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11.08.2004 – 07:37

IsoTis OrthoBiologics

IsoTis Announces 16% H1 Orthobiologics Sales Growth, and Provides Further 04 & 05 Guidance

    Lausanne, Switzerland and Irvine, California (ots/PRNewswire)

IsoTis OrthoBiologics (SWX/Euronext: ISON; TSX: ISO) today reported a 16% increase in orthobiologics sales of US$12.9 million for the first six months of fiscal 2004, compared to pro-forma orthobiologics sales of US$11.1 million for the first six months of 2003. Sales for the second quarter 2004 were US$6.4 million, representing a 10% increase over pro-forma sales from the same period last year.

    Orthobiologics Sales Analysis

    Sales increases have been primarily driven by the Company's Accell(R) technology. The two product lines using this technology, Accell(R) DBM100 and Accell Connexus(TM), now account for approximately 40% of sales.

    North American orthobiologic sales increased 10% to US$10.7 million for the first six months of 2004, compared to proforma sales of US$9.7 million for 2003. Second quarter sales increased 4% to US$5.3 million, compared to pro-forma second quarter 2003 sales of US$5.1 million. The Company recorded significant gains in international sales, which grew by 52% to US$2.2 million for the six month period as compared to US$1.4 million for the six month period in 2003. International sales for the quarter increased 47% to US$1.1 million from pro-forma second quarter 2003 sales of US$0.8 million, as IsoTis continues to develop and strengthen its international distribution channels.

    Results Comparison

    EBITDA loss for the first six months of 2004 was US$11.4 million, which reflects the merged operations of IsoTis/Modex and GenSci. This compares to an EBITDA loss of US$10.1 million in the same period of 2003, which reflects only the operations of IsoTis and Modex. The Company has incurred losses in 2004 as it has aggressively re-invested over 40% of its revenue in research and development. In addition, the Company has doubled its US field sales and training team in the second quarter to further support its independent distributors. The net loss for the first six months was US$12.2 million, or US$0.17 per share, compared to a net loss of US$10.7 million, or US$0.26 per share, for the same period of 2003. The company reported a net loss for the quarter of US$9 million, or US$0.13 per share compared with a loss of US$4.5 million, or US$0.11 per share in the same period last year.

    The balance sheet remains strong, with a cash plus restricted cash position at June 30 exceeding US$44 million.

@@start.t1@@      Second Quarter Significant Events
      - OsSatura TCP(TM) (Tricalcium Phosphate) launched with 510(k) clearance
         and CE mark, expanding synthetic bone graft substitute portfolio;
      - Jean-Pierre Boucher, former President Stryker Europe, appointed to
         Board of Directors;
      - Announced transfer production and product development to Irvine
         (California) per end of 2004;
      - Strengthened research effort through increased resources for
         IsoTis/Twente Research Institute;
      - Relocated Swiss corporate offices to more economic space in Lausanne;
      - Announced positive results Phase II Allox(TM) trial (part of EpiSource,
         IsoTis' wound management subsidiary, and under a licensing agreement
         with DFB/HealthPoint, one of the leading US wound management

    Pieter Wolters, Chief Executive Officer of IsoTis OrthoBiologics, said: "We are extremely pleased that while we have been integrating the operations of our newly formed company we have been able to show growth in a very competitive market place. We anticipate that the upcoming launch of our third product using the Accell technology will further build our competitive position as we continue to focus on opportunities in the rapidly growing orthopedics sector and the continuing shift towards biologically-based surgical solutions for musculoskeletal repair."

    Outlook 2004 & 2005

    During the remainder of 2004 through 2005, the Company expects to launch several new products for the orthobiologics market. Also during this time frame, the Company expects to obtain regulatory approval for certain products to add to its existing regulatory approved synthetic products and medical accessories.

    Based on internal growth the Company expects revenue from orthobiologic products to be in the US$25-US$28 million range for 2004. This compares to proforma orthobiologic product sales of approximately US$23 million for 2003.

    The company expects to continue investment in marketing, sales and training as well as in research and development of current products for 2004 and 2005 to drive the growth of the Company. Therefore, the Company expects to continue to incur losses at a similar rate through 2004. The operating loss for 2004 is expected to be between US$25-29 million as compared to a proforma operating loss of US$32 million in 2003. The operating loss range will result in an EBITDA range of US$18-23 million. Cash and restricted cash balances are expected to be in the US$25-US$30 million range at the end of 2004.

