Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s focused strategy for long-term sustainable growth, provide an update on its technology pipeline to serve more patients and share financial guidance today during its annual investor conference. Edwards enters 2025, its first full year as a purely structural heart company, in a strong position with major growth drivers in Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral and Tricuspid Therapies (TMTT), the continued long-term performance of Surgical, and future opportunities with Structural Heart Failure and Aortic Regurgitation (AR).

Highlights of today’s conference include:

  • Reaffirming original 2024 total company constant currency sales growth guidance of 8% to 10%
  • Advancing broad portfolio of structural heart therapies with meaningful catalysts in 2025:
    • TAVR growth reinforced by leading technology and EARLY TAVR
    • TMTT contribution accelerated by PASCAL, EVOQUE and SAPIEN M3
  • Projecting 2025 constant currency sales growth of 8% - 10%; adjusted EPS of $2.40 - $2.50
    • TAVR sales of $4.1 - $4.4 billion; maintaining constant currency growth of 5% - 7%, which assumes mid-year indication approval from EARLY TAVR
    • TMTT sales of $500 - $530 million; constant currency growth of 50% - 60%
  • Increasing contribution from an expanding set of structural heart therapies in 2026 and beyond; targeting 10% average annual total company sales growth and double-digit EPS growth
    • Mid-to-high single digit TAVR growth driven by EARLY TAVR and PROGRESS
    • TMTT increasing contribution to growth, reaching $2 billion by 2030
    • Increasing contribution from new therapeutic areas including Structural Heart Failure and AR

“It is an exciting day for Edwards as we share our vision for 2025 and how our talented team and focus in structural heart is enabling us to help even more patients,” said Bernard Zovighian, Edwards’ CEO. “We are projecting another year of strong total company sales growth of 8 to 10 percent. We have significant opportunities to grow TAVR and are proud to continue our deep commitment to advancing science and streamlining care for aortic stenosis patients. Our vision for TMTT has developed into a growth portfolio of differentiated technologies. In Surgical, we continue to see strong global adoption of our premium RESILIA technologies.”

Zovighian continued, “In 2026 and beyond, strong total company sales growth will be driven by meaningful catalysts with the potential to change aortic stenosis treatment, including EARLY TAVR and the expected successful outcome from the FDA-approved PROGRESS pivotal trial. TMTT’s portfolio of life-changing therapies including PASCAL, EVOQUE and SAPIEN M3 will drive multiple years of rapid growth, while AR and Structural Heart Failure will address two new significant patient opportunities.”

Topics to be discussed at today’s conference include:

Transcatheter Aortic Valve Replacement (TAVR) – Edwards’ TAVR is positioned for strong sustainable growth as many patients remain undiagnosed, untreated or experience treatment delays. The company’s SAPIEN platform of TAVR valves remains the category leader and the best-in-class therapy for lifetime management of aortic stenosis.

“The future of TAVR remains strong driven by greater awareness, patient access, advances in new technologies, as well as indication expansion and increased global adoption,” said Larry Wood, Edwards’ CVP and Group President, Transcatheter Aortic Valve Replacement and Surgical.

Upcoming milestones include:

  • Strong global adoption of the SAPIEN 3 Ultra RESILIA system
  • Transformation of patient care stemming from EARLY TAVR, a pivotal trial studying the treatment of patients with severe aortic stenosis without symptoms
  • Advancement through the follow-up process of PROGRESS, the fully enrolled pivotal trial studying the treatment of moderate aortic stenosis patients

Transcatheter Mitral and Tricuspid Therapies (TMTT) – Edwards is revolutionizing care for the millions of patients suffering from mitral and tricuspid valve diseases. The company has successfully commercialized a unique portfolio of differentiated therapies, including PASCAL and EVOQUE. 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.

“Continued progress across our unique portfolio of life-changing mitral and tricuspid therapies will result in more patients diagnosed and treated, and a significant long-term growth opportunity,” said Daveen Chopra, Edwards’ CVP, Transcatheter Mitral and Tricuspid Therapies.

Upcoming milestones include:

  • Commercialization in the U.S. and Europe of the EVOQUE tricuspid valve, including the recently approved larger 56mm valve
  • Continued global expansion of the PASCAL Precision system
  • CE Mark for SAPIEN M3, the world’s first transcatheter mitral valve replacement system, remains on-track for mid-year 2025, with U.S. approval in H1 2026
  • Completion of follow-up in CLASP IITR, a pivotal trial studying PASCAL for tricuspid patients

Surgical – Edwards remains committed to advancing its leadership in surgical therapies. 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 2025, Edwards will continue to drive adoption of its RESILIA portfolio, the new standard of tissue durability, including INSPIRIS, MITRIS and KONECT. Also in 2025, Edwards will continue to expand access to its best-in-class surgical innovations in emerging markets to help benefit millions of patients worldwide.

Structural Heart Failure – During 2025, Edwards plans to build a foundation for growth in Implantable Heart Failure Management, a meaningful long-term opportunity for patients suffering from heart failure. With the recent U.S. approval of the Cordella system, an implantable pulmonary artery pressure sensor allowing advanced heart failure management, Edwards will focus on building its commercial team and deploying physician training and case support to ensure high quality outcomes.

