Avid Bioservices, Inc. - Annual Report: 2006 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-K
ANNUAL
REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For
The Fiscal Year Ended April 30, 2006
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
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95-3698422
|
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(State
of incorporation)
|
(I.R.S.
Employer Identification No.)
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14272
Franklin Avenue, Tustin, California
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92780
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|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant's
telephone number, including area code: (714)
508-6000
Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Title
of Class
|
|
Name
of Each Exchange on Which Registered
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Common
Stock ($0.001 par value)
|
|
The
Nasdaq Stock Market, Inc. under
symbol “PPHM”
|
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act.
Yes o No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act.
Yes o No x
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes
x No
o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. x
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Act. (check
one):
Large
accelerated filer o
|
|
Accelerated
filer
x
|
|
Non-accelerated
filer o
|
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Act). Yes o No x
The
approximate aggregate market value of voting stock held by non-affiliates of
the
registrant was $168,445,000 as of October 31, 2005.
(1)
188,852,218
(Number
of shares of common stock outstanding as of July 7, 2006)
DOCUMENTS
INCORPORATED BY REFERENCE
Part
III
of this report incorporates certain information by reference from the
registrant’s proxy statement for the annual meeting of stockholders, which proxy
statement will be filed no later than 120 days after the close of the
registrant’s fiscal year ended April 30, 2006.
(1)
Excludes 2,493,505 shares of common stock held by directors and officers, and
any stockholder whose ownership exceeds five percent of the shares outstanding
as of October 31, 2005.
PEREGRINE
PHARMACEUTICALS, INC.
FORM
10-K ANNUAL REPORT
FISCAL
YEAR ENDED APRIL 30, 2006
TABLE
OF CONTENTS
PART
I
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1
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16
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26
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26
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26
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26
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PART
II
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27
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28
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29
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42
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42
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42
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42
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42
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PART
III
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45
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45
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45
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45
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45
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PART
IV
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46
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53
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i
PART
I
In
this
Annual Report, the terms “we”, “us”, “our”, “Company” and “Peregrine” refers to
Peregrine Pharmaceuticals, Inc., and our wholly owned subsidiary, Avid
Bioservices, Inc. This Annual Report contains forward-looking statements that
involve risks and uncertainties. The inclusion of forward-looking statements
should not be regarded as a representation by us or any other person that the
objectives or plans will be achieved because our actual results may differ
materially from any forward-looking statement. The words “may,” “should,”
“plans,” “believe,” “anticipate,” “estimate,” “expect,” their opposites and
similar expressions are intended to identify forward-looking statements, but
the
absence of these words does not necessarily mean that a statement is not
forward-looking. We caution readers that such statements are not guarantees
of
future performance or events and are subject to a number of factors that may
tend to influence the accuracy of the statements, including but not limited
to,
those risk factors outlined in the section titled “Risk Factors and
Forward-Looking Statements” as well as those discussed elsewhere in this Annual
Report. You should not unduly rely on these forward-looking statements, which
speak only as of the date of this Annual Report. We undertake no obligation
to
publicly revise any forward-looking statement to reflect circumstances or events
after the date of this Annual Report or to reflect the occurrence of
unanticipated events. You should, however, review the factors and risks we
describe in the reports we file from time to time with the Securities and
Exchange Commission (“SEC”) after the date of this Annual Report.
Our
Annual Report on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K, and all amendments to those reports filed with or
furnished to the SEC are available, free of charge, through our website at
www.peregrineinc.com
as soon
as reasonably practicable after such reports are electronically filed with
or
furnished to the SEC. The information on, or that can be accessed through,
our website is not part of this Annual Report.
Certain
technical terms used in the following description of our business are defined
in
the “Glossary of Terms”.
In
addition, we own or have rights to the registered trademark Cotara®. All other
company names, registered trademarks, trademarks and service marks included
in
this Annual Report are trademarks, registered trademarks, service marks or
trade
names of their respective owners.
Item
1. BUSINESS
Company
Overview
We
are a
biopharmaceutical company with a portfolio of clinical and pre-clinical stage
monoclonal antibody-based targeted therapeutics for the treatment of solid
cancers and viral infections. We are currently advancing three separate clinical
trial programs for the treatment of cancer and chronic hepatitis C virus (HCV)
infection. Under our Anti-Phosphatidylserine ("Anti-PS") Immunotherapeutic
technology platform, our lead candidate bavituximab (formerly known as
Tarvacin), is currently in a multi-center Phase I clinical trial for the
treatment of solid cancers as well as a multi-center phase Ib clinical trial
for
the treatment of chronic HCV infection. Our third clinical program is a dose
confirmation and dosimetry clinical trial using our lead Tumor Necrosis Therapy
("TNT") agent, Cotara®, for the treatment of glioblastoma multiforme, a deadly
form of brain cancer.
In
addition to our clinical programs, we are conducting internal research and
collaborating with researchers at top academic institutions to extend our
product pipeline to include new therapeutics and therapeutic adjuvants and
to
expand the potential of bavituximab anti-viral indications beyond the treatment
of HCV infection. In addition to our research efforts, we also operate a wholly
owned cGMP contract manufacturing subsidiary, Avid Bioservices, Inc. (“Avid”).
Avid provides several critical functions for Peregrine including the
manufacturing of all clinical supplies, commercial scale-up of products in
clinical trials, and assisting with the advancement of new clinical candidates.
1
In
addition to Peregrine related activities, Avid provides contract manufacturing
services for outside biotechnology and biopharmaceutical companies on a
fee-for-service basis. We believe the activities of Avid create significant
value for the Company allowing us to aggressively move our clinical and research
programs forward while bringing in revenues through outside contracts which
partially offsets our overall cash used in operations.
We
were
originally incorporated in California in June 1981 and reincorporated in the
State of Delaware on September 25, 1996. Our principal executive offices are
located at 14272 Franklin Avenue, Tustin, California, 92780 and our telephone
number is (714) 508-6000. Our internet website address is www.peregrineinc.com.
Information contained on our website does not constitute any part of this Annual
Report.
Our
Technology Platforms
Our
three
products in clinical trials fall under two technology platforms:
Anti-Phosphatidylserine (“Anti-PS”) Immunotherapeutics and Tumor Necrosis
Therapy (“TNT”).
Anti-PS
Immunotherapeutics
Peregrine’s
new class of Anti-Phosphatidylserine (“Anti-PS”) Immunotherapeutics are
monoclonal antibodies that target and bind to components of cells normally
only
found on the inner surface of the cell membrane. The main target is known as
phosphatidylserine (“PS”) which is normally not available for binding but
becomes exposed on the outside of cells under stress conditions including the
tumor microenvironment and during certain viral infections. Our first-in-class
Anti-PS Immunotherapeutics agent, bavituximab, helps stimulate the body's immune
defenses to destroy disease associated cells that have PS exposed on their
surface. It has shown promise in pre-clinical studies in multiple types of
cancer and viral diseases, both as a monotherapy and in combination with other
therapies, and has demonstrated a good safety profile and promising signs of
activity in pre-clinical and clinical studies completed to date.
Tumor
Necrosis Therapy (“TNT”)
Our
TNT
technology uses monoclonal antibodies that target and bind to Deoxyribonucleic
Acid (“DNA”) and associated histone proteins accessible in dead and dying cells
found at the core of solid tumors. TNT antibodies are potentially capable of
carrying a variety of therapeutic agents into the interior of solid tumors,
including radioisotopes and chemotherapeutic agents, in order to kill the tumor
from the inside out. Our most advanced TNT product, Cotara®, is an antibody
conjugated to Iodine 131, a therapeutic radioisotope that kills adjacent cells.
A product similar to Cotara® has been developed in China under a license from
Peregrine and is currently awaiting marketing approval for the treatment of
advanced lung cancer.
Our
Products in Clinical Trials
Bavituximab
for the Treatment of HCV Infection
Bavituximab,
a monoclonal antibody with unique anti-viral properties, has completed a Phase
Ia single dose clinical trial for the treatment of chronic HCV infections and
is
currently in a Phase Ib repeat dose clinical trial. Bavituximab attaches to
its
target which is specifically found on the surface of a broad class of viruses
known as enveloped viruses, which are responsible for about half of all human
viral diseases, including hepatitis C virus, influenza, human immunodeficiency
virus ("HIV"), cytomegalovirus ("CMV") and other virus strains that cause
serious and life-threatening diseases. Scientists studying bavituximab believe
the drug’s mechanism of action helps stimulate the body's natural immune
defenses to destroy both the virus particles and the cells they infect. Since
the target for bavituximab is only exposed on diseased cells, healthy cells
should not be directly affected by bavituximab.
2
We
filed
our first Investigational New Drug (“IND”) application using bavituximab for the
treatment of chronic hepatitis C virus (“HCV”) infection in April 2005. During
fiscal year 2006, we initiated and completed patient enrollment in a Phase
Ia
single dose escalation study in twenty-four (24) patients chronically infected
with HCV and who have failed prior therapies. In this study, approximately
90%
of the subjects were infected with the genotype 1 form of HCV, which is the
most
common and difficult to treat strain of the virus. At all four single dose
levels, bavituximab appeared to be safe and well tolerated with no dose limiting
toxicities or serious adverse events. Based on the safety data, we added an
additional six patients at a higher single dose level. No dose limiting
toxicities have been observed to date with respect to these patients, who are
currently in a 12-week follow up period. In June 2006, we announced the
initiation of a Phase Ib open-label, repeat-dose escalation clinical trial
of
bavituximab in patients with chronic HCV infection. This study will examine
the
safety and tolerability of bavituximab when administered 4 times over a two
week
period to patients with chronic HCV infection with a 12 week follow-up. The
Phase Ib study will enroll up to 24 patients at up to three clinical
centers. Patient screening and enrollment are currently ongoing. In
addition to the single agent clinical trials, a Phase I clinical study testing
bavituximab in combination with other HCV therapies is being
planned.
We
are
also working with top academic researchers and research organizations to study
the potential use of bavituximab to treat other viral infections. These
pre-clinical programs are primarily focused on evaluating bavituximab's
potential in virus infections with significant economic impact including HIV,
influenza, CMV, as well as biodefense applications. We anticipate that these
pre-clinical studies may help support additional clinical
indications.
Bavituximab
for the Treatment of Solid Cancers
Scientists
working with us have also determined that the target for bavituximab becomes
exposed on the cells that line blood vessels inside solid cancers. Since the
target is not exposed in normal tissues and is abundantly exposed on tumor
blood
vessels, it represents a unique and specific target for cancer therapy, while
minimizing effects on healthy cells. In pre-clinical solid cancer therapy
studies, including the treatment of breast, prostate and pancreatic tumors,
a
bavituximab equivalent (mouse versions of the antibody used in the mouse
studies) had promising anti-tumor activity as a stand-alone treatment. Common
cancer treatments such as chemo and radiation therapy increase the exposure
of
the PS target on tumor blood vessels and have been shown in pre-clinical studies
to enhance the anti-tumor effects of bavituximab equivalents.
Bavituximab
is currently in a Phase I clinical trial for which all solid cancer types are
eligible for enrollment. The clinical trial is designed to enroll up to 28
patients with advanced solid tumors that no longer respond to standard cancer
treatments. The objectives of this open-label, single and repeat dose escalation
study are to (i) determine the safety and tolerability of bavituximab
administered intravenously to patients with advanced cancer; (ii) characterize
the pharmacokinetic profile of bavituximab and; (iii) define the dose-limiting
toxicities, maximum tolerated dose and/or maximum effective dose of bavituximab.
Patients who demonstrate an objective response to therapy may be offered
continued treatment on an extension protocol. Patient screening and
enrollment are currently ongoing.
3
Cotara®
for the Treatment of Brain Cancer
Tumor
Necrosis Therapy (“TNT”) is a targeted cancer therapy that uses monoclonal
antibodies conjugated to therapeutic agents such as radioisotopes. TNT agents
carry and anchor the attached anti-cancer agent into the interior of tumors
to
kill them from the inside out. Cotara® is a TNT agent that binds to DNA and
associated histone proteins that become accessible in dead and dying cells
found
at the core of tumors. Cotara® is a monoclonal antibody targeting agent
conjugated to Iodine 131, a therapeutic radioisotope that kills tumor cells
near
the site of localization.
Cotara®
is currently in a dose confirmation and dosimetry clinical trial for the
treatment of recurrent glioblastoma multiforme (“GBM”) in collaboration with New
Approaches to Brain Tumor Therapy (“NABTT”), a brain tumor treatment consortium.
This study is partially funded by the National Cancer Institute ("NCI”) and
allows us to treat up to 28 patients although we expect this trial to enroll
9-12 patients in order to meet the primary objectives of the study. The
next step in the development of Cotara® will be to treat a group of
approximately 40 patients using a single administration of the drug with an
optimized delivery using two catheters. Taken together, the NABTT study along
with data collected from the treatment of the approximate 40 additional patients
should provide the safety, dosimetry and efficacy data that will support the
final design of the larger Phase III study. Cotara has been granted FDA orphan
drug status and fast track designation for the treatment of two lethal brain
cancers.
Earlier-Stage
Technologies
We
are
pursuing several earlier stage technologies including Vasopermeation Enhancement
Agents (“VEAs”) that are intended to improve the performance of standard cancer
drugs as an adjuvant. We are also evaluating several anti-angiogenesis and
Vascular Targeting Agents (“VTAs”) that complement our other anti-cancer
platforms, as further described below.
Vasopermeation
Enhancement Agents (“VEAs”) utilize monoclonal antibodies which are designed to
increase the uptake of cancer therapeutics and imaging agents into the tumor
at
the tumor site, potentially resulting in greater efficacy. VEAs work by using
monoclonal antibodies to deliver known vasoactive compounds (molecules that
cause tissues to become more permeable) selectively to solid tumors. VEAs
currently use the same targeting agent as TNT to deliver an agent that makes
the
blood vessels inside the tumor more permeable (leaky). Once localized at the
tumor site, VEAs alter the physiology and the permeability of the vessels and
capillaries that supply the tumor. In pre-clinical studies, drug uptake has
been
increased up to almost 400% in solid tumors when VEAs were administered several
hours prior to the chemotherapeutic treatment. VEAs are intended to be used
as a
pre-treatment for most existing cancer therapies and imaging agents.
Anti-Angiogenesis
agents work by inhibiting blood vessel growth. Peregrine has an antibody, termed
2C3, which inhibits a key tumor blood vessel growth factor known as Vascular
Endothelial Growth Factor (“VEGF”), thereby inhibiting the formation of blood
vessels in solid tumors. The 2C3 antibody is part of our anti-angiogenesis
compound family under development for the treatment of cancer and other diseases
dependent on aberrant blood vessel formation.
Vascular
Targeting Agent (“VTA”) technology utilizes monoclonal antibodies and other
targeting agents that recognize markers found on tumor blood vessels but not
on
normal blood vessels. VTAs act in a two-step process: the VTA first binds to
the
tumor blood vessels and then induces a blood clot in the tumor blood vessels.
The formation of the blood clot stops the flow of oxygen and nutrients to the
tumor cells, ultimately resulting in tumor cell death.
4
Licensing
Collaborations
The
following discussions cover our collaborations and licensing obligations related
to our products in clinical trials:
Anti-Phosphatidylserine
Immunotherapeutics
In
August
2001, we exclusively in-licensed the worldwide rights to this technology
platform from the University of Texas Southwestern Medical Center at
Dallas. During
November 2003 and October 2004, we entered into two non-exclusive license
agreements with Genentech, Inc. to license certain intellectual property rights
covering the methods and processes for producing antibodies used in connection
with the development of our Anti-Phosphatidylserine (“Anti-PS”)
Immunotherapeutics program. In March 2005, we entered into a worldwide
non-exclusive license agreement with Lonza Biologics for intellectual property
and materials relating to the expression of recombinant monoclonal antibodies
for use in the manufacture of Anti-Phosphatidylserine Immunotherapeutics. During
December 2003, we entered into an exclusive commercial license agreement with
an
unrelated entity covering the generation of the chimeric monoclonal antibody,
bavituximab.
Under
our
licensing agreements relating to the Anti-Phosphatidylserine Immunotherapeutics,
we typically pay an up-front license fee, annual maintenance fees, and are
obligated to pay future milestone payments based on development progress, plus
a
royalty on net sales or a percentage of sublicense income. Our aggregate future
milestone payments under the above in-licensing agreements are $7,100,000
assuming the achievement of all development milestones under the agreements
through commercialization of products, of which, we expect to pay up to $100,000
during fiscal year 2007 and $6,600,000 upon approval of the first
Anti-Phosphatidylserine Immunotherapeutics product. In addition, under one
of
the agreements, we are required to pay future milestone payments upon the
completion of Phase II clinical trial enrollment in the amount of 75,000 pounds
sterling, the amount of which will continue as an annual license fee thereafter,
plus a royalty on net sales of any products that we market that utilize the
underlying technology. In the event we utilize an outside contract manufacturer
other than Lonza Biologics to manufacture bavituximab, we would owe Lonza
Biologics 300,000 pounds sterling per year in addition to an increased royalty
on net sales.
Tumor
Necrosis Therapy (“TNT”)
We
acquired the rights to the TNT technology in July 1994 after the merger between
Peregrine and Cancer Biologics, Inc. was approved by our stockholders. The
assets acquired from Cancer Biologics, Inc. primarily consisted of patent rights
to the TNT technology.
In
October 2004, we entered into a worldwide non-exclusive license agreement with
Lonza Biologics (“Lonza”) for intellectual property and materials relating to
the expression of recombinant monoclonal antibodies for use in the manufacture
of Cotara®. Under the terms of the agreement, we will pay a royalty on net sales
of any products that we market that utilize the underlying technology. In the
event we or Lonza do not manufacture Cotara®, we would owe Lonza 300,000 pounds
sterling per year in addition to an increased royalty on net sales.
Out-Licensing
Collaborations
In
addition to internal product development efforts and related licensing
collaborations, we remain committed to our existing out-licensing collaborations
and the pursuit of select partnerships with pharmaceutical, biopharmaceutical
and diagnostic companies based on our broad intellectual property position.
The
following represents a summary of our key out-licensing
collaborations.
5
During
September 1995, we entered into an agreement with Cancer Therapeutics, Inc.
whereby we granted to Cancer Therapeutics, Inc. the exclusive right to
sublicense TNT to a major pharmaceutical company solely in the People’s Republic
of China. In addition, we are entitled to receive 50% of the distributed profits
received by Cancer Therapeutics, Inc. from the Chinese pharmaceutical company.
Cancer Therapeutics, Inc. has the right to 20% of the distributed profits under
the agreement with the Chinese pharmaceutical company. During March 2001, we
extended the exclusive licensing period granted to Cancer Therapeutics, which
now expires on December 31, 2016. In exchange for this extension, Cancer
Therapeutics, Inc. agreed to pay us ten percent (10%) of all other consideration
received by Cancer Therapeutics, Inc., excluding research funding. Through
fiscal year ended April 30, 2006, we have not received any amounts under the
agreement.
During
October 2000, we entered into a licensing agreement with Merck KGaA to
out-license a segment of our TNT technology for use in the application of
cytokine fusion proteins. During January 2003, we entered into an amendment
to
the license agreement, whereby we received an extension to the royalty period
from six years to ten years from the date of the first commercial sale. Under
the terms of the agreement, we will receive a royalty on net sales if a product
is approved under the agreement. Merck KGaA has not publicly disclosed the
development status of its program.
During
February 2001, we completed a licensing deal with SuperGen, Inc. (“SuperGen”) to
license a segment of our VTA technology, specifically related to Vascular
Endothelial Growth Factor (“VEGF”). Under the terms of the licensing agreement,
we are entitled to receive an annual license fee of $200,000 in cash or SuperGen
common stock until SuperGen files an Investigational New Drug Application in
the
United States utilizing the VEGF technology. In addition, we could receive
additional milestone payments based on SuperGen’s development success, plus
receive a royalty on net sales of all drugs commercialized by SuperGen utilizing
the VEGF technology. We could also receive additional consideration for each
clinical candidate that enters a Phase III clinical trial by SuperGen. As of
April 30, 2006, SuperGen has not filed an Investigational New Drug Application
in the United States utilizing the VEGF technology.
During
December 2002, we granted the exclusive rights for the development of diagnostic
and imaging agents in the field of oncology to Schering A.G. under our VTA
technology. Under the terms of the agreement, we received an up-front payment
and could also receive future milestone payments and a royalty on net sales,
as
defined in the agreement. Under the same agreement, we granted Schering A.G.
an
option to obtain certain non-exclusive rights to the VTA technology with
predetermined up-front fees and milestone payments as defined in the agreement.
Schering A.G. has not publicly disclosed the development status of its
program.
During
August 2005, we licensed certain intellectual property rights under our VTA
technology to Medarex, Inc., which allows Medarex, Inc. to develop and
commercialize certain monoclonal antibodies for the treatment of a wide range
of
solid tumors. Under the terms of the agreement we could receive up to $5.95
million in future payments based on the achievement of all clinical and
regulatory milestones combined with a royalty on net sales, as defined in the
agreement. Medarex, Inc. has not publicly disclosed the development status
of
its program.
During
January 2002, we commenced the operations of our wholly owned subsidiary, Avid
Bioservices, Inc., which was formed from the facilities and expertise of
Peregrine. Avid provides an array of contract manufacturing services, including
contract manufacturing of antibodies and proteins, cell culture development,
process development, and testing of biologics for biopharmaceutical and
biotechnology companies under current Good Manufacturing Practices (“cGMP”).
Avid’s current manufacturing capacity includes the following four bioreactors:
1,000 liter, 300 liter, 100 liter and 22.5 liter.
6
Operating
a cGMP facility requires highly specialized personnel and equipment that must
be
maintained on a continual basis. Prior to the formation of Avid, we manufactured
our own antibodies for over 10 years and developed the manufacturing expertise
and quality systems to provide the same service to other biopharmaceutical
and
biotechnology companies. We believe Avid’s existing facility is well positioned
to meet the growing needs of the industry. Avid is also well positioned to
increase its capacity in the future in order to become a significant supplier
of
contract manufacturing services.
Avid
provides an array of services for Peregrine as well as working with a variety
of
companies in the biotechnology and pharmaceutical industries. Even though much
of the process is very technical, knowledge of the process should assist you
in
understanding the overall business and complexities involved in cGMP
manufacturing. The manufacturing of monoclonal antibodies and recombinant
proteins under cGMP is a complex process and includes several phases before
the
finished drug product is released for clinical or commercial use. The first
phase of the manufacturing process is to receive the production cell line (the
cells that produce the desired protein) and any available process information
from the client. The cell line must be adequately tested according to FDA
guidelines by an outside laboratory to certify that it is suitable for cGMP
manufacturing. This testing generally takes between one and three months to
complete, depending on the necessary testing. The cell line that is used may
either be from a master cell bank (base cells from which all future cells will
be grown), which is already fully tested or may represent a research cell line.
In the case of a research cell line, Avid can use the research cell line to
produce master and working cell banks. Clients often request further development
through media screening and adaptation followed by small scale bioreactor
process development in 1 to 5 liter bioreactor systems. In parallel to the
production of the master and working cell banks, the growth and productivity
characteristics of the cell line may be evaluated in the research and
development labs and paper work to support the production plan. The whole
manufacturing process (master cell bank characterization, process development,
assay development, raw materials specifications, test methods, downstream
processing methods, purification methods, testing methods and final release
specifications) must be developed and documented prior to the commencement
of
manufacturing in the bioreactors. The second phase of the process is in the
manufacturing facility. Once the process is developed, pilot runs are generally
performed using smaller scale bioreactors, such as the 22.5 liter bioreactor,
in
order to verify the process. Once the process is set, a pilot run or runs at
full scale will be performed to finalize manufacturing batch records. Material
produced during these runs is often used for toxicology studies. After the
pilot
batch run(s) is completed, full-scale cGMP manufacturing is typically initiated.
Once the cGMP run(s) is completed, batch samples are sent to an outside lab
for
various required tests, including sterility and viral testing. Once the test
results verify the antibodies meet specifications, the product is released
for
clinical or commercial use.
Each
product manufactured is tailored to meet the specific needs of Peregrine or
the
client. Full process development from start to product release can take ten
months or longer. Research and development work can take from two months to
over
six months. All stages of manufacturing can generally take between one to
several weeks depending on the manufacturing method and process. Product testing
and release can take up to three months to complete.
Given
its
inherent complexity, necessity for detail, and magnitude (contracts may be
into
the millions of dollars), the contract negotiations and sales cycle for cGMP
manufacturing services can take a significant amount of time. Our anticipated
sales cycle from client introduction to signing an agreement will take anywhere
from between three to six months to over one year. Introduction to Avid’s
services will usually come from word of mouth, exposure from direct mailings,
exposure from attendance at conferences or from advertising in trade journals.
The sales cycle consists of the introduction phase, the proposal phase, the
audit phase, the contract phase and the project initiation phase.
To
date,
Avid has been audited and qualified by both large and small, domestic and
foreign biotechnology companies interested in the production of monoclonal
antibodies for clinical trial use. Additionally, Avid has been audited by the
European Agency for the Evaluation of Medicinal Products (“EMEA”), the United
States Food and Drug Administration (“FDA”) and the California Department of
Health.
In
2005, Avid was inspected by the FDA in a
Pre-Approval Inspection ("PAI") in support of a New Drug Application for a
commercial application by a client company. The Los Angeles District FDA office
did recommend to Washington that the facility be approved as a site for
the Active Pharmaceutical Ingredient ("API") for the client company. The
client's New Drug Application was in fact approved later in 2005 and includes
Avid as the source of the API. Avid is currently producing commerical product
for the client company under this approved New Drug Application.
7
Government
Regulation
Regulation
by governmental authorities in the United States and other countries is a
significant factor in our ongoing research and development activities and in
the
production of our products under development. Our products and our research
and
development activities, are subject to extensive governmental regulation in
the
U.S., including the Federal Food, Drug, and Cosmetic Act, as amended, the Public
Health Service Act, also as amended, as well as to other federal, state, and
local statutes and regulations. These laws, and similar laws outside the U.S.,
govern the clinical and non-clinical testing, manufacture, safety,
effectiveness, approval, labeling, distribution, sale, import, export, storage,
record keeping, reporting, advertising and promotion of our products, if
approved. Violations of regulatory requirements at any stage may result in
various adverse consequences, including regulatory delay in approving or refusal
to approve a product, enforcement actions, including withdrawal of approval,
labeling restrictions, seizure of products, fines, injunctions and/or civil
or
criminal penalties. Any product that we develop must receive all relevant
regulatory approvals or clearances before it may be marketed in a particular
country.
The
regulatory process, which includes extensive pre-clinical testing and clinical
trials of each clinical candidate to study its safety and efficacy, is
uncertain, takes many years and requires the expenditure of substantial
resources. We cannot assure you that the clinical trials of our product
candidates under development will demonstrate the safety and efficacy of those
product candidates to the extent necessary to obtain regulatory
approval.
The
activities required before a product may be marketed in the United States,
such
as Cotara® or bavituximab (formerly known as Tarvacin), are generally performed
in the following sequential steps:
1.
|
Pre-clinical
testing.
This generally includes laboratory testing of our products in animals
to
determine safety, efficacy and potential toxicity. Pre-clinical
studies must be conducted by laboratories that comply with FDA regulations
regarding good laboratory practice.
|
2.
|
Submission
to the FDA of an investigational new drug application
(“IND”). The
results of pre-clinical studies, together with manufacturing information,
analytical data and proposed clinical trial protocols, are submitted
to
the FDA as part of an IND, which must become effective before the
clinical
trials can begin. Once
the IND
is filed, the FDA has 30 days to review it. The IND will automatically
become effective 30 days after the FDA receives it, unless the FDA
indicates prior to the end of the 30-day period that the proposed
protocol
raises concerns that must be resolved to the FDA’s satisfaction before the
trials may proceed. If the FDA raises concerns, we may be unable
to
resolve the proposed protocol to the FDA’s approval in a timely fashion,
if at all.
|
3.
|
Completion
of clinical trials.
Human clinical trials are necessary to seek approval for a new drug
or
biologic and typically involve a three-phase process. In phase I,
small
clinical trials are generally conducted to determine the safety of
the
product. In phase II, clinical trials are generally conducted to
assess
safety, acceptable dose, and gain preliminary evidence of the efficacy
of
the product. In phase III, clinical trials are generally conducted to
provide sufficient data for the statistically valid proof of safety
and
efficacy. Clinical
trials must be conducted according to good clinical practices under
protocols that detail the trial’s objectives, inclusion and exclusion
criteria, the parameters to be used to monitor safety and the efficacy
criteria to be evaluated, and informed consent must be obtained from
all
study subjects. Each protocol must be submitted to the FDA as part
of the
IND. The FDA may impose a clinical hold on an ongoing clinical trial
if,
for example, safety concerns arise, in which case the study cannot
recommence without FDA authorization under terms sanctioned by the
Agency. In addition, before
a clinical trial can be initiated, each
clinical site or hospital administering the product must have the
protocol
reviewed and approved by an institutional review board (“IRB”). The IRB
will consider, among other things, ethical factors and the safety
of human
subjects. The IRB may require changes in a protocol, which may delay
initiation or completion of a study. Phase I, Phase II or
Phase III clinical trials may not be completed successfully within
any specific period of time, if at all, with respect to any of our
potential products. Furthermore, we, the FDA or an IRB may suspend
a
clinical trial at any time for various reasons, including a finding
that
the healthy individuals or the patients are being exposed to an
unacceptable health risk.
|
8
4.
|
Submission
to the FDA of a Biologics License Application (“BLA”) or New Drug
Application (“NDA”).
After completion of clinical studies for an investigational product,
a
Biologics License Application (“BLA”) or New Drug Application (“NDA”) is
submitted to the FDA for product marketing approval. No action can
be
taken to market any new drug or biologic product in the United States
until the FDA has approved an appropriate marketing application.
|
5.
|
FDA
review and approval of the BLA or NDA before the product is commercially
sold or shipped. The
results of pre-clinical studies and clinical trials and manufacturing
information are submitted to the FDA in the form of a BLA or NDA
for
approval of the manufacture, marketing and commercial shipment of
the
product. The FDA may take a number of actions after the BLA or NDA
is
filed, including but not limited to, denying
the BLA or NDA if applicable regulatory criteria are not satisfied,
requiring additional clinical testing or information; or requiring
post-market testing and surveillance to monitor the safety or efficacy
of
the product. Adverse events that are reported after marketing approval
can
result in additional limitations being placed on the product’s use and,
potentially, withdrawal of the product from the market. Any adverse
event,
either before or after marketing approval, can result in product
liability
claims against us.
|
In
addition, we are subject to regulation under state, federal, and international
laws and regulations regarding occupational safety, laboratory practices, the
use and handling of radioactive isotopes, environmental protection and hazardous
substance control, and other regulations. Our clinical trial and research and
development activities involve the controlled use of hazardous materials,
chemicals and radioactive compounds. Although we believe that our safety
procedures for handling and disposing of such materials comply with the
standards prescribed by state and federal regulations, the risk of accidental
contamination or injury from these materials cannot be completely eliminated.
