Edwards Lifesciences (EW) 10-K risk factor changes: FY2020 vs FY2019

Even if we [removed: are able to] [added: timely innovate and] develop [removed: new or differentiated] products, our ability to market them could be [removed: limited] [added: constrained] by [added: a number of different factors, including barriers in patients' treatment pathway (including disease awareness, detection, and diagnosis),] the need for regulatory clearance, restrictions imposed on approved indications, [removed: entrenched patterns of clinical practice, barriers in the patients' path to treatment,] [added: and] uncertainty over third-party [removed: reimbursement, or other factors.][added: reimbursement.]

[removed: Accordingly,] [added: Innovating] products [added: requires the devotion of significant financial and other resources to research and development activities; however, there is no certainty that the products] we are currently developing [removed: may not] [added: will] complete the development [removed: process] [added: process,] or [added: that we will] obtain the regulatory or other approvals required to market such products in a timely manner or at all.

We [removed: purchase certain] [added: rely on third parties for a broad range] of [removed: the] [added: raw and organic] materials and [removed: components used] [added: other items] in the [removed: manufacture] [added: design, manufacture, and sterilization] of our [removed: products from external suppliers,] [added: products,] and we purchase certain supplies [added: and services] from single sources for reasons of quality assurance, cost-effectiveness, availability, constraints resulting from regulatory [removed: requirements] [added: requirements,] and other reasons.

[added: -] General economic conditions [added: that] could adversely affect the financial viability of our [removed: suppliers, resulting in their inability to provide materials and components used in the manufacture of our products.][added: vendors;]

[removed: Certain suppliers may also elect] [added: - Vendors' election] to no longer service medical technology companies due to the burdens of applicable quality requirements and [removed: regulation.][added: regulations;]

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

[removed: In addition, quality] [added: Quality] is extremely important due to the serious and costly consequences of a product failure.

Disruptions can occur at any time, including during [removed: implementation of new equipment and systems to replace aging equipment, as well as during] production line transfers and expansions.

As we expand into new [removed: markets,] [added: markets and scale new products for commercial production,] we may face unanticipated [added: delays or] surges in demand which could strain our production capacity and lead to other types of disruption.

If [added: any of] these [added: manufacturing, logistics, or quality] problems arise or if we [added: or one of our suppliers or logistics partner] otherwise fail to meet [removed: our] internal quality standards or those of the FDA or other applicable regulatory body, [removed: which include detailed record-keeping requirements,] 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 [added: and production] could be delayed, and our business could otherwise be [added: materially] adversely affected.

[removed: In addition,] [added: Disruptions can also occur if] our manufacturing and warehousing [removed: facilities, as well as those of our suppliers and logistics partners, could be materially] [added: facilities are] damaged by earthquakes, hurricanes, volcanoes, fires, and other natural disasters or catastrophic circumstances.

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

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

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

[removed: We] [added: In addition, we] may be required to take charges or write-downs in connection with [removed: acquisitions.][added: acquisitions and divestitures.]

To the extent that the value of these assets [removed: declines,] [added: decline,] we may be required to write down the value of the assets.

[removed: *We face intense competition,] [added: We operate in highly competitive markets,] and if we do not compete effectively, our business will be [removed: harmed.*][added: harmed.]

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

[removed: *Unsuccessful] [added: Unsuccessful] clinical trials or procedures relating to products [removed: under development] could have a material adverse effect on our [removed: prospects.*][added: prospects.]

Such clinical trials and procedures are inherently uncertain and there can be no assurance that these trials or procedures will be enrolled or completed in a timely or cost-effective manner or result in a commercially viable product or [removed: expanded] indication; failure to do so could have a material adverse effect on our prospects.

Further, preliminary results from clinical trials or procedures may be contradicted by subsequent [removed: clinical analysis.][added: analyses.]

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

[removed: *The] [added: The] success of many of our products depends upon [removed: strong relationships with] certain key [removed: physicians.*][added: physicians.]

[removed: The development, marketing, and sale of many of our products requires us to] [added: We] maintain working relationships with physicians upon whom we rely to provide considerable knowledge and experience.

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

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

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

The failure of either our or our service providers’ information technology could disrupt our [removed: entire operation] [added: 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.

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

[added: Domestic and Global Economic Conditions.] We cannot predict to what extent [removed: the] [added: general domestic and] global economic conditions may negatively impact our business.

These and other conditions could also adversely affect our [removed: customers] [added: customers, payers, vendors] and [added: other stakeholders and] may impact their ability or decision to purchase our products or make payments on a timely basis.

[removed: Various laws, including] [added: For example, in] the [added: U.S., 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 “*Health Care Legislation*” [added: and “*Government Regulation and Other Matter*s”] in Part I, Item 1, [removed: “*Business.*”][added: “*Business*.”]

[added: Taxes.] We are subject to income taxes in the United States as well as other jurisdictions.

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

Our [added: income] tax [removed: expense] [added: provision] could [added: also] be impacted by changes in excess tax benefits of stock-based compensation, federal and state tax credits, non-deductible expenses, changes in the valuation of deferred tax assets and liabilities and our ability to utilize them, the applicability and creditability of withholding taxes, and effects from acquisitions.

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

[removed: These changing tax laws] [added: Failure in any of these areas] could have a material [removed: adverse] effect on our [removed: business.][added: prospects.]

We benefit from [added: various global] tax incentives extended to [removed: our foreign subsidiaries to] encourage investment or employment.

Several [added: foreign] jurisdictions have granted us tax incentives which require renewal at various times in the future.

We are subject to risks associated with public health threats and epidemics, including the novel coronavirus ("COVID-19").

We are subject to risks associated with public health threats and epidemics, including the global health concerns relating to the COVID-19 pandemic.

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

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

- Significant volatility or reductions in demand for our products;

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

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

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

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

predict.

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, U.S. 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.

Failure to successfully innovate and develop new and differentiated products in a timely manner and effectively market these products could have a material effect on our prospects.

Our continued growth and success depend on our ability to innovate and develop new and differentiated products in a timely manner and effectively market these products.

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

If preliminary clinical results are later contradicted, or if initial results cannot be

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

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

We rely on third parties in the design, manufacture, and sterilization of our products.

Any failure by or loss of a vendor could result in delays and increased costs, which may adversely affect our business.

We may experience supply interruptions due to a variety of factors, including:

- The limitation or ban of certain materials used in the manufacture of our products; and

- Delays or shortages due to trade or regulatory embargoes.

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

Our business and results of operations may be adversely affected if we are unable to recruit and retain qualified management and other personnel.

Our continued success depends, in large part, on our ability to hire and retain qualified people or otherwise have access to such qualified people globally and if we are unable to do so, our business and operations may be impaired or disrupted.

See "*Human Capital Management Strategy*" under "*Business*" in Part I, Item 1 included herein.

Competition for highly qualified people is intense, and there is no assurance that we will be successful in attracting or retaining replacements to fill vacant positions, successors to fill retirements or employees moving to new positions, or other highly qualified personnel.

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

countries.

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

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

- *Tax Reform*.

Our provision for income taxes could be materially impacted by changes in accounting principles or evolving tax laws, including, but not limited to, global corporate tax reform and base-erosion and tax transparency efforts.

- *Tax Audits*.

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

- *Tax Incentives*.

Other economic, political, and social risks. Our future results could be harmed by a variety of other factors associated with doing business internationally such as those enumerated in these risk factors as well as the following:

Reimbursement levels may be decreased in the future.

We expect that market demand, governmental regulation, third-party reimbursement policies, and societal pressures will continue to drive consolidation and increase pricing pressure.

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, Edwards 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.

*If we do not introduce new and differentiated products in a timely manner, our products may become more susceptible to competition or technologically obsolete and our operating results may suffer.*

The cardiovascular products industry is characterized by technological changes, frequent new product introductions, and evolving industry standards.

Without the timely introduction of new and differentiated products, our products could become more susceptible to competition or technologically obsolete and our revenue and operating results would suffer.

We devote significant financial and other resources to our research and development activities; however, the research and development process is prolonged and entails considerable uncertainty.

In addition, even if we are able to successfully develop new or differentiated products, they may not produce revenue in excess of the costs of development, and they may be rendered obsolete or less competitive by changing customer preferences or the introduction by our competitors of products with newer technologies or features or other factors.

*We may experience supply interruptions that could harm our ability to manufacture products.*

We use a broad range of raw and organic materials and other items from third party vendors in the design, manufacture and sterilization of our products.

Our Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid Therapies, and Surgical Structural Heart products are manufactured from treated natural animal tissue and man-made materials.

Our non-implantable products are manufactured from man-made raw materials including resins, chemicals, electronics, and metals.

We also contract with third parties for important services related to infrastructure and information technology.

While we work closely with suppliers to monitor their financial viability, assure continuity of supply, and maintain high quality and reliability, these efforts may not be successful.

In addition, due to the rigorous regulations and requirements of the FDA and foreign regulatory authorities regarding the manufacture of our products (including the need for approval of any change in supply arrangements), we may have difficulty establishing additional or replacement sources on a timely basis or at all if the need arises.

Although alternative supplier options are often considered and identified, we typically do not pursue regulatory qualification of alternative sources due to the strength of our existing supplier relationships and the time and expense associated with the regulatory validation process.

A change in suppliers could require significant effort or investment in circumstances where the items supplied are integral to product performance or incorporate unique technology, and the loss of any existing supply contract could have a material adverse effect on us.

Regulatory agencies in the United States or other international geographies from time to time have limited or banned the use of certain materials used in the manufacture of our products.

