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BioSpecifics Technologies Corporation (BSTC)
Q2 2013 Earnings Call
August 8, 2013 8:30 AM ET
Beth DelGiacco – IR
Tom Wegman – President
Ram Selvaraju – Aegis Capital
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Good morning, everyone, and welcome to today’s call. I hope you’ve had a chance to review our second quarter 2013 financial results press release which was issued earlier this morning. On the call today to discuss these results is Tom Wegman, the President of BioSpecifics. He also has with him (Pat Caldwell). Tom 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 are forward-including statements.
The forward-looking statements include statements concerning among other things the timing of initiating new clinical trials, reporting top line data from clinical trials and the success of clinical trials. The market opportunity for various indications, the potential for the XIAFLEX label to be expanded in the Dupuytren’s contracture indication. the expectation of XIAFLEX to be the first and only biologic therapy indicated for the treatment of Peyronie’s Disease is approval by the FDA and the potential commercial launch and an indication. 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 ability of Auxilium and its partners to achieve their objectives for XIAFLEX. The market for XIAFLEX in and initiation and outcome of clinical trials for additional indications. 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 its quarterly report for the quarter ended March 31, 2013 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. XIAFLEX made significant advances during the second quarter broadening its due to commercial reach into new overseas markets and making steady progress in clinical research to expand the current use of XIAFLEX at a potentially developed new indications. Most recently our partner Auxilium announced the promising long-term collaboration with Swedish Orphan Biovitrum or Sobi for the development, supply and commercialization of XIAPEX in 71 Eurasian and African countries for the treatment of Dupuytren’s contracture and Peyronie’s disease.
We are pleased with this strategic partnership and look forward to XIAPEX continuing to grow to new markets and reach patient suffering from Dupuytren’s and potentially Peyronie’s disease as well. And as far as the development pipeline Auxilium continues to try progress in cellulite and frozen shoulder and expects to initiate a Phase II trial for cellulite in the third quarter of 2013 and next stage trials for frozen shoulder in the fourth quarter of 2013.
Earlier in the quarter we announced progress in our own proprietary XIAFLEX development platform with the completed enrollment in the Phase II canine lipoma trial, Chien-804 with enrollment also completes for the Phase II trial for the treatment of human lipoma we planned to report top line data for both Chien-804 and the human lipoma Phase II trial by the end of 2013.
We will update you on the next milestones for both the BioSpecifics led programs and the Auxilium programs later in the call as well as further described the Sobi collaboration. We will also update you on the U.S commercial highlights from the second quarter for Dupuytren’s contracture and the upcoming landmark on FDAs decision on the approval of the supplemental Biologics License Application for Peyronie’s disease.
Before turning to these milestones in more detail I want to touch on exciting preclinical research that we are supporting in the women’s health field. Last month we announced that a poster titled Biomechanical Evaluation of Human Uterine Fibroids after Exposure to Purified Clostridial Collagenase was presented at the Society for the Study of Reproduction 46th Annual Meeting that took place in Montreal at the end of July.
The poster provided data which show that highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. Increase tissue rigidity has been implicated as a course of the morbidity associated with uterine fibroid. We believe the Collagenase therapy may potentially break the cycle of mechanical transaction and abnormally decrease cell apoptosis associated with the uterine fibroids.