    The previously announced closure of the Netherlands facility will result in reorganization charges, to be taken primarily in the fourth quarter of 2004, that are included in the guidance above. The facility is operating through November to meet Company objectives. Reorganization charges in the current quarter of US$1.8 million relate to a reserve against prior receipts of grant income in The Netherlands. Closure costs are estimated to total US$3-5 million dollars and will result in significant annual cost savings going forward. Additional reductions in future spending will result from the completion of the successful Phase II trial for Allox and relocation of the Company's Swiss corporate offices to smaller premises.

    For the full year 2005, IsoTis expects to close in on break-even in the course of the year, building on the organization and products put in place in 2004. With a more centralized operation and new products to offer, IsoTis is expressly focusing on and investing in products and technologies that will allow us to be on the cutting edge of the orthobiologics field well beyond 2005.

    Conference Call

    The Company will conduct a conference call for financial analysts at 4 p.m. CET (10 a.m. EDT; 7 a.m. PDT), today. Access to a simulcast via the IsoTis website at http://www.isotis.com. To participate in the conference call, dial: +41 91 610 5600 (Europe); +44 20 7107 0611 (UK); +1 866 291 4166 (toll free dial in US/Canada). Digital playback is available for 24 hours after the conference starting at 6 p.m. until 12 August 6 p.m., dial: +41 91 612 4330 (Europe); +44 20 7866 4300 (UK); +1 412 317 0088 (US/Canada); Conference ID: 794#. An audio stream of the conference call will also be available on IsoTis' website from August 12 through September 30, 2004.

    IsoTis OrthoBiologics was created in Q4 2003 through the merger of GenSci OrthoBiologics, a US-based orthobiology company, and IsoTis SA, a Swiss-Dutch biomedical company. IsoTis OrthoBiologics has a product portfolio with several natural and synthetic bone graft substitutes on the market and several others in development, sales of US$ 24 million in 2003, an established North American independent distribution network of 400 sales representatives, and a rapidly expanding international presence. IsoTis OrthoBiologics expects to have approximately 140 employees by the end of 2004.

    The field of orthobiologics combines advances in biotechnology, materials sciences and tissue biology to promote and enhance the body's natural ability to regenerate and repair musculoskeletal tissue. The company is a dedicated and global orthobiologics player focused on the market of orthopaedics and bone graft substitutes. IsoTis is developing a broad presence in both "natural" demineralized bone matrix (DBM) products and "synthetic" bone graft substitutes, carrier technologies and biologically-based growth factors. Orthobiologics is the fastest growing segment of the US$14 billion orthopedics market.

    Certain statements in this Press Release are "forward-looking statements," including those that refer to management's plans and expectations for future operations, prospects and financial condition. One can identify these forward-looking statements by use of words such as 'strategy,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'will,' 'continues,' 'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and other words of similar meaning. 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 S.A. only. 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 risk factors and uncertainties, including but not limited to the timely commencement and success of IsoTis' clinical trials and research endeavors, delays in receiving U.S. FDA or other regulatory approvals (a.o. EMEA, CE), market acceptance of the Company's products, 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. For a more detailed description of the risk factors and uncertainties affecting IsoTis, refer to the Joint Information Circular and to IsoTis' reports filed from time to time with the Swiss Stock Exchange (SWX), Euronext Amsterdam N.V., and SEDAR at http://www.sedar.com, as well as the Toronto Stock Exchange (TSX). 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.)

