NEW YORK, Dec. 7, 2017 /PRNewswire/ -- Edwards Lifesciences
Corporation (NYSE: EW), the global leader in patient-focused
innovations for structural heart disease and critical care
monitoring, will discuss the company's strategy for longer-term
growth, provide an update on its technology pipeline and share its
financial guidance during its annual investor conference today in
New York City.
Highlights of today's conference include:
- Reaffirming October 2017
financial guidance1
- Projected 2018 global sales of $3.5 to $3.9
billion, representing underlying2 growth of 9 to
10%
- Projected 2018 THVT sales of $2.1
to $2.4 billion, representing
underlying growth of 11 to 15%
- Estimated 2018 adjusted earnings per share3 of
$4.10 to $4.30
- Aggressive R&D investments pursuing large opportunities in
transcatheter valve therapies expected to drive continued organic
growth
"As we come to the end of 2017, our performance and
accomplishments this year significantly exceeded our expectations,
and we expect 2018 to be another strong year for Edwards
Lifesciences. Our global growth is being driven by our
transcatheter aortic valve therapies, and continued advancement in
each of our market-leading product lines," said Michael A. Mussallem, chairman and CEO.
"In 2018, we are projecting strong financial results while we
continue to invest aggressively to provide breakthrough therapies
for patients in need. During the year, we expect to achieve a
number of meaningful clinical milestones that will serve as
indicators of our progress in advancing multiple transcatheter
mitral and tricuspid programs."
Among the topics being discussed at today's conference are:
- Transcatheter Heart Valve Therapy – Edwards continues to
believe the global TAVR opportunity will exceed $5 billion by 2021 and continue to grow
thereafter, fueled by broader indications for its TAVR therapy,
greater therapy awareness and advances in the technology. Edwards
is also investing in research and development to produce
transformational TAVR technologies to further strengthen its
leadership position. The company continues to anticipate launches
of its Edwards SAPIEN 3 Ultra system and Edwards CENTERA valve
system in 2018. In its clinical trial studying low-risk surgical
patients, Edwards expects results to be presented in the first half
of 2019 followed by commercial approval in late 2019.
- Transcatheter Mitral and Tricuspid Therapies – Estimated
to be a more than $3 billion
opportunity by 2025, Edwards will discuss its multiple
transcatheter programs aimed at transforming care for the many
patients suffering from mitral and tricuspid regurgitation. The
company has made significant progress in many of its programs and
is expecting to achieve a number of meaningful clinical milestones
in 2018. Edwards plans to launch at least one transformational
therapy in Europe each year in
2018, 2019 and 2020 led by its Cardioband and PASCAL programs.
- Surgical Heart Valve Therapy – Edwards expects growth in
its market-leading surgical heart valve portfolio despite the
continued strong adoption of TAVR therapy in more developed
regions. The company is pursuing a robust pipeline of innovative
new products including the Edwards INTUITY Elite valve system, and
the Edwards INSPIRIS valve, which is expected to be introduced in
the U.S. and Japan in 2018. As
announced yesterday, Edwards acquired Harpoon Medical and plans to
launch this mitral repair therapy in Europe next year.
- Critical Care – Edwards plans to continue to distinguish
its leadership position in Critical Care technologies with the
ongoing rollout of its HemoSphere monitoring platform and further
expansion of its Enhanced Surgical Recovery programs. The company
is also pioneering a new predictive monitoring category with the
planned U.S. launch of its Acumen Hypotension Prediction Indicator
in 2018.
During the conference, Edwards' management will reaffirm the
company's financial guidance for 2017 and provide guidance for
2018.
Fiscal Year 2017
Outlook
|
December 2016
Guidance
|
Current
Guidance
|
Sales (and underlying
growth)
|
$3.0-$3.4 billion
(10-14% underlying growth)
|
High end
|
THVT underlying sales
growth
|
15-20%
|
Mid-point of
20-25%
|
SHVT underlying sales
growth
|
1-3%
|
3-4%
|
CC underlying sales
growth
|
5-7%
|
High end
|
Diluted Adjusted
EPS
|
$3.30-$3.45
|
$3.65-$3.85
|
Free Cash
Flow4
|
$575-$650
million
|
Exceed $675
million
|
|
Fiscal Year 2018
Guidance
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$
|
Underlying Growth
Rate
|
Sales
|
$3.5-$3.9
billion
|
9-10%
|
THVT Sales
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$2.1-$2.4 billion,
including approximately $15 million of TMTT product
sales
|
11-15%
|
SHVT Sales
|
$810-$850
million
|
2-4%
|
CC Sales
|
$610-$650
million
|
6-8%
|
Diluted Adjusted
EPS
|
$4.10-$4.30
|
|
Free Cash
Flow4
|
$700-$775
million
|
|
Note: All guidance excludes special items and assumes repeal or
suspension of Medical Device Excise Tax. Sales guidance assumes
current FX rates.
