LAUSANNE, Switzerland and IRVINE, California, April 27 /PRNewswire-FirstCall/ -- IsoTis SA, the orthobiologics company, today reported its results for the first quarter ended March 31, 2006. Revenues were $9.8 million for the first quarter of 2006, representing a 25% increase over revenue of $7.8 million in the first quarter of 2005.
Revenue Analysis
IsoTis’ chief distribution channels are its U.S. network of independent agents and its network of international distributors, while the remaining portion of its revenues is derived from private label agreements. In the first quarter of 2006, revenue from the U.S. network grew 14% to $6.4 million compared to $5.6 million in the first quarter of 2005; international revenue grew 42% to $2.4 million compared to $1.7 million in the first quarter of 2005.
Results Comparison & Cash Position
The loss from operations for the first quarter of 2006 was $2.5 million, compared to $2.3 million for the first quarter of 2005. The net loss for the first quarter of 2006 was $3.8 million, compared to net income of $0.9 million for the first quarter of 2005. The Company’s net loss was primarily attributable to the effects of a foreign exchange loss of $1.4 million recorded in the first quarter of 2006, compared to a foreign currency gain of $3.1 million in the first quarter of 2005.
At March 31, 2006 the company had cash and cash equivalents (including restricted cash) of $17.6 million.
Operational highlights
- Obtained 510(k) clearance for Accell Connexus and OrthoBlast II in dental indications
- Appointed of Alan Donze as VP of Sales
Pieter Wolters, President and CEO of IsoTis said, “We had an excellent first quarter marked by solid revenue growth, and we continue to witness increased acceptance of our proprietary Accell product family. As previously indicated, we increased our investments in marketing and product development in the first quarter to support the company’s further growth. I believe that we are well-positioned to achieve our objectives for 2006.”
Business Outlook for 2006
- IsoTis anticipates total revenues for full year 2006 to grow in excess of 20%.
- IsoTis is intensifying product & business development aimed at introducing new products.
Conference Call
The Company will conduct a conference call at 4.30 p.m. CET/10.30 a.m. ET/7.30 a.m. PT. Dial: +41-91-610-5609 (Europe); +44-20-7107-0613 (UK); +1-866-865-5144 (toll free dial in US/Canada); no password required. Digital playback is available for 24 hours after the conference starting at 6.00 p.m. until April 28, 6.00 p.m. CET, dial: +41-91-612-4330 (Europe); +44-20-7108-6233 (UK); +1-866-416-2558 (US/Canada); playback ID: 019#. The call will also be Webcast live on the IsoTis website at www.isotis.com. The Webcast will remain available on IsoTis’ website at least through June 30, 2006.
IsoTis has a product portfolio with several innovative and proprietary natural and synthetic bone graft substitutes on the market and others in development, an established North American independent distribution network, and an expanding international presence. The company’s main commercial operations are based out of Irvine, California; its international sales headquarters is based in Lausanne, Switzerland.
Certain statements in this Press Release are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including those that refer to management’s plans and expectations for future operations, prospects and financial condition. Words such as “strategy,” “expects,” “plans,” “anticipates,” “believes,” “will,” “continues,” “estimates,” “intends,” “projects,” “goals,” “targets” and other words of similar meaning are intended to identify such forward-looking statements. One can also identify them by the fact that they do not relate strictly to historical or current facts. Such statements are based on the current expectations of the management of IsoTis only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of IsoTis. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting IsoTis’ business, including but not limited to competitive sales and marketing environment, the timely commencement and success of IsoTis’ clinical trials and research endeavors, delays in receiving U.S. Food and Drug Administration or other regulatory approvals (a.o. EMEA, CE), market acceptance of the IsoTis’ products, effectiveness of our distribution channels, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the inability to obtain, or meet conditions imposed for the required governmental and regulatory approvals and consents. IsoTis expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. For a more detailed description of the risk factors and uncertainties affecting IsoTis, refer to the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2005, filed with the SEC and to IsoTis’ reports filed from time to time with the Swiss Stock Exchange (SWX), Euronext Amsterdam N.V., and SEDAR at www.sedar.com, as well as the Toronto Stock Exchange (TSX).
