Avid Bioservices, Inc. - Annual Report: 2007 (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, 2007
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
|
95-3698422
|
||
(State
of incorporation)
|
(I.R.S.
Employer Identification No.)
|
||
14282
Franklin Avenue, Tustin, California
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92780
|
||
(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:
Title
of Class
|
|
Name
of Each Exchange on Which Registered
|
Common
Stock ($0.001 par value)
Preferred
Stock Purchase Rights
|
|
The
Nasdaq Stock Market LLC
|
Securities
registered pursuant to Section 12(g) of the Act:
None
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 $260,138,000 as of October 31, 2006.
(1)
226,165,617
(Number
of shares of common stock outstanding as of July 6, 2007)
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, 2007.
(1)
Excludes 2,642,376 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, 2006.
PEREGRINE
PHARMACEUTICALS, INC.
FORM
10-K ANNUAL REPORT
FISCAL
YEAR ENDED APRIL 30, 2007
TABLE
OF CONTENTS
PART
I
Item
1.
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Business
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1
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Item
1A.
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Risk
Factors
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19
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Item
1B.
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Unresolved
Staff Comments
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29
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Item
2.
|
Properties
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29
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Item
3.
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Legal
Proceedings
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30
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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30
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PART
II
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|||
Item
5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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31
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Item
6.
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Selected
Financial Data
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32
|
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Item
7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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33
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Item
7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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46
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Item
8.
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Financial
Statements and Supplementary Data
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46
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Item
9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
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46
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Item
9A
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Controls
and Procedures
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46
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Item
9B.
|
Other
Information
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46
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PART
III
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|||
Item
10.
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Directors,
Executive Officers and Corporate Governance
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49
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Item
11.
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Executive
Compensation
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49
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Item
12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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49
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Item
13.
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Certain
Relationships and Related Transactions, and Director
Independence
|
49
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Item
14.
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Principal
Accountant Fees and Services
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49
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PART
IV
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|||
Exhibits
and Consolidated Financial Statement Schedules
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50
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||
Signatures
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57
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i
PART
I
In
this
Annual Report, the terms “we”, “us”, “our”, “Company” and “Peregrine” refer 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” 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 that 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 stage and pre-clinical
product candidates using monoclonal antibodies for the treatment of cancer
and viral diseases. We are advancing three separate clinical programs
encompassing two platform technologies: Anti-PhosphatidylSerine (“Anti-PS”)
Immunotherapeutics and Tumor Necrosis Therapy (“TNT”).
Our
lead
Anti-PS product, bavituximab, is in separate clinical trials for the treatment
of solid cancers and hepatitis C virus (“HCV”) infection. We have completed a
total of three bavituximab clinical trials treating over 60 patients with
chronic HCV infection or advanced solid cancers. Of the three completed studies,
we have completed Phase Ia and Phase Ib clinical trials in patients with chronic
HCV infection and we recently opened enrollment in the U.S. for a new
clinical study to evaluate bavituximab in patients co-infected with both HCV
and
human immunodeficiency virus (“HIV”) based on data from the previous two
studies. In addition, we recently completed a Phase Ib trial in which
bavituximab was administered in combination with chemotherapy in patients with
solid cancers and we are actively recruiting patients in a bavituximab Phase
I
monotherapy trial in patients with advanced solid cancers. Data from the Phase
Ib study are being used to plan Phase II bavituximab solid cancer clinical
studies expected to start later this year in India.
1
Under
our
TNT technology platform, our lead product candidate is Cotara®. We have
completed several clinical trials in over 85 patients with advanced solid
cancers. Previous clinical trials in patients with brain cancer demostrated
particularly promising results. Data from these prior clinical studies has
led
us to two ongoing Cotara® brain cancer studies including a Phase II clinical
trial in patients with glioblastoma multiforme at first replase in order to
better evaluate the safety and efficacy of Cotara®. In addition, we are actively
recruiting patients in a dose confirmation and dosimetry clinical trial in
patients with recurrent glioblastoma multiforme in order to further characterize
the distribution characteristics of Cotara®. These two studies are currently
open for enrollment.
The
following table represents a summary of our ongoing and anticipated clinical
trial programs:
Product
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Indication
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Trial
Design
|
Status
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|||
Bavituximab
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Solid
tumor cancers
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Phase
I repeat dose monotherapy safety study to treat up to 28 patients.
|
Study
is open for enrollment in the U.S.
|
|||
Bavituximab
plus chemotherapy and/or radiation therapy
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Solid
tumor cancers
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Phase
II studies.
|
Studies
are being planned and are expected to initiate later this year
in
India.
|
|||
Cotara®
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Brain
cancer (glioblastoma multiforme or GBM)
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Dosimetry
and dose confirmation study designed to treat up to 12 patients
with
recurrent GBM.
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Study
is open for enrollment in the U.S.
|
|||
Cotara®
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Brain
cancer (glioblastoma multiforme)
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Phase
II safety and efficacy study to treat up to 40 patients at 1st
relapse.
|
Study
is open for enrollment in India.
|
|||
Bavituximab
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Chronic
Hepatitis C Virus (“HCV”) infection (co-infected with HIV)
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Phase
Ib repeat dose safety study in 24 patients.
|
Study
is open for enrollment in the U.S.
|
|||
Bavituximab
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Chronic
Hepatitis C Virus (“HCV”) infection
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Phase
Ib safety and dosing study.
|
Study
is being planned and is expected to initiate later this year in
the
U.S.
|
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, therapeutic adjuvants and
diagnostic agents to expand the potential of our technology
pipeline.
In
addition to our research and development 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. In addition to
Peregrine-related activities, Avid provides contract manufacturing services
for
outside biotechnology and biopharmaceutical companies on a fee-for-service
basis.
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 14282 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”).
2
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
found
only on the inner surface of the cell membrane. Our 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, is believed to help stimulate
the
body's immune defenses to destroy disease-associated cells that have exposed
PS
on their surface. In addition, researchers believe that Anti-PS therapies also
may have a secondary mechanism of action that occurs under certain stressful
conditions at the cellular level, whereby the PS molecule expressed on the
surface of the cell has immunosuppressive effects and dampens the body’s normal
immune response to that cell. By blocking the PS molecule using bavituximab,
this technology may have the potential to block and turn-off this
immunosuppressive signal, allowing the immune system to generate a robust immune
response. Bavituximab 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 DNA and associated
histone proteins accessible in dead and dying cells found at the core of solid
tumors. Most solid tumors develop this core of dead or dying (necrotic) cells
in
the center of the tumor mass as it grows due to the lack of oxygen and
nutrients. The outer membranes of necrotic cancer cells become leaky,
which exposes the DNA and associated histone proteins making it an abundant
but
selective target for TNT monoclonal antibodies. TNT antibodies are then
potentially capable of carrying a variety of therapeutic agents into the
interior of solid tumors, including radioisotopes and chemotherapeutic agents,
thereby killing the tumor from the inside out. Our most advanced TNT product,
Cotara®, is an antibody attached to a radioactive isotope, Iodine 131, and like
a guided missile, the antibody is designed to target specific features at the
core of a tumor to deliver a toxic payload (Iodine 131) to neighboring viable
cells to literally kill the tumor from the inside out.
Our
Products in Clinical Trials
Bavituximab
for the Treatment of HCV Infection
Bavituximab
is a monoclonal antibody that targets and binds to PS. Our researchers and
collaborators have discovered that PS, the target for bavituximab, becomes
exposed on the surface of a broad class of viruses known as enveloped viruses,
as well as on the cells they infect. These pathogens are responsible for about
half of all human viral diseases, including hepatitis C virus (HCV), influenza,
human immunodeficiency virus (HIV), cytomegalovirus (CMV) and other virus
strains that cause serious and life-threatening conditions. Scientists studying
bavituximab believe the drug’s mechanism of action may help 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.
3
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 thirty (30) patients chronically infected
with HCV who had failed prior therapies. The primary goals of the Phase Ia
study
were to determine the safety and pharmacologic profiles of bavituximab in
patients with chronic HCV infection. Changes in viral load, measured as serum
HCV RNA levels, were also monitored. In the study, 30 patients with chronic
HCV
infection were administered one of five doses of bavituximab including 0.1,
0.3,
1, 3 and 6 milligrams per kilogram (mg/kg) of body weight. After a single dose
of bavituximab, among the patients administered 1, 3 and 6 mg/kg doses, 50%
achieved a maximum peak reduction in serum hepatitis C virus levels of greater
than 75% (0.6 log), with one patient having a maximum peak 97% (1.5 log)
reduction. 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 five dose levels, bavituximab appeared to be safe
and well tolerated with no dose limiting toxicities or serious adverse events.
Reported adverse events were mostly mild, infrequent, transient and likely
not
drug-related. We reported initial results of this study on June 7, 2006 and
final results were presented at the annual meeting of the American Association
for the Study of Liver Diseases in Boston, MA on October 30, 2006.
These
results supported the initiation and completion of a Phase Ib repeat dose HCV
trial during fiscal year 2007 with top-line results reported in February 2007.
The primary objective of the Phase Ib study was to determine the safety
tolerability and pharmacokinetic properties after multiple doses of single
agent
bavituximab in patients with chronic HCV infection. Changes in viral load,
measured as serum HCV RNA levels, were also monitored. Twenty-four patients
(four cohorts of six patients each) were enrolled in the study, with each cohort
scheduled to receive four doses of bavituximab over a 14-day period. Patients
received twice-weekly doses of bavituximab at escalating dose levels of 0.3,
1,
3 or 6 mg/kg of body weight. Patients in all cohorts were followed for 12 weeks.
The results indicate that bavituximab was generally safe and well-tolerated,
with no dose limiting toxicities or serious adverse events reported, and that
bavituximab showed signs of transient dose-dependent anti-viral activity. In
the
study, 83% of patients at the 3 mg/kg dose level demonstrated a maximum peak
reduction in HCV RNA levels of at least a 75% (0.6 log), with an average of
an
84% (0.8 log) peak reduction for those patients.
Based
on
these positive data, and on pre-clinical data indicating the potential of
bavituximab to bind to HIV virus and HIV infected cells, we decided to advance
bavituximab into a new HCV
trial. On May 17, 2007, we filed a new clinical trial protocol with the FDA
to
study bavituximab in HCV patients co-infected with HCV and HIV. The new study
is
an open-label, dose escalation study designed to assess the safety and
pharmacokinetics of bavituximab in up to 24 patients chronically infected with
HCV and HIV and we recently announced that this study is open for enrollment
in
the U.S. Patient cohorts will receive ascending dose levels of bavituximab
weekly for up to 8 weeks. HCV and HIV viral titers and other biomarkers will
be
tracked, although they are not formal study endpoints. In the U.S. alone, an
estimated 300,000 individuals are co-infected with HIV and HCV, representing
up
to 30% of all HIV-infected patients. Co-infected patients have been shown to
have a lower response to current HCV regimens and the adverse effects of these
regimens can be especially problematic for some HIV patients.
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 viral 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 future clinical
indications.
Bavituximab
for the Treatment of Solid Cancers
Scientists
working with us have determined that the target for bavituximab becomes
specifically exposed on tumor blood vessels. In pre-clinical solid cancer
therapy studies, including the treatment of breast, prostate and pancreatic
tumors, a bavituximab equivalent (mouse version of the antibody) had promising
anti-tumor activity as a stand-alone treatment. Researchers have shown in
pre-clinical studies that common cancer treatments such as chemotherapy and
radiation therapy stress the cells that line the tumor blood vessels and thereby
increase the exposure of the PS target on tumor blood vessels. This combination
therapy approach has been shown in pre-clinical studies to enhance the
anti-tumor effects of the bavituximab approach.
4
Bavituximab
is currently in a multi-center Phase I clinical trial in the U.S. for which
most
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 with an extension protocol. Patient screening and
enrollment are currently ongoing.
We
have
experienced delays in enrolling patients for this study, initially due to
certain FDA mandated requirements in the study’s protocol which limited the
number of cancer patients eligible for the study and the number of patients
willing to participate in the study due to the length of time between
treatments. We have since presented the FDA with data sufficient to allow
us to
amend the protocol and lessen such requirements as well as making other changes
to the protocol to make it more appealing to both physicians and patients.
While
we are hopeful that such changes will enable us to increase the rate of patient
enrollment, due to the competition with other cancer trials being conducted
in
the United States, we continue to face enrollment challenges in the United
States.
Based
on
data from the ongoing Phase I study and safety data generated from the Hepatitis
C clinical program, we were able to initiate a Phase
Ib open label trial of bavituximab in combination with chemotherapy in patients
with advanced solid tumors
in
November of 2006.
This trial, which was conducted in India, was designed to assess the safety
and
tolerability of up to eight weekly doses of bavituximab given in combination
with standard chemotherapy regimens including docetaxel, gemcitabine and
carboplatin/paclitaxel in 12 patients with late stage cancer who had failed
prior therapy. Patients in the trial were also assessed for tumor response,
although efficacy assessments were not formal endpoints of the study. Patients
were evaluated for tumor response according to Response Evaluation Criteria
in
Solid Tumors (RECIST) parameters, receiving CT or MRI scans prior to therapy
and
at the end of the combination treatment course.
On
May 31, 2007 we reported positive top-line results from the Phase Ib open label
trial. In
these
patients, the safety profile of bavituximab in combination with chemotherapy
appeared similar to that seen in advanced cancer patients undergoing
chemotherapy alone. The combination of bavituximab and chemotherapy showed
positive signs of clinical activity, achieving objective tumor response or
stable disease in 50% of the patients who were evaluable for tumor response.
Patients receiving bavituximab in combination with gemcitabine had positive
signs of clinical activity, with 75% achieving an objective tumor response
or
stable disease, while 50% of patients receiving bavituximab with
carboplatin/paclitaxel demonstrated an objective tumor response. Tumor
types in the trial included cancers of the breast, lung and ovary, among others.
Data
from
this study are being further analyzed to support the initiation of Phase II
cancer trials later this year in India.
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 monoclonal antibody targeting agent
conjugated to Iodine 131, a therapeutic radioisotope that kills tumor cells
near
the site of localization. Cotara® binds to DNA and associated histone proteins
that become accessible in dead and dying cells found at the core of tumors.
In
previous clinical studies Cotara® has demonstrated
encouraging results in patients with advanced brain cancer. One study
demonstrated a 58% increase in expected median survival time in a group of
patients suffering from recurrent glioblastoma multiforme (“GBM”) who were
treated with Cotara®. This was considered a promising development in this
serious and deadly disease.
