BioSpecifics Technologies Corp. Reports First Quarter 2013 Financial Results

 BioSpecifics Technologies Corp. Reports First Quarter 2013 Financial Results

PR Newswire

LYNBROOK, N.Y., May 10, 2013

LYNBROOK, N.Y., May 10, 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 reported its financial results for the first quarter ended March 31,
2013 and provided a corporate update.

"We are very pleased to have completed enrollment in our Phase II trials in
canine and human lipoma and we remain on track to report top-line data for
both trials in the second half of this year," reflected Thomas L. Wegman,
President of BioSpecifics. "In addition, there are a number of exciting
upcoming milestones for XIAFLEX this year. We are looking forward to the
potential approval of XIAFLEX for the treatment of Peyronie's Disease in the
third quarter of this year and if approved, we would anticipate the U.S.
commercial launch in this indication in the fourth quarter of 2013. We are
also eagerly awaiting the initiation of a new clinical trial for XIAFLEX in
frozen shoulder syndrome in the second half of this year, following the
announcement of the statistically significant top-line data from the Phase IIa
study, as well as the initiation of a Phase II study in the cellulite
indication during the same time period. Finally we believe there is tremendous
potential for XIAFLEX in the treatment of many medical conditions caused by
excess collagen accumulation and BioSpecifics will continue to devote its
efforts to the development in new clinical indications in the future."

First Quarter 2013 Financial Results

BioSpecifics reported a net income of $1.4 million for the first quarter ended
March 31, 2013, or $0.21 per basic share and $0.19 per diluted share, compared
to a net income of $0.7 million, or $0.12 per basic share and $0.11 per
diluted share for the same period in 2012.

Total revenue for the first quarter ended March 31, 2013 was $4.0 million,
compared to $2.6 million for the same period in 2012. This represents an
increase of approximately 54% from the same period in 2012.

Royalty, mark-up on cost of goods sold, and earn-out revenues for the first
quarter ended March 31, 2013 were $3.4 million, compared to $1.9 million for
the same period in 2012. Royalty and mark-up on cost of goods sold revenues
recognized under the Company's agreement with its strategic partner Auxilium
Pharmaceuticals, Inc. (Auxilium) for the first quarter of 2013 were $2.4
million, compared to $1.6 million for the same period in 2012. Royalty
revenues recognized from DFB Biotech, Inc. (DFB) for the first quarter of
2013, following the sale to Smith & Nephew plc, were $1.0 million, compared to
$0.3 million for the same period in 2012. 

Licensing revenue consists of licensing fees, sublicensing fees and
milestones. For the three months ended March 31, 2013, we recognized total
licensing revenue of approximately $0.5 million as compared to $0.7 million in
the 2012 period. In the 2013 period, licensing fees recognized of $0.5 million
were related to the exercise by Auxilium of its exclusive option 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. License fees recognized related to development
were $44,881 as compared to $109,275 in the comparable period of 2012. These
licensing fees related to cash payments received in prior years, which are
amortized over the expected development period. No sublicensing fees were
recognized so far in 2013 compared to $570,000 in the same period of 2012. In
the 2012 period, sublicensing fees recognized were related to the $10.0
million paid to Auxilium by 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.

Research and development expenses for the first quarter ended March 31, 2013
were $294,875, compared to $249,552 for the same period in 2012. This increase
in research and development expenses was primarily due to expenses related to
our clinical development and research programs.

General and administrative expenses for the first quarter ended March 31, 2013
were $1.6 million, compared to $1.1 million for the same period in 2012. The
increase in general and administrative expenses was due to increased third
party licensing and royalty fees, legal fees, investor relations and
consulting services.

The provision for income taxes for the three month period ended March 31, 2013
was $0.7 million, compared to $0.5 million for the same period in 2012. The
provision for income taxes is based on an estimated effective tax rate derived
from an estimate of consolidated earnings before taxes, adjusted for
nondeductible expenses and other permanent differences.For the three month
period ended March 31, 2013, the valuation allowance with respect to our net
deferred tax assets remained unchanged. As of March 31, 2013, our remaining
deferred tax assets were approximately $1.6 million.

As of March 31, 2013, BioSpecifics had cash and cash equivalents and
investments of $12.2 million, compared to $8.5 million as of December 31,
2012.

