Given Imaging plunges after cutting guidance

The capsule imaging diagnostic company also said it was only seeking partial FDA approval for PillCam Colon 2.

Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) reported higher profits on flat revenue for the second quarter of 2012, but cut its full-year guidance, due to the economic crisis in Europe and lower than predicted sales in Asia. The company added that it will submit to the US Food and Drug Administration (FDA) for partial approval of its PillCam Colon 2 endoscopic camera.

Revenue dipped to $44.5 million for the second quarter from $44.8 million for the corresponding quarter of 2011, due to foreign currency fluctuations. Excluding this factor, revenue would have risen 3% to $46 million. GAAP-based net profit rose 59% to $3 million ($0.10 per share) for the second quarter from $1.9 million for the corresponding quarter and non-GAAP net profit rose 21% to $4.9 million ($0.16 per share) from $4.1 million.

The second quarter results were overshadowed by the lowering of Given Imaging's revenue guidance from $190-200 million to $185-190 million, although it reiterated its non-GAAP earnings per share guidance to $0.70-0.80 with the caveat the lower end of the guidance range is more likely.

Given Imaging completed the clinical trials in the US and Japan. The US trial included 885 patients and the Japanese trial included 72 patients. It said, "In the company's view, its analysis of the data from the PillCam Colon 2 clinical trial in the US support an FDA submission for visualization of the colon in patients who are unable to undergo colonoscopy or in cases of incomplete colonoscopies, rather than a submission for general screening." On the basis of the PillCam Colon trial for visualization of the gastrointestinal mucosa for diagnosis of colonic pathologies, the company said, "Based on a preliminary review of the trial data, the Company believes the results support submission for the intended indication and plans to submit the results to Pharmaceuticals and Medical Devices Agency (PMDA) in the fourth quarter of this year."

Given Imaging said that these two submissions "may provide a significant opportunity" for the company to address a $1.7 billion market, comprising 3.3 million procedures annually, one-third of which are in the US and one-third in Japan. IT added that it believes that it will meet its 2016 revenue target of $450 million, which includes revenue projections for use of PillCam Colon.

Given Imaging president and CEO Homi Shamir said, "Ongoing initiatives to maximize efficiencies resulted in a solid increase in second quarter GAAP and non-GAAP earnings per share. Our top line revenue of $44.5 million reflects 6% increase in revenues from the Americas region. However, revenue growth was offset by a challenging southern European market, the weakness of the euro, as well as lower than anticipated revenue growth in the APAC region."

Given Imaging's share price was unchanged on Nasdaq yesterday at $15, giving a market cap of $461 million, but fell 18.5% in morning trading on the TASE to NIS 49.29, after the publication of the financial report.

Published by Globes [online], Israel business news - - on August 8, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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