In
the event of such an accident, we could be held liable for any damages that
result and any such liability could exceed our financial resources. In addition,
disposal of radioactive materials used in our clinical trials and research
efforts may only be made at approved facilities. We believe that we are in
material compliance with all applicable laws and regulations including those
relating to the handling and disposal of hazardous and toxic waste.
Our
product candidates, if approved, may also be subject to import laws in other
countries, the food and drug laws in various states in which the products are
or
may be sold and subject to the export laws of agencies of the United States
government.
In
addition, we must also adhere to current Good Manufacturing Practice (“cGMP”)
and product-specific regulations enforced by the FDA through its facilities
inspection program. Failure to comply with manufacturing regulations can result
in, among other things, warning letters, fines, injunctions, civil penalties,
recall or seizure of products, total or partial suspension of production,
refusal of the government to renew marketing applications and criminal
prosecution.
During
fiscal year 1999, the Office of Orphan Products Development of the FDA
determined that Cotara® qualified for orphan designation for the treatment of
glioblastoma multiforme and anaplastic astrocytoma (both brain cancers). The
1983 Orphan Drug Act (with amendments passed by Congress in 1984, 1985, and
1988) includes various incentives that have stimulated interest in the
development of orphan drug and biologic products. These incentives include
a
seven-year period of marketing exclusivity for approved orphan products, tax
credits for clinical research, protocol assistance, and research grants.
Additionally, legislation re-authorizing FDA user fees also created an exemption
for orphan products from fees imposed when an application to approve the product
for marketing is submitted. A grant of an orphan designation is not a guarantee
that a product will be approved. If a sponsor receives orphan drug exclusivity
upon approval, there can be no assurance that the exclusivity will prevent
another entity from receiving approval for the same or a similar drug for the
same or other uses.
9
Manufacturing
and Raw Materials
Manufacturing.
We
manufacture pharmaceutical-grade products to supply our previous and ongoing
clinical trials through our wholly owned subsidiary, Avid Bioservices, Inc.
We
have assembled a team of experienced scientific, production and regulatory
personnel to facilitate the manufacturing of our antibodies, including Cotara®
and bavituximab (formerly known as Tarvacin).
Our
bavituximab product is shipped directly from our facility to the clinical trial
sites. Our TNT antibodies are shipped to a third party facility for
radiolabeling (the process of attaching the radioactive agent, Iodine 131,
to
the antibody). From the radiolabeling facility, Cotara® (the radiolabeled-TNT
antibodies) is shipped directly to the clinical site for use in clinical trials.
Any
commercial radiolabeling supply arrangement will require a significant
investment of funds by us in order for a radiolabeling vendor to develop the
expanded facilities necessary to support our product. There can be no assurance
that material produced by our current radiolabeling supplier will be suitable
for commercial quantities to meet the possible demand of Cotara®, if approved.
We will continue with our research in radiolabeling scale-up, but we believe
this research will be eventually supported by a potential licensing or marketing
partner for Cotara®.
Raw
Materials.
Various
common raw materials are used in the manufacture of our products and in the
development of our technologies. These raw materials are generally available
from several alternate distributors of laboratory chemicals and supplies. We
have not experienced any significant difficulty in obtaining these raw materials
and we do not consider raw material availability to be a significant factor
in
our business.
Patents
and Trade Secrets
Peregrine
continues to seek patents on inventions originating from ongoing research and
development activities within the Company and in collaboration with other
companies and university researchers. Patents, issued or applied for, cover
inventions relating in general to cancer therapy and anti-viral therapy and
in
particular to different antibodies and conjugates, methods and devices for
labeling antibodies, and therapeutic uses of the antibodies and conjugates.
We
intend to pursue opportunities to license these technologies and any
advancements or enhancements, as well as to pursue the incorporation of our
technologies in the development of our own products.
Our
issued patents extend for varying periods according to the date of patent
application filing or grant and the legal term of patents in the various
countries where patent protection is obtained. The actual protection afforded
by
a patent, which can vary from country to country, depends upon the type of
patent, the scope of its coverage and the availability of legal remedies in
the
country. We have either been issued patents or have patent applications pending
that relate to a number of current and potential products including products
licensed to others. We consider that in the aggregate our patent applications,
patents and licenses under patents owned by third parties are of material
importance to our operations. In general, we have obtained licenses from various
parties that we deem to be necessary or desirable for the manufacture, use
or
sale of our products. These licenses (both exclusive and non-exclusive)
generally require us to pay royalties to the parties. The terms of the licenses,
obtained and that we expect to be obtained, are not expected to significantly
impact the cost structure or marketability of the Company’s
products.
10
In
general, the patent position of a biotechnology firm is highly uncertain and
no
consistent policy regarding the breadth of issued claims has emerged from the
actions of the U.S. Patent Office with respect to biotechnology patents. Similar
uncertainties also exist for biotechnology patents in important overseas
markets. Accordingly, there can be no assurance that our patents, including
those issued and those pending, will provide protection against competitors
with
similar technology, nor can there be any assurance that such patents will not
be
legally challenged, invalidated, infringed upon or designed around by
others.
International
patents relating to biologics are numerous and there can be no assurance that
current and potential competitors have not filed or in the future will not
file
patent applications or receive patents relating to products or processes
utilized or proposed to be used by the Company. In addition, there is certain
subject matter which is patentable in the United States but which may not
generally be patentable outside of the United States. Statutory differences
in
patentable subject matter may limit the protection the Company can obtain on
some of its products outside of the United States. These and other issues may
prevent the Company from obtaining patent protection outside of the United
States. Failure to obtain patent protection outside the United States may have
a
material adverse effect on the Company’s business, financial condition and
results of operations.
No
one
has sued us for infringement and no third party has asserted their patents
against us that we believe are of any merit. However, there can be no assurances
that such lawsuits have not been or will not be filed and, if so filed, that
we
will prevail or be able to reach a mutually beneficial settlement. We also
intend to continue to rely upon trade secrets and improvements, unpatented
proprietary know-how, and continuing technological innovation to develop and
maintain our competitive position in research and diagnostic products. We
typically place restrictions in our agreements with third parties, which
contractually restrict their right to use and disclose any of the Company's
proprietary technology with which they may be involved. In addition, we have
internal non-disclosure safeguards, including confidentiality agreements, with
our employees. There can be no assurance, however, that others may not
independently develop similar technology or that the Company's secrecy will
not
be breached.
Customer
Concentration and Geographic Area Financial Information
We
are
currently in the research and development phase for all of our products and
we
have not generated any product sales from any of our technologies under
development. For financial information concerning Avid’s customer concentration
and geographic areas of its customers, see Note 11, “Segment Reporting” to
the consolidated financial statements.
Marketing
Our Potential Products
We
intend
to sell our products, if approved, in the United States and internationally
in
collaboration with marketing partners or through an internal sales force. If
the
FDA approves Cotara® or bavituximab or our other product candidates under
development, the marketing of these product candidates will be contingent upon
us entering into an agreement with a company to market our products or upon
us
recruiting, training and deploying our own sales force. We do not presently
possess the resources or experience necessary to market Cotara®, bavituximab, or
our other product candidates and we currently have no arrangements for the
distribution of our product candidates, if approved. Development of an effective
sales force requires significant financial resources, time, and expertise.
There
can be no assurance that we will be able to obtain the financing necessary
to
establish such a sales force in a timely or cost effective manner or that such
a
sales force will be capable of generating demand for our product candidates.
11
Competition
The
pharmaceutical and biotechnology industry is intensely competitive and subject
to rapid and significant technological change. Many of the drugs that we are
attempting to discover or develop will be competing with existing therapies.
In
addition, we are aware of several pharmaceutical and biotechnology companies
actively engaged in research and development of antibody-based products that
have commenced clinical trials with, or have successfully commercialized,
antibody products. Some or all of these companies may have greater financial
resources, larger technical staffs, and larger research budgets than we have,
as
well as greater experience in developing products and running clinical trials.
We expect to continue to experience significant and increasing levels of
competition in the future. In addition, there may be other companies which
are
currently developing competitive technologies and products or which may in
the
future develop technologies and products which are comparable or superior to
our
technologies and products.
We
are
conducting the Cotara® dose confirmation and dosimetry clinical trial for the
treatment of recurrent brain cancer as a stand-alone study in collaboration
with
New Approaches to Brain Tumor Therapy (“NABTT”) consortium. Existing treatments
for brain cancer include the Gliadel® Wafer (polifeprosan 20 with carmustine
implant) from MGI Pharma, Inc. and Temodar® (temazolomide) from Schering-Plough
Corporation. Gliadel® is inserted in the tumor cavity following surgery and
releases a chemotherapeutic agent over time. Temodar® is administered orally to
patients receiving concurrent radiation therapy.
Because
Cotara® targets brain tumors from the inside out, it is a novel treatment
dissimilar from other drugs in development for this disease. Some of the
products that may compete within the brain cancer category include GLI-328
(Novartis), a gene therapy treatment that is injected into the walls of the
tumor cavity following surgery; IL13-PE38QQR (cintredekin besudotox) from
NeoPharm, Inc. continues in a Phase III trial; In March 2006 Eli Lilly and
Company began a Phase III trial of enzastuarin for the treatment of GBM;
TransMID™ (Xenova Group plc) is a product based on the diphtheria toxin and
began a Phase III trial in May 2004. In addition, Gleevec® by Novartis, which is
an oncology product marketed for other indications, is being tested in clinical
trials for the treatment of brain cancer.
Bavituximab
for the treatment of advanced solid cancers is currently in Phase I clinical
trials. There are a number of possible competitors with approved or
developmental targeted agents used in combination with standard chemotherapy
for
the treatment of cancer, including but not limited to, Avastin® by
Genentech, Inc., Gleevec® by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and
Genentech, Inc., Erbitux® by ImClone Systems Incorporated and Brystol-Myers
Squibb Company, Rituxan® and Herceptin® by Biogen Idec Inc. and Genentech, Inc.,
Herceptin® by Genentech, Inc. and panitumumab by Amgen®. There are a significant
number of companies developing cancer therapeutics using a variety of targeted
and non-targeted approaches. A direct comparison of these potential competitors
will not be possible until bavituximab advances to later-stage clinical
trials.
In
addition, we have completed a Phase I single-dose clinical trial evaluating
bavituximab for the treatment of HCV infection and have begun enrolling patients
in a multiple-dose Phase Ib clinical trial. Bavituximab is a first-in-class
approach for the treatment of HCV infection. We are aware of no other products
in development targeting PS as a potential therapy for HCV infection. There
are
a number of companies that have products approved and on the market for the
treatment of HCV, including but not limited to: Peg-Intron®
(pegylated interferon-alpha-2b), Rebetol®
(ribavirin), and Intron-A (interferon-alpha-2a), which are marketed by
Schering-Plough Corporation, and Pegasys®
(pegylated interferon-alpha-2a), Copegus®
(ribavirin USP) and Roferon-A®
(interferon-alpha-2a), which are marketed by Roche Pharmaceuticals, and
Infergen®
(interferon alfacon-1) now marketed by Valeant Pharmaceuticals International.
First line treatment for HCV has changed little since alpha interferon was
first
introduced in 1991. The current standard of care for HCV infection includes
a
combination of an alpha interferon (pegylated or non-pegylated) with ribavirin.
This combination therapy is generally associated with considerable toxicity
including flu-like symptoms, hematologic changes and central nervous system
disorders including depression. It is not uncommon for patients to discontinue
alpha interferon therapy because they are unable to tolerate the side effects
of
the treatment.
12
Future
treatments for HCV are likely to include a combination of these existing
products used as adjuncts with products now in development. Later-stage
developmental treatments include improvements to existing therapies, such as
Abluferon™ (albumin interferon) from Human Genome Sciences, Inc. and Viramidine™
(taribavirin), a prodrug analog of ribavirin being developed by Valeant
Pharmaceuticals International. Other developmental approaches include protease
inhibitors such as VX-950 from Vertex Pharmaceuticals Incorporated, and SCH7
from Schering-Plough Corporation, and NM283, a polymerase inhibitor by Idenix
Pharmaceuticals, Inc.
Research
and Development
A
major
portion of our operating expenses to date is related to research and
development. Research and development expenses primarily include (i) payroll
and
related costs associated with research and development personnel, (ii) costs
related to clinical and pre-clinical testing of our technologies under
development, (iii) costs to develop and manufacture the product candidates,
including raw materials and supplies, product testing, depreciation, and
facility related expenses, (iv) technology access and maintenance fees,
including intellectual property fees and fees incurred under licensing
agreements, (v) expenses for research services provided by universities and
contract laboratories, including sponsored research funding, and (vi) other
research and development expenses. Research and development expenses were
$12,415,000 in fiscal year 2006, $11,164,000 in fiscal year 2005, and $9,673,000
in fiscal year 2004.
Corporate
Governance
Our
Board
is committed to legal and ethical conduct in fulfilling its responsibilities.
The Board expects all directors, as well as officers and employees, to act
ethically at all times and to adhere to the policies comprising the Company's
Code of Business Conduct and Ethics. The Board of Directors (the "Board") of
the
Company adopted the corporate governance policies and charters. Copies of the
following corporate governance documents are posted on our website, and are
available free of charge, at www.peregrineinc.com:
(1) Peregrine Pharmaceuticals, Inc. Code of Business Conduct and Ethics
(2) Peregrine Pharmaceuticals, Inc. Charter of the Nominating Committee of
the Board of Directors, (3) Peregrine Pharmaceuticals, Inc. Charter of the
Audit
Committee of the Board of Directors, and (4) Peregrine Pharmaceuticals,
Inc. Charter of the Compensation Committee of the Board of Directors. If you
would like a printed copy of any of these corporate governance documents, please
send your request to Peregrine Pharmaceuticals, Inc., Attention: Corporate
Secretary, 14272 Franklin Avenue, Tustin, California 92780.
Human
Resources
As
of
April 30, 2006, we employed 102 full-time employees and 6 part-time employees.
Each of our employees has signed a confidentiality agreement and none are
covered by a collective bargaining agreement. We have never experienced
employment-related work stoppages and consider our employee relations to be
good.
13
GLOSSARY
OF TERMS
ADJUVANT
- An agent
added to a drug to increase or aid its effect.
ANGIOGENESIS
-
The
formation of new blood vessels.
ANTIBODY
- Protein
formed by the body to help defend against infection and disease.
ANTIGEN
- Any
substance that antagonizes or stimulates the immune system to produce
antibodies.
CHEMOTHERAPY -
Treatment
of disease by means of chemical substances or drugs.
CHIMERIC
-
A type
of antibody that is mostly human and partially mouse.
cGMP -
current
Good Manufacturing Practices; regulations established by the FDA for the
manufacture, processing, packing, or holding of a drug to assure that such
drug
meets the requirements of the Federal Food, Drug and Cosmetic Act as to safety,
and has the identity and strength and meets the quality and purity
characteristics that it purports or is represented to possess.
COTARA®
- The
trade
name of our first Tumor Necrosis Therapy (“TNT”) clinical compound. Cotara® is a
chimeric monoclonal antibody combined with Iodine 131 (radioisotope) that
targets dead and dying cells found primarily at the core of a
tumor.
CYTOKINE
- A
chemical messenger protein released by certain white blood cells. The cytokines
include the interferons, the interleukins, tumor necrosis factor, and many
others.
DNA
(DEOXYRIBONUCLEIC ACID) - A
complex
polynucleotide that is the carrier of genetic information.
ENDOTHELIAL
CELLS -
A layer
of flat cells that line blood vessels.
FDA -
the U.S.
Food and Drug Administration; the government agency responsible for regulating
the food, drug and cosmetic industries, including the commercial approval of
pharmaceuticals in the United States.
GLIOBLASTOMA
MULTIFORME
- A type
of brain tumor that forms from glial (supportive) tissue of the brain. Also
called grade IV astrocytoma.
IND
-
Investigational New Drug Application; the application submitted to the FDA
requesting permission to conduct human clinical trials.
MAXIMUM
TOLERATED DOSE
- The
highest nontoxic dose that can be reasonably given to patients.
MONOCLONAL
ANTIBODY - Antibodies
that have identical molecular structure and bind to a specific target. The
inherent selectivity of monoclonal
antibodies makes them ideally suited for targeting specific cells, such as
cancer cells or certain viruses, while bypassing most normal
tissue.
NECROSIS or
NECROTIC
- The
death and degradation of cells within a tissue.
ONCOLOGY
- The
study and treatment of cancer.
PHARMACOKINETIC
- Concerning
the study of how a drug is processed by the body, with emphasis on the time
required for absorption, distribution in the body metabolism and
excretion.
14
PHOSPHOLIPIDS
-
Phospholipids are normal cellular structures that are present in all cells
of
the human body and form the building blocks that make-up the outer and inner
surface of cells responsible for maintaining integrity and normal
functions.
PRE-CLINICAL
- Generally
refers to research that is performed in animals or tissues in the
laboratory.
PROTOCOL
- A
detailed plan for studying a treatment for a specific condition.
RADIOLABELING or
RADIOLABELED
-
Process of attaching a radioactive isotope, such as Iodine 131.
RECURRENT
- The
return or flare up of a condition thought to be cured or in
remission.
SOLID
TUMORS
- Cancer
cells which grow as a solid mass.
TUMOR
NECROSIS THERAPY (“TNT”)
-
Therapeutic agents that target dead and dying cells found primarily at the
core
of a tumor.
15
ITEM
1A.
RISK
FACTORS
This
Annual Report on Form 10-K contains forward-looking information based on our
current expectations. Because our actual results may differ materially from
any
forward-looking statements made by or on behalf of Peregrine, this section
includes a discussion of important factors that could affect our actual future
results, including, but not limited to, our potential product sales, potential
royalties, contract manufacturing revenues, expenses, net income(loss) and
earnings(loss) per common share.
If
We Cannot Obtain Additional Funding, Our Product Development And
Commercialization Efforts May Be Reduced Or Discontinued And We May Not Be
Able
To Continue Operations.
At
June
30, 2006, we had approximately $26.3 million in cash and cash equivalents.
We
have expended substantial funds on (i) the research, development and clinical
trials of our product candidates, and (ii) funding the operations of our wholly
owned subsidiary, Avid Bioservices, Inc. As a result, we
have
historically experienced negative cash flows from operations since our inception
and we expect the negative cash flows from operations to continue for the
foreseeable future, unless and until we are able to generate sufficient revenues
from Avid’s contract manufacturing services and/or from the sale and/or
licensing of our products under development. While we expect Avid to generate
revenues in the foreseeable future, we expect our monthly negative cash flow
to
continue for the foreseeable future due to our clinical trial activities using
Cotara® for the treatment of brain cancer, our ongoing clinical studies of
bavituximab for the treatment of both solid tumors and hepatitis C virus
infection, our anticipated research and development costs associated with the
possible expansion of our clinical indications using bavituximab for
the
treatment of other viral indications, including possible supporting trials
outside the U.S., our continued research directed towards our other technologies
in pre-clinical development, and our possible expansion of our manufacturing
capabilities. We believe we have sufficient cash on hand to meet our obligations
on a timely basis through
at least fiscal year 2007.
In
addition to the operations of Avid, we plan to obtain any necessary financing
through one or more methods including either equity or debt financing and/or
negotiating additional licensing or collaboration agreements for our technology
platforms. There can be no assurances that we will be successful in raising
such
funds on terms acceptable to us, or at all, or that sufficient additional
capital will be raised to complete the research, development, and clinical
testing of our product candidates.
Successful
Development Of Our Products Is Uncertain. To Date, No Revenues Have Been
Generated From The Commercial Sale Of Our Products And Our Products May Not
Generate Revenues In The Future.
Our
development of current and future product candidates is subject to the risks
of
failure inherent in the development of new pharmaceutical products and products
based on new technologies. These risks include:
·
|
delays
in product development, clinical testing or
manufacturing;
|
·
|
unplanned
expenditures in product development, clinical testing or
manufacturing;
|
·
|
failure
in clinical trials or failure to receive regulatory
approvals;
|
·
|
emergence
of superior or equivalent products;
|
·
|
inability
to manufacture on our own, or through others, product candidates
on a
commercial scale;
|
·
|
inability
to market products due to third party proprietary rights;
and
|
·
|
failure
to achieve market acceptance.
|
Because
of these risks, our research and development efforts or those of our partners
may not result in any commercially viable products. If significant portions
of
these development efforts are not successfully completed, required regulatory
approvals are not obtained, or any approved products are not commercially
successful, our business, financial condition and results of operations may
be
materially harmed.
Because
our licensing partners and we have not begun commercial sales of our products,
our revenue and profit potential is unproven and our limited operating history
makes it difficult for an investor to evaluate our business and prospects.
Our
technology may not result in any meaningful benefits to our current or potential
partners. No revenues have been generated from the commercial sale of our
products, and our products may not generate revenues in the future. Our business
and prospects should be considered in light of the heightened risks and
unexpected expenses and problems we may face as a company in an early stage
of
development in a new and rapidly evolving industry.
16
We
Have Had Significant Losses And We Anticipate Future
Losses.
We
have
incurred net losses in most fiscal years since we began operations in 1981.
The
following table represents net losses incurred during the past three fiscal
years ended April 30, 2006:
Net
Loss
|
||||
Fiscal
Year 2006
|
$
|
17,061,000
|
||
Fiscal
Year 2005
|
$
|
15,452,000
|
||
Fiscal
Year 2004
|
$
|
14,345,000
|
As
of
April 30, 2006, we had an accumulated deficit of $186,864,000. While we expect
to continue to generate revenues from Avid’s contract manufacturing services, in
order to achieve and sustain profitable operations, we must successfully develop
and obtain regulatory approval for our products, either alone or with others,
and must also manufacture, introduce, market and sell our products. The costs
associated with clinical trials and product manufacturing is very expensive
and
the time frame necessary to achieve market success for our products is long
and
uncertain. We do not expect to generate product or royalty revenues
for at least the next two years, and we may never generate product revenues
sufficient to become profitable or to sustain profitability.
Our
Product Development Efforts May Not Be Successful.
Since
our
inception, we have been engaged in the development of drugs and related
therapies for the treatment of people with cancer. During fiscal year 2005,
we
began exploring the use of one of our product candidates, bavituximab, for
the
treatment of viral infections (in particular enveloped viruses). We recently
completed a single dose Phase Ia trial for the treatment of people with the
hepatitis C virus (“HCV”) infection, including the extension of the study to
test an additional six patients at a higher dose. We have also recently
initiated a Phase 1b repeat dose study and are planning a combination therapy
study using bavituximab with standard anti-viral therapies. Our product
candidates have not received regulatory approval and are generally in research,
pre-clinical and clinical stages of development. If the results from any of
the
clinical trials are poor, those results may adversely affect our ability to
raise additional capital, which will affect our ability to continue full-scale
research and development for our antibody technologies. In addition, our product
candidates may take longer than anticipated to progress through clinical trials,
or patient enrollment in the clinical trials may be delayed or prolonged
significantly, thus delaying the clinical trials. Patient enrollment is a
function of many factors, including the size of the patient population, the
nature of the protocol, the proximity of patients to the clinical sites, and
the
eligibility criteria for the study. In addition, because our Cotara® product
currently in clinical trials represents a departure from more commonly used
methods for cancer treatment, potential patients and their doctors may be
inclined to use conventional therapies, such as chemotherapy, rather than enroll
patients in our clinical study.
Clinical
Trials Required For Our Product Candidates Are Expensive And Time Consuming,
And
Their Outcome Is Uncertain.
In
order
to obtain FDA approval to market a new drug product, we or our potential
partners must demonstrate proof of safety and efficacy in humans. To meet these
requirements, we or our potential partners will have to conduct extensive
pre-clinical testing and “adequate and well-controlled” clinical trials.
Conducting clinical trials is a lengthy, time-consuming and expensive process.
The length of time may vary substantially according to the type, complexity,
novelty and intended use of the product candidate, and often can be several
years or more per trial. Delays associated with products for which we are
directly conducting pre-clinical or clinical trials may cause us to incur
additional operating expenses. Moreover, we may continue to be affected by
delays associated with the pre-clinical testing and clinical trials of certain
product candidates conducted by our partners over which we have no control.
The
commencement and rate of completion of clinical trials may be delayed by many
factors, including, for example:
· |
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
· |
the
inability of patients to meet FDA imposed protocol
requirements;
|
· |
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices, or cGMPs, for use in
clinical
trials;
|
17
· |
the
need or desire to modify our manufacturing
processes;
|
· |
the
inability to adequately observe patients after
treatment;
|
· |
changes
in regulatory requirements for clinical
trials;
|
· |
the
lack of effectiveness during the clinical
trials;
|
· |
unforeseen
safety issues;
|
· |
delays,
suspension, or termination of the clinical trials due to the institutional
review board responsible for overseeing the study at a particular
study
site; and
|
· |
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
|
Even
if
we obtain positive results from pre-clinical or initial clinical trials, we
may
not achieve the same success in future trials. Clinical trials may not
demonstrate statistically sufficient safety and effectiveness to obtain the
requisite regulatory approvals for product candidates employing our
technology.
Clinical
trials that we conduct or that third-parties conduct on our behalf may not
demonstrate sufficient safety and efficacy to obtain the requisite regulatory
approvals for any of our product candidates. We expect to commence new clinical
trials from time to time in the course of our business as our product
development work continues. The failure of clinical trials to demonstrate safety
and effectiveness for our desired indications could harm the development of
that
product candidate as well as other product candidates. Any change in, or
termination of, our clinical trials could materially harm our business,
financial condition and results of operations.
Success
In Early Clinical Trials May Not Be Indicative Of Results Obtained In Later
Trials.
A
number
of new drugs and biologics have shown promising results in initial clinical
trials, but subsequently failed to establish sufficient safety and effectiveness
data to obtain necessary regulatory approvals. Data obtained from pre-clinical
and clinical activities are subject to varying interpretations, which may delay,
limit or prevent regulatory approval.
Positive
results from pre-clinical studies and our Phase I clinical trial should not
be
relied upon as evidence that later or larger-scale clinical trials will succeed.
The Phase I clinical trial of bavituximab for the treatment of the Hepatitis
C
virus (“HCV”) infection has been conducted only in small numbers of patients
that may not fully represent the diversity present in larger populations
infected with HCV. The limited results we have obtained may not predict results
from studies in larger numbers of patients drawn from more diverse populations
and also may not predict the ability of bavituximab to achieve a sustained
anti-viral response or the ability to provide a long-term therapeutic benefit.
These initial trials in HCV have not been designed to assess the long-term
therapeutic utility of bavituximab. We will be required to demonstrate through
larger-scale clinical trials that bavituximab is safe and effective for use
in a
diverse population before we can seek regulatory approval for its commercial
sale. There is typically an extremely high rate of attrition from the failure
of
drug candidates proceeding through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of
many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be
Profitable.
Even
if
bavituximab, Cotara®, or any future product candidate is approved for commercial
sale by the FDA or other regulatory authorities, the degree of market acceptance
of any approved product candidate by physicians, healthcare professionals and
third-party payors and our profitability and growth will depend on a number
of
factors, including:
· |
our
ability to provide acceptable evidence of safety and
efficacy;
|
· |
relative
convenience and ease of
administration;
|
· |
the
prevalence and severity of any adverse side
effects;
|
· |
availability
of alternative treatments;
|
· |
pricing
and cost effectiveness;
|
· |
effectiveness
of our or our collaborators’ sales and marketing strategy;
and
|
· |
our
ability to obtain sufficient third-party insurance coverage or
reimbursement.
|
18
In
addition, if bavituximab, Cotara®, or any future product candidate that we
discover and develop does not provide a treatment regimen that is more
beneficial than the current standard of care or otherwise provide patient
benefit, that product likely will not be accepted favorably by the market.
If
any products we may develop do not achieve market acceptance, then we may not
generate sufficient revenue to achieve or maintain profitability.
In
addition, even if our products achieve market acceptance, we may not be able
to
maintain that market acceptance over time if new products or technologies are
introduced that are more favorably received than our products, are more cost
effective or render our products obsolete.
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We
have
concluded a Phase I and Phase II study with Cotara® for the treatment of
recurrent Glioblastoma Multiforme (“GBM”), a deadly form of brain cancer. We are
currently collaborating with various universities that are members of the New
Approaches to Brain Tumor Therapy (“NABTT”) consortium to complete the dose
confirmation and dosimetry clinical trial. The next step in the development
of
Cotara® will be to treat a group of approximately 40 patients using a single
administration of the drug with an optimized delivery using two catheters.
Taken
together, the NABTT study along with data collected from the treatment of the
approximate 40 additional patients should provide the safety, dosimetry and
efficacy data that will support the final design of the larger Phase III study.
Once we complete the initial two parts of the Cotara® study for brain cancer,
substantial financial resources will be needed to complete the final part of
the
trial and any additional supportive clinical studies necessary for potential
product approval. We do not presently have the financial resources internally
to
complete the larger Phase III study. We therefore intend to continue to seek
a
licensing or funding partner for Cotara®, and hope that the data from this
collaboration with members of NABTT together with other data from additional
40
patients, will enhance our opportunities of finding such partner. If a partner
is not found for this technology, we may not be able to advance the project
past
its current state of development. Because there are a limited number of
companies which have the financial resources, the internal infrastructure,
the
technical capability and the marketing infrastructure to develop and market
a
radiopharmaceutical based anti-cancer drug, we may not find a suitable
partnering candidate for Cotara®. We also cannot assure you that we will be able
to find a suitable licensing partner for this technology. Furthermore, we cannot
assure you that if we do find a suitable licensing partner, the financial terms
that they propose will be acceptable to the Company.
Our
Dependency On One Radiolabeling Supplier May Negatively Impact Our Ability
To
Complete Clinical Trials And Market Our Products.
