SAN DIEGO, Nov. 9, 2017 /PRNewswire/ -- Pfenex Inc.
(NYSE American: PFNX) is a clinical-stage biotechnology company
developing complex therapeutic proteins. Using the patented Pfenex
Expression Technology® platform, the Company has created
an advanced pipeline of therapeutic equivalents, vaccines,
biologics and biosimilars. Today Pfenex Inc. reported financial
results for the third quarter ended September 30, 2017 and provided a business
update.
Business Review and Update
Today, Pfenex is pleased to announce the interim pharmacokinetic
(PK) results from ongoing Study PF708-301, which compares the
effects of PF708 and Forteo in osteoporosis patients. PF708 is a
teriparatide product candidate that is being developed through the
505(b)(2) regulatory pathway in the US and references
Forteo®, marketed by Eli Lilly for the treatment of
osteoporosis patients at a high risk of fracture, as the Reference
Listed Drug. Study PF708-301 completed enrollment in the third
quarter of 2017 with a total of 181 patients – 90 randomized to
PF708 and 91 to Forteo. The primary study endpoint is anti-drug
antibody formation after 24 weeks of drug treatment. The secondary
study endpoints are changes in bone mineral density and bone
turnover markers after 24 weeks of drug treatment, as well as PK
parameters for up to 4 hours after the first dose.
The interim PK data from the study are shown in Figure 1. The
PF708 and Forteo PK profiles are comparable, and there are no
statistically significant differences in key PK parameters. The
study is on-track for completion and top-line immunogenicity data
readout in the first half of 2018. Pfenex believes that results
from Study PF708-301, along with the previously-announced
bioequivalence findings from Study PF708-101 in healthy subjects,
should satisfy the clinical filing requirements for PF708 and
expects to submit the new drug application (NDA) to the FDA in the
third quarter of 2018. Pfenex believes it has sufficient cash
resources to fund all necessary activities leading up to and
including the submission of the NDA to the FDA.
Pfenex has completed a strategic review of PF582 and PF529,
biosimilar product candidates to Lucentis® and
Neulasta®, respectively. The strategic review considered
timeline for development and cost. While the market opportunities
remain attractive, Pfenex has decided to pause development
activities on PF582 and PF529 and focus development efforts
elsewhere within the product portfolio until strategic partnerships
for these candidates are forged. The company continues to engage
with potential strategic partners to monetize the assets.
Px563L and RPA563, novel anthrax vaccine candidates, are being
developed by Pfenex in response to the
United States government's unmet demand for increased
quantity, stability and dose-sparing regimens of anthrax vaccine.
The development of our anthrax candidates is funded by the U.S.
Department of Health and Human Services, through the Biomedical
Advanced Research and Development Authority, or BARDA, in
accordance with a cost plus fixed fee advanced development contract
valued at up to approximately $143.5
million. Recently, Pfenex completed a meeting with the FDA,
in which the Agency provided clear guidance for the proposed
clinical development and licensure plans for post-exposure
prophylaxis indication. Ahead of the phase 2 study initiation,
Pfenex expects to continue to demonstrate stability of the vaccine
candidates and complete manufacturing of the clinical supply.
Pfenex expects to initiate the phase 2 study by year-end 2018.
Pfenex is pleased to announce that during the third quarter, it
completed a process development milestone associated with its
collaboration with Jazz Pharmaceuticals. In July 2016, Pfenex and Jazz announced an agreement
under which Pfenex granted Jazz worldwide rights to develop and
commercialize multiple early stage hematology product candidates.
Under the agreement, Pfenex received upfront and option payments
totaling $15 million and may be
eligible to receive additional payments of up to $166 million based on the achievement of certain
development-, regulatory-, and sales-related milestones.
Financial Highlights for the Third Quarter 2017
Total Revenue decreased to $5.0
million in the three-month period ended September 30,
2017 compared to $48.8 million
in same period in 2016. This decrease in revenue was due to the
termination of our development and license agreement with Pfizer in
the third quarter of 2016 which resulted in accelerated recognition
of $45.8 million of revenue. This
decrease was partially offset by a $2.0
million increase in revenue comprised of revenue recognized
in connection with meeting a process development milestone under
our collaboration agreement with Jazz and increased government
contract revenue for our Px563L/RPA563 product candidate, as
greater activity occurred from two options exercised in
January 2017 under our existing
contract with the U.S. government allowing for continued
development. Given the nature of the development process, revenue
will fluctuate depending on stage of development.
