YOQNEAM, ISRAEL--(Marketwire - February 16, 2010) - Given Imaging Ltd. (NASDAQ: GIVN) today announced financial results for the fourth quarter and twelve months ended December 31, 2009.
For the twelve month period ended December 31, 2009, revenues increased by 13.3% to $141.8 million compared to $125.1 million in the same period of 2008. Revenues in the Americas region grew 18.6% to $89.7 million in 2009 compared to $75.6 million in the same period in 2008. Revenues in the EMEA region increased by 10.0% to $38.4 million, from $34.9 million in the same period in 2008, and revenues in the APAC region were $13.6 million, a decline of 6.7% from $14.6 million last year. Bravo pH Monitoring System revenues were $15.0 million in the 2009, representing 11% of total revenues and 15% of revenues in the Americas region.
Gross profit for the year increased to 76.6% from 73.6% in 2008. On a GAAP basis, net income for 2009 more than tripled to $14.3 million, or $0.47 per share on a fully diluted* basis, from $4.0 million or $0.13 per share for the same period in 2008. On a non-GAAP basis, net income for 2009 increased 67% to $19.5 million, or $0.64 per share on a fully diluted* basis, from $11.5 million or $0.37 per share in the same period in 2008.
Cash and cash equivalents, short-term investments and marketable securities at December 31, 2009 increased to $95.2 million. Net cash provided by operating activities was $24.2 million.
“I’m very proud with our performance in 2009 which demonstrates the strength of our business, despite the challenging economic environment. Our strong 2009 financial results reflect a record year in many aspects -- revenues, PillCam sales and profitability. The strong improvement in profitability stems from our ongoing efforts to improve operating efficiencies and increase revenues. We are also very pleased with our fourth quarter financial results including the solid 18.5% increase in revenues and record worldwide sales of 61,000 PillCam capsules,” said Homi Shamir, president and CEO of Given Imaging.
“Looking ahead, in 2010 we intend to continue the progress made last year and grow revenues by expanding sales of PillCam SB in newer markets and further penetrating established PillCam markets with new indications. We will also invest in growing the market for Bravo worldwide, and begin developing the market for PillCam COLON 2. At the same time, we remain committed to maximizing profitability and shareholder value.”
Fourth Quarter 2009 Analysis
Worldwide revenues were $40.0 million in the fourth quarter of 2009, an 18.5% increase from $33.8 million in the fourth quarter of 2008. Gross margin in the fourth quarter of 2009 increased to 76.6%, compared to 72.6% in the fourth quarter of 2008.
Revenues in the Americas region increased 16.0% to $24.0 million, from $20.7 million in the same period in 2008. Revenues in the EMEA region were $11.3 million, an increase of 16.5% from $9.7 million in the same period in 2008. Revenues in the APAC region were $4.7 million, an increase of 38.2% from $3.4 million last year.
Worldwide PillCam SB sales amounted to 60,800 capsules in the fourth quarter of 2009, a 9% increase compared to 55,800 capsules in the same period last year. PillCam SB sales in the Americas region increased 1.9% to 38,400 in the fourth quarter of 2009 compared to 37,700 the same period last year. PillCam SB sales in the EMEA region increased 16.9% to 15,900 in the fourth quarter of 2009, while PillCam SB sales in the APAC region increased 44% to 6,500.
Bravo pH Monitoring System revenues were $4.4 million in the fourth quarter representing 11% of total revenues and 15% of revenues in the Americas region.
On a GAAP basis, net income for the fourth quarter of 2009 increased to $5.4 million or $0.17 per share on a fully diluted* GAAP basis compared to a net loss of $ 2.0 million, or $0.07 per share, respectively, in the fourth quarter of 2008. Non-GAAP earnings per share for the fourth quarter of 2009 increased 33% to $6.4 million, or $0.21 per share, compared to $4.8 million, or $0.15 in the same period last year. A reconciliation of GAAP results to non-GAAP results is attached.
Supplemental fourth quarter 2009 data can be found at www.givenimaging.com in the Investor Relations section.
