filings.toolsEdwards Lifesciences 10-Q 2022-09-30
Filed 2022-10-28. 7 sections, 184K characters. Original on sec.gov · Markdown · JSON
Cover and table of contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| ☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended September 30, 2022
or
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-15525
EDWARDS LIFESCIENCES CORPORATION
(Exact name of registrant as specified in its charter)
| Delaware | 36-4316614 | |||||||||||||
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
One Edwards Way
Irvine, California 92614
(Address of principal executive offices and zip code)
(949) 250-2500
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
| Common Stock, par value $1.00 per share | EW | New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☒ | Accelerated filer | ☐ | Non-accelerated filer | ☐ | Smaller reporting company | ☐ | Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares outstanding of the registrant's common stock, $1.00 par value, as of October 24, 2022 was 618,260,499.
EDWARDS LIFESCIENCES CORPORATION
FORM 10-Q
For the quarterly period ended September 30, 2022
TABLE OF CONTENTS
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We intend the forward-looking statements contained in this report to be covered by the safe harbor provisions of such Acts. Statements other than statements of historical or current fact in this report or referred to or incorporated by reference into this report are "forward-looking statements" for purposes of these sections. These statements include, among other things, the expected impact of COVID-19 on our business, any predictions, opinions, expectations, plans, strategies, objectives and any statements of assumptions underlying any of the foregoing relating to the company's current and future business and operations, including, but not limited to, financial matters, development activities, clinical trials and regulatory matters, manufacturing and supply operations, and product sales and demand. These statements can sometimes be identified by the use of the forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "goal," "continue," "seek," "pro forma," "forecast," "intend," "guidance," "optimistic," "aspire," "confident," other forms of these words or similar words or expressions or the negative thereof. Statements of past performance, efforts, or results about which inferences or assumptions may be made can also be forward-looking statements and are not indicative of future performance or results; these statements can be identified by the use of words such as "preliminary," "initial," diligence," "industry-leading," "compliant," "indications," or "early feedback" or other forms of these words or similar words or expressions or the negative thereof. These forward-looking statements are subject to substantial risks and uncertainties that could cause our results or future business, financial condition, results of operations or performance to differ materially from our historical results or experiences or those expressed or implied in any forward-looking statements contained in this report. 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 United States Food and Drug Administration and other regulatory agencies; changes to tax laws; unexpected impacts or expenses of litigation or internal or government investigations; and other risks detailed under “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2021, 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. These forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If we do update or correct one or more of these statements, investors and others should not conclude that we will make additional updates or corrections.
Unless otherwise indicated or otherwise required by the context, the terms "we," "our," "it," "its," "Company," "Edwards," and "Edwards Lifesciences" refer to Edwards Lifesciences Corporation and its subsidiaries.
Part I. Financial Information
Item 1. Financial Statements
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED BALANCE SHEETS
(in millions, except par value; unaudited)
| September 30, 2022 | December 31, 2021 | ||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 1,247.8 | $ | 862.8 | |||||||
| Short-term investments (Note 4) | 490.9 | 604.0 | |||||||||
| Accounts receivable, net of allowances of $7.5 and $9.3, respectively | 618.1 | 582.2 | |||||||||
| Other receivables | 43.3 | 82.7 | |||||||||
| Inventories (Note 2) | 757.8 | 726.7 | |||||||||
| Prepaid expenses | 88.4 | 85.2 | |||||||||