In these circumstances, transition periods typically provide time to arrange for alternative materials.

If we are unable to identify alternative materials or suppliers and secure approval for their use in a timely manner, our business could be harmed.

In addition, for our suppliers located outside the United States, trade or regulatory embargoes imposed by foreign countries or the United States could result in delays or shortages that could harm our business.

*The manufacture of many of our products is highly complex and subject to strict quality controls.

Also, as we expand our manufacturing footprint, significant delays in construction and process validation could impact our production capacity.

Further, scaling a new product for commercial production can sometimes be delayed.

While we believe that our exposure to significant losses from a catastrophic disaster could be partially mitigated by our ability to manufacture, store, and distribute some of our products at other facilities, the losses could have a material adverse effect on our business for an indeterminate period of time before this transition is complete and operates without significant disruption.

*We may be required, from time to time, to recognize charges in connection with the write-down of our assets or dispositions of business operations or for other reasons.*

We manage a portfolio of research and development products.

We may also seek to dispose of other operations or products for strategic or other business reasons.

*We may not successfully identify and complete acquisitions or strategic alliances on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances, and such acquisitions could result in unforeseen operating difficulties and expenditures, require significant management resources, and require significant charges or write-downs.*

We may be unable to find suitable acquisition candidates or appropriate partners with which to form alliances.

Even if we identify appropriate acquisition or alliance candidates, we may be unable to complete the acquisitions or alliances on favorable terms, if at all.

In addition, the process of integrating an acquired business, technology, service, or product into our existing operations could result in unforeseen difficulties and expenditures.

Integration of an acquired company often requires significant expenditures as well as significant management resources that otherwise would be available for ongoing development of our other businesses.

Moreover, we may not realize the anticipated financial or other benefits of an acquisition or alliance.

Either of these situations could result in substantial charges, which could adversely affect our results of operations.

Acquisitions could also involve the issuance of equity securities, the incurrence of debt, contingent liabilities, or amortization of expenses related to other intangible assets, any of which could adversely impact our financial condition or results of operations.

In addition, equity or debt financing required for such acquisitions may not be available.

The cardiovascular medical technology industry is highly competitive.

We compete with many companies, some of which are larger, with better brand or name recognition, and broader product offerings.

Our customers consider many factors when selecting a product, including product reliability, breadth of product line, clinical outcomes, product availability, price, availability and rate of reimbursement, and services provided by the manufacturer.

In addition, our ability to compete will depend in large part on our ability to develop and acquire new or differentiated products and technologies, anticipate technology advances, and keep pace with other developers of cardiovascular therapies, including drug therapies, and technologies.

Our sales, technical, and other key personnel play an integral role in the development, marketing, and selling of new and existing products.

If we are unable to recruit, hire, develop, and retain a talented, competitive workforce, our ability to compete may be adversely affected.

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: 2019.][added: 2020.]

Also discussed is our financial position as of December 31, [removed: 2019.][added: 2020.]

For a discussion related to the results of operations for [added: 2019 compared to] 2018 [added: and a discussion related to our consolidated cash flows for 2019] compared to [removed: 2017,] [added: 2018,] refer to Part II, Item 7, "*Management's Discussion and Analysis of Financial Condition and Results of Operations*" in our [removed: 2018] [added: 2019] Annual Report on Form 10–K filed with the Securities and Exchange Commission on February [removed: 15, 2019.][added: 14, 2020.]

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 [removed: hemodynamic monitoring during surgery or in intensive care.]

Financial Highlights [added: and COVID-19]

[removed: ][added: ]

[removed: Partially offsetting this] [added: Our gross profit] increase [added: in 2020] was [added: 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.

In [removed: 2019,] [added: 2020,] we invested 17.3% of our net sales in research and development.

The following is a summary of important developments during [removed: 2019:][added: 2020:]

[removed: | • | we completed the acquisition of CAS Medical Systems, Inc. ("CASMED").] CASMED is a medical technology company dedicated to [removed: noninvasive] [added: non-invasive] monitoring of tissue oxygenation in the [removed: brain; |][added: brain.]

[removed: | • |] [added: -] we received CE Mark for the *Edwards PASCAL* transcatheter valve repair [removed: system; |][added: system for the treatment of European patients with tricuspid regurgitation;]

[removed: | • |] [added: -] we received [removed: FDA] [added: Chinese regulatory] approval [removed: to expand use of] [added: for] the *Edwards [removed: SAPIEN* and *SAPIEN 3 Ultra*] [added: SAPIEN 3*] transcatheter heart valve [removed: systems to] [added: for] the treatment of severe, symptomatic aortic stenosis patients [removed: who are determined to be] at [removed: low] [added: high] risk [removed: of] [added: for or unable to undergo] open-heart surgery; [removed: |]

| | [removed: Year] [added: | | Years] Ended December 31, | | | | | | | | [added: | | | | | | | | | |] Change | | | | | | [added: | | | | | | | | | | | | | | |]

| Total net sales | [added: | |] $ | [removed: 4,348.0] [added: 4,386.3] | | | [added: | |] $ | [removed: 3,722.8] [added: 4,348.0] | | | [added: | | | | | | | |] $ | [removed: 625.2] [added: 38.3] | | | [removed: 16.8] | [added: | | | | | | | 0.9 | |] % | [added: | | | | | |]

| Transcatheter Aortic Valve Replacement | [added: | |] $ | [removed: 2,737.9] [added: 2,857.3] | | | [added: | |] $ | [removed: 2,283.8] [added: 2,737.9] | | | [added: | | | | | | | |] $ | [removed: 454.1] [added: 119.4] | | | [removed: 19.9] | [added: | | | | | | | 4.4 | |] % | [added: | | | | | |]

| Transcatheter Mitral and Tricuspid Therapies | [added: | | 41.8 | | | | | |] 28.2 | | | | [removed: 2.9] | | | | [removed: 25.3] | | | | [removed: NM] [added: 13.6] | | [added: | | | | | | | | | | 48.5 | | % | | | | | | |]

| Surgical Heart Valve Therapy | [added: | | 761.8 | | | | | |] 841.7 | | | | [removed: 761.6] | | | | [removed: 80.1] | | | | [removed: 10.5] [added: (79.9)] | [added: | | | | | | | | | | | (9.5) | |] % | [added: | | | | | |]

[removed: ][added: ]

[removed: | • |] [added: 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 [removed: Europe (November 2018) and] the United States (December [removed: 2018); |][added: 2018) and in Europe (November 2018).]

[removed: ][added: ]

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

[removed: ][added: ]

[removed: | • | increased] [added: The decrease in net] sales of [added: Surgical products was due primarily to decreased sales of] aortic tissue [removed: valves] [added: valves, primarily] in [removed: Japan, Europe and] the United [removed: States, primarily] [added: States and Europe, due to] the [removed: *INSPIRIS RESILIA* aortic valve; |][added: impact of COVID-19.]

[removed: ][added: ]

[removed: ][added: ]

This [removed: decrease] [added: increase] was partially offset by [added: a)] a [removed: 1.5] [added: 1.0] percentage point [removed: increase] [added: decrease in 2020] due to the impact of foreign currency exchange rate fluctuations, [removed: including the settlement] [added: net] of [removed: foreign currency hedging contracts.][added: hedging, and b) incremental costs associated with COVID-19.]

[removed: ][added: ]

[removed: ][added: ]

Intellectual Property Litigation [removed: Expenses (Income),] [added: Expenses,] net

We incurred intellectual property litigation expenses, including settlements and external legal costs, of [removed: $33.4] [added: $405.4] million and [removed: $214.0] [added: $33.4] million during [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

The change in fair value of contingent consideration liabilities resulted in [removed: income] [added: expense] of [removed: $6.1] [added: $13.6] million [added: in 2020] and [removed: $5.7] [added: income of $6.1] million [removed: for the years ended December 31, 2019 and 2018, respectively.][added: in 2019.]

The income [added: in 2019] was due primarily to longer product development timelines, which reduced the probability of milestone [removed: achievements.][added: achievements, partially offset by the accretion of interest due to the passage of time and discount rate adjustments.]

For further information, see Note [removed: 11] [added: 22] to the "*Consolidated Financial Statements*."

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

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

Interest expense was [removed: $20.7] [added: $15.8] million and [removed: $29.9] [added: $20.7] million in [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

The decrease in interest [removed: expense] [added: income] resulted primarily from [removed: a] lower average [removed: debt] [added: interest rates, partially offset by a higher average investment] balance.

Interest income was [removed: $32.2] [added: $23.4] million and [removed: $32.0] [added: $32.2] million in [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

Other [removed: (Income) Expense,] [added: Income,] net

| | [added: | |] Years Ended December 31, | | | | | | | [added: | | | | | | | |]

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.

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

Our priority has been to support our clinician partners, protect the well-being of our employees, and maintain continuous access to our life-saving technologies while offering front-line in-hospital support.

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

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

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

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

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

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

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

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

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 COVID-19, and that trend continued through the fourth quarter of 2020.

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

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

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 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 | | % | | | | | | |

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

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

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

| Total net sales | | | $ | 4,386.3 | | | | | $ | 4,348.0 | | | | | | | | | | | $ | 38.3 | | | | | | | | | | | 0.9 | | % | | | | | | |

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.

Prior to 2019, TMTT and TAVR had been reported together.

Therefore, prior periods have been presented to conform with the updated product categories.

Our sales growth was driven by our TAVR products, primarily the *Edwards SAPIEN 3* transcatheter heart valve and the *Edwards SAPIEN 3 Ultra System*.

