Flamel Technologies CEO Discusses Q4 2010 Results - Earnings Call Transcript

Flamel Technologies S.A. (FLML)

Q4 2010 Earnings Conference Call

March 4, 2011, 8:30 am ET

Executives

Stephen Willard – CEO

Siân Crouzet – Principal Financial Officer

Analysts

Matt Kaplan – Ladenburg

David Moskowitz – Madison Williams Investment Company

Peter Butler – Glen Hill Investments

Peter Lux [ph]

Presentation

Operator

Good morning, ladies and gentlemen, and welcome to the Flamel Technologies announces fourth quarter and 2010 annual results call. Today’s call is being recorded. After prepared remarks, we will be opening the call to a Q&A period. As a reminder, today’s call is being recorded. It is now pleasure to turn the call over to Mr. Stephen Willard, CEO. Please go ahead, Mr. Willard.

Stephen Willard

Thank you very much, Mark. And good morning, ladies and gentlemen. We open, as always, with the forward-looking statement language, which is set out at the conclusion of today’s press release. All statements made on this call are subject to a variety of future events and risk factors, including those set forth in our filings with the SEC, particularly our Form 20-F, which are all publicly available. Please review them, as they are directly applicable to every element of this call.

2010 was a solid year for Flamel. We have advanced our projects in development with partners. The most important of these programs continues to be the long-acting beta interferon project that we are undertaking with Merck Serono. In the fourth quarter, we announced receipt of two payments totaling 4 million euros; the first related to our first clinical milestone for the development program and the second payment with respect to a technical achievement that we made at Merck Serono’s request.

We are pleased with the progress that we have made on this program and believe that we are creating substantial value, both on a standalone basis but also with respect to the validation that our success with beta interferon can bring to the entire Medusa platform.

We did fall short on our expectation of delivering two new license agreements in 2010, and I’m well aware of the disappointment felt by us all. This expectation was based on the nature of discussions that were underway at the time of our last conference call. Those discussions have obviously proceeded more slowly than we anticipated due to a variety of factors.

I should emphasize that these discussions are still ongoing, as we mentioned it in the press release issued yesterday. Throughout all our current discussions, we are mindful that the best agreements are not concluded at the highest price. Our focus is to arrive at terms that fairly reflect the value created for each individual program and partner, while bearing in mind that we have a portfolio of opportunities that we are developing, of which we deserve to be fairly compensated. We’ve been scrupulous in balancing these considerations. We strongly believe in the work that we are doing and that we will arrive at mutually beneficial terms that fairly reflect the value that we are creating for our partners.

One of our successes in 2010 was that we advanced the technology of our two intellectual property platforms in some very key ways. In addition to the clinically proven improvements in efficacy and safety that Medusa has already demonstrated, we now have data that demonstrate the improvements the platform delivers with respect to important additional issues.

Specifically, we have shown that Medusa, one, prevents protein aggregation; two, substantially enhances the solubility of insoluble or purely soluble drugs; and three, we can increase the stability of fragile proteins in peptides, which is very important for the pharmaceutical industry. As always, we are able to achieve these improvements without chemically or otherwise altering the molecules, which we believe lowers the risk associated with the programs that we are developing with our partners.

With respect to Micropump, we now have clinical results that show we are able to control and extend the release of small molecules and a long acting liquid formulation, as well as our previous success with tablets and capsules. We believe that this technology is applicable across a wide spectrum that covers both over-the-counter and prescription drugs. We are working actively to license Micropump in these areas.

This is the time of the call that I would normally turn it over to Siân for the financial portion of our prepared remarks. For obvious reasons, I will be picking up her role after she says a word or two.

Siân Crouzet

Good morning. As Steve has said, I think for obvious reasons that (inaudible) Steve to present the financial results today that I would normally have presented in other cases.

Stephen Willard

I’m very grateful that I have Siân here with me despite significant case of something or other. But I’m always grateful for her, both on these calls and day-to-day as we work together at Flamel.

Regarding our financial results, our fourth quarter profitability was a function of our success in working to develop the long-acting beta interferon product with Merck Serono as well as our ongoing commitment to tightly controlling costs. During the fourth quarter, our revenues grew to $13.5 million. Our license and research revenues of $8.8 million included the milestones from Merck Serono, as previously mentioned.

For the year 2010, license and research revenues were $19.7 million, representing more than 50% of our total revenues of $37.1 million and maintaining the trend from 2009. In the last quarter of 2010, royalty income grew from $1.7 million to $2.4 million. Coreg CR continues to enjoy exclusivity without generic competition. Sales have stabilized over 2010, generating a relative stability in our annual royalty revenue.

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