UPDATE 2-Edwards ramps up for heart valve launch, shares jump

* Sees launch of less-invasive heart valve in Q4 2011

* Forecasts strong revenue growth for full-year 2011

* Profit outlook is below views due to launch investment

* Shares rise 5 percent to new high
(Adds details of forecast, background, analyst comment,
updates share activity)

By Susan Kelly

CHICAGO, Dec 13 (BestGrowthStock) – Edwards Lifesciences Corp
(EW.N: ) forecast strong revenue growth in 2011 but less profit
than analysts had expected as it invests heavily in the launch
of its breakthrough replacement heart valve.

Edwards said on Monday it anticipates a U.S. launch of its
Sapien aortic valve, which is threaded into place through the
arteries as an alternative to open heart surgery, in the fourth
quarter of next year.

Shares of Edwards climbed to new all-time highs, rising 5
percent to $74.89 in Monday afternoon trading on the New York
Stock Exchange.

Edwards forecast 2011 earnings per share of $1.91 to $1.97,
excluding special items, which was below the average analyst
forecast of $2.12 per share according to Thomson Reuters
I/B/E/S.

“We view the 2011 guidance as a positive signal that
Edwards is confident in its business outlook and do not view
the slightly weaker EPS guidance, tied to higher spending, as a
concern,” Wachovia analyst Larry Biegelsen said.

Edwards’ Sapien heart valve, called a transcatheter valve
because it is implanted via a catheter inserted at the groin or
rib cage, has been sold in Europe since 2007.

The company predicted its transcatheter valve sales would
grow to between $300 million and $340 million in 2011, which
was above some analysts’ expectations. Edwards is forecasting
2010 transcatheter valve sales of about $200 million.

Edwards projected total company sales of between $1.59
billion and $1.67 billion next year, in line with analysts’
average forecast of $1.62 billion.

The company expects to invest about $40 million to prepare
for the U.S. launch of the Sapien valve.

“While this will moderate earnings growth in 2011, it
allows us to aggressively address this large unmet patient
need,” said Edwards Chief Executive Michael Mussallem.

In September, Edwards published data from one arm of its
pivotal U.S. clinical trial that showed implantation of the
Sapien valve reduced death rates by a wide margin, compared
with patients who received standard medical therapy.

Patients who participated in the study had severe aortic
stenosis, a narrowing of the valve, and were deemed too sick to
endure an open-heart procedure. Half of the patients had been
expected to die within two years.

Edwards recently submitted data from the Cohort B arm of
the study, called Partner, to the U.S. Food and Drug
Administration to support its application for a U.S. launch of
the device.

Edwards estimated U.S. sales of the Sapien valve at $20
million to $25 million in fourth-quarter 2011, after the U.S.
launch, and said sales of the device for the first four
quarters of the U.S. launch are projected to be $150 million to
$250 million.

Edwards also said it expects to launch its GlucoClear
hospital glucose monitoring system in 2012.
(Reporting by Susan Kelly, editing by Matthew Lewis and Tim
Dobbyn)

UPDATE 2-Edwards ramps up for heart valve launch, shares jump