BioSpecifics Technologies Corp. Reports Third Quarter 2012
Financial Results
LYNBROOK, N.Y., Nov. 8,
2012 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ:
BSTC), a biopharmaceutical company developing first in class
collagenase-based products marketed as XIAFLEX® in the U.S. and
XIAPEX® in Europe and Eurasia,
today announced its financial results for the third quarter ended
September 30, 2012 and provided a
corporate update.
"We are very happy with the ongoing clinical development
progress for our XIAFLEX pipeline, including the recent submission
of a sBLA filing by our partner Auxilium for the potential
treatment of Peyronie's disease," said Thomas L. Wegman, President of BioSpecifics.
"Additionally, Auxilium recently completed enrollment in its
cellulite Phase Ib and frozen shoulder Phase IIa studies and began
enrollment for its 600 patient label expansion study for
Dupuytren's contracture patients with multiple palpable cords. We
look forward to reporting top-line data from each of these studies
in the fourth quarter of 2012, the first quarter of 2013 and the
first half of 2014, respectively. We also anticipate that we will
complete enrollment in our internally-managed human and canine
lipoma Phase II trials during the first half of 2013. In addition,
we are very encouraged by the ongoing commercial initiatives
Auxilium has implemented to continue to expand XIAFLEX sales for
Dupuytren's contracture in the U.S."
Third Quarter 2012 Financial Results
BioSpecifics
reported net income of $0.5 million
for the third quarter ended September 30,
2012, or $0.07 per basic and
diluted common share, compared to a net income of $0.3 million, or $0.04 per basic and diluted common share, for the
same period in 2011.
Total revenue for the third quarter of 2012 was $2.4 million, compared to $1.9 million for the same period in 2011.
Royalty, mark-up on cost of goods sold, and earn-out revenues
for the third quarter of 2012 were $2.3
million, compared to $1.8
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
third quarter of 2012 were $1.5
million, compared to $1.1
million for the same period in 2011. Royalty revenues
recognized from DFB Biotech, Inc. for the third quarter of 2012 and
2011 were $0.8 million in each
period.
Total licensing revenue consisting of licensing, sublicensing
fees and milestones for the third quarter of 2012 and 2011 were
$0.1 million in each period. These
licensing fees related to cash payments received in prior years and
amortized over the expected development period. Milestone payments
recognized in the third quarter of 2012 were $28,500, compared to zero in the same period in
2011. In the third quarter of 2012, milestones recognized related
to the Notice of Compliance (approval) by Health Canada for XIAFLEX
for the treatment of Dupuytren's contracture in adults with a
palpable cord in Canada granted to
Actelion Pharmaceuticals Ltd. (Actelion).
Research and development expenses for the third quarter 2012
were $0.3 million, compared to
$0.2 million for the same period in
2011. The increase in research and development expenses was
primarily due to expenses related to BioSpecifics' clinical
development programs for XIAFLEX in human and canine lipomas.
General and administrative expenses for the third quarter of
2012 were $1.4 million, compared to
$1.2 million for the same period in
2011. The increase in general and administrative expenses was due
to legal fees, consulting services and third party royalty fees
partially offset by lower stock based compensation.
As of September 30, 2012,
BioSpecifics had cash and cash equivalents and investments of
$9.0 million, compared to
$8.8 million on June 30, 2012.
XIAFLEX for Dupuytren's Contracture
Worldwide net
revenues for XIAFLEX, as reported by Auxilium on November 7, 2012, were $15.7 million for the third quarter of 2012,
$13.2 million of which were in the
U.S., representing a 29% increased over the same period in
2011.
Auxilium 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. This study began enrollment in the third
quarter of 2012 and top-line data are expected in the first half of
2014. If successful, this study may allow Auxilium to seek a
XIAFLEX label expansion from the U.S. Food and Drug Administration
(FDA) for the concurrent treatment of multiple palpable cords in
adult Dupuytren's contracture patients.
In the third quarter of 2012, Auxilium also 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.
In September 2012, Auxilium
announced a safety update following 30 months of post-approval use
of XIAFLEX in the U.S. for the treatment of adult Dupuytren's
contracture patients with a palpable cord, which demonstrated that
there was no clinically meaningful change in the nature of events
that were expected relative to the clinical trial safety
profile.
Auxilium's strategic partner Actelion expects to make XIAFLEX
commercially available to adult Dupuytren's contracture patients in
Canada in the first half of 2013.
