LYNBROOK, N.Y., Aug. 9, 2017 /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 second quarter ended June 30, 2017 and provided a corporate
update.
"We continue to enroll patients in our ongoing Phase 1 trial of
XIAFLEX for the treatment of uterine fibroids and look forward to
reporting data in 2018. Our focus remains on investigating the
potential of XIAFLEX in serious medical conditions," said
Thomas L. Wegman, President of
BioSpecifics. "We also continue to support our partner Endo as they
work to advance XIAFLEX toward Phase 3 trials in cellulite and
review the commercial potential for their other licensed pipeline
indications."
Second Quarter 2017 Financial Results
BioSpecifics reported net income of $2.6
million for the second quarter ended June 30, 2017, or $0.37 per basic share and $0.36 per share on a fully diluted basis,
compared to net income of $2.6
million, or $0.37 per basic
share and $0.35 per share on a fully
diluted basis, for the same period in 2016.
Total revenue for the second quarter ended June 30, 2017 was $6.5
million, compared to $6.2
million for the same period in 2016. The increase in total
revenues for the quarterly period was primarily due to royalties
based on sales of XIAFLEX for the treatment of Peyronie's disease
and Dupuytren's contracture partially offset by lower mark-up on
cost of goods sold revenue under BioSpecifics' agreement with Endo
International plc (Endo).
Research and development expenses for the second quarter ended
June 30, 2017 were $0.3 million compared to $0.4 million for the same period in 2016.
General and administrative expenses for the second quarter ended
June 30, 2017 were $2.3 million compared to $1.9 million for the same period in 2016.
Provision for income taxes for the second quarter ended
June 30, 2017 were $1.4 million, compared to $1.3 million for the same period in 2016.
As of June 30, 2017, BioSpecifics
had cash and cash equivalents and investments of $58.5 million, compared to $52.8 million as of December 31, 2016.
XIAFLEX Commercial Highlights
On August 8, 2017, Endo reported
commercial highlights for XIAFLEX for the second quarter of 2017
(Endo's second quarter 2017 financials are reported in
BioSpecifics' third quarter 2017 financials). For the second
quarter of 2017, total revenues were $50.1
million compared to $42.4
million in the second quarter of 2016, an 18 percent growth.
Endo continues to anticipate high-single to low-double digit
revenue growth for sales of XIAFLEX in 2017.
XIAFLEX Pipeline Updates and Anticipated Upcoming
Milestones
BioSpecifics manages the development of XIAFLEX for uterine
fibroids and may initiate the development of new potential
indications, not licensed by Endo. In addition to Dupuytren's
contracture and Peyronie's disease, Endo's licensed rights include
human and canine lipoma, adhesive capsulitis, cellulite, lateral
hip fat and plantar fibromatosis.
- A Phase 1 trial of XIAFLEX for the treatment of uterine
fibroids was initiated by BioSpecifics in April 2017 and enrollment is ongoing. This Phase
1 open-label dose escalation study for the treatment of uterine
fibroids is being conducted at the Department of Gynecology &
Obstetrics at Johns Hopkins University.
The study is designed to enroll 15 female subjects treated prior to
hysterectomy. The primary endpoint will assess the safety and
tolerability of a single injection of XIAFLEX directly into the
uterine fibroids under transvaginal ultrasound guidance. The
secondary endpoints will assess symptoms of pain and bleeding,
quality of life throughout the study, shrinkage of XIAFLEX treated
fibroids in size, increased rates of apoptosis in treated fibroids
and a decrease in the collagen content of treated fibroids.
- Endo plans to initiate Phase 3 clinical trials of XIAFLEX for
the treatment of cellulite toward the end of 2017.
- A commercial review of additional indications and priority
programs, beyond cellulite, is ongoing by Endo and will determine
the clinical trial timelines for Endo's licensed indications moving
forward.
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 Europe
and Australia. Endo is partnered with Sobi, Actelion and Asahi
Kasei for Dupuytren's contracture and Peyronie's disease outside
the U.S. The XIAFLEX research and development pipeline includes
several additional promising indications. BioSpecifics is managing
the development of XIAFLEX for uterine fibroids and is conducting a
Phase 1 clinical trial. For more information, please
visit www.biospecifics.com.