| Other current assets | 267.6 | 237.1 | |||||||||
| Total current assets | 3,513.9 | 3,180.7 | |||||||||
| Long-term investments (Note 4) | 1,381.0 | 1,834.2 | |||||||||
| Property, plant, and equipment, net | 1,566.4 | 1,546.6 | |||||||||
| Operating lease right-of-use assets | 87.7 | 92.1 | |||||||||
| Goodwill | 1,158.7 | 1,167.9 | |||||||||
| Other intangible assets, net (Note 3) | 266.5 | 323.6 | |||||||||
| Deferred income taxes | 347.5 | 246.7 | |||||||||
| Other assets (Note 5) | 316.5 | 110.8 | |||||||||
| Total assets | $ | 8,638.2 | $ | 8,502.6 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 154.9 | $ | 204.5 | |||||||
| Accrued and other liabilities (Note 2) | 739.5 | 802.3 | |||||||||
| Operating lease liabilities | 23.5 | 25.5 | |||||||||
| Total current liabilities | 917.9 | 1,032.3 | |||||||||
| Long-term debt | 596.2 | 595.7 | |||||||||
| Contingent consideration liabilities (Note 7) | 25.7 | 62.0 | |||||||||
| Taxes payable | 142.9 | 190.0 | |||||||||
| Operating lease liabilities | 67.1 | 69.1 | |||||||||
| Uncertain tax positions | 295.6 | 259.0 | |||||||||
| Litigation settlement accrual (Note 2) | 153.9 | 191.3 | |||||||||
| Other liabilities | 221.1 | 267.3 | |||||||||
| Total liabilities | 2,420.4 | 2,666.7 | |||||||||
| Commitments and contingencies (Note 11) | |||||||||||
| Stockholders' equity | |||||||||||
| Preferred stock, $0.01 par value, authorized 50.0 shares, no shares outstanding | — | — | |||||||||
| Common stock, $1.00 par value, 1,050.0 shares authorized, 645.7 and 642.0 shares issued, and 619.4 and 624.1 shares outstanding, respectively | 645.7 | 642.0 | |||||||||
| Additional paid-in capital | 1,914.5 | 1,700.4 | |||||||||
| Retained earnings | 7,191.6 | 6,068.1 | |||||||||
| Accumulated other comprehensive loss (Note 12) | (256.0) | (157.7) | |||||||||
| Treasury stock, at cost, 26.3 and 17.9 shares, respectively | (3,278.0) | (2,416.9) | |||||||||
| Total stockholders' equity | 6,217.8 | 5,835.9 | |||||||||
| Total liabilities and stockholders' equity | $ | 8,638.2 | $ | 8,502.6 |
The accompanying notes are an integral part of these
consolidated condensed financial statements.
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(in millions, except per share information; unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Net sales | $ | 1,319.0 | $ | 1,310.2 | $ | 4,034.1 | $ | 3,902.8 | |||||||||||||||
| Cost of sales | 253.8 | 311.7 | 822.5 | 939.4 | |||||||||||||||||||
| Gross profit | 1,065.2 | 998.5 | 3,211.6 | 2,963.4 | |||||||||||||||||||
| Selling, general, and administrative expenses | 377.3 | 364.4 | 1,156.6 | 1,069.7 | |||||||||||||||||||
| Research and development expenses | 233.6 | 238.0 | 713.0 | 670.3 | |||||||||||||||||||
| Intellectual property litigation (income) expenses, net | (2.4) | 4.7 | 10.8 | 13.5 | |||||||||||||||||||
| Change in fair value of contingent consideration liabilities, net (Note 7) | (12.5) | 1.1 | (36.3) | (106.0) | |||||||||||||||||||
| Special charge (Note 3) | 66.8 | — | 66.8 | — | |||||||||||||||||||
| Operating income | 402.4 | 390.3 | 1,300.7 | 1,315.9 | |||||||||||||||||||
| Interest (income) expense, net | (6.9) | 0.8 | (8.4) | 1.5 | |||||||||||||||||||
| Other expense (income), net | 2.0 | (1.4) | 1.0 | (11.3) | |||||||||||||||||||
| Income before provision for income taxes | 407.3 | 390.9 | 1,308.1 | 1,325.7 | |||||||||||||||||||
| Provision for income taxes | 63.8 | 50.8 | 184.6 | 157.9 | |||||||||||||||||||
| Net income | $ | 343.5 | $ | 340.1 | $ | 1,123.5 | $ | 1,167.8 | |||||||||||||||
| Share information (Note 13) | |||||||||||||||||||||||
| Earnings per share: | |||||||||||||||||||||||
| Basic | $ | 0.55 | $ | 0.55 | $ | 1.81 | $ | 1.87 | |||||||||||||||
| Diluted | $ | 0.55 | $ | 0.54 | $ | 1.79 | $ | 1.85 | |||||||||||||||
| Weighted-average number of common shares outstanding: | |||||||||||||||||||||||
| Basic | 619.8 | 623.6 | 621.0 | 623.0 | |||||||||||||||||||
| Diluted | 624.5 | 631.7 | 626.9 | 631.0 |
The accompanying notes are an integral part of these
consolidated condensed financial statements.
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME
(in millions; unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Net income | $ | 343.5 | $ | 340.1 | $ | 1,123.5 | $ | 1,167.8 | |||||||||||||||
| Other comprehens |
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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
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
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 in the United States.
