Avid Bioservices, Inc. - Annual Report: 2008 (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, 2008
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
|
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. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company. See
definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (check
one):
Large
accelerated filer o
|
Accelerated
filer
x
|
Non-accelerated
filer o
|
Smaller
reporting company 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 $136,173,000 as of October 31, 2007.
(1)
226,210,617
(Number
of shares of common stock outstanding as of July 10, 2008)
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, 2008.
(1)
Excludes 2,976,758 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, 2007.
|
PEREGRINE
PHARMACEUTICALS, INC.
FORM
10-K ANNUAL REPORT
FISCAL
YEAR ENDED APRIL 30, 2008
TABLE
OF CONTENTS
PART
I
|
||
Item
1.
|
Business
|
1
|
Item
1A.
|
Risk
Factors
|
20
|
Item
1B.
|
Unresolved
Staff Comments
|
33
|
Item
2.
|
Properties
|
33
|
Item
3.
|
Legal
Proceedings
|
33
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
34
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PART
II
|
||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
35
|
Item
6.
|
Selected
Financial Data
|
36
|
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
37
|
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
50
|
Item
8.
|
Financial
Statements and Supplementary Data
|
50
|
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
|
50
|
Item
9A
|
Controls
and Procedures
|
50
|
Item
9B.
|
Other
Information
|
51
|
PART
III
|
||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
54
|
Item
11.
|
Executive
Compensation
|
54
|
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
54
|
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
54
|
Item
14.
|
Principal
Accountant Fees and Services
|
54
|
PART
IV
|
||
Item
15.
|
Exhibits
and Consolidated Financial Statement Schedules
|
55
|
Signatures
|
62
|
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® and Avid
Bioservices, Inc. 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
We are a
clinical stage biopharmaceutical company developing monoclonal antibodies
for the treatment of cancer and hepatitis C virus (HCV)
infection. We are advancing three separate clinical programs with our
first-in-class compounds bavituximab and Cotara® that employ our two platform
technologies: Anti-Phosphatidylserine (“Anti-PS”) therapeutics and
Tumor Necrosis Therapy (“TNT”).
Our lead
Anti-PS product, bavituximab, is being studied in two separate clinical trial
programs for the treatment of various solid tumors and HCV
infection. We have completed a Phase Ib cancer trial assessing the
safety and anti-tumor activity of bavituximab administered in combination with
chemotherapy in patients with solid cancers and announced top-line results in
May 2007. Data gathered from that Phase Ib study was utilized in the
design of three separate Phase II trials of bavituximab in combination with
chemotherapy for the treatment of solid tumors. Two of the trials are
designed to evaluate the combination of bavituximab and chemotherapy in patients
with advanced breast cancer and the third trial is designed to evaluate
bavituximab in combination with chemotherapy in patients with non-small cell
lung cancer (NSCLC). In addition, a Phase I safety trial evaluating
bavituximab as monotherapy in patients with advanced solid cancers is continuing
in the U.S. For the anti-viral program, we have completed two Phase I
studies of bavituximab as monotherapy in patients with chronic HCV infection,
and we are currently dosing patients in a third Phase I clinical study to
evaluate the safety, pharmacokinetics and anti-viral activity of bavituximab
over a longer dosing period in patients co-infected with HCV and the human
immunodeficiency virus (“HIV”).
1
Our lead
TNT technology product candidate, Cotara®, is a monoclonal antibody conjugated
to a radioisotope that is being assessed in clinical trials for the treatment of
glioblastoma multiforme (GBM), a deadly form of brain cancer. We have
completed a number of clinical trials of Cotara having treated in excess of 85
patients with advanced solid cancers. Positive data from these prior
trials provided the foundation for the two Cotara brain cancer studies currently
underway: A Phase II clinical trial is enrolling patients to assess
the safety and anti-tumor activity of Cotara in GBM patients at first
relapse. In addition, we are continuing to enroll patients in a dose
confirmation and dosimetry trial in patients with recurrent GBM to further
characterize the distribution characteristics of Cotara and to assess safety and
anti-tumor activity.
The following table summarizes our
current clinical trial programs:
Product
|
Indication
|
Trial
Design
|
Trial
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
I monotherapy repeat dose safety study designed to treat up to 28
patients.
|
Patient
enrollment is continuing in this study.
|
Bavituximab
plus docetaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
may be expanded to treat up to a total of 46 patients if six or more
objective tumor responses are observed in the initial 15
patients.
|
Patient
enrollment for the first 15 patients is complete and the pre-defined
primary endpoint of six or more objective tumor responses was achieved
with seven of fourteen evaluable patients achieving objective tumor
response at the first eight week evaluation point. The design
of the clinical trial now allows for an additional 31 study patients to be
enrolled. Patients are continuing to be monitored for secondary
endpoints.
|
Bavituximab
plus carboplatin
and
paclitaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
may be expanded to treat up to a total of 46 patients if promising results
are observed in the initial 15 patients.
|
Patient
enrollment is expected to begin shortly in this trial.
|
Bavituximab
plus carboplatin
and
paclitaxel
|
Non-small
cell lung cancer (NSCLC)
|
Phase
II study designed to treat 21 patients initially. Study may be expanded to
treat up to a total of 49 patients if promising results are observed in
the initial 21 patients.
|
Patient
enrollment was initiated in June 2008 and enrollment is
continuing.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
Study
enrollment is continuing in this study.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Phase
II safety and efficacy study to treat up to 40 patients at first
relapse.
|
Study
enrollment is continuing in this study.
|
Bavituximab
|
Chronic
hepatitis C virus (“HCV”)
infection
co-infected with HIV
|
Phase
Ib repeat dose safety study designed to treat up to 24
patients.
|
Study
enrollment is continuing in this
study.
|
2
In
addition to our clinical programs, we have a number of earlier-stage
technologies that are potential candidates for partnering. These
programs include potential new therapeutics, vaccine adjuvants and diagnostic
agents.
In
addition to our research and development efforts, we operate a wholly owned cGMP
(current Good Manufacturing Practices) contract manufacturing subsidiary, Avid
Bioservices®, Inc. (“Avid”). Avid provides contract manufacturing
services for biotechnology and biopharmaceutical companies on a fee-for-service
basis, from pre-clinical drug supplies up through commercial-scale drug
manufacture. In addition to these activities, Avid provides critical
services in support of Peregrine’s product pipeline including manufacture and
scale-up of pre-clinical and clinical drug supplies.
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”) technology and Tumor Necrosis Therapy (“TNT”)
technology.
Anti-PS
Technology Platform
Peregrine’s new class of
anti-phosphatidylserine (“anti-PS”) therapeutics are monoclonal antibodies that
target and bind to components of cells normally found only on the inner surface
of the cell membrane. This target is a specific phospholipid known as
phosphatidylserine (“PS”). PS becomes exposed on the outside of cells
under stress conditions, including on the surface of tumor blood vessels and
during certain viral infections. Our first-in-class anti-PS
therapeutic 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 to this direct effect, researchers believe that
anti-PS therapies also have a secondary mechanism of action that occurs under
certain stressful conditions at the cellular level. This secondary
mechanism involves the immunosuppressive effects of PS molecules expressed on
the surface of the cell, which act to dampen the body’s normal immune
response. By binding to the PS molecule and blocking its effects,
agents such as bavituximab may have the potential to turn-off this
immunosuppressive signal, allowing the immune system to generate a robust immune
response.
Tumor
Necrosis Therapy (“TNT”) Technology Platform
Our TNT technology uses monoclonal
antibodies that target and bind to DNA and associated histone proteins released
by the dead and dying (“necrotic”) cells found at the core of solid
tumors. Most solid tumors develop this core of necrotic cells due to
the lack of oxygen and nutrients at their center. This makes
the necrotic center of tumors an abundant but selective target for TNT-based
monoclonal antibodies. Similar to a guided missile, TNT antibodies
are also capable of carrying a variety of therapeutic agents into the interior
of these tumors, including radioisotopes and chemotherapeutic agents, which then
kill the neighboring tumor cells from the inside out, while sparing healthy
tissue. Our most advanced TNT product, Cotara, is an antibody
attached to the radioactive isotope, Iodine 131.
3
Our
Products in Clinical Trials
Bavituximab
for the Treatment of Solid Tumors
Scientists working with Peregrine have
determined that the Anti-PS target for bavituximab becomes specifically exposed
on tumor blood vessels. In pre-clinical cancer studies a bavituximab
equivalent (a mouse version of the human antibody) has demonstrated promising
anti-tumor activity as a stand-alone treatment for the treatment of breast,
prostate and pancreatic tumors. 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 and significantly
enhanced the anti-tumor effects of either agent alone.
On May 31, 2007, we reported positive
top-line results from the Phase Ib open label trial. 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. 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 also achieved an objective
tumor response. Tumor types in the trial included cancers of the
breast, lung and ovary, among others.
Clinical
data gathered from the Phase Ib study was utilized in the design of three
separate Phase II bavituximab studies. These trials all have a
two-stage design. An initial cohort of patients is first enrolled, dosed and
evaluated and then the study may be expanded if a sufficient number of patients
in the initial cohort meet the primary endpoint and the safety profile is
positive. The primary endpoint of the Phase II studies is to assess
overall response rate to the combination of bavituximab and
chemotherapy. Secondary objectives include measuring time to tumor
progression, duration of response, overall patient survival and safety
parameters. Tumor responses in all of the studies are being evaluated
using Response Evaluation Criteria in Solid Tumors (RECIST)
parameters. The trials are being conducted according to International
Conference on Harmonization (ICH) and Good Clinical Practices (GCP)
standards.
The first bavituximab Phase II trial
was initiated in January 2008 in advanced breast cancer
patients. Patients in this trial are being treated with the
combination of bavituximab and the chemotherapeutic agent docetaxel, a chemotherapy drug commonly
used in the treatment of breast cancer. We have completed enrollment
in the initial cohort of 15 patients in the Republic of Georgia. On
July 2, 2008, we announced that we met the pre-specified primary endpoint of six
or more objective tumor responses in the initial 15
patients. Fourteen of the 15 patients enrolled in Stage 1 were deemed
evaluable for tumor response, with seven achieving partial tumor responses and
seven having stable disease at week eight according to Response Evaluation
Criteria in Solid Tumors (RECIST) criteria. Patients may continue to
receive bavituximab as long as the cancer does not progress and side effects are
acceptable. The design of the clinical trial now allows for an
additional 31 study patients to be enrolled.
Patient enrollment in a second
bavituximab Phase II trial was initiated in June 2008 in India using bavituximab
in combination with the chemotherapeutic agents carboplatin and paclitaxel in
patients with non-small cell lung cancer (NSCLC). The study is
designed to assess the combination therapy in 21 patients initially, and could
be expanded to include up to an additional 28 patients if promising results are
seen in the first cohort. Patients may continue to receive
bavituximab as long as the cancer does not progress and side effects are
acceptable.
4
A third bavituximab Phase II trial for
advanced breast cancer patients is expected to begin shortly in
India. Patients will be treated with the combination of bavituximab
and chemotherapeutic agents carboplatin and paclitaxel. Fifteen
patients will be enrolled in the first cohort and the study can then be expanded
to include up to an additional 31 patients if promising results are
observed. Patients may continue to receive bavituximab as long as the
cancer does not progress and side effects are acceptable.
In
addition to our three Phase II bavituximab cancer trials, we are currently
enrolling patients in a multi-center Phase I monotherapy 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
determine the safety and tolerability of bavituximab administered intravenously
to patients with advanced cancer; characterize the pharmacokinetic profile of
bavituximab and 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
originally 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 subsequently presented the FDA with data sufficient to allow us
to amend the protocol and lessen such requirements as well as make other changes
to the protocol in an effort 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.
Cotara®
for the Treatment of Brain Cancer
Cotara®, our first Tumor Necrosis
Therapy (“TNT”) based agent, 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 prior 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 at the anticipated therapeutic dose being used in current
studies. 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
multi-center open label study is designed 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 dose
limiting toxicities and maximum tolerated dose and to characterize the
biodistribution and radiation dosimetry of Cotara.
On August
2, 2007, Peregrine announced first patient dosing in a Phase II trial in India
to assess Cotara in up to 40 GBM
patients who have experienced a first relapse. This study,
which is ongoing, is expected to be an integral part of the overall Cotara brain
cancer development program. Patients receive a single infusion of the
drug using the CED delivery method, and the study’s primary objective is to
confirm the maximum tolerated dose of Cotara in these
patients. Secondary objectives include estimates of overall patient
survival, progression-free survival and the proportion of patients alive at six
months post-treatment. The study is being conducted according to
internationally accepted ICH (International Conference on Harmonization) and GCP
(Good Clinical Practices) guidelines at multiple clinical
centers. Patient enrollment and dosing are ongoing.
5
Taken
together, the study results from Peregrine’s two ongoing Cotara trials 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 GBM.
We have
experienced delays in both these studies for reasons outside our
control. The dose confirmation and dosimetry trial was originally
co-sponsored and primarily managed by the NCI-funded New Approaches to Brain
Tumor Therapy (NABTT) consortium. Due to funding reductions at NABTT,
within the last year, we have assumed full sponsorship and control of the trial
and initiated several additional clinical trial centers. The phase II
India study initially experienced regulatory delays due to the serial nature of
manufacturing and clinical trial approvals as well as changes in key personnel
at the Drug Controller General office. Additionally, we have had to
invest in institutional infrastructure and coordination at the clinical site
level in order to enroll patients. While we are hopeful that such
changes will enable us to increase the rate of patient enrollment in both of
these studies, we expect to continue facing enrollment challenges.
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 affected by bavituximab.
We filed the first Investigational New
Drug (“IND”) application for bavituximab for the treatment of chronic hepatitis
C virus (“HCV”) infection in April 2005. Peregrine initiated and
completed a Phase Ia single dose escalation study in thirty (30) patients
chronically infected with HCV who had failed prior therapies. The
primary goal of the Phase Ia study was to assess the safety and pharmacologic
profile 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 HCV 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. In November 2007, at the 58th Annual
Meeting of the American Association for the Study of Liver Disease (AASLD), we
presented results from the Phase Ib repeat dose HCV trial. The
primary objective of the Phase Ib study was to determine the safety,
distribution and pharmacokinetic properties of 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. Anti-viral activity (decline of greater than or equal to
0.5 log10 reduction in HCV RNA) was observed at all dose levels. 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.
6
Based on
the data from these earlier HCV clinical studies and on pre-clinical data
indicating the potential of bavituximab to bind to HIV and HIV-infected cells,
Peregrine advanced bavituximab into a trial in HCV patients co-infected with
HIV. On October 10, 2007, Peregrine announced the dosing of the first
patient in this trial. Patient enrollment and dosing is currently
ongoing. The 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. Patient cohorts are receiving
ascending dose levels of bavituximab weekly for up to 8 weeks. HCV and HIV
viral titers and other biomarkers are being 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 also
have worked with top academic researchers and research organizations to study
the potential use of bavituximab to treat other viral
infections. These pre-clinical programs have primarily focused on
evaluating the potential of bavituximab and other anti-PS antibodies in viral
infections with significant economic impact including HIV, influenza and CMV, as
well as biodefense applications. The promising results of these
pre-clinical studies have contributed to Peregrine’s understanding of the
mechanism of action of bavituximab and its broad potential in viral
indications.