Cotara®
is currently in a dose confirmation and dosimetry clinical trial for the
treatment of recurrent GBM at several clinical sites in the U.S. The open
label
study design allows us to treat up to 12 GBM patients who have recurrent
disease. Patients are receiving Cotara® by convection-enhanced delivery (CED), a
National Institute of Health (NIH) developed technique that delivers the
agent
to the tumor with great precision. The study’s main objectives are to confirm
the maximum tolerated dose, to determine radiation dosimetry and to assess
overall patient survival, progression free survival and the proportion of
patients alive at six months following Cotara® administration.
We
initially commenced this study in collaboration
with New Approaches to Brain Tumor Therapy (NABTT), a consortium of leading
medical institutions funded by the National Cancer Institute, as a means
of
saving trial costs. Due to slower than expected patient enrollment and budget
cut-backs at NABTT, we have agreed to assume full responsibility and control
of
the study and are contracting directly with certain NABTT institutions, as
well
as adding other sites, such as the Medical University of South Carolina.
5
On
June
25, 2007, we reported that we had received regulatory approval in India for
a
new clinical trial designed to assess Cotara® in patients with GBM. The new
study is expected to be an integral part of our overall Cotara®
brain
cancer development program. It is being conducted according to internationally
accepted ICH (International Conference on Harmonization) and GCP (Good Clinical
Practices) guidelines at several clinical centers and is expected to enroll
up
to 40 patients who have GBM at first relapse. Patients will receive a single
infusion of the drug using CED. The endpoints of the trial are to confirm safety
and determine median survival time and median time to progression in
Cotara®-treated patients.
Taken
together, the U.S. study results along with data collected from the new study
in
India should provide the safety, dosimetry and initial efficacy data needed
to
support the design of the Phase III study. Cotara® has been granted FDA orphan
drug status and fast track designation for the treatment of glioblastoma and
another lethal brain cancer.
Earlier-Stage
Technologies
We
are
pursuing several earlier stage technologies including Vasopermeation Enhancement
Agents (“VEAs”) that are intended to be used as an adjuvant to improve the
performance of standard cancer drugs. We are also evaluating several
Anti-Angiogenesis Agents and Vascular Targeting Agents (“VTAs”) that complement
our other anti-cancer platforms, as further described below.
Vasopermeation
Enhancement Agents (VEAs)
- VEAs
are adjuvants that are intended to improve the performance of standard cancer
drugs. VEAs utilize monoclonal antibodies that are designed to increase the
uptake of cancer therapeutics and imaging agents into 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) to solid tumors selectively. VEAs currently use the
same targeting agent as our TNT compounds. 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
about 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. At the annual meeting
of
the American Association for Cancer Research (AACR) in April 2007, Peregrine
researchers reported they have recently identified VEA development candidates
for further testing in animals.
Anti-Angiogenesis
Agents -
Anti-Angiogenesis Agents work by inhibiting growth of new blood vessels.
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 Peregrine’s anti-angiogenesis compound family under development for the
treatment of cancer and other diseases dependent upon aberrant blood vessel
formation. At the 2007 AACR meeting, researchers presented pre-clinical studies
comparing Peregrine’s selective anti-VEGF antibody to Genentech’s
anti-angiogenesis anti-cancer drug Avastin®. Peregrine’s selective antibody
compared favorably on all efficacy parameters assessed, inhibiting tumor
growth
by 90% in pre-clinical cancer models. Antibodies with greater selectivity
may
have advantages in clinical use since they have the potential to inhibit
only
angiogenesis, while not impairing other functions of VEGF. Additional data
were
presented showing the efficacy of a fully human selective anti-VEGF antibody
developed by Peregrine, which is expected to help facilitate the pre-clinical
progress of this program.
6
Vascular
Targeting Agents (VTAs)
- VTAs
utilize monoclonal antibodies and other targeting agents that recognize markers
selectively found on tumor blood vessels while absent from normal blood vessels.
VTAs act in a two-step process: (1) the VTA first binds to the tumor blood
vessels and then (2) induces the formation of a blood clot in these vessels.
The
formation of the blood clot stops the flow of oxygen and nutrients to the tumor
cells, which ultimately results in tumor cell death. The potential of this
technology was documented in the January 1, 2007 issue of Clinical
Cancer Research
where
scientists demonstrated that the VTA technology could be used to target
microbubbles to tumor blood vessels in order to monitor the patient’s response
to anti-angiogenesis therapy, thereby identifying at an early stage which cancer
patients are benefiting from the treatment. Using the microbubble technology,
ultrasound images identified the number of tumor blood vessel markers that
were
present before and after treatment with several anti-angiogenic agents,
including Avastin®, and 2C3, a novel anti-angiogenic antibody in pre-clinical
development by Peregrine. A decrease in the number of tumor blood vessel markers
indicated that the treatment was working as intended. This capability is
potentially important because a significant proportion of cancer patients do
not
respond to Avastin®. The "personalized medicine" made feasible by this approach
therefore has the potential to increase the efficacy of cancer regimens, reduce
side effects from ineffective treatments and improve the overall cost
effectiveness of cancer therapy.
Studies
presented at the 2007 AACR meeting also assessed the anti-cancer properties
of
VTA-based immunocytokine fusion proteins--combinations of vascular targeting
agents such as bavituximab equivalents and immune system-stimulating cytokines
such as interferon and interleukin-2. Peregrine’s immunocytokine fusion proteins
showed robust anti-tumor efficacy in animal models of melanoma and B-cell
lymphoma, without the signs of toxicity that have limited the wide use of
cytokines as anti-cancer agents. In particular, the 85% reduction in tumor
growth observed in the B-cell lymphoma model serves as an important validation
of Peregrine’s VTA immunocytokine approach, and hematological cancers such as
lymphoma also represent potential new cancer indications for the Company.
In-Licensing
Collaborations
The
following discussions cover our collaborations and in-licensing obligations
related to our products in clinical trials:
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. 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 is included in research and development
expense 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
a
product is approved and 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
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 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.
7
Under
our
in-licensing agreements relating to the Anti-PS 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 and/or a percentage of sublicense income. Our aggregate
future milestone payments under the above in-licensing agreements are $6,900,000
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 2008 and $6,400,000 upon approval of the first Anti-PS
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 for commercial purposes, we would owe Lonza 300,000
pounds sterling per year in addition to an increased royalty on net
sales.
During
fiscal year 2006, we expensed $450,000 under in-licensing agreements covering
our Anti-PS Immunotherapeutics technology platform, which is included in
research and development expense.
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.
During
September 1995, we entered into an agreement with Cancer Therapeutics, Inc.,
a
California corporation, whereby we granted to Cancer Therapeutics Laboratories,
Inc. (“CTL”) 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. During January 2007, we filed a lawsuit against
CTL
alleging various breaches of contract under the agreement. The lawsuit is
currently in the discovery phase as further discussed in Part 1, Item 3 under
"Legal Proceedings" of this Annual Report. Through fiscal year ended April
30,
2007, 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.
8
During
February 2007, we entered into an amended and restated license agreement with
SuperGen, Inc. (“SuperGen”) revising the original licensing deal completed with
SuperGen in February 2001, to license a segment of our VTA technology,
specifically related to certain conjugates of vascular endothelial growth factor
(“VEGF”). Under the terms of the amended and restated license agreement, we will
receive annual license fees of up to $200,000 per year payable in cash or
SuperGen common stock until SuperGen files an Investigational New Drug
Application in the United States utilizing the VEGF conjugate technology. In
addition, we could receive up to $8.25 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, as amended. We could also receive
additional consideration for each clinical candidate that enters a Phase III
clinical trial by SuperGen. As of April 30, 2007, SuperGen has not filed an
Investigational New Drug Application in the United States utilizing the VEGF
conjugate 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, which we amortized as license revenue over an estimated period of
48
months through December 2006 in accordance with SAB No. 104. 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, under the terms
of the agreement, we could receive up to $1.2 million in future payments for
each product based on the achievement of all clinical and regulatory milestones
combined with 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 antibody conjugates 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.
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.
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.
9
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 that 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 process development
labs. 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 that 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 exhibiting at trade shows, exposure from
attending conferences and through word of mouth. 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 large and small and domestic and foreign
biotechnology companies interested in the production of monoclonal antibodies
for clinical trial and, as discussed below, commercial use. Additionally, Avid
has been audited by the European Regulatory authorities, 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
commercial product for the client company under this approved New Drug
Application.
10
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, 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. Some 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
trial 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. A clinical
trial 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 patients are being exposed to an unacceptable
health risk.
|
11
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.
12
Manufacturing
and Raw Materials
Manufacturing.
We
manufacture pharmaceutical-grade products to supply our 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.
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 proteins, 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.
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 and/or designed around by
others.
13
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 development of 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 10, “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
any of 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.
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 that are comparable or superior to
our
technologies and products.
14
We
are
conducting the Cotara® dose confirmation and dosimetry clinical trial for the
treatment of recurrent brain cancer as a stand-alone study directly with several
New Approaches to Brain Tumor Therapy (“NABTT”) sponsored university clinical
sites together with additional centers in the U.S. such as the Medical Center
of
South Carolina. We also recently opened enrollment in a Phase II study in India
using Cotara® to treat up to 40 patients for the treatment of recurrent brain
cancer. Existing treatments for brain cancer include the Gliadel® Wafer
(polifeprosan 20 with carmustine implant) from MGI Pharma, Inc. and Temodar®
(temozolomide) 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 with brain cancer.
Because
Cotara® targets brain tumors from the inside out, it is a novel treatment
dissimilar from other drugs in development for this disease. Some products
in
development may compete with Cotara® should they become approved for marketing.
These products include, but are not limited to CDX-110, a peptide vaccine under
development by Celldex. Merck KGaA is evaluating cilengitide in newly diagnosed
GBM patients. AstraZeneca is developing cediranib for patients with recurrent
GBM. In addition, oncology products marketed for other indications such as
Gleevec® (Novartis), Tarceva® (Genentech/OSI), Avastin® (Genentech) and Nexavar®
(Bayer), are being tested in clinical trials for the treatment of brain
cancer.
Bavituximab
for the treatment of advanced solid cancers is currently in a Phase I clinical
trial in the U.S. and we recently completed a Phase Ib clinical trial in India
for the treatment of patients with advanced solid tumors in combination with
chemotherapy. 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 Bristol-Myers
Squibb Company, Rituxan® and Herceptin® by Biogen Idec Inc. and Genentech, Inc.,
and Vectibix™ 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 Phase Ia single-dose and Phase Ib multiple dose
clinical trials evaluating bavituximab for the treatment of HCV. Bavituximab
is
a first-in-class approach for the treatment of HCV. We are aware of no other
products in development targeting phosphatidylserine 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 side effects 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.
15
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
Albuferon™ (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, but
are
not limited to, protease inhibitors such as telaprevir from Vertex
Pharmaceuticals Incorporated, and SCH7 from Schering-Plough Corporation, and
valopicitabine, 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
$15,876,000 in fiscal year 2007, $12,415,000 in fiscal year 2006, and
$11,164,000 in fiscal year 2005.
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, 14282 Franklin Avenue, Tustin, California 92780.
Human
Resources
As
of
April 30, 2007, we employed 112 full-time employees and 4 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.
16
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.
17
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 conducting a research study such as a clinical
trial.
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.
18
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, 2007, we had approximately $32.5 million in cash and cash equivalents,
including $20.9 million in net proceeds received under a Securities Purchase
Agreement dated June 28, 2007. 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.
Revenues
earned by Avid during fiscal years ended April 30, 2007, 2006 and 2005 amounted
to $3,492,000, $3,005,000 and $4,684,000, 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 total 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 2008.
We
currently expect our monthly negative cash flow to continue for the foreseeable
future
due to the anticipated increase in clinical trials, including trials associated
with bavituximab for the treatment of both solid tumors and hepatitis C virus
(“HCV”) infection and trials associated with Cotara® for the treatment of brain
cancer. In addition, we plan to expend additional resources on our continued
research and development directed towards our other technologies in pre-clinical
development, and our possible expansion of our manufacturing capabilities.
We
plan to obtain any necessary funding to support the costs of our clinical and
pre-clinical programs through one or more methods including either equity or
debt financing and/or negotiating additional licensing or collaboration
agreements for our technology platforms. As of June 30, 2007, we had
an
aggregate of approximately 5,031,000 shares available under our existing Form
S-3 registration statements for possible future registered transactions. In
addition, during January 2007, we filed a separate shelf registration statement
on Form S-3, File Number 333-139975, which allows us to issue, from time to
time, in one or more offerings, shares of our common stock for remaining
proceeds of up to $7,500,000. 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. However, 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.
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:
Net
Loss
|
|||||
Fiscal
Year 2007
|
$
|
20,796,000
|
|||
Fiscal
Year 2006
|
$
|
17,061,000
|
|||
Fiscal
Year 2005
|
$
|
15,452,000
|
19
As
of
April 30, 2007, we had an accumulated deficit of $207,660,000. 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.
The
Sale Of Substantial Shares Of Our Common Stock May Depress Our Stock
Price.
As
of
June 30, 2007, we had approximately 226,166,000 shares of our common stock
outstanding, including 30,000,000 shares of our common stock that were issued
pursuant to a Securities Purchase Agreement dated June 28, 2007. Substantially
all of these shares are eligible for trading in the public market, subject
in
some cases to volume and other limitations. The market price of our common
stock
may decline if our common stockholders sell a large number of shares of our
common stock in the public market, or the market perceives that such sales
may
occur.
We
could
also issue up to approximately 21,535,000 additional shares of our common stock
that are reserved for future issuance under our shelf registration statements,
stock option plans and for outstanding warrants, as further described in the
following table:
Number
of Shares
of
Common Stock Reserved For Issuance
|
|||
Shares
reserved for issuance under two effective shelf
registration statements
|
5,030,634
|
||
Common
shares reserved for issuance upon exercise of outstanding options
or
reserved for future option grants under our stock incentive
plans
|
16,144,355
|
||
Common
shares issuable upon exercise of outstanding warrants
|
360,000
|
||
Total
|
21,534,989
|
In
addition, the above table does not include shares of common stock that we could
issue under the registration statement we filed during January 2007 on Form
S-3,
File Number 333-139975, which allows us to issue, from time to time, in one
or
more offerings, shares of our common stock for remaining proceeds of up to
$7,500,000.
