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IsoTis OrthoBiologics

IsoTis Reports 2007 First Quarter Results

Irvine, California (ots/PRNewswire)

IsoTis, Inc (NASDAQ: ISOT),
an orthobiologics company, today reported results for the first
quarter ended March 31, 2007.
Revenue Analysis
Revenue was US$10.0 million for the first quarter of 2007,
representing a 2% increase over revenue of US$9.8 million for the
first quarter of 2006.
IsoTis' chief distribution channels are its U.S. network of
independent distributor agents and its network of international
stocking distributors, while the remaining portion of its revenues is
derived from private label partners in the United States and
internationally.
In the first quarter of 2007, revenue from the U.S. independent
distributor agents grew 7% to US$6.4 million compared to US$6.0
million in the first quarter of 2006; revenue from international
stocking distributors decreased 14% to US$2.1 million compared to
US$2.5 million in  the first quarter of 2006; and revenue from
private label partners grew 22%  to US$1.1 million compared to US$0.9
million in the first quarter of 2006.
Results Comparison & Cash Position
The net loss from operations before minority interest for the
first quarter of 2007 was US$5.5 million, compared to US$3.8 million
for the first quarter of 2006. Net loss for the first quarter of 2007
totaled US$5.0 million or US$0.79 per basic and diluted share as
compared with a net loss of US$3.8 million or US$0.54 per basic and
diluted share for the first quarter  of 2006. The first quarter
results were negatively impacted by several non-recurring items,
including approximately US$1.6 million of costs for outside advisors
and exchange agents in four jurisdictions associated with the
Company's successful transformation to a US-based NASDAQ listed
company, and a restructuring charge of US$0.6 million for the Dutch
facility which  is no longer in use by the Company.
At March 31, 2007, IsoTis had cash and cash equivalents and
restricted cash of US$10.5 million. The net decrease in cash and cash
equivalents in the first quarter of 2007 amounted to US$ 5.5 million
compared to US$ 2.3 million in the first quarter of 2006. The first
quarter cash flow was negatively impacted by several non-recurring
items, including payments of approximately US$1.0 million to outside
advisors and exchange agents related  to the transformation to a
US-based NASDAQ listed company, as well as a  build-up in inventory
of US$ 0.9 million. The Company needs and intends to  raise
additional funds for operations and is actively considering various
financing alternatives.
Regulatory update
Further to the Company's disclosure on February 14, 2007, the
Company continues to communicate with the U.S. Food and Drug
Administration (FDA) on the regulatory status of our Accell products.
Based on these constructive communications, the Company continues to
believe the Accell family of products are Class II medical devices
that are subject to the 510(k) clearance process, although the
Company can make no assurances in this regard. This belief is
consistent with the treatment of other competing products, the
Company's prior discussions with the FDA and the 510(k) clearance
previously received for Accell Connexus.
Highlights Q1 2007 & Year to Date
  • Patent for Reverse Phase Medium platform technology (May)
  • Sale of PolyActive IP Estate for US$1.7 million up-front (April)
  • Appointment of James P. Abraham as SVP Sales (April)
  • NASDAQ listing on January 26 after successful completion of exchange offer
Pieter Wolters, President and CEO of IsoTis said, "We are happy to
report that the sales of our Accell products showed growth of 13%
compared with the same quarter of last year. During the first quarter
we faced the uncertainty about the regulatory status of our Accell
products, which limited our ability to raise capital from the public
market. Given these circumstances, I commend the IsoTis team and our
distributors who remained focused on executing our plan."
Conference Call
IsoTis has scheduled a conference call to discuss these results
today May 15, 2007 at 5 p.m. EST (2 p.m. PST, 11 p.m. CET). US Dial
In: toll free 1-800-798-2864; toll 1-617-614-6206; UK Dial In
44-20-7365- 8426; Continental Europe Dial In: 41-1-800-9569;
password: IsoTis. Digital playback is available from May 15 at 8:00
p.m. for 24 hours. US Dial In:  1-617801-6888; European Dial In
44-20-7365-8427; playback ID: 94317272. To listen to the conference
call live via the internet, visit the Investors section of the IsoTis
website at www.isotis.com. Please go to the website 15 minutes prior
to the call to register, download and install the necessary audio
software.
About IsoTis
IsoTis is an orthobiologics company that develops, manufactures
and markets proprietary products for the treatment of musculoskeletal
diseases and disorders. IsoTis' current orthobiologics products are
bone graft substitutes that promote the regeneration of bone and are
used to repair natural, trauma-related and surgically-created defects
common in orthopedic procedures, including spinal fusions. IsoTis'
current commercial business is highlighted by its Accell line of
products, which the company believes represents the next generation
in bone graft substitution.
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, the Company's need to raise additional capital to
continue operations, a 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 (i.e.,. EMEA, CE),
including the risk that the FDA determines that our Accell Putty and
Accell TBM products are not human tissue or class II medical devices,
that the Company is unable to obtain 510(k) clearance for its Accell
products, that the FDA requires the Company to obtain premarket
approval of its Accell products prior to continuing their marketing,
that the FDA requires the Company to produce additional clinical data
to support approval or clearance of its products, that the FDA
imposes compliance measures against the Company for the marketing of
its Accell products, including imposing fines and injunctions or
causing the Company to recall its Accell products, market acceptance
of IsoTis' products, effectiveness of IsoTis' 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 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
Annual Report on Form 20-F for the fiscal year ended December 31,
2006 of IsoTis S.A. (the predecessor to IsoTis, Inc.), and its other
reports filed with the SEC, IsoTis S.A.'s reports filed from time to
time with the Swiss Stock Exchange (SWX), Euronext Amsterdam N.V.,
SEDAR at www.sedar.com and the Toronto Stock Exchange (TSX) and the
quarterly report on Form 10-Q for the quarter ended March 31, 2007
and other reports filed with the SEC from time to time by IsoTis,
Inc.
    IsoTis Inc.
    Consolidated Statements of Operations
    US Dollars
                                                    Three Months Ended
                                              March 31, 2007 March 31, 2006
