Flamel Technologies SA (NASDAQ:FLML) Q4 2014 Earnings Conference Call - Final Transcript

Mar 19, 2015 • 10:00 am ET


Flamel Technologies SA (NASDAQ:FLML) Q4 2014 Earnings Conference Call - Final Transcript


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Good morning, ladies and gentlemen and welcome to the Flamel Technologies Fourth Quarter 2014 Results Conference Call. Please note that this call is being recorded. Now, I'd like to turn the call over to Mr. Bob Yedid of Investor Relations. Please go ahead, sir.

Bob Yedid

Good morning and welcome to the Flamel Technologies fourth quarter 2014 conference call. This is Bob Yedid of ICR Investor Relations. Before we begin, I will start with some cautionary statements. (Forward-Looking Cautionary Statement). After the prepared remarks, we will be opening the call to a question-and-answer period.

At this time, it's my pleasure to turn the conference over to Mike Anderson, Chief Executive Officer of Flamel Technologies. Mike?

Mike Anderson

Good morning, ladies and gentlemen. Thank you very much for joining us today. I'm excited about our company and pleased to report that Flamel has made significant progress in a number of commercial and pipeline areas.

In just over one year, we have launched Bloxiverz and Vazculep, presented positive clinical data for Micropump Sodium Oxybate, LiquiTime Ibuprofen and Medusa Exenatide, divested our contract manufacturing facility, so that we can focus on proprietary product development and successfully move our intangibles assets, including intellectual property and other assets to our Irish entity as part of a global reorganization after having established operations in Ireland in 2014.

I'll focus my remarks on a number of topics today, including Bloxiverz sales and developments in the neostigmine market, Vazculep's continued success and market share gains post-launch, progress of our pipeline of proprietary products, including Micropump Sodium Oxybate and LiquiTime Ibuprofen, and the status of our other proprietary drugs in our pipeline. After my remarks, Sian Crouzet, our Principal Financial Officer will discuss our fourth quarter financials.

We are excited that during the fourth quarter Bloxiverz was able to continue gaining market share as manufactures of unapproved neostigmines were ordered by the FDA to cease manufacturing of their products as of July 30, 2014. By our estimates those unapproved products were exhausted in the channel in January and early February 2015. Flamel is pleased to report that we were supplying 100% of the market demand to wholesalers and GPOs by the end of February according to prescription data sources.

As you know, we increased our wholesale acquisition costs or WAC price for Bloxiverz from $35.80 to $98.75 in mid-January, and as of mid-February, we have been shipping at the increased contract price to all customers. Despite the anticipated entrance of another branded competitor in the neostigmine market in the second quarter, our price action will allow Flamel and its shareholders to enjoy and earn an attractive return on our substantial investment in Bloxiverz.

The investments included the cost of preparing and submitting the NDA filing, obtaining FDA approval, fulfilling our post-marketing commitments to the agency and building substantial inventories of Bloxiverz to demonstrate to the FDA that Flamel was capable of supplying 100% of the markets need. This was done to persuade the agency to take regulatory action against unapproved manufacturers as per its