Our 2018 Surgical sales in the United States were reduced by a $82.5 million sales return reserve related to our conversion to a consignment inventory model.

Our gross profit increase was driven by our sales performance noted above and was positively impacted by an improved product mix, led by TAVR products.

The increase in our net income and diluted earnings per share in 2019 was primarily driven by the aforementioned sales growth, partially offset by a 2018 tax benefit and the charge in 2019 related to strategic decisions regarding our TAVR portfolio.

| | |

| --- | --- |

| • | we reached an agreement with Boston Scientific Corporation ("Boston Scientific") in January 2019 to settle all outstanding patent disputes for a one-time payment to Boston Scientific of $180.0 million; |

| • | we received CE Mark to expand use of the *Edwards SAPIEN 3* transcatheter heart valve for the treatment of patients diagnosed with aortic stenosis who are at low risk for open-heart surgery; and |

| • | we received FDA approval for an Early Feasibility Study to evaluate the safety and function of the *Edwards EVOQUE* tricuspid valve replacement system. |

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

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

| | 2019 | | | | 2018 | | | | $ | | | | % | |

| United States | $ | 2,532.7 | | | $ | 2,055.3 | | | $ | 477.4 | | | 23.2 | % |

| Europe | 941.2 | | | | 885.1 | | | | 56.1 | | | | 6.4 | % |

| Japan | 444.7 | | | | 396.8 | | | | 47.9 | | | | 12.1 | % |

| Rest of World | 429.4 | | | | 385.6 | | | | 43.8 | | | | 11.3 | % |

| International | 1,815.3 | | | | 1,667.5 | | | | 147.8 | | | | 8.9 | % |

| Critical Care | 740.2 | | | | 674.5 | | | | 65.7 | | | | 9.7 | % |

NM - Not meaningful

The increase in net sales of TAVR products was due primarily to:

| • | higher sales of the *Edwards SAPIEN 3* valve, particularly in the United States, driven by strong therapy adoption; and |

partially offset by:

| • | foreign currency exchange rate fluctuations, which decreased net sales by $32.7 million, due primarily to the weakening of the Euro against the United States dollar. |

The March 2019 results of the PARTNER 3 Trial demonstrated superiority of *SAPIEN 3* TAVR over surgery in the low risk patient population.

In August 2019, we received FDA approval to expand use of the *Edwards* *SAPIEN 3* and *SAPIEN 3 Ultra* transcatheter heart valve systems to the treatment of severe, symptomatic aortic stenosis patients who are determined to be at low risk of open-heart surgery.

Given the approval for patients at low surgical risk and the continued excellence and versatility of our balloon expandable platform, we decided to discontinue the *CENTERA* program*.* While the *CENTERA* valve has demonstrated excellent clinical outcomes and is performing well for patients, the time and resources required to optimize deliverability and expand the indications to match the *SAPIEN 3* valve are significant.

In November 2019, we received CE Mark to expand use of the *Edwards SAPIEN 3* transcatheter heart valve for the treatment of patients diagnosed with aortic stenosis who are at low risk for open-heart surgery.

In mitral repair, we continue to enroll our CLASP IID U.S. pivotal trial to study *PASCAL* in primary, or degenerative, mitral valve disease.

We also have initiated enrollment in our CLASP IIF pivotal trial for patients with secondary, or functional, mitral valve disease.

In September 2019, we received FDA approval for our CLASP IITR pivotal trial to study *PASCAL* in patients with symptomatic severe tricuspid regurgitation.

In the fourth quarter of 2019, we received FDA approval for an Early Feasibility Study to evaluate the safety and function of the *Edwards EVOQUE* tricuspid valve replacement system.

The increase in net sales of Surgical products was due primarily to:

| • | sales return reserves in 2018 of $82.5 million in the United States related to our conversion to a consignment inventory model; and |

| • | foreign currency exchange rate fluctuations, which decreased net sales by $14.5 million, due primarily to the weakening of the Euro against the United States dollar. |

At the end of 2019, we received European regulatory approval for *HARPOON Beating Heart Mitral Valve Repair System*, and are in the process of beginning our commercial launch.

*2019 Compared with 2018*

The increase in net sales of Critical Care products was driven by our *HemoSphere* advanced monitoring platform, primarily in the United States, partially offset by foreign currency exchange rate fluctuations, which decreased net sales by $9.1 million, due primarily to the weakening of the Euro and various other currencies against the United States dollar.

On April 18, 2019, we completed the acquisition of CASMED, a medical technology company dedicated to noninvasive monitoring of tissue oxygenation in the brain.

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

As of December 31, [removed: 2019,] [added: 2020,] we had [removed: $894.0] [added: $985.9] million of investments in [removed: fixed-rate] debt securities which had an average remaining term to maturity of approximately [removed: 1.0] [added: 1.56] years.

Taking into consideration the average maturity of our [removed: fixed-rate] debt securities, a hypothetical 0.5% to 1.0% absolute increase in interest rates at December 31, [removed: 2019] [added: 2020] would have resulted in a [removed: $4.6] [added: $7.8] million to [removed: $9.2] [added: $15.6] million decrease in the fair value of these investments.

As of December 31, [removed: 2019,] [added: 2020,] we had $600.0 million of 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: 2019,] [added: 2020,] there were no borrowings outstanding under the Credit Agreement.

Based on our December 31, [removed: 2019] [added: 2020] variable debt levels, a hypothetical 1.0% absolute increase in [removed: our] 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: 2019,] [added: 2020,] a hypothetical 1.0% absolute increase in market interest rates would decrease the fair value of the fixed-rate debt by approximately [removed: $44.7] [added: $43.2] million.

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

The total notional amount of our derivative financial instruments entered into for foreign currency management purposes at December 31, [removed: 2019] [added: 2020] was [removed: $1.6] [added: $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: $117.0] [added: $141.5] million.

At December 31, [removed: 2019,] [added: 2020,] all derivative financial instruments were with bank counterparties assigned investment grade ratings by national rating agencies.

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

In [removed: 2019,] [added: 2020,] we had no customers that represented 10% or more of our total net sales or accounts receivable, net.

As of December 31, [removed: 2019,] [added: 2020,] we had [removed: $894.0] [added: $985.9] million of investments in [removed: fixed-rate] debt securities of various companies, of which [removed: $556.2] [added: $766.5] million were long-term.

In addition, we had [removed: $29.3] [added: $35.1] million of investments in equity instruments of public and private companies.

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

Edwards Lifesciences Corporation is 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.

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

Sales of our transcatheter aortic valve replacement products represented [added: 65%,] 63%, [removed: 61%,] and [removed: 59%] [added: 61%] of our net sales in [added: 2020,] 2019, [removed: 2018,] and [removed: 2017,] [added: 2018,] respectively.

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

*INSPIRIS* is now [removed: a] [added: the] leading aortic [added: surgical] valve in the [removed: U.S. and in Japan.][added: world.]

In addition to our replacement valves, we are the worldwide leader in surgical heart valve repair [removed: therapies, which include annuloplasty rings.][added: therapies.]

[removed: At the end of 2019,] [added: In 2020,] we [removed: received European regulatory approval for] [added: launched] the *HARPOON Beating Heart Mitral Valve Repair System*, which can help transform care for many patients with degenerative mitral regurgitation.

Sales of our surgical tissue heart valve products represented [added: 16%,] 17%, [removed: 18%,] and [removed: 21%] [added: 18%] of our net sales in [added: 2020,] 2019, [removed: 2018,] and [removed: 2017,] [added: 2018,] respectively.

Edwards’ complete hemodynamic portfolio helps clinicians make proactive clinical decisions that can improve patient outcomes, and includes the minimally invasive *FloTrac* system, the noninvasive *ClearSight* system, and [removed: recently added] *ForeSight,* the noninvasive tissue oximetry system.

Sales of our core hemodynamic products represented 9%, [removed: 10%,] [added: 9%,] and 10% of our net sales in [added: 2020,] 2019, [removed: 2018,] and [removed: 2017,] [added: 2018,] respectively.

[removed: compete] [added: We believe that we are competitive] primarily [removed: on the basis of] [added: because we deliver superior] clinical [removed: superiority] [added: outcomes that are] supported by extensive data, and innovative features that enhance patient benefit, product performance, and [removed: reliability.][added: reliability; these superior clinical outcomes are in part due to the level of customer and clinical support we provide.]

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

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

In Surgical Structural Heart, our primary competitors include Medtronic PLC, [removed: Abbott Laboratories, LivaNova,] [added: Abbott,] and 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 [removed: PLC.][added: PLC, now part of Masimo.]

We are not dependent on any single customer and no single customer accounted for 10% or more of our net sales in [removed: 2019.][added: 2020.]

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

In [removed: 2019, 58%] [added: 2020, 57%] of our net sales were derived from sales to customers in the United States.

International. In [removed: 2019, 42%] [added: 2020, 43%] of our net sales were derived internationally through our direct sales forces and independent distributors.

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

We purchase certain materials and components used in manufacturing our products from external [added: suppliers.]

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

In [removed: 2019,] [added: 2020,] 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: 21%] [added: 1%] year over year to 17% of [removed: 2019] [added: 2020] sales.

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 [removed: products.]

In Transcatheter Mitral and Tricuspid Therapies, we are making significant investments in innovation and clinical evidence to develop technologies designed to treat mitral and tricuspid valve [removed: diseases and other structural heart conditions.][added: diseases.]

We also rely upon trade secrets, know-how, continuing innovations, [removed: and] licensing [removed: opportunities] [added: opportunities, and non-disclosure agreements] to develop and maintain our competitive position.

