Edwards Comments on JenaValve Acquisition

Key Terms

aortic regurgitation medical

Aortic regurgitation is a heart valve condition where the aortic valve fails to close fully, allowing blood to leak backward from the main artery into the heart instead of flowing efficiently to the body. It matters to investors because it creates demand for diagnostics, medical devices, surgeries and long-term care, influences clinical trial results and treatment costs, and can affect hospital, device-maker and insurer revenues—like a persistent leak that raises repair and insurance bills over time.

transcatheter medical

Transcatheter describes medical procedures or devices delivered through a thin, flexible tube (catheter) that is threaded through blood vessels or small body openings to reach the heart or other organs without open surgery. It matters to investors because transcatheter approaches enable faster recovery, shorter hospital stays and larger patient pools for treatments that once required major operations, which can expand market demand and affect device and hospital revenues.

non-GAAP financial

Non-GAAP refers to financial measures that companies use to show their earnings or performance without including certain expenses or income that are often added back to give a different picture. It matters because it can make a company's results look better or more favorable, but it may also hide important costs, so investors need to look at both GAAP (official rules) and non-GAAP numbers to get a full understanding.

diluted financial

Diluted describes how the value or claim of each existing share is reduced when additional shares could be issued or converted from things like stock options, warrants, or convertible debt. For investors it matters because diluted measures show a more complete picture of per-share earnings and ownership, like adding more slices to a pie so each slice becomes smaller — helping you judge how future share creation could lower your stake or earnings per share.

pivotal trial medical

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

Rule 10b5-1 regulatory

Rule 10b5-1 is a regulation that allows company insiders to buy or sell their shares at predetermined times, even if they have access to non-public information. It acts like setting a schedule in advance for transactions, helping prevent accusations of unfair trading. This rule provides a way for insiders to plan trades transparently, giving investors confidence that these transactions are not based on hidden information.

Rule 144 regulatory

Rule 144 is a U.S. securities regulation that sets conditions under which restricted or insider-held shares can be legally resold to the public, such as required holding periods, availability of public information, limits on how much can be sold at once, and certain filing requirements. For investors it matters because it determines when previously locked-up shares can enter the market — like a release valve that can increase supply, affect share price, and signal insider intent.

IRVINE, Calif.--(BUSINESS WIRE)-- 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.

[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.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260109944511/en/

Media: Amy Meshulam, media@edwards.com

Investors: investor_relations@edwards.com

Source: Edwards Lifesciences Corporation