BioSpecifics Reports Third Quarter 2019 Financial and Operating Results
LYNBROOK, N.Y., Nov. 8, 2019 /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 third quarter ended September 30, 2019 and provided a corporate update.
"As we approach the end of 2019, BioSpecifics is entering its next phase of growth as we seek to unlock new opportunities to generate value for all our stakeholders," said J. Kevin Buchi, chief executive officer of BioSpecifics. "We are excited by the prospect of adding a third marketed XIAFLEX indication to our commercial pipeline with the potential FDA approval of CCH for the treatment of cellulite. BioSpecifics today is a profitable, commercial-stage organization with a diverse development pipeline focused on CCH and the team is eager to build on this trajectory."
Third Quarter 2019 Financial Results
BioSpecifics reported net income of $6.3 million for the third quarter ended September 30, 2019, or $0.86 per basic share and $0.85 per share on a fully diluted basis, compared to net income of $5.0 million, or $0.69 per basic share and $0.69 per share on a fully diluted basis, for the same period in 2018.
Total revenue for the third quarter ended September 30, 2019 was $9.4 million, compared to $8.2 million for the same period in 2018. The increase in total revenues for the quarterly period was primarily due to royalties associated with higher net sales of XIAFLEX® in Peyronie's Disease and Dupuytren's Contracture.
Research and development expenses for the third quarter ended September 30, 2019 were $0.1 million compared to $0.2 million for the same period in 2018.
General and administrative expenses for the third quarter ended September 30, 2019 were $2.0 million, compared to $2.2 million for the same period in 2018.
Provision for income taxes for the third quarter ended September 30, 2019 were $1.6 million, compared to $1.1 million for the same period in 2018.
As of September 30, 2019, BioSpecifics had cash and cash equivalents and investments of $98.4 million, compared to $82.0 million as of December 31, 2018.
As of September 30, 2019, BioSpecifics had 7,343,119 million shares of common stock outstanding.
Commercial & Pipeline Highlights
-- BioSpecifics' Royalty Revenues from the XIAFLEX® Commercial Franchise
Grew by 15% Year-Over-Year for the Third Quarter of 2019: XIAFLEX®
revenue growth was primarily attributable to royalties associated with
higher net sales of XIAFLEX® in Dupuytren's Contracture and Peyronie's
Disease.
-- BLA filing for CCH for Treatment of Cellulite Submitted in September
2019: On September 6, 2019, Endo announced that it filed its Biologics
License Application (BLA) with the U.S. Food and Drug Administration
(FDA) for CCH for the treatment of cellulite.
-- New XIAFLEX® Data Presented at the 20(th) Annual Fall Meeting of the
Sexual Medicine Society of North America: In October 2019, Endo
announced that five new studies of XIAFLEX® for the treatment of
Peyronie's Disease were presented at the 20(th) Annual Fall Meeting of
the Sexual Medicine Society of North America (SMSNA) which continue to
support further patient and physician education.
-- New Data Presented on MRI Evaluation of Cellulite at the American
Society for Dermatologic Surgery Annual Meeting: In October 2019, Endo
announced the presentation of a case study comparison of the use of a
standing MRI versus a prone MRI for the evaluation of cellulite. The
comparison results showed a <10° difference between the angle of
collagen septae orientation relative to the dermis in the standing and
prone MRI. Septae orientation in the prone position was not
perpendicular to the skin.
Corporate Highlights
-- Appointment of New Chief Executive Officer: In October 2019,
BioSpecifics announced the appointment of J. Kevin Buchi as Chief
Executive Officer, bringing the company diversified leadership
experience, coupled with a strong life sciences background.
-- Appointment of Jennifer Chao as Chairman of Board of Directors: In
October 2019, BioSpecifics announced the appointment of Jennifer Chao as
chairman of the board of directors, who previously served as an
independent director of the board since 2015.
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 the U.S. 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, lipomas, lateral hip fat, 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 and its partners 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 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 Nine months ended
September 30,
September 30,
2019 2018 2019 2018
Revenues:
Royalties $9,442,253 $8,168,081 $26,424,380 $23,068,585
Licensing revenue 39,679
Total Revenues 9,442,253 8,168,081 26,424,380 23,108,264
Costs and expenses:
Research and development 143,185 162,625 454,042 569,648
General and administrative 1,978,078 2,232,077 6,613,362 6,345,662
Total costs and expenses 2,121,263 2,394,702 7,067,404 6,915,310
Operating income 7,320,990 5,773,379 19,356,976 16,192,954
Other income:
Interest income 504,909 359,637 1,471,489 851,334
Other, net 96,663
504,909 359,637 1,471,489 947,997
Income before income tax expense 7,825,899 6,133,016 20,828,465 17,140,951
Provision for income tax expense (1,552,966) (1,089,966) (3,712,477) (3,271,366)
Net income $6,272,933 $5,043,050 $17,115,988 $13,869,585
Earnings per share:
Basic $0.86 $0.69 $2.34 $1.92
Diluted $0.85 $0.69 $2.33 $1.89
Shares used in calculation of earnings per share:
Basic 7,334,212 7,281,388 7,306,665 7,230,106
Diluted 7,359,034 7,356,885 7,347,701 7,327,029
BioSpecifics Technologies Corp.
Selected Condensed Consolidated Balance Sheet Data
(Unaudited)
September 30, December 31,
2019
2018 (1)
Cash and cash equivalents $12,769,293 $13,176,452
Investments 85,582,252 68,806,977
Accounts receivable 17,768,757 16,518,687
Deferred tax assets 313,768
Working capital 100,539,030 95,730,440
Total assets 118,471,289 100,092,042
Deferred tax liability,
net 593,059
Total stockholders'
equity 117,001,002 97,588,520
(1)
The selected consolidated balance sheet information for the year ended December 31, 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.
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SOURCE BioSpecifics Technologies Corp.
