Pfenex Inc. (NYSE American: PFNX) reported financial results for
the second quarter ended June 30, 2020 and provided a business
update.
“The second quarter of 2020 marked a significant milestone for
Pfenex as our partner, Alvogen, launched Teriparatide Injection in
the U.S. in June.” said Eef Schimmelpennink, CEO of Pfenex.
“Making the product commercially available while we continue to
seek therapeutic equivalence (TE) rating relative to Forteo®
(teriparatide injection), provided an opportunity to accelerate
patient access to a cost-effective alternative to this important
drug and initial market feedback has been encouraging.
Following the FDA’s April General Advice Letter and as
part of an active and on-going dialogue, the FDA has provided
additional direction around the methodology to be used in a new
comparative use human factors (CUHF) study focused on a larger
group of Forteo experienced users in order to support a therapeutic
equivalence evaluation. Having taken the totality of feedback into
account, including a General Advice Letter dated July 2020, Alvogen
has recently provided the FDA with an updated CUHF protocol.”
“Outside of the U.S. we made significant progress as PF708 was
issued a positive opinion by the CHMP, which we believe positions
the product candidate for final approval by the European Commission
in the second half of 2020. Furthermore, with Alvogen, we continue
to increase the number of partners supporting the global regulatory
and commercial strategy for PF708, with two new sublicensees in
Latin America.”
“The second quarter of 2020 also saw interest in the
capabilities of the Pfenex Expression Technology platform from
collaboration partners, highlighted by today’s announcement of our
research collaboration with Merck, as well as continued momentum
across our other late stage and commercial collaborations,
including the first commercial agreement by SII with its
CRM197-based Pneumosil vaccine; patient enrollment in Jazz
Pharmaceuticals’ Phase 3 clinical trial of JZP-458, which has
received fast-track designation; and positive Phase 3 data shared
by Merck for its CRM197-based V114 pneumococcal vaccine
candidate.”
“The realization of what we believe to be potential near-term
revenue opportunities is expected to enable us to continue
expanding our collaborations and partnerships as well as pursue
novel biopharmaceutical development,” he continued. “Looking
forward, we believe there are several important milestones on the
horizon that have the potential to drive long-term shareholder
value, including the continued preclinical development of our next
generation molecules and continued portfolio expansion with VHH
single domain antibody candidates” concluded Mr. Schimmelpennink.
Business Review and Update
Teriparatide Injection Product
PF708 is approved in the U.S. under the 505(b)(2) regulatory
pathway, with Forteo® (teriparatide injection) as the listed drug,
and commercially launched under the brand name Teriparatide
Injection. Outside of the U.S., PF708 remains in various stages of
regulatory and marketing application processes and, upon approval,
may be marketed as Teriparatide Injection or under various
tradenames, such as Bonsity, Livogiva, or Qutavina. Pfenex
refers to the product as Teriparatide Injection for discussions
related to the U.S. market, as PF708 in markets where regulatory
approval is pending or outstanding, and as teriparatide injection
product in general discussions of the product.
In June 2020, Pfenex’s commercialization partner for
Teriparatide Injection, Alvogen, initiated the U.S. commercial
launch of Teriparatide Injection prior to obtaining a positive FDA
decision on TE. In conjunction with the launch, Alvogen
continues to negotiate with major U.S. health care plans, several
of which added the product to their formularies, commenced digital
marketing campaigns and shipped initial stocking orders to
wholesalers. Pfenex is eligible to receive tiered royalties on
gross profits earned from Alvogen’s sale of Teriparatide Injection
of 25% to 40%, which increases to 50% on all gross profits if the
TE designation is awarded.
In its July 2020 General Advice Letter, the FDA provided
additional feedback and direction regarding the methodology to be
used in a new CUHF study the FDA deemed necessary to help support a
therapeutic equivalence evaluation. In response, we worked
with Alvogen to finalize a CUHF protocol intended to address the
FDA’s feedback. The new protocol has been delivered to the
FDA for its review. We intend to commence the study after the
FDA’s review of the protocol.
In June 2020, the Committee for Medicinal Products for Human Use
of Medicines provided a positive opinion on PF708. The CHMP’s
recommendation will now be considered by the European Commission to
determine whether to grant marketing authorization, which typically
occurs within 67 days of the CHMP recommendation and could
potentially lead to regulatory approval as early as the second half
of 2020. If approved, PF708 would receive marketing
authorization in the more than 25 member states of the European
Union, as well as in Iceland, Liechtenstein and Norway.
