Avid Bioservices, Inc. - Annual Report: 2009 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
________________________
FORM 10-K
(Mark
One)
x ANNUAL REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For
the fiscal year ended April 30, 2009
OR
o TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For
the transition period from _______ to _______
Commission
file number: _____
PEREGRINE PHARMACEUTICALS,
INC.
(Exact
name of Registrant as specified in its charter)
Delaware
|
95-3698422
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
14282
Franklin Avenue, Tustin, California
|
92780
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(714)
508-6000
|
|
(Registrant's
telephone number, including area code)
|
|
Securities
registered pursuant to Section 12(b) of the Act:
|
|
Title
of Each 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 whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such
files). Yes o
No
o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405) 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
aggregate market value of Common Stock held by non-affiliates as of October 31,
2008 was 58,026,551.
(1)
Number of
shares of Common Stock outstanding as of July 10,
2009: 236,964,414
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, 2009.
_________
(1) Excludes 3,031,574
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,
2008.
PEREGRINE
PHARMACEUTICALS, INC.
Fiscal
Year 2009 10-K Annual Report
Table
of Contents
PART
I
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||
Item 1
|
Business
|
1
|
Overview
|
1
|
|
Products
in Clinical Stage Development
|
2
|
|
Understanding
the Mechanism of Action of Our Technology Platforms
|
6
|
|
Government
Contract With The Defense Threat Reduction Agency
|
6
|
|
Preclinical
Programs
|
6
|
|
In-Licensing
Collaborations
|
7
|
|
Out-Licensing
Collaborations
|
7
|
|
Contract
Manufacturing Services
|
9
|
|
Government
Regulation
|
10
|
|
Manufacturing
and Raw Materials
|
12
|
|
Patents
and Trade Secrets
|
13
|
|
Customer
Concentration and Geographic Area Financial Information
|
14
|
|
Marketing
Our Potential Products
|
14
|
|
Competition
|
14
|
|
Research
and Development
|
15
|
|
Corporate
Governance
|
16
|
|
Human
Resources
|
16
|
|
Glossary
of Terms
|
17
|
|
Item 1A
|
Risk
Factors
|
19
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Item 1B
|
Unresolved
Staff Comments
|
36
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Item 2
|
Properties
|
36
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Item 3
|
Legal
Proceedings
|
36
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Item 4
|
Submission
of Matters to a Vote of Security Holders
|
38
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PART
II
|
||
Item 5
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
38
|
Item 6
|
Selected
Financial Data
|
39
|
Item 7
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
40
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Item 7A
|
Quantitative
and Qualitative Disclosures About Market Risk
|
54
|
Item 8
|
Financial
Statements and Supplementary Data
|
55
|
Item 9
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
|
55
|
Item
9A
|
Controls
and Procedures
|
55
|
Item
9B
|
Other
Information
|
55
|
PART
III
|
||
Item
10
|
Directors,
Executive Officers and Corporate Governance
|
58
|
Item
11
|
Executive
Compensation
|
58
|
Item
12
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
58
|
Item
13
|
Certain
Relationships and Related Transactions, and Director
Independence
|
58
|
Item
14
|
Principal
Accounting Fees and Services
|
58
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PART
IV
|
||
Item
15
|
Exhibits
and Consolidated Financial Statement
|
59
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Schedules
|
64
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|
Signatures
|
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
|
Overview
We are a
clinical stage biopharmaceutical company that manufactures and develops
monoclonal antibodies for the treatment of cancer and serious viral
infections. We are advancing three separate clinical programs with
our novel compounds bavituximab and Cotara® that are the first clinical
candidates under our Anti-Phosphatidylserine (“Anti-PS”) therapeutics and Tumor
Necrosis Therapy (“TNT”) platforms.
In
addition to our clinical programs, we are performing pre-clinical research on
bavituximab and an equivalent fully human antibody as a potential broad-spectrum
treatment for viral hemorrhagic fever infections under a contract 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 an initial 24-month base period, with $14.3
million having been appropriated through the current federal fiscal year ending
September 30, 2009.
1
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 addresses
are www.peregrineinc.com
and www.avidbio.com. Information
contained on, or can be accessed through, our website does not constitute any
part of this Annual Report.
Products
in Clinical Stage Development
Our products in clinical trials are
focused on the treatment of cancer and HCV
infection. The below table is a summary of our clinical trials
and the current status of each clinical trial. Additional information pertaining
to each clinical trial is further discussed below.
Product
|
Indication
|
Trial
Design
|
Trial
Status
|
|||||||
Bavituximab
|
Solid
tumor cancers
|
Phase
I monotherapy repeat dose safety study designed to treat up to 28
patients.
|
In
June 2009, we completed planned patient enrollment in this
study. Patient treatments and follow-up are
continuing.
|
|||||||
Bavituximab
plus docetaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study was expanded
to treat up to a total of 46 patients based on early promising results
observed in the initial 15 patients.
|
The
trial was fully enrolled in May 2009. Patient treatment and
follow-up are continuing.
|
|||||||
Bavituximab
plus carboplatin and paclitaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study was expanded
to treat up to a total of 46 patients based on early promising results
observed in the initial 15 patients.
|
Patient
enrollment was initiated in April 2009 in the final 31-patient second
stage of the trial. The study is actively enrolling
patients.
|
|||||||
Bavituximab
plus carboplatin and paclitaxel
|
Non-small
cell lung cancer (“NSCLC”)
|
Phase
II study designed to treat up to 21 patients initially. Study was expanded
to treat up to a total of 49 patients based on early promising results
observed in the initial 21 patients.
|
Patient
enrollment was initiated in April 2009 in the final 28-patient second
stage of the trial. The study is actively enrolling
patients.
|
|||||||
Cotara®
|
Glioblastoma
multiforme (“GBM”)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
This
trial is nearing completion of planned patient
enrollment.
