IRVINE, Calif., Dec. 10, 2020 /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 guidance today during
its annual investor conference.
Highlights1 of today's conference
include:
- Presenting long-term strategic initiatives and growth
outlook
- Projecting 2021 global sales of $4.9-5.3 billion; underlying growth in the
mid-teens
- Projecting 2021 TAVR sales of $3.2-3.6 billion; underlying growth 15-20%
- Estimating 2021 adjusted earnings per share $2.00-2.20
"Putting patients first has never been more important than it is
in 2020, and I am humbled by the agility, resourcefulness and
passion of our partners and employees in maintaining their
important work on behalf of patients during this particularly
difficult time," said Michael A.
Mussallem, chairman and CEO. "Although we expect the
pandemic to have a continuing impact on the global healthcare
system, we are very optimistic about 2021 and we anticipate
returning to strong, double-digit top-line growth. At the same
time, we continue to aggressively pursue breakthrough therapies for
the millions of patients with structural heart diseases and
critical illnesses, which will help patients and result in success
at Edwards in the years ahead."
Among the topics being discussed at today's conference are:
Transcatheter Aortic Valve Replacement (TAVR)
– Edwards continues to believe the global TAVR opportunity
will reach $7+ billion by 2024, with continuing growth thereafter,
fueled by therapy expansion, technology advances and geographic
expansion. Edwards will continue investing in groundbreaking
trials, as well as research and development, to produce additional
transformational TAVR technologies to help more patients and
further strengthen its long-term leadership position. Additional
highlights and expected 2021 milestones include:
- EARLY TAVR, a clinical trial studying the treatment of severe
aortic stenosis patients before symptoms develop, expected to
complete enrollment
- FDA approval to begin moderate aortic stenosis pivotal clinical
trial
- Japan low risk approval
expected in late 2021
- SAPIEN 3 pulmonic valve with Alterra pre-stent system expected
to receive U.S. approval
- SAPIEN X4 clinical trial enrollment anticipated to begin
Transcatheter Mitral and Tricuspid Therapies (TMTT) –
Edwards is guided by the vision to lead and transform treatment for
patients with mitral and tricuspid valve disease, with the goal of
changing the practice of medicine. The company strives to achieve
this by focusing on three key value drivers: a portfolio of
differentiated therapies, positive results from pivotal clinical
trials and favorable real-world clinical outcomes. Progress
across these areas will result in more patients diagnosed and
treated and, in turn, a $3 billion
mitral and tricuspid opportunity by 2025, with significant growth
beyond 2025. Additional highlights and expected milestones
include:
- Initial clinical experience with the next-generation PASCAL
delivery system expected in 2021
- Initial clinical experience with the next-generation EVOQUE
mitral system expected in 2021
- Continued enrollment in PASCAL CLASP IID, CLASP IIF and CLASP
IITR pivotal trials
- Continued enrollment in the ENCIRCLE pivotal trial for SAPIEN
M3
- TRISCEND study for EVOQUE tricuspid enrolling rapidly;
initiating TRISCEND II pivotal trial
- U.S. approval for PASCAL DMR expected in late 2022
- EVOQUE tricuspid European approval expected in 2022
Surgical Structural Heart – The current $1.8 billion surgical structural heart
opportunity is expected to grow mid-single digits through 2026
driven by global cardiac procedure growth. Edwards remains
committed to advancing its leadership position as the partner of
choice for surgeons by delivering new technologies that enhance
patient outcomes. Adoption of Edwards' flagship surgical heart
valve, INSPIRIS RESILIA, remains robust in the U.S., Japan, and Europe and the company looks forward to its
launch in China in 2021. In 2021,
the company will also be enrolling patients in the RESTORE pivotal
trial for U.S. approval of HARPOON, the echo-guided beating-heart
mitral valve repair system. Also in 2021, Edwards expects to launch
a new surgical mitral valve, MITRIS RESILIA, in the U.S. and
Japan.
Critical Care – Edwards plans to drive growth and
leadership with innovations in critical care technologies,
including its pioneering work in Smart Recovery, by further
advancing hemodynamic monitoring solutions. The company is
currently integrating a full range of 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. Furthermore, Edwards anticipates
the launch of its Viewfinder connectivity solution in 2021.
During the conference, Edwards management will update the
company's financial guidance for 2020 and provide guidance for
2021. In the third quarter, underlying sales grew 3.7% and
previously the company expected similar fourth quarter
growth. Even with the recent resurgence of COVID, sequential
growth is still trending positive compared to the third quarter,
but underlying growth is trending flat year-over-year versus the
fourth quarter of 2019, when sales grew nearly 20%.
The company is planning that COVID will continue to stress the
global healthcare system at least through the winter and
recover during the balance of 2021. As the pandemic persists, the
company anticipates that hospitals will be better able to treat
non-COVID patients who need care for structural heart conditions
such as aortic stenosis compared to earlier this year.
