $600.0 million of 4.3% fixed-rate unsecured senior notes due June 15, 2028, which were classified as long-term obligations as of December 31, 2020, 2019 and 2018.

Amounts outstanding under our Five-Year Credit Agreement ("Credit Agreement") have been classified as long-term obligations in accordance with the terms of the Credit Agreement.

(c) The per share amounts for the prior periods presented have been retroactively adjusted to reflect the three-for-one stock split effected in the second quarter of 2020.

[removed: DECEMBER] [added: | December] 31, 2020 [added: | | | | | | | | | | | | | | | | | | | | | | | |]

| [Report of Independent Registered Public Accounting [removed: Firm](#if12725e820b640d3be478e9249641078_67)] [added: Firm (PCAOB ID](#i8e6404ebd98d416daa7f88f48159b601_67) 238[)](#i8e6404ebd98d416daa7f88f48159b601_67)] | | | [removed: [39](#if12725e820b640d3be478e9249641078_67)] [added: [40](#i8e6404ebd98d416daa7f88f48159b601_67)] | | |

| [Consolidated Balance Sheets as of December [removed: 31,] [added: 31,](#i8e6404ebd98d416daa7f88f48159b601_70) 2021 [and](#i8e6404ebd98d416daa7f88f48159b601_70)] 2020 [removed: and 2019](#if12725e820b640d3be478e9249641078_70)] | | | [removed: [42](#if12725e820b640d3be478e9249641078_70)] [added: [43](#i8e6404ebd98d416daa7f88f48159b601_70)] | | |

| For the Years Ended December 31, [added: 2021,] 2020, [removed: 2019,] and [removed: 2018:] [added: 2019:] | | | | | |

| [Consolidated Statements of [removed: Operations](#if12725e820b640d3be478e9249641078_76)] [added: Operations](#i8e6404ebd98d416daa7f88f48159b601_73)] | | | [removed: [43](#if12725e820b640d3be478e9249641078_76)] [added: [44](#i8e6404ebd98d416daa7f88f48159b601_73)] | | |

| [Consolidated Statements of Comprehensive [removed: Income](#if12725e820b640d3be478e9249641078_79)] [added: Income](#i8e6404ebd98d416daa7f88f48159b601_76)] | | | [removed: [44](#if12725e820b640d3be478e9249641078_79)] [added: [45](#i8e6404ebd98d416daa7f88f48159b601_76)] | | |

| [Consolidated Statements of Cash [removed: Flows](#if12725e820b640d3be478e9249641078_82)] [added: Flows](#i8e6404ebd98d416daa7f88f48159b601_79)] | | | [removed: [45](#if12725e820b640d3be478e9249641078_82)] [added: [46](#i8e6404ebd98d416daa7f88f48159b601_79)] | | |

| [Consolidated Statements of Stockholders' [removed: Equity](#if12725e820b640d3be478e9249641078_85)] [added: Equity](#i8e6404ebd98d416daa7f88f48159b601_82)] | | | [removed: [46](#if12725e820b640d3be478e9249641078_85)] [added: [47](#i8e6404ebd98d416daa7f88f48159b601_82)] | | |

| [Notes to Consolidated Financial [removed: Statements](#if12725e820b640d3be478e9249641078_88)] [added: Statements](#i8e6404ebd98d416daa7f88f48159b601_85)] | | | [removed: [47](#if12725e820b640d3be478e9249641078_88)] [added: [48](#i8e6404ebd98d416daa7f88f48159b601_85)] | | |

We have audited the accompanying consolidated balance sheets of Edwards Lifesciences Corporation and its subsidiaries (the “Company”) as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] 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: 2020,] [added: 2021,] 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: 2020,] [added: 2021,] 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: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] 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: 2020,] [added: 2021,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

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

As described in [removed: Notes 2 and] [added: Note] 17 to the consolidated financial statements, the Company had [removed: a gross] [added: an] uncertain [added: gross] tax position liability balance of [removed: $281.8] [added: $358.4] million as of December 31, [removed: 2020, primarily] [added: 2021, of which a majority is] related to [added: intercompany] transfer pricing.

[removed: The] [added: As disclosed by management, the] Company is subject to income taxes in the United States and numerous foreign jurisdictions.

[removed: As disclosed by management, the] [added: The] Company’s income tax returns in these jurisdictions are periodically audited by domestic and foreign tax authorities.

The principal considerations for our determination that performing procedures relating to uncertain tax positions related to intercompany transfer pricing is a critical audit matter are the significant judgment by management when determining uncertain tax positions related to intercompany transfer pricing, including a high degree of estimation uncertainty in [removed: evaluating whether certain tax filing positions taken by management will be upheld by] [added: estimating] the [removed: related local tax authority.][added: ultimate resolution to intercompany pricing controversies between countries when there are numerous possible outcomes.]

