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Edwards Lifesciences (EW) sees FY24 adjusted earnings per share of $2.70 - $2.80

December 7, 2023 8:35 AM EST

Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s sharpened focus and strategy for longer-term growth, provide an update on its technology pipeline and share financial guidance1 today during its annual investor conference.

Highlights of today’s conference include:

  • Expecting early completion of enrollment in PROGRESS, studying moderate AS patients, in early 2024
  • Expecting data from EARLY TAVR, studying severe asymptomatic AS patients, at TCT 2024
  • Commercializing EVOQUE tricuspid valve in Europe; expecting U.S. approval mid-2024
  • Expecting CE Mark for SAPIEN M3 by the end of 2025
  • Reaffirming 2023 financial guidance
  • Projecting 2024 global sales of $6.3 - $6.6 billion; constant currency growth of 8% - 10%
  • Estimating 2024 adjusted earnings per share of $2.70 - $2.80
  • Projecting 2024 TAVR sales of $4.0 - $4.3 billion; constant currency growth of 8% - 10%
  • Projecting 2024 TMTT sales of $280 - $320 million
  • Announcing intent to spin-off Critical Care at the end of 2024

(Consensus sees FY24 EPS of $2.80)

“We expect our sharpened focus in structural heart to drive sustainable growth in the years to come as we embark on a new era of innovation to address large unmet patient needs,” said Bernard Zovighian, Edwards’ CEO. “I’m pleased with our performance in 2023 as we have reinforced our TAVR leadership position with new clinical evidence and reached an inflection point with new approved mitral and tricuspid technologies. In 2024, we are projecting strong sales growth and look forward to launching breakthrough technologies and progressing on multiple important clinical trials.”

Among the topics being discussed at today’s conference are:

Transcatheter Aortic Valve Replacement (TAVR) After more than 20 years of rigorous clinical experience and over 1 million patients treated, Edwards’ TAVR is positioned for strong sustainable growth as many patients remain undiagnosed and untreated. Edwards is confident that the future of TAVR remains strong driven by greater awareness, patient activation, advances in new technologies such as RESILIA, as well as indication expansion and increased global adoption. Upcoming milestones include:

  • PROGRESS, a pivotal trial studying the treatment of moderate aortic stenosis patients, expected to complete enrollment in early 2024
  • Data from EARLY TAVR, a pivotal trial studying the treatment of patients with severe aortic stenosis without symptoms, expected to be presented at the TCT Conference in 2024
  • Strong global adoption of SAPIEN 3 Ultra RESILIA; expected CE Mark approval in early 2024
  • Continuing to enroll in ALLIANCE, a pivotal trial studying the next-generation SAPIEN X4

Transcatheter Mitral and Tricuspid Therapies (TMTT) – Edwards’ remains focused on transforming treatment for the millions of patients suffering from mitral and tricuspid valve diseases. To achieve this, the company is focused on commercializing a portfolio of differentiated therapies, while committed to its strategy of breakthrough innovation, positive clinical trial results to support approvals and adoption, and favorable real-world clinical outcomes. Continued progress across these areas will result in more patients diagnosed and treated with Edwards’ repair and replacement technologies, and a significant long-term growth opportunity. Upcoming milestones include:

  • European commercialization of the EVOQUE tricuspid valve; expected U.S. approval mid-2024
  • CE Mark for SAPIEN M3 is expected by the end of 2025
  • Continued U.S. and European expansion of PASCAL Precision; initiating Japan launch
  • Completion of enrollment in CLASP IITR, a pivotal trial studying PASCAL for tricuspid patients

Surgical Structural Heart – Edwards remains committed to advancing its leadership in surgical structural heart 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 2024, Edwards will continue to drive adoption of its flagship surgical aortic heart valve, INSPIRIS RESILIA, which is creating the new standard of tissue durability. Also in 2024, Edwards expects to accelerate its surgical mitral leadership with the global commercialization of its MITRIS RESILIA valve.

Critical Care – During 2024, Edwards plans to support the growth and leadership of innovations in advanced patient monitoring, with the goal of improving the quality of care for millions of patients annually. Critical Care is currently integrating a full range of Smart monitoring technologies onto the seventh generation of its HemoSphere platform creating a unique offering of enhanced recovery tools.

Strategic Spin-off of Critical Care

Edwards intends to complete a tax-free spin-off of Critical Care at the end of 2024. The planned separation will enable sharpened focus as Edwards pursues expanded opportunities for TAVR, TMTT and Surgical patients, as well as new investments in interventional heart failure technologies.

“We are proud of the Critical Care team, its rich legacy of pioneering innovation and the contributions they have made to our company, and we look forward to an even stronger future for Critical Care,” said Zovighian.

The spin-off will enable Critical Care to have increased focus and flexibility to build upon its global leadership position in advanced patient monitoring, transforming care through AI-enabled smart monitoring solutions while expanding its reach to millions of patients around the world. Katie Szyman, Corporate Vice President of Critical Care since 2015, will be Chief Executive Officer of the new company upon completion of the transaction. More information regarding the planned spin-off will be provided during the course of 2024, and the company is planning a mid-year SEC Form 10 submission.

2023 Outlook

During the conference, Edwards’ management will reaffirm the company’s 2023 financial guidance and provide guidance for 2024.

December 2022

Guidance

October 2023

Guidance Unchanged

Sales

$5.6 - $6.0 billion

$5.9 - $6.1 billion

TAVR

$3.6 - $4.0 billion

$3.85 - $4.0 billion

TMTT

$160 - $200 million

$180 - $200 million

Surgical Structural Heart

$870 - $970 million

$960 million - $1.0 billion

Critical Care

$840 - $940 million

$870 - $940 million

FX Impact on Sales

~$100 million unfavorable

~$40 million unfavorable

Adjusted EPS

$2.45 - $2.60

$2.47 - $2.53

2024 Guidance

Amount

(at current rates)

Constant Currency

Growth Rate

Sales

$6.3 - $6.6 billion

8% - 10%

TAVR

$4.0 - $4.3 billion

8% - 10%

TMTT

$280 - $320 million

--

Surgical Structural Heart

$1.0 - $1.1 billion

Mid-single digits

Critical Care

$900 million - $1.0 billion

Mid-single digits

FX Impact on Sales

~$50 million unfavorable

~1.0pp downside

to reported growth

Adjusted Gross Profit Margin

76% - 78%

--

SG&A as a % of Sales

29% - 30%

--

R&D as a % of Sales

17% - 18%

--

Adjusted Operating Margin

29% - 30%

--

Tax Rate

14% - 17%

--

Adjusted EPS

$2.70 - $2.80

9% - 11%

Free Cash Flow

$1.1 - $1.4 billion

--

Diluted Shares Outstanding

600 - 610 million

--

Edwards announced today that the Board of Directors approved $1 billion of additional share repurchase authorization. This is consistent with past practice of the Board of Directors authorizing additional amounts under the share repurchase program when prior authorizations near completion.

In addition to Bernard Zovighian, other members of Edwards’ management team presenting include:

Larry Wood, Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Daveen Chopra, Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Wayne Markowitz, General Manager and Senior Vice President, Surgical Structural Heart
Katie Szyman, Corporate Vice President, Critical Care
Scott Ullem, Corporate Vice President, Chief Financial Officer

Clinical perspectives will also be provided by the following:

TAVR

Sam Dawkins, MBBS, DPhil, Interventional Cardiology, John Radcliffe Hospital – Oxford, U.K.
Martin Leon, MD, Interventional Cardiology, Columbia Medical Center – New York, N.Y.
Curtiss Stinis, MD, Interventional Cardiology, Scripps Health – San Diego, Calif.
Vinod Thourani, MD, Cardiac Surgery, Piedmont Heart Institute – Atlanta, Ga.

TMTT

Stephen Cohen, MD, Interventional Cardiology, NYU Langone Health – New York, N.Y.
Susheel Kodali, MD, Interventional Cardiology, Columbia Medical Center – New York, N.Y.
Azeem Latib, MD, Interventional Cardiology, Montefiore Health System – New York, N.Y.
Raj Makkar, MD, Interventional Cardiology, Smidt Heart Institute – Los Angeles, Calif.

Surgical Structural Heart

Pavan Atluri, MD, Cardiac Surgery, Hospital of the University of Pennsylvania – Philadelphia, Pa.
Joseph Bavaria, MD, Cardiac Surgery, Hospital of the University of Pennsylvania – Philadelphia, Pa.
Michael Borger, MD, Cardiac Surgery, Leipzig Heart Center – Leipzig, Germany
Mario Castillo-Sang, MD, Cardiothoracic Surgeon, St. Elizabeth Edgewood Hospital – Edgewood, Ky.
Ralph Damiano Jr., MD, Cardiac Surgery, Barnes-Jewish Hospital – St. Louis, Mo.
Michael Mack, MD, Cardiac Surgery, Baylor Scott & White Health – Plano, Texas.
Vinod Thourani, MD, Cardiac Surgery, Piedmont Heart Institute – Atlanta, Ga.

Critical Care

Maxime Cannesson MD, PhD, Anesthesiologist, UCLA Health – Los Angeles, Calif.
Desiree Chappel, CRNA, Vice President of Clinical Quality, NorthStar Anesthesia - Louisville, Ky.
Steve Garvin, CRNA, Director of Clinical Quality, NorthStar Anesthesia – Louisville, Ky.

“It is an exciting day for Edwards as we share our vision for 2024 and beyond, and how our talented team and expanded opportunities will enable us to help even more patients in the future,” said Zovighian. “We are confident in Edwards’ continued momentum, driven by new indications, new technologies and new adjacencies for structural heart disease patients.”

Conference Call and Webcast Information

The Edwards Lifesciences 2023 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.



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