@@start.t2@@                                                  Three            Three
      IsoTis S.A.                          Months          Months    Six Months    Six Months
      US Dollars - Unaudited         Ended            Ended         Ended            Ended
      Consolidated Statements of
      Operations                         30-Jun-04    30-Jun-03      30-Jun-04      30-Jun-03
        Product sales                  6,414,237        454,413    13,004,852      1,073,803
        Government grants                 12,045         98,683          37,141         224,033
        Research and development
         contracts                                    0                 0                  0          19,271
      Total revenues                  6,426,282        553,096    13,041,993      1,317,107
      Costs and expenses
        Costs of sales                 2,942,624        294,788      5,759,165         516,309
        Research and development 2,629,798    2,610,585      5,462,040      6,885,321
        Marketing and selling      3,179,278    1,221,855      6,014,479      2,204,445
        General and
         administrative                4,850,293    1,334,550      8,217,831      2,879,925
        Reorganization costs        1,793,733                 0      1,793,733                  0
      Total operating expenses 15,395,726    5,461,778    27,247,248    12,486,000
      Loss from operations      (8,969,444) (4,908,682) (14,205,255) (11,168,893)
      Interest income                      85,756        246,772         229,829         691,100
      FX gain on foreign
        exchange                              949,474                 0      1,916,516                  0
      FX gain/(loss) on
        intercompany account         (989,179)                0          17,748                  0
      Interest expense and other (62,750)      (78,300)      (142,146)      (100,923)
      Net loss before taxes,
        minority interest and
        extraordinary item        (8,986,143) (4,740,210) (12,183,308) (10,578,716)
      Minority interest                          0         63,154                  0         138,996
      Net loss from continuing
        operations                    (8,986,143) (4,677,056) (12,183,308) (10,439,719)
      Net gain/(loss) from
        discontinued operations              0        151,718                  0        (273,312)
      Net loss                         (8,986,143) (4,525,338) (12,183,308) (10,713,032)
      Basic and diluted net loss
        per share
         Continuing operations        ($0.13)        ($0.11)         ($0.17)         ($0.25)
         Discontinued operations      $0.00          $0.00            $0.00          ($0.01)
         Net loss per share            ($0.13)        ($0.11)         ($0.17)         ($0.26)
      Weighted average ordinary
        shares outstanding         69,804,834  41,433,629    69,691,793    41,327,695
      IsoTis S.A.
      US Dollars - Unaudited
      Consolidated Balance Sheets                                30-Jun-04         31-Dec-03
      Current assets:
        Cash and cash equivalents                                37,262,325        50,104,682
        Restricted Cash                                                 2,218,071         1,629,802
        Trade receivables, net                                      4,617,164         3,588,780
        Inventories                                                        8,544,839         6,366,588
        Unbilled receivables                                            401,301         1,732,402
        Value added tax receivable                                  207,193            476,651
        Prepaid expenses and other current assets          851,299         1,073,284
      Total current assets                                         54,102,192        64,972,189
      Non-current assets:
        Restricted Cash                                                 5,330,951         6,519,385
        Property, plant and equipment, net                  4,084,172         5,113,851
        Goodwill                                                          16,383,069        16,383,069
        Intangible assets, net                                    21,895,031        23,134,485
      Total non-current assets                                  47,693,223        51,150,790
      Total assets                                                    101,795,415      116,122,979
      Liabilities and shareholders' equity
      Current liabilities:
        Trade payables                                                  3,655,770         4,007,873
        Accrued liabilities                                          8,474,235         7,292,133
        Deferred revenue                                                            0              98,893
        Current portion of capital lease obligations                0            631,783
        Current portion of interest-bearing loans        6,291,723         6,213,502
      Total current liabilities                                 18,421,728        18,244,184
      Non-current liabilities:
        Capital lease obligations                                              0              36,140
        Interest-bearing loans and borrowings              3,499,998         4,079,341
      Total non-current liabilities                            3,499,998         4,115,481
      Total shareholders' equity                                79,873,689        93,763,314
      Total liabilities and shareholders' equity    101,795,415      116,122,979
      IsoTis S.A.                                                        Six Months        Six Months
      US Dollars - Unaudited                                              Ended                Ended
      Consolidated Statements of Cash Flows                30-Jun-04         30-Jun-03
      Cash flows from operating activities
      Net loss                                                          (12,183,308)    (10,713,032)
      Adjustments to reconcile net loss to
        net cash used in operating activities
        (net of effect of business combination):
      Depreciation and amortization                            2,777,780         1,094,279
      Stock based compensation expense                          160,650         1,589,351
      Minority interest                                                            0         (138,996)
      Change in operating assets and liabilities:
      Inventories                                                        (2,207,049)         (149,601)
      Trade receivables                                              (1,074,952)         (637,710)
      Other current assets                                          1,751,208         1,117,652
      Deferred revenue                                                  (100,900)          (83,122)
      Trade and other payables                                        875,186        (3,264,561)
      Net cash flows used in operating activities  (10,001,385)    (11,185,740)
      Cash flows from investing activities
      Purchase of intangible assets                              (367,753)         (385,868)
