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Gentium Reports Fourth Quarter And Year End 2012 Financial Results

  • Total product sales of EUR 27.63 million (US$ 36.43 million) exceeding Company's product sales guidance of EUR 22-25 million (US$ 29-33 million)
  • Defibrotide uptake increased by 35% with sales of EUR 22.77 million (US$ 30.02 million)
  • Net income of EUR 0.77 million (US$ 1.02 million)
  • Cash flow positive and stronger cash position

VILLA GUARDIA (COMO), Italy, March 28, 2013 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today reported financial results for the quarter and year ended December 31, 2012. 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 31, 2012, EUR 1.00 = $1.3186.

"We are pleased to report that Defibrotide uptake increased by 35% in 2012 when compared with 2011, and that we achieved revenue above our guidance of €22-25 million," stated Salvatore Calabrese, SVP Finance and Chief Financial Officer of Gentium S.p.A. "The Company continues to be cash flow positive and has strengthened its cash position and the Company's balance sheet in 2012 while funding its operations and research and development activities."

"We continue to see an increased uptake of Defibrotide both to treat and prevent veno-occlusive disease (VOD)," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "In 2012, we have strengthened our presence in the Nordics, Baltics, Central, Eastern and Western Europe, and the Middle East, and Asia by entering into local distribution agreements with specialized regional partners which are distributing Defibrotide on a named-patient basis. We plan to continue to explore additional partnerships for the distribution of Defibrotide in new countries where it is currently unavailable."

"On the regulatory front, we remain confident in the favorable benefit/risk profile of Defibrotide, which is the only option recommended by The European Group for Blood and Marrow Transplantation for the treatment of VOD, an unmet medical need for which no known agents are currently approved, continued Dr. Islam. We intend to appeal the recently announced negative opinion adopted by the European Medicines Agency regarding our Marketing Authorization Application and expect a re-examination opinion in Q3 2013. We continue to work on our plan to address the issues raised by the US FDA with regard to our NDA and will continue to work closely with the FDA with the aim to file a new NDA in 2013."

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