LYNBROOK, N.Y., March 14, 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 fourth quarter and full
year ended December 31, 2017 and
provided a corporate update.
"2018 is off to a solid start with the Phase 3 cellulite trials
for CCH now initiated and positive interim data recently presented
for our ongoing Phase 1 uterine fibroids trial, which is advancing
toward a top-line data readout this year. In 2017, we continued to
be pleased with our royalty revenues from XIAFLEX net sales and
look forward to the continued growth of this product and the
ongoing profitability of our business," said Thomas L. Wegman, President of BioSpecifics. "In
2018, we will also continue to work with our partner Endo to ensure
that XIAFLEX and CCH are able to fulfill their commercial
and clinical potential."
Fourth Quarter and Full Year 2017 Financial Results
BioSpecifics reported net income of $2.6
million for the fourth quarter ended December 31, 2017, or $0.37 per basic share and $0.36 per share on a fully diluted basis,
compared to net income of $2.9
million, or $0.41 per basic
share and $0.40 per share on a fully
diluted basis, for the same period in 2016. For the full year ended
December 31, 2017, the Company
reported a net income of $11.3
million, or $1.58 per basic
share and $1.55 per share on a fully
diluted basis, compared to net income of $11.4 million, or $1.61 per basic share and $1.56 per share on a fully diluted basis for the
same period in 2016.
Total revenue for the fourth quarter ended December 31, 2017 was $6.7
million, compared to $6.6
million for the same period in 2016. For the full year ended
December 31, 2017, total revenue was
$27.4 million, compared to
$26.3 million for the same period in
2016. The increase in total revenues for the quarterly and year-end
periods was primarily due to royalty revenues related to the net
sales of XIAFLEX.
Royalty and mark-up on cost of goods sold (COGS) revenues
recognized under BioSpecifics' agreement with Endo for the fourth
quarter ended December 31, 2017 were
$6.7 million compared to $6.6 million for the same period in 2016, an
increase of $0.1 million or 2
percent. Total royalty and mark-up on COGS revenues for the year
ended December 31, 2017 increased to
$27.4 million as compared to
$25.4 million in the same period in
2016. This increase in royalties and the mark-up on COGS in each
quarterly and year end periods was primarily due to royalty
revenues related to the net sales of XIAFLEX.
Licensing revenue consists of licensing fees, sublicensing fees
and milestones. BioSpecifics recognized licensing revenue for the
fourth quarter ended December 31,
2017 and 2016 of approximately $4,000 in each period.
Licensing fees recognized for the years ended December 31, 2017 and 2016 were $18,000 and $0.8
million, respectively. In the 2017 period, licensing fees
recognized were related to the cash payments received under the
agreement with Endo in prior years and amortized over the expected
development period. In the 2016 period, licensing fees of
$0.8 million were recognized related
to the exercise of an opt-in right by Endo for the human lipoma
indication.
Milestone revenue recognized for the years ended December 31, 2017 and 2016 was zero and
$28,500, 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.
Research and development (R&D) expenses for the fourth
quarter ended December 31, 2017 and
2016 were $0.3 million in each
period. For the year ended December 31,
2017, R&D expenses were $1.2
million, compared to $1.3
million in the same period in 2016.
General and administrative expenses for the fourth quarter ended
December 31, 2017 were $1.6 million, compared to $2.0 million for the same period in 2016. For the
year ended, December 31, 2017,
general and administrative expenses were $8.5 million, compared to $7.9 million in the same period in 2016.
Provision for income taxes for the fourth quarter ended
December 31, 2017 were $2.4 million, compared to $1.5 million for the same period in 2016. For the
year ended December 31, 2017,
provision for income taxes were $7.0
million as compared to $6.0
million in the same period of 2016. The increase in 2017 as
compared to 2016 was primarily due to the Company's initial
analysis of the Tax Cuts and Job Act. The Company has made
reasonable estimates of its 2017 impact and due to the federal
corporate rate reduction, a re-measurement of deferred tax assets
and liabilities resulted in the recording of a charge of
approximately $1.1 million.
As of December 31, 2017,
BioSpecifics had cash and cash equivalents and investments of
$65.1 million, compared to
$52.8 million as of December 31, 2016.
XIAFLEX Commercial Highlights
On February 27, 2018, Endo
reported commercial highlights for XIAFLEX for the fourth quarter
and full year of 2017 (Endo's fourth quarter 2017 financials are
reported in BioSpecifics' first quarter 2018 financials). For the
fourth quarter of 2017, net revenues were $61.3 million compared to $55.5 million for the fourth quarter of 2016, a
10 percent increase, primarily driven by a full year of
direct-to-consumer initiatives intended to increase patient
awareness. Full year 2017 net revenues were $213.4 million compared to $189.7 million for the full year of 2016, a 12
percent increase.
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 presented interim data from the ongoing Phase 1
study of CCH for the treatment of uterine fibroids in a poster on
March 9, 2018 at the Society for
Reproductive Investigation's 65th Annual Scientific Meeting in
San Diego, CA. The data show the
safety and effectiveness of the injection method in five patients.
Three patients were injected with CCH and underwent a hysterectomy
24-96 hours after the injection. Two patients subsequently were
injected with a higher dose of collagenase, and underwent a
hysterectomy 63 days after the injection. The collagenase-treated
tissue samples showed not only the reduction of collagen content
but also the disruption of the tissue pattern, while in control
tissues the collagen remained abundant and compact. The digestion
of collagen did not extend beyond the capsule of any fibroid. No
adverse event occurred in these patients.
