On August 9, 2019 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 second quarter ended June 30, 2019 and provided a corporate update (Press release, BioSpecifics Technologies, AUG 9, 2019, View Source [SID1234538568]).
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"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
BioSpecifics’ Royalty Revenues from the XIAFLEX Commercial Franchise Grew by 13% Year-Over-Year for the Second Quarter. The XIAFLEX commercial franchise royalty revenue growth was primarily attributable to increased net sales of XIAFLEX in Peyronie’s Disease and Dupuytren’s Contracture, driven by Endo’s continued successful commercial execution and promotional investment.
Phase 2 Clinical Trial of Uterine Fibroids Future Development Plans Underway: BioSpecifics and its clinical partners continue to analyze the full Phase 1 data to guide the design of a Phase 2 study of collagenase clostridium histolyticum (CCH) for the treatment of uterine fibroids. BioSpecifics will present new data from the Phase 1 clinical trial at an upcoming medical meeting in the second half of 2019. Data from the Phase 1 clinical trial of CCH for the treatment of uterine fibroids were presented at the 66th Annual Meeting of the Society of Reproductive Investigation (SRI) on March 2019 in Paris, France. The reported data showed safety and statistically significant reductions in collagen content compared to control fibroids with a median reduction of 39 percent (p<0.05), as well as a 21 percent average reduction in density of collagen bundles.
New Data Presentations of CCH for the Treatment of Cellulite at Top Aesthetic Medical Meetings:
Endo reported data from the RELEASE-1 and RELEASE-2 Phase 3 studies during the "Premier Global Hot Topics Session" at the Annual Meeting of the American Society for Aesthetic Plastic Surgery on May 17, 2019 in New York, NY. The reported data showed that a greater percentage of women treated with CCH (CCH vs. placebo: RELEASE 1, n=210 vs n=213; RELEASE-2, n=214 vs n=206) met the primary endpoint versus placebo in both the RELEASE-1 (P=0.006) and RELEASE-2 (P=0.002) studies. In addition, statistically significant improvements with CCH vs placebo were observed in eight of eight (RELEASE-1) and seven of eight (RELEASE-2) secondary endpoints. Other patient-centric endpoints were also evaluated, including improvement in the Subject Global Aesthetic Improvement Scale (S-GAIS), a five-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the subject. Most adverse events observed in CCH-treated patients were mild/moderate and injection-site related.
Endo also reported Phase 2 and Phase 3 data at the Vegas Cosmetic Surgery Meeting in June 2019.
Expansion of Patient Awareness and Future Growth Initiatives for Marketed XIAFLEX Indications: In June 2019, Endo announced that nationally recognized urologist and author, Aaron Spitz, M.D., partnered with Endo and the "Ask About the Curve" campaign to encourage men to get in touch with their anatomy and learn about the signs and symptoms of Peyronie’s Disease. Endo also has continued future growth initiates for Dupuytren’s Contracture with "Facts on Hand" in partnership with Tim Herron, four-time PGA Tour winner and Damon Adamany, M.D. of the CORE Institute.
BLA filing for CCH for Treatment of Cellulite Expected in 2H19: Endo reported that it expects to file its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for CCH for the treatment of cellulite in the second half of 2019, with an expected commercial launch in the second half of 2020, subject to FDA approval.