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IsoTis OrthoBiologics

/OFF HOLD OFF HOLD OFF HOLD -- IsoTis OrthoBiologics/

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

Please add the following ticker symbols to the first paragraph of the
release. (SWX/Euronext: ISO; TSX: ISO; Reuters: ISON.S;  Reuters:
ISO.TO; ASX: ISON.AS)
IsoTis OrthoBiologics (SWX/Euronext: ISO; TSX: ISO; Reuters:
ISON.S;  Reuters: ISO.TO; ASX: ISON.AS) 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.
    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
      companies)
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.)
                                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
    Revenues
     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
    Assets
    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       $         %
    Revenues
    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       $         %
    Revenues
    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%
Web site: http://www.isotis.com

Contact:

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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  • 11.08.2004 – 07:40

    /ON HOLD ON HOLD ON HOLD -- IsoTis OrthoBiologics/

    /ON HOLD ON HOLD ON HOLD -- IsoTis OrthoBiologics, EDB1011437 Please place the following release: "IsoTis Announces 16% H1 Orthobiologics Sales Growth, and Provides Further 04 & 05 Guidance" ON HOLD. ots Originaltext: IsoTis OrthoBiologics Im Internet recherchierbar: http://www.newsaktuell.ch Contact: Hans Herklots, +41-21-620-6011, Fax: +41-21-620-6060, hans.herklots@isotis.com, or Louis G. Plourde, ...

  • 11.08.2004 – 07:37

    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 ...