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8-K - FORM 8-K - BIOSPECIFICS TECHNOLOGIES CORP | form8k.htm |
BioSpecifics Technologies Corp. Reports Third Quarter 2017 Financial Results
LYNBROOK, N.Y., Nov. 10, 2017 /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, 2017 and provided a corporate update.
"BioSpecifics continues to make important progress as we remain focused on further developing XIAFLEX for the treatment of serious medical conditions. We are excited about the potential of our ongoing Phase 1 trial of XIAFLEX for the treatment of uterine fibroids and look forward to reporting data in 2018," said Thomas L. Wegman, President of BioSpecifics. "Additionally, we look forward to our partner Endo initiating Phase 3 trials of XIAFLEX for the treatment of cellulite in the coming months."
Third Quarter 2017 Financial Results
BioSpecifics reported net income of $2.7 million for the third quarter ended September 30, 2017, or $0.38 per basic share and $0.37 per share on a fully diluted basis, compared to net income of $3.1 million, or $0.43 per basic share and $0.42 per share on a fully diluted basis, for the same period in 2016.
Total revenue for the third quarter ended September 30, 2017 was $6.5 million, compared to $6.9 million for the same period in 2016. Royalty revenue increased by $0.4 million for the 2017 quarter as compared to the 2016 quarter primarily due to increased sales of XIAFLEX for the treatment of Peyronie's disease and Dupuytren's contracture, whereas total revenue was lower due to the exercise of an opt-in right by Endo for the human lipoma indication of $750,000 in the 2016 period.
Research and development expenses for the third quarter ended September 30, 2017 were $0.4 million compared to $0.3 million for the same period in 2016.
General and administrative expenses for the third quarter ended September 30, 2017 were $2.2 million compared to $1.8 million for the same period in 2016.
Provision for income taxes for the third quarter ended September 30, 2017 were $1.5 million, compared to $1.8 million for the same period in 2016.
As of September 30, 2017, BioSpecifics had cash and cash equivalents and investments of $61.3 million, compared to $52.8 million as of December 31, 2016.
XIAFLEX Commercial Highlights
On November 9, 2017, Endo reported commercial highlights for XIAFLEX for the third quarter of 2017 (Endo's third quarter 2017 financials are reported in BioSpecifics' fourth quarter 2017 financials). For the third quarter of 2017, total revenues were $52.5 million compared to $47.7 million in the third quarter of 2016, an 10 percent growth. Endo continues to expect high-single to low-double digit revenue growth for sales of XIAFLEX in 2017.
Endo announced a partnership with Tim Herron, a four-time PGA Tour winner, and Damon Adamany, MD, of the CORE Institute, launched Facts on Hand, an unbranded campaign to raise awareness of Dupuytren's Contracture, a progressive, potentially disfiguring hand condition. Endo also recently launched several direct-to-consumer initiatives intended to increase patient awareness of XIAFLEX as a possible treatment option for Dupuytren's Contracture and Peyronie's Disease.
XIAFLEX Pipeline Updates and Anticipated Upcoming Milestones
BioSpecifics manages the development of XIAFLEX for the treatment of uterine fibroids. The Phase 1 clinical trial is currently enrolling. BioSpecifics 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.
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The Phase 1 clinical trial of XIAFLEX for the treatment of uterine fibroids is ongoing and BioSpecifics plans to announce results in 2018. The study, being conducted at the Department of Gynecology & Obstetrics at Johns Hopkins University, is designed to enroll 15 subjects administered XIAFLEX prior to hysterectomy. The primary endpoint of the study will assess the safety and tolerability of a single injection of XIAFLEX 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 as well as size, collagen content and rate of apoptosis of XIAFLEX treated fibroids. |
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Endo plans to initiate Phase 3 clinical trials of XIAFLEX for the treatment of cellulite in the coming months following discussions with the U.S. Food and Drug Administration. |
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Endo continues its commercial review of additional indications and are strongly considering, in particular, adhesive capsulitis and plantar fibromatosis. |
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 Europe and Australia. Endo is partnered with Paladin Labs, Sobi,
Actelion and Asahi Kasei for Dupuytren's contracture and/or Peyronie's disease
outside the U.S. The XIAFLEX research and development pipeline includes several
additional promising indications. BioSpecifics is managing the development of
XIAFLEX for uterine fibroids and is conducting a Phase 1 clinical trial. For
more information, please visit www.biospecifics.com.
