Empresas y finanzas

Gentium Reports First Quarter Financial Results; Provides Financial and Clinical Update



    Gentium S.p.A. (NASDAQ: GENT) (the "Company") today reported
    financial results for the quarter ended March 31, 2007. Highlights of
    the first quarter of 2007 and recent weeks as of June 7, 2007,
    include:

    -- Continued progress with the Phase III clinical trial in the
    U.S. evaluating Defibrotide as a potential treatment of severe
    Veno-Occlusive Disease (VOD) with Multiple Organ Failure
    (Severe VOD): this study has enrolled 39 patients.

    -- Progress with the Phase II/III clinical trials of Defibrotide
    in Europe for the prevention of VOD in children. This study is
    expected to be conducted in 35 centers and 130 patients have
    been enrolled in the trial.

    -- Completed Phase I of Phase I/II study of Defibrotide to treat
    advanced and refractory multiple myeloma patients, presented
    preliminary Phase I data at the Annual Meeting of Society of
    Hematology (ASH) 2006. The Company expects to update interim
    results from this trial at the upcoming International Myeloma
    Workshop in Kos, Greece June 25th to 30th. The Company expects
    to present final Phase I data in the second half of 2007.

    -- At the American Association of Cancer Research meeting in
    April, the Company presented preclinical data to support the
    potential mechanism for Defibrotide anti-tumor activity in
    multiple myeloma. Two posters presented data that suggest that
    Defibrotide may suppress tumor-associated angiogenesis and
    tumor dissemination through suppression of heparanase with a
    subsequent reduction in the release of stores of growth
    factors from the extra-cellular matrix. This, in part, may
    explain Defibrotide's anti-MM activity both in vitro and in
    vivo.

    -- The Company presented updated preclinical data at the World
    Congress of Nephrology in April which suggests that
    Defibrotide may have activity in diabetic nephropathy. Data
    demonstrated that Defibrotide not only has an effect on the
    down-regulation of heparanase gene expression, but also
    decreases its enzymatic activity in endothelial cells. Since
    heparanase is a critical factor in maintaining glomerular
    basement membrane integrity and is elevated in diabetic
    nephropathy, results suggest that it should be considered for
    the management of this disease.

    -- The Company completed the acquisition of the Italian marketing
    authorizations for Defibrotide and related trademarks, as well
    as certain other related assets, from Crinos S.p.A. (Crinos)
    for EUR 16 million in cash and other considerations. This
    acquisition provides the company control over the distribution
    of Defibrotide, as well as enabling Gentium to market directly
    or seek a partner in Europe.

    -- The Company strengthened its cash position raising $45.2
    million net proceeds through a private placement of ordinary
    shares in February.

    Clinical Highlights and Outlook

    Commenting on Gentium's clinical and operational progress during
    the quarter, Laura Ferro, M.D., Chairman and Chief Executive Officer,
    said, "Over the past quarter the Company has undertaken a series of
    complementary initiatives which support progress in research,
    clinical, and operations activities. The clinical potential for
    Defibrotide continues to expand with additional data to support the
    elucidation of the mechanism of action for Defibrotide in cancer, VOD,
    as well as metabolically induced indications such as diabetic
    nephropathy."

    Dr. Ferro continued, "We believe that the next eighteen months
    will be pivotal for the Company as we expect to complete accrual and
    report results in both the Company's prevention and treatment trials
    with Defibrotide. We remain on track to complete patient enrollment in
    U.S. Phase III pivotal trial of Defibrotide to treat Severe VOD this
    trial during the second half of 2007."

    "The acquisition of Crinos assets represented a major milestone
    for Gentium as it allows us to better manage this key asset in the
    European markets. It also gives us control over its distribution and
    the flexibility to market Defibrotide ourselves or alternatively seek
    marketing partners in the European market, both of which have long
    been strategic objectives. In addition, we strengthened our balance
    sheet by raising $45.2 million in net proceeds, which should allow us
    to support our clinical development programs and which we believe will
    provide us with the capital to complete our Phase III programs."

    Financial Highlights

    The Company reports its financial condition and operating results
    using U.S. Generally Accepted Accounting Principles (GAAP). The
    Company's financial statements are prepared using the Euro as its
    functional currency. On March 31, 2007, EUR 1.00 = $ 1.3318.

