-- Regulatory In late October, the company received the CE Mark to market PillCam COLON throughout the European Union. -- PillCam SB Reimbursement -- France: In late July, the French National Authority for Health completed the first step in advancing universal reimbursement for PillCam SB capsule. The codification process is expected to be completed during 2007. -- Israel: Israel's Ministry of Health approved reimbursement for PillCam SB for patients with iron deficiency anemia as a result of obscure gastrointestinal bleeding as well as for suspected Crohn's disease. -- Spain: Spain's National Health Service now includes PillCam Capsule Endoscopy for the small bowel in its portfolio of health services. Individuals with symptoms of persistent obscure gastrointestinal bleeding of presumed small bowel origin following negative upper and lower endoscopies may undergo the PillCam SB procedure at hospitals and clinics that offer it. -- PillCam ESO Reimbursement First Coast Service Options, Inc., which administers Florida and Connecticut Medicare, designated PillCam ESO as a diagnostic tool for patients who are unable to undergo conventional endoscopy or are diagnosed with portal hypertension and require immediate evaluation of esophageal varices. Over 3 million individuals will now have access to PillCam ESO under this designation.Nine Month Financial Results For the nine month period ended September 30, 2006, sales were $67.6 million compared to $62.4 million in the same period in 2005. Gross profit for the nine month period was 74.9% compared to 74.2% in 2005. On a GAAP basis, net loss for the first nine months of 2006 was $3.0 million or $0.10 per share, compared to net income of $2.8 million, or $0.095 per share, on a fully diluted basis for the same period in 2005. The nine month period ended September 30, 2006 includes the impact of $4.1 million in expenses due to the adoption of FAS 123R. The Company reported non-GAAP net income of $1.2 million, or $0.04 per share, on a diluted basis in the nine months of 2006. 2006 Guidance The company reiterates its full year 2006 guidance of revenues of between $92 million to $97 million. The Company also announced that it increased its prior guidance for non-GAAP, fully diluted earnings per share from a range of $0.04 to $0.14 to $0.07 to $0.14 for the full year 2006. Third Quarter Webcast Information Given Imaging will host a conference call tomorrow, Thursday, November 2, 2006, at 9:00 am Eastern time to discuss third quarter results. To participate in the teleconference, please dial 800-753-9048 fifteen minutes before the conference begins. International callers should dial 913-312-1278. 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 November 10, 2006 by dialing 888-203-1112. International callers should dial 719-457-0820. The replay participant code is 4578816. 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. More than 400,000 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 Consolidated Subsidiaries Consolidated Balance Sheets In thousands except share data September 30, December 31, ------------ ----------- 2006 2005 ------------ ----------- (Unaudited) (Audited) ------------ ----------- Assets Current assets Cash and cash equivalents $ 35,206 $ 65,356 Short-term investments 12,966 288 Accounts receivable: Trade (Net of provisions for doubtful debts of $700 and $431 as of September 30, 2006 and December 31, 2005, respectively) 16,543 18,325 Other 1,634 6,264 Inventories 18,445 16,172 Prepaid expenses 2,081 1,020 Deferred taxes 1,448 1,219 Advances to suppliers 77 332 ----------- ----------- Total current assets 88,400 108,976 ----------- ----------- Deposits 457 401 Marketable securities 42,137 21,664 Assets held for severance benefits 1,821 1,690 Fixed assets, at cost, less accumulated depreciation 15,327 13,862 Other assets, at cost, less accumulated amortization 2,833 2,517 ----------- ----------- Total assets $ 150,975 $ 149,110 =========== =========== Given Imaging Ltd. and its Consolidated Subsidiaries Consolidated Balance Sheets In thousands except share data September 