SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 14, 2017
JUNIPER PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
33 Arch Street
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: (617) 639-1500
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|☐||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|☐||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
|Item 2.05||Costs Associated With Exit or Disposal Activities.|
On September 14, 2017, the Compensation Committee of the Board of Directors (the Board) of Juniper Pharmaceuticals, Inc. (the Company) approved a reduction of its workforce by approximately 8%, primarily in the areas of new product R&D, as part of a strategic reprioritization. This action is expected to be substantially complete by the end of 2017.
As a result of this reduction in force and strategic reprioritization, the Company estimates that it will incur aggregate charges of approximately $0.6 million to $0.7 million for one-time severance and employee related costs and future obligations due under our manufacturing and development contracts in the third quarter of 2017, of which approximately $0.4 million to $0.5 million are expected to result in cash expenditures by the end of 2017. The charges the Company expects to incur in connection with this reduction in force and strategic reprioritization are subject to a number of assumptions, and actual results may materially differ. The Company may also incur other material charges not currently contemplated due to events that may occur as a result of, or associated with, these actions.
|Item 5.02.||Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.|
(b) Departure of Certain Officers
As part of the strategic reprioritization and reduction in force described elsewhere in the Current Report, Bridget Martell, M.D., Chief Medical Officer, is leaving the Company. Dr. Martells employment with the Company will terminate effective September 18, 2017.
(e) Compensatory Arrangements of Certain Departing Officers
Upon the termination of Dr. Martells employment as described in Item 5.02(b) above, the Company will enter into a separation agreement and release of the Company and its affiliates with Dr. Martell pursuant to the terms of the amended and restated employment agreement by and between the Company and Dr. Martell dated as of April 12, 2017 (the Employment Agreement). According to such separation agreement and release and consistent with the terms of the Employment Agreement, Dr. Martell shall receive six (6) months of base salary continuation and six (6) months of COBRA continuation medical benefits subsidized by the Company following her departure, provided that she does not revoke such separation agreement and release. In addition, based on the approval of the Compensation Committee of the Board, the separation agreement and release extends the period during which Dr. Martell has the right to exercise options that were vested as of her termination date from 90 days to 180 days, provided that she does not revoke such separation agreement and release.
|Item 8.01||Other Events.|
On September 18, 2017, the Company issued a press release announcing the Companys strategic reprioritization and reduction in force, and the departure of Dr. Martell as discussed in Item 5.02(b) above. A copy of the press release is filed herewith as Exhibit 99.1 to this Report on Form 8-K and is incorporated herein by reference.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||Press release issued by Juniper Pharmaceuticals, Inc. on September 18, 2017.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|JUNIPER PHARMACEUTICALS, INC.|
|By:||/s/ Jeffrey E. Young|
Jeffrey E. Young
Senior Vice President, Finance, Chief Financial Officer and Treasurer
Date: September 18, 2017
Juniper Pharmaceuticals Announces Strategic Reprioritization
- Changes Designed to Drive Continued Growth in Core Businesses of
Crinone® and Juniper Pharma Services, Focus R&D Strategy
BOSTON, September 18, 2017 Juniper Pharmaceuticals (Nasdaq:JNP), a womens health therapeutics company, today announced a corporate reprioritization to allow the Company to focus its resources on the core businesses of Crinone® progesterone gel and Juniper Pharma Services (JPS), both of which continue to drive strong double-digit annual growth. As part of this initiative, the Company will begin to focus its research and development organization on JNP-0201 for hormone replacement therapy (HRT) as the Companys potential lead intravaginal ring (IVR) program and seek to potentially partner its other IVR programs. These actions are expected to result in cost savings that will position Juniper to achieve at least a cash flow neutral position for 2018.
This initiative streamlines expenses and provides us with financial flexibility as we assess growth opportunities to advance our strategy, said Alicia Secor, Junipers President and CEO. Growth of Crinone in key markets, combined with our efforts to expand both the JPS technical and geographical reach, are expected to deliver continued margin expansion and increased cash flows. In addition, we are also working to drive additional growth for the long-term by extending our Crinone relationship with Merck KGaA. In support of our strategic prioritization, we also plan to execute a more focused approach to our IVR portfolio and look to business development strategies to advance non-core areas of our pipeline.
Junipers base business continues to deliver strong growth with Crinone and JPS combined revenues of $25.2 million through the first six months of 2017. The Company achieved 17% annual growth for its combined core businesses in 2016, and expects a similar level of strong growth for 2017. In addition, Juniper ended the second quarter of 2017 with a cash balance of $21.5 million.