2010 Guidance
The company expects 2010 revenues to be between $154 and $160 million. The company expects GAAP EPS to be between $0.50 - $0.58, and non-GAAP EPS of between $0.76 - $0.84.
Recent Developments
-- In November, the Company introduced its second-generation PillCam® COLON capsule at the Gastro 2009 Conference in London. This advanced PillCam system contains proprietary, innovative technologies, including intelligent functionality and superior imaging, designed to provide physicians with clear and precise views of the colon and polyps of interest. Following receipt of the CE mark in September 2009, The Company plans to gradually make PillCam COLON 2 available in Europe during 2010. -- At the UEGW meeting, independent investigators presented results of an initial 98-patient feasibility PillCam COLON 2 study. The study was published in the December 2009 edition of the journal Endoscopy. To access the study visit: http://delivery.sheridan.com/downloads/mobile/THIEME_161122_CP.exe Conference Call / Webcast Information
U.S. Call / Webcast
The company will host a conference call in English at 9:00am ET on Wednesday, February 17, 2010. To participate in this teleconference, please dial 888-684-1277 fifteen minutes before the conference is scheduled to begin. Callers outside of the U.S. should dial 913-312-1483. 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 March 3, 2010, by dialing 888-203-1112. Callers outside of the U.S. should dial 719-457-0820. The replay participant code is 6876444.
A separate conference call in Hebrew will take place on February 17, at 2:00pm Israel time, 7am ET. To access this call, please dial +972 3 9180609 ten minutes before the call is scheduled to begin. A replay of the call will be available from February 17th until February 19th by dialing +972 3 9255900.
Upcoming Events
Given Imaging management will be presenting at the following investor conferences:
-- February 23 -- Yuval Yanai, Chief Financial Officer, will present at the NASDAQ OMX/Oppenheimer 14th Israeli Equities Conferences in New York City. Mr. Yanai’s presentation is scheduled for 1:55pm ET. This presentation will be webcast live at www.givenimaging.com. -- February 25 -- Homi Shamir, President and CEO, will present at the Lazard Capital Markets Medical Device Conference in Salt Lake City. -- March 3 -- Yuval Yanai will present to a group of institutional investors at an event sponsored by Morgan Stanley in Brussels, Belgium. -- March 4 -- Homi Shamir will present at the Morningstar/NYSSA Healthcare Conference in New York City. Mr. Shamir’s presentation is scheduled for 11am ET. About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam SB, the esophagus through PillCam ESO and the colon with PillCam COLON [PillCam COLON is not cleared for use in the USA]. The PillCam capsules are miniature video cameras that patients ingest. Given Imaging’s other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). Given Imaging’s products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to better diagnose diseases of the esophagus, small bowel and colon and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. Given Imaging’s headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia and Singapore. For more information, please visit 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 certain items and are therefore not calculated in accordance with generally accepted accounting principles (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.
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) our ability to develop and bring to market new products, (2) our ability to successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) lack of an appropriate bowel preparation materials to be used with our PillCam COLON capsule, (8) protection and validity of patents and other intellectual property rights, (9) the impact of currency exchange rates, (10) the effect of competition by other companies, (11) the outcome of significant litigation, (12) our ability to obtain reimbursement for our product from government and commercial payors, (13) quarterly variations in operating results, (14) the possibility of armed conflict or civil or military unrest in Israel, (15) the impact of global economic conditions, (16) our ability to successfully integrate acquired businesses, (17) changes and reforms in applicable healthcare laws and regulations and (18) 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, 2008. 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.