Alvogen entered into a distribution and commercialization
agreement with two sublicensees, one a large, multinational
pharmaceutical company to commercialize PF708 in Brazil, Columbia,
Mexico, Ecuador, Paraguay, and Peru, upon receipt of applicable
marketing authorizations.
From a global commercialization perspective, teriparatide
injection is supported by a network of 10 regional commercial
partners covering 48 countries. As of August 6, 2020,
teriparatide injection has been included within six regulatory and
marketing submissions and has achieved one approval covering one
country with the five additional submissions still under
review.
Pfenex believes Teriparatide Injection and PF708, upon approval
for marketing in other countries, as well as a positive therapeutic
equivalence designation from the FDA, has the potential to enhance
patient access to an important treatment as a potential
cost-effective alternative to Forteo, which had $1.4 billion in
global sales in 2019.
Jazz Collaboration Agreement
Pfenex has a development and license agreement with Jazz
Pharmaceuticals plc (Jazz) for multiple hematologic oncology
products including PF743 (JZP-458), a recombinant Erwinia
asparaginase, and PF745 (JZP-341), a long-acting Erwinia
asparaginase. Jazz has received fast track designation for PF743,
and recently stated that it anticipates the filing of the biologics
license application as early as the fourth quarter of 2020.
The Phase 3 clinical trial, consisting of approximately 100
patients with a planned interim analysis at approximately 50
patients, is being conducted in collaboration with Children's
Oncology Group.
Under the terms of the development and license agreement, Pfenex
is eligible to receive an aggregate total of up to $224.5 million
in development and sales milestone fees. At June 30, 2020,
$162.5 million of development and sales milestones are still
eligible to be received by Pfenex, including up to $3.5 million for
development milestones, $34.0 million in regulatory milestones and
$125 million in sales milestones. Pfenex is eligible to receive
tiered royalties based on worldwide sales of any products resulting
from the collaboration.
Pfenex believes PF743 and PF745, upon approval, have the
potential to resolve historical product supply challenges and
enhance global patient access to an important therapy as an
alternative to Erwinaze.
Pfenex also continues to progress PF690, a pegaspargase, in
accordance with the Jazz agreement. Jazz maintains an
exclusive option to license this product pursuant to certain option
triggers.
CRM197
CRM197 is a non-toxic mutant of diphtheria toxin. It is a well
characterized protein and functions as a carrier for
polysaccharides and haptens, making them immunogenic. CRM197 is
used in prophylactic and therapeutic vaccine candidates. The
Company has developed unique CRM197 production strains based on its
Pfenex Expression Technology platform. Preclinical grade and
cGMP CRM197 is supplied to several vaccine development focused
pharmaceutical customers and unique strains have been exclusively
licensed to Merck and SII for use in their conjugate vaccine
products including candidates for pneumococcal and meningitis
bacterial infections. Pneumococcus bacterium is a leading
cause of severe pneumonia and major cause of morbidity and
mortality worldwide.
Merck is using CRM197 produced by Pfenex Expression Technology
in its V114 (PCV-15) vaccine, an investigational 15-valent
conjugate vaccine for the prevention of pneumococcal disease,
currently in 17 Phase 3 studies. In June, Merck announced positive
results from two of the initial Phase 3 studies evaluating the
safety, tolerability and immunogenicity of V114, which were
published via the International Symposium on Pneumococci and
Pneumococcal Diseases online digital library. Merck also announced
its plans to continue to work with the FDA and other regulatory
authorities around the world on filing plans for licensure of this
vaccine as additional data from the Phase 3 programs become
available. If approved, V114 is expected to be positioned as a key
product in the pneumococcal vaccine market. In accordance
with our license agreement, Pfenex is eligible to receive
regulatory milestones and royalties on the net sales of V114.
SII is using CRM197 produced by Pfenex Expression Technology in
multiple programs. SII developed a 10-valent pneumococcal conjugate
vaccine, Pneumosil, which achieved World Health Organization
prequalification in the fourth quarter of 2019. SII recently
announced a new arrangement with the United Nations International
Children's Fund (UNICEF) to supply ten million doses of Pneumosil
annually for a period of ten years. The supply arrangement
may allow low- and middle-income countries to access the drug under
UNICEF’s Vaccine Alliance’s Advance Market Commitment.
