BioSpecifics Technologies revenues increases by 100% for the third quarter ended September 30, 2009

Nov 6 2009

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

"We were extremely happy that, in September of this year, the FDA's Arthritis Advisory Committee unanimously recommended, by a vote of 12-0, the approval of XIAFLEX(TM) for the treatment of Dupuytren's disease, and we are eagerly awaiting a response on the Biologics License Application that was submitted by our partner, Auxilium," stated Thomas L. Wegman, President of BioSpecifics. "We also look forward to the Phase IIb results testing XIAFLEX in Peyronie's disease, which Auxilium expects to report in December."

"I am very pleased that for the nine months ended September 30, 2009, as compared to the nine months ended September 30, 2008, Company revenues increased by 100% and, during the same period, the Company's net loss decreased," continued Mr. Wegman.

Three Months Ended September 30, 2009 and 2008

The Company reported a net loss of $0.4 million for the third quarter ended September 30, 2009, or ($0.06) per basic and diluted common share, compared to a net loss of $0.2 million, or ($0.04) per basic and diluted common share, for the same period in 2008.

Revenue for the third quarter ended September 30, 2009 was $0.8 million, compared to $0.3 million for the same period in 2008. The increase in revenue was due to earn-out payments triggered by certain net sales levels of topical collagenase under the earn-out payment provision of the Company's Asset Purchase Agreement with DFB Biotech, Inc.

Research and development expenses for the third quarter ended September 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 expenses, facility costs and overhead.

General and administrative expenses for the third quarter ended September 30, 2009 totaled $1.2 million, compared to $0.9 million for the same period in 2008. The increase in general and administrative expenses was primarily due to outside consulting expenses, directors' fees, legal fees and the Company incurring certain facility costs which were previously reimbursable under its Transition Services Agreement with DFB Biotech, which expired in October 2008.

As of September 30, 2009, the Company held cash, cash equivalents and short-term investments of $9.3 million.

Nine Months Ended September 30, 2009 and 2008

The Company reported a net loss of $1.4 million for the nine months ended September 30, 2009, or ($0.23) per basic and diluted common share, compared to a net loss of $1.5 million, or ($0.25) per basic and diluted common share, for the same period in 2008.

Revenue for the nine months ended September 30, 2009 was $2.4 million, compared to $1.2 million for the same period in 2008. The increase in revenue was due to earn-out payments triggered by certain net sales levels of topical collagenase under the earn-out payment provision of the Company's Asset Purchase Agreement with DFB Biotech and a milestone payment received and recognized from Auxilium Pharmaceuticals, Inc.

Third Quarter Corporate Highlights

• In its September 3, 2009 edition, The New England Journal of Medicine published data from the pivotal CORD I Phase III clinical trial of XIAFLEX for the treatment of Dupuytren's disease, a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers, in an article entitled "Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture." The article describes the positive results observed in the largest, prospective, double blind, placebo controlled clinical trial ever conducted in the field of Dupuytren's contracture.

• On September 16, 2009, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended, by a vote of 12 to 0, that the FDA approve XIAFLEX for the treatment of Dupuytren's disease.