Recent Corporate Highlights:

In April 2013, BioSpecifics completed enrollment in its placebo-controlled,
randomized Phase II trial, Chien-804, to evaluate the efficacy of XIAFLEX for
the treatment of subcutaneous benign lipomas in 32 canines randomized 1:1
XIAFLEX to placebo. The lipoma volume will be measured at baseline, 1 month
and 3 months with the primary efficacy endpoint being the relative change in
lipoma volume from baseline to 3 months, as determined by CT scan.

In March 2013, Auxilium announced positive, statistically significant top-line
data from the Phase IIa study of XIAFLEX in frozen shoulder syndrome. The
study involved 50 adult men and women at 11 U.S. sites. Four cohorts of 10
patients each received up to three ultrasound-guided injections of varying
doses of XIAFLEX (ranging from 0.29mg to 0.58mg in three different volumes;
0.5, 1.0, or 2.0 mL), separated by a minimum of 21 days. All patients were
instructed to perform home shoulder exercises. The fifth cohort of ten
patients received no XIAFLEX injections and only performed home shoulder
exercises. The study's primary endpoint was the change (in degrees) from
baseline to the day 92 follow-up in active forward flexion in the affected
shoulder compared to the exercise-only cohort. Safety assessments were made
during all study visits and immunogenicity testing was performed at screening
and at day 92.

In March 2013, BioSpecifics reported that it has completed enrollment for its
14-patient single center dose-escalation Phase II clinical trial of XIAFLEX
for the treatment of human lipoma. The study is a single injection, open-label
trial and XIAFLEX is being administered in four ascending doses (0.058 mg to
0.44 mg). The primary efficacy endpoint will be a change in the visible
surface area of the target lipoma, as determined at six months
post-injection.

On 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 demonstrate the significant therapeutic opportunity of XIAFLEX
for this indication. Auxilium presented more data from this trial at the
American Urological Association annual meeting held on May 4-8, 2013 in San
Diego, California.

In 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 cellulite. BioSpecifics
received a license fee payment of $500,000 in January 2013 in connection with
this exercise.

Upcoming Anticipated Milestones:

BioSpecifics' Clinical Indications for XIAFLEX:

  oBioSpecifics is currently managing the development of XIAFLEX for the
    treatment of human lipoma and canine lipoma in two Phase II trials. The
    Company expects to report top-line data from both of these trials in the
    second half of 2013.

XIAFLEX for Dupuytren's Contracture:

  oTop-line data from Auxilium's Phase IV Dupuytren's contracture retreatment
    clinical trial are expected in the fourth quarter of 2013.
  oActelion, Auxilium's partner in Canada, plans to launch XIAFLEX in Canada
    in the second quarter of 2013.
  oAuxilium is conducting a study with XIAFLEX for the concurrent treatment
    of multiple palpable cords that, if successful, may allow Auxilium to seek
    FDA approval of the expansion of the Dupuytren's label. Auxilium expects
    to complete study enrollment in the second quarter of 2013.

Additional 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 Authorization Application to the European
    Medicines Agency also in the fourth quarter of 2013.
  oAuxilium is also currently managing the clinical development of XIAFLEX
    for the treatment of cellulite and frozen shoulder syndrome (adhesive
    capsulitis). 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 was reported in December 2012 and Auxilium announced that it
    planned to initiate a Phase II clinical trial in the second half of 2013.
    Auxilium expects progression in the second half of 2013 into a new
    clinical trial of XIAFLEX for the treatment of frozen shoulder syndrome.

