LYNBROOK, N.Y., Aug. 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 second quarter ended
June 30, 2018 and provided a
corporate update.
"The first half of 2018 was a period of significant clinical
development for XIAFLEX. We continued to focus on the execution of
our ongoing Phase 1 clinical trial in uterine fibroids and have now
completed patient enrollment. Uterine fibroids are the most
prevalent tumor of the female reproductive tract, for which
non-invasive treatment options are very limited, and we expect to
report top-line data later this year. Additionally, our partner Our
Endo reported rapid enrollment in the second quarter for the Phase
3 clinical trials for the treatment of cellulite, and we now
anticipate top-line data in the fourth quarter of 2018," said
Thomas L. Wegman, President of
BioSpecifics. "On the commercial front, we were also pleased with
the sustained revenue growth and continued efforts of the direct to
consumer advertising campaigns for XIAFLEX in its two commercial
indications, Dupuytren's Contracture and Peyronie's Disease, and we
reported second quarter 2018 revenues of $7.1 million. These revenues were driven by
Endo's reported 27 percent revenue growth year-over-year and our
partner also increased their full year revenue guidance into the
high-teens percentage growth range."
Second Quarter 2018 Financial Results
BioSpecifics reported net income of $4.3
million for the second quarter ended June 30, 2018, or $0.60 per basic share and $0.59 per share on a fully diluted basis,
compared to net income of $2.6
million, or $0.37 per basic
share and $0.36 per share on a fully
diluted basis, for the same period in 2017.
Total revenue for the second quarter ended June 30, 2018 was $7.1
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 an increase
in royalties associated with higher net sales of XIAFLEX which was
partially offset by lower mark-up on cost of goods sold revenue in
the U.S and 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
second quarter ended June 30, 2018 of
$35,270 and $4,409 for the same period in 2017.
Research and development (R&D) expenses for the second
quarter ended June 30, 2018 were
$0.2 million compared to $0.3 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,
preclinical and other R&D programs.
General and administrative expenses for the second quarter ended
June 30, 2018 were $2.0 million, compared to $2.3 million for the same period in 2017. The
decrease in general and administrative expenses was mainly due to
the lower consulting and patent fees partially offset by higher
amortization associated with deferred royalty buy-down and
third-party royalties associated with XIAFLEX.
Provision for income taxes for the second quarter ended
June 30, 2018 were $1.0 million, compared to $1.4 million for the same period in 2017.
As of June 30, 2018, BioSpecifics
had cash and cash equivalents and investments of $73.7 million, compared to $65.1 million as of December 31, 2017.
The BioSpecifics Board of Directors has authorized an increase
in the repurchase amount in the Company's stock repurchase program,
previously approved by the Board in August
2015, under which BioSpecifics is authorized to repurchase
up to $3.0 million of its outstanding
common stock. This decision reflects BioSpecifics' positive outlook
for the future, confidence it will remain profitable on an ongoing
annual basis and its continued commitment to increasing value for
its stockholders.
Pursuant to the repurchase program, BioSpecifics plans to
repurchase stock through a broker in the open market, provided that
the timing, actual number and price per share of the common stock
to be purchased will be subject to market conditions, applicable
legal requirements, including Rule 10b-18 of the Securities Exchange Act of 1934, as
amended, and various other factors. BioSpecifics intends to hold
any reacquired stock in treasury. The repurchase program may be
suspended or discontinued at any time by the Board of Directors.
BioSpecifics has no obligation to repurchase common stock under the
repurchase program.
As of June 30, 2018, BioSpecifics
had 7,244,233 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.
- Endo is conducting two ongoing Phase 3 clinical trials of CCH
for the treatment of cellulite. Top-line results are expected in
the fourth quarter of 2018.
- BioSpecifics has completed patient enrollment in its Phase 1
clinical trial of CCH for the treatment of uterine fibroids with
top-line data expected in late 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 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.
- 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. 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, whether Endo will meet
its projected fiscal year 2018 growth for XIAFLEX, whether
BioSpecifics will achieve its corporate goals and remain profitable
on an ongoing basis, the plans for the repurchase of stock and
reacquired stock, and the suspension or discontinuation of the
repurchase program. 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 Report
on Form 10-Q for the quarter ended March 31,
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
|
|
Six months
ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2018(1)
|
|
2017
|
|
2018(1)
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$7,061,139
|
|
$6,531,107
|
|
$14,146,139
|
|
$14,217,317
|
Licensing revenue
|
|
35,270
|
|
4,409
|
|
39,679
|
|
8,818
|
Total
Revenues
|
|
7,096,409
|
|
6,535,516
|
|
14,185,818
|
|
14,226,135
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
211,796
|
|
337,731
|
|
407,023
|
|
592,512
|
General
and administrative
|
|
1,985,212
|
|
2,315,283
|
|
4,054,845
|
|
4,741,000
|
Total
costs and expenses
|
|
2,197,008
|
|
2,653,014
|
|
4,461,868
|
|
5,333,512
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
4,899,401
|
|
3,882,502
|
|
9,723,950
|
|
8,892,623
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
273,746
|
|
140,995
|
|
491,697
|
|
242,748
|
Other,
net
|
|
81,985
|
|
23,423
|
|
96,663
|
|
25,985
|
|
|
355,731
|
|
164,418
|
|
588,360
|
|
268,733
|
|
|
|
|
|
|
|
|
|
Income before income
tax expense
|
|
5,255,132
|
|
4,046,920
|
|
10,312,310
|
|
9,161,356
|
Provision for income
tax expense
|
|
(954,465)
|
|
(1,422,829)
|
|
(2,033,039)
|
|
(3,192,512)
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$
4,300,667
|
|
$
2,624,091
|
|
$
8,279,271
|
|
$
5,968,844
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.60
|
|
$
0.37
|
|
$
1.15
|
|
$
0.83
|
Diluted
|
|
$
0.59
|
|
$
0.36
|
|
$
1.13
|
|
$
0.81
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
7,215,057
|
|
7,170,223
|
|
7,204,040
|
|
7,167,251
|
Diluted
|
|
7,315,276
|
|
7,329,118
|
|
7,309,325
|
|
7,330,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioSpecifics
Technologies Corp.
|
|
|
Selected Condensed
Consolidated Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
|
2018(1)
|
|
2017
(2)
|
|
|
Cash and cash
equivalents
|
|
|
|
$
12,960,475
|
|
$
7,333,810
|
|
|
Investments
|
|
|
|
60,749,407
|
|
57,719,945
|
|
|
Accounts
receivable
|
|
|
|
12,893,893
|
|
4,655,105
|
|
|
Deferred tax
assets
|
|
|
|
321,603
|
|
1,739,706
|
|
|
Working
capital
|
|
|
|
79,008,754
|
|
64,241,667
|
|
|
Total
assets
|
|
|
|
89,330,315
|
|
74,996,394
|
|
|
Long-term
liabilities
|
|
|
|
-
|
|
5,340,708
|
|
|
Total stockholders'
equity
|
|
|
|
86,936,808
|
|
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.
|
|
|
|
|
|
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SOURCE BioSpecifics Technologies Corp.