As a result of the focused R&D strategy, the Company will implement an approximately 8% headcount reduction, primarily in the areas of new product R&D, resulting in an estimated annual savings in personnel-related costs of approximately $1.9 million beginning in 2018. The Company also expects to reduce its overall new product R&D spend in connection with its revised focus. As a result of the reduction in force, the Company estimates that it will incur aggregate charges of approximately $0.6 million to $0.7 million for one-time severance and other employee related costs and future obligations due under our manufacturing and development contracts in the third quarter of 2017, of which approximately $0.4 million to $0.5 million are expected to result in cash expenditures by the end of 2017. In addition to the headcount reduction, Bridget Martell, M.D., Chief Medical Officer, will be stepping down from the Company effective today, September 18, 2017.
Ms. Secor added: These changes reflect our commitment to the prudent use of capital as we build shareholder value. We thank Dr. Martell and our departing colleagues for their dedicated service to Juniper. Their efforts have advanced our IVR technology and positioned us to build value by prioritizing a lead candidate for internal development and pursue a partnering strategy for other assets.
Focused R&D Organization
Junipers IVR pipeline candidates, JNP-0101, JNP-0201 and JNP-0301, remain on track for topline pre-clinical data by year end, studies which are designed to support clinical development in overactive bladder (OAB), HRT and the prevention of pre-term birth, respectively. As part of its focused R&D strategy the Company will prioritize these programs as follows:
|||Juniper expects to prioritize JNP-0201, a combination of Estradiol plus natural progesterone IVR for HRT to address symptoms of menopause, for internal development. Pending the outcome of the in vivo preclinical studies, the Company plans to advance JNP-0201 toward an investigational new drug (IND) filing next year.|
|||Following a Type C meeting with the U.S. Food and Drug Administration (FDA), the Company has determined that the clinical data and funding requirements to support a registration pathway for JNP-0301 will require the support of a partner to ensure successful development and commercialization.|
|||Based on assessments of the clinical and commercial investment required to advance a program in OAB, the Company will suspend further investment in JNP-0101 and seek a development partner for this candidate.|
The current FDA guidance around the clinical and regulatory pathway for the development of JNP-0201 as a hormone replacement therapy is clearly defined and provides a strong rationale for prioritizing this program, stated Ms. Secor. With no FDA-approved combination product for HRT, and the differentiating aspect of a combination natural hormone IVR for monthly administration, focusing our resources on the advancement of JNP-0201 provides us with the highest potential return on investment. For JNP-0301 and JNP-0101, the completion of the on-going in vivo studies will enable us to generate important data in a cost-effective manner in support of our partnering efforts.
Driving Continued Growth in Core Businesses
Junipers core businesses consist of Crinone, which is partnered with Merck KGaA for sale in markets outside of the U.S, and JPS, which provides world-class, fee-for-service contract development and manufacturing services to pharmaceutical and biotechnology companies around the world. Juniper expects continued growth in these businesses, supported by the following:
|||For Crinone, Juniper expects that Merck KGaA will continue to drive growth in existing markets while also supporting launches in key markets, including Japan.|
|||To support the long-term potential of Crinone, Juniper will evaluate opportunities to increase supply chain capacity to meet growing demand.|
|||Through continued expansion and investment in the JPS technical team and manufacturing capability, the Company has successfully increased its client base, including U.S.-based clients, and the scope of projects.|
We have delivered double-digit growth for both Crinone and JPS, and we will continue to focus our efforts to drive additional growth in these key
businesses, stated Ms. Secor. We have doubled the amount of Crinone we have produced for our partner Merck KGaA in the past four years, and are committed to ensuring that we are well-positioned to meet the growing demand for this product. Through JPS, we have quickly established a strong reputation as being a trusted and expert provider for the development of challenging and complex molecules. With our increased capacity and offerings, we are well-positioned to capture additional growth as the pace of outsourcing of product development activities increases.
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 womens 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 the corporate reprioritization, reduction in force and restructuring charges, the potential cost savings resulting from these changes and the ability to achieve at least a cash flow neutral position in 2018, the timing of an IND for JNP-201, the potential to partner Junipers other product candidates, the potential to complete a contract extension under Junipers CRINONE supply contract with Merck, the ability to continue to grow the JPS business, the strength of Junipers 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 Companys 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 managements 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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