Forward-Looking Statements
This press 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 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 in this press release include
statements concerning, among other things, the progression of our
Phase 1 clinical trial of XIAFLEX for the treatment of uterine
fibroids; whether and when we will report data from our Phase 1
clinical trial of XIAFLEX for the treatment of uterine fibroids;
whether and when Endo will initiate the Phase 3 clinical trials of
XIAFLEX for the treatment of cellulite; whether Endo will achieve
high-single to low-double-digit revenue growth for XIAFLEX in 2017;
the outcome of Endo's commercial assessment regarding the
additional indications and priority programs and the timing of
Endo's determination of clinical trial timelines for its licensed
indications. In some cases, these statements can be identified by
forward-looking words such as "believe," "expect," "plan", "may,"
"will," "can," and "could," 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 and various assumptions. There can
be no assurance that BioSpecifics will realize its expectations or
that BioSpecifics' 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 that will
determine the amount of milestone, royalty, mark-up on cost of
goods sold, license and sublicense income 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, 2016,
Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and its Current Reports on Form
8-K filed with the Securities and Exchange Commission. All
forward-looking statements included in this press release are made
as of the date hereof, are expressly qualified in their entirety by
the cautionary statements included in this press release and,
except as may be required by law, BioSpecifics assumes no
obligation to update these forward-looking statements.
BioSpecifics
Technologies Corp.
|
Condensed
Consolidated Income Statement
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$6,531,107
|
|
$6,167,811
|
|
$14,217,317
|
|
$12,723,458
|
Licensing revenue
|
|
4,409
|
|
12,345
|
|
8,818
|
|
24,689
|
Total
Revenues
|
|
6,535,516
|
|
6,180,156
|
|
14,226,135
|
|
12,748,147
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
337,731
|
|
444,477
|
|
592,512
|
|
692,977
|
General
and administrative
|
|
2,315,283
|
|
1,902,083
|
|
4,741,000
|
|
4,066,416
|
Total
costs and expenses
|
|
2,653,014
|
|
2,346,560
|
|
5,333,512
|
|
4,759,393
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
3,882,502
|
|
3,833,596
|
|
8,892,623
|
|
7,988,754
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
140,995
|
|
67,327
|
|
242,748
|
|
120,030
|
Other,
net
|
|
23,423
|
|
9,836
|
|
25,985
|
|
31,194
|
|
|
164,418
|
|
77,163
|
|
268,733
|
|
151,224
|
|
|
|
|
|
|
|
|
|
Income before income
tax expense
|
|
4,046,920
|
|
3,910,759
|
|
9,161,356
|
|
8,139,978
|
Provision for income
tax expense
|
|
(1,422,829)
|
|
(1,338,044)
|
|
(3,192,512)
|
|
(2,738,139)
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$
2,624,091
|
|
$
2,572,715
|
|
$
5,968,844
|
|
$
5,401,839
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.37
|
|
$
0.37
|
|
$
0.83
|
|
$
0.77
|
Diluted
|
|
$
0.36
|
|
$
0.35
|
|
$
0.81
|
|
$
0.74
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
7,170,223
|
|
7,018,652
|
|
7,167,251
|
|
7,015,158
|
Diluted
|
|
7,329,118
|
|
7,268,527
|
|
7,330,875
|
|
7,272,328
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioSpecifics
Technologies Corp.
|
|
|
Selected Condensed
Consolidated Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
|
2017
|
|
2016
(1)
|
|
|
Cash and cash
equivalents
|
|
|
|
$
6,029,964
|
|
$
4,763,364
|
|
|
Investments
|
|
|
|
52,512,293
|
|
48,026,242
|
|
|
Accounts and income
tax receivable
|
|
|
|
4,953,487
|
|
4,305,503
|
|
|
Deferred tax
assets
|
|
|
|
3,072,116
|
|
3,290,122
|
|
|
Working
capital
|
|
|
|
55,895,116
|
|
53,403,332
|
|
|
Total
assets
|
|
|
|
70,297,953
|
|
64,696,280
|
|
|
Long-term
liabilities
|
|
|
|
5,661,179
|
|
6,417,702
|
|
|
Total stockholders'
equity
|
|
|
|
62,097,227
|
|
56,281,943
|
|
|
|
|
|
|
|
|
|
|
|
(1)
The selected consolidated balance sheet information for the year
ended December 31, 2016 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.
|
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SOURCE BioSpecifics Technologies Corp.