We
have
procured our antibody radioactive isotope combination services (“radiolabeling”)
with Iso-tex Diagnostics, Inc. for all U.S. clinical trials using Cotara®. If
this supplier is unable to continue to qualify its facility or radiolabel and
supply our antibody in a timely manner, our current clinical trial or potential
licensing partner’s clinical trials using radiolabeling technology could be
adversely affected and delayed. While there are other suppliers for radioactive
isotope combination services, our clinical trial would be delayed for up to
twelve to eighteen months because it may take that amount of time to certify
a
new facility under current Good Manufacturing Practices and qualify the product,
plus we would incur significant costs to transfer our technology to another
vendor. Prior to commercial distribution of any of our products, if approved,
we
will be required to identify and contract with a company for commercial antibody
manufacturing and radioactive isotope combination services. An antibody that
has
been combined with a radioactive isotope, such as Iodine 131, cannot be stored
for long periods of time, as it must be used within one week of being
radiolabeled to be effective. Accordingly, any change in our existing or future
contractual relationships with, or an interruption in supply from, any such
third-party service provider or antibody supplier could negatively impact our
ability to complete ongoing clinical trials conducted by us or a potential
licensing partner.
Our
Manufacturing Facilities May Not Continue To Meet Regulatory Requirements And
Have Limited Capacity.
Before
approving a new drug or biologic product, the FDA requires that the facilities
at which the product will be manufactured be in compliance with current Good
Manufacturing Practices, or cGMP requirements. To be successful, our therapeutic
products must be manufactured for development and, following approval, in
commercial quantities, in compliance with regulatory requirements and at
acceptable costs. Currently, we manufacture all pre-clinical and clinical
material through Avid Bioservices, our wholly owned subsidiary. While we believe
our current facilities are adequate for the manufacturing of product candidates
for clinical trials, our facilities may not be adequate to produce sufficient
quantities of any products for commercial sale.
19
If
we are
unable to establish and maintain a manufacturing facility or secure third-party
manufacturing capacity within our planned time frame and cost parameters, the
development and sales of our products, if approved, may be materially harmed.
We
may
also encounter problems with the following:
·
|
production
yields;
|
·
|
quality
control and quality assurance;
|
·
|
shortages
of qualified personnel;
|
·
|
compliance
with FDA regulations, including the demonstration of purity and
potency;
|
·
|
changes
in FDA requirements;
|
·
|
production
costs; and/or
|
·
|
development
of advanced manufacturing techniques and process
controls.
|
In
addition, we or any third-party manufacturer will be required to register the
manufacturing facilities with the FDA and other regulatory authorities. The
facilities will be subject to inspections confirming compliance with cGMP or
other regulations. If any of our third-party manufacturers or we fail to
maintain regulatory compliance, the FDA can impose regulatory sanctions
including, among other things, refusal to approve a pending application for
a
new drug product or biologic product, or revocation of a pre-existing approval.
As a result, our business, financial condition and results of operations may
be
materially harmed.
We
May Have Significant Product Liability Exposure Because We Maintain Only Limited
Product Liability Insurance.
We
face
an inherent business risk of exposure to product liability claims in the event
that the administration of one of our drugs during a clinical trial adversely
affects or causes the death of a patient. Although we maintain product liability
insurance for clinical studies in the amount of $3,000,000 per occurrence or
$3,000,000 in the aggregate on a claims-made basis, this coverage may not be
adequate. Product liability insurance is expensive, difficult to obtain and
may
not be available in the future on acceptable terms, if at all. Our inability
to
obtain sufficient insurance coverage on reasonable terms or to otherwise protect
against potential product liability claims in excess of our insurance coverage,
if any, or a product recall, could negatively impact our financial position
and
results of operations.
In
addition, the contract manufacturing services that we offer through Avid expose
us to an inherent risk of liability as the antibodies or other substances
manufactured by Avid, at the request and to the specifications of our customers,
could possibly cause adverse effects or have product defects. We obtain
agreements from our customers indemnifying and defending us from any potential
liability arising from such risk. There can be no assurance that such
indemnification agreements will adequately protect us against potential claims
relating to such contract manufacturing services or protect us from being named
in a possible lawsuit. Although Avid has procured insurance coverage, there
is
no guarantee that we will be able to maintain our existing coverage or obtain
additional coverage on commercially reasonable terms, or at all, or that such
insurance will provide adequate coverage against all potential claims to which
we might be exposed. A partially successful or completely uninsured claim
against Avid would have a material adverse effect on our consolidated
operations.
The
Liquidity Of Our Common Stock Will Be Adversely Affected If Our Common Stock
Is
Delisted From The Nasdaq Capital Market.
Our
common stock is presently traded on The Nasdaq Capital Market. To maintain
inclusion on The Nasdaq Capital Market, we must continue to meet the following
six listing requirements:
1.
|
Net
tangible assets of at least $2,500,000 or market capitalization of
at
least $35,000,000 or net income of at least $500,000 in either our
latest
fiscal year or in two of our last three fiscal
years;
|
2.
|
Public
float of at least 500,000 shares;
|
3.
|
Market
value of our public float of at least
$1,000,000;
|
4.
|
A
minimum closing bid price of $1.00 per share of common stock, without
falling below this minimum bid price for a period of thirty consecutive
trading days;
|
5.
|
At
least two market makers; and
|
6.
|
At
least 300 stockholders, each holding at least 100 shares of common
stock.
|
20
We
cannot
guarantee that we will be able to maintain the minimum closing bid price
requirement or maintain any of the other requirements in the future. The market
price of our common stock has generally been highly volatile. During the fiscal
year 2006, the trading price of our common stock on The Nasdaq Capital Market
ranged from $0.88 per share to $1.76 per share. If we fail to meet any of The
Nasdaq Capital Market listing requirements, the market value of our common
stock
could fall and holders of common stock would likely find it more difficult
to
dispose of the common stock. During the third quarter ended January 31, 2006,
the closing bid price of our common stock was less than $1.00 for a period
of 27
consecutive trading days. Had the closing bid price not equaled at least $1.00
prior to the close of the 30th day, we would have been out of compliance with
a
continued listing requirement and subject to delisting if we did not regain
compliance in accordance with the Nasdaq listing rules within 180 days
thereafter.
If
our
common stock is delisted, we would apply to have our common stock quoted on
the
over-the-counter electronic bulletin board. Upon any such delisting, our common
stock would become subject to the regulations of the Securities and Exchange
Commission relating to the market for penny stocks. A penny stock, as defined
by
the Penny Stock Reform Act, is any equity security not traded on a national
securities exchange or quoted on the NASDAQ Global or Capital Market, that
has a
market price of less than $5.00 per share. The penny stock regulations generally
require that a disclosure schedule explaining the penny stock market and the
risks associated therewith be delivered to purchasers of penny stocks and impose
various sales practice requirements on broker-dealers who sell penny stocks
to
persons other than established customers and accredited investors. The
broker-dealer must make a suitability determination for each purchaser and
receive the purchaser’s written agreement prior to the sale. In addition, the
broker-dealer must make certain mandated disclosures, including the actual
sale
or purchase price and actual bid offer quotations, as well as the compensation
to be received by the broker-dealer and certain associated persons. The
regulations applicable to penny stocks may severely affect the market liquidity
for our common stock and could limit your ability to sell your securities in
the
secondary market.
The
Sale Of Substantial Shares Of Our Common Stock May Depress Our Stock
Price.
As
of
April 30, 2006, we had approximately 179,382,000 shares of our common stock
outstanding, and for that date the last reported sales price of our common
stock
was $1.39 per share.
We
could
also issue up to approximately 38,798,000 additional shares of our common stock
reserved for future issuance under our shelf registration statements, stock
option plans and outstanding warrants, as further described in the following
table:
Number
of Shares
of
Common Stock Reserved For Issuance
|
||||
Shares
reserved for under two effective shelf
registration statements
|
15,179,180
|
|||
Common
shares reserved for issuance under stock option plans
|
11,307,279
|
|||
Common
shares available for future grant under option plans
|
5,346,418
|
|||
Common
shares issuable upon exercise of outstanding warrants
|
6,964,653
|
|||
Total
|
38,797,530
|
Ofthe
total
warrants and options outstanding as of April 30, 2006, approximately 11,205,000
options and warrants would be considered dilutive to stockholders because
we
would receive an amount per share which is less than the market price of
our
common stock at April 30, 2006.
21
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock.
The
market price of our common stock and the market prices of securities of
companies in the biotechnology sector have generally been highly volatile and
are likely to continue to be highly volatile.
The
following table shows the high and low sales price and trading volume of our
common stock for each quarter in the three years ended April 30, 2006:
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
||||||||
High
|
Low
|
High
|
Low
|
||||||
Fiscal
Year 2006
|
|||||||||
Quarter
Ended April 30, 2006
|
$1.76
|
$1.20
|
9,922
|
391
|
|||||
Quarter
Ended January 31, 2006
|
$1.40
|
$0.88
|
12,152
|
|
251
|
||||
Quarter
Ended October 31, 2005
|
$1.28
|
$0.91
|
4,619
|
156
|
|||||
Quarter
Ended July 31, 2005
|
$1.31
|
$0.92
|
7,715
|
178
|
|||||
Fiscal
Year 2005
|
|||||||||
Quarter
Ended April 30, 2005
|
$1.64
|
$1.11
|
5,945
|
223
|
|||||
Quarter
Ended January 31, 2005
|
$1.45
|
$0.99
|
6,128
|
160
|
|||||
Quarter
Ended October 31, 2004
|
$1.96
|
$0.95
|
2,141
|
148
|
|||||
Quarter
Ended July 31, 2004
|
$1.92
|
$0.88
|
1,749
|
131
|
|||||
Fiscal
Year 2004
|
|||||||||
Quarter
Ended April 30, 2004
|
$2.85
|
$1.56
|
3,550
|
320
|
|||||
Quarter
Ended January 31, 2004
|
$3.14
|
$2.01
|
6,062
|
201
|
|||||
Quarter
Ended October 31, 2003
|
$2.44
|
$1.25
|
18,060
|
314
|
|||||
Quarter
Ended July 31, 2003
|
$2.19
|
$0.60
|
12,249
|
255
|
The
market price of our common stock may be significantly impacted by many factors,
including, but not limited to:
·
|
Announcements
of technological innovations or new commercial products by us or
our
competitors;
|
·
|
publicity
regarding actual or potential clinical trial results relating to
products
under development by us or our
competitors;
|
·
|
our
financial results or that of our
competitors;
|
·
|
published
reports by securities analysts;
|
·
|
announcements
of licensing agreements, joint ventures, strategic alliances, and
any
other transaction that involves the sale or use of our technologies
or
competitive technologies;
|
·
|
developments
and/or disputes concerning our patent or proprietary
rights;
|
·
|
regulatory
developments and product safety
concerns;
|
·
|
general
stock trends in the biotechnology and pharmaceutical industry
sectors;
|
·
|
public
concerns as to the safety and effectiveness of our
products;
|
·
|
economic
trends and other external factors, including but not limited to,
interest
rate fluctuations, economic recession, inflation, foreign market
trends,
national crisis, and disasters; and
|
·
|
health
care reimbursement reform and cost-containment measures implemented
by
government agencies.
|
These
and
other external factors have caused and may continue to cause the market price
and demand for our common stock to fluctuate substantially, which may limit
or
prevent investors from readily selling their shares of common stock, and may
otherwise negatively affect the liquidity of our common stock.
22
If
We Are Unable To Obtain, Protect And Enforce Our Patent Rights, We May Be Unable
To Effectively Protect Or Exploit Our Proprietary Technology, Inventions And
Improvements.
Our
success depends in part on our ability to obtain, protect and enforce
commercially valuable patents. We try to protect our proprietary positions
by
filing United States and foreign patent applications related to our proprietary
technology, inventions and improvements that are important to developing our
business. However, if we fail to obtain and maintain patent protection for
our
proprietary technology, inventions and improvements, our competitors could
develop and commercialize products that would otherwise infringe upon our
patents.
Our
patent position is generally uncertain and involves complex legal and factual
questions. Legal standards relating to the validity and scope of claims in
the
biotechnology and biopharmaceutical fields are still evolving. Accordingly,
the
degree of future protection for our patent rights is uncertain. The risks and
uncertainties that we face with respect to our patents include the
following:
·
|
the
pending patent applications we have filed or to which we have exclusive
rights may not result in issued patents or may take longer than we
expect
to result in issued patents;
|
·
|
the
claims of any patents that issue may not provide meaningful
protection;
|
·
|
we
may be unable to develop additional proprietary technologies that
are
patentable;
|
·
|
the
patents licensed or issued to us may not provide a competitive
advantage;
|
·
|
other
parties may challenge patents licensed or issued to
us;
|
·
|
disputes
may arise regarding the invention and corresponding ownership rights
in
inventions and know-how resulting from the joint creation or use
of
intellectual property by us, our licensors, corporate partners and
other
scientific collaborators; and
|
·
|
other
parties may design around our patented
technologies.
|
We
May Become Involved In Lawsuits To Protect Or Enforce Our Patents That Would
Be
Expensive And Time Consuming.
In
order
to protect or enforce our patent rights, we may initiate patent litigation
against third parties. In addition, we may become subject to interference or
opposition proceedings conducted in patent and trademark offices to determine
the priority and patentability of inventions. The defense of intellectual
property rights, including patent rights through lawsuits, interference or
opposition proceedings, and other legal and administrative proceedings, would
be
costly and divert our technical and management personnel from their normal
responsibilities. An adverse determination of any litigation or defense
proceedings could put our pending patent applications at risk of not being
issued.
Furthermore,
because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of litigation.
For example, during the course of this kind of litigation, confidential
information may be inadvertently disclosed in the form of documents or testimony
in connection with discovery requests, depositions or trial testimony. This
disclosure could materially adversely affect our business and financial
results.
We
May Not Be Able To Compete With Our Competitors In The Biotechnology Industry
Because Many Of Them Have Greater Resources Than We Do And They Are Further
Along In Their Development Efforts.
The
pharmaceutical and biotechnology industry is intensely competitive and subject
to rapid and significant technological change. Many of the drugs that we are
attempting to discover or develop will be competing with existing therapies.
In
addition, we are aware of several pharmaceutical and biotechnology companies
actively engaged in research and development of antibody-based products that
have commenced clinical trials with, or have successfully commercialized,
antibody products. Some or all of these companies may have greater financial
resources, larger technical staffs, and larger research budgets than we have,
as
well as greater experience in developing products and running clinical trials.
We expect to continue to experience significant and increasing levels of
competition in the future. In addition, there may be other companies which
are
currently developing competitive technologies and products or which may in
the
future develop technologies and products which are comparable or superior to
our
technologies and products.
We
are
conducting the Cotara® dose confirmation and dosimetry clinical trial for the
treatment of recurrent brain cancer as a stand-alone study in collaboration
with
New Approaches to Brain Tumor Therapy (“NABTT”) consortium. Existing treatments
for brain cancer include the Gliadel® Wafer (polifeprosan 20 with carmustine
implant) from MGI Pharma, Inc. and Temodar® (temazolomide) from Schering-Plough
Corporation. Gliadel® is inserted in the tumor cavity following surgery and
releases a chemotherapeutic agent over time. Temodar® is administered orally to
patients receiving concurrent radiation therapy.
23
Because
Cotara® targets brain tumors from the inside out, it is a novel treatment
dissimilar from other drugs in development for this disease. Some of the
products that may compete within the brain cancer category include GLI-328
(Novartis), a gene therapy treatment that is injected into the walls of the
tumor cavity following surgery; IL13-PE38QQR (cintredekin besudotox) from
NeoPharm continues in a Phase III trial; In March 2006 Eli Lilly and Company
began a Phase III trial of enzastuarin for the treatment of GBM; TransMID
(Xenova Group plc) is a product based on the diphtheria toxin and began a Phase
III trial in May 2004. In addition, Gleevec® by Novartis, which is an oncology
product marketed for other indications, is being tested in clinical trials
for
the treatment of brain cancer.
Bavituximab
for the treatment of advanced solid cancers is currently in Phase I clinical
trials. There are a number of possible competitors with approved or
developmental targeted agents used in combination with standard chemotherapy
for
the treatment of cancer, including but not limited to, Avastin® by
Genentech, Inc., Gleevec® by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and
Genentech, Inc., Erbitux® by ImClone Systems Incorporated and Brystol-Myers
Squibb Company, Rituxan® and Herceptin® by Biogen Idec Inc. and Genentech, Inc.,
Herceptin® by Genentech, Inc. and panitumumab by Amgen®. There are a significant
number of companies developing cancer therapeutics using a variety of targeted
and non-targeted approaches. A direct comparison of these potential competitors
will not be possible until bavituximab advances to later-stage clinical
trials.
In
addition, we have completed a Phase I single-dose clinical trial evaluating
bavituximab for the treatment of HCV and have begun enrolling patients in a
multiple-dose Phase Ib clinical trial. Bavituximab is a first-in-class approach
for the treatment of HCV. We are aware of no other products in development
targeting PS as a potential therapy for HCV. There are a number of companies
that have products approved and on the market for the treatment of HCV,
including but not limited to: Peg-Intron® (pegylated interferon-alpha-2b),
Rebetol® (ribavirin), and Intron-A (interferon-alpha-2a), which are marketed by
Schering-Plough Corporation, and Pegasys® (pegylated interferon-alpha-2a),
Copegus® (ribavirin USP) and Roferon-A® (interferon-alpha-2a), which are
marketed by Roche Pharmaceuticals, and Infergen® (interferon alfacon-1) now
marketed by Valeant Pharmaceuticals International. First line treatment for
HCV
has changed little since alpha interferon was first introduced in 1991. The
current standard of care for HCV includes a combination of an alpha interferon
(pegylated or non-pegylated) with ribavirin. This combination therapy is
generally associated with considerable toxicity including flu-like symptoms,
hematologic changes and central nervous system disorders including depression.
It is not uncommon for patients to discontinue alpha interferon therapy because
they are unable to tolerate the side effects of the treatment.
Future
treatments for HCV are likely to include a combination of these existing
products used as adjuncts with products now in development. Later-stage
developmental treatments include improvements to existing therapies, such as
Abluferon™ (albumin interferon) from Human Genome Sciences, Inc. and Viramidine™
(taribavirin), a prodrug analog of ribavirin being developed by Valeant
Pharmaceuticals International. Other developmental approaches include protease
inhibitors such as VX-950 from Vertex Pharmaceuticals Incorporated, and SCH7
from Schering-Plough Corporation, and NM283, a polymerase inhibitor by Idenix
Pharmaceuticals, Inc.
New
And Potential New Accounting Pronouncements May Impact Our Future Financial
Position And Results Of Operations
There
may
be potential new accounting pronouncements or regulatory rulings, which may
have
an impact on our future financial position and results of operations. For
example, in December 2004, the FASB issued an amendment to SFAS No. 123,
Accounting For Stock-Based Compensation (“SFAS No. 123R”), which we adopted May
1, 2006. SFAS No. 123R eliminates the ability to account for share-based
compensation transactions using Accounting Principles Board Opinion No. 25
(“APB No. 25”), and instead requires companies to recognize compensation expense
using a fair-value based method for costs related to share-based payments
including stock options. The adoption of SFAS No. 123R will materially
impact our financial position and results of operations for future periods.
Although we have not yet determined the final impact of SFAS No. 123R, we
believe the non-cash compensation expense for fiscal year 2007 related to the
adoption of SFAS No. 123R may be up to approximately $1,000,000 based on actual
shares granted and unvested as of April 30, 2006. However, the actual
share-based compensation expense recorded in fiscal year 2007 as a result of
adopting SFAS No. 123R may differ materially from our estimate as a result
of
changes in a number of factors that affect the amount of non-cash compensation
expense, including the number of options granted by our Board of Directors
during fiscal year 2007, the price of our common stock on the date of grant,
the
volatility of our stock price, the estimate of the expected life of options
granted and the risk free interest rates as measured at the grant date. Also,
a
change in accounting pronouncements or taxation rules or practices can have
a
significant effect on our reported results and may even affect our reporting
of
transactions completed before the change is effective. Other new accounting
pronouncements or taxation rules and varying interpretations of accounting
pronouncements or taxation practice have occurred and may occur in the future.
Changes to existing rules, future changes, if any, or the questioning of current
practices may adversely affect our reported financial results or the way we
conduct our business, which may also adversely affect our stock
price.
24
If
We Lose Qualified Management And Scientific Personnel Or Are Unable To Attract
And Retain Such Personnel, We May Be Unable To Successfully Develop Our Products
Or We May Be Significantly Delayed In Developing Our
Products.
Our
success is dependent, in part, upon a limited number of key executive officers,
each of whom is an at-will employee, and also upon our scientific researchers.
For example, because of his extensive understanding of our technologies and
product development programs, the loss of Mr. Steven W. King, our President
and
Chief Executive Officer, would adversely affect our development efforts and
clinical trial programs during the six to twelve month period that we estimate
it would take to find and train a qualified replacement.
We
also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical personnel.
We
face intense competition in our recruiting activities, including competition
from larger companies with greater resources. We do not know if we will be
successful in attracting or retaining skilled personnel. The loss of certain
key
employees or our inability to attract and retain other qualified employees
could
negatively affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By
the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to protect
stockholders against unsolicited attempts to acquire control of us that do
not
offer a fair price to our stockholders as determined by our Board of Directors.
Under the plan, the acquisition of 15% or more of our outstanding common stock
by any person or group, unless approved by our board of directors, will trigger
the right of our stockholders (other than the acquiror of 15% or more of our
common stock) to acquire additional shares of our common stock, and, in certain
cases, the stock of the potential acquiror, at a 50% discount to market price,
thus significantly increasing the acquisition cost to a potential acquiror.
In
addition, our certificate of incorporation and by-laws contain certain
additional anti-takeover protective devices. For example,
·
|
no
stockholder action may be taken without a meeting, without prior
notice
and without a vote; solicitations by consent are thus
prohibited;
|
·
|
special
meetings of stockholders may be called only by our Board of Directors;
and
|
·
|
our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares,
of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into
a large
number of shares of common stock could prevent a potential acquiror
from
gaining effective economic or voting
control.
|
Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these provisions may
frustrate or prevent any attempts by our stockholders to replace or remove
our
current management by making it more difficult for stockholders to replace
members of our Board of Directors, which is responsible for appointing the
members of our management.
25
ITEM
1B. UNRESOLVED
STAFF COMMENTS
Not
Applicable.
ITEM
2. PROPERTIES
Our
corporate, research and development, and clinical trial operations are located
in two Company-leased office and laboratory buildings with aggregate square
footage of approximately 47,770 feet. The facilities are adjacent to one another
and are located at 14272 and 14282 Franklin Avenue, Tustin, California
92780-7017. We currently make combined monthly lease payments of approximately
$62,000 for these facilities with a 3.35% rental increase every two years.
The
next rental increase is scheduled for December 2006. The lease, which commenced
in December 1998, has an initial twelve-year term with two five-year term
extensions. During December 2005, we entered into a lease amendment with our
landlord and extended the original lease term for seven additional years through
December 2017 while maintaining our two five-year term extensions that could
extend our lease through December 2027. In addition, our monthly lease payments
still increase at a rate of 3.35% every two years under the lease amendment.
We
believe our facilities are adequate for our current needs and that suitable
additional substitute space would be available if needed.
ITEM
3. LEGAL
PROCEEDINGS
In
the
ordinary course of business, we are at times subject to legal proceedings and
disputes. We currently are not aware of any such legal proceeding or claim
that
we believe will have, individually or in the aggregate, a material adverse
effect on our business, prospects, operating results or cash flows.
ITEM
4. SUBMISSION
OF
MATTERS TO A VOTE OF SECURITY
HOLDERS
There
were no matters submitted to a vote of security holders during the quarter
ended
April 30, 2006.
26
PART
II
ITEM 5. |
MARKET
FOR
REGISTRANT'S COMMON EQUITY AND RELATED
STOCKHOLDERS’ MATTERS AND ISSUER PURCHASES OF EQUITY
SECURITIES
|
(a) Market
Information.
The
Company is listed on the The Nasdaq Capital Market under the stock trading
symbol “PPHM”. The following table shows the high and low sales price of the
Company’s common stock for each quarter in the two years ended April 30, 2006:
Common
Stock Sales Price
|
||||
High
|
Low
|
|||
Fiscal
Year 2006
|
||||
Quarter
Ended April 30, 2006
|
$1.76
|
$1.20
|
||
Quarter
Ended January 31, 2006
|
$1.40
|
$0.88
|
||
Quarter
Ended October 31, 2005
|
$1.28
|
$0.91
|
||
Quarter
Ended July 31, 2005
|
$1.31
|
$0.92
|
||
Fiscal
Year 2005
|
||||
Quarter
Ended April 30, 2005
|
$1.64
|
$1.11
|
||
Quarter
Ended January 31, 2005
|
$1.45
|
$0.99
|
||
Quarter
Ended October 31, 2004
|
$1.96
|
$0.95
|
||
Quarter
Ended July 31, 2004
|
$1.92
|
$0.88
|
(b) Holders.
As of
June 30, 2006, the number of stockholders of record of the Company's common
stock was 5,875.
(c) Dividends.
No
dividends on common stock have been declared or paid by the Company. The Company
intends to employ all available funds for the development of its business and,
accordingly, does not intend to pay any cash dividends in the foreseeable
future.
(d) Securities
Authorized for Issuance Under Equity Compensation.
The
information included under Item 12 of Part III of this Annual Report is hereby
incorporated by reference into this Item 5 of Part II of this Annual
Report.
27
ITEM
6. SELECTED
FINANCIAL
DATA
The
following selected financial data has been derived from audited consolidated
financial statements of the Company for each of the five years in the period
ended April 30, 2006. These selected financial summaries should be read in
conjunction with the financial information contained for each of the three
years
in the period ended April 30, 2006, included in the consolidated financial
statements and notes thereto, Management's Discussion and Analysis of Results
of
Operations and Financial Condition, and other information provided elsewhere
herein.
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
||||||||||||||||
FIVE
YEARS ENDED APRIL 30,
|
||||||||||||||||
2006
|
2005
|
2004
|
2003
|
2002
|
||||||||||||
Revenues
|
$
|
3,193,000
|
$
|
4,959,000
|
$
|
3,314,000
|
$
|
3,921,000
|
$
|
3,766,000
|
||||||
Net
loss
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
$
|
(14,345,000
|
)
|
$
|
(11,559,000
|
)
|
$
|
(11,718,000
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
$
|
(0.11
|
)
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
|
Weighted
average common shares outstanding
|
168,294,782
|
144,812,001
|
134,299,407
|
116,468,353
|
104,540,204
|
CONSOLIDATED
BALANCE SHEET DATA
|
||||||||||||||||
AS
OF APRIL 30,
|
||||||||||||||||
2006
|
2005
|
2004
|
2003
|
2002
|
||||||||||||
Cash
and cash equivalents
|
$
|
17,182,000
|
$
|
9,816,000
|
$
|
14,884,000
|
$
|
3,137,000
|
$
|
6,072,000
|
||||||
Working
capital
|
$
|
15,628,000
|
$
|
7,975,000
|
$
|
13,631,000
|
$
|
1,949,000
|
$
|
4,007,000
|
||||||
Total
assets
|
$
|
22,676,000
|
$
|
14,245,000
|
$
|
19,137,000
|
$
|
5,399,000
|
$
|
7,866,000
|
||||||
Long-term
debt
|
$
|
545,000
|
$
|
434,000
|
$
|
-
|
$
|
760,000
|
$
|
-
|
||||||
Accumulated
deficit
|
$
|
(186,864,000
|
)
|
$
|
(169,803,000
|
)
|
$
|
(154,351,000
|
)
|
$
|
(140,006,000
|
)
|
$
|
(128,447,000
|
)
|
|
Stockholders’
equity
|
$
|
17,626,000
|
$
|
9,610,000
|
$
|
14,759,000
|
$
|
2,131,000
|
$
|
5,083,000
|
28
ITEM
7. MANAGEMENT'S
DISCUSSION
AND ANALYSIS OF
FINANCIALCONDITION
AND RESULTS OF OPERATIONS
The
following discussion is included to describe the Company’s financial position
and results of operations for each of the three years in the period ended April
30, 2006. The consolidated financial statements and notes thereto contain
detailed information that should be referred to in conjunction with this
discussion.
Overview
We
are a
biopharmaceutical company with a portfolio of clinical and pre-clinical stage
monoclonal antibody-based targeted therapeutics for the treatment of solid
cancers and viral infections. We are currently advancing three separate clinical
trial programs for the treatment of cancer and chronic hepatitis C virus (“HCV”)
infections. Under our Anti-Phosphatidylserine (“Anti-PS”) Immunotherapeutic
platform technology, our lead candidate bavituximab (formerly known as
Tarvacin), is currently in a multi-center Phase I clinical trial for the
treatment of solid cancers as well as a multi-center phase Ib clinical trial
for
the treatment of chronic HCV infection. Our third clinical program is a dose
confirmation and dosimetry clinical trial using our lead Tumor Necrosis Therapy
(TNT) agent, Cotara®, for the treatment of glioblastoma multiforme, a deadly
form of brain cancer.
We
are
organized into two reportable operating segments: (i) Peregrine, the parent
company, is engaged in the research and development of monoclonal antibody-based
targeted therapeutics and (ii) Avid Bioservices, Inc., (“Avid”) a wholly owned
subsidiary, is engaged in providing bio-manufacturing services for Peregrine
and
outside customers on a fee-for-services basis.
29
Results
of Operations
The
following table compares the consolidated statements of operations for the
fiscal years ended April 30, 2006, 2005 and 2004. This table provides you
with
an overview of the changes in the statement of operations for the comparative
periods, which changes are further discussed below.
