Current Report Filing (8-k)
June 11 2018 - 4:13PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
June 11, 2018
Pfenex Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-36540
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27-1356759
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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10790 Roselle Street
San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858)
352-4400
(Registrants telephone number, including area code)
Not Applicable
(Former
name or former address, if changed since last report.)
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined
in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule
12b-2
of the Securities Exchange Act of 1934 (17 CFR
§240.12b-2).
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 Definitive Agreement
On June 11, 2018, Pfenex Inc. (the Company) and Alvogen Malta Operations Ltd. (Alvogen) entered into a Development and
License Agreement (the Agreement) pursuant to which Alvogen will have the exclusive right to commercialize and manufacture PF708 (teriparatide) (the Product), a therapeutic equivalent candidate to Eli Lilly &
Companys Forteo
®
, in the United States. The Company will retain exclusive rights to the Product in all countries outside of the United States except Mainland China, Hong Kong, Singapore,
Malaysia and Thailand where the Company has granted rights to another collaboration partner.
In consideration for the licenses and other
rights granted in the Agreement, the Company will receive an upfront payment of $2.5 million and may be eligible to receive an additional $25 million in support and regulatory milestone payments. The Company may also be eligible to receive
a 50% gross profit split on sales if the product is rated as Therapeutic Equivalent (AP), and otherwise tiered split up to 40%.
Under the
terms and conditions of the Agreement, the Company will be responsible for obtaining FDA approval for the Product at its cost and expense, except that Alvogen will provide a
one-time
development support
payment of $2.5 million and bear fifty percent of any PDUFA (Prescription Drug User Fee Act) fees that may be payable with respect to the Product. Additionally, Alvogen will support certain agreed costs incurred by Company after June 1,
2018, or provide resources at its expense, related to the preparation and filing the NDA for the Product. Following the receipt of FDA approval for the Product, Alvogen will be obligated to use diligent efforts to continue to develop, manufacture
and commercialize the Product in the United States at its cost and expense.
The Company and Alvogen will establish an executive steering
committee and working subcommittees, each with an equal number of representatives, to review and oversee the collaboration. Each party has ultimate decision making authority with respect to a specified limited set of issues, and all other matters
will be resolved by consensus. Otherwise, in the event of failure to reach consensus or certain disputes, the Agreement provides for an expedited dispute resolution process, except for disputes concerning patents and trademarks, which instead will
be submitted to a court of competent jurisdiction. Subject to the oversight of the executive steering committee, Alvogen will control the intellectual property strategy for the Product and any defensive litigation related to the Product at its
expense.
Unless terminated earlier, the Agreement will continue for a period of ten years following the first commercial sale of the
Product in the United States. The Agreement includes customary termination provisions and effects thereof, including reimbursement by the Company of $2.5 million if the Agreement is terminated for safety reasons, failure to timely achieve FDA
approval or the Companys breach or insolvency.
In the event of an assignment of the Agreement, any entity to whom the agreement is
assigned will be obligated to assume the responsibilities of the assigning party.
The foregoing summary of the Agreement does not purport
to be complete and is qualified in its entirety by reference to the Agreement, which will be filed as an exhibit to the Companys Quarterly Report on Form
10-Q
for the quarter ended June 30, 2018.
The Company intends to submit a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant to
Rule 24b-2
under the Securities Exchange Act of 1934, as amended, requesting that
it be permitted to redact certain portions of the Agreement. The omitted materials will be included in the request for confidential treatment.
Item 7.01. Regulation FD Disclosure.
On June 11, 2018, the Company issued a press release announcing it entered into the Agreement. A copy of the press release announcing the
Agreement is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information referenced under Item 7.01 (including Exhibit 99.1 referenced in
Item 9.01 below) of this Current Report shall not be deemed to be filed for purposes of Section 18 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.
Item 8.01. Other Events.
The
description of the Agreement in Item 1.01 above is incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form
8-K
contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. 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 Pfenexs expectations, strategy, plans or intentions. Forward-looking statements in this communication include, but are not limited to, statements regarding the future potential of PF708,
including development and commercialization of PF708; the potential to receive future milestone and royalty payments under Pfenexs agreement with Alvogen; the expected timing of Pfenexs submission of the NDA for PF708; the expectation
for PF708 to obtain marketing approval in the United States; Pfenexs expectation to develop the product under the 505(b)(2) regulatory pathway in the United States; the belief that this agreement will help advance development and
commercialization of PF708; potential market opportunities for PF708; the potential for the collaboration to support the PF708 program for the NDA submission to the FDA; and the belief that Alvogen will be able to quickly leverage its commercial
operations in the U.S. in bringing PF708 to market. 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; Pfenexs
ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives; Pfenexs 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
Pfenexs business and operating results is contained in Pfenexs Quarterly Report on Form
10-Q
for the quarter ended March 31, 2018 and in Pfenexs 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 9.01 Financial Statements and Exhibits.
(d) Exhibits
-2-
SIGNATURES
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.
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PFENEX INC.
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Date: June 11, 2018
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By:
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/s/ Susan A. Knudson
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Susan A. Knudson
Chief Financial Officer
(Principal Financial Officer)
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