LYNBROOK, N.Y., May 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 first quarter ended
March 31, 2018 and provided a
corporate update.
"We are enthusiastic about the sustained year-over-year revenue
growth of our CCH product, XIAFLEX, in its marketed indications,
Dupuytren's Contracture and Peyronie's Disease, and by the
potential progress of the broader CCH development pipeline. During
the first quarter of 2018, XIAFLEX became commercially available in
Canada for Peyronie's Disease and
our partner Endo reported updated data from the Phase 2b clinical trial of CCH for the treatment of
cellulite at the American Society for Aesthetic Plastic Surgery,"
said Thomas L. Wegman, President of
BioSpecifics. "We also remain focused on identifying and developing
CCH for medically necessary indications, and we remain on track to
report preliminary data later this year for our ongoing Phase 1
clinical trial in uterine fibroids, a painful condition of the
reproductive tract in which benign tumors contain large amounts of
collagen and we are excited by the potential of CCH to alleviate
patients' symptoms and ultimately avoid invasive
surgery."
First Quarter 2018 Financial Results
BioSpecifics reported net income of $4.0
million for the first quarter ended March 31, 2018, or $0.55 per basic share and $0.54 per share on a fully diluted basis,
compared to net income of $3.3
million, or $0.47 per basic
share and $0.46 per share on a fully
diluted basis, for the same period in 2017.
The Company adopted Accounting Standard Codification (ASC) 606,
Revenue from Contracts with Customers, as of January 1, 2018, applying the
modified-retrospective method, changed the timing of its
recognition of royalty and mark-up on cost of goods sold revenue.
Beginning in 2018, BioSpecifics recorded these royalty revenues
based on estimates of the net sales and mark-up on cost of goods
sold that occurred during the relevant period thereby eliminating
the previously utilized one quarter lag. Previously, these amounts
were not recognized until they were fixed and determinable. In
addition, deferred revenue associated with the pre-payment of
foreign mark-up on cost of goods sold revenue will no longer be
recognized over time based on sales by non-affiliated sub-licensees
of Endo outside of the U.S. and, under ASC 606, would have been
recognized when the Company amended its License Agreement in 2016.
Prior period amounts have not been adjusted and the Company
recognized a cumulative-effect adjustment to retained earnings on
January 1, 2018 of $10.3 million.
Total revenue for the first quarter ended March 31, 2018 was $7.1
million, compared to $7.7
million for the same period in 2017. The decrease in total
revenues for the quarterly period was primarily due to 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, which was partially offset by an increase in royalties
associated with slightly higher overall net sales of XIAFLEX.
Licensing revenue consists of licensing fees, sublicensing fees
and milestones. BioSpecifics recognized licensing revenue for the
first quarter ended March 31, 2018
and 2017 of approximately $4,409 in
each period.
Research and development (R&D) expenses for the first
quarter ended March 31, 2018 were
$0.2 million compared to $0.3 million for the same period in 2017.
General and administrative expenses for the first quarter ended
March 31, 2018 were $2.1 million, compared to $2.4 million for the same period in 2017.
Provision for income taxes for the first quarter ended
March 31, 2017 were $1.1 million, compared to $1.8 million for the same period in 2017.
As of March 31, 2018, BioSpecifics
had cash and cash equivalents and investments of $64.2 million, compared to $65.1 million as of December 31, 2017. The Company's cash and cash
equivalents and investments were slightly lower due to the timing
of Endo's payment of its quarterly XIAFLEX royalties, which was
received in April 2018.
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.
- In April 2018, Endo presented
clinical data from the Phase 2b study
of CCH for the treatment of cellulite during the Premier Global Hot
Topics session at the annual meeting of the American Society for
Aesthetic Plastic Surgery (ASAPS). A statistically significant
proportion of CCH subjects reported being "Satisfied" or "Very
Satisfied" with their cellulite treatment compared to placebo
subjects. CCH was also well-tolerated by all dose groups. Most
adverse events (AEs) were mild to moderate and primarily limited to
the local injection area such as injection site bruising
(approximately 75 percent) and injection site pain (approximately
59 percent) with 92 percent of all related AEs were mild to
moderate in the CCH group compared to 96 percent in the placebo
group.
- In April 2018, Paladin Labs, a
subsidiary of Endo, announced the commercial availability of
XIAFLEX® in Canada for
the treatment of Peyronie's Disease.
- In February 2018, Endo initiated
two Phase 3 clinical trials of CCH for the treatment of cellulite.
Top-line results 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 later
this year. 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.
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 and whether and when BioSpecifics will release data
from the Phase 1 clinical trial of CCH for the treatment of uterine
fibroids. 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 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
|
|
|
|
|
March
31,
|
|
|
|
|
2018
(1)
|
|
2017
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$7,085,000
|
|
$7,686,210
|
|
|
|
|
Licensing revenue
|
|
4,409
|
|
4,409
|
|
|
|
|
Total
Revenues
|
|
7,089,409
|
|
7,690,619
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
195,227
|
|
254,781
|
|
|
|
|
General
and administrative
|
|
2,069,633
|
|
2,425,717
|
|
|
|
|
Total
costs and expenses
|
|
2,264,860
|
|
2,680,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
4,824,549
|
|
5,010,121
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
217,951
|
|
101,753
|
|
|
|
|
Other,
net
|
|
14,678
|
|
2,562
|
|
|
|
|
|
|
232,629
|
|
104,315
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income
tax expense
|
|
5,057,178
|
|
5,114,436
|
|
|
|
|
Provision for income
tax expense
|
|
(1,078,574)
|
|
(1,769,683)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$
3,978,604
|
|
$
3,344,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
0.55
|
|
$
0.47
|
|
|
|
|
Diluted
|
|
$
0.54
|
|
$
0.46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
7,192,900
|
|
7,164,245
|
|
|
|
|
Diluted
|
|
7,303,336
|
|
7,332,736
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioSpecifics
Technologies Corp.
|
|
|
Selected Condensed
Consolidated Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
|
|
|
2018(1)
|
|
2017
(2)
|
|
|
Cash and cash
equivalents
|
|
|
|
$
12,558,901
|
|
$
7,333,810
|
|
|
Investments
|
|
|
|
51,591,397
|
|
57,719,945
|
|
|
Accounts and income
tax receivable
|
|
|
|
19,165,670
|
|
4,723,838
|
|
|
Deferred tax
assets
|
|
|
|
403,944
|
|
1,739,706
|
|
|
Working
capital
|
|
|
|
78,192,406
|
|
64,241,667
|
|
|
Total
assets
|
|
|
|
86,374,936
|
|
74,996,394
|
|
|
Deferred
revenue
|
|
|
|
117,635
|
|
6,398,687
|
|
|
Total stockholders'
equity
|
|
|
|
81,844,689
|
|
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.
|
|
|
|
|
|
|
|
|
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/biospecifics-technologies-corp-reports-first-quarter-2018-financial-results-300644806.html
SOURCE BioSpecifics Technologies Corp.