These procedures included testing the effectiveness of controls relating to [removed: recognition of the liability for uncertain tax positions related to] intercompany transfer [removed: pricing] [added: pricing,] and controls over measurement of the liability.

These procedures also included, among [removed: others,] [added: others] (i) testing the information used in the calculation of the liability for uncertain tax [removed: positions,] [added: positions related to intercompany transfer pricing,] including [removed: U.S.] [added: US] federal filing [removed: positions] [added: positions,] and the related final [added: 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 [removed: of] management’s assessment of possible outcomes of uncertain tax positions related to intercompany transfer [removed: pricing;] [added: pricing controversies between countries;] and (iv) evaluating the status and results of income tax audits with the relevant tax authorities.

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

As of December 31, [removed: 2020,] [added: 2021,] the Company had a contingent consideration liability of [removed: $186.1] [added: $62.0] million.

[removed: As disclosed by management, payment] [added: Payment] of additional consideration is contingent upon the acquired company reaching certain performance milestones, such as attaining specified [removed: revenue] [added: sales] levels or obtaining regulatory approvals.

[added: These inputs] include (1) the discount rate used to present value the projected cash flows, (2) the probability of milestone achievement, (3) the projected payment dates, and (4) the volatility of future [removed: revenue.][added: sales.]

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 [removed: 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 revenue.]

These procedures also included, among [removed: others,] [added: others] (i) testing management’s process for estimating the fair value of [added: these] contingent consideration liabilities and (ii) testing management’s probability weighted discounted cash flow analysis or [removed: a] Monte Carlo simulation [added: 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 [removed: revenue.][added: sales.]

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

The [added: 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 [removed: certain] [added: the reasonableness of] significant [removed: assumptions, including] [added: assumptions related to] the discount rate and volatility of future [removed: revenue.][added: sales.]

We have served as the Company’s auditor since [removed: 1999][added: 1999.]

| | | | [removed: December] [added: As of December] 31, | | | | | | | | |

| | | | [added: 2021 | | | | | |] 2020 | | | | | | 2019 | | |

| Cash and cash equivalents | | | $ | [added: 862.8 | | | | | $ |] 1,183.2 | | | | | $ | 1,179.1 | |

| Short-term investments (Note 7) | | | [removed: 219.4] [added: 604.0] | | | | | | [removed: 337.8] [added: 219.4] | | |

| Accounts receivable, net of allowances of [removed: $9.6] [added: $9.3] and [removed: $8.7,] [added: $9.6,] respectively | | | [removed: 514.6] [added: 582.2] | | | | | | [removed: 543.6] [added: 514.6] | | |

| Other receivables | | | [removed: 88.2] [added: 82.7] | | | | | | [removed: 55.5] [added: 88.2] | | |

| Inventories (Note 5) | | | [removed: 802.3] [added: 726.7] | | | | | | [removed: 640.9] [added: 802.3] | | |

| Prepaid expenses | | | [removed: 75.1] [added: 85.2] | | | | | | [removed: 59.1] [added: 75.1] | | |

| Other current assets | | | [removed: 208.2] [added: 237.1] | | | | | | [removed: 168.0] [added: 208.2] | | |

DECEMBER 31, 2021

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

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.

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

February 14, 2022

| Other liabilities | | | 267.3 | | | | | | 252.4 | | |

| Total liabilities | | | 2,666.7 | | | | | | 2,662.8 | | |

| Collections of notes receivable | | | 20.0 | | | | | | — | | | | | | — | | |

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

Equity method investments are considered impaired when

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

The guidance is effective for annual periods beginning after December 15, 2021, and should be applied either prospectively or retrospectively.

In addition, the

| | | | 2021 | | | | | | 2020 | | |

| | | | $ | 726.7 | | | | | $ | 802.3 | |

| | | | 2,201.2 | | | | | | 1,993.7 | | |

| | | | $ | 1,546.6 | | | | | $ | 1,395.2 | |

| | | | 2021 | | | | | | 2020 | | |

| Legal and insurance (Notes 3 and 18) | | | 79.1 | | | | | | 60.8 | | |

| | | | $ | 802.3 | | | | | $ | 670.2 | |

| Conversion of notes receivable to equity investment | | | $ | 21.5 | | | | | $ | 4.5 | | | | | $ | — | |

