Edwards Lifesciences Corp 10-Q for FY2025 Q3
Edwards Lifesciences Corp (EW)
10-Q
2025-11-05
For: 2025-09-30
View Original
Added on
April 09, 2026
About this 10-Q
Edwards Lifesciences Corp filed this 10-Q on November 5, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $1.55B
- up 14.7% from $1.35B a year earlier
- Net income
- $291.1M
- down 90.5% from net income of $3.07B a year earlier
- Diluted EPS
- $0.50
- down 90.3% from $5.13 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, 2025
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 31, 2025 was 580.3 million.
EDWARDS LIFESCIENCES CORPORATION
FORM 10-Q
For the quarterly period ended September 30, 2025
TABLE OF CONTENTS
Page Number | ||||||||
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act” and together with the Securities Act, the “Acts”). 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 safe harbor provisions. 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,” or other forms of these words or similar words or expressions or the negatives thereof. Statements regarding 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,” “potential,” “possible,” “diligence,” “industry-leading,” “compliant,” “indications,” “early feedback,” or other forms of these words or similar words or expressions or the negatives 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: our ability to complete or realize the anticipated benefits of the sale of our discontinued product groups; our ability to develop new products and avoid manufacturing and quality issues; risks or challenges related to integrating acquired businesses; clinical trial or commercial results or new product approvals and therapy adoption; the impact of domestic and global conditions, including current and future tariff actions; dependence on physicians, research institutions, and hospital systems; competition in the markets in which we operate; our reliance on vendors, suppliers, and other third parties; damage, failure, or interruption of our information technology systems; the impact of public health crises; consolidation in the healthcare industry; our ability to protect our intellectual property; our compliance with applicable regulations; our exposure to product liability claims; use of our products in unapproved circumstances; changes to reimbursement for our products; the impact of currency exchange rates; 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, 2024, filed with the U.S. Securities and Exchange Commission (“SEC”) on February 28, 2025,and as such risks and uncertainties may be further amended, supplemented or superseded from time to time by our subsequent reports on Forms 10-Q and 8-K we file with the SEC. 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, except as required by law. 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, except as required by law.
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, 2025 | December 31, 2024 | ||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
Short-term investments (Note 5) | |||||||||||
Accounts receivable, net of allowances of $ | |||||||||||
| Other receivables | |||||||||||
Inventories (Note 2) | |||||||||||
| Prepaid expenses | |||||||||||
| Other current assets | |||||||||||
Current assets of discontinued operations (Note 4) | |||||||||||
| Total current assets | |||||||||||
Long-term investments (Note 5) | |||||||||||
| Property, plant, and equipment, net | |||||||||||
| Operating lease right-of-use assets | |||||||||||
| Goodwill | |||||||||||
| Other intangible assets, net | |||||||||||
| Deferred income taxes | |||||||||||
Other assets (Note 2) | |||||||||||
Non-current assets of discontinued operations (Note 4) | |||||||||||
| Total assets | $ | $ | |||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | $ | |||||||||
Accrued and other liabilities (Note 2) | |||||||||||
| Operating lease liabilities | |||||||||||
Current liabilities of discontinued operations (Note 4) | |||||||||||
| Total current liabilities | |||||||||||
| Long-term debt | |||||||||||
| Operating lease liabilities | |||||||||||
| Uncertain tax positions | |||||||||||
| Other liabilities | |||||||||||
| Non-current liabilities of discontinued operations (Note 4) | |||||||||||
| 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 Edwards Lifesciences Corporation stockholders' equity | |||||||||||
| Noncontrolling interest | |||||||||||
| Total stockholders' equity | |||||||||||
| Total liabilities and 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, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net sales | $ | $ | $ | $ | |||||||||||||||||||
| Cost of sales | |||||||||||||||||||||||
| Gross profit | |||||||||||||||||||||||
| Selling, general, and administrative expenses | |||||||||||||||||||||||
| Research and development expenses | |||||||||||||||||||||||
Certain litigation expenses | |||||||||||||||||||||||
Change in fair value of contingent consideration liabilities | ( | ( | |||||||||||||||||||||
Restructuring charges and separation costs (Note 3) | |||||||||||||||||||||||
Intangible assets impairment charges | |||||||||||||||||||||||
| Other operating (income) expense, net | ( | ( | |||||||||||||||||||||
| Operating income, net | |||||||||||||||||||||||
| Interest income, net | ( | ( | ( | ( | |||||||||||||||||||
Loss on impairment (Note 6) | |||||||||||||||||||||||
| Other non-operating income, net | ( | ( | ( | ( | |||||||||||||||||||
| Income from continuing operations before provision for income taxes | |||||||||||||||||||||||
| Provision for income taxes | |||||||||||||||||||||||
| Net income from continuing operations | |||||||||||||||||||||||
| (Loss) income from discontinued operations, net of tax | ( | ( | |||||||||||||||||||||
| Net income | |||||||||||||||||||||||
| Net loss attributable to noncontrolling interest | ( | ( | ( | ( | |||||||||||||||||||
| Net income attributable to Edwards Lifesciences Corporation | $ | $ | $ | $ | |||||||||||||||||||
Share information (Note 13) | |||||||||||||||||||||||
| Earnings (loss) per share: | |||||||||||||||||||||||
| Basic | |||||||||||||||||||||||
| Continuing operations | $ | $ | $ | $ | |||||||||||||||||||
| Discontinued operations | $ | $ | $ | ( | $ | ||||||||||||||||||
| Basic earnings per share | $ | $ | $ | $ | |||||||||||||||||||
| Diluted | |||||||||||||||||||||||
| Continuing operations | $ | $ | $ | $ | |||||||||||||||||||
| Discontinued operations | $ | $ | $ | ( | $ | ||||||||||||||||||
| Diluted earnings per share | $ | $ | $ | $ | |||||||||||||||||||
| 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, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net income | $ | $ | $ | $ | |||||||||||||||||||
Other comprehensive income (loss), net of tax (Note 12): | |||||||||||||||||||||||
| Foreign currency translation adjustments | ( | ( | |||||||||||||||||||||
Unrealized gain (loss) on hedges | ( | ( | ( | ||||||||||||||||||||
Unrealized pension credits | |||||||||||||||||||||||
Unrealized gain on available-for-sale investments | |||||||||||||||||||||||
Other comprehensive income (loss), net of tax | ( | ( | ( | ||||||||||||||||||||
| Comprehensive income | |||||||||||||||||||||||
Comprehensive loss attributable to noncontrolling interest | ( | ( | ( | ( | |||||||||||||||||||
| Comprehensive income attributable to Edwards Lifesciences Corporation | $ | $ | $ | $ | |||||||||||||||||||
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, | |||||||||||
| 2025 | 2024 | ||||||||||
| 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) | |||||||||||
Gain on sale of business | ( | ||||||||||
Intangible assets impairment charges | |||||||||||
Change in fair value of contingent consideration liabilities | ( | ||||||||||
| Deferred income taxes | ( | ( | |||||||||
Gain on remeasurement of previously held interest upon acquisition | ( | ||||||||||
Loss on impairment | |||||||||||
| 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 | ( | ||||||||||
| Intellectual property agreement accrual | ( | ( | |||||||||
| Other | ( | ( | |||||||||
| Net cash provided by operating activities | |||||||||||
| Cash flows from investing activities | |||||||||||
| Capital expenditures | ( | ( | |||||||||
| Investments in unconsolidated affiliates | ( | ( | |||||||||
Purchases of held-to-maturity investments (Note 5) | ( | ( | |||||||||
Proceeds from held-to-maturity investments (Note 5) | |||||||||||
Purchases of available-for-sale investments (Note 5) | ( | ( | |||||||||
Proceeds from available-for-sale investments (Note 5) | |||||||||||
| Investments in intangible assets | ( | ||||||||||
Payment for working capital adjustment and sale of product group (Note 4) | ( | ||||||||||
| Business combinations, net of cash | ( | ||||||||||
| Payment for acquisition options | ( | ( | |||||||||
| Issuances of notes receivable | ( | ( | |||||||||
| Other | ( | ( | |||||||||
| Net cash (used in) provided by investing activities | ( | ||||||||||
| Cash flows from financing activities | |||||||||||
| Purchases of treasury stock | ( | ( | |||||||||
Equity forward contract related to accelerated share repurchase agreement (Note 10) | ( | ||||||||||
Purchase of remaining noncontrolling interest in subsidiary (Note 6) | ( | ||||||||||
| 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 (decrease) 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 (Note 2) | $ | $ | |||||||||
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 Edwards Lifesciences Corporation Stockholders' Equity | Noncontrolling Interest | Total Stockholders' Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued under stock plans and other | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2025 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive loss, net of tax | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued under stock plans and other | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2025 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income, net of tax | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued under stock plans and other | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Purchase of noncontrolling interest | ( | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2025 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
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 Edwards Lifesciences Corporation Stockholders' Equity | Noncontrolling Interest | Total Stockholders' Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive gain, net of tax | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued under stock plans | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2024 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive gain, net of tax | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued under equity plans | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of treasury stock | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2024 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
| 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, 2024 | $ | $ | ( | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||
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 U.S. 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, 2024. 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. Certain reclassifications have been made to prior period financial statements to conform to classifications used in the current period.
The consolidated condensed financial statements include the accounts of all wholly-owned subsidiaries and variable interest entities (“VIEs”) for which the Company is the primary beneficiary. The Company attributes the net income or losses of its consolidated VIE to controlling and noncontrolling interests using the hypothetical liquidation at book value method. All intercompany accounts and transactions have been eliminated in consolidation.
On September 3, 2024, the Company sold its Critical Care product group (“Critical Care”). The historical results of Critical Care are reflected as discontinued operations in the Company's consolidated condensed financial statements through the date of disposition. In addition, as a next step in the Company's disposal plan to exit businesses that are not focused on implantable medical innovations for structural heart disease, the historical results of a small non-core product group that the Company planned to sell are also included in discontinued operations for all periods presented. Unless otherwise indicated, the information in the notes to the consolidated condensed financial statements refer only to Edwards Lifesciences' continuing operations. For more information, see Note 4.
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 the opinion of management, the unaudited 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 Note 2 to the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024.
New Accounting Standards Not Yet Adopted
In September 2025, the Financial Accounting Standards Board (“FASB”) issued accounting guidance on derivatives and hedging and revenue from contracts with customers. The amendment provides clarity on application of derivative accounting to contracts with features based on operations or activities of one of the parties to the contract and the diversity in accounting for share-based noncash consideration from a customer that is consideration for the transfer of goods and services. The guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within those periods and can be applied on a prospective or modified retrospective basis. Early adoption is permitted. The Company is currently evaluating the impact the guidance will have on its consolidated financial statements.
In September 2025, the FASB issued accounting guidance on Internal-Use Software related to accounting for internal-use software costs. The amendment in this update improve the operability of the guidance by clarifying the criteria for capitalization, which begins when both of the following occur: (1) management has authorized and committed to funding the software project and (2) it is probable that the project will be completed and the software will be used to perform the function intended. The guidance is effective for fiscal years beginning after December 15, 2027, and interim periods within those periods. Early adoption is permitted. The guidance can be applied on a fully prospective basis, a modified basis for in-process projects, or a full retrospective basis. The Company is currently evaluating the impact the guidance will have on its consolidated financial statements.
7
In November 2024, the FASB issued an amendment to the accounting guidance on income statement presentation to require disclosure, in the notes to the financial statements, of disaggregated information about certain costs and expenses, including purchases of inventory, employee compensation, and depreciation and amortization included in each relevant expense caption within continuing operations. The guidance is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. The Company is currently evaluating the impact the guidance will have on its consolidated financial statements.
In December 2023, the FASB issued an amendment to the accounting guidance on income taxes, which requires entities to provide additional information in the rate reconciliation and additional disaggregated disclosures about income taxes paid. This guidance requires public entities to disclose in their rate reconciliation table additional categories of information about federal, state, and foreign income taxes and to provide more details about the reconciling items in some categories if the items meet a quantitative threshold. The guidance is effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of this guidance to impact its financial statements, but expects that the guidance will impact its income tax disclosures.
