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): April 18, 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
(Registrant’s 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. ☐
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Item 1.01
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Entry into a Material Definitive Agreement
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On April 18, 2018, Pfenex Inc. (the
“Company” or “Pfenex”) and China NT Pharma Group Company Limited (“NT Pharma”) entered into a Development and License Agreement (the “Agreement”), pursuant to which Pfenex granted an exclusive license to NT
Pharma to commercialize PF708, a teriparatide therapeutic equivalent to Eli Lilly & Company’s Forteo
®
(the “Product”), in Mainland China, Hong Kong, Singapore, Malaysia
and Thailand (each a “Region,” and collectively, the “Territory”) and a
non-exclusive
license to conduct development activities in the Territory with respect to the Product. The Company
will retain exclusive rights to the Product in all countries outside of the Territory. Under the terms of the Agreement, the Company received a payment of $2.5 million upon signing of the Agreement and may be eligible to receive additional
payments of up to $22.5 million based on the achievement of certain development, regulatory, and sales-related milestones. The Company may also be eligible to receive double-digit royalties on net Product sales.
The Agreement sets forth the parties’ respective obligations with respect to the development and commercialization of the Product. The
Company and NT Pharma will establish an Executive Steering Committee (the “Committee”), each with an equal number of representatives, to review and oversee the strategy and key decisions related to the activities under the Agreement. All
matters must be resolved by consensus of the Committee; however, if the Committee is unable to do so, the Chief Executive Officer of each party has ultimate decision making authority with respect to a specified set of issues.
Under the terms and conditions of the Agreement, the Company will supply the Product to NT Pharma and NT Pharma will, at its expense, be
responsible for all preclinical and clinical studies, if required, to receive regulatory approval in each Region and any ongoing Product development requirements in the Territory. The Company will be responsible for commercial manufacturing and will
provide NT Pharma with the Product for commercial sale at a mutually agreed transfer price. NT Pharma will, at its expense, be responsible for all regulatory submissions in the Territory, so long as the Company provides regulatory support
documentation reasonably requested by NT Pharma. If either party fails to fulfill certain obligations under the Agreement, the other party may terminate the Agreement with additional monetary payments made to the
non-breaching
party.
The Agreement will continue in full force and effect until terminated. Each
party will have the right to terminate the Agreement unilaterally under certain circumstances, including the right to terminate based upon an uncured material breach by the other 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 Company’s 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.
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Item 7.01.
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Regulation FD Disclosure.
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On April 18, 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.
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
Section 27A of the Securities Act of 1933 and Section 21E 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 the future potential of PF708, including development and commercialization of PF708; the potential to receive future milestone and royalty payments under Pfenex’s agreement
with NT Pharma; the expectation for PF708 to obtain marketing approval in key pharmaceutical markets; the belief that this collaboration will accelerate development and commercialization of PF708; the potential for the collaboration to drive sales
of PF708 in key pharmaceutical markets; the belief that NT Pharma is well positioned to complete the development and commercialization of PF708; and the potential for future collaborations with Pfenex and NT Pharma. 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 Annual Report on
Form 10-K
for the year ended December 31, 2017 and in Pfenex’s subsequent reports filed with the Securities and Exchange Commission. The forward-looking statements
in this Current Report on
Form 8-K
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.
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Item 9.01
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Financial Statements and Exhibits.
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(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: April
18, 2018
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By:
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/s/ Susan A. Knudson
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Susan A. Knudson
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Chief Financial Officer
(Principal
Financial Officer)
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Exhibit 99.1
Pfenex and NT Pharma Enter into a Development and License Agreement
for Pfenex’s PF708 Therapeutic Equivalent Candidate to Forteo
®
SAN DIEGO and HONG KONG April 18, 2018— Pfenex Inc. (NYSE AMERICAN: PFNX) and China NT Pharma Group Company Limited (NT Pharma) (HKG:1011) today
announced an agreement under which Pfenex granted NT Pharma
non-exclusive
development and exclusive commercialization rights to PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly &
Company’s Forteo
®
, in Mainland China, Hong Kong, Singapore, Malaysia and Thailand.
In
accordance with the agreement, Pfenex received a payment of $2.5 million upon signing of the agreement and may be eligible to receive additional payments of up to $22.5 million based on the achievement of certain development, regulatory,
and sales-related milestones. Pfenex may also be eligible to receive double-digit royalties on net product sales. NT Pharma will be responsible for any further development required to achieve regulatory approval as well as commercialization
activities in the territory.
