Edwards Lifesciences Corp 10-Q for FY2022 Q3
Edwards Lifesciences Corp (EW)
10-Q
2022-10-28
For: 2022-09-30
View Original
Added on
April 09, 2026
About this 10-Q
Edwards Lifesciences Corp filed this 10-Q on October 28, 2022, covering the quarter ended September 30, 2022 (FY2022 Q3).
Headline figures
Quarter ended September 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $1.32B
- up 0.7% from $1.31B a year earlier
- Diluted EPS
- $0.55
- up 1.9% from $0.54 a year earlier
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
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||||||||||
(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 | ||||||
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.
| ☒ | 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
Page Number | ||||||||
Item 6. | ||||||||
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 | $ | $ | |||||||||
| Short-term investments (Note 4) | |||||||||||
Accounts receivable, net of allowances of $ | |||||||||||
| Other receivables | |||||||||||
| Inventories (Note 2) | |||||||||||
| Prepaid expenses | |||||||||||
| Other current assets | |||||||||||
| Total current assets | |||||||||||
| Long-term investments (Note 4) | |||||||||||
| Property, plant, and equipment, net | |||||||||||
| Operating lease right-of-use assets | |||||||||||
| Goodwill | |||||||||||
| Other intangible assets, net (Note 3) | |||||||||||
| Deferred income taxes | |||||||||||
| Other assets (Note 5) | |||||||||||
| Total assets | $ | $ | |||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued and other liabilities (Note 2) | |||||||||||
| Operating lease liabilities | |||||||||||
Total current liabilities | |||||||||||
| Long-term debt | |||||||||||
| Contingent consideration liabilities (Note 7) | |||||||||||
| Taxes payable | |||||||||||
| Operating lease liabilities | |||||||||||
| Uncertain tax positions | |||||||||||
| Litigation settlement accrual (Note 2) | |||||||||||
| Other liabilities | |||||||||||
| Total liabilities | |||||||||||
| Commitments and contingencies (Note 11) | |||||||||||
| Stockholders' equity | |||||||||||
Preferred stock, $ | |||||||||||
Common stock, $ | |||||||||||
| Additional paid-in capital | |||||||||||
| Retained earnings | |||||||||||
| Accumulated other comprehensive loss (Note 12) | ( | ( | |||||||||
Treasury stock, at cost, | ( | ( | |||||||||
| Total stockholders' equity | |||||||||||
| Total liabilities and stockholders' equity | $ | $ | |||||||||
The accompanying notes are an integral part of these
consolidated condensed financial statements.
1
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 | $ | $ | $ | $ | |||||||||||||||||||
| Cost of sales | |||||||||||||||||||||||
| Gross profit | |||||||||||||||||||||||
| Selling, general, and administrative expenses | |||||||||||||||||||||||
| Research and development expenses | |||||||||||||||||||||||
| Intellectual property litigation (income) expenses, net | ( | ||||||||||||||||||||||
| Change in fair value of contingent consideration liabilities, net (Note 7) | ( | ( | ( | ||||||||||||||||||||
| Special charge (Note 3) | |||||||||||||||||||||||
| Operating income | |||||||||||||||||||||||
| Interest (income) expense, net | ( | ( | |||||||||||||||||||||
| Other expense (income), net | ( | ( | |||||||||||||||||||||
| Income before provision for income taxes | |||||||||||||||||||||||
| Provision for income taxes | |||||||||||||||||||||||
| Net income | $ | $ | $ | $ | |||||||||||||||||||
Share information (Note 13) | |||||||||||||||||||||||
| Earnings per share: | |||||||||||||||||||||||
| Basic | $ | $ | $ | $ | |||||||||||||||||||
| Diluted | $ | $ | $ | $ | |||||||||||||||||||
| Weighted-average number of common shares outstanding: | |||||||||||||||||||||||
| Basic | |||||||||||||||||||||||
| Diluted | |||||||||||||||||||||||
The accompanying notes are an integral part of these
consolidated condensed financial statements.
2
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 | $ | $ | $ | $ | |||||||||||||||||||
| Other comprehensive (loss) income, net of tax (Note 12): | |||||||||||||||||||||||
| Foreign currency translation adjustments | ( | ( | ( | ( | |||||||||||||||||||
| Unrealized gain on hedges | |||||||||||||||||||||||
| Unrealized pension costs | ( | ( | ( | ||||||||||||||||||||
| Unrealized loss on available-for-sale investments | ( | ( | ( | ( | |||||||||||||||||||
| Reclassification of realized investment losses to earnings | |||||||||||||||||||||||
| Other comprehensive (loss) income | ( | ( | |||||||||||||||||||||
| Comprehensive income | $ | $ | $ | $ | |||||||||||||||||||
The accompanying notes are an integral part of these
consolidated condensed financial statements.
3
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(in millions; unaudited)
| Nine Months Ended September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Cash flows from operating activities | |||||||||||
| Net income | $ | $ | |||||||||
| Adjustments to reconcile net income to net cash provided by operating activities: | |||||||||||
| Depreciation and amortization | |||||||||||
| Non-cash operating lease cost | |||||||||||
| Stock-based compensation (Note 9) | |||||||||||
| Impairment charge (Note 3) | |||||||||||
| Change in fair value of contingent consideration liabilities, net (Note 7) | ( | ( | |||||||||
| Loss (gain) on investments, net | ( | ||||||||||
| Deferred income taxes | ( | ||||||||||
| Other | |||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts and other receivables, net | ( | ( | |||||||||
| Inventories | ( | ||||||||||
| Accounts payable and accrued liabilities | ( | ||||||||||
| Income taxes | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Litigation settlement accrual | ( | ( | |||||||||
| Other | ( | ( | |||||||||
| Net cash provided by operating activities | |||||||||||
| Cash flows from investing activities | |||||||||||
| Capital expenditures | ( | ( | |||||||||
| Purchases of held-to-maturity investments (Note 4) | ( | ( | |||||||||
| Proceeds from held-to-maturity investments (Note 4) | |||||||||||
| Purchases of available-for-sale investments (Note 4) | ( | ( | |||||||||
| Proceeds from available-for-sale investments (Note 4) | |||||||||||
| Payment for acquisition options | ( | ( | |||||||||
| Issuances of notes receivable | ( | ( | |||||||||
| Collections of notes receivable | |||||||||||
| Other | ( | ( | |||||||||
| Net cash provided by (used in) investing activities | ( | ||||||||||
| Cash flows from financing activities | |||||||||||
| Proceeds from issuance of debt | |||||||||||
| Payments on debt and finance lease obligations | ( | ( | |||||||||
| Purchases of treasury stock | ( | ( | |||||||||
| Proceeds from stock plans | |||||||||||
| Other | ( | ( | |||||||||
| Net cash used in financing activities | ( | ( | |||||||||
| Effect of currency exchange rate changes on cash, cash equivalents, and restricted cash | |||||||||||
| Net increase in cash, cash equivalents, and restricted cash | |||||||||||
| Cash, cash equivalents, and restricted cash at beginning of period | |||||||||||
| Cash, cash equivalents, and restricted cash at end of period | $ | $ | |||||||||
The accompanying notes are an integral part of these
consolidated condensed financial statements.