[removed: We] [added: Additionally, we] are a party to [removed: several] [added: numerous] license agreements with [removed: unrelated] [added: 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 [removed: monitor] [added: undertake reasonable measures to protect our patent rights, including monitoring] the products of our competitors for possible infringement of our owned and licensed patents.

[removed: We] [added: Moreover, we] own certain [removed: United States] [added: U.S.] registered trademarks used in our business.

Our products and facilities are subject to regulation by numerous government agencies, including the [added: U.S.] FDA, European [removed: Community Notified Bodies,] [added: Union Member States competent authorities,] and the Japanese Pharmaceuticals and Medical Devices Agency, to confirm compliance with the various laws and regulations governing the development, testing, manufacturing, labeling, marketing, and distribution of our products.

The FDA regulates design, development, testing, clinical studies, manufacturing, labeling, promotion, and record keeping for medical [added: devices, and reporting of adverse events, recalls, or other field actions by manufacturers and users to identify potential problems with marketed medical devices.]

Ultimately, the FDA may not authorize the commercial release of a medical device if it determines the device is not safe and effective or does not meet other [removed: standards for clearance.][added: regulatory standards.]

Additionally, the failure to comply with FDA or comparable regulatory standards or the discovery of previously unknown product problems could result in fines, delays, [removed: or] suspensions [added: or withdrawals] of regulatory clearances or approvals, seizures, injunctions, recalls, refunds, civil money penalties, or criminal prosecution.

Moreover, the FDA and several other United States agencies administer controls over the export of medical devices from the United States and the import of [added: medical] devices into the United States, which could also subject us to sanctions for noncompliance.

[removed: | • |] [added: -] federal, state, and foreign anti-kickback laws and regulations, which generally prohibit payments to [added: anyone, including] physicians [removed: or other purchasers of medical products] as an inducement to purchase [added: or recommend] a product; [removed: |]

[removed: | • |] [added: -] the Stark law, which prohibits physicians from referring Medicare or Medicaid patients to a provider that bills these programs for the provision of certain designated health services if the physician (or a member of the physician's immediate family) has a financial relationship with that provider; [removed: |]

[removed: | • |] [added: -] federal and state laws and regulations that protect the confidentiality of certain patient health information, including patient records, and restrict the use and disclosure of such information, in particular, the Health Insurance Portability and Accountability Act of 1996; [removed: |]

[removed: | • |] [added: -] the Physician Payments Sunshine Act, which requires public disclosure of the financial relationships of United States physicians and teaching hospitals with applicable manufacturers, including medical device, pharmaceutical, and biologics companies; [removed: |]

[removed: | • |] [added: -] the False Claims Act, which prohibits the submission of false or otherwise improper claims for payment to a federally funded health care program, and health care fraud statutes that prohibit false statements and improper claims to any third-party payor; and [removed: |]

with congenital heart disease.

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

Our two-platform strategy positions us for leadership in the mid-to-long term.

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

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

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

We believe the demand for surgical structural heart therapies is growing worldwide and that our innovation strategy will continue to extend our leadership and patient impact.

products.

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

We own or have rights to a substantial number of patents and have patent applications pending both in the U.S. and in foreign countries.

We continue to innovate and file new patent applications to protect the full range of our products and technologies.

Compliance with these regulations has not had a material effect on our capital expenditures, earnings, or competitive position to date, but new

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

We cannot estimate the expenses we may incur to comply with potential new laws or changes to existing laws, or the other potential effects these laws may have on our business.

To assist in our

Human Capital Management Strategy

Human Capital Management ("HCM") Governance

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

The primary goals of our talent management strategy are to attract and maintain a motivated, professional workforce and to ensure alignment on our patient-focused innovation strategy.

Our Board of Directors has oversight over human capital management with time dedicated at each regularly scheduled meeting to discuss talent management, including, among other things, talent strategy, diversity, succession planning, employee development, employee health, safety, and welfare, results of employee surveys, and compensation.

The Board of Directors also approves Key Operating Drivers, which are strategic milestones that include financial objectives and are tracked using a point system across our entire organization, that focus the Company and management toward short, medium, and long-term goals that align with our talent management strategy.

In addition, the Chief Executive Officer ("CEO") has talent management related performance goals tied to his compensation; these Performance Management Objectives are tracked and, then, reported to and evaluated by our Board of Directors.

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

The purpose of our TDR process is to align our business strategy with talent strategies, assess talent against future organizational needs, evaluate critical talent populations, and enhance the strength of our succession planning.

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

Culture

Investing in our workforce means our employees can stay focused on our patient-focused innovation strategy and the development of life-saving therapies for the patients we serve.

We are committed to maintaining a culture where we celebrate diversity, ensure that employees' voices are heard, and promote good health and safety.

We strive to offer competitive employee benefits packages and are committed to fair and equitable pay practices.

We track compensation patterns in all geographies where we operate, and we regularly look for ways to ensure fair and equitable pay.

We are committed to fostering an environment where all employees can grow and thrive.

A diverse workforce results in a broader range of perspectives, helping drive our commitment to innovation.

We believe in empowering our employees and providing avenues that enable their voices to be heard.

We conduct a multilingual global employee survey, called *my*Voice, to pulse our employees and gain their feedback in a confidential manner.

We gain insights on various topics including patient focus, diversity, inclusion and belonging, quality, innovation, and engagement.

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

In addition, during each quarterly townhall meeting, our CEO has an "Ask Mike" section in which he answers questions that have been submitted to him by employees.

Answers to questions that are not covered in the townhall meeting are posted online internally.

We understand that good health leads to better performance.

Edwards offers a competitive employee benefits package that includes, among other things, health and welfare insurance, health savings accounts, family support services, and a variety of site-specific programs.

valve disease using catheter-based approaches for patients who have severe symptomatic aortic stenosis and certain patients with congenital heart disease.

We believe that we

Customer and clinical support, and data that demonstrate both improvement in a patient's quality of life and a product's cost-effectiveness, are additional aspects of competition.

suppliers.

We own more than 4,700 issued United States patents, pending United States patent applications, issued foreign patents, and pending foreign patent applications.

We also have licensed various United States and foreign patents and patent applications that relate to aspects of the technology incorporated in certain of our products, including our heart valves and annuloplasty rings.

We also own or have rights in United States and foreign patents and patent applications in the field of transcatheter heart valve repair and replacement.

In addition, we own or have rights in United States and foreign patents and patent applications that cover catheters, systems and methods for hemodynamic monitoring, and vascular access products, among others.

devices, and reporting of adverse events, recalls, or other field actions by manufacturers and users to identify potential problems with marketed medical devices.

| | |

| --- | --- |

National laws conforming

business, including the United States, Europe, and Japan.

Health Care Legislation. In 2010, significant reforms to the health care system were adopted as law in the United States as part of the Affordable Care Act.

The law included provisions that, among other things, created programs to encourage a shift to value-based care, required all individuals to have health insurance (with limited exceptions), and imposed increased taxes.

The law required the medical technology industry to pay a 2.3% excise tax on United States sales of most medical devices.

The excise tax, which increased our operating expenses, was suspended for calendar years 2016 through 2019.

In December 2019, this legislation was repealed.

Employees

We emphasize competitive compensation, benefits, equity participation, and a positive and attractive work environment in our efforts to attract and retain qualified personnel, and employ a rigorous talent management system.

[removed: FORM 10-K][added: FORM 10-K]

| ☒ | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

For the Fiscal Year [removed: Ended December] [added: Ended December] 31, [removed: 2019][added: 2020]

| ☐ | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

Commission File [removed: Number 1-15525][added: Number 1-15525]

| Delaware | | | [added: | | | | | |] 36-4316614 | | [added: | | | |]

| (State or other jurisdiction of incorporation or organization) | | | [added: | | | | | |] (I.R.S. Employer Identification No.) | | [added: | | | |]

| One Edwards Way | [added: | |] Irvine | [added: | |] California | [added: | |] 92614 | | [added: | | | |]

| (Address of Principal Executive Offices) | | | [added: | | | | | |] (Zip Code) | | [added: | | | |]

| Securities registered pursuant to Section 12(b) of the Act: | | | [added: | | | | | |]

| Title of each class | [added: | |] Trading Symbols(s) | [added: | |] Name of each exchange on which registered: | [added: | |]

| Common Stock, par value $1.00 per share | [added: | |] EW | [added: | |] New York Stock Exchange | [added: | |]

| Securities registered pursuant to Section 12(g) of the Act: None | | | [added: | | | | | |]

| Large accelerated filer | [added: | |] ☒ | [added: | |] Accelerated filer | [added: | |] ☐ | [added: | |] Non-accelerated filer | [added: | |] ☐ | [added: | |] Smaller reporting company | [added: | |] ☐ | [added: | |] Emerging growth company | [added: | |] ☐ | [added: | |]

The aggregate market value of the registrant's common stock held by non-affiliates as of June [removed: 28, 2019] [added: 30, 2020] (the last trading day of the registrant's most recently completed second quarter): [removed: $34,109,197,847] [added: $42,640,586,293] 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: 2020,] [added: 2021,] was [removed: 209,122,578.][added: 624,518,873.]

Portions of the registrant's proxy statement for the [removed: 2020] [added: 2021] Annual Meeting of Stockholders (to be filed within 120 days of December 31, [removed: 2019)] [added: 2020)] are incorporated by reference into Part III, as indicated herein.

