Breaking News

Tweet TWEET

Edwards Lifesciences Outlines Growth Strategy at Annual Investor Conference

Edwards Lifesciences Outlines Growth Strategy at Annual Investor Conference 
2014 Growth Impacted by Early TAVR Competitive Launches; Strong
Pipeline Positions Company for Sustainable Longer-Term Growth;
Transcatheter Mitral First-in-Human Procedures to Begin This Month 
NEW YORK, NY -- (Marketwired) -- 12/09/13 --  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 goals for 2014 during its annual
investor conference today in New York City. Edwards will also
reaffirm its current 2013 total sales and earnings guidance, which
includes diluted earnings per share of $3.00 to $3.10, excluding
special items.  
"We expect 2014 will be an important year for Edwards Lifesciences as
we bring next generation transcatheter heart valves to three key
geographies," said Michael A. Mussallem, chairman and CEO. "We
continue to invest aggressively to provide breakthrough innovations
for patients with unmet needs, positioning Edwards to extend its
leadership and drive sustainable long-term growth. 
"While patient demand for our SAPIEN transcatheter valve therapy
remains strong worldwide, Edwards will face new competition in the
U.S. and Europe early in 2014. With the uncertain timing of these
competitive entries, as well as the regulatory approvals of our own
next-generation technologies, we are providing a wide range of
forecasted THV sales. As such, total global THV sales for 2014 are
estimated to be between $700 million and $820 million."  
During the conference, Edwards' management will present the company's
financial guidance for 2014, which include total net sales of $2.05
billion to $2.25 billion, a gross profit margin of approximately 73
percent, a wide range around a diluted EPS estimate of $3.00, and
free cash flow(1) of $325 million to $425 million, with all guidance
excluding special items. "We also expect to continue our investment
in research and development of approximately 16 percent of sales in
2014, which positions us well to serve many more patients with our
innovative technologies," said Mussallem. 
Among the specific topics to be discussed at today's event are: 


 
--  Transcatheter Heart Valves - Building on high procedural success rates
    and distinguished clinical evidence, Edwards expects to maintain its
    leadership position with the introduction of next-generation
    transcatheter valves in the U.S., Europe and Japan. In the U.S., the
    company anticipates receiving regulatory approval for Edwards SAPIEN
    XT during the first half of 2014, while the company's Edwards SAPIEN 3
    valve remains on track to receive European regulatory approval by the
    end of 2013. In Japan, where market conditions and reimbursement are
    favorable, the recent launch of SAPIEN XT is progressing well. Total
    THV sales in Japan for 2014 are estimated to be $40 million to $50
    million.
    
    
    Patient enrollment in the study of Edwards' self-expanding CENTERA
    valve with an enhanced delivery system is expected to commence in
    early 2014, with European regulatory approval targeted for mid-2015.
    U.S. trial enrollment for SAPIEN 3 is well underway and FDA approval
    for this cutting-edge valve is anticipated by mid-2016.
    
    
--  Surgical Heart Valve Therapy - Edwards is making substantial
    investments in new surgical valve technologies designed to extend its
    leadership by enabling less invasive procedures and improving patient
    recovery. In 2014, the company expects to initiate the European
    commercial launch of its enhanced EDWARDS INTUITY Elite valve system,
    aided by the recent approval in Germany of higher reimbursement. Also
    during the year, Edwards plans to complete enrollment in the U.S.
    clinical trials of both EDWARDS INTUITY Elite and the GLX advanced
    tissue platform. Additionally, the company will discuss the Zeta
    next-generation surgical valve platform, designed to broaden tissue
    valve therapy options, especially for younger patients.
    
    
    Edwards expects to generate Surgical Heart Valve Therapy sales of
    $810 million to $850 million in 2014, representing a 4 to 7 percent
    underlying growth rate.
    
    
--  Critical Care - In 2014, Edwards expects to build upon its global
    leadership in hemodynamic monitoring systems by broadening the
    application of the company's technologies for enhanced recovery of
    moderate and high risk surgical patients. The company also plans to
    introduce its ClearSight noninvasive platform, which is being
    integrated into its EV1000 monitor. Additionally, Edwards will update
    its GlucoClear hospital glucose monitoring system, which has potential
    to address a large unmet need.
    
    
    Critical Care sales are projected to be $535 million to $575 million
    for 2014, representing 3 to 6 percent underlying growth.
    
