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cijfers en outlook (zie isotis.com)

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  1. al massimo 24 februari 2004 08:43
    Bron: Isotis.com

    "IsoTis Full Year Results 2003

    IsoTis Announces 2003 Results in Line With Previous Guidance
    First Post-Merger Quarter, Q4, Shows Combined 19% YOY Sales Growth

    LAUSANNE, Switzerland, IRVINE, CA, USA, BILTHOVEN, The Netherlands - February 24, 2004 – IsoTis OrthoBiologics (SWX/Euronext: ISON; TSX: ISO) today reported its results for the full year 2003 and the fourth quarter ended December 31, 2003. Unaudited combined revenues of the merged companies for the full year 2003 were US$ 24 million, while the combined operational results were a loss of US$ 24.4 million. These numbers are in line with guidance the Company has consistently given since announcing the merger between IsoTis and GenSci OrthoBiologics in June 2003.

    Vital Signs After First Post Merger Quarter
    The IsoTis - GenSci merger closed on October 27, 2003. During the preceding 4 quarters, combined sales growth had been virtually flat. With less than 2 months as an effectively combined company, IsoTis OrthoBiologics reported a robust 19% combined sales growth to US$ 5.8 million, from US$ 4.8 million in Q4 2002. Based on these results and preliminary data from the beginning of 2004, the company is confident that it can continue to improve sales as the year progresses and the efficacy of its sales and marketing strategy continues to increase both in the US and internationally.

    After Two Mergers, a Clear Path towards Profitability
    IsoTis OrthoBiologics is the result of the merger between IsoTis and GenSci OrthoBiologics of Irvine, California, completed in October 2003. Less than a year prior to this, IsoTis N.V merged with Swiss-based Modex SA. These two back-to-back mergers were instrumental in establishing a competitive and near term profitable business in the rapidly emerging field of orthobiologics, a market growing at double the rate of the overall orthopaedics sector. The company, focused on the bone graft substitute segment of the orthopaedics market, is developing further novel, leading edge orthobiology products for musculoskeletal repair in spine, trauma, total joint and craniofacial surgical applications.

    By 2005, the orthobiologics market is estimated to grow to US$ 1.5 billion; management expects the combined natural and synthetic bone graft substitute market segment in which IsoTis is competing to be at US$ 600 million. On the basis of targeted revenues of US$ 50 million by 2005, IsoTis OrthoBiologics expects to break even in terms of cash flow and profit during that year.

    Highlights Full Year & Q4 2003
    2003 results, comparative 2002 numbers, and the analysis in the body of this announcement are presented on a combined basis, as if both mergers had occurred as of January 1, 2002. Exhibit 2 shows the combined balance sheets and statement of operations. After two successive mergers in slightly more than a year, management believes that the combined presentation of results provides the most accurate and transparent insight into the company's financial situation in 2003, and the most meaningful basis for comparison with previous reporting periods.

    The combined results set forth have not been prepared in accordance with Regulation S-X under the Securities Act of 1934. These non-GAAP measures are reconciled to their most directly comparable GAAP measures in Exhibit 3.

    Financial Highlights (combined)
    US$ 24 million FY revenues
    US$ 5.8 million Q4 sales, 19% increase YOY
    US$ 24.4 million FY loss from operations
    US$ 29.9 million FY net loss
    US$ 50.1 million cash balances at December 31
    Change from IFRS to US GAAP reporting, and from Euro to US$ reporting currency

    Operational Highlights

    Merger & integration between IsoTis and GenSci OrthoBiologics completed
    150 employees (90 in the US, 60 in Europe)
    Experienced management
    US network of 50 independent distributors with 400 sales reps
    Expanding international distribution channel
    6 products on the market, 4 to be launched in 2004, 11 more in development
    Unique, synergistic and complementary technology platforms
    Best in class natural bone (DBM) technology
    Advanced synthetic materials
    Reverse phase medium, carrier system
    Senior appointments of VPs sales and marketing for US and International
    CE mark and FDA 510 (k) for OsSatura
    AATB accreditation of Irvine facility
    Wound management subsidiary EpiSource established (cash flow neutral)
    Chronic wound treatment Allox licensed to US wound management leader HealthPoint
    Drug delivery spin-off Chienna sold to OctoPlus

    Course of events Q4 (combined)
    With the merger between IsoTis and GenSci OrthoBiologics just completed, IsoTis OrthoBiologics was able to make a major marketing and sales effort in the last two months of the year 2003. It succeeded in increasing its product sales to US$ 5.8 million, a 19% increase over the same quarter in 2002. The combined operational loss for the quarter was US$ 12.6 million.

    Much effort went into reenergizing the company's US independent distributor network, and in expanding the international distribution channels. To support these efforts, new marketing materials were developed, and a corporate campaign was launched to create brand awareness for IsoTis OrthoBiologics among orthopedic surgeons, hospitals and distributors. Product development progressed well, and the company anticipates four product launches in 2004 to support its further growth. In addition, a range of in-vivo and clinical studies have been initiated to reinforce the competitive edge of the company's innovative products.

    Financial Results FY 2003 (combined)
    As expected, product sales for the year ended December 31, 2003, increased slightly to US$ 23.7 million compared to 2002 (US$ 23.3 million). Some 90% of product sales were recorded in North America and 10% internationally. As a result of the spin-off of its R&D group in The Netherlands, government grants decreased some US$ 1.3 million in 2003 compared to 2002, impacting total revenues, which were US$ 24 million, compared to US$ 25.3 million in the previous year.