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

| | | | 2021 | | | | | | 2020 | | |

| 2022 | | | $ | 27.5 | |

| 2023 | | | 23.0 | | |

| 2024 | | | 13.6 | | |

| 2025 | | | 8.3 | | |

| 2026 | | | 7.5 | | |

| Thereafter | | | 24.6 | | |

| | | | 2021 | | | | | | 2020 | | |

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

| | | | $ | 2,192.7 | | | | | $ | 2.9 | | | | | $ | (11.9) | | | | | $ | 2,183.7 | | | | | $ | 924.3 | | | | | $ | 11.6 | | | | | $ | — | | | | | $ | 935.9 | |

| Due in 1 year or less | | | $ | 162.0 | | | | | $ | 162.0 | | | | | $ | 441.3 | | | | | $ | 442.0 | |

| Due after 5 years through 10 years | | | — | | | | | | — | | | | | | 8.7 | | | | | | 8.6 | | |

| | | | $ | 162.0 | | | | | $ | 162.0 | | | | | $ | 2,192.7 | | | | | $ | 2,183.7 | |

(a) Consists of mortgage- and asset-backed securities.

| | | | December 31, 2021 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| United States government and agency securities | | | $ | 85.1 | | | | | $ | (0.7) | | | | | $ | — | | | | | $ | — | | | | | $ | 85.1 | | | | | $ | (0.7) | |

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

The unrealized losses were largely due to changes in interest rates and were considered temporary.

Change in Accounting Principle

As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in which it accounts for leases in 2019.

company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Also, the evaluation of audit evidence available to support the tax liabilities for uncertain tax positions related to intercompany transfer pricing is complex and required significant auditor judgment as the nature of the evidence is highly subjective and the audit effort involved the use of professionals with specialized skill and knowledge.

These inputs

Also, the evaluation of audit evidence available to support the fair value of the contingent consideration liabilities is complex and resulted in significant auditor judgment as the nature of the evidence is highly subjective and the audit effort involved the use of professionals with specialized skill and knowledge.

February 12, 2021

EDWARDS LIFESCIENCES CORPORATION

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

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

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

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

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

EDWARDS LIFESCIENCES CORPORATION

| Special gain (Note 4) | | | — | | | | | | — | | | | | | (7.1) | | |

EDWARDS LIFESCIENCES CORPORATION

| Payment of contingent consideration | | | — | | | | | | — | | | | | | (15.1) | | |

| BALANCE AT DECEMBER 31, 2017 | | | 212.0 | | | | | | $ | 212.0 | | | | | 2.3 | | | | | | $ | (252.1) | | | | | $ | 1,166.9 | | | | | $ | 1,962.1 | | | | | $ | (132.7) | | | | | $ | 2,956.2 | |

| Impact to retained earnings from adoption of ASU 2016-16 and ASU 2018-02 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 10.4 | | | | | | (7.8) | | | | | | 2.6 | | |

| BALANCE AT JANUARY 1, 2018 | | | 212.0 | | | | | | 212.0 | | | | | | 2.3 | | | | | | (252.1) | | | | | | 1,166.9 | | | | | | 1,972.5 | | | | | | (140.5) | | | | | | 2,958.8 | | |

| Shares issued in payment for contingent consideration liabilities | | | | | | | | | | | | | | | (0.3) | | | | | | 32.2 | | | | | | 2.7 | | | | | | | | | | | | | | | | | | 34.9 | | |

2.

Certain reclassifications of previously reported amounts have been made to conform to classifications used in the current year.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

For available-to-sale debt securities, any additional impairment not recorded through an allowance for credit losses is recognized in “*Accumulated Other Comprehensive Loss.*”

On January 1, 2019, the Company adopted an amendment to the guidance on leases using a modified retrospective transition approach.

For performance-based restricted stock units, the Company recognizes stock-based compensation expense if and when the Company concludes that it is probable that the performance condition will be achieved, net of estimated forfeitures.

The Company reassesses the probability of vesting at each quarter end and adjusts the stock-based compensation expense based on its probability assessment.

performance goals as determined on the vesting date.

The guidance aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software.

The guidance also requires an entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement.

The guidance was effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years.

In August 2018, the FASB issued an amendment to the accounting guidance on fair value measurements.

The guidance modifies the disclosure requirements on fair value measurements, including the removal of disclosures of the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements.

The guidance also adds certain disclosure requirements related to Level 3 fair value measurements.

The guidance was effective for fiscal years, and interim periods within those fiscal years,

beginning after December 15, 2019.

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) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of December 31, [removed: 2020.][added: 2021.]

Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of December 31, [removed: 2020] [added: 2021] 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: 2020.][added: 2021.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2020] [added: 2021] 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: 2020] [added: 2021] that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.