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, 2025 | December 31, 2024 | ||||||||||
| Inventories | |||||||||||
| Raw materials | $ | $ | |||||||||
| Work in process | |||||||||||
| Finished products | |||||||||||
| $ | $ | ||||||||||
At September 30, 2025 and December 31, 2024, $216.3 million and $181.7 million, respectively, of the Company's finished products inventories were held on consignment.
8
| September 30, 2025 | December 31, 2024 | ||||||||||
| Other assets | |||||||||||
Tax receivable (Note 14) | $ | $ | |||||||||
| Notes and other receivables | |||||||||||
| Acquisition options | |||||||||||
| Long-term prepaid royalties | |||||||||||
| Fair value of derivatives | |||||||||||
| Other long-term assets | |||||||||||
| $ | $ | ||||||||||
| Accrued and other liabilities | |||||||||||
| Employee compensation and withholdings | $ | $ | |||||||||
| Accrued rebates | |||||||||||
| Taxes payable | |||||||||||
Legal and insurance accrual | |||||||||||
| Property, payroll, and other taxes | |||||||||||
| Liability under transition services agreement | |||||||||||
| Research and development accruals | |||||||||||
| Litigation settlement | |||||||||||
| Fair value of derivatives | |||||||||||
| Unfavorable contract liability | |||||||||||
| Accrued professional services | |||||||||||
| Accrued realignment reserves | |||||||||||
| Accrued marketing expenses | |||||||||||
| Accrued relocation costs | |||||||||||
| Other accrued liabilities | |||||||||||
| $ | $ | ||||||||||
Supplemental Cash Flow Information
(in millions)
| Nine Months Ended September 30, | |||||||||||
| 2025 | 2024 | ||||||||||
| Cash paid during the year for: | |||||||||||
Income taxes (a) (Note 14) | $ | $ | |||||||||
| Amounts included in the measurement of operating lease liabilities | $ | $ | |||||||||
| Non-cash investing and financing transactions: | |||||||||||
| Right-of-use assets obtained in exchange for new lease liabilities | $ | $ | |||||||||
| Capital expenditures accruals | $ | $ | |||||||||
______________________________________
(a) Includes $29.7 million of cash paid for income taxes from discontinued operations for the nine months ended September 30, 2024. No cash was paid for income taxes from discontinued operations for the nine months ended September 30, 2025.
9
Cash, Cash Equivalents, and Restricted Cash
(in millions)
| September 30, 2025 | December 31, 2024 | ||||||||||
| Continuing operations | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Restricted cash included in other current assets | |||||||||||
| Restricted cash included in other assets | |||||||||||
| Total | $ | $ | |||||||||
| Discontinued operations | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Total | $ | $ | |||||||||
| Total cash, cash equivalents, and restricted cash | $ | $ | |||||||||
Amounts included in restricted cash primarily represent funds placed in escrow related to litigation.
Intangible Assets
In August 2025, the Company recorded a $40.0 million charge related to the full impairment of certain developed technology assets due to management’s determination that the assets are no longer expected to generate future economic benefit. The impairment was recognized in Intangible Assets Impairment Charges within operating income on the consolidated condensed statement of operations during the three and nine months ended September 30, 2025. There were no
3. RESTRUCTURING CHARGES AND SEPARATION COSTS
In September 2024, the Company recorded an expense of $32.9 million related primarily to severance expenses associated with a global workforce realignment impacting approximately 2 % of the Company's employees. The following table presents details of the restructuring liability, which is included in Accrued and Other Liabilities (in millions):
| Restructuring Liability | |||||
Balance at December 31, 2024 | $ | ||||
| Payments | ( | ||||
Balance at September 30, 2025 | $ | ||||
The Company's remaining severance obligations are expected to be substantially paid by the end of 2025.
In the three and nine months ended September 30, 2025, the Company recorded expenses of $0.1 million and $8.5 million, respectively, primarily related to costs incurred for professional advisory services associated with the sale of Critical Care. For further information, see Note 4.
4. DISCONTINUED OPERATIONS
On June 3, 2024, the Company entered into a definitive agreement to sell Critical Care to Becton, Dickinson and Company (“BD”), and the sale was completed on September 3, 2024. In addition, as a next step in the Company's disposal plan to exit businesses that are not focused on implantable medical innovations for structural heart disease, the Company had committed to a plan to sell a non-core product group, with the sale expected to be completed in the fourth quarter of 2025.
Critical Care and the aforementioned non-core product group (collectively, the “discontinued product groups”) were historically reported in each of the Company's segments (United States, Europe, Japan, and Rest of World).
10
The Company concluded that the Critical Care product group met the criteria to be classified as held-for-sale in June 2024 and that the non-core product group met the criteria to be classified as held-for-sale in September 2024. For more information, see Note 16. The Company determined that, when considered together, the conditions for discontinued operations presentation had been met with respect to the discontinued product groups. A component of an entity is reported in discontinued operations after meeting the criteria for held-for-sale classification if the disposition represents a strategic shift that has (or will have) a major effect on the entity's operations and financial results. The Company analyzed the quantitative and qualitative factors relevant to the discontinued product groups, including their significance to the Company’s overall net income and total assets, and determined that those conditions for discontinued operations presentation had been met. As such, the historical financial condition and results of the discontinued product groups have been reflected as discontinued operations in the Company's consolidated condensed financial statements. The assets and liabilities associated with the discontinued product groups are classified as assets and liabilities of discontinued operations in the Company's consolidated condensed balance sheets. Prior period amounts have been adjusted to reflect the discontinued operations presentation.
In connection with the sale of Critical Care, the Company entered into a Transition Services Agreement (“TSA”) to provide certain support services for up to 36 months from the closing date of the sale (with certain extension rights as provided therein). These support services may be in the areas of accounting, information technology, human resources, quality assurance, regulatory affairs, customer support, and global supply chain, among others. In connection with the TSA, the Company recorded an unfavorable contract liability of $115.1 million, which will be recognized over the TSA term. As of September 30, 2025, the remaining unfavorable contract liability was $47.1 million, included in Accrued and Other Liabilities and Other Liabilities.
In addition, Edwards and BD entered into other agreements to provide a framework for the ongoing activities between the Company and BD after the sale and until the end of the TSA including, but not limited to, a manufacturing and supply agreement, a quality agreement, and interim operating model agreements to support the commercial operations until full transfer of all regulatory licenses to BD and completion of services under the TSA agreement. Under these agreements, the Company will continue to provide certain services to BD during the term of these agreements including serving as an undisclosed selling and purchasing agent for the Critical Care product group on behalf of BD for a period of up to 36 months.
As of September 30, 2025, the Company had a net payable of approximately $84.4 million to BD related to the services under the agreements. The Company recorded income from the TSA of $12.7 million and $50.5 million, respectively, during the three and nine months ended September 30, 2025, which is recorded in Other Operating (Income) Expense, net on the Company's consolidated condensed statements of operations.
During the nine months ended September 30, 2025, the Company paid BD $36.3 million for certain working capital adjustments in connection with the sale of Critical Care.
Details of Income from Discontinued Operations are as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net sales | $ | $ | $ | $ | |||||||||||||||||||
| Cost of sales | |||||||||||||||||||||||
| Gross profit | |||||||||||||||||||||||
| Selling, general, and administrative expenses | |||||||||||||||||||||||
| Research and development expenses | |||||||||||||||||||||||
| Separation costs | |||||||||||||||||||||||
Operating loss, net | ( | ( | ( | ( | |||||||||||||||||||
Other non-operating (income) expense, net | ( | ( | |||||||||||||||||||||
| (Loss) income from discontinued operations before provision for income taxes | ( | ( | |||||||||||||||||||||
(Benefit) provision from income taxes from discontinued operations | ( | ( | |||||||||||||||||||||
(Loss) income from discontinued operations, net of tax | $ | ( | $ | $ | ( | $ | |||||||||||||||||
11
Separation costs related primarily to consulting, legal, tax, and other professional advisory services associated with the sale of Critical Care and non-core product group.
Details of assets and liabilities of discontinued operations are as follows (in millions):
| September 30, 2025 | December 31, 2024 | ||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Accounts receivable, net of allowances | |||||||||||
| Inventories | |||||||||||
| Prepaid expenses | |||||||||||
| Total current assets of discontinued operations | $ | $ | |||||||||
| Property, plant, and equipment, net | $ | $ | |||||||||
| Operating lease right-of-use assets | |||||||||||
| Goodwill | |||||||||||
| Total non-current assets of discontinued operations | $ | $ | |||||||||
| Accrued and other liabilities | $ | $ | |||||||||
| Operating lease liabilities | |||||||||||
| Total current liabilities of discontinued operations | $ | $ | |||||||||
| Operating lease liabilities | |||||||||||
| Total non-current liabilities of discontinued operations | $ | $ | |||||||||
Cash flows attributable to the Company's discontinued operations are included in the Company's consolidated condensed statements of cash flows. Significant non-cash operating and investing activities attributable to discontinued operations consisted of the following (in millions):
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| Depreciation and amortization | $ | $ | |||||||||||||||||||||
| Stock-based compensation | $ | $ | |||||||||||||||||||||
| Inventory reserves and write offs | $ | $ | |||||||||||||||||||||
| Capital expenditures | $ | $ | |||||||||||||||||||||
12
5. INVESTMENTS
Debt Securities
Investments in debt securities at the end of each period were as follows (in millions):
| September 30, 2025 | December 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||
| U.S. 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, 2025, were as follows (in millions):
| Held-to-Maturity | Available-for-Sale | ||||||||||||||||||||||
| Amortized Cost | Fair Value | Amortized Cost | Fair Value | ||||||||||||||||||||
| Due in 1 year or less | $ | $ | $ | $ | |||||||||||||||||||
| Due after 1 year through 5 years | |||||||||||||||||||||||
Instruments not due at a single maturity date (a) | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
_______________________________________
(a) Consists of mortgage-backed and 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, 2025 and December 31, 2024, aggregated by investment category and the length of time that individual securities have been in a continuous loss position (in millions):
| September 30, 2025 | |||||||||||||||||||||||||||||||||||
| Less than 12 Months | 12 Months or Greater | Total | |||||||||||||||||||||||||||||||||
| Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | ||||||||||||||||||||||||||||||
| U.S. government and agency securities | $ | $ | $ | $ | ( | $ | $ | ( | |||||||||||||||||||||||||||
| Asset-backed securities | ( | ( | ( | ||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | ( | |||||||||||||||||||||||||||||||||
| $ | $ | ( | $ | $ | ( | $ | $ | ( | |||||||||||||||||||||||||||
13
| December 31, 2024 | |||||||||||||||||||||||||||||||||||
| Less than 12 Months | 12 Months or Greater | Total | |||||||||||||||||||||||||||||||||
| Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | Fair Value | Gross Unrealized Losses | ||||||||||||||||||||||||||||||
| U.S. 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 financial condition and near-term prospects of the issuer, including the credit quality of the security's issuer, (2) the Company's intent to sell the security, and (3) whether it is more likely than not the Company will have to sell the security before recovery of its amortized cost. The unrealized losses on the debt securities were largely due to changes in interest rates, not credit quality, and as of September 30, 2025, the Company did not intend to sell the securities, and it was not more likely than not that it would be required to sell the securities before recovery of the unrealized losses, and, therefore, the unrealized losses are considered temporary.
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 (in millions):
| September 30, 2025 | December 31, 2024 | ||||||||||
| Equity method investments | |||||||||||
| Carrying value of equity method investments | $ | $ | |||||||||
| Equity securities | |||||||||||
| Carrying value of marketable equity securities | |||||||||||
| Carrying value of non-marketable equity securities | |||||||||||
| Total investments in unconsolidated entities | $ | $ | |||||||||
The Company makes equity investments in limited liability companies that invest in qualified community development entities 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. The NMTC is equal to 39 % of the qualified investment and is taken over seven years . These limited liability companies are 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.
Marketable equity securities consist of investments with readily determinable fair values over which the Company does not own a controlling interest or exercise significant influence. 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, 2025, the Company recorded cumulative upward adjustments of $9.4 million based on observable price changes and cumulative downward adjustments of $7.0 million due to impairments and observable price changes.