Government
Contract With The Defense Threat Reduction Agency
On June
30, 2008, we were awarded a five-year contract worth up to $44.4 million to test
and develop bavituximab and an equivalent fully human antibody as potential
broad-spectrum treatments for viral hemorrhagic fever infections. The
initial contract was awarded through the Transformational Medical Technologies
Initiative (TMTI) of the U.S. Department of Defense's Defense Threat Reduction
Agency (DTRA). In pre-clinical animal models, bavituximab has
demonstrated encouraging anti-viral activity as a potential treatment for viral
hemorrhagic fevers. This federal contract is expected to provide us
with up to $22.3 million in funding over a 24-month base period, with $5
million appropriated immediately for the current federal fiscal year ending
September 30, 2008. The remainder of the $22.3 million in funding is
expected to be appropriated over the remainder of the two-year base period
ending June 29, 2010. Subject to the progress of the program and
budgetary considerations in future years, the contract can be extended beyond
the base period to cover up to $44.4 million in funding over the five-year
contract period. Work under this contract commenced on June 30,
2008.
Earlier-Stage
Technologies / Pre-Clinical Studies
We have
historically developed 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, Anti-Angiogenesis
Agents, and Vascular Targeting Agents (“VTAs”), that complement our other
anti-cancer platforms. In order to focus our efforts and resources on
our current clinical programs, we have curtailed our efforts in developing these
pre-clinical programs and we are actively seeking partners to further develop
these technologies.
In
addition, we also conduct pre-clinical studies relevant to bavituximab and our
anti-PS technology platform. Positive scientific results were
reported on a number of these programs in fiscal year 2008.
In
September 2007, a study published in Clinical
Cancer Research confirmed the potential of bavituximab combined with
radiation in lung cancer, showing that a bavituximab equivalent combined with
radiation reduced tumor growth by 80% in a mouse lung cancer model. The study
also confirmed key aspects of bavituximab's mechanism of action in combination
with radiation therapy.
7
On April 15, 2008 at the 2008 Annual
Meeting of the American Association for Cancer Research (AACR), Peregrine
reported that pre-clinical study results confirmed a unique mechanism by which
bavituximab is thought to affect the tumor microenvironment and contribute to
its anti-tumor efficacy. The research showed similar effects for
bavituximab and for PGN635, a fully human version of the bavituximab
antibody. In the in vitro and
in vivo studies, Peregrine researchers
showed that both bavituximab and PGN635 cause the destruction of targeted cells.
They demonstrated that by blocking the anti-inflammatory signals of the
phosphatidylserine found on the surface of targeted cells, these anti-PS
antibodies could create a unique tumor microenvironment, by enhancing production
of pro-inflammatory cytokines and decreasing production of anti-inflammatory
cytokines. In addition, the studies showed that similar to
bavituximab, PGN635 localizes to tumors but not to healthy tissue.
At the
2008 AACR meeting, Peregrine also reported pre-clinical study results
demonstrating the vaccine-like ability of immunocytokine proteins combining its
anti-PS antibodies and cytokines, such as IL-2, to generate robust and
protective immune responses in a highly aggressive mouse brain cancer
model. Eighty percent of the mice receiving prophylactic
pre-treatment with irradiated breast cancer and immunocytokine cells did not
develop any tumors and remained tumor-free through 270 days post-treatment,
while all of the control animals receiving irradiated breast tumor cells alone
developed lethal tumors.
Peregrine also reported pre-clinical
study results at the 2008 AACR meeting demonstrating that a mouse equivalent of
Peregrine's bavituximab, administered in combination with the chemotherapeutic
agent docetaxel, demonstrated excellent signs of efficacy in a model of
hormone-refractory prostate cancer. This data confirmed and extended
the results of previous studies of Peregrine's anti-PS antibodies in models of
prostate cancer. Researchers reported that in a mouse model of
hormone-refractory prostate cancer, the combination of the bavituximab
equivalent antibody and docetaxel significantly decreased the growth of tumors,
eliminated detectable metastases and prevented tumor
re-growth. Survival time was more than doubled in animals receiving
combination therapy compared to controls, and was substantially longer than the
survival of animals treated with either therapy alone. This increase in
anti-tumor efficacy and anti-metastatic activity was achieved with no apparent
increase in toxicity compared to docetaxel alone.
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 will pay a royalty on net sales of any products
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.
8
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.
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
$6,850,000 assuming the achievement of all development milestones under the
agreements through commercialization of products, of which, $6,400,000 is due
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 years 2008 and 2006, we expensed $50,000 and $450,000,
respectively under in-licensing agreements covering our Anti-PS
Immunotherapeutics technology platform, which is included in research and
development expense. We did not incur any milestone related expenses
during fiscal year 2007.
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. from the Chinese
pharmaceutical company, 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 I, Item 3 under “Legal Proceedings” of this Annual
Report. Through fiscal year ended April 30, 2008, we have not
received any amounts under the agreement.
9
During
October 2000, we entered into a licensing agreement with Merck KGaA to
out-license a segment of our TNT technology for use in the application of
cytokine fusion proteins. During January 2003, we entered into an
amendment to the license agreement, whereby we received an extension to the
royalty period from six years to ten years from the date of the first commercial
sale. Under the terms of the agreement, we would receive a royalty on
net sales if a product is approved under the agreement. Merck KGaA
has not publicly disclosed the development status of its program.
During
February 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, 2008, 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.
Contract
Manufacturing Services
During
January 2002, we commenced the operations of our wholly owned subsidiary, Avid
Bioservices, Inc. (“Avid”), 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.
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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
full scale runs will be performed to finalize manufacturing batch
records. Material produced during these runs is often used for
toxicology studies. After completing the pilot batch run(s),
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 from 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, small, domestic and foreign biotechnology companies
interested in the production of monoclonal antibodies for clinical trials 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”) supporting a New Drug Application for
commercial application by a client company. The Los Angeles District
FDA office recommended 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.
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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:
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1.
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Pre-clinical
testing. This generally includes evaluation of our
products in the laboratory or in animals to determine characterization,
safety and efficacy. Some pre-clinical studies must be
conducted by laboratories that comply with FDA regulations regarding good
laboratory practice.
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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.
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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.
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4.
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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.
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5.
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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.
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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
recurrent 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.
13
Cotara® was granted Fast Track designation by
the FDA in fiscal year 2002 for the treatment of recurrent glioblastoma
multiforme. This designation facilitates the development and
expedites the review of new drugs that are intended to treat serious or
life-threatening conditions and that demonstrate the potential to address unmet
medical needs. The Fast Track mechanism is described in the Food and
Drug Administration Modernization Act of 1997 (FDAMA). The benefits of Fast
Track include scheduled meetings to seek FDA input into development plans,
the option of submitting a New Drug Application in sections rather than all
components simultaneously, and the option of requesting evaluation of studies
using surrogate endpoints.
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 or to contract research organizations that distribute the clinical trial
materials to clinical 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.
14
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.
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 therapeutic and diagnostic products. We typically
place restrictions in our agreements with third parties, which contractually
restrict their right to use and disclose any of the Company's proprietary
technology with which they may be involved. In addition, we have
internal non-disclosure safeguards, including confidentiality agreements, with
our employees. There can be no assurance, however, that others may
not independently develop similar technology or that the Company's secrecy will
not be breached.
Customer
Concentration and Geographic Area Financial Information
We are
currently in the research and development phase for all of our products and we
have not generated any product sales from any of our technologies under
development. For financial information concerning Avid’s customer
concentration and geographic areas of its customers, see Note 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.
15
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.
We are conducting the Cotara® dose
confirmation and dosimetry clinical trial for the treatment of recurrent
glioblastoma multiforme (“GBM”), the most aggressive form of brain
cancer. Approved 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: Neuradiab, a radiolabeled anti-tenascin monoclonal antibody
sponsored by Bradmer Pharmaceuticals, CDX-110, a peptide vaccine under
development by Celldex, cilengitide in newly diagnosed GBM patients being
evaluated by Merk KGaA, and cediranib for patients with recurrent GBM being
developed by AstraZeneca. 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
is currently in clinical trials for the treatment of advanced solid
cancers. 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 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 are 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 Three Rivers Pharmaceuticals,
LLC. 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.
16
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 boceprevir from Schering-Plough
Corporation.
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 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 $18,279,000 in
fiscal year 2008, $15,876,000 in fiscal year 2007, and $12,415,000 in fiscal
year 2006.
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, 2008, we employed 129 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.
17
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.
18
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.
19
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 April
30, 2008, we had $15,130,000 in cash and cash equivalents. We have
expended substantial funds on (i) the research, development and clinical trials
of our product candidates, and (ii) funding the operations of our wholly owned
subsidiary, Avid Bioservices, Inc. As a result, we have historically
experienced negative cash flows from operations since our inception and we
expect the negative cash flows from operations to continue for the foreseeable
future. Our net losses incurred during the past three fiscal years
ended April 30, 2008, 2007 and 2006 amounted to $23,176,000, $20,796,000, and
$17,061,000, respectively. 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, we expect such losses
to continue in fiscal year 2009.
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. As discussed in Note 1 to the consolidated financial
statements, there exists substantial doubt regarding our ability to continue as
a going concern.
We will
need additional capital to support the costs of our clinical and pre-clinical
programs through one or more methods including either equity or debt
financing. If we raise additional capital through the issuance of debt
securities, the debt securities may be secured and any interest payments would
reduce the amount of cash available to operate and grow our business. If
we raise additional capital through the issuance of equity securities, such
issuances will likely cause dilution to our stockholders, particularly if we are
required to do so during periods when our common stock is trading at
historically low price levels. As of April 30, 2008, we had an
aggregate of approximately 5,031,000 shares available under our existing
effective Form S-3 registration statements for possible future registered
transactions. In addition, we filed a separate shelf registration
statement on Form S-3, File Number 333-139975, under which we may issue, from
time to time, in one or more offerings, shares of our common stock for remaining
gross proceeds of up to $7,500,000.
We may
also raise additional capital though negotiating licensing or collaboration
agreements for our technology platforms. In addition, our wholly
owned subsidiary Avid Bioservices, Inc., represents an additional asset in our
portfolio and we are actively pursuing strategic initiatives for Avid as a means
of raising additional capital.
Although
we will continue to explore these potential opportunities, 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 or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid
Bioservices, Inc. to complete the research, development, and clinical testing of
our product candidates. Based on our current projections, which
includes projected revenues from existing customers of Avid Bioservices, Inc.,
combined with the projected revenues from our government contract, we believe we
have sufficient cash on hand combined with amounts expected to be received from
Avid customers and from our government contract to meet our obligations as
they become due through at least fiscal year 2009. There are a number
of uncertainties associated with our financial projections, including but not
limited to, termination of contracts and technical challenges, which would
reduce or delay our future projected cash-inflows. The uncertainties
surrounding our future cash inflows have raised substantial doubt regarding our
ability to continue as a going concern. Our independent registered
public accountants have included an explanatory paragraph related to the
uncertainity of our ability to continue as a going concern in their opinion on
our 2008 consolidated financial statements.
20
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 2008
|
$ | 23,176,000 | ||
Fiscal
Year 2007
|
$ | 20,796,000 | ||
Fiscal
Year 2006
|
$ | 17,061,000 |
As of
April 30, 2008, we had an accumulated deficit of $230,836,000. 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 and/or royalty 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 April 30, 2008, there were
approximately 226,211,000 shares of our common stock
outstanding. 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 20,921,509 additional shares of our common stock that are
reserved for future issuance under our shelf registration statements and stock
option plans, 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 |
15,890,875
|
|||
Total
|
20,921,509
|
In
addition, the above table does not include shares of common stock that we have
available to issue from the registration statement we filed during January 2007
on Form S-3, File Number 333-139975, under which we may issue, from time to
time, in one or more offerings, shares of our common stock for remaining gross
proceeds of up to $7,500,000.
Of the
total options outstanding as of April 30, 2008, approximately 4,073,000 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 April 30,
2008.
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.
21
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock.
The
market price of our common stock and the market prices of securities of
companies in the biotechnology sector have generally been highly volatile and
are likely to continue to be highly volatile.
The following table shows the high and
low sales price and trading volume of our common stock for each quarter in the
three fiscal years ended April 30, 2008:
Common
Stock
Sales
Price
|
Common
Stock
Daily
Trading Volume
(000’s
omitted)
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
Fiscal
Year 2008
|
||||||||||||||||
Quarter
Ended April 30, 2008
|
$ |
0.73
|
$ | 0.35 | 3,846 | 130 | ||||||||||
Quarter
Ended January 31, 2008
|
$ | 0.65 | $ | 0.35 | 3,111 | 140 | ||||||||||
Quarter
Ended October 31, 2007
|
$ | 0.79 | $ | 0.54 | 2,631 | 169 | ||||||||||
Quarter
Ended July 31, 2007
|
$ | 1.40 | $ | 0.72 | 21,653 | 237 | ||||||||||
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 |
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, including our abilities to
continue as a going concern;
|
|
·
|
the
offering and sale of shares of our common stock at a discount under an
equity transaction;
|
|
·
|
changes
in our capital structure, including but not limited to any potential
reverse stock split;
|
|
·
|
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.
|
22
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.
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.
|
On July
25, 2007, we received a deficiency notice from The Nasdaq Stock Market notifying
us that we had not met the $1.00 minimum closing bid price requirement for
thirty consecutive trading days as set forth above. According to the
Nasdaq notice, we were automatically afforded an initial “compliance period” of
180 calendar days, or until January 22, 2008, to regain compliance with this
requirement. Although we did not achieve compliance with the minimum
closing bid price requirement after the initial 180 calendar day period, on
January 22, 2008, we received a letter from the Nasdaq Stock Market providing us
with the additional “compliance period” of 180 calendar days, or until July 21,
2008, to regain compliance. In order to regain compliance with the
minimum closing bid price, the closing bid price of our common stock must be
$1.00 or more for at least 10 consecutive trading days. If we are not
able to demonstrate compliance with the minimum bid price rule by July 21, 2008,
the company will be notified by the Nasdaq Stock Market that our common stock
will be delisted. If this occurs, we will have the opportunity to
appeal the determination to delist our common stock. We intend to
pursue all available options to ensure our continued listing on the Nasdaq Stock
Market. Although we currently meet all other Nasdaq listing
requirements, the market price of our common stock has generally been highly
volatile and we cannot guarantee that we will be able to regain compliance with
the minimum closing bid price requirement within the required compliance
period. 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.
23
Successful
Development Of Our Products Is Uncertain. To Date, No Revenues Have
Been Generated From The Commercial Sale Of Our Products And Our Products May Not
Generate Revenues In The Future.
Our
development of current and future product candidates is subject to the risks of
failure inherent in the development of new pharmaceutical products and products
based on new technologies. These risks include:
|
·
|
delays
in product development, clinical testing or
manufacturing;
|
|
·
|
unplanned
expenditures in product development, clinical testing or
manufacturing;
|
|
·
|
failure
in clinical trials or failure to receive regulatory
approvals;
|
|
·
|
emergence
of superior or equivalent products;
|
|
·
|
inability
to manufacture on our own, or through others, product candidates on a
commercial scale;
|
|
·
|
inability
to market products due to third party proprietary rights;
and
|
|
·
|
failure
to achieve market acceptance.
|
Because
of these risks, our research and development efforts or those of our partners
may not result in any commercially viable products. If significant
portions of these development efforts are not successfully completed, required
regulatory approvals are not obtained, or any approved products are not
commercially successful, our business, financial condition and results of
operations may be materially harmed.