Fiscal Year 2021
Non-GAAP Guidance1
|
Amount
|
Sales
|
$4.9 - $5.3
billion
(mid-teens
underlying growth)
|
TAVR
|
$3.2 - $3.6
billion
(15-20% underlying
growth)
|
Surgical Structural
Heart
|
$800 - $900
million
|
Critical
Care
|
$725 - $800
million
|
TMTT
|
~$80
million
|
FX Impact on Sales
(at current rates)
|
~$35 million
favorable
|
Gross Profit
Margin
|
76-77%
|
SG&A and R&D
as a % of Sales
|
Similar to
pre-COVID
|
Operating
Margin
|
29% - 30%
|
Tax Rate (including
~5pp ETB benefit)
|
11% - 15%
|
Adjusted
EPS
|
$2.00 -
$2.20
|
Capital
Expenditures
|
~$350
million
|
Shares
Outstanding
|
~630
million
|
In addition to Mr. Mussallem, other members of Edwards'
management team presenting include:
Todd
Brinton, MD, Corporate Vice President, Chief Scientific
Officer;
Daveen Chopra, Corporate Vice
President, Surgical Structural Heart;
Jean-Luc Lemercier, Corporate
Vice President, EMEA, Canada and
Latin America;
Katie Szyman, Corporate Vice
President, Critical Care;
Scott Ullem, Corporate Vice
President, Chief Financial Officer;
Huimin Wang, MD, Corporate
Vice President, Japan,
Asia and Pacific;
Larry Wood, Corporate Vice
President, Transcatheter Aortic Valve Replacement; and
Bernard
Zovighian, Corporate Vice President,
Transcatheter Mitral and Tricuspid Therapies.
We will also have a number of guest speakers to provide clinical
perspective, including:
TAVR
Bassem
Chehab, MD, FACC, Interventional Cardiology, Ascension
Via Christi – Kansas City,
Kan.
Suzanne Baron, MD,
MSc, Interventional Cardiology, Lahey Hospital –
Burlington, Mass.
Martin Leon, MD, FACC,
Interventional Cardiology, Columbia
University Medical Center – New
York
Surgical Structural Heart
Joseph Bavaria, MD, Cardiac
Surgery, Penn Medicine – Philadelphia,
Pa.
TMTT
Neil
Fam, MD, MSc, FRCPC, Interventional Cardiology,
St. Michael's Hospital –
Toronto, Canada
Raj Makkar, MD, Interventional Cardiology, Cedars-Sinai
Medical Center – Los Angeles,
Calif.
Stephan Von Bardeleben, MD,
Interventional Cardiology, Univ. Medical Center – Mainz,
Germany
Critical Care
Simon
Davies, MD, MBChB FRCA, Consultant Anesthetist, York
Teaching Hospital – York,
England
Michael Sander, MD, PhD,
Chair, Dept. of Anesthesiology, University Hospital – Geissen,
Germany
Thomas Scheeren, MD, PhD,
Professor of Anesthesiology, University Medical Center –
Netherlands
Gumersindo Solares, MD,
Anesthesiologist, Marques de Valdecilla – Santander, Spain
Webcast Information
The Edwards Lifesciences 2020 virtual investor conference can be
accessed via live webcast at http://ir.edwards.com/ beginning at
9:00 a.m. Pacific Time
today. The presentations are available on the Edwards
website. The webcast will also be available for replay after
the conference concludes.
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," "expect," "intend," "guidance," "outlook,"
"optimistic," "aspire," "unstoppable," "confident" or other
forms of these words or similar expressions and include, but are
not limited to, statements made by Mr. Mussallem, the potential
opportunity sizes for TAVR and for transcatheter mitral and
tricuspid therapies, 2020 and 2021 financial guidance, expected
impact of COVID-19, expected benefits of technological
developments, expected growth of opportunities in the long-term,
expected investment, expected expansion in geographies, timing and
results of milestones in R&D and expect timing and enrollment
in clinical trials, and expected regulatory approvals, clinical
milestones, product introductions and product
launches. 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 and
difficult to predict. 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 risks and uncertainties
associated with the COVID-19 pandemic, the timing and pace of
therapy adoption, particularly in TAVR and transcatheter mitral and
tricuspid therapies; unpredictability of the effectiveness and
timing of new product launches; competitive dynamics; the timing
and extent of regulatory approvals and reimbursement levels 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, particularly in our TAVR patent litigation;
unpredictability of changes in accounting standards and tax laws;
and other risks detailed in the company's periodic reports filed
with the Securities and Exchange Commission. These filings, along
with important safety information about our products, may be found
at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Alterra,
CLASP, Edwards SAPIEN, Edwards SAPIEN 3, ENCIRCLE, EVOQUE, HARPOON,
HemoSphere, INSPIRIS, MITRIS, PASCAL, SAPIEN, SAPIEN 3, SAPIEN M3,
SAPIEN X4, TRISCEND, and Viewfinder are trademarks of Edwards
Lifesciences Corporation. All other trademarks are the property of
their respective owners. HARPOON and PASCAL are not available for
commercial sale in the United
States. EVOQUE, MITRIS, SAPIEN M3, SAPIEN X4, and Viewfinder
are not available for commercial sale in any country.
____________________
[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 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, the conversion to a consignment
inventory system for surgical structural heart ("Surgical"), the
positive impact of transcatheter aortic valve
replacement stocking sales in Germany and the negative impact
of de-stocking, sales return reserves associated with product
upgrades, and proforma sales results of business acquisitions.
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, significant pension curtailments,
realignment expenses, charitable contributions to the Edwards
Lifesciences Foundation 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