EDWARDS LIFESCIENCES CORPORATION Overview
The following discussion and analysis contains forward-looking statements within the meaning of the federal securities laws, and should be read in conjunction with the disclosures we make concerning risks and other factors that may affect our business and operating results. See "Note Regarding Forward-Looking Statements" preceding Part I, Item 1 in this Quarterly Report on Form 10-Q. We are the global leader in patient-focused medical innovations for structural heart disease and critical care monitoring. Driven by a passion to help patients, we partner with the world's leading clinicians and researchers and invest in research and development to transform care for those impacted by structural heart disease or who require hemodynamic monitoring during surgery or in intensive care. We conduct operations worldwide and are managed in the following geographical regions:United States ,Europe ,Japan , and Rest of World. Our products are categorized into the following areas: Transcatheter Aortic Valve Replacement ("TAVR"), Transcatheter Mitral and Tricuspid Therapies ("TMTT"), Surgical Structural Heart ("Surgical"), and Critical Care. Financial Highlights and Market Update [[Image Removed: ew-20220930_g1.jpg]][[Image Removed: ew-20220930_g2.jpg]] The COVID-19 pandemic has adversely impacted, and may further adversely impact, nearly all aspects of our business and markets, including our workforce and the operations of our customers, suppliers, and business partners. Our priority has been to maintain access for patients to our life-saving technologies while providing continuous front-line support to our clinician partners, and protecting the well-being of our employees. 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. During the first quarter of 2021, COVID-19 stressed the global healthcare system during the winter months. However, we saw strong recovery beginning in the second quarter of 2021 as widespread vaccine adoption contributed to an increased number of patients. However, the Delta variant had a significant impact on hospital resources during the last two months of the third quarter of 2021, especially inthe United States . During the first quarter of 2022, the Omicron variant had a pronounced impact on hospital capacity, resources, and procedure volumes inJanuary 2022 , especially inthe United States . Outsidethe United States , we experienced a less pronounced year-over-year impact from the pandemic. During the second and third quarter of 2022, our sales were impacted by slower than expected improvement inUnited States hospital staffing shortages and foreign currency headwinds. Also, during the third quarter of 2022, we faced COVID headwinds inJapan , which created significant strain on hospital capacity. 26
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Despite the challenging macroeconomic factors, our net sales for the first nine months of 2022 were$4.0 billion , representing an increase of$131.3 million over the first nine months of 2021, driven primarily by sales of our TAVR products. Our gross profit increase in the nine months endedSeptember 30, 2022 was driven by our sales growth and the positive impact of our foreign currency hedging program. The decrease in our diluted earnings per share in the nine months endedSeptember 30, 2022 was driven by a) changes in the fair value of our contingent consideration liabilities, which resulted in a$97.0 million after tax gain in the first nine months of 2021 compared to a$34.0 million after tax gain in the first nine months of 2022, b) an after-tax charge of$53.3 million in the three months endedSeptember 30, 2022 , primarily related to the impairment of intangible assets due to our decision to exit our HARPOON surgical mitral repair system program and c) increased sales and marketing and research and development expenses in 2022. These decreases were partially offset by the aforementioned gross profit increase. We continue to closely monitor the impact of COVID-19 on all aspects of our business and geographies, including its impact on our customers, employees, suppliers, vendors, business partners, and distribution channels. The extent to which 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, outbreak surges in geographic regions in which we operate and their severity (including new and more contagious variants of COVID-19), its severity, the actions to contain the virus or address its impact, the timing, distribution, public acceptance and efficacy of vaccines and other treatments, and the associated impact on economic and operating conditions. Even after the COVID-19 outbreak has subsided, we may continue to experience materially adverse impacts on our financial condition and results of operations. In addition to the impacts described above, the global economy, including the financial and credit markets, has recently experienced extreme volatility and disruptions, including increases to inflation rates, rising interest rates, declines in consumer confidence, declines in economic growth, and uncertainty about economic stability. The severity and duration of the impact of these conditions on our business cannot be predicted. See Item 1A, "Risk Factors," for additional information.
