LYNBROOK, N.Y., March 15, 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 collagenase
clostridium histolyticum (CCH) marketed as
XIAFLEX® in the U.S. and
Xiapex® in Europe, today announced its
financial results for the fourth quarter and full year ended
December 31, 2016 and provided a
corporate update.
"During 2016, not only did revenues of XIALFEX grow 20 percent
from the prior year, but we were also happy to report positive
Phase 2 data for two pipeline indications, cellulite and human
lipoma. We are continuing to work with our partner Endo to maximize
the potential of XIAFLEX both commercially and clinically and look
forward the initiation of the Phase 3 trials for cellulite in the
second half of this year," said Thomas L.
Wegman, President of BioSpecifics. "Turning to the
development programs that we manage ourselves, the initiation of
our Phase 1 clinical trial in uterine fibroids in the first quarter
of 2017 is very important as it supports our business objective to
develop XIAFLEX for medically necessary indications."
Fourth Quarter and Full Year 2016 Financial Results
BioSpecifics reported net income of $2.9
million for the fourth quarter ended December 31, 2016, or $0.41 per basic share and $0.40 per share on a fully diluted basis,
compared to net income of $2.7
million, or $0.38 per basic
share and $0.36 per share on a fully
diluted basis, for the same period in 2015. For the full year ended
December 31, 2016, the Company
reported a net income of $11.4
million, or $1.61 per basic
share and $1.56 per share on a fully
diluted basis, compared to net income of $9.6 million, or $1.41 per basic share and $1.32 per share on a fully diluted basis for the
same period in 2015.
Total revenue for the fourth quarter ended December 31, 2016 was $6.6
million, compared to $6.1
million for the same period in 2015. For the full year ended
December 31, 2016, total revenue was
$26.3 million, compared to
$22.8 million for the same period in
2015. The increase in total revenues for the quarterly and year-end
periods was primarily due to increased royalties from the sale of
XIAFLEX offset by lower licensing, sublicensing and milestone fees
received by BioSpecifics from its partner Endo International plc
(Endo).
Royalty and mark-up on cost of goods sold (COGS) revenues
recognized under BioSpecifics' agreement with Endo for the fourth
quarter ended December 31, 2016 were
$6.6 million, compared to
$5.2 million for the same period in
2015, an increase of $1.4 million, or
27 percent. Total royalty and mark-up on COGS revenues for the year
ended December 31, 2016 increased to
$25.4 million as compared to
$20.8 million in the same period in
2015. This increase in royalties and the mark-up on COGS in each of
the quarterly and year end periods was primarily due to the
increased sales of XIAFLEX for the treatment of Peyronie's disease
and a moderate increase in sales of XIAFLEX for the treatment of
Dupuytren's contracture reported to us by Endo.
Licensing revenue consists of licensing fees, sublicensing fees
and milestones. BioSpecifics recognized licensing revenue of
approximately $33,000 for the fourth
quarter ended December 31, 2016 as
compared to $0.9 million in the
corresponding 2015 period. Licensing revenue for the year ended
December 31, 2016 was $0.8 million, compared to $1.9 million in the same period in 2015.
Licensing fees recognized for the years ended December 31, 2016 and 2015 were $0.8 million and $1.0
million, respectively. In the 2016 period, licensing fees
recognized of $0.8 million were
related to the exercise of an opt-in right by Endo for the human
lipoma indication. In 2015 period, licensing fees recognized of
$1.0 million were related to the
early opt-in exercise by Endo for XIAFLEX to two new potential
indications, lateral hip fat and plantar fibromatosis.
Milestone revenue recognized for the years ended December 31, 2016 and 2015 were $28,500 and $0.9
million, respectively. The $28,500 milestone revenue recognized in the 2016
period related to the approval of XIAFLEX in Australia for the treatment of Peyronie's
disease by Actelion. The $1.0 million
(net of foreign tax withholding) milestone revenue recognized in
the 2015 period related to the first commercial sale of XIAFLEX by
Asahi for the treatment of Dupuytren's contracture in Japan.
In addition, for the years ended 2016 and 2015, the Company
recognized certain licensing fees related to the cash payments
received under the agreement with Endo in prior years and amortized
them over the expected development period of approximately
$41,000 and $49,000, respectively.
Research and development (R&D) expenses for the fourth
quarter ended December 31, 2016 and
2015 were $0.3 million in each
period. For the year ended December 31,
2016, research and development expenses were $1.3 million, compared to $1.0 million in the same period in 2015.
General and administrative expenses for the fourth quarter ended
December 31, 2016 and 2015 were
$2.0 million in each period. For the
year ended December 31, 2016, general
and administrative expenses were $7.9
million, compared to $7.3
million in the same period in 2015.
Provision for income taxes for the fourth quarter ended
December 31, 2016 were $1.5 million, compared to $1.3 million for the same period in 2015. For the
year ended December 31, 2016,
provision for income taxes were $6.0
million as compared to $4.9
million in the same period of 2015.
As of December 31, 2016,
BioSpecifics had cash and cash equivalents and investments of
$52.8 million, compared to
$37.1 million as of December 31, 2015.
XIAFLEX Commercial Highlights
On February 28, 2017, Endo
reported commercial highlights for XIAFLEX for the fourth quarter
and full year of 2016 (Endo's fourth quarter 2016 financials are
reported in BioSpecifics' first quarter 2017 financials). For the
fourth quarter of 2016, net revenues were $55.5 million compared to $50.2 million in the fourth quarter of 2015, an
11 percent growth. Full year 2016 net revenues were $189.7 million compared to $158.1 million for the full year of 2015, a 20
percent growth. Endo expects high-single to low-double-digit
revenue growth in 2017.