In addition, Actelion expects to file for approval of XIAFLEX for
the treatment of Dupuytren's contracture in Australia, Brazil and Mexico by the end of the 2012.
XIAFLEX for Peyronie's Disease
On November 7, 2012, BioSpecifics announced
Auxilium's submission of a supplemental Biologics License
Application (sBLA) to the FDA for XIAFLEX for the potential
treatment of Peyronie's disease, an excess of inelastic collagen
causing penile curvature deformity. If approved by the FDA, which
Auxilium anticipates by the end of 2013, XIAFLEX is expected to be
the first and only biologic therapy indicated for the treatment of
Peyronie's disease.
The sBLA submission is based on data from the Auxilium's IMPRESS
(The Investigation for Maximal Peyronie's Reduction Efficacy and
Safety Studies) Phase III clinical program and other controlled and
uncontrolled clinical studies. In August
2012, BioSpecifics announced that additional data were
presented at the Sexual Medicines Society of North America (SMSNA)/International Society
for Sexual Medicine (ISSM) Joint Annual Meeting on August 27 and 29, 2012 in Chicago, IL. These data demonstrated that 58%
of patients with curvature deformity of 30 to 60, and 73% of
patients with curvature deformity of 60 to 90 degrees, reported
that they were "very bothered" or "extremely bothered" about their
condition. In addition, photographs and data were presented from a
subset of IMPRESS patients involved in the first study ever to use
3-D photographic technology for 360 degree assessment of penile
curvature deformity in Peyronie's disease patients.
Additional Anticipated Milestones for XIAFLEX
Pipeline
BioSpecifics is currently managing the clinical
development of XIAFLEX for the treatment of human lipoma and canine
lipoma in two Phase II clinical trials. BioSpecifics anticipates
that it will complete enrollment for its 14 patient dose escalation
Phase II trial for the treatment of human lipoma in the first half
of 2013. BioSpecifics anticipates that it will also complete
enrollment for Chien-804, its Phase II clinical trial evaluating 32
canines with benign subcutaneous lipomas randomized 1:1 XIAFLEX to
placebo, during the same time period.
Auxilium is 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. Top-line data from the Phase Ib single site,
open-label dose escalation study of XIAFLEX for cellulite are
expected in the fourth quarter of 2012. Top-line data from the
Phase IIa study of XIAFLEX for frozen shoulder are expected in the
first quarter of 2013.
Auxilium and Pfizer Inc. Collaboration Termination
As
reported by Auxilium on November 7,
2012, Auxilium and Pfizer Inc. have terminated their
collaboration agreement for the development, commercialization and
supply of XIAPEX for the treatment of Dupuytren's contracture and
the potential treatment of Peyronie's disease in the European Union
and certain other European and Eurasian countries to be effective
as of April 24, 2013. After the
termination date, rights to commercialize XIAPEX and responsibility
for regulatory activities for XIAPEX in these countries will revert
to Auxilium.
Webcast and Conference Call
BioSpecifics will host a
conference call today at 4:30 p.m.
EST to discuss these third quarter 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:
http://www.videonewswire.com/event.asp?id=90670.
A replay of the call will be available one hour after the end of
the conference on November 8, 2012
until 9:00 a.m. EST on November 23, 2012. To access the replay, please
dial 1-877-344-7529 (domestic) or 1-412-317-0088 (international)
and reference the access code 10020975. 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
and Canada. XIAFLEX is also in
clinical development for the treatment of several additional
promising indications: Auxilium recently submitted a supplemental
Biologics License Application (sBLA) to the FDA for XIAFLEX for the
potential treatment of Peyronie's disease based on positive results
reported from its two Phase III clinical studies. 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 clinical
development of XIAFLEX for the treatment of human lipoma and canine
lipoma, which are both in Phase II 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 these 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.
