-- The American Medical Association (AMA) and the Center for Medicare and Medicaid Services (CMS) assigned a Permanent Level 1 CPT Code for PillCam ESO which became effective on January 1, 2007. -- United Healthcare revised its small bowel capsule endoscopy coverage to include suspected and known celiac disease. United Healthcare serves more than 18 million customers. -- Trailblazer Health Enterprises, a Part B Medicare carrier serving more than 3.6 million individuals in Delaware, the District of Columbia, Maryland, Texas and Virginia issued a new policy covering capsule endoscopy of the small bowel for a variety of indications including celiac and Crohn's disease. The policy also states that esophageal capsule endoscopy may be used to evaluate esophageal varices in patients with portal hypertension as an alternative to upper GI endoscopy.Corporate Development In January 2007, Given Imaging announced that it will lead a European consortium for developing an integrated imaging-biosensing screening system for cancer of the gastrointestinal tract. 2007 World Economic Forum Given Imaging was honored at the 2007 World Economic Forum in Davos, Switzerland as a Technology Pioneer. Twelve Month Financial Results For the year ended December 31, 2006, sales were $95 million compared to $86.8 million in 2005. Gross profit for 2006 was 74.6% which was the same as gross profit for 2005. On a GAAP basis, net loss for 2006 was $1.5 million or $0.05 per share, compared to net income of $6.3 million, or $0.21 per share, on a fully diluted basis in 2005. The 2006 Statements of Operations include the impact of $5.2 million in expenses due to the adoption of FAS 123R. The Company reported non-GAAP net income of $3.7 million, or $0.13 per share, on a diluted basis in 2006. 2007 Guidance The company expects full year 2007 revenues of between $114 million to $119 million. The company expects full year 2007 GAAP, fully diluted earnings per share of between $0.21 - $0.31 per share. Non-GAAP, fully diluted earnings per share in 2007 is expected to be in a range of $0.34 to $0.44. Both GAAP and non-GAAP expected net income do not include expenses related to the Company's patent litigation with Olympus. Fourth Quarter Webcast Information Given Imaging will host a conference call tomorrow, February 28, 2007, at 9:00 a.m. Eastern time to discuss fourth quarter and full year 2006 results. To participate in the teleconference, please dial (866) 293-8970 fifteen minutes before the conference begins. International callers should dial (913) 312-1230. The call will also be webcast live at www.givenimaging.com. A replay of the call will be available for thirty days on the company's website, or until March 7, 2007 by dialing 888-203-1112. International callers should dial 719-457-0820. The replay participant code is 8791440. About Given Imaging Ltd. Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam™ Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 50 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. Nearly 500,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit http://www.givenimaging.com. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam Colon (2) changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the impact of the newly adopted SFAS 123R for expensing option-based payments, (11) the possibility of armed conflict or civil or military unrest in Israel, and (12) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
Given Imaging Ltd. and its subsidiaries Consolidated Balance Sheets (In thousands except per share data) December 31 ------------------------------ 2005 2006 Audited Unaudited Assets Current assets Cash and cash equivalents $ 65,356 $ 44,510 Short-term investments 288 17,245 Accounts receivable: Trade, net 18,325 18,887 Other 6,264 1,463 Inventories 16,172 18,168 Advances to suppliers 332 82 Deferred taxes 1,219 1,374 Prepaid expenses 1,020 1,340 -------------- -------------- Total current assets 108,976 103,069 Assets held for employees severance payments 1,690 1,984 Marketable securities 21,664 34,769 Fixed assets, at cost, less accumulated depreciation 13,862 14,811 Other assets, net 2,918 3,544 -------------- -------------- Total Assets $ 149,110 $ 158,177 ============== ============== Given Imaging Ltd. and its subsidiaries Consolidated Balance Sheets (In thousands except share data) December 31 ------------------------------ 2005 2006 Audited Unaudited Liabilities and shareholders' equity Current liabilities Current installments of obligation under capital lease $ 11 $ 13 Accounts payable: Trade 5,529 5,550 Other 13,886 14,620 Deferred income 3,333 3,871 ------------- ------------- Total current liabilities 22,759 24,054 ------------- ------------- Long-term liabilities Deferred income 22,172 20,411 Obligation under capital lease 34 20 Liability in respect of employees severance payments 2,040 2,407 ------------- ------------- Total long-term liabilities 24,246 22,838 ------------- ------------- Total liabilities 47,005 46,892 ------------- ------------- Commitments and contingencies Minority interest 61 3,499 Shareholders equity Share capital: Ordinary Shares, NIS 0.05 par value each (90,000,000 shares authorized as of December 31, 2005 and 2006, 27,950,281 and 28,641,291 shares issued and fully paid as of December 31, 2005 and 2006, respectively) 327 335 Additional paid-in capital 148,955 156,197 Capital reserve 2,166 2,166 Accumulated deficit (49,404) (50,912) ------------- ------------- Total shareholders' equity 102,044 107,786 ------------- ------------- Total liabilities and shareholders' equity $ 149,110 $ 158,177 ============= ============= Consolidated Statements of Operations (In thousands except share and per share data) Year ended Three month period December 31, Ended December 31, ------------------------ ------------------------ 2005 2006 2005 2006 Audited Unaudited Unaudited Unaudited ----------- ----------- ----------- ----------- Revenues $ 86,776 $ 95,029 $ 24,400 $ 27,472 Cost of revenues 22,070 24,154 6,000 7,185 ----------- ----------- ----------- ----------- Gross profit 64,706 70,875 18,400 20,287 ----------- ----------- ----------- ----------- Operating expenses Research and development, gross (8,833) (12,678) (2,754) (3,304) Royalty bearing government grants 1,244 1,867 372 580 ----------- ----------- ----------- ----------- Research and development, net (7,589) (10,811) (2,382) (2,724) Sales and marketing (43,281) (50,732) (11,054) (13,609) General and administrative (9,657) (16,027) (2,644) (3,773) ----------- ----------- ----------- ----------- Total operating expenses (60,527) (77,570) (16,080) (20,106) ----------- ----------- ----------- ----------- Operating profit (loss) 4,179 (6,695) 2,320 181 Financial income, net 762 3,980 607 1,022 ----------- ----------- ----------- ----------- Profit (loss) before taxes on income and minority share 4,941 (2,715) 2,927 1,203 Taxes on income 286 (127) 281 (99) ----------- ----------- ----------- ----------- Profit (loss) before minority share 5,227 (2,842) 3,208 1,104 Minority share in losses of subsidiary 1,116 1,334 313 357 ----------- ----------- ----------- ----------- Net profit (loss) $ 6,343 $ (1,508) $ 3,521 $ 1,461 =========== =========== =========== =========== Profit (loss) per share Basic profit (loss) per Ordinary Share $ 0.23 $ (0.05) $ 0.13 $ 0.05 =========== =========== =========== =========== Diluted profit (loss) per Ordinary Share $ 0.21 $ (0.05) $ 0.12 $ 0.05 =========== =========== =========== =========== Weighted average number of Ordinary Shares used to compute basic profit (loss) per Ordinary Share 27,781,223 28,053,849 27,920,441 28,073,231 =========== =========== =========== =========== Weighted average number of Ordinary Shares used to compute diluted profit (loss) per Ordinary Share 29,695,164 28,053,849 29,950,208 29,833,686 =========== =========== =========== ===========
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR Email Contact Email Contact