On August 4, 2016 Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women’s health therapeutics company, reported financial and other results for the three-month period ended June 30, 2016 (Press release, Juniper Pharmaceuticals, AUG 4, 2016, View Source;p=RssLanding&cat=news&id=2193006 [SID:1234514246]). Recent highlights include:
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!
· Product and service revenue increased 15% and 24%, respectively, versus the second quarter of 2015;
· Balance sheet remains strong;
Crinone (progesterone gel) approved in Japan under the brand OneCrinone;
· Completed enrollment of Phase 2b trial of COL-1077 10% lidocaine vaginal gel in women undergoing a minimally invasive pipelle-directed endometrial biopsy;
· Two Phase 1 studies of COL-1077 published in the international peer-reviewed medical journal Clinical Pharmacology in Drug Development;
· Phase 1 proof-of-concept study demonstrating the ability of Juniper’s intravaginal ring to successfully deliver the nine amino acid peptide leuprolide published in the influential peer-reviewed Journal of Controlled Release; and,
· Alicia Secor appointed President and CEO, and a director of the Company.
"I am very excited to join the Company, and congratulate the team on a strong second quarter," said Alicia Secor, Juniper’s President and CEO. "I look forward to building on this momentum as we work to transform Juniper into a leading, global, women’s health company."
"Strong growth of the ex-U.S. Crinone franchise and Juniper Pharma Services drove revenue up 16% to $11.9 million for the second quarter of 2016 versus the same period last year," said George O. Elston, Juniper’s Chief Financial Officer. "This solid year-to-date performance has enabled us to maintain a stable, healthy cash position while advancing our proprietary R&D programs."
"We are uniquely positioned to leverage our world-class service and platform capabilities to develop and commercialize important new therapeutics for women," Ms. Secor continued. "I look forward to advancing our current product candidates and expanding our portfolio to fulfill our mission to deliver value-added treatments that meet the unique and underserved healthcare needs of women."
The Company continues to expect to report top-line results of its recently-completed Phase 2b clinical trial of COL-1077 10% lidocaine bioadhesive vaginal gel this quarter and, assuming positive outcomes, to advance this candidate into Phase 3 in 2017.
If successful, COL-1077 is expected to fill an unmet need for pain management in women undergoing minimally-invasive gynecologic procedures. There are over seven million such procedures performed annually in the United States, with no standard of care for pre-treatment analgesia.
Juniper’s intravaginal ring ("IVR") programs continue to advance toward clinical development. The most advanced IVR product candidate is JNP-0101, an oxybutynin IVR for the treatment of overactive bladder in women. IND-enabling studies are underway including a study, defined in the Company’s pre-IND meeting with the FDA, to evaluate the pharmacokinetics of JNP-0101 in a representative animal model.
The Company is accelerating the Chemistry Manufacturing and Controls ("CMC") and production scale-up for JNP-0101 beyond its existing in-house capacity to further develop the go-to-market formulation and commercial manufacturing process ahead of its IND filing, which is now expected in 2017. This activity is intended to reduce CMC-related risks as JNP-0101 moves through clinical trials and toward commercialization in the $1.3 billion U.S. overactive bladder market.
Second Quarter Financial Results
Second quarter total revenues increased 16% to $11.9 million, compared with $10.2 million for the quarter ended June 30, 2015.
Product revenues were $7.6 million, an increase of $1.0 million, or 15%, versus the second quarter of last year, driven by continued in-market growth and new market sales of Crinone (progesterone gel) by Merck KGaA, Darmstadt, Germany.
Service revenues from Juniper Pharma Services were $3.4 million, an increase of $0.7 million, or 24%, versus the second quarter of last year, as we experienced continued strong growth in customer volume. Royalty revenues, based on Allergan’s sales of Crinone, were essentially unchanged at $0.9 million.
Gross profit increased to $5.4 million as compared with $4.6 million in the prior year quarter.
Total operating expenses were $7.2 million in the second quarter of 2016, a $2.2 million increase as compared to the prior year quarter.
Sales and marketing costs increased $0.1 million to $0.4 million in the second quarter of 2016, reflecting continued investment in the U.S. market by Juniper Pharma Services.
The $1.4 million increase in R&D spending as compared to the prior year quarter was predominantly driven by costs associated with the Phase 2b clinical trial of COL-1077. R&D expense also includes preclinical development costs for the IVR pipeline product candidates: JNP-0101 (oxybutynin IVR), JNP-0201 (estradiol + progesterone IVR for symptoms of menopause), and JNP-0301 (progesterone IVR for the prevention of preterm birth).
The $0.7 million increase in general and administrative costs as compared to the prior year quarter was primarily driven by the creation of an internal business development function that was not in place in 2015 along with costs associated with CEO succession and organizational growth.
Juniper recorded a net loss of $1.7 million, or $(0.16) per diluted share, in the second quarter of 2016, compared to a net loss of $0.3 million, or ($0.03) per diluted share, in the same period of 2015.
Liquidity
Cash and cash equivalents were $13.0 million as of June 30, 2016, versus $13.5 million at March 31, 2016 and $13.9 million at December 31, 2015. The decrease in cash and cash equivalents was primarily the result of capital expenditures.
Outlook
Based on year-to date revenues and expectations for the second half of the year, Juniper now anticipates full-year 2016 revenue growth in the low- to mid-teen percentage range over 2015 results.