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): January 7, 2018
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 1.01. Entry Into a Material Agreement
On January 7, 2018, Juniper Pharmaceuticals, Inc. (the Company) entered into a new supply agreement (the New Supply Agreement) with Ares Trading S.A. (an affiliate of Merck KGaA) for the sale of CRINONE (progesterone vaginal gel containing progesterone in a concentration of 8.0%) in all territories outside the United States during the period commencing after the expiration of the existing supply agreement (which now expires on June 30, 2020) through December 31, 2024. The terms of the existing supply agreement will remain in effect until June 30, 2020.
Under the terms of the New Supply Agreement, the Company will sell CRINONE to Merck KGaA at specified prices, subject to adjustment on an annual basis, based on applicable product configurations, expected sales volumes, changes in the consumer price index and other factors. The New Supply Agreement includes guaranteed product unit volumes for each calendar year commencing in 2021. Under the New Supply Agreement, the Company will seek to expand the production capacity of the supply chain in order to satisfy expected demand during the applicable time periods.
Consistent with the terms of the existing supply agreement, the New Supply Agreement requires Merck KGaA to provide a rolling 18-month forecast of its CRINONE requirements on a county-by-country basis. The first four months of each forecast are considered firm orders. Merck KGaA will be solely responsible for all market authorizations in the applicable territories. During the term of the New Supply Agreement, the Company has agreed not to manufacture or sell to another party outside the United States any vaginal gel product containing progesterone, and Merck KGaA has agreed to purchase its entire requirement of CRINONE from the Company, subject to certain exceptions. The New Supply Agreement includes customary indemnification provisions pursuant to which the Company agrees to indemnify Merck KGaA for third party claims arising out of the Companys failure to comply with the agreement or to supply CRINONE in accordance with the applicable specifications.
Unless earlier terminated, the New Supply Agreement covers the supply of CRINONE for the period commencing July 1, 2020 through December 31, 2024. The New Supply Agreement may be terminated by mutual agreement or by either party in the event of a material breach or in the event of a partys insolvency.
The Company expects to file the New Supply Agreement as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2018. The foregoing description of the New Supply Agreement is qualified in its entirety by reference to the complete text of such agreement when filed.
Item 7.01 Regulation FD Disclosure.
On January 8, 2018, the Company issued a press release related to the New Supply Agreement. A copy of the press release is furnished and attached as Exhibit 99.1 hereto and is incorporated herein by reference. The information being furnished pursuant to Item 7.01 of this Current Report on Form 8-K and contained in Exhibit 99.1 shall not be deemed to be filed for purposes of Section 18 of the Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits
|99.1||Press Release dated January 8, 2018, furnished herewith.|
|99.1||Press Release dated January 8, 2018, furnished herewith.|
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|
|Name:||Jeffrey E. Young|
Senior Vice President, Finance,
Chief Financial Officer and
Date: January 8, 2018
Juniper Pharmaceuticals Announces 4.5-Year Extension
through 2024 of CRINONE® Supply Agreement with Merck
KGaA, Darmstadt, Germany
BOSTON, January 08, 2018 Juniper Pharmaceuticals (Nasdaq:JNP), a diversified healthcare company focused on womens health, today announced the extension of its supply agreement for CRINONE® (progesterone gel) with an affiliate of Merck KGaA, Darmstadt, Germany. The amended agreement extends the supply term an additional 4.5 years and at least through to December 31, 2024. The current term was due to expire in May 2020. Merck KGaA, Darmstadt, Germany has marketing rights worldwide except the United States, where CRINONE® is marketed by Allergan plc.
Our longstanding collaboration with Merck KGaA, Darmstadt, Germany to supply CRINONE® progesterone gel for sale outside of the U.S. remains an extremely important core business for us. We anticipate approximately 20% growth in 2017, and expect continued long-term growth throughout the extension period, said Alicia Secor, Junipers President and CEO. The expansion of this relationship with Merck KGaA, Darmstadt, Germany has been a strategic priority for us, and we look forward to continuing to work with the Merck KGaA Darmstadt, Germany team to support the long-term potential of this product.
Under the terms of the amended license and supply agreement, Juniper will remain the supplier of CRINONE® to Merck KGaA, Darmstadt, Germany and will continue to sell CRINONE® to Merck KGaA, Darmstadt, Germany for the more than 90 countries outside of the U.S. where CRINONE® is sold. The agreement also sets from 1 July 2020, a volume tiered, fixed price per unit with minimum annual volume guarantees. In addition, Juniper has committed to increase the capacity of its supply chain in line with the projected growth of the product.
Juniper previously reported that CRINONE® product revenues increased 19% year-over-year in the third quarter of 2017. The Company recently announced that it expects continued strong double-digit revenue growth for its core business, CRINONE® and JPS, in 2018.
CRINONE® 8% (progesterone gel) is a bioadhesive progesterone vaginal gel indicated for progesterone supplementation of the luteal phase in women as part of an ART (assisted reproductive technology) procedure, among other indications depending upon the country.
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 anticipated demand and growth rates for Junipers core businesses, CRINONE and JPS, and Junipers intention to expand the capacity of its CRINONE supply chain to meet anticipated demand in future periods. 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 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. 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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