Form 10-K Annual [removed: Report—2019][added: Report—2020]

| [Item [removed: 1.](#s1154817EFD531A13D77D0530A19FF039)] [added: 1.](#if12725e820b640d3be478e9249641078_16)] | [removed: [Business](#s1154817EFD531A13D77D0530A19FF039)] | [removed: [2](#s1154817EFD531A13D77D0530A19FF039)] | [added: [Business](#if12725e820b640d3be478e9249641078_16) | | | [2](#if12725e820b640d3be478e9249641078_16) | | |]

| [Item [removed: 1A.](#s345EA835C12E4259556E0530A1D2F395)] [added: 1A.](#if12725e820b640d3be478e9249641078_19)] | [added: | |] [Risk [removed: Factors](#s345EA835C12E4259556E0530A1D2F395)] [added: Factors](#if12725e820b640d3be478e9249641078_19)] | [removed: [10](#s345EA835C12E4259556E0530A1D2F395)] | [added: | [11](#if12725e820b640d3be478e9249641078_19) | | |]

| [Item [removed: 1B.](#sC047979666C7B52605600530A1F38296)] [added: 1B.](#if12725e820b640d3be478e9249641078_22)] | [added: | |] [Unresolved Staff [removed: Comments](#sC047979666C7B52605600530A1F38296)] [added: Comments](#if12725e820b640d3be478e9249641078_22)] | [removed: [19](#sC047979666C7B52605600530A1F38296)] | [added: | [17](#if12725e820b640d3be478e9249641078_22) | | |]

| [Item [removed: 2.](#s50FE0A84AA42FFEA4795052FA2D0C471)] [added: 2.](#if12725e820b640d3be478e9249641078_25)] | [removed: [Properties](#s50FE0A84AA42FFEA4795052FA2D0C471)] | [removed: [20](#s50FE0A84AA42FFEA4795052FA2D0C471)] | [added: [Properties](#if12725e820b640d3be478e9249641078_25) | | | [18](#if12725e820b640d3be478e9249641078_25) | | |]

| [Item [removed: 3.](#sB132843B9E34F89CF76C0530A247C882)] [added: 3.](#if12725e820b640d3be478e9249641078_28)] | [added: | |] [Legal [removed: Proceedings](#sB132843B9E34F89CF76C0530A247C882)] [added: Proceedings](#if12725e820b640d3be478e9249641078_28)] | [removed: [20](#sB132843B9E34F89CF76C0530A247C882)] | [added: | [18](#if12725e820b640d3be478e9249641078_28) | | |]

| [Item [removed: 4.](#sB646D86F512E4C551E680530A279994B)] [added: 4.](#if12725e820b640d3be478e9249641078_31)] | [added: | |] [Mine Safety [removed: Disclosures](#sB646D86F512E4C551E680530A279994B)] [added: Disclosures](#if12725e820b640d3be478e9249641078_31)] | [removed: [20](#sB646D86F512E4C551E680530A279994B)] | [added: | [18](#if12725e820b640d3be478e9249641078_31) | | |]

| [Item [removed: 5.](#sD989FB01ED158FBD4863052E04A2A76C)] [added: 5.](#if12725e820b640d3be478e9249641078_37)] | [added: | |] [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#sD989FB01ED158FBD4863052E04A2A76C)] [added: Securities](#if12725e820b640d3be478e9249641078_37)] | [removed: [21](#sD989FB01ED158FBD4863052E04A2A76C)] | [added: | [19](#if12725e820b640d3be478e9249641078_37) | | |]

| [Item [removed: 6.](#sA820BD9E10CFFFCB64BC0530A2EE9AA6)] [added: 6.](#if12725e820b640d3be478e9249641078_40)] | [added: | |] [Selected Financial [removed: Data](#sA820BD9E10CFFFCB64BC0530A2EE9AA6)] [added: Data](#if12725e820b640d3be478e9249641078_40)] | [removed: [23](#sA820BD9E10CFFFCB64BC0530A2EE9AA6)] | [added: | [21](#if12725e820b640d3be478e9249641078_40) | | |]

| [Item [removed: 7.](#s01B65C92E0029293576A0530A31EFF9C)] [added: 7.](#if12725e820b640d3be478e9249641078_43)] | [added: | |] [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#s01B65C92E0029293576A0530A31EFF9C)] [added: Operations](#if12725e820b640d3be478e9249641078_43)] | [removed: [23](#s01B65C92E0029293576A0530A31EFF9C)] | [added: | [21](#if12725e820b640d3be478e9249641078_43) | | |]

| [Item [removed: 7A.](#sE0D581518236F7F7ED540530A44BDDFE)] [added: 7A.](#if12725e820b640d3be478e9249641078_58)] | [added: | |] [Quantitative and Qualitative Disclosures About Market [removed: Risk](#sE0D581518236F7F7ED540530A44BDDFE)] [added: Risk](#if12725e820b640d3be478e9249641078_58)] | [removed: [37](#sE0D581518236F7F7ED540530A44BDDFE)] | [added: | [35](#if12725e820b640d3be478e9249641078_58) | | |]

| [Item [removed: 8.](#s5F215FABA1D613B88DC8052DC77C2029)] [added: 8.](#if12725e820b640d3be478e9249641078_61)] | [added: | |] [Financial Statements and Supplementary [removed: Data](#s5F215FABA1D613B88DC8052DC77C2029)] [added: Data](#if12725e820b640d3be478e9249641078_61)] | [removed: [39](#s5F215FABA1D613B88DC8052DC77C2029)] | [added: | [38](#if12725e820b640d3be478e9249641078_61) | | |]

| [Item [removed: 9.](#sF4659F680A3C9B05CE250530AA573E77)] [added: 9.](#if12725e820b640d3be478e9249641078_166)] | [added: | |] [Changes in and Disagreements With Accountants on Accounting and Financial [removed: Disclosure](#sF4659F680A3C9B05CE250530AA573E77)] [added: Disclosure](#if12725e820b640d3be478e9249641078_166)] | [removed: [96](#sF4659F680A3C9B05CE250530AA573E77)] | [added: | [91](#if12725e820b640d3be478e9249641078_166) | | |]

| [Item [removed: 9A.](#s9E128DE37CB55E0727F10530AA6A46FD)] [added: 9A.](#if12725e820b640d3be478e9249641078_169)] | [added: | |] [Controls and [removed: Procedures](#s9E128DE37CB55E0727F10530AA6A46FD)] [added: Procedures](#if12725e820b640d3be478e9249641078_169)] | [removed: [96](#s9E128DE37CB55E0727F10530AA6A46FD)] | [added: | [92](#if12725e820b640d3be478e9249641078_169) | | |]

| [Item [removed: 9B.](#sBCA618934548FC6C26AC0530AA9CF14D)] [added: 9B.](#if12725e820b640d3be478e9249641078_172)] | [added: | |] [Other [removed: Information](#sBCA618934548FC6C26AC0530AA9CF14D)] [added: Information](#if12725e820b640d3be478e9249641078_172)] | [removed: [97](#sBCA618934548FC6C26AC0530AA9CF14D)] | [added: | [92](#if12725e820b640d3be478e9249641078_172) | | |]

| [removed: [PART III](#s3B7BFCF8406F49B46F77052DD0C2BE3B)] [added: [PART III](#if12725e820b640d3be478e9249641078_175)] | | | [added: | | | | | |]

| [Item [removed: 10.](#sBDCA3A10690B9C82BEAB0530AAEF8FC9)] [added: 10.](#if12725e820b640d3be478e9249641078_178)] | [added: | |] [Directors, Executive Officers and Corporate [removed: Governance](#sBDCA3A10690B9C82BEAB0530AAEF8FC9)] [added: Governance](#if12725e820b640d3be478e9249641078_178)] | [removed: [98](#sBDCA3A10690B9C82BEAB0530AAEF8FC9)] | [added: | [93](#if12725e820b640d3be478e9249641078_178) | | |]

| [Item [removed: 11.](#sBDE304930929D5CFF0BB0530AB11DC49)] [added: 11.](#if12725e820b640d3be478e9249641078_181)] | [added: | |] [Executive [removed: Compensation](#sBDE304930929D5CFF0BB0530AB11DC49)] [added: Compensation](#if12725e820b640d3be478e9249641078_181)] | [removed: [98](#sBDE304930929D5CFF0BB0530AB11DC49)] | [added: | [93](#if12725e820b640d3be478e9249641078_181) | | |]

| [Item [removed: 12.](#s9E59FF16D1E7AEB8751C0530AB445704)] [added: 12.](#if12725e820b640d3be478e9249641078_184)] | [added: | |] [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#s9E59FF16D1E7AEB8751C0530AB445704)] [added: Matters](#if12725e820b640d3be478e9249641078_184)] | [removed: [98](#s9E59FF16D1E7AEB8751C0530AB445704)] | [added: | [93](#if12725e820b640d3be478e9249641078_184) | | |]

| [Item [removed: 13.](#s898F6FE5E99DC78907D30530AB657D7D)] [added: 13.](#if12725e820b640d3be478e9249641078_187)] | [added: | |] [Certain Relationships and Related Transactions, and Director [removed: Independence](#s898F6FE5E99DC78907D30530AB657D7D)] [added: Independence](#if12725e820b640d3be478e9249641078_187)] | [removed: [98](#s898F6FE5E99DC78907D30530AB657D7D)] | [added: | [93](#if12725e820b640d3be478e9249641078_187) | | |]

| [Item [removed: 14.](#s9955657CF160781063B30530AB96B8D9)] [added: 14.](#if12725e820b640d3be478e9249641078_190)] | [added: | |] [Principal Accounting Fees and [removed: Services](#s9955657CF160781063B30530AB96B8D9)] [added: Services](#if12725e820b640d3be478e9249641078_190)] | [removed: [98](#s9955657CF160781063B30530AB96B8D9)] | [added: | [93](#if12725e820b640d3be478e9249641078_190) | | |]

| [Item [removed: 15.](#s9423574966FC35F168A80530ABE91B4F)] [added: 15.](#if12725e820b640d3be478e9249641078_196)] | [added: | |] [Exhibits and Financial Statement [removed: Schedules](#s9423574966FC35F168A80530ABE91B4F)] [added: Schedules](#if12725e820b640d3be478e9249641078_196)] | [removed: [99](#s9423574966FC35F168A80530ABE91B4F)] | [added: | [94](#if12725e820b640d3be478e9249641078_196) | | |]

| [Item [removed: 16.](#sC8C50870926B5AB949320530AC0A01B1)] [added: 16.](#if12725e820b640d3be478e9249641078_199)] | [added: | |] [Form 10-K [removed: Summary](#sC8C50870926B5AB949320530AC0A01B1)] [added: Summary](#if12725e820b640d3be478e9249641078_199)] | [removed: [102](#sC8C50870926B5AB949320530AC0A01B1)] | [added: | [96](#if12725e820b640d3be478e9249641078_199) | | |]