* Based on fully diluted shares of 30,423,162 at Dec 31, 2009, and 30,798,360 at Dec 31, 2008
Given Imaging Ltd. and its Consolidated Subsidiaries Specified Items For the Three Months Ended December 31, 2008 and 2009 (Unaudited, dollars in thousands) Termination Research Selling General Of And And And Marketing Other Tax Development Marketing Admin Agreement Expenses Benefit Total Three month period ended December 31, 2009 Compensation expenses $ (29) $ 110 $ 1,309 $ - $ - $ - $ 1,390 Impairment of Goodwill - - - - 483 - 483 Tax benefit - - - - - (857) (857) ------- -------- -------- -------- -------- ------- ------- Total $ (29) $ 110 $ 1,309 $ - $ 483 $ (857) $ 1,016 ======= ======== ======== ======== ======== ======= ======= Three month period ended December 31, 2008 Compensation expenses $ 37 $ 453 $ 1,302 $ - $ - $ - $ 1,792 Write-off of Bravo IPR&D 4,700 - - - - - 4,700 Impairment of goodwill - - - - 406 - 406 Total $ 4,737 $ 453 $ 1,302 $ - $ 406 $ - $ 6,898 ======= ======== ======== ======== ======== ======= ======= Given Imaging Ltd. and its Consolidated Subsidiaries Specified Items For the Twelve Months Ended December 31, 2008 and 2009 (Unaudited, dollars in thousands) Termination Research Selling General Of And And And Marketing Other Tax Development Marketing Admin Agreement Expenses Benefit Total Twelve month period ended December 31, 2009 Compensation expenses $ 257 $ 1,619 $ 5,392 $ - $ - $ - $ 7,268 Impairment of goodwill - - - - 483 - 483 Tax (benefit) - - - - - (2,608) (2,608) -------- -------- ------- ------- -------- ------- ------- Total $ 257 $ 1,619 $ 5,392 $ - $ 483 $(2,608) $ 5,143 ======== ======== ======= ======= ======== ======= ======= Twelve month period ended December 31, 2008 Compensation expenses $ 307 $ 1,756 $ 4,855 $ - $ - $ - $ 6,918 IP Litigation expenses - - 3,375 - - - 3,375 Patent litigation settlement - - (2,333) - - - (2,333) Termination of marketing agreement - - - (5,443) - - (5,443) Impairment of goodwill - - - - 406 - 406 Write-off of Bravo IPR&D 4,700 - - - - - 4,700 -------- -------- ------- ------- -------- ------- ------- Total $ 5,007 $ 1,756 $ 5,897 $(5,443) $ 406 $ - $ 7,623 ======== ======== ======= ======= ======== ======= ======= Given Imaging Ltd. and its Consolidated Subsidiaries Reconciliation of GAAP results to non-GAAP results For the three and nine months ended December 31, 2009 and 2008 Condensed, in thousands except share and per share data Q4 2009 Q4 2008 Specified Non Specified Non GAAP Items (*) GAAP GAAP Items (*) GAAP ------- ------- ------- ------- -------- ------- Revenues $40,040 - $40,040 $33,776 - $33,776 Cost of revenues (9,379) - (9,379) (9,265) - (9,265) ------- ------- ------- ------- -------- ------- Gross profit 30,661 - 30,661 24,511 - 24,511 ------- ------- ------- ------- -------- ------- Gross profit as a % of revenues 76.6% - 76.6% 72.6 % - 72.6% Operating expenses Research and development, net (4,211) (29) (4,240) (7,857) 4,737 (3,120) Sales and marketing (16,171) 110 (16,061) (14,333) 453 (13,880) General and administrative (4,898) 1,309 (3,589) (4,871) 1,302 (3,569) Termination of marketing agreement - - - - - - Other, net (889) 483 (406) (867) 406 (461) ------- ------- ------- ------- -------- ------- Total operating expenses (26,169) 1,873 (24,296) (27,928) 6,898 (21,030) ------- ------- ------- ------- -------- ------- Operating profit (loss) 4,492 1,873 6,365 (3,417) 6,898 3,481 Operating profit as a % of revenues 11.2% 15.9% (10.1%) 10.3% ------- ------- ------- ------- -------- ------- Financing income, net 308 - 308 809 - 809 ------- ------- ------- ------- -------- ------- Profit (loss) before taxes on income 4,800 1,873 6,673 (2,608) 6,898 4,290 Income tax benefit (expense) 382 (857) (475) (17) - (17) ------- ------- ------- ------- -------- ------- Net