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Defibrotide usage increased 38% to EUR 11.35 million (USD 14.29 million) for the six-month period ended June 30, 2012 from EUR 8.23 million in the prior-year period
Product sales of EUR 13.68 million (USD 17.22 million) for the six-month period ended June 30, 2012, recording an increase of EUR 2.88 million or 27%
Non-GAAP adjusted EBITDA of EUR 1.86 million (USD 2.34 million) for the first half of 2012
VILLA GUARDIA (COMO), Italy, Sept. 13, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today reported financial results for the first half of 2012 and the second quarter ended June 30, 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 June 30, 2012, EUR 1.00 = $1.259.
"We are pleased to report that Defibrotide usage in the six- and three-month periods ended June 30, 2012 increased by 38% and 47%, respectively, when compared to the six and three-month periods ended June 30, 2011. Defibrotide product sales for the three-month period ended June 30, 2012 amounted to EUR 6.42 million (USD 8.08 million), which is the highest of any quarter since the commencement of our cost recovery and named-patient programs. Additionally, we recorded a 30% increase in Defibrotide sales for the three-month period ended June 30, 2012 compared to the quarter ended March 31, 2012," stated Salvatore Calabrese, Senior Vice President and Chief Financial Officer of Gentium S.p.A. "We also returned to profitability, with a net income of EUR 0.82 million for the second quarter ended June 30, 2012. We reiterate our previously reported 2012 product sales guidance of EUR 23-25 million."
"Since the beginning of the year, we have entered into three regional distribution partnerships for Defibrotide with leading players, and we are pleased that the number of countries that have access to Defibrotide has increased," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "Our Marketing Authorization Application (MAA) for Defibrotide in Europe continues to progress and we will be presenting Oral Explanations to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on September 19
th. Following this presentation, we can expect the CHMP to issue a final opinion in the fourth quarter of 2012. In the US, we maintain an ongoing dialogue and continue to work closely with the US Food and Drug Administration (FDA) in connection with the resubmission of our New Drug Application (NDA), which we expect to file in the first half of 2013."
Conference Call with Management TodayAs previously announced, Gentium will host a conference call today at 8:00 a.m. ET / 2:00 p.m. CET. To participate in the call, interested parties may dial 1 866 966 9439 (North America toll-free) or +44 (0) 1452 555 566 (international/toll) and use Conference ID 27676054. Participants must register ten minutes before the call is scheduled to begin. Individuals may also access the live webcast at http://www.gentium.com/investors/event-calendar .The event will be archived for replay for 30 days. The replay can be accessed on the Company's website, http://www.gentium.comor by dialing 1 866 247 4222 (North America toll-free) or +44 (0) 1452 55 00 00 (international/toll) and using Conference ID 27676054#.Company Developments in the first six-month period ended June 30, 2012:
Appointed Swedish Orphan Biovitrum AB as the exclusive distributor of Defibrotide in the Nordic and Baltic territories; appointed PharmaSwiss S.A., a division of Valeant Pharmaceuticals International, Inc. as the exclusive distributor of Defibrotide in a number of Central, Eastern and Southern European countries.
Published results of a Phase III Defibrotide trial for the prevention of veno-occlusive disease (VOD) in pediatric patients in the Lancet publication.
Hosted a symposium on Defibrotide at the Annual Meeting of the European Group for Blood and Marrow Transplantation in Geneva, Switzerland.
For the six-month period ended June 30, 2012, compared to the six-month period ended June 30, 2011:
Product sales were EUR 13.68 million compared to EUR 10.80 million, recording an increase of EUR 2.88 million or 27%.
Defibrotide net sales through the named-patient and cost recovery programs amounted to EUR 11.35 million compared to EUR 8.23 million, recording an increase of EUR 3.12 million or 38%. Sales of the Company's active pharmaceutical ingredients (API) amounted to EUR 2.33 million compared to EUR 2.56 million, a decrease of EUR 0.23 million or 9%.
Total revenues were EUR 14.17 million compared to EUR 12.77 million.
Operating costs and expenses were EUR 14.02 million compared to EUR 9.69 million. Research and development expenses, which are included in operating costs and expenses, were EUR 5.01 million compared to EUR 2.66 million.
Sales and marketing expenses, which are also included in operating costs and expenses were EUR 2.70 million compared to EUR 0.78 million.
Operating income was EUR 0.14 million compared to EUR 3.08 million.
Net income/(loss) was EUR (0.09) million compared to EUR 2.67 million.
Basic and diluted net income/(loss) per share was EUR (0.01) compared to a basic and diluted net income per share of EUR 0.18 and EUR 0.17, respectively.
For the second quarter ended June 30, 2012, as compared to the second quarter ended June 30, 2011:
Product sales were EUR 8.02 million compared to EUR 5.71 million, recording an increase of EUR 2.31 million or 40%. Defibrotide net sales through the named-patient and cost recovery programs were EUR 6.42 million compared to EUR 4.37 million, recording an increase of EUR 2.05 or 47%. Sales of the Company's API amounted to EUR 1.61 million compared to EUR 1.33 million, an increase of EUR 0.28 million or 21%.
Total revenues were EUR 8.51 million, compared with EUR 6.72 million.
Operating costs and expenses were EUR 7.72 million, compared with EUR 5.52 million. Research and development expenses, which are included in operating costs and expenses, were EUR 2.84 million, compared with EUR 1.43 million.
Sales and marketing expenses, which are also included in operating costs and expenses, were EUR 1.49 million compared to EUR 0.53 million
Operating income was EUR 0.79 million, compared with EUR 1.20 million.
Net income was EUR 0.82 million, compared with EUR 0.97 million.
Basic and diluted net income per share were EUR 0.05, compared to a basic and diluted net income per share of EUR 0.07 and EUR 0.06, respectively.
Cash and cash equivalents were EUR 10.32 million as of June 30, 2012 compared to EUR 9.99 million at December 31, 2011.