BioSpecifics Technologies Corp. Reports Fourth Quarter and Full Year 2012
LYNBROOK, N.Y., March 12, 2013
LYNBROOK, N.Y., March 12, 2013 /PRNewswire/ -- BioSpecifics Technologies Corp.
(NASDAQ: BSTC), a biopharmaceutical company developing first in class
collagenase-based products marketed as XIAFLEX^® in the U.S., today announced
its financial results for the fourth quarter and full year ended December 31,
2012 and provided a corporate update.
"We are looking forward to the potential FDA approval of XIAFLEX for the
treatment of Peyronie's disease followed by the anticipated commercial launch
in the fourth quarter of this year, and believe in the strong commercial
opportunity for XIAFLEX for this devastating disease," reflected Thomas L.
Wegman, President of BioSpecifics. "We are also very pleased to announce today
that we have completed enrollment in our Phase II clinical trial for XIAFLEX
for human lipoma ahead of schedule, and that we remain on track to complete
enrollment in our canine lipoma Phase II trial in the first half of 2013. We
plan to report top-line data for both trials in the second half of 2013. We
are also encouraged by the clinical progress Auxilium is making for XIAFLEX in
Dupuytren's contracture patients with multiple palpable cords, cellulite and
frozen shoulder. We anticipate reporting development progress for all of these
indications beginning later this year."
Fourth Quarter & Full Year 2012 Financial Results
BioSpecifics reported net income of $1.1 million for the fourth quarter ended
December 31, 2012, or $0.17 per basic share and $0.16 per share on a fully
diluted basis, compared to net income of $71,326, or $0.01 per basic and
diluted common share for the same period in 2011. For the full year ended
December 31, 2012, the Company reported net income of $3.0 million, or $0.47
per share on a basic and $0.43 per share on a fully diluted basis, compared to
net income of $6.6 million, or $1.04 per share on a basic and $0.95 on a fully
diluted basis in the same period in 2011.
Total revenue for the fourth quarter of 2012 was $3.5 million, compared to
$2.6 million for the same period in 2011. For the full year ended December 31,
2012, total revenue was $11.1 million, compared to $11.4 million in the same
period in 2011.
Royalty, mark-up on cost of goods sold, and earn-out revenues for the fourth
quarter of 2012 were $2.5 million, compared to $1.9 million for the same
period in 2011. Royalty and mark-up on cost of goods sold revenues recognized
under BioSpecifics' agreement with Auxilium Pharmaceuticals, Inc. (Auxilium)
for the fourth quarter of 2012 were $1.6 million, compared to $1.1 million for
the same period in 2011. Royalty revenues recognized from DFB Biotech, Inc.
for the fourth quarter of 2012 were $0.8 million compared to $0.7 million for
the same period in 2011. Total royalty, mark-up on cost of goods sold and
earn-out revenues for the year ended December 31, 2012 increased to $9.2
million as compared to $6.3 million in the same period in 2011.
Total licensing fees consisting of licensing and sublicensing fees and
milestones for the year ended December 31, 2012 were $2.0 million, compared to
$5.0 million in the same period in 2011. Licensing fees recognized from
Auxilium for the full year 2012 and 2011 were $0.4 million in each period.
These licensing fees related to cash payments received in prior years and
amortized over the expected development period. Sublicensing fees recognized
for the full year ended December 31, 2012 were $570,000 compared to $750,000
in the same period in 2011. 2012 sublicensing fees were related to the $10.0
million paid to Auxilium by Actelion Pharmaceuticals Ltd. (Actelion) for the
rights to develop and commercialize XIAFLEX for the treatment of Dupuytren's
contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico.
2011 sublicensing fees were related to the $15.0 million paid to Auxilium by
Asahi Kasei Pharma Corporation for the rights to commercialize XIAFLEX for the
treatment of Dupuytren's contracture and Peyronie's disease in Japan.
