WILIMINGTON, Del., March 16, 2020
/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
North America, today announced its
financial results for the fourth quarter and full year ended
December 31, 2019 and provided a
corporate update.
![](https://mma.prnewswire.com/media/1134448/BioSpecifics_Technologies_Corp_Logo.jpg)
"BioSpecifics generated strong growth in 2019. We reported a 16%
increase in royalty revenue received from our partner Endo's sales
of XIAFLEX® and our fully diluted earnings per share
grew by 22%. Looking forward, we have a number of reasons to be
enthusiastic about the future growth potential for
XIAFLEX®. First, the market for XIAFLEX® in
Dupuytren's contracture and Peyronie's disease continues to expand,
second the FDA's decision on Endo's new BLA for the treatment of
cellulite is expected in July 2020
and third Endo has announced the commencement of development
programs in two new indications, adhesive capsulitis and plantar
fibromatosis," said J. Kevin Buchi,
chief executive officer of BioSpecifics. "Operating from a position
of sound financial strength, we intend to explore opportunities
beyond XIAFLEX®."
Fourth Quarter and Full Year 2019 Financial Results
BioSpecifics reported net income of $7.3
million for the fourth quarter ended December 31, 2019, or $1.00 per basic share and $1.00 per share on a fully diluted basis,
compared to net income of $6.2
million, or $0.85 per basic
share and $0.84 per share on a fully
diluted basis, for the same period in 2018. For the full year ended
December 31, 2019, the Company
reported a net income of $24.5
million, or $3.34 per basic
share and $3.33 per share on a fully
diluted basis, compared to a net income of $20.1 million, or $2.77 per basic share and $2.73 per share on a fully diluted basis for the
same period in 2018.
Total revenue for the fourth quarter ended December 31, 2019 was $11.8 million, compared to $9.9 million for the same period in 2018. For the
full year ended December 31, 2019,
total revenue was $38.2 million,
compared to $33.0 million for the
same period in 2018.
As of December 31, 2019,
BioSpecifics had cash and cash equivalents and investments of
$105.8 million, compared to
$82.0 million as of December 31, 2018.
As of December 31, 2019,
BioSpecifics had 7,339,578 million shares of common stock
outstanding.
Commercial & Pipeline Highlights and Anticipated Upcoming
Milestones
- BioSpecifics' Royalty Revenues from the XIAFLEX®
Commercial Franchise Grew by 16% Year-Over-Year for 2019:
XIAFLEX® royalty revenue growth was attributable to
royalties associated with higher net sales of XIAFLEX®
by Endo International plc (Endo), in Dupuytren's contracture and
Peyronie's disease.
- Net Sales of XIAFLEX® Expected to Continue to
Grow in 2020: BioSpecifics' partner, Endo, expects that
XIAFLEX® full year revenue growth will be approximately
20 percent in 2020.
- Endo's Biologics License Application (BLA) filing for CCH
for Treatment of Cellulite Accepted by U.S. Food and Drug
Administration (FDA) in November
2019: On November 19,
2019, the FDA accepted for review the original BLA for CCH
for the treatment of cellulite in the buttocks. The Prescription
Drug User Fee Act (PDUFA) date for the BLA, has been set for
July 6, 2020.