Profit (loss) 5,182 1,016 6,198 (2,625) 6,898 4,273 Net loss attributable to non-controlling interest 187 - 187 562 - 562 ------- ------- ------- ------- -------- ------- Net profit (loss) attributable to shareholders $ 5,369 $ 1,016 $ 6,385 $(2,063) $ 6,898 $ 4,835 ======= ======= ======= ======= ======== ======= Net profit (loss) attributable to shareholders as a % of revenues 13.4% 15.9% (6.1)% 14.3% Earnings per share Basic Earnings (losses) attributable to shareholders per Ordinary Share $ 0.18 $ 0.04 $ 0.22 $ (0.07) 0.24 $ 0.17 ======= ======= ======= ======= ======== ======= Diluted Earnings (losses) attributable to shareholders per Ordinary Share $ 0.17 $ 0.03 $ 0.20 $ (0.07) 0.23 $ 0.16 ======= ======= ======= ======= ======== ======= (*) See specified items Given Imaging Ltd. and its Consolidated Subsidiaries Reconciliation of GAAP results to non-GAAP results For the three and nine months ended December 31, 2009 and 2008 Condensed, in thousands except share and per share data YTD 2009 YTD 2008 Specified Non Specified Non GAAP Items (*) GAAP GAAP Items (*) GAAP -------- -------- -------- -------- -------- -------- Revenues $141,763 - $141,763 $125,108 - $125,108 Cost of revenues (33,145) - (33,145) (33,001) - (33,001) -------- -------- -------- -------- -------- -------- Gross profit 108,618 - 108,618 92,107 - 92,107 -------- -------- -------- -------- -------- -------- Gross profit as a % of revenues 76.6% - 76.6% 73.6% - 73.6% Operating expenses Research and development, net (16,733) 257 (16,476) (18,296) 5,007 (13,289) Sales and marketing (61,428) 1,619 (59,809) (60,902) 1,756 (59,146) General and administrative (18,919) 5,392 (13,527) (19,320) 5,897 (13,423) Termination of marketing agreement - - - 5,443 (5,443) - Other, net (1,220) 483 (737) (867) 406 (461) -------- -------- -------- -------- -------- -------- Total operating expenses (98,300) 7,751 (90,549) (93,942) 7,623 (86,319) -------- -------- -------- -------- -------- -------- Operating profit (loss) 10,318 7,751 18,069 (1,835) 7,623 5,788 Operating profit as a % of revenues 7.3% 12.7% (1.5%) 4.6% -------- -------- -------- -------- -------- -------- Financing income, net 1,584 - 1,584 4,004 - 4,004 -------- -------- -------- -------- -------- -------- Profit before taxes on income 11,902 7,751 19,653 2,169 7,623 9,792 Income tax benefit (expense) 1,542 (2,608) (1,066) (250) - (250) -------- -------- -------- -------- -------- -------- Net Profit 13,444 5,143 18,587 1,919 7,623 9,542 Net loss attributable to non-controlling interest 891 - 891 2,087 - 2,087 -------- -------- -------- -------- -------- -------- Net profit attributable to shareholders $ 14,335 $ 5,143 $ 19,478 $ 4,006 $ 7,623 $ 11,629 ======== ======== ======== ======== ======== ======== Net profit attributable to shareholders as a % of revenues 10.1% 13.7% 3.2% 9.3% Earnings per share Basic Earnings attributable to shareholders per Ordinary Share $ 0.49 $ 0.18 $ 0.67 $ 0.14 $ 0.26 $ 0.40 ======== ======== ======== ======== ======== ======== Diluted Earnings attributable to shareholders per Ordinary Share $ 0.47 $ 0.17 $ 0.64 $ 0.13 $ 0.25 $ 0.38 ======== ======== ======== ======== ======== ======== (*) See specified items Given Imaging Ltd. and its Subsidiaries Consolidated Balance Sheets (In thousands except per share data) December 31, ----------------- 2009 2008 Assets Current assets Cash and cash equivalents $ 46,458 $ 31,697 Short-term investments 31,736 28,509 Accounts receivable: Trade, net 24,742 21,673 Other 3,799 4,662 Inventories 17,302 18,931 Advances to suppliers 534 3,540 Deferred tax assets 2,207 1,178 Prepaid expenses 1,036 1,631 -------- -------- Total current assets 127,814 111,821 Deposits 1,062 1,094 Assets held for employees’ severance payments 4,968 