Milestone revenue recognized for the years ended December 31, 2012 and 2011
were $1.0 million and $3.8 million, respectively. In 2012, BioSpecifics
recognized a $1.0 million milestone related to the U.S. Food and Drug
Administration's (FDA) December 2012 acceptance of Auxilium's supplemental
Biologics License Application (sBLA) for XIAFLEX for the potential treatment
of Peyronie's disease. BioSpecifics also recognized a milestone of $28,500
related to the Notice of Compliance (approval) granted by Health Canada for
XIAFLEX for the treatment of Dupuytren's contracture for adult patients with a
palpable cord in Canada to Auxilium. In 2011, BioSpecifics recognized a $2.6
million milestone related to the first sale of XIAFLEX in Europe, a $637,500
milestone related to the first sale of XIAFLEX in Germany, and a $637,500
milestone related to the first sale of XIAFLEX in Spain.
Research and development expenses for the fourth quarters of 2012 and 2011
were $0.3 million in each period. For the year ended December 31, 2012,
research and development expenses were $1.2 million, compared to $1.0 million
in the same period in 2011. This increase in research and development expenses
was primarily due to expenses related to BioSpecifics' internally-managed
human and canine lipoma XIAFLEX clinical development programs.
General and administrative expenses for the fourth quarter of 2012 were $1.2
million, compared to $1.1 million for the same period in 2011. For the year
ended December 31, 2012, general and administrative expenses were $4.8
million, compared to $5.2 million in the same period in 2011. The decrease in
general and administrative expenses was due to lower stock based compensation
and general legal fees partially offset by third party royalty fees and
Income tax expenses for the fourth quarter of 2012 were $1.0 million as
compared to $1.2 million for the same period in 2011. For the year ended
December 31, 2012, income tax expense was $2.2 million as compared to an
income tax benefit of $1.3 million in the same period of 2011. In the 2011
period, the $1.3 million in income tax benefit consisted of an income tax
expense of $2.3 million which was offset by a one-time $3.6 million tax
benefit related to the Company's deferred tax asset valuation allowance and
the recording of the Company's deferred tax assets as BioSpecifics believes
that its tax assets are more likely than not to be realized as it achieved
sustained profitability on an on-going annual basis. In making such
determination, the Company considered all available positive and negative
evidence, including future reversals of existing taxable temporary
differences, projected future taxable income, tax planning strategies and
recent financial operations.
As of December 31, 2012, BioSpecifics had cash and cash equivalents and
investments of $8.5 million, compared to $9.0 million on September 30, 2012.
Recent Corporate Highlights:
oBioSpecifics reported today that it has completed enrollment for its 14
patient dose escalation Phase II clinical trial for the treatment of human
oAs reported by Auxilium on February 26, 2013, XIAFLEX U.S. revenue for the
fourth quarter of 2012 increased 30% over the fourth quarter of 2011 to
$17.5 million. For the year ended December 31, 2012, XIAFLEX U.S. revenue
increased 31% over the same period in 2011 to $55.2 million.
oOn February 4, 2013, The Journal of Urology electronically published the
uncorrected proof of the pivotal IMPRESS (The Investigation for Maximal
Peyronie's Reduction Efficacy and Safety Studies) trials. These Phase III
studies were conducted by Auxilium and assessed XIAFLEX for the treatment
of Peyronie's disease, an excess of inelastic collagen causing penile
curvature deformity, and demonstrated the significant therapeutic
opportunity of XIAFLEX for this indication.
oIn January 2013, Auxilium exercised its exclusive option under the Second
Amended and Restated Development and License Agreement, dated as of August
31, 2011, to expand the field of its license for injectable collagenase to
include the potential treatment of adult patients with edematous
fibrosclerotic panniculopathy, commonly known as cellulite. BioSpecifics
received a license fee payment of $500,000 in January 2013 in connection
with this exercise.
oIn December 2012, Auxilium's sBLA submission to the FDA for XIAFLEX for
the potential treatment of Peyronie's disease was accepted for filing.