Healthcare Environment, Opportunities, and Challenges
The medical technology industry is highly competitive and continues to evolve. Our success is measured both by the development of innovative products and the value we bring to our stakeholders. We are committed to developing new technologies and providing innovative patient care, and we are committed to defending our intellectual property in support of those developments. Despite the challenges of the COVID-19 pandemic, our dedicated field teams have found creative ways to support physicians, our engineers continued to advance innovation, and our colleagues worked diligently to keep our clinical trials on track. In the first nine months of 2022, we invested 17.7% of our net sales in research and development. Results of OperationsNet Sales by Region (dollars in millions) Three Months Ended Nine Months Ended September 30, Percent September 30, Percent 2022 2021 Change Change 2022 2021 Change Change United States$ 786.8 $ 753.2 $ 33.6 4.4 %$ 2,337.1 $ 2,223.6 $ 113.5 5.1 % Europe 270.1 291.1 (21.0) (7.2) % 884.0 880.9 3.1 0.4 % Japan 104.1 125.9 (21.8) (17.3) % 362.5 390.0 (27.5) (7.1) % Rest of World 158.0 140.0 18.0 12.9 % 450.5 408.3 42.2 10.3 % Outside of the United States 532.2 557.0 (24.8) (4.4) % 1,697.0 1,679.2 17.8 1.1 % Total net sales$ 1,319.0 $ 1,310.2 $ 8.8 0.7 %$ 4,034.1 $ 3,902.8 $ 131.3 3.4 % Net sales outside ofthe United States include the impact of foreign currency exchange rate fluctuations. The impact of foreign currency exchange rate fluctuations on net sales is not necessarily indicative of the impact on net income due to the corresponding effect of foreign currency exchange rate fluctuations on international manufacturing and operating costs, and our hedging activities. 27
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Table of ContentsNet Sales byProduct Group (dollars in millions) Three Months Ended Nine Months Ended September 30, Percent September 30, Percent 2022 2021 Change Change 2022 2021 Change Change Transcatheter Aortic Valve Replacement$ 862.3 $ 857.8 $ 4.5 0.5 %$ 2,650.5 $ 2,551.0 $ 99.5 3.9 % Transcatheter Mitral and Tricuspid Therapies 29.7 22.3 7.4 34.2 % 84.6 60.7 23.9 39.5 % Surgical Structural Heart 219.7 217.4 2.3 1.1 % 669.0 667.8 1.2 0.2 % Critical Care 207.3 212.7 (5.4) (2.6) % 630.0 623.3 6.7 1.1 % Total net sales$ 1,319.0 $ 1,310.2 $ 8.8 0.7 %$ 4,034.1 $ 3,902.8 $ 131.3 3.4 %
Transcatheter Aortic Valve Replacement Sales
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Net sales of TAVR products increased for the three and nine months ended
•higher sales of the Edwards SAPIEN platform in 2022, primarily the Edwards SAPIEN 3 Ultra valve inthe United States andEurope , and the Edwards SAPIEN 3 inJapan ; partially offset by: •foreign currency exchange rate fluctuations, which decreased net sales outside ofthe United States by$44.4 million and$97.1 million for the three and nine months endedSeptember 30, 2022 , respectively, primarily due to the weakening of the Euro and the Japanese yen againstthe United States dollar. During the first nine months of 2022, we continued to advance our EARLY TAVR pivotal trial, studying the treatment of severe aortic stenosis patients before their symptoms develop, and our PROGRESS pivotal trial, studying moderate aortic stenosis patients. During the second quarter of 2022, we began treating patients in our ALLIANCE pivotal trial, studying our next-generation TAVR technology, SAPIEN X4, and during the third quarter of 2022, we announced the launch of the SAPIEN 3 Ultra Resilia valve inthe United States . 28
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Transcatheter Mitral and Tricuspid Therapies Sales
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Net sales of TMTT products increased for the three and nine months ended
DuringAugust 2022 , we received European regulatory approval for PASCAL Precision for patients suffering from mitral and tricuspid regurgitation, and inSeptember 2022 , we receivedUnited States Food and Drug Administration approval for PASCAL Precision for patients with degenerative mitral regurgitation. In mitral replacement, we continued to treat patients with our two transcatheter mitral replacement therapies through the ENCIRCLE pivotal trial for SAPIEN M3 and the MISCEND study for EVOQUE Eos. We also continued to make progress in enrolling the TRISCEND II pivotal trial of the EVOQUE replacement system and the CLASP IITR pivotal trial with the PASCAL repair system in patients with symptomatic, severe tricuspid regurgitation. 29
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Surgical Structural Heart Sales
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Net sales of Surgical products increased for the three and nine months endedSeptember 30, 2022 primarily due to increased sales of the INSPIRIS RESILIA aortic valve, primarily inthe United States andEurope , and the MITRIS RESILIA valve, primarily inthe United States . These increases were partially offset by the impact of foreign currency exchange rate fluctuations, which decreased net sales outside ofthe United States by$14.7 million and$32.1 million for the three and nine months endedSeptember 30, 2022 , respectively, primarily due to the weakening of the Euro and the Japanese yen againstthe United States dollar. InMarch 2022 , we receivedUnited States Food and Drug Administration approval for the MITRIS RESILIA valve and initiated the product launch inthe United States inApril 2022 . MITRIS RESILIA is a tissue valve replacement specifically designed for the heart's mitral position and incorporates our advanced RESILIA technology. 30