Years
Ended April 30,
|
Years
Ended April 30,
|
||||||||||||||||||
2006
|
2005
|
$
Change
|
2005
|
2004
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing
|
$
|
3,005
|
$
|
4,684
|
$
|
(1,679
|
)
|
$
|
4,684
|
$
|
3,039
|
$
|
1,645
|
||||||
License
revenue
|
188
|
275
|
(87
|
)
|
275
|
275
|
0
|
||||||||||||
Total
revenues
|
3,193
|
4,959
|
(1,766
|
)
|
4,959
|
3,314
|
1,645
|
||||||||||||
COST
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
3,297
|
4,401
|
(1,104
|
)
|
4,401
|
2,212
|
2,189
|
||||||||||||
Research
and development
|
12,415
|
11,164
|
1,251
|
11,164
|
9,673
|
1,491
|
|||||||||||||
Selling,
general and administrative
|
6,564
|
5,098
|
1,466
|
5,098
|
4,225
|
873
|
|||||||||||||
Total
cost and expenses
|
22,276
|
20,663
|
1,613
|
20,663
|
16,110
|
4,553
|
|||||||||||||
LOSS
FROM OPERATIONS
|
(19,083
|
)
|
(15,704
|
)
|
(3,379
|
)
|
(15,704
|
)
|
(12,796
|
)
|
(2,908
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Recovery
of note receivable
|
1,229
|
-
|
1,229
|
-
|
-
|
-
|
|||||||||||||
Interest
and other income
|
846
|
265
|
581
|
265
|
291
|
(26
|
)
|
||||||||||||
Interest
and other expense
|
(53
|
)
|
(13
|
)
|
(40
|
)
|
(13
|
)
|
(1,840
|
)
|
1,827
|
||||||||
NET
LOSS
|
$
|
(17,061
|
)
|
$
|
(15,452
|
)
|
$
|
(1,609
|
)
|
$
|
(15,452
|
)
|
$
|
(14,345
|
)
|
$
|
(1,107
|
)
|
30
Total
Revenues
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005:
The
decrease in revenues of $1,766,000 during the year ended April 30, 2006 compared
to the prior year was due to a decrease in contract manufacturing revenue of
$1,679,000 combined with a decrease in license revenue of $87,000. The decrease
in contract manufacturing revenue was primarily due to a decrease in the number
of completed manufacturing runs associated with unrelated entities compared
to
the prior year during which time we significantly increased our utilization
of
our manufacturing facility to manufacture clinical grade materials to support
Peregrine’s three active clinical trials and other products under development.
We
expect
to continue to generate contract manufacturing revenue during fiscal year 2007
based on the anticipated completion of in-process customer related projects
and
the anticipated demand for Avid’s services under outstanding proposals. Although
Avid is presently working on several active projects for unrelated entities
and
has submitted project proposals with various potential customers, we cannot
estimate nor can we determine the likelihood that we will be successful in
completing these ongoing projects or convert any of these outstanding project
proposals into definitive agreements during the remainder of fiscal year
2007.
Year
Ended April 30, 2005 Compared to the Year Ended April 30, 2004:
The
increase in revenues of $1,645,000 during the year ended April 30, 2005 compared
to the prior year was due to an increase in contract manufacturing revenue
of
the same amount. The fiscal year 2005 increase in contract manufacturing revenue
was primarily due to an increase in the number of manufacturing runs associated
with unrelated entities completed in fiscal year 2005 compared to fiscal year
2004.
Cost
of Contract Manufacturing
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005:
The
decrease in cost of contract manufacturing of $1,104,000 during the year ended
April 30, 2006 compared to the prior year was primarily related to the current
year decrease in contract manufacturing revenue. The current year decrease
was
offset by the write-off of unusable work-in-process inventory generated for
an
unrelated entity during the quarter ended April 30, 2006 combined with an
estimated contract loss provision for the same unrelated entity, which amount
in
the aggregate totaled $882,000.
Year
Ended April 30, 2005 Compared to the Year Ended April 30, 2004:
The
increase in cost of contract manufacturing of $2,189,000 during the year ended
April 30, 2005 compared to fiscal year 2004 was primarily due to the fiscal year
2005 increase in contract manufacturing revenue. In addition, the increase
was
further supplemented by costs associated with the write-off of unusable
work-in-process inventory generated during the quarter ended April 30, 2005
in
the amount of $605,000.
31
Research
and Development Expenses
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005:
The
increase in research and development expenses of $1,251,000 during the year
ended April 30, 2006 compared to the prior year was primarily due to a net
increase in expenses associated with our following platform technologies under
development:
o |
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab)
-
During fiscal year 2006, Anti-PS Immunotherapeutics program expenses
increased $3,202,000 from $5,069,000 in fiscal year 2005 to $8,271,000
in
fiscal year 2006. This current year increase in Anti-PS Immunotherapeutics
program expenses resulted primarily from the advancement of our first
Anti-PS Immunotherapeutic agent, bavituximab (formerly known as Tarvacin).
During the current fiscal year, we increased manufacturing, in-house
antibody development, and clinical trials expenses of bavituximab
as we
supported the manufacturing commercial scale-up efforts and clinical
trial
expenses to support two separate Phase I clinical studies using
bavituximab for the treatment of advanced solid cancers and chronic
hepatitis C virus infection. The foregoing expenses were supplemented
with
an increase in technology access fees associated with clinical trial
milestones achieved during the current fiscal year in accordance
with
third party licensing agreements, an increase in sponsored research
fees,
and an increase in outside animal research studies to support the
possible
expansion of bavituximab clinical trials in other anti-viral indications.
These increases were primarily offset by a decrease in pre-clinical
toxicology study expenses incurred in the prior year to support the
bavituximab Investigational New Drug (“IND”) applications that were filed
in the prior fiscal year combined with a decrease in intellectual
property
access fees and a decrease in outside antibody development fees related
to
our humanized antibody in
development.
|
o |
Tumor
Necrosis Therapy (“TNT”) (Cotara®)
-
During fiscal year 2006, TNT program expenses decreased $811,000
from
$3,183,000 in fiscal year 2005 to $2,372,000 in fiscal year 2006.
The
decrease in TNT program expenses is primarily due to a decrease in
payroll
and related expenses and radiolabeling process development expenses
incurred in the prior year to support the initiation of the Cotara® dose
confirmation and dosimetry clinical trial for the treatment of brain
cancer in collaboration with the New Approaches to Brain Tumor Therapy
consortium, and to support other development programs associated
with our
TNT technology platform. These decreases were further supplemented
by a
decrease in technology access fees incurred in the prior year supporting
the production of monoclonal antibodies for Cotara®.
|
o |
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis -
During fiscal year 2006, VTA and Anti-Angiogenesis pre-clinical program
expenses decreased $922,000 from $2,338,000 in fiscal year 2005 to
$1,416,000 in fiscal year 2006. The decrease in VTA and Anti-Angiogenesis
pre-clinical program expenses is primarily due to a decrease in
intellectual property access fees and sponsored research fees as
our
outside researchers are currently focused on the development of our
Anti-PS Immunotherapeutics technology
platform.
|
o |
Vasopermeation
Enhancements Agents (“VEAs”) - During
fiscal year 2006, VEA program expenses decreased $211,000 from $567,000
in
fiscal year 2005 to $356,000 in fiscal year 2006. The decrease in
VEA
program expenses is primarily due to a decrease in sponsored research
fees
and technology license fees combined with a decrease in antibody
development fees regarding expenses incurred in the prior year. In
January
2005, we entered into an agreement with Merck KGaA of Darmstadt,
Germany,
that gave us access to Merck's technology and expertise in protein
expression to advance the development of our VEA technology and other
platform technologies. We are currently developing a clinical candidate
under our VEA technology utilizing Merck’s expertise in protein
expression.
|
32
We
expect
research and development expenses to increase over the near term primarily
under
the following ongoing research and development programs:
1.
|
Bavituximab
clinical studies for the treatment of solid tumors and chronic hepatitis
C
virus infection and the possible expansion of clinical trials into
other
anti-viral indications;
|
2.
|
Cotara®
clinical study for the treatment of brain cancer in collaboration
with New
Approaches to Brain Tumor Therapy (“NABTT”), a brain tumor treatment
consortium;
|
3.
|
Anti-PS
Immunotherapeutics
research
and development program;
|
4.
|
2C3
(anti-angiogenesis antibody) research and development
program;
|
5.
|
Vascular
Targeting Agent research and development program;
and
|
6.
|
Vasopermeation
Enhancement Agent research and development
program.
|
Due
to
the number of ongoing research programs, if we fail to obtain additional funding
during fiscal year 2007, we may be forced to scale back our product development
efforts, or our operations, in a manner that will ensure we can pay our
obligations as they come due in the ordinary course of business beyond fiscal
year 2007.
Year
Ended April 30, 2005 Compared to the Year Ended April 30, 2004:
The
increase in research and development expenses of $1,491,000 during the year
ended April 30, 2005 compared to the prior year was primarily due to a net
increase in expenses associated with our following platform technologies under
development:
o
|
Anti-Phosphatidylserine ("Anti-PS")
Immunotherapeutics (bavituximab)
-
During fiscal year 2005, Anti-PS Immunotherapeutics (bavituximab)
program expenses increased $1,992,000 to $5,069,000 compared to $3,077,000
in fiscal year 2004. The increase in Anti-PS
Immunotherapeutics (bavituximab)
program expenses of $1,992,000 was primarily due to increases in
payroll
and related expenses, various clinical trial start-up expenses, and
allocated manufacturing expenses to support two separate Investigational
New Drug (“IND”) applications that were filed with the U.S. Food &
Drug Administration (“FDA”) during fiscal year 2005 using bavituximab, our
lead Anti-PS Immunotherapeutics product,
for the treatment of solid cancer tumors and chronic hepatitis C
virus
infection, in addition to supporting the related bavituximab Phase
I
clinical studies associated with these IND’s. In addition, intellectual
property access fees increased during fiscal year 2005 as we expanded
our
rights under the Anti-PS Immunotherapeutics platform.
These increases were offset by a decrease in antibody development
and
access fees associated with the timing of various payments due under
our
licensing agreements to support bavituximab and other related antibodies
under development.
|
o
|
TNT
(Cotara®)
-
During fiscal year 2005, TNT (Cotara®) program expenses increased $833,000
to $3,183,000 compared to $2,350,000 in fiscal year 2004. The increase
in
TNT (Cotara®) program expenses of $833,000 is primarily due to an increase
in manufacturing expenses, payroll and related expenses, and radiolabeling
process expenses to support the planned initiation of the Cotara® dose
confirmation and dosimetry clinical study for the treatment of brain
cancer in collaboration with the New Approaches to Brain Tumor Therapy
consortium, and to support the increase in research and development
programs associated with our TNT technology platform. These increases
were
further supplemented by an increase in technology access fees, which
was
primarily due to an up-front license fee to obtain certain worldwide
non-exclusive rights used in the manufacturing process for the Cotara®
antibody.
|
33
o
|
VEA
-
During fiscal year 2005, VEA program expenses decreased $624,000
to
$567,000 compared to $1,191,000 in fiscal year 2004. The decrease
in VEA
program expenses of $624,000 is primarily due to a decrease in sponsored
research fees paid to University of Southern California and stock-based
compensation expense associated with the amortization of the fair
value of
options granted to non-employee consultants performing research and
development activities that were fully amortized in fiscal year 2003.
These decreases were further supplemented by a decrease in allocated
manufacturing expenses as we increased our efforts associated with
the
manufacturing of bavituximab and Cotara® during fiscal year 2005 and a
decrease in technology access fees. In January 2005, we entered into
an
agreement with Merck KGaA of Darmstadt, Germany, that will provide
us
access to Merck’s technology and expertise in protein expression to
advance the development of our VEA
technology.
|
o
|
VTA
and Anti-Angiogenesis
-
During fiscal year 2005, VTA and Anti-angiogenesis program expenses
decreased $481,000 to $2,338,000 compared to $2,819,000 in fiscal
year
2004. The decrease in VTA and Anti-Angiogenesis program expenses
of
$481,000 is primarily due to a decrease in intellectual property
access
fees, antibody development fees and manufacturing expenses, offset
with an
increase in payroll and related fees to support our increase in active
VTA
and Anti-Angiogenesis pre-clinical research programs.
|
o
|
Other
research programs
-
During fiscal year 2005, other research program expenses decreased
$229,000 to $7,000 compared to $236,000 in fiscal year 2004. The
decrease
in other research program expenses of $229,000 is primarily due to
allocated expenses incurred in the fiscal year 2003 to manufacture
LYM
materials for research purposes only.
|
The
following represents the research and development expenses (“R&D Expenses”)
we incurred by each major technology platform under development:
Technology
Platform
|
R&D
Expenses-
Year
Ended
April
30, 2004
|
R&D
Expenses-
Year
Ended
April
30, 2005
|
R&D
Expenses-
Year
Ended
April
30, 2006
|
R&D
Expenses-
May
1, 1998 to
April
30, 2006
|
|||||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
3,077,000
|
$
|
5,069,000
|
$
|
8,271,000
|
$
|
16,417,000
|
|||||
TNT
(Cotara®)
|
2,350,000
|
3,183,000
|
2,372,000
|
31,188,000
|
|||||||||
VTA
and Anti-Angiogenesis
|
2,819,000
|
2,338,000
|
1,416,000
|
11,907,000
|
|||||||||
VEA
|
1,191,000
|
567,000
|
356,000
|
5,724,000
|
|||||||||
Other
research programs
|
236,000
|
7,000
|
-
|
13,441,000
|
|||||||||
Total
R&D Expenses
|
$
|
9,673,000
|
$
|
11,164,000
|
$
|
12,415,000
|
$
|
78,677,000
|
From
inception to April 1998, we have expensed $20,898,000 on research and
development of our product candidates, with the costs primarily being closely
split between TNT and prior developed technologies. In addition to the
above costs, we have expensed an aggregate of $32,004,000 for the acquisition
of
our TNT and VTA technologies, which were acquired during fiscal years 1995
and
1997, respectively.
Looking
beyond the next twelve months, it is extremely difficult for us to reasonably
estimate all future research and development costs associated with each of
our
technologies due to the number of unknowns and uncertainties associated with
pre-clinical and clinical trial development. These unknown variables and
uncertainties include, but are not limited to:
34
· |
the
uncertainty of our capital resources to fund research, development
and
clinical studies beyond fiscal year 2007;
|
· |
the
uncertainty of future costs associated with our pre-clinical candidates,
including Vascular Targeting Agents, Anti-Angiogenesis Agents, and
Vasopermeation Enhancement Agents, which costs are dependent on the
success of pre-clinical development. We are uncertain whether or
not these
product candidates will be successful and we are uncertain whether
or not
we will incur any additional costs beyond pre-clinical development;
|
· |
the
uncertainty of future clinical trial results;
|
· |
the
uncertainty of the ultimate number of patients to be treated in any
clinical trial;
|
· |
the
uncertainty of the Food and Drug Administration allowing our studies
to
move forward from Phase I clinical studies to Phase II and Phase
III
clinical studies;
|
· |
the
uncertainty of the rate at which patients are enrolled into any current
or
future study. Any delays in clinical trials could significantly increase
the cost of the study and would extend the estimated completion
dates;
|
· |
the
uncertainty of terms related to potential future partnering or licensing
arrangements; and
|
· |
the
uncertainty of protocol changes and modifications in the design of
our
clinical trial studies, which may increase or decrease our future
costs.
|
We
or our
potential partners will need to do additional development and clinical testing
prior to seeking any regulatory approval for commercialization of our product
candidates as all of our products are in discovery, pre-clinical or clinical
development. Testing, manufacturing, commercialization, advertising, promotion,
exporting and marketing, among other things, of our proposed products are
subject to extensive regulation by governmental authorities in the United States
and other countries. The testing and approval process requires substantial
time,
effort and financial resources, and we cannot guarantee that any approval will
be granted on a timely basis, if at all. Companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in conducting
advanced human clinical trials, even after obtaining promising results in
earlier trials. Furthermore, the United States Food and Drug Administration
may
suspend clinical trials at any time on various grounds, including a finding
that
the subjects or patients are being exposed to an unacceptable health risk.
Even
if regulatory approval of a product is granted, such approval may entail
limitations on the indicated uses for which it may be marketed. Accordingly,
we
or our potential partners may experience difficulties and delays in obtaining
necessary governmental clearances and approvals to market our products, and
we
or our potential partners may not be able to obtain all necessary governmental
clearances and approvals to market our products.
Selling,
General and Administrative Expenses
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005:
Selling,
general and administrative expenses consist primarily of payroll and related
expenses, director fees, legal and accounting fees, investor and public relation
fees, insurance, and other expenses relating to our general management,
administration, and business development activities of the Company.
The
increase in selling, general and administrative expenses of $1,466,000 during
the year ended April 30, 2006 compared to the prior year is primarily due to
an
increase in payroll and related expenses of $517,000 from $2,357,000 in fiscal
year 2005 to $2,874,000 in fiscal year 2006 primarily due to an increase in
headcount across most corporate functions to support our increased operations,
which were offset by a decrease in consulting fees associated with the prior
year business development efforts of the Company. During fiscal year 2006,
we
hired a Vice President of Business Development whose responsibilities include
those previously performed by outside consultants. The current year increase
is
also due to an increase in (i) stock based compensation expense of $230,000
from
$110,000 in fiscal year 2005 to $340,000 in fiscal year 2006 associated with
the
amortization of the fair value of options and warrants provided to non-employee
consultants for business development and general corporate services, (ii)
investor and public relation fees of $167,000 from $248,000 in fiscal year
2005
to $415,000 in fiscal year 2006 primarily due to services provided by public
relation firms assisting the Company with its investor and public relations
activities, whose services were not utilized in the prior year, (iii) travel
and
related expenses of $141,000 from $243,000 in fiscal year 2005 to $384,000
in
fiscal year 2006 primarily associated with our participation in several investor
conferences and non-deal marketing road shows during the current year combined
with an increase in travel associated with business development and other
corporate activities, and (iv) board of director fees of $137,000 from $276,000
in fiscal year 2005 to $413,000 in fiscal year 2006 primarily due to an increase
in the number of non-employee directors combined with an increase in the number
of Company Board meetings. These increases were supplemented with increases
in
other general corporate matters primarily associated with an incremental
increase in corporate legal fees and facility expenses combined with fees
associated with the adoption of the Company’s Stockholder Rights Agreement in
March 2006.
35
Year
Ended April 30, 2005 Compared to the Year Ended April 30, 2004:
The
increase in selling, general and administrative expenses of $873,000 during
the
year ended April 30, 2005 compared to fiscal year 2004 is primarily due to
an
increase in (i) payroll and related expenses of $173,000 from $2,184,000 in
fiscal year 2004 to $2,357,000 in fiscal year 2005 primarily due to an increase
in headcount across most corporate functions to support the increased operations
primarily pertaining to Avid and the expansion of the our pre-clinical and
clinical development plans, which were offset by a decrease in consulting fees
associated with the prior year business development efforts of Avid, (ii) audit
and accounting fees of $253,000 from $164,000 in fiscal year 2004 to $417,000
in
fiscal year 2005 primarily related to the implementation of Section 404 of
the
Sarbanes-Oxley Act of 2002, (iii) legal fees of $345,000 from $196,000 in fiscal
year 2004 to $541,000 in fiscal year 2005 primarily pertaining to litigation
and
disputes that were settled in fiscal year 2006 and other patent and corporate
matters, (iv) public relation fees of $141,000 from $107,000 in fiscal year
2004
to $248,000 in fiscal year 2005 primarily due to the addition of a new public
relations firm assisting the Company with its public relations activities,
and
(v) facility and related expenses of $114,000 from $204,000 in fiscal year
2004
to $318,000 in fiscal year 2005 primarily related to an increased allocation
of
lease expense resulting from the termination of a sub-lease arrangement combined
with an increase in other facility related expenses associated with the increase
in employee headcount in the general and administrative departments. These
increases were offset by an $188,000 decrease in director fees from $464,000
in
fiscal year 2004 to $276,000 in fiscal year 2005 primarily due to a one-time
aggregate director fee of $180,000 incurred in the prior year associated with
our director’s increased oversight responsibilities mandated by the
Sarbanes-Oxley Act of 2002. Prior to fiscal year 2004, directors did not receive
any cash compensation other than the reimbursement of expenses.
Recovery
of Note Receivable
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005
The
increase in recovery of note receivable of $1,229,000 during the year ended
April 30, 2006 compared to the prior year is due the recovery of a previously
fully reserved note receivable in the amount of $1,229,000 during the current
year as further discussed in Note 3, "Note Receivable" to the consolidated
financial statements.
Interest
and Other Income
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005
The
increase in interest and other income of $581,000 during the year ended April
30, 2006 compared to the prior year is due to a $212,000 increase in interest
income as a result of a higher average cash balance on hand and higher
prevailing interest rates during the current year compared to the prior year
combined with a $369,000 increase in other income, which is primarily due to
$363,000 of other income recorded during the quarter ended April 30, 2006 in
accordance with a March 2006 global legal settlement.
36
Interest
and Other Expense
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005:
The
increase in interest and other expense of $40,000 during the year ended April
30, 2006 compared to the prior year is primarily due to an increase in long-term
debt as we financed additional laboratory equipment during the current fiscal
year.
Year
Ended April 30, 2005 Compared to the Year Ended April 30, 2004:
The
decrease in interest and other expense of $1,827,000 during the year ended
April
30, 2005 compared to fiscal year 2004 is primarily due to a decrease in non-cash
interest expense of $1,811,000 associated with the amortization of the
convertible debt discount and debt issuance costs in fiscal year 2004. We did
not incur any interest expense associated with convertible debt discount and
debt issuance costs during fiscal year 2005 as all outstanding convertible
debt
was converted into common stock and associated discount and issuance costs
were
fully amortized in fiscal year 2004.
Critical
Accounting Policies
The
methods, estimates and judgments we use in applying our most critical accounting
policies have a significant impact on the results we report in our consolidated
financial statements. We evaluate our estimates and judgments on an ongoing
basis. We base our estimates on historical experience and on assumptions that
we
believe to be reasonable under the circumstances. Our experience and assumptions
form the basis for our judgments about the carrying value of assets and
liabilities that are not readily apparent from other sources. Actual results
may
vary from what we anticipate and different assumptions or estimates about the
future could change our reported results. We believe the following accounting
policies are the most critical to us, in that they are important to the
portrayal of our financial statements and they require our most difficult,
subjective or complex judgments in the preparation of our consolidated financial
statements:
We
recognize revenues pursuant to the SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition.
In
accordance with SAB No. 104, revenue is generally realized or realizable and
earned when (i) persuasive evidence of an arrangement exists, (ii) delivery
has
occurred or services have been rendered, (iii) the seller's price to the buyer
is fixed or determinable, and (iv) collectibility is reasonably assured.
In
addition, we comply with Financial Accounting Standards Board’s Emerging Issues
Task Force No. 00-21 (“EITF 00-21”), Revenue
Arrangements with Multiple Deliverables.
In
accordance with EITF 00-21, we recognize revenue for delivered elements only
when the delivered element has stand-alone value and we have objective and
reliable evidence of fair value for each undelivered element. If the fair value
of any undelivered element included in a multiple element arrangement cannot
be
objectively determined, revenue is deferred until all elements are delivered
and
services have been performed, or until fair value can objectively be determined
for any remaining undelivered elements.
Revenues
associated with licensing agreements primarily consist of nonrefundable up-front
license fees and milestones payments. Revenues under licensing agreements are
recognized based on the performance requirements of the agreement. Nonrefundable
up-front license fees received under license agreements, whereby continued
performance or future obligations are considered inconsequential to the relevant
licensed technology, are generally recognized as revenue upon delivery of the
technology. Nonrefundable up-front license fees, whereby we have an ongoing
involvement or performance obligations, are generally recorded as deferred
revenue and generally recognized as revenue over the term of the performance
obligation or relevant agreement. Milestone payments are generally recognized
as
revenue upon completion of the milestone assuming there are no other continuing
obligations. Under some license agreements, the obligation period may not be
contractually defined. Under these circumstances, we must exercise judgment
in
estimating the period of time over which certain deliverables will be provided
to enable the licensee to practice the license.
37
Contract
manufacturing revenues are generally recognized once the service has been
provided and/or upon shipment of the product to the customer. We also record
a
provision for estimated contract losses, if any, in the period in which they
are
determined.
In
July
2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF
99-19”), Reporting
Revenue Gross as a Principal versus Net as an Agent.
EITF
99-19 summarized the EITF’s views on when revenue should be recorded at the
gross amount billed to a customer because it has earned revenue from the sale
of
goods or services, or the net amount retained (the amount billed to the customer
less the amount paid to a supplier) because it has earned a fee or commission.
In addition, the EITF released Issue 00-10 (“EITF 00-10”), Accounting
for Shipping and Handling Fees and Costs,
and
Issue 01-14 (“EITF 01-14”), Income
Statement Characterization of Reimbursements Received for “Out-of-Pocket”
Expenses Incurred.
EITF
00-10 summarized the EITF’s views on how the seller of goods should classify in
the income statement amounts billed to a customer for shipping and handling
and
the costs associated with shipping and handling. EITF 01-14 summarized the
EITF’s views on when the reimbursement of out-of-pocket expenses should be
characterized as revenue or as a reduction of expenses incurred. Our revenue
recognition policies are in compliance with EITF 99-19, EITF 00-10 and EITF
01-14 whereby we record revenue for the gross amount billed to customers (the
cost of raw materials, supplies, and shipping, plus the related handling mark-up
fee) and we record the cost of the amounts billed as cost of sales as we act
as
a principal in these transactions.
Allowance
for Doubtful Accounts.
We
continually monitor our allowance for doubtful accounts for all receivables.
A
considerable amount of judgment is required in assessing the ultimate
realization of these receivables and we estimate an allowance for doubtful
accounts based on factors that appear reasonable under the
circumstances.
Liquidity
and Capital Resources
As
of
April 30, 2006, we had $17,182,000 in cash and cash equivalents compared to
$9,816,000 at April 30, 2005. During June 2006, we received an additional
$13,000,000 in net proceeds from the sale of shares of our common stock and
we
have $26,318,000 in cash and cash equivalents at June 30, 2006. Although we
have
sufficient cash on hand to meet our current planned obligations through at
least
fiscal year 2007, our development efforts are highly dependent on our ability
to
raise additional capital to support our future operations.
We
have
expended substantial funds on the development of our product candidates and
we
have incurred negative cash flows from operations for the majority of our years
since inception. Since inception, we have generally financed our operations
primarily through the sale of our common stock and issuance of convertible
debt,
which has been supplemented with payments received from various licensing
collaborations and through the revenues generated by Avid. We expect negative
cash flows from operations to continue until we are able to generate sufficient
revenue from the contract manufacturing services provided by Avid and/or from
the sale and/or licensing of our products under development.
Revenues
earned by Avid during fiscal years ended April 30, 2006, 2005 and 2004 amounted
to $3,005,000, $4,684,000 and $3,039,000, respectively. We expect that Avid
will
continue to generate revenues which should partially offset our consolidated
cash flows used in operations, although we expect those near term revenues
will
be insufficient to cover anticipated cash flows used in operations. In addition,
revenues from the sale and/or licensing of our products under development are
always uncertain. Therefore, our ability to continue our clinical trials and
development efforts is highly dependent on the amount of cash and cash
equivalents on hand combined with our ability to raise additional capital to
support our future operations beyond fiscal year 2007.
38
We
plan
to raise additional capital primarily through the registered offer and sale
of
shares of our common stock from our shelf registration statements on Form S-3
which, as of June 30, 2006, we had an aggregate of approximately 5,893,000
shares available for possible future registered transactions; provided, however,
in connection with our recent financing on June 16, 2006, we agreed not to
(i)
file another shelf registration statement pursuant to Rule 415 of the Securities
Act of 1933, as amended, for a period of one hundred eighty days following
June
16, 2006, nor (ii) without the prior written consent of the purchaser in such
financing, prior to January 2, 2007, enter into any subsequent or further offer
or sale of securities at a price or possible price below $2.50 per share.
Notwithstanding the availability of our Form S-3, given uncertain market
conditions and the volatility of our stock price and trading volume, we may
not
be able to sell our securities at prices or on terms that are favorable to
us,
if at all.
In
addition to equity financing, we actively explore various other sources of
funding, including possible debt financing and leveraging our many assets,
including our intellectual property portfolio. Our broad intellectual property
portfolio allows us to develop products internally while at the same time we
are
able to out-license certain areas of the technology, which would not interfere
with our internal product development efforts.
There
can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all, or that sufficient additional revenues will
be generated from Avid or under potential licensing agreements to complete
the
research, development, and clinical testing of our product candidates beyond
fiscal year 2007.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the year ended April 30, 2006 compared to the prior year are
as
follows:
Cash
Used In Operating Activities.
Cash
used in operating activities is primarily driven by changes in our net loss.
However, cash used in operating activities generally differs from our reported
net loss as a result of non-cash operating expenses or differences in the timing
of cash flows as reflected in the changes in operating assets and liabilities.
During the year ended April 30, 2006, cash used in operating activities
increased $3,789,000 to $16,957,000 compared to $13,168,000 for the year ended
April 30, 2005. The increase in cash used in operating activities was primarily
related to the timing of cash flows as reflected in the changes in operating
assets and payment or reduction of liabilities in the aggregate amount of
$1,910,000. The amount of the increase was further supplemented by an increase
of $1,879,000 in net cash used in operating activities after deducting non-cash
operating expenses and adjustments to net loss and before considering the
changes in operating assets and liabilities. This increase was primarily due
to
a decrease in contract manufacturing revenue combined with an increase in
research and development expenses and selling, general and administrative
expenses.
39
The
changes in operating activities as a result of non-cash operating expenses
or
differences in the timing of cash flows as reflected in the changes in operating
assets and liabilities are as follows:
Year
Ended April 30,
|
|||||||
2006
|
2005
|
||||||
Net
loss, as reported
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
Less
non-cash operating expenses:
Depreciation
Stock-based
compensation expense
Stock
issued for research services
Stock
bonus plan compensation expense
Gain
on sale of property
Recovery
of note receivable
|
415,000
499,000
1,048,000
44,000
(6,000
(1,229,000
|
)
)
|
325,000
231,000
485,000
-
-
-
|
||||
Net
cash used in operating activities before changes in
operating
assets and liabilities
|
$
|
(16,290,000
|
)
|
$
|
(14,411,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(667,000
|
)
|
$
|
1,243,000
|
||
Net
cash used in operating activities
|
$
|
(16,957,000
|
)
|
$
|
(13,168,000
|
)
|
Cash
Provided By (Used In) Investing Activities.
