NEW YORK, Dec. 8, 2016 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:
- Projected 2017 global sales of $3.0 to
$3.4 billion, representing underlying1 growth of
10 to 14%
- Projected 2017 THVT sales of $1.7 to
$2.0 billion, representing underlying growth of 15 to
20%
- Estimated 2017 adjusted earnings per share2 of
$3.30 to $3.45
- Q4 2016 sales trending at the lower end of the guidance range
driven by SHVT and FX
- TAVR opportunity expected to exceed $5
billion by 2021 with significant opportunity beyond
- 2017 a pivotal year of clinical experience in transcatheter
mitral and tricuspid therapies
"We expect another year of strong performance for Edwards
Lifesciences in 2017, led by growth in sales of SAPIEN 3 and
continued leadership in all our core businesses," said Michael A. Mussallem, chairman and CEO.
"We are projecting strong financial results next year while we
continue to invest aggressively to provide breakthrough therapies
for even more patients in need."
During the conference, Edwards' management will present the
company's financial guidance for 2017. Edwards expects
underlying sales growth of 10 to 14 percent, or $3.0 billion to $3.4 billion. Additionally,
the company expects diluted adjusted earnings per share of
$3.30 to $3.45. This includes
estimated net dilution of $0.10 per
share from the pending acquisition of Valtech Cardio, and an
estimated $0.08 to $0.13 per share benefit from the accounting
change related to stock-based compensation. The company also
expects free cash flow3 of $575
million to $650 million, with all guidance excluding special
items.
At the conference, Edwards will update its fourth quarter 2016
sales guidance. The company's fourth quarter 2016 sales are
trending towards the lower end of the previously stated
$750 million to $790 million
guidance, driven by lower Surgical Heart Valve Therapy (SHVT) sales
trending below October guidance and the impact of foreign
exchange. Transcatheter Heart Valve Therapy (THVT) sales for
the fourth quarter are expected to be in the range of $415 million to $430 million, consistent with its
October guidance. Critical Care sales are trending consistent
with guidance.
Among the topics to be discussed at today's conference are:
- Transcatheter Heart Valve Therapy – Edwards will
discuss the company's growing confidence in its long-term TAVR
outlook. Management will also discuss the various components
that expand the TAVR opportunity, which it continues to expect to
exceed $5 billion by 2021, and the
additional global opportunity beyond 2021. Additionally, the
company will explain its updated understanding of the much larger
prevalence of severe symptomatic aortic stenosis (AS) and lower
treatment rates, reflecting the under-diagnosis and under-treatment
of the disease.
The company will also discuss its plans to address the three
primary factors driving the expected growth including broader
indications for the TAVR therapy, advances in the technology and
greater therapy awareness. Edwards is investing aggressively
in research and development to generate transformational new TAVR
products to further distinguish its leadership position. In
2017, the company continues to anticipate European regulatory
approval for its Edwards SAPIEN 3 Ultra System and Edwards CENTERA
Valve System. The company is also initiating a groundbreaking
clinical trial to expand TAVR therapy to treat asymptomatic severe
AS patients.
Edwards expects to generate THVT sales of $1.7 billion to $2.0 billion in 2017,
representing a 15 to 20 percent underlying growth rate.
- Surgical Heart Valve Therapy – The continued strong
adoption of TAVR therapy has resulted in a less predictable outlook
for surgical heart valve solutions in the U.S. and Europe, however regions with less TAVR
penetration should continue to deliver strong growth.
Edwards is well positioned to extend its global leadership in
surgical heart valves with a robust pipeline of innovative new
products including the Edwards INTUITY Elite Valve System and the
Edwards INSPIRIS valve, which are launching in 2017.
Edwards expects to generate Surgical Heart Valve Therapy sales of
$750 million to $790 million in 2017,
representing a 1 to 3 percent underlying growth
rate.
- Critical Care – Edwards continues to expand Enhanced
Surgical Recovery (ESR) programs, with the aim of establishing ESR
as the standard of care, through the launch of its Hypotension
Prediction Indicator and Acumen software. The company is also
strengthening its core hemodynamic product portfolio with the 2017
launch of HemoSphere, its new hemodynamic monitoring platform,
which received CE Mark in December.
Edwards expects to generate Critical Care sales of $560 million to $600 million in 2017,
representing a 5 to 7 percent underlying growth rate.
- Structural Heart Initiatives – Edwards will discuss the
opportunity to transform care for the many patients suffering from
mitral and tricuspid regurgitation. Transcatheter therapies
for these patients represent a multi-billion dollar opportunity
requiring long-term investment and involving multiple risks.
Edwards will detail its structural heart disease investments, which
have produced multiple promising early clinical-stage mitral and
tricuspid therapies. The company expects 2017 to be a pivotal
year of additional clinical experience.
