PR Newswire
LYNBROOK, N.Y., Aug. 9, 2019
LYNBROOK, N.Y., Aug. 9, 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 second quarter ended June 30, 2019 and provided a corporate update.
"Throughout the second quarter of 2019, the team at BioSpecifics has been focused on continued internal execution and the clinical progression of our CCH development pipeline and the commercial development of our XIAFLEX franchise. Following positive Phase 1 uterine fibroids data, we are working to develop a clinical path forward for this medically necessary indication, and as we further evaluate and analyze this data, we plan to present it in the second half of this year," said Dr. Ron Law, Ph.D., J.D., Principal Executive Officer of BioSpecifics. "We are encouraged by the continued emphasis from our partner, Endo, on the importance of patient awareness and future growth initiatives for both of our commercial indications for XIAFLEX, Peyronie's Disease and Dupuytren's Contracture. We also look forward to adding a potential third marketed indication, with an upcoming BLA filing for the treatment of cellulite, which is expected to occur in the second half of 2019."
Second Quarter 2019 Financial Results
BioSpecifics reported net income of $6.4 million for the second quarter ended June 30, 2019, or $0.88 per basic share and $0.87 per share on a fully diluted basis, compared to net income of $4.8 million, or $0.67 per basic share and $0.66 per share on a fully diluted basis, for the same period in 2018.
Total revenue for the second quarter ended June 30, 2019 was $8.9 million, compared to $7.9 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, and slightly higher mark-up on cost of goods sold revenue.
Research and development expenses for the second quarter ended June 30, 2019 and 2018 were approximately $0.2 million in each period.
General and administrative expenses for the second quarter ended June 30, 2019 were $1.7 million, compared to $2.0 million for the same period in 2018.
Provision for income taxes for the second quarter ended June 30, 2019 and 2018 was $1.1 million in each period.
As of June 30, 2019, BioSpecifics had cash and cash equivalents and investments of $93.5 million, compared to $82.0 million as of December 31, 2018.
As of June 30, 2019, BioSpecifics had 7,331,917 million shares of common stock outstanding.
Commercial & Pipeline Highlights and Anticipated Upcoming Milestones
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 indications, including two Phase 3 clinical trials for the treatment of cellulite with most recent data reported in the second quarter of 2019, a BLA submission expected in the second half of 2019 and an expected commercial launch in the second half of 2020 upon approval. BioSpecifics is managing the development of CCH for the treatment of uterine fibroids. The full Phase 1 data was presented at the 66th Annual Society for Reproductive Investigation in March 2019 and additional data will be presented at an upcoming medical meeting in the second half of 2019. 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." These forward looking statements include statements regarding the timing of the submission by Endo, 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 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") and Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 (the "Form 10-Q"), specifically in Part I, Item IA under the heading "Risk Factors" of the 2018 Annual Report and under the section "Management's Discussion and Analysis" in the 2018 Annual Report and the Form 10-Q. 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 | Six months ended | |||||||
June 30, | June 30, | |||||||
2019 | 2018 | 2019 | 2018 | |||||
Revenues: | ||||||||
Royalties | $ 8,852,986 | $7,815,504 | $ 16,982,127 | $14,900,504 | ||||
Licensing revenue | - | 35,270 | - | 39,679 | ||||
Total Revenues | 8,852,986 | 7,850,774 | 16,982,127 | 14,940,183 | ||||
Costs and expenses: | ||||||||
Research and development | 161,321 | 211,796 | 310,857 | 407,023 | ||||
General and administrative | 1,728,125 | 2,043,952 | 4,635,284 | 4,113,585 | ||||
Total costs and expenses | 1,889,446 | 2,255,748 | 4,946,141 | 4,520,608 | ||||
Operating income | 6,963,540 | 5,595,026 | 12,035,986 | 10,419,575 | ||||
Other income: | ||||||||
Interest income | 517,156 | 273,746 | 966,580 | 491,697 | ||||
Other, net | - | 81,985 | - | 96,663 | ||||
517,156 | 355,731 | 966,580 | 588,360 | |||||
Income before income tax expense | 7,480,696 | 5,950,757 | 13,002,566 | 11,007,935 | ||||
Provision for income tax expense | (1,054,236) | (1,102,826) | (2,159,511) | (2,181,400) | ||||
Net income | 6,426,460 | $4,847,931 | 10,843,055 | $8,826,535 | ||||
Earnings per share: | ||||||||
Basic | $ 0.88 | $ 0.67 | $ 1.49 | $ 1.23 | ||||
Diluted | $ 0.87 | $ 0.66 | $ 1.48 | $ 1.21 | ||||
Shares used in calculation of earnings per share: | ||||||||
Basic | 7,308,268 | 7,215,057 | 7,292,663 | 7,204,040 | ||||
Diluted | 7,349,696 | 7,315,276 | 7,344,008 | 7,309,325 | ||||
BioSpecifics Technologies Corp. | ||||||||
Selected Condensed Consolidated Balance Sheet Data | ||||||||
(Unaudited) | ||||||||
June 30, | December 31, | |||||||
2019 | 2018 (1) | |||||||
Cash and cash equivalents | $ 13,972,558 | $ 13,176,452 | ||||||
Investments | 79,537,326 | 68,806,977 | ||||||
Accounts receivable | 16,729,636 | 16,518,687 | ||||||
Deferred tax assets | 154,309 | 313,768 | ||||||
Working capital | 101,429,118 | 95,730,440 | ||||||
Total assets | 111,899,857 | 100,092,042 | ||||||
Total stockholders' equity | 110,310,421 | 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. | ||||||||
View original content to download multimedia:http://www.prnewswire.com/news-releases/biospecifics-technologies-corp-reports-second-quarter-2019-financial-and-operating-results-300899498.html
SOURCE BioSpecifics Technologies Corp.
We use cookies to tailor your experience, measure site performance and present relevant offers and advertisements. By clicking ‘Accept’ or any content on this site, you agree that cookies can be placed on your browser. You can view our privacy policy to learn more.
If you would like to get more data, alerts and access to Real Vision videos, join us as an Insider Tracking Advantage Ultra member