LYNBROOK, N.Y., Nov. 10, 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 third quarter ended September 30, 2017 and provided a corporate
update.
"BioSpecifics continues to make important progress as we remain
focused on further developing XIAFLEX for the treatment of serious
medical conditions. We are excited about the potential of our
ongoing Phase 1 trial of XIAFLEX for the treatment of uterine
fibroids and look forward to reporting data in 2018," said
Thomas L. Wegman, President of
BioSpecifics. "Additionally, we look forward to our partner Endo
initiating Phase 3 trials of XIAFLEX for the treatment of cellulite
in the coming months."
Third Quarter 2017 Financial Results
BioSpecifics reported net income of $2.7
million for the third quarter ended September 30, 2017, or $0.38 per basic share and $0.37 per share on a fully diluted basis,
compared to net income of $3.1
million, or $0.43 per basic
share and $0.42 per share on a fully
diluted basis, for the same period in 2016.
Total revenue for the third quarter ended September 30, 2017 was $6.5 million, compared to $6.9 million for the same period in 2016. Royalty
revenue increased by $0.4 million for
the 2017 quarter as compared to the 2016 quarter primarily due to
increased sales of XIAFLEX for the treatment of Peyronie's disease
and Dupuytren's contracture, whereas total revenue was lower due to
the exercise of an opt-in right by Endo for the human lipoma
indication of $750,000 in the 2016
period.
Research and development expenses for the third quarter ended
September 30, 2017 were $0.4 million compared to $0.3 million for the same period in 2016.
General and administrative expenses for the third quarter ended
September 30, 2017 were $2.2 million compared to $1.8 million for the same period in 2016.
Provision for income taxes for the third quarter ended
September 30, 2017 were $1.5 million, compared to $1.8 million for the same period in 2016.
As of September 30, 2017,
BioSpecifics had cash and cash equivalents and investments of
$61.3 million, compared to
$52.8 million as of December 31, 2016.
XIAFLEX Commercial Highlights
On November 9, 2017, Endo reported
commercial highlights for XIAFLEX for the third quarter of 2017
(Endo's third quarter 2017 financials are reported in BioSpecifics'
fourth quarter 2017 financials). For the third quarter of 2017,
total revenues were $52.5 million
compared to $47.7 million in the
third quarter of 2016, an 10 percent growth. Endo continues to
expect high-single to low-double digit revenue growth for sales of
XIAFLEX in 2017.
Endo announced a partnership with Tim
Herron, a four-time PGA Tour winner, and Damon Adamany, MD, of the CORE Institute,
launched Facts on Hand, an unbranded campaign to raise awareness of
Dupuytren's Contracture, a progressive, potentially disfiguring
hand condition. Endo also recently launched several
direct-to-consumer initiatives intended to increase patient
awareness of XIAFLEX as a possible treatment option for Dupuytren's
Contracture and Peyronie's Disease.
XIAFLEX Pipeline Updates and Anticipated Upcoming
Milestones
BioSpecifics manages the development of XIAFLEX for the
treatment of uterine fibroids. The Phase 1 clinical trial is
currently enrolling. BioSpecifics 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.
- The Phase 1 clinical trial of XIAFLEX for the treatment of
uterine fibroids is ongoing and BioSpecifics plans to announce
results in 2018. The study, being conducted at the Department of
Gynecology & Obstetrics at Johns Hopkins
University, is designed to enroll 15 subjects administered
XIAFLEX prior to hysterectomy. The primary endpoint of the study
will assess the safety and tolerability of a single injection of
XIAFLEX directly into the uterine fibroid under transvaginal
ultrasound guidance. The secondary endpoints will assess symptoms
of pain and bleeding, quality of life throughout the study as well
as size, collagen content and rate of apoptosis of XIAFLEX treated
fibroids.
- Endo plans to initiate Phase 3 clinical trials of XIAFLEX for
the treatment of cellulite in the coming months following
discussions with the U.S. Food and Drug Administration.
- Endo continues its commercial review of additional
indications.
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 Paladin Labs, Sobi,
Actelion and Asahi Kasei for Dupuytren's contracture and/or
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. 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 Reports on Form 10-Q for
the quarters ended March 31, 2017 and June 30, 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
|
|
Nine months
ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$6,511,700
|
|
$6,119,815
|
|
$20,729,017
|
|
$18,843,273
|
Licensing revenue
|
|
4,408
|
|
762,345
|
|
13,226
|
|
787,034
|
Total
Revenues
|
|
6,516,108
|
|
6,882,160
|
|
20,742,243
|
|
19,630,307
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
356,847
|
|
312,907
|
|
949,359
|
|
1,005,884
|
General
and administrative
|
|
2,175,501
|
|
1,843,368
|
|
6,916,501
|
|
5,909,785
|
Total
costs and expenses
|
|
2,532,348
|
|
2,156,275
|
|
7,865,860
|
|
6,915,669
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
3,983,760
|
|
4,725,885
|
|
12,876,383
|
|
12,714,638
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
193,462
|
|
80,674
|
|
436,210
|
|
200,704
|
Other,
net
|
|
14,667
|
|
6,254
|
|
40,651
|
|
37,448
|
|
|
208,129
|
|
86,928
|
|
476,861
|
|
238,152
|
|
|
|
|
|
|
|
|
|
Income before income
tax expense
|
|
4,191,889
|
|
4,812,813
|
|
13,353,244
|
|
12,952,790
|
Provision for income
tax expense
|
|
(1,477,057)
|
|
(1,759,220)
|
|
(4,669,569)
|
|
(4,497,359)
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$2,714,832
|
|
$3,053,593
|
|
$8,683,675
|
|
$8,455,431
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$0.38
|
|
$0.43
|
|
$1.21
|
|
$1.20
|
Diluted
|
|
$0.37
|
|
$0.42
|
|
$1.19
|
|
$1.16
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
7,164,934
|
|
7,062,543
|
|
7,166,470
|
|
7,031,068
|
Diluted
|
|
7,314,609
|
|
7,280,375
|
|
7,325,602
|
|
7,277,780
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioSpecifics
Technologies Corp.
|
|
|
Selected Condensed
Consolidated Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
|
|
2017
|
|
2016
(1)
|
|
|
Cash and cash
equivalents
|
|
|
|
$
6,422,358
|
|
$
4,763,364
|
|
|
Investments
|
|
|
|
54,883,779
|
|
48,026,242
|
|
|
Accounts and income
tax receivable
|
|
|
|
4,738,815
|
|
4,305,503
|
|
|
Deferred tax
assets
|
|
|
|
2,992,001
|
|
3,290,122
|
|
|
Working
capital
|
|
|
|
59,569,454
|
|
53,403,332
|
|
|
Total
assets
|
|
|
|
72,260,984
|
|
64,696,280
|
|
|
Long-term
liabilities
|
|
|
|
5,555,743
|
|
6,417,702
|
|
|
Total stockholders'
equity
|
|
|
|
64,707,797
|
|
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.