BioSpecifics received a $1 million milestone payment from Auxilium in
January 2013 in connection with this acceptance by the FDA.
oIn June 2012, Auxilium announced positive top-line efficacy and safety
results of the IMPRESS studies' co-primary endpoints. In IMPRESS I and
IMPRESS II at 52 weeks, both co-primary endpoints met statistical
significance for mean percent improvement in penile curvature deformity
and mean improvement in the Peyronie's Disease Questionnaire bother domain
for XIAFLEX subjects vs. placebo patients. Additionally, XIAFLEX was
generally well-tolerated. If approved by the FDA, XIAFLEX is expected to
be the first and only biologic therapy indicated for the treatment of
oIn July 2012, Auxilium announced positive top-line data from the
open-label Phase IIIb clinical trial designed to assess the safety and
efficacy of concurrent administration of two injections of XIAFLEX into
the same hand of adult Dupuytren's contracture patients with multiple
palpable cords. In this study, 60 patients at eight sites throughout the
U.S. and Australia received two concurrent injections of 0.58 mg of
XIAFLEX per affected hand and efficacy was based on a single injection per
contracted joint. At 30 days, 60% of all joints, 76% of
metacarpophalangeal and 33% proximal interphalangeal joints achieved
clinical success (defined as joint correction to 0 to 5 degrees) following
this single injection when two 0.58 mg doses of XIAFLEX were administered
concurrently into the same hand.
Upcoming Anticipated Events:
oBioSpecifics' Clinical Indications for XIAFLEX:
oBioSpecifics plans to complete enrollment in its Phase II trial,
Chien-804, evaluating 32 canines with benign subcutaneous lipomas
randomized 1:1 XIAFLEX to placebo in the first half of 2013.
oThe Company expects to report top-line data from both its Phase II
clinical trial for the treatment of human lipoma and Chien-804 in the
second half of 2013.
oXIAFLEX for Dupuytren's Contracture:
oAuxilium anticipates that U.S. full year 2013 XIAFLEX net revenues
will be in the range of $65 to $75 million and ex-U.S. and deferred
revenues for XIAFLEX will be in the range of $10 to $15 million.
oAuxilium is currently conducting an open-label clinical trial
evaluating XIAFLEX for the concurrent treatment of multiple palpable
cords in approximately 600 adult patients with Dupuytren's
contracture in the U.S, Australia, New Zealand and the EU. This study
began enrollment in the third quarter of 2012 and top-line data are
expected in the first quarter of 2014. If successful, this study may
allow Auxilium to seek a XIAFLEX label expansion from the FDA for the
concurrent treatment of multiple palpable cords in adult Dupuytren's
oIn the third quarter of 2012, Auxilium completed enrollment in its
Phase IV Dupuytren's contracture retreatment clinical trial. Top-line
data from this study are expected in the fourth quarter of 2013.
oActelion, Auxilium's partner in Canada, plans to launch XIAFLEX in
Canada in the first half of 2013.
oAdditional Clinical Indications for XIAFLEX:
oUnder the Prescription Drug User Fee Act, the FDA is expected to take
action by September 6, 2013 on Auxilium's application for the U.S.
approval of XIAFLEX for the treatment of Peyronie's disease. If
approved, Auxilium plans to execute the commercial launch in the
fourth quarter of 2013 and submit a Marketing Authorisation
Application to the European Medicines Agency.
oAuxilium is also currently managing the clinical development of
XIAFLEX for the treatment of cellulite and frozen shoulder syndrome
(adhesive capsulitis). In the third quarter of 2012, Auxilium
completed enrollment in its cellulite Phase Ib and frozen shoulder
Phase IIa studies. Following positive top-line 30-day data from the
Phase Ib single site, open-label dose escalation study of XIAFLEX for
the potential treatment of cellulite that was reported in December
2012, Auxilium announced that it planned to initiate a Phase II
clinical trial in the second half of 2013. Top-line data from the
Phase IIa study of XIAFLEX for frozen shoulder are expected in the
first quarter of 2013, and Auxilium plans to initiate a Phase II
study in the second half of 2013.