|
|||||||
Cotara®
|
Glioblastoma
multiforme (“GBM”)
|
Phase
II safety and efficacy study to treat up to 40 patients at first
relapse.
|
This
study is actively enrolling patients and enrollment is over halfway
completed
|
|||||||
Bavituximab
|
Chronic
hepatitis C virus (“HCV”) infection co-infected with HIV
|
Phase
Ib repeat dose safety study designed to treat up to 24
patients.
|
This
study is actively enrolling
patients.
|
2
Bavituximab
for the Treatment of Solid Tumors
We are currently running four clinical
trials testing bavituximab for the treatment of solid tumors. Three of these
clinical trials are Phase II trials evaluating bavituximab in combination with
commonly prescribed chemotherapeutic drugs in patients with advanced breast or
lung cancer. These Phase II trials utilize a two-stage design in
which 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 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. Our fourth active bavituximab oncology clinical trial is a
Phase I trial evaluating bavituximab as solo therapy in patients with advanced
solid tumors that no longer respond to standard cancer
treatments. The following is a more thorough discussion of our four
clinical trials using bavituximab for the treatment of solid
tumors.
Phase II Study - Bavituximab
Plus Docetaxel in Advanced Breast Cancer Patients. On May 4,
2009, we announced that we had completed patient enrollment in a Phase II trial
evaluating bavituximab in combination with docetaxel in advanced breast cancer
patients. In the trial's two-stage design, 15 patients with advanced
breast cancer were enrolled in the trial's first cohort. Ten of the 14 evaluable
patients in this cohort demonstrated an objective tumor response according to
RECIST criteria, exceeding the pre-defined primary efficacy endpoint needed to
expand enrollment in the trial. These preliminary results compare favorably with
historical response rates for docetaxel as a solo therapy in advanced breast
cancer patients. An additional 31 patients were then enrolled to
fulfill the planned study total of 46 patients overall. Patients are
currently undergoing treatment and follow-up, and may continue to receive
bavituximab as long as the cancer does not progress and side effects are
acceptable. Preliminary data from this trial was the subject of an
oral presentation at the 2009 American Society of Clinical Oncology (“ASCO”)
Annual Meeting.
Phase II Study - Bavituximab
Plus Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer (“NSCLC”)
Patients. Patient enrollment is continuing in this Phase II
trial evaluating bavituximab plus carboplatin and paclitaxel in patients with
non-small cell lung cancer. In this trial's two-stage design, 21
patients were enrolled in the trial's first cohort. On April 20,
2009, we reported that 11 of the 17 evaluable patients in this cohort
demonstrated an objective tumor response according to RECIST criteria, exceeding
the pre-defined primary efficacy endpoint needed to expand enrollment in the
trial. Tumor response data to date from this trial compares favorably
to published studies with current standard-of-care lung cancer
treatments. Currently the trial is in the process of enrolling an
additional 28 patients to fulfill the planned study total of 49 patients
overall. Patients may continue to receive bavituximab as long as the
cancer does not progress and side effects are acceptable.
Phase II Study - Bavituximab
Plus Carboplatin and Paclitaxel in Advanced Breast Cancer
Patients. A second bavituximab Phase II breast cancer trial is
enrolling patients, evaluating bavituximab plus carboplatin and paclitaxel in
patients with advanced breast cancer. In this trial's two-stage
design, 15 patients were enrolled in the trial's first cohort. We
reported on April 27, 2009, that nine of the 14 evaluable patients in this
cohort demonstrated an objective tumor response according to RECIST criteria,
exceeding the pre-defined primary efficacy endpoint needed to expand enrollment
in the trial. Currently the trial is in the process of enrolling an
additional 31 patients to fulfill the planned study total of 49 patients
overall. Patients may continue to receive bavituximab as long as the
cancer does not progress and side effects are acceptable.
3
Phase I Study - Bavituximab
in Advanced Cancer Patients. In addition to our
three Phase II bavituximab cancer trials, in June 2009 we announced we completed
planned patient enrollment in a multi-center Phase I monotherapy trial for which
most solid cancer types were eligible for enrollment. The clinical
trial was designed to enroll up to 28 patients with advanced solid tumors who no
longer respond to standard cancer treatments. The objectives of this
open-label dose escalation study are to (i) determine the safety and
tolerability of bavituximab administered intravenously to patients with advanced
cancer; (ii) characterize the pharmacokinetic profile of bavituximab and (iii)
define the dose-limiting toxicities, maximum tolerated dose and/or maximum
effective dose of bavituximab. Patients who demonstrate an objective
response to therapy may be offered continued treatment under an extension
protocol. Interim data from this trial was presented at the 2009
American Society of Clinical Oncology (“ASCO”) Annual Meeting.
We
believe bavituximab may have broad potential for the treatment of multiple
cancers when used in combination with commonly prescribed chemotherapeutic drugs
based on its target, mechanism of action, pre-clinical studies and the promising
early signs of efficacy against multiple tumor types with an acceptable safety
profile in three separate Phase II clinical trials.
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. In prior clinical studies, Cotara® has demonstrated
encouraging results in patients with advanced brain cancer. One
previous 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 rang being used in
current studies. This was considered a promising development in this
serious and deadly disease. Cotara® is being studied in two separate
clinical trials as follows:
Dose Confirmation and
Dosimetry Study - Cotara® in GBM Patients. Cotara®
is currently in a dose confirmation and dosimetry clinical trial for the
treatment of recurrent GBM at several clinical sites. 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®. In May 2009, we
announced we were actively screening for the final patient in the planned
patient enrollment. Preliminary data from the trial was presented at
the 2009 Society for Nuclear Medicine Annual Meeting showing that
Cotara® specifically localizes to brain tumors at high concentrations with
minimal radiation exposure to other organs, and that all of the GBM patients in
the study cohort discussed in the presentation had surpassed the expected median
six-month survival time for this patient population.