During
the year ended April 30, 2006, net cash provided by investing activities
amounted to $440,000 primarily due to the recovery of a previously fully
reserved note receivable in the amount of $1,229,000 offset by the purchase
of
property in the amount of $618,000 to support the expanded research efforts
of
Peregrine and the expanded services of Avid combined with an increase in other
assets of $171,000 related to security deposits paid to GE Capital Corporation
on notes payable. The net cash used in investing activities for the year ended
April 30, 2005 was primarily due to the purchase of laboratory equipment in
the
amount $1,090,000 to support our research efforts and the expanded services
of
Avid, combined with an increase in other assets of $101,000 primarily related
to
security deposits paid to GE Capital Corporation on notes payable.
Cash
Provided By Financing Activities.
Net cash
provided by financing activities increased $14,592,000 to $23,883,000 for the
year ended April 30, 2006 compared to net cash provided of $9,291,000 for the
same prior year period. Cash provided by financing activities during fiscal
year
2006 was primarily due to proceeds received under five separate security
purchase agreements whereby we sold and issued a total of 24,707,217 shares
of
our common stock in exchange for aggregate net proceeds of $22,894,000, which
was supplemented with net proceeds of $733,000 from this exercise of stock
options and warrants and $566,000 received from the financing of laboratory
equipment with GE Capital Corporation. Cash provided by financing activities
during fiscal year 2005 was primarily due to proceeds received from the sale
of
stock under two separate security purchase agreements in the aggregate amount
of
$6,486,000 supplemented with net proceeds of $2,137,000 from this exercise
of
stock options and warrants and $733,000 received from the financing of
laboratory equipment with GE Capital Corporation.
Contractual
Obligations
Contractual
obligations represent future cash commitments and liabilities under agreements
with third parties, and exclude contingent liabilities for which we cannot
reasonably predict future payments. The following chart represents our
contractual obligations as of April 30, 2006, aggregated by type:
40
Payments
Due by Period (in thousands)
|
||||||||||||||||
Total
|
<
1 year
|
1-3
years
|
4-5
years
|
After
5 years
|
||||||||||||
Operating
leases, net (1)
|
$
|
9,749
|
$
|
804
|
$
|
2,404
|
$
|
1,627
|
$
|
4,914
|
||||||
Notes
payable (2)
|
996
|
475
|
521
|
-
|
-
|
|||||||||||
Capital
lease obligation (3)
|
70
|
19
|
51
|
-
|
-
|
|||||||||||
Other
long-term liabilities - minimum license obligations (4)
|
100
|
100
|
-
|
-
|
-
|
|||||||||||
Total
contractual obligations
|
$
|
10,915
|
$
|
1,398
|
$
|
2,976
|
$
|
1,627
|
$
|
4,914
|
______________
(1)
|
Represents
our (i) facility operating lease in Tustin, California under a
non-cancelable lease agreement, (ii) facility operating lease in
Houston,
Texas, which has an original three year lease term, and (iii) various
office equipment leases, which generally have a five year lease term.
|
(2)
|
Represents
our note payable agreements entered into with General Electric Capital
Corporation during fiscal years 2006 and 2005 to finance laboratory
equipment.
|
(3)
|
Represents
our capital lease agreement to finance certain office
equipment.
|
(4)
|
We
periodically enter into licensing agreements with third parties to
obtain
exclusive or non-exclusive licenses for certain technologies. The
terms of
certain of these agreements require us to pay future milestone payments
based on product development success. We anticipate we may make milestone
payments in the amount of $100,000 during fiscal year 2007 under
in-licensing agreements pertaining to our bavituximab clinical trials.
Other milestones fees under these and other licensing agreements
cannot be
predicted due to the uncertainty of future clinical trial results
and
development milestones and therefore, cannot be reasonably predicted
or
estimated at the present time.
|
Recently
Issued Accounting Pronouncements
In
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
123R (“SFAS No. 123R”), Share-Based
Payment (Revised 2004),
which
requires companies to recognize in the financial statements the fair value
of
all employee share-based payments, including grants of employee stock options
as
well as compensatory employee stock purchase plans, for interim periods
beginning after June 15, 2005. In April 2005, the Securities and Exchange
Commission adopted a rule amendment that delayed the compliance dates of SFAS
No. 123R such that we are now allowed to adopt the new standard no later than
May 1, 2006. SFAS No. 123R eliminates the ability to account for share-based
compensation using APB No. 25, and the pro forma disclosures previously
permitted under SFAS No. 123 no longer will be an alternative to financial
statement recognition.
We
adopted SFAS No. 123R on May 1, 2006, using the “modified-prospective
method,” in which compensation cost is recognized beginning with the effective
date (a) based on the requirements of SFAS No. 123R for all
share-based payments granted after the effective date and (b) based on the
requirements of SFAS No. 123 for all awards granted to employees prior to
the effective date of SFAS No. 123R that remain unvested on the
effective date. We apply the Black-Scholes valuation model in determining the
fair value of share-based payments to employees, which will then be amortized
on
a straight-line basis. Although we have not yet determined the final impact
of
SFAS No. 123R, we believe the non-cash compensation expense for fiscal year
2007
related to the adoption of SFAS No. 123R may be up to approximately $1,000,000
based on actual shares granted and unvested as of April 30, 2006. However,
the
actual expense recorded during fiscal year 2007 as a result of the adoption
of
SFAS No. 123R may differ materially from our estimate as a result of
changes in a number of factors that affect the amount of non-cash compensation
expense, including the number of options granted by our Board of Directors
during fiscal year 2007, the price of our common stock on the date of grant,
the
volatility of our stock price, the estimate of the expected life of options
granted and the risk free interest rates as measured at the grant date.
41
ITEM
7A. QUANTITATIVE
AND
QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Changes
in United States interest rates would affect the interest earned on our cash
and
cash equivalents. Based on our overall interest rate exposure at April 30,
2006,
a near-term change in interest rates, based on historical movements, would
not
materially affect the fair value of interest rate sensitive instruments.
ITEM
8. FINANCIAL
STATEMENTS
AND SUPPLEMENTARY
DATA
Reference
is made to the financial statements included in this Report at pages F-1 through
F-33.
ITEM
9. CHANGES
IN
AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURES
Not
applicable.
ITEM
9A. CONTROLS
AND
PROCEDURES
(a)
Evaluation of Disclosure Controls and Procedures.
The term
“disclosure controls and procedures” (defined in Rule 13a-15(e) under the
Securities and Exchange Act of 1934 (the “Exchange Act”) refers to the controls
and other procedures of a company that are designed to ensure that information
required to be disclosed by a company in the reports that it files under the
Exchange Act is recorded, processed, summarized and reported within the required
time periods. Under the supervision and with the participation of our
management, including our chief executive officer and chief financial officer,
we have conducted an evaluation of the effectiveness of the design and operation
of our disclosure controls and procedures, as of April 30, 2006. Based on this
evaluation, our president and chief executive office and our chief financial
officer concluded that our disclosure controls and procedures were effective
as
of April 30, 2006 to ensure the timely disclosure of required information in
our
Securities and Exchange Commission filings.
Because
of inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. In addition, the design of any system of
control is based upon certain assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed in achieving its
stated goals under all future events, no matter how remote. Accordingly, even
effective internal control over financial reporting can only provide reasonable
assurance of achieving their control objectives.
(b)
Management’s Report on Internal Control Over Financial
Reporting.
Management’s Report on Internal Control Over Financial Reporting, which appears
on the following page, is incorporated herein by this reference. Our
management’s assessment of the effectiveness of our internal control over
financial reporting as of April 30, 2006 has been audited by Ernst & Young
LLP, an independent registered public accounting firm, as stated in its report
which appears on page 44 of this Annual Report, and which is incorporated herein
by this reference.
(c)
Changes in Internal Control over Financial Reporting. There
have been no changes in our internal control over financial reporting during
the
fourth quarter of the fiscal year ended April 30, 2006 that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
ITEM
9B. OTHER
INFORMATION
None.
42
PEREGRINE
PHARMACEUTICALS, INC.
MANAGEMENT’S
REPORT ON
INTERNAL
CONTROL OVER FINANCIAL REPORTING
The
management of the Company is responsible for establishing and maintaining
effective internal control over financial reporting and for the assessment
of
the effectiveness of internal control over financial reporting. The Company’s
internal control over financial reporting is a process designed, as defined
in
Rule 13a-15(f) under the Securities and Exchange Act of 1934, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of consolidated financial statements for external purposes in
accordance with generally accepted accounting principles.
The
Company’s internal control over financial reporting is supported by written
policies and procedures that:
·
|
pertain
to the maintenance of records that, in reasonable detail, accurately
and
fairly reflect the transactions and dispositions of the Company’s
assets;
|
·
|
provide
reasonable assurance that transactions are recorded as necessary
to permit
preparation of consolidated financial statements in accordance with
generally accepted accounting principles, and that receipts and
expenditures of the Company are being made only in accordance with
authorizations of the Company’s management and directors;
and
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company’s assets that
could have a material effect on the consolidated financial
statements.
|
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
In
connection with the preparation of the Company’s annual consolidated financial
statements, management of the Company has undertaken an assessment of the
effectiveness of the Company’s internal control over financial reporting based
on criteria established in Internal Control - Integrated Framework issued by
the
Committee of Sponsoring Organizations of the Treadway Commission (“the COSO
Framework”). Management’s assessment included an evaluation of the design of the
Company’s internal control over financial reporting and testing of the
operational effectiveness of the Company’s internal control over financial
reporting.
Based
on
this assessment, management has concluded that the Company’s internal control
over financial reporting was effective as of April 30, 2006.
Ernst
& Young LLP, the independent registered public accounting firm that audited
the company’s consolidated financial statements included in this Annual Report
on Form 10-K, has issued an attestation report on management’s assessment of
internal control over financial reporting which appears on the following page.
|
|
|
|
|
|
|
|
|
By:
|
|
/s/
Steven
W. King
|
|
By:
|
|
/s/
Paul
J. Lytle
|
|
|
|
Steven
W. King,
|
|
|
|
Paul
J. Lytle
|
|
|
|
|
President
and Chief Executive Officer
|
|
|
|
Chief
Financial Officer
|
|
|
July
7,
2006
43
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The
Board
of Directors and Stockholders of Peregrine Pharmaceuticals, Inc.
We
have
audited management's assessment, included in the accompanying Management's
Annual Report on Internal Control Over Financial Reporting included in Item
9A,
that Peregrine Pharmaceuticals, Inc. (the “Company”) maintained effective
internal control over financial reporting as of April 30, 2006, based on
criteria established in Internal Control--Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (the COSO
criteria). Peregrine Pharmaceuticals, Inc.'s management is responsible for
maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting.
Our responsibility is to express an opinion on management's assessment and
an
opinion on the effectiveness of the Company’s internal control over financial
reporting based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control
over
financial reporting, evaluating management's assessment, testing and evaluating
the design and operating effectiveness of internal control, and performing
such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A
company's internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company's internal control
over
financial reporting includes those policies and procedures that (1) pertain
to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors
of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company's
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In
our
opinion, management's assessment that Peregrine Pharmaceuticals, Inc. maintained
effective internal control over financial reporting as of April 30, 2006 is
fairly stated, in all material respects, based on the COSO criteria. Also,
in
our opinion, Peregrine Pharmaceuticals, Inc. maintained, in all material
respects, effective internal control over financial reporting as of April 30,
2006, based on the COSO criteria.
We
also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of Peregrine
Pharmaceuticals, Inc. as of April 30, 2006 and 2005, and the related
consolidated statements of operations, stockholders' equity and cash flows
for
each of the three years in the period ended April 30, 2006 and our report dated
July 12, 2006 expressed an unqualified opinion thereon.
/s/
Ernst & Young LLP
Orange
County, California
July
12,
2006
44
PART
III
ITEM
10. DIRECTORS
AND
EXECUTIVE OFFICERS OF THE REGISTRANT
The
information required by this item, including, without limitation, disclosure
regarding our Code of Ethics, is incorporated by reference to the information
set forth under the caption “Directors and Executive Officers” in our 2006 Proxy
Statement to be filed within 120 days after the end of our fiscal year
ended April 30, 2006.
ITEM
11. EXECUTIVE
COMPENSATION
The
information required by this item is incorporated by reference to the
information set forth under the caption “Executive Compensation” in our 2006
Proxy Statement to be filed within 120 days after the end of our fiscal
year ended April 30, 2006.
ITEM
12. SECURITY
OWNERSHIP
OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS
The
information required by this item is incorporated by reference to the
information set forth under the caption “Common Stock Ownership of Certain
Beneficial Owners and Management” in our 2006 Proxy Statement to be filed within
120 days after the end of our fiscal year ended April 30,
2006.
ITEM
13. CERTAIN
RELATIONSHIPS
AND RELATED
TRANSACTIONS
The
information required by this item is incorporated by reference to the
information set forth under the caption “Certain Relationships and Related
Transactions” in our 2006 Proxy Statement to be filed within 120 days after
the end of our fiscal year ended April 30, 2006.
The
information required by this item is incorporated by reference to the
information set forth under the caption “Independent Registered Public
Accounting Firm Fees” in our 2006 Proxy Statement to be filed within
120 days after the end of our fiscal year ended April 30,
2006.
45
PART
IV
ITEM 15. |
EXHIBITS
AND
CONSOLIDATED FINANCIAL STATEMENT
SCHEDULES
|
(a) | (1) |
Consolidated
Financial Statements
|
Index
to
consolidated financial statements:
Page
|
||
F-1
|
||
F-2
|
||
F-4
|
||
F-5
|
||
F-6
|
||
F-8
|
(2) |
Financial
Statement Schedules
|
The
following schedule is filed as part of this Form 10-K:
All
other
schedules for which provision is made in the applicable accounting regulations
of the Securities and Exchange Commission are not required under the related
instructions or are inapplicable and therefore have been omitted.
46
(3)
|
Exhibits
|
Exhibit
Number
|
Description
|
|
3.1
|
Certificate
of Incorporation of Techniclone Corporation, a Delaware corporation
(Incorporated by reference to Exhibit B to the Company’s 1996 Proxy
Statement as filed with the Commission on or about August 20,
1996).
|
|
3.2
|
Amended
and Restated Bylaws of Peregrine Pharmaceuticals, Inc. (formerly
Techniclone Corporation), a Delaware corporation (Incorporated
by reference to Exhibit 3.1 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended October 31, 2003).
|
|
3.3
|
Certificate
of Designation of 5% Adjustable Convertible Class C Preferred Stock
as
filed with the Delaware Secretary of State on April 23, 1997.
(Incorporated by reference to Exhibit 3.1 contained in Registrant’s
Current Report on Form 8-K as filed with the Commission on or about
May
12, 1997).
|
|
3.4
|
Certificate
of Amendment to Certificate of Incorporation of Techniclone Corporation
to
effect the name change to Peregrine Pharmaceuticals, Inc., a Delaware
corporation. (Incorporated by reference to Exhibit 3.4 contained
in
Registrant’s Annual Report on Form 10-K for the year ended April 30,
2001).
|
|
3.5
|
Certificate
of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals,
Inc. to increase the number of authorized shares of the Company’s common
stock to two hundred million shares (Incorporated
by reference to Exhibit 3.5 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended October 31, 2003).
|
|
3.6
|
Certificate
of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals,
Inc. to increase the number of authorized shares of the Company’s common
stock to two hundred fifty million shares (Incorporated by reference
to
Exhibit 3.6 to Registrant’s Quarterly Report on Form 10-Q for the quarter
ended October 31, 2005).
|
|
3.7
|
Certificate
of Designation of Rights, Preferences and Privileges of Series D
Participating Preferred Stock of the Registrant, as filed with the
Secretary of State of the State of Delaware on March 16, 2006.
(Incorporated by reference to Exhibit 3.7 to Registrant’s Current Report
on Form 8-K as filed with the Commission on March 17,
2006).
|
|
4.1
|
Form
of Certificate for Common Stock (Incorporated by reference to the
exhibit
of the same number contained in Registrant’s Annual Report on Form 10-K
for the year end April 30, 1988).
|
4.13
|
Form
of Stock Purchase Warrant to be issued to the Equity Line Subscribers
pursuant to the Regulation D Common Stock Equity Subscription Agreement
(Incorporated by reference to Exhibit 4.7 contained in Registrant’s
Current Report on Form 8-K as filed with the Commission on or about
June
29, 1998).
|
47
Exhibit
Number
|
Description
|
|
4.16
|
Form
of Non-qualified Stock Option Agreement by and between Registrant,
Director and certain consultants dated December 22, 1999 (Incorporated
by
reference to the exhibit contained in Registrant’s Registration Statement
on Form S-3 (File No. 333-40716)).*
|
|
4.17
|
Peregrine
Pharmaceuticals, Inc. 2002 Non-Qualified Stock Option Plan (Incorporated
by reference to the exhibit contained in Registrant’s Registration
Statement in Form S-8 (File No. 333-106385)).*
|
|
4.18
|
Form
of 2002 Non-Qualified Stock Option Agreement (Incorporated by reference
to
the exhibit contained in Registrant’s Registration Statement in Form S-8
(File No. 333-106385)).*
|
|
4.19
|
Preferred
Stock Rights Agreement, dated as of March 16, 2006, between the Company
and Integrity Stock Transfer, Inc., including the Certificate of
Designation, the form of Rights Certificate and the Summary of Rights
attached thereto as Exhibits A, B and C, respectively (Incorporated
by
reference to Exhibit 4.19 to Registrant’s Current Report on Form 8-K as
filed with the Commission on March 17,
2006).
|
10.40
|
1996
Stock Incentive Plan (Incorporated by reference to the exhibit contained
in Registrant's Registration Statement in form S-8 (File No.
333-17513)).*
|
|
10.41
|
Stock
Exchange Agreement dated as of January 15, 1997 among the stockholders
of
Peregrine Pharmaceuticals, Inc. and Registrant (Incorporated by reference
to Exhibit 2.1 to Registrant's Quarterly Report on Form 10-Q for
the
quarter ended January 31, 1997).
|
|
10.42
|
First
Amendment to Stock Exchange Agreement among the Stockholders of Peregrine
Pharmaceuticals, Inc. and Registrant (Incorporated by reference to
Exhibit
2.1 contained in Registrant’s Current Report on Form 8-K as filed with the
Commission on or about May 12, 1997).
|
|
10.43
|
Termination
and Transfer Agreement dated as of November 14, 1997 by and between
Registrant and Alpha Therapeutic Corporation (Incorporated by reference
to
Exhibit 10.1 contained in Registrant’s Current Report on Form 8-K as filed
with the commission on or about November 24, 1997).
|
|
10.47
|
Real
Estate Purchase Agreement by and between Techniclone Corporation
and 14282
Franklin Avenue Associates, LLC dated December 24, 1998 (Incorporated
by
reference to Exhibit 10.47 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended January 31, 1999).
|
|
10.48
|
Lease
and Agreement of Lease between TNCA, LLC, as Landlord, and Techniclone
Corporation, as Tenant, dated as of December 24, 1998 (Incorporated
by
reference to Exhibit 10.48 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended January 31, 1999).
|
|
10.49
|
Promissory
Note dated as of December 24, 1998 between Techniclone Corporation
(Payee)
and TNCA Holding, LLC (Maker) for $1,925,000 (Incorporated by reference
to
Exhibit 10.49 to Registrant's Quarterly Report on Form 10-Q for the
quarter ended January 31, 1999).
|
48
Exhibit
Number
|
Description
|
|
10.50
|
Pledge
and Security Agreement dated as of December 24, 1998 for $1,925,000
Promissory Note between Grantors and Techniclone Corporation (Secured
Party) (Incorporated by reference to Exhibit 10.50 to Registrant's
Quarterly Report on Form 10-Q for the quarter ended January 31,
1999).
|
|
10.56
|
License
Agreement dated as of March 8, 1999 by and between Registrant and
Schering
A.G. (Incorporated
by reference to Exhibit 10.56 to Registrant's Annual Report on Form
10-K
for the year ended April 30, 1999).**
|
|
10.57
|
Patent
License Agreement dated October 8, 1998 between Registrant and the
Board
of Regents of the University of Texas System for patents related
to
Targeting the Vasculature of Solid Tumors (Vascular Targeting Agent
patents) (Incorporated
by reference to Exhibit 10.57 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 1999).
|
|
10.58
|
Patent
License Agreement dated October 8, 1998 between Registrant and the
Board
of Regents of the University of Texas System for patents related
to the
Coagulation of the Tumor Vasculature (Vascular Targeting Agent patents)
(Incorporated
by reference to Exhibit 10.58 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 1999).
|
|
10.59
|
License
Agreement between Northwestern University and Registrant dated August
4,
1999 covering the LYM-1 and LYM-2 antibodies (Oncolym) (Incorporated
by reference to Exhibit 10.59 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 1999).
|
|
10.67
|
Warrant
to purchase 750,000 shares of Common Stock of Registrant issued to
Swartz
Private Equity, LLC dated November 19, 1999 (Incorporated
by reference to Exhibit 10.67 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended January 31, 2000).
|
10.73
|
Common
Stock Purchase Agreement to purchase up to 6,000,000 shares of
Common
Stock of Registrant issued to ZLP Master Fund, LTD, ZLP Master
Technology
Fund, LTD, Eric Swartz, Michael C. Kendrick, Vertical Ventures
LLC and
Triton West Group, Inc. dated November 16, 2001 (Incorporated by
reference
to Exhibit 10.73 to Registrant’s Current Report on Form 8-K dated November
19, 2001, as filed with the Commission on November 19,
2001).
|
|
10.74
|
Form
of Warrant to be issued to Investors pursuant to the Common Stock
Purchase
Agreement dated November 16, 2001 (Incorporated by reference to
Exhibit
10.74 to Registrant’s Current Report on Form 8-K dated November 19, 2001,
as filed with the Commission on November 19, 2001).
|
|
10.75
|
Common
Stock Purchase Agreement to purchase 1,100,000 shares of Common
Stock of
Registrant issued to ZLP Master Fund, LTD and Vertical Capital
Holdings,
Ltd. dated January 28, 2002 (Incorporated by reference to Exhibit
10.75 to
Registrant’s Current Report on Form 8-K dated January 31, 2002, as filed
with the Commission on February 5, 2002).
|
|
10.76
|
Form
of Warrant to be issued to Investors pursuant to the Common Stock
Purchase
Agreement dated January 28, 2002 (Incorporated by reference to
Exhibit
10.76 to Registrant’s Current Report on Form 8-K dated January 31, 2002,
as filed with the Commission on February 5, 2002).
|
|
10.77
|
Securities
Purchase Agreement dated as of August 9, 2002 between Registrant
and
Purchasers (Incorporated by reference to Exhibit 10.77 to Registrant’s
Registration Statement on Form S-3 (File No. 333-99157), as filed
with the
Commission on September 4, 2002).
|
49
Exhibit
Number
|
Description
|
|
10.78
|
Form
of Convertible Debentures issued to Purchasers pursuant to Securities
Purchase Agreement dated August 9, 2002 (Incorporated by reference
to
Exhibit 10.78 to Registrant’s Registration Statement on Form S-3 (File No.
333-99157), as filed with the Commission on September 4,
2002).
|
|
10.79
|
Registration
Rights Agreement dated August 9, 2002 between Registrant and Purchasers
of
Securities Purchase Agreements dated August 9, 2002 (Incorporated
by
reference to Exhibit 10.79 to Registrant’s Registration Statement on Form
S-3 (File No. 333-99157), as filed with the Commission on September
4,
2002).
|
|
10.80
|
Form
of Warrant to be issued to Purchasers pursuant to Securities Purchase
Agreement dated August 9, 2002 (Incorporated by reference to Exhibit
10.80
to Registrant’s Registration Statement on Form S-3 (File No. 333-99157),
as filed with the Commission on September 4,
2002).
|
10.81
|
Form
of Warrant issued to Debenture holders pursuant to Securities Purchase
Agreement dated August 9, 2002 (Incorporated by reference to Exhibit
10.81
to Registrant’s Registration Statement on Form S-3 (File No. 333-99157),
as filed with the Commission on September 4, 2002).
|
|
10.82
|
Form
of Adjustment Warrant issued to Investors pursuant to Securities
Purchase
Agreement dated August 9, 2002 (Incorporated by reference to Exhibit
10.82
to Registrant’s Registration Statement on Form S-3 (File No. 333-99157),
as filed with the Commission on September 4, 2002).
|
|
10.83
|
Securities
Purchase Agreement dated as of August 9, 2002 between Registrant
and ZLP
Master Fund, Ltd. (Incorporated by reference to Exhibit 10.83 to
Registrant’s Registration Statement on Form S-3 (File No. 333-99157), as
filed with the Commission on September 4, 2002).
|
|
10.84
|
Registration
Rights Agreement dated August 9, 2002 between Registrant and ZLP
Master
Fund, Ltd. (Incorporated by reference to Exhibit 10.84 to Registrant’s
Registration Statement on Form S-3 (File No. 333-99157), as filed
with the
Commission on September 4, 2002).
|
|
10.85
|
Form
of Warrant to be issued to ZLP Master Fund, Ltd. pursuant to Securities
Purchase Agreement dated August 9, 2002 (Incorporated by reference
to
Exhibit 10.85 to Registrant’s Registration Statement on Form S-3 (File No.
333-99157), as filed with the Commission on September 4,
2002).
|
|
10.86
|
Form
of Adjustment Warrant issued to ZLP Master Fund, Ltd. pursuant
to
Securities Purchase Agreement dated August 9, 2002 (Incorporated
by
reference to Exhibit 10.86 to Registrant’s Registration Statement on Form
S-3 (File No. 333-99157), as filed with the Commission on September
4,
2002).
|
|
10.87
|
Common
Stock Purchase Agreement dated June 6, 2003 between Registrant
and eight
institutional investors (Incorporated
by reference to Exhibit 10.87 to Registrant's Quarterly Report
on Form
10-Q for the quarter ended July 31, 2003).
|
10.88
|
Common
Stock Purchase Agreement dated June 6, 2003 between Registrant
and one
institutional investor (Incorporated
by reference to Exhibit 10.88 to Registrant's Quarterly Report
on Form
10-Q for the quarter ended July 31, 2003).
|
50
Exhibit
Number
|
Description
|
|
10.89
|
Common
Stock Purchase Agreement dated June 26, 2003 between Registrant and
seven
institutional investors (Incorporated
by reference to Exhibit 10.89 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 2003).
|
|
10.90
|
Common
Stock Purchase Agreement dated July 24, 2003 between Registrant and
one
institutional investor (Incorporated
by reference to Exhibit 10.90 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 2003).
|
|
10.91
|
Common
Stock Purchase Agreement dated September 18, 2003 between Registrant
and
one institutional investor (Incorporated
by reference to Exhibit 10.91 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended October 31, 2003).
|
10.92
|
Common
Stock Purchase Agreement dated January 22, 2004 between Registrant
and one
institutional investor (Incorporated
by reference to Exhibit 10.92 to Registrant's Quarterly Report
on Form
10-Q for the quarter ended January 31, 2004).
|
|
10.93
|
Common
Stock Purchase Agreement dated March 31, 2004 between Registrant
and one
institutional investor (Incorporated by reference to Exhibit 10.93
to
Registrant’s Annual Report on Form 10-K for the year ended April 30,
2005).
|
|
10.95
|
2003
Stock Incentive Plan Non-qualified Stock Option Agreement (Incorporated
by
reference to the exhibit contained in Registrant’s Registration Statement
in form S-8 (File No. 333-121334).*
|
|
10.96
|
2003
Stock Incentive Plan Incentive Stock Option Agreement (Incorporated
by
reference to the exhibit contained in Registrant’s Registration Statement
in form S-8 (File No. 333-121334)).*
|
|
10.97
|
Common
Stock Purchase Agreement dated January 31, 2005 between Registrant
and one
institutional investor (Incorporated by reference to Exhibit 10.97
to
Registrant’s Quarterly Report on Form 10-Q for the quarter ended January
31, 2005).
|
|
10.98
|
Form
of Incentive Stock Option Agreement for 2005 Stock Incentive Plan
(Incorporated by reference to Exhibit 10.98 to Registrant’s Current Report
on Form 8-K as filed with the Commission on October 28,
2005).*
|
|
10.99
|
Form
of Non-Qualified Stock Option Agreement for 2005 Stock Incentive
Plan
(Incorporated by reference to Exhibit 10.99 to Registrant’s Current Report
on Form 8-K as filed with the Commission on October 28,
2005).*
|
|
10.100
|
Peregrine
Pharmaceuticals, Inc. 2005 Stock Incentive Plan (Incorporated by
reference
to Exhibit B to Registrant’s Definitive Proxy Statement filed with the
Commission on August 29, 2005).*
|
|
10.101
|
First
Amendment to Lease and Agreement of Lease between TNCA, LLC, as
Landlord,
and Peregrine Pharmaceuticals, Inc., as Tenant, dated December
22, 2005
(Incorporated by reference to Exhibit 99.1 and 99.2 to Registrant’s
Current Report on Form 8-K as filed with the Commission on December 23,
2005).
|
51
Exhibit
Number
|
Description
|
|
10.102
|
Common
Stock Purchase Agreement dated May 11, 2005 between Registrant and
one
institutional investor (Incorporated by reference to Registrant’s Current
Report on Form 8-K as filed with the Commission on May 11,
2005).
|
|
10.103
|
Common
Stock Purchase Agreement dated June 22, 2005 between Registrant and
one
institutional investor (Incorporated by reference to Exhibit 99.1
to
Registrant’s Current Report on Form 8-K as filed with the Commission on
June 24, 2005).
|
|
10.104
|
Common
Stock Purchase Agreement dated November 23, 2005 between Registrant
and
one institutional investor (Incorporated by reference to Registrant’s
Current Report on Form 8-K as filed with the Commission on November
23,
2005).
|
|
10.105
|
Common
Stock Purchase Agreement dated April 5, 2006 between Registrant and
one
institutional investor (Incorporated by reference to Exhibit 99.2
to
Registrant’s Current Report on Form 8-K as filed with the Commission on
April 6, 2006).
|
10.106
|
Form
of Incentive Stock Bonus Plan dated February 13, 2006 between
Registrant and key employees and consultants. **, ***
|
|
21
|
Subsidiaries
of Registrant ***
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm ***
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.***
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.***
|
|
32
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant
to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.***
|
|
_______________________________
|
||
*
**
***
|
This
Exhibit is a management contract or a compensation plan or
arrangement.
Portions
omitted pursuant to a request of confidentiality filed separately
with the
Commission.
