Key Developments: Given Imaging Ltd (GIVN.O)
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21 May 2013
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Latest Key Developments (Source: Significant Developments)
Given Imaging Ltd Announces New Data Highlighting PillCam COLON Comparability To Colonoscopy In Detecting Adenomas
Given Imaging Ltd announced a secondary analysis of data from prospective, multicenter clinical trial to assess the accuracy and safety of PillCam COLON for detecting lesions at least 6 mm in size. Dr. Rex presented data from the 16-site study, podium presentation 907, Accuracy of PillCam Colon 2 for Detecting Subjects with Adenomas ≥ 6 mm. Overall, 884 patients at average risk for colon cancer as defined by the U.S. Multi-Society Task Force guidelines on colorectal cancer screening were enrolled into the pivotal study. Following bowel prep, the patients visited the investigator's office in the morning and ingested a PillCam COLON capsule endoscope. The resulting video sequences were stored and saved until after the patients had a traditional optical colonoscopy four to six weeks later. When doctors found evidence of a polyp on the PillCam COLON sequences that they didn't see during the colonoscopy, a follow-up colonoscopy was performed to confirm or rule out the capsule finding. The data analysis applied to the subset of subjects showed PillCam COLON had 88% sensitivity and 82% specificity in detecting adenomas at least 6 mm in size and 92% sensitivity and 95% specificity in detecting adenomas at least 10 mm in size. These data provide preliminary evidence that PillCam COLON approaches the effectiveness of optical colonoscopy to detect conventional adenomas and, like colonoscopy, provides direct visualization of the entire colon mucosa. Full Article
Given Imaging Ltd Reaffirms FY 2013 Guidance
Given Imaging Ltd announced that it is encouraged by second quarter strong revenues to date and the Company remain on track to meet the fiscal 2013 financial guidance provided earlier this year. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $199 million and EPS of $0.77 for fiscal 2013. Full Article
Given Imaging Ltd Issues FY 2013 Revenue Guidance In Line With Analysts' Estimates; EPS Guidance Above Analysts' Estimates
Given Imaging Ltd announced that for fiscal 2013, it expects revenue to be in the range of $195-$205 million. Earnings per share (EPS) will be between $0.55-$0.63 on a GAAP-basis and between $0.80-$0.88 on a Non-GAAP-basis. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $202.32 million and EPS of $0.68 for fiscal 2013. Full Article
Given Imaging Ltd Halts Sale Review, Investor May Sell Stake-Reuters
Reuters reported that Given Imaging is no longer considering a sale or merger and will instead focus on its existing operating plan, as well as potential acquisitions and alliances, the camera-in-a-pill maker said. The Israeli medical devices maker also said 45.5% shareholder Discount Investment Corp planned to seek and consider a sale of its stake in one block. There can be no assurance that any transaction will occur, Given Imaging added. Terms of the transaction were not disclosed. Full Article
Given Imaging Ltd Submits PillCam COLON 2 Application to FDA for U.S. Regulatory Clearance
Given Imaging Ltd announced that it has filed a U.S. Food and Drug Administration (FDA) application seeking regulatory clearance to market its PillCam COLON 2 for visualization of the lower gastrointestinal tract. The PillCam COLON 2 capsule endoscopy system is complementary to colonoscopy and the proposed indication for use meets an unmet need and makes it an attractive imaging tool for patients who are at a higher risk for complications from colonoscopy as well as for patients who received an incomplete optical colonoscopy. The diagnostic use of PillCam COLON 2 may improve the standard of care for patients who are currently unable to undergo an exam, while minimizing potential adverse events, and reducing the risks associated with radiation-based alternative procedures such as CT colonography or double-contrast barium enema. Based on guidance provided by the FDA, Given Imaging has submitted its PillCam COLON 2 application through a direct de novo pathway. Under new guidelines specified by the FDA Safety and Innovation Act (FDASIA) of 2012, the Company believes that the direct de novo pathway may expedite the regulatory approval process by a few months. Full Article
Given Imaging Ltd Reaffirms FY 2012 Guidance
Given Imaging Ltd announced that for fiscal 2012, it expects revenues to be between $185 million and $190 million and earnings per share to be between $0.45 and $0.55 on a GAAP basis, and between $0.70 and $0.80 on a non-GAAP basis. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $187 million and EPS of $0.70 for fiscal 2012. Full Article
Given Imaging Ltd Acquires Assets Of SmartPill Corporation
Given Imaging Ltd announced that it has acquired from The SmartPill Corporation, a U.S. based-company, the assets related to the SmartPill GI Monitoring System for $6 million. The SmartPill is an ingestible capsule that uses sensor technology to measure pH, pressure and temperature in the GI tract. The SmartPill System measures gastric emptying and total GI (stomach, small bowel and colon) transit times and is used to evaluate motility disorders like gastroparesis and constipation. Given Imaging does not expect that this acquisition will have a meaningful contribution to its fourth quarter 2012 revenues. The Company will record the acquisition expenses in its fiscal year 2012 financial statements. Full Article
Given Imaging Ltd. Lowers FY 2012 Revenue Guidance; Reaffirms FY 2012 EPS Guidance
Given Imaging Ltd. announced that as a result of ongoing economic weakness in Europe, associated with the weak Euro and the lower than forecast revenue in the Asia Pacific region in the first half of 2012, the Company is lowering its revenue guidance for fiscal 2012 from between $190 million and $200 million to between $185 and $190 million. Despite lowering top-line guidance, the Company believes that initiatives to maximize profitability will enable the Company to achieve its earnings per share (EPS) guidance of between $0.45 and $0.55 on a GAAP basis, and between $0.70 and $0.80 on a non-GAAP basis. Full Article
Given Imaging Ltd. Issues FY 2012 Guidance In Line With Analysts' Estimates
Given Imaging Ltd. announced that for fiscal 2012, it expects revenue to be in the range of $190-$200 million. Earnings per share to be between $0.45 - $0.55 on a GAAP basis and between $0.70-$0.80 on a non-GAAP basis (EPS). According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $191 million and EPS of $0.72 for fiscal 2012. Full Article
Given Imaging Ltd. Raises FY 2011 Revenue Guidance; Sees FY 2011 EPS At Low End Of Prior Range
Given Imaging Ltd. announced that for fiscal 2011, it expects revenues to be between $173-$177 million compared to prior revenue guidance of between $165-$173 million. The Company now expects that earnings per share (EPS) to be toward the lower end of prior guidance of between $0.35-$0.40 on a GAAP basis and between $0.65-$0.70 on a non-GAAP basis primarily due to one-time charges that lowered gross margin in the first half of this year. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $170 million and EPS of $0.65 for fiscal 2011. Full Article
UPDATE 1-Given Imaging halts sale review, investor may sell control
TEL AVIV, Jan 15 - Given Imaging is no longer considering a sale or merger and will instead focus on its existing operating plan, as well as potential acquisitions and alliances, the camera-in-a-pill maker said on Tuesday.
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