On November 9, 2018 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, reported its financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, BioSpecifics Technologies, NOV 9, 2018, View Source [SID1234531193]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are encouraged by the positive data recently reported for CCH in two new potential indications. We announced positive topline results from our Phase 1 clinical trial of CCH for the treatment of uterine fibroids in October and our partner Endo announced positive data from the Phase 3 clinical trials of CCH for the treatment of cellulite in November. The preliminary safety and efficacy data from our uterine fibroids trial demonstrates the promising potential for CCH injection for the treatment of this highly prevalent women’s health disease for which very limited non-surgical options are available," said Thomas L. Wegman, President of BioSpecifics. "With regard to our commercial pipeline and revenues, we were pleased to see continued growth for our two marketed indications for XIAFLEX, Peyronie’s Disease and Dupuytren’s Contracture with 22 percent year-over-year revenue growth for the quarter."
Third Quarter 2018 Financial Results
BioSpecifics reported net income of $5.0 million for the third quarter ended September 30, 2018, or $0.69 per basic share and $0.69 per share on a fully diluted basis, compared to net income of $2.7 million, or $0.38 per basic share and $0.37 per share on a fully diluted basis, for the same period in 2017.
Total revenue for the third quarter ended September 30, 2018 was $8.2 million, compared to $6.5 million for the same period in 2017. The increase in total revenues for the quarterly period was primarily due to royalties associated with higher net sales of XIAFLEX in Dupuytren’s contracture and Peyronie’s disease partially offset by lower mark-up on cost of goods sold revenue in prepaid foreign mark-up on cost of goods sold revenue recognized under new revenue standard ASC 606, as of January 1, 2018.
Licensing revenue consists of licensing fees, sublicensing fees and milestones. BioSpecifics recognized licensing revenue for the third quarter ended September 30, 2018 of zero and $4,408 for the same period in 2017.
Research and development (R&D) expenses for the third quarter ended September 30, 2018 were $0.2 million compared to $0.4 million for the same period in 2017. The decrease in the 2018 period, as compared to the 2017 period, was mainly due to lower consulting fees associated with clinical costs and other R&D programs.
General and administrative expenses for the third quarter ended September 30, 2018 and 2017 were $2.2 million in each period.
Provision for income taxes for the third quarter ended September 30, 2018 were $1.1 million, compared to $1.5 million for the same period in 2017.
As of September 30, 2018, BioSpecifics had cash and cash equivalents and investments of $77.0 million, compared to $65.1 million as of December 31, 2017.
As of September 30, 2018, BioSpecifics had 7,283,528 shares of common stock outstanding.
XIAFLEX/CCH Pipeline Updates and Anticipated Upcoming Milestones
BioSpecifics manages the development of collagenase clostridium histolyticum (CCH) for the treatment of uterine fibroids and 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. BioSpecifics has entered into different in-licensing and royalty agreements in respect of indications currently marketed and under development. It is company policy not to announce publicly royalty rates for potential future indications under development before commercialization. It is important to emphasize that in-licensing royalty rates vary from indication to indication and it should not be assumed that the in-licensing royalty rates for potential future indications will be the same as those for currently marketed indications.
Positive Topline Phase 1 Uterine Fibroid Data Reported in October: BioSpecifics announced positive topline results from the Phase 1 clinical trial of CCH for the treatment of uterine fibroids. The study met the primary endpoint of safety and tolerability with no observed clinically significant adverse reactions. Pharmacodynamic changes were noted in all secondary endpoints with the exception of apoptosis. Statistically significant reductions in collagen content were observed as compared to control fibroids with a median reduction of 39 percent (p<0.05), as well as statistically significant reductions in collagen distribution as compared to control fibroids with an average reduction in density of collagen bundles of 21 percent.
Positive Phase 3 RELEASE-1 and RELEASE-2 Cellulite Data Reported in November: Endo announced positive results from two Phase 3 studies, RELEASE-1 and RELEASE-2, of CCH for the treatment of cellulite with highly statistically significant levels of improvement in the appearance in the target buttock at Day 71 reported. The study achieved the primary endpoint (RELEASE-1, p=0.006 & RELEASE-2, p=0.002) of composite responder analysis demonstrating at least a 2-level composite improvement independently reported by patient and clinician on the photonumeric scales of cellulite severity. Secondary endpoints included both investigator and patient assessments of cellulite appearance as measured by CR-PCSS (Clinician Reported- Photonumeric Cellulite Severity Scale) and PR-PCSS (Patient Reported- Photonumeric Cellulite Severity Scale) scores, SRSS (Subject Self Rating Scale) and the Subject-Global Aesthetic Improvement Scale. Eight out of eight key secondary endpoints were achieved for RELEASE-1 and seven out of eight secondary endpoints were achieved for RELEASE-2. CCH was well-tolerated in actively treated subjects with most adverse events being mild to moderate in severity and primarily limited to the local injection area.
XIAFLEX Expected to Continue to Grow in the Low 20 Percent Range: XIAFLEX future growth initiatives continue to support the increase in disease state awareness for both Peyronie’s Disease and Dupuytren’s Contracture through direct to consumer campaigns.