Company Announcements

Innovation with Purpose, Powered by Science, Centered on Patients: Edwards’ Commitment to Drive Value for the Healthcare Ecosystem

IRVINE, Calif.--(BUSINESS WIRE)--Dec. 4, 2025-- 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.”

Highlights of today’s conference include:

• Reaffirming our previously increased 2025 total company constant currency sales growth guidance of the high end of 9% to 10%; and EPS of $2.56 to $2.62
• Projecting 2026 constant currency sales growth of 8% - 10%; adjusted leveraged EPS of $2.80 - $2.95, including dilution from planned JenaValve acquisition, with ~100bps of operating margin expansion at the midpoint:
  • TAVR sales of $4.6 - $4.9 billion; constant currency growth of 6% - 8%
  • TMTT sales of $740 - $780 million; constant currency growth of 35% - 45%
  • Surgical sales of $1.05 - $1.13 billion; mid-single digit constant currency growth
• Advancing broad and balanced portfolio of structural heart therapies in 2026 and beyond with:
  • SAPIEN as the global TAVR benchmark enabling a new era of proactive disease management
  • Groundbreaking TMTT portfolio with PASCAL, EVOQUE and SAPIEN M3 systems
  • Surgical performance driving RESILIA innovations to transform patients’ lives globally
  • New therapeutic areas including Structural Heart Failure and TAVR-AR
• Increasing contribution from our expanding structural heart portfolio in the long term; targeting ~10% average annual constant currency sales growth with EPS leverage:
  • Mid-to-high single digit TAVR growth
  • TMTT to reach $2 billion by 2030
  • Additional growth contribution from Structural Heart Failure and TAVR-AR

Topics to be discussed at today’s conference include:

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, 10 New England Journal of Medicine publications 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:

• Continued adoption of SAPIEN 3 Ultra RESILIA globally and asymptomatic patient treatment
• U.S. TAVR guideline updates expected by Q4 2026
• Updated TAVR National Coverage Determination (NCD) expected by Q4 2026
• Presentation of PROGRESS clinical evidence expected at TCT 2026, the pivotal trial studying the treatment of moderate aortic stenosis patients

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:

• Continued follow-up of the recently fully-enrolled CLASP IIF, the pivotal trial studying the PASCAL system in patients with functional MR
• FDA approval of the SAPIEN M3 mitral valve, the world’s first transcatheter mitral valve replacement system, remains on-track for early 2026
• Launch of next-generation PASCAL system, advancing outcomes for tricuspid and mitral patients, and FDA approval of PASCAL for TR, expected in Q4 2026
• TRISCEND II 2-year data on EVOQUE tricuspid valve expected in Q2 2026; next-generation technology, expected in H2 2027

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:

• Launch of TRIFORMIS in the U.S., the first surgical valve that will be indicated and designed for the tricuspid position, expected in H2 2026
• COMMENCE 10-year data on RESILIA tissue, expected in H2 2026

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.

2026 Guidance

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 Officer
Daveen Chopra, Transcatheter Mitral and Tricuspid Therapies (TMTT)
Diane Gomez-Thinnes, Implantable Heart Failure Management
Dan Lippis, Transcatheter Aortic Valve Replacement (TAVR)
YJ Oh, Surgical
Scott Ullem, Chief Financial Officer

Conference Call and Webcast Information

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 or www.edwards.com.

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.

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.

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Media Contact: Amy Meshulam, media@edwards.com
Investor Contact: Mark Wilterding, investor_relations@edwards.com

Source: Edwards Lifesciences Corporation