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BioSpecifics Technologies Corp. (BSTC)
Q1 2013 Earnings Call
May 10, 2013 08:30 am ET
Tom Wegman – President
[Beth Dejoco] – Stern Investor Relations
[Wi Chen] – Aegis Capital
Nathan Jorgensen – Stifel Nicolaus
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Good afternoon, everyone, and welcome to today’s call. I hope you’ve had a chance to review our Q1 2013 financial results press release which was issued earlier today. On the call today to discuss these results is Tom Wegman, the President of BioSpecifics. He will provide you with a corporate update and a financial summary for the quarter. After that we will open the call for your questions.
Before we begin let me remind you that during today’s call BioSpecifics will make forward-looking statements within the meaning of and made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact including statements regarding our strategy; future operations; future financial position; future revenues; projected costs; prospects; plans and objectives of management; expected revenue growth; and the assumptions underlying or relating to such statements are forward-looking statements.
The forward-looking statements include statements concerning among other things the timing of reporting top line data from BioSpecifics Phase II clinical trial of XIAFLEX for the treatment of human lipoma and its Phase II trial for the treatment of canine lipoma; the market opportunity for various indications; the timing for Auxilium to initiate a Phase II trial of XIAFLEX in the treatment for cellulite and a new clinical trial of XIAFLEX as a treatment for frozen shoulder; the timing of making XIAFLEX available in Canada as a treatment for Dupuytren’s contracture; the potential for XIAFLEX growth in the Dupuytren’s contracture indication and Auxilium’s ability to gain market share; the potential (inaudible) Auxilium to seek from the FDA a XIAFLEX label expansion for the concurrent treatment of multiple palpable cords in adult Dupuytren’s contracture patients; the expectation of XIAFLEX to be the first and only biologic therapy indicated for the treatment of Peyronie’s Disease; and the timing of the review and potential approval by the FDA of XIAFLEX as a treatment for Peyronie’s Disease and its potential commercial launch.
In some cases these statements can be identified by forward-looking words such as “believe,” “expect,” “anticipate,” “plan,” “estimate,” “likely,” “may,” “will,” “could,” “continue,” “project,” “predict,” “goal,” the negative or plural of these words and other similar expressions. These forward-looking statements are predictions based on BioSpecifics’ current expectations and its projections about future events.
There are a number of important factors that could cause BioSpecifics’ actual results to differ materially from those indicated by such forward-looking statements including the timing of regulatory filings and actions; the ability of Auxilium and its partners Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals to achieve their objectives for XIAFLEX in the applicable territories; the market for XIAFLEX in and initiation and outcome of clinical trials for additional indications including frozen shoulder, cellulite, human lipoma and canine lipoma, all of which will determine the amount of milestone royalty and sub-license income BioSpecifics may receive; the potential of XIAFLEX to be used in additional indications; the timing of results of any clinical trials; the receipt of any applicable milestone payments from Auxilium or the royalty payments BioSpecifics is entitled to receive will exceed set off; and other risk factors set forth in BioSpecifics’ Annual Report on Form 10(k) for the year ended December 31, 2012, and its current report on Form 8(k) filed with the Securities and Exchange Commission.
All forward-looking statements made on this call are made as of the date hereof and BioSpecifics assumes no obligation to update these forward-looking statements. I will now turn the call over to Tom.
Thank you Beth, and good morning everyone. So far 2013 has been a very productive year for us as we’ve reached several milestones in advancing our pipeline into new and promising clinical indications. We completed enrollment in the human and canine lipoma trials and plan to report top line data from both of these trials in the second half of 2013.
Additionally, during Q1 Auxilium announced positive top line data from the Phase IIa trial from XIAFLEX in frozen shoulder syndrome. Finally, Auxilium opted into its right to develop XIAFLEX in cellulite and we received a license fee payment of $500,000 in January, 2013.
In addition to the developments we’ve seen in these new indications we continued to benefit from XIAFLEX sales for Dupuytren’s contracture. Let me begin by providing more detail on the recent advances in the XIAFLEX pipeline.
As I mentioned, our own proprietary XIAFLEX development pipeline involving human and canine lipomas reached important milestones this quarter. We are pleased to have completed enrollment in the canine lipoma trial. The placebo controlled randomized Phase II trial Chien-804 will evaluate the relative change from baseline of lipoma volume three months post injection in 32 canines with benign subcutaneous lipomas randomized 1:1 XIAFLEX to placebo. Canine lipomas are encapsulated fat deposits that occur under the skin and affect an estimated 1.7 million dogs in the United States.
Additionally, in March we completed enrollment of the 14 patient single-center dose escalation Phase II clinical trial of XIAFLEX for the treatment of human lipoma. The primary efficacy endpoint of the study is a change in the visible surface area of the target lipoma as determined at six months post injection. Approximately 1% of the general human population has a lipoma and they typically occur in people from 40 to 60 years of age.