4
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY
(in millions; unaudited)
| Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Par Value | Shares | Amount | Additional Paid-in Capital | Retained Earnings | Accumulated Other Comprehensive Loss | Total Stockholders' Equity | ||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2021 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | |||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued under stock plans | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2022 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | |||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
Common stock issued under equity plans | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2022 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | |||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
Common stock issued under equity plans | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2022 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these
consolidated condensed financial statements.
5
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY
(in millions; unaudited)
| Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Par Value | Shares | Amount | Additional Paid-in Capital | Retained Earnings | Accumulated Other Comprehensive Loss | Total Stockholders' Equity | ||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2020 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | |||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued under stock plans | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2021 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | |||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | |||||||||||||||||||||||||||||||||||||||||||||||
Common stock issued under equity plans | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2021 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | |||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | |||||||||||||||||||||||||||||||||||||||||||||||
Common stock issued under equity plans | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2021 | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these
consolidated condensed financial statements.
6
1. BASIS OF PRESENTATION
The accompanying interim consolidated condensed financial statements and related disclosures have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") and should be read in conjunction with the consolidated financial statements and notes included in Edwards Lifesciences' Annual Report on Form 10-K for the year ended December 31, 2021. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America ("GAAP") have been condensed or omitted.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements. Actual results could differ from those estimates. In particular, the COVID-19 pandemic has adversely impacted, and may further adversely impact, nearly all aspects of the Company's business and markets, including its workforce and the operations of its customers, suppliers, and business partners. The full extent to which the pandemic will directly or indirectly impact the Company's business, results of operations and financial condition, including sales, expenses, manufacturing, clinical trials, research and development costs, reserves and allowances, fair value measurements, asset impairment charges, contingent consideration obligations, and the effectiveness of the Company's hedging instruments, will depend on future developments that are highly uncertain and difficult to predict. These developments include, but are not limited to, the duration and spread of the outbreak (including new and more contagious
variants of COVID-19), its severity, the actions to contain the virus or address its impact, the timing, distribution, public acceptance and efficacy of vaccines and other treatments, and the associated impact on economic and operating conditions.
In the opinion of management, the interim consolidated condensed financial statements reflect all adjustments necessary for a fair statement of the results for the interim periods presented. All such adjustments, unless otherwise noted herein, are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year.
There have been no material changes to the Company's significant accounting policies from those described in the Company's Annual Report on Form 10-K for the year ended December 31, 2021.
Recently Adopted Accounting Standards
The Company evaluates all new accounting pronouncements issued by the Financial Accounting Standards Board ("FASB") for applicability to the Company's consolidated condensed financial statements. Unless otherwise discussed below, the Company has not identified any other recently issued standards that are relevant to the Company's condensed consolidated financial statements or disclosures.
In November 2021, the FASB issued an amendment to the accounting guidance on government assistance. The guidance requires certain disclosures about transactions with a government that are accounted for by applying a grant or contribution model. The guidance was effective for annual periods beginning after December 15, 2021. The adoption of this guidance was applied prospectively and did not have an impact on the Company's consolidated financial statements.
2. OTHER CONSOLIDATED FINANCIAL STATEMENT DETAILS
Composition of Certain Financial Statement Captions
(in millions)
Components of selected captions in the consolidated condensed balance sheets consisted of the following:
| September 30, 2022 | December 31, 2021 | ||||||||||
| Inventories | |||||||||||
| Raw materials | $ | $ | |||||||||
| Work in process | |||||||||||
| Finished products | |||||||||||
| $ | $ | ||||||||||
At September 30, 2022 and December 31, 2021, $105.0 million and $125.8 million, respectively, of the Company's finished products inventories were held on consignment.
7
| September 30, 2022 | December 31, 2021 | ||||||||||
| Accrued and other liabilities | |||||||||||
| Employee compensation and withholdings | $ | $ | |||||||||
| Taxes payable | |||||||||||
| Property, payroll, and other taxes | |||||||||||
| Research and development accruals | |||||||||||
| Accrued rebates | |||||||||||
| Fair value of derivatives | |||||||||||
| Accrued marketing expenses | |||||||||||
Legal and insurance (a) | |||||||||||
| Accrued relocation costs | |||||||||||
| Accrued professional services | |||||||||||
| Accrued realignment reserves | |||||||||||
| Other accrued liabilities | |||||||||||
| $ | $ | ||||||||||
_______________________________________
Supplemental Cash Flow Information
(in millions)
| Nine Months Ended September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Cash paid during the year for: | |||||||||||
| Income taxes | $ | $ | |||||||||
| Amounts included in the measurement of lease liabilities: | |||||||||||
Operating cash flows from operating leases | $ | $ | |||||||||
| Non-cash investing and financing transactions: | |||||||||||
| Right-of-use assets obtained in exchange for new lease liabilities | $ | $ | |||||||||
| Capital expenditures accruals | $ | $ | |||||||||
| Conversion of notes receivable to equity investment | $ | $ | |||||||||
Cash, Cash Equivalents, and Restricted Cash
(in millions)
| September 30, 2022 | December 31, 2021 | |||||||||||||
| Cash and cash equivalents | $ | $ | ||||||||||||
| Restricted cash included in other current assets | ||||||||||||||
| Restricted cash included in other assets | ||||||||||||||
| Total cash, cash equivalents, and restricted cash | $ | $ | ||||||||||||
Amounts included in restricted cash primarily represent funds placed in escrow related to litigation.
3. SPECIAL CHARGE
8
4. INVESTMENTS
Debt Securities
Investments in debt securities at the end of each period were as follows (in millions):
| September 30, 2022 | December 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||
| Held-to-maturity | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||||||||||||||||||||||||||||
| Bank time deposits | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
| Available-for-sale | |||||||||||||||||||||||||||||||||||||||||||||||
| Bank time deposits | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
| Commercial paper | |||||||||||||||||||||||||||||||||||||||||||||||
| United States government and agency securities | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Asset-backed securities | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Municipal securities | ( | ||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | $ | $ | ( | $ | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||
The cost and fair value of investments in debt securities, by contractual maturity, as of September 30, 2022, were as follows:
| Held-to-Maturity | Available-for-Sale | ||||||||||||||||||||||
| Amortized Cost | Fair Value | Amortized Cost | Fair Value | ||||||||||||||||||||
| (in millions) | |||||||||||||||||||||||
| Due in 1 year or less | $ | $ | $ | $ | |||||||||||||||||||
| Due after 1 year through 5 years | |||||||||||||||||||||||
| Due after 5 years through 10 years | |||||||||||||||||||||||
Instruments not due at a single maturity date (a) | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
_______________________________________
(a) Consists primarily of asset-backed securities.