6. INVESTMENTS IN VARIABLE INTEREST ENTITIES
The Company reviews its investments in other entities to determine whether the Company is the primary beneficiary of a VIE. The Company would be the primary beneficiary of the VIE, and would be required to
14
consolidate the VIE, if it has the power to direct the significant activities of the entity and the obligation to absorb losses or receive benefits from the entity that may be significant to the VIE. The Company's maximum loss exposure to VIEs, prior to the exercise of options to acquire the entities, is limited to its investment in the VIEs, which include equity investments, options to acquire, and promissory notes.
Purchase of noncontrolling interest
In February 2023, the Company acquired a majority equity interest in Vectorious Medical Technologies (“Vectorious”) pursuant to a preferred stock purchase agreement, and amended and restated a previous option agreement to acquire the remaining equity interest. Edwards concluded that it was the primary beneficiary and consolidated Vectorious. During the three months ended September 30, 2025, the Company acquired the remaining noncontrolling interest of Vectorious for $233.7 million, increasing the Company's total ownership from 61 % to 100 %. The acquisition was accounted for as an equity transaction as there was no change in control. The carrying value of the noncontrolling interest at the acquisition date was $60.4 million. The difference between the fair value of consideration paid and the carrying value was recognized as an adjustment to additional paid-in capital of $173.3 million. No gain or loss was recognized in the consolidated condensed statements of operations.
The effects of changes in the Company's ownership interest on the Company's stockholders' equity are as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net income attributable to Edwards Lifesciences Corporation | $ | $ | $ | $ | |||||||||||||||||||
Transfer to the noncontrolling interest: | |||||||||||||||||||||||
Decrease in additional paid-in capital for purchase of noncontrolling interest | ( | ( | |||||||||||||||||||||
Transfer to the noncontrolling interest | ( | ( | |||||||||||||||||||||
Change from net income attributable to Edwards Lifesciences Corporation and transfer to noncontrolling interest | $ | $ | $ | $ | |||||||||||||||||||
Unconsolidated VIEs
Edwards has relationships with various VIEs that it does not consolidate as Edwards lacks the power to direct the activities that significantly impact the economic success of these entities.
In July 2024, the Company entered into an Agreement and Plan of Merger (“the Agreement”) to acquire JenaValve Technology, Inc. (“JenaValve”). Concurrently, the Company entered into a Promissory Note agreement (the “Promissory Note”) to loan JenaValve up to $75.0 million. The Promissory Note includes an automatic funding extension clause whereby the Company will continue to fund up to an additional $30.0 million through January 23, 2026, provided that the Agreement remains in effect and has not been terminated or expired. As of September 30, 2025 and December 31, 2024, the Company had advanced $75.0 million and $15.0 million, respectively, under the Promissory Note (included in Other Assets on the consolidated condensed balance sheets). The Agreement includes certain termination clauses under which, if the Agreement is terminated under specified circumstances, the Company will be required to forgive the outstanding Promissory Note as of the termination date and invest in a $45.0 million convertible promissory note as a termination loan. On August 6, 2025, the United States Federal Trade Commission moved to block the proposed acquisition of JenaValve, alleging anticompetitive concerns. The Company intends to continue to pursue regulatory approval of the acquisition and estimates a final determination by the court regarding such acquisition by the end of the first quarter of 2026. In October 2025, the Company advanced an additional $7.5 million under the Promissory Note.
In August 2022, the Company entered into an option agreement with a medical device company. Under the option agreement, the Company paid $47.1 million for an option to acquire the medical device company, which was included in Other Assets on the consolidated balance sheets as of December 31, 2024. In June 2025, the Company decided not to exercise its option to acquire the medical device company due to slower than anticipated progress by the medical device company toward achieving commercialization of the product. As a result, the Company recognized a $47.1 million loss on impairment, included in Loss on Impairment within non-operating income on the consolidated condensed statement of operations. During the three months ended September 30, 2025, the
15
Company entered into a simple agreement for future equity where it invested $10.0 million in the medical device company’s stock (included in Other Assets).
In April 2021, the Company entered into a promissory note agreement, a preferred stock purchase agreement, and an option agreement with a privately-held medical device company (the “Investee”). The secured promissory note provides for borrowings up to $45.0 million. In April 2025, the Company invested $1.8 million in the Investee's preferred equity securities and $4.0 million for the option to acquire the Investee. In August 2025, the Company invested an additional $1.2 million in the Investee’s preferred equity securities and $2.6 million for the option to acquire the Investee. At both September 30, 2025 and December 31, 2024, the Company had advanced a total of $45.0 45.8 million and $42.8 million, respectively, in the Investee's preferred equity securities (included in Long-term Investments) and had paid $27.5 million and $20.9 million, respectively, for an option to acquire the Investee (included in Other Assets). In October 2025, the Company advanced an additional $15.0 million under the promissory note.
In December 2024, the Company entered into an option agreement and an amended preferred stock purchase agreement with a medical technology company. The Company had previously made an investment in preferred equity securities of the medical technology company under a prior preferred stock purchase agreement in 2021. Under the agreements, the Company paid $30.0 million in December 2024 for an option to acquire the medical technology company. The Company had invested $20.0 million in the preferred equity securities as of December 31, 2024. In addition, in May 2025, under the terms of the agreements, the Company paid an additional $10.0 million for the option and invested $15.0 million in the medical technology company’s preferred equity securities upon the medical technology company’s achievement of a pre-defined milestone. The Company also agreed to loan the medical technology company up to $40.0 million upon the medical technology company's achievement of certain milestones. As of September 30, 2025 and December 31, 2024, the Company had invested $35.0 million and $20.0 million, respectively, in the medical technology company's preferred equity securities (included in Long-term Investments), and $40.0 million and $30.0 million, respectively, in the option to acquire the medical technology company (included in Other Assets).
In February 2019, the Company entered into a warrant agreement with a medical device company and paid $35.0 million for an option to acquire the medical device company. In June 2022, the Company entered into a convertible promissory note with the medical device company. Under the convertible promissory note agreement, the Company agreed to loan the medical device company up to $47.5 million. In June 2025, the Company entered into a new convertible promissory note agreement to loan the medical device company up to $30.0 million and amended its warrant agreement to provide the Company with the option to extend the warrant right period for consideration of $16.5 million. As of September 30, 2025 and December 31, 2024, the Company had advanced $77.5 million and $47.5 million, respectively, under the promissory notes (included in Other Assets). The $35.0
In June 2025, the Company entered into a preferred share purchase agreement with a medical solutions company, under which the Company invested $30.0 million in the medical solutions company's preferred equity securities (included in Long-term Investments).
In addition, Edwards has made equity investments through the NMTC program in limited liability companies that are considered VIEs. For more information, see Note 5.
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.
16
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, 2025, the fair value of the notes payable, based on Level 2 inputs, was $602.2 million.
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, 2025 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
| Assets | |||||||||||||||||||||||
| Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Available-for-sale investments: | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Asset-backed securities | |||||||||||||||||||||||
| U.S. government and agency securities | |||||||||||||||||||||||
| Commercial paper | |||||||||||||||||||||||
| Equity investments in unconsolidated entities | |||||||||||||||||||||||
| Investments held for deferred compensation plans | |||||||||||||||||||||||
| Derivatives | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| Liabilities | |||||||||||||||||||||||
| Derivatives | $ | $ | $ | $ | |||||||||||||||||||
| Contingent consideration liabilities | |||||||||||||||||||||||
| Other | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| December 31, 2024 | |||||||||||||||||||||||
| Assets | |||||||||||||||||||||||
| Cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Available-for-sale investments: | |||||||||||||||||||||||
| Bank time deposits | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Asset-backed securities | |||||||||||||||||||||||
| U.S. government and agency securities | |||||||||||||||||||||||
| Commercial paper | |||||||||||||||||||||||
| Municipal securities | |||||||||||||||||||||||
| Equity investments in unconsolidated entities | |||||||||||||||||||||||
| Investments held for deferred compensation plans | |||||||||||||||||||||||
| Derivatives | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| Liabilities | |||||||||||||||||||||||
| Derivatives | $ | $ | $ | $ | |||||||||||||||||||
| Contingent consideration liabilities | |||||||||||||||||||||||
| Other | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
17
Cash Equivalents and Available-for-sale Investments
Cash equivalents included money market funds for the periods presented above. 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 corporate debt securities, asset-backed securities, commercial paper, United States and foreign government and agency securities, and municipal 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.
Deferred Compensation Plans
The Company holds investments 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 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 derivative instruments are recognized on the balance sheet at their fair value. Fair value was measured using quoted foreign exchange rates, interest rates, yield curves, and cross-currency swap basis rates. The estimates presented herein are not necessarily indicative of the amounts that the Company could realize in a current market exchange.
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 include (1) the discount rate used to calculate the present value of the projected cash flows (ranging from 3.6 % to 11.6 %; with a weighted average of 11.4 %), (2) the probability of milestone achievement (ranging from 0 % to 60 %; with a weighted average of 60 %), (3) the projected payment dates (ranging from 2028 to 2032; with a weighted average of 2032), and (4) the volatility of future revenue (25 %). 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.
During the three and nine months ended September 30, 2025, the Company recorded $12.5
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The following tables summarize the changes in fair value of Level 3 financial instruments measured at fair value on a recurring basis (in millions):
| Contingent Consideration | Other | Total | |||||||||||||||
Balance at December 31, 2024 | $ | $ | $ | ||||||||||||||
| Payments | ( | ( | |||||||||||||||
| Changes in fair value | ( | ( | |||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | ||||||||||||||
| Contingent Consideration | Other | Total | |||||||||||||||
Balance at December 31, 2023 | $ | $ | $ | ||||||||||||||
| Additions | |||||||||||||||||
| Changes in fair value | ( | ( | |||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | ||||||||||||||
8. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES
The Company uses derivative financial instruments to manage its currency exchange rate risk and interest rate risk as summarized below. Notional amounts are stated in United States dollar equivalents at spot exchange rates at the respective dates. The Company does not enter into these arrangements for trading or speculation purposes.
| Notional Amount | |||||||||||
| September 30, 2025 | December 31, 2024 | ||||||||||
| (in millions) | |||||||||||
| Foreign currency forward exchange contracts | $ | $ | |||||||||
| Cross-currency swap contracts | |||||||||||
Derivative financial instruments involve credit risk in the event the counterparty should default. 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 1.5 years (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 foreign 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
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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, 2025 | December 31, 2024 | |||||||||||||||||
| Foreign currency contracts | Other current assets | $ | $ | |||||||||||||||||
| Foreign currency contracts | Other assets | $ | $ | |||||||||||||||||
| Cross-currency swap contracts | Other assets | $ | $ | |||||||||||||||||
| Foreign currency contracts | Accrued and other liabilities | $ | $ | |||||||||||||||||
| Foreign currency contracts | Other liabilities | $ | $ | |||||||||||||||||
| Derivatives not designated as hedging instruments | ||||||||||||||||||||
| Liabilities | ||||||||||||||||||||
| Foreign currency contracts | Accrued and other liabilities | $ | $ | |||||||||||||||||
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, 2025 | 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, 2024 | |||||||||||||||||||||||||||||||||||
| Derivative assets | |||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||
| Cross-currency swap contracts | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||
| Derivative liabilities | |||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||
The following table presents 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):
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| Amount of Gain or (Loss) Recognized in Other Comprehensive Income on Derivative (Effective Portion) | ||||||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||||||
| Cash flow hedges | ||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||
| Net investment hedges | ||||||||||||||||||||||||||
| Cross-currency swap contracts | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
The cross-currency swap contracts have an expiration date of June 15, 2028. At the maturity of the cross-currency swap contracts, the Company will deliver the notional amount of €257.2 million and will receive $300.0 million from the counterparties. The Company receives semi-annual interest payments from the counterparties based on a fixed interest rate until maturity of the agreements.