We have not experienced any material impact to our internal control over financial reporting despite the fact that many of our employees are working remotely due to the COVID-19 pandemic.

We are continually monitoring and assessing the potential impact of COVID-19 on our internal controls to minimize the impact on their design and operating effectiveness.

PART III

None.

PART III

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: 2021] [added: 2022] Annual Meeting of Stockholders (the "Proxy Statement") (which Proxy Statement will be filed with the SEC within 120 days of December 31, [removed: 2020).][added: 2021).]

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

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

See [removed: “Index] [added: “*Index] to Consolidated Financial [removed: Statements”] [added: Statements*”] in Part II, Item 8 herein.

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

| 3.3 | | | [Bylaws of Edwards Lifesciences [removed: Corporation](http://www.sec.gov/Archives/edgar/data/1099800/000109980016000046/ewexhibit31bylaws.htm)[, as](http://www.sec.gov/Archives/edgar/data/1099800/000109980016000046/ewexhibit31bylaws.htm) [amended] [added: Corporation, as amended] and restated as [removed: of February 25, 2016] [added: of](https://www.sec.gov/Archives/edgar/data/0001099800/000119312521216533/d111792dex31.htm) [July 15, 2021] (incorporated by reference to Exhibit 3.1 in Edwards Lifesciences' report on Form [removed: 8-K](http://www.sec.gov/Archives/edgar/data/1099800/000109980016000046/ewexhibit31bylaws.htm) [filed on](http://www.sec.gov/Archives/edgar/data/1099800/000109980016000046/ewexhibit31bylaws.htm) [March 2, 2016)](http://www.sec.gov/Archives/edgar/data/1099800/000109980016000046/ewexhibit31bylaws.htm)] [added: 8-K filed on](https://www.sec.gov/Archives/edgar/data/0001099800/000119312521216533/d111792dex31.htm) [July 15, 2021)](https://www.sec.gov/Archives/edgar/data/0001099800/000119312521216533/d111792dex31.htm)] | | |

| [removed: +4.2] [added: 4.2] | | | [Description of Edwards Lifesciences Corporation's Capital [removed: Stock](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-4210xkq42020.htm)] [added: Stock](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-4210xkq42021.htm)] | | |

| 4.4 | | | [removed: [First] [added: [Second] Supplemental Indenture, dated as of [removed: October 3, 2013,] [added: June 15, 2018,] to the Indenture (incorporated by reference to Exhibit [removed: 4.1] [added: 4.2] in Edwards Lifesciences' report on Form [removed: 8-K](http://www.sec.gov/Archives/edgar/data/1099800/000110465913073805/a13-20141_7ex4d1.htm) [filed] [added: 8-K filed] on [removed: October 3, 2013)](http://www.sec.gov/Archives/edgar/data/1099800/000110465913073805/a13-20141_7ex4d1.htm)] [added: June 15, 2018) ("Second Supplemental Indenture")](http://www.sec.gov/Archives/edgar/data/1099800/000119312518194499/d609576dex42.htm)] | | |

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

| 10.1 | | | [Five-Year Credit Agreement, dated as of April 30, 2018, among Edwards Lifesciences Corporation and certain of its subsidiaries, as Borrowers, the lenders signatory thereto, Bank of America, N.A., as Administrative 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 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form [removed: 8-K](http://www.sec.gov/Archives/edgar/data/1099800/000119312518143174/d579000dex101.htm) [filed] [added: 8-K filed] on April 30, 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000119312518143174/d579000dex101.htm) | | |

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

| [removed: *10.7] [added: *10.8] | | | [Edwards Lifesciences Corporation 2018 Edwards Incentive Plan (incorporated by reference to Exhibit 10.7 in Edwards [removed: Lifesciences](http://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm)['](http://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm) [report] [added: Lifesciences' report] on Form 10-K for the fiscal year ended December 31, 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000109980019000004/ex-10710xkq42018.htm) | | |

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

| [removed: *10.9] [added: *10.10] | | | [Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related Long-Term Stock Program Global Nonqualified Stock Option Award Agreement for awards granted prior to May 2015 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended March 31, 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746911004794/a2203819zex-10_1.htm) | | |

| [removed: *10.10] [added: *10.12] | | | [Edwards Lifesciences Corporation Form of [removed: Participant Restricted Stock Unit Statement and related] Long-Term Stock [added: Incentive Compensation] Program Global Restricted Stock Unit Award Agreement for awards granted [removed: prior to] [added: beginning] May [removed: 2015 (incorporated by reference to Exhibit 10.2 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended March 31, 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746911004794/a2203819zex-10_2.htm)] [added: 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101210xkq42021.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 (incorporated by reference to Exhibit 10.3 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended June 30, 2015)](http://www.sec.gov/Archives/edgar/data/1099800/000109980015000024/ex-10310xqq22015.htm)] [added: 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101110xkq42021.htm)] | | |