Webcast and Conference Call

The Company will host a conference call today at 8:30 AM EDT to discuss these
first quarter 2013 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=93618

A replay of the call will be available one hour after the end of the
conference on May 10, 2013 until 9:00 a.m. EDT on May 27, 2013. To access the
replay, please dial 1-877-344-7529 (domestic) or 1-412-317-0088
(international) and reference the access code 10028021. 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 to date.
Injectable collagenase is marketed as XIAFLEX^® in the U.S. for the treatment
of adult Dupuytren's contracture patients with a palpable cord in the palm by
BioSpecifics' partner, Auxilium Pharmaceuticals, Inc., and is approved for
Dupuytren's contracture in the EU and Canada. XIAFLEX is also in clinical
development for the treatment of several additional promising indications. The
U.S. Food & Drug Administration has accepted for filing Auxilium's
supplemental Biologics License Application for XIAFLEX for the potential
treatment of Peyronie's disease. The FDA is expected to take action on the
application by September 6, 2013, and, if approved, XIAFLEX will be the first
and only biologic treatment indicated for Peyronie's disease. Auxilium is also
testing XIAFLEX for frozen shoulder syndrome (adhesive capsulitis) and
cellulite. Auxilium has reported positive top-line data from a Phase IIa
frozen shoulder study and expects to initiate a new clinical trial in the
second half of 2013. BioSpecifics is currently managing the clinical
development of XIAFLEX for the treatment of human and canine lipomas, which
are both in Phase II clinical trials, with top-line data from both trials
expected in the second half of 2013. Auxilium is currently partnered with
Asahi Kasei Pharma Corporation for the development and commercialization of
XIAFLEX 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. 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, including statements regarding our strategy, future
operations, future financial position, future revenues, projected costs,
prospects, plans and objectives of management, expected revenue growth, and
the assumptions underlying or relating to such statements, are
"forward-looking statements". The forward-looking statements in this release
include statements concerning, among other things, the timing of reporting
top-line data from BioSpecifics' Phase II clinical trial of XIAFLEX for the
treatment of human lipoma and its Phase II trial for the treatment of canine
lipoma; the timing of the review and potential approval by the FDA of XIAFLEX
as a treatment for Peyronie's disease and its potential commercial launch; the
timing of making XIAFLEX available in Canada as a treatment for Dupuytren's
contracture; the timing for Auxilium to initiate a Phase II trial of XIAFLEX
as a treatment for cellulite and a new clinical trial of XIAFLEX as a
treatment for frozen shoulder; the timing of reporting top-line data from
Auxilium's Phase IV Dupuytren's contracture retreatment clinical trial; 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; and the expectation of XIAFLEX to be the first and only
biologic therapy indicated for the treatment of Peyronie's disease. 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
Pharmaceuticals, Inc., 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 Pharmaceuticals, Inc.; whether royalty
payments BioSpecifics is entitled to receive will exceed set-offs; and other
risk factors set forth in BioSpecifics' Annual Report on Form 10-K for the
year ended December 31, 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
                                 March 31
                                 2013                       2012
Revenues:                                       (Unaudited)
 Net sales                     $    2,243              $    7,504
 Royalties                     3,432,900                  1,899,969
 Licensing revenue             544,881                    679,275
 Total Revenues           3,980,024                  2,586,748
Costs and expenses:
 Research and development      294,874                    249,552
 General and administrative    1,618,482                  1,088,722
 Total costs and          1,913,356                  1,338,274
expenses
Operating income                 2,066,668                  1,248,474
Other income:
 Interest Income               5,866                      9,493
Income before income tax         2,072,534                  1,257,967
 Income tax benefit (expense)  (719,450)                  (515,577)
Net income                       $ 1,353,084                $  742,390
Basic net income per share       $     0.21             $     0.12
Diluted net income per share     $     0.19             $     0.11
Shares used in computation of
basic
 net income per share        6,356,954                  6,336,503
Shares used in computation of
diluted
 net income per share        6,955,452                  6,969,936



BioSpecifics Technologies Corp.
Selected Consolidated Balance Sheet Data
(Unaudited)
                                           March 31,   December 31
                                           2013         2012
Cash and cash equivalents                  $ 7,248,418  $  3,383,737
Short term investments                     4,962,964    5,120,000
Accounts and income tax receivable, net    2,961,216    5,133,430
Deferred tax assets                        1,554,220    1,573,051
Working capital                            14,323,607   13,151,273
Total assets                               20,104,913   18,390,264
Long-term liabilities                      190,108      207,390
Total stockholders' equity                 18,631,881   17,458,346



SOURCE BioSpecifics Technologies Corp.

Website: http://www.biospecifics.com
Contact: BioSpecifics Technologies Corp., Thomas L. Wegman, President, (516)
593-7000, thomas_wegman@biospecifics.com