The following tables present the effect of derivative instruments on the consolidated condensed statements of operations (in millions):
| Location and Amount of Gain or (Loss) Recognized in Income | |||||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2025 | Nine Months Ended September 30, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||
| Cost of sales | Interest income, net | Other non-operating income, net | Cost of sales | Interest income, net | Other non-operating income, net | ||||||||||||||||||||||||||||||||||||||||||
| Total amounts presented in the consolidated condensed statements of operations | $ | ( | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
| The effects of cash flow hedges: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
| Amount of gain (loss) reclassified from accumulated other comprehensive loss into income | $ | ( | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||||||
| The effects of net investment hedges: | |||||||||||||||||||||||||||||||||||||||||||||||
| Cross currency swap contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
| Amount excluded from effectiveness testing | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
| The effects of non-designated hedges: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | $ | $ | $ | ( | ||||||||||||||||||||||||||||||||||||||||
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| Location and Amount of Gain or (Loss) Recognized in Income | |||||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
| Cost of sales | Interest income, net | Other non-operating income, net | Cost of sales | Interest income, net | Other non-operating income, net | ||||||||||||||||||||||||||||||||||||||||||
| Total amounts presented in the consolidated condensed statements of operations | $ | ( | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
| The effects of fair value hedges: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
| Hedged items | $ | $ | $ | $ | $ | $ | ( | ||||||||||||||||||||||||||||||||||||||||
| Derivatives designated as hedging instruments | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
| Amount excluded from effectiveness testing (amortized) | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
| The effects of cash flow hedges: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
| Amount of gain (loss) reclassified from accumulated other comprehensive loss into income | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
| The effects of net investment hedges: | |||||||||||||||||||||||||||||||||||||||||||||||
| Cross currency swap contracts: | |||||||||||||||||||||||||||||||||||||||||||||||
| Amount excluded from effectiveness testing | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||||
| The effects of non-designated hedges: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency contracts | $ | $ | $ | ( | $ | $ | $ | ||||||||||||||||||||||||||||||||||||||||
The Company expects that during the next twelve months it will reclassify to earnings a $7.1 million loss currently recorded in Accumulated Other Comprehensive Loss.
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, 2025 and 2024 was as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| 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, 2025, 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 $324.1 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 31 months.
On May 8, 2025, the Company’s stockholders approved the amendment and restatement of the Company’s 2001 Employee Stock Purchase Plan for United States and international employees to (1) increase the total number of shares of the Company’s common stock available for issuance to the Company’s United States employees by 4.2 million shares to a new total share limit of 43.8 million shares, and (2) increase the total number of shares of the Company’s common stock available for issuance to the Company’s international employees by 1.5 million shares to a new total share limit of 12.3 million shares.
During the nine months ended September 30, 2025, the Company granted 1.8 million stock options at a weighted-average exercise price per share of $74.78 and 1.6 million restricted stock units at a weighted-average grant-date fair value per share of $75.01 . During the nine months ended September 30, 2025, the Company also
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granted 0.1 million market-based restricted stock units at a weighted-average grant-date fair value per share of $89.94 . The market-based restricted stock units granted during the nine months ended September 30, 2025 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 % of the target number of shares granted.
Fair Value Disclosures
The fair value of market-based restricted stock units was determined using a Monte Carlo simulation model, which uses multiple input variables to determine the probability of satisfying the market condition requirements. The weighted-average assumptions used to determine the fair value of the market-based restricted stock units granted during the nine months ended September 30, 2025 and 2024 included a risk-free interest rate of 3.8 % and 4.5 %, respectively, and an expected volatility rate of 37.9 % and 32.4 %, 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, | |||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Risk-free interest rate | |||||||||||||||||||||||
| Expected dividend yield | |||||||||||||||||||||||
| Expected volatility | |||||||||||||||||||||||
| Expected term (years) | |||||||||||||||||||||||
| Fair value, per option | $ | $ | $ | $ | |||||||||||||||||||
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, | |||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Risk-free interest rate | |||||||||||||||||||||||
| Expected dividend yield | |||||||||||||||||||||||
| Expected volatility | |||||||||||||||||||||||
| Expected term (years) | |||||||||||||||||||||||
| Fair value, per share | $ | $ | $ | $ | |||||||||||||||||||
10. ACCELERATED SHARE REPURCHASE
During 2025 and 2024, 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 of the Company's common stock during the term of the applicable agreements, 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 | |||||||||||||||||||||||||||||||||||||
| April 2024 | $ | $ | % | May 2024 | $ | |||||||||||||||||||||||||||||||||||||||
| August 2024 | $ | $ | % | December 2024 | $ | |||||||||||||||||||||||||||||||||||||||
| February 2025 | $ | $ | % | July 2025 | $ | |||||||||||||||||||||||||||||||||||||||
| August 2025 | $ | $ | % | September 2025 | $ | |||||||||||||||||||||||||||||||||||||||
The ASR agreements were 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,
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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 initially recorded in Additional Paid-in Capital and subsequently, upon settlement, was transferred to Treasury Stock on the consolidated condensed 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
On September 28, 2021, Aortic Innovations LLC, a non-practicing entity (“Plaintiff”), 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. Edwards obtained a judgment of non-infringement, which Plaintiff appealed, and argument was held before the U.S. Court of Appeals for the Federal Circuit on June 2, 2025. On October 27, 2025, the Federal Circuit affirmed the district court’s claim construction in favor of the Company. Plaintiff’s remaining claims were reassigned to Judge Noreika (Case No. 23-cv-00158) on June 18, 2025 and are proceeding. The Company cannot predict the outcome of the litigation or the potential impact on its financial statements. The Company is vigorously defending itself in this litigation.
The European Commission (the “Commission”) is investigating certain business practices of Edwards, including its unilateral pro-innovation (anti-copycat) policy and patent practices. The Company is cooperating with the Commission and believes its business practices support healthy competition. The Company cannot predict the outcome of the investigation or the potential impact on its financial statements.
On March 22, 2024, Fortis Advisors, LLC, in its capacity as the designated representative of the former stockholders of Harpoon Medical, Inc. filed suit against the Company in the Court of Chancery of the State of Delaware, alleging breach of the Agreement and Plan of Merger, dated December 8, 2015, by and between Harpoon Medical, Inc. and Edwards (the “Agreement”). Fortis seeks acceleration and payment of all contingent milestone payments in the Agreement. The trial is scheduled for December 2025. The Company is vigorously defending itself in this litigation.
On October 14, 2024, a purported stockholder of Edwards filed a putative securities class action (the “Securities Class Action”) complaint against the Company and certain of its executive officers in the United States District Court for the Central District of California, captioned Patel v. Edwards Lifesciences Corporation, et al., No. 24-cv-02221. The complaint alleges violations of various securities laws based on alleged false or misleading statements regarding our business prospects. The complaint seeks damages, interest, costs and other fees. On September 17, 2025, the Court held a hearing on the Company’s Motion to Dismiss, and on September 19, 2025, the Court granted in part and denied in part the motion.
On December 31, 2024, Plaintiff Manh Ho filed a shareholder derivative action in the United States District Court for the Central District of California, captioned Ho v. Zovighian, et al., Case No. 8:24-cv-02822, purportedly on behalf of Edwards against certain of its officers and directors for alleged violations of federal securities laws, breaches of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets (the “Ho Action”). On January 17, 2025, Plaintiff Barbara Sheridan filed a different shareholder derivative action in the United States District Court for the Central District of California, Sheridan v. Zovighian, et al., Case No. 8:25-cv-00097, purportedly on behalf of Edwards against certain of its officers and directors for similar alleged violations (the “Sheridan Action”). Both the Ho Action and the Sheridan Action are based on the same facts as the Securities Class Action. On April 10, 2025, the Court consolidated the Ho Action and the Sheridan Action. The Company cannot predict the outcome of the litigation or the potential impact on its financial statements. The Company intends to defend itself against the lawsuits vigorously.
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The Company is or may be a party to, or may otherwise be responsible for, other 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, the Company's operations or health care regulations, contingent consideration, commercial matters, 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 Company's financial results for that period.
As of September 30, 2025 and December 31, 2024, the Company has accrued an aggregate estimated liability of $85.5 million and $10.5 million, respectively, related to its outstanding legal proceedings within Accrued and Other Liabilities on the consolidated condensed balance sheets. The Company is not able to estimate the amount or range of any loss for legal contingencies related to outstanding legal proceedings for which there is no accrual or additional loss for matters for which an accrual has been taken.
The Company is subject to various environmental laws and regulations both within and outside of the United States. The Company's 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 the Company's financial results. The Company's threshold for disclosing material environmental legal proceedings involving a governmental authority where potential monetary sanctions are involved is $1 million.
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 (Loss) on Hedges | Unrealized Loss on Available-for-sale Investments | Unrealized Pension Costs | Total Accumulated Other Comprehensive Loss | |||||||||||||||||||||||||
| December 31, 2024 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
Other comprehensive income (loss) before reclassifications | ( | ||||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ( | |||||||||||||||||||||||||
Deferred income tax benefit (expense) | ( | ||||||||||||||||||||||||||||
| March 31, 2025 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
Other comprehensive income (loss) before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ( | |||||||||||||||||||||||||
Deferred income tax benefit (expense) | ( | ||||||||||||||||||||||||||||
| June 30, 2025 | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
Other comprehensive (loss) income before reclassifications | ( | ||||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ||||||||||||||||||||||||||
Deferred income tax expense | ( | ( | ( | ( | |||||||||||||||||||||||||
| September 30, 2025 | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
25
| Foreign Currency Translation Adjustments | Unrealized Gain (Loss) on Hedges | Unrealized Loss on Available-for-sale Investments | Unrealized Pension Costs | Total Accumulated Other Comprehensive Loss | |||||||||||||||||||||||||
| December 31, 2023 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
Other comprehensive (loss) income before reclassifications | ( | ||||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ||||||||||||||||||||||||||
Deferred income tax expense | ( | ( | ( | ( | ( | ||||||||||||||||||||||||
| March 31, 2024 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
Other comprehensive income (loss) before reclassifications | ( | ||||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ||||||||||||||||||||||||||
Deferred income tax (expense) benefit | ( | ( | ( | ||||||||||||||||||||||||||
| June 30, 2024 | $ | ( | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||
Other comprehensive income (loss) before reclassifications | ( | ( | |||||||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive loss | ( | ( | ( | ( | |||||||||||||||||||||||||
Deferred income tax benefit | |||||||||||||||||||||||||||||
| September 30, 2024 | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
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 | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||||||||
| Foreign currency translation adjustments | $ | $ | $ | $ | Other non-operating income, net | ||||||||||||||||||||||||
| ( | ( | ( | ( | Provision for income taxes | |||||||||||||||||||||||||
| $ | $ | $ | $ | Net of tax | |||||||||||||||||||||||||
(Loss) gain on hedges | $ | ( | $ | $ | $ | Cost of sales | |||||||||||||||||||||||
| Other non-operating income, net | |||||||||||||||||||||||||||||
| ( | Total before tax | ||||||||||||||||||||||||||||
| ( | ( | ( | Provision for income taxes | ||||||||||||||||||||||||||
| $ | ( | $ | $ | $ | Net of tax | ||||||||||||||||||||||||
Gain (loss) on available-for-sale investments | $ | $ | $ | $ | ( | Interest income, net | |||||||||||||||||||||||
| ( | ( | ( | Provision for income taxes | ||||||||||||||||||||||||||
| $ | $ | $ | $ | ( | Net of tax | ||||||||||||||||||||||||
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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, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net Income for Earnings Per Share Calculations: | |||||||||||||||||||||||
| Income from continuing operations, net of tax | $ | $ | $ | $ | |||||||||||||||||||
| Net loss attributable to noncontrolling interests | ( | ( | ( | ( | |||||||||||||||||||
| Income from continuing operations attributable to Edwards Lifesciences Corporation | |||||||||||||||||||||||
| (Loss) income from discontinued operations | ( | ( | |||||||||||||||||||||
| Net income attributable to Edwards Lifesciences Corporation | $ | $ | $ | $ | |||||||||||||||||||
| Weighted Average Shares: | |||||||||||||||||||||||
| Basic weighted-average shares outstanding | |||||||||||||||||||||||
| Dilutive effect of stock plans | |||||||||||||||||||||||
| Dilutive weighted-average shares outstanding | |||||||||||||||||||||||
| Earnings per Share: | |||||||||||||||||||||||
| Basic: | |||||||||||||||||||||||
| Continuing operations | $ | $ | $ | $ | |||||||||||||||||||
| Discontinued operations | ( | ||||||||||||||||||||||
| Basic earnings per share | $ | $ | $ | $ | |||||||||||||||||||
| Diluted: | |||||||||||||||||||||||
| Continuing operations | $ | $ | $ | $ | |||||||||||||||||||
| Discontinued operations | ( | ||||||||||||||||||||||
| Diluted earnings per share | $ | $ | $ | $ | |||||||||||||||||||
Stock options, restricted stock units, and market-based restricted stock units to purchase an aggregate of 7.5 million and 10.4 million common shares for the three months ended September 30, 2025 and 2024, respectively, and 8.3 million and 7.8 million shares for the nine months ended September 30, 2025 and 2024, respectively, were outstanding but were not included in the computation of diluted earnings per share for such periods because the effect would have been anti-dilutive.
