IRVINE,
Calif., Dec. 8, 2022 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW) will discuss the company's
strategy for longer-term growth, provide an update on its
technology pipeline and share its financial guidance1
today during its annual investor conference.
Highlights of today's conference include:
- Global market opportunity across 4 product groups projected to
double to nearly $20 billion by
2028
- Reaffirming October 2022
financial guidance
- Projecting 2023 global sales of $5.6 - $6.0
billion; underlying growth of 9% - 12%
- Projecting 2023 TAVR sales of $3.6 - $4.0
billion; underlying growth of 9% - 12%
- Projecting 2023 TMTT sales of $160 - $200
million
- Estimating 2023 adjusted earnings per share of $2.45 - $2.60
- Focused long-term growth investments with 2023 R&D planned
at 17% - 18% of sales
- Meaningful progress on 8 pivotal trials across TAVR and
TMTT
"I'm proud of the meaningful progress that the company made in
2022 advancing our strategic milestones to drive future success,"
said Michael A. Mussallem, chairman
and CEO. "In 2023, we are projecting strong underlying sales
growth while we continue to aggressively pursue breakthrough
therapies for millions of patients suffering from structural heart
diseases. During the year, we look forward to significant
milestones, including new product launches and progress on multiple
important clinical trials. We remain confident that our
innovative therapies will continue to drive strong organic growth
in the years to come as we embark on a new era of structural heart
innovation."
Among the topics being discussed at today's conference are:
Transcatheter Aortic Valve Replacement (TAVR)
– Edwards is confident that TAVR fundamentals remain strong
and believes that hospital staffing challenges are transient and
will gradually improve. To address these challenges, Edwards
is focusing on supporting its hospital partners and engaging with
the clinical community to address undertreatment. The company
continues to believe that the global TAVR market opportunity will
reach $10 billion by 2028, driven by
greater awareness and advances in new technologies, as well as
indication expansion and increased global adoption. The
company will continue investing in groundbreaking trials and
research and development to help more patients and further
strengthen its long-term leadership position. Highlights and
expected milestones in 2023 include:
- Strong adoption of SAPIEN 3 Ultra RESILIA, anticipating stable
selling prices and share
- EARLY TAVR, a pivotal trial studying the treatment of severe
aortic stenosis patients before symptoms develop, is fully enrolled
and advancing through the follow-up process
- Continued enrollment in PROGRESS, a pivotal trial studying the
treatment of moderate aortic stenosis patients
- Continued enrollment in ALLIANCE, a pivotal trial studying the
next-generation SAPIEN X4
Transcatheter Mitral and Tricuspid Therapies (TMTT) –
With the global market opportunity estimated to reach $5 billion by 2028, Edwards will discuss its
strategy to use minimally invasive technology aimed at transforming
treatment for the millions of patients suffering from mitral and
tricuspid valve diseases. To transform treatment and unlock
this significant long-term growth opportunity, the company will
remain focused on three key value drivers: a portfolio of
differentiated therapies, 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' comprehensive
portfolio of catheter-based technologies. Highlights and
expected milestones in 2023 include:
- Continued U.S. and European launch of PASCAL Precision
- Presentation of CLASP IID full cohort data for PASCAL, with
1-year follow-up
- Completion of enrollment in the main cohort of the ENCIRCLE
pivotal trial for SAPIEN M3
- European approval of the EVOQUE tricuspid valve expected by
year-end
- Completion of enrollment in the TRISCEND II pivotal trial for
the EVOQUE tricuspid valve
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 2023, Edwards looks
forward to broadening the adoption of its flagship surgical aortic
heart valve, INSPIRIS RESILIA, which is changing the standards of
tissue durability in cardiac surgery. Also in 2023, Edwards
expects to accelerate its surgical mitral valve leadership with the
ongoing launch of its MITRIS RESILIA valve.
Critical Care – Edwards plans to drive growth and
leadership with innovations in critical care technologies, with the
goal of improving the quality of care for millions of patients
annually. The company is currently integrating a full range
of Smart Recovery technologies on the HemoSphere monitoring
platform that will create a unique offering of enhanced recovery
tools to further strengthen the company's leadership in smart
monitoring. Edwards is committed to growing adoption of its
Critical Care products with the goal of getting patients home to
their families faster.
During the conference, Edwards' management will reaffirm the
company's 2022 financial guidance and provide guidance for 2023.
Looking ahead to 2023, the company is planning for a gradual
improvement in hospital staffing with growth across all major
regions.