Because
we have not begun the commercial sale of any 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
various 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 or obtain regulatory approval to conduct additional
clinical trials, 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.
24
Clinical
Trials Required For Our Product Candidates Are Expensive And Time
Consuming, And Their Outcome Is
Uncertain.
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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:
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obtaining
regulatory approval to commence a clinical
trial;
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reaching
agreement on acceptable terms with prospective contract research
organizations, or CROs, and trial sites, the terms of which can be subject
to extensive negotiation and may vary significantly among different CROs
and trial sites;
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slower
than expected rates of patient recruitment due to narrow screening
requirements;
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the
inability of patients to meet FDA or other regulatory authorities imposed
protocol requirements;
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the
inability to retain patients who have initiated a clinical trial but may
be prone to withdraw due to various clinical or personal reasons, or who
are lost to further follow-up;
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the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices, or cGMPs, for use in clinical
trials;
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the
need or desire to modify our manufacturing
processes;
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the
inability to adequately observe patients after
treatment;
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changes
in regulatory requirements for clinical
trials;
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the
lack of effectiveness during the clinical
trials;
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unforeseen
safety issues;
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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
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government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
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Even if
we obtain positive results from pre-clinical or initial clinical trials, we may
not achieve the same success in future trials. Clinical trials may
not demonstrate statistically sufficient safety and effectiveness to obtain the
requisite regulatory approvals for product candidates employing our
technology.
Clinical
trials that we conduct or that third-parties conduct on our behalf may not
demonstrate sufficient safety and efficacy to obtain the requisite regulatory
approvals for any of our product candidates. We expect to commence
new clinical trials from time to time in the course of our business as our
product development work continues. The failure of clinical trials to
demonstrate safety and effectiveness for our desired indications could harm the
development of that product candidate as well as other product
candidates. Any change in, or termination of, our clinical trials
could materially harm our business, financial condition and results of
operations.
25
Our
International Clinical Trials May Be Delayed Or Otherwise Adversely
Impacted By Social, Political And Economic Factors Affecting The
Particular Foreign Country.
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We are
presently conducting clinical trials in India and the Republic of
Georgia. Our ability to successfully initiate, enroll and complete a
clinical trial in either country, or in any future foreign country in which we
may initiate a clinical trial, are subject to numerous risks unique to
conducting business in foreign countries, including:
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difficulty
in establishing or managing relationships with clinical research
organizations and physicians;
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different
standards for the conduct of clinical trials and/or health care
reimbursement;
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our
inability to locate qualified local consultants, physicians, and
partners;
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the
potential burden of complying with a variety of foreign laws, medical
standards and regulatory requirements, including the regulation of
pharmaceutical products and treatment;
and
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general
geopolitical risks, such as political and economic instability, and
changes in diplomatic and trade
relations.
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Because
we will be conducting a number of our Phase II clinical trials in India and the
Republic of Georgia and potentially other foreign countries, any disruption to
our international clinical trial program could significantly delay our product
development efforts. In addition, doing business in the Republic of
Georgia, which is in Eastern Europe, involves other significant risks which
could materially and adversely affect our business as there remains a high
degree of political instability in many parts of Eastern Europe.
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.
26
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:
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our
ability to provide acceptable evidence of safety and
efficacy;
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relative
convenience and ease of
administration;
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the
prevalence and severity of any adverse side
effects;
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availability
of alternative treatments;
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pricing
and cost effectiveness;
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effectiveness
of our or our collaborators’ sales and marketing strategy;
and
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our
ability to obtain sufficient third-party insurance coverage or
reimbursement.
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In
addition, if bavituximab, Cotara®, or any future product candidate that we
discover and develop does not provide a treatment regimen that is more
beneficial than the current standard of care or otherwise provide patient
benefit, that product likely will not be accepted favorably by the
market. If any products we may develop do not achieve market
acceptance, then we may not generate sufficient revenue to achieve or maintain
profitability.
In addition, even if our products
achieve market acceptance, we may not be able to maintain that market acceptance
over time if new products or technologies are introduced that are more favorably
received than our products, are more cost effective or render our products
obsolete.
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We have 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 oncology drug, we may not find a suitable partnering
candidate for Cotara®. We also cannot ensure that we will be able to
find a suitable licensing partner for this technology. Furthermore,
we cannot ensure that if we do find a suitable licensing partner, the financial
terms that they propose will be acceptable to the Company.
27
Our
Dependency On Our Radiolabeling Suppliers 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 is unable to continue to
qualify its 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 facilities that can 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:
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production
yields;
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quality
control and quality assurance;
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shortages
of qualified personnel;
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compliance
with FDA or other regulatory authorities regulations, including the
demonstration of purity and
potency;
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changes
in FDA or other regulatory authorities
requirements;
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production
costs; and/or
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development
of advanced manufacturing techniques and process
controls.
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In
addition, we or any third-party manufacturer will be required to register the
manufacturing facilities with the FDA and other regulatory authorities, provided
it had not already registered. 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.
28
We
Currently Depend On a Government Contract To Partially Fund Our Research And
Development Efforts. If Our Current Government Funding Is Reduced Or
Delayed, Our Drug Development Efforts May Be Negatively Affected.
On June
30, 2008, we were awarded a five-year contract worth up to $44.4 million to test
and develop bavituximab and an equivalent fully human antibody as potential
broad-spectrum treatments for viral hemorrhagic fever infections. The
initial contract was awarded through the Transformational Medical Technologies
Initiative (TMTI) of the U.S. Department of Defense's Defense Threat Reduction
Agency (DTRA). This federal contract is expected to provide us with
up to $22.3 million in funding over a 24-month base period, with $5 million
appropriated immediately for the current federal fiscal year ending September
30, 2008. The remainder of the $22.3 million in funding is expected
to be appropriated over the remainder of the two-year base period ending June
29, 2010. Subject to the progress of the program and budgetary
considerations in future years, the contract can be extended beyond the base
period to cover up to $44.4 million in funding over the five-year contract
period. Work under this contract commenced on June 30,
2008. If we do not receive the expected funding under this contract,
we may not be able to develop therapeutics to treat hemorrhagic fever virus
infection nor otherwise receive the other indirect benefits that may be derived
from receipt of the full funding under this contract.
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.
29
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:
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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;
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the
claims of any patents that issue may not provide meaningful
protection;
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we
may be unable to develop additional proprietary technologies that are
patentable;
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the
patents licensed or issued to us may not provide a competitive
advantage;
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other
parties may challenge patents licensed or issued to
us;
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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
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other
parties may design around our patented
technologies.
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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 a 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.
30
We are conducting the Cotara® dose
confirmation and dosimetry clinical trial for the treatment of recurrent
glioblastoma multiforme (“GBM”), the most aggressive form of brain
cancer. Approved 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: Neuradiab, a radiolabeled anti-tenascin monoclonal antibody
sponsored by Bradmer Pharmaceuticals, CDX-110, a peptide vaccine under
development by Celldex, cilengitide in newly diagnosed GBM patients being
evaluated by Merk KGaA, and cediranib for patients with recurrent GBM being
developed by AstraZeneca. 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
is currently in clinical trials for the treatment of advanced solid
cancers. 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 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 are 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 Three Rivers Pharmaceuticals,
LLC. 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 boceprevir from Schering-Plough Corporation.
31
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 & Chief Executive Officer and Director, would adversely
affect our development efforts and clinical trial programs during the six to
twelve month period that we estimate it would take to find and train a qualified
replacement.
We also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical
personnel. We face intense competition in our recruiting activities,
including competition from larger companies with greater
resources. We do not know if we will be successful in attracting or
retaining skilled personnel. The loss of certain key employees or our
inability to attract and retain other qualified employees could negatively
affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to
protect stockholders against unsolicited attempts to acquire control of us that
do not offer a fair price to our stockholders as determined by our Board of
Directors. Under the plan, the acquisition of 15% or more of our
outstanding common stock by any person or group, unless approved by our board of
directors, will trigger the right of our stockholders (other than the acquiror
of 15% or more of our common stock) to acquire additional shares of our common
stock, and, in certain cases, the stock of the potential acquiror, at a 50%
discount to market price, thus significantly increasing the acquisition cost to
a potential acquiror. In addition, our certificate of incorporation
and by-laws contain certain additional anti-takeover protective
devices. For example,
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no
stockholder action may be taken without a meeting, without prior notice
and without a vote; solicitations by consent are thus
prohibited;
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special
meetings of stockholders may be called only by our Board of Directors;
and
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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.
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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.
32
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.
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 original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai MediPharm and its
related entities, and Alan Epstein, MD. The lawsuit alleges claims
for breach of contract, interference with contractual relations, declaratory
relief, and injunctive relief against the defendants. Peregrine's
claims stem from a 1995 license agreement with CTL, and two amendments thereto
(collectively referred to as the "License Agreement"). Peregrine
claims that CTL breached the License Agreement by, among other things, (i) not
sharing with Peregrine all inventions, technology, know-how, patents and other
information, derived and/or developed in the People's Republic of China and/or
at the CTL laboratory, as was required under the License Agreement; (ii) not
splitting revenue appropriately with Peregrine as required under the License
Agreement; (iii) utilizing Peregrine's licensed technologies outside of the
People's Republic of China; and (iv) failing to enter a sublicense agreement
with a Chinese sponsor obligating the Chinese sponsor to comply with the terms
and obligations in the License Agreement. Peregrine further alleges
that Medibiotech and Shanghai Medipharm Biotech Co., Ltd. ("Medipharm Entities")
interfered with the License Agreement, leading to CTL's
breaches. This interference by the Medipharm Entities includes: 1)
posturing Shanghai Medipharm as the designated sublicensee under the License
Agreement, without binding any of the Medipharm Entities to the terms
and obligations of an appropriate sublicense agreement called for under the
License Agreement; 2) entering into a license agreement with defendant Epstein
("Epstein License Agreement") instead of CTL; 3) restricting the information CTL
was allowed to provide to Peregrine, thereby prohibiting CTL from providing to
Peregrine all information required under the License Agreement; and 4) providing
compensation to CTL, and its principals, so that CTL would enter agreements that
prohibited CTL from performing under the License Agreement. These
same monetary inducements also interfered with the 1999 Material Transfer
Agreement between Peregrine and Dr. Epstein ("MTA"), and caused Dr. Epstein to
breach the MTA. Dr. Epstein has attempted to have our claims against
him referred to binding Arbitration. The Superior Court has declined
his request.
33
On March 28, 2007, CTL filed a
cross-complaint, which it 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. We are challenging
the cross-complaint on the basis that not only did CTL fail to allege an
agreement with which the Company interfered, they have been unable to produce
the alleged sublicense agreement with MediPharm despite our repeated
demands.
On
February 22, 2008, the MediPharm entities filed a cross-complaint alleging, as a
third party beneficiary, that that the Company breached the Agreement by
double-licensing the technology licensed to CTL to another party, intentionally
interfered with a prospective economic advantage, and unjust
enrichment. MediPharm’s cross-complaint, which seeks $30 million in
damages, is in part predicated on MediPharm being the “Chinese Sponsor” under
the Agreement. We intend to bring pre-trial motions to dispose of the
MediPharm cross-complaint.
The
discovery phase on the aforementioned cases is still ongoing. Until
we complete the 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,
2008.
34
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, 2008:
Common
Stock Sales Price
|
||||||||
High
|
Low
|
|||||||
Fiscal
Year 2008
|
||||||||
Quarter
Ended April 30, 2008
|
$ | 0.73 | $ | 0.35 | ||||
Quarter
Ended January 31, 2008
|
$ | 0.65 | $ | 0.35 | ||||
Quarter
Ended October 31, 2007
|
$ | 0.79 | $ | 0.54 | ||||
Quarter
Ended July 31, 2007
|
$ | 1.40 | $ | 0.72 | ||||
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 |
(b) Holders. As of
June 30, 2008, the number of stockholders of record of the Company's common
stock was 5,800.
(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, 2008, warrants to
purchase an aggregate of 53,416 shares of the Company’s common stock were
exercised by two institutional investors on a cash basis under separate
transactions for net proceeds of $46,000 and the issuance of 53,416 shares of
our common stock.
35
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, 2008. 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,
2008, 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,
|
||||||||||||||||||||
2008
|
2007
|
2006
|
2005
|
2004
|
||||||||||||||||
Revenues
|
$ | 6,093,000 | $ | 3,708,000 | $ | 3,193,000 | $ | 4,959,000 | $ | 3,314,000 | ||||||||||
Net
loss
|
$ | (23,176,000 | ) | $ | (20,796,000 | ) | $ | (17,061,000 | ) | $ | (15,452,000 | ) | $ | (14,345,000 | ) | |||||
Basic
and diluted loss per common share
|
$ | (0.10 | ) | $ | (0.11 | ) | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.11 | ) | |||||
Weighted
average common shares outstanding
|
221,148,342 | 192,297,309 | 168,294,782 | 144,812,001 | 134,299,407 |
CONSOLIDATED
BALANCE SHEET DATA
|
||||||||||||||||||||
AS
OF APRIL 30,
|
||||||||||||||||||||
2008
|
2007
|
2006
|
2005
|
2004
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 15,130,000 | $ | 16,044,000 | $ | 17,182,000 | $ | 9,816,000 | $ | 14,884,000 | ||||||||||
Working
capital
|
$ | 12,403,000 | $ | 14,043,000 | $ | 15,628,000 | $ | 7,975,000 | $ | 13,631,000 | ||||||||||
Total
assets
|
$ | 23,057,000 | $ | 22,997,000 | $ | 22,676,000 | $ | 14,245,000 | $ | 19,137,000 | ||||||||||
Long-term
debt
|
$ | 22,000 | $ | 149,000 | $ | 545,000 | $ | 434,000 | $ | - | ||||||||||
Accumulated
deficit
|
$ | (230,836,000 | ) | $ | (207,660,000 | ) | $ | (186,864,000 | ) | $ | (169,803,000 | ) | $ | (154,351,000 | ) | |||||
Stockholders’
equity
|
$ | 15,595,000 | $ | 16,989,000 | $ | 17,626,000 | $ | 9,610,000 | $ | 14,759,000 |
36
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, 2008. The consolidated financial statements and notes thereto
contain detailed information that should be referred to in conjunction with this
discussion.
Overview
We are a
clinical stage biopharmaceutical company developing monoclonal antibodies
for the treatment of cancer and hepatitis C virus ("HCV")
infection. We are advancing three separate clinical programs with our
first-in-class compounds bavituximab and Cotara® that employ our two platform
technologies: Anti-Phosphatidylserine (“Anti-PS”) therapeutics and
Tumor Necrosis Therapy (“TNT”). Our lead Anti-PS product, bavituximab, is being
evaluated under two separate clinical programs 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
clinical studies for the treatment of patients with brain cancer.
We are
organized into two reportable operating segments: (i) Peregrine, the parent
company, is engaged in the research and development of monoclonal antibody
products for the treatment of cancer and viral infections and (ii) Avid
Bioservices®, Inc., (“Avid”) a wholly owned subsidiary, is engaged in providing
contract manufacturing services for Peregrine and outside customers on a
fee-for-services basis.