During the first quarter of 2022, the Omicron variant had a pronounced impact on hospital capacity, resources, and procedure volumes in January 2022, especially in the United States. Outside the 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 in United States hospital staffing shortages and foreign currency headwinds. Also, during the third quarter of 2022, we faced COVID headwinds in Japan, which created significant strain on hospital capacity.
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 ended September 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 ended September 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 ended September 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 Operations
Net Sales by Region
(dollars in millions)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| Percent Change | Percent Change | ||||||||||||||||||||||||||||||||||||||||||||||
| 2022 | 2021 | Change | 2022 | 2021 | 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 of the 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.
Net Sales by Product Group
(dollars in millions)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| Percent Change | Percent Change | ||||||||||||||||||||||||||||||||||||||||||||||
| 2022 | 2021 | Change | 2022 | 2021 | 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
Net sales of TAVR products increased for the three and nine months ended September 30, 2022 driven by:
- higher sales of the Edwards SAPIEN platform in 2022, primarily the Edwards SAPIEN 3 Ultra valve in the United States and Europe, and the Edwards SAPIEN 3 in Japan;
partially offset by:
- foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by $44.4 million and $97.1 million for the three and nine months ended September 30, 2022, respectively, primarily due to the weakening of the Euro and the Japanese yen against the 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 in the United States*.*
Transcatheter Mitral and Tricuspid Therapies Sales
Net sales of TMTT products increased for the three and nine months ended September 30, 2022 primarily due to continued adoption of our PASCAL system in Europe.
During August 2022, we received European regulatory approval for PASCAL Precision for patients suffering from mitral and tricuspid regurgitation, and in September 2022, we received United 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.
Surgical Structural Heart Sales
Net sales of Surgical products increased for the three and nine months ended September 30, 2022 primarily due to increased sales of the INSPIRIS RESILIA aortic valve, primarily in the United States and Europe, and the MITRIS RESILIA valve, primarily in the United States. These increases were partially offset by the impact of foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by $14.7 million and $32.1 million for the three and nine months ended September 30, 2022, respectively, primarily due to the weakening of the Euro and the Japanese yen against the United States dollar.
In March 2022, we received United States Food and Drug Administration approval for the MITRIS RESILIA valve and initiated the product launch in the United States in April 2022. MITRIS RESILIA is a tissue valve replacement specifically designed for the heart's mitral position and incorporates our advanced RESILIA technology.
Critical Care Sales
Net sales of Critical Care products decreased for the three months ended September 30, 2022 and increased for the nine months ended September 30, 2022 primarily due to:
- increased demand for our enhanced surgical recovery products and pressure monitoring products, primarily in the United States;
partially offset by:
- foreign currency exchange rate fluctuations, which decreased net sales outside of the United States by $11.7 million and $25.8 million for the three and nine months ended September 30, 2022, respectively, primarily due to the weakening of the Japanese yen and the Euro against the United States dollar.
Gross Profit
The increase in gross profit as a percentage of net sales for the three and nine months ended September 30, 2022 was driven by a 4.4 percentage point and 3.6 percentage point increase for the three and nine months ended September 30, 2022, respectively, from the impact of our foreign currency hedging program, which includes hedge contract gains and natural hedges (primarily the strengthening of the United States dollar against the Japanese yen and the Euro).
Selling, General, and Administrative ("SG&A") Expenses
SG&A expenses increased for the three and nine months ended September 30, 2022 primarily due to a resumption of in-person commercial activities and higher field-based personnel-related costs, primarily TAVR and TMTT in the United States. Foreign currency exchange rate fluctuations decreased expenses by $21.0 million and $43.4 million for the three and nine months ended September 30, 2022, respectively, primarily due to the strengthening of the United States dollar against the Euro and the Japanese yen.
Research and Development ("R&D") Expenses
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 ended September 30, 2022, respectively, and expense of $1.1 million and a gain of $106.0 million for three and nine months ended September 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 ended September 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 ended September 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
In September 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, in September 2022, recorded an $11.7 million contingent consideration gain associated with the exit.
Other Expense (Income), net
(in millions)
| Three Months Ended September 30, | Nine Months Ended 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) |
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 September 30, 2022 relates to an insurance recovery for damaged cargo shipments of heart valves.