Forward-Looking Statements
This press release 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 in this press release include statements concerning, among other
things, the progression of our Phase 1 clinical trial of XIAFLEX for the
treatment of uterine fibroids; whether and when we will report data from our
Phase 1 clinical trial of XIAFLEX for the treatment of uterine fibroids; whether
and when Endo will initiate the Phase 3 clinical trials of XIAFLEX for the
treatment of cellulite; whether Endo will achieve high-single to
low-double-digit revenue growth for XIAFLEX in 2017; the outcome of Endo's
commercial assessment regarding the additional indications, in particular
adhesive capsulitis and plantar fibromatosis. In some cases, these statements
can be identified by forward-looking words such as "believe," "expect," "plan",
"may," "will," "can," and "could," the negative or plural of these words, and
other similar expressions. These forward-looking statements are predictions
based on BioSpecifics' current expectations and its projections about future
events and various assumptions. There can be no assurance that BioSpecifics will
realize its expectations or that BioSpecifics' 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 that will determine the amount of
milestone, royalty, mark-up on cost of goods sold, license and sublicense income
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, 2016, Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2017 and June 30, 2017 and its Current Reports
on Form 8-K filed with the Securities and Exchange Commission. All
forward-looking statements included in this press release are made as of the
date hereof, are expressly qualified in their entirety by the cautionary
statements included in this press release and, except as may be required by law,
BioSpecifics assumes 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, | |||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||
Revenues: | ||||||||||||
Royalties | $ | 6,511,700 | $ | 6,119,815 | $ | 20,729,017 | $ | 18,843,273 | ||||
Licensing revenue | 4,408 | 762,345 | 13,226 | 787,034 | ||||||||
Total Revenues | 6,516,108 | 6,882,160 | 20,742,243 | 19,630,307 | ||||||||
Costs and expenses: | ||||||||||||
Research and development | 356,847 | 312,907 | 949,359 | 1,005,884 | ||||||||
General and administrative | 2,175,501 | 1,843,368 | 6,916,501 | 5,909,785 | ||||||||
Total costs and expenses | 2,532,348 | 2,156,275 | 7,865,860 | 6,915,669 | ||||||||
Operating income | 3,983,760 | 4,725,885 | 12,876,383 | 12,714,638 | ||||||||
Other income: | ||||||||||||
Interest income | 193,462 | 80,674 | 436,210 | 200,704 | ||||||||
Other, net | 14,667 | 6,254 | 40,651 | 37,448 | ||||||||
208,129 | 86,928 | 476,861 | 238,152 | |||||||||
Income before income tax expense | 4,191,889 | 4,812,813 | 13,353,244 | 12,952,790 | ||||||||
Provision for income tax expense | (1,477,057 | ) | (1,759,220 | ) | (4,669,569 | ) | (4,497,359 | ) | ||||
Net income | $ | 2,714,832 | $ | 3,053,593 | $ | 8,683,675 | $ | 8,455,431 | ||||
Earnings per share: | ||||||||||||
Basic | $ | 0.38 | $ | 0.43 | $ | 1.21 | $ | 1.20 | ||||
Diluted | $ | 0.37 | $ | 0.42 | $ | 1.19 | $ | 1.16 | ||||
Shares used in calculation of earnings per share: | ||||||||||||
Basic | 7,164,934 | 7,062,543 | 7,166,470 | 7,031,068 | ||||||||
Diluted | 7,314,609 | 7,280,375 | 7,325,602 | 7,277,780 |
BioSpecifics Technologies Corp.
Selected Condensed
Consolidated Balance Sheet Data
(Unaudited) | ||||||
September 30, | December 31, | |||||
2017 | 2016 (1) | |||||
Cash and cash equivalents | $ | 6,422,358 | $ | 4,763,364 | ||
Investments | 54,883,779 | 48,026,242 | ||||
Accounts and income tax receivable | 4,738,815 | 4,305,503 | ||||
Deferred tax assets | 2,992,001 | 3,290,122 | ||||
Working capital | 59,569,454 | 53,403,332 | ||||
Total assets | 72,260,984 | 64,696,280 | ||||
Long-term liabilities | 5,555,743 | 6,417,702 | ||||
Total stockholders' equity | 64,707,797 | 56,281,943 |
(1)The selected consolidated balance sheet information for the year ended December 31, 2016 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.
CONTACT: BioSpecifics Technologies Corp., Thomas L. Wegman, President, (516) 593-7000, thomas_wegman@biospecifics.com