- In February 2018, Endo announced
the initiation of two pivotal Phase 3 RELEASE clinical trials of
CCH for the treatment of cellulite. These multicenter, randomized,
double-blind, placebo-controlled studies will evaluate the safety
and efficacy of CCH in reducing the appearance of cellulite. These
two U.S. studies are expected to enroll 840 women, 420 per trial,
aged 18 years or older with moderate-to-severe buttock cellulite.
Each subject will receive up to three treatments in which CCH, 0.84
mg per treatment area, or placebo will be administered. The two
treatment areas include the left and right buttock. Each treatment
visit will occur approximately 21 days apart. A total of 12
injections will be administered into cellulite dimples per
treatment area per visit. Cellulite severity will be assessed at
the beginning and conclusion of treatment. The assessments will be
conducted by each patient and clinician using two validated
photonumeric cellulite severity scales developed by Endo and
third-party psychometric experts. The primary endpoint of the
studies is a composite responder analysis demonstrating at least a
2-level composite improvement on the photonumeric cellulite
severity scale, independently reported by both the patient and
clinician. Key secondary endpoints include the percentage of
subjects that experience at least a 1-level or 2-level improvement
in patient reported assessment, percentage of subjects with a
1-level composite improvement, percentage of satisfied subjects,
change from baseline in a cellulite impact scale and the percentage
of subjects with at least a 1-level or 2-level improvement in the
global aesthetic improvement scale (GAIS).
- Top-line results for the Phase 3 trials of CCH for cellulite
are expected in the first quarter of 2019.
- BioSpecifics is conducting an ongoing Phase 1 clinical trial of
CCH for the treatment of uterine fibroids with data expected in
2018. This Phase 1 open-label dose escalation study is being
conducted at the Department of Gynecology & Obstetrics at
Johns Hopkins University and is
designed to enroll 15 female subjects treated prior to
hysterectomy. The trial's primary endpoint will assess the safety
and tolerability of a single injection of CCH 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 in addition to size, collagen
content and rate of apoptosis of CCH treated fibroids.
- Endo continues its commercial review of additional licensed
indications, including adhesive capsulitis (frozen shoulder) and
plantar fibromatosis.
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. The CCH research and development pipeline
includes several additional promising indications. BioSpecifics is
managing the development of CCH for uterine fibroids and is
conducting a Phase 1 clinical trial. 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 top-line results for the Phase 3 trials of CCH
for cellulite; whether and when BioSpecifics will release data from
the Phase 1 clinical trial of CCH for the treatment of uterine
fibroids; and 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, 2016, Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2017,
June 30, 2017 and September 30, 2017 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
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
(Unaudited)
|
|
(Audited)
|
Royalties
|
|
$
6,697,100
|
|
$
6,587,739
|
|
$
27,426,117
|
|
$
25,431,012
|
Licensing revenue
|
|
4,409
|
|
32,909
|
|
17,635
|
|
819,943
|
Total
Revenues
|
|
6,701,509
|
|
6,620,648
|
|
27,443,752
|
|
26,250,955
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
273,918
|
|
322,039
|
|
1,223,277
|
|
1,327,923
|
General
and administrative
|
1,625,823
|
|
1,986,832
|
|
8,542,324
|
|
7,896,616
|
Total
costs and expenses
|
1,899,741
|
|
2,308,871
|
|
9,765,601
|
|
9,224,539
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
4,801,768
|
|
4,311,777
|
|
17,678,151
|
|
17,026,416
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
200,358
|
|
95,079
|
|
636,568
|
|
295,783
|
Other,
net
|
|
10,422
|
|
15,357
|
|
51,074
|
|
52,805
|
|
|
210,780
|
|
110,436
|
|
687,642
|
|
348,588
|
|
|
|
|
|
|
|
|
|
Income before
provision for income taxes
|
5,012,548
|
|
4,422,213
|
|
18,365,793
|
|
17,375,004
|
Provision for Income taxes
|
(2,367,958)
|
|
(1,505,406)
|
|
(7,037,527)
|
|
(6,002,765)
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$
2,644,590
|
|
$
2,916,807
|
|
$
11,328,266
|
|
$
11,372,239
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.37
|
|
$
0.41
|
|
$
1.58
|
|
$
1.61
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
0.36
|
|
$
0.40
|
|
$
1.55
|
|
$
1.56
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
Basic
|
|
7,183,255
|
|
7,151,752
|
|
7,170,701
|
|
7,061,404
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
7,309,469
|
|
7,295,239
|
|
7,321,805
|
|
7,283,262
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioSpecifics
Technologies Corp.
|
Selected
Consolidated Balance Sheet Data(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31
|
|
|
|
|
2017
|
|
2016
|
Cash and cash
equivalents
|
|
|
|
$
7,333,810
|
|
$
4,763,364
|
Investments
|
|
|
|
57,719,945
|
|
48,026,242
|
Accounts and income
tax receivable
|
|
4,723,838
|
|
4,305,503
|
Deferred tax
assets
|
|
|
|
1,739,706
|
|
3,290,122
|
Working
capital
|
|
|
|
64,241,667
|
|
53,403,332
|
Total
assets
|
|
|
|
74,996,394
|
|
64,696,280
|
Deferred
revenue
|
|
|
|
6,398,687
|
|
7,597,550
|
Total stockholders'
equity
|
|
|
|
67,516,838
|
|
56,281,943
|
|
|
|
|
|
|
|
(1)The selected consolidated
balance sheets for the years ended December 31, 2017 and 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.