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 outside the United States which have statutory tax rates typically lower than the 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 ended September 30, 2022 and 2021, respectively, and 14.1% and 11.9% for the nine months ended September 30, 2022 and 2021, respectively. The increase in the effective rate between the nine months ended September 30, 2022 and 2021 was primarily due to a reduced tax benefit from employee share-based compensation and the estimated impact of U.S. foreign tax credit regulations published by the U.S. Treasury on January 4, 2022. These regulations limit the amount of foreign taxes that are creditable against U.S. income taxes. In addition, the effective rates for the nine months ended September 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 and California 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 between the United States and Switzerland 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 to IRS 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 between the United States and Japan covering tax years 2015 through 2019; and during 2018, APAs between Japan and Singapore and between Switzerland and Japan covering tax years 2015 through 2019. We have filed to renew all the APAs which cover transactions with Japan for the years 2020 and forward. The execution of some or all these APA renewals depends on many variables outside of our control.
At September 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 in India for years from 2010.
The audits of our United States federal income tax returns through 2014 have been closed. The IRS 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. The IRS 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 the IRS for the 2015-2017 tax years relating to transfer pricing involving certain Surgical/TAVR intercompany royalty transactions between our United States and Switzerland subsidiaries. The NOPA proposes an increase to our United 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
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 the IRS's rebuttal to our protest and were notified that the case had been transferred to the IRS 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 to IRS examination, and those transactions and related tax positions remain uncertain as of September 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.
On August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law. The IRA includes, among other provisions, changes to the U.S. corporate income tax system, including a 15% minimum tax based on “adjusted financial statement income,” which is effective for tax years beginning after December 31, 2022, and a one percent excise tax on net repurchases of stock after December 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 of September 30, 2022, cash and cash equivalents and short-term investments held in the United States and outside of the 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 on April 28, 2023 and provided up to an aggregate of $750.0 million in borrowings in multiple currencies. In July 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 on July 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 of September 30, 2022, no amounts were outstanding under the New Credit Agreement. For further information, see Note 6 to the "Consolidated Condensed Financial Statements."
In June 2018, we issued $600.0 million of 4.3% fixed-rate unsecured senior notes (the "2018 Notes") due June 15, 2028. As of September 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 ended September 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 of Equity Securities and Use of Proceeds,” for additional information about our share repurchase program. As of September 30, 2022, we had remaining authority to purchase $1,781.6 million of our common stock under the share repurchase program.
At September 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 ended December 31, 2021.
Consolidated Cash Flows - For the nine months ended September 30, 2022 and 2021:
Net cash flows provided by operating activities of $935.4 million for the nine months ended September 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 ended September 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 $756.6 million for the nine months ended September 30, 2021 consisted primarily of net purchases of investments of $507.6 million and capital expenditures of $236.0 million.
Net cash used in financing activities of $746.1 million for the nine months ended September 30, 2022 consisted primarily of purchases of treasury stock of $861.1 million, partially offset by proceeds from stock plans of $118.9 million.
Net cash used in financing activities of $294.3 million for the nine months ended September 30, 2021 consisted primarily of purchases of treasury stock of $416.3 million, partially offset by proceeds from stock plans of $124.7 million.
Critical Accounting Policies and Estimates
The consolidated condensed financial statements have been prepared in accordance with accounting principles generally accepted in the 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 ended December 31, 2021. There have been no significant changes from the information discussed therein.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk, Foreign Currency Risk, Credit Risk, and Concentrations of Risk
For a complete discussion of our exposure to interest rate risk, foreign currency risk, credit risk, and concentrations of risk, refer to Item 7A "Quantitative and Qualitative Disclosures About Market Risk" in our Annual Report on Form 10-K for the year ended December 31, 2021. There have been no material changes from the information discussed therein.