XIAFLEX Pipeline Updates and Anticipated Upcoming
Milestones
BioSpecifics manages the development of XIAFLEX for uterine
fibroids, and initiates 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.
- BioSpecifics expects to initiate a Phase 1 clinical trial of
XIAFLEX in uterine fibroids in the first quarter of 2017. This
open-label dose escalation Phase 1 study will enroll 15 female
subjects treated prior to hysterectomy and is being conducted at
the Department of Gynecology & Obstetrics at Johns Hopkins University. Three subjects will be
injected with saline only to evaluate the safety and effectiveness
of the injection method and the remaining 12 subjects will be
injected with increasing doses of XIAFLEX. The primary endpoint
will assess the safety and tolerability of a single injection
directly into the uterine lipomas at three doses under transvaginal
ultrasound guidance. The secondary endpoints will assess symptoms
of pain and bleeding, quality of life throughout the study,
shrinkage of treated fibroids in size, increased rates of apoptosis
in treated fibroids and a decrease in the collagen content of
treated fibroids.
- In November 2016, the Company
reported positive, statistically significant results from a Phase
2b study for the treatment of cellulite, or edematous
fibrosclerotic panniculopathy. Trial subjects receiving XIAFLEX
showed statistically significant levels of improvement in the
appearance of cellulite with treatment, as measured by the trial's
primary endpoint (p<0.001), compared to those subjects receiving
placebo. Endo has announced that it is planning to publish the full
Phase 2b data and to initiate Phase 3 clinical trials in this
indication in the second half of 2017.
- In June 2016, BioSpecifics
reported positive, statistically significant, top-line results from
a placebo-controlled, double-blind Phase 2 clinical trial for the
treatment of human lipoma. The trial met its primary endpoint of
reduction in the visible surface area of the target lipomas
relative to placebo, as determined by caliper, at six months post
injection (p<0.0001). In July
2016, Endo notified BioSpecifics that it was exercising its
right to opt-in for this indication, bringing their total number of
licensed indications to eight.
- A commercial assessment of additional indications, 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 twelve 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 plans to
initiate clinical development in the first quarter of 2017. 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 and when
Endo will publish full Phase 2b data and initiate Phase 3 clinical
trials in cellulite; the timing of the Company's initiation of a
Phase 1 clinical trial in uterine fibroids; whether Endo will
achieve high-single to low-double-digit revenue growth in 2017; the
outcome of Endo's commercial assessment regarding the XIAFLEX
R&D pipeline. 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, 2015, Quarterly Reports
on Form 10-Q for the quarters ended June 30,
2016 and September 30, 2016
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.
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Twelve months
ended
|
|
|
December
31
|
|
December
31
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
(Unaudited)
|
|
(Audited)
|
Royalties
|
|
6,587,739
|
|
5,226,523
|
|
25,431,012
|
|
20,800,757
|
Licensing revenue
|
|
32,909
|
|
912,344
|
|
819,943
|
|
1,949,378
|
Total
Revenues
|
|
6,620,648
|
|
6,138,867
|
|
26,250,955
|
|
22,750,135
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
322,039
|
|
279,250
|
|
1,327,923
|
|
1,034,288
|
General
and administrative
|
|
1,986,831
|
|
1,965,101
|
|
7,896,616
|
|
7,272,532
|
Total
costs and expenses
|
|
2,308,870
|
|
2,244,351
|
|
9,224,539
|
|
8,306,820
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
4,311,778
|
|
3,894,516
|
|
17,026,416
|
|
14,443,315
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
95,079
|
|
33,980
|
|
295,783
|
|
92,926
|
Other,
net
|
|
15,357
|
|
8,609
|
|
52,805
|
|
14,719
|
|
|
110,436
|
|
42,589
|
|
348,588
|
|
107,645
|
|
|
|
|
|
|
|
|
|
Income before
provision for income taxes
|
|
4,422,214
|
|
3,937,105
|
|
17,375,004
|
|
14,550,960
|
Provision for Income taxes
|
|
(1,505,406)
|
|
(1,278,556)
|
|
(6,002,765)
|
|
(4,933,328)
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$
2,916,808
|
|
$
2,658,549
|
|
$
11,372,239
|
|
$
9,617,632
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.41
|
|
$
0.38
|
|
$
1.61
|
|
$
1.41
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
0.40
|
|
$
0.36
|
|
$
1.56
|
|
$
1.32
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
7,151,752
|
|
6,915,929
|
|
7,061,404
|
|
6,827,355
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
7,295,239
|
|
7,311,514
|
|
7,283,262
|
|
7,272,989
|
BioSpecifics
Technologies Corp.
|
Selected
Consolidated Balance Sheet Data(1)
|
|
|
|
|
|
|
December
31
|
|
2016
|
|
2015
|
Cash and cash
equivalents
|
$
4,763,364
|
|
$
5,137,875
|
Investments
|
48,026,242
|
|
31,944,083
|
Accounts and income
tax receivable
|
4,305,503
|
|
3,464,763
|
Deferred tax
assets
|
3,290,122
|
|
622,972
|
Working
capital
|
53,403,332
|
|
37,530,357
|
Total
assets
|
64,696,280
|
|
45,698,113
|
Deferred
revenue
|
7,597,550
|
|
198,757
|
Total stockholders'
equity
|
56,281,943
|
|
44,810,209
|
|
|
|
|
|
|
|
|
(1)The selected consolidated
balance sheets for the years ended December 31, 2016 and 2015 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.