    
--  Transcatheter Mitral Valve Development - With extensive experience in
    pioneering the treatment of mitral valve disease, Edwards is well
    positioned to lead the development of transcatheter mitral valve
    replacement (TMVR) therapies. During 2013, the company has conducted
    extensive work in the design, testing and preclinical study of a novel
    TMVR technology prior to initiating the first-in-human phase. As
    previously communicated, Edwards expects first-in-human procedures
    with its mitral valve replacement technology to begin this month.
    
    
--  Additional Financial Guidance - Edwards expects a 2014 gross profit
    margin of approximately 73 percent, lower than the estimated 74
    percent projected for the fourth quarter 2013. The change in 2014 is
    driven mainly by higher product manufacturing costs, particularly the
    SAPIEN 3 transcatheter valve, and a negative foreign exchange impact,
    which together more than offset a favorable product mix compared to
    the prior year.

  
In addition to Mr. Mussallem, other members of Edwards' management team
presenting at the conference include: 
Thomas M. Abate, corporate vice president and chief financial
officer;
 Donald E. Bobo, Jr., corporate vice president, Heart Valve
Therapy;
 Carlyn D. Solomon, corporate vice president, Critical Care
and Vascular; and
 Larry L. Wood, corporate vice president,
Transcatheter Heart Valves. 
Guest Speakers to Provide Clinical Perspective
 Also speaking at the
conference are interventional cardiologists Markus Kasel, MD,
Director of the Structural Heart Programs at The German Heart Centre,
Munich and Klinikum Augsburg in Augsburg; Randolph P. Martin, MD,
Chief, Structural & Valvular Center of Excellence and Principal
Advisor Marcus Heart Valve Center at Piedmont Heart Institute,
Atlanta; Wesley R. Pedersen, MD, Director, Transcatheter Valve
Therapy Program at Minneapolis Heart Institute Foundation,
Minneapolis; Stephen R. Ramee, MD, Director, Heart Valve Program at
Ochsner Heart and Vascular Institute, New Orleans; Samin K. Sharma,
MD, Director of Clinical Cardiology and President of the Mount Sinai
Heart Network at Mount Sinai Medical Center, New York; and
cardiothoracic surgeon Michael J. Mack, MD, Director, Cardiovascular
Disease at Baylor Scott and White Healthcare System, Dallas. 
Webcast Information
 The Edwards Lifesciences 2013 Investor
Conference can be accessed via live webcast at
http://ir.edwards.com/investor-conference.cfm beginning at 8:30 a.m.
Eastern Time on December 9, 2013. 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 that enable 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 2013 and 2014 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; strategies to maintain leadership positions and lead in
the development of TMVR; and expectations regarding the development
and introduction of new products, indications and technologies
(including expected timelines and outcomes of clinical trials,
regulatory approvals, and first-in-human trials). 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
transcatheter valve programs (THV) and the ability of the Company to
continue to lead in the development of its product categories; the
rate of growth in the U.S. THV marketplace; the Company's success in
developing new products and creating new opportunities for its
products; uncertainties associated with the timing and extent of
regulatory approvals, expanded indications and reimbursement levels
for our products, particularly THV; unexpected quality or
manufacturing issues; reimbursement for the Company's products; the
impact of competitive products, particularly TAVR products in the
U.S.; changes in currency exchange rates; actions by the U.S. Food
and Drug Administration and other regulatory agencies; costs and
impact of litigation; 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, 2012.  
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 and foreign exchange
fluctuations, and "excluding special items" to also exclude gains and
losses from special items such as significant investments,
litigation, 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, CENTERA,
ClearSight, EV1000, EDWARDS INTUITY Elite, Edwards SAPIEN, Edwards
SAPIEN XT, SAPIEN, SAPIEN 3, GlucoClear, and GLX are trademarks of
Edwards Lifesciences Corporation.  
(1) Free cash flow is defined as cash flow from operating activities
less capital expenditures. 
Edwards Lifesciences Corporation
One Edwards Way
Irvine, CA USA 92614 
Phone: 949.250.2500 
Fax: 949.250.2525
www.edwards.com 
Media Contact: 
Sarah Huoh
949-250-5070 
Investor Contact: 
David K. Erickson
949-250-6826 
 
 
Press spacebar to pause and continue. Press esc to stop.