Going
Concern
The Company’s consolidated financial
statements have been prepared on a going concern basis, which contemplates the
realization of assets and the satisfaction of liabilities in the normal course
of business. The financial statements do not include any adjustments
relating to the recoverability of the recorded assets or the classification of
liabilities that may be necessary should it be determined that we are unable to
continue as a going concern.
At April
30, 2008, we had approximately $15,130,000 in cash and cash
equivalents. We have expended substantial funds on (i) the research,
development and clinical trials of our product candidates, and (ii) funding the
operations of our wholly owned subsidiary, Avid Bioservices, Inc. As
a result, we have historically experienced negative cash flows from operations
since our inception and we expect the negative cash flows from operations to
continue for the foreseeable future. Our net losses incurred during
the past three fiscal years ended April 30, 2008, 2007 and 2006 amounted to
$23,176,000, $20,796,000, and $17,061,000, respectively. 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, we expect such losses to continue in fiscal year
2009.
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. As discussed in Note 1 to
the consolidated financial statements, there exists substantial doubt regarding
our ability to continue as a going concern.
We will need additional capital to
support the costs of our clinical and pre-clinical programs through one or more
methods including either equity or debt financing. As of April 30,
2008, we had an aggregate of approximately 5,031,000 shares available under our
existing effective Form S-3 registration statements for possible future
registered transactions. In addition, we filed a separate shelf
registration statement on Form S-3, File Number 333-139975, under which we may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000.
37
We may also raise additional capital
though negotiating licensing or collaboration agreements for our technology
platforms. In addition, our wholly owned subsidiary Avid Bioservices,
Inc., represents an additional asset in our portfolio and we are actively
pursuing strategic initiatives for Avid as a means of raising additional
capital.
Although we will continue
to explore these potential opportunities, 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 or partnering agreements or from a potential strategic
transaction related to our subsidiary, Avid Bioservices, Inc. to complete the
research, development, and clinical testing of our product
candidates. Based on our current projections, which includes
projected revenues from existing customers of Avid Bioservices, Inc., combined
with the projected revenues from our government contract, we believe we have
sufficient cash on hand combined with amounts expected to be received from Avid
customers and from our government contract to meet our obligations as they
become due through at least fiscal year 2009. There are a number of
uncertainties associated with our financial projections, including but not
limited to, termination of contracts and technical challenges, which would
reduce or delay our future projected cash-inflows. The uncertainties
surrounding our future cash inflows have raised substantial doubt regarding our
ability to continue as a going concern.
Results
of Operations
The following table compares the
consolidated statements of operations for the fiscal years ended April 30, 2008,
2007 and 2006. This table provides 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,
|
|||||||||||||||||||||||
2008
|
2007
|
$
Change
|
2007
|
2006
|
$
Change
|
|||||||||||||||||||
(in
thousands)
|
(in
thousands)
|
|||||||||||||||||||||||
REVENUES:
|
||||||||||||||||||||||||
Contract
manufacturing
|
$ | 5,897 | $ | 3,492 | $ | 2,405 | $ | 3,492 | $ | 3,005 | $ | 487 | ||||||||||||
License
revenue
|
196 | 216 | (20 | ) | 216 | 188 | 28 | |||||||||||||||||
Total
revenues
|
6,093 | 3,708 | 2,385 | 3,708 | 3,193 | 515 | ||||||||||||||||||
COST
AND EXPENSES:
|
||||||||||||||||||||||||
Cost
of contract manufacturing
|
4,804 | 3,296 | 1,508 | 3,296 | 3,297 | (1 | ) | |||||||||||||||||
Research
and development
|
18,279 | 15,876 | 2,403 | 15,876 | 12,415 | 3,461 | ||||||||||||||||||
Selling,
general and administrative
|
7,150 | 6,446 | 704 | 6,446 | 6,564 | (118 | ) | |||||||||||||||||
Total
cost and expenses
|
30,233 | 25,618 | 4,615 | 25,618 | 22,276 | 3,342 | ||||||||||||||||||
LOSS
FROM OPERATIONS
|
(24,140 | ) | (21,910 | ) | (2,230 | ) | (21,910 | ) | (19,083 | ) | (2,827 | ) | ||||||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||||||||||
Recovery
of note receivable
|
- | - | - | - | 1,229 | (1,229 | ) | |||||||||||||||||
Interest
and other income
|
989 | 1,160 | (171 | ) | 1,160 | 846 | 314 | |||||||||||||||||
Interest
and other expense
|
(25 | ) | (46 | ) | 21 | (46 | ) | (53 | ) | 7 | ||||||||||||||
NET
LOSS
|
$ | (23,176 | ) | $ | (20,796 | ) | $ | (2,380 | ) | $ | (20,796 | ) | $ | (17,061 | ) | $ | (3,735 | ) |
38
Total
Revenues
Year
Ended April 30, 2008 Compared to the Year Ended April 30, 2007:
The
increase in revenues of $2,385,000 during the year ended April 30, 2008 compared
to the prior year was due to an increase in contract manufacturing revenue of
$2,405,000 offset by a $20,000 decrease in license revenue. The
increase in contract manufacturing revenue was primarily due to an increase in
services provided to unrelated entities on a fee-for-service basis associated
with an increase in product development services including an increase in the
number of completed manufacturing runs compared to the prior year.
We expect
to continue to generate contract manufacturing revenue during fiscal year 2009
based on the anticipated completion of in-process customer related projects and
the anticipated demand for Avid’s services under signed contracts and
outstanding proposals.
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 fiscal year 2006 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 fiscal year
2007 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, Revenue Recognition, 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.
Cost
of Contract Manufacturing
Year
Ended April 30, 2008 Compared to the Year Ended April 30, 2007:
The
increase in cost of contract manufacturing of $1,508,000 during the year ended
April 30, 2008 compared to the prior year was directly related to the current
year increase in contract manufacturing revenue. In addition, the
cost of contract manufacturing as a percentage of contract manufacturing
revenues improved from 94% in fiscal year 2007 to 81% in fiscal year 2008, which
was primarily due to an increase in contract manufacturing revenues combined
with improved efficiencies in costs associated with manufacturing
runs.
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
fiscal year 2006, we reported an 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 fiscal year
2005.
39
Research
and Development Expenses
Year
Ended April 30, 2008 Compared to the Year Ended April 30, 2007:
The
increase in research and development (“R&D”) expenses of $2,403,000 during
the year ended April 30, 2008 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,
|
||||||||||||
2008
|
2007
|
$
Change
|
||||||||||
Technology
Platform:
|
||||||||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$ | 11,371,000 | $ | 9,324,000 | $ | 2,047,000 | ||||||
TNT
(Cotara®)
|
3,942,000 | 3,898,000 | 44,000 | |||||||||
VTA
and Anti-Angiogenesis Agents
|
2,350,000 | 2,037,000 | 313,000 | |||||||||
VEA
|
616,000 | 617,000 | (1,000 | ) | ||||||||
Total
R&D Expenses
|
$ | 18,279,000 | $ | 15,876,000 | $ | 2,403,000 |
|
o
|
Anti-PhosphatidylSerine
(“Anti-PS”) Immunotherapeutics (bavituximab) – The increase in
Anti-PS Immunotherapeutics program expenses of $2,047,000 during the year
ended April 30, 2008 compared to the prior year is primarily due to
increases in clinical trial and manufacturing expenses to support the
advancement of four clinical trials using bavituximab for the treatment of
solid tumors and one clinical trial for the treatment of HCV patients
co-infected with HIV. During fiscal year 2008, we submitted two
separate Phase II clinical protocols in India, one to treat patients with
non-small cell lung cancer (“NSCLC”) and one to treat patients with breast
cancer, both of which received initial protocol approval in January
2008. In addition, we initiated and completed patient
enrollment in the first part of our two-stage Phase II study in the
Republic of Georgia and treated 15 patients with breast cancer using our
product bavituximab in combination with chemotherapy. These
expenses were further supplemented by increases in pre-clinical
development expenses to support the possible expansion of bavituximab to
treat other viral infections. The foregoing increases in
Anti-PS Immunotherapeutics were offset by a decrease in non-cash
stock-based compensation expense associated with shares of common stock
earned by employees in the prior fiscal year under a stock bonus plan,
which expired in fiscal year 2007.
|
|
o
|
Tumor Necrosis Therapy (“TNT”)
(Cotara®) – TNT program expenses remained in line with the prior
year and increased slightly by $44,000 as we continued our efforts to
support the advancement of our two ongoing Cotara® clinical trials for the
treatment of brain cancer in the U.S. and
India.
|
|
o
|
Vascular Targeting Agents
(“VTAs”) and Anti-Angiogenesis Agents – The increase in VTA and
Anti-Angiogenesis Agents program expenses of $313,000 during the year
ended April 30, 2008 compared to the prior year is primarily due to
increases in manufacturing expenses as we developed a manufacturing
process at a 1,000 liter scale for our anti-angiogensis
product. These increases in manufacturing expense were offset
by decreases in pre-clinical program expenses associated with our VTA
program. Although VTA and Anti-Angiogenesis program expenses
increased overall compared to the prior year, we have significantly
curtailed these research efforts and are currently seeking partners to
further advance these
technologies.
|
40
|
o
|
Vasopermeation Enhancements
Agents (“VEAs”) – VEA program
expenses remained in line with the prior year and decreased slightly by
$1,000 as we have initiated efforts to significantly curtail our
development expenses associated with this program and are focusing our
efforts on seeking partners to further advance this
technology.
|
Based on
our current projections, which includes estimated clinical trial enrollment
rates that are always uncertain, we expect research and development expenses in
fiscal year 2009 to remain in line with fiscal year 2008. During
fiscal year 2009, we expect to direct the majority of our research and
development expenses on our bavituximab and Cotara® clinical
programs.
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 year ended April 30, 2006 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 fiscal year 2006 is primarily from
continuing efforts to support the development and clinical development of
our first Anti-PS Immunotherapeutics agent, bavituximab. During
fiscal year 2007, 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 fiscal year 2007 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 fiscal year 2006 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 fiscal year 2006 in accordance with
third party licensing
agreements.
|
41
|
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 fiscal year 2006 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 for 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.
|
|
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 fiscal year 2006 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 fiscal year 2006 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 fiscal year 2006 associated with an
annual license fee due under a former license
agreement.
|
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 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 U.S. 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 future costs associated with our pre-clinical candidates,
including Vascular Targeting Agents, Anti-Angiogensis Agents, and
Vasopermeation Enhancement Agents, which costs are dependent on the
success of pre-clinical development. We are not certain whether
these product candidates will be successful or whether we will incur any
additional costs beyond pre-clinical development given our above stated
intent to find partners to move these programs
forward;
|
|
·
|
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.
|
42
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.
Selling,
General and Administrative Expenses
Year
Ended April 30, 2008 Compared to the Year Ended April 30, 2007:
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
increase in selling, general and administrative expenses of $704,000 during the
year ended April 30, 2008 compared to the prior year is primarily due to
increases in payroll and related expenses, corporate legal fees, and travel and
related expenses. Payroll and related expenses increased $564,000
from $2,837,000 in fiscal year 2007 compared to $3,401,000 in fiscal year 2008
primarily due to an increase in headcount to support increased operations
combined with an increase in consulting fees primarily associated with the
expansion of our business development activities. Corporate legal
fees increased $322,000 from $417,000 in fiscal year 2007 to $739,000 in fiscal
year 2008 primarily related to legal fees associated with the lawsuit described
in this Annual Report on Form 10-K under Part I, Item 3, “Legal Proceedings”,
combined with legal fees associated with other corporate
matters. Travel and related expenses increased $150,000 from $394,000
in fiscal year 2007 compared to $544,000 in fiscal year 2008 primarily due to
increased business development efforts in the U.S., Europe and Asia and
increased participation in corporate and investor relation
activities. These increases in selling, general and administrative
expenses were offset with a decrease in non-cash stock-based compensation
expense of $240,000 from $535,000 in fiscal year 2007 to $295,000 in fiscal year
2008 primarily associated with the amortization of the fair value of options
granted to employees in accordance with the adoption of SFAS No. 123R and
non-cash expenses associated with shares of common stock earned by employees in
the prior year under a stock bonus plan, which expired in fiscal year
2007.
Year
Ended April 30, 2007 Compared to the Year Ended April 30, 2006:
The
decrease in selling, general and administrative expenses of $118,000 during the
year ended April 30, 2007 compared to fiscal year 2006 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 fiscal year 2006 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 fiscal year 2006 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 fiscal year
2007 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.
43
Recovery
of Note Receivable
Year
Ended April 30, 2008 Compared to the Year Ended April 30, 2007 and April 30,
2006
During
fiscal year 2006, we recovered a previously fully reserved note receivable in
the amount of $1,229,000 which amount did not occur in either fiscal year 2008
or fiscal year 2007 as further discussed in Note 4, “Recovery of Note
Receivable” to the accompanying consolidated financial statements.
Interest
and Other Income
Year
Ended April 30, 2008 Compared to the Year Ended April 30, 2007
The
decrease in interest and other income of $171,000 during the year ended April
30, 2008 compared to the prior year is due to a $129,000 decrease in other
income primarily associated with the sale of a trademark name in the prior year
combined with a $42,000 decrease in interest income primarily resulting from
lower prevailing interest rates.
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 fiscal year 2006 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 fiscal year 2007 compared to fiscal year 2006
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 fiscal year 2006 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 fiscal year 2007 in the amount of $130,000.
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.
44
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 obligations are considered
inconsequential to the relevant licensed technology, are generally recognized as
revenue upon delivery of the technology. Nonrefundable up-front
license fees, whereby we have an ongoing involvement or performance obligations,
are recorded as deferred revenue and 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.
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
We
currently maintain four equity compensation plans which 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 granting of options are share-based payments and are
subject to the fair value recognition provisions of Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment (Revised
2004), which 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. On May 1, 2006, we adopted SFAS No.
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. Under the modified-prospective method results for fiscal
year 2006 have not been restated.
45
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 two to four
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 prior to November 1, 2007 was based on the expected time to
exercise using the “simplified” method allowable under the Security and Exchange
Commission’s (SEC’s) Staff Accounting Bulletin No. 107 (“SAB No.
107”). Effective November 1, 2007, the expected term reflects actual
historical exercise activity and assumptions regarding future exercise activity
of unexercised, outstanding options and will be applied to all option grants
subsequent to October 31, 2007. 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 losses from operations for fiscal
years ended April 30, 2008 and 2007 included stock-based compensation expenses
of $829,000 and $964,000, respectively. As of April 30, 2008, the total
estimated unrecognized compensation cost related to non-vested stock options was
$1,949,000. This cost is expected to be recognized over a weighted
average period of 2.25 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. As of April 30, 2008, based on our analysis of our accounts
receivable balances and based on historical collectibility of receivables from
our current customers we determined no allowance for doubtful accounts was
necessary.
Liquidity
and Capital Resources
At April 30, 2008, we had $15,130,000
in cash and cash equivalents compared to $16,044,000 at April 30,
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. Our net losses incurred during the past three
fiscal years ended April 30, 2008, 2007 and 2006 amounted to $23,176,000,
$20,796,000, and $17,061,000, respectively. 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, we
expect such losses to continue in fiscal year 2009.