| [removed: *10.12] [added: *10.13] | | | [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global [added: Performance-Based] Restricted Stock Unit Award Agreement for awards granted beginning May [removed: 2015 (incorporated by reference to Exhibit 10.4 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended June 30, 2015)](http://www.sec.gov/Archives/edgar/data/1099800/000109980015000024/ex10410-qq22015.htm)] [added: 2015](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101310xkq42021.htm)] | | |

| *10.15 | | | [Edwards Lifesciences [removed: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm) [2020](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm) [Nonemployee] [added: Corporation 2020 Nonemployee] Directors Stock Incentive [removed: Program](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm) [](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm)[(incorporated by reference to](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm) [Appendix B in Edwards Lifesciences'](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm) [Definitive Proxy Statement filed on March 25, 2020](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm)[)](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm)] [added: Program](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101510xkq42021.htm)] | | |

| [removed: +*10.16] [added: *10.16] | | | [Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related Nonemployee Directors Stock Incentive Program Nonqualified Stock Option Award [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-101610xkq42020.htm)] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101610xkq42021.htm)] | | |

| [removed: +*10.17] [added: *10.17] | | | [Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program Restricted Stock Units [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-101710xkq42020.htm)] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101710xkq42021.htm)] | | |

| [removed: +*10.18] [added: *10.18] | | | [Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program Restricted Stock [removed: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-101810xkq42020.htm)] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-101810xkq42021.htm)] | | |

| *10.19 | | | [Edwards Lifesciences Corporation Executive Deferred Compensation Plan, as amended and restated [removed: effective](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_7.htm) [as of](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_7.htm) [November] [added: effective as of November] 9, 2011 (incorporated by reference to Exhibit 10.7 in Edwards Lifesciences' report on Form 10-K for the fiscal year ended December 31, 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_7.htm) | | |

| 21.1 | | | [Subsidiaries of Edwards Lifesciences [removed: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-21110xkq42020.htm)] [added: Corporation](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-21110xkq42021.htm)] | | |

| 23 | | | [Consent of Independent Registered Public Accounting [removed: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-2310xkq42020.htm)] [added: Firm](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-2310xkq42021.htm)] | | |

| 31.1 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-31110xkq42020.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-31110xkq42021.htm)] | | |

| 31.2 | | | [Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-31210xkq42020.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-31210xkq42021.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/1099800/000109980021000007/ex-3210xkq42020.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1099800/000109980022000005/ex-3210xkq42021.htm)] | | |

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

| 4.6 | | | [Form of Global Note for the 4.300% Senior Notes due 2028 (incorporated by reference to Exhibit A in the Second Supplemental Indenture filed as Exhibit 4.2 in Edwards Lifesciences' report on Form 8-K](http://www.sec.gov/Archives/edgar/data/1099800/000119312518194499/d609576dex42.htm) [filed on June 15, 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000119312518194499/d609576dex42.htm) | | |

| *10.13 | | | [Edwards Lifesciences Corporation Form of Performance-Based Restricted Stock Unit Award Statement and related Long-Term Stock Program Global Performance-Based Restricted Stock Unit Award Agreement for awards granted beginning May 2015 (incorporated by reference to Exhibit 10.5 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended June 30, 2015)](http://www.sec.gov/Archives/edgar/data/1099800/000109980015000024/ex-10510xqq22015.htm) | | |

| February [removed: 12, 2021] [added: 14, 2022] | | | By: | | | | | | /s/ MICHAEL A. MUSSALLEM | | |

| /s/ MICHAEL A. MUSSALLEM | | | Chairman of the Board and Chief Executive Officer | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ SCOTT B. ULLEM | | | Corporate Vice President, Chief Financial Officer | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ ROBERT W.A. SELLERS | | | Vice President, Corporate Controller | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ KIERAN T. GALLAHUE | | | Director | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ LESLIE S. HEISZ | | | Director | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ PAUL A. LAVIOLETTE | | | Director | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ STEVEN R. LORANGER | | | Director | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ MARTHA H. MARSH | | | Director | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ RAMONA SEQUEIRA | | | Director | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| /s/ NICHOLAS J. VALERIANI | | | Director | | | February [removed: 12, 2021] [added: 14, 2022] | | |

| | | | | | | | | |

| /s/ WILLIAM J. LINK, PH.D. | | | Director | | | February 12, 2021 | | |

| William J. Link, Ph.D. | | | | | | | | |