Cost of revenue increased to $1.8
million in the three-month period ended September 30,
2017 compared to $1.3 million in same
period in 2016. This increase in cost of revenue was mainly due to
an increase in costs for our Px563L/RPA563 product candidate under
our government contracts related to the two options exercised in
January 2017. Given the nature of the
development process, these costs will fluctuate depending on stage
of development.
Research and development expenses decreased to
$8.1 million in the three-month
period ended September 30, 2017
compared to $8.7 million in same
period in 2016. This decrease in research and development expenses
was primarily due to the stage of development of our pipeline
programs. Expenses decreased for materials and subcontractors for
PF529 and PF530, which were partially offset due to clinical trial
expenses for PF708.
Selling, general and administration expenses decreased to
$4.0 million in the three-month
period ended September 30, 2017
compared to $4.4 million in same
period in 2016.
Cash and cash equivalents as of September 30, 2017 was $48.4 million.
Cautionary Note Regarding Forward-Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or Pfenex's future financial or operating performance. 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 Pfenex's product candidates, including future plans to
advance, develop, manufacture and commercialize its product
candidates; Pfenex's expectation to receive data from the PF708
clinical program in the first half of 2018 and its expectation to
submit an NDA in the third quarter of 2018; Pfenex's expectations
with respect to the sufficiency of its cash resources; Pfenex's
expectations regarding the timing of the release of additional
clinical trial data for its product candidates; Pfenex's
expectations regarding the timing and advancement of clinical
trials and the types of future clinical trials for its product
candidates, including PF708 and Px563L/RPA563; Pfenex's
expectations regarding the expected regulatory pathways for its
product candidates, including the development of PF708 pursuant to
the 505(b)(2) regulatory pathway; Pfenex's expectations regarding
the sufficiency of its clinical trials to satisfy regulatory
requirements; Pfenex's expectation for potential partnership
opportunities for its product candidates; Pfenex's expectation that
it will continue to demonstrate stability of Px563L/RPA563 and
complete manufacturing of the clinical supply; Pfenex's expectation
that it will initiate a phase 2 study for Px563L/RPA563 by year-end
2018; and Pfenex's expectations with respect to the timing of
future regulatory filings for its product candidates. Pfenex's
expectations and beliefs regarding these matters may not
materialize, and actual results in future periods are subject to
risks and uncertainties that could cause actual results to differ
materially from those projected. 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, Pfenex's
ability to successfully demonstrate the efficacy and safety of its
product candidates; the pre-clinical and clinical results for its
product candidates, which may not support further development of
product candidates or may require Pfenex to conduct additional
clinical trials or modify ongoing clinical trials or regulatory
pathways; challenges related to commencement, patient enrollment,
completion, and analysis of clinical trials; difficulties in
achieving and demonstrating biosimilarity in formulations; Pfenex's
ability to manage operating expenses; 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 its 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 period ended December 31,
2016 and in its other filings with the Securities and
Exchange Commission. Additional information will also be set forth
in Pfenex's Quarterly Report on Form 10-Q for the period ended
September 30, 2017 to be 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.
About Pfenex Inc.
Pfenex Inc. is a clinical-stage biotechnology company developing
complex therapeutic proteins. Using the patented Pfenex Expression
Technology® platform, the Company has created an
advanced pipeline of therapeutic equivalents, vaccines, biologics
and biosimilars. The Company's lead product candidates are PF708, a
therapeutic equivalent candidate to Forteo®
(teriparatide) for the treatment of osteoporosis, and its novel
anthrax vaccine candidates, Px563L and RPA563, funded through an
advanced development contract with the US government. In addition,
Pfenex is developing hematology/oncology products in collaboration
with Jazz Pharmaceuticals. Furthermore, the Company's pipeline
includes biosimilar candidates to Lucentis® and
Neulasta®.
PFENEX
INC.