Filed
herewith.
|
52
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this Report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
PEREGRINE PHARMACEUTICALS, INC. | ||
|
|
|
Dated: July 7, 2006 | By: | /s/ Steven W. King |
|
||
Steven W. King, President and Chief Executive Officer |
POWER
OF ATTORNEY
KNOW
ALL
PERSONS BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Steven W. King, President and Chief Executive Officer,
and Paul J. Lytle, Chief Financial Officer and Corporate Secretary, and each
of
them, his true and lawful attorneys-in-fact and agents, with the full power
of
substitution and re-substitution, for him and in his name, place and stead,
in
any and all capacities, to sign any amendments to this report, and to file
the
same, with exhibits thereto and other documents in connection therewith, with
the Securities and Exchange Commission, granting unto each said attorney-in-fact
and agent full power and authority to do and perform each and every act in
person, hereby ratifying and confirming all that said attorney-in-fact and
agent, or either of them, or their or his substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has
been
signed below by the following persons on behalf of the Registrant and in the
capacities and on the dates indicated:
Signature
|
Capacity
|
Date
|
||
/s/
Steven W. King
|
President
& Chief Executive
|
July
7, 2006
|
||
Steven
W. King
|
Officer
(Principal Executive
|
|||
Officer)
|
||||
/s/
Paul J. Lytle
|
Chief
Financial Officer
|
July
7, 2006
|
||
Paul
J. Lytle
|
(Principal
Financial and
|
|||
Principal
Accounting Officer)
|
||||
/s/
Carlton M. Johnson
|
Director
|
July
7, 2006
|
||
Carlton
M. Johnson
|
||||
/s/
David H. Pohl
|
Director
|
July
7, 2006
|
||
David
H. Pohl
|
||||
/s/
Eric S. Swartz
|
Director
|
July
7, 2006
|
||
Eric
S. Swartz
|
||||
/s/
Dr. Thomas A. Waltz
|
Director
|
July
7, 2006
|
||
Thomas A. Waltz, M.D. |
53
REPORT
OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
The
Board
of Directors and Stockholders of Peregrine Pharmaceuticals, Inc.
We
have
audited the accompanying consolidated balance sheets of Peregrine
Pharmaceuticals, Inc. (the “Company”) as of April 30, 2006 and 2005, and the
related consolidated statements of operations, stockholders’ equity, and cash
flows for each of the three years in the period ended April 30, 2006. Our audits
also included the financial statement schedule listed in the Index at
Item 15 (a)(2). These financial statements and schedule are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these financial statements and schedule based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Peregrine
Pharmaceuticals, Inc. at April 30, 2006 and 2005, and the consolidated
results of its operations and its cash flows for each of the three years in
the
period ended April 30, 2006, in conformity with U.S. generally accepted
accounting principles. Also, in our opinion, the related financial statement
schedule, when considered in relation to the basic financial statements taken
as
a whole, presents fairly in all material respects the information set forth
therein.
We
also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the effectiveness of Peregrine Pharmaceuticals,
Inc.'s internal control over financial reporting as of April 30, 2006, based
on
criteria established in Internal Control--Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission and our report
dated July 12, 2006 expressed an unqualified opinion thereon.
/s/
Ernst & Young LLP
Orange
County, California
July
12,
2006
F-1
PEREGRINE
PHARMACEUTICALS,
INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2006 AND 2005
2006
|
2005
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
17,182,000
|
$
|
9,816,000
|
|||
Trade
and other receivables, net of allowance for doubtful accounts of
nil and
$69,000, respectively
|
579,000
|
486,000
|
|||||
Inventories
|
885,000
|
627,000
|
|||||
Prepaid
expenses and other current assets
|
1,466,000
|
1,197,000
|
|||||
Total
current assets
|
20,112,000
|
12,126,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
618,000
|
494,000
|
|||||
Laboratory
equipment
|
3,444,000
|
3,029,000
|
|||||
Furniture,
fixtures and computer equipment
|
666,000
|
647,000
|
|||||
4,728,000
|
4,170,000
|
||||||
Less
accumulated depreciation and amortization
|
(2,822,000
|
)
|
(2,532,000
|
)
|
|||
Property,
net
|
1,906,000
|
1,638,000
|
|||||
OTHER
ASSETS:
|
|||||||
Note
receivable, net of allowance of nil
and $1,512,000, respectively
|
-
|
-
|
|||||
Other
|
658,000
|
481,000
|
|||||
Total
other assets
|
658,000
|
481,000
|
|||||
TOTAL
ASSETS
|
$
|
22,676,000
|
$
|
14,245,000
|
F-2
PEREGRINE
PHARMACEUTICALS,
INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2006 AND 2005 (continued)
LIABILITIES AND STOCKHOLDER'S EQUITY |
2006
|
2005
|
|||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,233,000
|
$
|
1,325,000
|
|||
Accrued
clinical trial site fees
|
170,000
|
8,000
|
|||||
Accrued
legal and accounting fees
|
250,000
|
549,000
|
|||||
Accrued
royalties and license fees
|
138,000
|
149,000
|
|||||
Accrued
payroll and related costs
|
850,000
|
806,000
|
|||||
Notes
payable, current portion
|
429,000
|
234,000
|
|||||
Capital
lease obligation, current portion
|
15,000
|
-
|
|||||
Deferred
revenue
|
563,000
|
517,000
|
|||||
Other
current liabilities
|
836,000
|
563,000
|
|||||
Total
current liabilities
|
4,484,000
|
4,151,000
|
|||||
Notes
payable, less current portion
|
498,000
|
434,000
|
|||||
Capital
lease obligation, less current portion
|
47,000
|
-
|
|||||
Deferred
license revenue
|
21,000
|
50,000
|
|||||
Commitments
and contingencies
|
|||||||
STOCKHOLDERS’
EQUITY:
|
|||||||
Preferred
stock - $.001 par value; authorized 5,000,000
shares;
non-voting; nil shares outstanding
|
-
|
-
|
|||||
Common
stock-$.001 par value; authorized 250,000,000 shares;
outstanding
– 179,382,191 and 152,983,460, respectively
|
179,000
|
153,000
|
|||||
Additional
paid-in-capital
|
204,546,000
|
180,011,000
|
|||||
Deferred
stock compensation
|
(235,000
|
)
|
(751,000
|
)
|
|||
Accumulated
deficit
|
(186,864,000
|
)
|
(169,803,000
|
)
|
|||
Total
stockholders’ equity
|
17,626,000
|
9,610,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
22,676,000
|
$
|
14,245,000
|
See
accompanying notes to consolidated financial statements.
F-3
PEREGRINE
PHARMACEUTICALS,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
2006
|
2005
|
2004
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
3,005,000
|
$
|
4,684,000
|
$
|
3,039,000
|
||||
License
revenue
|
188,000
|
275,000
|
275,000
|
|||||||
Total
revenues
|
3,193,000
|
4,959,000
|
3,314,000
|
|||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
3,297,000
|
4,401,000
|
2,212,000
|
|||||||
Research
and development
|
12,415,000
|
11,164,000
|
9,673,000
|
|||||||
Selling,
general and administrative
|
6,564,000
|
5,098,000
|
4,225,000
|
|||||||
Total
costs and expenses
|
22,276,000
|
20,663,000
|
16,110,000
|
|||||||
LOSS
FROM OPERATIONS
|
(19,083,000
|
)
|
(15,704,000
|
)
|
(12,796,000
|
)
|
||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Recovery
of note receivable
|
1,229,000
|
-
|
-
|
|||||||
Interest
and other income
|
846,000
|
265,000
|
291,000
|
|||||||
Interest
and other expense
|
(53,000
|
)
|
(13,000
|
)
|
(1,840,000
|
)
|
||||
NET
LOSS
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
$
|
(14,345,000
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
168,294,782
|
144,812,001
|
134,299,407
|
|||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
$
|
(0.11
|
)
|
See
accompanying notes to consolidated financial statements.
F-4
PEREGRINE
PHARMACEUTICALS,
INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
Additional
|
Deferred
|
Total
|
|||||||||||||||||
Common
Stock
|
Paid-In
|
Stock
|
Accumulated
|
Stockholders’
|
|||||||||||||||
Shares
|
Amount
|
Captital
|
Compensation
|
Deficit
|
Equity
|
||||||||||||||
BALANCES,
April 30, 2003
|
119,600,501
|
$
|
120,000
|
$
|
142,274,000
|
$
|
(257,000
|
)
|
$
|
(140,006,000
|
)
|
$
|
2,131,000
|
||||||
Common
stock issued for cash under June 6, 2003 Financing, net of issuance
costs
of $104,000
|
2,412,448
|
2,000
|
1,969,000
|
-
|
-
|
1,971,000
|
|||||||||||||
Common
stock issued for cash under June 26, 2003 Financing, net of issuance
costs
of $101,000
|
1,599,997
|
2,000
|
1,737,000
|
-
|
-
|
1,739,000
|
|||||||||||||
Common
stock issued for cash under option granted under June 26, 2003
Financing,
net of issuance costs of $54,000
|
1,599,997
|
2,000
|
1,784,000
|
-
|
-
|
1,786,000
|
|||||||||||||
Common
stock issued for cash under July 24, 2003 Financing, net of issuance
costs
of $13,000
|
2,000,000
|
2,000
|
2,885,000
|
-
|
-
|
2,887,000
|
|||||||||||||
Common
stock issued for cash under September 18, 2003 Financing, net of
issuance
costs of $19,000
|
2,800,000
|
2,000
|
5,271,000
|
-
|
-
|
5,273,000
|
|||||||||||||
Common
stock issued for cash under November 17, 2003 Financing, net of
issuance
costs of $1,000
|
2,000,000
|
2,000
|
4,254,000
|
-
|
-
|
4,256,000
|
|||||||||||||
Common
stock issued for cash under January 22, 2004 Financing, net of
issuance
costs of $1,000
|
1,000,000
|
1,000
|
2,274,000
|
-
|
-
|
2,275,000
|
|||||||||||||
Common
stock issued to an unrelated entity for research services under
a research
collaboration agreement, net of issuance costs of under
$1,000
|
243,101
|
-
|
648,000
|
-
|
-
|
648,000
|
|||||||||||||
Common
stock issued upon conversion of convertible debt
|
2,817,645
|
3,000
|
2,392,000
|
-
|
-
|
2,395,000
|
|||||||||||||
Common
stock issued upon exercise of options and warrants, net of issuance
costs
of $134,000
|
5,194,493
|
5,000
|
3,467,000
|
-
|
-
|
3,472,000
|
|||||||||||||
Reversal
of deferred stock compensation associated with the cancellation
of
unvested options
|
-
|
-
|
(52,000
|
)
|
28,000
|
-
|
(24,000
|
)
|
|||||||||||
Deferred
stock compensation
|
-
|
-
|
66,000
|
(66,000
|
)
|
-
|
-
|
||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
295,000
|
-
|
295,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(14,345,000
|
)
|
(14,345,000
|
)
|
|||||||||||
BALANCES,
April 30, 2004
|
141,268,182
|
141,000
|
168,969,000
|
-
|
(154,351,000
|
)
|
14,759,000
|
||||||||||||
Common
stock issued for cash under March 31, 2004 Financing, net of issuance
costs of $43,000
|
3,000,000
|
3,000
|
3,204,000
|
-
|
-
|
3,207,000
|
|||||||||||||
Common
stock issued for cash under January 31, 2005 Financing, net of
issuance
costs of $1,000
|
3,000,000
|
3,000
|
3,276,000
|
-
|
-
|
3,279,000
|
|||||||||||||
Common
stock issued to various unrelated entities for research
services
|
1,174,682
|
1,000
|
1,448,000
|
-
|
-
|
1,449,000
|
|||||||||||||
Common
stock issued upon exercise of options and warrants, net of issuance
costs
of $5,000
|
4,540,596
|
5,000
|
2,132,000
|
-
|
-
|
2,137,000
|
|||||||||||||
Deferred
stock compensation
|
-
|
-
|
982,000
|
(982,000
|
)
|
-
|
-
|
||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
231,000
|
-
|
231,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(15,452,000
|
)
|
(15,452,000
|
)
|
|||||||||||
BALANCES,
April 30, 2005
|
152,983,460
|
153,000
|
180,011,000
|
(751,000
|
)
|
(169,803,000
|
)
|
9,610,000
|
|||||||||||
Common
stock issued for cash under January 31, 2005 Financing, net of
issuance
costs of $6,000
|
1,582,217
|
1,000
|
1,575,000
|
-
|
-
|
1,576,000
|
|||||||||||||
Common
stock issued for cash under May 11, 2005 Financing, net of issuance
costs
of $11,000
|
3,125,000
|
3,000
|
2,986,000
|
-
|
-
|
2,989,000
|
|||||||||||||
Common
stock issued for cash under June 22, 2005 Financing, net of issuance
costs
of $29,000
|
8,000,000
|
8,000
|
6,683,000
|
-
|
-
|
6,691,000
|
|||||||||||||
Common
stock issued for cash under November 23, 2005 Financing, net of
issuance
costs of $1,000
|
8,000,000
|
8,000
|
6,711,000
|
-
|
-
|
6,719,000
|
|||||||||||||
Common
stock issued for cash under April 5, 2006 Financing, net of issuance
costs
of $1,000
|
4,000,000
|
4,000
|
4,915,000
|
-
|
-
|
4,919,000
|
|||||||||||||
Common
stock issued to various unrelated entities for research
services
|
695,820
|
1,000
|
906,000
|
-
|
-
|
907,000
|
|||||||||||||
Common
stock issued upon exercise of options and warrants
|
966,742
|
1,000
|
732,000
|
-
|
-
|
733,000
|
|||||||||||||
Common
stock issued under the Company's stock bonus plan
|
28,952
|
-
|
44,000
|
-
|
-
|
44,000
|
|||||||||||||
Deferred
stock compensation
|
-
|
-
|
(17,000
|
)
|
17,000
|
-
|
-
|
||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
499,000
|
-
|
499,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(17,061,000
|
)
|
(17,061,000
|
)
|
|||||||||||
BALANCES,
April 30, 2006
|
179,382,191
|
$
|
179,000
|
$
|
204,546,000
|
$
|
(235,000
|
)
|
$
|
(186,864,000
|
)
|
$
|
17,626,000
|
See
accompanying notes to consolidated financial statements.
F-5
PEREGRINE
PHARMACEUTICALS,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
2006
|
2005
|
2004
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||
Net
loss
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
$
|
(14,345,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
|
415,000
|
325,000
|
374,000
|
|||||||
Stock-based
compensation expense
|
499,000
|
231,000
|
271,000
|
|||||||
Amortization
of discount on convertible debt and debt issuance costs
|
-
|
-
|
1,811,000
|
|||||||
Stock
issued for research services
|
1,048,000
|
485,000
|
616,000
|
|||||||
Stock
bonus plan compensation expense
|
44,000
|
-
|
-
|
|||||||
Gain
on sale of property
|
(6,000
|
)
|
-
|
-
|
||||||
Recovery
of note receivable
|
(1,229,000
|
)
|
-
|
-
|
||||||
Changes
in operating assets and liabilities:
|
||||||||||
Trade
and other receivables
|
(93,000
|
)
|
1,034,000
|
(1,275,000
|
)
|
|||||
Short-term
investments
|
-
|
-
|
242,000
|
|||||||
Inventories
|
(258,000
|
)
|
613,000
|
(864,000
|
)
|
|||||
Prepaid
expenses and other current assets
|
(410,000
|
)
|
7,000
|
49,000
|
||||||
Accounts
payable
|
(92,000
|
)
|
(6,000
|
)
|
771,000
|
|||||
Accrued
clinical trial site fees
|
162,000
|
(46,000
|
)
|
(206,000
|
)
|
|||||
Deferred
revenue
|
17,000
|
(1,082,000
|
)
|
918,000
|
||||||
Accrued
payroll and related expenses
|
44,000
|
303,000
|
189,000
|
|||||||
Other
accrued expenses and current liabilities
|
(37,000
|
)
|
420,000
|
198,000
|
||||||
Net
cash used in operating activities
|
(16,957,000
|
)
|
(13,168,000
|
)
|
(11,251,000
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||
Property
acquisitions
|
(618,000
|
)
|
(1,090,000
|
)
|
(411,000
|
)
|
||||
Increase
in other assets, net
|
(171,000
|
)
|
(101,000
|
)
|
(250,000
|
)
|
||||
Recovery
of note receivable
|
1,229,000
|
-
|
-
|
|||||||
Net
cash provided by (used in) investing activities
|
440,000
|
(1,191,000
|
)
|
(661,000
|
)
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||
Proceeds
from issuance of common stock, net of issuance costs of
$48,000,
$49,000, and $428,000, respectively
|
23,627,000
|
8,623,000
|
23,659,000
|
|||||||
Proceeds
from issuance of notes payable
|
566,000
|
733,000
|
-
|
|||||||
Principal
payments on notes payable and capital lease
|
(310,000
|
)
|
(65,000
|
)
|
-
|
|||||
Net
cash provided by financing activities
|
23,883,000
|
9,291,000
|
23,659,000
|
F-6
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
2006
|
2005
|
2004
|
||||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
$
|
7,366,000
|
$
|
(5,068,000
|
)
|
$
|
11,747,000
|
|||
CASH
AND CASH EQUIVALENTS, Beginning of year
|
9,816,000
|
14,884,000
|
3,137,000
|
|||||||
CASH
AND CASH EQUIVALENTS, End of year
|
$
|
17,182,000
|
$
|
9,816,000
|
$
|
14,884,000
|
||||
SUPPLEMENTAL
INFORMATION:
|
||||||||||
Interest
paid
|
$
|
49,000
|
$
|
13,000
|
$
|
78,000
|
||||
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||||
Property
acquired under capital lease
|
$
|
65,000
|
$
|
-
|
$
|
-
|
||||
Conversion
of convertible debt into common stock
|
$
|
-
|
$
|
-
|
$
|
2,395,000
|
||||
Common
stock issued for research fees and prepayments for future research
services
|
$
|
907,000
|
$
|
1,449,000
|
$
|
648,000
|
For
supplemental information relating to conversion of convertible debentures into
common stock, common stock issued in exchange for services, property acquired
under capital lease, and property financed in exchange for notes payable, see
Notes 4, 7 and 8.
See
accompanying notes to consolidated financial statements.
F-7
PEREGRINE
PHARMACEUTICALS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
1.
|
ORGANIZATION
AND BUSINESS DESCRIPTION
|
Organization
- In
this Annual Report, “Peregrine,” “Company,” “we,” “us,” and “our,” refer to
Peregrine Pharmaceuticals, Inc and our wholly owned subsidiary Avid Bioservices,
Inc.. We were incorporated in the state of Delaware on September 25, 1996.
We
were originally incorporated in California in June 1981 under the name
Techniclone International Corporation and subsequently merged into Techniclone
Corporation, a Delaware corporation, in March
1997.
We
changed our name to Peregrine Pharmaceuticals, Inc. in October 2000.
In
January 2002, we formed our wholly owned subsidiary, Avid Bioservices, Inc.
(“Avid”).
Business
Description - We
are a
biopharmaceutical company with a portfolio of clinical and pre-clinical stage
monoclonal antibody-based targeted therapeutics for the treatment of solid
cancers and viral infections. We are currently advancing three separate clinical
trial programs for the treatment of cancer and chronic hepatitis C virus (“HCV”)
infections. Under our Anti-Phosphatidylserine (“Anti-PS”) Immunotherapeutic
platform technology, our lead candidate bavituximab (formerly known as
Tarvacin), is currently in a multi-center Phase I clinical trial for the
treatment of solid cancers as well as a multi-center phase Ib clinical trial
for
the treatment of chronic HCV infection. Our third clinical program is a dose
confirmation and dosimetry clinical trial using our lead Tumor Necrosis Therapy
(TNT) agent, Cotara®, for the treatment of glioblastoma multiforme, a deadly
form of brain cancer. We are organized into two reportable operating segments:
(i) Peregrine, the parent company, is engaged in the research and development
of
monoclonal antibody-based targeted therapeutics and (ii) Avid Bioservices,
Inc.,
(“Avid”) a wholly owned subsidiary, is engaged in providing bio-manufacturing
services for Peregrine and outside customers on a fee-for-services basis.
We
have
expended substantial funds on the development of our product candidates and
we
have incurred negative cash flows from operations for the majority of our years
since inception. Since inception, we have generally financed our operations
primarily through the sale of our common stock and issuance of convertible
debt,
which has been supplemented with payments received from various licensing
collaborations and through the revenues generated by Avid. We expect negative
cash flows from operations to continue until we are able to generate sufficient
revenue from the contract manufacturing services provided by Avid and/or from
the sale and/or licensing of our products under development.
Revenues
earned by Avid during fiscal years ended April 30, 2006, 2005 and 2004 amounted
to $3,005,000, $4,684,000 and $3,039,000, respectively. We expect that Avid
will
continue to generate revenues which should partially offset our consolidated
cash flows used in operations, although we expect those near term revenues
will
be insufficient to cover anticipated cash flows used in operations. In addition,
revenues from the sale and/or licensing of our products under development are
always uncertain. Therefore, our ability to continue our clinical trials and
development efforts is highly dependent on the amount of cash and cash
equivalents on hand combined with our ability to raise additional capital to
support our future operations beyond fiscal year 2007. At April 30, 2006, we
had
$17,182,000 in cash and cash equivalents compared to $9,816,000 at April 30,
2005. In addition, during June 2006 we received an additional $13,000,000 in
net
proceeds from the sale of 9,285,714 shares of our common stock under a common
stock purchase agreement dated June 16, 2006 (Note 8).
We
plan
to raise additional capital primarily through the registered offer and sale
of
shares of our common stock from our shelf registration statements on Form S-3
which, as of June 30, 2006, we had an aggregate of approximately 5,893,000
shares available for possible future registered transactions; provided, however,
in connection with our recent financing on June 16, 2006, we agreed not to
(i)
file another shelf registration statement pursuant to Rule 415 of the Securities
Act of 1933, as amended, for a period of one hundred eighty days following
June
16, 2006, nor (ii) without the prior written consent of the purchaser in such
financing, prior to January 2, 2007, enter into any subsequent or further offer
or sale of securities at a price or possible price below $2.50 per share.
Notwithstanding the availability of our Form S-3, given uncertain market
conditions and the volatility of our stock price and trading volume, we may
not
be able to sell our securities at prices or on terms that are favorable to
us,
if at all.
F-8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
There
can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all, or that sufficient additional revenues will
be generated from Avid or under potential licensing agreements to complete
the
research, development, and clinical testing of our product candidates beyond
fiscal year 2007.
2. |
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Basis
of Presentation - The
accompanying consolidated financial statements include the accounts of the
Peregrine and its wholly owned subsidiary, Avid Bioservices, Inc. All
intercompany balances and transactions have been eliminated.
Cash
and Cash Equivalents -
We
consider all highly liquid, short-term investments with an initial maturity
of
three months or less to be cash equivalents.
Allowance
for Doubtful Accounts -
We
continually monitor our allowance for doubtful accounts for all receivables.
A
considerable amount of judgment is required in assessing the ultimate
realization of these receivables and we estimate an allowance for doubtful
accounts based on factors that appear reasonable under the
circumstances.
Prepaid
Expenses - Our
prepaid expenses primarily represent pre-payments made to secure the receipt
of
services at a future date. During fiscal year 2006 and 2005, we prepaid
various research and development related services through the issuance of our
shares of common stock with unrelated entities, which are expensed once the
services have been provided under the terms of the arrangement. As of April
30,
2006 and April 30, 2005, prepaid expenses and other current assets in the
accompanying consolidated financials statements include $866,000 and $1,028,000,
respectively, in research and development services prepaid in shares of our
common stock.
Inventories -
Inventories are stated at the lower of cost or market and includes raw
materials, direct labor, and overhead costs associated with our wholly owned
subsidiary, Avid. Cost is determined by the first-in, first-out method.
Inventories consist of the following at April 30, 2006 and April 30,
2005:
2006
|
2005
|
||||||
Raw
materials
|
$
|
565,000
|
$
|
445,000
|
|||
Work-in-process
|
320,000
|
182,000
|
|||||
Total
inventories
|
$
|
885,000
|
$
|
627,000
|
Concentrations
of Credit Risk
- The
majority of trade and other receivables as of April 30, 2006, are from customers
in the United States and Australia. Most contracts require up-front payments
and
installment payments as the project progresses. We perform periodic credit
evaluations of our ongoing customers and generally do not require collateral,
but we can terminate any contract if a material default occurs. Reserves are
maintained for potential credit losses and such losses have been within our
estimates.
F-9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Comprehensive
Loss -
Comprehensive loss is equal to net loss for all periods presented.
Property
-
Property is recorded at cost. Depreciation and amortization are computed using
the straight-line method over the estimated useful lives of the related asset,
generally ranging from three to ten years. Amortization of leasehold
improvements is calculated using the straight-line method over the shorter
of
the estimated useful life of the asset or the remaining lease term.
Impairment
-
Long-lived assets are reviewed for impairment when events or changes in
circumstances indicate that the carrying amount of such assets may not be
recoverable. We assess recoverability of our long-term assets by comparing
the
remaining carrying value to the value of the underlying collateral or the fair
market value of the related long-term asset based on undiscounted cash flows.
Long-lived assets are reported at the lower of carrying amount or fair value
less cost to sell.
Deferred
Revenue -
Deferred revenue primarily consists of up-front contract fees and installment
payments received by Avid prior to the recognition of revenues under contract
manufacturing, and development agreements and up-front license fees received
by
Peregrine under technology licensing agreements. Deferred revenue is generally
recognized once the service has been provided, all obligations have been met
and/or upon shipment of the product to the customer.
Revenue
Recognition -
We
currently derive revenues primarily from licensing agreements associated with
Peregrine’s technologies under development and from contract manufacturing
services provided by Avid.
We
recognize revenues pursuant to the SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition.
In
accordance with SAB No. 104, revenue is generally realized or realizable and
earned when (i) persuasive evidence of an arrangement exists, (ii) delivery
has
occurred or services have been rendered, (iii) the seller's price to the buyer
is fixed or determinable, and (iv) collectibility is reasonably assured.
In
addition, we comply with Financial Accounting Standards Board’s Emerging Issues
Task Force No. 00-21 (“EITF 00-21”), Revenue
Arrangements with Multiple Deliverables.
In
accordance with EITF 00-21, we recognize revenue for delivered elements only
when the delivered element has stand-alone value and we have objective and
reliable evidence of fair value for each undelivered element. If the fair value
of any undelivered element included in a multiple element arrangement cannot
be
objectively determined, revenue is deferred until all elements are delivered
and
services have been performed, or until fair value can objectively be determined
for any remaining undelivered elements.
Revenues
associated with licensing agreements primarily consist of nonrefundable up-front
license fees and milestones payments. Revenues under licensing agreements are
recognized based on the performance requirements of the agreement. Nonrefundable
up-front license fees received under license agreements, whereby continued
performance or future obligations are considered inconsequential to the relevant
licensed technology, are generally recognized as revenue upon delivery of the
technology. Nonrefundable up-front license fees, whereby ongoing involvement
or
performance obligations exist, are generally recorded as deferred revenue and
generally recognized as revenue over the term of the performance obligation
or
relevant agreement. Milestone payments are recognized as revenue upon the
achievement of mutually agreed milestones, provided that (i) the milestone
event is substantive and its achievement is not reasonably assured at the
inception of the agreement, and (ii) there are no continuing performance
obligations associated with the milestone payment. Under a license agreement
with Schering A.G. (Note 7), the obligation period was not contractually defined
in relation to a $300,000 upfront fee. Under this circumstance, we exercised
judgment in estimating the period of time over which certain deliverables will
be provided to enable the licensee to practice the license, which was determined
to be 48 months. The estimated period of 48 months was primarily determined
based on the historical experience with Schering A.G. under a separate license
agreement.
F-10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Contract
manufacturing revenues are generally recognized once the service has been
provided and/or upon shipment of the product to the customer. We also record
a
provision for estimated contract losses, if any, in the period in which they
are
determined.
In
July
2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF
99-19”), Reporting
Revenue Gross as a Principal versus Net as an Agent.
EITF
99-19 summarized the EITF’s views on when revenue should be recorded at the
gross amount billed to a customer because it has earned revenue from the sale
of
goods or services, or the net amount retained (the amount billed to the customer
less the amount paid to a supplier) because it has earned a fee or commission.
In addition, the EITF released Issue 00-10 (“EITF 00-10”), Accounting
for Shipping and Handling Fees and Costs,
and
Issue 01-14 (“EITF 01-14”), Income
Statement Characterization of Reimbursements Received for “Out-of-Pocket”
Expenses Incurred.
EITF
00-10 summarized the EITF’s views on how the seller of goods should classify in
the income statement amounts billed to a customer for shipping and handling
and
the costs associated with shipping and handling. EITF 01-14 summarized the
EITF’s views on when the reimbursement of out-of-pocket expenses should be
characterized as revenue or as a reduction of expenses incurred. Our revenue
recognition policies are in compliance with EITF 99-19, EITF 00-10 and EITF
01-14 whereby we record revenue for the gross amount billed to customers (the
cost of raw materials, supplies, and shipping, plus the related handling mark-up
fee) and we record the cost of the amounts billed as cost of sales as we act
as
a principal in these transactions.
Fair
Value of Financial Instruments - Our
financial instruments consist principally of cash and cash equivalents,
receivables, inventories, accounts payable, and accrued liabilities. We believe
all of the financial instruments' recorded values approximate fair values due
to
the short-term nature of these instruments.
Use
of Estimates
- The
preparation of our financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ from these
estimates.
Basic
and Diluted Net Loss Per Common Share
- Basic
and diluted net loss per common share are calculated in accordance with
Statement of Financial Accounting Standards No. 128, Earnings
per Share.