Upcoming Annual Meeting:
oThe Company announced that its Board of Directors has scheduled the
Company's Annual Meeting of Stockholders to be held on June 19, 2013 in
New York City.
Webcast and Conference Call
BioSpecifics will host a conference call today at 4:30 p.m. EDT to discuss
these fourth quarter and full year 2012 results.
In order to participate in the conference call, please dial 1-800-860-2442
(domestic) or 1-412-858-4600 (international). The live webcast can be accessed
under "Calendar of Events" in the Investor Relations section of the Company's
website at www.biospecifics.com or you may use the link:
A replay of the call will be available one hour after the end of the
conference on March 12, 2013 until 9:00 a.m. EDT on March 27, 2013. To access
the replay, please dial 1-877-344-7529 (domestic) or 1-412-317-0088
(international) and reference the access code 10025434. The archived webcast
will be available for 90 days in the Investor Relations section of
BioSpecifics' website at www.biospecifics.com.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has
developed injectable collagenase for twelve clinical indications. Injectable
collagenase is currently marketed as XIAFLEX^® in the U.S. for the treatment
of adult Dupuytren's contracture patients with a palpable cord by Auxilium
Pharmaceuticals, Inc. (Auxilium) and is approved for Dupuytren's contracture
in the European Union, Switzerland and Canada. XIAFLEX is also in clinical
development for the treatment of several additional promising indications. A
supplemental Biologics License Application is currently under standard review
at the U.S. Food and Drug Administration for XIAFLEX for the treatment of
Peyronie's disease. Auxilium is also testing XIAFLEX for frozen shoulder
syndrome (adhesive capsulitis) and cellulite in Phase IIa and Phase Ib
clinical trials, respectively. BioSpecifics is currently managing the
development of XIAFLEX for two indications, human lipoma and canine lipoma
(Chien-804), both of which are in Phase Il clinical trials. Auxilium is
currently partnered with Asahi Kasei Pharma Corporation for the development
and commercialization of injectable collagenase for Dupuytren's contracture
and Peyronie's disease in Japan and with Actelion Pharmaceuticals Ltd. for the
same indications in Canada, Australia, Brazil and Mexico. Pfizer Inc. has
marketing rights to XIAPEX^® (the EU trade name for XIAFLEX) for Dupuytren's
contracture in 46 countries in Eurasia through April 24, 2013. For more
information, please visit www.biospecifics.com.
This release includes "forward-looking statements" within the meaning of, and
made pursuant to the safe harbor provisions of, the Private Securities
Litigation Reform Act of 1995. All statements other than statements of
historical fact are "forward-looking statements." The forward-looking
statements include statements concerning, among other things, the timing of
the review and potential approval by the FDA of XIAFLEX as a treatment for
Peyronie's disease; the timing of the potential US commercial launch and
submission of the MAA to the EMA with respect to the use of XIAFLEX for the
treatment of Peyronie's disease and its commercial potential; the development
progress of various indications and the extent to which these indications are
promising; the expectation of XIAFLEX to be the first and only biologic
therapy indicated for the treatment of Peyronie's disease; the timing of
completing enrollment in BioSpecifics' Phase II trial of XIAFLEX for the
treatment of canine lipoma; the timing of reporting top-line data from
BioSpecifics' Phase II trials of XIAFLEX for the treatment of human and canine
lipoma; the anticipated net revenues of XIAFLEX in respect of Dupuytren's
contracture-related sales; the timing of making XIAFLEX available in Canada as
a treatment for Dupuytren's contracture; the timing of results from Auxilium's
clinical trials for Dupuytren's contracture (release of top-line data for
contracture retreatment clinical trial and multi-cord trial) and frozen
