Flamel Technologies SA ( FLML) Q3 2010 Earnings Call Transcript November 5, 2010 8:30 am ET Executives Stephen Willard – CEO Sian Crouzet – Principal Financial Officer Analysts Matt Kaplan – Ladenburg Thalmann David Moskowitz – Madison Williams Presentation Operator
We also announced last month that we have received a letter from the FDA in response to our Citizen's Petition that we submitted regarding Coreg CR. Our petition detailed our concerns that any generic formulation submitted for approval to the FDA be concerted according to the criteria applied to the submission of Coreg CR. We particularly focused on the demonstrated safety and efficacy of Coreg CR in the treatment of congestive heart failure patients. A copy of the FDA's letter is available on our website.We are very pleased with the portions of our Citizen's Petition which were granted and we believe that the FDA has taken a very serious and thoughtful approach to the issues we raised for the protection of patients taking potential generic copies of Coreg CR. As we have previously discussed, URL Pharmaceuticals filed an ANDA application for Coreg CR approximately two and a half years ago. To our knowledge, they are the only company that has filed an ANDA application for an extended release carvedilol phosphate formulation and they are the only company to have responded to the Citizen's Petition that we submitted to the FDA. To date, no approval from the FDA for any extended release carvedilol phosphate formulation has occurred. I would like to ask Sian Crouzet, our Principal Financial Officer, to review our third quarter financial results and then I will discuss the Merck Serono program and other ongoing work before we open the call for questions. Sian? Sian Crouzet Thank you, Steve. There are a couple of elements I would like to highlight in our third quarter results. Firstly, they do not include the two milestones we have recently achieved on the development program with Merck Serono. The first milestone of 3 million euros that was announced last month was paid this week. The second milestone of 1 million euros referred to in our press release last night is expected to be paid in the next month. Both of these events will impact our fourth-quarter earnings and cash position.
Now, in relation to our third quarter results, we have witnessed a drop in revenues, year on year. As discussed last quarter, we have advanced a number of projects and as a consequence work on these projects is correspondingly reduced while clinical trials are ongoing. That said, we are maintaining a steady pipeline of feasibility projects with different partners.Product sales and services relating to the production of Coreg CR micro particles were $1.8 million compared with $2.6 million in the third quarter of 2009. And other revenues, primarily royalties on the sales of Coreg CR were $2.1 million compared with $2.5 million in the year ago period. Our costs and expenses have declined during the third quarter from $13.2 million in 2009 to $11.2 million. The decline is across all three categories, as we maintain our commitment to strict cost control in light of reduced revenues. Production costs declined from $2.6 million to $1.5 million in the current period. R&D declined from $7.5 million to $6.7 million and SG&A from $3.1 million to $2.9 million. Net loss for the quarter was comparable with the third quarter of 2009, at $3.3 million and a net loss per share of $0.14. We finished the third quarter with cash and marketable securities of $32.1 million. And as mentioned at the outset, the two recently announced milestones from Merck Serono will impact our fourth quarter financial results. I will now turn the call back over to Steve. Stephen Willard Thank you very much, Sian. Obviously, we are especially pleased with the progress that we continue to make in our work with Merck Serono on an extended release formulation of beta interferon. Last night, we announced that we have achieved a second milestone during the fourth quarter. According to the terms agreed, we will receive 1 million for that milestone. And that's two milestones achieved with Merck Serono in the space of just one month. Read the rest of this transcript for free on seekingalpha.com