* Q4 profit of 90 cents excluding items tops analysts' 77
* Company backs its full-year profit and sales outlook
By Susan Kelly
Feb 4 Edwards Lifesciences Corp on Monday
posted fourth-quarter earnings that beat analyst expectations on
strong sales of its replacement heart valve that is implanted in
a less-invasive procedure than open-heart surgery.
The medical device maker said sales of the new valve, called
Sapien, surged more than 72 percent in the quarter.
For patients with diseased heart valves, the Sapien product
offers an alternative valve replacement method to open-heart
surgery in which the patient's breastbone is cut open and the
heart temporarily stopped. Doctors expect such minimally
invasive techniques for replacing valves to eventually become
the standard of care.
The initial product launch in 2011 included only inoperable
patients, for whom the valves were threaded to the heart from
the femoral artery in the leg using a catheter.
Edwards gained U.S. approval last fall to sell the Sapien
transcatheter valve for use in a wider group of patients. It
also won approval for a second delivery approach involving an
incision through the ribs.
"The quarter certainly shows this is gaining momentum in the
United States," said Jefferies & Co analyst Raj Denhoy.
Valves implanted via the newer approach through the ribs
generated more than 45 percent of U.S. Sapien sales in the
quarter, reflecting strong interest in the procedure, Edwards
Chief Executive Michael Mussallem told analysts on a conference
Edwards said fourth-quarter net income rose to $91.1
million, or 77 cents per share, from $63.1 million, or 53 cents
per share, a year ago.
Excluding special items, the Irvine, California-based
medical device maker reported a profit of 90 cents per share,
compared with 62 cent per share, a year ago. Analysts had
expected Edwards to earn 77 cents were share, excluding special
items, according Thomson Reuters I/B/E/S.
Fourth-quarter net sales increased 18.7 percent to $510.5
million. Sales of transcatheter heart valves climbed 72.8
percent in the quarter, to $161 million, driven by the ongoing
U.S. launch of the Sapien brand valve. U.S. transcatheter valve
sales were $80.7 million.
Patients who receive replacement heart valves have aortic
valve stenosis, a condition in which calcium deposits clog the
valve and reduce blood flow, which can lead to heart failure or
cardiac arrest. A replacement valve helps restore normal blood
Edwards sells its next-generation transcatheter valve, a
smaller and easier-to-implant device called Sapien XT, in
Europe. Among its competitors in Europe are Medtronic Inc
, whose transcather valve is currently in U.S. clinical
trials. St Jude Medical Inc late last year also won
approval from European regulators to sell a transcatheter aortic
Edwards said it expects to submit its application to sell
Sapien XT in the United States to U.S. regulators by mid-year.
Edwards said it continues to expect a full-year profit of
$3.21 to $3.31 per share excluding items, on sales of $2.1
billion to $2.2 billion. Analysts had forecast a full-year
profit of $3.27 per share on sales of $2.14 billion.
Edwards' shares rose less than 1 percent to $93.75 in
after-hours trading from a close of $93.06 Monday on the New
York Stock Exchange.