Biospecifics Technologies reports Q2 2009 financials

Aug 12 2009

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the second quarter ended June 30, 2009.

"We were very pleased to report in April that the FDA accepted Auxilium's BLA with Priority Review for XIAFLEX(TM) for the treatment of Dupuytren's disease and we are looking forward to the Arthritis Advisory Committee review of XIAFLEX(TM) on September 16," stated Thomas L. Wegman, President of BioSpecifics Technologies Corp. "Clinical trials have demonstrated the potential of XIAFLEX(TM) in a number of important therapeutic indications and we look forward to providing updates for this promising product."

The Company reported a net loss of $0.1 million for the second quarter ended June 30, 2009, or $0.01 per basic and diluted common share, compared to a net loss of $0.8 million, or $0.14 per basic and diluted common share, for the same period in 2008.

Revenue for the second quarter ended June 30, 2009 was $1.2 million, compared to $0.4 million for the same period in 2008. The increase in revenue was due to a milestone payment received and recognized from Auxilium Pharmaceuticals, Inc. and earn-out royalties from the sales of topical collagenase under the earn out payment provision of the Asset Purchase Agreement after certain net sales levels were achieved by DFB Biotech, Inc. and its affiliates.

Research and development expenses for the second quarter ended June 30, 2009 and 2008 were approximately $0.1 million in each respective quarter. Research and development expenses include employee related expenses, costs of materials, lab expense, facility costs and overhead.

General and administrative expenses for the second quarter ended June 30, 2009 totaled $1.1 million, compared to $1.2 million for the same period in 2008. The decrease in general and administrative expenses was primarily due to employee stock-based compensation costs and lower legal fees partially offset by outside consulting services.

As of June 30, 2009, BioSpecifics held cash and cash equivalents of $9.3 million, compared to $10.7 million on March 31, 2009.

Second Quarter Corporate Highlights

• On April 28, 2009, the FDA accepted for Priority Review Auxilium's BLA for XIAFLEX(TM) for the treatment of Dupuytren's disease. The drug candidate will be reviewed by the Arthritis Advisory Committee, the advisory committee to the FDA's Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), at a meeting scheduled to take place on September 16, 2009 at the Holiday Inn in Gaithersburg, MD. If XIAFLEX(TM) is approved by the FDA, Auxilium plans to launch in the U.S. within 60 days.
• On June 29, 2009, BioSpecifics announced that it was added to the Russell 3000((R)) and Russell 2000 Indexes. The Russell 3000 Index measures the performance of the largest 3000 U.S. companies representing approximately 98% of the investable U.S. equity market. The Russell 2000 Index measures the performance of the small-cap segment of the U.S. equity universe. The Russell 2000 Index is a subset of the Russell 3000 Index representing approximately 8% of the total market capitalization of that index. It includes approximately 2,000 of the smallest securities based on a combination of their market cap and current index membership.