BOSTON, Jan. 2, 2018 /PRNewswire/ -- Juniper Pharmaceuticals (Nasdaq: JNP), a diversified healthcare company focused on women's health, today provided financial guidance for 2018, reflecting continued strength in the Company's core businesses, Juniper Pharma Services (JPS) and CRINONE® (progesterone gel), and provided an overview of strategic priorities for 2018. The Company also announced positive top-line pharmacokinetic data from in vivo animal studies evaluating each of the Company's three IVR formulations.
"Our plans for 2018 are designed to build upon our strong performance across our core businesses, JPS and CRINONE, in 2017," said Alicia Secor, Chief Executive Officer. "We are determined to continue the growth trajectory in both of our core businesses, while remaining financially strong and fiscally responsible to maximize shareholder value."
- Continued strong double-digit revenue growth for CRINONE® and JPS is expected in 2018.
- Based on growth trends seen in CRINONE® and JPS, and a continued commitment to prudent use of cash, the Company anticipates being cash flow positive in 2018.
"Another highlight for 2017 was the successful completion of in vivo animal studies that we believe supports advancement of our IVR technology platform. Based on these data, we will continue to make targeted investments to support certain IND-enabling activities in our priority program, JNP-0201, while maintaining optionality to partner this program. We will also continue to advance discussions with potential partners around JNP-0101 and JNP-0301," continued Ms. Secor.
Preclinical IVR data
- Rapid absorption of estradiol and progesterone from JNP-0201 IVR was demonstrated, with peak concentrations within the first 4-8 hours.
- Each IVR candidate achieved its targeted release (JNP-0101 delivery of oxybutynin over 28 days, JNP-0201 delivery of natural progesterone and estradiol over 28 days, and JNP-0301 delivery of natural progesterone over 14 days) and demonstrated an improved pharmacokinetic profile with little to no daily fluctuations over the course of treatment compared to marketed products in direct in vivo animal studies.
"This IVR technology was designed to deliver molecules of any size, both low and high molecular weight, as well as multiple drugs simultaneously at any desired release rate and at a range of doses, while allowing for controlled delivery over time with extended duration in a single administration," said Robert Langer, ScD, Institute Professor at Massachusetts Institute of Technology, co-developer of the novel IVR technology, and a member of the Juniper Scientific Advisory Board. "These results suggest that this technology platform may eventually allow for improved patient compliance and convenience over other routes of administration with the potential to address various women's health needs."
- JPS will continue to focus on the expansion of its pharmaceutical development and manufacturing services to new and existing customers seeking solutions for difficult to formulate products. Capital expenditures planned for 2018 will provide capacity expansion capabilities intended to drive future growth.
- Active discussions with partner Merck KGaA to extend the CRINONE® Progesterone Gel agreement are progressing, and the expansion of this relationship remains a strategic priority for the Company.
- Partnering opportunities are being explored for JNP-0101, the oxybutynin IVR for the treatment of overactive bladder (OAB), and JNP-0301, a natural progesterone IVR for the prevention of pre-term birth (PTB) in women with a short cervical length at mid-pregnancy.
- Support of IND-enabling activities for JNP-0201 remains ongoing, while the Company maintains optionality to partner this program.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. core businesses include its CRINONE® (progesterone gel) franchise and Juniper Pharma Services, which provides high-end fee-for-service pharmaceutical development and clinical trials manufacturing to clients. The Company is also leveraging its differentiated intravaginal ring technology, which offers the potential to address unmet needs in women's health. 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 plc 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 management's expectations concerning future financial results and financial condition, including double-digit revenue growth and becoming cash flow positive in 2018, statements relating to the preclinical in vivo animal data for Juniper's product candidates and IVR technology platform, statements relating to the advancement of Juniper's product candidates, including a potential IND and IND-enabling activities for JNP-0201 and potential partnering agreements for these product candidates, statements concerning the successful negotiation and completion of an extension of the CRINONE® supply agreement with Merck KGaA and statements relating to the ability to continue to grow the JPS business, the strength of Juniper's core business, product candidates and future results. 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. These risks and uncertainties include, but are not limited to: risks associated with potential employee retention challenges following our restructuring; risks associated with the drug development process generally, including the outcomes of planned clinical trials and the regulatory review process; the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies or following commercial launch, if such product candidates are approved; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Juniper Pharmaceuticals' ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risk associated with Juniper Pharmaceuticals' ability to manage operating expenses and/or obtain additional funding to support its business activities; and risks associated with Juniper Pharmaceuticals' dependence on third parties, particularly with respect to JPS and CRINONE®. For a discussion of certain risks and uncertainties associated with Juniper Pharmaceuticals' forward-looking statements, please review the Company's reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2016 and subsequent filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Juniper Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.
Laura Perry or Heather Savelle
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SOURCE Juniper Pharmaceuticals, Inc.