    Significant items in result from operations and net result
    The operational combined result for the year was a loss of US$ 24.4. The net result for the year was a loss of US$ 29.9 million. Included in the net result are a number of significant items which deserve further attention:
    · The principal difference between the operational and net result is US$ 5.4 million of foreign exchange losses. Accounting rules require the company to value assets of its group companies at year end in Euro and CHF. A further disclosure is provided below under "foreign exchange losses".
    · Also included in the operational and net results are:
    o US$ 8.7 million profit on reduction of GenSci's Chapter 11 liabilities
    o US$ 2.7 million non-cash charge for stock options
    o Approximately US$ 3 million of other non-cash provisions and write offs
    o Approximately US$ 2 million for the phase II clinical trial of Allox, scheduled to be completed in 2004 as part of the cash flow neutral wound management company EpiSource
    .
    Foreign exchange results – an accounting detail
    Included in the net results for 2004 are US$ 3 million in foreign exchange losses on US dollar denominated bank accounts in the name of IsoTis NV (The Netherlands) and US$ 2.3 million of unrealized foreign exchange losses on US dollar denominated intercompany loans in the name of IsoTis SA (Switzerland). The functional currencies of the Netherlands and Switzerland
  2. al massimo 24 februari 2004 09:39
    Foreign exchange results – an accounting detail
    Included in the net results for 2004 are US$ 3 million in foreign exchange losses on US dollar denominated bank accounts in the name of IsoTis NV (The Netherlands) and US$ 2.3 million of unrealized foreign exchange losses on US dollar denominated intercompany loans in the name of IsoTis SA (Switzerland). The functional currencies of the Netherlands and Switzerland operations, for accounting purposes, are the Euro and Swiss Franc, respectively.

    Since the merger with GenSci, IsoTis' predominant "business currency" is the US Dollar. Consequently, IsoTis changed its reporting currency to US$, and converted a large part of its strategic cash pool into US dollars in November 2003 in line with the Company's long-term objectives. While these actions make sense from a business point of view, as a result of a change in currency exchange rates in the last two months of the year, accounting rules require the company to value these assets of its individual group companies with local functional currencies other than the US$ (Euro and CHF in this instance) and record a loss on foreign exchange.

    In the interest of providing an additional insight in the financial status of the company, Management specifically wishes to highlight these points, and will do so in the future again, whether the prescribed accounting treatment leads to a loss (like this year) or a gain (as can be expected if the US$ re-appreciates in value vis-à-vis the Euro and CHF).

    Outlook 2004 and 2005
    Management expects that full-year 2004 revenues will be in excess of US$ 30 million, and that 2004 EBITDA from continuing activities will be less than US$ 10 million negative. Management expects IsoTis OrthoBiologics to become cash-flow break-even and profitable during 2005 on the basis of targeted revenues exceeding US$ 50 million.

    Certain statements in this Press Release are "forward-looking statements", as that term is defined in U.S. federal securities laws, including those that refer to management's plans and expectations for future operations, prospects and financial condition. These forward-looking statements can be identified by use of words such as 'strategy,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'will,' 'continues,' 'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and other words of similar meaning. Such statements are based on the current expectations of the management of IsoTis only. Reliance should not be placed on these statements because they are subject to known and unknown risks and can be affected by factors that are beyond IsoTis' control. Actual results could differ materially from current expectations due to a number of factors, including the timely commencement and success of clinical trials and research endeavors, delays in receiving U.S. FDA or other regulatory approvals (a.o. EMEA, CE), market acceptance of products, development of competing therapies and technologies, the terms of any future strategic alliances, the need for additional capital, the inability to obtain, or meet conditions imposed for required governmental and regulatory approvals. For a more detailed description of the factors affecting IsoTis, refer to the Joint Information Circular and to IsoTis' reports submitted to the Swiss Stock Exchange (SWX), Euronext Amsterdam N.V., SEDAR at www.sedar.com, the Toronto Stock Exchange (TSX), and the U.S. Securities and Exchange Commission.

    This communication shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction."
  3. [verwijderd] 24 februari 2004 12:08
    De "belegger" spreekt vandaag boekdelen. Iedere Isotis adept weet dat deze cijfers in de lijn der verwachting liggen en wat gebeurt er; toch dik in de min. Mijn zin in Isotis is voorlopig over en dit ligt niet aan Isotis maar aan een paar market makers en misselijkmakende traders die de koers bewust om zeep helpen, alweer, uiteraard bijgestaan door de wederom briljante verslaglegging, wars van nuances, door dow jones nieuwsdienst. Ook niks nieuws overigens.

    08.34 : verlies Isotis Orthobiologics loopt op.
    Blijkbaar kreeg de redacteur een beetje spijt en hoppa, kijk eens aan :
    08.52 : Isotis verwacht voor 2005 winstgevend te zijn.

    Nou, met zulke vrienden heb je geen vijanden nodig.

    Traders, dow jones nieuwsdienst en market makers, wederom bedankt voor jullie inspanningen om de koers naar de kloten te helpen.

  4. Mark'Oh 24 februari 2004 17:06
    Niet zo gefrustreerd he, alsof het allemaal de schuld is van Dow Jones. Als je er zo slecht van slaapt, kun je je aandelen beter verkopen vrees ik, het komt allemaal wel goed hoor.
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