Pfenex Inc. (NYSEMKT:PFNX) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On December18, 2017, Pfenex Inc. (the “Company”) and Jazz Pharmaceuticals Ireland Limited (“Jazz”) entered into an amended and restated version (the “Amendment”) of their existing License and Option Agreement (the “Collaboration Agreement”), to which the parties arecollaboratively developing certain hematology products (the “Products”). Under the terms of the Amendment, the Company will receive an amendment fee of $5 million following signing of the Amendment and the parties agreed to a revised economic structure with potential payments to the Company totaling up to $224.5 million, including upfront and option payments, the payment of the amendment fee and potential payments for the achievement of certain development, regulatory and sales milestones. The Amendment also provides for tiered royalties on worldwide sales of any Products resulting from the collaboration, at rates reduced from those under the 2016 Collaboration Agreement. In addition, under the Amendment Jazz is granted a unilateral right, after receipt of regulatory approval for each Product, to make a one-time payment to the Company to replace the royalty payment obligation for such Product. The amount of such payment will be determined by the Company and Jazz or by an independent third party in the event the parties cannot reach agreement. to the Amendment, in addition to the $5 million amendment fee in the fourth quarter, Pfenex earned a $13.5 million milestone in connection with the collaboration by achieving a development milestone.
The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December31, 2017. The Company intends to submit a FOIA Confidential Treatment Request to the Securities and Exchange Commission to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Amendment. The omitted materials will be included in the request for confidential treatment.
|Item 1.01.||Regulation FD Disclosure.|
On December19, 2017, the Company issued a press release announcing it entered into the Amendment. A copy of the press release announcing the Amendment is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information referenced under Item 1.01 (including Exhibit 99.1 referenced in Item 1.01 below) of this Current Report shall not be deemed to be “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report. This Current Report shall not be deemed an admission as to the materiality of any information in the Current Report that is required to be disclosed solely by Regulation FD.
The description of the Amendment in Item 1.01 above is incorporated herein by reference.
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section27A of the Securities Act of 1933 and Section21E of the Securities Exchange Act of 1934. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Pfenex’s expectations, strategy, plans or intentions. Forward-looking statements in this communication include, but are not limited to, statements regarding Pfenex’s future plans to develop, manufacture and commercialize these product candidates and the potential to receive future milestone and royalty payments under Pfenex’s agreements with Jazz Pharmaceuticals. Actual results may differ materially from those indicated by these forward-looking statements as a result of the uncertainties inherent in the clinical drug development process, including, without limitation, challenges in successfully demonstrating the efficacy and safety of product candidates; the pre-clinical and clinical results for product candidates, which may not support further development of product candidates or may require additional clinical trials or
modifications of ongoing clinical trials or regulatory pathways; challenges related to commencement, patient enrollment, completion, and analysis of clinical trials; Pfenex’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives; Pfenex’s dependence on third parties for development, manufacture, marketing, sales and distribution of products; unexpected expenditures; and difficulties in obtaining and maintaining intellectual property protection for product candidates. Information on these and additional risks, uncertainties, and other information affecting Pfenex’s business and operating results is contained in Pfenex’s Quarterly Report on Form 10-Q for the quarter ended September30, 2017, and in Pfenex’s subsequent reports filed with the Securities and Exchange Commission. The forward-looking statements in this communication are based on information available to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.
|Item 1.01||Financial Statements and Exhibits.|
|99.1||Press Release dated December 19, 2017.|
Pfenex Inc. ExhibitEX-99.1 2 d449273dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Pfenex earns $18.5 million in milestones and updates Worldwide License and Option Agreement with Jazz Pharmaceuticals SAN DIEGO December 19,…To view the full exhibit click
About Pfenex Inc. (NYSEMKT:PFNX)
Pfenex Inc. is a clinical-stage biotechnology company. The Company is engaged in the development of biosimilar and therapeutic equivalent products to branded therapeutics and other high-value and difficult-to-manufacture proteins. Its lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab). Its next advanced product candidates are PF530 and PF708. PF530 is a biosimilar candidate to Betaseron (interferon beta-1b). PF708 is being developed as a therapeutically equivalent peptide to Forteo (teriparatide), which is for the treatment of osteoporosis. In addition to its three advanced product candidates, its pipeline includes over four other biosimilar candidates, as well as vaccines and next generation biologic candidates. Its product candidates are enabled by its protein production platform, Pfenex Expression Technology. It is also developing Px563L, an anthrax vaccine candidate, and Px533 as a prophylactic vaccine candidate against malaria infection.