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GNT Gentium Spa Ads

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Share Name Share Symbol Market Type
Gentium Spa Ads AMEX:GNT AMEX Ordinary Share
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Gentium Reports Second Quarter Financial Results, Provides Clinical Update

10/08/2005 9:00am

Business Wire


Gentium Spa (AMEX:GNT)
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Gentium S.p.A. (AMEX:GNT) (the "Company") today reported financial results for the three- and six-month periods ended June 30, 2005. Highlights of the second quarter of 2005 and recent weeks include: -- Completed an initial public offering of 2.7 million American Depositary Shares (ADS) (including the exercise of part of the underwriters over-allotment option), which are listed on the American Stock Exchange (1 ADS = 1 share), and raised gross proceeds of $24.3 million; -- Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the company's lead product candidate, Defibrotide for the treatment of severe Veno-Occlusive Disease (VOD) with multiple organ failure ("Severe VOD"); -- FDA deemed the Company's Chemistry, Manufacturing & Controls (CMC) submission to be adequate for initiation of Phase III studies with Defibrotide for treating Severe VOD. Laura Ferro, M.D., chairman and chief executive officer of Gentium said, "We continue to build upon our extensive experience to develop pharmaceutical products derived from DNA. During the second quarter we made important progress with clinical development of our lead product candidate, which addresses a life-threatening disease for which there are no current treatment options. We are participating in clinical programs in the U.S. and in Europe, and as a result of the costs expect to incur losses for the foreseeable future. Our costs and expenses will be partially offset by revenues derived from the sale of Defibrotide in Italy for vascular disease with risk of thrombosis and from the sale of various active pharmaceutical ingredients. "We look forward to initiating Phase III trials in the U.S. with Defibrotide for treating Severe VOD pending FDA agreement on our trial protocol, and to bringing this therapy for such a potentially devastating complication to market," she added. 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 (EUR), its native currency. On June 30, 2005, EUR 1.00 = $1.21. For the second quarter ended June 30, 2005, compared with the prior-year's second quarter: -- Total revenues were EUR 1.2 million, compared to EUR 1.0 million -- Operating costs and expenses were EUR 2.9 million, compared to EUR 2.1 million -- Operating loss was EUR 1.7 million, compared to EUR 1.1 million -- Interest expense was EUR 2.11 million, compared to EUR 0.03 million -- Pre-tax loss was EUR 4.3 million, compared to EUR 1.1 million -- Net loss was EUR 4.3 million, compared to EUR 1.2 million -- Basic and diluted net loss per share was EUR 0.81 and EUR 0.80, compared to EUR 0.23 and EUR 0.23 For the six months ended June 30, 2005, compared with the comparable prior-year's six month period: -- Total revenues were EUR 1.9 million, compared to EUR 1.8 million -- Operating costs and expenses were EUR 4.8 million, compared to EUR 3.5 million -- Operating loss was EUR 2.9 million, compared to EUR 1.7 million -- Interest expense was EUR 4.26 million, compared to EUR 0.06 million -- Pre-tax loss was EUR 7.7 million, compared to EUR 1.7 million -- Net loss was EUR 7.7 million, compared to EUR 1.7 million -- Basic and diluted net loss per share was EUR 1.50 and EUR 1.48, compared to EUR 0.34 and EUR 0.34 -- Cash used in operating activities was EUR 3.5 million, compared to EUR 1.0 million -- Cash and cash equivalents amounted to EUR 10.5 million as of June 30, 2005. Subsequent to the close of the quarter, the underwriters of the Company's IPO exercised part of their over-allotment option, purchasing 300,000 shares for additional gross proceeds of $2.7 million (approximately EUR 2.2 million). Dr. Ferro commented, "As we have taken the significant step of becoming a publicly traded company and have continued to build the infrastructure to achieve our business objectives, the resulting increases in operating expenses and interest expense were significant factors in the size of our losses." Operating Results and Trends -- The Company's manufacturing facility was closed from February through August 2004 for a major upgrade; therefore, comparisons of 2005 operating results with 2004 results may not be meaningful. -- The increase in revenue for the three- and six-month periods compared with the prior year is primarily the result of the closing of the Company's manufacturing facility in the prior-year periods for upgrades. -- Cost of goods sold increased for the three- and six-month periods compared with the prior-year period as a result of increased sales in the 2005 periods and manufacturing overhead in 2005 that the Company did not have in 2004 