Of
the
total warrants and options outstanding as of June 30, 2007, approximately
1,443,000 options 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 June 30, 2007.
In
addition, we will need to raise substantial additional capital in the future
to
fund our operations. If we raise additional funds by issuing equity securities,
the market price of our securities may decline and our existing stockholders
may
experience significant dilution.
20
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 fiscal years ended April 30, 2007:
Common
Stock
Sales
Price
|
Common
Stock Daily Trading Volume
(000’s
omitted)
|
||||||||
High
|
Low
|
High
|
Low
|
||||||
Fiscal
Year 2007
|
|||||||||
Quarter
Ended April 30, 2007
|
$1.26
|
$0.86
|
6,214
|
408
|
|||||
Quarter
Ended January 31, 2007
|
$1.39
|
$1.09
|
4,299
|
203
|
|||||
Quarter
Ended October 31, 2006
|
$1.48
|
$1.12
|
3,761
|
277
|
|||||
Quarter
Ended July 31, 2006
|
$1.99
|
$1.30
|
23,790
|
429
|
|||||
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
|
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;
|
·
|
the
offering and sale of shares of our common stock at a discount under
an
equity transaction;
|
·
|
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
|
·
|
healthcare
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.
21
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.
|
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 ended April 30, 2007, the trading price of our common stock on The Nasdaq
Capital Market ranged from $0.86 per share to $1.99 per share. Most recently,
the closing bid price of our common stock has been below $1.00 since June 12,
2007 or 19 consecutive trading days as of July 9, 2007. If the closing bid
price
of our common stock is below $1.00 per share for a period of thirty consecutive
trading days, we will receive a deficiency notice from NASDAQ®,
and we
will automatically be afforded a "compliance period" of 180 calendar days within
which to regain compliance. To demonstrate compliance with the minimum closing
bid price requirement, we must maintain a closing bid price of at least $1.00
per share for 10 consecutive trading days. If we are still not in compliance
with the minimum closing bid price requirement after the initial 180 calendar
day period but we are in compliance with all initial listing requirements other
than the bid requirement, we will be afforded an additional "compliance period"
of 180 calendar days within which to regain compliance. If we fail to regain
compliance with the minimum closing bid price requirement or fail to comply
with
any other 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.
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 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.
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.
|
22
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
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.
Our
Product Development Efforts May Not Be Successful.
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;
|
·
|
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.
23
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 trials should not
be
relied upon as evidence that later or larger-scale clinical trials will succeed.
The Phase I studies we have completed to date have been designed to primarily
assess safety in a small number of patients. The limited results we have
obtained may not predict results for any future studies and also may not predict
future therapeutic benefit. We will be required to demonstrate through
larger-scale clinical trials that bavituximab and Cotara® are safe and effective
for use in a diverse population before we can seek regulatory approval for
their
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.
|
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.
24
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We
have
completed Phase I and Phase I/II studies with Cotara® for the treatment of brain
cancer. In addition, we are currently conducting a dose confirmation and
dosimetry clinical trial in
patients with recurrent glioblastoma multiforme (“GBM”) in the U.S. In June
2007, we opened enrollment in a Phase II safety and efficacy study in India
using a single administration of the drug through an optimized delivery method.
Taken
together, the current U.S. study along with data collected from the Phase II
safety and efficacy study in India should provide the safety, dosimetry and
efficacy data that will support the final design of the larger Phase III study.
Once we complete these two Cotara® studies for the treatment of GBM, 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 the U.S.
and the Phase II study in India 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”)
for Cotara® with Iso-tex Diagnostics, Inc. for all U.S. clinical trials and with
the Board of Radiation & Isotope Technology (“BRIT”) for our Phase II study
in India. If either of these suppliers are unable to continue to qualify their
respective facility or radiolabel and supply our antibody in a timely manner,
our current clinical trials using radiolabeling technology could be adversely
affected and significantly delayed. While there are other suppliers for
radioactive isotope combination services in the U.S., 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. In addition, the number of companies in India
that
could perform these radiolabeling services is very limited. 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.
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.
|
25
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.
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.
|
26
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 have an material adverse effect on our business and our
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 that 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 directly with several
New Approaches to Brain Tumor Therapy (“NABTT”) sponsored university clinical
sites together with additional centers in the U.S. such as the Medical Center
of
South Carolina. We also recently opened enrollment in a Phase II study in India
using Cotara® to treat up to 40 patients for the treatment of recurrent brain
cancer. Existing treatments for brain cancer include the Gliadel® Wafer
(polifeprosan 20 with carmustine implant) from MGI Pharma, Inc. and Temodar®
(temozolomide) 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 with brain cancer.
Because
Cotara® targets brain tumors from the inside out, it is a novel treatment
dissimilar from other drugs in development for this disease. Some products
in
development may compete with Cotara® should they become approved for marketing.
These products include, but are not limited to CDX-110, a peptide vaccine under
development by Celldex. Merck KGaA is evaluating cilengitide in newly diagnosed
GBM patients. AstraZeneca is developing cediranib for patients with recurrent
GBM. In addition, oncology products marketed for other indications such as
Gleevec® (Novartis), Tarceva® (Genentech/OSI), Avastin® (Genentech) and Nexavar®
(Bayer), are being tested in clinical trials for the treatment of brain
cancer.
Bavituximab
for the treatment of advanced solid cancers is currently in a Phase I clinical
trial in the U.S. and we recently completed a Phase Ib clinical trial in India
for the treatment of patients with advanced solid tumors in combination with
chemotherapy. 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 Bristol-Myers
Squibb Company, Rituxan® and Herceptin® by Biogen Idec Inc. and Genentech, Inc.,
and Vectibix™ 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.
27
In
addition, we have completed Phase Ia single-dose and Phase Ib multiple dose
clinical trials evaluating bavituximab for the treatment of HCV. Bavituximab
is
a first-in-class approach for the treatment of HCV. We are aware of no other
products in development targeting phosphatidylserine 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 side effects 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
Albuferon™ (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, but
are
not limited to, protease inhibitors such as telaprevir from Vertex
Pharmaceuticals Incorporated, and SCH7 from Schering-Plough Corporation, and
valopicitabine, 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, as discussed in Note 3, “Stock-Based
Compensation,” in the notes to the condensed consolidated financial statements.
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. Our adoption of SFAS No. 123R is expected to
materially impact our financial position and results of operations for future
periods. During the fiscal year ended April 30, 2007, our loss from operations
included non-cash stock-based compensation expense of $964,000 related to the
adoption of SFAS No. 123R. 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.
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.
28
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.
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
$64,000 for these facilities with a 3.35% rental increase every two years.
The
next rental increase is scheduled for December 2008. 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
will continue to 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.
29
ITEM
3. LEGAL
PROCEEDINGS
In
the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. Although we currently are not aware of any such legal
proceedings or claim that we believe will have, individually or in the
aggregate, a material adverse effect on our business, operating results or
cash
flows, however, we did file or are involved with the following
lawsuits:
On
January 12, 2007, we filed a complaint in the Superior Court of the State of
California for the County of Orange against Cancer Therapeutics Laboratories
(“CTL”). The lawsuit alleges that CTL has breached various agreements with the
Company by (i) failing to pay to the Company its contractual share of the
proceeds received by CTL when it formed a joint venture with a company in China
involving the Company’s technology that had been licensed to CTL pursuant to an
earlier agreement (the “Agreement”), (ii) failing to procure a sublicense with
the company in China prior to transferring the Company’s technology to such
company in China, and (iii) failing to provide the Company with access to CTL’s
books and records, as required by the Agreement. Based on early discovery,
we
amended the complaint on May 4, 2007 to include claims against Shanghai
Medipharm and its related entities, and Alan Epstein, M.D alleging that these
defendants collaborated to interfere with the Agreement by entering into a
secret economic relationship between themselves and designed not to share
profits and know-how with Company in violation of the Agreement, including
proprietary technologies that they developed and are required to share with
Company. The Company is seeking unspecified damages and declaratory relief
with
respect to the termination of the Agreement with CTL, the exclusion of certain
technology from the Agreement, and an accounting of all monies, data and other
items that should been paid or given to the Company under the
Agreement.
On
March
28, 2007, CTL filed a cross-complaint, which they amended on May 30, 2007,
alleging that the Company breached the Agreement, improperly terminated the
Agreement, is interfering with CTL’s agreements with various Medipharm entities
and is double-licensing the technology licensed to CTL to another party. CTL’s
cross-complaint, which seeks $20 million in damages, is in part predicated
on
the existence of a sublicense agreement between CTL and Medipharm. While we
are
objecting to the cross-complaint on several grounds, we are challenging the
cross-complaint on the basis that not only did CTL fail to allege an agreement
with which Company interfered, they have been unable to produce the alleged
sublicense agreement with Medipharm despite our repeated demands.
The
discovery phase on the aforementioned cases has only recently commenced. Until
we complete the initial discovery phase and our objections are considered,
we
cannot estimate the magnitude of the claims of the parties against each other
or
probable outcome of the litigation.
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, 2007.
30
PART
II
ITEM
5. MARKET
FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDERS’ MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
(a) Market
Information.
The
Company is listed on 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, 2007:
Common
Stock Sales Price
|
||||
High
|
Low
|
|||
Fiscal
Year 2007
|
||||
Quarter
Ended April 30, 2007
|
$1.26
|
$0.86
|
||
Quarter
Ended January 31, 2007
|
$1.39
|
$1.09
|
||
Quarter
Ended October 31, 2006
|
$1.48
|
$1.12
|
||
Quarter
Ended July 31, 2006
|
$1.99
|
$1.30
|
||
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
|
(b) Holders.
As of
June 30, 2007, the number of stockholders of record of the Company's common
stock was 5,835.
(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.
(e) Recent
Sale of Unregistered Securities. During the year ended April 30, 2007,
warrants to purchase an aggregate of 6,266,788 shares of the Company’s common
stock were exercised by three institutional investors on a cash basis under
various transactions for net proceeds of $4,836,000 and the issuance of
6,266,788 shares of our common stock.
31
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, 2007. 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, 2007, 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,
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
Revenues
|
$
|
3,708,000
|
$
|
3,193,000
|
$
|
4,959,000
|
$
|
3,314,000
|
$
|
3,921,000
|
||||||
Net
loss
|
$
|
(20,796,000
|
) |
$
|
(17,061,000
|
) |
$
|
(15,452,000
|
) |
$
|
(14,345,000
|
) |
$
|
(11,559,000
|
) | |
Basic
and diluted loss per common share
|
$
|
(0.11
|
) |
$
|
(0.10
|
) |
$
|
(0.11
|
) |
$
|
(0.11
|
) |
$
|
(0.10
|
) | |
Weighted
average common shares outstanding
|
$
|
192,297,309
|
$
|
168,294,782
|
$
|
144,812,001
|
$
|
134,299,407
|
$
|
116,468,353
|
CONSOLIDATED
BALANCE SHEET DATA
AS
OF APRIL 30,
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
Cash
and cash equivalents
|
$
|
16,044,000
|
$
|
17,182,000
|
$
|
9,816,000
|
$
|
14,884,000
|
$
|
3,137,000
|
||||||
Working
capital
|
$
|
14,043,000
|
$
|
15,628,000
|
$
|
7,975,000
|
$
|
13,631,000
|
$
|
1,949,000
|
||||||
Total
assets
|
$
|
22,997,000
|
$
|
22,676,000
|
$
|
14,245,000
|
$
|
19,137,000
|
$
|
5,399,000
|
||||||
Long-term
debt
|
$
|
149,000
|
$
|
545,000
|
$
|
434,000
|
$
|
-
|
$
|
760,000
|
||||||
Accumulated
deficit
|
$
|
(207,660,000
|
)
|
$
|
(186,864,000
|
)
|
$
|
(169,803,000
|
)
|
$
|
(154,351,000
|
)
|
$
|
(140,006,000
|
)
|
|
Stockholders’
equity
|
$
|
16,989,000
|
$
|
17,626,000
|
$
|
9,610,000
|
$
|
14,759,000
|
$
|
2,131,000
|
32
ITEM
7. MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
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, 2007. 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 stage and
pre-clinical product candidates using monoclonal antibodies for the
treatment of cancer and viral diseases. We are advancing three separate clinical
programs encompassing two platform technologies: Anti-PhosphatidylSerine
(“Anti-PS”) Immunotherapeutics and Tumor Necrosis Therapy (“TNT”). Our lead
Anti-PS product, bavituximab, is in separate Phase I clinical trials for the
treatment of solid cancers and hepatitis C virus (“HCV”) infection. Under our
TNT technology platform, our lead candidate Cotara®, is advancing through two
brain cancer clinical studies including a Phase II clinical trial in which
up to
40 patients with glioblastoma multiforme will be treated in order to better
evaluate efficacy of Cotara® and a dose confirmation and dosimetry clinical
trial in up to 12 patients with glioblastoma multiforme in order to further
characterize the distribution characteristics of Cotara®.
We
are
organized into two reportable operating segments: (i) Peregrine, the parent
company, is engaged in the research and development of monoclonal antibody-based
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.
