-- Revenues Increased 15% Over Q3 2006 -- Q3 2007 GAAP Net Income Increased 123% to $1.7 million, or $0.05 per share vs. Q3 2006 Net Income of $741,000 or $0.02 per share on a fully diluted basis -- Q3 2007 non-GAAP Net Income increased 153% to $4.7 million or, $0.15 per share vs. Q3 2006 Net Income of $1.9 million or $0.06 per share on a fully diluted basis -- Company lowering 2007 revenue guidance but reaffirming EPS guidanceGiven Imaging Ltd. (
-- National Government Services (NGS), the Medicare Part B Carrier serving more than 6 million individuals in New York, New Jersey, Kentucky and Indiana, issued a new coverage policy for cirrhotic patients for the evaluation of esophageal varices using capsule endoscopy of the esophagus. The policy becomes effective December 1st.PillCam SB Reimbursement
-- NGS also revised language pertaining to PillCam SB by expanding the base of reimbursed indications to include the detection of small bowel tumors, evaluation of malabsorption syndrome, and small bowel evaluation prior to a small bowel surgical resection to control loss of blood or protein.Third Quarter Conference Call / Webcast Information U.S. Call / Webcast Given Imaging will host a conference call for English speakers at 9am ET on Thursday, November 1. To participate in this teleconference, please dial (866) 409-1560 fifteen minutes before the conference begins. Callers outside of the U.S. should dial (913) 312-6690. The call will also be webcast live at www.givenimaging.com. To access, click "About Given Imaging." The webcast will be available in the Investor Relations section. A replay of the call will be available for two weeks on the Company's website, or until November 15, 2007 by dialing (888) 203-1112. Callers outside of the U.S. should dial (719) 457-0820. The replay participant code is 6368714. Hebrew Call The Company will host a separate conference call in Hebrew on November 1 at 9am Israel time. To access this call, please dial +972 3 9180609 fifteen minutes before this conference begins. A replay of the call will be available until November 6 by dialing +972 3 9255928. 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 a number of 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 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union, and is pending clearance with the United States Food and Drug Administration. More than 600,000 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 operating subsidiary companies in the United States, Germany, France, Japan and Australia. For more information, visit http://www.givenimaging.com. Use of Non-GAAP Measures This press release provides financial measures for net income and basic and diluted earnings per share that exclude stock-based compensation expense and patent litigation expenses and are therefore not calculated in accordance with generally accepted accounting principals (GAAP). Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our performance that enhances management's and investors' ability to evaluate the Company's net income and earnings per share and to compare it with historical net income and earnings per share prior to the adoption of FAS 123R and the beginning of our patent litigation in the U.S. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when evaluating the business internally and therefore felt it is important to make these non-GAAP adjustments available to investors. 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) our ability to receive regulatory clearance or approval to market our products or 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 possibility of armed conflict or civil or military unrest in Israel, and (11) 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, 2006. 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 share data September 30 December 31 ------------ ------------ 2007 2006 ------------ ------------ (Unaudited) (Audited) ------------ ------------ Assets Current assets Cash and cash equivalents $ 42,094 $ 44,510 Short-term investments 27,842 17,245 Accounts receivable: Trade (Net of provisions for doubtful debts of $726 and of $787 as of September 30, 2007, and December 31, 2006, respectively) 18,884 18,887 Other 3,761 1,463 Inventories 18,882 18,168 Prepaid expenses 2,262 1,340 Deferred taxes 1,683 1,374 Advances to suppliers 257 82 ------------ ------------ Total current assets 115,665 103,069 ------------ ------------ Deposits 918 469 Assets held for severance benefits 2,657 1,984 Marketable Securities 33,407 34,769 Fixed assets, at cost, less accumulated depreciation 14,841 14,811 Other assets, at cost, less accumulated amortization 3,595 3,075 ------------ ------------ Total Assets $ 171,083 $ 158,177 ============ ============ Given Imaging Ltd. and its Subsidiaries Consolidated Balance Sheets In thousands except share data September 30 December 31 ------------ ------------ 2007 2006 ------------ ------------ (Unaudited) (Audited) ------------ ------------ Liabilities and shareholders' equity Current liabilities Current installments of obligation under capital lease $ 25 $ 13 Accounts payable Trade 7,346 5,550 Other 15,906 14,620 Deferred income 4,701 3,871 ----------- ----------- Total current liabilities 27,978 24,054 ----------- ----------- Long-term liabilities Deferred income 19,136 20,411 Obligation under capital lease, net - 20 Liability for employee severance benefits 3,149 2,407 ----------- ----------- Total long-term liabilities 22,285 22,838 ----------- ----------- Total liabilities 50,263 46,892 ----------- ----------- Minority interest 2,779 3,499 ----------- ----------- Shareholders' equity Share capital: Ordinary Shares, NIS $0.05 par value each (90,000,000 shares authorized; 29,182,574 and 28,641,291 shares issued and fully paid as of September 30, 2007, and December 31, 2006, respectively) 342 335 Additional paid-in capital 164,095 156,197 Capital reserve 2,166 2,166 Accumulated deficit (48,562) (50,912) ----------- ----------- Total shareholders' equity 118,041 107,786 ----------- ----------- Total liabilities and shareholders' equity $ 171,083 $ 158,177 =========== =========== Given Imaging Ltd. and its Subsidiaries Consolidated Statements of Operations In thousands except share and per share data Nine month period Three month period Year ended ended September 30 ended September 30 December 31 --------------------- --------------------- ----------- 2007 2006 2007 2006 2006 ---------- ---------- ---------- ---------- ---------- (Unaudited)(Unaudited)(Unaudited)(Unaudited) (Audited) ---------- ---------- ---------- ---------- ---------- Revenues $ 78,572 $ 67,557 $ 27,676 $ 24,050 $ 95,029 Cost of revenues (19,960) (16,969) (7,114) (6,058) (24,154) ---------- ---------- ---------- ---------- ---------- Gross profit 58,612 50,588 20,562 17,992 70,875 ---------- ---------- ---------- ---------- ---------- Operating expenses Research and development, gross (9,093) (9,374) (3,105) (2,753) (12,678) Royalty bearing participation 1,673 1,287 980 447 1,867 ---------- ---------- ---------- ---------- ---------- Research and development, net (7,420) (8,087) (2,125) (2,306) (10,811) Sales and marketing expenses (38,581) (37,123) (13,169) (11,239) (50,732) General and administrative expenses (14,507) (12,254) (5,486) (4,410) (16,027) ---------- ---------- ---------- ---------- ---------- Total operating expenses (60,508) (57,464) (20,780) (17,955) (77,570) ---------- ---------- ---------- ---------- ---------- Operating loss (1,896) (6,876) (218) 37 (6,695) Financing income, net 4,015 2,958 2,086 581 3,980 ---------- ---------- ---------- ---------- ---------- Profit (loss) before taxes on income 2,119 (3,918) 1,868 618 (2,715) Taxes on income (489) (28) (245) (254) (127) ---------- ---------- ---------- ---------- ---------- Profit (loss) before minority share 1,630 (3,946) 1,623 364 (2,842) Minority share in losses of subsidiary 720 977 33 377 1,334 ---------- ---------- ---------- ---------- ---------- Net profit (loss) $ 2,350 $ (2,969)$ 1,656 $ 741 $ (1,508) ========== ========== ========== ========== ========== Basic profit (loss) per Ordinary Share $ 0.08 $ (0.10)$ 0.06 $ 0.02 $ (0.05) ========== ========== ========== ========== ========== Diluted profit (loss) per Ordinary Share $ 0.08 $ (0.10)$ 0.05 $ 0.02 $ (0.05) ========== ========== ========== ========== ========== Weighted average number of Ordinary Shares used to compute basic profit (loss) per Ordinary Share 28,880,299 28,017,914 29,119,996 28,061,356 28,053,849 ========== ========== ========== ========== ========== Weighted average number of Ordinary Shares used to compute diluted profit (loss) per Ordinary Share 30,911,256 28,017,914 31,239,196 29,377,249 28,053,849 ========== ========== ========== ========== ==========
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR