BOSTON, March 10, 2016 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today announced financial results for the three- and twelve-month periods ended December 31, 2015.
"2015 was a transformative year for Juniper, with strong performance in every aspect of our business," stated Frank Condella, Chief Executive Officer. "We made significant progress in R&D, advancing COL-1077 10% lidocaine vaginal gel into the clinic as a promising anesthetic for pain associated with minimally-invasive gynecologic procedures. We look forward to reporting results from this 185-patient randomized, double-blinded Phase 2b study in the third quarter.
"Another important 2015 event was securing the global license to a novel segmented intra-vaginal ring (IVR) that holds great potential to profoundly improve the delivery of therapeutics to women. Our initial IVR product candidates are designed to better address the needs of women suffering from overactive bladder and the symptoms of menopause, and for the prevention of preterm birth.
"We are well positioned to fully fund our 2016 operations and planned R&D activities with cash flow from our base business and cash on hand. With successful execution of our current operating plans, we can potentially launch three new products within the next five years with a combined market opportunity well over $1 billion," Condella concluded.
Full Year Financial Results
Total revenues increased 16% year-over-year to $37.6 million in the year ended December 31, 2015, as compared to $32.5 million in the previous year. The increase was primarily driven by higher sales of CRINONE® (progesterone gel) to Merck KGaA, Darmstadt, Germany, and higher service revenues.
Product revenues from Merck KGaA increased 29% to $22.2 million in 2015, compared with $17.2 million in the prior year. The $5.0 million increase primarily reflects continued in-market demand for CRINONE®, combined with entry into new markets in 2015.
Service revenues increased 33% to $11.7 million for the twelve months ended December 31, 2015, as compared with $8.8 million in the prior year. The $2.9 million increase primarily reflects increases in customer volume across our service offerings. In local currency, revenues increased 44% year over year; however this was dampened by the effect of the strong U.S. Dollar relative to the British Pound.
Royalties totaled $3.7 million in 2015, compared with $6.3 million in the prior year. The decrease in 2015 was primarily driven by a $2.2 million one-time benefit from the monetization of intellectual property that benefitted 2014.
Gross profit increased to $16.1 million in the year ended December 31, 2015, as compared with $14.8 million in the prior year. Gross profit as a percentage of total revenues was 43% for the full year 2015, compared to 46% in the prior year. Excluding the impact of the monetization of intellectual property, the gross margin was 42% in the prior year.
Operating expenses increased to $18.7 million in 2015, up from $11.0 million in the prior year. The $7.7 million increase was primarily driven by a $6.3 million increase in research and development (R&D) costs associated with Juniper's renewed focus on drug development.
R&D expense in 2015 was largely driven by costs for the ongoing Phase 2b clinical trial of COL-1077 10% lidocaine bioadhesive vaginal gel for pain associated with minimally invasive gynecologic procedures. 2015 R&D expense also includes development costs for our IVR product candidates.
General and administrative costs increased by $1.9 million, while sales and marketing costs were $0.5 million lower in 2015 versus 2014.
The Company recorded a net loss of $2.1 million, or ($0.20) per diluted share, in the twelve months ended December 31, 2015. The result compares with net income of $3.4 million, or $0.27 per diluted share, for the twelve months ended December 31, 2014.
Non-GAAP Adjusted EBITDA was $1.6 million for the 2015 period compared to $7.0 million for the 2014 period. We have determined not to provide Non-GAAP Adjusted EBITDA figures for future periods, as management believes this measure will not provide meaningful supplemental information regarding our performance in such periods.
Fourth Quarter Financial Results
Fourth quarter total revenues increased to $7.6 million, compared with $7.3 million for the quarter ended December 31, 2014. A $1.5 million increase in service revenues was partially offset by lower product revenues and royalties in the fourth quarter of 2015 versus the prior year period.
Gross profit increased to $3.0 million, compared with $2.8 million in the prior year quarter.
Total operating expenses were $2.7 million higher in the fourth quarter of 2015 as compared to the prior year quarter. The increase was largely driven by a $1.5 million increase in R&D spending and a $1.3 million increase in general and administrative costs in the fourth quarter of 2015 versus the prior year period.
As a result, Juniper recorded a net loss of $2.1 million, or ($0.19) per diluted share, in the fourth quarter of 2015, compared to a net loss of $0.5 million, or ($0.05) per diluted share, in the same period of 2014.
Liquidity
Cash and cash equivalents were $13.9 million as of December 31, 2015, versus $16.8 million at December 31, 2014, largely due to changes in working capital.
Financial Outlook
Juniper expects modest revenue growth in 2016 as the strong U.S. Dollar continues to have a negative translation impact on our service and ex-U.S. CRINONE revenue despite strong in-market growth for those businesses. Juniper is positioned to fund 2016 operations and planned R&D activities from cash flow generated by core business operations and our existing cash position.
Conference Call
As previously announced, Juniper's management will hold a conference call to discuss financial results for the fourth quarter and full year ended December 31, 2015, as follows:
Date: | Thursday, March 10, 2016 |
Time: | 8:30 a.m. EST |
Dial-in numbers: | Toll free: (866) 374-4635 (U.S.), (855) 669-9657 (Canada), or |
International: (412) 902-4218 | |
Webcast (live & archive): | www.juniperpharma.com, under 'Investors' or click here |
The teleconference replay will be available at approximately one hour after completion through Wednesday, March 16, 2016, at (877) 344-7529 (U.S.), (855) 669-9658 (Canada) or (412) 317-0088 (International). The conference ID for the replay is 10081480.
The archived webcast will be available for one year via the aforementioned URLs.
Use of Non-GAAP Adjusted Financial Information
Included in this press release and the conference call referenced above are non-GAAP financial measures as defined by U.S. Securities and Exchange Commission Regulation G. The GAAP financial measure most directly comparable to such non-GAAP financial measure used or discussed, and a reconciliation of the differences between such non-GAAP financial measure and the comparable GAAP financial measure, is included in this press release after the condensed consolidated financial statements below.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. is focused on developing therapeutics that address unmet medical needs in women's health. The Company is advancing a pipeline of proprietary product candidates that leverage novel intra-vaginal drug delivery technologies. Juniper's commercial product, CRINONE® 8% (progesterone gel), is marketed by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide and by Allergan, Inc. in the U.S. Please visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals is a trademark of Juniper Pharmaceuticals, Inc., in the U.S. and EU.
CRINONE® is a registered trademark of Merck KGaA, Darmstadt, Germany, outside the U.S. and of Allergan, Inc. in the U.S.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing of clinical trials for Juniper's product candidates and the announcement of results from these trials; the potential of Juniper's IVR to improve the delivery of therapeutics to women; and our anticipated cash flow and expenses from operations and our ability to fund 2016 operations and planned R&D activities internally. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.
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