33
Results
of Operations
The
following table compares the consolidated statements of operations for the
fiscal years ended April 30, 2007, 2006 and 2005. 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,
|
||||||||||||||||||
2007
|
2006
|
$
Change
|
2006
|
2005
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing
|
$
|
3,492
|
$
|
3,005
|
$
|
487
|
$
|
3,005
|
$
|
4,684
|
$
|
(1,679
|
)
|
||||||
License
revenue
|
216
|
188
|
28
|
188
|
275
|
(87
|
)
|
||||||||||||
Total
revenues
|
3,708
|
3,193
|
515
|
3,193
|
4,959
|
(1,766
|
)
|
||||||||||||
COST
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
3,296
|
3,297
|
(1
|
)
|
3,297
|
4,401
|
(1,104
|
)
|
|||||||||||
Research
and development
|
15,876
|
12,415
|
3,461
|
12,415
|
11,164
|
1,251
|
|||||||||||||
Selling,
general and administrative
|
6,446
|
6,564
|
(118
|
)
|
6,564
|
5,098
|
1,466
|
||||||||||||
|
|||||||||||||||||||
Total
cost and expenses
|
25,618
|
22,276
|
3,342
|
22,276
|
20,663
|
1,613
|
|||||||||||||
LOSS
FROM OPERATIONS
|
(21,910
|
)
|
(19,083
|
)
|
(2,827
|
)
|
(19,083
|
)
|
(15,704
|
)
|
(3,379
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Recovery
of note receivable
|
-
|
1,229
|
(1,229
|
)
|
1,229
|
-
|
1,229
|
||||||||||||
Interest
and other income
|
1,160
|
846
|
314
|
846
|
265
|
581
|
|||||||||||||
Interest
and other expense
|
(46
|
)
|
(53
|
)
|
7
|
(53
|
)
|
(13
|
)
|
(40
|
)
|
||||||||
NET
LOSS
|
$
|
(20,796
|
)
|
$
|
(17,061
|
)
|
$
|
(3,735
|
)
|
$
|
(17,061
|
)
|
$
|
(15,452
|
)
|
$
|
(1,609
|
)
|
34
Total
Revenues
Year
Ended April 30, 2007 Compared to the Year Ended April 30, 2006:
The
increase in revenues of $515,000 during the year ended April 30, 2007 compared
to the prior year was due to an increase in contract manufacturing revenue
of
$487,000 combined with an increase in license revenue of $28,000. The increase
in contract manufacturing revenue was primarily due to the increase in services
provided to unrelated entities on a fee-for-service basis combined with the
collection of disputed services in the amount of $300,000 during the current
year associated with manufacturing services performed during the year ended
April 30, 2005. Since collectibility of the receivable was not reasonably
assured, in accordance with SAB No. 104, we did not recognize revenue in prior
years and the related work-in-process inventory was written off and included
in
cost of contract manufacturing during the year ended April 30, 2005.
We
expect
to continue to generate contract manufacturing revenue during fiscal year 2008
based on the anticipated completion of in-process customer related projects
and
the anticipated demand for Avid’s services under outstanding proposals. Avid is
presently working on several active projects for existing clients and has
submitted project proposals to various potential clients. Since the timing
to
initiate and complete projects for existing clients and our ability to convert
outstanding proposals into new contracts and new business is at the discretion
of our clients or potential clients, we cannot reasonably estimate with a high
degree of likelihood our revenues for fiscal year 2008.
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 fiscal year 2005 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
fiscal year 2005 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.
Cost
of Contract Manufacturing
Year
Ended April 30, 2007 Compared to the Year Ended April 30, 2006:
The
cost
of contract manufacturing as a percentage of contract manufacturing revenues
improved from 110% in fiscal year 2006 to 94% in fiscal year 2007. In the prior
year, we reported an in increase in cost of contract manufacturing as a
percentage of revenues primarily due to the write-off of unusable
work-in-process inventory generated for an unrelated entity combined with an
estimated contract loss provision for the same entity during the prior year.
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 fiscal year 2005 was primarily related to the fiscal
year 2006 decrease in contract manufacturing revenue. The fiscal year 2006
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.
35
Research
and Development Expenses
Year
Ended April 30, 2007 Compared to the Year Ended April 30, 2006:
The
increase in research and development (“R&D”) expenses of $3,461,000 during
the year ended April 30, 2007 compared to the prior year was primarily due
to an
increase in expenses associated with each of our following platform technologies
under development:
R&D
Expenses -
Fiscal
Year Ended
April 30,
|
||||||||||
2007
|
2006
|
$
Change
|
||||||||
Technology
Platform:
|
||||||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
9,324,000
|
$
|
8,271,000
|
$
|
1,053,000
|
||||
TNT
(Cotara®)
|
3,898,000
|
2,372,000
|
1,526,000
|
|||||||
VTA
and Anti-Angiogenesis Agents
|
2,037,000
|
1,416,000
|
621,000
|
|||||||
VEA
|
617,000
|
356,000
|
261,000
|
|||||||
Total
R&D Expenses
|
$
|
15,876,000
|
$
|
12,415,000
|
$
|
3,461,000
|
o
Anti-PhosphatidylSerine (“Anti-PS”) Immunotherapeutics
(bavituximab)
- The
increase in Anti-PS Immunotherapeutics program expenses of $1,053,000 during
the
year ended April 30, 2007 compared to the prior year is primarily from
continuing efforts to support the development and clinical development of our
first Anti-PS Immunotherapeutics agent, bavituximab. During the current fiscal
year, clinical trial expenses increased as we advanced the development of two
separate Phase I clinical programs using bavituximab for the treatment of
advanced solid cancers and chronic hepatitis C virus infection (“HCV”),
including the initiation and completion of a Phase Ib study in India during
the
current fiscal year using bavituximab for the treatment of advanced solid
cancers in combination with chemotherapy. These increases in clinical trial
expenses were further supplemented with increases in payroll and related
expenses, including non-cash stock-based compensation expense associated with
the amortization of the fair value of options granted to employees in accordance
with the adoption of SFAS No. 123R on May 1, 2006 and non-cash expenses
associated with shares of common stock earned by employees under our February
2006 Stock Bonus Plan. These amounts were offset by a decrease in non-cash
stock-based compensation expenses associated with non-employee consultants.
These increases in Anti-PS Immunotherapeutics program expenses were further
offset by decreases in (i) manufacturing expenses incurred in the prior year
regarding manufacturing commercial scale-up efforts to support our clinical
trials, (ii) outside antibody development fees related to a humanized antibody
in development, and (iii) technology access fees primarily associated with
clinical milestones achieved during the prior year in accordance with third
party licensing agreements.
o
Tumor
Necrosis Therapy (“TNT”) (Cotara®)
- The
increase in TNT program expenses of $1,526,000 during the year ended April
30,
2007 compared to the prior year is primarily due to increased clinical trial
expenses to support the Cotara® dose confirmation and dosimetry clinical trial
for the treatment of recurrent glioblastoma multiforme (“GBM”)and the initiation
of a Phase II clinical trial in India in patients with GBM at first relapse.
These increases in clinical trial expenses were further supplemented with
increases in payroll and related expenses to support our Cotara® clinical
studies and in-house TNT research and development efforts combined with an
increase in non-cash stock-based compensation expense primarily associated
with
the amortization of the fair value of options granted to employees in accordance
with the adoption of SFAS No. 123R on May 1, 2006.
36
o
Vascular Targeting Agents (“VTAs”) and Anti-Angiogenesis Agents
-
The
increase in VTA and Anti-Angiogenesis Agents program expenses of $621,000 during
the year ended April 30, 2007 compared to the prior year is primarily due to
increases in payroll and related expenses, manufacturing expenses and outside
research studies associated with increased efforts to advance the pre-clinical
development of our VTA and Anti-Angiogenesis Agents programs. These increases
were further supplemented by an increase in non-cash stock-based compensation
expense primarily associated with the amortization of the fair value of options
granted to employees in accordance with the adoption of SFAS No. 123R on May
1,
2006.
o
Vasopermeation Enhancements Agents (“VEAs”) - The
increase in VEA program expenses of $261,000 during the year ended April
30, 2007 compared to the prior year is primarily due to increases in payroll
and
related expenses, laboratory materials and outside antibody development studies
associated with increased efforts to advance the pre-clinical development of
our
VEA program. These increases were further supplemented by an increase in
non-cash stock-based compensation expense primarily associated with the
amortization of the fair value of options granted to employees in accordance
with the adoption of SFAS No. 123R on May 1, 2006. The above VEA increases
were
offset with a decrease in technology license fees incurred in the prior year
associated with an annual license fee due under a former license
agreement.
We
expect
research and development expenses to increase over the near term primarily
under
the following ongoing research and development programs:
1.
|
Ongoing
and anticipated bavituximab clinical studies for the treatment of
solid
tumors and chronic hepatitis C virus
infection;
|
2.
|
Cotara®
clinical studies for the treatment of glioblastoma multiforme in
two
separate clinical studies;
|
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.
|
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 each of our following platform technologies
under development:
R&D
Expenses -
Fiscal
Year Ended
April 30,
|
||||||||||
2006
|
2005
|
$
Change
|
||||||||
Technology
Platform:
|
||||||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
8,271,000
|
$
|
5,069,000
|
$
|
3,202,000
|
||||
TNT
(Cotara®)
|
2,372,000
|
3,183,000
|
(811,000
|
)
|
||||||
VTA
and Anti-Angiogenesis Agents
|
1,416,000
|
2,338,000
|
(922,000
|
)
|
||||||
VEA
|
356,000
|
567,000
|
(211,000
|
)
|
||||||
Other
research programs
|
-
|
7,000
|
(7,000
|
)
|
||||||
Total
R&D Expenses
|
$
|
12,415,000
|
$
|
11,164,000
|
$
|
1,251,000
|
37
o
Anti-PhosphatidylSerine (“Anti-PS”) Immunotherapeutics
(bavituximab)
- The
increase in Anti-PS Immunotherapeutics program expenses of $3,202,000 during
the
year ended April 30, 2006 compared to fiscal year 2005 resulted primarily from
the advancement of our first Anti-PS Immunotherapeutic agent, bavituximab.
During fiscal year 2006, 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 fiscal year 2006 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 fiscal year 2005 to support the
bavituximab Investigational New Drug (“IND”) applications that were filed in
fiscal year 2005 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®)
- The
decrease in TNT program expenses of $811,000 during the year ended April 30,
2006 compared to fiscal year 2005 is primarily due to a decrease in payroll
and
related expenses and radiolabeling process development expenses incurred in
fiscal year 2005 to support the initiation of the Cotara® dose confirmation and
dosimetry clinical trial for the treatment of recurrent GBM 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 fiscal year 2005 supporting the production of monoclonal antibodies
for Cotara®.
o
Vascular Targeting Agents (“VTAs”) and Anti-Angiogenesis Agents
-
The
decrease in VTA and Anti-Angiogenesis Agents program expenses of $922,000 during
the year ended April 30, 2006 compared to the prior year is primarily due to
a
decrease in intellectual property access fees and sponsored research fees as
our
outside researchers were focused on the development of our Anti-PS
Immunotherapeutics technology platform.
o
Vasopermeation Enhancements Agents (“VEAs”) -
The
decrease in VEA program expenses of $211,000 during the year ended April 30,
2006 compared to the prior year 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 fiscal year 2005. 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.
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:
·
|
the
uncertainty of our capital resources to fund research, development
and
clinical studies beyond fiscal year 2008;
|
|
·
|
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;
|
38
·
|
the
uncertainty of future clinical trial results;
|
|
·
|
the
uncertainty of the ultimate number of patients to be treated in
any
current or future 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, 2007 Compared to the Year Ended April 30, 2006:
Selling,
general and administrative expenses consist primarily of payroll and related
expenses, director fees, legal and accounting fees, stock-based compensation
expense, investor and public relation fees, insurance, and other expenses
relating to the general management, administration, and business development
activities of the Company.
The
decrease in selling, general and administrative expenses of $118,000 during
the
year ended April 30, 2007 compared to the prior year is primarily due to
decreases in corporate legal fees, investor and public relation fees, and
payroll and related expenses. Corporate legal fees decreased $146,000 from
$563,000 in fiscal year 2006 to $417,000 in fiscal year 2007 primarily due
to
corporate legal fees incurred in the prior year associated with a legal
settlement related to certain technology agreements with a university that
was
reached in March 2006. Investor and public relation fees decreased $138,000
from
$415,000 in fiscal year 2006 to $277,000 in fiscal year 2007 primarily due
to
consolidating the outsourcing of our investor and public relation activities.
Payroll and related expenses remained in line with the prior year and decreased
slightly from $2,874,000 in fiscal year 2006 compared to $2,837,000 in fiscal
year 2007. These decreases in selling, general and administrative expenses
were
offset with an increase in non-cash stock-based compensation expense of $156,000
from $379,000 in fiscal year 2006 to $535,000 in fiscal year 2007 due to the
adoption of SFAS No. 123R on May 1, 2006 and the issuance of non-cash stock
bonuses during the current year associated with the achievement of
pre-determined milestones as set forth in the Company’s February 2006 Stock
Bonus Plan, which were offset by a decrease in non-cash stock-based compensation
expenses associated with non-employee consultants. In addition, we incurred
incremental increases in other general corporate related expenses primarily
associated with facility related expenses and directors and officers insurance
fees.
39
Year
Ended April 30, 2006 Compared to the Year Ended April 30, 2005:
The
increase in selling, general and administrative expenses of $1,466,000 during
the year ended April 30, 2006 compared to fiscal year 2005 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 fiscal year
2006
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
fiscal year 2005, (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 fiscal year 2006 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.
Recovery
of Note Receivable
Year
Ended April 30, 2007 Compared to the Year Ended April 30, 2006 and April 30,
2005
During
fiscal year 2006, we recovered a previously fully reserved note receivable
in
the amount of $1,229,000 which amount did not repeat in either fiscal year
2007
and fiscal year 2005 as further discussed in Note 4, “Recovery of Note
Receivable” to the accompanying consolidated financial statements.
Interest
and Other Income
Year
Ended April 30, 2007 Compared to the Year Ended April 30, 2006
The
increase in interest and other income of $314,000 during the year ended April
30, 2007 compared to the prior year is due to a $556,000 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
offset with a net decrease in other income of $242,000. The net decrease in
other income is primarily due to $363,000 of other income recorded during the
prior year in connection with a legal settlement related to certain technology
agreements with a university, which amount was offset by the sale of a trademark
name during the current year in the amount of $130,000.
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 fiscal year 2005 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
connection with a legal settlement related to certain technology agreements
with
a university.
40
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:
Revenues
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 milestone 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 obligation 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.
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.
41
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.
Stock-based
Compensation Expense
Prior
to
May 1, 2006, we accounted for our equity compensation plans in accordance with
Accounting Principles Board No. 25 (“APB No. 25”), Accounting
for Stock Issued to Employees and Related Interpretations,
as
permitted by Financial Accounting Standards Board Statement of Financial
Accounting Standard No. 123 (“SFAS No. 123”), Accounting
for Stock-Based Compensation.
Accordingly, no compensation expense was recognized in our financial statements
related to stock option grants, as all options granted under our equity
compensation plans had an exercise price at least equal to the fair market
value
of the underlying common stock on the grant date. Effective May 1, 2006, we
adopted the fair value recognition provisions of Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based
Payment (Revised 2004),
using
the modified-prospective method. Under the modified-prospective method,
stock-based compensation cost recognized beginning May 1, 2006 includes: (a)
compensation cost for all share-based payments granted prior to, but not yet
vested as of May 1, 2006, based on the grant date fair value estimated in
accordance with the original provisions of SFAS No. 123, and (b) compensation
cost for all share-based payments granted on or subsequent to May 1, 2006,
based
on the grant date fair value estimated in accordance with the provisions of
SFAS
No. 123R. Results for prior periods have not been restated.