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. As discussed in Note 1 to
the consolidated financial statements, there exists substantial doubt regarding
our ability to continue as a going concern.
We will need additional capital to
support the costs of our clinical and pre-clinical programs through one or more
methods including either equity or debt financing. As of April 30,
2008, we had an aggregate of approximately 5,031,000 shares available under our
existing effective Form S-3 registration statements for possible future
registered transactions. In addition, we filed a separate shelf
registration statement on Form S-3, File Number 333-139975, under which we may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000.
46
We may also raise
additional capital though negotiating licensing or collaboration agreements for
our technology platforms. In addition, our wholly owned subsidiary
Avid Bioservices, Inc., represents an additional asset in our portfolio and we
are actively pursuing strategic initiatives for Avid as a means of raising
additional capital. We have not classified the related assets
as held for sale in accordance with Statement of Financial Accounting Standards
No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, as the partnering or sale of
such assets are not currently probable under Statement of Financial
Accounting Standards No. 5, Accounting for
Contingencies.
Although
we will continue to explore these potential opportunities, 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 or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid
Bioservices, Inc. to complete the research, development, and clinical testing of
our product candidates. Based on our current projections, which
includes projected revenues from existing customers of Avid Bioservices, Inc.,
combined with the projected revenues from our government contract, we believe we
have sufficient cash on hand combined with amounts expected to be received from
Avid customers and from our government contract to meet our obligations as they
become due through at least fiscal year 2009. There are a number of
uncertainties associated with our financial projections, including but not
limited to, termination of contracts and technical challenges, which would
reduce or delay our future projected cash-inflows. The uncertainties
surrounding our future cash inflows have raised substantial doubt regarding our
ability to continue as a going concern.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the year ended April 30, 2008 compared to the prior year are as
follows:
Cash Used In Operating
Activities. Cash used in operating activities is primarily
driven by changes in our net loss. However, cash used in operating
activities generally differs from our reported net loss as a result of non-cash
operating expenses or differences in the timing of cash flows as reflected in
the changes in operating assets and liabilities. During the year
ended April 30, 2008, cash used in operating activities increased $2,448,000 to
$20,927,000 compared to $18,479,000 for the year ended April 30,
2007. The increase in cash used in operating activities was primarily
due to an increase in net loss reported during fiscal year 2008 after taking
into consideration non-cash operating expenses of $3,235,000. This
amount was offset by a net change in operating assets and payment or reduction
of liabilities in the aggregate amount of $787,000. The increase in
our fiscal year 2008 net loss was primarily due to current period increases in
cost of contract manufacturing, research and development expenses and selling,
general and administrative expenses, which were offset by an increase in
contract manufacturing revenue.
47
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,
|
||||||||
2008
|
2007
|
|||||||
Net
loss, as reported
|
$ | (23,176,000 | ) | $ | (20,796,000 | ) | ||
Less non-cash operating expenses: | ||||||||
Depreciation
and amortization
|
486,000 | 475,000 | ||||||
Stock-based
compensation and common stock
issued under stock bonus plan
|
850,000 | 1,324,000 | ||||||
Amortization
of expenses paid in shares of common
stock
|
- | 391,000 | ||||||
Loss
(gain) on sale of property
|
- |
1,000
|
||||||
Net cash used in operating activities before changes in operating assets
and liabilities
|
$ | (21,840,000 | ) | $ | (18,605,000 | ) | ||
Net change in operating assets and liabilities
|
$ | 913,000 | $ | 126,000 | ||||
Net cash used in operating activities
|
$ | (20,927,000 | ) | $ | (18,479,000 | ) |
Cash Used In Investing
Activities. Net cash used in investing activities amounted to
$580,000 for the year ended April 30, 2008 compared to net cash used in
investing activities of $80,000 during the same prior year
period. This increase in net cash used in investing activities of
$500,000 was primarily due to a $471,000 increase in property acquisitions to
support our current operations combined with a $179,000 increase in other
assets. These increases in net cash used in investing activities were
offset by the receipt of $150,000 in net security deposits from GE Capital
Corporation during the current fiscal year upon the payment in full of various
note payable amounts.
Cash Provided By Financing
Activities. Net
cash provided by financing activities increased $3,172,000 to $20,593,000 for
the year ended April 30, 2008 compared to net cash provided of $17,421,000 for
the same prior year period. Cash provided by financing activities
during fiscal year 2008 was primarily due to proceeds received under a security
purchase agreement whereby we sold and issued a total of 30,000,000 shares of
our common stock in exchange for net proceeds of $20,859,000, which was
supplemented with net proceeds of $73,000 from the exercise of stock options and
warrants. Cash provided by financing activities during fiscal year
2007 was primarily due to net proceeds received from the sale of our common
stock under a security purchase agreement in the amount of $12,970,000
supplemented with net proceeds of $4,895,000 from the exercise of stock options
and warrants.
48
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, 2008, 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)
|
$ | 8,198 | $ | 816 | $ | 2,468 | $ | 1,682 | $ | 3,232 | ||||||||||
Capital
lease obligation (2)
|
47 | 24 | 23 | - | - | |||||||||||||||
Other
long-term liabilities - minimum license obligations (3)
|
- | - | - | - | - | |||||||||||||||
Total
contractual obligations
|
$ | 8,245 | $ | 840 | $ | 2,491 | $ | 1,682 | $ | 3,232 |
______________
|
(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 a three year lease term under a First Amendment to Lease
Agreement dated March 1, 2008, and (iii) various office equipment leases,
which generally have five year lease
terms.
|
|
(2)
|
Represents
capital lease agreements to finance certain office and laboratory
equipment. Amounts include principal and
interest.
|
|
(3)
|
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 do not anticipate making any milestone payments
under any of our licensing agreements for at least the next fiscal
year. In
addition, milestone payments beyond fiscal year 2009 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
September 2006, the Financial Accounting Standards Board (“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 our fiscal year 2009, beginning May 1,
2008. Our adoption of SFAS No. 157 is not expected to have a material
impact 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 will be effective for our fiscal year 2009,
beginning May 1, 2008. Our adoption of SFAS No. 159 is not expected to
have a material impact on our consolidated financial
statements.
49
In June 2007, the FASB ratified EITF
Issue No. 07-3 (“EITF No. 07-3”), Accounting for Non-Refundable
Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities, which requires nonrefundable advance payments for
goods and services that will be used or rendered for future research and
development activities be deferred and capitalized. These amounts
will be recognized as expense in the period that the related goods are delivered
or the related services are performed. EITF No. 07-3 will be
effective for our fiscal year 2009, beginning May 1, 2008. Our
adoption of EITF No. 07-3 is not expected to have a material impact on our
consolidated financial statements.
In November 2007, the FASB ratified
EITF Issue 07-01 (“EITF No. 07-01”), Accounting for Collaborative
Arrangements, which defines collaborative arrangements and requires that
revenues and costs incurred with third parties that do not participate in the
collaborative arrangements be reported in the statement of operations gross or
net pursuant to the guidance in EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent. Classification of
payments made between participants of a collaborative arrangement are to be
based on other applicable authoritative accounting literature or, in the absence
of other applicable authoritative accounting literature, based on analogy to
authoritative accounting literature or a reasonable, rational, and consistently
applied accounting policy election. EITF No. 07-01 will be
effective for fiscal years beginning after December 15, 2008, which we
would be required to implement no later than May 1, 2009, and applied as a
change in accounting principal to all prior periods retrospectively for all
collaborative arrangements existing as of the effective date. We have
not yet evaluated the potential impact of adopting EITF No. 07-01 on our
consolidated financial statements.
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, 2008, 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-32.
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, 2008. 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, 2008
to ensure the timely disclosure of required information in our Securities and
Exchange Commission filings.
50
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 and the report of our
independent registered public accounting firm on our internal control over
financial reporting, which appear on the following pages, are 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, 2008 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
ITEM
9B. OTHER INFORMATION
None.
51
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, 2008.
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 the Company’s internal control
over financial reporting which appears on the following page.
By:
|
/s/
Steven W.
King
|
By:
|
/s/
Paul J.
Lytle
|
|||||
Steven
W. King,
|
Paul
J. Lytle
|
|||||||
President
& Chief Executive Officer, and Director
|
Chief
Financial Officer
|
July 11,
2008
52
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board
of Directors and Stockholders of Peregrine Pharmaceuticals, Inc.
We have
audited Peregrine Pharmaceutical Inc.’s (the “Company”) internal control over
financial reporting as of April 30, 2008, based on criteria established in
Internal Control--Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (the COSO criteria). The Company’s
management is responsible for maintaining effective internal control over
financial reporting. Our responsibility is to express 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, Peregrine Pharmaceuticals, Inc. maintained, in all material respects,
effective internal control over financial reporting as of April 30, 2008, 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, 2008 and 2007, and the related
consolidated statements of operations, stockholders' equity and cash flows for
each of the three years in the period ended April 30, 2008 and our report dated
July 10, 2008 expressed an unqualified opinion including an explanatory
paragraph thereon.
/s/ Ernst & Young
LLP
|
|
Orange County, California | |
July 10, 2008 |
53
PART III
ITEM
10. DIRECTORS, EXECUTIVE
OFFICERS AND CORPORATE GOVERNANCE
The information required by this Item
regarding our directors, executive officers and committees 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 2008 Definitive Proxy Statement to be filed within 120 days
after the end of our fiscal year ended April 30, 2008 (the “2008 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 caption “Section 16(a) Beneficial Ownership
Reporting Compliance” in our 2008 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 2008 Definitive Proxy
Statement to be filed within 120 days after the end of our fiscal year
ended April 30, 2008.
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 Beneficial
Owners” in our 2008 Definitive Proxy Statement to be filed within
120 days after the end of our fiscal year ended April 30,
2008.
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 2008 Definitive Proxy
Statement to be filed within 120 days after the end of our fiscal year
ended April 30, 2008.
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 2008 Definitive
Proxy Statement to be filed within 120 days after the end of our fiscal
year ended April 30, 2008.
54
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, 2008 and 2007
|
F-2
|
Consolidated
Statements of Operations for each of the three years in the period ended
April 30, 2008
|
F-4
|
Consolidated
Statements of Stockholders' Equity for each of the three years in the
period ended April 30, 2008
|
F-5
|
Consolidated
Statements of Cash Flows for each of the three years in the period ended
April 30, 2008
|
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,
2008
|
F-32
|
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.
55
(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).
|
3.8
|
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 three hundred twenty five million shares (Incorporated by
reference to Exhibit 3.8 to Registrant’s Quarterly Report on Form 10-Q for
the quarter ended October 31, 2007).
|
3.9
|
Amended
and Restated Bylaws of Peregrine Pharmaceuticals, Inc., a Delaware
corporation (Incorporated by reference to Exhibit 3.9 to Registrant’s
Current Report on Form 8-K as filed with the Commission on December 21,
2007).
|
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).
|
56
Exhibit
Number
|
Description
|
4.16
|
Form
of Non-qualified Stock Option Agreement by and between Registrant,
Director and certain consultants dated December 22, 1999 (Incorporated by
reference to the exhibit contained in Registrant’s Registration Statement
on Form S-3 (File No. 333-40716)).*
|
4.17
|
Peregrine
Pharmaceuticals, Inc. 2002 Non-Qualified Stock Option Plan (Incorporated
by reference to the exhibit contained in Registrant’s Registration
Statement in Form S-8 (File No. 333-106385)).*
|
4.18
|
Form
of 2002 Non-Qualified Stock Option Agreement (Incorporated by reference to
the exhibit contained in Registrant’s Registration Statement in Form S-8
(File No. 333-106385)).*
|
4.19
|
Preferred
Stock Rights Agreement, dated as of March 16, 2006, between the Company
and Integrity Stock Transfer, Inc., including the Certificate of
Designation, the form of Rights Certificate and the Summary of Rights
attached thereto as Exhibits A, B and C, respectively (Incorporated by
reference to Exhibit 4.19 to Registrant’s Current Report on Form 8-K as
filed with the Commission on March 17,
2006).
|
10.40
|
1996
Stock Incentive Plan (Incorporated by reference to the exhibit contained
in Registrant's Registration Statement in form S-8 (File No.
333-17513)).*
|
10.41
|
Stock
Exchange Agreement dated as of January 15, 1997 among the stockholders of
Peregrine Pharmaceuticals, Inc. and Registrant (Incorporated by reference
to Exhibit 2.1 to Registrant's Quarterly Report on Form 10-Q for the
quarter ended January 31, 1997).
|
10.42
|
First
Amendment to Stock Exchange Agreement among the Stockholders of Peregrine
Pharmaceuticals, Inc. and Registrant (Incorporated by reference to Exhibit
2.1 contained in Registrant’s Current Report on Form 8-K as filed with the
Commission on or about May 12, 1997).
|
10.43
|
Termination
and Transfer Agreement dated as of November 14, 1997 by and between
Registrant and Alpha Therapeutic Corporation (Incorporated by reference to
Exhibit 10.1 contained in Registrant’s Current Report on Form 8-K as filed
with the commission on or about November 24, 1997).
|
10.47
|
Real
Estate Purchase Agreement by and between Techniclone Corporation and 14282
Franklin Avenue Associates, LLC dated December 24, 1998 (Incorporated by
reference to Exhibit 10.47 to Registrant's Quarterly Report on Form 10-Q
for the quarter ended January 31, 1999).
|
10.48
|
Lease
and Agreement of Lease between TNCA, LLC, as Landlord, and Techniclone
Corporation, as Tenant, dated as of December 24, 1998 (Incorporated by
reference to Exhibit 10.48 to Registrant's Quarterly Report on Form 10-Q
for the quarter ended January 31, 1999).
|
10.49
|
Promissory
Note dated as of December 24, 1998 between Techniclone
Corporation (Payee) and TNCA Holding, LLC (Maker) for $1,925,000
(Incorporated by reference to Exhibit 10.49 to Registrant's Quarterly
Report on Form 10-Q for the quarter ended January 31,
1999).
|
57
Exhibit
Number
|
Description
|
10.50
|
Pledge
and Security Agreement dated as of December 24, 1998 for $1,925,000
Promissory Note between Grantors and Techniclone Corporation (Secured
Party) (Incorporated by reference to Exhibit 10.50 to Registrant's
Quarterly Report on Form 10-Q for the quarter ended January 31,
1999).
|
10.56
|
License
Agreement dated as of March 8, 1999 by and between Registrant and Schering
A.G. (Incorporated by reference to Exhibit 10.56 to Registrant's Annual
Report on Form 10-K for the year ended April 30,
1999).**
|
10.57
|
Patent
License Agreement dated October 8, 1998 between Registrant and the Board
of Regents of the University of Texas System for patents related to
Targeting the Vasculature of Solid Tumors (Vascular Targeting Agent
patents) (Incorporated by reference to Exhibit 10.57 to Registrant's
Quarterly Report on Form 10-Q for the quarter ended July 31,
1999).
|
10.58
|
Patent
License Agreement dated October 8, 1998 between Registrant and the Board
of Regents of the University of Texas System for patents related to the
Coagulation of the Tumor Vasculature (Vascular Targeting Agent patents)
(Incorporated by reference to Exhibit 10.58 to Registrant's Quarterly
Report on Form 10-Q for the quarter ended July 31,
1999).