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

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

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

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

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

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 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 U.S. Food and Drug Administration and other regulatory agencies; unexpected litigation impacts or expenses; 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 Securities and Exchange Commission.

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| [PART I](#s2297F87E6BA82D28A9A90530A14C9879) | | |

| [PART II](#sFCDAE350A21F2CFCB2320530A2990E4D) | | |

| [PART IV](#s970E6B7C3785DBF35C8B0530ABB77A60) | | |

| | [Signatures](#s5AA3AF7AECA05DB4215E0530AC3BE1E1) | [103](#s5AA3AF7AECA05DB4215E0530AC3BE1E1) |

Investors are cautioned not to unduly rely on such forward-looking statements.

See "Risk Factors" in Part I, Item 1A below for a discussion of these risks, as such risks may be amended, supplemented or superseded from time to time by our subsequent reports on Forms 10-Q and 8-K.

| North America | | | | | [added: | | | | | | |]

| Irvine, California | [removed: (1] | [removed: )] | [added: (1)] | [added: | | | | |] Corporate Headquarters, Research and Development, Regulatory and Clinical Affairs, Manufacturing, Marketing, Administration | [added: | |]

| Draper, Utah | [removed: (1] | [removed: )] | [added: (1),(2)] | [added: | | | | |] Manufacturing, Administration | [added: | |]

| Haina, Dominican Republic | [removed: (2] | [removed: )] | [added: (1),(2)] | [added: | | | | |] Manufacturing | [added: | |]

| Añasco, Puerto Rico | [removed: (2] | [removed: )] | [added: (2)] | [added: | | | | |] Manufacturing | [added: | |]

| Central America | | | | | [added: | | | | | | |]

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

| Europe | | | | | [added: | | | | | | |]

| Nyon, Switzerland | [removed: (1] | [removed: )] | [added: (1)] | [added: | | | | |] Administration, Marketing | [added: | |]

| Prague, Czech Republic | [removed: (2] | [removed: )] | [added: (2)] | [added: | | | | |] Administration | [added: | |]

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

| Asia | | | | | [added: | | | | | | |]

| Tokyo, Japan | [removed: (2] | [removed: )] | [added: (2)] | [added: | | | | |] Administration, Marketing, Distribution | [added: | |]

| Shanghai, China | [removed: (2] | [removed: )] | [added: (2)] | [added: | | | | |] Administration, Marketing | [added: | |]

| Singapore | [added: | |] (1),(2) | | | [added: | | |] Manufacturing, Distribution, Administration | [added: | |]

[removed: |] (1) [removed: |] Owned property. [removed: |]

[removed: |] (2) [removed: |] Leased property. [removed: |]

The Dominican Republic lease expires in 2022; the Puerto Rico property has two leases that expire in 2023; the Costa Rica lease expires in 2021; the Prague, Czech Republic lease expires in 2026; the Shannon, Ireland lease expires in 2024; the Tokyo, Japan lease expires in 2021; the Shanghai, China lease expires in 2021; [removed: and] Singapore has one land lease that expires in 2036 and one that expires in [removed: 2041.][added: 2041; Caesarea, Israel has one lease that expires in 2021 and one that expires in 2030; and the Or Yehuda, Israel lease expires in 2023.]

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| Caesarea, Israel | | | (2) | | | | | | Research and Development | | |

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

We do not anticipate difficulty in renewing existing leases as they expire or in finding alternative facilities.

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On January 31, [removed: 2020,] [added: 2021,] there were [removed: 9,357] [added: 8,876] stockholders of record of our common stock.

On [removed: November 15, 2017,] [added: May 8, 2019,] the Board of Directors approved a stock repurchase program authorizing us to purchase on the open market, including pursuant to a Rule 10b5-1 [removed: plan, or] [added: plan and] in privately negotiated transactions, up to $1.0 billion of our common stock.

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

We did not purchase any of our common stock during the fourth quarter of [removed: 2019] [added: 2020] and, as of December 31, [removed: 2019,] [added: 2020,] we had remaining authority to purchase [removed: $1.2 billion] [added: $625.0 million] of common stock.

The cumulative total return listed below assumes an initial investment of $100 at the market close on December 31, [removed: 2014] [added: 2015] and reinvestment of dividends.

[removed: ][added: ]

| | [added: | |] Total Cumulative Return | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| | [removed: 2015] | | [added: 2016] | | [removed: 2016] | | | | 2017 | | | | [added: | |] 2018 | | | | [added: | |] 2019 | | | [added: | | | 2020 | | |]

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| 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 | | |

On May 8, 2019, the Board of Directors approved a new stock repurchase program providing for an additional $1.0 billion of repurchases of our common stock.

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| Edwards Lifesciences | $ | 124.01 | | | $ | 147.12 | | | $ | 176.97 | | | $ | 240.49 | | | $ | 366.29 | |

| S&P 500 | 101.38 | | | | 113.51 | | | | 138.29 | | | | 132.23 | | | | 173.86 | | |

| S&P 500 Health Care Equipment | 105.97 | | | | 112.85 | | | | 147.71 | | | | 171.70 | | | | 222.04 | | |

| | | [added: | | | |] As of or for the Years Ended December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| | | [added: | | | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| | | [added: | | | |] (in millions, except per share data) | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| OPERATING RESULTS | [added: | |] Net sales | [added: | |] $ | [removed: 4,348.0] [added: 4,386.3] | | | [added: | |] $ | [removed: 3,722.8] [added: 4,348.0] | | | [added: | |] $ | [removed: 3,435.3] [added: 3,722.8] | | | [added: | |] $ | [removed: 2,963.7] [added: 3,435.3] | | | [added: | |] $ | [removed: 2,493.7] [added: 2,963.7] | |

| | [added: | |] Gross profit | [added: | | 3,305.7 | | | | | |] 3,233.6 | | | | [added: | |] 2,783.4 | | | | [removed: 2,560.0] | | [added: 2,560.0] | | [removed: 2,166.3] | | | | [removed: 1,876.5] [added: 2,166.3] | | |

| | [added: | |] Operating income (a) | [added: | | 897.6 | | | | | |] 1,146.8 | | | | [added: | |] 748.2 | | | | [removed: 1,089.4] | | [added: 1,089.4] | | [removed: 751.2] | | | | [removed: 636.1] [added: 751.2] | | |

| | [added: | |] Net income (a) | [added: | | 823.4 | | | | | |] 1,046.9 | | | | [added: | |] 722.2 | | | | [removed: 583.6] | | [added: 583.6] | | [removed: 569.5] | | | | [removed: 494.9] [added: 569.5] | | |

| COMMON STOCK INFORMATION | [added: | |] Net income per common share [removed: (a):] [added: (a) (c):] | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| | [added: | |] Cash dividends declared per common share | [added: | |] — | | | | [added: | |] — | | | | [added: | |] — | | | | [added: | |] — | | | | [added: | |] — | | |

| BALANCE SHEET DATA | [added: | |] Total assets | [added: | |] $ | [removed: 6,488.1] [added: 7,237.1] | | | [added: | |] $ | [removed: 5,323.7] [added: 6,488.1] | | | [added: | |] $ | [removed: 5,666.4] [added: 5,323.7] | | | [added: | |] $ | [removed: 4,518.5] [added: 5,666.4] | | | [added: | |] $ | [removed: 4,056.3] [added: 4,518.5] | |

| | [added: | |] Long-term debt (b) | [added: | | 595.0 | | | | | |] 594.4 | | | | [added: | |] 593.8 | | | | [removed: 438.4] | | [added: 438.4] | | [removed: 822.3] | | | | [removed: 596.9] [added: 822.3] | | |

[removed: | (a) |] The above results for [removed: 2019 include special charges of $64.6 million. The above results for 2018 include special charges of $109.1 million (primarily the impairment of intangible assets) and a $180.0 million ($137.5 million, net of tax) charge in 2018 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. [removed: 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. |]

[removed: | (b) |] In [removed: 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, [added: 2020,] 2019 and 2018. [removed: 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. |]

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

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

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

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

(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.

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.

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.

