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Defibrotide usage increased by 32% to EUR 6.49 million (US$ 8.31 million).
Product sales of EUR 7.54 million (US$ 9.65 million) for the three month period ended March 31, 2013, recording an increase of 33%.
Cash flow positive and stronger cash position.
Non-GAAP Adjusted EBITDA of EUR 1.64 million (US$ 2.10 million).
VILLA GUARDIA (COMO), Italy, May 14, 2013 (GLOBE NEWSWIRE) --Gentium S.p.A. (Nasdaq:GENT) (the "Company") today reported financial results for the quarter ended March 31, 2013. 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 March 31, 2013, EUR 1.00 = $1.28.
"We are pleased to report that Defibrotide usage increased by 32% and by 15%, respectively, when compared to the prior-year period and to the fourth quarter of 2012. Defibrotide demand outside the US continue to remain strong, representing 93% of the Defibrotide total product sales for the three month period ended March 31, 2013. The Company continues to be cash flow positive and profitable," stated Salvatore Calabrese, SVP & Chief Financial Officer of Gentium S.p.A.
"We are pleased that Defibrotide continues to be made available to patients around the world through our named-patient and cost recovery programs and our distribution partnerships allow easier and faster access for the treating physicians. We continue to explore additional partnerships for the distribution of Defibrotide in new countries where it is currently unavailable," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of the Company. "On the regulatory front, we recently requested a re-examination of the negative opinion adopted by the European Medicines Agency's Committee for Medical Products for Human Use, the appeal process is expected to be completed in Q3 2013. We continue to work closely with the FDA towards a resubmission of our NDA, and expect to file in 2013."