Additionally, SII received Indian marketing authorization for
Pneumosil in July 2020, enabling commercialization of the product
in this key market. In accordance with our license agreement,
Pfenex is eligible to receive royalties on net sales.
Preclinical grade and cGMP CRM197 are also used by several
additional commercial partners focused on pharmaceutical vaccine
development and research.
Development Programs
Pfenex continues to expand its product candidate pipeline
through both wholly owned and partnered next generation and novel
development programs leveraging the Pfenex Expression Technology
platform. The Pfenex Expression Technology platform has
historically demonstrated success in producing engineered binding
proteins with the capability to rapidly generate putative lead
candidates for assessment, down selection, and development of a
long-term production strain.
In August 2020, Pfenex and Merck signed a research and
collaboration agreement to evaluate a specified set of proteins to
be produced via the Pfenex Expression Technology platform. Under
the terms of the arrangement, Pfenex will receive an upfront
payment in the amount of $2.5 million dollars and research funding.
If the evaluation is successful Pfenex could potentially receive a
$2.5 million dollar success fee and up to $95 million in
development and sales milestones for Merck products against each of
the three exclusive targets.
Over the past twelve months, Pfenex has expanded the
capabilities of the Pfenex Expression Technology platform to
include the development of VHH single domain antibodies. VHH single
domain antibodies contain a single variable domain and two constant
domains consisting of only heavy chains. VHH antibodies are fully
functional and have attractive attributes from a biopharmaceutical
development perspective, including their smaller size (12-15 kD),
ability to be linked together for multivalency and/or half-life
extension, nano to picomolar affinities, stability, and their
opportunities to address biologic targets of interest covering a
variety of disease states that have not been remedied by existing
therapies.
Multiple partners are currently licensing the use of the Pfenex
Expression Technology platform in the development of their lead
product candidates and platform capabilities, including Arcellx,
who recently presented preclinical data demonstrating the utility
of its ARC-sparX platform technology as directed against the CD123
antigen, a therapeutic target for hematologic malignancies
including acute myelogenous leukemia. Arcellx has previously
entered into a commercial license with Pfenex for the production of
the soluble targeting component, or sparX protein, of the
product.
PF810, a wholly-owned, peptide based next generation
therapeutic, was added to our pipeline in the third quarter of
2019. The program leverages substantial internal chemistry,
manufacturing and controls and clinical knowledge and to date the
product candidate has achieved in-vivo proof of concept in two
species including non-human primates. Subject to successful
development work and preclinical studies we intend to file an IND
for the product as early as 2021.
PF901 is a hematology focused wholly owned novel VHH antibody
based therapeutic and is the first product candidate to emerge from
our VHH antibody discovery platform. We have completed in
vivo proof of concept and the lead product candidate is currently
going through affinity maturation. Subject to successful
development work and preclinical studies we plan to select the lead
candidate for the product as early as 2021.
Pfenex continues to progress its wholly-owned product candidate
pipeline, with the intention to produce, isolate, and select novel
lead product candidates that may be internally developed,
co-developed, or out licensed. Development efforts are increasingly
weighted toward product candidates based upon the Pfenex Expression
Technology platform’s new VHH single domain antibody
capabilities. Pfenex has generated potential lead VHH single
domain antibody binders to selected, validated biological targets
and continues to assess these candidates for further
development. During the second quarter of 2020, putative lead
candidates against a selected target of interest were identified
and characterized in vitro, with one molecule subsequently
achieving in vivo proof of concept. This molecule has been
advanced to affinity maturation.
