LYNBROOK, N.Y., Nov. 9, 2018 /PRNewswire/ -- BioSpecifics
Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that
originated and continues to develop collagenase-based therapies
with a first in class collagenase-based product marketed as
XIAFLEX® in the U.S. and Xiapex® in Europe, today
announced its financial results for the third quarter ended
September 30, 2018 and provided a
corporate update.
"We are encouraged by the positive data recently reported for
CCH in two new potential indications. We announced positive topline
results from our Phase 1 clinical trial of CCH for the treatment of
uterine fibroids in October and our partner Endo announced positive
data from the Phase 3 clinical trials of CCH for the treatment of
cellulite in November. The preliminary safety and efficacy data
from our uterine fibroids trial demonstrates the promising
potential for CCH injection for the treatment of this highly
prevalent women's health disease for which very limited
non-surgical options are available," said Thomas L. Wegman, President of BioSpecifics.
"With regard to our commercial pipeline and revenues, we were
pleased to see continued growth for our two marketed indications
for XIAFLEX, Peyronie's Disease and Dupuytren's Contracture with 22
percent year-over-year revenue growth for the quarter."
Third Quarter 2018 Financial Results
BioSpecifics
reported net income of $5.0 million
for the third quarter ended September 30,
2018, or $0.69 per basic share
and $0.69 per share on a fully
diluted basis, compared to net income of $2.7 million, or $0.38 per basic share and $0.37 per share on a fully diluted basis, for the
same period in 2017.
Total revenue for the third quarter ended September 30, 2018 was $8.2 million, compared to $6.5 million for the same period in 2017. The
increase in total revenues for the quarterly period was primarily
due to royalties associated with higher net sales of XIAFLEX in
Dupuytren's contracture and Peyronie's disease partially offset by
lower mark-up on cost of goods sold revenue in prepaid foreign
mark-up on cost of goods sold revenue recognized under new revenue
standard ASC 606, as of January 1,
2018.
Licensing revenue consists of licensing fees, sublicensing fees
and milestones. BioSpecifics recognized licensing revenue for the
third quarter ended September 30,
2018 of zero and $4,408 for
the same period in 2017.
Research and development (R&D) expenses for the third
quarter ended September 30, 2018 were
$0.2 million compared to $0.4 million for the same period in 2017. The
decrease in the 2018 period, as compared to the 2017 period, was
mainly due to lower consulting fees associated with clinical costs
and other R&D programs.
General and administrative expenses for the third quarter ended
September 30, 2018 and 2017 were
$2.2 million in each period.
Provision for income taxes for the third quarter ended
September 30, 2018 were $1.1 million, compared to $1.5 million for the same period in 2017.
As of September 30, 2018,
BioSpecifics had cash and cash equivalents and investments of
$77.0 million, compared to
$65.1 million as of December 31, 2017.
As of September 30, 2018,
BioSpecifics had 7,283,528 shares of common stock outstanding.
XIAFLEX/CCH Pipeline Updates and Anticipated Upcoming
Milestones
BioSpecifics manages the development of collagenase clostridium
histolyticum (CCH) for the treatment of uterine fibroids and has
the right to initiate the development of any new potential
indication not licensed by Endo. Endo's licensed indications
include Dupuytren's Contracture and Peyronie's Disease, both
approved and marketed; in addition to cellulite, adhesive
capsulitis, human and canine lipoma, lateral hip fat and plantar
fibromatosis. BioSpecifics has entered into different in-licensing
and royalty agreements in respect of indications currently marketed
and under development. It is company policy not to announce
publicly royalty rates for potential future indications under
development before commercialization. It is important to emphasize
that in-licensing royalty rates vary from indication to indication
and it should not be assumed that the in-licensing royalty rates
for potential future indications will be the same as those for
currently marketed indications.
