BioSpecifics Technologies Corp. Reports First Quarter 2009 Financial Results
“The FDA’s recent acceptance of Auxilium’s Biologic License Application (BLA) for XIAFLEX(TM) with Priority Review for Dupuytren’s disease represents the culmination of many years of successful clinical development and we are very much looking forward to the PDUFA date in
The Company reported a net loss of
Revenue for the quarter ended
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
First Quarter and Recent Corporate Highlights
- BioSpecifics’ common stock began trading on the Nasdaq Global Market under the ticker BSTC on
January 9, 2009.
February 2, 2009, Auxilium announced the completion of enrollment in a randomized, double-blind, placebo-controlled U.S. Phase IIb clinical trial for XIAFLEX(TM) for Peyronie’s disease. Over 120 patients were enrolled, and all dosing was completed on April 30, 2009. Top-line results from the study are expected to be reported in the fourth quarter of 2009.
February 3, 2009, BioSpecifics announced that it received an upfront sublicense payment of $6.375 millionon January 30, 2009from Auxilium as a result of its partnership agreement with Pfizer to market XIAFLEX(TM) in 48 countries including Europe.
April 28, 2009, the FDA accepted for Priority Review Auxilium’s BLA for XIAFLEX(TM) for the treatment of Dupuytren’s disease. Auxilium filed the BLA on February 27, 2009and included data from 1,082 subjects and over 2,600 injections. The Prescription Drug User Fee Act (PDUFA) date has been set for August 28, 2009. If approved by the FDA, Auxilium plans to launch in the U.S. within 60 days, which would be the end of the calendar year.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for three clinical indications: Dupuytren’s disease; Peyronie’s disease; and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium Pharmaceuticals, Inc. has announced the acceptance of the Biologic License Application (BLA) and Priority Review by the U.S. Food and Drug Administration for injectable collagenase XIAFLEX(TM) in the treatment of Dupuytren’s disease. Pfizer, Inc. is responsible for commercialization of XIAFLEX(TM) in
More information about the Company may be found on its website at www.biospecifics.com.
Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any 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, our expected revenue growth, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the ability of our partner Auxilium to obtain regulatory approval of XIAFLEX(TM) in
BioSpecifics Technologies Corp. Consolidated Statements of Operations (Unaudited) Three months ended March 31, 2009 2008 Revenues: Net sales $7,191 $12,753 Licensing fees 266,281 266,281 Consulting fees 70,000 122,185 Total revenues 343,472 401,219 Costs and expenses: Research and development 115,871 94,271 General and administrative 1,166,971 800,456 Total cost and expenses 1,282,842 894,727 Operating loss (939,370) (493,508) Other expense (income): Investment Income 2,857 30,275 Interest expense - (451) Other income (expense) (9,463) - (6,606) 29,824 Loss before income tax (945,976) (463,684) Income tax expense - - Net loss $(945,976) $(463,684) Basic and diluted net loss per share $(0.16) $(0.08) Shares used in computation of basic and diluted net loss per share 6,008,834 5,633,177 BioSpecifics Technologies Corp. Selected Consolidated Balance Sheet Data (Unaudited) March 31, 2009 December 31, 2008 Cash and cash equivalents $10,741,213 $3,494,150 Short-term investments - 900,000 Accounts receivable, net 66,834 6,952,781 Working capital 8,801,546 9,422,245 Total assets 12,314,812 12,831,361 Long-term liabilities 4,574,337 4,660,427 Total stockholders' equity 5,665,150 6,178,539
SOURCE BioSpecifics Technologies Corp.