Actual maturities may differ from the contractual maturities due to call or prepayment rights.
The following tables present gross unrealized losses and fair values for those investments that were in an unrealized loss position as of September 30, 2022 and December 31, 2021, aggregated by investment category and the length of time that individual securities have been in a continuous loss position (in millions):
| September 30, 2022 | |||||||||||||||||||||||||||||||||||
| Less than 12 Months | 12 Months or Greater | Total | |||||||||||||||||||||||||||||||||
| Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | ||||||||||||||||||||||||||||||
| United States government and agency securities | $ | $ | ( | $ | $ | ( | $ | $ | ( | ||||||||||||||||||||||||||
| Asset-backed securities | ( | ( | ( | ||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | ( | ( | ||||||||||||||||||||||||||||||||
| Municipal securities | ( | ( | |||||||||||||||||||||||||||||||||
| $ | $ | ( | $ | $ | ( | $ | $ | ( | |||||||||||||||||||||||||||
9
| December 31, 2021 | |||||||||||||||||||||||||||||||||||
| Less than 12 Months | 12 Months or Greater | Total | |||||||||||||||||||||||||||||||||
| Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | ||||||||||||||||||||||||||||||
| United States government and agency securities | $ | $ | ( | $ | $ | $ | $ | ( | |||||||||||||||||||||||||||
| Asset-backed securities | ( | ( | |||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | ( | |||||||||||||||||||||||||||||||||
| $ | $ | ( | $ | $ | $ | $ | ( | ||||||||||||||||||||||||||||
The Company reviews its investments in debt securities to determine if there has been an other-than-temporary decline in fair value. Consideration is given to 1) the length of time and the extent to which the security's fair value has been below cost, 2) the financial condition and near term prospects of the issuer, including the credit quality of the security's issuer, 3) the Company's intent to sell the security, and 4) whether it is more likely than not the Company will have to sell the security before recovery of its amortized cost. During the nine months ended September 30, 2022, the decline in fair value of the debt securities was largely due to changes in interest rates, not credit quality, and as of September 30, 2022, the Company did not intend to sell the securities, and it was not more likely than not that it will be required to sell the securities, before recovery of the unrealized losses.
Investments in Unconsolidated Entities
The Company has a number of equity investments in unconsolidated entities. These investments are recorded in " Long-term Investments" on the consolidated condensed balance sheets, and are as follows:
| September 30, 2022 | December 31, 2021 | ||||||||||
| (in millions) | |||||||||||
| Equity method investments | |||||||||||
| Carrying value of equity method investments | $ | $ | |||||||||
| Equity securities | |||||||||||
| Carrying value of non-marketable equity securities | |||||||||||
| Total investments in unconsolidated entities | $ | $ | |||||||||
During the nine months ended September 30, 2022, the Company made $13.2 million of equity investments in limited liability companies that invest in qualified community development entities ("CDEs") through the New Markets Tax Credit ("NMTC") program. The NMTC program provides federal tax incentives to investors to make investments in distressed communities and promotes economic improvements through the development of successful businesses in these communities. The NMTC is equal to 39 % of the qualified investment and is taken over seven years . These limited liability companies are variable interest entities ("VIEs"). The Company determined that it is not the primary beneficiary of the VIEs because it does not have the power to direct the activities that most significantly impact the economic performance of the VIEs, and therefore the Company does not consolidate these entities. Instead, the NMTC investments are accounted for as equity method investments.
Non-marketable equity securities consist of investments in privately held companies without readily determinable fair values, and are reported at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. As of September 30, 2022, the Company had recorded cumulative upward adjustments of $8.0 million based on observable price changes, and cumulative downward adjustments of $2.6 million due to impairments and observable price changes.
10
5. INVESTMENTS IN VARIABLE INTEREST ENTITIES
Edwards has relationships with various variable interest entities that it does not consolidate as Edwards lacks the power to direct the activities that significantly impact the economic success of these entities.
In August 2022, the Company entered into an option agreement with a medical device company. Under the option agreement, Edwards paid $47.1 million for an option to acquire the medical device company. The $47.1 million option is included in "Other Assets" on the consolidated condensed balance sheet.
In June 2022, the Company entered into a convertible promissory note and amended its existing warrant agreement with a medical device company. Under the convertible promissory note agreement, the Company has agreed to loan the medical device company up to $47.5 million, of which $32.5 million has been advanced as of September 30, 2022. In addition, the Company amended its warrant agreement under which the Company had previously paid $35.0 million for an option to acquire the medical device company. The amendment extends the warrant right period. The $35.0 million warrant and the $32.5 million note receivable are included in "Other Assets" on the consolidated condensed balance sheet.
In May 2022, the Company entered into an option agreement with a medical technology company. Under the option agreement, Edwards paid $60.0 million, of which $10 million was paid in 2021 as a deposit, for an option to acquire the medtech company. The $60.0 million option is included in "Other Assets" on the consolidated condensed balance sheet.
6. DEBT
7. FAIR VALUE MEASUREMENTS
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. The Company prioritizes the inputs used to determine fair values in one of the following three categories:
Level 1—Quoted market prices in active markets for identical assets or liabilities.
Level 2—Inputs, other than quoted prices in active markets, that are observable, either directly or indirectly.
Level 3—Unobservable inputs that are not corroborated by market data.
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its entirety falls has been determined based on the lowest level input that is significant to the fair value measurement in its entirety.
The consolidated condensed financial statements include financial instruments for which the fair market value of such instruments may differ from amounts reflected on a historical cost basis. Financial instruments of the Company consist of cash deposits, accounts and other receivables, investments, accounts payable, certain accrued liabilities, and borrowings under a revolving credit agreement. The carrying value of these financial instruments generally approximates fair value due to their short-term nature. Financial instruments also include notes payable. As of September 30, 2022, the fair value of the notes payable, based on Level 2 inputs, was $560.8 million.