COVID Update
As the COVID-19 pandemic has developed, Pfenex has taken
numerous steps to help ensure the health and safety of its
employees and their families. The Company is maintaining social
distancing and enhanced cleaning protocols and usage of personal
protective equipment, where appropriate. Employees whose tasks can
be performed offsite have been instructed to work from home and
only critical program work in the lab has continued with staggered
lab employee work shifts to minimize risk of exposure to
COVID-19. To date, Pfenex has not incurred any significant
losses or disruptions in the completion or progression of its
various initiatives as a result of these changes
Financial Highlights for the Second Quarter
2020
Total Revenue decreased by $2.0 million, or
72%, to $0.8 million in the three months ended June 30, 2020,
compared to $2.8 million in the same period in 2019. The
decrease in revenue was primarily due to a decrease in revenue from
services provided to BARDA and Arcellx and license revenue related
to the Jazz agreement. During the three months ended June 30,
2020, royalty revenue from the U.S. sales of Teriparatide Injection
was $0.4 million and service-based revenue was $0.4 million.
Cost of Revenue decreased by approximately $0.4
million, or 39%, to $0.7 million in the three-month period ended
June 30, 2020, compared to $1.1 million in the same period in 2019.
The decrease was primarily due to a decrease in sales of our CRM197
product and declining service revenue.
Research and development expenses increased by
approximately $0.7 million, or 15%, to $5.5 million in the
three-month period ended June 30, 2020, compared to $4.8 million in
same period in 2019. The increase was primarily due to increased
investments in our novel biopharmaceutical program development,
partially offset by reductions in PF708 development expenses.
Selling, general and administrative expenses
increased by approximately $0.4 million, or 8%, to $4.9 million in
the three-month period ended June 30, 2020, compared to $4.5
million in the same period in 2019. The increases were primarily
due to legal fees.
Cash and cash equivalents as of June 30, 2020,
were $61.2 million. Pfenex believes that its existing cash and cash
equivalents and cash inflow from operations will be sufficient to
meet its anticipated cash needs for at least the next 12
months.
Conference Call
Information
The Pfenex management will host a conference call and webcast
today at 4:30 PM Eastern Time. Participants may access the call by
dialing 877-705-6003 (Domestic) or 201-493-6725 (International),
the conference ID number is: 13705182. The call will also be
webcast and can be accessed from the Investors section of the
Company’s website at www.pfenex.com or
http://public.viavid.com/index.php?id=140248.
A replay of the call will also be available through August 13th.
Participants may access the replay from the Investors section of
the Company’s website at www.pfenex.com or
http://public.viavid.com/index.php?id=140248.
About Teriparatide Injection
Product
PF708 was approved in the U.S. under the 505(b)(2) regulatory
pathway, with Forteo® (teriparatide injection) as the reference
drug, and commercially launched under the brand name Teriparatide
Injection. Teriparatide Injection is indicated, among other uses,
for the treatment of osteoporosis in certain patients at high risk
for fracture. Outside the U.S., PF708 remains in various stages of
regulatory application processes and, upon approval, may be
marketed as Teriparatide Injection or under various tradenames,
such as Bonsity, Livogiva, or Qutavina. The Company refers to
the product as Teriparatide Injection for discussions related to
the U.S. market, as PF708 in markets where regulatory approval is
pending or outstanding, and as teriparatide injection product in
general discussions of the product.
Alvogen has exclusive rights to commercialize and manufacture
the teriparatide injection product in the United States, European
Union (EU), certain countries in the Middle East and North Africa
(MENA), and the Rest of World territories (the latter defined as
all countries outside of the EU, U.S. and MENA, excluding Mainland
China, Hong Kong, Singapore, Malaysia and Thailand). Beijing
Kangchen Biological Technology Co., Ltd. (Kangchen) has exclusive
rights to commercialize PF708 in Mainland China, Hong Kong,
Singapore, Malaysia and Thailand.
The Company transferred the U.S. FDA new drug application (NDA)
for Teriparatide Injection to Alvogen in November 2019.
Alvogen is responsible for fulfilling all regulatory requirements
associated with maintaining the Teriparatide Injection NDA,
including discussions with the FDA regarding TE. The
therapeutic equivalence rating for this product is primarily based
on the FDA evaluating three distinct requirements that center
around showing pharmaceutical equivalence, bioequivalence and human
factors comparability, of which pharmaceutical equivalence and
bioequivalence have been demonstrated in data submitted to the FDA
supporting the NDA approval of Teriparatide Injection. A
therapeutic equivalence designation from the FDA for Teriparatide
Injection, could permit Teriparatide Injection to be automatically
substituted for Forteo, depending on applicable laws and policies
within each of the 50 states in the U.S.