|
10.59
|
License
Agreement between Northwestern University and Registrant dated August
4, 1999 covering the LYM-1 and LYM-2 antibodies (Oncolym) (Incorporated by
reference to Exhibit 10.59 to Registrant's Quarterly Report on Form 10-Q
for the quarter ended July 31, 1999).
|
10.67
|
Warrant
to purchase 750,000 shares of Common Stock of Registrant issued to Swartz
Private Equity, LLC dated November 19, 1999 (Incorporated by reference to
Exhibit 10.67 to Registrant's Quarterly Report on Form 10-Q for the
quarter ended January 31, 2000).
|
10.73
|
Common
Stock Purchase Agreement to purchase up to 6,000,000 shares of Common
Stock of Registrant issued to ZLP Master Fund, LTD, ZLP Master Technology
Fund, LTD, Eric Swartz, Michael C. Kendrick, Vertical Ventures LLC and
Triton West Group, Inc. dated November 16, 2001 (Incorporated by reference
to Exhibit 10.73 to Registrant’s Current Report on Form 8-K dated November
19, 2001, as filed with the Commission on November 19,
2001).
|
10.74
|
Form
of Warrant to be issued to Investors pursuant to the Common Stock Purchase
Agreement dated November 16, 2001 (Incorporated by reference to Exhibit
10.74 to Registrant’s Current Report on Form 8-K dated November 19, 2001,
as filed with the Commission on November 19, 2001).
|
10.75
|
Common
Stock Purchase Agreement to purchase 1,100,000 shares of Common Stock of
Registrant issued to ZLP Master Fund, LTD and Vertical Capital Holdings,
Ltd. dated January 28, 2002 (Incorporated by reference to Exhibit 10.75 to
Registrant’s Current Report on Form 8-K dated January 31, 2002, as filed
with the Commission on February 5, 2002).
|
10.76
|
Form
of Warrant to be issued to Investors pursuant to the Common Stock Purchase
Agreement dated January 28, 2002 (Incorporated by reference to Exhibit
10.76 to Registrant’s Current Report on Form 8-K dated January 31, 2002,
as filed with the Commission on February 5,
2002).
|
58
Exhibit
Number
|
Description
|
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).
|
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).
|
59
Exhibit
Number
|
Description
|
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).
|
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).
|
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).
|
60
Exhibit
Number
|
Description
|
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).
|
10.108
|
Placement
Agent Agreement dated June 27, 2007, between Registrant and Rodman &
Renshaw, LLC (Incorporated by reference to Exhibit 1.1 to Registrant’s
Current Report on Form 8-K as filed with the Commission on June 28,
2007).
|
10.109
|
Form
of Securities Purchase Agreement dated June 28, 2007 (Incorporated by
reference to Exhibit 4.1 to Registrant’s Current Report on Form 8-K as
filed with the Commission on June 28, 2007).
|
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.
|
61
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.
Dated: July
11, 2008
|
PEREGRINE
PHARMACEUTICALS, INC.
By: /s/
STEVEN W.
KING
Steven
W. King,
President
& Chief Executive Officer, and
Director
|
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
Steven W.
King
|
President
& Chief Executive Officer
(Principal Executive
Officer), and
Director
|
July 11, 2008 |
/s/
Paul J.
Lytle
Paul J.
Lytle
|
Chief
Financial Officer
(Principal Financial
and Principal Accounting
Officer)
|
July 11, 2008 |
/s/
Carlton M.
Johnson
Carlton
M. Johnson
|
Director | July 11, 2008 |
/s/
David H.
Pohl
David H.
Pohl
|
Director | July 11, 2008 |
/s/
Eric S.
Swartz
Eric S.
Swartz
|
Director | July 11, 2008 |
/s/
Dr. Thomas A.
Waltz
Thomas A.
Waltz, M.D.
|
Director | July 11, 2008 |
62
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, 2008 and 2007, and the
related consolidated statements of operations, stockholders’ equity, and cash
flows for each of the three years in the period ended April 30,
2008. 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, 2008 and 2007, and the consolidated
results of its operations and its cash flows for each of the three years in the
period ended April 30, 2008, 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), Peregrine Pharmaceuticals, Inc.'s internal
control over financial reporting as of April 30, 2008, 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
10, 2008 expressed an unqualified opinion thereon.
The
accompanying financial statements have been prepared assuming Peregrine
Pharmaceuticals, Inc. will continue as a going concern. As more fully
described in Note 1, the Company’s recurring losses from operations and
recurring negative cash flows from operating activities raise substantial doubt
about its ability to continue as a going concern. Management’s plans
in regards to these matters are also described in Note 1. The
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the outcome of this
uncertainty.
/s/ Ernst & Young LLP | |
Orange
County, California
July 10,
2008
|
|
F-1
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2008 AND 2007
2008
|
2007
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 15,130,000 | $ | 16,044,000 | ||||
Trade
and other receivables
|
605,000 | 750,000 | ||||||
Inventories,
net
|
2,900,000 | 1,916,000 | ||||||
Prepaid
expenses and other current assets
|
1,208,000 | 1,188,000 | ||||||
Total
current assets
|
19,843,000 | 19,898,000 | ||||||
PROPERTY:
|
||||||||
Leasehold
improvements
|
669,000 | 646,000 | ||||||
Laboratory
equipment
|
4,140,000 | 3,533,000 | ||||||
Furniture,
fixtures and computer equipment
|
919,000 | 873,000 | ||||||
5,728,000 | 5,052,000 | |||||||
Less
accumulated depreciation and amortization
|
(3,670,000 | ) | (3,212,000 | ) | ||||
Property,
net
|
2,058,000 | 1,840,000 | ||||||
Other
assets
|
1,156,000 | 1,259,000 | ||||||
TOTAL
ASSETS
|
$ | 23,057,000 | $ | 22,997,000 |
F-2
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2008 AND 2007 (continued)
2008
|
2007
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 2,060,000 | $ | 1,683,000 | ||||
Accrued
clinical trial site fees
|
237,000 | 228,000 | ||||||
Accrued
legal and accounting fees
|
450,000 | 392,000 | ||||||
Accrued
royalties and license fees
|
222,000 | 337,000 | ||||||
Accrued
payroll and related costs
|
1,084,000 | 874,000 | ||||||
Notes
payable, current portion
|
- | 379,000 | ||||||
Capital
lease obligation, current portion
|
22,000 | 17,000 | ||||||
Deferred
revenue
|
2,196,000 | 1,060,000 | ||||||
Customer
deposits
|
838,000 | 585,000 | ||||||
Other
current liabilities
|
331,000 | 300,000 | ||||||
Total
current liabilities
|
7,440,000 | 5,855,000 | ||||||
Notes
payable, less current portion
|
- | 119,000 | ||||||
Capital
lease obligation, less current portion
|
22,000 | 30,000 | ||||||
Deferred
license revenue
|
- | 4,000 | ||||||
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 325,000,000 shares; outstanding -
226,210,617 and 196,112,201, respectively
|
226,000 | 196,000 | ||||||
Additional
paid-in-capital
|
246,205,000 | 224,453,000 | ||||||
Accumulated
deficit
|
(230,836,000 | ) | (207,660,000 | ) | ||||
Total
stockholders' equity
|
15,595,000 | 16,989,000 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 23,057,000 | $ | 22,997,000 |
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, 2008
2008
|
2007
|
2006
|
||||||||||
REVENUES:
|
||||||||||||
Contract
manufacturing revenue
|
$ | 5,897,000 | $ | 3,492,000 | $ | 3,005,000 | ||||||
License
revenue
|
196,000 | 216,000 | 188,000 | |||||||||
Total
revenues
|
6,093,000 | 3,708,000 | 3,193,000 | |||||||||
COSTS
AND EXPENSES:
|
||||||||||||
Cost
of contract manufacturing
|
4,804,000 | 3,296,000 | 3,297,000 | |||||||||
Research
and development
|
18,279,000 | 15,876,000 | 12,415,000 | |||||||||
Selling,
general and administrative
|
7,150,000 | 6,446,000 | 6,564,000 | |||||||||
Total
costs and expenses
|
30,233,000 | 25,618,000 | 22,276,000 | |||||||||
LOSS
FROM OPERATIONS
|
(24,140,000 | ) | (21,910,000 | ) | (19,083,000 | ) | ||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||
Recovery
of note receivable
|
- | - | 1,229,000 | |||||||||
Interest
and other income
|
989,000 | 1,160,000 | 846,000 | |||||||||
Interest
and other expense
|
(25,000 | ) | (46,000 | ) | (53,000 | ) | ||||||
NET
LOSS
|
$ | (23,176,000 | ) | $ | (20,796,000 | ) | $ | (17,061,000 | ) | |||
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
221,148,342 | 192,297,309 | 168,294,782 | |||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.10 | ) | $ | (0.11 | ) | $ | (0.10 | ) |
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, 2008
Additional
|
Deferred
|
Total
|
||||||||||||||||||||||
Common
Stock
|
Paid-In
|
Stock
|
Accumulated
|
Stockholders’
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Compensation
|
Deficit
|
Equity
|
|||||||||||||||||||
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 | |||||||||||||||||
Common
stock issued for cash under June 28, 2007 Financing, net of issuance costs
of $1,641,000
|
30,000,000 | 30,000 | 20,829,000 | - | - | 20,859,000 | ||||||||||||||||||
Common
stock issued upon exercise of options
|
45,000 | - | 27,000 | - | - | 27,000 | ||||||||||||||||||
Common
stock issued upon exercise of warrants, net of issuance costs of
nil
|
53,416 | - | 46,000 | - | - | 46,000 | ||||||||||||||||||
Stock-based
compensation
|
- | - | 850,000 | - | - | 850,000 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (23,176,000 | ) | (23,176,000 | ) | ||||||||||||||||
BALANCES,
April 30, 2008
|
226,210,617 | $ | 226,000 | $ | 246,205,000 | $ | - | $ | (230,836,000 | ) | $ | 15,595,000 |
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, 2008
2008
|
2007
|
2006
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (23,176,000 | ) | $ | (20,796,000 | ) | $ | (17,061,000 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
486,000 | 475,000 | 415,000 | |||||||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
850,000 | 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 | ) | ||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Trade
and other receivables
|
145,000 | (171,000 | ) | (93,000 | ) | |||||||
Inventories
|
(984,000 | ) | (1,031,000 | ) | (258,000 | ) | ||||||
Prepaid
expenses and other current assets
|
(203,000 | ) | (113,000 | ) | (410,000 | ) | ||||||
Accounts
payable
|
377,000 | 450,000 | (92,000 | ) | ||||||||
Accrued
clinical trial site fees
|
9,000 | 58,000 | 162,000 | |||||||||
Deferred
revenue
|
1,132,000 | 480,000 | 17,000 | |||||||||
Accrued
payroll and related expenses
|
210,000 | 63,000 | 44,000 | |||||||||
Other
accrued expenses and current liabilities
|
227,000 | 390,000 | (37,000 | ) | ||||||||
Net
cash used in operating activities
|
(20,927,000 | ) | (18,479,000 | ) | (16,957,000 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Refund
of security deposits on notes payable (net of applied
security
deposits
on notes payable of $175,000 in 2008)
|
150,000 | - | - | |||||||||
Property
acquisitions
|
(691,000 | ) | (220,000 | ) | (618,000 | ) | ||||||
(Increase)
decrease in other assets, net
|
(39,000 | ) | 140,000 | (171,000 | ) | |||||||
Recovery
of note receivable
|
- | - | 1,229,000 | |||||||||
Net
cash (used in) provided by investing activities
|
(580,000 | ) | (80,000 | ) | 440,000 | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from issuance of common stock, net of issuance costs
of
$1,641,000,
$46,000, and $48,000, respectively
|
20,932,000 | 17,865,000 | 23,627,000 | |||||||||
Proceeds
from issuance of notes payable
|
- | - | 566,000 | |||||||||
Principal
payments on notes payable and capital lease (net of applied
security
deposits on notes payable of $175,000 in 2008)
|
(339,000 | ) | (444,000 | ) | (310,000 | ) | ||||||
Net
cash provided by financing activities
|
20,593,000 | 17,421,000 | 23,883,000 |
F-6
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2008 (continued)
2008
|
2007
|
2006
|
||||||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
$ | (914,000 | ) | $ | (1,138,000 | ) | $ | 7,366,000 | ||||
CASH
AND CASH EQUIVALENTS, Beginning of year
|
16,044,000 | 17,182,000 | 9,816,000 | |||||||||
CASH
AND CASH EQUIVALENTS, End of year
|
$ | 15,130,000 | $ | 16,044,000 | $ | 17,182,000 | ||||||
SUPPLEMENTAL
INFORMATION:
|
||||||||||||
Interest
paid
|
$ | 25,000 | $ | 50,000 | $ | 49,000 | ||||||
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||||||
Property
acquired under capital lease
|
$ | 13,000 | $ | - | $ | 65,000 | ||||||
Applied
security deposit on payoff of notes payable to GE Capital
|
$ | 175,000 | $ | - | $ | - | ||||||
Common
stock issued for research fees and prepayments for future research
services
|
$ | - | $ | 931,000 | $ | 907,000 |
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, 2008
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 developing 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 currently in a third Phase I clinical study to evaluate the
safety and anti-viral activity of bavituximab over a longer dosing period in
patients co-infected with HCV and the Human Immunodeficiency Virus
(“HIV”). Bavituximab as an anti-cancer agent is in a Phase I
monotherapy trial for the treatment of solid tumors in the U.S. and has recently
completed enrollment in the first stage of a two-stage Phase II trial for the
treatment of breast cancer in combination with chemotherapy in the Republic of
Georgia. In addition during June 2008, we initiated two separate
Phase II studies in India for the treatment of patients with non-small cell lung
cancer and breast cancer, respectively, using bavituximab in combination with
chemotherapy. 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 monoclonal antibodies for
the treatment of cancer and viral diseases and (ii) Avid Bioservices®, Inc.,
(“Avid”) our wholly owned subsidiary, is engaged in providing contract
manufacturing services for Peregrine and outside customers on a fee-for-services
basis.
Going Concern – The Company’s
consolidated financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. The financial statements do not
include any adjustments relating to the recoverability of the recorded assets or
the classification of liabilities that may be necessary should it be determined
that we are unable to continue as a going concern.
At April
30, 2008, we had $15,130,000 in cash and cash equivalents. We have
expended substantial funds on (i) the research, development and clinical trials
of our product candidates, and (ii) funding the operations of
Avid. 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. Our net
losses incurred during the past three fiscal years ended April 30, 2008, 2007
and 2006 amounted to $23,176,000, $20,796,000, and $17,061,000,
respectively. 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, we expect such losses to continue
in fiscal year 2009.
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.
F-8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
We will need additional capital to
support the costs of our clinical and pre-clinical programs through one or more
methods including either equity or debt financing. As of April 30,
2008, we had an aggregate of approximately 5,031,000 shares available under our
existing effective Form S-3 registration statements for possible future
registered transactions. In addition, we filed a separate shelf
registration statement on Form S-3, File Number 333-139975, under which we may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000.
We may also raise additional capital
though negotiating licensing or collaboration agreements for our technology
platforms. In addition, Avid represents an additional asset in our
portfolio and we are actively pursuing strategic initiatives for Avid as a means
of raising additional capital.