11
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The following table summarizes the Company's financial instruments which are measured at fair value on a recurring basis (in millions):
| September 30, 2022 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
| Assets | |||||||||||||||||||||||
| Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Available-for-sale investments: | |||||||||||||||||||||||
Corporate debt securities | |||||||||||||||||||||||
Asset-backed securities | |||||||||||||||||||||||
| United States government and agency securities | |||||||||||||||||||||||
Municipal securities | |||||||||||||||||||||||
| Investments held for deferred compensation plans | |||||||||||||||||||||||
| Derivatives | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| Liabilities | |||||||||||||||||||||||
| Derivatives | $ | $ | $ | $ | |||||||||||||||||||
| Deferred compensation plans | |||||||||||||||||||||||
| Contingent consideration liabilities | |||||||||||||||||||||||
| Other liability | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| December 31, 2021 | |||||||||||||||||||||||
| Assets | |||||||||||||||||||||||
| Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Available-for-sale investments: | |||||||||||||||||||||||
Bank time deposits | |||||||||||||||||||||||
Corporate debt securities | |||||||||||||||||||||||
Asset-backed securities | |||||||||||||||||||||||
| United States government and agency securities | |||||||||||||||||||||||
Commercial paper | |||||||||||||||||||||||
Municipal securities | |||||||||||||||||||||||
| Investments held for deferred compensation plans | |||||||||||||||||||||||
| Derivatives | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| Liabilities | |||||||||||||||||||||||
| Derivatives | $ | $ | $ | $ | |||||||||||||||||||
| Deferred compensation plans | |||||||||||||||||||||||
| Contingent consideration liabilities | |||||||||||||||||||||||
| Other liability | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
Cash Equivalents and Available-for-sale Investments
The Company estimates the fair values of its money market funds based on quoted prices in active markets for identical assets. The Company estimates the fair values of its time deposits, commercial paper, United States and foreign government and agency securities, municipal securities, asset-backed securities, and corporate debt securities by taking into consideration valuations obtained from third-party pricing services. The pricing services use industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades and broker-dealer quotes on the same or similar securities, benchmark yields, credit spreads, prepayment and default projections based on historical data, and other observable inputs. The Company independently reviews and validates the pricing received from the third-party pricing service by comparing the prices to prices reported by a secondary pricing source. The Company’s validation procedures have not resulted in an adjustment to the pricing received from the pricing service.
12
Deferred Compensation Plans
The Company holds investments in trading securities related to its deferred compensation plans. The investments are in a variety of stock, bond and money market mutual funds. The fair values of these investments and the corresponding liabilities are based on quoted market prices.
Derivative Instruments
The Company uses derivative financial instruments in the form of foreign currency forward exchange contracts and cross currency swap contracts to manage foreign currency exposures. All derivatives contracts are recognized on the balance sheet at their fair value. The fair value of the derivative financial instruments was estimated based on quoted market foreign exchange rates, cross currency swap basis rates, and market discount rates. Judgment was employed in interpreting market data to develop estimates of fair value; accordingly, the estimates presented herein are not necessarily indicative of the amounts that the Company could realize in a current market exchange. The use of different market assumptions or valuation methodologies could have a material effect on the estimated fair value amounts.
Contingent Consideration Liabilities
Certain of the Company's acquisitions involve contingent consideration arrangements. Payment of additional consideration is contingent upon the acquired company reaching certain performance milestones, such as attaining specified sales levels or obtaining regulatory approvals. These contingent consideration liabilities are measured 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. These inputs as of September 30, 2022 include (1) the discount rate used to present value the projected cash flows (ranging from 2.8 % to 12.3 %; weighted average of 4.1 %), (2) the probability of milestone achievement (ranging from 0 % to 50 %; weighted average of 39.6 %), (3) the projected payment dates (2026), and (4) the volatility of future sales (ranging from 45.0 % to 55.0 %; weighted average of 55.0 %). The weighted average of each of the above inputs was determined based on the relative fair value of each obligation. The use of different assumptions could have a material effect on the estimated fair value amounts.
| Contingent Consideration | Other liability | Total | |||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | ||||||||||||||
| Changes in fair value | ( | ( | |||||||||||||||
| Balance at September 30, 2022 | $ | $ | $ | ||||||||||||||
| Contingent Consideration | Other liability | Total | |||||||||||||||
Balance at December 31, 2020 | $ | $ | $ | ||||||||||||||
| Additions | |||||||||||||||||
| Changes in fair value | ( | ( | |||||||||||||||
| Balance at September 30, 2021 | $ | $ | $ | ||||||||||||||
The contingent consideration liabilities related to certain of the Company's previous business acquisitions were reduced in the nine months ended September 30, 2022 by $30.9 million due to both the changes in projected probabilities of milestone achievement and the Company's decision during the third quarter of 2022 to exit its HARPOON surgical mitral repair system program (see Note 3). The contingent consideration liabilities were reduced in the nine months ended September 30, 2021 by $105.2 million due to changes in the projected probabilities and timing of milestone achievements and the projected timing of cash inflows.
8. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES
13
| Notional Amount | |||||||||||
| September 30, 2022 | December 31, 2021 | ||||||||||
| (in millions) | |||||||||||
| Foreign currency forward exchange contracts | $ | $ | |||||||||
| Cross currency swap contracts | |||||||||||
Derivative financial instruments involve credit risk in the event the counterparty should default. It is the Company's policy to execute such instruments with global financial institutions that the Company believes to be creditworthy. The Company diversifies its derivative financial instruments among counterparties to minimize exposure to any one of these entities. The Company also uses International Swap Dealers Association master-netting agreements. The master-netting agreements provide for the net settlement of all contracts through a single payment in a single currency in the event of default, as defined by the agreements.
The Company uses foreign currency forward exchange contracts and cross currency swap contracts to manage its exposure to changes in currency exchange rates from (a) future cash flows associated with intercompany transactions and certain local currency expenses expected to occur within the next 13 months (designated as cash flow hedges), (b) its net investment in certain foreign subsidiaries (designated as net investment hedges) and (c) foreign currency denominated assets or liabilities (designated as fair value hedges). The Company also uses foreign currency forward exchange contracts that are not designated as hedging instruments to offset the transaction gains and losses associated with revaluation of certain assets and liabilities denominated in currencies other than their functional currencies (resulting principally from intercompany and local currency transactions).
All derivative financial instruments are recognized at fair value in the consolidated condensed balance sheets. For each derivative instrument that is designated as a fair value hedge, the gain or loss on the derivative included in the assessment of hedge effectiveness is recognized immediately to earnings, and offsets the loss or gain on the underlying hedged item. The Company reports in "Accumulated Other Comprehensive Loss" the gain or loss on derivative financial instruments that are designated, and that qualify, as cash flow hedges. The Company reclassifies these gains and losses into earnings in the same line item and in the same period in which the underlying hedged transactions affect earnings. Changes in the fair value of net investment hedges are reported in "Accumulated Other Comprehensive Loss" as a part of the cumulative translation adjustment and would be reclassified into earnings if the underlying net investment is sold or substantially liquidated. The portion of the change in fair value related to components excluded from the hedge effectiveness assessment are amortized into earnings over the life of the derivative. The gains and losses on derivative financial instruments for which the Company does not elect hedge accounting treatment are recognized in the consolidated statements of operations in each period based upon the change in the fair value of the derivative financial instrument. Cash flows from net investment hedges are reported as investing activities in the consolidated statements of cash flows, and cash flows from all other derivative financial instruments are reported as operating activities.