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
Three Months Ended
September 30,
|
Nine
Months Ended
September 30,
|
(in thousands,
except per share data)
|
2017
|
2016
|
2017
|
2016
|
Revenue
|
$
5,024
|
$
48,824
|
$
10,871
|
$
54,723
|
Cost of
revenue
|
1,766
|
1,285
|
3,481
|
4,001
|
|
|
|
|
|
Gross
profit
|
3,258
|
47,539
|
7,390
|
50,722
|
|
|
|
|
|
Operating
expense
|
|
Selling, general and
administrative
|
3,999
|
4,405
|
13,973
|
12,935
|
Research and
development
|
8,112
|
8,690
|
24,708
|
21,763
|
|
|
|
|
|
Total operating
expense
|
12,111
|
13,095
|
38,681
|
34,698
|
|
|
|
|
|
(Loss) income from
operations
|
(8,853)
|
34,444
|
(31,291 )
|
16,024
|
Other income,
net
|
35
|
52
|
117
|
98
|
|
|
|
|
|
Net (loss) income
before income taxes
|
(8,818)
|
34,496
|
(31,174)
|
16,122
|
Income tax
expense
|
—
|
—
|
—
|
(1 )
|
|
|
|
|
|
Net (loss)
income
|
$
(8,818 )
|
$
34,496
|
$
(31,174 )
|
$
16,121
|
|
|
|
|
|
Net (loss) income per
common share
|
|
|
|
|
Basic
|
$
(0.37)
|
$
1.47
|
$
(1.33)
|
$
0.69
|
|
|
|
|
|
Diluted
|
$
(0.37)
|
$
1.46
|
$
(1.33)
|
$
0.68
|
|
|
|
|
|
Weighted-average
common shares used to compute net (loss) income per
share
|
|
|
|
|
Basic
|
23,539
|
23,400
|
23,488
|
23,378
|
|
|
|
|
|
Diluted
|
23,539
|
23,689
|
23,488
|
23,674
|
|
|
|
|
|
PFENEX
INC.
|
Consolidated
Balance Sheets
|
|
|
September 30, 2017 (unaudited)
|
December 31, 2016
|
|
(in thousands)
|
Assets
|
|
|
Current
assets
|
|
|
Cash and cash
equivalents
|
$
48,373
|
$
81,501
|
Restricted
cash
|
200
|
—
|
Accounts and unbilled
receivables, net
|
3,339
|
2,822
|
Income tax
receivable
|
717
|
717
|
Other current
assets
|
1,672
|
1,878
|
|
|
|
Total current
assets
|
54,301
|
86,918
|
Property and
equipment, net
|
7,308
|
5,246
|
Other long term
assets
|
80
|
80
|
Intangible assets,
net
|
4,903
|
5,301
|
Goodwill
|
5,577
|
5,577
|
|
|
|
Total
assets
|
$
72,169
|
$
103,122
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
Current
liabilities
|
|
|
Accounts
payable
|
$
1,674
|
$
1,284
|
Accrued
liabilities
|
10,908
|
9,358
|
Current portion of
deferred revenue
|
4,761
|
6,516
|
Current portion of
capital lease obligations
|
237
|
54
|
|
|
|
Total current
liabilities
|
17,580
|
17,212
|
Deferred revenue,
less current portion
|
2,467
|
5,739
|
Capital lease
obligations, less current portion
|
476
|
26
|
|
|
|
Total
liabilities
|
20,523
|
22,977
|
Commitments and
contingencies
|
|
|
Stockholders'
equity
|
|
|
Preferred stock,
$0.001 par value, 10,000,000 shares authorized; no shares issued
and outstanding
|
—
|
—
|
Common stock, $0.001
par value, 200,000,000 shares authorized; 23,548,280 and 23,429,501
shares issued and outstanding at September 30, 2017 and
December 31, 2016, respectively
|
24
|
24
|
Additional paid-in
capital
|
218,819
|
216,144
|
Accumulated
deficit
|
(167,197)
|
(136,023 )
|
|
|
|
Total stockholders'
equity
|
51,646
|
80,145
|
|
|
|
Total liabilities and
stockholders' equity
|
$
72,169
|
$
103,122
|
|
|
|
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SOURCE Pfenex Inc.