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14. INCOME TAXES
The Company's effective income tax rate attributable to continuing operations was 16.1 % and 10.1 % for the three months ended September 30, 2025 and 2024, respectively, and 16.1 % and 9.2 % for the nine months ended September 30, 2025 and 2024, respectively. The increase in the effective rate between the nine months ended September 30, 2025 and 2024 was primarily due to an increase in global minimum tax (“Pillar Two,” as noted below), a decrease in the tax benefit from employee share-based compensation, and a decrease in the benefit from favorable global income tax audit settlements. In addition, the effective rates for the nine months ended September 30, 2025 and 2024 were lower than the federal statutory rate of 21% primarily due to (1) foreign earnings taxed at lower rates, (2) United States federal and California research and development credits, and (3) the tax benefit from employee share-based compensation. The effective rates include a tax benefit (shortfall) from employee share-based compensation attributable to continuing operations of $(0.3 ) million and $0.6 million for the three months ended September 30, 2025 and 2024, respectively, and $0.8 million and $10.1 million for the nine months ended September 30, 2025 and 2024, respectively.
Many countries are implementing some or all of the Organisation for Economic Co-operation and Development’s Base Erosion and Profit Shifting Pillar Two (“Pillar Two”) rules that impose a global minimum tax of 15% on reported profits. Although Pillar Two provides a framework for applying the minimum tax, countries may enact Pillar Two slightly differently than the model rules and on different timelines and may adjust domestic tax incentives in response to Pillar Two. In addition, in January 2025, the United States issued an executive order announcing opposition to aspects of these rules. As countries continue to enact and refine the Pillar Two rules, the Company will evaluate the potential effects of Pillar Two on its effective tax rate. In 2025, the Company expects the Pillar Two provisions to result in additional tax expense of approximately $50 million.
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 financial condition and results of operations. The Company strives to resolve open matters with each tax authority at the examination level and could reach an 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 materially different from that reflected in the consolidated financial statements. Furthermore, the Company may later decide to challenge any assessments, if made, and may exercise its right to appeal. 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, 2025 and December 31, 2024, the gross liability recorded for income taxes associated with uncertain tax positions was $746.9 million and $678.8 million, respectively. The Company estimates that these liabilities would be reduced by $362.6 million and $319.9 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 $384.3 million and $358.9 million, respectively, if not required, would favorably affect the Company's effective tax rate. Management believes that adequate amounts of tax and related penalty and interest have been provided for any adjustments that may result from these uncertain tax positions.
In the first quarter of 2022, the Company executed an Advance Pricing Agreement (“APA”) between Japan and Switzerland covering distribution transactions for tax years 2020 through 2024, and in 2023, the Company executed an APA between Japan and the United States covering tax years 2020 through 2024. The Company also executed an APA in the fourth quarter of 2024 between Japan and Singapore covering tax years 2022 through 2026 with roll-back terms to cover the distribution of transcatheter aortic valve replacement (“TAVR”) products beginning in 2020 and the distribution of Surgical Structural Heart (“Surgical”) products beginning in 2018. Also in the fourth quarter of 2024, the Company filed with the Japanese tax authorities an APA renewal application between Japan and the United States covering tax years 2025 through 2029. The Company filed the APA renewal application with the United States tax authorities in the first quarter of 2025 and is engaged in ongoing discussions.
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 completed during the second quarter of 2021, except for transfer pricing and related matters. The IRS is currently examining the 2018 through 2020 tax years.
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At September 30, 2025, all material state, local, and foreign income tax matters have been concluded for years through 2015.
During 2021, the Company received a Notice of Proposed Adjustment (“NOPA”) from the IRS for the 2015 through 2017 tax years relating to transfer pricing involving Surgical/TAVR intercompany royalty transactions between the Company's United States and Switzerland subsidiaries. The NOPA proposed a substantial increase to the Company's United States taxable income, which could result in additional tax expense for the 2015 through 2017 period of approximately $255 million and reflects a departure from a transfer pricing method the Company had previously agreed upon with the IRS. The Company disagreed with the NOPA and pursued an administrative appeal with the IRS Independent Office of Appeals (“Appeals”). The Appeals process culminated in the third quarter of 2023 when the Company and Appeals concluded that a satisfactory resolution of the matter at the administrative level was not possible.
During the fourth quarter of 2023, Appeals issued a notice of deficiency (“NOD”) increasing the Company's 2015 through 2017 United States federal income tax in amounts resulting from the income adjustments previously reflected in the NOPA. The additional tax sought in excess of the Company's filing position is $269.3 million before consideration of interest and a repatriation tax offset.
The Company plans to vigorously contest the additional tax claimed by the IRS through the judicial process. Final resolution of this matter is not likely within the next 12 months. The Company believes the amounts previously accrued related to this uncertain tax position are appropriate for a number of reasons, including the interpretation and application of relevant tax laws and accounting standards to the Company's facts and, accordingly, has not accrued any additional amount based on the NOD and other proceedings to date. Nonetheless, the outcome of the judicial process cannot be predicted with certainty, and it is possible that the outcome of that process could have a material impact on the Company's consolidated financial statements. As noted below, similar material tax disputes may arise for the 2018 through 2024 tax years. The Company made deposits with the IRS of $75 million in November 2022, and $305.1 million in March 2024, to prevent the further accrual of interest on that portion of any additional tax and interest the Company may ultimately be found to owe while the Company prepares to contest through the judicial process the IRS's entitlement to any of the additional tax claimed by the IRS. The IRS converted those deposits to advance payments and, on December 20, 2024, the Company filed administrative claims for refunds of those payments with the IRS for the 2015 through 2017 tax years. Though the IRS could still deny those refund claims, the Company is now able to sue for refunds in the appropriate judicial forum even without an IRS denial.
Surgical/TAVR intercompany royalty transactions covering tax years 2018 through 2024 remain subject to IRS examination, and those transactions and related tax positions remain uncertain as of September 30, 2025. The Company has considered this information, as well as information regarding the NOD and other proceedings described above, in its evaluation of its uncertain tax positions. The impact of these unresolved transfer pricing matters, net of any correlative tax adjustments, may be significant to the Company’s consolidated financial statements. Based on the information currently available and numerous possible outcomes, the Company cannot reasonably estimate what, if any, changes in its existing uncertain tax positions may occur in the next 12 months and, therefore, has continued to record the uncertain tax positions as a long-term liability.
During the first quarter of 2024, the Company received a notice of assessment from the Israel Tax Authority (the “ITA”) wherein the ITA claimed that the Company owes approximately $110 million of tax excluding interest and penalties in connection with a claimed 2017 transfer of intellectual property. On July 31, 2025, the ITA formally informed the Company that it was withdrawing its 2017 assessment but reserves the right to evaluate whether intellectual property was transferred in later years. The Company maintains that it did not transfer intellectual property outside of Israel and would vigorously defend that position through administrative proceedings including with appeals if the issue is raised in later years. If necessary, the Company expects to defend that position through judicial proceedings. During the fourth quarter of 2024, the Company received a notice of assessment from the ITA claiming that the Company owes additional tax of approximately $16 million excluding interest and penalties for the 2018 through 2022 tax years based entirely on the collateral impacts of the 2017 assessment. The Company filed a formal appeal in the first quarter of 2025 and, if necessary, expects to defend its position through judicial proceedings. While the appeals process for the 2018 through 2022 years runs through March 2026, the Company expects the 2018 through 2022 assessment to also be withdrawn prior to expiration of the appeals process based on the ITA’s conclusion that IP was not transferred in 2017.
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On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The OBBBA did not have a material impact to the Company’s estimated annual effective rate for 2025 and the Company is currently evaluating the potential impact on future periods.
15. SEGMENT INFORMATION
Edwards Lifesciences conducts operations worldwide and is managed in the following four reportable segments: United States, Europe, Japan, and Rest of World. All regions sell products that are used to treat advanced cardiovascular disease. The Company's operating segments are organized primarily based on economic characteristics as well as other characteristics, including types of customers, nature of the regulatory environment, and product offerings.
The Company's geographic segments are reported based on the financial information provided to the Chief Operating Decision Maker (“CODM”), which is the Company's Chief Executive Officer. The CODM evaluates the performance of the Company's reportable segments based on segment net sales and segment operating income. The CODM considers budget or forecast-to-actual results variances for segment operating income on a periodic basis for evaluating the performance of each segment and making decisions about allocating capital and other resources to each segment.
Segment net sales are based on actual foreign exchange rates. Segment expenses and segment operating income are based on internally derived foreign exchange rates 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 corporate research and development expenses, manufacturing variances, corporate headquarters costs, net interest income, global marketing expenses, impairment charges, stock-based compensation, foreign currency hedging activities, certain litigation costs, changes in the fair value of contingent consideration liabilities, most of the Company's amortization, and a portion of the Company's depreciation expense. The CODM does not receive information on total assets by reportable segment.
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The table below presents information about Edwards Lifesciences' reportable segments (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Segment Net Sales | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | |||||||||||||||||||||||
| Rest of World | |||||||||||||||||||||||
| Total segment net sales | $ | $ | $ | $ | |||||||||||||||||||
| Cost of Sales | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | |||||||||||||||||||||||
| Rest of World | |||||||||||||||||||||||
| Total segment cost of sales | $ | $ | $ | $ | |||||||||||||||||||
| Selling, general, and administrative expenses | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | |||||||||||||||||||||||
| Rest of World | |||||||||||||||||||||||
| Total segment selling, general, and administrative expenses | $ | $ | $ | $ | |||||||||||||||||||
| Other Segment Items | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | ( | ( | ( | ( | |||||||||||||||||||
| Rest of World | ( | ( | ( | ( | |||||||||||||||||||
Total other segment items (a) | $ | $ | $ | $ | ( | ||||||||||||||||||
| Segment Operating Income | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | |||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Japan | |||||||||||||||||||||||
| Rest of World | |||||||||||||||||||||||
| Total segment operating income | $ | $ | $ | $ | |||||||||||||||||||
_______________________________________________________________________________
(a) Other segment items include research and development expenses and foreign currency.
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The table below presents a reconciliation of segment operating income to consolidated pre-tax income (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Pre-tax Income Reconciliation | |||||||||||||||||||||||
| Segment operating income | $ | $ | $ | $ | |||||||||||||||||||
| Unallocated amounts: | |||||||||||||||||||||||
| Corporate items | ( | ( | ( | ( | |||||||||||||||||||
Separation costs (Note 3) | ( | ( | ( | ( | |||||||||||||||||||
Intangible assets impairment charges | ( | ( | |||||||||||||||||||||
| Certain litigation expenses | ( | ( | ( | ( | |||||||||||||||||||
| Change in fair value of contingent consideration liabilities | |||||||||||||||||||||||
| Foreign currency | ( | ( | |||||||||||||||||||||
| Consolidated operating income | |||||||||||||||||||||||
| Non-operating income | |||||||||||||||||||||||
| Consolidated pre-tax income | $ | $ | $ | $ | |||||||||||||||||||
Enterprise-wide Information
(in millions)
Enterprise-wide information is based on actual foreign exchange rates used in the Company's consolidated financial statements. Refer to the segment information above for United States net sales. Sales within any other individual country were less than 10 percent of the Company's consolidated net sales for all periods presented.