Investment Risk
We are exposed to investment risks related to changes in the underlying financial condition and credit capacity of certain of our investments. As of September 30, 2022, we had $1.8 billion of investments in debt securities of various companies, of which $1.3 billion were long-term. In addition, we had $108.9 million of investments in equity instruments of public and private companies. Should these companies experience a decline in financial performance, financial condition, or credit capacity, or fail to meet certain development milestones, including as a result of the impact of COVID-19 or interest rate fluctuations on their business or operations or otherwise, a decline in the investments' value may occur, resulting in unrealized or realized losses.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures. Our management, including the Chief Executive Officer and the Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our 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 September 30, 2022. Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of September 30, 2022 that our disclosure controls and procedures are designed at a reasonable assurance level and effective in providing reasonable assurance that the information we are required to disclose in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission's rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting. There have been no changes in our internal control over financial reporting during the quarter ended September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part II. Other Information
Item 1. Legal Proceedings
We are reviewing and investigating whether business activities in Japan and other markets violate certain provisions of the Foreign Corrupt Practices Act ("FCPA"). We voluntarily notified the United States Securities and Exchange Commission ("SEC") and the United States Department of Justice ("DOJ") during 2021 that we have engaged outside counsel to conduct this review and investigation. We have provided status updates to the SEC and DOJ since that time. Any determination that our operations or activities are not in compliance with existing laws, including the FCPA, could result in the imposition of fines, penalties, and equitable remedies. We cannot currently predict the outcome of the review and investigation or the potential impact on our financial statements.
On September 28, 2021, Aortic Innovations LLC, a non-practicing entity, filed a lawsuit against Edwards Lifesciences Corporation and certain of its subsidiaries (“Edwards”) in the United States District Court for the District of Delaware alleging that Edwards’ SAPIEN 3 Ultra product infringes certain of its patents. We are unable to predict the ultimate outcome of this matter or estimate a range of possible exposure; therefore, no amount has been accrued. We believe the claims to be without merit and will vigorously defend ourselves in this litigation.
We are subject to various environmental laws and regulations both within and outside of the United States. Our operations, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. While it is difficult to quantify the potential impact of continuing compliance with environmental protection laws, management believes that such compliance will not have a material impact on our financial results. Our threshold for disclosing material environmental legal proceedings involving a governmental authority where potential monetary sanctions are involved is $1 million. On May 26, 2022, we received a “show cause” letter from the Environmental Protection Agency ("EPA") for alleged violations of the Resource Conservation and Recovery Act hazardous waste management requirements at our Irvine facility. Based on our current assessment of the matter, including our belief regarding potential immaterial monetary sanctions, we will not provide disclosures regarding this matter in the future.
Item 1A. Risk Factors
A description of the risk factors associated with our business is contained in the “Risk Factors” section of our Annual Report on Form 10-K for our fiscal year ended December 31, 2021. There have been no material changes to our risk factors as previously reported.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer Purchases of Equity Securities
| Period | Total Number of Shares (or Units) Purchased (a) | Average Price Paid per Share (or Unit) | Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs (in millions) (b) | |||||||||||||||||||||||||||||||
| July 1, 2022 through July 31, 2022 | 75,873 | $ | 95.42 | 70,808 | $ | 1,873.3 | |||||||||||||||||||||||||||||
| August 1, 2022 through August 31, 2022 | 235,913 | 96.98 | 235,913 | 1,850.4 | |||||||||||||||||||||||||||||||
| September 1, 2022 through September 30, 2022 | 822,174 | 85.38 | 808,228 | 1,781.6 | |||||||||||||||||||||||||||||||
| Total | 1,133,960 | 88.46 | 1,114,949 | ||||||||||||||||||||||||||||||||
(a) The difference between the total number of shares (or units) purchased and the total number of shares (or units) purchased as part of publicly announced plans or programs is due to shares withheld by us to satisfy tax withholding obligations in connection with the vesting of restricted stock units issued to employees.
(b) On May 4, 2021, the Board of Directors approved a stock repurchase program providing for up to $1.0 billion of repurchases of our common stock. In July 2022, the Board of Directors approved an additional $1.5 million of repurchases of our common stock under this program, effective July 28, 2022. Repurchases under the program may be made on the open market, including pursuant to a Rule 10b5-1 plan, and in privately negotiated transactions. The repurchase program does not have an expiration date.
Item 6. Exhibits
The exhibits listed in the Exhibit Index below are filed, furnished, or incorporated by reference as part of this report on Form 10-Q.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| EDWARDS LIFESCIENCES CORPORATION | |||||||||||
| (Registrant) | |||||||||||
| Date: | October 28, 2022 | By: | /s/ SCOTT B. ULLEM | ||||||||
| Scott B. Ullem Chief Financial Officer (Principal Financial Officer; Duly Authorized Officer) | |||||||||||
| Date: | October 28, 2022 | By: | /s/ ROBERT W.A. SELLERS | ||||||||
| Robert W.A. Sellers Corporate Controller (Principal Accounting Officer) |