Edwards Lifesciences Reaffirms Strategy for Sustainable, Differentiated Growth at Annual Investor Conference

IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) will outline its patient-focused strategy and share financial guidance during its annual investor conference. Entering 2026 with momentum for sustainable differentiated growth, Edwards is uniquely positioned with leading therapies across its core structural heart innovations for patients with aortic stenosis (AS), mitral regurgitation (MR), tricuspid regurgitation (TR) and pulmonic diseases, and expanding into emerging opportunities to advance treatments for aortic regurgitation (AR) and structural heart failure.

“As we enter 2026, we are poised for sustainable growth and long-term value creation,” said Bernard Zovighian, Edwards’ CEO. “For the more than 20 million structural heart patients worldwide, we are continuing to bring novel and differentiated innovations and world-class evidence to transform care. In addition, we are excited to pioneer therapies for the many structural heart patient groups currently unaddressed today, such as those with asymptomatic AS and those with mitral, tricuspid or aortic regurgitation in need of a transcatheter replacement. Edwards is the only company committed to delivering first-of-its-kind innovations for all of these patients, leveraging our 65 years of leadership and valve expertise. This approach underscores our unwavering commitment to creating long-term value for patients, physicians, health systems and shareholders.”

Transcatheter Aortic Valve Replacement (TAVR)– Edwards’ TAVR is positioned as the global benchmark, entering a new era of proactive disease management. The company’s SAPIEN platform, with new indications and proven durability, remains the best-in-class therapy for lifetime management of patients with severe AS. SAPIEN is also the most studied valve, with more than 15 years of distinguished clinical trials involving over 10,000 patients, 10New England Journal of Medicinepublications and 1.2 million patients treated around the world. Edwards’ leadership strategy of differentiated innovation, world-class evidence generation and indication expansion is driving guideline and policy evolution and improved patient access and long-term adoption of the SAPIEN platform.

Anticipated upcoming milestones include:

Transcatheter Mitral and Tricuspid Therapies (TMTT)– Edwards is advancing its vision to meet the complex unmet needs of patients with mitral and tricuspid disease with a differentiated portfolio comprised of repair and replacement technologies. The company has successfully commercialized a unique portfolio of therapies, including the PASCAL, EVOQUE and SAPIEN M3 systems, transforming care by enabling personalized therapy. At the same time, the company remains committed to its strategy of transformative product innovation, robust and expanding clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes.

Anticipated upcoming milestones include:

Surgical– Edwards remains committed to advancing its leadership in surgical therapies and transforming patients’ lives globally with leading surgical innovations. The company is focused on identifying and solving critical unmet needs in cardiac surgery to help patients live longer, healthier and more active lives. In 2026, Edwards will continue to drive adoption of its RESILIA tissue portfolio, the standard of tissue durability, including the INSPIRIS, MITRIS and KONECT platforms.

Anticipated upcoming milestones include:

Structural Heart Failure– Edwards plans to establish a new data-driven, patient-engaged standard of care with its implantable pressure sensor guided management solutions, a meaningful long-term opportunity for patients suffering from heart failure. In 2026 and beyond, Edwards will continue to invest internally in R&D, and externally in adjacent therapies, to transform patient care while building its team and deploying clinician and patient education and awareness.

Transcatheter Aortic Valve Replacement for Aortic Regurgitation (TAVR-AR)– AR is a deadly and progressive disease that affects a significant and growing number of patients with limited treatment options. As the pioneer in valve innovation, Edwards is well-positioned to lead this next frontier of aortic valve disease treatment and expects this to be the beginning of a long-term, iterative strategy similar to TAVR for AS.

In addition to Zovighian, several clinical perspectives will be provided, along with presentations from other members of Edwards’ management team:

Todd Brinton, MD,Chief Scientific OfficerDaveen Chopra, Transcatheter Mitral and Tricuspid Therapies (TMTT)Diane Gomez-Thinnes, Implantable Heart Failure ManagementDan Lippis, Transcatheter Aortic Valve Replacement (TAVR)YJ Oh, SurgicalScott Ullem, Chief Financial Officer

The investor conference can be accessed via live webcast at ir.edwards.com beginning at 8:30 a.m. Pacific Time today. The presentations will be available on the Edwards website. The webcast will be archived on the “Investor Relations” section of the Edwards website at ir.edwards.com orwww.edwards.com.

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 atwww.edwards.comand follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as “may,” “will,” “should,” “anticipate,” “believe,” “plan,” “project,” “estimate,” “potential,” “predict,” "early clinician feedback," “expect,” “intend,” “guidance,” “outlook,” “optimistic,” “aspire,” “confident” or other forms of these words or similar expressions and include, but are not limited to, statements made by Mr. Zovighian, statements in the highlights of today’s conference section, full year 2025 financial guidance and financial guidance for 2026, 2027 and beyond, statements regarding dilution due to JenaValve in the company’s financial outlook which assumes that the company prevails on the Federal Trade Commission’s case blocking the acquisition of JenaValve, statements regarding long-term growth opportunity, durability of products, increase in more diagnosed and treated patients, and timing of clinical trials, regulatory approvals, data releases, product development and product launches, high-quality patient outcomes and the rate of adoption of TAVR. No inferences or assumptions should be made from statements of past performance, efforts, or results which may not be indicative of future performance or results. 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, difficult to predict, may be outside of the company’s control and may be subject to the satisfaction of certain customary conditions. The company's forward-looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include risk and uncertainties associated with clinical trial or commercial results or new product approvals and therapy adoption; unpredictability of product launches; competitive dynamics; changes to reimbursement for the company's products; the company’s success in developing new products and avoiding manufacturing and quality issues; labor and employment markets; the impact of currency exchange rates; the timing or results of R&D and clinical trials; unanticipated actions by the U.S. Food and Drug Administration and other regulatory agencies; unexpected litigation impacts or expenses; and other risks detailed in the company's filings with the Securities and Exchange Commission (SEC). These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, CLASP, CLASP II, EARLY TAVR, EVOQUE, INSPIRIS, KONECT, MITRIS, PASCAL, PROGRESS, RESILIA, SAPIEN, SAPIEN M3, SAPIEN 3, SAPIEN 3 Ultra, and TRIFORMIS are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

[1] Guidance for underlying sales growth and adjusted earnings per share are provided on a non-GAAP basis, adjusted for special items described below, due to the inherent difficulty in forecasting such items without unreasonable efforts. The Company is not able to provide a reconciliation of these 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.

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles (“GAAP”), the Company uses non-GAAP financial measures. Management makes adjustments to the GAAP measures for items (both charges and gains) that (a) do not reflect the core operational activities of the Company, (b) are commonly adjusted within the Company’s industry to enhance comparability of the Company’s financial results with those of its peer group, or (c) are inconsistent in amount or frequency between periods (albeit such items are monitored and controlled with equal diligence relative to core operations).

The Company uses the term “underlying” or “organic” growth rate when referring to non-GAAP sales information as adjusted for items referenced in (a) – (c) above, which in the future may exclude, as applicable, items such as foreign exchange rate fluctuations, sales return reserves associated with product upgrades, and proforma sales results of business acquisitions and divestitures. The Company uses the term “adjusted earnings per share” which may in the future also exclude intellectual property litigation income and expenses, amortization of intangible assets, fair value adjustments to contingent consideration liabilities arising from acquisitions, impairments of long-lived assets, the purchase of intellectual property, realignment expenses, and the impact from implementation of tax law changes and settlements.