The
fair
value of each option grant is estimated using the Black-Scholes option valuation
model and are amortized as compensation expense on a straight-line basis over
the requisite service periods of the awards, which is generally the vesting
period (typically 4 years). Use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model inputs. Expected
volatility is based on daily historical volatility of our stock covering the
estimated expected term. The expected term of options granted is based on the
expected time to exercise using the “simplified” method allowable under the
Security and Exchange Commission’s Staff Accounting Bulletin No. 107. The
risk-free interest rate is based on U.S. Treasury notes with terms within the
contractual life of the option at the time of grant. In addition, SFAS No.
123R
requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those
estimates.
Our
loss
from operations for the fiscal year April 30, 2007 included stock-based
compensation expense of $964,000. As
of
April 30, 2007, the total estimated unrecognized compensation cost related
to
non-vested stock options was $1,764,000, which amount is expected to be
recognized over a weighted average period of 2.94 years.
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 these factors at that point in time.
42
Liquidity
and Capital Resources
As
of
April 30, 2007, we had $16,044,000 in cash and cash equivalents compared to
$17,182,000 at April 30, 2006. On June 28, 2007, we raised an additional
$20,900,000 in net proceeds under a Securities
Purchase Agreement with
several institutional investors. As of June 30, 2007, we had approximately
$32,452,000 in cash and cash equivalents including the net proceeds received
under the June 28, 2007 Securities Purchase Agreement. Although we have
sufficient cash on hand to meet our planned obligations through at least fiscal
year 2008 based on our current projections, 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 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, 2007, 2006 and 2005 amounted
to $3,492,000, $3,005,000 and $4,684,000, 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 total 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 2008.
We
may
raise additional capital through the sale of shares of our common stock, which
as of June 30, 2007, we have approximately 5,031,000 shares available for
possible future registered transactions under two separate registration
statements. In addition, during January 2007, we filed a separate registration
statement on Form S-3, File Number 333-139975, which allows us to issue, from
time to time, in one or more offerings, shares of our common stock for remaining
proceeds of up to $7,500,000. However, 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 2008.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the year ended April 30, 2007 compared to the prior year are
as
follows:
43
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, 2007, cash used in operating activities
increased $1,522,000 to $18,479,000 compared to $16,957,000 for the year ended
April 30, 2006. The increase in cash used in operating activities was primarily
related to an increase of $2,315,000 in net cash used in operating activities
before considering changes in operating assets and liabilities. This increase
was primarily due to an increase in research and development expenses offset
by
a decrease in selling, general and administrative expenses and an increase
in
contract manufacturing revenue. This increase in cash used in operating
activities before changes in operating assets and liabilities was offset by
a
net change in operating assets and payment or reduction of liabilities in the
aggregate amount of $793,000.
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,
|
||||||||
2007
|
2006
|
|||||||
Net
loss, as reported
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
||
Less
non-cash operating expenses:
|
||||||||
Depreciation
and amortization
|
475,000
|
415,000
|
||||||
Stock-based
compensation and common stock issued under stock bonus plan
|
1,324,000
|
543,000
|
||||||
Amortization
of expenses paid in shares of common stock
|
391,000
|
1,048,000
|
||||||
Loss
(gain) on sale of property
|
1,000
|
(6,000
|
)
|
|||||
Recovery
of note receivable
|
-
|
(1,229,000
|
)
|
|||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(18,605,000
|
)
|
$
|
(16,290,000
|
)
|
||
Net
change in operating assets and liabilities
|
$
|
126,000
|
$
|
(667,000
|
)
|
|||
Net
cash used in operating activities
|
$
|
(18,479,000
|
)
|
$
|
(16,957,000
|
)
|
Cash
(Used In) Provided By Investing Activities.
Net cash
used in investing activities amount to $80,000 for the year ended April 30,
2007
compared to net cash provided by investing activities of $440,000 during the
same prior year period. This decrease in net cash provided by investing
activities of $520,000 was primarily due to the recovery of a note receivable
in
the amount of $1,229,000 during the prior year offset by a current year decrease
of $398,000 in property acquisitions and a $311,000 decrease in other assets
primarily related to security deposits paid in the prior year to GE Capital
Corporation on notes payable and prior year installment payments made on certain
laboratory equipment.
Cash
Provided By Financing Activities.
Net cash
provided by financing activities decreased $6,462,000 to $17,421,000 for the
year ended April 30, 2007 compared to net cash provided of $23,883,000 for
the
same prior year period. Cash provided by financing activities during fiscal
year
2007 was primarily due to proceeds received under a Security Purchase Agreement
whereby we sold and issued a total of 9,285,714 shares of our common stock
in
exchange for aggregate net proceeds of $12,970,000, which was supplemented
with
net proceeds of $4,895,000 from the exercise of stock options and warrants.
Cash
provided by financing activities during fiscal year 2006 was primarily due
to
net proceeds received from the sale of our common stock under various security
purchase agreements in the amount of $22,894,000 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.
44
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, 2007, aggregated by type:
Payments
Due by Period (in thousands)
|
||||||||||||||||
Total
|
<
1 year
|
1-3
years
|
4-5
years
|
After
5 years
|
||||||||||||
Operating
leases, net (1)
|
$
|
8,945
|
$
|
815
|
$
|
2,394
|
$
|
1,654
|
$
|
4,082
|
||||||
Notes
payable (2)
|
520
|
398
|
122
|
-
|
-
|
|||||||||||
Capital
lease obligation (3)
|
51
|
19
|
32
|
-
|
-
|
|||||||||||
Other
long-term liabilities - minimum license obligations (4)
|
100
|
100
|
-
|
-
|
-
|
|||||||||||
Total
contractual obligations
|
$
|
9,616
|
$
|
1,332
|
$
|
2,548
|
$
|
1,654
|
$
|
4,082
|
______________
(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 five year lease terms.
|
(2)
|
Represents
our note payable agreements entered into with General Electric Capital
Corporation during fiscal years 2006 and 2005 to finance laboratory
equipment. Amounts include principal and
interest.
|
(3)
|
Represents
our capital lease agreement to finance certain office equipment.
Amounts
include principal and interest.
|
(4)
|
Represents
licensing agreements we periodically enter into 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 2008
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
June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48 (“FIN 48”), Accounting
for Uncertainty in Income Taxes—An Interpretation of FASB Statement No.
109,
which
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. FIN 48 will be effective for fiscal years beginning
after
December 15, 2006. We adopted FIN 48 on May 1, 2007 and are currently evaluating
the impact of FIN 48, which we believe will not have a significant impact on
our
consolidated financial statements.
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157 (“SFAS No. 157”), Fair
Value Measurements,
which
defines fair value, establishes a framework for measuring fair value under
GAAP,
and expands disclosures about fair value measurements. SFAS No. 157 will be
effective for fiscal years beginning after November 15, 2007, which we
would be required to implement no later than May 1, 2008. We have not yet
evaluated the potential impact of adopting SFAS No. 157 on our consolidated
financial statements.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
No.
159 (“SFAS No. 159”), The
Fair Value Option for Financial Assets and Financial Liabilities - Including
an
amendment of FASB statement No. 115 .
SFAS
No. 159 permits entities to choose to measure many financial instruments and
certain other items at fair value. If the fair value method is selected, a
business entity shall report unrealized gains and losses on
elected items in earnings at each subsequent reporting date. The
standard also establishes presentation and disclosure requirements designed
to
facilitate comparisons between companies that choose different measurement
attributes for similar types of assets and liabilities. SFAS No. 159 is
effective for fiscal years beginning after November 15, 2007, which we would
be
required to implement no later than May 1, 2008. We have not yet evaluated
the potential impact of adopting SFAS No. 159 on our consolidated financial
statements.
45
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,
2007,
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-30.
ITEM
9. CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURES
None.
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, 2007. Based on this
evaluation, our president and chief executive officer and our chief financial
officer concluded that our disclosure controls and procedures were effective
as
of April 30, 2007 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, 2007 has been audited by Ernst & Young
LLP, an independent registered public accounting firm, as stated in its report
which appears on page 48 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, 2007 that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
ITEM
9B. OTHER
INFORMATION
None.
46
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, 2007.
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.
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|
|
|
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|
|
|
|
By:
|
|
/s/Steven
W. King
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By:
|
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/s/Paul
J. Lytle
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Steven
W. King,
|
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|
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Paul
J. Lytle
|
|
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|
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President
and Chief Executive Officer
|
|
|
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Chief
Financial Officer
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|
July
9,
2007
47
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 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, 2007, 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, 2007, 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,
2007, 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, 2007 and 2006, and the related
consolidated statements of operations, stockholders' equity and cash flows
for
each of the three years in the period ended April 30, 2007 and our report dated
July 9, 2007 expressed an unqualified opinion thereon.
/s/
Ernst & Young
LLP
Orange
County, California
July
9,
2007
48
PART
III
ITEM
10. DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
information required by this Item regarding our directors, executive officers
and committies of our board of directors is incorporated by reference to the
information set forth under the captions “Election of Directors” and “Executive
Compensation and Related Matters” in our 2007 Definitive Proxy Statement to be
filed within 120 days after the end of our fiscal year ended April 30, 2007
(the
“2007 Definitive Proxy Statement”).
Information
required by this Item regarding Section 16(a) reporting compliance is
incorporated by reference to the information set forth under the the caption
“Section 16(a) Beneficial Ownership Reporting Compliance” in our 2007 Proxy
Statement.
Information
required by this Item regarding our code of ethics is incorporated by reference
to the information set forth under the caption “Corporate Governance” in
Part
I
of this Annual Report on Form 10-K.
ITEM
11. EXECUTIVE
COMPENSATION
The
information required by this Item is incorporated by reference to the
information set forth under the caption “Executive Compensation and Related
Matters” in our 2007 Definitive Proxy Statement to be filed within 120 days
after the end of our fiscal year ended April 30, 2007.
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 “Security Ownership of Directors and
Executive Officers and Certain Benefical Owners” in our 2007 Definitive Proxy
Statement to be filed within 120 days after the end of our fiscal year
ended April 30, 2007.
ITEM
13. CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The
information required by this Item is incorporated by reference to the
information set forth under the captions “Certain Relationships and Related
Transactions” and “Compensation Committee Interlocks and Insider Participation”
in our 2007 Definitive Proxy Statement to be filed within 120 days after
the end
of our fiscal year ended April 30, 2007.
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 2007 Definitive Proxy Statement to be filed within
120 days after the end of our fiscal year ended April 30,
2007.
49
PART
IV
ITEM
15.
|
EXHIBITS
AND FINANCIAL STATEMENT SCHEDULES
|
|
(a)
|
(1)
Consolidated
Financial Statements
|
|
Index
to consolidated financial statements:
|
||
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
F-1
|
|
Consolidated
Balance Sheets as of April 30, 2007 and 2006
|
F-2
|
|
Consolidated
Statements of Operations for each of the three years in the period
ended
April 30, 2007
|
F-4
|
|
Consolidated
Statements of Stockholders' Equity for each of the three years
in the
period ended April 30, 2007
|
F-5
|
|
Consolidated
Statements of Cash Flows for each of the three years in the period
ended
April 30, 2007
|
F-6
|
|
Notes
to Consolidated Financial Statements
|
F-8
|
|
(2)
Financial
Statement Schedules
|
||
The
following schedule is filed as part of this Form 10-K:
|
||
Schedule
II- Valuation of Qualifying Accounts for each of the three years
in the
period ended April 30, 2007
|
F-30
|
|
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.
50
(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).
|
|
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)).*
|
51
Exhibit
Number
|
Description
|
|
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).
|
|
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).
|
52
Exhibit
Number
|
Description
|
|
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).
|
53
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).
|
54
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).
|
|
55
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 Performance Share Award Agreement / Stock Bonus Plan dated February
13,
2006 between Registrant and key employees and consultants.
**
|
|
10.107
|
Common
Stock Purchase Agreement dated June 16, 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
June 19, 2006).
|
|
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.
|
56
SIGNATURES
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 9, 2007 | 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
9, 2007
|
||
Steven
W. King
|
Officer
(Principal Executive Officer)
|
|||
/s/
Paul J. Lytle
|
Chief
Financial Officer
|
July
9, 2007
|
||
Paul
J. Lytle
|
(Principal
Financial and Principal Accounting Officer)
|
|||
/s/
Carlton M. Johnson
|
Director
|
July
9, 2007
|
||
Carlton
M. Johnson
|
||||
/s/
David H. Pohl
|
Director
|
July
9, 2007
|
||
David
H. Pohl
|
||||
/s/
Eric S. Swartz
|
Director
|
July
9, 2007
|
||
Eric
S. Swartz
|
||||
/s/
Dr. Thomas A. Waltz
|
Director
|
July
9, 2007
|
||
Thomas A. Waltz |
57
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, 2007 and 2006, and the
related consolidated statements of operations, stockholders’ equity, and cash
flows for each of the three years in the period ended April 30, 2007. Our audits
also included the financial statement schedule listed in the Index at
Item 15 (a)(2). These consolidated financial statements and
schedule are the responsibility of the Company’s management. Our responsibility
is to express an opinion on these consolidated 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, 2007 and 2006, and the consolidated
results of its operations and its cash flows for each of the three years in
the
period ended April 30, 2007, 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.
As
discussed in Note 1 to the consolidated financial statements, the Company
changed its method of accounting for Share-Based Payments in accordance with
Statement of Financial Accounting Standards No. 123 (revised 2004) effective
May
1, 2006.
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, 2007, 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 9, 2007 expressed an unqualified opinion thereon.