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Critical Care Sales
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Net sales of Critical Care products decreased for the three months ended
•increased demand for our enhanced surgical recovery products and pressure
monitoring products, primarily in
partially offset by:
•foreign currency exchange rate fluctuations, which decreased net sales outside ofthe United States by$11.7 million and$25.8 million for the three and nine months endedSeptember 30, 2022 , respectively, primarily due to the weakening of the Japanese yen and the Euro againstthe United States dollar. 31
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Gross Profit [[Image Removed: ew-20220930_g7.jpg]] The increase in gross profit as a percentage of net sales for the three and nine months endedSeptember 30, 2022 was driven by a 4.4 percentage point and 3.6 percentage point increase for the three and nine months endedSeptember 30, 2022 , respectively, from the impact of our foreign currency hedging program, which includes hedge contract gains and natural hedges (primarily the strengthening ofthe United States dollar against the Japanese yen and the Euro). Selling, General, and Administrative ("SG&A") Expenses [[Image Removed: ew-20220930_g8.jpg]] SG&A expenses increased for the three and nine months endedSeptember 30, 2022 primarily due to a resumption of in-person commercial activities and higher field-based personnel-related costs, primarily TAVR and TMTT inthe United States . Foreign currency exchange rate fluctuations decreased expenses by$21.0 million and$43.4 million for the three and nine months endedSeptember 30, 2022 , respectively, primarily due to the strengthening ofthe United States dollar against the Euro and the Japanese yen. 32
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Research and Development ("R&D") Expenses
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R&D expenses increased for the nine months ended September 30, 2022 primarily
due to continued investments in our transcatheter innovations, including
increased clinical trial activity. R&D expenses decreased during the three
months ended September 30, 2022 primarily driven by lower performance-based
compensation expenses and certain non-recurring expenses in the prior year
period which more than offset the aforementioned investments in our
transcatheter innovations.
Change in Fair Value of Contingent Consideration Liabilities, net
The change in fair value of contingent consideration liabilities resulted in gains of$12.5 million and$36.3 million for the three and nine months endedSeptember 30, 2022 , respectively, and expense of$1.1 million and a gain of$106.0 million for three and nine months endedSeptember 30, 2021 , respectively. The gains in 2022 were due to changes in projected probabilities of milestone achievement and our decision in the third quarter of 2022 to exit our HARPOON surgical mitral repair system program. The gain in the nine months endedSeptember 30, 2021 was due to changes in the projected probabilities and timing of milestone achievements and the projected timing of cash inflows. The expense in the three months endedSeptember 30, 2021 was due to the accretion of interest due to the passage of time. For further information, see Note 3 and Note 7 to the "Consolidated Condensed Financial Statements."
Special Charge
InSeptember 2022 , we decided to exit our HARPOON surgical mitral repair system program. As a result, we recorded a charge of$68.4 million , of which$66.8 million was included in "Special Charge" and$1.6 million was included in "Cost of Sales" on the consolidated condensed statements of operations. The charge primarily related to the full impairment of intangible assets associated with the technology and other related exit costs. We believe that no additional contingent consideration is due and, inSeptember 2022 , recorded an$11.7 million contingent consideration gain associated with the exit. Other Expense (Income), net (in millions) Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Foreign exchange losses (gains), net$ 1.0 $ (0.7) $ 5.3 $ (5.1) Gain on insurance settlement - - (3.8) - Loss (gain) on investments 0.6 (0.5) 0.7 (4.6) Other 0.4 (0.2) (1.2) (1.6) Other expense (income), net$ 2.0 $ (1.4) $ 1.0 $ (11.3) 33
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The net foreign exchange losses (gains) relate to the foreign currency fluctuations primarily in our global trade and intercompany receivable and payable balances, partially offset by the gains and losses on foreign currency derivative instruments.
The gain on insurance settlement in the nine months ended
The loss (gain) on investments primarily represents our net share of gains and losses in investments accounted for under the equity method, and realized gains and losses on investments in equity securities.
