Juniper Pharmaceuticals Reports Second Quarter 2015 Financial Results

BOSTON, Aug. 4, 2015 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company") a women's health specialty pharmaceutical company, today announced financial results for the three months ended June 30, 2015. Highlights include:

• Patient enrollment is underway and on track in the Phase 2 clinical study of COL-1077 10% lidocaine bioadhesive gel;
• Total revenues increased 53% year-over-year to $10.2 million, driven by an 89% increase in product revenues and 29% growth in service revenues;
• $16.1 million in cash and equivalents at June 30, 2015.

"This was a robust quarter for Juniper Pharmaceuticals, with solid revenue growth reflecting strength in the CRINONE^® franchise and our pharmaceutical services business," stated Frank Condella, Chief Executive Officer. "The recent approval of CRINONE^® in nine additional European Union countries will support the ongoing expansion of our product revenues and reinforces our expectation for low double-digit revenue growth this year."

The Company continues to advance its drug development activities on several fronts, with focus on developing therapeutics for unmet medical needs in women's health. 

Enrollment is underway at 13 of 15 planned U.S. study centers in the ongoing Phase 2 trial of COL-1077, with the remaining two sites expected to come online by the end of August. This study is evaluating the safety and efficacy of COL-1077 in women undergoing pipelle-directed endometrial biopsy with tenaculum placement. The primary endpoint of this study is the reduction in pain intensity at the time of biopsy. Results are expected in mid-2016.

The Company is prioritizing identified opportunities that would leverage its proprietary bioadhesive gel and segmented intra-vaginal ring technologies. These include initial indications in OB/Reproductive, Rheumatologic, GYN Endocrine, Endocrine-Bone, and Uro-Gynecological health. Juniper plans to announce by the end of this year the second product it will move into development.   

Juniper has assembled an exceptional team of drug development and formulation experts, both in-house and on its Scientific Advisory Board comprised of leading experts in women's health. The Company is leveraging this expertise and its world-class pharmaceutical development and clinical manufacturing capabilities to support both its global client base and its proprietary drug development activities. These unique resources, along with the Company's cash position, provide a strong platform for future growth.

Second Quarter Financial Results

Revenues for the three-month period ended June 30, 2015 were $10.2 million, an increase of 53% as compared to $6.7 million for the three-month period ended June 30, 2014. On a sequential basis, revenues rose 23% versus the first quarter of 2015.

Product revenues for the second quarter increased 89% to $6.6 million, compared with $3.5 million in the prior year period. The $3.1 million increase continues the return of normalized CRINONE^® (progesterone gel) shipments beginning in the third quarter of 2014. On a sequential basis, product revenues rose 36% versus the first quarter of 2015.   

On a U.S. dollar basis, second quarter service revenues increased 29% year-over-year to $2.7 million, primarily due to higher customer volumes across the Company's service offering. On a local currency basis, second quarter service revenues increased 41% year-over-year and 9% versus the first quarter of 2015.

Royalty revenues were $0.9 million in the quarter, compared with $1.0 million in the prior year period. The decrease largely reflects the monetization of a legacy product royalty stream in the third quarter of 2014, with no corresponding revenue in 2015.

Gross profit rose 67% to $4.6 million in the second quarter of 2015, as compared to $2.8 million in the prior year period. Gross profit as a percentage of total revenues was 45%, up from 42% in the prior year quarter.  

Total operating expenses increased to $5.0 million in the second quarter, compared to $2.7 million in the prior year period. The increase was largely driven by $2.1 million of research and development (R&D) costs. R&D costs during the quarter included expenses associated with the initiation of the Phase 2 study of COL-1077 in late May 2015. No R&D expenses were incurred in the second quarter of 2014.

The Company reported an operating loss of $0.3 million, compared with an operating profit of $0.1 million in the year-ago period.

The second quarter net loss was $0.3 million, or ($0.03) per diluted share. In the second quarter of 2014, the net loss was $10 thousand, or ($0.01) per diluted share. Adjusted EBITDA was $0.6 million in the second quarter of 2015 compared with $0.8 million in the second quarter of 2014.

Cash and cash equivalents were $16.1 million as of June 30, 2015.

Recent Business Highlights

• Merck KGaA, Darmstadt, Germany, was granted new marketing authorization for CRINONE^® in nine European Union countries: Bulgaria, Estonia, France, Iceland, Latvia, Lithuania, the Netherlands, Poland, and Romania. Juniper Pharmaceuticals is the exclusive supplier of CRINONE^® to Merck, KGaA, Darmstadt, Germany.
• James Geraghty was elected as Chairman of the Board. Mr. Geraghty is an industry leader with 30 years of strategic and leadership experience, including more than 20 years as a senior member of executive teams at biotechnology companies developing and commercializing innovative therapies.
• Biotechnology industry veteran Ann Merrifield joined Juniper's Board of Directors. Ms. Merrifield was formerly President and Chief Executive Officer of PathoGenetix, and previously held executive roles at Genzyme Corporation.

Conference Call

As previously announced, Juniper's management will hold a conference call to discuss financial results for the second quarter ended June 30, 2015, as follows:

The teleconference replay will be available approximately one hour after completion through Friday, August 21, 2015, at (877) 344-7529 (U.S.), (855) 669-9658 (Canada), or (412) 317-0088 (International). The conference ID for the replay is 10069118.  The archived webcast will be available for one year via the aforementioned URLs.

About Juniper Pharmaceuticals

Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (formerly Columbia Laboratories) is a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women's health.  Juniper has a successful heritage in developing pharmaceutical products, including CRINONE^® 8% (progesterone gel), which is marketed by Allergan, Inc. in the U.S. and by Merck and of Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide. The Company is uniquely positioned to leverage in-house pharmaceutical development, clinical trial manufacturing, and analytical capabilities to advance an internal development pipeline, while also providing valuable consultative services to its pharmaceutical industry customers. Please visit www.juniperpharma.com for more information.

Juniper Pharmaceuticals and Juniper Pharma Services are trademarks of Juniper Pharmaceuticals, Inc., in the U.S. and EU.

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