BioSpecifics Technologies Corp. Reports First Quarter 2009 Financial Results
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LYNBROOK, N.Y., May 11 /PRNewswire-FirstCall/ -- 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
SOURCE BioSpecifics Technologies Corp.
Thomas Wegman, +1-516-593-7000, thomas_wegman@biospecifics.com
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