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Defibrotide Phase 3 interim data presented at ASH from on-going Treatment IND shows significant increase in complete response and decrease in mortality
On track to submit US and EU regulatory filings by end of Q2 2011
Total revenues of EUR 24.5 million (US$ 32.6 million). Cash flow positive and stronger cash position
Net income of EUR 4.08 million (US$ 5.41 million) marks first year of profitability
VILLA GUARDIA (COMO), Italy, March 28, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today reported financial results for the quarter and year ended December 31, 2010. The Company reports its financial 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 December 30, 2010, EUR 1.00 = $1.3269.
"We are pleased to report that, for the first time, the Company achieved profitability for the full year, posting net income of EUR 4.08 million (US$ 5.41 million) for the year ended December 31, 2010," stated Salvatore Calabrese, SVP Finance and Chief Financial Officer of Gentium S.p.A. "The Company has been cash flow positive and has significantly strengthened its cash position in 2010. Overall, total revenues doubled in 2010 compared with 2009. The product sales increased significantly as a result of increased distribution of Defibrotide through the expanded access programs and increased productivity of our manufacturing plant. We are pleased that we have achieved revenue within our range of guidance. We expect to remain cash flow positive in 2011 and currently project product revenues to be in the range of €23 – €25 million ($30 – $35million) in 2011."
"During the year, Gentium initiated and completed a number of pre-clinical and clinical studies required by regulatory authorities," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "Currently, preparation of an electronic Common Technical Document (eCTD) is on-going and we remain on track to submit for marketing authorization to U.S. and European regulatory authorities by the end of the second quarter in 2011. Key events in 2010 have included the expansion of the existing license agreement with our commercial partner, Sigma-Tau, which included an upfront payment of $7.0 million; presentation of Defibrotide clinical results for VOD and acute GvHD at important international conferences, such as EBMT, ISH, APBMT and ASH; and an increase in the uptake of Defibrotide around the world from 100 clinics to more than 240 in over 33 countries. We look forward to the projected milestones for 2011 and will strive to deliver on these during the course of this year."