Provision for Income Taxes
The provision for income taxes consists of provisions for federal, state, and foreign income taxes. We operate in an international environment with significant operations in various locations outsidethe United States which have statutory tax rates typically lower thanthe United States tax rate. Accordingly, the consolidated income tax rate is a composite rate reflecting the earnings in the various locations and the applicable rates. Our effective income tax rate was 15.7% and 13.0% for the three months endedSeptember 30, 2022 and 2021, respectively, and 14.1% and 11.9% for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase in the effective rate between the nine months endedSeptember 30, 2022 and 2021 was primarily due to a reduced tax benefit from employee share-based compensation and the estimated impact ofU.S. foreign tax credit regulations published by theU.S. Treasury onJanuary 4, 2022 . These regulations limit the amount of foreign taxes that are creditable againstU.S. income taxes. In addition, the effective rates for the nine months endedSeptember 30, 2022 and 2021 were lower than the federal statutory rate of 21% primarily due to (1) foreign earnings taxed at lower rates, (2) Federal andCalifornia research and development credits, and (3) the tax benefit from employee share-based compensation. In the normal course of business, the Internal Revenue Service ("IRS") and other taxing authorities are in different stages of examining various years of our tax filings. During these audits we may receive proposed audit adjustments that could be material. Therefore, there is a possibility that an adverse outcome in these audits could have a material effect on our results of operations and financial condition. We strive to resolve open matters with each tax authority at the examination level and could reach agreement with a tax authority at any time. While we have accrued for matters we believe are more likely than not to require settlement, the eventual outcome with a tax authority may result in a tax liability that is more or less than that reflected in the consolidated condensed financial statements. Furthermore, we may later decide to challenge any assessments, if made, and may exercise our right to appeal. The uncertain tax positions are reviewed quarterly and adjusted as events occur that affect potential liabilities for additional taxes, such as lapsing of applicable statutes of limitations, proposed assessments by tax authorities, negotiations between tax authorities, identification of new issues, and issuance of new legislation, regulations, or case law. We executed an Advance Pricing Agreement ("APA") in 2018 betweenthe United States andSwitzerland governments for tax years 2009 through 2020 covering various, but not all, transfer pricing matters. The unagreed transfer pricing matters, namely Surgical Structural Heart and Transcatheter Aortic Valve Replacement (collectively "Surgical/TAVR") intercompany royalty transactions, then reverted toIRS Examination for further consideration as part of the respective years' regular tax audits. In addition, we executed other bilateral APAs as follows: during 2017, an APA betweenthe United States andJapan covering tax years 2015 through 2019; and during 2018, APAs betweenJapan andSingapore and betweenSwitzerland andJapan covering tax years 2015 through 2019. We have filed to renew all the APAs which cover transactions withJapan for the years 2020 and forward. The execution of some or all these APA renewals depends on many variables outside of our control. AtSeptember 30, 2022 , all material state, local, and foreign income tax matters have been concluded for years through 2015. While not material, we continue to address matters inIndia for years from 2010. The audits of ourUnited States federal income tax returns through 2014 have been closed. TheIRS audit field work for the 2015 through 2017 tax years was substantially completed during the fourth quarter of 2020, except for transfer pricing and related matters. TheIRS began its examination of the 2018 through 2020 tax years during the first quarter of 2022. During 2021, we received a Notice of Proposed Adjustment ("NOPA") from theIRS for the 2015-2017 tax years relating to transfer pricing involving certain Surgical/TAVR intercompany royalty transactions between ourUnited States andSwitzerland subsidiaries. The NOPA proposes an increase to ourUnited States taxable income, which could result in additional tax expense for this period of approximately$200 million and represents a significant change to previously agreed upon transfer 34
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pricing methodologies for these types of transactions. We have formally disagreed with the NOPA and submitted a formal protest on the matter during the fourth quarter of 2021. During the second quarter of 2022, we received theIRS's rebuttal to our protest and were notified that the case had been transferred to theIRS Independent Office of Appeals . We continue to evaluate all possible remedies available to us, which could take several years to resolve. No payment of any amount related to the NOPA is required to be made, if at all, until all applicable proceedings have been completed. We believe the amounts previously accrued related to this uncertain tax position are sufficient and, accordingly, have not accrued any additional amount based on the NOPA received. Certain Surgical/TAVR intercompany royalty transactions covering tax years 2015-2022 that were not resolved under the APA program remain subject toIRS examination, and those transactions and related tax positions remain uncertain as ofSeptember 30, 2022 . We have considered this information, as well as information regarding the NOPA and rebuttal described above, in our evaluation of our uncertain tax positions. The impact of these unresolved transfer pricing matters, net of any correlative repatriation tax adjustment, may be significant to our consolidated condensed financial statements. Based on the information currently available and numerous possible outcomes, we cannot reasonably estimate what, if any, changes in our existing uncertain tax positions may occur in the next 12 months and, therefore, have continued to record the uncertain tax positions as a long-term liability. OnAugust 16, 2022 , the Inflation Reduction Act of 2022 ("IRA") was signed into law. The IRA includes, among other provisions, changes to theU.S. corporate income tax system, including a 15% minimum tax based on "adjusted financial statement income," which is effective for tax years beginning afterDecember 31, 2022 , and a one percent excise tax on net repurchases of stock afterDecember 31, 2022 . While we continue to evaluate the IRA and its application to our business, we do not expect the IRA will have a material impact on our consolidated financial statements.