30, December 31, ------------ ----------- 2006 2005 ------------ ----------- (Unaudited) (Audited) ------------ ----------- Liabilities and shareholders' equity Current liabilities Current installments of obligation under capital lease $ 12 $ 11 Accounts payable: Trade 3,894 5,529 Other 12,892 13,886 Deferred revenue 3,383 3,333 ----------- ----------- Total current liabilities 20,181 22,759 ----------- ----------- Long-term liabilities Deferred income 20,824 22,172 Obligation under capital lease, net 21 34 Liability for employee severance benefits 2,217 2,040 ----------- ----------- Total long-term liabilities 23,062 24,246 ----------- ----------- Total liabilities 43,243 47,005 ----------- ----------- Minority interest 3,856 61 Shareholders equity Share capital: Ordinary Shares, NIS 0.05 par value each (90,000,000 shares authorized as of September 30, 2006 and December 31, 2005, 28,073,231 and 27,950,281 shares issued and fully paid as of September 30, 2006 and December 31, 2005, respectively) 329 327 Additional paid-in capital 153,754 148,955 Capital reserve 2,166 2,166 Accumulated deficit (52,373) (49,404) ----------- ----------- Total shareholders' equity 103,876 102,044 ----------- ----------- Total liabilities and shareholders' equity $ 150,975 $ 149,110 =========== =========== Given Imaging Ltd. and its Consolidated Subsidiaries Consolidated Statements of Operations In thousands except share and per share data Nine-month period Three-month period Year ended ended ended September 30, September 30, December 31, --------------------- --------------------- ----------- 2006 2005 2006 2005 2005 --------- --------- --------- --------- --------- (Unaudited) (Unaudited) (Unaudited) (Unaudited) (Audited) --------- --------- --------- --------- --------- Revenues $ 67,557 $ 62,376 $ 24,050 $ 19,841 $ 86,776 Cost of revenues 16,969 16,070 6,058 4,618 22,070 ---------- ---------- ---------- ---------- ---------- Gross profit 50,588 46,306 17,992 15,223 64,706 ---------- ---------- ---------- ---------- ---------- Operating expenses Research and development, gross (9,374) (6,079) (2,753) (2,061) (8,833) Royalty bearing participation 1,287 872 447 374 1,244 ---------- ---------- ---------- ---------- ---------- Research and development, net (8,087) (5,207) (2,306) (1,687) (7,589) Sales and marketing expenses (37,123) (32,227) (11,239) (9,778) (43,281) General and administrative expenses (12,254) (7,013) (4,410) (2,539) (9,657) ---------- ---------- ---------- ---------- ---------- Total operating expenses (57,464) (44,447) (17,955) (14,004) (60,527) ---------- ---------- ---------- ---------- ---------- Operating profit (loss) (6,876) 1,859 37 1,219 4,179 Financing income, net 2,958 155 581 519 762 ---------- ---------- ---------- ---------- ---------- Profit (loss) before taxes on income (3,918) 2,014 618 1,738 4,941 Taxes on income (28) 5 (254) (53) 286 ---------- ---------- ---------- ---------- ---------- Profit (loss) before minority share (3,946) 2,019 364 1,685 5,227 Minority share in losses of subsidiary 977 803 377 253 1,116 ---------- ---------- ---------- ---------- ---------- Net (loss) profit $ (2,969) $ 2,822 $ 741 $ 1,938 $ 6,343 ========== ========== ========== ========== ========== Basic (loss) profit per Ordinary Share $ (0.10) $ 0.10 $ 0.02 $ 0.07 $ 0.23 ========== ========== ========== ========== ========== Diluted (loss) profit per Ordinary Share $ (0.10) $ 0.09 $ 0.02 $ 0.07 $ 0.21 ========== ========== ========== ========== ========== Weighted average number of Ordinary Shares outstanding used in basic profit per Ordinary Share calculation 28,017,914 27,736,989 28,061,356 27,829,442 27,781,223 ========== ========== ========== ========== ========== Weighted average number of Ordinary Shares outstanding used in diluted profit per Ordinary Share calculation 28,017,914 29,731,618 29,377,249 29,568,874 29,695,164 ========== ========== ========== ========== ==========
Contact Information: For further information contact: Yuval Yanai Given Imaging Ltd. Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR Email Contact/ Email Contact