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Gentium S.p.A. (GENT)
Q2 2013 Earnings Call
August 13, 2013 7:00 AM ET
Khalid Islam – Chairman and CEO
Salvatore Calabrese – CFO and SVP, Finance
Adrian Haigh – SVP, Commercial Operations
Gene Mack – Brean Murray Carret & Co
David Nierengarten – Wedbush
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These statements involve known and unknown risks uncertainties and other factors including those described in the risk factors sections of the company’s Form 20-F for related fiscal year that may cause our actual results performance or achievements including with respect to any financial forecast or the possibility of any future regulatory approval, to be materially different from the results performances or achievements expressed or implied by the forward-looking statements.
Given these uncertainties, you should not place any reliance on these forward-looking statements. At this time, all participants are in a listen-only mode. There will be a presentation followed by a question and answer session. (Operator Instructions) I must advise you that this conference is being recorded today, on Tuesday the 13th of August 2013.
I would now like to hand the conference over to your speaker today, Dr. Islam, CEO and Chairman of the Board. Please go ahead.
Thank you Josephine. Ladies and gentlemen, good morning to those joining us from the US and good afternoon to those joining us from Europe. It is my great pleasure on behalf of Gentium to welcome to you to Gentium’s half year 2013 financial and operating results conference call.
Joining me on the call today is our Chief Financial Officer, Mr. Sal Calabrese, and our Head of Commercial, Mr. Adrian Haigh. The agenda for the call is as follows: I will first touch on some of the regulatory activities in 2013 and will then hand over to Sal to go through the detailed financial information. We’ll then hold the Q&A session to address any questions you may have.
As you are all aware which was the end of the first quarter of this year, we informed on a negative opinion expressed by the Committee for Human Medical Products CHMP of the European Medicine Agency EMA for Defibrotide for the prevention and treatment of veno-occlusive disease.
In April, we have appealed against this issue and following the next scientific group meeting and an oral explanation meeting with the CHMP we’re delighted that the CHMP expressed an opinion recommending a marketing authorization for Defibrotide for the treatment of severe VOD.
First of all, let me say what pleases all the most is that finally there will be an approved drug available for patients with VOD. When approved, Defibrotide will be a life-saving drug and the first ever drug approved for the treatment of severe VOD which as you all know, carries an unacceptable mortality.
Second of all, we are pleased that we have a positive opinion and this has been quite a turnaround, during this year, there have been six appeals against CHMP decisions and Defibrotide has been the only successful appeal with around 23 24 of the 28 countries working in favor of a positive opinion.
And finally, we are pleased that when approved, we’ll have the possibility to market the drug through our expert commercial teams.
I would also like to take a few minutes and explain the European Regulatory process as our – drug approval, the positive recommendation from the CHMP for an exceptional approval we now go to the EU Commission for ratification. This process takes around two to three months, so but expect that we have approval at the earliest at the end of September and probably early October.
This is an orphan disease and the regulatory procedure is a centralized procedure which means whether a marketing authorization is issued, Defibrotide is approved and the same time, for all of the EU member states and all the 28 European countries.
Once approved, our commercial team will commence to undertake pricing and reimbursement discussions in each country and unfortunately, this is not a centralized procedure, but each country has its own rules and regulations.
So one of the EU states are rapid and some take longer. For example, the German regulations will allow us to price the drug in market and a discussion with the German authorities might be required the following year, if the sales exceed a certain threshold which actually €Germany’s 50 million in Germany only.
In other countries, these regulations will vary and our team has prepared to help the CAs to start approaching the first countries in preparation of launch upon approval. So a commercial launch can only be expected to take place towards the end of Q3 2013 at the earliest.
What else is happening on the Defibrotide front? We have also been progressing on the remediation plan for the issues raised by the USFDA for a new drug application or an NDA. We have maintained the dialogue with the USFDA and continuing to work closely with them to address the issues.
We expect to file our remediate dataset in a new NDA and continue to aim for the end of 2013 for filing. We are also expecting to have results available in the coming quarter from the investigator at Phase I Pharmacokinetic study in Japan.