Phase II Study - Cotara® in
GBM Patients. Patient enrollment and dosing is also ongoing in
a Phase II trial to assess Cotara® in up to 40 GBM patients who have experienced
a first relapse. This study 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. The
study’s primary objective is to confirm the maximum tolerated dose of Cotara® in
these relapsed 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. In March 2009, we announced that we were reducing the number
of clinical sites to concentrate on enrolling patients at our top-enrolling
sites, which have enrolled the majority of patients in the study to
date. We believe that by focusing our efforts on the key clinical
sites, we can reduce the operational cost of the study with a minimal impact on
actual enrollment rates. In May 2009, we announced that we had
enrolled over half of the planned patients in this study.
4
Taken
together, we believe the study results from Peregrine’s two ongoing Cotara
trials could provide the safety, dosimetry and initial efficacy data needed to
support the design of a Phase III study. Cotara has been
granted FDA/EMEA orphan drug status for GBM and anaplastic astrocytoma and fast
track designation in the U.S. for the treatment of recurrent GBM.
Bavituximab
for the Treatment of HCV Infection
Bavituximab
is a monoclonal antibody that targets and binds to phosphatidylserine
(“PS”). Our researchers and collaborators have discovered that PS
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
initiated and completed a Phase I single dose escalation study in 30 patients
chronically infected with HCV who had failed prior therapies. The
primary goal of the Phase I 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.
These
results supported the initiation and completion of a Phase I repeat dose HCV
trial. The primary objective of the Phase I 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.
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. 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 eight
weeks. HCV and HIV viral titers and other biomarkers are being
tracked, although they are not formal study endpoints.
5
Understanding
the Mechanism of Action of 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 product, 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.
Government
Contract with the Defense Threat Reduction Agency
On June 30, 2008, we were awarded a
five-year contract potentially 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 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 $14.3 million
having been appropriated through the current federal fiscal year ending
September 30, 2009. 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 through three one-year option terms. Work under this
contract commenced on June 30, 2008 and direct costs associated with the
contract are included in research and development expense in the accompanying
consolidated statements of operations.
Pre-clinical
Programs
We have historically developed several
earlier stage technologies that are intended to be used as an adjuvant to
improve the performance of standard cancer drugs, anti-angiogenesis agents, and
vascular targeting agents, 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.
6
In-Licensing
Collaborations
The
following discussions cover our collaborations and in-licensing obligations
related to our products in clinical trials:
Anti-Phosphatidylserine
(“Anti-PS”) Program
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
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
("Lonza ") 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 program, 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 product. In addition, under one of the
agreements, we are required to pay future milestone payments upon the completion
of Phase II clinical trial enrollment in the amount of 75,000 pounds sterling,
the amount of which will continue as an annual license fee thereafter, plus a
royalty on net sales of any products that we market that utilize the underlying
technology. In the event we utilize an outside contract manufacturer
other than Lonza to manufacture bavituximab for commercial purposes, we would
owe Lonza 300,000 pounds sterling per year in addition to an increased royalty
on net sales.
During
fiscal year 2008, we expensed $50,000 under in-licensing agreements covering our
Anti-PS program, which is included in research and development expense in the
accompanying consolidated statements of operations. We did not
incur any milestone related expenses during fiscal years 2009 and
2007.
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 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.
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:
7
During
September 1995, we entered into an agreement with Cancer Therapeutics, Inc.
("CTL"), a California corporation, whereby we granted to CTL the exclusive right
to sublicense TNT to a major pharmaceutical company solely in the People’s
Republic of China. In
accordance with a Settlement Agreement and Mutual General Release (“Settlement
Agreement”) dated June 4, 2009 with CTL as further discussed in Part I, Item 3
under “Legal Proceedings” of this Annual Report, CTL agreed to issue to
Peregrine 950,000 shares of Medibiotech (which represents 50% of the shares of
Medibiotech owned by CTL) in lieu of any of the financial terms included in the
September 1995 agreement.
During
October 2000, we entered into a licensing agreement with Merck KGaA to
out-license a segment of our TNT technology for use in the application of
cytokine fusion proteins. During January 2003, we entered into an
amendment to the license agreement, whereby we received an extension to the
royalty period from six years to ten years from the date of the first commercial
sale. Under the terms of the agreement, we 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 Vascular Targeting Agents
("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, 2009, 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 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.
8
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 biomanufacturing
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 cGMP manufacturing operations
includes the following four bioreactors: two (2) 1,000 liter, 300
liter, and 100 liter. Avid also maintains spinner flasks and
bioreactors in our process development laboratory ranging from 1 to 100
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 more than 10 years and developed the
manufacturing expertise and quality systems to provide the same service to other
biopharmaceutical and biotechnology companies. Avid is also well
positioned to increase its capacity in the future in order to become a
significant supplier of contract manufacturing services.
Avid
provides an array of services for Peregrine as well as working with a variety of
companies in the biotechnology and pharmaceutical industries. Even
though much of the process is very technical, knowledge of the process should
assist you in understanding the overall business and complexities involved in
cGMP manufacturing. The manufacturing of monoclonal antibodies and
recombinant proteins under cGMP is a complex process that includes several
phases before the finished drug product is released for clinical or commercial
use. The first phase of the manufacturing process, called technology
transfer phase, 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 and/or other regulatory guidelines 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
laboratories. 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 36 or 100 liter
bioreactors, 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 taken for various required tests,
including sterility and viral testing. Once the test results verify
that the antibodies meet specifications, the product is released for research,
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 more than 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.
9
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 six months to more than one
year. Introduction to Avid’s services will usually come from
exhibiting at trade shows, exposure from attending and presenting at industry
conferences and through word of mouth or referrals. 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 has been subsequently inspected by the FDA most
recently in January 2009 with no objectionable citations. Avid is
currently producing commercial product for the client company under this
approved New Drug Application.