- Positive Topline Phase 1 Uterine Fibroid Data Reported in
October: BioSpecifics announced positive topline results from
the Phase 1 clinical trial of CCH for the treatment of uterine
fibroids. The study met the primary endpoint of safety and
tolerability with no observed clinically significant adverse
reactions. Pharmacodynamic changes were noted in all secondary
endpoints with the exception of apoptosis. Statistically
significant reductions in collagen content were observed as
compared to control fibroids with a median reduction of 39 percent
(p<0.05), as well as statistically significant reductions in
collagen distribution as compared to control fibroids with an
average reduction in density of collagen bundles of 21
percent.
- Positive Phase 3 RELEASE-1 and RELEASE-2 Cellulite Data
Reported in November: Endo announced positive results from two
Phase 3 studies, RELEASE-1 and RELEASE-2, of CCH for the treatment
of cellulite with highly statistically significant levels of
improvement in the appearance in the target buttock at Day 71
reported. The study achieved the primary endpoint (RELEASE-1,
p=0.006 & RELEASE-2, p=0.002) of composite responder analysis
demonstrating at least a 2-level composite improvement
independently reported by patient and clinician on the photonumeric
scales of cellulite severity. Secondary endpoints included both
investigator and patient assessments of cellulite appearance as
measured by CR-PCSS (Clinician Reported- Photonumeric Cellulite
Severity Scale) and PR-PCSS (Patient Reported- Photonumeric
Cellulite Severity Scale) scores, SRSS (Subject Self Rating Scale)
and the Subject-Global Aesthetic Improvement Scale. Eight out of
eight key secondary endpoints were achieved for RELEASE-1 and seven
out of eight secondary endpoints were achieved for RELEASE-2. CCH
was well-tolerated in actively treated subjects with most adverse
events being mild to moderate in severity and primarily limited to
the local injection area.
- XIAFLEX Expected to Continue to Grow in the Low 20 Percent
Range: XIAFLEX future growth initiatives continue to support
the increase in disease state awareness for both Peyronie's Disease
and Dupuytren's Contracture through direct to consumer
campaigns.
About BioSpecifics Technologies Corp.
BioSpecifics
Technologies Corp. is a biopharmaceutical company that has
developed injectable collagenase for thirteen clinical indications
to date. Injectable collagenase is marketed as XIAFLEX® in the
U.S. for the treatment of Dupuytren's contracture and Peyronie's
disease by BioSpecifics' partner, Endo International plc (Endo).
XIAFLEX® is also commercialized
in Japan, Europe, Canada and Australia for
Dupuytren's contracture and for Peyronie's disease
in Canada, Europe and Australia. The CCH
research and development pipeline includes several additional
promising indications, including Phase 3 clinical trials for the
treatment of cellulite with top-line data expected in the fourth
quarter of 2018. BioSpecifics is managing the development of CCH
for the treatment of uterine fibroids the Phase 1 clinical trial
with full data expected in the first quarter of 2019. For more
information, please visit www.biospecifics.com.
Forward-Looking Statements
This report 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 the Company's
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 include statements concerning, among
other things, whether revenue for Peyronie's disease and
Dupuytren's contracture will continue to grow, whether Endo
will meet its projected fiscal year 2018 growth for XIAFLEX, and
whether BioSpecifics will achieve its corporate goals and remain
profitable on an ongoing basis. In some cases, these statements can
be identified by forward-looking words such as "expect," "plan,"
"anticipate," "potential," "estimate," "can," "will," "continue,"
the negative or plural of these words, and other similar
expressions. These forward-looking statements are predictions based
on our current expectations and our projections about future events
and various assumptions. There can be no assurance that we will
realize our expectations or that our beliefs will prove correct.