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net Sales by Major Product Group | |||||||||||||||||||||||
| Transcatheter Aortic Valve Replacement | $ | $ | $ | $ | |||||||||||||||||||
| Transcatheter Mitral and Tricuspid Therapies | |||||||||||||||||||||||
| Surgical Structural Heart | |||||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
16. SUBSEQUENT EVENT
In October 2025, the Company entered into a definitive agreement to sell its non-core product group for $85 million up-front consideration, subject to customary adjustments, and additional earnouts of up to $40 million. The historical results of the non-core product group are reflected as discontinued operations in the Company's consolidated condensed financial statements for all periods presented. The transaction is expected to close in the fourth quarter of 2025. For more information, see Note 4.
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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Overview
The following discussion and analysis contains forward-looking statements within the meaning of the federal securities laws and should be read in conjunction with the disclosures we make concerning risks and other factors that may affect our business and operating results. See “Note Regarding Forward-Looking Statements” preceding Part I, Item 1 in this Quarterly Report on Form 10-Q.
We are the leading global structural heart disease innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence, and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. 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 groups: Transcatheter Aortic Valve Replacement (“TAVR”), Transcatheter Mitral and Tricuspid Therapies (“TMTT”), and Surgical Structural Heart (“Surgical”).
On September 3, 2024, we sold our Critical Care product group (“Critical Care”). In addition, as a next step in our disposal plan to exit businesses that are not focused on implantable medical innovations for structural heart disease, we have entered into a definitive agreement to sell a non-core product group for $85 million up-front consideration, subject to customary adjustments, and additional earnouts of up to $40 million. The sale is expected to close in the fourth quarter of 2025. We concluded that Critical Care met the criteria to be classified as held-for-sale in June 2024 and that the non-core product group met the criteria to be classified as held-for-sale in September 2024. We determined that, when considered together, the conditions for discontinued operations presentation had been met with respect to Critical Care and the non-core product group (collectively, the “discontinued product groups”). As such, the historical financial condition and results of the discontinued product groups have been reflected as discontinued operations in our consolidated condensed financial statements. Prior period amounts have been adjusted to reflect the discontinued operations presentation. Our discussion and analysis of our results of operations is reflective of our continuing operations. See Note 4 to the Consolidated Condensed Financial Statements for further information.
In response to recent changes to U.S. trade policy, such as increased tariffs on imports and including non-U.S. retaliatory tariffs, we have and will continue to assess potential impacts on our business. As needed, we will pursue options to mitigate the impact of tariffs, including through our supply chain and potential exemptions and exclusions. Failure to sufficiently mitigate the impact of tariffs, including significant inflation and other impacts on our customers, could also reduce demand for our products and adversely affect our business, financial condition and results of operations. Given the uncertainties around U.S. trade policy and future tariff rates, we are unable to predict the nature of the tariffs and whether we will be able to successfully mitigate their impact.
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Financial Highlights
Our net sales for the first nine months of 2025 were $4.5 billion, representing an increase of $444.3 million compared to the first nine months of 2024, driven primarily by sales of our TAVR and TMTT products.
Our gross profit increased in the nine months ended September 30, 2025, driven primarily by our sales growth. Gross profit as a percentage of sales decreased primarily due to impact from foreign currency rate fluctuations and higher operational expenses. The decrease in our diluted earnings per share in the nine months ended September 30, 2025, was driven by our aforementioned operational performance.
Healthcare Environment, Opportunities, and Challenges
The medical technology industry is highly competitive and continues to evolve. We measure our success both by the development of innovative products and the value we bring to our stakeholders. We are committed to developing new technologies and innovations, and we are committed to defending our intellectual property in support of those developments. Our vision for growth is to treat patients with both valvular and non-valvular structural heart disease, such as heart failure, which is a natural progression of the disease for many patients suffering from aortic stenosis and mitral and tricuspid regurgitation.
We are dedicated to generating robust clinical, economic, and quality-of-life evidence that is increasingly expected by patients, clinicians, and payors in the current healthcare environment, with the goal of encouraging the adoption of innovative new medical therapies that demonstrate superior outcomes.
New Accounting Standards
Information on new accounting standards is included in Note 1 to the Consolidated Condensed Financial Statements.
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Results of Operations
Net Sales by Region
(dollars in millions)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| Percent Change | Percent Change | ||||||||||||||||||||||||||||||||||||||||||||||
| 2025 | 2024 | Change | 2025 | 2024 | Change | ||||||||||||||||||||||||||||||||||||||||||
| United States | $ | 907.5 | $ | 804.6 | $ | 102.9 | 12.8 | % | $ | 2,636.1 | $ | 2,393.1 | $ | 243.0 | 10.2 | % | |||||||||||||||||||||||||||||||
| Europe | 387.9 | 319.8 | 68.1 | 21.3 | % | 1,107.9 | 978.0 | 129.9 | 13.3 | % | |||||||||||||||||||||||||||||||||||||
| Japan | 90.1 | 81.4 | 8.7 | 10.6 | % | 267.2 | 253.9 | 13.3 | 5.2 | % | |||||||||||||||||||||||||||||||||||||
| Rest of World | 167.6 | 148.6 | 19.0 | 12.7 | % | 486.8 | 428.7 | 58.1 | 13.5 | % | |||||||||||||||||||||||||||||||||||||
| Outside of the United States | 645.6 | 549.8 | 95.8 | 17.4 | % | 1,861.9 | 1,660.6 | 201.3 | 12.1 | % | |||||||||||||||||||||||||||||||||||||
| Total net sales | $ | 1,553.1 | $ | 1,354.4 | $ | 198.7 | 14.7 | % | $ | 4,498.0 | $ | 4,053.7 | $ | 444.3 | 11.0 | % | |||||||||||||||||||||||||||||||
Net sales outside of the United States include the impact of foreign currency exchange rate fluctuations, as further detailed in the discussion below. The impact of foreign currency exchange rate fluctuations on net sales is not necessarily indicative of the impact on net income due to the corresponding effect of foreign currency exchange rate fluctuations on international manufacturing and operating costs, and our hedging activities.
Net Sales by Product Group
(dollars in millions)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| Percent Change | Percent Change | ||||||||||||||||||||||||||||||||||||||||||||||
| 2025 | 2024 | Change | 2025 | 2024 | Change | ||||||||||||||||||||||||||||||||||||||||||
| Transcatheter Aortic Valve Replacement | $ | 1,149.9 | $ | 1,023.3 | $ | 126.6 | 12.4 | % | $ | 3,327.4 | $ | 3,069.8 | $ | 257.6 | 8.4 | % | |||||||||||||||||||||||||||||||
| Transcatheter Mitral and Tricuspid Therapies | 145.2 | 91.1 | 54.1 | 59.3 | % | 394.9 | 247.0 | 147.9 | 59.8 | % | |||||||||||||||||||||||||||||||||||||
| Surgical Structural Heart | 258.0 | 240.0 | 18.0 | 7.5 | % | 775.7 | 736.9 | 38.8 | 5.3 | % | |||||||||||||||||||||||||||||||||||||
| Total net sales | $ | 1,553.1 | $ | 1,354.4 | $ | 198.7 | 14.7 | % | $ | 4,498.0 | $ | 4,053.7 | $ | 444.3 | 11.0 | % | |||||||||||||||||||||||||||||||
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Transcatheter Aortic Valve Replacement Sales
Net sales of TAVR products increased for the three and nine months ended September 30, 2025, driven by higher sales of the Edwards SAPIEN platform in 2025, primarily due to higher sales of the Edwards SAPIEN 3 Ultra RESILIA valve in the United States and Europe. In addition, during the three and nine months ended September 30, 2025, foreign currency exchange rate fluctuations increased net sales outside of the United States by $17.0 million and $13.2 million, respectively, primarily due to the strengthening of the Euro against the United States dollar.
In April 2025, we received United States Food and Drug Administration approval for the SAPIEN 3 platform for severe aortic stenosis patients without symptoms.
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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, 2025, primarily due to higher sales of our PASCAL transcatheter edge-to-edge repair system and our continued launch of the EVOQUE tricuspid valve replacement system in the United States and Europe.
In April 2025, we received a CE Mark for the Edwards SAPIEN M3 mitral valve replacement system for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation who are deemed unsuitable for surgery or transcatheter edge-to-edge therapy.
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Surgical Structural Heart Sales
Net sales of Surgical products increased for the three and nine months ended September 30, 2025, primarily due to higher sales of the INSPIRIS RESILIA aortic valve in the United States, Europe and Rest of World, the MITRIS RESILIA valve in the United States, Europe, and China, and the KONECT RESILIA tissue valved conduit in the United States.
In June 2025, we received a CE Mark for the KONECT RESILIA aortic valved conduit, the first ready-to-implant solution with RESILIA tissue specifically designed for bio-Bentall procedures.
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Gross Profit
Our gross profit increased in the three and nine months ended September 30, 2025, primarily driven by our sales growth discussed above. Gross profit as a percentage of net sales decreased for the three and nine months ended September 30, 2025, primarily driven by a 1.1 percentage point negative impact from foreign currency rate fluctuations, including the settlement of foreign currency hedging contracts, for the three months ended September 30, 2025, and higher operational expenses for both the three and nine months ended September 30, 2025.
Selling, General, and Administrative (“SG&A”) Expenses
SG&A expenses increased for the three and nine months ended September 30, 2025, primarily due to (a) higher field-based personnel-related costs in support of our growth strategy initiatives, primarily in the United States (b) increased performance-based compensation expenses, and (b) increased professional services costs to support the transition services agreement. Foreign currency exchange rate fluctuations increased expenses by $7.3 million and $1.9 million during the three and nine months ended September 30, 2025, primarily due to the weakening of United States dollar against the Euro.
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Research and Development (“R&D”) Expenses
R&D expenses increased for the three and nine months ended September 30, 2025, primarily due to increased clinical activity related to our recent investments in implantable heart failure management innovations and higher performance-based compensation expense, partially offset by decreased investments in our transcatheter aortic valve innovations.
Certain Litigation Expenses
We incurred certain litigation expenses related to legal proceedings, intellectual property litigation and tax litigation of $90.4 million and $10.8 million during the three months ended September 30, 2025 and 2024, respectively, and $116.8 million and $27.8 million during the nine months ended September 30, 2025 and 2024, respectively (See Note 11 to the Consolidated Condensed Financial Statements).
Change in Fair Value of Contingent Consideration Liabilities
The change in fair value of contingent consideration liabilities resulted in net gain of $12.5 million in the three and nine months ended September 30, 2025. The net gain was primarily due to changes in projected probabilities of milestone achievements. There were no changes in fair value of contingent consideration liabilities recognized in the three and nine months ended September 30, 2024.
Intangible Assets Impairment Charges
Intangible assets impairment charges of $40.0 million in three and nine months ended September 30, 2025 related to full impairment of certain developed technology assets. There were no intangible assets impairment charges recognized in the three and nine months ended September 30, 2024.
Other Operating (Income) Expense
Other operating income, net of $12.5 million and $52.9 million in three and nine months ended September 30, 2025, respectively, included income from a transition services agreement of $12.7 million and $50.5 million, respectively (see Note 4 to the Consolidated Condensed Financial Statements).
Interest Income
Interest income was $38.6 million and $112.5 million for the three and nine months ended September 30, 2025, respectively, and $24.3 million and $56.3 million for the three and nine months ended September 30, 2024, respectively. The increase in interest income was primarily due to a higher average investment balance during the three and nine months ended September 30, 2025.
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Loss on Impairment
Loss on impairment of $47.1 million in the nine months ended September 30, 2025 included loss on impairment related to our determination to not exercise an option to acquire one of our VIE investments (see Note 6 to the Consolidated Condensed Financial Statements).
