Juniper's total revenues increase 19% to $8.3 million in first quarter 2015

Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), today announced financial results for the three-month period ended March 31, 2015. First quarter financial highlights include:

• Total revenues were $8.3 million, an increase of 19% as compared to $7.0 million in the first quarter of 2014;
• Product revenues increased 41% year-over-year, enabled by the return of normalized CRINONE^® (progesterone gel) shipments to Merck Serono in the fourth quarter of 2014;
• Service revenues grew 9% year-over-year and 42% from the fourth quarter of 2014, on a local currency basis;
• Operating profit excluding R&D expense related to drug development was $0.6 million, versus an operating loss of $0.1 million in the prior year period;
• $16.3 million in cash and equivalents at March 31, 2015.

"The first quarter marked a turning point in Juniper Pharmaceuticals' return as a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women's health," stated Frank Condella, Chief Executive Officer.

"We delivered strong quarterly results, with revenues up 19% year-over-year, and also achieved multiple goals critical to the successful execution of our proprietary product development strategy. These include filing an Investigational New Drug Application for COL-1077, a 10% lidocaine bioadhesive gel; in-licensing a proprietary intra-vaginal ring technology; and forming a Scientific Advisory Board comprised of renowned physicians and scientists.

"In the second quarter, we anticipate the initiation of a Phase II clinical study of COL-1077 as an acute use anesthetic in women undergoing transvaginal pipelle-directed endometrial biopsy, a minimally invasive gynecologic procedure. There are over five million such procedures performed in the U.S. each year, yet there is no approved acute-use anesthetic available. This is a significant market opportunity, and we believe COL-1077 can address the unmet need for a safe and effective localized pain treatment for these patients.

"We continue to execute our strategy to invest cash flow generated by the CRINONE^® franchise and service business to substantially fund our proprietary product pipeline; COL-1077 is the first in an anticipated series of women's health product opportunities. We are continuing to leverage Juniper Pharma Services' expertise in formulation, pharmaceutical development, and manufacturing to accelerate our drug development, and look forward to announcing our next product candidate later this year," continued Mr. Condella.

First Quarter Financial Results

First quarter revenues were $8.3 million, an increase of 19% as compared to $7.0 million in the same period of 2014.

Product revenues for the first three months of 2015 increased 41% to $4.9 million, compared with $3.5 million in the year-ago period. The $1.4 million increase reflects the return of more normalized CRINONE^® shipments to Merck Serono. As previously disclosed, importation of CRINONE^® in a large market was not permitted during a routine marketing license renewal, which reduced revenues from Merck Serono in the first half of 2014.

On a U.S. dollar basis, first quarter service revenues were stable year-over-year at $2.5 million. On a local currency basis, first quarter service revenues increased 9% year-over-year and 42% versus the fourth quarter of 2014. The revenue growth was largely driven by an increase in clinical trials manufacturing and value-added services during the period.

Royalty revenues were $1.0 million in the quarter, compared with $1.1 million in the year-ago period. The decline is due to the monetization of a legacy product royalty stream in the third quarter of 2014.

Gross profit rose 26% to $3.4 million in the first quarter of 2015, as compared to $2.7 million in the prior year period. Gross profit as a percentage of total revenues was 41%, up from 39% in the prior-year quarter, largely due to a shift in revenue mix towards higher-margin CRINONE^® sales during the 2015 period.

Total operating expenses increased to $4.3 million in the first quarter of 2015, compared to $2.9 million in the prior year period, driven largely by $1.4 million of research and development (R&D) costs. R&D expenses in the quarter include internal and consulting costs associated with the advancement of COL-1077 and costs associated with establishing the strategic advisory agreements with Drs Langer and Crowley. No R&D expenses were incurred in the first quarter of 2014.

The Company reported an operating loss of $0.8 million, compared with an operating loss of $0.1 million in the year-ago period. Excluding R&D expense, the Company would have reported an operating profit of $0.6 million in the first quarter of 2015.

The first quarter net loss was $0.7 million, or ($0.06) per diluted share, which includes $1.4 million of R&D costs that did not occur in the prior year period. In the first quarter of 2014, net income was $0.2 million, or a net loss of ($0.01) per diluted share. Adjusted EBITDA was $0.4 million in the first quarter of 2015 compared with $0.5 million in the first quarter of 2014.

Cash and cash equivalents were $16.3 million as of March 31, 2015, compared with $16.8 million at December 31, 2014.

Recent Business Highlights

• Filed an Investigational New Drug application for COL-1077, a 10% lidocaine bioadhesive vaginal gel intended as an acute use anesthetic for minimally invasive gynecologic procedures. A randomized, double-blinded, placebo controlled Phase II clinical trial is planned to commence during the second quarter and will enroll 150 patients at fifteen U.S. sites.
• Licensed exclusive worldwide rights to a proprietary intra-vaginal ring technology for the delivery of one or more pharmaceuticals at different dosages and release rates in a single segmented ring. This patient-administered device is intended to be utilized as a key drug delivery platform for Juniper's emerging proprietary product pipeline. The technology was developed by esteemed scientists Dr. Robert Langer (MIT) and Dr. William Crowley (Massachusetts General Hospital and Harvard Medical School), who have joined Juniper as strategic advisors.
• Established a Scientific Advisory Board ("SAB") comprised of prominent physicians and scientists who will provide scientific and clinical advice on the identification and advancement of product candidates for Juniper's women's health portfolio. The SAB consists of: Ginger D. Constantine, MD; William F. Crowley Jr., MD; Martyn Davies, BSc, Ph.D., FRPharmS, CChem, FRSC; Robert S. Langer, Sc.D.; and, Daniel A. Shames, MD, FACS.
• Columbia Laboratories commenced trading under its new name, Juniper Pharmaceuticals, (Nasdaq: JNP) and the Company's Nottingham, UK-based subsidiary Molecular Profiles, Ltd, was renamed Juniper Pharma Services, effective April 13, 2015. The single Juniper brand formalizes the experience and capabilities the Company has built across its CRINONE^® franchise, service business, and proprietary product development platforms.

Financial Outlook

In-market sales of CRINONE^® continue to be strong, and the resumption of normalized shipments should lead to increased product sales this year. Juniper also expects service revenues, in local currency, to be higher in 2015. Accordingly, the Company maintains its guidance of low double-digit total net revenue growth for the full year. In line with Juniper's strategy, operating cash flow will be used to substantially fund proprietary drug development activities as R&D spending is expected to increase during 2015.

"We are laser focused on advancing this strategy, as we believe an expanded product portfolio is a key driver for creating long-term shareholder value," concluded Mr. Condella.