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 Endo and its
partners, Asahi Kasei Pharma Corporation, Actelion Ltd. and Swedish
Orphan Biovitrum AB, to achieve their objectives for XIAFLEX in
their applicable territories; the market for XIAFLEX in, and
timing, initiation and outcome of clinical trials for, additional
indications, which will determine the amount of milestone, royalty,
mark-up on cost of goods sold, license and sublicense income that
BioSpecifics may receive; the potential of XIAFLEX to be used in
additional indications; Endo modifying its objectives or allocating
resources other than to XIAFLEX; and other risk factors identified
in BioSpecifics' Annual Report on Form 10-K for the year ended
December 31, 2017, Quarterly Reports
on Form 10-Q for the quarters ended March
31, 2018 and June 30, 2018 and
its Current Reports on Form 8-K filed with the Securities and
Exchange Commission. All forward-looking statements included in
this Report are made as of the date hereof, are expressly qualified
in their entirety by the cautionary statements included in this
Report and, except as may be required by law, we assume no
obligation to update these forward-looking statements.
BioSpecifics
Technologies Corp.
|
Condensed
Consolidated Income Statement
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2018(1)
|
|
2017
|
|
2018(1)
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
8,168,081
|
|
$
6,511,700
|
|
$
23,068,585
|
|
$
20,729,017
|
Licensing revenue
|
|
-
|
|
4,408
|
|
39,679
|
|
13,226
|
Total
Revenues
|
|
8,168,081
|
|
6,516,108
|
|
23,108,264
|
|
20,742,243
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
162,625
|
|
356,847
|
|
569,648
|
|
949,359
|
General
and administrative
|
|
2,232,077
|
|
2,175,501
|
|
6,345,662
|
|
6,916,501
|
Total
costs and expenses
|
|
2,394,702
|
|
2,532,348
|
|
6,915,310
|
|
7,865,860
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
5,773,379
|
|
3,983,760
|
|
16,192,954
|
|
12,876,383
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
359,637
|
|
193,462
|
|
851,334
|
|
436,210
|
Other,
net
|
|
-
|
|
14,667
|
|
96,663
|
|
40,651
|
|
|
359,637
|
|
208,129
|
|
947,997
|
|
476,861
|
|
|
|
|
|
|
|
|
|
Income before income
tax expense
|
|
6,133,016
|
|
4,191,889
|
|
17,140,951
|
|
13,353,244
|
Provision for income
tax expense
|
|
(1,089,966)
|
|
(1,477,057)
|
|
(3,271,366)
|
|
(4,669,569)
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
5,043,050
|
|
2,714,832
|
|
13,869,585
|
|
8,683,675
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.69
|
|
$
0.38
|
|
$
1.92
|
|
$
1.21
|
Diluted
|
|
$
0.69
|
|
$
0.37
|
|
$
1.89
|
|
$
1.19
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
7,281,388
|
|
7,164,934
|
|
7,230,106
|
|
7,166,470
|
Diluted
|
|
7,356,885
|
|
7,314,609
|
|
7,327,029
|
|
7,325,602
|
BioSpecifics
Technologies Corp.
|
Selected Condensed
Consolidated Balance Sheet Data
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
2018(1)
|
|
2017
(2)
|
Cash and cash
equivalents
|
|
|
|
$
13,381,013
|
|
$
7,333,810
|
Investments
|
|
|
|
63,597,533
|
|
57,719,945
|
Accounts
receivable
|
|
|
|
14,455,354
|
|
4,655,105
|
Deferred tax
assets
|
|
|
|
275,526
|
|
1,739,706
|
Working
capital
|
|
|
|
85,858,681
|
|
64,241,667
|
Total
assets
|
|
|
|
93,552,934
|
|
74,996,394
|
Long-term
liabilities
|
|
|
|
-
|
|
5,340,708
|
Total stockholders'
equity
|
|
|
|
91,742,421
|
|
67,516,838
|
|
(1) As of
January 1, 2018, the Company adopted the requirements of ASC 606
using the modified retrospective adoption method, and as a result,
there is a lack of comparability of certain amounts to the prior
periods presented.
|
|
(2) The
selected consolidated balance sheet information for the year ended
December 31, 2017 have been derived from the audited financial
statements but do not include all of the information and footnotes
required by accounting principles generally accepted in the United
States for complete financial statements.
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/biospecifics-technologies-corp-reports-third-quarter-2018-financial-results-300747220.html
SOURCE BioSpecifics Technologies Corp.