Edwards will highlight the early human experience with its new
transseptal delivery system for the Edwards-CardiAQ mitral
valve. The company is planning for a CE Mark for this valve
in 2018. The company will also discuss in more detail the
pending acquisition of Valtech Cardio, which is expected to close
in early 2017. A CE Mark study is continuing to enroll for
the tricuspid application.
Edwards will also introduce its new PASCAL transcatheter mitral
valve repair system. The first patients have already been
treated with this system, and the company plans to initiate a CE
Mark study in 2017. In addition, the company will highlight
the early promising patient experience treating tricuspid
regurgitation with the Edwards FORMA tricuspid spacer, and is
planning for a CE Mark in 2018.
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: Philippe Généreux, M.D.,
Co-Director of the Structural Heart Program, Morristown Medical
Center, in New Jersey, and
Wilson Szeto, M.D., Chief of
Cardiovascular Surgery at Penn Presbyterian Medical Center at the
University of Pennsylvania.
Webcast Information
The Edwards Lifesciences 2016 Investor Conference can be
accessed via live webcast at http://ir.edwards.com/ beginning at
9:00 a.m. Eastern Time on
December 8, 2016. 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 may include, but are not
limited to, Mr. Mussallem's statements; the Company's 2016 and 2017
financial goals or expectations for sales, underlying sales growth,
adjusted earnings per share (including estimates for components
related to acquisitions and a change in accounting standards), free
cash flow and other financial expectations; expectations regarding
the size of the TAVR opportunity; strategies to maintain leadership
positions and lead in the development of new structural heart
technologies; and expectations regarding the development and
introduction of new products, indications and technologies
(including expected timelines and outcomes of feasibility studies,
clinical trials, and regulatory approvals). 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. Our
forward-looking statements speak only as of the date on which they
are made and we do 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 unexpected changes or developments in
opportunities for the Company's products and the ability of the
Company to continue to develop safe and effective new products and
therapies; uncertainties associated with the timing and extent of
regulatory approvals, expanded indications and reimbursement levels
for our products; unexpected quality or manufacturing issues;
unexpected costs or impacts from litigation; the impact of
competitive products; changes in currency exchange rates; changes
to variables incorporated into financial results which are outside
of the company's control; actions by the U.S. Food and Drug
Administration and other regulatory agencies; 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, 2015.
To supplement the consolidated financial results prepared in
accordance with Generally Accepted Accounting Principles ("GAAP"),
the Company uses non-GAAP financial measures. The Company uses the
term "underlying" when referring to non-GAAP sales information,
which excludes discontinued and acquired products, sales return
reserves associated with THV product upgrades, and foreign exchange
fluctuations, and "excluding special items" and "adjusted" to also
exclude gains and losses from special items such as significant
investments, litigation, amortization of intangibles, THV sales
return reserves and related costs, and business development
transactions. Guidance for sales and sales growth rates is provided
on an "underlying" basis, and projections for diluted earnings per
share, gross profit margin, and free cash flow are also provided on
the same non-GAAP (or "excluding special items") basis due to the
inherent difficulty in forecasting such items. Management does not
consider the excluded items part of day-to-day business or
reflective of the core operational activities of the Company as
they result from transactions outside the ordinary course of
business. Management uses non-GAAP financial measures internally
for strategic decision making, forecasting future results and
evaluating current performance. By disclosing non-GAAP financial
measures, management intends to provide investors with a more
meaningful, consistent comparison of the Company's core operating
results and trends for the periods presented. These non-GAAP
financial measures are used in addition to and in conjunction with
results presented in accordance with GAAP and reflect an additional
way of viewing aspects of the company's operations that, when
viewed with its GAAP results, provide a more complete understanding
of factors and trends affecting the company's business. These
non-GAAP measures should be considered as a supplement to, and not
as a substitute for, or superior to, the corresponding measures
calculated in accordance with generally accepted accounting
principles. Non-GAAP financial measures are not prepared in
accordance with GAAP; therefore, the information is not necessarily
comparable to other companies. The Company is not able to provide a
reconciliation of projections for underlying sales and sales growth
or projected gross profit margin, projected earnings per share
guidance and projected free cash flow, excluding special items, to
expected reported results due to the unknown effect, timing and
potential significance of special charges or gains, and
management's inability to forecast foreign currency changes and
charges associated with future transactions and initiatives.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS
INTUITY Elite, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, Edwards
INSPIRIS, Edwards CENTERA, CardiAQ, PASCAL, HemoSphere and FORMA
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
______________________
[1] "Underlying" amounts are non-GAAP items and in this press
release exclude foreign exchange fluctuations and other special
items.
[2] "Adjusted earnings per share" is a non-GAAP item and in this
press release excludes amortization of intellectual property, gains
and losses from significant investments, impairments, litigation,
business development transactions and other special items on a
diluted basis.
[3] "Free cash flow" is defined as cash flow from operating
activities less capital expenditures.
[4] Guidance for underlying sales growth and adjusted earnings
per share is provided on a non-GAAP basis, adjusted for special
items 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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SOURCE Edwards Lifesciences Corporation