Forward Looking Statements
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 results from Auxilium's clinical trials
for Dupuytren's contracture (phase IIIb for concurrent treatment of
multiple palpable cords and phase IV retreatment), cellulite, and
frozen shoulder; the timing of the potential FDA approval, if any,
of XIAFLEX for Peyronie's disease; the timing for completing
enrollment for trials for the use of XIAFLEX as a treatment of
human lipoma and canine lipoma; being encouraged by Auxilium's
ongoing commercial initiatives to continue to expand XIAFLEX sales
for Dupuytren's contracture in the U.S.; the potential for Auxilium
to receive approval to expand the label for Dupuytren's
contracture; the timing of making XIAFLEX available in Canada as a treatment of Dupuytren's
contracture; the timing of filing for approval of XIAFLEX for the
treatment of Dupuytren's contracture in Australia, Brazil, and Mexico; the potential for XIAFLEX to be the
first and only biologic therapy indicated for the treatment of
Peyronie's disease; and the potential for XIAFLEX as a treatment in
additional 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 ability of BioSpecifics'
partner, Auxilium, and its partners, Asahi Kasei Pharma Corporation
and Actelion Pharmaceuticals Canada Inc., to achieve their
objectives for XIAFLEX in their applicable territories; the
potential market for XIAFLEX in a given indication, the potential
of XIAFLEX to be used in additional indications, and the
initiation, timing and outcome of clinical trials of XIAFLEX for
additional indications; the timing of regulatory filings and
action; the receipt of any applicable milestone payments from
Auxilium; 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 and second 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
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three
months ended
|
|
Nine
months ended
|
|
September 30,
|
|
September 30,
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Revenues:
|
|
|
|
|
|
|
|
Net sales
|
$
3,378
|
|
$
1,683
|
|
$
12,128
|
|
$
13,457
|
Royalties
|
2,307,073
|
|
1,810,436
|
|
6,698,355
|
|
4,461,683
|
Licensing revenues
|
137,774
|
|
109,276
|
|
926,324
|
|
4,265,327
|
Consulting fees
|
-
|
|
-
|
|
-
|
|
46,667
|
Total
Revenues
|
2,448,225
|
|
1,921,395
|
|
7,636,807
|
|
8,787,134
|
|
|
|
|
|
|
|
|
Costs
and expenses:
|
|
|
|
|
|
|
|
Research and development
|
293,221
|
|
224,150
|
|
947,119
|
|
707,015
|
General and administrative
|
1,375,477
|
|
1,245,145
|
|
3,614,125
|
|
4,172,687
|
Total
costs and expenses
|
1,668,698
|
|
1,469,295
|
|
4,561,244
|
|
4,879,702
|
|
|
|
|
|
|
|
|
Operating income
|
779,527
|
|
452,100
|
|
3,075,563
|
|
3,907,432
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
Interest and other income
|
8,292
|
|
7,813
|
|
27,556
|
|
55,540
|
|
|
|
|
|
|
|
|
Income
before income tax
|
787,819
|
|
459,913
|
|
3,103,119
|
|
3,962,972
|
Income tax benefit (expense)
|
(316,772)
|
|
(190,077)
|
|
(1,223,000)
|
|
2,567,328
|
|
|
|
|
|
|
|
|
Net
income
|
$
471,047
|
|
$
269,836
|
|
$1,880,119
|
|
$6,530,300
|
|
|
|
|
|
|
|
|
Basic
net income per share
|
$
0.07
|
|
$
0.04
|
|
$
0.30
|
|
$
1.03
|
|
|
|
|
|
|
|
|
Diluted
net income per share
|
$
0.07
|
|
$
0.04
|
|
$
0.27
|
|
$
0.92
|
|
|
|
|
|
|
|
|
Shares
used in computation of basic net income per share
|
6,343,210
|
|
6,362,951
|
|
6,341,031
|
|
6,337,237
|
|
|
|
|
|
|
|
|
Shares
used in computation of diluted net income per share
|
6,961,652
|
|
7,085,945
|
|
6,985,290
|
|
7,133,341
|
|
|
|
|
|
|
|
|
BioSpecifics Technologies Corp.
|
Selected Consolidated Balance Sheet
Data
|
(Unaudited)
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
2012
|
|
2011
|
Cash and
cash equivalents
|
|
$
3,823,860
|
|
$3,196,831
|
Short term
investments
|
|
5,190,000
|
|
5,000,000
|
Accounts
and income tax receivable, net
|
|
3,276,526
|
|
3,481,637
|
Deferred
tax assets (short and long-term)
|
|
2,428,545
|
|
3,047,955
|
Deferred
royalty buydown
|
|
2,750,000
|
|
1,250,000
|
Working
capital
|
|
12,169,287
|
|
11,970,264
|
Total
assets
|
|
17,840,782
|
|
16,265,073
|
Long-term
liabilities
|
|
224,673
|
|
276,520
|
Total
stockholders' equity
|
|
16,696,443
|
|
14,872,314
|
|
|
|
|
|
SOURCE BioSpecifics Technologies Corp.