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 attributable to continuing operations was 16.1% and 10.1% for the three months ended September 30, 2025 and 2024, respectively, and 16.1% and 9.2% for the nine months ended September 30, 2025 and 2024, respectively. The increase in the effective rate between the nine months ended September 30, 2025 and 2024 was primarily due to an increase in global minimum tax (“Pillar Two,” as noted below), a decrease in the tax benefit from employee share-based compensation, and a decrease in the benefit from favorable global income tax audit settlements. In addition, the effective rates for the nine months ended September 30, 2025 and 2024 were lower than the federal statutory rate of 21% primarily due to (1) foreign earnings taxed at lower rates, (2) United States federal and California research and development credits, and (3) the tax benefit from employee share-based compensation. The effective rates include a tax benefit (shortfall) from employee share-based compensation attributable to continuing operations of $(0.3) million and $0.6 million for the three months ended September 30, 2025 and 2024, respectively, and $0.8 million and $10.1 million for the nine months ended September 30, 2025 and 2024, respectively.
Many countries are implementing some or all of the Organisation for Economic Co-operation and Development’s Base Erosion and Profit Shifting Pillar Two (“Pillar Two”) rules that impose a global minimum tax of 15% on reported profits. Although Pillar Two provides a framework for applying the minimum tax, countries may enact Pillar Two slightly differently than the model rules and on different timelines and may adjust domestic tax incentives in response to Pillar Two. In addition, in January 2025, the United States issued an executive order announcing opposition to aspects of these rules. As countries continue to enact and refine the Pillar Two rules, we will evaluate the potential effects of Pillar Two on our effective tax rate. In 2025, we expect the Pillar Two provisions to result in additional tax expense of approximately $50 million.
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 financial condition and results of operations. We strive to resolve open matters with each tax authority at the examination level and could reach an 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 final outcome with a tax authority may result in a tax liability that is materially different from that reflected in the consolidated 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 believe that adequate amounts of tax and related penalty and interest have been provided for any adjustments that may result from our uncertain tax positions.
In the first quarter of 2022, we executed an Advance Pricing Agreement (“APA”) between Japan and Switzerland covering distribution transactions for tax years 2020 through 2024, and in 2023, we executed an APA between Japan and the United States covering tax years 2020 through 2024. We also executed an APA in the fourth quarter of 2024 between Japan and Singapore covering tax years 2022 through 2026 with roll-back terms to cover the distribution of TAVR products beginning in 2020 and the distribution of Surgical products beginning in 2018. Also in the fourth quarter of 2024, we filed with the Japanese tax authorities an APA renewal application between Japan and the United States covering tax years 2025 through 2029. We filed the APA renewal application with the United States tax authorities in the first quarter of 2025 and are engaged in ongoing discussions.
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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 completed during the second quarter of 2021, except for transfer pricing and related matters. The IRS is currently examining the 2018 through 2020 tax years. At September 30, 2025, all material state, local, and foreign income tax matters have been concluded for years through 2015.
During 2021, we received a Notice of Proposed Adjustment (“NOPA”) from the IRS for the 2015 through 2017 tax years relating to transfer pricing involving Surgical/TAVR intercompany royalty transactions between our United States and Switzerland subsidiaries. The NOPA proposed a substantial increase to our United States taxable income, which could result in additional tax expense for the 2015 through 2017 period of approximately $255 million and reflects a departure from a transfer pricing method we had previously agreed upon with the IRS. We disagreed with the NOPA and pursued an administrative appeal with the IRS Independent Office of Appeals (“Appeals”). The Appeals process culminated in the third quarter of 2023 when we and Appeals concluded that a satisfactory resolution of the matter at the administrative level was not possible.
During the fourth quarter of 2023, Appeals issued a notice of deficiency (“NOD”) increasing our 2015 through 2017 United States federal income tax in amounts resulting from the income adjustments previously reflected in the NOPA. The additional tax sought in excess of our filing position is $269.3 million before consideration of interest and a repatriation tax offset.
We plan to vigorously contest the additional tax claimed by the IRS through the judicial process. Final resolution of this matter is not likely within the next 12 months. We believe the amounts previously accrued related to this uncertain tax position are appropriate for a number of reasons, including the interpretation and application of relevant tax laws and accounting standards to our facts and, accordingly, have not accrued any additional amount based on the NOD and other proceedings to date. Nonetheless, the outcome of the judicial process cannot be predicted with certainty, and it is possible that the outcome of that process could have a material impact on our consolidated financial statements. As noted below, similar material tax disputes may arise for the 2018 through 2024 tax years. We made deposits with the IRS of $75 million in November 2022, and $305.1 million in March 2024, to prevent the further accrual of interest on that portion of any additional tax and interest we may ultimately be found to owe while we prepare to contest through the judicial process the IRS's entitlement to any of the additional tax claimed by the IRS. The IRS converted those deposits to advance payments, and, on December 20, 2024, we filed administrative claims for refunds of those payments with the IRS for the 2015 through 2017 tax years. Though the IRS could still deny those refund claims, we are now able to sue for refunds in the appropriate judicial forum even without an IRS denial.
Surgical/TAVR intercompany royalty transactions covering tax years 2018 through 2024 remain subject to IRS examination, and those transactions and related tax positions remain uncertain as of September 30, 2025. We have considered this information, as well as information regarding the NOD and other proceedings described above, in our evaluation of our uncertain tax positions. The impact of these unresolved transfer pricing matters, net of any correlative tax adjustments, may be significant to our consolidated 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.
During the first quarter of 2024, we received a notice of assessment from the Israel Tax Authority (the “ITA”) wherein the ITA claimed that we owe approximately $110 million of tax excluding interest and penalties in connection with a claimed 2017 transfer of intellectual property. On July 31, 2025, the ITA formally informed us that it was withdrawing its 2017 assessment but reserves the right to evaluate whether intellectual property was transferred in later years. We maintain that we did not transfer intellectual property outside of Israel and would vigorously defend that position through administrative proceedings including with appeals if the issue is raised in later years. If necessary, we expect to defend that position through judicial proceedings. During the fourth quarter of 2024, we received a notice of assessment from the ITA claiming that we owe additional tax of approximately $16 million excluding interest and penalties for the 2018 through 2022 tax years based entirely on the collateral impacts of the 2017 assessment. We filed a formal appeal in the first quarter of 2025 and, if necessary, expect to defend its position through judicial proceedings. While the appeals process for the 2018 through 2022 years runs through March 2026, we expect the 2018 through 2022 assessment to also be withdrawn prior to expiration of the appeals process based on the ITA’s conclusion that IP was not transferred in 2017.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act,
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modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The OBBBA did not have a material impact to our estimated annual effective rate for 2025 and we are currently evaluating the potential impact on future periods.
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, 2025, cash and cash equivalents, and short-term investments held in the United States and outside of the United States were $3.4 billion and $438.0 million, respectively.
We have a Five-year Credit Agreement (the “Credit Agreement”) which provides for a $750.0 million multi-currency unsecured revolving credit facility and matures on July 15, 2027. We may increase the amount available under the 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, 2025, no amounts were outstanding under the Credit Agreement.
In June 2018, we issued $600.0 million of 4.3% fixed-rate unsecured senior notes (the “2018 Notes”) due June 15, 2028. We may redeem the 2018 Notes, in whole or in part, at any time and from time to time at specified redemption prices. As of September 30, 2025, we have not elected to redeem any of the 2018 Notes. As of September 30, 2025, the carrying value of the 2018 Notes was $598.2 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, 2025, under the Board authorized repurchase program, we repurchased a total of 11.2 million shares at an aggregate cost of $844.9 million, including pursuant to $750 million accelerated share repurchase agreements executed during the period (see Note 10 to the Consolidated Condensed Financial Statements). As of September 30, 2025, we had remaining authority to purchase $2.1 billion of our common stock under the share repurchase program.
In July 2024, we entered into agreements and plans of mergers to acquire multiple medical device companies for a total aggregate cash purchase price of $1.5 billion, subject to certain adjustments. Three of these transactions closed in 2024, and upon closing we paid $1.1 billion. These three agreements include up to an additional $225.0 million of potential payments upon achievement of certain regulatory, performance, and sales milestones. The remaining agreement is expected to close in 2026 for an aggregate cash purchase price of $500.0 million, subject to certain adjustments, plus up to an additional $445.0 million upon achievement of certain regulatory and sales milestones.
We have purchased options to acquire and have agreed to provide promissory notes to various entities. These arrangements could result in additional cash outlays in the future should we decide to exercise the options or should the entities draw on the promissory notes.
At September 30, 2025, 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, 2024.
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Consolidated Cash Flows - For the nine months ended September 30, 2025 and 2024:
Net cash flows provided by operating activities of $1,144.3 million for the nine months ended September 30, 2025, increased $474.5 million over the same period last year primarily due to (1) lower tax payments during the nine months ended September 30, 2025, which included $175.3 million of local tax payments associated with the sale of Critical Care, compared to the nine months ended September 30, 2024, which included a $305.1 million tax deposit we made to mitigate interest on potential tax liabilities we are contesting through the judicial process (see Note 14 to the Consolidated Condensed Financial Statements), and (2) improved operating performance.
Net cash used in investing activities of $514.6 million for the nine months ended September 30, 2025, consisted primarily of net purchases of investments of $198.5 million, capital expenditures of $162.8 million, an issuance of notes receivable of $93.4 million, a payment for a net working capital adjustment of $36.3 million related to the sale of Critical Care, and payment of acquisition options of $19.6 million.
Net cash provided by investing activities of $2.9 billion for the nine months ended September 30, 2024, consisted primarily of the sale of our Critical Care product group for proceeds of $3.9 billion, partially offset by capital expenditures of $202.6 million and net proceeds from investments of $2.3 million.
Net cash used in financing activities of $945.4 million for the nine months ended September 30, 2025, consisted primarily of purchases of treasury stock of $852.8 million and purchase of the remaining noncontrolling interest in a subsidiary of $233.7 million, partially offset by proceeds from stock plans of $141.8 million.
Net cash used in financing activities of $1.0 billion for the nine months ended September 30, 2024, consisted primarily of purchases of treasury stock of $1.2 billion, partially offset by proceeds from stock plans of $150.9 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 sales 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 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, 2024. There have been no significant changes from the information discussed therein.
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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, 2024. There have been no material changes from the information discussed therein.
Investment Risk
We are exposed to investment risks related to changes in the underlying financial condition and credit capacity of certain of our investments. As of September 30, 2025, we had $1,223.2 million of investments in debt securities, of which $66.9 million were long-term. In addition, we had $207.9 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, a decline in the investments' value may occur, resulting in unrealized or realized losses. See Note 5 to the Consolidated Condensed Financial Statements for additional information.
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, 2025. Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of September 30, 2025, 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, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 5. Other Information
In connection with the previously-announced transition of Scott Ullem from his role as the Company’s Chief Financial Officer by midyear 2026, the Company entered into a transition agreement with Mr. Ullem on November 4, 2025 (the “Encore Agreement”). Mr. Ullem will continue to be employed with the Company on a full-time basis through June 30, 2026, and the Encore Agreement provides that Mr. Ullem will be employed with the Company on a reduced schedule as a Strategic Advisor, to provide support for the transition of his duties and on such other matters as the Company may request his assistance, from July 1, 2026 through June 30, 2028 (subject to earlier termination in accordance with the Encore Agreement; the “Encore Period”). As compensation during the Encore Period, Mr. Ullem will be entitled to (A) base salary of $25,000 and a bonus of 45% of such base salary for the first month of the Encore Period, and (B) total base salary of $271,250 for the last twenty-three months of the Encore Period (collectively, “Encore Compensation”). The Encore Agreement terminates Mr. Ullem’s Change-in-Control Severance Agreement with the Company effective June 30, 2026. However, the Encore Agreement also provides that, should the Company terminate Mr. Ullem’s employment due to his death, disability, or without “Cause” (as defined in the Encore Agreement) before June 30, 2028, Mr. Ullem will (so long as he (or his estate) provides the Company with a general release of claims) be entitled to (1) continued payment of his Encore Compensation (as severance) through June 30, 2028, and (2) accelerated vesting of his then-outstanding and unvested stock options, restricted stock units and performance-based restricted stock units granted by us (subject to satisfaction of any applicable performance-based vesting conditions).