Although
we will continue to explore these potential opportunities, 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 or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid to
complete the research, development, and clinical testing of our product
candidates. Based on our current projections, which includes
projected revenues from existing customers of Avid, combined with the projected
revenues from our government contract, we believe we have sufficient cash on
hand combined with amounts expected to be received from Avid customers and from
our government contract to meet our obligations as they become due through at
least fiscal year 2009. There are a number of uncertainties
associated with our financial projections, including but not limited to,
termination of contracts and technical challenges, which would reduce or delay
our future projected cash-inflows. The uncertainties surrounding our
future cash inflows have raised substantial doubt regarding our ability to
continue as a going concern.
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. As of April 30, 2008 and 2007, based on our analysis of our
accounts receivable balances, we determined no allowance for doubtful accounts
was necessary.
Prepaid Expenses - Our
prepaid expenses primarily represent pre-payments made to secure the receipt of
services at a future date. In addition, we have prepaid various research
and development related services through the issuance of shares of our common
stock to unrelated entities, which are expensed once the services have been
provided under the terms of the arrangement. As of April 30, 2008 and
2007, prepaid expenses and other current assets in the accompanying consolidated
financial statements include $475,000 in research and development services
prepaid with shares of our common stock to Affitech AS 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, 2008 (continued)
Inventories - Inventories are stated at
the lower of cost or market and include 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,:
2008
|
2007
|
|||||||
Raw
materials, net
|
$ | 1,115,000 | $ | 810,000 | ||||
Work-in-process
|
1,785,000 | 1,106,000 | ||||||
Total inventories
|
$ | 2,900,000 | $ | 1,916,000 |
Concentrations of Credit Risk
- The majority of trade and other receivables as of April 30, 2008, are from
customers in the United States and Germany. 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. Allowances are maintained for potential credit losses and as
of April 30, 2008 and 2007 no allowances were deemed necessary.
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.
Customer Deposits - Customer deposits
primarily represents advance payments received from customers prior to the
initiation of contract manufacturing services.
Deferred Revenue - Deferred
revenue primarily consists of installment payments received by Avid prior to the
recognition of revenues under customer service 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, 2008 (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.
F-11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
Reclassification - Certain
amounts in fiscal year 2007 consolidated financial statements have been
reclassified to conform to the current year presentation.
Use of Estimates - The
preparation of our financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ from
these estimates.
Basic and 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,
2008.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 928,801, 2,071,087 and
3,433,414 shares of common stock for the fiscal years ended April 30, 2008, 2007
and 2006, 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 10,455,216,
7,218,883 and 9,090,374 shares of common stock for the fiscal years ended April
30, 2008, 2007 and 2006, 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.
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.
In June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48 (“FIN No. 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 No. 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosures and transition. We adopted the provisions of FIN No. 48
on May 1, 2007 (Note 11).
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 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, 2008 (continued)
Recent Accounting
Pronouncements - In September 2006, the Financial
Accounting Standards Board (“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 our fiscal year 2009, beginning May 1,
2008. Our adoption of SFAS No. 157 is not expected to have a
material impact 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 will be effective for our
fiscal year 2009, beginning May 1, 2008. Our adoption of SFAS No.
159 is not expected to have a material impact on our consolidated financial
statements.
In June
2007, the FASB ratified EITF Issue No. 07-3 (“EITF No. 07-3”), Accounting for Non-Refundable
Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities, which requires nonrefundable advance payments for
goods and services that will be used or rendered for future research and
development activities be deferred and capitalized. These amounts
will be recognized as expense in the period that the related goods are delivered
or the related services are performed. EITF No. 07-3 will be
effective for our fiscal year 2009, beginning May 1, 2008. Our adoption of EITF No. 07-3 is not
expected to have a material impact on our consolidated financial
statements.
In
November 2007, the FASB ratified EITF Issue 07-01 (“EITF No. 07-01”), Accounting for Collaborative
Arrangements, which defines collaborative arrangements and requires that
revenues and costs incurred with third parties that do not participate in the
collaborative arrangements be reported in the statement of operations gross or
net pursuant to the guidance in EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent. Classification of
payments made between participants of a collaborative arrangement are to be
based on other applicable authoritative accounting literature or, in the absence
of other applicable authoritative accounting literature, based on analogy to
authoritative accounting literature or a reasonable, rational, and consistently
applied accounting policy election. EITF No. 07-01 will be
effective for fiscal years beginning after December 15, 2008, which we
would be required to implement no later than May 1, 2009, and applied as a
change in accounting principal to all prior periods retrospectively for all
collaborative arrangements existing as of the effective date. We have
not yet evaluated the potential impact of adopting EITF No. 07-01 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 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 two to four year period and no options are exercisable
after ten years from the date of grant.
F-13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
Prior to
May 1, 2006, 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
year 2006 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.
On 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 No. 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 fiscal year 2006 have
not been restated.
Our net
loss for fiscal years ended April 30, 2008 and 2007, increased $829,000 ($0.004
per basic and diluted share) and $964,000 ($0.005 per basic and diluted share),
respectively, as a result of the adoption of SFAS No. 123R, which costs are
included in the accompanying consolidated statements of operations as
follows:
2008
|
2007
|
|||||||
Research
and development
|
$ | 534,000 | $ | 589,000 | ||||
Selling,
general and administrative
|
295,000 | 375,000 | ||||||
Total
|
$ | 829,000 | $ | 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 2 to 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 prior to the adoption of SFAS No. 123R (adopted
May 1, 2006) was based on the average estimated expected life of the options
granted during the fiscal year. The expected term of options granted
subsequent to the adoption of SFAS No. 123R through our quarter ended October
31, 2007 was based on the expected time to exercise using the “simplified”
method allowable under the Securities and Exchange Commission’s Staff Accounting
Bulletin No. 107. Effective November 1, 2007, the expected term
reflects actual historical exercise activity and assumptions regarding future
exercise activity of unexercised, outstanding options and is applied to all
option grants subsequent to October 31, 2007. 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, 2008, 2007 and 2006, were as follows:
F-14
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
Year
Ended April 30,
|
||||||||||||
2008
|
2007
|
2006
|
||||||||||
Risk-free
interest rate
|
3.77% | 4.83% | 3.88% | |||||||||
Expected
life (in years)
|
6.02 | 6.25 | 5.49 | |||||||||
Expected
volatility
|
82% | 98% | 103% | |||||||||
Expected
dividend yield
|
- | - | - |
As of
April 30, 2008, options to purchase up to 14,689,064 shares of our common stock
were issued and outstanding under the Option Plans with a weighted average
exercise price of $1.24 per share and expire at various dates through March 31,
2018. Options to purchase up to 1,201,811 shares of common stock were
available for future grant under the Option Plans as of April 30,
2008.
The
following summarizes all stock option transaction activity for fiscal year ended
April 30, 2008:
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
|||||||||
Outstanding,
May 1, 2007
|
11,537,946 | $ | 1.54 | ||||||||||
Granted
|
4,231,894 | $ | 0.48 | ||||||||||
Exercised
|
(45,000 | ) | $ | 0.60 | |||||||||
Canceled
or expired
|
(1,035,776 | ) | $ | 1.49 | |||||||||
Outstanding,
April 30, 2008
|
14,689,064 | $ | 1.24 | 6.09 | $ | 177,000 | |||||||
Exercisable
and expected to vest
|
14,355,394 | $ | 1.25 | 6.02 | $ | 173,000 | |||||||
Exercisable,
April 30, 2008
|
9,990,396 | $ | 1.51 | 4.67 | $ | 97,000 |
The
weighted-average grant date fair value of options granted during the years ended
April 30, 2008, 2007 and 2006 was $0.35, $1.05 and $0.91 per share,
respectively. The aggregate intrinsic value of stock options
exercised during the years ended April 30, 2008, 2007 and 2006 was $19,000,
$38,000 and $55,000, respectively.
Cash
proceeds from stock options exercised during the years ended April 30, 2008,
2007 and 2006 totaled $27,000, $59,000 and $122,000, respectively.
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, 2008, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,949,000. This cost is expected to be
recognized over a weighted average vesting period of 2.25 years based on current
assumptions.
F-15
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
As
discussed above, results for fiscal year 2006 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 year
ended April 30, 2006 had we applied the fair value recognition provisions of
SFAS No. 123 to our stock option grants:
Net
loss, as reported
|
$ | (17,061,000 | ) | |
Deduct:
Total stock-based employee compensation expense determined
under
the fair value based method for all awards
|
(1,755,000 | ) | ||
Net
loss, pro forma
|
$ | (18,816,000 | ) | |
Basic
and diluted net loss per share:
|
||||
Net
loss, as reported
|
$ | (0.10 | ) | |
Net
loss, pro forma
|
$ | (0.11 | ) |
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 2008, 2007 and 2006 associated with non-employees
amounted to $21,000, $57,000 and $499,000, 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.
F-16
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
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.
5. NOTES PAYABLE
AND CAPITAL LEASE OBLIGATIONS
During
fiscal years 2005 and 2006, we entered into five separate note payable
agreements with an aggregate original principal amount of approximately
$1,299,000 (the “Notes”) with General Electric Capital (“GE”) to finance certain
laboratory equipment. The Notes bore interest at various rates
ranging from 5.78% to 6.87% per annum with monthly payments ranging from
approximately $3,000 to $12,000 over a period of 36 months. In
addition, under the terms of the Notes, we paid GE a security deposit equal to
25% of the original principal amount of the Notes that totaled $325,000 in
aggregate. The security deposits were due and payable to us at the
time the Notes were paid in full.
During
January 2008, we paid in full the balance of the Notes, which amount was offset
by an applied security deposit in the amount of $175,000. In
addition, the remaining security deposit of $150,000 was refunded back to us in
January 2008.
Notes
Payable consist of the following at April 30, 2008 and April 30,
2007:
April
30,
2008
|
April
30,
2007
|
|||||||
Note
payable dated November 2004; 5.78% per annum; monthly payments of
$11,000
|
$ | - | $ | 83,000 | ||||
Note
payable dated December 2004; 5.85% per annum; monthly payments of
$12,000
|
- | 103,000 | ||||||
Note
payable dated June 2005; 6.39% per annum; monthly payments of
$8,000
|
- | 117,000 | ||||||
Note
payable dated November 2005; 6.63% per annum; monthly payments of
$3,000
|
- | 60,000 | ||||||
Note
payable dated March 2006; 6.87% per annum; monthly payments of
$6,000
|
- | 135,000 | ||||||
- | 498,000 | |||||||
Less
current portion
|
(- | ) | (379,000 | ) | ||||
Notes
payable, less current portion
|
$ | - | $ | 119,000 |
F-17
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
During December 2005, we financed
certain equipment under a capital lease agreement in the amount of
$65,000. The agreement bears interest at a rate of 6.30% per annum
with payments due monthly in the amount of approximately $1,600 through December
2009.
During April 2008, we financed certain
equipment under a capital lease agreement in the amount of
$15,000. The agreement bears interest at a rate of 6.56% per annum
with payments due monthly in the amount of approximately $400 through April
2011.
The equipment purchased under these
capital leases is included in property in the accompanying consolidated
financial statements at April 30, 2008 as follows:
Laboratory
equipment
|
$ | 13,000 | ||
Furniture,
fixtures and office equipment
|
68,000 | |||
Less
accumulated depreciation
|
(32,000 | ) | ||
Net
book value
|
$ | 49,000 |
Minimum future capital lease payments
as of April 30, 2008 are as follows:
Year
ending April 30:
|
||||
2009
|
24,000 | |||
2010
|
18,000 | |||
2011
|
5,000 | |||
Total
minimum lease payments
|
47,000 | |||
Amount
representing interest
|
(3,000 | ) | ||
Net
present value minimum lease payments
|
44,000 | |||
Less current
portion
|
22,000 | |||
$ | 22,000 |
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, during fiscal years 2008 and 2007
and $758,000 during fiscal year 2006.
During fiscal year 2004, we entered
into an operating lease agreement to lease certain office equipment, which has a
5-year term and expires during fiscal year 2009. The remaining annual
minimum lease payments are $12,000.
F-18
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (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 expired in February
2008. During March 2008, we entered into a First Amendment to Lease
with the landlord to our original lease agreement to extend the lease term for
an additional 3-year term to expire in February 2011. Annual minimum
lease payments for fiscal years 2009, 2010 and 2011 under the First Amendment to
Lease total $23,000, $24,000 and $21,000, respectively, plus a pro rata share of
monthly operating expenses. Rent expense under the lease agreement
totaled $24,000 during fiscal year 2008 and $21,000 during fiscal years 2007 and
2006.
At April 30, 2008, future minimum lease
payments under all non-cancelable operating leases are as follows:
Year
ending April 30:
|
Minimum
Lease Payments
|
|||
2009
|
$ | 816,000 | ||
2010
|
820,000 | |||
2011
|
825,000 | |||
2012
|
823,000 | |||
2013
|
832,000 | |||
Thereafter
|
4,082,000 | |||
$ | 8,198,000 |
Rental Income
– Sublease rental income totaled $35,000 and $59,000 for fiscal years
2007 and 2006, respectively. There was no sublease rental income
during fiscal year 2008.
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 original
complaint has been amended three times based on the ongoing discovery to include
claims against Shanghai MediPharm and its related entities, and Alan Epstein,
MD. The lawsuit alleges claims for breach of contract, interference
with contractual relations, declaratory relief, and injunctive relief against
the defendants. Peregrine's claims stem from a 1995 license agreement
with CTL, and two amendments thereto (collectively referred to as the "License
Agreement"). Peregrine claims that CTL breached the License Agreement
by, among other things, (i) not sharing with Peregrine all inventions,
technology, know-how, patents and other information, derived and/or developed in
the People's Republic of China and/or at the CTL laboratory, as was
required under the License Agreement; (ii) not splitting revenue appropriately
with Peregrine as required under the License Agreement; (iii) utilizing
Peregrine's licensed technologies outside of the People's Republic of China; and
(iv) failing to enter a sublicense agreement with a Chinese sponsor obligating
the Chinese sponsor to comply with the terms and obligations in the License
Agreement. Peregrine further alleges that Medibiotech and Shanghai
Medipharm Biotech Co., Ltd. ("Medipharm Entities") interfered with the License
Agreement, leading to CTL's breaches. This interference by the
Medipharm Entities includes: 1) posturing Shanghai Medipharm as the designated
sublicensee under the License Agreement, without binding any of the Medipharm
Entities to the terms and obligations of an appropriate sublicense
agreement called for under the License Agreement; 2) entering into a license
agreement with defendant Epstein ("Epstein License Agreement") instead of CTL;
3) restricting the information CTL was allowed to provide to Peregrine, thereby
prohibiting CTL from providing to Peregrine all information required under the
License Agreement; and 4) providing compensation to CTL, and its principals, so
that CTL would enter agreements that prohibited CTL from performing under the
License Agreement. These same monetary inducements also interfered
with the 1999 Material Transfer Agreement between Peregrine and Dr. Epstein
("MTA"), and caused Dr. Epstein to breach the MTA. Dr. Epstein has
attempted to have our claims against him referred to binding
Arbitration. The Superior Court has declined his
request.
F-19
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
On March 28, 2007, CTL filed a
cross-complaint, which it 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. We are challenging
the cross-complaint on the basis that not only did CTL fail to allege an
agreement with which the Company interfered, they have been unable to produce
the alleged sublicense agreement with MediPharm despite our repeated
demands.