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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2.
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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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3.
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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.
11
Our
product candidates, if approved, may also be subject to import laws in other
countries, the food and drug laws in various states in which the products are or
may be sold and subject to the export laws of agencies of the United States
government.
In
addition, we must also adhere to current Good Manufacturing Practice (“cGMP”)
and product-specific regulations enforced by the FDA through its facilities
inspection program. Failure to comply with manufacturing regulations
can result in, among other things, warning letters, fines, injunctions, civil
penalties, recall or seizure of products, total or partial suspension of
production, refusal of the government to renew marketing applications and
criminal prosecution.
During
fiscal year 1999, the Office of Orphan Products Development of the FDA
determined that Cotara® qualified for orphan designation for the treatment of
glioblastoma multiforme and anaplastic astrocytoma (both brain
cancers). The 1983 Orphan Drug Act (with amendments passed by
Congress in 1984, 1985, and 1988) includes various incentives that have
stimulated interest in the development of orphan drug and biologic
products. These incentives include a seven-year period of marketing
exclusivity for approved orphan products, tax credits for clinical research,
protocol assistance, and research grants. Additionally, legislation
re-authorizing FDA user fees also created an exemption for orphan products from
fees imposed when an application to approve the product for marketing is
submitted. A grant of an orphan designation is not a guarantee that a
product will be approved. If a sponsor receives orphan drug
exclusivity upon approval, there can be no assurance that the exclusivity will
prevent another entity from receiving approval for the same or a similar drug
for the same or other uses.
Cotara®
was granted Fast Track designation by the FDA 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 bavituximab and
Cotara®.
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®.
12
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 and diagnostic 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 our
products.
In
general, the patent position of a biotechnology firm is highly uncertain and no
consistent policy regarding the breadth of issued claims has emerged from the
actions of the U.S. Patent Office and courts 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 us. 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 we can obtain
on some of our products outside of the United States. These and other
issues may prevent us 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 our business, financial condition and
results of operations.
13
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 our 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 our 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 bavituximab or Cotara® 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 bavituximab, Cotara®, or any of our other product candidates
and we currently have no arrangements for the distribution of our product
candidates, if approved. Development of an effective sales force
requires significant financial resources, time, and expertise. There
can be no assurance that we will be able to obtain the financing necessary to
establish such a sales force in a timely or cost effective manner or that such a
sales force will be capable of generating demand for our product
candidates.
Competition
The
pharmaceutical and biotechnology industry is intensely competitive and subject
to rapid and significant technological change. Many of the drugs that
we are attempting to discover or develop will be competing with existing
therapies. In addition, we are aware of several pharmaceutical and
biotechnology companies actively engaged in research and development of
antibody-based products that have commenced clinical trials with, or have
successfully commercialized, antibody products. Some or all of these
companies may have greater financial resources, larger technical staffs, and
larger research budgets than we have, as well as greater experience in
developing products and running clinical trials. We expect to
continue to experience significant and increasing levels of competition in the
future. In addition, there may be other companies which are currently
developing competitive technologies and products or which may in the future
develop technologies and products that are comparable or superior to our
technologies and products.
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 Eisai, Inc.,
Temodar® (temozolomide) from Schering-Plough Corporation and Avastin®
(bevacizumab) from Genentech, Inc.. 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. Avastin® is a monoclonal antibody that targets vascular
endothelial growth factor to prevent the formation of new tumor blood
vessels.
14
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: 131I-TM601, a radiolabeled chlorotoxin peptide being developed by
TransMolecular, Inc., CDX-110, a peptide vaccine under development by Celldex,
cilengitide, an integrin-targeting peptide being evaluated by Merk KGaA, and
cediranib, a VEGFR tyrosine kinase inibitor being developed by
AstraZeneca. In addition, oncology products marketed for other
indications such as Gleevec® (Novartis), Tarceva® (Genentech/OSI), 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. 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 $18,424,000 in fiscal year 2009, $18,279,000 in fiscal year 2008, and
$15,876,000 in fiscal year 2007.
15
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, 2009, we employed 133 full-time employees and 5 part-time
employees. Each of our employees has signed a confidentiality
agreement and none are covered by a collective bargaining
agreement. We have never experienced employment-related work
stoppages and consider our employee relations to be good.
16
Glossary
of Terms
Adjuvant – An agent added to a drug to
increase or aid its effect.
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.
Bavituximab - Our first
monoclonal antibody in clinical development for the treatment of cancer and
hepatitis C virus infection under our Anti-PS technology platform.
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 and/or other regulatory bodies 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.
EMEA - European Medicines
Agency.
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.
17
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.
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 - 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.
Response Evaluation Criteria In Solid
Tumors (“RECIST”) – A set of published rules that define when cancer
patients improve (“respond”), stay the same (“stable”) or worsen (“progression”)
during treatments.
Solid tumors - Cancer cells
which grow as a solid mass.
Tumor Necrosis Therapy (“TNT”)
- Therapeutic agents that target dead and dying cells found primarily at the
core of a tumor.
18
ITEM
1A.
|
RISK
FACTORS
|
This
Annual Report on Form 10-K contains forward-looking information based on our
current expectations. Because our actual results may differ
materially from any forward-looking statements made by or on behalf of
Peregrine, this section includes a discussion of important factors that could
affect our actual future results, including, but not limited to, our potential
product sales, potential royalties, contract manufacturing revenues, expenses,
net income(loss) and earnings(loss) per common share.
If
We Cannot Obtain Additional Funding, Our Product Development And
Commercialization Efforts May Be Reduced Or Discontinued And We May Not Be Able
To Continue Operations.
At April
30, 2009, we had $10,018,000 in cash and cash equivalents. We have
expended substantial funds on the research, development and clinical trials of
our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2009, 2008, and 2007 amounted
to $16,524,000, $23,176,000, and $20,796,000, 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 for the foreseeable
future.