- Development in Two New Indications, Adhesive Capsulitis and
Plantar Fibromatosis, Announced in 2020: Endo announced in 2020
that it expects to begin development in two new indications,
adhesive capsulitis and plantar fibromatosis. Adhesive capsulitis,
also known as frozen shoulder, is an inflammation and thickening of
the shoulder capsule due to collagen which causes decreased motion
in the shoulder. Plantar fibromatosis is a non-malignant thickening
of the feet's deep connective tissue or fascia. There are currently
no FDA-approved pharmaceutical therapies available to treat either
condition.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a commercial-stage
biopharmaceutical company. The company discovered and developed a
proprietary form of injectable collagenase (CCH) which is currently
marketed by BioSpecifics' partner, Endo International plc (Endo),
as XIAFLEX® in North
America for the treatment of Dupuytren's contracture and
Peyronie's disease. Endo expects a commercial approval in the
second half of 2020 for a third CCH indication, cellulite, subject
to U.S. Food and Drug Administration approval. The CCH research and
development pipeline includes several additional potential
indications; adhesive capsulitis, plantar fibromatosis and uterine
fibroids. 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, shareholder value, expected
revenue growth, the effect of recent management and board
leadership changes, and the assumptions underlying or relating to
such statements, are "forward-looking statements." These
forward-looking statements include statements regarding the timing
of, the approval by the FDA, and the commercial launch of CCH for
the treatment of cellulite. 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, but not
limited to: the timing of regulatory filings and action; the
ability of Endo to achieve its objectives for XIAFLEX®; 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 the Company's Annual Report on
Form 10-K for the year ended December 31,
2018 (the "2018 Annual Report"), specifically in Part I,
Item IA under the heading "Risk Factors" of the 2018 Annual Report
and risk factors identified in our other filings 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
|
|
Year
ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$11,763,375
|
|
$9,853,179
|
|
$38,187,755
|
|
$32,921,764
|
Licensing revenue
|
|
-
|
|
-
|
|
-
|
|
39,679
|
Total
Revenues
|
|
11,763,375
|
|
9,853,179
|
|
38,187,755
|
|
32,961,443
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
136,289
|
|
187,128
|
|
590,331
|
|
756,776
|
General
and administrative
|
|
2,672,010
|
|
2,460,327
|
|
9,285,372
|
|
8,805,989
|
Total
costs and expenses
|
|
2,808,299
|
|
2,647,455
|
|
9,875,703
|
|
9,562,765
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
8,955,076
|
|
7,205,724
|
|
28,312,052
|
|
23,398,678
|
|
|
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
515,107
|
|
443,317
|
|
1,986,855
|
|
1,294,651
|
Other,
net
|
|
-
|
|
7,285
|
|
(259)
|
|
103,948
|
|
|
515,107
|
|
450,602
|
|
1,986,596
|
|
1,398,599
|
|
|
|
|
|
|
|
|
|
Income before income
tax expense
|
|
9,470,183
|
|
7,656,326
|
|
30,298,648
|
|
24,797,277
|
Provision for income
tax expense
|
|
(2,116,363)
|
|
(1,472,642)
|
|
(5,828,840)
|
|
(4,744,008)
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$
7,353,820
|
|
$
6,183,684
|
|
$
24,469,808
|
|
$
20,053,269
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
1.00
|
|
$
0.85
|
|
$
3.35
|
|
$
2.77
|
Diluted
|
|
$
1.00
|
|
$
0.84
|
|
$
3.33
|
|
$
2.73
|
|
|
|
|
|
|
|
|
|
Shares used in
calculation of earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
7,340,306
|
|
7,278,134
|
|
7,315,144
|
|
7,242,212
|
Diluted
|
|
7,358,484
|
|
7,341,864
|
|
7,351,385
|
|
7,333,368
|
BioSpecifics
Technologies Corp.
|
|
|
Selected Condensed
Consolidated Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
|
2019
(1)
|
|
2018
(1)
|
|
|
Cash and cash
equivalents
|
|
|
|
$
4,999,183
|
|
$
13,176,452
|
|
|
Investments
|
|
|
|
100,808,942
|
|
68,806,977
|
|
|
Accounts
receivable
|
|
|
|
19,065,919
|
|
16,518,687
|
|
|
Deferred tax
assets
|
|
|
|
-
|
|
313,768
|
|
|
Working
capital
|
|
|
|
107,848,984
|
|
95,730,440
|
|
|
Total
assets
|
|
|
|
126,653,268
|
|
100,092,042
|
|
|
Deferred tax
liability, net
|
|
|
|
572,660
|
|
-
|
|
|
Total stockholders'
equity
|
|
|
|
124,491,102
|
|
97,588,520
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)The selected consolidated
balance sheet information for the years ended December 31, 2019 and
2018 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 to download
multimedia:http://www.prnewswire.com/news-releases/biospecifics-reports-fourth-quarter-and-full-year-2019-financial-and-operating-results-301025004.html
SOURCE BioSpecifics Technologies Corp.