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Given Imaging Reports 2008 Results

Given Imaging Ltd. (Given Imaging) has reported revenues of $125.1 million for the full year of 2008, up 11%, compared with the revenues of $112.9 million in the previous year-end. It has also reported a net income of $4.1 million or $0.13 per diluted share, for the full year of 2008, compared with a net income of $15.2 million or $0.49 per diluted share, in the previous year-end.

Worldwide revenues were $33.8 million in the fourth quarter of 2008, down 1.5% from $34.3 million in the fourth quarter of 2007. Gross margin in the fourth quarter of 2008 was 72.6%, against gross margin of 71.5% in the fourth quarter of 2007, excluding a one-time charge of $4.8 million (1).

Net loss for the fourth quarter of 2008 was $2.0 million or $0.07 per share, against net income of $12.8 million, or $0.41 per share on a fully diluted basis in the fourth quarter of 2007. Net loss for the fourth quarter of 2008 includes a one-time charge of $4.7 million, resulting from the write-off of in-process R&D associated with the acquisition of the Bravo pH monitoring business. Excluding this one-time charge, net income for the fourth quarter of 2008 was $2.7 million, or $0.09 per share on a fully diluted basis. Net income for the fourth quarter of 2007 included, among other items, a gain of $22.9 million, and a tax expense of $3.0 million, both resulting from the termination of the agreement with Johnson & Johnson. Excluding this one-time charge, net loss for the fourth quarter of 2007 was $7.1 million, or $0.24 per share.

Cash and cash equivalents, short-term investments and marketable securities at December 31, 2008 totaled $90.3 million.

“We are pleased that in 2008 we were able to deliver top-line growth of 11%. We achieved these results in spite of the economic downturn and a slower than anticipated start in Japan,” said Homi Shamir, president and chief executive officer of Given Imaging. “Last year, we continued to focus on investing in talent, global expansion, partnerships and new product development. I am pleased to report that we demonstrated clear progress on all fronts. We enter 2009 with opportunities to expand PillCam SB sales around the world, an additional world-class partner in Japan and several new exciting products to launch in 2009 including the Bravo pH monitoring system, which is the gold standard test for diagnosing GERD. We also plan to initiate clinical trials for PillCam COLON 2 during 2009 which could prove to be invaluable as either a screening tool for colon cancer or a complementary test to colonoscopy. As we begin 2009, we recognize the uncertain economic environment and are cautiously optimistic about continuing to increase both our top and bottom lines this year with strong contributions from all of our regions.”

Fourth Quarter 2008 Revenue Analyses

Sales in the Americas region were $20.7 million, down 5% from sales of $21.9 million in the same period in 2007. Sales in the EMEA region increased by 16% to $9.7 million, against $8.3 million, in the same period in 2007, while APAC sales declined by 16% to $3.4 million against $4.0 million in the same period in 2007.

Worldwide PillCam SB sales amounted to 55,800 capsules in the fourth quarter of 2008, an increase of two% against the same period last year. PillCam SB sales in the Americas region decreased by 5%, to 37,700 in the fourth quarter of 2008 against 39,800 in the fourth quarter of 2007. PillCam SB sales in the EMEA and Asia/Pacific regions increased 19% and 23%, respectively, against the fourth quarter of 2007. Worldwide reorders of PillCam SB increased by 9% to about 54,800 against about 50,600 in the fourth quarter of 2007. Reorders of PillCam SB in the Americas region increased by 1% to 37,300 against 36,900 in the fourth quarter of 2007. Reorders in the EMEA region increased by 18%, while APAC reorders increased by 72%.

In the fourth quarter of 2008, PillCam sales accounted for 83% of total revenues against 79% in the same period of 2007.

Supplemental fourth quarter data can be found at www.givenimaging.com in the Investor Relations section.

Twelve Month Financial Results

Gross profit for the twelve month period was 73.6% against 69.4% in 2007. Gross profit for 2007, net of the effect of the one-time charge, was 73.7%. Net income for 2008, net of the effect of the one-time charge of $4.7 million resulting from the acquisition of Bravo was $8.8 million, or $0.29 per share on a fully diluted basis. A table detailing certain items affecting net income in the fourth quarter and full fiscal year of 2007 and 2008 is available below.

Net cash generated from operating activities during 2008 totaled $9.5 million.

Total revenues increased in each of our regions with the Americas growing by 3% to $75.5 million, EMEA increasing by 28% to $34.9 million and the APAC region growing by 25% to $14.5 million. Overall PillCam SB revenues for 2008 grew by 14% over PillCam SB revenues in 2007. The company sold over 210,000 PillCam SB capsules in 2008.

2009 Outlook

The company projects full year 2009 revenues to be between $141 million and $148 million. The company expects fully diluted EPS of between $0.20 and $0.28.