Therefore, our ability to continue our
clinical trials and development efforts and to continue as a going concern 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 to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
With
respect to financing our operations through the issuance of equity, on
March 26, 2009, we entered into an At Market Issuance Sales Agreement (“AMI
Agreement”) with Wm Smith & Co., pursuant to which we may sell shares of our
common stock through Wm Smith & Co., as agent, in registered transactions
from our shelf registration statement on Form S-3, File Number 333-139975, for
aggregate gross proceeds of up to $7,500,000. Shares of common stock
sold under this arrangement were to be sold at market prices. As of
April 30, 2009, we had sold 1,477,938 shares of common stock under the AMI
Agreement for aggregate net proceeds of $550,000. Subsequent to April
30, 2009, we raised net proceeds of $6,685,000 after deducting commissions of 3%
paid to Wm Smith & Co. under the AMI Agreement in exchange for 9,275,859
shares of common stock.
With respect to financing our
operations through the issuance of debt, on December 9, 2008, we entered into a
loan and security agreement pursuant to which we had the ability to borrow up to
$10,000,000 (“Loan Agreement”). On December 19, 2008, we received
initial funding of $5,000,000, in which principal and interest are payable over
a thirty (30) month period commencing after the initial six month interest only
period. The amount payable under the Loan Agreement is secured by
generally all assets of the Company as further explained in Note 5 to the
consolidated financial statements. Under the Loan Agreement, we had
an option, which expired June 30, 2009, to borrow a second tranche in the amount
of $5,000,000 upon the satisfaction of certain clinical and financial conditions
as set forth in the Loan Agreement. Although we had satisfied the
required clinical and financial conditions by June 30, 2009, we determined that
exercising the option to borrow the second tranche, and issuing the additional
warrants to the Lenders, was not in the best interests of the Company or our
stockholders.
19
In addition to the above, we may also
raise additional capital through additional equity offerings or licensing our
products or technology platforms or entering into similar collaborative
arrangements. In order to raise capital through the issuance of
equity, we plan to file a new shelf registration statement on Form S-3 to
register up to $50 million gross in proceeds from the sale of our common
stock. Although we are not required to issue any shares of common
stock under this registration statement, we plan to register the underlying
shares of common stock as a potential method of raising additional capital to
support our drug development efforts.
While we
will continue to consider and 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 to
complete the research, development, and clinical testing of our product
candidates. Based on our current projections and assumptions, which
include projected revenues under signed contracts with 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
2010. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of third party
or government contracts, technical challenges, or possible reductions in funding
under our government contract, which could reduce or delay our future projected
cash-inflows. In addition, under the Loan Agreement, in the event our
contract with the Defense Threat Reduction Agency is terminated or canceled for
any reason, including reasons pertaining to budget cuts by the government or
reduction in government funding for the program, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessible by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
fiscal year 2010 unless we raise additional capital. The
uncertainties surrounding our future cash inflows have raised substantial doubt
regarding our ability to continue as a going concern.
Our Outstanding
Indebtedness To MidCap Financial LLC and BlueCrest Capital Finance, L.P. Imposes
Certain Restrictions On How We Conduct Our Business. In Addition, All
Of Our Assets, Including Our Intellectual Property, Are Pledged To Secure This
Indebtedness. If We Fail To Meet Our Obligations To The Lenders, Our
Payment Obligations May Be Accelerated And The Collateral Securing The Debt May
Be Sold To Satisfy These Obligations.
Pursuant
to a Loan and Security Agreement dated December 9, 2008 (the “Loan
Agreement”), MidCap Financial LLC and BlueCrest Capital Finance, L.P. (the
“Lenders”) have provided us a three-year, $5,000,000 working capital loan, which
funded on December 19, 2008. As collateral to secure our repayment
obligations to the Lenders, we and our wholly-owned subsidiary, Avid
Bioservices, Inc., have granted the Lenders a first priority security interest
in generally all of our respective assets, including our intellectual
property.
The
Loan Agreement also contains various covenants that restrict our operating
flexibility. Pursuant to the Loan Agreement, we may not, among other
things:
|
●
|
incur
additional indebtedness, except for certain permitted indebtedness.
Permitted indebtedness is defined to include accounts payable incurred in
the ordinary course of business, leases of equipment or property incurred
in the ordinary course of business not to exceed in the aggregate $100,000
outstanding at any one time;
|
|
●
|
incur
additional liens on any of our assets except for certain permitted liens
including but not limited to non-exclusive licenses of our intellectual
property in the ordinary course of business and exclusive licenses of
intellectual property provided they are approved by our board of directors
and do not involve bavituximab or
Cotara;
|
20
|
●
|
make
any payment of subordinated debt, except as permitted under the applicable
subordination or intercreditor
agreement;
|
|
●
|
merge
with or acquire any other entity, or sell all or substantially all of our
assets, except as permitted under the Loan
Agreement;
|
|
●
|
pay
dividends (other than stock dividends) to our
shareholders;
|
|
●
|
redeem
any outstanding shares of our common stock or any outstanding options or
warrants to purchase shares of our common stock except in connection with
the repurchase of stock from former employees and consultants pursuant to
share repurchase agreements provided such repurchases do not exceed
$50,000 in the aggregate during any twelve-month
period;
|
|
●
|
enter
into transactions with affiliates other than on arms-length terms;
and
|
|
●
|
make
any change in any of our business objectives, purposes and operations
which has or could be reasonably expected to have a material adverse
effect on our business.
|
These
provisions could have important consequences for us, including (i) making
it more difficult for us to obtain additional debt financing from another
lender, or obtain new debt financing on terms favorable to us, because a new
lender will have to be willing to be subordinate to the lenders,
(ii) causing us to use a portion of our available cash for debt repayment
and service rather than other perceived needs and/or (iii) impacting our
ability to take advantage of significant, perceived business
opportunities. Our failure to timely repay our obligations under the
Loan Agreement or meet the covenants set forth in the Loan Agreement could give
rise to a default under the agreement. In the event of an uncured
default, the Loan Agreement provides that all amounts owed to the Lender may be
declared immediately due and payable and the Lenders have the right to enforce
their security interest in the assets securing the Loan Agreement. In
such event, the Lenders could take possession of any or all of our assets in
which they hold a security interest, and dispose of those assets to the extent
necessary to pay off our debts, which would materially harm our
business.