The following table presents the location and fair value amounts of derivative instruments reported in the consolidated condensed balance sheets (in millions):
| Fair Value | ||||||||||||||||||||
| Derivatives designated as hedging instruments | Balance Sheet Location | September 30, 2022 | December 31, 2021 | |||||||||||||||||
| Assets | ||||||||||||||||||||
| Foreign currency contracts | Other current assets | $ | $ | |||||||||||||||||
| Foreign currency contracts | Other assets | $ | $ | |||||||||||||||||
| Cross currency swap contracts | Other assets | $ | $ | |||||||||||||||||
| Liabilities | ||||||||||||||||||||
| Foreign currency contracts | Accounts payable and accrued liabilities | $ | $ | |||||||||||||||||
14
The following table presents the effect of master-netting agreements and rights of offset on the consolidated condensed balance sheets (in millions):
| Gross Amounts Not Offset in the Consolidated Balance Sheet | |||||||||||||||||||||||||||||||||||
| Gross Amounts Offset in the Consolidated Balance Sheet | |||||||||||||||||||||||||||||||||||
| Net Amounts Presented in the Consolidated Balance Sheet | |||||||||||||||||||||||||||||||||||
| September 30, 2022 | Gross Amounts | Financial Instruments | Cash Collateral Received | Net Amount | |||||||||||||||||||||||||||||||
| Derivative assets | |||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||
| Cross currency swap contracts | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||
| Derivative liabilities | |||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||
| December 31, 2021 | |||||||||||||||||||||||||||||||||||
| Derivative assets | |||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||
| Cross currency swap contracts | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||
| Derivative liabilities | |||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||
The following tables present the effect of derivative and non-derivative hedging instruments on the consolidated condensed statements of operations and consolidated condensed statements of comprehensive income (in millions):
| Amount of Gain or (Loss) Recognized in OCI on Derivative (Effective Portion) | Amount of Gain or (Loss) Reclassified from Accumulated OCI into Income (Effective Portion) | |||||||||||||||||||||||||||||||
| Three Months Ended September 30, | Location of Gain or (Loss) Reclassified from Accumulated OCI into Income | Three Months Ended September 30, | ||||||||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||||||
| Cash flow hedges | ||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | Cost of sales | $ | $ | ( | ||||||||||||||||||||||||||
| Selling, general, and administrative expenses | $ | $ | ( | |||||||||||||||||||||||||||||
| Amount of Gain or (Loss) Recognized in OCI on Derivative (Effective Portion) | Amount of Gain or (Loss) Reclassified from Accumulated OCI into Income (Effective Portion) | |||||||||||||||||||||||||||||||
| Nine Months Ended September 30, | Location of Gain or (Loss) Reclassified from Accumulated OCI into Income | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||||||
| Cash flow hedges | ||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | Cost of sales | $ | $ | ( | ||||||||||||||||||||||||||
| Selling, general, and administrative expenses | $ | $ | ( | |||||||||||||||||||||||||||||
| Amount of Gain or (Loss) Recognized in OCI on Derivative (Effective Portion) | Amount of Gain or (Loss) Recognized in Income on Derivative (Amount Excluded from Effectiveness Testing) | |||||||||||||||||||||||||||||||
| Three Months Ended September 30, | Location of Gain or (Loss) Recognized in Income on Derivative (Amount Excluded from Effectiveness Testing) | Three Months Ended September 30, | ||||||||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||||||
| Net investment hedges | ||||||||||||||||||||||||||||||||
| Cross currency swap contracts | $ | $ | Interest (income) expense, net | $ | $ | |||||||||||||||||||||||||||
15
| Amount of Gain or (Loss) Recognized in OCI on Derivative (Effective Portion) | Amount of Gain or (Loss) Recognized in Income on Derivative (Amount Excluded from Effectiveness Testing) | |||||||||||||||||||||||||||||||
| Nine Months Ended September 30, | Location of Gain or (Loss) Reclassified from Accumulated OCI into Income | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||||||
| Net investment hedges | ||||||||||||||||||||||||||||||||
| Cross currency swap contracts | $ | $ | Interest (income) expense, net | $ | $ | |||||||||||||||||||||||||||
| Amount of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| Three Months Ended September 30, | ||||||||||||||||||||
| Location of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| 2022 | 2021 | |||||||||||||||||||
| Fair value hedges | ||||||||||||||||||||
| Foreign currency contracts | Other expense (income), net | $ | $ | |||||||||||||||||
| Amount of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| Nine Months Ended September 30, | ||||||||||||||||||||
| Location of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| 2022 | 2021 | |||||||||||||||||||
| Fair value hedges | ||||||||||||||||||||
| Foreign currency contracts | Other expense (income), net | $ | $ | |||||||||||||||||
| Amount of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| Three Months Ended September 30, | ||||||||||||||||||||
| Location of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| 2022 | 2021 | |||||||||||||||||||
| Derivatives not designated as hedging instruments | ||||||||||||||||||||
| Foreign currency contracts | Other expense (income), net | $ | $ | |||||||||||||||||
| Amount of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| Nine Months Ended September 30, | ||||||||||||||||||||
| Location of Gain or (Loss) Recognized in Income on Derivative | ||||||||||||||||||||
| 2022 | 2021 | |||||||||||||||||||
| Derivatives not designated as hedging instruments | ||||||||||||||||||||
| Foreign currency contracts | Other expense (income), net | $ | $ | |||||||||||||||||
16
The following tables present the effect of fair value and cash flow hedge accounting on the consolidated condensed statements of operations (in millions):
| Location and Amount of Gain or (Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships | |||||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2022 | Nine Months Ended September 30, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||
| Cost of sales | Selling, general, and administrative expenses | Other Expense (Income), net | Cost of sales | Selling, general, and administrative expenses | Other Expense (Income), net | ||||||||||||||||||||||||||||||||||||||||||
| Total amounts of income and expense line items presented in the consolidated condensed statements of operations in which the effects of fair value or cash flow hedges are recorded | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||||||||||||||||||
| The effects of cash flow hedging: | |||||||||||||||||||||||||||||||||||||||||||||||
Gain (loss) on fair value hedging relationships: | |||||||||||||||||||||||||||||||||||||||||||||||
Foreign currency contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
Hedged items | $ | $ | $ | ( | $ | $ | $ | ( | |||||||||||||||||||||||||||||||||||||||
Derivatives designated as hedging instruments | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
Amount excluded from effectiveness testing recognized in earnings based on an amortization approach | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
Gain (loss) on cash flow hedging relationships: | |||||||||||||||||||||||||||||||||||||||||||||||
Foreign currency contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
Amount of gain (loss) reclassified from accumulated OCI into income | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
| Location and Amount of Gain or (Loss) Recognized in Income on Fair Value and Cash Flow Hedging Relationships | |||||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2021 | Nine Months Ended September 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||
| Cost of sales | Selling, general, and administrative expenses | Other Expense (Income), net | Cost of sales | Selling, general, and administrative expenses | Other Expense (Income), net | ||||||||||||||||||||||||||||||||||||||||||
| Total amounts of income and expense line items presented in the consolidated condensed statements of operations in which the effects of fair value or cash flow hedges are recorded | $ | ( | $ | ( | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||
| The effects of fair value and cash flow hedging: | |||||||||||||||||||||||||||||||||||||||||||||||
Gain (loss) on fair value hedging relationships: | |||||||||||||||||||||||||||||||||||||||||||||||
Foreign currency contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
Hedged items | $ | $ | $ | ( | $ | $ | $ | ( | |||||||||||||||||||||||||||||||||||||||
Derivatives designated as hedging instruments | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
Amount excluded from effectiveness testing recognized in earnings based on an amortization approach | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
Gain (loss) on cash flow hedging relationships: | |||||||||||||||||||||||||||||||||||||||||||||||
Foreign currency contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
Amount of gain (loss) reclassified from accumulated OCI into income | $ | ( | $ | ( | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||
The Company expects that during the next twelve months it will reclassify to earnings a $38.1 million gain currently recorded in "Accumulated Other Comprehensive Loss."