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

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

| | Basic | $ | 5.03 | | | $ | 3.45 | | | $ | 2.77 | | | $ | 2.67 | | | $ | 2.30 | |

| | Diluted | 4.93 | | | | 3.38 | | | | 2.70 | | | | 2.61 | | | | 2.25 | | |

| | |

| --- | --- |

[removed: DECEMBER 31, 2019][added: | | | | December 31, 2019 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [Report of Independent Registered Public Accounting [removed: Firm](#sA36BFE293F722DB88E960530A46CBE59)] [added: Firm](#if12725e820b640d3be478e9249641078_67)] | [removed: [40](#sA36BFE293F722DB88E960530A46CBE59)] | [added: | [39](#if12725e820b640d3be478e9249641078_67) | | |]

| Financial Statements: | | [added: | | | |]

| [Consolidated Balance Sheets as of December 31, [removed: 2019] [added: 2020] and [removed: 2018](#s7C902646E7D6AF59D4BC052DC6685DC4)] [added: 2019](#if12725e820b640d3be478e9249641078_70)] | [removed: [43](#s7C902646E7D6AF59D4BC052DC6685DC4)] | [added: | [42](#if12725e820b640d3be478e9249641078_70) | | |]

| For the Years Ended December 31, [added: 2020,] 2019, [removed: 2018,] and [removed: 2017:] [added: 2018:] | | [added: | | | |]

| [Consolidated Statements of [removed: Operations](#sAFE8F768EF9DA9ABCE4B052DC4518AB3)] [added: Operations](#if12725e820b640d3be478e9249641078_76)] | [removed: [44](#sAFE8F768EF9DA9ABCE4B052DC4518AB3)] | [added: | [43](#if12725e820b640d3be478e9249641078_76) | | |]

| [Consolidated Statements of Comprehensive [removed: Income](#sE835D9891077A4E70A07052DC619DDE3)] [added: Income](#if12725e820b640d3be478e9249641078_79)] | [removed: [45](#sE835D9891077A4E70A07052DC619DDE3)] | [added: | [44](#if12725e820b640d3be478e9249641078_79) | | |]

| [Consolidated Statements of Cash [removed: Flows](#sA051B7DE8DE8A712FC6F052DC7536EFB)] [added: Flows](#if12725e820b640d3be478e9249641078_82)] | [removed: [46](#sA051B7DE8DE8A712FC6F052DC7536EFB)] | [added: | [45](#if12725e820b640d3be478e9249641078_82) | | |]

| [Consolidated Statements of Stockholders' [removed: Equity](#sFF69C8DCA250A09C092F052DC5DDBB62)] [added: Equity](#if12725e820b640d3be478e9249641078_85)] | [removed: [47](#sFF69C8DCA250A09C092F052DC5DDBB62)] | [added: | [46](#if12725e820b640d3be478e9249641078_85) | | |]

| [Notes to Consolidated Financial [removed: Statements](#sC3D78EFE45E4E5151F32052DC88C9E93)] [added: Statements](#if12725e820b640d3be478e9249641078_88)] | [removed: [48](#sC3D78EFE45E4E5151F32052DC88C9E93)] | [added: | [47](#if12725e820b640d3be478e9249641078_88) | | |]

We have audited the accompanying consolidated balance sheets of Edwards Lifesciences Corporation and its subsidiaries (the “Company”) as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] 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: 2019,] [added: 2020,] 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: 2019,] [added: 2020,] 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: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2019] [added: 2020] 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: 2019,] [added: 2020,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

As described in Notes 2 and 17 to the consolidated financial statements, the Company had a gross uncertain tax position liability balance of [removed: $203.1] [added: $281.8] million as of December 31, [removed: 2019,] [added: 2020,] primarily related to transfer pricing.

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 [removed: there was] [added: the] significant judgment by management when determining uncertain tax positions related to intercompany transfer pricing, including a high degree of estimation uncertainty in evaluating whether certain tax filing positions taken by management will be upheld by the related local tax authority.

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

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 [removed: knowledge to assist in evaluating the audit evidence obtained.][added: knowledge.]

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

These procedures also included, among others, (i) testing the information used in the calculation of the liability for uncertain tax positions, including [removed: intercompany agreements, international, federal, and state] [added: U.S. federal] filing [removed: positions,] [added: positions] and the related final 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: the completeness] of management’s assessment of [removed: both the identification] [added: possible outcomes] of uncertain tax positions related to intercompany transfer [removed: pricing and possible outcomes of each uncertain tax position;] [added: pricing;] 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 completeness and measurement of the Company’s uncertain tax positions related to intercompany transfer pricing, including evaluating the reasonableness of management’s assessment of whether tax positions are more-likely-than-not [removed: of being] [added: to be] sustained and the amount of potential benefit to be realized, [added: and] the application of relevant tax [removed: laws, and estimated interest and penalties.][added: laws.]

As of December 31, [removed: 2019,] [added: 2020,] the Company had a contingent consideration liability of [removed: $172.5] [added: $186.1] million.

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

[removed: 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 revenue.

The principal considerations for our determination that performing procedures relating to the fair value of contingent consideration liabilities is a critical audit matter are [removed: there was] [added: the] significant judgment by management when estimating the fair value of these contingent [removed: obligations,] [added: 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.

Also, the evaluation of audit evidence available to support the fair value of the contingent consideration liabilities is complex and [removed: required] [added: 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 [removed: knowledge to assist in evaluating the audit evidence obtained.][added: knowledge.]

These procedures also included, among others, (i) testing management’s process for estimating the fair value of contingent consideration liabilities and (ii) testing management’s probability weighted discounted cash flow analysis or [added: a] Monte Carlo simulation 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 [removed: assumptions, including] [added: assumptions related to] the discount rate, the probability of milestone achievement, the projected payment dates, and the volatility of future revenue.

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

| | [added: | |] December 31, | | | | | | | [added: | |]

| | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | |

| ASSETS | | | | | | | | [added: | | | |]

| Current assets | | | | | | | | [added: | | | |]

| Cash and cash equivalents | [added: | |] $ | [added: 1,183.2 | | | | | $ |] 1,179.1 | | | [added: | |] $ | 714.1 | |

| Short-term investments (Note 7) | [removed: 337.8] | | [added: 219.4] | | [removed: 242.4] | | | [added: | 337.8 | | |]

| Other receivables | [removed: 55.5] | | [added: 88.2] | | [removed: 80.4] | | | [added: | 55.5 | | |]

| Inventories (Note 5) | [removed: 640.9] | | [added: 802.3] | | [removed: 607.0] | | | [added: | 640.9 | | |]

| Prepaid expenses | [removed: 59.1] | | [added: 75.1] | | [removed: 54.3] | | | [added: | 59.1 | | |]

| Other current assets | [removed: 168.0] | | [added: 208.2] | | [removed: 131.8] | | | [added: | 168.0 | | |]

| Total current assets | [removed: 2,984.0] | | [added: 3,091.0] | | [removed: 2,286.9] | | | [added: | 2,984.0 | | |]

| | | | | | |

| | | | | | |

| | | | | | |

| | | | | | |

| All other schedules are omitted as they are not applicable or the required information is furnished in the Consolidated Financial Statements or notes thereto. | | | | | |

These inputs

February 12, 2021

| Accounts receivable, net of allowances of $9.6 and $8.7, respectively | | | 514.6 | | | | | | 543.6 | | |

| Litigation settlement accrual (Notes 3 and 18) | | | 233.0 | | | | | | — | | |

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

| Basic | | | $ | 1.32 | | | | | $ | 1.68 | | | | | $ | 1.15 | |

| Diluted | | | $ | 1.30 | | | | | $ | 1.64 | | | | | $ | 1.13 | |

| Basic | | | 622.6 | | | | | | 624.8 | | | | | | 627.6 | | |

| Diluted | | | 631.9 | | | | | | 636.7 | | | | | | 640.9 | | |

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

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

| Unrealized pension costs | | | (4.2) | | | | | | (1.9) | | | | | | 0.6 | | |

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

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

| Net income | | | $ | 823.4 | | | | | $ | 1,046.9 | | | | | $ | 722.2 | |

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

| Litigation settlement accrual | | | 270.5 | | | | | | (180.0) | | | | | | 180.0 | | |

| Other | | | 16.3 | | | | | | 19.7 | | | | | | 1.4 | | |

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

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

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

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

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

| Issuances of notes receivable | | | (27.0) | | | | | | (12.9) | | | | | | (0.6) | | |

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

| Other | | | (12.1) | | | | | | (11.1) | | | | | | (23.0) | | |

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

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

| Cash, cash equivalents, and restricted cash at end of year | | | $ | 1,200.2 | | | | | $ | 1,184.4 | | | | | $ | 715.9 | |

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

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

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

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

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| | |

| --- | --- |

| Other schedules are not applicable and have not been submitted. | |

These contingent

February 14, 2020

EDWARDS LIFESCIENCES CORPORATION

| | | | | | | | |

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

| Accounts receivable, net (Note 5) | 543.6 | | | | 456.9 | | |

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

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

| Other operating expenses | — | | | | — | | | | 0.7 | | |

| Special (gains) charges, net (Note 4) | — | | | | (7.1 | | ) | | 50.2 | | |

| Basic | $ | 5.03 | | | $ | 3.45 | | | $ | 2.77 | |

| Diluted | $ | 4.93 | | | $ | 3.38 | | | $ | 2.70 | |

| Basic | 208.3 | | | | 209.2 | | | | 210.9 | | |

| Diluted | 212.2 | | | | 213.6 | | | | 215.9 | | |

| Defined benefit pension plans | (1.9 | | ) | | 0.6 | | | | 3.5 | | |

| Other | 16.2 | | | | 1.4 | | | | 8.4 | | |

| Deposit of cash in escrow | — | | | | — | | | | (25.0 | | ) |

| Other | (24.0 | | ) | | (23.6 | | ) | | (22.5 | | ) |

| BALANCE AT DECEMBER 31, 2016 | 242.6 | | | $ | 242.6 | | | 31.0 | | | $ | (2,499.3 | ) | | $ | 1,167.8 | | | $ | 3,906.3 | | | $ | (198.4 | ) | | $ | 2,619.0 | |

| BALANCE AT JANUARY 1, 2017 | 242.6 | | | 242.6 | | | | 31.0 | | | (2,499.3 | | ) | | 1,167.8 | | | | 3,915.6 | | | | (198.4 | | ) | | 2,628.3 | | |

| Shares issued to acquire business | | | | | | | | (2.8 | ) | | 264.3 | | | | 2.2 | | | | | | | | | | | | 266.5 | | |

| Retirement of treasury stock | (33.6 | ) | | (33.6 | | ) | | (33.6 | ) | | 2,746.2 | | | | (175.5 | | ) | | (2,537.1 | | ) | | | | | | — | | |

The Company includes estimated amounts in the transaction price to the extent it is

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

The Company periodically reviews its investments for impairment.

