NEW YORK, Dec. 8, 2014 /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 2015
during its annual investor conference today in New York City.
Edwards will also reaffirm its current 2014 total sales and
earnings guidance, which includes diluted earnings per share of
$3.33 to $3.39, excluding special
items.
"We expect 2015 to be another year of attractive organic sales
growth for Edwards Lifesciences as we continue executing our
focused innovation strategy to provide breakthrough therapies for
patients in need," said Michael A.
Mussallem, chairman and CEO. "Sales of our
market-leading technologies, together with greater operating
leverage, position us for strong financial performance."
During the conference, Edwards' management will present the
company's financial guidance for 2015. Edwards expects sales
of $2.3 billion to $2.5 billion,
which at current foreign exchange rates reflects an estimated
$90 million unfavorable impact.
Underlying sales growth is expected to be 7 to 11 percent.
Additionally, the company expects a gross profit margin of
approximately 75 percent, a diluted EPS range of $3.90 to $4.10, and free cash flow of
$375 million to $425 million, with
all guidance excluding special items. "We also expect to continue
our strategic investment in research and development of 15 to 16
percent of sales in 2015, which positions Edwards for longer term
growth, and enables us to serve more patients and drive greater
shareholder value," said Mussallem.
Among the specific topics to be discussed at today's event
are:
- Transcatheter Heart Valves – Edwards is well positioned to
continue strengthening its global leadership by providing
innovative, best-in-class therapies. Newer devices with
additional sizes, improving economics, and increasing awareness of
this compelling alternative to traditional therapy, are expected to
broaden the availability of transcatheter technology and double
sales of global TAVR procedures to more than $3 billion in 2019. Edwards will update its
product development timelines including the now anticipated U.S.
launch of SAPIEN 3 for high risk patients early in 2016.
Edwards expects to generate THV sales of $1.0 billion to $1.1 billion in 2015,
representing a 15 to 25 percent underlying growth rate, even as
competition intensifies.
- Surgical Heart Valve Therapy – Substantial investments in new
technologies coupled with an aging global population are expected
to drive continued growth of Edwards' leading surgical heart valve
platform over the longer term, even as the adoption of
transcatheter heart valves is expected to moderate its growth rate.
At the conference, the company will discuss its new product
strategies including the planned 2016 U.S. introduction of its
minimally invasive EDWARDS INTUITY Elite valve, new tissue
treatment technology, and expanded surgical options for younger
patients.
Edwards expects to generate Surgical Heart Valve Therapy sales,
which includes surgical heart valves and cardiac surgery products,
of $780 million to $820 million in
2015, representing a 1 to 3 percent underlying growth rate.
Underlying sales of surgical heart valve products alone are
expected to grow 3 to 5 percent.
- Critical Care – In 2015, 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 more informed fluid management decisions for their patients,
which can result in clinical and economic benefits.
Edwards expects to generate Critical Care sales of $520 million to $570 million in 2015,
representing a 2 to 4 percent underlying growth rate.
Edwards announced today that Katie Szyman will be joining the
company at the start of 2015 as corporate vice president, critical
care. She comes to Edwards from Medtronic, where she has held a
number of leadership roles during the last 20 years, including
senior vice president, channel management, and group president of
Medtronic Diabetes. "We are very pleased to welcome
Katie to Edwards, and are confident that her passion for
helping patients and her extensive leadership experience will be
valuable to our critical care organization," said Mussallem.
- Edwards is continuing to make progress in its FORTIS
transcatheter mitral valve program. Patients in Europe and Canada continue to be enrolled in prospective
feasibility studies, and a feasibility study in the U.S. is
expected to commence in 2015. Although the journey to
commercialization may be long and durable success will require
significantly more experience, the company continues to believe
transcatheter mitral technologies have the potential to address a
large patient need.
Edwards is also announcing two strategic investments. First, the
company made a structured investment in CardioKinetix, Inc., a
privately held medical device company pioneering a catheter-based
treatment for heart failure. This transaction increases
Edwards' existing minority interest in CardioKinetix and provides
an option to purchase the remaining outstanding shares for a future
payment, plus additional milestone payments based on future
regulatory and reimbursement approvals. In the second
investment, the company acquired intellectual property that
broadens its transcatheter mitral valve development efforts.
Additional details of both investments were not
disclosed.
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;
Scott B. Ullem, Chief
Financial Officer; and
Larry L. Wood, Corporate Vice
President, Transcatheter Heart Valves.
Guest Speakers to Provide Clinical Perspective
Also
speaking at the conference are Brian K.
Whisenant, MD, Intermountain Heart Institute Cardiology,
Michael M. Borger, MD, PhD,
NewYork/Presbyterian/Columbia
University, and Professor Monty G.
Mythen, University College London Hospitals.
Webcast Information
The Edwards Lifesciences 2014
Investor Conference can be accessed via live webcast at
http://ir.edwards.com/2014-investor-conference.cfm beginning at
9:00 a.m. Eastern Time on
December 8, 2014. 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 2014 and 2015
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 new technologies such as
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 THV
procedures globally; the Company's success in developing new
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; 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, 2013.
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" and "adjusted"
to also exclude gains and losses and sales return reserve 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.
Free cash flow is defined as cash flow from operating activities
less capital expenditures.
"Underlying" amounts are non-GAAP and in this press release
assume a constant foreign currency rate in 2014.
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SOURCE Edwards Lifesciences Corporation