Basic
net loss per common share is computed by dividing our net loss by the weighted
average number of common shares outstanding during the period excluding the
dilutive effects of options, warrants, and convertible instruments. Diluted
net
loss per common share is computed by dividing the net loss by the sum of the
weighted average number of common shares outstanding during the period plus
the
potential dilutive effects of options, warrants, and convertible debt
outstanding during the period. Potentially dilutive common shares consist of
stock options and warrants calculated in accordance with the treasury stock
method, but are excluded if their effect is antidilutive. The potential dilutive
effect of convertible debt was calculated using the if-converted method assuming
the conversion of the convertible debt as of the earliest period reported or
at
the date of issuance, if later. Because the impact of options, warrants, and
other convertible instruments are antidilutive during periods of net loss,
there
was no difference between basic and diluted loss per share amounts for the
three
years ended April 30, 2006. The dilutive effect of the following shares issuable
upon the exercise of options, warrants, and convertible debt outstanding during
the period were excluded from dilutive net loss per common share because their
effect is antidilutive since we reported a net loss in the periods
presented:
F-11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
2006
|
2005
|
2004
|
||||||||
Common
stock equivalent shares assuming issuance of shares represented by
outstanding stock options and warrants utilizing the treasury stock
method
|
3,433,414
|
6,485,168
|
11,462,682
|
|||||||
Common
stock equivalent shares assuming issuance of shares upon conversion
of
convertible debt utilizing the if-converted method
|
-
|
-
|
563,054
|
|||||||
Total
|
3,433,414
|
6,485,168
|
12,025,736
|
Weighted
average outstanding options and warrants to purchase up to 9,090,374, 11,946,248
and 8,393,083 shares of common stock for the fiscal years ended April 30, 2006,
2005 and 2004, respectively, were also excluded from the calculation of diluted
earnings per common share because their exercise prices were greater than the
average market price during the period.
During
June 2006, we issued 9,285,714 shares of our common stock under a common stock
purchase agreement dated June 16, 2006 (Note 8) in exchange for net proceeds
of
$13,000,000, which additional shares have been excluded from basic and dilutive
net loss per common share for the year ended April 30, 2006.
Income
Taxes -
We
utilize the liability method of accounting for income taxes as set forth in
Statement of Financial Accounting Standards No. 109, Accounting
for Income Taxes.
Under
the liability method, deferred taxes are determined based on the differences
between the consolidated financial statements and tax basis of assets and
liabilities using enacted tax rates. A valuation allowance is provided when
it
is more likely than not that some portion or the entire deferred tax asset
will
not be realized.
Research
and Development
-
Research and development costs are charged to expense when incurred in
accordance with Statement of Financial Accounting Standards No. 2,
Accounting
for Research and Development Costs.
Research and development expenses primarily include (i) payroll and related
costs associated with research and development personnel, (ii) costs related
to
clinical and pre-clinical testing of our technologies under development, (iii)
costs to develop and manufacture the product candidates, including raw materials
and supplies, product testing, depreciation, and facility related expenses,
(iv)
technology access and maintenance fees, including intellectual property fees
and
fees incurred under licensing agreements, (v) expenses for research services
provided by universities and contract laboratories, including sponsored research
funding, and (vi) other research and development expenses.
F-12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Stock-based
Compensation
- In
December 2002, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards No. 148 (“SFAS No. 148”),
Accounting
for Stock-Based Compensation-Transition and Disclosure.
SFAS
No. 148 amends SFAS No. 123 (“SFAS No. 123”), Accounting
for Stock-Based Compensation, and
provides alternative methods of transition for a voluntary change to the fair
value based method of accounting for stock-based employee compensation. In
addition, SFAS No. 148 amends the disclosure requirements of SFAS No. 123 to
require prominent disclosures in both annual and interim financial statements
about the method of accounting for stock-based employee compensation, and the
effect of the method used on reported results.
We
have
not adopted a method under SFAS No. 148 to expense stock options, but rather
we
continue to apply the provisions of SFAS No. 123; however, we have adopted
the
additional disclosure provisions of the statement. As SFAS No. 123 permits,
we
elected to continue accounting for our employee stock options in accordance
with
Accounting Principles Board Opinion No. 25 (“APB No. 25”), Accounting
for Stock Issued to Employees and
Related Interpretations.
APB No.
25 requires compensation expense to be recognized for stock options when the
market price of the underlying stock exceeds the exercise price of the stock
option on the date of the grant.
We
utilize the guidelines in APB No. 25 for measurement of stock-based transactions
for employees and, accordingly, no compensation expense has been recognized
for
the options in the accompanying consolidated financial statements for the three
years ended April 30, 2006.
Had
we
used a fair value model for measurement of stock-based transactions for
employees under SFAS No. 123 and amortized the expense over the vesting period,
pro forma information would be as follows:
2006
|
2005
|
2004
|
||||||||
Net
loss, as reported
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
$
|
(14,345,000
|
)
|
|
Stock-based
employee compensation cost that would have been included in the
determination of net loss if the fair value based method had been
applied
to all awards
|
(1,755,000
|
)
|
(2,828,000
|
)
|
(2,541,000
|
)
|
||||
Pro
forma net loss as if the fair value based method had been applied
to all
awards
|
$
|
(18,816,000
|
)
|
$
|
(18,280,000
|
)
|
$
|
(16,886,000
|
)
|
|
Basic
and diluted loss per common share, as reported
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
$
|
(0.11
|
)
|
|
Basic
and diluted loss per common share, pro forma
|
$
|
(0.11
|
)
|
$
|
(0.13
|
)
|
$
|
(0.13
|
)
|
The
fair
value of stock options on the date of grant and the assumptions used to estimate
the fair value of the stock options using the Black-Scholes option valuation
model, were as follows:
2006
|
2005
|
2004
|
||||||||
Weighted
average fair value of stock options granted
|
$
|
0.91
|
$
|
0.80
|
$
|
1.59
|
||||
Risk-free
interest rate
|
3.88%
|
|
3.38%
|
|
2.31%
|
|
||||
Expected
life (in years)
|
5.49
|
4.00
|
4.00
|
|||||||
Expected
volatility factor
|
103%
|
|
115%
|
|
124%
|
|
||||
Expected
dividend yield
|
-
|
-
|
-
|
F-13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Stock-based
compensation expense recorded during each of the three years in the periods
ended April 30, 2006 primarily relate to stock option grants issued to
non-employee consultants. The fair value of these options are measured utilizing
the Black-Scholes option valuation model and are being amortized over the
estimated period of service or related vesting period in accordance with the
provisions of SFAS No. 123 and EITF 96-18, Accounting
for Equity Instruments That Are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services.
Stock-based compensation expense recorded during fiscal years 2006, 2005 and
2004 amounted to $499,000, $231,000, and $271,000, respectively.
In
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
123R (“SFAS No. 123R”), Share-Based
Payment (Revised 2004),
which
requires companies to recognize in the financial statements the fair value
of
all employee share-based payments, including grants of employee stock options
as
well as compensatory employee stock purchase plans, for interim periods
beginning after June 15, 2005. In April 2005, the Securities and Exchange
Commission adopted a rule amendment that delayed the compliance dates of SFAS
No. 123R such that we are now allowed to adopt the new standard no later than
May 1, 2006. SFAS No. 123R eliminates the ability to account for share-based
compensation using APB No. 25, and the pro forma disclosures previously
permitted under SFAS No. 123 will no longer be an alternative to financial
statement recognition.
We
adopted SFAS No. 123R on May 1, 2006, using the “modified-prospective
method,” in which compensation cost is recognized beginning with the effective
date (a) based on the requirements of SFAS No. 123R for all
share-based payments granted after the effective date and (b) based on the
requirements of SFAS No. 123 for all awards granted to employees prior to
the effective date of SFAS No. 123R that remain unvested on the
effective date. We apply the Black-Scholes valuation model in determining the
fair value of share-based payments to employees, which will then be amortized
on
a straight-line basis. Although we have not yet determined the final impact
of
SFAS No. 123R, we believe the non-cash compensation expense for fiscal year
2007
related to the adoption of SFAS No. 123R may be up to approximately $1,000,000
based on actual shares granted and unvested as of April 30, 2006. However,
the
actual expense recorded during fiscal year 2007 as a result of the adoption
of
SFAS No. 123R may differ materially from our estimate as a result of
changes in a number of factors that affect the amount of non-cash compensation
expense, including the number of options to be granted by our Board of Directors
during fiscal year 2007, the price of our common stock on the date of grant,
the
volatility of our stock price, the estimate of the expected life of options
granted and the risk free interest rates as measured at the grant date.
In
addition, during February 2006, our Compensation Committee of the Board of
Directors approved the Company’s Stock Bonus Plan to promote the interests of
the Company and its stockholders by issuing key employees and consultants a
predetermined number of shares of the Company’s common stock upon achievement of
various research and clinical goals (“Performance Goals”). Compensation expense
associated with shares issued under the Stock Bonus Plan is calculated in
accordance with APB
No.
25 and EITF 96-18. In
accordance with APB No. 25 and EITF 96-18, we will record compensation expense
at each reporting period when it becomes probable that a Performance Goal under
the Stock Bonus Plan will be achieved and this accrual will be carefully
assessed at each subsequent reporting period and adjusted accordingly until
the
Performance Goal is actually achieved. Decreases or increases to these accruals
will be accounted for as cumulative catch-up adjustments under FIN 28,
Accounting
for Stock Appreciation Rights and Other Variable Stock Option or Awards
Plans.
During
fiscal year 2006, we recorded $83,000 in compensation expense under the Stock
Bonus Plan, of which, $39,000 is included in accrued payroll and related costs
in the accompanying consolidated financial statements as of April 30, 2006.
F-14
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Recent
Accounting Pronouncements -
In
November 2004, the FASB issued Statement of Financial Accounting Standards
No.
151 (“SFAS No. 151”), Inventory
Costs.
SFAS
No. 151 amends the guidance in ARB No. 43, Chapter 4, Inventory Pricing, to
improve financial reporting by clarifying that abnormal amounts of idle facility
expense, freight, handling costs, and wasted materials (spoilage) should be
recognized as current-period charges and by requiring the allocation of fixed
production overheads to inventory based on the normal capacity of the production
facilities. The standard is effective for inventory costs incurred during fiscal
years beginning after June 15, 2005. We adopted SFAS No. 151 on May 1, 2006,
which we do not expect will have a significant impact on our consolidated
financial condition and results of operations.
In
May
2005, the FASB issued Statement of Financial Accounting Standards No. 154 (“SFAS
No. 154”), Accounting
Changes and Error Corrections.
SFAS
No. 154 applies to all voluntary changes in accounting principle, and changes
the requirements for accounting for and reporting of a change in accounting
principle. SFAS No. 154 also requires retrospective application to prior
periods’ financial statements of a voluntary change in accounting principle
unless it is impracticable. SFAS No. 154 is effective for accounting changes
and
corrections of errors made in fiscal years beginning after December 15,
2005. We adopted SFAS No. 151 on May 1, 2006, which we do not expect will have
a
significant impact on our consolidated financial condition and results of
operations.
3. |
NOTE
RECEIVABLE
|
During
December 1998, we completed the sale and subsequent leaseback of our two
facilities in Tustin, California and recorded an initial note receivable from
the buyer of $1,925,000 as part of the consideration. During the quarter ended
October 31, 1999, we established a 100% reserve for the note receivable in
the
amount of $1,887,000 based on our then financial condition and the underlying
terms of the note agreement. We reduce the reserve as monthly payments are
received and we record the reduction as interest and other income in the
accompanying consolidated statements of operations. On December 22, 2005, we
entered into a First Amendment to Lease and Agreement of Lease (“First
Amendment”) with the landlord to our original lease dated December 24, 1998 and
extended the original lease term for seven years, which extends our contractual
commitment under the operating lease through December 2017. In addition, the
monthly lease payment terms under the original lease, which increase at a rate
of 3.35% every two years, have not been modified. In connection with this First
Amendment, we entered into a separate agreement with the landlord on December
22, 2005 regarding the immediate payoff of our note receivable in the amount
of
$1,229,000 after reducing the principal amount by twenty percent (20%), which
amount was recorded as recovery of note receivable in the accompanying
consolidated statements of operations during fiscal year 2006.
F-15
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
The
following represents a rollforward of the allowance of the note receivable
for
the two years ended April 30, 2006:
2006
|
2005
|
||||||
Allowance
balance, beginning
|
$
|
1,581,000
|
$
|
1,645,000
|
|||
Principal
payments received
|
(1,274,000
|
)
|
(64,000
|
)
|
|||
Note
receivable payoff reduction
|
(307,000
|
)
|
-
|
||||
Allowance
balance, ending
|
$
|
-
|
$
|
1,581,000
|
4. |
NOTES
PAYABLE AND CAPITAL LEASE
OBLIGATION
|
During
fiscal years 2006 and 2005, we entered into the following note payable
agreements with General Electric Capital Corporation (“GE”) to finance certain
laboratory equipment. Notes payable consist of the following at April 30, 2006
and April 30, 2005:
April
30,
2006
|
April
30,
2005
|
||||||
Note
payable dated November 2004; 5.78% per annum;
monthly
payments of $11,000 due through December 2007
|
$
|
202,000
|
$
|
314,000
|
|||
Note
payable dated December 2004; 5.85% per annum;
monthly
payments of $12,000 due through January 2008
|
232,000
|
354,000
|
|||||
Note
payable dated June 2005; 6.39% per annum; monthly
payments
of $8,000 due through July 2008
|
205,000
|
-
|
|||||
Note
payable dated November 2005; 6.63% per annum;
monthly
payments of $3,000 due through December 2008
|
92,000
|
-
|
|||||
Note
payable dated March 2006; 6.87% per annum;
monthly
payments of $6,000 due through April 2009
|
196,000
|
-
|
|||||
927,000
|
668,000
|
||||||
Less
current portion
|
(429,000
|
)
|
(234,000
|
)
|
|||
Notes
payable, less current portion
|
$
|
498,000
|
$
|
434,000
|
Under
the
terms of the GE note payable agreements, we paid security deposits equal to
25%
of the amount financed, which are due and payable to us at the end of the term
of each note agreement. As of April 30, 2006 and April 30, 2005, security
deposits totaling $325,000 and $183,000, respectively, are included in other
long-term assets in the accompanying consolidated financial
statements.
Minimum
future principal payments on notes payable as of April 30, 2006 are as
follows:
Year
ending April 30:
|
||||
2007
|
429,000
|
|||
2008
|
379,000
|
|||
2009
|
119,000
|
|||
Total
|
$
|
927,000
|
F-16
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
During
December 2005, we financed certain equipment under a capital lease agreement
in
the amount of $65,000. The agreement bears interest at a rate of 6.30% per
annum
with payments due monthly in the amount of approximately $1,600 through December
2009.
The
equipment purchased under the capital lease is included in property in the
accompanying consolidated financial statements as follows at April 30, 2006:
Furniture,
fixtures and office equipment
|
$
|
68,000
|
||
Less
accumulated depreciation
|
(5,000
|
)
|
||
Net
book value
|
$
|
63,000
|
Minimum
future lease payments under the capital lease as of April 30, 2006 are as
follows:
Year
ending April 30:
|
||||
2007
|
$
|
19,000
|
||
2008
|
19,000
|
|||
2009
|
19,000
|
|||
2010
|
13,000
|
|||
Total
minimum lease payments
|
70,000
|
|||
Amount
representing interest
|
(8,000
|
)
|
||
Net
present value minimum lease payments
|
62,000
|
|||
Less
current portion
|
15,000
|
|||
$
|
47,000
|
5.
|
COMMITMENTS
AND CONTINGENCIES
|
Operating
Leases
- In
December 1998, we sold and subsequently leased back our two facilities in
Tustin, California. The lease has an original lease term of 12 years with two
5-year renewal options and includes scheduled rental increases of 3.35% every
two years. On
December 22, 2005, we entered into a First Amendment to Lease and Agreement
of
Lease (“First Amendment”) with the landlord to our original lease dated December
24, 1998 and extended the original lease term for seven additional years to
expire on December 31, 2017 while maintaining our two 5-year renewal options
that could extend our lease to December 31, 2027. In addition, our monthly
lease
payments still increase at a rate of 3.35% every two years under the First
Amendment. We record rent expense on a straight-line basis and the differences
between the amounts paid and the amounts expensed are included in other accrued
liabilities in the accompanying consolidated financial statements. Annual rent
expense under the lease agreement totaled $758,000 during fiscal year 2006
and
$735,000 during fiscal years 2005 and 2004.
During
fiscal year 2004, we entered into an operating lease agreement to lease certain
office equipment. The lease has a 5-year term and annual minimum lease payments
are $29,000.
During
February 2005, we entered into an operating lease agreement to lease certain
office space in Houston, Texas. The lease has a 3-year term and annual minimum
lease payments are $20,000 plus a pro rata share of monthly operating expenses.
Rent expense under the lease agreement totaled $21,000 and $4,000 during fiscal
years 2006 and 2005, respectively.
F-17
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
At
April
30, 2006, future minimum lease payments and sublease income under all
non-cancelable operating leases are as follows:
Year
ending
April
30:
|
Minimum
Lease Payments
|
Sublease
Income
|
Net
Lease
Payments
|
|||||||
2007
|
$
|
804,000
|
$
|
(40,000
|
)
|
$
|
764,000
|
|||
2008
|
815,000
|
-
|
815,000
|
|||||||
2009
|
793,000
|
-
|
793,000
|
|||||||
2010
|
796,000
|
-
|
796,000
|
|||||||
2011
|
805,000
|
-
|
805,000
|
|||||||
Thereafter
|
5,736,000
|
-
|
5,736,000
|
|||||||
|
$
|
9,749,000
|
$
|
(40,000
|
)
|
$
|
9,709,000
|
Rental
Income
- We
currently sublease portions of our unused space. Sublease rental income totaled
$59,000, $99,000 and $179,000 for fiscal years 2006, 2005 and 2004,
respectively.
Legal
Proceedings
- From
time to time, we are subject to legal proceeding and disputes during the
ordinary course of business. We currently are not aware of any such legal
proceeding or claim that we believe will have, individually or in the aggregate,
a material adverse effect on our business, prospects, operating results or
cash
flows.
6. |
CONVERTIBLE
DEBT
|
On
August
9, 2002, we entered into a private placement with four investors under a
Debenture Securities Purchase Agreement (“Debt SPA”), whereby we issued
Convertible Debentures (“Convertible Debt”) for gross proceeds of $3,750,000.
The Convertible Debt was fully converted into 4,411,764 shares of common stock,
of which, 1,594,119 shares of our common stock were issued during fiscal year
2003 and 2,817,645 shares of our common stock were issued during fiscal year
2004.
In
accordance with EITF 00-27, Application
of Issue No. 98-5 to Certain Convertible Instruments,
we
initially recorded the convertible debt net of discount of (i) the relative
fair
value of the warrants issued in the amount of $1,321,000 and (ii) the intrinsic
value of the embedded conversion feature in the amount of $1,143,000. The
relative fair value of the warrants was determined in accordance with the
Black-Scholes valuation model based on the warrant terms. The debt discount,
along with the debt issuance costs, were amortized as non-cash interest expense
on a straight-line basis over the term of the Convertible Debt, which
approximated the effective interest method. Upon conversion of the Convertible
Debt, the entire unamortized debt discount and debt issuance costs remaining
at
the date of conversion that was attributed to the converted Convertible Debt
were immediately recognized as interest expense in the accompanying consolidated
statements of operations. During fiscal year 2004, we recognized $1,635,000
in
non-cash interest expense associated with the Convertible Debt, which amount
was
included in interest and other expense in the accompanying consolidated
statements of operations. As
of
April 30, 2004, all outstanding Convertible Debt was converted into common
stock
and the associated discount was fully amortized as non-cash interest expense
in
the accompanying financial statements.
F-18
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Under
the
Debt SPA, each Debenture holder was granted a detachable warrant equal to 75%
of
the quotient obtained by dividing the principal amount of the Convertible Debt
by the Conversion Price or an aggregate of 3,308,827 warrants. The detachable
warrants have a 4-year term with an exercise price of $0.75 per share. During
fiscal year 2006 and 2004, Debenture holders exercised 796,765 and 2,244,120
warrants, respectively, under the Debt SPA for gross proceeds of $598,000 and
$1,683,000, respectively, at the exercise price of $0.75 per share. As of April
30, 2006, 267,942 warrants were outstanding under the Debt SPA (Note
10).
In
connection with the Convertible Debt, we incurred approximately $363,000 in
debt
issuance costs, including placement agent fees of $318,000, which was amortized
as interest expense on a straight-line basis over the life of the Convertible
Debt, which approximates the effective interest method. Upon conversion of
the
Convertible Debt, the entire unamortized debt issuance costs remaining at the
date of conversion that was attributed to the converted Convertible Debt was
immediately recognized as interest expense in the accompanying consolidated
statements of operations. During
fiscal year 2004, we expensed $175,000 in
debt
issuance costs included
in interest and other expense in the accompanying consolidated statements
of operations.
As of
April 30, 2004, the debt issuance costs were completely amortized.
7. |
LICENSE,
RESEARCH AND DEVELOPMENT AGREEMENTS
|
The
following represents a summary of our key collaborations for the development
and
commercialization of our products in clinical trials, bavituximab and
Cotara®.
In
addition, we do not perform any research and development activities for any
unrelated entities.
Tumor
Necrosis Therapy
(“TNT”)
Cotara®
is the trade name of our first TNT-based product currently in clinical trials
for the treatment of brain cancer. We acquired the rights to the TNT technology
in July 1994 after the merger between Peregrine and Cancer Biologics, Inc.
was
approved by our stockholders. The assets acquired from Cancer Biologics, Inc.
primarily consisted of patent rights to the TNT technology. To date, no product
revenues have been generated from our TNT technology.
In
October 2004, we entered into a worldwide non-exclusive license agreement with
Lonza Biologics (“Lonza”) for intellectual property and materials relating to
the expression of recombinant monoclonal antibodies for use in the manufacture
of Cotara®. Under the terms of the agreement, we paid an upfront fee of 75,000
pounds sterling ($141,000 U.S.) which amount is included in research and
development expense in the accompanying consolidated financial statements in
fiscal year 2005, and we will pay a royalty on net sales of any products that
we
market that utilize the underlying technology. In the event we or Lonza do
not
manufacture Cotara®, we would owe Lonza 300,000 pounds sterling per year in
addition to an increased royalty on net sales.
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics
Bavituximab
(formerly known as Tarvacin) is the generic name for our first product in
clinical trials under our Anti-PS Immunotherapeutics technology platform.
Bavituximab is currently in a Phase I clinical trial for the treatment of solid
cancers and also in a Phase Ib clinical trial for the treatment of hepatitis
C
virus infection. In August 2001, we exclusively in-licensed the worldwide rights
to this technology platform from the University of Texas Southwestern Medical
Center at Dallas. During November 2003 and October 2004, we entered into two
non-exclusive license agreements with Genentech, Inc. to license certain
intellectual property rights covering the methods and processes for producing
antibodies used in connection with the development of our Anti-PS
Immunotherapeutics program. During December 2003, we entered into an exclusive
commercial license agreement with an unrelated entity covering the generation
of
the chimeric monoclonal antibody, bavituximab. In March 2005, we entered into
a
worldwide non-exclusive license agreement with Lonza Biologics for intellectual
property and materials relating to the expression of recombinant monoclonal
antibodies for use in the manufacture of bavituximab.
F-19
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Under
our
in-licensing agreements relating to the Anti-Phosphatidylserine
Immunotherapeutics technology, we typically pay an up-front license fee, annual
maintenance fees, and are obligated to pay future milestone payments based
on
development progress, plus a royalty on net sales or a percentage of sublicense
income. Our aggregate future milestone payments under the above in-licensing
agreements are $7,100,000 assuming the achievement of all development milestones
under the agreements through commercialization of products, of which, we expect
to pay up to $100,000 during fiscal year 2007 and $6,600,000 upon approval
of
the first Anti-Phosphatidylserine Immunotherapeutics product. In addition,
under
one of the agreements, we are required to pay future milestone payments upon
the
completion of Phase II clinical trial enrollment in the amount of 75,000 pounds
sterling, the amount of which will continue as an annual license fee thereafter,
plus a royalty on net sales of any products that we market that utilize the
underlying technology. In the event we utilize an outside contract manufacturer
other than Lonza to manufacture bavituximab, we would owe Lonza 300,000 pounds
sterling per year in addition to an increased royalty on net sales.
During
fiscal years 2006 and 2004, we expensed $450,000 and $100,000, respectively,
under in-licensing agreement covering our Anti-PS Immunotherapeutics technology
platform, which is included in research and development expense in the
accompanying consolidated financial statements.
Other
Licenses Covering Products in Pre-Clinical
Development
During
August 2001, we entered into an exclusive worldwide license for a new
pre-clinical compound from the University of Texas Southwestern Medical Center.
This new compound, named 2C3, added to our anti-cancer platform technologies
in
the anti-angiogenesis field. Under this license agreement, we paid an up-front
license fee and are obligated to pay annual maintenance fees, future milestone
payments based on development progress, plus a royalty on net sales. Our
aggregate future milestone payments under this exclusive worldwide license
are
$450,000 assuming the achievement of all development milestones under the
agreement through commercialization of the product. We do not anticipate making
any milestone payments under this agreement for at least the next fiscal year.
In
April
1997, in conjunction with the acquisition of Vascular Targeting Technologies,
Inc. (formerly known as Peregrine Pharmaceuticals, Inc.), we gained access
to
certain exclusive licenses for Vascular Targeting Agents (“VTAs”) technologies
from various institutions. In conjunction with various licensing agreements
covering our VTA technology, we are required to pay combined annual fees of
$50,000 plus milestone payments based on the development success of the
technologies and a royalty on net sales. Our aggregate future milestone payments
under these exclusive licenses are $1,688,000 assuming the achievement of all
development milestones under the agreements through commercialization of the
product, which are due at various stages of clinical development in accordance
with the applicable license. We do not anticipate making any milestone payments
for at least the next year under these agreements.
During
February 2000, we entered into an exclusive worldwide licensing transaction
with
the University of Southern California for its Permeability Enhancing Protein
(“PEP”) in exchange for an up-front payment plus future milestone payments and a
royalty on net sales based on development success. The PEP technology is
classified under our Vasopermeation Enhancing Agent (“VEA”) technology, which is
designed to increase the uptake of chemotherapeutic agents into tumors. PEP
is
designed to be used in conjunction with the VEA technology platform. Our
aggregate future milestone payments under our PEP and VEA exclusive worldwide
licensing agreements are $115,000 assuming the achievement of all development
milestones under the agreement through commercialization of the product. We
do
not anticipate making any milestone payments for at least the next fiscal year
under this agreement.
F-20
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
During
June 2003, September 2004, and November 2004, we entered into various binding
term sheets with an unrelated entity regarding the generation of up to nine
human antibodies under our platform technologies to be used as possible future
clinical candidates. Under the terms of the binding terms sheets, we paid a
non-refundable upfront technology access fee for each human antibody project
initiated and we are obligated to pay future milestones payments based on the
achievement of development milestones, plus a royalty on net sales. Our
aggregate future milestone payments range from $5.75 million to $6.05 million
per human antibody generated by the unrelated entity upon the achievement of
certain development milestones through commercialization. During fiscal years
2006, 2005 and 2004, we expensed $185,000, $150,000 and $200,000, respectively,
in non-refundable upfront technology access fees under the binding term sheets
upon the initiation to generate four human antibodies, the amounts of which
are
included in research and development expense in the accompanying consolidated
financial statements.
During
December 2003, we entered into a research collaboration agreement with an
unrelated entity regarding the humanization of one of our
Anti-Phosphatidylserine Immunotherapeutic antibodies to be used as a possible
future generation clinical candidate. Under the terms of the research
collaboration agreement, we are required to pay a non-refundable up-front
license fee, antibody development milestone fees, clinical development milestone
fees and a royalty on net sales. During January and October 2004, we issued
and
sold 243,101 and 107,665 shares of our common stock to the unrelated entity,
respectively, for payment of the non-refundable up-front license fee of 90,000
pounds sterling and for aggregate antibody development milestone fees of 360,000
pounds sterling. These shares were valued at $802,000 based on the more readily
determinable value of the services received or the fair value of the common
stock issued, of which, $186,000 and $616,000 was recorded as research and
development expense in the accompanying consolidated financial statements during
fiscal year 2005 and 2004, respectively. Our minimum aggregate future milestone
payments under this agreement are $3,250,000 assuming the achievement of all
development milestones under the agreement through commercialization of the
product. We do not anticipate making any milestone payments for at least the
next fiscal year under this agreement.
During
July 2004, we announced that we entered into a worldwide exclusive licensing
agreement for intellectual property related to Phosphatidylserine conjugates
and
Anti-Phosphatidylserine (Anti-PS) antibodies from The University of Texas M.
D.
Anderson Cancer Center related to generating an immune response for the
treatment of cancer and other indications. Under the terms of the agreement,
we
paid The University of Texas M. D. Anderson Cancer Center a non-refundable
up-front fee of $150,000, which is included in research and development expense
in fiscal year 2005 in the accompanying consolidated financial statements,
and
we are obligated to pay future milestone fees based on the clinical progress
of
products that fall under the licensed intellectual property and a royalty on
net
sales as defined in the agreement. Our aggregate future milestone payments
under
this licensing agreement are $1,700,000 assuming the achievement of all
development milestones under the agreement through commercialization of the
product. We do not anticipate making any milestone payments for at least the
next fiscal year under this agreement.
F-21
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Out-Licensing
Collaborations
In
addition to our in-licensing collaborations, the following represents a summary
of our key out-licensing collaborations.
During
September 1995, we entered into an agreement with Cancer Therapeutics, Inc.
whereby we granted to Cancer Therapeutics, Inc. the exclusive right to
sublicense TNT to a major pharmaceutical company solely in the People’s Republic
of China. In addition, we are entitled to receive 50% of the distributed profits
received by Cancer Therapeutics, Inc. from the Chinese pharmaceutical company.
Cancer Therapeutics, Inc. has the right to 20% of the distributed profits under
the agreement with the Chinese pharmaceutical company. During March 2001, we
extended the exclusive licensing period granted to Cancer Therapeutics, which
now expires on December 31, 2016. In exchange for this extension, Cancer
Therapeutics, Inc. agreed to pay us ten percent (10%) of all other consideration
received by Cancer Therapeutics, Inc., excluding research funding. Through
fiscal year ended April 30, 2006, we have not received any amounts under the
agreement.
During
October 2000, we entered into a licensing agreement with Merck KGaA to
out-license a segment of our TNT technology for use in the application of
cytokine fusion proteins. During January 2003, we entered into an amendment
to
the license agreement, whereby we received an extension to the royalty period
from six years to ten years from the date of the first commercial sale. Under
the terms of agreement, we would receive a royalty on net sales if a product
is
approved under the agreement. Merck KGaA has not publicly disclosed the
development status of its program.
