LYNBROOK, N.Y., Nov. 8, 2019 /PRNewswire/ --Â 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 XIAFLEXÂ®Â in the U.S. and XiapexÂ®Â inÂ Europe, today announced its financial results for the third quarter ended September 30, 2019 and provided a corporate update.Â Â
"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 XIAFLEXÂ®Â 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 XIAFLEXÂ® Commercial Franchise Grew by 15% Year-Over-Year for the Third Quarter of 2019: XIAFLEXÂ® revenue growth was primarily attributable to royalties associated with higher net sales of XIAFLEXÂ® 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 XIAFLEXÂ® Data Presented at the 20th Annual Fall Meeting of the Sexual Medicine Society of North America: In October 2019, Endo announced that five new studies of XIAFLEXÂ® for the treatment of Peyronie's Disease were presented at the 20th 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 <10Â° 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.
- 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 XIAFLEXÂ® 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.
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 XIAFLEXÂ® in their applicable territories; the market for XIAFLEXÂ® 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 XIAFLEXÂ® to be used in additional indications; Endo modifying its objectives or allocating resources other than to XIAFLEXÂ®; 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
Three months ended
Nine months ended
Â Â Royalties
Â Â Licensing revenue
Â Â Â Â Â Â Â Total Revenues
Costs and expenses:
Â Â Research and development
Â Â General and administrative
Â Â Â Â Â Â Â Total costs and expenses
Â Â Interest income
Â Â Other, net
Income before income tax expense
Provision for income tax expense
$ Â 6,272,933
$ Â Â 5,043,050
$ Â 17,115,988
$ Â 13,869,585
Earnings per share:
$ Â Â Â Â Â Â 0.86
$ Â Â Â Â Â Â Â 0.69
$ Â Â Â Â Â Â Â Â 2.34
$ Â Â Â Â Â Â Â 1.92
$ Â Â Â Â Â Â 0.85
$ Â Â Â Â Â Â Â 0.69
$ Â Â Â Â Â Â Â Â 2.33
$ Â Â Â Â Â Â Â 1.89
Shares used in calculation of earnings per share:
BioSpecifics Technologies Corp.
Selected Condensed Consolidated Balance Sheet Data
Cash and cash equivalents
$ Â Â Â 12,769,293
$ Â Â Â 13,176,452
Deferred tax assets
Deferred tax liability, net
Total stockholders' equity
(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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