because of the closing of its manufacturing facility for the upgrade. -- The Company increased its employee headcount from 35 at the end of 2004 to 52 at June 30, 2005. Other general and administrative expense increases were primarily the result of building corporate infrastructure, public company expenses and an increase in internally provided administrative services to replace administrative services previously provided by affiliates, which began to occur in the second quarter. In the fourth quarter of 2004 and the first quarter of 2005, the Company issued approximately $8.0 million of convertible notes. As a result, interest expense increased dramatically in 2005. In conjunction with the Company's initial public offering, $2.9 million of these notes were converted into common equity and the balance was repaid in June and July of 2005. The Company incurred interest expense of EUR 4.2 million, which included non-cash interest expense of EUR 3.9 million from amortization of the issue discount and issue costs, on these notes during the six-month period ended June 30, 2005. Clinical Highlights and Outlook Commenting on Gentium's clinical progress, Dr. Ferro reported, "During the second quarter we achieved a number of important clinical milestones. We were granted Fast Track designation by the FDA for our initial product candidate, Defibrotide for the treatment of Severe VOD, which has previously been granted Orphan Drug status. We have a meeting scheduled with FDA officials later in the third quarter with the goal of finalizing the protocol for our U.S. Phase III clinical trial. The upgrades made to our manufacturing facility in 2004 positioned the Company for its CMC submission to the FDA. The acceptance by the FDA of this submission was a major milestone necessary for the initiation of this Phase III trial. Upon securing approval of our Phase III protocol, we expect to begin treating patients immediately, as we will be using the same centers and clinical investigators from the Phase II trial." Dr. Ferro continued, "We have expanded the terms of our licensing agreement for Defibrotide for the treatment of Severe VOD with our marketing partner, Sigma Tau, to include Canada, South America and Central America, in addition to the previously negotiated marketing rights to the U.S. Sigma Tau also has a right of first refusal to market Defibrotide for the prevention of VOD in the Americas. "The Consorzio Mario Negri Sud, a private, non-profit institute in Italy that carries out basic research in cell biology related to pharmacology and biomedicine, is conducting a multi-center Phase II/III clinical trial in Europe and Israel for the treatment of VOD after stem cell transplant. We expect this trial to include approximately 340 patients. We also have studies and plans for studies with Defibrotide for the prevention of VOD underway. We are co-sponsoring with the European Group for Blood and Marrow Transplantation a Phase II/III clinical trial in Europe for the use of Defibrotide to prevent VOD in children. We expect this study to include 270 patients enrolled by several centers in Europe beginning later this year. We also expect to start a second Phase II clinical trial in Europe later this year for use of Defibrotide to prevent VOD in adults. We expect this trial to include approximately 300 patients enrolled by several centers in Europe. Finally, we are planning to begin an exploratory clinical trial of Defibrotide for the treatment of refractory multiple myeloma by the first quarter of 2006." About Gentium Gentium, located in Como, 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. 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 Prospectus filed with the Securities and Exchange Commission under Rule 424(b)(4) under the caption "Risk Factors." -0- *T Gentium S.p.A. Balance Sheets (Amounts in EUR) December 31, June 30, (000's omitted) 2004 2005 ---------------- -------------- (unaudited) ASSETS Cash and cash equivalents 2,461 10,476 Receivables 9 7 Receivables from related parties 1,490 1,977 Inventories 886 1,384 Prepaid expenses and other current assets 1,617 832 ---------------- -------------- Total Current Assets 6,463 14,676 Property, manufacturing facility and equipment, at cost 16,152 16,631 Less: Accumulated depreciation 7,609 8,300 ---------------- -------------- Property, manufacturing facility and equipment, net 8,543 8,331 Intangible assets, net 243 252 Other non-current assets 660 623 ---------------- -------------- 15,909 23,882 ================ ============== LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) Bank overdraft 100 - Accounts payable 3,927 3,635 Payables to related parties 1,498 1,131 Short-term bank borrowings 2,690 0 Accrued expenses and other current liabilities 432 558 Current maturities of long-term debt 2,781 1,814 Convertible notes payable, net of discount 2,082 827 Deferred income 564 421 ---------------- -------------- Total Current Liabilities 14,074 8,386 Long-term debt, net of current maturities 3,361 2,821 Termination indemnities 548 627 ---------------- -------------- Total Liabilities 17,983 11,834 Ordinary Shares (Par value: 1.00. 