Gentium Reports Fourth Quarter and Year End 2011 Financial Results

Defibrotide usage increased by 28% to EUR 16.89 million (US$ 21.91 million) Total product sales of EUR 21.73 million (US$ 28.19 million) Net income of EUR 2.71 million (US$ 3.52 million) Cash flow positive and stronger cash position

VILLA GUARDIA (COMO), Italy, March 27, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT - News) (the "Company") today reported financial results for the quarter and year ended December 31, 2011. 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, 2011, EUR 1.00 = $1.2973.

"We are pleased to report that Defibrotide usage increased by 28% in 2011 when compared with 2010, and total product sales fell within our most recent range of guidance of EURO21-23 million ($27.2 -$29.8 million). We have been able to finance the establishment of our European commercial team, repay the current portion of our long-term debt and fund our working capital," stated Salvatore Calabrese, SVP Finance and Chief Financial Officer of Gentium S.p.A. "We ended 2011 with a net income of EURO2.71 million ($3.52 million), which was impacted by a tax reform that established a minimum corporate tax, expenses incurred in connection with the establishment of our commercialization infrastructure, and the termination of the ratable accounting of 2010 Sigma-Tau upfront payments. In 2011, the Company remained cash flow positive and strengthened our cash position. For 2012, we project revenues from product sales to be in the range of EURO22-EURO25 million ($29-$32 million)."

"The recent publication of the Defibrotide prevention study in The Lancet (vol 379) and the commentary on the outcome of the study as 'one that will hopefully change practice in pediatric patients and might also provide an impetus to investigate treatment options for adult patients' is very encouraging," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "We continue to see an increased usage of Defibrotide globally. Through our recently established license and distribution agreements with several specialized partners and our expanded commercial infrastructure, we are attending in a more timely manner to physician requests worldwide. We continue to explore opportunities for new partnerships that would enable us to provide Defibrotide in countries where the drug is currently unavailable. On the regulatory front, we have submitted our response to the Day 120 List of Questions (the "LoQs") issued by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), and will continue to work closely with the EMA on our marketing authorization application ("MAA") for Defibrotide in Europe. Additionally, we continue to work on our remediation plan to address the issues raised by the US Food and Drug Administration ("FDA") with respect to our New Drug Application ("NDA") for Defibrotide, and we are hopeful that we would be in a position to file a new NDA as early as 2012."

As previously announced, Gentium will host a conference call today (March 27 2012) at 8:00 a.m. ET / 2:00 p.m. CET to discuss the 2011 financial results and to provide a business update to interested parties. To participate in the call, please dial 1-866-966-9439 (US toll-free) or +44(0)1452-555-566 (international/toll) using the Conference ID 62307659. Participants must register ten minutes before the call is scheduled to begin.

The call will also be broadcast live on the internet at http://www.gentium.com and will be archived for replay for 30 days. The replay can be accessed on the Company's website, http://www.gentium.com or by calling 1-866-247-4222 (US toll-free) or +44(0)1452-550-000 (international/toll) using Conference ID 62307659.

2011 Corporate Highlights:

Financial Highlights

For the year ended December 31, 2011 compared to the year ended December 31, 2010:

In addition, cash and cash equivalents amounted to EUR 9.99 million as of December 31, 2011.

View post:
Gentium Reports Fourth Quarter and Year End 2011 Financial Results