2022 Outlook
|
December 2021
Guidance
|
October
Guidance
Unchanged
|
Sales
|
$5.5 - $6.0
billion
|
Low
end
$5.35 - $5.55
billion
|
TAVR
|
$3.7 - $4.0
billion
|
Low
end
$3.5 - $3.7
billion
|
Surgical Structural
Heart
|
$870 - $950
million
|
$870 - $950
million
|
Critical
Care
|
$820 - $900
million
|
$820 - $900
million
|
TMTT
|
$140 - $170
million
|
Q4 similar to
Q3
|
FX Impact on
Sales
|
~$120 million
unfavorable
|
~$270 million
unfavorable
|
Adjusted EPS
|
$2.50 -
$2.65
|
$2.40 -
$2.50
|
2023 Guidance
|
Amount
(at current
rates)
|
Underlying Growth
Rate
|
Sales
|
$5.6 - $6.0
billion
|
9 - 12%
|
TAVR
|
$3.6 - $4.0
billion
|
9 - 12%
|
Surgical Structural
Heart
|
$870 - $970
million
|
Mid
single-digits
|
Critical
Care
|
$840 - $940
million
|
Mid
single-digits
|
TMTT
|
$160 - $200
million
|
--
|
FX Impact on
Sales
|
~$100 million
unfavorable
|
1.5pp
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
|
~30%
|
--
|
Tax Rate
|
13% - 17%
|
--
|
Adjusted EPS
|
$2.45 -
$2.60
|
--
|
Free Cash
Flow
|
$1.0 - $1.4
billion
|
--
|
Diluted Shares
Outstanding
|
610 - 615
million
|
--
|
In addition to Mr. Mussallem, other members of Edwards'
management team presenting include:
Larry
Wood, Corporate Vice President, Transcatheter Aortic
Valve Replacement;
Bernard
Zovighian, Corporate Vice President,
Transcatheter Mitral and Tricuspid Therapies;
Daveen Chopra, Corporate Vice
President, Surgical Structural Heart;
Katie Szyman, Corporate Vice
President, Critical Care; and
Scott Ullem, Corporate Vice
President, Chief Financial Officer
Clinical perspectives will also be provided by the following
physicians:
TAVR
Brian Lindman,
MD, Interventional Cardiology, Vanderbilt Medical Center –
Nashville, Tenn.
Sammy Elmariah, MD,
Interventional Cardiology, UCSF Cardiology – San Francisco, Calif.
TMTT
D. Scott Lim,
MD, Interventional Cardiology, University
of Virginia – Charlottesville,
VA.
Nishtha Sodhi, MD,
Interventional Cardiology, University of
Virginia – Charlottesville,
VA.
Linda Gillam, MD, MPH
Cardiology, Atlantic Health System – Morristown, N.J.
Robert Smith, MD, Cardiac
Surgery, Baylor Scott & White –
Plano, Tex.
Sam Dawkins, MBBS, DPhil,
Interventional Cardiology, John Radcliffe Hospital – Oxford, U.K.
Surgical Structural Heart
Michael Chu,
MD, FRCSC, Cardiac Surgery, London Health Sciences Center –
Ontario, Canada
Michael Mack, MD, Cardiac
Surgery, Baylor Scott & White
Health – Plano, Tex.
Ralph Damiano Jr., MD,
Cardiac Surgery, Washington University
School of Medicine – St. Louis,
MO
Olaf Wendler, MD, PhD, FRCS,
Cardiac Surgery, Cleveland Clinic London – London, UK
Gorav Ailawadi, MD, MBA,
Cardiac Surgery, University of Michigan
– Ann Arbor, Mich.
Ismail El-Hamamsy, MD, PhD, Cardiac Surgery, Mount
Sinai Hospital System – New York,
N.Y.
Pavan Atluri, MD, Cardiac Surgery, University of Pennsylvania – Philadelphia, Penn.
Critical Care
Ashish Khanna,
MD, MS, FCCP, FCCM, FASA, Wake Forest
University – Winston-Salem,
N.C.
David Stout, MD,
Anesthesiologist, Swedish Hospital – Seattle, Wash.
Conference Call and Webcast Information
The Edwards Lifesciences 2022 investor conference can be
accessed via live webcast at ir.edwards.com beginning at
10:00 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. Mussallem, statements in the highlights of
today's conference section, full year 2022 financial guidance and
finance guidance for 2023, statements regarding the TAVR and TMTT
opportunity, statements regarding 2023 milestones, statements
regarding the RESILIA tissue technology, and the international
adoption of TAVR, the compounded annual growth rate, 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, and may be outside of the
company's control. 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 the
COVID pandemic, 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; 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),
including its Annual Report on Form 10-K for the year ended
December 31, 2021, its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2022, its
Quarterly Report on its Form 10-Q for the quarter ended
June 30, 2022, its Quarterly Report
on its Form 10-Q for the quarter ended September 30, 2022 and its other filings with the
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 TRISCEND 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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SOURCE Edwards Lifesciences Corporation