On February 22, 2008, the MediPharm
entities filed a cross-complaint alleging, as a third party beneficiary, that
that the Company breached the Agreement by double-licensing the technology
licensed to CTL to another party, intentionally interfered with a prospective
economic advantage, and unjust enrichment. MediPharm’s
cross-complaint, which seeks $30 million in damages, is in part predicated on
MediPharm being the “Chinese Sponsor” under the Agreement. We intend
to bring pre-trial motions to dispose of the MediPharm
Cross-Complaint.
The discovery phase on the
aforementioned cases is still ongoing. Until we complete the
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.
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® and our products in pre-clinical
development. 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 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-20
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (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
$6,850,000 assuming the achievement of all development milestones under the
agreements through commercialization of products, of which, $6,400,000 is due
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. We do not
anticipate making any milestone payments under these agreements for at least the
next fiscal year.
During
fiscal years 2008 and 2006, we expensed $50,000 and $450,000, respectively 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-21
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (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 fiscal 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 year
2006, we expensed $185,000 in non-refundable upfront technology access fees
under the research collaboration agreement upon the initiation to generate one
fully human monoclonal antibody, the amount of which is included in research and
development expense in the accompanying consolidated financial
statements. We did not incur any non-refundable upfront technology
access fees during fiscal years 2008 and 2007.
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 pay a non-refundable up-front license fee, antibody development milestone
fees, clinical development milestone fees and a royalty on net
sales. 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-22
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (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 a
non-refundable up-front license fee and 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.
During
June 2007, we entered into an exclusive license agreement with The Regents of
the University of California regarding the use of certain Anti-PS antibodies to
be used as a possible future generation clinical candidate. Under the
terms of the agreement, we paid a non-refundable up-front license fee of
$25,000, which is included in research and development expense in fiscal year
2008 in the accompanying consolidated financial statements. In
addition, under the terms of the agreement, we are obligated to pay an annual
maintenance fee, clinical development milestone fees and a royalty on net
sales. Our aggregate future clinical development milestone payments
under the license agreement are $735,000 assuming the achievement of all
developmental 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. from the Chinese pharmaceutical company,
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 I, Item 3 under “Legal Proceedings” of this Annual
Report. Through fiscal year ended April 30, 2008, we have not
received any amounts under the agreement.
F-23
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
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 disclosed the development status of its program to Peregrine.
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, 2008, 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 allowed Medarex, Inc. to develop and
commercialize certain monoclonal antibody conjugates for the treatment of a wide
range of solid tumors. During September 2007, the agreement was
terminated by Medarex, Inc.
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-24
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (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.
Increased
Authorized Shares Of Common Stock
On
October 22, 2007, the stockholders of the Company approved an increase in the
number of authorized shares of common stock from 250,000,000 to
325,000,000. In November 2007, we filed an amendment to our
Certificate of Incorporation with the Secretary of State of Delaware which
effected the foregoing increase.
Financing
Under Shelf Registration Statements On Form S-3
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.
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 $20,859,000 after deducting
placement agent fees and estimated costs associated with the
offering. As of April 30, 2008, we could raise up to an additional
$7,500,000 in gross proceeds under the January 2007 Shelf registration
statement.
During
fiscal years 2007 and 2006, 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
|
F-25
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
The
following tables summarize the financing transactions we entered into during
fiscal years 2006 and 2007 under the above shelf registration
statements:
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 |
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, 2008, an aggregate of 5,030,634 shares of common stock were available
for issuance under shelf registration statements 333-121450 and 333-132872 noted
above.
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
20,921,509 shares of our common stock at April 30, 2008 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
|
14,689,064 | |||
Options
available for future grant
|
1,201,811 | |||
Total
shares reserved
|
20,921,509 |
9. WARRANTS
As of
April 30, 2008, we had no warrants to purchase common stock issued and
outstanding. In addition, there were no warrants to purchase common
stock granted during fiscal years 2008, 2007 and 2006.
During
fiscal year 2008, warrants to purchase 53,416 shares of our common stock were
exercised for net proceeds of $46,000. 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.
F-26
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
During
fiscal years 2008, 2007 and 2006, warrants to purchase 369,449, 275,000 and
5,764,631 shares of common stock, respectively, expired
unexercised.
10. SEGMENT
REPORTING
Our
business is organized into two reportable operating
segments. Peregrine is engaged in the research and development of
monoclonal antibody products for the treatment of cancer and viral
infections. Avid is engaged in providing contract manufacturing
services for Peregrine and outside customers on a fee-for-service
basis.
The
accounting policies of the operating segments are the same as those described in
Note 2. We primarily evaluate the performance of our segments based
on net revenues, gross profit or loss (exclusive of research and development
expenses, selling, general and administrative expenses, and interest and other
income/expense) and long-lived assets. Our segment net revenues shown
below are derived from transactions with external customers. Our
segment gross profit represents net revenues less cost of sales. Our
long-lived assets consist of leasehold improvements, laboratory equipment, and
furniture, fixtures and computer equipment and are net of accumulated
depreciation.
Segment
information is summarized as follows:
2008
|
2007
|
2006
|
||||||||||
Net
Revenues:
|
||||||||||||
Contract
manufacturing and development of biologics
|
$ | 5,897,000 | $ | 3,492,000 | $ | 3,005,000 | ||||||
Products
in research and development
|
196,000 | 216,000 | 188,000 | |||||||||
Total
revenues, net
|
$ | 6,093,000 | $ | 3,708,000 | $ | 3,193,000 | ||||||
Gross
Profit (Loss):
|
||||||||||||
Contract
manufacturing and development of biologics
|
$ | 1,093,000 | $ | 196,000 | $ | (292,000 | ) | |||||
Products
in research and development
|
196,000 | 216,000 | 188,000 | |||||||||
Total
gross profit (loss)
|
$ | 1,289,000 | $ | 412,000 | $ | (104,000 | ) | |||||
Research
and development expense
|
(18,279,000 | ) | (15,876,000 | ) | (12,415,000 | ) | ||||||
Selling,
general and administrative expense
|
(7,150,000 | ) | (6,446,000 | ) | (6,564,000 | ) | ||||||
Other
income, net
|
964,000 | 1,114,000 | 2,022,000 | |||||||||
Net
loss
|
$ | (23,176,000 | ) | $ | (20,796,000 | ) | $ | (17,061,000 | ) |
F-27
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
Net
revenues generated from Avid were primarily from the following
customers:
2008
|
2007
|
2006
|
||||||||
Customer
revenues as a % of net revenues:
|
||||||||||
United
States (customer A)
|
84% | 11% | 73% | |||||||
Germany
(one customer)
|
7% | 51% | 10% | |||||||
Australia
(one customer)
|
2% | 14% | 5% | |||||||
China
(one customer)
|
0% | 10% | 0% | |||||||
Other
customers
|
7% | 14% | 12% | |||||||
Total
customer revenues as a % of net revenues
|
100% | 100% | 100% |
Net
revenues generated from Peregrine during fiscal years 2008, 2007 and 2006 were
primarily from annual license fees received under the license agreement with
SuperGen, Inc. (Note 7) combined with the amortized portion of up-front license
fees received under two separate license agreements.
Long-lived assets consist of the
following:
2008
|
2007
|
|||||||
Long-lived
Assets, net:
|
||||||||
Contract
manufacturing and development of biologics
|
$ | 1,825,000 | $ | 1,527,000 | ||||
Products
in research and development
|
233,000 | 313,000 | ||||||
Total
long-lived assets, net
|
$ | 2,058,000 | $ | 1,840,000 |
11. INCOME
TAXES
In June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48 (“FIN No. 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. Under FIN No. 48, tax positions are recognized in the
financial statements when it is more likely than not the position will be
sustained upon examination by the tax authorities. An uncertain
income tax position will not be recognized if it has less than a 50% likelihood
of being sustained upon examination by the tax authorities. FIN No.
48 also provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosures and
transition.
We
adopted the provisions of FIN No. 48 on May 1, 2007. There were
no unrecognized tax benefits as of the date of adoption and as a result of the
implementation of FIN No. 48, we did not recognize an increase in the liability
for unrecognized tax benefits. In addition, there are no unrecognized
tax benefits included in our consolidated balance sheet that would, if
recognized, affect our effective tax rate.
It is our
policy to recognize interest and penalties related to income tax matters in
interest and other expense in our consolidated statement of
operations. We did not recognize interest or penalties related to
income taxes for the fiscal year ended April 30, 2008, and we did not accrue for
interest or penalties as of April 30, 2008.
F-28
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
We are
primarily subject to U.S. federal and California state
jurisdictions. To our knowledge, all tax years remain open to
examination by U.S. federal and state authorities.
The
adoption of FIN No. 48 did not impact our financial condition, results of
operations, or cash flows. At April 30, 2008, we had total deferred
tax assets of $3,922,000. Due to uncertainties surrounding our
ability to generate future taxable income to realize these tax assets, a full
valuation has been established to offset our total deferred tax
assets. Additionally, the future utilization of our net operating
loss and general business and research and development credit carry forwards to
offset future taxable income may be subject to an annual limitation, pursuant to
Internal Revenue Code Sections 382 and 383, as a result of ownership changes
that may have occurred previously or that could occur in the
future. We have not yet performed a Section 382 analysis to determine
the limitation of the net operating loss and general business and research and
development credit carry forwards. Until this analysis has been
performed, we have removed the deferred tax assets for net operating losses of
$64,107,000 and general business and research and development credits of
$118,000 generated through April 30, 2008 from our deferred tax asset schedule
and have recorded a corresponding decrease to our valuation
allowance. When this analysis is finalized, we plan to update our
unrecognized benefits under FIN No. 48. Due to the existence of the
valuation allowance, future changes in our unrecognized tax benefits will not
impact our effective tax rate.
At April
30, 2008, we had federal net operating loss carry forwards and tax credit carry
forwards of approximately $169,948,000 and $118,000,
respectively. The net operating loss carry forwards expire in fiscal
years 2009 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 carry forwards begin to expire in fiscal year 2009 and are available to
offset the future taxes of our subsidiary. We also have state net
operating loss carry forwards of approximately $101,589,000 at April 30, 2008,
which begin to expire in fiscal year 2009.
The
provision for income taxes consists of the following for the three years ended
April 30, 2008:
2008
|
2007
|
2006
|
||||||||||
Provision
for federal income taxes at statutory rate
|
$ | (7,880,000 | ) | $ | (7,071,000 | ) | $ | (5,801,000 | ) | |||
State
income taxes, net of federal benefit
|
(1,309,000 | ) | (1,202,000 | ) | (995,000 | ) | ||||||
Expiration
and adjustment of loss carry forwards
|
64,484,000 | 73,000 | 719,000 | |||||||||
Change
in valuation allowance
|
(55,510,000 | ) | 8,132,000 | 6,048,000 | ||||||||
Increase
of effective tax rate for net state deferred tax asset
|
- | - | - | |||||||||
Other,
net
|
215,000 | 68,000 | 29,000 | |||||||||
Income
tax (expense) benefit
|
$ | - | $ | - | $ | - |
F-29
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
Deferred
income taxes reflect the net effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and
the amounts for income tax purposes. Significant components of our
deferred tax assets at April 30, 2008 and 2007 are as follows:
2008
|
2007
|
|||||||
Net
operating loss carry forwards
|
$ | - | $ | 55,756,000 | ||||
Stock-based
compensation
|
1,891,000 | 2,067,000 | ||||||
General
business and research and development credits
|
- | 118,000 | ||||||
Deferred
revenue
|
875,000 | 424,000 | ||||||
Accrued
liabilities
|
1,156,000 | 1,067,000 | ||||||
Total
deferred tax assets
|
3,922,000 | 59,432,000 | ||||||
Less
valuation allowance
|
(3,922,000 | ) | (59,432,000 | ) | ||||
Net
deferred tax assets
|
$ | - | $ | - |
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 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
30, 2008, we were awarded a five-year contract worth up to $44.4 million to test
and develop bavituximab and an equivalent fully human antibody as potential
broad-spectrum treatments for viral hemorrhagic fever infections. The
initial contract was awarded through the Transformational Medical Technologies
Initiative (TMTI) of the U.S. Department of Defense's Defense Threat Reduction
Agency (DTRA). This federal contract is expected to provide us with
up to $22.3 million in funding over a 24-month base period, with $5 million
appropriated immediately for the current federal fiscal year ending September
30, 2008. The remainder of the $22.3 million in funding is expected
to be appropriated over the remainder of the two-year base period ending June
29, 2010. Subject to the progress of the program and budgetary
considerations in future years, the contract can be extended beyond the base
period to cover up to $44.4 million in funding over the five-year contract
period. Work under this contract commenced on June 30,
2008.
F-30
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008 (continued)
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,
|
January
31,
|
October
31,
|
July
31,
|
April
30,
|
January
31,
|
October
31,
|
July
31,
|
|||||||||||||||||||||||||
2008
|
2008
|
2007
|
2007
|
2007
|
2007
|
2006
|
2006
|
|||||||||||||||||||||||||
Net revenues
|
$ | 901,000 | $ | 1,675,000 | $ | 1,892,000 | $ | 1,625,000 | $ | 2,240,000 | $ | 363,000 | $ | 684,000 | $ | 421,000 | ||||||||||||||||
Cost
of sales
|
$ | 932,000 | (a) | $ | 1,289,000 | $ | 1,402,000 | $ | 1,181,000 | $ | 2,049,000 | $ | 223,000 | $ | 494,000 | $ | 530,000 | (b) | ||||||||||||||
Gross
profit (loss)
|
$ | (31,000 | ) | $ | 386,000 | $ | 490,000 | $ | 444,000 | $ | 191,000 | $ | 140,000 | $ | 190,000 | $ | (109,000 | ) | ||||||||||||||
Operating
expenses
|
$ | 6,266,000 | $ | 6,788,000 | $ | 7,043,000 | $ | 5,332,000 | $ | 5,630,000 | $ | 5,420,000 | $ | 5,590,000 | $ | 5,682,000 | ||||||||||||||||
Net
loss
|
$ | (6,159,000 | ) | $ | (6,154,000 | ) | $ | (6,207,000 | ) | $ | (4,656,000 | ) | $ | (5,244,000 | ) | $ | (5,025,000 | ) | $ | (5,070,000 | ) | $ | (5,457,000 | ) | ||||||||
Basic
and diluted loss per
common
share
|
$ | (0.02 | ) | $ | (0.03 | ) | $ | (0.03 | ) | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.03 | ) | $ | (0.03 | ) |
______________
(a)
|
Cost
of sales for the quarter ended April 30, 2008 includes the write-off of
unusable work-in-process inventory associated with two customers, which in
the aggregate totaled $381,000.
|
|
(b)
|
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.
|
F-31
PEREGRINE PHARMACEUTICALS, INC. |
SCHEDULE
II
|
VALUATION
OF QUALIFYING ACCOUNTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2008
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,
2006
|
$ | 1,581,000 | $ | - | $ | (1,581,000 | ) | $ | - | |||||||
Valuation
reserve for note and other receivables for the year ended April 30,
2007
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Valuation
reserve for note and other receivables for the year ended April 30,
2008
|
$ | - | $ | - | $ | - | $ | - |
F-32