EX-99.1 2 btc051109exh991.htm EXHIBIT 99.1 BioSpecifics Technologies Corp: Exhibit 99.1 - Prepared by TNT Filings Inc.

Exhibit 99.1

BioSpecifics Technologies Corp. Reports First Quarter 2009 Financial Results

LYNBROOK, N.Y. – May 11, 2009 - BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the first quarter ended March 31, 2009.

"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 August 2009, when we hope that physicians and patients will have access to this drug candidate," remarked Thomas Wegman, President of BioSpecifics Technologies Corp. "We are delighted that XIAFLEX(TM) is advancing through the clinic, and so far this year we have secured milestone payments from Auxilium as a result of the European marketing agreement with Pfizer as well as the BLA Priority Review acceptance for Dupuytren's disease."

The Company reported a net loss of $946 thousand for the quarter ended March 31, 2009, or $(0.16) per diluted common share, compared to a net loss of $464 thousand, or $(0.08) per diluted common share, for the same period in 2008.

Revenue for the quarter ended March 31, 2009 was $343 thousand, compared to $401 thousand for the same period in 2008. The decrease in revenue was mainly due to an Auxilium consulting agreement signed in October 2007 which terminated during the second quarter of 2008.

Research and development expenses for the quarter ended March 31, 2009 were $116 thousand, compared to $94 thousand for the same period in 2008.

General and administrative expenses for the quarter ended March 31, 2009 totaled $1.2 million, compared to $0.8 million for the same period in 2008. The increases in general and administrative expenses were primarily due to higher stock-based compensation expense and outside consulting expense partially offset by lower legal fees.

As of March 31, 2009, BioSpecifics held cash, cash equivalents and short-term investments of $10.7 million, compared to $4.4 million as of December 31, 2008.

First Quarter and Recent Corporate Highlights

  • BioSpecifics' common stock began trading on the Nasdaq Global Market under the ticker BSTC on January 9, 2009.

  • On 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.

  • On February 3, 2009, BioSpecifics announced that it received an upfront sublicense payment of $6.375 million on January 30, 2009 from Auxilium as a result of its partnership agreement with Pfizer to market XIAFLEX(TM) in 48 countries including Europe.

  • On 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, 2009 and 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 Europe and other territories.

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 the United States for Dupuytren's disease and Peyronie's disease and the ability of Pfizer to obtain regulatory approval of XIAFLEX(TM) in its territory for these same indications, which will determine the amount of milestone, royalty and sublicense income payments we may receive; the amount of earn out payments we may receive from DFB Biotech Inc. and its affiliates; whether Auxilium exercises its option under our license agreement for additional indications; the potential benefits of our existing license and development agreements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company's Form 10-K for the year ended December 31, 2008 and subsequent reports filed with the SEC. The Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.


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