The foregoing summary of the Encore Agreement is qualified in its entirety by reference to the full text of the Encore Agreement, which is filed as Exhibit 10.1 to this Quarterly Report on Form 10-Q.
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Part II. Other Information
Item 1. Legal Proceedings
Please see Part I, Item 1, Note 11 to the Consolidated Condensed Financial Statements of this Quarterly Report on Form 10-Q for a description of our legal proceedings, which is incorporated by reference herein.
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, 2024. 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 Purchased | Average Price Paid per Share | Total Number of Shares 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) (a) (b) | ||||||||||||||||||||||||||||
July 1, 2025 through July 31, 2025 | 886,758 | $ | 71.06 | 886,758 | $ | 1,091.5 | ||||||||||||||||||||||||||
August 1, 2025 through August 31, 2025 | 5,108,557 | 79.05 | 5,108,557 | 687.7 | ||||||||||||||||||||||||||||
September 1, 2025 through September 30, 2025 | 1,723,262 | 77.87 | 1,723,262 | 2,053.5 | ||||||||||||||||||||||||||||
| Total | 7,718,577 | 77.86 | 7,718,577 | |||||||||||||||||||||||||||||
(a) In August 2024, the Board of Directors approved a stock repurchase program providing for up to $1.5 billion of repurchases of our common stock. In September 2025, the Board of Directors approved an additional $1.5 billion of repurchases under this program. 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.
(b) In August 2025, we entered into a $500.0 million accelerated share repurchase (“ASR”) agreement and received, on August 19, 2025, an initial delivery of 5.1 million shares of our common stock, representing approximately 80 percent of the total contract value. The ASR agreement settled on September 15, 2025 and we received an additional 1.2 million shares of our common stock. Shares purchased pursuant to the ASR agreement are presented in the table above in the periods in which they were received.
Item 5. Other Information
Rule 10b5-1 Trading Plans
During the third quarter of 2025, none of our directors or Section 16 officers adopted terminated
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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 | |||||||||||
| 3.4 | |||||||||||
10.1*# | |||||||||||
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) | ||||||||||
______________________________________________________________________________
* Represents management contract or compensatory plan.
# Filed herewith.
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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: | November 5, 2025 | By: | /s/ SCOTT B. ULLEM | ||||||||
Scott B. Ullem Corporate Vice President, Chief Financial Officer (Principal Financial Officer; Duly Authorized Officer) | |||||||||||
| Date: | November 5, 2025 | By: | /s/ ANDREW M. DAHL | ||||||||
Andrew M. Dahl Senior Vice President, Corporate Controller (Principal Accounting Officer) | |||||||||||
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Exhibit 10.1
ENCORE AGREEMENT
To: | Scott B. Ullem | Date: | November 4, 2025 | ||||||||
From: | Christine McCauley | CC: | Bernard Zovighian | ||||||||
Subject: Encore – Work Continuity
On behalf of Edwards Lifesciences LLC (“Edwards” or the “Company”), we are pleased to offer you participation in the Edwards Encore contingent work program (“Encore”) in connection with your decision to retire from your current role with Edwards and its affiliates.
As discussed, as part of Encore, you will continue to work for Edwards on a reduced schedule beginning July 1, 2026, on the terms and conditions below. While you are employed with Edwards during Encore, you will, in good faith and to the best of your abilities, support Edwards and its affiliates in the transition of your duties and on such matters as the Company may reasonably request your assistance.
Following are the details of your role, transition, and changes to your compensation during the Encore period:
ENCORE PERIOD: | July 1, 2026 through June 30, 2028 (the “Retirement Date”). Your duties during the Encore period will be set forth on Exhibit A. | ||||
| TITLE: | Edwards Strategic Advisor | ||||
Terms for July 1, 2026 – July 31, 2026 (or as mutually agreed upon by the parties hereto)
| MONTHLY BASE SALARY: | $25,000 | ||||
| EIP BONUS TARGET: | 45% of Monthly Base Salary | ||||
| HEALTH CARE BENEFITS: | Eligible | ||||
| VACATION ACCRUAL: | 50% of 7.69 hours per payroll period | ||||
| SICK TIME: | 20 hours (annualized) | ||||
| ESPP: | Eligible | ||||
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| Long Term Incentive | Existing grants continue to vest during the specified Encore period. Not entitled to any new grants. | ||||
| Phone Reimbursement | Eligible | ||||
Terms for August 1, 2026 – June 30, 2028
| MONTHLY BASE SALARY: | $11,793.48 | ||||
| EIP BONUS TARGET: | 0% (ineligible) | ||||
| HEALTH CARE BENEFITS: | |||||
| Medical | Eligible through June 30, 2027 COBRA effective July 1, 2027 | ||||
| Dental/Vision | Eligible through July 31, 2026 COBRA effective August 1, 2026 (up to a maximum of 18 months in total) | ||||
| VACATION ACCRUAL: | 10% of 7.69 hours per payroll period | ||||
| SICK TIME: | 4 hours (annualized) | ||||
Please understand that nothing in this letter agreement modifies the at-will nature of your employment with Edwards, meaning that you or the Company may terminate your employment at any time (including, and notwithstanding anything else contained herein to the contrary, before the Retirement Date), for any (or no) reason, with or without prior notice, and with or without cause. Your Change-in-Control Severance Agreement, dated January 3, 2014, or any similar agreement or arrangement with Edwards Lifesciences Corporation (“ELC”), Edwards, or any affiliate is hereby terminated as of June 30, 2026, after which, and except as set forth in this letter agreement, you are not entitled to any benefits thereunder or with respect thereto. In addition, you acknowledge and agree that you are not entitled to any benefits (contingent or otherwise) under any other agreement or offer letter with Edwards or any affiliate (except that your Employment Agreement, as defined below, including any obligation thereunder continues in effect). In addition (and except as provided in the next paragraph), you will not be entitled to benefits under any severance plan, policy, or arrangement of Edwards or any affiliate, in the event of the following: (i) a termination of your employment with Edwards or any affiliate for Cause1 during the Encore Period and before the Retirement Date, or (ii) your retirement on the Retirement Date.
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During the Encore Period, in the event Edwards (or any successor) terminates your employment without Cause2 or you die or become disabled before the Retirement Date, then (subject to your satisfaction of the Conditions3):
(1)Edwards (or any successor) will continue to pay you (as severance) your base salary and target level EIP bonus(es) at the applicable levels provided for herein through the Retirement Date as though Edwards had not terminated your employment;
(2)All your then-outstanding and unvested stock options granted by ELC, as well as your then-outstanding and unvested restricted stock units granted by ELC that are not subject to performance-based vesting conditions, will vest in full as of the date of such separation of your employment (with the stock option exercise timing to remain subject to the standard Edwards retirement rules and the restricted stock units to be subject to the payment timing rules of the award applicable to a “retirement” as set forth in the respective award agreement); and
(3)All your then-outstanding and unvested restricted stock units granted by ELC that are subject to performance-based vesting conditions will remain outstanding and eligible to vest in full at the end of the applicable performance period based on the extent (if any) to which the applicable performance-based vesting conditions are satisfied (subject to vesting at the applicable “target” level pursuant to the applicable award terms if a “Change in Control” (as defined for purposes of the award) of ELC occurs during the applicable performance period).
While you are employed with Edwards (or any successor) during Encore, your salary will be paid in accordance with the Company’s regular payroll practices at the annualized rate provided for above. Your position is classified as a salaried, exempt position and as such, you are not eligible to receive overtime compensation. Edwards Incentive Plan (“EIP”) benefits are subject to, and will be determined in accordance with, the terms of the EIP. Employee Stock Purchase Plan, health care, and other benefits are subject to the terms and conditions of the applicable plan document(s) and Company policy. Edwards reserves the right to revise compensation and benefit terms from time to time, and to amend and terminate benefit plans from time to time so long as such revisions, amendments and terminations do not adversely affect you vis-a-vis other employees. All forms of compensation are subject to applicable withholding requirements.
You agree that, during Encore, you will continue to comply with all applicable Edwards and ELC policies. In addition, your obligations under your Employment Agreement, dated as of December 12, 2013, with Edwards, as may be amended (the “Employment Agreement”) continues in effect and applies as to your employment under Encore.
This letter agreement supersedes and replaces any prior understandings, negotiations, or agreements, whether oral, written or implied, between you, on the one hand, and Edwards and its affiliates, on the other hand, regarding the matters described in this letter agreement. This letter agreement may be amended only by a written agreement signed by both you and by an authorized officer of Edwards. This letter agreement and all of your rights and obligations
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hereunder are personal to you and may not be transferred or assigned by you at any time. This letter agreement is intended to comply with, and not result in, any tax, penalty or interest under, Section 409A of the Internal Revenue Code and the regulations promulgated thereunder, and will be construed and interpreted consistent with such intent. Any installment payments pursuant to this letter agreement will be treated as a series of separate payments for such purposes.
If you have any questions about your participation in Encore or the terms provided above, please contact me directly.
Best regards,
/s/ Christine McCauley
Christine McCauley
CVP, Human Resources
Your signature below constitutes your acceptance of participation in the Encore program, as well as your acknowledgment and agreement with the terms and conditions provided above.
ACCEPTED AND AGREED:
| /s/ Scott B. Ullem | Dated: November 4, 2025 | |||||||
| Scott B. Ullem | ||||||||
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_________________________
1 As used in this letter agreement, “Cause” means the occurrence of any of the following:
(a)You are convicted of (or enter a plea of guilty, nolo contendere, or a similar plea to) a felony or any crime involving moral turpitude, embezzlement, fraud, conversion of property or false statements or other similar acts;
(b)You are materially negligent in performing, or you materially fail to perform (other than by reason of your death or disability, as reasonably determined), your duties to the Company or ELC, which circumstance or failure (if reasonably capable of a cure) is not cured withing 30 days after the Company delivers written notice to you that identifies and describes the alleged circumstance or failure;
(c)You violate in any material respect an Edwards or ELC policy applicable to you or you breach in any material respect your Employment Agreement, which breach or violation (if reasonably capable of a cure) is not cured within 30 days after the Company delivers written notice to you that identifies and describes the alleged violation or breach; or
(d)You engage in a material act of fraud, dishonesty or other material act of willful misconduct in the course of your duties for Edwards or any of its affiliates or you engage in conduct that causes material harm to the name, reputation or business interests of Edwards or any of its affiliates.
2 As used in this letter agreement, “Conditions” means the following:
(a)You or your estate timely (as provided below) provide Edwards with a valid, executed general release agreement (“General Release”) substantially in the form attached hereto on Exhibit B, and such General Release is not revoked by you (in whole or in part) pursuant to any revocation rights afforded by applicable law. You or your estate must execute and return such General Release to Edwards within the appropriate timeframe required to make the Release maximally enforceable under the ADEA after your separation from Edwards. In no event will you be entitled to exercise any options, or receive payment for any equity awards, that accelerate in connection with such separation of your employment unless and until such General Release condition is timely satisfied.
(b)If, after separation of your employment, Edwards discovers that Cause existed to terminate your employment, or if you breach any of your ongoing obligations under your Employment Agreement after separation of your employment, Edwards may terminate payment of any remaining unpaid portion of your severance benefits and you will have no further right with respect thereto or in respect thereof (and, for clarity, such payment termination shall not alter the enforceability of the General Release).
5
Exhibit 31.1
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATIONS PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
CERTIFICATION
I, Bernard J. Zovighian, 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: | November 5, 2025 | By: | /s/ BERNARD J. ZOVIGHIAN | ||||||||
Bernard J. Zovighian 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: | November 5, 2025 | By: | /s/ SCOTT B. ULLEM | ||||||||
Scott B. Ullem Corporate Vice President, 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, 2025 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), we, Bernard J. Zovighian, 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.
| November 5, 2025 | /s/ BERNARD J. ZOVIGHIAN | ||||
Bernard J. Zovighian Chief Executive Officer | |||||
| November 5, 2025 | /s/ SCOTT B. ULLEM | ||||
Scott B. Ullem Corporate Vice President, Chief Financial Officer | |||||