      Purchase of property, plant and equipment          (286,999)                    0
      Proceeds from sale of property,
        plant and equipment                                                        0            148,946
      Change in restricted cash                                      496,331                      0
      Payment of business combination transaction
        costs                                                                              0          (788,462)
      Net cash flows provided by (used in)
        investing activities                                          (158,421)      (1,025,384)
      Cash flow from financing activities
      Proceeds from issuance of ordinary shares            461,166                      0
      Proceeds from interest-bearing loans
        and borrowings                                                                0         1,549,223
      Repayments of interest-bearing loans
        and borrowings                                                    (981,063)         (283,028)
      Net cash provided by (used in) financing
        activities                                                          (519,897)        1,266,195
      Gain (loss) on cash held in foreign currency  (2,162,654)        1,515,628
      Net increase (decrease) in cash and
        cash equivalents
      Continuing operations                                      (12,842,357)      (9,429,301)
      Discontinued operations                                                  0        (1,790,408)
      Net increase (decrease) in cash and
        cash equivalents                                            (12,842,357)    (11,219,709)
      Cash and cash equivalents at the beginning
        of the year                                                      50,104,682        85,306,817
      Cash and cash equivalents at the end
        of the year                                                      37,262,325        74,087,108
      Proforma Sales Analysis for the Combined Companies:
      IsoTis S.A.
      US Dollars - Unaudited
                                                            Three            Three
                                                          Months          Months  Q2 2004 vs. Q2 2003
                                                            Ended            Ended      Variance Analysis
                                                         30-Jun-04      30-Jun-03          $              %
      Product sales - OrthoBiologic    6,386,973      5,823,301      563,672        10%
      Product sales - Other                      27,264         300,387    (273,123)    -91%
      Government grants                            12,045         104,379      (92,334)    -88%
      Total revenues                            6,426,282      6,228,067      198,215         3%
                                                            Six                Six
                                                          Months          Months  H1 2004 vs. H1 2003
                                                            Ended            Ended      Variance Analysis
                                                         30-Jun-04      30-Jun-03          $              %
      Product sales - OrthoBiologic  12,858,408    11,128,921  1,729,487        16%
      Product sales - Other                    146,445         639,635    (493,190)    -77%
      Government grants                            37,140         229,734    (192,594)    -84%
      Research and development
        contracts                                                0          19,272      (19,272)  -100%
      Total revenues                          13,041,993    12,017,562  1,024,431         9%
                                                          Three            Three
                                                          Months          Months  Q2 2004 vs. Q2 2003
                                                          Ended            Ended        Variance Analysis
                                                         30-Jun-04      30-Jun-03            $              %
      Product sales - OrthoBiologic
      North America                              5,265,697      5,062,135      203,562         4%
      Europe and other International  1,121,276         761,166      360,110        47%
      Total OrthoBiologic revenues      6,386,973      5,823,301      563,672        10%
                                                            Six                Six
                                                          Months          Months  H1 2004 vs. H1 2003
                                                            Ended            Ended      Variance Analysis
                                                         30-Jun-04      30-Jun-03          $              %
      Product sales - OrthoBiologic
      North America                            10,657,630      9,681,217      976,413        10%
      Europe and other International  2,200,778      1,447,704      753,074        52%
      Total OrthoBiologic revenues    12,858,408    11,128,921  1,729,487        16%
      IsoTis S.A.
      US Dollars - Unaudited
      Consolidated Balance Sheet                                 30-Jun-04         31-Dec-03
      Cash and cash equivalents                                 37,262,325        50,104,682
      Restricted Cash - Current                                  2,218,071         1,629,802
      Restricted Cash - Long Term                                5,330,951         6,519,385
      Total non-current assets                                  44,811,347        58,253,869
      IsoTis S.A.                                                        Six Months        Six Months
      US Dollars - Unaudited                                              Ended                Ended
      Consolidated Statements of Operations                30-Jun-04         30-Jun-03
      Loss from operations                                        (14,205,255)    (11,168,893)
      Depreciation and amortization                            2,777,780         1,094,279
      EBITDA                                                              (11,427,475)    (10,074,614)
      IsoTis S.A.                                                    Three Months        Six Months
      US Dollars - Unaudited                                              Ended                Ended
      Consolidated Statements of Operations                30-Jun-04         30-Jun-04
      Total revenues                                                    6,426,282        13,041,993
      Research and development                                    2,629,798         5,462,040
      Research and development - Reinvestment %                    41%                  42%@@end@@

    Web site: http://www.isotis.com

ots Originaltext: IsoTis OrthoBiologics
Im Internet recherchierbar: http://www.newsaktuell.ch

Hans Herklots, +41-21-620-6011, Fax: +41-21-620-6060,
hans.herklots@isotis.com, or Louis G. Plourde, 1-800-561-2955 (North
America), or +1-514-277-5984, louis.plourde@isotis.com, both of
IsoTis OrthoBiologics

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