During
February 2001, we completed a licensing deal with SuperGen, Inc. (“SuperGen”) to
license a segment of our VTA technology, specifically related to Vascular
Endothelial Growth Factor (“VEGF”). Under the terms of the licensing agreement,
we will receive an annual license fee of $200,000 in cash or SuperGen common
stock until SuperGen files an Investigational New Drug Application in the United
States utilizing the VEGF technology. In addition, we could receive additional
milestone payments based on SuperGen’s development success, plus receive a
royalty on net sales of all drugs commercialized by SuperGen utilizing the
VEGF
technology. We could also receive additional consideration for each clinical
candidate that enters a Phase III clinical trial by SuperGen. As of April 30,
2006, SuperGen has not filed an Investigational New Drug Application in the
United States utilizing the VEGF technology.
During
December 2002, we granted the exclusive rights for the development of diagnostic
and imaging agents in the field of oncology to Schering A.G. under our VTA
technology. Under the terms of the agreement, we received an up-front payment
of
$300,000 that is being amortized over an estimated period of 48 months, of
which, $50,000 is included in deferred license revenue in accordance with SAB
No. 104 in the accompanying consolidated financial statements at April 30,
2006.
Under this license agreement, the obligation period was not contractually
defined and we exercised judgment in estimating the period of time over which
certain deliverables will be provided to enable the licensee to practice the
license. The estimated period of 48 months was primarily determined based on
the
historical experience with Schering A.G. under a separate license agreement.
In
addition, we could also receive future milestone payments and a royalty on
net
sales, as defined in the agreement. Under the same agreement, we granted
Schering A.G. an option to obtain certain non-exclusive rights to the VTA
technology with predetermined up-front fees and milestone payments as defined
in
the agreement. Schering A.G. has not publicly disclosed the development status
of its program.
F-22
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
During
August 2005, we licensed certain intellectual property rights under our VTA
technology to Medarex, Inc., which allows Medarex, Inc. to develop and
commercialize certain monoclonal antibodies for the treatment of a wide range
of
solid tumors. Under the terms of the agreement, we could receive up to $5.95
million in future payments based on the achievement of all clinical and
regulatory milestones combined with a royalty on net sales, as defined in the
agreement. Medarex has not publicly disclosed the development status of its
program.
8. |
STOCKHOLDERS'
EQUITY
|
Adoption
of a Stockholder Rights Agreement
On
March
16, 2006, our Board of Directors adopted a Stockholder Rights Agreement (“Rights
Agreement”) that is designed to strengthen the ability of the Board of Directors
to protect the interests of our stockholders against potential abusive or
coercive takeover tactics and to enable all stockholders the full and fair
value
of their investment in the event that an unsolicited attempt is made to acquire
Peregrine. The adoption of the Rights Agreement is not intended to prevent
an
offer the Board of Directors concludes is in the best interest of Peregrine
and
its stockholders.
Under
the
Rights Agreement, the Board of Directors declared a dividend of one preferred
share purchase right (a “Right”) for each share of our common stock held by
shareholders of record as of the close of business on March 27, 2006. Each
Right
will entitle holders of each share of our common stock to buy one thousandth
(1/1,000th)
of a
share of Peregrine’s Series D Participating Preferred Stock, par value $0.001
per share, at an exercise price of $11.00 per share, subject to adjustment.
The
Rights are neither exercisable nor traded separately from our common stock.
The
Rights will become exercisable and will detach from the common shares if a
person or group acquires 15% or more of our outstanding common stock, without
prior approval from our Board of Directors, or announces a tender or exchange
offer that would result in that person or group owning 15% or more of our common
stock. Each Right, when exercised, entitles the holder (other than the acquiring
person or group) to receive common stock of the Company (or in certain
circumstances, voting securities of the acquiring person or group) with a value
of twice the Rights exercise price upon payment of the exercise price of the
Rights.
Peregrine
will be entitled to redeem the Rights at $0.001 per Right at any time prior
to a
person or group achieving the 15% threshold. The Rights will expire on March
16,
2016.
Financing
Under Shelf Registration Statements On Form S-3
During
fiscal years 2006, 2005, and 2004, we entered into various financing
transactions under the following shelf registration statements on Form S-3,
which were declared effective by the Securities and Exchange Commission on
various dates described in the below table, allowing us to issue, from time
to
time, in one or more offerings the following number of shares of our common
stock and warrants to purchase shares of our common stock:
Registration
Statement
No.
|
Shelf
Effective Date
|
Number
of Shares of
Common
Stock Registered
|
Number
of Warrants
Registered
|
333-71086
|
November
2001
|
10,000,000
|
2,000,000
|
333-103965
|
March
2003
|
10,000,000
|
-
|
333-109982
|
October
2003
|
12,000,000
|
-
|
333-121450
|
December
2004
|
12,000,000
|
-
|
333-128322
|
September
2005
|
12,000,000
|
-
|
333-132872
|
March
2006
|
15,000,000
|
-
|
F-23
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
The
following tables summarize the financing transactions we entered into during
fiscal years 2004, 2005, and 2006 under the above shelf registration
statements:
FISCAL
YEAR 2004
|
||||||||||
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Number
of
Warrants
Issued
|
Net
Issuance
Value
|
|||||||
Common
stock purchase agreement dated June 6, 2003
|
2,412,448
|
150,000
|
$
|
1,971,000
|
||||||
Common
stock purchase agreement dated June 26, 2003
|
1,599,997
|
-
|
$
|
1,739,000
|
||||||
Option
granted under the common stock purchase agreement dated June 26,
2003
|
1,599,997
|
-
|
$
|
1,786,000
|
||||||
Common
stock purchase agreement dated July 24, 2003
|
2,000,000
|
-
|
$
|
2,887,000
|
||||||
Common
stock purchase agreement dated September 18, 2003
|
2,800,000
|
-
|
$
|
5,273,000
|
||||||
Common
stock purchase agreement dated November 17, 2003
|
2,000,000
|
-
|
$
|
4,256,000
|
||||||
Common
stock purchase agreement dated January 22, 2004
|
1,000,000
|
-
|
$
|
2,275,000
|
||||||
Common
stock issued to unrelated entities for research services
|
243,101
|
-
|
$
|
648,000
|
||||||
13,655,543
|
150,000
|
$
|
20,835,000
|
FISCAL
YEAR 2005
|
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Number
of
Warrants
Issued
|
Net
Issuance
Value
|
|||||||
Common
stock purchase agreement dated March 31, 2004
|
3,000,000
|
-
|
$
|
3,207,000
|
||||||
Common
stock purchase agreement dated January 31, 2005
|
3,000,000
|
-
|
$
|
3,279,000
|
||||||
Common
stock issued to unrelated entities for research services
|
1,174,682
|
-
|
$
|
1,449,000
|
||||||
7,174,682
|
-
|
$
|
7,935,000
|
FISCAL
YEAR 2006
|
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Number
of
Warrants
Issued
|
Net
Issuance
Value
|
|||||||
Common
stock purchase agreement dated January 31, 2005
|
1,582,217
|
-
|
$
|
1,576,000
|
||||||
Common
stock purchase agreement dated May 11, 2005
|
3,125,000
|
-
|
$
|
2,989,000
|
||||||
Common
stock purchase agreement dated June 22, 2005
|
8,000,000
|
-
|
$
|
6,691,000
|
||||||
Common
stock purchase agreement dated November 23, 2005
|
8,000,000
|
-
|
$
|
6,719,000
|
||||||
Common
stock purchase agreement dated April 5, 2006
|
4,000,000
|
-
|
$
|
4,919,000
|
||||||
Common
stock issued to unrelated entities for research services
|
695,820
|
-
|
$
|
907,000
|
||||||
25,403,037
|
-
|
$
|
23,801,000
|
As
of
April 30, 2006, an aggregate of 15,179,180 shares of common stock were available
for issuance under two of the shelf registration statements noted above.
F-24
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
On
June
16, 2006, we entered into a Common Stock Purchase Agreement whereby we sold
9,285,714 shares of our common stock in exchange for net proceeds of
$13,000,000. As of June 30, 2006, an aggregate 5,893,466 shares of common stock
were registered and available for issuance under two separate shelf registration
statements.
Financing
Under Securities Purchase Agreement
In
addition to the above financing transactions pursuant to our shelf registration
statements, on August 9, 2002, we entered into a private placement with two
investors under a Securities Purchase Agreement (“SPA”) and issued an aggregate
of 1,923,078 shares of our common stock in exchange for gross proceeds of
$1,250,000. In conjunction with the private placement, we issued warrants to
purchase up to an aggregate of 1,442,309 shares of our common stock. The
warrants have a four year term and are exercisable six months after the date
of
issuance at an exercise price of $0.71 per share. During fiscal year 2004,
the
two investors exercised all 1,442,309 warrants in exchange for gross proceeds
of
$1,024,000 at the exercise price of $0.71 per share.
Also
on
August 9, 2002, we agreed to sell 3,298,462 shares of our common stock at a
negotiated price of $0.65 per share in exchange for gross proceeds of $2,144,000
to one investor. In conjunction with this offering, we issued a four-year
warrant to purchase up to 4,648,846 shares of our common stock at an exercise
price of $0.71 per share. As of April 30, 2006, warrants to purchase up to
4,648,846 shares our common stock, which expire in August 2006, were outstanding
under the SPA.
Shares
Of Common Stock Authorized And Reserved For Future
Issuance
In
accordance with our shares reserved for issuance under our Shelf registration
statements, stock option plans and warrant agreements, we have reserved
38,797,530 shares of our common stock at April 30, 2006 for future issuance,
calculated as follows:
Number
of
shares
reserved
|
||||
Shares
reserved under two effective shelf registration statements
|
15,179,180
|
|||
Options
issued and outstanding
|
11,307,279
|
|||
Options
available for future grant
|
5,346,418
|
|||
Warrants
issued and outstanding
|
6,964,653
|
|||
Total
shares reserved
|
38,797,530
|
In
addition, up to 1,302,033 shares
of
common stock could potentially be issued under our 2005 Stock Option Plan for
the possible issuance of shares under our Stock Bonus Plan (Note
9).
F-25
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
9.
|
STOCK
OPTIONS
|
We
maintain four equity compensation plans, the 1996 Plan, the 2002 Plan, the
2003
Plan, and the 2005 Plan. The 1996, 2003 and 2005 Plans were approved by our
stockholders while the 2002 Plan was not submitted for stockholder approval.
Equity
Compensation Plans Approved by Stockholders
We
have
three incentive stock option plans with outstanding options as of April 30,
2006: the 1996 Plan, the 2003 Plan, and the 2005 Plan. The plans provide for
the
granting of options to purchase shares of our common stock at prices not less
than the fair market value of our common stock at the date of grant and
generally expire ten years after the date of grant.
The
1996
Plan originally provided for the issuance of options to purchase up to 4,000,000
shares of our common stock. The number of shares for which options may be
granted under the 1996 Plan automatically increases for all subsequent common
stock issuances by us in an amount equal to 20% of such subsequent issuances
up
to a maximum of 10,000,000 options as long as the total shares allocated to
the
1996 Plan do not exceed 20% of our authorized stock. As a result of issuances
of
our common stock subsequent to the adoption of the 1996 Plan, the number of
shares for which options may be granted has increased to 10,000,000. Options
granted generally vest over a period of four years with a maximum term of ten
years. As of April 30, 2006, options to purchase 4,321,328 shares of our common
stock were outstanding under the 1996 Plan and 56,437 options were available
for
grant under the 1996 Plan.
During
October 2003, our stockholders approved the 2003 Stock Incentive Plan (“2003
Plan”) for the issuance of options to purchase up to 5,000,000 shares of the
Company’s common stock. The 2003 Plan provides for the granting of options to
purchase shares of our common stock at prices not less than the fair market
value of the stock at the date of grant and which generally expire ten years
after the date of grant. As of April 30, 2006, options to purchase 4,745,508
shares of our common stock were outstanding under the 2003 Plan and 254,492
options were available for grant under the 2003 Plan.
During
October 2005, our stockholders approved the 2005 Stock Incentive Plan (“2005
Plan”) which provides for the granting of stock options to purchase shares of
our common stock at prices not less than the fair market value of our common
stock on the date of grant or for the direct issuance of stock as a bonus for
services rendered. The 2005 Plan provides for the issuance of up to 5,000,000
shares of common stock. Options granted under the 2005 Plan generally expire
ten
years after the date of grant. As of April 30, 2006, there were no options
outstanding to purchase shares of our common stock under the 2005 Plan and
4,971,048 options were available for grant under the 2005 Plan. In addition,
during February 2005, the Compensation Committee of the Board of Directors
approved a Stock Bonus Plan that would reward key employees and consultants
in
shares of the Company’s common stock, which shares would be issued under our
2005 Plan. The total options available for grant of 4,971,048 under the 2005
Plan excludes shares of our common stock reserved for under our Stock Bonus
Plan
due to the uncertainty of achieving the performance milestones that are required
to be achieved before shares of common stock are issued under the Stock Bonus
Plan. In the event that all remaining milestones were achieved under the Stock
Bonus Plan, we would issue up to 1,302,033 additional shares of common stock
under the 2005 Plan during fiscal year 2007 for the achievement of performance
milestones.
F-26
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Equity
Compensation Plans Not Approved by Stockholders
During
June 2002, we adopted a broad-based non-qualified stock option plan (“2002
Plan”) for the issuance of up to 3,000,000 options. The 2002 Plan provides for
the granting of options to purchase shares of our common stock at prices not
less than the fair market value of our common stock at the date of grant and
generally expire ten years after the date of grant. As of April 30 2006, options
to purchase 2,058,779 shares of our common stock were outstanding under the
2002
Plan and 64,441 options were available for grant under the 2002 Plan.
In
addition to the 2002 Plan, during 1999, we granted non-qualified options, which
are not part of any compensation plan, to purchase up to an aggregate of
1,500,000 shares of our common stock. As of April 30, 2006, options to purchase
181,664 shares of our common stock were outstanding. The resale of the
underlying shares of common stock is registered on a registration statement
on
Form S-3.
Option
activity for all option plans for each of the three years ended April 30, 2006
is as follows:
2006
|
2005
|
2004
|
|||||||||||||||||
Shares
|
Weighted
Average
Exercise
Price
|
Shares
|
Weighted
Average
Exercise
Price
|
Shares
|
Weighted
Average
Exercise
Price
|
||||||||||||||
BALANCE,
|
|||||||||||||||||||
Beginning
of year
|
11,182,640
|
$1.61
|
11,704,205
|
$1.48
|
9,580,458
|
$1.16
|
|||||||||||||
Granted
|
1,128,481
|
$1.14
|
3,149,829
|
$1.52
|
4,187,947
|
$2.09
|
|||||||||||||
Exercised
|
(154,230
|
)
|
$0.79
|
(2,120,806
|
)
|
$0.66
|
(1,131,242
|
)
|
$0.61
|
||||||||||
Forfeited
or Expired
|
(849,612
|
)
|
$1.80
|
(1,550,588
|
)
|
$1.77
|
(932,958
|
)
|
$1.99
|
||||||||||
BALANCE,
|
|||||||||||||||||||
End
of year
|
11,307,279
|
$1.
56
|
11,182,640
|
$1.61
|
11,704,205
|
$1.48
|
Additional
information regarding options outstanding as of April 30, 2006 is as
follows:
Options
Outstanding
|
Options
Exercisable
|
||||
Range
of Per
Share
Exercise
Prices
|
Number
of Shares
Outstanding
|
Weighted
Average
Remaining
Contractual
Life
(years)
|
Weighted
Average
Per
Share
Exercise
Price
|
Number
of Shares Exercisable
|
Weighted
Average
Per
Share
Exercise
Price
|
$
0.34 - $ 1.05
|
2,470,284
|
5.64
|
$
0.63
|
1,765,078
|
$
0.50
|
$
1.06 - $ 1.31
|
2,264,616
|
6.23
|
$
1.20
|
1,766,182
|
$
1.21
|
$
1.32 - $ 1.62
|
2,412,351
|
7.34
|
$
1.49
|
1,172,135
|
$
1.51
|
$
1.63 - $ 2.19
|
558,900
|
6.76
|
$
1.92
|
359,575
|
$
1.95
|
$
2.20 - $ 5.28
|
3,601,128
|
7.15
|
$
2.41
|
3,416,562
|
$
2.42
|
$
0.34 - $ 5.28
|
11,307,279
|
6.66
|
$
1.56
|
8,479,532
|
$
1.62
|
F-27
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
10.
|
WARRANTS
|
As
of
April 30, 2006, we had warrants outstanding to purchase up to 6,964,653 shares
of our common stock at exercise prices ranging between $0.71 and $2.50 per
share
with a weighted average exercise price of $0.86 per share.
Additional
information regarding warrants outstanding as of April 30, 2006, is as follows:
Range
of Per Share
Exercise
Prices
|
Number
of Warrants
Outstanding
|
Weighted
Average
Per
Share
Exercise
Price
|
Expiration
Date
or
Date Range
|
|||
$0.71
- $0.75
|
4,916,788
|
$0.71
|
8/8/06
|
|||
$0.86
|
62,865
|
$0.86
|
6/8/07
|
|||
$1.00
|
1,350,000
|
$1.00
|
11/16/06
|
|||
$1.47
- $2.50
|
635,000
|
$1.72
|
1/31/07
- 3/31/08
|
|||
$0.71
- $2.50
|
6,964,653
|
$0.86
|
8/6/06
- 3/31/08
|
During
fiscal years 2005 and 2004, we granted 350,000 warrants and 150,000 warrants,
respectively, under two separate transactions. There were no warrants granted
during fiscal year 2006. The relative fair value of the warrants was determined
in accordance with the Black-Scholes valuation model based on the underlying
warrant terms. The warrants granted during fiscal year 2005 pertain to services
being provided by a non-employee consultant. The warrant has a three year term,
an exercise price of $1.47 per share, expires March 31, 2008, and was
outstanding at April 30, 2006. We utilized the Black-Scholes valuation model
to
calculate the fair value of the warrant, which was recorded as stock-based
compensation in the accompanying consolidated financial statements. The warrants
granted in fiscal year 2004 to purchase up to 150,000 shares of our common
stock
were issued in connection with the common stock purchase agreement dated June
6,
2003, of which, 62,865 warrants were outstanding at April 30, 2006. The warrants
have a 4-year term with an exercise price of $0.86 per share and expire in
June
2007.
During
fiscal year 2006, warrants to purchase 812,512 shares of our common stock were
exercised on a cash basis under various transactions for net proceeds of
$611,000 and the issuance of 812,512 shares of our common stock. During fiscal
year 2005, warrants to purchase 2,495,414 shares of our common stock were
exercised on a combined cash and cashless basis under various transactions
for
net proceeds of $747,000 and the issuance of 2,419,790 shares of our common
stock. During fiscal year 2004, warrants to purchase 4,087,871 shares of our
common stock were exercised on a combined cash and cashless basis under various
transactions for net proceeds of $2,786,000 and the issuance of 4,063,251 shares
of our common stock.
During
fiscal years 2006 and 2005, 5,764,631 and 324,638 warrants, respectively, to
purchase shares of common stock expired unexercised.
During
fiscal year 2005, Swartz Private Equity, LLC (“SPE”) exercised 699,000 warrants
granted in November 1999 in exchange for gross proceeds of $328,000, the
exercise of which is included in the total warrant exercises during fiscal
year
2005. The warrant was originally granted on November 19, 1999 in consideration
of a commitment by SPE to fund a $35,000,000 equity line financing over a three
year term at an exercise price of $0.46875 per share. This agreement was entered
into and approved by the previous Board of Directors. Mr. Eric Swartz, a member
of our Board of Directors, maintains a 50% ownership in SPE. We utilized the
Black-Scholes valuation model to calculate the fair value of the warrant, which
was recorded as stock-based compensation expense in the accompanying
consolidated financial statements.
F-28
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
11.
|
SEGMENT
REPORTING
|
Our
business is organized into two reportable operating segments. Peregrine is
engaged in the research and development of targeted therapeutics for the
treatment of viral infections and cancer using
monoclonal antibodies.
Avid is
engaged in providing contract manufacturing of biologics and related services
to
biopharmaceutical and biotechnology businesses.
The
accounting policies of the operating segments are the same as those described
in
Note 2. We primarily evaluate the performance of our segments based on net
revenues, gross profit or loss (exclusive of research and development expenses,
selling, general and administrative expenses, and interest and other
income/expense) and long-lived assets. Our segment net revenues shown below
are
derived from transactions with external customers. Our segment gross profit
represents net revenues less cost of sales. Our long-lived assets consist of
leasehold improvements, laboratory equipment, and furniture, fixtures and
computer equipment and are net of accumulated depreciation.
Segment
information for fiscal years 2006, 2005 and 2004 is summarized as
follows:
2006
|
2005
|
2004
|
||||||||
Net
Revenues:
|
||||||||||
Contract
manufacturing and development of biologics
|
$
|
3,005,000
|
$
|
4,684,000
|
$
|
3,039,000
|
||||
Research
and development of biotherapeutics
|
188,000
|
275,000
|
275,000
|
|||||||
Total
net revenues
|
$
|
3,193,000
|
$
|
4,959,000
|
$
|
3,314,000
|
||||
Gross
Profit (Loss):
|
||||||||||
Contract
manufacturing and development of biologics
|
$
|
(292,000
|
)
|
$
|
283,000
|
$
|
827,000
|
|||
Research
and development of biotherapeutics
|
188,000
|
275,000
|
275,000
|
|||||||
Total
gross profit (loss)
|
$
|
(104,000
|
)
|
$
|
558,000
|
$
|
1,102,000
|
|||
Research
and development expense of biotherapeutics
|
(12,415,000
|
)
|
(11,164,000
|
)
|
(9,673,000
|
)
|
||||
Selling,
general and administrative expense
|
(6,564,000
|
)
|
(5,098,000
|
)
|
(4,225,000
|
)
|
||||
Net
other income (expense)
|
2,022,000
|
252,000
|
(1,549,000
|
)
|
||||||
Net
loss
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
$
|
(14,345,000
|
)
|
F-29
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Net
revenues generated from Avid during fiscal years 2006, 2005 and 2004 were
primarily from the following customers:
2006
|
2005
|
2004
|
|||
Customer
revenues as a % of net revenues:
|
|||||
United
States (customer A)
|
73%
|
51%
|
4%
|
||
United
States (customer B)
|
2%
|
15%
|
24%
|
||
Germany
(one customer)
|
10%
|
0%
|
3%
|
||
Israel
(one customer)
|
1%
|
32%
|
67%
|
||
Other
customers
|
14%
|
2%
|
2%
|
||
Total
customer revenues as a % of net revenues
|
100%
|
100%
|
100%
|
Net
revenues generated from Peregrine during fiscal years 2006, 2005 and 2004 were
primarily from annual license fees received under the license agreement with
SuperGen, Inc. combined with the amortized portion of an up-front license fee
received under the December 2003 license agreement with Schering A.G. (Note
7).
Long-lived
assets consist of the following at April 30, 2006 and April 30,
2005:
2006
|
2005
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,516,000
|
$
|
1,291,000
|
|||
Research
and development of biotherapeutics
|
390,000
|
347,000
|
|||||
Total
long-lived assets, net
|
$
|
1,906,000
|
$
|
1,638,000
|
12. |
INCOME
TAXES
|
The
provision for income taxes consists of the following for the three years ended
April 30, 2006:
2006
|
2005
|
2004
|
||||||||
Provision
for federal income taxes at statutory rate
|
$
|
(5,801,000
|
)
|
$
|
(5,254,000
|
)
|
$
|
(4,877,000
|
)
|
|
State
income taxes, net of federal benefit
|
(995,000
|
)
|
(902,000
|
)
|
(837,000
|
)
|
||||
Expiration
and adjustment of loss carryforwards
|
719,000
|
4,513,000
|
891,000
|
|||||||
Change
in valuation allowance
|
6,048,000
|
1,628,000
|
6,746,000
|
|||||||
Increase
of effective tax rate for net state deferred tax asset
|
-
|
-
|
(1,941,000
|
)
|
||||||
Other,
net
|
29,000
|
15,000
|
18,000
|
|||||||
Income
tax (expense) benefit
|
$
|
-
|
$
|
-
|
$
|
-
|
F-30
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
Deferred
income taxes reflect the net effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes
and
the amounts for income tax purposes. Significant components of our deferred
tax
assets at April 30, 2006 and 2005 are as follows:
2006
|
2005
|
||||||
Net
operating loss carryforwards
|
$
|
48,147,000
|
$
|
41,628,000
|
|||
Stock-based
compensation
|
1,676,000
|
1,495,000
|
|||||
General
business and research and development credits
|
118,000
|
118,000
|
|||||
Deferred
revenue
|
233,000
|
226,000
|
|||||
Accrued
liabilities
|
1,126,000
|
1,785,000
|
|||||
Total
deferred tax assets
|
51,300,000
|
45,252,000
|
|||||
Less
valuation allowance
|
(51,300,000
|
)
|
(45,252,000
|
)
|
|||
Net
deferred tax assets
|
$
|
-
|
$
|
-
|
At
April
30, 2006, we had federal net operating loss carryforwards and tax credit
carryforwards of approximately $131,000,000 and $118,000, respectively. The
net
operating loss carryforwards expire in fiscal years 2007 through 2026. The
net
operating losses of $2,986,000 applicable to Vascular Targeting Technologies,
our wholly-owned subsidiary, can only be offset against future income of that
subsidiary. The tax credit carryforwards begin to expire in fiscal year 2008
and
are available to offset the future taxes or our subsidiary. We also have state
net operating loss carryforwards of approximately $68,200,000 at April 30,
2006,
which begin to expire in fiscal year 2007.
Due
to
ownership changes in our common stock, there may be limitations on our ability
to utilize our net operating loss carryforwards in the future.
13. |
RELATED
PARTY TRANSACTION
|
During
fiscal years 2005 and 2004, we paid Equiplace Securities, LLC (“Equiplace”)
$12,000 and $72,000, respectively, for Avid business development services
provided by employees of Equiplace under a Finder’s Agreement. Mr. Swartz, a
member of our Board of Directors, owns fifty percent (50%) of Equiplace. The
Finder Fee Agreement was canceled on June 30, 2004 and no commissions were
paid
under the agreement.
14. |
BENEFIT
PLAN
|
During
fiscal year 1997, we adopted a 401(k) benefit plan (the “Plan”) for all regular
employees who are at least the age of 21, work at least 25 hours per week and
have three or more months of continuous service. The Plan provides for employee
contributions of up to 100% of their compensation or a maximum of
$15,000.
We
made no matching contributions to the Plan since its inception.
15. |
SUBSEQUENT
EVENTS
|
On
June
16, 2006, we entered into a Common Stock Purchase Agreement with one
institutional investor whereby we sold 9,285,714 shares of our common stock
in
exchange for net proceeds of $13,000,000 (Note 8).
F-31
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
(continued)
16.
|
SELECTED
QUARTERLY FINANCIAL DATA
(UNAUDITED)
|
Selected
quarterly financial information for each of the two most recent fiscal years
is
as follows:
Quarter
Ended
|
||||||||||||||||||||||||||||
April
30,
|
January
31,
|
October
31,
|
July
31,
|
April
30,
|
January
31,
|
October
31,
|
July
31,
|
|||||||||||||||||||||
2006
|
2006
|
2005
|
2005
|
2005
|
2005
|
2004
|
2004
|
|||||||||||||||||||||
Net
revenues
|
$
|
901,000
|
$
|
1,528,000
|
$
|
556,000
|
$
|
208,000
|
$
|
919,000
|
$
|
1,353,000
|
$
|
2,183,000
|
$
|
504,000
|
||||||||||||
Cost
of sales
|
$
|
1,477,000
|
(a) |
$
|
1,088,000
|
$
|
428,000
|
$
|
304,000
|
(b) |
$
|
1,136,000
|
(c) |
$
|
1,273,000
|
$
|
1,544,000
|
$
|
448,000
|
|||||||||
Gross
profit (loss)
|
$
|
(576,000
|
)
|
$
|
440,000
|
$
|
128,000
|
$
|
(96,000
|
)
|
$
|
(217,000
|
)
|
$
|
80,000
|
$
|
639,000
|
$
|
56,000
|
|||||||||
Operating
expenses
|
$
|
4,934,000
|
$
|
4,922,000
|
$
|
4,814,000
|
$
|
4,309,000
|
$
|
4,498,000
|
$
|
3,886,000
|
$
|
4,341,000
|
$
|
3,537,000
|
||||||||||||
Net
loss
|
$
|
(5,038,000
|
)
|
$
|
(3,113,000
|
)
|
$
|
(4,571,000
|
)
|
$
|
(4,339,000
|
)
|
$
|
(4,657,000
|
)
|
$
|
(3,744,000
|
)
|
$
|
(3,638,000
|
)
|
$
|
(3,413,000
|
)
|
||||
Basic
and diluted loss
per
common
share
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
______________
(a) |
Cost
of sales for the quarter ended April 30, 2006 includes the write-off
of
unusable work-in-process inventory generated during the quarter ended
April 30, 2006 in the amount of $698,000 combined with a contract
loss
provision associated with one customer in the amount of
$184,000.
|
(b) |
Cost
of sales for the quarter ended July 31, 2005 includes additional
costs
incurred during the quarter ended July 31, 2005 to provide additional
data
to support required studies for current
customers.
|
(c) |
Cost
of sales for the quarter ended April 30, 2005 includes the write-off
of
unusable work-in-process inventory generated during the quarter ended
April 30, 2005 in the amount of
$605,000.
|
F-32
PEREGRINE
PHARMACEUTICALS,
INC.
SCHEDULE
II
VALUATION
OF QUALIFYING ACCOUNTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2006
Balance
at
|
Charged
|
Balance
|
|||||||||||
Beginning
|
to
costs and
|
at
end
|
|||||||||||
Description
|
of
period
|
expenses
|
Deductions
|
of
period
|
|||||||||
Valuation
reserve for note and other receivables for
the
year ended April 30, 2004
|
$
|
1,704,000
|
$
|
-
|
$
|
(59,000
|
)
|
$
|
1,645,000
|
||||
Valuation
reserve for note and other receivables for
the
year ended April 30, 2005
|
$
|
1,645,000
|
$
|
-
|
$
|
(64,000
|
)
|
$
|
1,581,000
|
||||
Valuation
reserve for note and other receivables for
the
year ended April 30, 2006
|
$
|
1,581,000
|
$
|
-
|
$
|
(1,581,000
|
)
|
$
|
-
|
F-33