17
9. STOCK-BASED COMPENSATION
Stock-based compensation expense related to awards issued under the Company's incentive compensation plans for the three and nine months ended September 30, 2022 and 2021 was as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Cost of sales | $ | $ | $ | $ | |||||||||||||||||||
| Selling, general, and administrative expenses | |||||||||||||||||||||||
| Research and development expenses | |||||||||||||||||||||||
| Total stock-based compensation expense | |||||||||||||||||||||||
| Income tax benefit | ( | ( | ( | ( | |||||||||||||||||||
| Total stock-based compensation expense, net of tax | $ | $ | $ | $ | |||||||||||||||||||
At September 30, 2022, the total remaining compensation cost related to nonvested stock options, restricted stock units, market-based restricted stock units, and employee stock purchase plan ("ESPP") subscription awards amounted to $220.3 million, which will be amortized on a straight-line basis over each award's requisite service period. The weighted-average remaining requisite service period is 32 months.
During the nine months ended September 30, 2022, the Company granted 1.6 million stock options at a weighted-average
exercise price per share of $105.18 , and 0.7 million restricted stock units at a weighted-average grant-date fair value per share of $104.41 . During the nine months ended September 30, 2022, the Company also granted 0.1 million market-based restricted stock units at a weighted-average grant-date fair value per share of $124.92 and issued an additional 0.1 million shares of common stock related to a previous year's grant of market-based restricted stock units since the payout percentage achieved at the end of the performance period was in excess of the targeted shares. The market-based restricted stock units granted during the nine months ended September 30, 2022 vest based on a combination of certain service and market conditions. The actual number of shares issued will be determined based on the Company's total shareholder return relative to a selected industry peer group over a three-year performance period and may range from 0 % to 175.0 % of the targeted number of shares granted.
Fair Value Disclosures
The weighted-average assumptions used in a Monte Carlo simulation model to determine the fair value of the market-based restricted stock units granted during the nine months ended September 30, 2022 and 2021 included an average risk-free interest rate of 2.9 % and 0.4 %, respectively, and an expected volatility rate of 33.9 % and 34.4 %, respectively.
The following table includes the weighted-average grant-date fair values of stock options granted during the periods indicated and the related weighted-average assumptions used in the Black-Scholes option pricing model:
Option Awards | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Risk-free interest rate | % | % | % | % | |||||||||||||||||||
| Expected dividend yield | |||||||||||||||||||||||
| Expected volatility | % | % | % | % | |||||||||||||||||||
| Expected term (years) | |||||||||||||||||||||||
| Fair value, per option | $ | $ | $ | $ | |||||||||||||||||||
18
The following table includes the weighted-average grant-date fair values for ESPP subscriptions granted during the periods indicated and the related weighted-average assumptions used in the Black-Scholes option pricing model:
ESPP | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Risk-free interest rate | % | % | % | % | |||||||||||||||||||
| Expected dividend yield | |||||||||||||||||||||||
| Expected volatility | % | % | % | % | |||||||||||||||||||
| Expected term (years) | |||||||||||||||||||||||
| Fair value, per share | $ | $ | $ | $ | |||||||||||||||||||
10. ACCELERATED SHARE REPURCHASE
During 2022 and 2021, the Company entered into accelerated share repurchase ("ASR") agreements providing for the repurchase of the Company's common stock based on the volume-weighted average price ("VWAP") of the Company's common stock during the term of the applicable agreement, less a discount. The following table summarizes the terms of the ASR agreements (dollars and shares in millions, except per share data):
| Initial Delivery | Final Settlement | |||||||||||||||||||||||||||||||||||||||||||
| Agreement Date | Amount Paid | Shares Received | Price per Share | Value of Shares as % of Contract Value | Settlement Date | Total Shares Received | Average Price per Share | |||||||||||||||||||||||||||||||||||||
| February 2021 | $ | $ | % | March 2021 | $ | |||||||||||||||||||||||||||||||||||||||
| January 2022 | $ | $ | % | February 2022 | $ | |||||||||||||||||||||||||||||||||||||||
The ASR agreements were each accounted for as two separate transactions: (1) the value of the initial delivery of shares was recorded as shares of common stock acquired in a treasury stock transaction on the acquisition date, and (2) the remaining amount of the purchase price paid was recorded as a forward contract indexed to the Company's own common stock and was recorded in "Additional Paid-in Capital" on the consolidated balance sheets. The initial delivery of shares resulted in an immediate reduction of the outstanding shares used to calculate the weighted-average common shares outstanding for basic and diluted earnings per share. The Company determined that the forward contracts indexed to the Company's common stock met all the applicable criteria for equity classification and, therefore, were not accounted for as a derivative instrument.