A marketing authorization application for PF708 has been filed
and accepted with the EMA using the biosimilar pathway with
Forsteo® as the reference medicinal product, and the CHMP issued a
positive opinion in June 2020. Additional marketing
authorization applications for PF708 have been filed in Saudi
Arabia, Canada, Hong Kong, Singapore, Malaysia and Thailand.
About Pfenex Inc.
Pfenex is a development and licensing biotechnology company with
commercial products and product candidates focused on leveraging
its proprietary protein production platform, Pfenex Expression
Technology®, to develop next generation and novel protein
therapeutics to meaningfully improve existing therapies and create
novel therapies for some of the biological targets linked to
critical diseases still waiting to successfully be addressed. Using
the patented Pfenex Expression Technology platform, Pfenex has
created a broad pipeline that is diversified across multiple
assets, including U.S. Food and Drug Administration (FDA) approved,
next generation and novel biopharmaceutical products. Pfenex’s lead
product, which has been transferred to Alvogen, is Teriparatide
Injection (previously referred to as PF708 and Bonsity™), a
therapeutic equivalent candidate to Forteo® (teriparatide
injection). Teriparatide Injection has been commercialized in the
U.S. for, among other uses, the treatment of osteoporosis in
certain patients at high risk for fracture, and marketing
authorization applications are pending in other jurisdictions. In
addition, Pfenex is developing hematologic oncology products in
collaboration with Jazz Pharmaceuticals, including PF743, a
recombinant Erwinia asparaginase, and PF745, a half-life extended
recombinant Erwinia asparaginase. Pfenex also uses its Pfenex
Expression Technology platform to produce CRM197, a diphtheria
toxoid carrier protein for use in prophylactic and therapeutic
vaccines.
Pfenex investors and others should note that Pfenex announces
material information to the public about Pfenex through a variety
of means, including its website (http://www.pfenex.com/), its
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 its disclosure
obligations under Regulation FD. Pfenex encourages its investors
and others to monitor and review the information Pfenex makes
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.
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. 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 future 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 developed products, product
candidates, and the company in general, including the potential to
obtain marketing authorization in the European Union for PF708
(branded in Europe as Livogiva™); the expected timing of marketing
authorization in Europe; the potential to improve patient access;
the potential benefits of Teriparatide Injection and PF708;
Pfenex’s expectations with respect to the cost of Teriparatide
Injection and PF708; potential market opportunities for
Teriparatide Injection and PF708; the potential to receive and the
timing of potential milestone payments and future royalties;
regulatory developments, including expectations with respect to the
timing of an additional CUHF study; the FDA’s review of therapeutic
equivalence for Teriparatide Injection and the timing of that
review; the expected timing of filing and IND for PF810; the timing
of selecting the lead candidate with respect to our VHH antibody
discovery platform; Pfenex’s expectations with respect to the
potential benefits of Pneumosil; Pfenex’s expectations with respect
to the sufficiency of its cash resources; Pfenex’s expectations
with respect to PF743 and PF745, including the potential to resolve
supply chain challenges; and the potential to drive long-term
shareholder value. 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 various factors,
including: the European Commission may not affirm the CHMP opinion
and grant a centralized marketing authorization; the FDA may not
grant an “A” therapeutic equivalence designation for Teriparatide
Injection; 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;
Pfenex's ability to manage operating expenses; impacts related to
the COVID-19 pandemic; 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; litigation and other proceedings regarding
intellectual property rights; 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 Quarterly Report on
Form 10-Q for the quarter ended June 30, 2020 and in its other
filings 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.