                                                (Unaudited)    (Unaudited)
    Revenue
    Product sales                             $ 9,974,489    $ 9,778,365
    Other revenue                                       -         35,816
    Total revenue                               9,974,489      9,814,181
    Operating expenses
    Costs of sales                              4,004,696      3,693,828
    Sales and marketing                         4,604,682      4,313,790
    General and administrative                  5,371,081      2,607,195
    Research and development                    1,561,021      1,713,821
    Impairment of intangible assets
    Total operating expenses                   15,541,480     12,328,634
    Loss from operations                       (5,566,991)    (2,514,453)
    Interest income                               106,213        140,835
    Interest expense                             (128,057)       (27,860)
    Foreign exchange gain (loss)                    7,034     (1,402,787)
    Other income                                   38,405              -
    Net loss before taxes and
    minority interest                          (5,543,396)    (3,804,265)
    Minority interest                             498,520              -
    Provision for income taxes                     (5,000)             -
    Net loss                                 $ (5,049,876)  $ (3,804,265)
    Basic and diluted net loss per share          $ (0.79)       $ (0.54)
    Weighted average common shares outstanding
    Basic                                       6,373,735      7,087,316
    Diluted                                     6,373,735      7,087,316
                                           March 31, 2007      December 31,
                                                                      2006
                                              (Unaudited)
    Assets
    Current assets:
    Cash and cash equivalents                $ 7,872,232      $ 13,362,915
    Restricted cash                            1,599,123         1,659,787
    Trade receivables, net                     7,686,038         7,463,194
    Other receivables                            213,234           374,061
    Inventories                               15,111,769        14,211,189
    Prepaid expenses and other current assets    957,641           923,746
    Total current assets                      33,440,037        37,994,892
    Non-current assets:
    Restricted cash                            1,000,000         1,250,000
    Property, plant and equipment, net         4,217,118         3,907,175
    Goodwill                                  16,383,069        16,383,069
    Intangible assets, net                    10,381,626        11,026,656
    Total non-current assets                  31,981,813        32,566,900
    Total assets                            $ 65,421,850      $ 70,561,792
    Liabilities and shareholders' equity
    Current liabilities:
    Trade payables                           $ 5,581,137       $ 6,707,212
    Accrued liabilities                        7,529,353         6,560,894
    Deferred revenue                           1,396,702         1,342,797
    Current portion of interest-bearing loans  4,462,235         3,751,201
    and borrowings
    Total current liabilities                 18,969,427        18,362,104
    Non-current liabilities:
    Interest-bearing loans and borrowings      1,375,808         1,696,963
    Deferred revenue                           4,456,939         4,792,638
    Other long term liabilities                  258,315           279,025
    Total non-current liabilities              6,091,062         6,768,626
    Minority interest                          3,862,907                 -
                                                     581               709
                                             142,966,585       157,595,924
                                              18,318,985        20,141,408
                                            (124,787,697)     (132,306,984)
    Total shareholders' equity                36,498,454        45,431,062
    Total liabilities and
    shareholders' equity                    $ 65,421,850      $ 70,561,792
                                                    Three Months Ended
                                              March 31, 2007  March 31, 2006
                                                 (Unaudited)    (Unaudited)
    Cash flows from operating activities
    Net loss from continuing operations         $ (5,049,876)  $ (3,804,265)
    Adjustments to reconcile net loss
    to net cash used in operating
    activities:
    Depreciation and amortization                    844,727        831,187
    Bad debt expense                                   8,210        (15,557)
    Loss on sale of assets                                 -           (642)
    Stock-based compensation expense                 378,131         89,669
    Foreign currency transaction (gain) loss          (7,034)     1,402,787
    Minority interest                               (498,520)             -
    Change in operating assets and
    liabilities:
    Inventories                                      (889,775)       21,965
    Trade receivables                                (201,174)     (216,208)
    Other current assets                              137,454      (462,626)
    Deferred revenue                                 (281,794)     (207,830)
    Trade and other payables                         (143,396)      300,971
    Other long term liabilities                       (20,710)            -
    Net cash flows used in operating               (5,723,757)   (2,029,435)
    activities
    Cash flows from investing activities
    Purchase of propert, plant and equipment         (503,428)     (421,138)
    Change in restricted cash                         318,143       250,000
    Net cash flows used in investing                 (185,285)     (171,138)
    activities
    Cash flow from financing activities
    Proceeds from issuance of common shares                 -        97,561
    Proceeds from interest-bearing loans and          389,313             -
    borrowings
    Repayment of interest-bearing loans and                 -      (253,827)
    borrowings
    Net cash flows provided by (used in)               389,313      (156,266)
    financing activities
    Gain on cash held in foreign currency               29,046        12,134
    Net decrease in cash and cash                   (5,490,683)   (2,344,705)
    equivalents
    Cash and cash equivalents at the                13,362,915    15,714,442
    beginning of the period
    Cash and cash equivalents at the end of        $ 7,872,232  $ 13,369,737
    the period

Contact:

For information contact: Rob Morocco, CFO, +1-949-855-7155,
robert.morocco@isotis.com Hans Herklots, Director IR, +1-949-855-7195
or +41-21-620-6011, hans.herklots@isotis.com

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