When the fair value of an investment declines below cost, management uses the following criteria to determine if such a decline should be considered other-than-temporary and result in a recognized loss:

| • | the duration and extent to which the market value has been less than cost; |

| • | the financial condition and near term prospects of the investee/issuer; |

| • | the reasons for the decline in market value; |

| • | the Company's ability and intent to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value; and |

| • | the investee's performance against product development milestones. |

When evaluating its allowances for doubtful accounts related to receivables from customers in certain European countries that have historically paid beyond the stated terms, the Company's analysis considers a number of factors, including evidence of the customer's ability to comply with credit terms, economic conditions, and procedures implemented by the Company to collect the historical receivables.

Additional allowances for doubtful accounts may be required if there is deterioration in past due balances, if economic conditions are less favorable than the Company has anticipated, or for customer-specific circumstances, such as financial difficulty.

The allowance for doubtful accounts related to both short-term and long-term receivables was $14.7 million and $13.6 million at December 31, 2019 and 2018, respectively.

The allowance for excess and slow moving inventory was $42.6 million and $30.3 million at December 31, 2019 and 2018, respectively.

For the purposes of identifying and measuring impairment, long-lived

The Company at times has used interest rate swaps to convert a portion of its fixed-rate debt into variable-rate debt.

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: 2019.][added: 2020.]

Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of December 31, [removed: 2019] [added: 2020] 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: 2019.][added: 2020.]

[added: The effectiveness of the] Company's internal control over financial reporting as of December 31, [removed: 2019] [added: 2020] has been audited by PricewaterhouseCoopers LLP, [removed: an] [added: the] independent registered public accounting [removed: firm,] [added: 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: 2019] [added: 2020] 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.

The effectiveness of the

Certain information required by this Item will be set forth under the headings [removed: "Corporate] [added: "Board of Directors Matters—Proposal 1 - Election of Directors—Board of Director Nominees," "Board of Directors Matters—Corporate] Governance Policies and Practices," [added: and] "Executive Compensation and Other Information—Executive [removed: Officers," and "Other Matters and Business—Additional Information" and "—Delinquent Section 16(a) Reports"] [added: Officers"] in the definitive proxy [removed: materials] [added: statement] to be filed in connection with the Company's [removed: 2020] [added: 2021] Annual Meeting of Stockholders (the "Proxy Statement") (which Proxy Statement will be filed with the SEC within 120 days of December 31, [removed: 2019).][added: 2020).]

The Company has adopted a code of ethics that applies to all directors and employees, including the Company's principal executive officer, principal financial [removed: officer] [added: officer,] and [removed: controller] [added: principal accounting officer,] or persons performing similar functions.

The code of ethics (business practice standards) is posted on the Company's website, which is found at www.edwards.com under [removed: "Investors-Corporate Governance-Corporate Responsibility-Global] [added: "Investors—Corporate governance—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 [removed: heading] [added: headings] "Audit Matters—Fees Paid to Principal Accountants" [added: and "Audit Matters—Pre-Approval of Services"] in the Proxy Statement is incorporated herein by reference.

| Exhibit No. | | [removed: Exhibit No.] | [added: Description | | |]

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

| [removed: 3.2] [added: 3.3] | | [added: |] [Bylaws of Edwards Lifesciences [removed: Corporation amended] [added: 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] and restated as of February 25, 2016 (incorporated by reference to Exhibit 3.1 in Edwards Lifesciences' report on Form [removed: 8-K dated March] [added: 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: | |]

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

| [removed: 4.2] [added: +4.2] | | [added: |] [Description of Edwards Lifesciences Corporation's Capital [removed: Stock](https://www.sec.gov/Archives/edgar/data/1099800/000109980020000005/ex-4210xkq42019.htm)] [added: Stock](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-4210xkq42020.htm)] | [added: | |]

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

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

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

| 4.6 | | [added: |] [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 [removed: 8-K, filed] [added: 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) | [added: | |]

| 10.1 | | [added: |] [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, filed] [added: 8-K](http://www.sec.gov/Archives/edgar/data/1099800/000119312518143174/d579000dex101.htm) [filed] on April 30, 2018)](http://www.sec.gov/Archives/edgar/data/1099800/000119312518143174/d579000dex101.htm) | [added: | |]

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

| *10.3 | | [added: |] [Edwards Lifesciences Corporation Form of Employment Agreement (incorporated by reference to Exhibit 10.8 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended March 31, 2003)](http://www.sec.gov/Archives/edgar/data/1099800/000104746903018615/a2110800zex-10_8.htm) | [added: | |]

| *10.4 | | [added: |] [Edwards Lifesciences Corporation Amended and Restated Employment Agreement for Michael A. [removed: Mussallem dated] [added: 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] 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) | [added: | |]

| *10.5 | | [added: |] [Edwards Lifesciences Corporation Amended and Restated Chief Executive Officer Change-in-Control Severance Agreement, dated October 9, 2012 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended September 30, 2012)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912010132/a2211501zex-10_1.htm) | [added: | |]

| *10.6 | | [added: |] [Edwards Lifesciences Corporation Form of Change-in-Control Severance Agreement (incorporated by reference to Exhibit 10.2 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended September 30, 2012)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912010132/a2211501zex-10_2.htm) | [added: | |]

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

| [removed: *10.8] [added: *10.15] | | [added: |] [Edwards Lifesciences [removed: Corporation Long-Term] [added: 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 Directors] Stock Incentive [removed: Compensation Program, as amended and restated as of February 23, 2017 (incorporated] [added: 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 [removed: to Appendix A] [added: to](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm) [Appendix B] in Edwards [removed: Lifesciences' Definitive] [added: Lifesciences'](https://www.sec.gov/Archives/edgar/data/1099800/000119312520085079/d843930ddef14a.htm) [Definitive] Proxy Statement filed on March [removed: 30, 2017)](http://www.sec.gov/Archives/edgar/data/1099800/000104746917002200/a2231371zdef14a.htm)] [added: 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: | |]

| *10.9 | | [added: |] [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) | [added: | |]

| *10.10 | | [added: |] [Edwards Lifesciences Corporation Form of Participant Restricted Stock Unit Statement and related Long-Term Stock Program Global Restricted Stock Unit Award Agreement for awards granted prior to May 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: | |]

| *10.11 | | [added: |] [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Nonqualified Stock Option Award Agreement for awards granted beginning May 2015 (incorporated by reference to Exhibit 10.3 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: | |]

| *10.12 | | [added: |] [Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program Global Restricted Stock Unit Award Agreement for awards granted beginning May 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: | |]

| *10.13 | | [added: |] [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) | [added: | |]

| *10.14 | | [added: |] [Edwards Lifesciences Corporation Nonemployee Directors Stock Incentive Program, as amended and restated as of February 25, 2016 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended March 31, 2016)](http://www.sec.gov/Archives/edgar/data/1099800/000109980016000053/ex-10110xqq12016.htm) | [added: | |]

| [removed: *10.15] [added: +*10.16] | | [added: |] [Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related Nonemployee Directors Stock Incentive Program Nonqualified Stock Option Award [removed: Agreement (incorporated by reference to Exhibit 10.2 in Edwards Lifesciences' report on Form 10-Q for the quarterly period ended June 30, 2013)](http://www.sec.gov/Archives/edgar/data/1099800/000104746913008139/a2216134zex-10_2.htm)] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-101610xkq42020.htm)] | [added: | |]

| [removed: *10.16] [added: +*10.17] | | [added: |] [Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program Restricted Stock Units [removed: Agreement (incorporated by reference to Exhibit 10.4 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_4.htm)] [added: Agreement](https://www.sec.gov/Archives/edgar/data/1099800/000109980021000007/ex-101710xkq42020.htm)] | [added: | |]

| [removed: *10.17] [added: *10.21] | | [added: |] [Edwards Lifesciences Corporation Form of [removed: Nonemployee Directors Stock Incentive Program Restricted Stock] [added: Indemnification] Agreement (incorporated by reference to Exhibit [removed: 10.5] [added: 10.20] in Edwards Lifesciences' report on Form [removed: 10-Q] [added: 10-K] for the [removed: quarterly period] [added: fiscal year] ended [removed: March] [added: December] 31, [removed: 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746911004794/a2203819zex-10_5.htm)] [added: 2011)](http://www.sec.gov/Archives/edgar/data/1099800/000104746912001617/a2207417zex-10_20.htm)] | [added: | |]