shoulder; the potential for Auxilium to seek from the FDA a XIAFLEX label
expansion for the concurrent treatment of multiple palpable cords in adult
Dupuytren's contracture patients; the timing for Auxilium to initiate a phase
II trial of XIAFLEX as a treatment for cellulite; the timing for Auxilium to
initiate a Phase II trial of XIAFLEX as a treatment for frozen shoulder; and
the potential market for XIAFLEX as a treatment for various indications. In
some cases, these statements can be identified by forward-looking words such
as "believe," "expect," "anticipate," "plan," "estimate," "likely," "may,"
"will," "could," "continue," "project," "predict," "goal," the negative or
plural of these words, and other similar expressions. These forward-looking
statements are predictions based on BioSpecifics' current expectations and its
projections about future events. There are a number of important factors that
could cause BioSpecifics' actual results to differ materially from those
indicated by such forward-looking statements, including the timing of
regulatory filings and action; the ability of BioSpecifics' partner, Auxilium,
and its partners, Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals
Ltd., to achieve their objectives for XIAFLEX in their applicable territories;
the market for XIAFLEX in, and initiation and outcome of clinical trials for,
additional indications including frozen shoulder, cellulite, human lipoma and
canine lipoma, all of which will determine the amount of milestone, royalty
and sublicense income BioSpecifics may receive; the potential of XIAFLEX to be
used in additional indications; the timing of results of any clinical trials;
the receipt of any applicable milestone payments from Auxilium; whether
royalty payments BioSpecifics is entitled to receive will exceed set-offs; and
other risk factors identified in BioSpecifics' Annual Report on Form 10-K for
the year ended December 31, 2011, its Quarterly Reports on Form 10-Q for the
first, second and third quarters of 2012 and its Current Reports on Form 8-K
filed with the Securities and Exchange Commission. All forward-looking
statements included in this release are made as of the date hereof, and
BioSpecifics assumes no obligation to update these forward-looking statements.
BioSpecifics Technologies Corp.
Consolidated Statements of Operations
Three months ended Twelve months ended
December 31 December 31
2012 2011 2012 2011
Revenues: (Unaudited) (Audited)
Net sales $ $ 8,541 $ $
6,091 18,219 21,998
Royalties 2,457,299 1,853,276 9,155,654 6,314,959
Licensing revenue 1,044,881 746,775 1,971,205 5,012,102
Consulting fees - - - 46,667
Total Revenues 3,508,271 2,608,592 11,145,078 11,395,726
Costs and expenses:
Research and 302,636 265,063 1,249,755 972,078
General and 1,160,703 1,059,194 4,774,828 5,231,881
Total costs 1,463,339 1,324,257 6,024,583 6,203,959
Operating income 2,044,932 1,284,335 5,120,495 5,191,767
Interest Income 7,078 14,719 34,634 55,780
Other, net - 1,344 - 15,823
7,078 16,063 34,634 71,603
Income before income 2,052,010 1,300,398 5,155,129 5,263,370
Income tax benefit (951,054) (1,229,072) (2,174,054) 1,338,256
Net income $ 1,100,956 $ 71,326 $ $ 6,601,626
Basic net income per $ $ 0.01 $ $
share 0.17 0.47 1.04
Diluted net income per $ $ 0.01 $ $
share 0.16 0.43 0.95
Shares used in
computation of basic
net income per 6,381,665 6,350,770 6,351,245 6,340,648
Shares used in
computation of diluted
net income per 6,971,453 6,857,966 6,981,527 6,952,386
BioSpecifics Technologies Corp.
Selected Consolidated Balance Sheet Data
Cash and cash $ 3,383,737 $
Short term investments 5,120,000 5,000,000
Accounts and income 5,133,430 3,481,637
tax receivable, net
Deferred tax assets 1,573,051 3,047,955
Working capital 13,151,273 11,970,264
Total assets 18,390,264 16,265,073
Long-term liabilities 207,390 276,520
Total stockholders' 17,458,346 14,872,314
SOURCE BioSpecifics Technologies Corp.
Contact: BioSpecifics Technologies Corp., Thomas L. Wegman, President,
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