5,000,000 and 7,759,505 shares issued and outstanding at December 31, 2004, and June 30, 2005, respectively) 5,000 7,760 Additional paid-in capital 4,737 23,811 Parent company investment 1,097 1,097 Accumulated deficit (12,908) (20,620) ---------------- -------------- Total Shareholders' Equity (Deficit) (2,074) 12,048 ---------------- -------------- 15,909 23,882 ================ ============== As of June 30, 2005, EUR 1.00 = $1.21 Gentium S.p.A. Statements of Operations Six months ended Three months ended (Amounts in EUR) June 30, June 30, (000's omitted except 2004 2005 2004 2005 share data) ----------- ----------- ----------- ----------- (unaudited) (unaudited) (unaudited) (unaudited) Revenues: Sales to affiliates 1,072 1,717 657 1,098 Third-party product sales 253 - 221 - ----------- ----------- ----------- ----------- Total product sales 1,325 1,717 878 1,098 Other income and revenues 428 217 78 147 ----------- ----------- ----------- ----------- Total Revenues 1,753 1,934 956 1,245 Operating costs and expenses: Cost of goods sold 871 1,320 578 892 Research and development 1,529 1,994 894 1,245 Charges from affiliates 570 581 323 310 General and administrative 450 911 275 504 Depreciation and amortization 30 43 19 20 ----------- ----------- ----------- ----------- Operating income (loss) (1,697) (2,915) (1,133) (1,726) Interest expense (61) (4,255) (30) (2,105) Other income, net 1 10 - 8 Foreign currency exchange gain (loss), net 53 (520) 17 (465) ----------- ----------- ----------- ----------- Pre-tax income (loss) (1,704) (7,680) (1,146) (4,288) Income tax expense (benefit): Current 32 32 16 16 Deferred (37) - - - ----------- ----------- ----------- ----------- (5) 32 16 16 ----------- ----------- ----------- ----------- ----------- ----------- ----------- ----------- Net loss (1,699) (7,712) (1,162) (4,304) =========== =========== =========== =========== Net loss per share: Basic (0.34) (1.50) (0.23) (0.81) =========== =========== =========== =========== Diluted (0.34) (1.48) (0.23) (0.80) =========== =========== =========== =========== Weighted average shares used to compute net loss per share: Basic 5,000,000 5,152,459 5,000,000 5,303,242 =========== =========== =========== =========== Diluted 5,000,000 5,212,459 5,000,000 5,363,242 =========== =========== =========== =========== As of June 30, 2005, EUR 1.00 = $1.21 Gentium S.p.A. Statements of Cash Flows For the Six Months Ended (Amounts in EUR) June 30, (000's omitted) 2004 2005 ---------------- -------------- (unaudited) (unaudited) Cash Flows From Operating Activities: Net loss (1,699) (7,712) Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Depreciation and amortization 125 733 Non-cash interest expense - 3,873 Unrealized foreign currency exchange loss - 569 Stock-based compensation - 106 Services received from parent 0 0 Deferred income tax benefit (37) 32 Changes in operating assets and liabilities: Accounts receivable 2,140 (485) Inventories 273 (498) Prepaid expenses and other current assets (729) 229 Other assets 43 37 Accounts payable and accrued expenses 1,402 (343) Deferred income (155) (143) Termination indemnities (23) 79 Income taxes payable (304) 0 ---------------- -------------- Net cash provided by (used in) operating activities 1,036 (3,523) Cash Flows From Investing Activities: Capital expenditures (3,506) (478) Proceeds from disposal of intangibles (98) (52) ---------------- -------------- Net cash used in investing activities (3,604) (530) Cash Flows From Financing Activities: Proceeds from long-term debt - 1,465 Debt Issue Costs - (190) Repayments of long-term debt (200) (307) Repayment of Series A Senior Convertible Notes - (3,394) Proceeds (Repayments) of short-term borrowings 416 (2,790) Proceeds from issuance of common stock, net - 14,584 Proceeds of loan from affiliate 2,400 - Repayments of loan from affiliate - (1,200) Capital contribution by shareholder - 3,900 ---------------- -------------- Net cash provided by financing activities 2,616 12,068 Increase in cash and cash equivalents 48 8,015 Cash and cash equivalents, beginning of period 23 2,461 ---------------- -------------- Cash and cash equivalents, end of period 71 10,476 ================ ============== Supplemental disclosure of cash flow information: Cash paid for interest, net of capitalized amount 28 401 Cash paid for income taxes - - Supplemental disclosure of non-cash investing and financing activities: Equipment acquired under capital lease 127 127 Conversion of notes payable to stockholders into common stock - 2,408 Valuation of warrants issued in connection with convertible notes - 597 Value of beneficial conversion feature in connection with convertible notes and warrants - 5,192 As of June 30, 2005, EUR 1.00 = $1.21 *T

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