IsoTis S.A. Consolidated Statements of Operations-Unaudited US Dollars Three Months Ended March 31, 2006 March 31, 2005 Revenues Product sales $ 9,778,365 $ 7,807,218 Other revenue 35,816 - Total revenues 9,814,181 7,807,218 Operating expenses Costs of sales 3,693,828 2,934,013 Research and development 1,713,821 1,115,731 Marketing and selling 4,313,790 2,999,044 General and administrative 2,607,195 3,026,384 Total operating expenses 12,328,634 10,075,172 Loss from operations (2,514,453) (2,267,954) Interest income 140,835 129,573 Interest expense and other (27,860) (51,713) Foreign exchange (loss) gain (1,402,787) 3,138,941 Net (loss) income before taxes (3,804,265) 948,847 Provision for income taxes - - Net (loss) income $ (3,804,265) $ 948,847 Basic and diluted net (loss) income $ (0.05) $ 0.01 per share Weighted average common shares outstanding Basic 70,873,158 70,113,269 Diluted 70,873,158 71,783,909 IsoTis S.A. Consolidated Balance Sheets - Unaudited US Dollars March 31, 2006 December 31, 2005 Assets Current assets: Cash and cash equivalents $ 13,369,737 $ 15,714,442 Restricted cash 2,214,034 2,184,063 Trade receivables, net 6,562,148 6,306,518 Inventories 10,037,690 10,020,906 Unbilled receivables 302,585 295,115 Value added tax receivable 153,417 95,505 Prepaid expenses and other current assets 1,181,156 761,355 Total current assets 33,820,767 35,377,904 Non-current assets: Restricted cash 2,000,000 2,250,000 Property, plant and equipment, net 1,610,930 1,359,280 Goodwill 16,383,069 16,383,069 Intangible assets, net 12,938,081 13,585,250 Total non-current assets 32,932,080 33,577,599 Total assets $ 66,752,847 $ 68,955,503 Liabilities and shareholders’ equity Current liabilities: Trade payables $ 3,825,202 $ 2,910,114 Accrued liabilities 6,176,463 6,680,989 Deferred revenue 140,000 344,719 Current portion of interest-bearing loans and borrowings 1,012,001 1,015,471 Total current liabilities 11,153,666 10,951,293 Non-current liabilities: Interest-bearing loans and borrowings 1,794,889 2,043,781 Total non-current liabilities 1,794,889 2,043,781 Total shareholders’ equity 53,804,292 55,960,429 Total liabilities and shareholders’ equity $ 66,752,847 $ 68,955,503 IsoTis S.A. Consolidated Statements of Cash Flows-Unaudited US Dollars Three Months Ended March 31, 2006 March 31, 2005 Cash flows from operating activities Net (loss) income from continuing operations $ (3,804,265) $ 948,847 Adjustments to reconcile net loss from continuing operations to net cash used in operating activities: Depreciation and amortization 831,187 260,288 Bad debt expense (17,277) - (Gain) loss of sale of assets (642) 1,513 Stock-based compensation expense 89,669 294,745 Foreign currency transaction loss (gain) 1,402,787 (3,138,941) Change in operating assets and liabilities: Inventories 21,965 443,585 Trade receivables (183,374) (951,348) Other current assets (462,626) 346,840 Deferred revenue (207,830) (23,090) Trade and other payables 300,971 (980,663) Restructuring provision - (592,609) Net cash flows used in operating activities (2,029,435) (3,390,833) Cash flows from investing activities Purchase of property, plant and equipment (421,138) (262,367) Change in restricted cash 250,000 248,153 Proceeds from sale of property, plant and - 726,581 equipment and assets Net cash flows (used in) provided by (171,138) 712,367 investing activities Cash flow from financing activities Proceeds from issuance of common shares 97,561 210,735 Repayments of interest-bearing loans and (253,827) (2,527,304) borrowings Net cash flows used in financing activities (156,266) (2,316,569) Gain (loss) on cash held in foreign currency 12,134 (26,672) Net decrease in cash and cash equivalents (2,344,705) (5,021,707) Cash and cash equivalents at the beginning 15,714,442 25,539,602 of the period Cash and cash equivalents at the end of the $ 13,369,737 $ 20,517,895 period
IsoTis OrthoBiologics
CONTACT: For information contact: Hans Herklots, Tel: +41(0)21-620-6011,E-mail: hans.herklots@isotis.com ; Director IR Rob Morocco, CFO,+1-949-855-7155, robert.morocco@isotis.com