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BioSpecifics Second Quarter: Revenues $2.2 Million, Net Income $130,000, Dupuytren's Progress, Facilities Improvements

PRNewswire
LYNBROOK, N.Y.
Sep 19, 2001

BioSpecifics Technologies Corp. (NASDAQ: BSTC) reported revenues for the second quarter ended July 31, 2001 of $2.2 million versus $2.1 million a year ago. Net income was $130,000 or $.03 per share compared to $87,400 or $.02 per share a year ago. For the six months ended July 31, 2001, revenues were $5.0 million versus $3.5 million a year ago. Net income for the six months ended July 31, 2001 was $305,000 or $.07 per share versus $21,500 or $.01 per share a year ago.

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Higher revenues during the six months ended July 31, 2001 were the result of the timing of deliveries of BioSpecifics' Collagenase ABC enzyme to Abbott Laboratories (NYSE: ABT), which acquired Knoll Pharmaceutical Company earlier this year. BioSpecifics is delivering to Abbott Collagenase ABC enzyme, the active ingredient in the topical prescription drug Collagenase Santyl® Ointment, from inventory that was produced prior to the voluntary closure and renovation of production facilities, as this inventory completes the final stage of processing. At the beginning of the six months ended July 31, 2001, BioSpecifics' delivered some of this inventory to Abbott to fulfill an order that had originally been scheduled for delivery during the fourth quarter of the prior fiscal year, which ended January 31, 2001. During the six months ended July 31, 2001, royalty revenue increased to $1.2 million versus $928,000 in the year ago period. Looking out to the current fiscal third quarter that ends October 31, 2001, BioSpecifics does not expect to make deliveries to Abbott because none of this inventory in process will be completed by then. We may make deliveries to Abbott during the fiscal fourth quarter of the year ending January 31, 2002, although there can be no assurance that this inventory will be completed by then. BioSpecifics will continue to earn royalties from sales by Smith & Nephew of Santyl® Ointment during the third quarter that ends October 31, 2001.

Smith & Nephew, Inc. (NYSE: SNN) acquired the right to market BioSpecifics' Santyl® Ointment in January 2000. Abbott compounds Santyl® Ointment from our active ingredient, which it then sells to Smith & Nephew for marketing in the United States and Canada.

End of Phase 2 Conference with FDA for Treatment of Dupuytren's Disease

Research and development progress on injectable Collagenase ABC is on schedule. As previously announced, BioSpecifics successfully concluded Phase 2 for its drug Cordase™ for the treatment of Dupuytren's Disease. This product is also in Phase 2 studies for the treatment of adhesive capsulitis (frozen shoulder). In addition, long-term clinical results of collagenase treatment for Peyronie's disease are being analyzed and expanded trials are planned within the next year.

Early phase clinical studies are also underway for collagenase treatment of lipomas. While these developments are encouraging, there can be no assurance that the FDA will approve this injectable Collagenase ABC enzyme.

Production Facility Construction Completed

As previously announced, BioSpecifics has completed construction and commenced first stage production runs at its advanced biopharmaceutical manufacturing facility for production of Collagenase ABC. Full-scale production is taking place in stages. BioSpecifics must submit to the FDA documentation for approval of the facility and new Collagenase ABC inventory being produced at the facility, which is located in the Netherlands Antilles, before this new inventory can be released to Abbott for use as a pharmaceutical. There can be no assurance that FDA approval will be obtained, or that additional funds will not be necessary in order to obtain FDA approval.

Founded in 1990, BioSpecifics Technologies Corp. is a biopharmaceutical company with a focus on wound healing and tissue remodeling. It has pioneered the application of collagenase for several disease conditions, notably dermal ulcers, pressure sores (bedsores), and second and third degree burns. BioSpecifics produces Collagenase ABC, the essential ingredient in the prescription drug Collagenase Santyl® Ointment sold in the United States, and under other trademarks abroad.

BioSpecifics is also actively pursuing injectable applications of the enzyme for the treatment of a number of diseases. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity for wound healing are being pursued.

  Santyl® is a registered trademark of Abbott Laboratories (NYSE: ABT).

                      Visit BioSpecifics' website at
                       http://www.biospecifics.com
           its Dupuytren's Disease patient discussion forum at
                    http://www.biospecifics.com/forum/
          and its Peyronie's Disease patient discussion forum at
                 http://www.biospecifics.com/forum/index2

Forward-looking statements in this release involve a number of risks and uncertainties including, but not limited to, government regulation, the ability of the Company to complete the renovation at its manufacturing facilities and adequately address concerns of the FDA, product demand, pricing, market acceptance, changing economic conditions, risks in product and technology development, the effect of the Company's accounting policies, and other risk factors detailed in the Company's filings with the Securities and Exchange Commission.

             BioSpecifics Technologies Corp. and Subsidiaries
                          Results of Operations

                               (Unaudited)                 (Unaudited)
                            Three Months ended          Six Months ended
                                 July 31,                    July 31,
                            2001          2000         2001          2000

  Revenues            $2,159,000    $2,064,000   $4,951,000   $3,503,000,
  Income from
   operations            131,000       233,600      298,000       228,900

  Income before taxes    130,000        81,500      305,000        16,600
  Income tax
   benefit (Note)             --         5,900           --         5,900
  Net income            $130,000       $87,400     $305,000       $21,500

  Basic net income
   per share                $.03          $.02         $.07          $.01
  Diluted net income
   per share                $.03          $.02         $.07          $.01

  Weighted average
   common shares
    outstanding        4,534,000     4,529,800    4,532,000     4,529,800
  Weighted average
   dilutive potential
    common shares      4,645,700     4,557,700    4,601,100     4,586,100

  Cash & Investments  $1,529,000    $4,030,000   $1,529,000    $4,030,000
  R&D Expense            292,000       365,000      568,000       776,600

  Note: Primarily orphan drug tax credits.

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SOURCE: BioSpecifics Technologies Corp.

Contact: Albert Horcher of BioSpecifics Technologies Corp.,
+1-516-593-7000; or Deborah Duke Passik of William Dunk Partners,
+1-919-929-4100, for BioSpecifics Technologies Corp.

Website: http://www.biospecifics.com/