BOSTON, Sept. 18, 2017 /PRNewswire/ -- Juniper
Pharmaceuticals (Nasdaq: JNP), a women's 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 Company's 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,
Juniper's 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."
Juniper's 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
Juniper's 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
Juniper's 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
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 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 Juniper's other product
candidates, the potential to complete a contract extension under
Juniper's CRINONE supply contract with Merck, 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.
Investor Contact:
Argot Partners
Laura Perry or Heather Savelle
212-600-1902
laura@argotpartners.com
heather@argotpartners.com
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SOURCE Juniper Pharmaceuticals, Inc.