“This agreement will expand NT Pharma’s orthopedic product portfolio which currently includes Miacalcic franchise
acquired from Novartis. The collaboration with Pfenex will leverage the strengths and resources of both companies to accelerate the development and commercialization of the product,” said Mr. Ng Tit, NT Pharma Chairman and Chief Executive
Officer. “This partnership will open further discussion on potential partnering for other Pfenex pipeline product candidates.”
“We are
pleased to announce our collaboration with NT Pharma, a recognized pharmaceutical leader in China and the Asia Pacific region. Upon receipt of the relevant marketing approvals, we believe this collaboration will allow us to drive sales of PF708 in
key pharmaceutical markets,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “NT Pharma is well positioned to complete the development and commercialization of the product in the territory given its demonstrated experience in
the orthopedic space.”
About
Pfenex
Inc.
We are a clinical-stage development and licensing biotechnology company focused on leveraging our Pfenex Expression Technology
®
to improve protein therapies for unmet patient needs. Using the patented Pfenex Expression Technology platform, we have created an advanced pipeline of therapeutic equivalents, vaccines,
biologics and biosimilars. Our lead product candidates are PF708, a therapeutic equivalent candidate to Forteo
®
(teriparatide) for the treatment of osteoporosis, and our novel anthrax vaccine
candidates, Px563L and RPA563, funded through an advanced development contract with the U.S. government. In addition, we are developing hematology/oncology products, including PF743, a recombinant crisantaspase, and PF745, a recombinant
crisantaspase with half-life extension technology, in collaboration with Jazz Pharmaceuticals. Furthermore, our pipeline includes biosimilar candidates to Lucentis
®
and
Neulasta
®
.
About China NT Pharma Group Company Limited (NT Pharma)
NT Pharma is a technology-based pharmaceutical company which is principally engaged in the investment, research and development (“R&D”),
manufacturing and sales of pharmaceutical products in the People’s Republic of China (“China” or “PRC”) and countries overseas, with its products covering therapeutic areas of severe illness such as oncology, orthopedics,
Central Nervous System (“CNS”), hepatology and respiratory system. NT Pharma owns two new Class 1 drugs in China, one well-known international brand-name drug, and a number of generic drugs, and the Group conducts its production
through three of its subsidiaries, namely Suzhou First Pharmaceutical Co., Ltd. (“Suzhou First”), Jiangsu NT Biopharma Co., Ltd. (“Jiangsu Biopharma”) and NT Pharma Changsha Pharmaceutical Co., Ltd. (“Changsha Pharma”)
and overseas partnered CMO. The Group also owns several sales and distribution companies with around 1,000 sales professionals and R&D specialists. The Group has an extensive promotion network in China, covering nearly 10,000 hospitals.
Pfenex Cautionary Note Regarding Forward-Looking Statements
This press release 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 Pfenex’s expectations, strategy, plans or intentions. Forward-looking statements in this press release 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 Pfenex’s agreement with NT Pharma; the expectation for PF708 to obtain marketing approval in key pharmaceutical markets; the belief that this agreement will
accelerate development and commercialization of PF708; the potential for the collaboration to drive sales of PF708 in key pharmaceutical markets; the belief that NT Pharma is well positioned to complete the development and commercialization of
PF708; and the potential for future collaborations with Pfenex and NT Pharma. 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 Annual Report on Form
10-K
for the year ended December 31, 2017 and in
Pfenex’s subsequent reports filed with the
Securities and Exchange Commission. The forward-looking statements in this press release 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.
Pfenex investors and others should note that we announce material
information to the public about the Company through a variety of means, including our website (http://www.pfenex.com/), our investor relations website (http://pfenex.investorroom.com/), press releases, SEC filings, public conference calls, corporate
Twitter account (https://twitter.com/pfenex), Facebook page
(https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/),
and LinkedIn page
(https://www.linkedin.com/company/pfenex-inc)
in order to achieve broad,
non-exclusionary
distribution of information to the public and to comply with our disclosure
obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated
from time to time.
Pfenex Contact
Susan A. Knudson
Chief Financial Officer
(858)
352-4324
SKnudson@pfenex.com