NEW YORK (Thomson Financial) - Shares of Given Imaging Ltd. slumped Tuesday
after the company received a not substantially equivalent (NSE) letter from the
Food and Drug Administration regarding its application to market PillCam Colon
in the U.S.
Shares of the wireless imaging systems company dropped nearly 17% to $12.88,
it's lowest since Oct. 31, 2003.
"While we are disappointed by the FDA's decision, we are evaluating our
options to bring PillCam Colon to the U.S. market as quickly as possible," the
company said.
The FDA's decision isn't expected to have material impact on Given Imaging's
fiscal 2008 revenue since PillCam Colon sales in the U.S. weren't expected to be
significant.
PillCam Colon is an ingestible video capsule featuring a disposable,
miniature video camera used to detect gastrointestinal disorders. It was
recently launched in Europe and other countries.
Given Imaging, based in Yoqneam, Israel, will report fourth-quarter and
fiscal 2007 results and provide fiscal 2008 guidance after market's close on
Feb. 20.
Oppenheimer analyst Amit Hazan expects fourth-quarter results to be in-line
or slightly above his earnings estimate of 12 cents a share and sales of $31.1
million.
He lowered his fiscal 2008 estimates to remove U.S. PillCam Colon sales, now
expecting earnings of 43 cents from 44 cents and sales of $127.8 million from
$129.8 million.
"We still view the Colon opportunity as more hope than reality today and
suspect the improved Colon2 capsule will be key," Hazan said. "It is still early
here, but the hope is that its sensitivity will be at higher levels that are
deemed more clinically useful (more competitive to traditional colonoscopy)."
The company's stock was last down 15% at $13.09.
Melinda Peer
mp/vj
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