In
The Event Our Contract With The DTRA Is Terminated, Our Loan Requires Us To
Place A Significant Amount Of Our Cash In A Restricted Bank
Account.
Under the terms of the Loan Agreement,
if our contract with the Defense Threat Reduction Agency is terminated while any
principal balance of the loan is outstanding, we will be required to at all
times thereafter maintain cash and cash equivalents in an amount of at least
eighty percent (80%) of the then outstanding principal balance of the loan in a
restricted account over which we will not be permitted to make withdrawals or
otherwise exercise control.
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 for each of the past three fiscal
years:
Net
Loss
|
||||
Fiscal
Year 2009
|
$ | 16,524,000 | ||
Fiscal
Year 2008
|
$ | 23,176,000 | ||
Fiscal
Year 2007
|
$ | 20,796,000 |
As of
April 30, 2009, we had an accumulated deficit of $247,360,000. 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 three years, and we
may never generate product and/or royalty revenues sufficient to become
profitable or to sustain profitability.
21
The Sale Of
Substantial Shares Of Our Common Stock May Depress Our Stock Price.
As of
April 30, 2009, there were 227,688,555 shares of our common stock
outstanding. Subsequent to April 30, 2009, we issued an additional
9,275,859 shares of common stock under an At Market Issuance Sales Agreement in
exchange for $6,685,000 in net proceeds after deducting commissions of
3%. 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 17,146,892
additional shares of our common stock that are reserved for future issuance
under our stock option plans and for outstanding warrants, as further described
in the following table:
Number
of Shares
of
Common Stock
Reserved
For Issuance
|
||||
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
15,454,845 | |||
Common
shares issuable upon exercise of outstanding warrants
|
1,692,047 | |||
Total
|
17,146,892 |
Of the
total options and warrants outstanding as of April 30, 2009, 3,158,649 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,
2009.
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.
Current
Economic Conditions And Capital Markets Are In A Period Of Disruption And
Instability Which Could Adversely Affect Our Ability To Access The Capital
Markets, And Thus Adversely Affect Our Business And Liquidity.
The
current economic conditions and financial crisis have had, and will continue to
have, a negative impact on our ability to access the capital markets, and thus
have a negative impact on our business and liquidity. The shortage of
liquidity and credit combined with recent substantial losses in worldwide equity
markets could lead to an extended worldwide recession. We may face
significant challenges if conditions in the capital markets do not
improve. Our ability to access the capital markets has been and
continues to be severely restricted at a time when we need to access such
markets, which could have a negative impact on our business plans, including our
pre-clinical studies and clinical trial schedules and other research and
development activities. Even if we are able to raise capital, it may
not be at a price or on terms that are favorable to us. We cannot
predict the occurrence of future disruptions or how long the current conditions
may continue.
22
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, 2009:
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
Fiscal
Year 2009
|
||||||||||||||||
Quarter
Ended April 30, 2009
|
$ | 0.52 | $ | 0.30 | 3,509 | 68 | ||||||||||
Quarter
Ended January 31, 2009
|
$ | 0.47 | $ | 0.22 | 1,298 | 93 | ||||||||||
Quarter
Ended October 31, 2008
|
$ | 0.40 | $ | 0.23 | 1,318 | 77 | ||||||||||
Quarter
Ended July 31, 2008
|
$ | 0.53 | $ | 0.31 | 2,997 | 103 | ||||||||||
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 |
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.
|
23
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 required under NASDAQ listing rules. 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. After the initial 180 calendar day period, we remained
noncompliant with the minimum closing bid price requirement but because we were
in compliance with all other initial listing requirements, we were afforded an
additional “compliance period” of 180 calendar days, or until July 21,
2008. Because we did not regain compliance, i.e., the closing bid
price of the Company’s common stock did not meet or exceed $1.00 per share for a
minimum of ten (10) consecutive business days prior to July 21, 2008, on July
22, 2008 we received a notice from The NASDAQ Stock Market indicating that we
were not in compliance with the minimum bid price requirement for continued
listing, and as a result our common stock is subject to delisting. On
July 28, 2008, we requested a hearing with the NASDAQ Listing Qualifications
Panel (“Panel”) to review the delisting determination. Our request
for a hearing stayed the delisting pending a decision by the
Panel. The oral hearing took place September 4, 2008 at which we
presented to the Panel our definitive plan to achieve and sustain long-term
compliance with the listing requirements of the NASDAQ Capital
Market. On September 16, 2008, we received a letter from the NASDAQ
Stock Market informing us that the Panel had determined to grant our request to
remain listed, subject to the condition that on or before January 20, 2009, we
must evidence a closing bid price for our common stock of $1.00 or more for a
minimum of ten prior consecutive trading days.
On
October 21, 2008, we conducted our 2008 annual meeting of stockholders at which
our stockholders approved an amendment to our certificate of incorporation to
effect a reverse stock split of the outstanding shares of our common stock at a
ratio to be determined by our Board of Directors within a range of three-for-one
and ten-for-one. Subsequent to our annual meeting of stockholders,
the NASDAQ Stock Market suspended the bid price and market value of publicly
held shares continued listing requirements through April 17, 2009. As
a result of this suspension, the exception granted to us by the Panel, which
required us to demonstrate compliance with the closing minimum bid price
requirement by January 20, 2009, has now been extended to no later
than November 11, 2009. On July 14, 2009, we received a letter
from The NASDAQ Stock Market informing us that NASDAQ does not anticipate that
it will further extend its suspension of the bid price requirement.
