On March 14, 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 fourth quarter and full year ended December 31, 2017 and provided a corporate update (Press release, BioSpecifics Technologies, MAR 14, 2018, View Source [SID1234524755]).
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"2018 is off to a solid start with the Phase 3 cellulite trials for CCH now initiated and positive interim data recently presented for our ongoing Phase 1 uterine fibroids trial, which is advancing toward a top-line data readout this year. In 2017, we continued to be pleased with our royalty revenues from XIAFLEX net sales and look forward to the continued growth of this product and the ongoing profitability of our business," said Thomas L. Wegman, President of BioSpecifics. "In 2018, we will also continue to work with our partner Endo to ensure that XIAFLEX and CCH are able to fulfill their commercial and clinical potential."
Fourth Quarter and Full Year 2017 Financial Results
BioSpecifics reported net income of $2.6 million for the fourth quarter ended December 31, 2017, or $0.37 per basic share and $0.36 per share on a fully diluted basis, compared to net income of $2.9 million, or $0.41 per basic share and $0.40 per share on a fully diluted basis, for the same period in 2016. For the full year ended December 31, 2017, the Company reported a net income of $11.3 million, or $1.58 per basic share and $1.55 per share on a fully diluted basis, compared to net income of $11.4 million, or $1.61 per basic share and $1.56 per share on a fully diluted basis for the same period in 2016.
Total revenue for the fourth quarter ended December 31, 2017 was $6.7 million, compared to $6.6 million for the same period in 2016. For the full year ended December 31, 2017, total revenue was $27.4 million, compared to $26.3 million for the same period in 2016. The increase in total revenues for the quarterly and year-end periods was primarily due to royalty revenues related to the net sales of XIAFLEX.
Royalty and mark-up on cost of goods sold (COGS) revenues recognized under BioSpecifics’ agreement with Endo for the fourth quarter ended December 31, 2017 were $6.7 million compared to $6.6 million for the same period in 2016, an increase of $0.1 million or 2 percent. Total royalty and mark-up on COGS revenues for the year ended December 31, 2017 increased to $27.4 million as compared to $25.4 million in the same period in 2016. This increase in royalties and the mark-up on COGS in each quarterly and year end periods was primarily due to royalty revenues related to the net sales of XIAFLEX.
Licensing revenue consists of licensing fees, sublicensing fees and milestones. BioSpecifics recognized licensing revenue for the fourth quarter ended December 31, 2017 and 2016 of approximately $4,000 in each period. Licensing fees recognized for the years ended December 31, 2017 and 2016 were $18,000 and $0.8 million, respectively. In the 2017 period, licensing fees recognized were related to the cash payments received under the agreement with Endo in prior years and amortized over the expected development period. In the 2016 period, licensing fees of $0.8 million were recognized related to the exercise of an opt-in right by Endo for the human lipoma indication.
Milestone revenue recognized for the years ended December 31, 2017 and 2016 was zero and $28,500, respectively. The $28,500 milestone revenue recognized in the 2016 period related to the approval of XIAFLEX in Australia for the treatment of Peyronie’s Disease by Actelion.
Research and development (R&D) expenses for the fourth quarter ended December 31, 2017 and 2016 were $0.3 million in each period. For the year ended December 31, 2017, R&D expenses were $1.2 million, compared to $1.3 million in the same period in 2016.
General and administrative expenses for the fourth quarter ended December 31, 2017 were $1.6 million, compared to $2.0 million for the same period in 2016. For the year ended, December 31, 2017, general and administrative expenses were $8.5 million, compared to $7.9 million in the same period in 2016.
Provision for income taxes for the fourth quarter ended December 31, 2017 were $2.4 million, compared to $1.5 million for the same period in 2016. For the year ended December 31, 2017, provision for income taxes were $7.0 million as compared to $6.0 million in the same period of 2016. The increase in 2017 as compared to 2016 was primarily due to the Company’s initial analysis of the Tax Cuts and Job Act. The Company has made reasonable estimates of its 2017 impact and due to the federal corporate rate reduction, a re-measurement of deferred tax assets and liabilities resulted in the recording of a charge of approximately $1.1 million.
As of December 31, 2017, BioSpecifics had cash and cash equivalents and investments of $65.1 million, compared to $52.8 million as of December 31, 2016.
XIAFLEX Commercial Highlights
On February 27, 2018, Endo reported commercial highlights for XIAFLEX for the fourth quarter and full year of 2017 (Endo’s fourth quarter 2017 financials are reported in BioSpecifics’ first quarter 2018 financials). For the fourth quarter of 2017, net revenues were $61.3 million compared to $55.5 million for the fourth quarter of 2016, a 10 percent increase, primarily driven by a full year of direct-to-consumer initiatives intended to increase patient awareness. Full year 2017 net revenues were $213.4 million compared to $189.7 million for the full year of 2016, a 12 percent increase.
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 presented interim data from the ongoing Phase 1 study of CCH for the treatment of uterine fibroids in a poster on March 9, 2018 at the Society for Reproductive Investigation’s 65th Annual Scientific Meeting in San Diego, CA. The data show the safety and effectiveness of the injection method in five patients. Three patients were injected with CCH and underwent a hysterectomy 24-96 hours after the injection. Two patients subsequently were injected with a higher dose of collagenase, and underwent a hysterectomy 63 days after the injection. The collagenase-treated tissue samples showed not only the reduction of collagen content but also the disruption of the tissue pattern, while in control tissues the collagen remained abundant and compact. The digestion of collagen did not extend beyond the capsule of any fibroid. No adverse event occurred in these patients.
In February 2018, Endo announced the initiation of two pivotal Phase 3 RELEASE clinical trials of CCH for the treatment of cellulite. These multicenter, randomized, double-blind, placebo-controlled studies will evaluate the safety and efficacy of CCH in reducing the appearance of cellulite. These two U.S. studies are expected to enroll 840 women, 420 per trial, aged 18 years or older with moderate-to-severe buttock cellulite. Each subject will receive up to three treatments in which CCH, 0.84 mg per treatment area, or placebo will be administered. The two treatment areas include the left and right buttock. Each treatment visit will occur approximately 21 days apart. A total of 12 injections will be administered into cellulite dimples per treatment area per visit. Cellulite severity will be assessed at the beginning and conclusion of treatment. The assessments will be conducted by each patient and clinician using two validated photonumeric cellulite severity scales developed by Endo and third-party psychometric experts. The primary endpoint of the studies is a composite responder analysis demonstrating at least a 2-level composite improvement on the photonumeric cellulite severity scale, independently reported by both the patient and clinician. Key secondary endpoints include the percentage of subjects that experience at least a 1-level or 2-level improvement in patient reported assessment, percentage of subjects with a 1-level composite improvement, percentage of satisfied subjects, change from baseline in a cellulite impact scale and the percentage of subjects with at least a 1-level or 2-level improvement in the global aesthetic improvement scale (GAIS).
Top-line results for the Phase 3 trials of CCH for cellulite are expected in the first quarter of 2019.
BioSpecifics is conducting an ongoing Phase 1 clinical trial of CCH for the treatment of uterine fibroids with data expected in 2018. This Phase 1 open-label dose escalation study is being conducted at the Department of Gynecology & Obstetrics at Johns Hopkins University and is designed to enroll 15 female subjects treated prior to hysterectomy. The trial’s primary endpoint will assess the safety and tolerability of a single injection of CCH 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 in addition to size, collagen content and rate of apoptosis of CCH treated fibroids.
Endo continues its commercial review of additional licensed indications, including adhesive capsulitis (frozen shoulder) and plantar fibromatosis.