    For the first quarter ended March 31, 2007 compared with the
    prior-year's first quarter:

    -- Total revenues were EUR 1.25 million, compared with EUR 0.95
    million

    -- Operating costs and expenses were EUR 5.42 million, compared
    with EUR 3.94 million

    -- Research and development expenses, which are included in
    operating costs and expenses, were EUR 3.07 million, compared
    with EUR 1.67 million

    -- Operating loss was EUR 4.17 million, compared with EUR 2.99
    million

    -- Interest income (expense), net, was EUR 0.26 million, compared
    with EUR 0.05 million

    -- Net loss was EUR 4.77 million, compared with EUR 3.10 million

    -- Basic and diluted net loss per share was EUR 0.36 compared
    with EUR 0.32 per share

    Operating Results and Trends

    The fluctuation in product sales revenues for the three-month
    period compared with the prior-year period is primarily due to greater
    demand for our products from our two main customers. Sales to
    affiliates represented 78% and 99% of the total product sales in the
    three months ended March 31, 2007 and 2006, respectively, and
    increased 4% to EUR 951 thousand. Sales to third parties increased to
    EUR 267 thousand mainly due to higher demand for our active
    pharmaceutical ingredient sulglicotide in the Korean market for EUR 82
    and due to sales of finished products for EUR 182 directly to
    distributors instead of going though Sirton.

    Cost of goods sold was EUR 754 thousand for the three month period
    ended March 31, 2007 compared to EUR 711 thousand for the comparable
    period in 2006. Cost of goods sold as a percentage of product sales
    was 61.9% at in the 2007 period compared to 77.7% in the 2006 period.

    Research and development spending increased during the three-month
    periods in 2007 compared with 2006, primarily due to the costs
    associated with the Company's U.S. Phase III trial for the treatment
    of Severe VOD. Growth in headcount and outside services to support
    increased activity in our clinical trials, primarily contract research
    organization expenses and stock-based compensation expense also
    contributed to increased research and development expenses.

    General and administrative expenses were EUR 1.29 million and EUR
    1.3 million for the three month period ended March 31, 2007 and 2006,
    respectively. General and administrative expenses for the 2007 period
    were thus in line with the comparable period in 2006 and include
    personnel costs, facilities related expenses, general corporate
    expenses of being a public Company and stock based compensation
    expense of EUR 167 thousand.

    Interest income (expense), net, increased to EUR 263 in the first
    quarter of 2007 over comparable period in 2006. Interest income
    amounted to EUR 341 and EUR 85 in the three months ended March 31,
    2007 and 2006, respectively, an increase of EUR 256. The increase is a
    result of a higher amount of invested funds as a result of the private
    placement in 2007. Interest expense totaled EUR 78 and EUR 33 in the
    three months ended March 31, 2007 and 2006, respectively.

    The Company ended the first quarter of 2007 with EUR 40.41 million
    in cash and cash equivalents, compared with cash and cash equivalents
    of EUR 10.21 million as of December 31, 2006.

    About Gentium

    Gentium, S.p.A., located in Como, Italy, is a biopharmaceutical
    Company focused on the research, discovery and development of drugs to
    treat and prevent a variety of vascular diseases and conditions
    related to cancer and cancer treatments. Defibrotide, the Company's
    lead product candidate, is an investigational drug that has been
    granted Orphan Drug status and Fast Track Designation by the U.S. FDA
    for the treatment of Severe VOD as well as the prevention of VOD and
    Orphan Medicinal Product Designation by the European Commission both
    to treat and to prevent VOD.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements." In some
    cases, you can identify these statements by forward-looking words such
    as "may," "might," "will," "should," "expect," "plan," "anticipate,"
    "believe," "estimate," "predict," "potential" or "continue," the
    negative of these terms and other comparable terminology. These
    statements are not historical facts but instead represent the
    Company's belief regarding future results, many of which, by their
    nature, are inherently uncertain and outside the Company's control. It
    is possible that actual results may differ, possibly materially, from
    those anticipated in these forward-looking statements. For a
    discussion of some of the risks and important factors that could
    affect future results, see the discussion in our Form 20-F under the
    caption "Risk Factors."