/s/
Ernst & Young LLP
Orange
County, California
July
9,
2007
F-1
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2007 AND 2006
2007
|
2006
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
16,044,000
|
$
|
17,182,000
|
|||
Trade
and other receivables
|
750,000
|
579,000
|
|||||
Inventories,
net
|
1,916,000
|
885,000
|
|||||
Prepaid
expenses and other current assets
|
1,188,000
|
1,466,000
|
|||||
Total
current assets
|
19,898,000
|
20,112,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
646,000
|
618,000
|
|||||
Laboratory
equipment
|
3,533,000
|
3,444,000
|
|||||
Furniture,
fixtures and computer equipment
|
873,000
|
666,000
|
|||||
5,052,000
|
4,728,000
|
||||||
Less
accumulated depreciation and amortization
|
(3,212,000
|
)
|
(2,822,000
|
)
|
|||
Property,
net
|
1,840,000
|
1,906,000
|
|||||
Other
assets
|
1,259,000
|
658,000
|
|||||
TOTAL
ASSETS
|
$
|
22,997,000
|
$
|
22,676,000
|
F-2
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2007 AND 2006 (continued)
2007
|
2006
|
||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,683,000
|
$
|
1,233,000
|
|||
Accrued
clinical trial site fees
|
228,000
|
170,000
|
|||||
Accrued
legal and accounting fees
|
392,000
|
250,000
|
|||||
Accrued
royalties and license fees
|
337,000
|
138,000
|
|||||
Accrued
payroll and related costs
|
874,000
|
850,000
|
|||||
Notes
payable, current portion
|
379,000
|
429,000
|
|||||
Capital
lease obligation, current portion
|
17,000
|
15,000
|
|||||
Deferred
revenue
|
1,060,000
|
563,000
|
|||||
Other
current liabilities
|
885,000
|
836,000
|
|||||
Total
current liabilities
|
5,855,000
|
4,484,000
|
|||||
Notes
payable, less current portion
|
119,000
|
498,000
|
|||||
Capital
lease obligation, less current portion
|
30,000
|
47,000
|
|||||
Deferred
license revenue
|
4,000
|
21,000
|
|||||
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
–
196,112,201 and 179,382,191, respectively
|
196,000
|
179,000
|
|||||
Additional
paid-in-capital
|
224,453,000
|
204,546,000
|
|||||
Deferred
stock compensation
|
-
|
(235,000
|
)
|
||||
Accumulated
deficit
|
(207,660,000
|
)
|
(186,864,000
|
)
|
|||
Total
stockholders’ equity
|
16,989,000
|
17,626,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
22,997,000
|
$
|
22,676,000
|
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, 2007
2007
|
2006
|
2005
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
3,492,000
|
$
|
3,005,000
|
$
|
4,684,000
|
||||
License
revenue
|
216,000
|
188,000
|
275,000
|
|||||||
Total
revenues
|
3,708,000
|
3,193,000
|
4,959,000
|
|||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
3,296,000
|
3,297,000
|
4,401,000
|
|||||||
Research
and development
|
15,876,000
|
12,415,000
|
11,164,000
|
|||||||
Selling,
general and administrative
|
6,446,000
|
6,564,000
|
5,098,000
|
|||||||
Total
costs and expenses
|
25,618,000
|
22,276,000
|
20,663,000
|
|||||||
LOSS
FROM OPERATIONS
|
(21,910,000
|
)
|
(19,083,000
|
)
|
(15,704,000
|
)
|
||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Recovery
of note receivable
|
-
|
1,229,000
|
-
|
|||||||
Interest
and other income
|
1,160,000
|
846,000
|
265,000
|
|||||||
Interest
and other expense
|
(46,000
|
)
|
(53,000
|
)
|
(13,000
|
)
|
||||
NET
LOSS
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
192,297,309
|
168,294,782
|
144,812,001
|
|||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.11
|
)
|
$
|
(0.10
|
)
|
$
|
(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, 2007
Additional
|
Deferred
|
Total
|
|||||||||||||||||
Common
Stock
|
Paid-In
|
Stock
|
Accumulated
|
Stockholders’
|
|||||||||||||||
Shares
|
Amount
|
Captital
|
Compensation
|
Deficit
|
Equity
|
||||||||||||||
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
|
|||||||||||
Common
stock issued for cash under June 16, 2006 Financing, net of issuance
costs
of $30,000
|
9,285,714
|
10,000
|
12,960,000
|
-
|
-
|
12,970,000
|
|||||||||||||
Common
stock issued to various unrelated entities for prepaid research
services
|
862,832
|
1,000
|
930,000
|
-
|
-
|
931,000
|
|||||||||||||
Common
stock issued upon exercise of options
|
65,350
|
-
|
59,000
|
-
|
-
|
59,000
|
|||||||||||||
Common
stock issued upon exercise of warrants, net of issuance costs of
$16,000
|
6,266,788
|
6,000
|
4,830,000
|
-
|
-
|
4,836,000
|
|||||||||||||
Common
stock issued under stock bonus plan
|
249,326
|
-
|
342,000
|
-
|
-
|
342,000
|
|||||||||||||
Elimination
of deferred stock compensation upon adoption of SFAS No. 123R
|
-
|
-
|
(235,000
|
)
|
235,000
|
-
|
-
|
||||||||||||
Stock-based
compensation
|
-
|
-
|
1,021,000
|
-
|
-
|
1,021,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(20,796,000
|
)
|
(20,796,000
|
)
|
|||||||||||
BALANCES,
April 30, 2007
|
196,112,201
|
$
|
196,000
|
$
|
224,453,000
|
$
|
-
|
$
|
(207,660,000
|
)
|
$
|
16,989,000
|
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, 2007
2007
|
2006
|
2005
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||
Net
loss
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and amortization
|
475,000
|
415,000
|
325,000
|
|||||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
1,324,000
|
543,000
|
231,000
|
|||||||
Amortization
of expenses paid in shares of common stock
|
391,000
|
1,048,000
|
485,000
|
|||||||
Loss
(gain) on sale of property
|
1,000
|
(6,000
|
)
|
-
|
||||||
Recovery
of note receivable
|
-
|
(1,229,000
|
)
|
-
|
||||||
Changes
in operating assets and liabilities:
|
||||||||||
Trade
and other receivables
|
(171,000
|
)
|
(93,000
|
)
|
1,034,000
|
|||||
Inventories
|
(1,031,000
|
)
|
(258,000
|
)
|
613,000
|
|||||
Prepaid
expenses and other current assets
|
(113,000
|
)
|
(410,000
|
)
|
7,000
|
|||||
Accounts
payable
|
450,000
|
(92,000
|
)
|
(6,000
|
)
|
|||||
Accrued
clinical trial site fees
|
58,000
|
162,000
|
(46,000
|
)
|
||||||
Deferred
revenue
|
480,000
|
17,000
|
(1,082,000
|
)
|
||||||
Accrued
payroll and related expenses
|
63,000
|
44,000
|
303,000
|
|||||||
Other
accrued expenses and current liabilities
|
390,000
|
(37,000
|
)
|
420,000
|
||||||
Net
cash used in operating activities
|
(18,479,000
|
)
|
(16,957,000
|
)
|
(13,168,000
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||
Property
acquisitions
|
(220,000
|
)
|
(618,000
|
)
|
(1,090,000
|
)
|
||||
Decrease
(increase) in other assets, net
|
140,000
|
(171,000
|
)
|
(101,000
|
)
|
|||||
Recovery
of note receivable
|
-
|
1,229,000
|
-
|
|||||||
Net
cash (used in) provided by investing activities
|
(80,000
|
)
|
440,000
|
(1,191,000
|
)
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||
Proceeds
from issuance of common stock, net of issuance costs of $46,000,
$48,000, and $49,000, respectively
|
17,865,000
|
23,627,000
|
8,623,000
|
|||||||
Proceeds
from issuance of notes payable
|
-
|
566,000
|
733,000
|
|||||||
Principal
payments on notes payable and capital lease
|
(444,000
|
)
|
(310,000
|
)
|
(65,000
|
)
|
||||
Net
cash provided by financing activities
|
17,421,000
|
23,883,000
|
9,291,000
|
F-6
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
2007
|
2006
|
2005
|
||||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
$
|
(1,138,000
|
)
|
$
|
7,366,000
|
$
|
(5,068,000
|
)
|
||
CASH
AND CASH EQUIVALENTS, Beginning of year
|
17,182,000
|
9,816,000
|
14,884,000
|
|||||||
CASH
AND CASH EQUIVALENTS, End of year
|
$
|
16,044,000
|
$
|
17,182,000
|
$
|
9,816,000
|
||||
SUPPLEMENTAL
INFORMATION:
|
||||||||||
Interest
paid
|
$
|
50,000
|
$
|
49,000
|
$
|
13,000
|
||||
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||||
Property
acquired under capital lease
|
$
|
-
|
$
|
65,000
|
$
|
-
|
||||
Common
stock issued for research fees and prepayments for future research
services
|
$
|
931,000
|
$
|
907,000
|
$
|
1,449,000
|
For
supplemental information relating to common stock issued in exchange for
services, property acquired under capital lease, and property financed in
exchange for notes payable, see Notes 5 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, 2007 (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. Peregrine was incorporated under the laws of the state of
California in June 1981, reincorporated in Delaware in September 1996 and
commenced operations of Avid Bioservices, Inc. (“Avid”) in January 2002.
Business
Description - Peregrine
a
biopharmaceutical company with a portfolio of clinical stage and pre-clinical
product candidates using monoclonal
antibodies (“MAb”)
for the treatment of cancer and viral diseases.
We are
advancing three separate clinical programs encompassing two platform
technologies: Anti-PhosphatidylSerine (“Anti-PS”) Immunotherapeutics and Tumor
Necrosis Therapies (“TNT”). Our lead Anti-PS Immunotherapeutic MAb product,
bavituximab, is in clinical trials for the treatment of both solid cancer tumors
and hepatitis C virus (“HCV”) infection. Bavituximab as an anti-viral
agent has completed Phase Ia and Phase Ib clinical studies for the treatment
of
HCV infection and is in pre-clinical studies for human immunodeficiency virus
(“HIV”) and
other
life-threatening viral infections. Bavituximab as an anti-cancer agent is in
a
Phase I monotherapy trial for the treatment of solid tumors in the U.S. and
it
recently completed a Phase Ib trial in combination with chemotherapy in patients
with solid tumors in India. Under our TNT platform technology, our lead
candidate Cotara®, is currently in a dose confirmation and dosimetry clinical
trial in the U.S. and in a Phase II clinical trial in India, both 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 targeted therapeutics
and
(ii) Avid Bioservices, Inc., (“Avid”) our wholly owned subsidiary, is engaged in
contract manufacturing and related 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 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, 2007, 2006 and 2005 amounted
to $3,492,000, $3,005,000 and $4,684,000, 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 our anticipated consolidated cash flows used in
operations. In addition, revenues that may be generated 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 2008. At April 30, 2007, we had $16,044,000 in cash and cash
equivalents. On June 28, 2007, we raised an additional $20,900,000 in net
proceeds under a Securities Purchase Agreement with several institutional
investors (Note 8). We believe we have sufficient cash on hand to continue
our
research,
development, and clinical testing of our product candidates through
at least fiscal year 2008.
F-8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
We
may
raise additional capital through the sale of shares of our common stock to
continue our research, development, and clinical testing of our product
candidates beyond fiscal year 2008. We have approximately 5,031,000 shares
available for possible future registered transactions under two separate
registration statements. In addition, during January 2007, we filed a separate
registration statement on Form S-3, File Number 333-139975, which allows us
to
issue, from time to time, in one or more offerings, shares of our common stock
for remaining proceeds of up to $7,500,000. However, 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.
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 2008.
2. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation - The
accompanying consolidated financial statements include the accounts of 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 these factors at that point in time.
Prepaid
Expenses - Our
prepaid expenses primarily represent pre-payments made to secure the receipt
of
services at a future date. We have prepaid various research and
development related services through the issuance of shares of our common stock
to unrelated entities during fiscal year 2007 and 2006, which are expensed
once
the services have been provided under the terms of the arrangement. As of April
30, 2007 and 2006, prepaid expenses and other current assets in the accompanying
consolidated financials statements include $475,000 and $866,000, respectively,
in research and development services prepaid with shares of our common stock.
These
prepaid research and development balances as of April 30, 2007 and April 30,
2006 include amounts paid in shares of our common stock to Affitech AS of
$475,000 under a research collaboration agreement for the generation of fully
human monoclonal antibodies against two targets that are currently undefined
and
contain no expiration clauses. We will expense these prepaid targets once they
are defined and delivered to Affitech AS in accordance with the terms of the
agreement, which we expect will occur within the next twelve months.
F-9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
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, 2007 and April 30,
2006:
2007
|
2006
|
||||||||
Raw
materials, net
|
$
|
810,000
|
$
|
565,000
|
|||||
Work-in-process
|
1,106,000
|
320,000
|
|||||||
Total
inventories
|
$
|
1,916,000
|
$
|
885,000
|
Concentrations
of Credit Risk
- The
majority of trade and other receivables as of April 30, 2007, are from customers
in the United States, Germany and Israel. Most contracts require up-front
payments and installment payments during the term of the service. 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.
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.
F-10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
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 our historical experience with Schering A.G. under a separate license
agreement.
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.
F-11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
Basic
and Dilutive Net Loss Per Common Share
- Basic
and dilutive 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 and warrants. 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 and warrants outstanding during the period calculated in accordance
with the treasury stock method, but are excluded if their effect is
anti-dilutive. Because the impact of options and warrants are anti-dilutive
during periods of net loss, there was no difference between basic and diluted
loss per common share amounts for the three years ended April 30, 2007.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 2,071,087, 3,433,414 and
6,485,168 shares of common stock for the fiscal years ended April 30, 2007,
2006
and 2005, respectively, since the impact of such options and warrants are
anti-dilutive during periods of net loss.
The
calculation of weighted average diluted shares outstanding also excludes
weighted average outstanding options and warrants to purchase up to 7,218,883,
9,090,374 and 11,946,248 shares of common stock for the fiscal years ended
April
30, 2007, 2006 and 2005, respectively, as the exercise prices of those options
were greater than the average market price of our common stock during the
respective periods, resulting in an anti-dilutive effect.
On
June
28, 2007, we issued 30,000,000 shares of our common stock under a Securities
Purchase Agreement (Note 8) in exchange for net proceeds of approximately
$20,900,000, which additional shares have been excluded from the calculation
of
basic and dilutive net loss per common share for the year ended April 30,
2007.
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, 2007 (continued)
Recent
Accounting Pronouncements - In
June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48 (“FIN 48”), Accounting
for Uncertainty in Income Taxes—An Interpretation of FASB Statement No.