Transcatheter Aortic Valve Replacement (TAVR-AR) – Edwards will invest to accelerate the development of Aortic Regurgitation (AR) therapies to enable earlier patient access. AR is a deadly undertreated disease that currently has no catheter-based option. As the pioneers 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.

2025 Guidance

Sales

$5.6 - $6.0 billion

(8% - 10% constant currency growth)

TAVR

$4.1 - $4.4 billion

(5% - 7% constant currency growth)

TMTT

$500 - $530 million

(50% - 60% constant currency growth)

Surgical

$970 million - $1.05 billion

(mid-single digit constant currency growth)

FX Impact on Sales

~$100 million unfavorable

(~2pt downside to reported growth)

Adjusted Gross Profit Margin

78% - 79%

Adjusted Operating Margin

27% - 28%

Tax Rate

15% - 18%

Adjusted EPS

$2.40 - $2.50

Diluted Shares Outstanding

585 – 595 million

In addition to Zovighian, Wood and Chopra, other members of Edwards’ management team presenting include:

Todd Brinton, M.D., F.A.C.C., Chief Scientific Officer Diane Gomez-Thinnes, CVP, Implantable Heart Failure Management Wayne Markowitz, SVP, Surgical Scott Ullem, Chief Financial Officer

The conference will also include a session with:

Michael Mack, MD, Director of Cardiothoracic Surgery at Baylor Scott & White Health – Dallas, Texas. Carrie Redick, RN, MSN, NEA-BC, Director of Interventional Cardiology and Structural Heart at Atlantic Health Systems – Morristown, N.J.

Clinical perspectives will also be provided by:

TAVR

Philippe Généreux, MD, Interventional Cardiology, Gagnon Cardiovascular Institute, Morristown Medical Center – Morristown, N.J. Brian R. Lindman, MD, MSCI, Interventional Cardiology, Vanderbilt Health – Nashville, Tenn. Mark Russo, MD, MS, Cardiac Surgery, Robert Wood Johnson Medical School – New Brunswick, N.J. David A. Wood, MD, Interventional Cardiology, University of British Columbia Hospital – Vancouver, Canada

TMTT

Suzanne V. Arnold, MD, MHA, Interventional Cardiology, University of Missouri-Kansas City School of Medicine – Kansas City, Mo. Charles Davidson, MD, Interventional Cardiology, Northwestern Medicine – Evanston, Ill. Rebecca T. Hahn, MD, Interventional Cardiology, New York-Presbyterian Hospital – New York, N.Y. Susheel Kodali, MD, Interventional Cardiology, Columbia Medical Center – New York, N.Y. Raj Makkar, MD, Interventional Cardiology, Smidt Heart Institute – Los Angeles, Calif. Rahul P. Sharma, MBBS, FRACP, Interventional Cardiology, Stanford Healthcare – Stanford, Calif. Thomas E. Waggoner, DO, Interventional Cardiology, Tucson Medical Center – Tucson, Ariz. Firas Zahr, MD, Interventional Cardiology, Oregon Health & Science University Hospital – Portland, Ore.

Surgical

Gorav Ailawadi, MD, MBA, Cardiac Surgery, University of Michigan – Ann Arbor, Mich. Pavan Atluri, MD, Cardiothoracic Surgeon, Hospital of the University of Pennsylvania – Philadelphia, Penn. Ismail El-Hamamsy, MD, PhD, Cardiac Surgery, Mount Sinai – New York, N.Y. Derek MacDonald, MD, Cardiothoracic Surgeon, Sudbury Regional Hospital – Sudbury, Canada Richard J. Shemin, MD, Cardiothoracic Surgeon, UCLA Health – Los Angeles, Calif. Vinod Thourani, MD, Cardiac Surgery, Piedmont Heart Institute – Atlanta, Ga.

Implantable Heart Failure Management

Dr. Liviu Klein, MD, MS, Director of Advanced Heart Failure, UCSF – San Francisco, Calif.

Conference Call and Webcast Information

The investor conference can be accessed via live webcast at ir.edwards.com beginning at 8:30 a.m. Eastern 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 Messrs. Zovighian, Wood, and Chopra, statements in the highlights of today’s conference section, full year 2024 financial guidance and financial guidance for 2025, 2026 and beyond, long-term growth catalysts in 2025, statements regarding the strength of the future of TAVR, long-term growth opportunity, increase in more diagnosed and treated patients, high-quality outcomes, CMS national coverage determination expectations, the RESILIA tissue technology, the global adoption of TAVR, and TAVR and TMTT milestones, and statements regarding transforming patient treatment, approvals, pivotal trials, clinical outcomes and adoption. 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, ALLIANCE, CLASP, CLASP II, Cordella, EARLY TAVR, EVOQUE, INSPIRIS, MITRIS, PASCAL, PASCAL Precision, PROGRESS, RESILIA, SAPIEN, SAPIEN M3, SAPIEN X4, SAPIEN 3, and SAPIEN 3 Ultra 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.

Media Contact: Amy Hytowitz, 949-250-5070 Investor Contact: Mark Wilterding, 949-250-6826

Edwards Lifesciences (NYSE:EW)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024 Haga Click aquí para más Gráficas Edwards Lifesciences.
Edwards Lifesciences (NYSE:EW)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024 Haga Click aquí para más Gráficas Edwards Lifesciences.