3,686 Marketable securities 16,956 30,063 Long-term inventory 6,015 - Fixed assets, less accumulated depreciation 13,843 15,115 Deferred tax assets 192 - Intangible assets less accumulated amortization 11,284 12,067 Goodwill 3,586 4,069 -------- -------- Total Assets $185,720 $177,915 ======== ======== Given Imaging Ltd. and its Subsidiaries Consolidated Balance Sheets (In thousands except share data) December 31, ------------------ 2009 2008 Liabilities and shareholders’ equity Current liabilities Current installments of obligation under capital lease $ 145 $ 114 Accounts payable: Trade 6,789 7,418 Other 20,060 17,612 Deferred income 234 1,523 -------- -------- Total current liabilities 27,228 26,667 -------- -------- Long-term liabilities Obligation under capital lease 356 485 Liability in respect of employees’ severance payments 5,530 4,599 -------- -------- Total long-term liabilities 5,886 5,084 -------- -------- Total liabilities 33,114 31,751 -------- -------- Commitments and contingencies Equity Shareholders’ equity: Ordinary Shares, NIS 0.05 par value each (90,000,000 shares authorized as of December 31, 2008 and 2009, 29,257,785 and 29,370,972 shares issued and fully paid as of December 31, 2008 and 2009, respectively) 345 343 Additional paid-in capital 182,203 173,983 Capital reserve 2,166 2,166 Accumulated other comprehensive income (loss) 399 (600) Accumulated deficit (33,185) (31,721) -------- -------- Shareholders’ equity 151,928 144,171 -------- -------- Non-controlling interests 678 1,993 -------- -------- Total equity 152,606 146,164 -------- -------- Total liabilities, shareholders’ equity and non-controlling interests $185,720 $177,915 ======== ======== Given Imaging Ltd. and its Subsidiaries Consolidated Statements of Operations (In thousands except share and per share data) Year ended December 31, ---------------------------------- 2009 2008 2007 ---------- ---------- ---------- Revenues $ 141,763 $ 125,108 $ 112,868 Cost of revenues (33,145) (33,001) (29,721) Early repayment of royalty bearing government Grants - - (4,843) ---------- ---------- ---------- Gross profit 108,618 92,107 78,304 ---------- ---------- ---------- Operating expenses Research and development, gross (17,842) (15,126) (12,847) In-process research and development acquired in a business combination - (4,700) - ---------- ---------- ---------- (17,842) (19,826) (12,847) Government grants 1,109 1,530 1,242 ---------- ---------- ---------- Research and development, net (16,733) (18,296) (11,605) Sales and marketing (61,428) (60,902) (55,446) General and administrative (18,919) (19,320) (20,981) Termination of marketing agreement - 5,443 22,860 Other, net (1,220) (867) (422) ---------- ---------- ---------- Total operating expenses (98,300) (93,942) (65,594) ---------- ---------- ---------- Operating profit (loss) 10,318 (1,835) 12,710 Financial income, net 1,584 4,004 5,520 ---------- ---------- ---------- Profit before taxes on income 11,902 2,169 18,230 Income tax benefit (expense) 1,542 (250) (4,548) ---------- ---------- ---------- Net Profit 13,444 1,919 13,682 Net loss attributable to non-controlling interest 891 2,087 1,503 ---------- ---------- ---------- Net profit attributable to shareholders $ 14,335 $ 4,006 $ 15,185 ========== ========== ========== Earnings per share: Basic Earnings per Ordinary Share $ 0.49 $ 0.14 $ 0.52 ========== ========== ========== Diluted Earnings per Ordinary Share $ 0.47 $ 0.13 $ 0.49 ========== ========== ========== Weighted average number of Ordinary Shares used to compute basic Earnings per Ordinary Share 29,281,897 29,254,035 28,961,968 ========== ========== ========== Weighted average number of Ordinary Shares used to compute diluted Earnings per Ordinary Share 30,423,162 30,798,360 31,030,459