109,
which
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. FIN 48 will be effective for fiscal years beginning
after
December 15, 2006. We adopted FIN 48 on May 1, 2007 and are currently evaluating
the impact of FIN 48, which we believe will not have a significant impact on
our
consolidated financial statements.
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157 (“SFAS No. 157”), Fair
Value Measurements,
which
defines fair value, establishes a framework for measuring fair value under
GAAP,
and expands disclosures about fair value measurements. SFAS No. 157 will be
effective for fiscal years beginning after November 15, 2007, which we
would be required to implement no later than May 1, 2008. We have not yet
evaluated the potential impact of adopting SFAS No. 157 on our consolidated
financial statements.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
No.
159 (“SFAS No. 159”), The
Fair Value Option for Financial Assets and Financial Liabilities
-
Including an amendment of FASB statement No. 115 .
SFAS
No.
159
permits entities to choose to measure many financial instruments and certain
other items at fair value. If the fair value method is selected, a business
entity shall report unrealized gains and losses on
elected items in earnings at each subsequent reporting date. The
standard also establishes presentation and disclosure requirements designed
to
facilitate comparisons between companies that choose different measurement
attributes for similar types of assets and liabilities. SFAS No.
159
is effective for fiscal years beginning after November 15, 2007, which we would
be required to implement no later than May 1, 2008. We have not yet
evaluated the potential impact of adopting SFAS No. 159 on our consolidated
financial statements.
3.
STOCK-BASED
COMPENSATION
We
currently maintain four equity compensation plans referred to as the 1996 Plan,
the 2002 Plan, the 2003 Plan, and the 2005 Plan (collectively referred to as
the
“Option Plans”). The 1996, 2003 and 2005 Plans were approved by our stockholders
while the 2002 Plan was not submitted for stockholder approval. The Option
Plans
provide for the granting of options to purchase shares of our common stock
at
exercise prices not less than the fair market value of our common stock at
the
date of grant. The options generally vest over a four year period and no options
are exercisable after ten years from the date of grant.
Prior
to
fiscal year 2007, we accounted for stock options granted under the Option Plans
in accordance with Accounting Principles Board No. 25 (“APB No. 25”),
Accounting
for Stock Issued to Employees and Related Interpretations,
as
permitted by FASB Statement of Financial Accounting Standard No. 123 (“SFAS No.
123”), Accounting
for Stock-Based Compensation.
Accordingly, no compensation expense was recognized in the accompanying
consolidated statements of operations for fiscal years 2006 and 2005 related
to
stock option grants, as all options granted under the Option Plans had an
exercise price at least equal to the fair market value of the underlying common
stock on the grant date.
Effective
May 1, 2006, we adopted Statement of Financial Accounting Standards No. 123R
(“SFAS No. 123R”), Share-Based
Payment (Revised 2004),
which
supersedes our previous accounting under APB No. 25. SFAS No. 123R requires
the
recognition of compensation expense, using a fair value based method, for costs
related to all share-based payments including grants of employee stock options.
In addition, SFAS No. 123R requires companies to estimate the fair value of
share-based payment awards on the date of grant using an option-pricing model.
The value of the portion of the award that is ultimately expected to vest is
recognized as expense on a straight-line basis over the requisite service
periods (vesting period). We adopted SFAS 123R using the modified-prospective
method and, accordingly, stock-based compensation cost recognized beginning
May
1, 2006 includes: (a) compensation cost for all share-based payments granted
prior to, but not yet vested as of May 1, 2006, based on the grant date fair
value estimated in accordance with the original provisions of SFAS No. 123,
and
(b) compensation cost for all share-based payments granted on or subsequent
to
May 1, 2006, based on the grant date fair value estimated in accordance with
the
provisions of SFAS No. 123R. Results for prior periods have not been
restated.
F-13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
As
a
result of adopting SFAS No. 123R on May 1, 2006, our net loss for the year
ended
April 30, 2007 was increased by $964,000 ($0.01 per basic and diluted share),
which costs are included in the accompanying consolidated statements of
operations as follows:
2007
|
||||
Research
and development
|
$
|
589,000
|
||
Selling,
general and administrative
|
375,000
|
|||
Total
|
$
|
964,000
|
||
The
fair
value of each option grant is estimated using the Black-Scholes option valuation
model and is amortized as compensation expense on a straight-line basis over
the
requisite service period of the award, which is generally the vesting period
(typically 4 years). The use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model inputs. The expected
volatility is based on the daily historical volatility of our stock covering
the
estimated expected term. The expected term of options granted during fiscal
year
2007 is based on the expected time to exercise using the “simplified” method
allowable under the Securities and Exchange Commission’s Staff Accounting
Bulletin No. 107. Prior to fiscal year 2007, the expected term was based on
the
average estimated expected life of the options granted during the fiscal year.
The risk-free interest rate is based on U.S. Treasury notes with terms within
the contractual life of the option at the time of grant. The expected dividend
yield assumption is based on our expectation of future dividend payouts. We
have never declared or paid any cash dividends on our common stock and
currently do not anticipate paying such cash dividends. In
addition, SFAS No. 123R requires forfeitures to be estimated at the time of
grant and revised, if necessary, in subsequent periods if actual forfeitures
differ from those estimates. The fair value of stock options on the date of
grant and the weighted-average assumptions used to estimate the fair value
of
the stock options using the Black-Scholes option valuation model for fiscal
years ended April 30, 2007, 2006 and 2005, were as follows:
Year
Ended April 30,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Risk-free
interest rate
|
4.83%
|
|
3.88%
|
|
3.38%
|
|
||||
Expected
life (in years)
|
6.25
|
5.49
|
4.00
|
|||||||
Expected
volatility
|
98%
|
|
103%
|
|
115%
|
|
||||
Expected
dividend yield
|
-
|
-
|
-
|
As
of
April 30, 2007, options to purchase up to 11,537,946 shares of our common stock
were issued and outstanding under the Option Plans with a weighted average
exercise price of $1.54 per share and expire at various dates through April
16,
2017. Options to purchase up to 4,651,409 shares of common stock were available
for future grant under the Option Plans as of April 30, 2007.
F-14
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
The
following summarizes all stock option transaction activity for fiscal year
ended
April 30, 2007:
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
||||||
Outstanding,
May 1, 2006
|
11,307,279
|
$
1.56
|
||||||||
Granted
|
1,005,260
|
$
1.29
|
||||||||
Exercised
|
(65,350)
|
$
0.90
|
||||||||
Canceled
or expired
|
(709,243)
|
$
1.63
|
||||||||
Outstanding,
April 30, 2007
|
11,537,946
|
$
1.54
|
5.84
|
$
916,000
|
||||||
|
||||||||||
Exercisable
and expected to vest
|
11,321,992
|
$
1.54
|
5.79
|
$
912,000
|
||||||
Exercisable,
April 30, 2007
|
9,251,102
|
$
1.59
|
5.20
|
$
888,000
|
||||||
The
weighted-average grant date fair value of options granted during the years
ended
April 30, 2007, 2006 and 2005 was $1.05, $0.91 and $0.80 per share,
respectively. The aggregate intrinsic value of stock options exercised during
the years ended April 30, 2007, 2006 and 2005 was $38,000, $55,000 and
$1,217,000, respectively.
Cash
proceeds from stock options exercised during the years ended April 30, 2007,
2006 and 2005 totaled $59,000, $122,000 and $1,393,000.
We
issue
shares of common stock that are reserved for issuance under the Option Plans
upon the exercise of stock options, and we do not expect to repurchase shares
of
common stock from any source to satisfy our obligations under our compensation
plans.
As
of
April 30, 2007, the total estimated unrecognized compensation cost related
to
non-vested stock options was $1,764,000. This cost is expected to be recognized
over a weighted average vesting period of 2.94 years based on current
assumptions.
As
discussed above, results for prior periods have not been restated to reflect
the
effects of implementing SFAS No. 123R. Prior to May 1, 2006, we accounted for
our stock option grants in accordance with APB No. 25 and provided the pro
forma
disclosures required by SFAS No. 123. The following table illustrates the effect
on net loss and net loss per share for the years ended April 30, 2006 and 2005
had we applied the fair value recognition provisions of SFAS No. 123 to our
stock option grants:
F-15
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
YEAR
ENDED APRIL 30,
|
|||||||
2006
|
2005
|
||||||
Net
loss, as reported
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
Deduct:
Total stock-based employee compensation expense determined under
the fair
value based method for all awards
|
(1,755,000
|
)
|
(2,828,000
|
)
|
|||
Net
loss, pro forma
|
$
|
(18,816,000
|
)
|
$
|
(18,280,000
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
Net
loss, as reported
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
|
Net
loss, pro forma
|
$
|
(0.11
|
)
|
$
|
(0.13
|
)
|
Periodically,
we grant stock options to non-employee consultants. The fair value of options
granted to non-employees are measured utilizing the Black-Scholes option
valuation model and are amortized over the estimated period of service or
related vesting period in accordance with 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 2007, 2006 and
2005 associated with non-employees amounted to $57,000, $499,000 and $231,000,
respectively.
In
addition, during February 2006, our Compensation Committee of the Board of
Directors approved a Stock Bonus Plan that remained in effect through April
30,
2007 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 was calculated in accordance with APB
No.
25 and EITF 96-18. In
accordance with APB No. 25 and EITF 96-18, we recorded compensation expense
at
each reporting period when it became probable that a Performance Goal under
the
Stock Bonus Plan would be achieved and this accrual was carefully assessed
at
each subsequent reporting period and adjusted accordingly until the Performance
Goal was actually achieved. Decreases or increases to these accruals were
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 years 2007 and 2006, we recorded $304,000 and $83,000, respectively,
in
compensation expense under the Stock Bonus Plan.
4.
RECOVERY
OF 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 reduced the reserve as monthly payments were
received and we recorded 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, which amount was recorded as recovery of note receivable in the
accompanying consolidated statements of operations during fiscal year 2006.
F-16
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
5.
NOTES
PAYABLE AND CAPITAL LEASE OBLIGATION
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, 2007 and April 30, 2006:
April
30,
2007
|
April
30,
2006
|
||||||
Note
payable dated November 2004; 5.78% per annum; monthly payments of
$11,000
due through December 2007
|
$
|
83,000
|
$
|
202,000
|
|||
Note
payable dated December 2004; 5.85% per annum; monthly payments of
$12,000
due through January 2008
|
103,000
|
232,000
|
|||||
Note
payable dated June 2005; 6.39% per annum; monthly payments of $8,000
due
through July 2008
|
117,000
|
205,000
|
|||||
Note
payable dated November 2005; 6.63% per annum; monthly payments of
$3,000
due through December 2008
|
60,000
|
92,000
|
|||||
Note
payable dated March 2006; 6.87% per annum; monthly payments of $6,000
due
through April 2009
|
135,000
|
196,000
|
|||||
498,000
|
927,000
|
||||||
Less
current portion
|
(379,000
|
)
|
(429,000
|
)
|
|||
Notes
payable, less current portion
|
$
|
119,000
|
$
|
498,000
|
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, 2007 and April 30, 2006, security
deposits totaling $325,000 are included in the accompanying consolidated
financial statements as follows:
2007
|
2006
|
||||||
Prepaid
expenses and other current assets
|
$
|
183,000
|
$
|
-
|
|||
Other
long-term assets
|
142,000
|
325,000
|
|||||
Total
security deposits
|
$
|
325,000
|
$
|
325,000
|
F-17
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
Minimum
future principal payments on notes payable as of April 30, 2007 are as
follows:
Year
ending April 30:
|
||||
2008
|
379,000
|
|||
2009
|
119,000
|
|||
Total
|
$
|
498,000
|
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, 2007:
Furniture,
fixtures and office equipment
|
$
|
68,000
|
||
Less
accumulated depreciation
|
(18,000
|
)
|
||
Net
book value
|
$
|
50,000
|
Minimum
future lease payments under the capital lease as of April 30, 2007 are as
follows:
Year
ending April 30:
|
||||
2008
|
19,000
|
|||
2009
|
19,000
|
|||
2010
|
13,000
|
|||
Total
minimum lease payments
|
51,000
|
|||
Amount
representing interest
|
(4,000
|
)
|
||
Net
present value minimum lease payments
|
47,000
|
|||
Less
current portion
|
17,000
|
|||
$
|
30,000
|
6.
|
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. Our monthly lease payments
will continue to 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 current
liabilities in the accompanying consolidated financial statements. Annual rent
expense under the lease agreement totaled $807,000, $758,000 and $735,000 during
fiscal years 2007, 2006 and 2005, respectively.
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.
F-18
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
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 during fiscal years
2007
and 2006 and $4,000 during fiscal year 2005.
At
April
30, 2007, future minimum lease payments under all non-cancelable operating
leases are as follows:
Year
ending April 30:
|
Minimum
Lease Payments
|
|||
2008
|
$
|
815,000
|
||
2009
|
793,000
|
|||
2010
|
796,000
|
|||
2011
|
805,000
|
|||
2012
|
822,000
|
|||
Thereafter
|
4,914,000
|
|||
|
$
|
8,945,000
|
Rental
Income
-
Sublease rental income totaled $35,000, $59,000 and $99,000 for fiscal years
2007, 2006 and 2005, respectively. As of April 30, 2007, we have no sublease
rental arrangements.
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.
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 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 a product is approved and 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.
F-19
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
Anti-PhosphatidylSerine
(“Anti-PS”) Immunotherapeutics
Bavituximab
is the generic name for our first product in clinical trials under our Anti-PS
Immunotherapeutics technology platform. 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 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.
Under
our
in-licensing agreements relating to the Anti-PS 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 and/or a percentage of sublicense income. Our aggregate
future milestone payments under the above in-licensing agreements are $6,900,000
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 2008 and $6,400,000 upon approval of the first Anti-PS
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 for commercial purposes, we would owe Lonza 300,000
pounds sterling per year in addition to an increased royalty on net
sales.
During
fiscal year 2006, we expensed $450,000 upon the completion of clinical
milestones in accordance with in-licensing agreements covering our Anti-PS
Immunotherapeutics technology platform, which is included in research and
development expense in the accompanying consolidated financial statements.
We
did not incur any milestone related expenses during fiscal year
2007.
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.
F-20
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
In
April
1997, 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.