11. COMMITMENTS AND CONTINGENCIES
The Company is reviewing and investigating whether business activities in Japan and other markets violate certain provisions of the Foreign Corrupt Practices Act ("FCPA"). The Company voluntarily notified the SEC and the United States Department of Justice ("DOJ") during 2021 that it has engaged outside counsel to conduct this review and investigation. The Company has provided status updates to the SEC and DOJ since that time. Any determination that the Company’s operations or activities are not in compliance with existing laws, including the FCPA, could result in the imposition of fines, penalties, and equitable remedies. The Company cannot currently predict the outcome of the review and investigation or the potential impact on its 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. The Company is unable to predict the ultimate outcome of this matter or estimate a range of possible exposure; therefore, no amount has been accrued. The Company intends to vigorously defend itself in this litigation.
The Company is or may be a party to, or may otherwise be responsible for, pending or threatened lawsuits including those related to products and services currently or formerly manufactured or performed, as applicable, by the Company, workplace and employment matters, matters involving real estate, Company operations or health care regulations, or governmental investigations (the "Lawsuits"). The Lawsuits raise difficult and complex factual and legal issues and are subject to many uncertainties, including, but not limited to, the facts and circumstances of each particular case or claim, the jurisdiction in which each suit is brought, and differences in applicable law. Management does not believe that any loss relating to the Lawsuits would have a material adverse effect on the Company's overall financial condition, results of operations or cash flows. However, the resolution of one or more of the Lawsuits in any reporting period, could have a material adverse impact on the
19
20
12. ACCUMULATED OTHER COMPREHENSIVE LOSS
The following tables summarize the activity for each component of "Accumulated Other Comprehensive Loss" (in millions):
| Foreign Currency Translation Adjustments | Unrealized Gain on Hedges | Unrealized Loss on Available-for-sale Investments | Unrealized Pension Costs | Total Accumulated Other Comprehensive Loss | |||||||||||||||||||||||||
| December 31, 2021 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
| Other comprehensive (loss) gain before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ||||||||||||||||||||||||||
| Deferred income tax (expense) benefit | ( | ( | |||||||||||||||||||||||||||
| March 31, 2022 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
| Other comprehensive (loss) gain before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ||||||||||||||||||||||||||
| Deferred income tax expense | ( | ( | ( | ( | |||||||||||||||||||||||||
| June 30, 2022 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
| Other comprehensive (loss) gain before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ||||||||||||||||||||||||||
| Deferred income tax (expense) benefit | ( | ( | ( | ||||||||||||||||||||||||||
| September 30, 2022 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
| Foreign Currency Translation Adjustments | Unrealized Loss on Hedges | Unrealized Gain on Available-for-sale Investments | Unrealized Pension Costs | Total Accumulated Other Comprehensive Loss | |||||||||||||||||||||||||
| December 31, 2020 | $ | ( | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||||||
| Other comprehensive (loss) gain before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ||||||||||||||||||||||||||
| Deferred income tax (expense) benefit | ( | ( | ( | ||||||||||||||||||||||||||
| March 31, 2021 | $ | ( | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||||||
| Other comprehensive gain (loss) before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ||||||||||||||||||||||||||||
| Deferred income tax expense | ( | ( | ( | ||||||||||||||||||||||||||
| June 30, 2021 | $ | ( | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||||||
| Other comprehensive (loss) gain before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ||||||||||||||||||||||||||||
| Deferred income tax (expense) benefit | ( | ( | ( | ||||||||||||||||||||||||||
| September 30, 2021 | $ | ( | $ | $ | $ | ( | $ | ( | |||||||||||||||||||||
21
The following table provides information about amounts reclassified from "Accumulated Other Comprehensive Loss" (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||
| Affected Line on Consolidated Condensed Statements of Operations | |||||||||||||||||||||||||||||
Details about Accumulated Other Comprehensive Loss Components | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||
| Foreign currency translation adjustments | $ | $ | $ | $ | Other expense (income), net | ||||||||||||||||||||||||
| ( | ( | ( | ( | Provision for income taxes | |||||||||||||||||||||||||
| $ | $ | $ | $ | Net of tax | |||||||||||||||||||||||||
| Gain (loss) on hedges | $ | $ | ( | $ | $ | ( | Cost of sales | ||||||||||||||||||||||
| ( | ( | Selling, general, and administrative expenses | |||||||||||||||||||||||||||
| Other expense (income), net | |||||||||||||||||||||||||||||
| ( | ( | Total before tax | |||||||||||||||||||||||||||
| ( | ( | Provision for income taxes | |||||||||||||||||||||||||||
| $ | $ | ( | $ | $ | ( | Net of tax | |||||||||||||||||||||||
| Loss on available-for-sale investments | $ | ( | $ | ( | $ | ( | $ | ( | Other expense (income), net | ||||||||||||||||||||
| Provision for income taxes | |||||||||||||||||||||||||||||
| $ | ( | $ | ( | $ | ( | $ | ( | Net of tax | |||||||||||||||||||||
13. EARNINGS PER SHARE
Basic earnings per share is computed by dividing net income by the weighted-average common shares outstanding during the period. Diluted earnings per share is computed based on the weighted-average common shares outstanding plus the effect of dilutive potential common shares outstanding during the period calculated using the treasury stock method. Dilutive potential common shares include employee equity share options, nonvested shares, and similar equity instruments granted by the Company. Potential common share equivalents have been excluded where their inclusion would be anti-dilutive.
The table below presents the computation of basic and diluted earnings per share (in millions, except for per share information):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Basic: | |||||||||||||||||||||||
| Net income | $ | $ | $ | $ | |||||||||||||||||||
| Weighted-average shares outstanding | |||||||||||||||||||||||
| Basic earnings per share | $ | $ | $ | $ | |||||||||||||||||||
| Diluted: | |||||||||||||||||||||||
| Net income | $ | $ | $ | $ | |||||||||||||||||||
| Weighted-average shares outstanding | |||||||||||||||||||||||
| Dilutive effect of stock plans | |||||||||||||||||||||||
| Dilutive weighted-average shares outstanding | |||||||||||||||||||||||
| Diluted earnings per share | $ | $ | $ | $ | |||||||||||||||||||
22
14. INCOME TAXES
The Company's effective income tax rates were 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 is 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. The effective rates include a tax benefit from employee share-based compensation of $3.4 million and $12.9 million for the three months ended September 30, 2022 and 2021, respectively, and $36.7 million and $50.7 million for the nine months ended September 30, 2022 and 2021, respectively.
In the normal course of business, the Internal Revenue Service (“IRS”) and other taxing authorities are in different stages of examining various years of the Company's tax filings. During these audits the Company 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 the Company's results of operations and financial condition. The Company strives to resolve open matters with each tax authority at the examination level and could reach agreement with a tax authority at any time. While the Company has accrued for matters it believes are more likely than not to require settlement, the final 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, the Company may later decide to challenge any assessments, if made, and may exercise its 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.
As of September 30, 2022 and December 31, 2021, the gross liability recorded for income taxes associated with uncertain tax positions was $418.3 million and $358.4 million, respectively. The Company estimates that these liabilities would be reduced by $169.2 million and $135.1 million, respectively, from offsetting tax benefits associated with the correlative effects of potential transfer pricing adjustments, state income taxes, and timing adjustments. The net amounts of $249.1 million and $223.3 million, respectively, if not required, would favorably affect the Company's effective tax rate.
The Company 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, the Company 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. The Company has filed to renew all of the APAs which cover transactions with Japan for the years 2020 and forward. The execution of some or all of these APA renewals depends on many variables outside of the Company's control.
As of September 30, 2022, all material state, local, and foreign income tax matters have been concluded for years through 2015. While not material, the Company continues to address matters in India for years from 2010.
The audits of the Company’s 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, the Company 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 the Company's United States and Switzerland subsidiaries. The NOPA proposes an increase to the Company's 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. The Company has 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, the Company received the IRS's rebuttal to its protest and was notified that the case had been transferred to the IRS Independent Office of Appeals. The Company continues to evaluate all possible remedies available to it, 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. The Company believes the amounts previously accrued related to this uncertain tax position are sufficient and, accordingly, has not accrued any additional amount based on the NOPA received.
23
15. SEGMENT INFORMATION
Edwards Lifesciences conducts operations worldwide and is managed in the following geographical regions: United States, Europe, Japan, and Rest of World. All regions sell products that are used to treat advanced cardiovascular disease.
The Company's geographic segments are reported based on the financial information provided to the Chief Operating Decision Maker (the Chief Executive Officer). The Company evaluates the performance of its geographic segments based on net sales and operating income. Segment net sales and segment operating income are based on internally derived standard foreign exchange rates, which may differ from year to year, and do not include inter-segment profits. Because of the interdependence of the reportable segments, the operating profit as presented may not be representative of the geographical distribution that would occur if the segments were not interdependent. Net sales by geographic area are based on the location of the customer. There were no customers that represented 10% or more of the Company's total net sales.
Certain items are maintained at the corporate level and are not allocated to the segments. The non-allocated items include net interest income, global marketing expenses, corporate research and development expenses, manufacturing variances, corporate headquarters costs, special gains and charges, stock-based compensation, foreign currency hedging activities, certain litigation costs, changes in the fair value of contingent consideration liabilities, and most of the Company's amortization expense. Although most of the Company's depreciation expense is included in segment operating income, due to the Company's methodology for cost build-up, it is impractical to determine the amount of depreciation expense included in each segment and, therefore, a portion is maintained at the corporate level. The Company neither discretely allocates assets to its operating segments, nor evaluates the operating segments using discrete asset information.
The table below presents information about Edwards Lifesciences' reportable segments (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Segment Net Sales | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | |||||||||||||||||||||||
| Rest of World | |||||||||||||||||||||||
| Total segment net sales | $ | $ | $ | $ | |||||||||||||||||||
| Segment Operating Income | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | |||||||||||||||||||||||
| Rest of World | |||||||||||||||||||||||
| Total segment operating income | $ | $ | $ | $ | |||||||||||||||||||
24
The table below presents reconciliations of segment net sales to consolidated net sales and segment operating income to consolidated pre-tax income (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Net Sales Reconciliation | |||||||||||||||||||||||
| Segment net sales | $ | $ | $ | $ | |||||||||||||||||||
| Foreign currency | ( | ( | |||||||||||||||||||||
| Consolidated net sales | $ | $ | $ | $ | |||||||||||||||||||
| Pre-tax Income Reconciliation | |||||||||||||||||||||||
| Segment operating income | $ | $ | $ | $ | |||||||||||||||||||
| Unallocated amounts: | |||||||||||||||||||||||
| Corporate items | ( | ( | ( | ( | |||||||||||||||||||
| Special charge (Note 3) | ( | ( | |||||||||||||||||||||
| Intellectual property litigation income (expenses), net | ( | ( | ( | ||||||||||||||||||||
| Change in fair value of contingent consideration liabilities, net | ( | ||||||||||||||||||||||
| Foreign currency | |||||||||||||||||||||||
| Consolidated operating income | |||||||||||||||||||||||
| Non-operating (expense) income | |||||||||||||||||||||||
| Consolidated pre-tax income | $ | $ | $ | $ | |||||||||||||||||||
Enterprise-wide Information
(in millions)
The following enterprise-wide information is based on actual foreign exchange rates used in the Company's consolidated condensed financial statements.
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Net Sales by Geographic Area | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | |||||||||||||||||||||||
| Rest of World | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| Net Sales by Major Product Area | |||||||||||||||||||||||
| Transcatheter Aortic Valve Replacement | $ | $ | $ | $ | |||||||||||||||||||
| Transcatheter Mitral and Tricuspid Therapies | |||||||||||||||||||||||
| Surgical Structural Heart | |||||||||||||||||||||||
| Critical Care | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
25
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.
26
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.
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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.
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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.
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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.
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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.
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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.
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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) | |||||||||||||||
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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 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
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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 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.
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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.
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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.
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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.
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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.
| Exhibit No. | Description | ||||||||||
| 3.1 | |||||||||||
| 3.2 | |||||||||||
| 3.3 | |||||||||||
| 31.1 | |||||||||||
| 31.2 | |||||||||||
| 32 | |||||||||||
| 101.INS | XBRL Inline Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document | ||||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | ||||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | ||||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | ||||||||||
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | ||||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | ||||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | ||||||||||
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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) | |||||||||||
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Exhibit 31.1
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATIONS PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
CERTIFICATION
I, Michael A. Mussallem, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Edwards Lifesciences Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| Date: | October 28, 2022 | By: | /s/ MICHAEL A. MUSSALLEM | ||||||||
Michael A. Mussallem Chairman of the Board and Chief Executive Officer | |||||||||||
Exhibit 31.2
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATIONS PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
CERTIFICATION
I, Scott B. Ullem, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Edwards Lifesciences Corporation;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
| Date: | October 28, 2022 | By: | /s/ SCOTT B. ULLEM | ||||||||
Scott B. Ullem Chief Financial Officer | |||||||||||
Exhibit 32
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Edwards Lifesciences Corporation (the "Company") on Form 10-Q for the period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), we, Michael A. Mussallem, Chairman of the Board and Chief Executive Officer of the Company, and Scott B. Ullem, Corporate Vice President, Chief Financial Officer, certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| October 28, 2022 | /s/ MICHAEL A. MUSSALLEM | ||||
Michael A. Mussallem Chairman of the Board and Chief Executive Officer | |||||
| October 28, 2022 | /s/ SCOTT B. ULLEM | ||||
Scott B. Ullem Chief Financial Officer | |||||