LYNBROOK, N.Y., Aug. 9, 2016 /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 collagenase clostridium histolyticum, or CCH, marketed as XIAFLEX® in the U.S. and Xiapex® in Europe, today announced its financial results for the second quarter ended June 30, 2016 and provided a corporate update.
"We made significant progress advancing our clinical development programs during the second quarter. Specifically, we were pleased to report positive, statistically significant results from our Phase II clinical trial of CCH for the treatment of human lipoma in June and are pleased with Endo's decision to opt-in to this indication, triggering a $750,000 opt-in payment from Endo, which we will receive in the third quarter of 2016. We also continued to lay the groundwork for the initiation of our Phase I clinical trial of CCH to treat uterine fibroids in the second half of this year," said Thomas L. Wegman, President of BioSpecifics. "We are working closely with our partner Endo to develop and advance the CCH pipeline and look forward to their initiation of four key clinical programs in areas of significant unmet need such as adhesive capsulitis, plantar fibromatosis, lateral hip fat and Dupuytren's nodules."
Second Quarter 2016 Financial Results
BioSpecifics reported net income of $2.6 million for the second quarter ended June 30, 2016, or $0.37 per basic share and $0.35 per share on a fully diluted basis, compared to net income of $1.8 million, or $0.26 per basic share and $0.24 per share on a fully diluted basis, for the same period in 2015.
Total revenue for the second quarter ended June 30, 2016 was $6.2 million, compared to $4.7 million for the same period in 2015.The increase in total revenue was due to the increased sales of XIAFLEX reported to BioSpecifics by its partner Endo International plc (Endo).
Royalty and mark-up on cost of goods sold (COGS) revenues recognized under BioSpecifics' agreement with Endo for the second quarter ended June 30, 2016 were $6.2 million, compared to $4.7 million for the same period in 2015, an increase of $1.5 million, or 32%. This increase in royalties and the mark-up on COGS was primarily due to the increase in sales of XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease.
Licensing revenue consists of licensing fees, sublicensing fees and milestone payments. For the second quarter ended June 30, 2016 and 2015, the Company recognized licensing revenue related to the development of CCH, of approximately $12,000 in each period.
Research and development expenses for the second quarter ended June 30, 2016 were $0.4 million, compared to $0.3 million in the same period in 2015.
General and administrative expenses for the second quarter ended June 30, 2016 were $1.9 million, compared to $1.8 million for the same period in 2015.
Provision for income taxes for the second quarter ended June 30, 2016 were $1.3 million, compared to $0.9 million for the same period in 2015.
As of June 30, 2016, BioSpecifics had cash and cash equivalents and investments of $45.8 million, compared to $37.1 million as of December 31, 2015.
XIAFLEX Commercial Highlights
On August 8, 2016, Endo reported commercial highlights for the second quarter of 2016 (Endo's second quarter 2016 financials are reported in BioSpecifics' third quarter 2016 financials). For the second quarter of 2016, U.S. demand vials were approximately 8,197 for Peyronie's disease and approximately 6,530 for Dupuytren's contracture, equaling overall demand vials of approximately 14,727, a 12% increase over the second quarter 2015, driven primarily by a 19% year over year increase in Peyronie's disease demand vials.
For the second quarter of 2016, Endo reported that U.S. net revenues were $42.4 million and worldwide net revenues were $45.2 million. Endo now expects a low double-digit percentage growth rate for U.S. XIAFLEX pro forma revenue in 2016.
CCH Pipeline Updates and Anticipated Upcoming Milestones
BioSpecifics manages the development of collagenase clostridium histolyticum (CCH) for uterine fibroids, and initiates the development of CCH in new potential indications, not licensed by Endo. In addition to Dupuytren's contracture and Peyronie's disease, Endo's licensed rights include human and canine lipoma, adhesive capsulitis, cellulite, lateral hip fat and plantar fibromatosis. Endo has also discussed the potential expansion into currently un-licensed indications including uterine fibroids, capsular contracture of the breast, Dercum's disease, knee arthrofibrosis, urethral strictures, hypertrophic scars and keloids.
- On July 29, 2016, Endo notified BioSpecifics that it was exercising its right to opt-in for the human lipoma indication, bringing their total number of licensed indications to eight. As a result of Endo's opt-in for this indication, in addition to a an opt-in payment of $750,000, to be received in the third quarter of 2016, they are now responsible for all costs for future clinical development and will owe potential future milestone, royalty and cost of goods payments to BioSpecifics.
- In June 2016, BioSpecifics reported positive, statistically significant, top-line results from a placebo-controlled, double-blind Phase II clinical trial of CCH for the treatment of human lipoma. The trial met its primary endpoint of reduction in the visible surface area of the target lipomas relative to placebo, as determined by caliper, at six months post injection (p<0.0001). There were no serious adverse events reported during the trial.
- In May 2016, BioSpecifics announced the publication of data highlighting the efficacy of collagenase clostridium histolyticum (CCH) for the treatment of uterine fibroids in the May 2016 issue of the American Journal of Obstetrics & Gynecology in an article titled, "Loss of Stiffness in Collagen-Rich Uterine Fibroids after Digestion with Purified Collagenase Clostridium Histolyticum." The data show that highly purified CCH can reduce the stiffness of human uterine fibroids ex-vivo and potentially decrease their size.
- BioSpecifics expects to initiate a Phase I clinical trial of CCH in uterine fibroids in the second half of 2016.
- During their second quarter 2016 earnings call, Endo confirmed its plans to initiate clinical trials in four licensed indications in the second half of 2016. In the third quarter of 2016, Endo plans to initiate a Phase IIb trial in adhesive capsulitis and a Phase II trial in plantar fibromatosis and in the fourth quarter of 2016, a Phase II trial in lateral hip fat and a registration trial in Dupuytren's nodules.
Webcast and Conference Call
BioSpecifics will host a conference call today at 4:30 p.m. ET to discuss these second quarter 2016 results. In order to participate in the conference call, please dial 1-866-364-3867 (domestic) or 1-412-902-4213 (international). The live webcast can be accessed under "Events and Presentation" in the "Investors" section of the Company's website at www.biospecifics.com or you may use the link: https://www.webcaster4.com/Webcast/Page/967/16309.
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