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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) January 9, 2026
EDWARDS LIFESCIENCES CORPORATION
(Exact name of registrant as specified in its charter)
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| Delaware | | 1-15525 | | 36-4316614 |
(State or other jurisdiction of incorporation) | | (Commission file number) | | (IRS Employer Identification No.) |
One Edwards Way
Irvine, California 92614
(Address of principal executive offices and zip code)
(949) 250-2500
(Registrant's telephone number, including area code)
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| N/A |
(Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $1.00 per share | EW | New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
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. ☐
Item 7.01. Other Events.
On January 9, 2026 Edwards Lifesciences Corporation (the “Company”) issued a press release announcing that the United States District Court for the District of Columbia has granted the motion from the U.S. Federal Trade Commission for an injunction blocking the Company’s proposed acquisition of JenaValve Technology, Inc (“JenaValve”). As a result, the Company will not acquire JenaValve.
A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference. In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
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| (d) | | Exhibits |
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| 99.1 | | |
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| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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 hereunto duly authorized.
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| | EDWARDS LIFESCIENCES CORPORATION |
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| By: | /s/ Mark D. Peterson |
| | | Mark D. Peterson |
Date: January 9, 2026 | | Corporate Vice President, General Counsel |
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| Edwards Lifesciences Corporation One Edwards Way · Irvine, CA USA · 92614 Phone: 949.250.2500 · Fax: 949.250.2525 www.edwards.com
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EDWARDS COMMENTS ON JENAVALVE ACQUISITION
IRVINE, Calif., January 9, 2026 – Edwards Lifesciences (NYSE: EW) today announced that the U.S. District Court for the District of Columbia has granted the motion from the U.S. Federal Trade Commission (FTC) for an injunction blocking the company’s proposed acquisition of JenaValve Technology. As a result, Edwards will not acquire JenaValve.
Edwards disagrees with the decision and believes that the acquisition would have been in the best interest of a large, growing and underserved group of patients.
Aortic regurgitation (AR) is a deadly, progressive disease. It is typically under-detected and under-referred and carries very high mortality if left untreated. As a company pioneering first-of-its-kind innovations for unaddressed structural heart patient groups, Edwards remains committed to leading the AR therapy for patients in need. The company will continue to deliver novel therapies and world-class evidence to transform patient care, including advancing the SOJOURN transcatheter AR valve and enrolling patients in the JOURNEY pivotal trial.
In light of this update, Edwards is revising its full-year 2026 adjusted1 EPS guidance to $2.90 – $3.05 from earlier guidance of $2.80 – $2.95. Any additional updates will be provided at the Fourth Quarter Earnings Call in February.
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart 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. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
Forward Looking Statements
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of
1 Adjusted earnings per share is a non-GAAP item computed on a diluted basis and in this release also excludes certain litigation expenses, amortization of intangible assets, loss on impairment and separation costs. See “Non-GAAP Financial Information” in this release. Diluted earnings per share are from continuing operations.
these words and include, but are not limited to, statements regarding the company’s plans to deliver novel therapies and world-class evidence to transform care including advancing the SOJOURN valve and enrolling patients in the JOURNEY trial, financial guidance updates and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our 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. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.
Non-GAAP Financial Information
Projections for diluted earnings per share from continuing operations are provided on a non-GAAP basis as adjusted to exclude certain litigation expenses, amortization of intangible assets, loss on impairment, and separation costs. The company is not able to provide a reconciliation of the non-GAAP guidance to comparable GAAP measures due to the unknown effect, timing, and potential significance of special charges or gains, and management’s inability to forecast charges associated with future transactions and initiatives
Edwards, Edwards Lifesciences, and the stylized E logo, are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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