24
We intend
to pursue all available options to ensure our continued listing on the NASDAQ
Stock Market, including, if necessary, effecting the reverse stock split of our
outstanding common stock previously approved by our
stockholders. 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 of The NASDAQ Capital Market
listing requirements, the market value of our common stock could fall and
holders of common stock would likely find it more difficult to dispose of the
common stock.
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.
If
We Effect A Reverse Stock Split, The Liquidity of Our Common Stock And Market
Capitalization Could Be Adversely Affected.
A reverse
stock split is often viewed negatively by the market and, consequently, can lead
to a decrease in our overall market capitalization. If the per share
market price does not increase proportionately as a result of the reverse split,
then the value of our company as measured by our market capitalization will be
reduced, perhaps significantly. In addition, because the reverse
split will significantly reduce the number of shares of our common stock that
are outstanding, the liquidity of our common stock could be adversely affected
and you may find it more difficult to purchase or sell shares of our common
stock.
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:
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delays
in product development, clinical testing or
manufacturing;
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unplanned
expenditures in product development, clinical testing or
manufacturing;
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failure
in clinical trials or failure to receive regulatory
approvals;
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emergence
of superior or equivalent products;
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inability
to manufacture on our own, or through others, product candidates on a
commercial scale;
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inability
to market products due to third party proprietary rights;
and
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failure
to achieve market acceptance.
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25
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.
We
Are Primarily Focusing Our Activities And Resources On The Development Of
Bavituximab And Depend On Its Success.
We are
focusing most of our near-term research and development activities and resources
on bavituximab, and we believe a significant portion of the value of our Company
relates to our ability to develop this drug candidate. The development of
bavituximab is subject to many risks, including the risks discussed in other
risk factors. If the results of clinical trials of bavituximab, the
regulatory decisions affecting bavituximab, the anticipated or actual timing and
plan for commercializing bavituximab, or, ultimately, the market acceptance of
bavituximab do not meet our, your, analysts’ or others’ expectations, the market
price of our common stock could be adversely affected.
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.
Clinical
Trials Required For Our Product Candidates Are Expensive And Time Consuming, And
Their Outcome Is Uncertain.
In order
to obtain FDA approval to market a new drug product, we or our potential
partners must demonstrate proof of safety and efficacy in humans. To
meet these requirements, we or our potential partners will have to conduct
extensive pre-clinical testing and “adequate and well-controlled” clinical
trials. Conducting clinical trials is a lengthy, time-consuming and
expensive process. The length of time may vary substantially
according to the type, complexity, novelty and intended use of the product
candidate, and often can be several years or more per trial. Delays
associated with products for which we are directly conducting pre-clinical or
clinical trials may cause us to incur additional operating
expenses. Moreover, we may continue to be affected by delays
associated with the pre-clinical testing and clinical trials of certain product
candidates conducted by our partners over which we have no
control. The commencement and rate of completion of clinical trials
may be delayed by many factors, including, for example:
26
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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.
We
Rely On Third Parties To Conduct Our Clinical Trials And Many Of Our Preclinical
Studies. If Those Parties Do Not Successfully Carry Out Their
Contractual Duties Or Meet Expected Deadlines, Our Drug Candidates May Not
Advance In A Timely Manner Or At All.
In the
course of our discovery, preclinical testing and clinical trials, we rely on
third parties, including universities, investigators and clinical research
organizations, to perform critical services for us. For example, we rely on
third parties to conduct our clinical trials and many of our preclinical
studies. Clinical research organizations and investigators are responsible for
many aspects of the trials, including finding and enrolling patients for testing
and administering the trials. Although we rely on these third parties
to conduct our clinical trials, we are responsible for ensuring that each of our
clinical trials is conducted in accordance with its investigational plan and
protocol. Moreover, the FDA and foreign regulatory authorities
require us to comply with regulations and standards, commonly referred to as
good clinical practices, or GCPs, for conducting, monitoring, recording and
reporting the results of clinical trials to ensure that the data and results are
scientifically credible and accurate and that the trial subjects are adequately
informed of the potential risks of participating in clinical
trials. Our reliance on third parties does not relieve us of these
responsibilities and requirements. These third parties may not be
available when we need them or, if they are available, may not comply with all
regulatory and contractual requirements or may not otherwise perform their
services in a timely or acceptable manner, and we may need to enter into new
arrangements with alternative third parties and our clinical trials may be
extended, delayed or terminated. These independent third parties may
also have relationships with other commercial entities, some of which may
compete with us. In addition, if such third parties fail to perform
their obligations in compliance with our clinical trial protocols, our clinical
trials may not meet regulatory requirements or may need to be
repeated. As a result of our dependence on third parties, we may face
delays or failures outside of our direct control. These risks also
apply to the development activities of our collaborators, and we do not control
our collaborators’ research and development, clinical trials or regulatory
activities. We do not expect any drugs resulting from our
collaborators’ research and development efforts to be commercially available for
many years, if ever.
27
We
Do Not Have Experience As a Company Conducting Large-Scale Clinical Trials, Or
In Other Areas Required For The Successful Commercialization And Marketing Of
Our Product Candidates.
Preliminary results from clinical
trials of bavituximab may not be indicative of successful outcomes in later
stage trials. Negative or limited results from any current or future
clinical trial could delay or prevent further development of our product
candidates which would adversely affect our business.
We have no experience as a Company in
conducting large-scale, late stage clinical trials, and our experience with
early-stage clinical trials with small numbers of patients is
limited. In part because of this limited experience, we cannot be
certain that planned clinical trials will begin or be completed on time, if at
all. Large-scale trials would require either additional financial and
management resources, or reliance on third-party clinical investigators,
clinical research organizations (“CROs”) or consultants. Relying on third-party
clinical investigators or CROs may force us to encounter delays that are outside
of our control. Any such delays could have a material adverse effect
on our business.