Company Contact:
InvestorRelations@pfenex.com
PFENEX INC.Consolidated
Statements of Operations(unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
June 30, |
June 30, |
(in thousands, except per share data) |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and service revenue |
|
$ |
741 |
|
|
$ |
2,196 |
|
|
$ |
1,042 |
|
|
$ |
8,790 |
|
Product revenue |
|
|
40 |
|
|
|
615 |
|
|
|
421 |
|
|
|
1,883 |
|
Total revenue |
|
|
781 |
|
|
|
2,811 |
|
|
|
1,463 |
|
|
|
10,673 |
|
Cost of revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and service |
|
|
652 |
|
|
|
811 |
|
|
|
893 |
|
|
|
1,713 |
|
Product |
|
|
28 |
|
|
|
308 |
|
|
|
127 |
|
|
|
973 |
|
Total cost of revenue |
|
|
680 |
|
|
|
1,119 |
|
|
|
1,020 |
|
|
|
2,686 |
|
Gross profit |
|
|
101 |
|
|
|
1,692 |
|
|
|
443 |
|
|
|
7,987 |
|
Operating expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
5,535 |
|
|
|
4,812 |
|
|
|
11,345 |
|
|
|
12,691 |
|
Selling, general and administrative |
|
|
4,895 |
|
|
|
4,520 |
|
|
|
9,627 |
|
|
|
9,063 |
|
Total operating expense |
|
|
10,430 |
|
|
|
9,332 |
|
|
|
20,972 |
|
|
|
21,754 |
|
Net loss from operations |
|
|
(10,329 |
) |
|
|
(7,640 |
) |
|
|
(20,529 |
) |
|
|
(13,767 |
) |
Other income, net |
|
|
3 |
|
|
|
71 |
|
|
|
51 |
|
|
|
140 |
|
Net loss from before income taxes |
|
|
(10,326 |
) |
|
|
(7,569 |
) |
|
|
(20,478 |
) |
|
|
(13,627 |
) |
Income tax provision |
|
|
5 |
|
|
|
— |
|
|
|
4 |
|
|
|
1 |
|
Net loss |
|
$ |
(10,331 |
) |
|
$ |
(7,569 |
) |
|
$ |
(20,482 |
) |
|
$ |
(13,628 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.61 |
) |
|
$ |
(0.43 |
) |
Weighted-average common shares used in calculating net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
34,291 |
|
|
|
31,527 |
|
|
|
33,721 |
|
|
|
31,503 |
|
PFENEX INC. Consolidated
Balance Sheets
|
|
June 30, |
|
|
|
|
2020 |
December 31, |
(unaudited) |
2019 |
|
|
(in thousands) |
|
Assets |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
61,036 |
|
|
$ |
55,624 |
|
Restricted cash |
|
|
200 |
|
|
|
200 |
|
Accounts and unbilled receivables, net |
|
|
1,509 |
|
|
|
5,628 |
|
Other current assets |
|
|
1,781 |
|
|
|
2,308 |
|
Total current assets |
|
|
64,526 |
|
|
|
63,760 |
|
Property and equipment,
net |
|
|
8,590 |
|
|
|
7,744 |
|
Right-of-use asset |
|
|
3,517 |
|
|
|
3,903 |
|
Other long-term assets |
|
|
82 |
|
|
|
170 |
|
Intangible assets, net |
|
|
3,481 |
|
|
|
3,733 |
|
Goodwill |
|
|
5,577 |
|
|
|
5,577 |
|
Total assets |
|
$ |
85,773 |
|
|
$ |
84,887 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,317 |
|
|
$ |
673 |
|
Accrued liabilities |
|
|
5,096 |
|
|
|
7,351 |
|
Current portion of deferred revenue |
|
|
125 |
|
|
|
75 |
|
Lease liabilities – short-term |
|
|
834 |
|
|
|
951 |
|
Other current liabilities |
|
|
599 |
|
|
|
616 |
|
Total current liabilities |
|
|
8,971 |
|
|
|
9,666 |
|
Lease liabilities –
long-term |
|
|
2,496 |
|
|
|
2,896 |
|
Deferred revenue, less current
portion |
|
|
300 |
|
|
|
|
|
Other non-current
liabilities |
|
|
113 |
|
|
|
26 |
|
Total liabilities |
|
|
11,880 |
|
|
|
12,588 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized; no
shares issued |
|
|
— |
|
|
|
— |
|
and outstanding |
Common stock, par value $0.001, 200,000,000 shares authorized;
34,296,593 and |
|
|
35 |
|
|
|
33 |
|
32,266,708 shares issued and outstanding at June 30, 2020
and December 31, |
2019, respectively |
Additional paid-in capital |
|
|
292,082 |
|
|
|
270,008 |
|
Accumulated deficit |
|
|
(218,224 |
) |
|
|
(197,742 |
) |
Total stockholders’ equity |
|
|
73,893 |
|
|
|
72,299 |
|
Total liabilities and stockholders’ equity |
|
$ |
85,773 |
|
|
$ |
84,887 |
|
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