First Qtr. First Qtr. 2008 2007 ----------- ------------ GAAP net income (loss) $ 1.1 $ 0.1 ----------- ------------ InScope gain (5.4) ----------- ------------ Compensation expenses (FAS123R) 1.5 1.1 ----------- ------------ IP Litigation expenses 2.9 (*)0.4 ----------- ------------ Non-GAAP net income $ 0.1 (*)$ 1.6 ----------- ------------ Non-GAAP EPS $ 0.00 $ 0.05 ----------- ------------(*)Reclassified to a non-GAAP item. The Company did not report this amount as a non-GAAP item when it reported first quarter 2007 results. Gross margin in the first quarter of 2008 was 71.1%, compared to 73.9% in the first quarter of 2007. For the first quarter of 2008, net cash provided by operating activities totaled $6.9 million. Cash and cash equivalents, short-term investments and marketable securities at March 31, 2008 totaled $109.2 million. First Quarter 2008 Revenue Analysis Sales in the Americas region were $15.8 million, up 2% from the $15.4 million in the same period in 2007. EMEA sales increased 39% to $8.2 million compared to $5.9 million in the same period in 2007, while APAC sales increased 75% to $3.1 million from $1.8 million in the same period in 2007. Worldwide PillCam SB sales were 46,100 in the first quarter of 2008, an increase of 9.5% compared to the same period last year. PillCam SB sales in the Americas were 29,900 in the first quarter of 2008 compared to 30,200 in the first quarter of 2007. Reorders of PillCam SB in the Americas region grew 5.7% to 29,300 compared to 27,700 the first quarter of 2007. PillCam SB sales in the EMEA region increased 12.7% and sales in APAC regions more than doubled compared to the first quarter of 2007. The increase in PillCam SB sales in the APAC region is mainly attributable to sales in Japan. PillCam sales accounted for 85% of total revenues compared to 87% of total sales in the same period of last year. Reorders of PillCam SB increased 15% to approximately 44,600 compared to approximately 38,700 in the first quarter of 2007. Supplemental first quarter data can be found at www.givenimaging.com in the Investor Relations section. 2008 Guidance The Company reaffirms its fiscal 2008 revenue guidance of $130 - $136 million and non-GAAP, fully-diluted earnings per share of $0.44 to $0.52. Upon signing the final intellectual property settlement agreement with Olympus Corporation in the near term, the Company expects full year 2008 GAAP, fully-diluted earnings per share to be in the range of $0.26 and $0.34. This guidance does not take into account the $2.33 million pre-tax payment the Company expects to receive from Olympus Corporation once the settlement is finalized, which may result in additional pre-tax earnings per share of up to $0.08. The following table reconciles GAAP and non-GAAP EPS guidance for fiscal 2008:
2008 --------------- GAAP EPS $ 0.26 - $ 0.34 --------------- InScope gain (0.17) --------------- Compensation expenses (FAS123R) 0.23 --------------- IP Litigation expenses 0.12 --------------- Non-GAAP EPS $ 0.44 - $ 0.52 ---------------Conference Call / Webcast Information U.S. Call / Webcast Given Imaging will host a conference call Wednesday, May 14, 2008, at 9:00 a.m. Eastern time to discuss first quarter 2008 results. To participate in the teleconference, please dial 1-800-289-0544 fifteen minutes before the conference begins. International callers should dial 913-312-1402. The call will also be webcast live at www.givenimaging.com. A replay of the call will be available for two weeks on the company's website, or until May 28, 2008 by dialing 888-203-1112. International callers should dial 719-457-0820. The replay participant code is 4237742. Hebrew Call The company will host a separate conference call in Hebrew on May 14 at 7:00 a.m. Eastern time. To access this call, please dial +972-3-9180650 ten minutes before the conference is scheduled to begin. A replay of the call will be available until May 16 by dialing +972-3-9255939. 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. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 700,000 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, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). 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. Forward-Looking Statements 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) our ability to obtain reimbursement for our product from government and commercial 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, 2007. 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 March 31, December 31, ------------ ------------ 2008 2007 ------------ ------------ (Unaudited) (Audited) ------------ ------------ Assets Current assets Cash and cash equivalents $ 43,117 $ 37,103 Short-term investments 23,594 23,191 Accounts receivable: Trade (Net of provisions for doubtful debts of $286 and of $329 as of March 31, 2008 and December 31, 2007, respectively) 18,364 23,315 Other 3,466 10,385 Inventories 16,560 15,960 Prepaid expenses 1,206 1,289 Deferred tax assets 1,188 1,350 Advances to suppliers 253 190 ------------ ------------ Total current assets 107,748 112,783 ------------ ------------ Deposits 916 892 Assets held for employee severance payments 3,477 3,007 Marketable Securities 42,235 41,629 Fixed assets, at cost, less accumulated depreciation 15,408 15,422 Other assets, at cost, less accumulated amortization 3,663 3,583 ------------ ------------ Total Assets $ 173,447 $ 177,316 ============ ============ Given Imaging Ltd. and its Consolidated Subsidiaries Consolidated Balance Sheets In thousands except share data March 31, December 31, ----------- ----------- 2008 2007 ----------- ----------- (Unaudited) (Audited) ----------- ----------- Liabilities and shareholders' equity Current liabilities Current installments of obligation under capital lease $ 133 $ 121 Accounts payable Trade 9,781 7,275 Other 16,593 21,012 Deferred income 2,887 9,379 ----------- ----------- Total current liabilities 29,394 37,787 ----------- ----------- Long-term liabilities Deferred income - - Obligation under capital lease, net 561 448 Liability in respect of employees' severance payments 4,071 3,490 ----------- ----------- Total long-term liabilities 4,632 3,938 ----------- ----------- Total liabilities 34,026 41,725 ----------- ----------- Minority interest 2,679 1,996 ----------- ----------- Shareholders' equity Share capital: Ordinary Shares, NIS 0.05 par value each (90,000,000 shares authorized; 29,252,785 and 29,241,785 shares issued and fully paid as of March 31, 2008 and December 31, 2007, respectively) 343 343 Additional paid-in capital 168,520 166,813 Capital reserve 2,166 2,166 Accumulated other comprehensive income 364 - ----------- ----------- Accumulated deficit (34,651) (35,727) ----------- ----------- Total shareholders' equity 136,742 133,595 ----------- ----------- Total liabilities and shareholders' equity $ 173,447 $ 177,316 =========== =========== Given Imaging Ltd. and its Consolidated Subsidiaries Consolidated Statements of Operations In thousands except share and per share data Three month period ended March 31, Year Ended ---------------------- December 31, 2008 2007 2007 ---------- ---------- ---------- (Unaudited) (Unaudited) (Audited) ---------- ---------- ---------- Revenues $ 27,124 $ 23,052 $ 112,868 Cost of revenues (7,835) (6,022) (29,721) Early repayment of royalty bearing government grants - - (4,843) ---------- ---------- ---------- Gross profit 19,289 17,030 78,304 ---------- ---------- ---------- Operating expenses Research and development, gross (3,796) (2,783) (12,847) Royalty and non-royalty bearing grants 420 93 1,242 ---------- ---------- ---------- Research and development, net (3,376) (2,690) (11,605) Sales and marketing (14,962) (11,506) (55,446) General and administrative (7,279) (3,943) (20,981) Termination of marketing agreement 5,443 - 22,860 Other - - (422) ---------- ---------- ---------- Total operating expenses (20,174) (18,139) (65,594) ---------- ---------- ---------- Operating income (loss) (885) (1,109) 12,710 Financing income, net 1,596 1,202 5,520 ---------- ---------- ---------- Profit before taxes on income and minority share 711 93 18,230 Income tax expense (159) (247) (4,548) ---------- ---------- ---------- Profit (loss) before minority share 552 (154) 13,682 Minority share in losses of subsidiary 524 225 1,503 ---------- ---------- ---------- Net profit $ 1,076 $ 71 $ 15,185 ========== ========== ========== Earnings per share Basic Earnings per Ordinary Share $ 0.04 $ 0.00 $ 0.52 ========== ========== ========== Diluted Earnings per Ordinary Share $ 0.03 $ 0.00 $ 0.49 ========== ========== ========== Weighted average number of Ordinary Shares used to compute basic profit per Ordinary share 29,250,952 28,659,520 28,961,968 ========== ========== ========== Weighted average number of Ordinary Shares used to compute dilute Earnings per Ordinary share 31,094,578 30,503,871 31,030,458 ========== ========== ========== Given Imaging Ltd. and its Consolidated Subsidiaries Consolidated Statements of Cash Flows In thousands except share and per share data Three month period ended March 31, Year Ended ---------------------- December 31, 2008 2007 2007 ---------- ---------- ---------- (Unaudited) (Unaudited) (Audited) ---------- ---------- ---------- Cash flows from operating activities: Net profit $ 1,076 $ 71 $ 15,185 Adjustments required to reconcile net profit to net cash used in operating activities: Minority share in losses of subsidiary (524) (225) (1,503) Depreciation and amortization 1,265 1,150 4,771 Deferred tax assets 162 (239) 24 Stock options compensation 1,511 1,109 5,651 Excess tax benefits related to stock based compensation - - (693) Other 172 73 380 Net decrease (increase) in trading securities (89) 3,078 5,092 Decrease (increase) in accounts receivable - trade 4,951 2,139 (4,428) Decrease (increase) in accounts receivable - other 7,550 (745) (8,922) Decrease (increase) in prepaid expenses 83 (426) 51 Increase in advances to suppliers (63) (43) (108) Decrease (Increase) in inventories (600) 781 2,208 Increase (decrease) in accounts payable (2,088) (3,601) 8,570 Increase (decrease) in deferred income (6,492) 42 (14,903) ---------- ---------- ---------- Net cash provided by operating activities 6,914 3,164 11,375 ---------- ---------- ---------- Cash flows from investing activities: Purchase of fixed assets and intangible assets (1,247) (692) (5,772) Deposits (25) (11) (355) Proceeds from sales of marketable securities 18,446 - 18,753 Proceeds from sales of fixed assets 25 Acquisition of marketable securities (19,627) (17,358) (36,584) ---------- ---------- ---------- Net cash used in investing activities (2,428) (18,061) (23,958) ---------- ---------- ---------- Cash flows from financing activities: Principal payments on capital lease obligation (50) (3) (37) Proceeds from the issuance of Ordinary Shares 196 352 4,280 Excess tax benefits related to stock based compensation - - 693 Issuance of shares by consolidated company to the minority 1,207 - - ---------- ---------- ---------- Net cash provided by financing activities 1,353 349 4,936 ---------- ---------- ---------- Effect of exchange rate changes on cash 175 49 240 ---------- ---------- ---------- Increase (decrease) in cash and cash equivalents 6,014 (14,499) (7,407) Cash and cash equivalents at beginning of period 37,103 44,510 44,510 ---------- ---------- ---------- Cash and cash equivalents at end of period $ 43,117 $ 30,011 $ 37,103 ========== ========== ========== Supplementary cash flow information Income taxes paid $ 77 $ 75 $ 1,098 ========== ========== ========== Assets acquired under capital lease $ 109 $ - $ 569 ========== ========== ==========
Contact Information: For further information contact: Fern Lazar David Carey Lazar Partners Ltd. 1-212-867-1768