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
“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.
About Edwards
Lifesciences
Edwards Lifesciences is the global leader of patient-focused
innovations for structural heart disease and critical care
monitoring. We are driven by a passion for patients, dedicated to
improving and enhancing lives through partnerships with clinicians
and stakeholders across the global healthcare landscape. For more
information, visit Edwards.com and follow us on Facebook,
Instagram, LinkedIn, Twitter 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 2023 financial guidance
and financial guidance for 2024, statements regarding the company’s
global market opportunity, statements regarding 2024 milestones,
statements regarding the RESILIA tissue technology, and the global
adoption of TAVR, the compounded annual growth rate, statements
regarding transforming patient treatment, approvals, pivotal
trials, clinical outcomes and adoption, and statements regarding,
or relating to, the intention to spin-off the Critical Care product
group at the end of 2024 and statements regarding the filing of a
related Form 10 with the SEC in mid-year 2024. 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, EARLY TAVR, EVOQUE, ENCIRCLE,
HemoSphere, INSPIRIS, INSPIRIS RESILIA, MITRIS, MITRIS RESILIA,
PASCAL, PASCAL Precision, PROGRESS, RESILIA, SAPIEN, SAPIEN M3,
SAPIEN X4, SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA 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.
“Free cash flow” is defined as cash flows
from operating activities less capital expenditures.
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Media Contact: Amy Hytowitz, 949-250-5070 Investor Contact: Mark
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