During
fiscal year 2007, we entered into a research collaboration agreement and a
development and commercialization agreement with an unrelated entity regarding
the generation and commercialization of up to fifteen fully human monoclonal
antibodies under our platform technologies to be used as possible future
clinical candidates. These agreements incorporate the various binding term
sheets we entered into with the unrelated entity during June 2003, September
2004, and November 2004. Under the terms of the research collaboration
agreement, we pay a non-refundable upfront technology access fee for each human
antibody project initiated. In addition, under the terms of the development
and
commercialization agreement, 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 $6.35
million per fully human antibody generated by the unrelated entity upon the
achievement of certain development milestones through commercialization. During
fiscal years 2007, 2006 and 2005, we expensed nil, $185,000 and $150,000,
respectively, in non-refundable upfront technology access fees under the
research collaboration agreement upon the initiation to generate two fully
human
monoclonal 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-PS
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 fiscal year 2005, we expensed $186,000 in antibody development milestones
fees, the amount of which is included in research and development expense in
the
accompanying consolidated financial statements. 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.
F-21
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
During
July 2004, we announced that we entered into a worldwide exclusive licensing
agreement for intellectual property related to PhosphatidylSerine conjugates
and
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.
During
March 2007, we entered into a worldwide exclusive licensing agreement for
intellectual property related to the use of beta-2-glycoprotein I as an
anti-angiogenesis agent from The University of Texas M.D. Anderson Cancer
Center. 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 2007 in the
accompanying consolidated financial statements. In addition, under the terms
of
the agreement we are obligated to pay annual maintenance fees, clinical
development milestone fees and a royalty on net sales. Our aggregate future
clinical development milestone payments under this licensing agreement are
$1,425,000 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.
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.,
a
California corporation, whereby we granted to Cancer Therapeutics Laboratories,
Inc. (“CTL”) the exclusive right to sublicense TNT to a major pharmaceutical
company solely in the People’s Republic of China. 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. During January 2007, we filed a lawsuit alleging breach of
contract against CTL alleging various breaches of contract under the
agreement. The lawsuit is currently in the discovery phase as further
discussed in Part 1, Item 3 under "Legal Proceedings" of this Annual Report.
Through fiscal year ended April 30, 2007, 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.
F-22
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
During
February 2007, we entered into an amended and restated license agreement with
SuperGen, Inc. (“SuperGen”) revising the original licensing deal completed with
SuperGen in February 2001 to license a segment of our VTA technology,
specifically related to certain conjugates Vascular Endothelial Growth Factor
(“VEGF”). Under the terms of the amended and restated license agreement, we will
receive annual license fees of up to $200,000 per year payable in cash or
SuperGen common stock until SuperGen files an Investigational New Drug
Application in the United States utilizing the VEGF conjugate technology. In
addition, we could receive up to $8.25 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, as amended. We could also receive
additional consideration for each clinical candidate that enters a Phase III
clinical trial by SuperGen. As of April 30, 2007, SuperGen has not filed an
Investigational New Drug Application in the United States utilizing the VEGF
conjugate 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, which we amortized as license revenue over an estimated period of
48
months through December 2006 in accordance with SAB No. 104 in the accompanying
consolidated financial statements. 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, under the terms of the agreement,
we
could receive up to $1.2 million in future payments for each product based
on
the achievement of all clinical and regulatory milestones combined with 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 antibody conjugates 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.
F-23
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
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 2007, 2006, and 2005, 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 table below, allowing us to issue, from time
to time, in one or more offerings the following number of shares of our common
stock to purchase shares of our common stock:
Registration
Statement No.
|
Shelf
Effective Date
|
Number
of Shares of
Common
Stock Registered
|
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
|
The
following tables summarize the financing transactions we entered into during
fiscal years 2005, 2006, and 2007 under the above shelf registration
statements:
Fiscal
Year 2005
|
|||||||
Description
of Financing Transaction
|
Number
of Common Stock Shares 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
|
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
|
F-24
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
Fiscal
Year 2007
|
|||||||
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Net
Issuance Value
|
|||||
Common
stock purchase agreement dated June 16, 2006
|
9,285,714
|
$
|
12,970,000
|
||||
Common
stock issued to unrelated entities for research services
|
862,832
|
$
|
931,000
|
||||
10,148,546
|
$
|
13,901,000
|
As
of
April 30, 2007, an aggregate of 5,030,634 shares of common stock were available
for issuance under two of the shelf registration statements noted above.
During
January 2007, we filed a registration statement on Form S-3, File Number
333-139975 (“January 2007 Shelf”) which was declared effective by the Securities
and Exchange Commission, allowing us to issue, from time to time, in one or
more
offerings, shares of common stock for proceeds up to $30,000,000. As of April
30, 2007, we had not issued any shares of common stock under this shelf
registration statement.
On
June
28, 2007, we entered into a Securities Purchase Agreement with several
institutional investors whereby we sold 30,000,000 shares of our common stock
in
exchange for gross proceeds of $22,500,000 under the January 2007 Shelf. We
received net proceeds of $20,900,000 after deducting placement agent fees and
estimated costs associated with the offering. As of June 30, 2007, we could
raise up to an additional $7,500,000 in gross proceeds under the January 2007
Shelf registration statement.
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
21,642,854 shares of our common stock at April 30, 2007 for future issuance,
calculated as follows:
Number
of
shares
reserved
|
||||
Shares
reserved under two effective shelf registration statements
|
5,030,634
|
|||
Options
issued and outstanding
|
11,537,946
|
|||
Options
available for future grant
|
4,651,409
|
|||
Warrants
issued and outstanding
|
422,865
|
|||
Total
shares reserved
|
21,642,854
|
9.
WARRANTS
As
of
April 30, 2007, we had warrants outstanding to purchase up to 422,865 shares
of
our common stock at exercise prices ranging between $0.86 and $2.50 per share
with a weighted average exercise price of $1.40 per share and expire at various
dates through March 31, 2008.
F-25
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
Additional
information regarding warrants outstanding as of April 30, 2007, is as follows:
Per
Share
Exercise
Price
|
Number
of Warrants Outstanding
|
Weighted
Average Per Share Exercise Price
|
Expiration
Date
|
||||
$0.86
|
62,865
|
6/8/07
|
|||||
$1.47
|
350,000
|
3/31/08
|
|||||
$2.50
|
10,000
|
3/25/08
|
|||||
$0.86
- $2.50
|
422,865
|
$1.40
|
6/8/07
- 3/31/08
|
During
fiscal year 2005, we granted 350,000 warrants to a non-employee consultant
for
services provided to the Company. 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, 2007. 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. There were no warrants granted
during fiscal years 2007 and 2006.
During
fiscal year 2007, warrants to purchase 6,266,788 shares of our common stock
were
exercised for net proceeds of $4,836,000. During
fiscal year 2006, warrants to purchase 812,512 shares of our common stock were
exercised for net proceeds of $611,000. 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
resulted in the issuance of 2,419,790 shares of our common stock.
During
fiscal years 2007, 2006 and 2005, warrants to purchase 275,000, 5,764,631 and
324,638 shares of common stock, respectively, 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.
10.
SEGMENT
REPORTING
Our
business is organized into two reportable operating segments. Peregrine is
engaged in the research and development of targeted products for the treatment
of cancer and viral infections 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.
F-26
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
Segment
information for fiscal years 2007, 2006 and 2005 is summarized as
follows:
2007
|
2006
|
2005
|
||||||||
Net
Revenues:
|
||||||||||
Contract
manufacturing and development of biologics
|
$
|
3,492,000
|
$
|
3,005,000
|
$
|
4,684,000
|
||||
Products
in research and development
|
216,000
|
188,000
|
275,000
|
|||||||
Total
revenues, net
|
$
|
3,708,000
|
$
|
3,193,000
|
$
|
4,959,000
|
||||
Gross
Profit (Loss):
|
||||||||||
Contract
manufacturing and development of biologics
|
$
|
196,000
|
$
|
(292,000
|
)
|
$
|
283,000
|
|||
Products
in research and development
|
216,000
|
188,000
|
275,000
|
|||||||
Total
gross profit (loss)
|
$
|
412,000
|
$
|
(104,000
|
)
|
$
|
558,000
|
|||
Research
and development expense
|
(15,876,000
|
)
|
(12,415,000
|
)
|
(11,164,000
|
)
|
||||
Selling,
general and administrative expense
|
(6,446,000
|
)
|
(6,564,000
|
)
|
(5,098,000
|
)
|
||||
Other
income, net
|
1,114,000
|
2,022,000
|
252,000
|
|||||||
Net
loss
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
Net
revenues generated from Avid during fiscal years 2007, 2006 and 2005 were
primarily from the following customers:
2007
|
2006
|
2005
|
|||||||||||
Customer
revenues as a % of net revenues:
|
|||||||||||||
United
States (customer A)
|
11
|
%
|
|
73
|
%
|
|
51
|
%
|
|||||
United
States (customer B)
|
0
|
%
|
|
2
|
%
|
|
15
|
%
|
|||||
Germany
(one customer)
|
51
|
%
|
|
10
|
%
|
|
0
|
%
|
|||||
Israel
(one customer)
|
8
|
%
|
|
1
|
%
|
|
32
|
%
|
|||||
Australia
(one customer)
|
14
|
%
|
|
5
|
%
|
|
0
|
%
|
|||||
China
(one customer)
|
10
|
%
|
|
0
|
%
|
|
2
|
%
|
|||||
Other
customers
|
6
|
%
|
|
9
|
%
|
|
0
|
%
|
|||||
Total
customer revenues as a % of net revenues
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
Net
revenues generated from Peregrine during fiscal years 2007, 2006 and 2005 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).
F-27
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
Long-lived
assets consist of the following at April 30, 2007 and April 30,
2006:
2007
|
2006
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,527,000
|
$
|
1,516,000
|
|||
Products
in research and development
|
313,000
|
390,000
|
|||||
Total
long-lived assets, net
|
$
|
1,840,000
|
$
|
1,906,000
|
11.
INCOME
TAXES
The
provision for income taxes consists of the following for the three years ended
April 30, 2007:
2007
|
2006
|
2005
|
||||||||
Provision
for federal income taxes at statutory rate
|
$
|
(7,071,000
|
)
|
$
|
(5,801,000
|
)
|
$
|
(5,254,000
|
)
|
|
State
income taxes, net of federal benefit
|
(1,202,000
|
)
|
(995,000
|
)
|
(902,000
|
)
|
||||
Expiration
and adjustment of loss carryforwards
|
73,000
|
719,000
|
4,513,000
|
|||||||
Change
in valuation allowance
|
8,132,000
|
6,048,000
|
1,628,000
|
|||||||
Increase
of effective tax rate for net state deferred tax asset
|
-
|
-
|
-
|
|||||||
Other,
net
|
68,000
|
29,000
|
15,000
|
|||||||
Income
tax (expense) benefit
|
$
|
-
|
$
|
-
|
$
|
-
|
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, 2007 and 2006 are as follows:
2007
|
2006
|
||||||
Net
operating loss carryforwards
|
$
|
55,756,000
|
$
|
48,147,000
|
|||
Stock-based
compensation
|
2,067,000
|
1,676,000
|
|||||
General
business and research and development credits
|
118,000
|
118,000
|
|||||
Deferred
revenue
|
424,000
|
233,000
|
|||||
Accrued
liabilities
|
1,067,000
|
1,126,000
|
|||||
Total
deferred tax assets
|
59,432,000
|
51,300,000
|
|||||
Less
valuation allowance
|
(59,432,000
|
)
|
(51,300,000
|
)
|
|||
Net
deferred tax assets
|
$
|
-
|
$
|
-
|
At
April
30, 2007, we had federal net operating loss carryforwards and tax credit
carryforwards of approximately $150,100,000 and $118,000, respectively. The
net
operating loss carryforwards expire in fiscal years 2008 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 $80,900,000 at April 30,
2007,
which begin to expire in fiscal year 2008.
F-28
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
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.
12.
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
$15,500.
We made no matching contributions to the Plan since its inception.
13.
SUBSEQUENT
EVENTS
On
June
28, 2007, we sold 30,000,000 shares under a Securities Purchase Agreement with
several institutional investors in exchange for net proceeds of $20,900,000
(Note 8).
14. 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,
2007
|
January
31,
2007
|
October
31,
2006
|
July
31,
2006
|
April
30,
2006
|
January
31,
2006
|
October
31,
2005
|
July
31,
2005
|
||||||||||||||||||
Net
revenues
|
$
|
2,240,000
|
$
|
363,000
|
$
|
684,000
|
$
|
421,000
|
$
|
901,000
|
$
|
1,528,000
|
$
|
556,000
|
$
|
208,000
|
|||||||||
Cost
of sales
|
$
|
2,049,000
|
$
|
223,000
|
$
|
494,000
|
$
|
530,000
|
(a)
|
$
|
1,477,000
|
(b)
|
$
|
1,088,000
|
$
|
428,000
|
$
|
304,000
|
(c)
|
||||||
Gross
profit (loss)
|
$
|
191,000
|
$
|
140,000
|
$
|
190,000
|
$
|
(109,000
|
)
|
$
|
(576,000
|
)
|
$
|
440,000
|
$
|
128,000
|
$
|
(96,000
|
)
|
||||||
Operating
expenses
|
$
|
5,630,000
|
$
|
5,420,000
|
$
|
5,590,000
|
$
|
5,682,000
|
$
|
4,934,000
|
$
|
4,922,000
|
$
|
4,814,000
|
$
|
4,309,000
|
|||||||||
Net
loss
|
$
|
(5,244,000
|
)
|
$
|
(5,025,000
|
)
|
$
|
(5,070,000
|
)
|
$
|
(5,457,000
|
)
|
$
|
(5,038,000
|
)
|
$
|
(3,113,000
|
)
|
$
|
(4,571,000
|
)
|
$
|
(4,339,000
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
______________
(a)
|
Cost
of sales for the quarter ended July 31, 2006 includes the write-off
of
unusable work-in-process inventory combined with an estimated contract
loss provision associated with one customer, which in the aggregate
totaled $208,000.
|
(b)
|
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.
|
(c)
|
Cost
of sales for the quarter ended July 31, 2005 includes additional
costs of
$99,000 incurred during the quarter ended July 31, 2005 to provide
additional data to support required studies for current
customers.
|
F-29
PEREGRINE
PHARMACEUTICALS,
INC. SCHEDULE
II
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007 (continued)
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,
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
|
)
|
$
|
-
|
||||
Valuation
reserve for note and other receivables for the year ended April 30,
2007
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
F-30