In addition to Mr. Mussallem, other members of Edwards'
management team presenting at the conference include:
Donald
E. Bobo, Jr., Corporate Vice President, Strategy &
Corporate Development;
Katie
M. Szyman, Corporate Vice President, Critical
Care;
Scott
B. Ullem, Chief Financial Officer;
Larry
L. Wood, Corporate Vice President, Transcatheter Heart
Valves; and
Bernard
J. Zovighian, Corporate Vice President,
Surgical Heart Valve Therapy.
Guest Speakers to Provide Clinical Perspective
Also speaking at the conference are: Martin B. Leon, MD,
Professor of Medicine and Director, Center for Interventional
Vascular Therapy, Columbia University
Medical Center in New York, and
David A. Wood, MD, Structural &
Interventional Cardiology, Vancouver General Hospital &
St. Paul's Hospital in
Vancouver, and Clinical Professor,
University of British Columbia.
Other Financial Developments
During the fourth quarter, the company is contributing
$25 million to the Edwards
Lifesciences Foundation, whose mission is to support health- and
community-focused charitable organizations. The contribution is
being funded out of the successful litigation proceeds of
$113 million the company recently
received from Neovasc Inc. at the conclusion of the lawsuit for
theft of trade secrets.
Webcast Information
The Edwards Lifesciences 2017 Investor Conference can be
accessed via live webcast at http://ir.edwards.com/ beginning at
9:00 a.m. Eastern Time on
December 7, 2017. The webcast
will also be live streamed via the Edwards conference app available
for free download at the Apple App Store or Google Play. The
webcast will also be archived on the Edwards Web site after the
conference concludes.
About Edwards
Lifesciences
Edwards Lifesciences, based in Irvine,
Calif., is the global leader in patient-focused medical
innovations for structural heart disease, as well as critical care
and surgical monitoring. Driven by a passion to help patients, the
company collaborates with the world's leading clinicians and
researchers to address unmet healthcare needs, working to improve
patient outcomes and enhance lives. For more information, visit
www.Edwards.com and follow us on Twitter @EdwardsLifesci.
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," "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, 2017 and 2018 financial guidance, expected
advances in R&D, and expected new product approvals, clinical
milestones and product introductions. 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 uncertainties associated with the timing and
pace of therapy adoption, particularly in THVT and transcatheter
mitral and tricuspid therapies; unpredictability of the
effectiveness and timing of new product launches; changing
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 THVT patent litigation; unpredictability of changes in
accounting standards and tax laws; and other risks detailed in the
company's filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-K for the year ended
December 31, 2016. These filings, along with important safety
information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS
INTUITY, EDWARDS INTUITY Elite, Edwards SAPIEN, Edwards SAPIEN 3,
Enhanced Surgical Recovery program, SAPIEN, SAPIEN 3, and SAPIEN 3
Ultra are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners. The
Edwards SAPIEN 3 Ultra System is not currently available for
commercial sale in any country.
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[1]
|
Guidance for sales,
underlying sales growth and adjusted earnings per share is provided
on a non-GAAP basis, adjusted for special items discussed below,
due to the inherent difficulty in forecasting such items. The
Company is not able to provide a reconciliation of the 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.
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[2]
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"Underlying" growth
rates are non-GAAP items and in this press release exclude foreign
exchange fluctuations, sales return reserves associated with THVT
product upgrades, the positive impact of 2017 THVT stocking sales
in Germany, the negative impact of de-stocking, and other
special items.
|
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[3]
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"Adjusted earnings
per share" is a non-GAAP item computed on a diluted basis and in
this press release excludes impairment of long-lived assets,
intellectual property litigation expenses, amortization of
intellectual property, fair value adjustments to contingent
consideration liabilities arising from acquisitions, realignment
expenses, the positive impact of 2017 THVT stocking sales in
Germany, and the negative impact of de-stocking, and other special
items.
|
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[4]
|
"Free cash flow" is
defined as cash flow from operating activities less capital
expenditures. For 2017, this figure excludes the impact of
the Neovasc litigation payment, net of the Edwards Foundation
contribution.
|
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SOURCE Edwards Lifesciences Corporation