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    GENTIUM S.p.A.
    Balance Sheets
    (Amounts in thousands, except share and per share data)

    ---------------------------
    December 31, March 31,
    2006 2007
    (unaudited)
    ------------ -----------
    ASSETS
    Cash and cash equivalents EUR 10,205 EUR 40,407
    Restricted Cash 4,000 4,000
    Receivables from third parties 227 162
    Receivables from related parties 3,478 4,439
    Inventories, net 1,499 1,846
    Prepaid expenses and other current
    assets 1,427 1,316
    ------------ -----------
    Total Current Assets 20,836 52,170

    Property, manufacturing facility and
    equipment, at cost 18,944 19,171
    Less: Accumulated depreciation 9,550 9,783
    ------------ -----------
    Property, manufacturing facility and
    equipment, net 9,394 9,388

    Intangible assets, net of amortization 586 665
    Marketable securities 560 527
    Other non-current assets 4,017 4,017
    ------------ -----------
    Total Assets EUR 35,393 EUR 66,767
    ============ ===========

    LIABILITIES AND SHAREHOLDERS' EQUITY
    Accounts payable EUR 4,734 EUR 5,263
    Payables to related parties 454 875
    Accrued expenses and other current
    liabilities 1,198 1,258
    Current maturities of long-term debt 140 105
    Current portion of capital lease
    obligation 43 43
    Deferred income 724 765
    ------------ -----------
    Total Current Liabilities 7,293 8,309

    Long-term debt, net of current
    maturities 5,683 5,560
    Capital lease obligation 48 48
    Termination indemnities 682 696
    ------------ -----------
    Total Liabilities 13,706 14,613
    ------------ -----------

    Share capital (par value: EUR 1.00;
    15,100,292 and 17,454,292 shares
    authorized; 11,773,613 and 14,191,294
    shares issued at December 31, 2006 and
    March 31 2007, respectively) 11,774 14,191
    Additional paid in capital 49,476 82,332
    Other comprehensive income 32 (1)
    Accumulated deficit (39,595) (44,368)
    ------------ -----------
    Total Shareholders' Equity 21,687 52,154
    ------------ -----------
    Total Liabilities and Shareholders'
    Equity EUR 35,393 EUR 66,767
    ============ ===========
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    GENTIUM S.p.A.
    Statements of Operations
    (Unaudited, amounts in thousands except share and per share data)

    Three Months Ended
    March 31,
    ----------------------------
    2006 2007
    ---------- -----------
    Revenues:
    Sales to affiliates EUR 912 EUR 951
    Third party product sales 3 267
    ---------- -----------
    Total product sales 915 1,218
    Other income and revenues 35 35
    ---------- -----------
    Total Revenues 950 1,253

    Operating costs and expenses:
    Cost of goods sold 711 754
    Charges from affiliates 215 226
    Research and development 1,675 3,075
    General and administrative 1,296 1,291
    Depreciation and amortization 42 75
    ---------- -----------
    (3,939) (5,421)
    ---------- -----------
    Operating loss (2,989) (4,168)

    Foreign currency exchange gain (loss),
    net (168) (868)
    Interest income, net 52 263
    ---------- -----------
    Net loss EUR (3,105) EUR (4,773)
    ---------- -----------

    Net loss per share:
    Basic and diluted net loss per share EUR (0.32) EUR (0.36)
    ========== ===========

    Weighted average shares used to compute
    basic and diluted net loss per share 9,610,630 13,117,049
    *T

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    GENTIUM S.p.A.
    Statements of Cash Flows
    (Unaudited, amounts in thousands)

    Three Months Ended
    March 31,
    -----------------------
    2006 2007
    ------- -------
    Cash Flows From Operating Activities:
    Net loss EUR (3,105) EUR (4,773)
    ------- -------
    Adjustments to reconcile net income to net
    cash used in operating activities:
    Unrealized foreign exchange loss 140 815
    Depreciation and amortization 219 278
    Non cash share based compensation 213 241
    Deferred income (35) (35)
    Changes in operating assets and liabilities:
    Accounts receivable (131) (897)
    Inventories (152) (347)
    Prepaid expenses and other current and non
    current assets 188 109
    Accounts payable, accrued expenses and
    other long term liabilities 639 1,033
    ------- -------
    Net cash used in operating activities (2,024) (3,575)
    ------- -------

    Cash Flows From Investing Activities
    Capital expenditures (198) (228)
    Intangible expenditures (274) (120)
    ------- -------
    Net cash used in investing activities (472) (348)
    ------- -------

    Cash Flows From Financing Activities:
    Repayments of long-term debt (401) (82)
    Proceeds from warrant and stock option
    exercise exercises - 549
    Proceeds from private placement, net - 34,485
    ------- -------
    Net cash provided by/(used in) financing
    activities (401) 34,952
    ------- -------

    Increase/(decrease) in cash and cash
    equivalents (2,897) 31,029
    Effect of exchange rate on cash and cash
    equivalents (142) (827)
    Cash and cash equivalents, beginning of period 12,785 10,205
    ------- -------
    Cash and cash equivalents, end of period EUR 9,746 40,407
    ======= =======
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