Liquidity and Capital Resources
Our sources of cash liquidity include cash and cash equivalents, short-term investments, cash from operations, and amounts available under credit facilities. We believe that these sources are sufficient to fund the current and long-term requirements of working capital, capital expenditures, and other financial commitments. However, we periodically consider various financing alternatives and may, from time to time, seek to take advantage of favorable interest rate environments or other market conditions. As ofSeptember 30, 2022 , cash and cash equivalents and short-term investments held inthe United States and outside ofthe United States were$1,051.3 million and$687.4 million , respectively. We had a Five-Year Credit Agreement (the "Prior Credit Agreement") which was scheduled to mature onApril 28, 2023 and provided up to an aggregate of$750.0 million in borrowings in multiple currencies. InJuly 2022 , we entered into a new Five-Year Credit Agreement (the "New Credit Agreement") which provides for a$750.0 million multi-currency unsecured revolving credit facility and replaced the Prior Credit Agreement. The New Credit Agreement matures onJuly 15, 2027 . We may increase the amount available under the New Credit Agreement by up to an additional$250.0 million in the aggregate and extend the maturity date for an additional year, subject to agreement of the lenders. As ofSeptember 30, 2022 , no amounts were outstanding under the New Credit Agreement. For further information, see Note 6 to the "Consolidated Condensed Financial Statements." InJune 2018 , we issued$600.0 million of 4.3% fixed-rate unsecured senior notes (the "2018 Notes") dueJune 15, 2028 . As ofSeptember 30, 2022 , the carrying value of the 2018 Notes was$596.2 million . From time to time, we repurchase shares of our common stock under share repurchase programs authorized by the Board of Directors. We consider several factors in determining when to execute share repurchases, including, among other things, expected dilution from stock plans, cash capacity, and the market price of our common stock. During the nine months endedSeptember 30, 2022 , under the Board authorized repurchase program, we repurchased a total of 8.3 million shares at an aggregate cost of$844.9 million . See Part II, Item 2, "Unregistered Sales ofEquity Securities and Use of Proceeds," for additional information about our share repurchase program. As ofSeptember 30, 2022 , we had remaining authority to purchase$1,781.6 million of our common stock under the share repurchase program. AtSeptember 30, 2022 , there had been no material changes in our cash requirements from known contractual and other obligations, including commitments for capital expenditures, as disclosed in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," of our Annual Report on Form 10-K for the year endedDecember 31, 2021 . 35
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Consolidated Cash Flows - For the nine months ended
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Net cash flows provided by operating activities of$935.4 million for the nine months endedSeptember 30, 2022 decreased$423.1 million over the same period last year primarily due to a higher bonus payout in 2022 associated with 2021 performance, an increase in inventory builds compared to the prior year, and an increase in tax payments. Net cash provided by investing activities of$157.6 million for the nine months endedSeptember 30, 2022 consisted primarily of net proceeds from investments of$474.7 million , partially offset by capital expenditures of$175.7 million and payments of$107.6 million for options to acquire other companies. For further information, see Note 5 to the "Consolidated Condensed Financial Statements."
Net cash used in investing activities of
Net cash used in financing activities of
Net cash used in financing activities of
Critical Accounting Policies and Estimates
The consolidated condensed financial statements have been prepared in accordance with accounting principles generally accepted inthe United States which require us to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated condensed financial statements and revenues and expenses during the periods reported. Actual results could differ from those estimates. Information with respect to our critical accounting policies and estimates which we believe could have the most significant effect on our reported results and require subjective or complex judgments by management is contained on pages 34-36 in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," of our Annual Report on Form 10-K for the year endedDecember 31, 2021 . There have been no significant changes from the information discussed therein.
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