IRVINE, Calif., Dec. 9, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, will discuss
the company's strategy for longer term growth, provide an update on
its technology pipeline and share its financial guidance for 2016
during its annual investor conference today at its corporate
headquarters in Irvine,
Calif.
Highlights of today's conference include:
- Projected 2016 global sales of $2.50 to
$2.75 billion, representing underlying1 growth of
7 to 11%
- Projected 2016 THVT sales of $1.2 to
$1.4 billion, representing underlying growth of 10 to
18%
- Estimated 2016 adjusted earnings per share2 of
$2.30 to $2.40 ($4.60 to $4.80 pre-stock split)
- Global TAVR opportunity now estimated to exceed $5 billion in 2021
- Upcoming anticipated THVT milestones include late 2016
intermediate risk U.S. approval and initiation of a low-risk trial
during the year
- Reaffirming current 2015 financial guidance
"We expect another year of strong performance for Edwards
Lifesciences in 2016 led by growth in SAPIEN 3 valve sales and
continued leadership in our core businesses," said Michael A. Mussallem, chairman and CEO.
"Despite foreign exchange headwinds, we are projecting solid
financial results next year while we continue to invest
aggressively to provide breakthrough therapies for patients in
need."
During the conference, Edwards' management will present the
company's financial guidance for 2016. Edwards expects sales
of $2.50 billion to $2.75 billion,
which reflects an estimated $55
million unfavorable impact at current foreign exchange rates
compared to 2015, due to the strengthening dollar. Underlying sales
growth is expected to be 7 to 11 percent. Additionally, the
company expects a gross profit margin of 74 to 75 percent, diluted
earnings per share of $2.30 to $2.40
($4.60 to $4.80 pre-stock split) and
free cash flow3 of $400 million
to $440 million, with all guidance excluding special
items.
Beginning in 2016, the company's adjusted earnings per share
will exclude amortization expense. "We also expect to
continue our significant R&D investment at approximately 16
percent of sales to expand patient access to TAVR and pursue our
focused innovation strategy. This positions Edwards to
deliver longer term growth and greater shareholder value," said
Mussallem.
Among the topics to be discussed at today's event are:
- Transcatheter Heart Valve Therapy (THVT) – Building on
the excellent clinical outcomes of its market leading SAPIEN 3
valve, Edwards is well positioned to strengthen its global
leadership. The company continues to anticipate a late 2016
approval to treat intermediate risk patients in the U.S., with a
minimal contribution to sales in the year. Edwards will also
discuss transcatheter valve product development, including the new
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System, as well as
plans to initiate a trial in 2016 to study patients with a lower
risk indication. Based on expanded indications and the significant
number of still untreated patients suffering from severe aortic
stenosis, Edwards now estimates the global TAVR opportunity will
exceed $5 billion in 2021.
Edwards expects to generate THVT
sales of $1.2 billion to $1.4 billion
in 2016, representing a 10 to 18 percent underlying growth rate,
even as competition intensifies.
- Surgical Heart Valve Therapy – Edwards is well
positioned to extend its leadership in the surgical heart valve
product line with the planned 2016 U.S. introduction of its EDWARDS
INTUITY Elite rapid deployment valve system. The company will
discuss the anticipated 2017 launch of its new INSPIRIS valve
platform, which utilizes its novel RESILIA tissue technology and
VFit expansion feature. Over the longer-term, new, innovative
technologies directed at unmet patient needs are expected to drive
continued growth of its surgical platform, even as the adoption of
transcatheter heart valves moderates its growth rate.
Edwards expects to generate
Surgical Heart Valve Therapy sales of $780
million to $820 million in 2016, representing a 3 to 6
percent underlying growth rate.
- Critical Care – In 2016, Edwards expects to continue
building upon its global leadership in hemodynamic monitoring by
expanding the benefits of Enhanced Surgical Recovery (ESR) to a
broader patient population with its ClearSight noninvasive
platform. ESR represents an underpenetrated opportunity to
help clinicians make better informed fluid management decisions for
their patients, which can reduce complications and lengths of stay.
The company will also discuss its development of a
next-generation hemodynamic monitor, and an integrated semi-closed
loop system for standardized management of patient fluid
levels.
Edwards expects to generate
Critical Care sales of $510 million to $550
million in 2016, representing a 2 to 4 percent underlying
growth rate.
- Structural Heart Initiatives – Edwards is continuing to
invest in a number of structural heart initiatives to address large
unmet patient needs. A U.S. early feasibility study of the
company's CardiAQ-Edwards transcatheter mitral valve replacement
technology is expected to commence shortly, and a CE Mark study
should begin in mid-2016. Further product enhancements to
this platform are also in development. Edwards' management
will also discuss the development of other innovative structural
heart technologies.
In addition, Edwards is announcing a structured investment in
Harpoon Medical, Inc., a privately held medical technology company
that is pioneering a beating-heart, transcatheter therapy for
minimally invasive surgical repair of a degenerative mitral
valve. This transaction includes an upfront investment and an
exclusive option to acquire the company.
In addition to Mr. Mussallem, other members of Edwards'
management team presenting at the conference include:
Donald
E. Bobo, Jr., Corporate Vice President, Heart Valve
Therapy, Corporate Strategy & Development;
Katie
M. Szyman, Corporate Vice President, Critical
Care;
Scott
B. Ullem, Chief Financial Officer;
Larry
L. Wood, Corporate Vice President, General Manager,
Transcatheter Heart Valves; and
Bernard
J. Zovighian, Vice President, General Manager,
Surgical Heart Valves.
Guest Speakers to Provide Clinical Perspective
Also
speaking at the conference are: Maurice E.
Sarano, M.D., Consultant Cardiovascular Diseases and
Professor of Medicine, Mayo Clinic in Rochester, Minn., and Vinod H. Thourani, M.D., Chief of Cardiothoracic
Surgery, Emory Hospital and Co-Director, Structural Heart and Valve
Center, Emory University School of
Medicine in Atlanta.
Webcast Information
The Edwards Lifesciences 2015
Investor Conference can be accessed via live webcast at
http://ir.edwards.com/ beginning at 11:00
a.m. Eastern Time on December
9, 2015. 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 is the
global leader in the science of heart valves and hemodynamic
monitoring. Driven by a passion to help patients, the company
partners with clinicians to develop innovative technologies in the
areas of structural heart disease and critical care monitoring,
enabling them to save and enhance lives. Additional company
information can be found at www.edwards.com.
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 2015 and 2016
financial goals or expectations for sales and sales growth, gross
profit margin, earnings per share, R&D expense, 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; 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, 2014.
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, ClearSight,
Edwards INTUITY, EDWARDS INTUITY Elite, Edwards SAPIEN, Edwards
SAPIEN 3, Edwards SAPIEN 3 Ultra, INSPIRIS, RESILIA, SAPIEN, SAPIEN
3, Edwards SAPIEN XT, SAPIEN 3 Ultra, and VFit are trademarks of
Edwards Lifesciences Corporation. All other trademarks are
the property of their respective owners.
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[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 and other special items on a diluted
basis.
|
[3]
"Free cash flow" is defined as cash flow
from operating activities less capital expenditures.
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SOURCE Edwards Lifesciences Corporation