We also
do not currently have marketing and distribution capabilities for our product
candidates. Developing an internal sales and distribution capability would be an
expensive and time-consuming process. We may enter into agreements
with third parties that would be responsible for marketing and
distribution. However, these third parties may not be capable of
successfully selling any of our product candidates. The inability to
commercialize and market our product candidates could materially affect our
business.
Our
International Clinical Trials May Be Delayed Or Otherwise Adversely Impacted By
Social, Political And Economic Factors Affecting The Particular Foreign
Country.
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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● | geopolitical risks, such as political and economic instability, and changes in diplomatic and trade relations. |
28
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 our pre-clinical studies, Phase I and the first stage of our Phase
II 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. In addition, while we have completed the first
stage of all three of our Phase II studies, and obtained positive results with
respect to our primary endpoints, our Phase II trials are open-label, Simon
two-stage design trials to evaluate the safety and efficacy on bavituximab in
combination with chemotherapy drugs in a limited number of
patients. The limited results we have obtained, and will obtain in
the Phase II trials, may not predict results for any future studies and also may
not predict future therapeutic benefit of our drug candidates. We
will be required to demonstrate through larger-scale clinical trials that
bavituximab and Cotara® are safe and effective for use in a diverse population
before we can seek regulatory approval for their commercial
sale. There is typically an extremely high rate of attrition from the
failure of drug candidates proceeding through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be Profitable.
Even if
bavituximab, Cotara®, or any future product candidate is approved for commercial
sale by the FDA or other regulatory authorities, the degree of market acceptance
of any approved product candidate by physicians, healthcare professionals and
third-party payors and our profitability and growth will depend on a number of
factors, including:
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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.
29
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”). We are also currently conducting a Phase II safety and
efficacy study 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 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 our clinical studies 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.
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.
30
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.
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 up to a five-year contract potentially 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 $14.3 million having been appropriated through the
current federal fiscal year ending September 30, 2009. 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.
31
Federal
Government Contracts Contain Provisions Giving Government Customers A Variety Of
Rights That Are Unfavorable To Us, Including The Ability To Terminate A Contract
At Any Time For Convenience.
Federal
government contracts, such as our contract with the DTRA, contain provisions,
and are subject to laws and regulations, that give the government rights and
remedies not typically found in commercial contracts. These provisions may allow
the government to:
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Reduce,
cancel, or otherwise modify our contracts or related
subcontract agreements;
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Decline
to exercise an option to renew a multi-year
contract;
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Claim
rights in products and systems produced by
us;
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Prohibit
future procurement awards with a particular agency as a result of a
finding of an organizational conflict of interest based upon prior related
work performed for the agency that would give a contractor an unfair
advantage over competing
contractors;
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Subject
the award of contracts to protest by competitors, which may require the
contracting federal agency or department to suspend our performance
pending the outcome of the protest;
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Suspend
or debar us from doing business with the federal government or with a
governmental agency; and
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Control
or prohibit the export of our products and
services.
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If the
government terminates our contract for convenience, we may recover only our
incurred or committed costs, settlement expenses and profit on work completed
prior to the termination. If the government terminates our contract for default,
we may not recover even those amounts, and instead may be liable for excess
costs incurred by the government in procuring undelivered items and services
from another source. If the DTRA were to unexpectedly terminate or cancel, or
decline to exercise the option to extend our contract beyond the base period,
our revenues, product development efforts and operating results would be
materially harmed.
We
May Have Significant Product Liability Exposure Because We Maintain Only Limited
Product Liability Insurance.
We face
an inherent business risk of exposure to product liability claims in the event
that the administration of one of our drugs during a clinical trial adversely
affects or causes the death of a patient. Although we maintain
product liability insurance for clinical studies in the amount of $3,000,000 per
occurrence or $3,000,000 in the aggregate on a claims-made basis, this coverage
may not be adequate. Product liability insurance is expensive,
difficult to obtain and may not be available in the future on acceptable terms,
if at all. Our inability to obtain sufficient insurance coverage on
reasonable terms or to otherwise protect against potential product liability
claims in excess of our insurance coverage, if any, or a product recall, could
negatively impact our financial position and results of operations.
In
addition, the contract manufacturing services that we offer through Avid expose
us to an inherent risk of liability as the antibodies or other substances
manufactured by Avid, at the request and to the specifications of our customers,
could possibly cause adverse effects or have product defects. We
obtain agreements from our customers indemnifying and defending us from any
potential liability arising from such risk. There can be no assurance
that such indemnification agreements will adequately protect us against
potential claims relating to such contract manufacturing services or protect us
from being named in a possible lawsuit. Although Avid has procured
insurance coverage, there is no guarantee that we will be able to maintain our
existing coverage or obtain additional coverage on commercially reasonable
terms, or at all, or that such insurance will provide adequate coverage against
all potential claims to which we might be exposed. A partially
successful or completely uninsured claim against Avid would have a material
adverse effect on our consolidated operations.
32
If
We Are Unable To Obtain, Protect And Enforce Our Patent Rights, We May Be Unable
To Effectively Protect Or Exploit Our Proprietary Technology, Inventions And
Improvements.
Our
success depends in part on our ability to obtain, protect and enforce
commercially valuable patents. We try to protect our proprietary
positions by filing United States and foreign patent applications related to our
proprietary technology, inventions and improvements that are important to
developing our business. However, if we fail to obtain and maintain
patent protection for our proprietary technology, inventions and improvements,
our competitors could develop and commercialize products that would otherwise
infringe upon our patents.
Our
patent position is generally uncertain and involves complex legal and factual
questions. Legal standards relating to the validity and scope of
claims in the biotechnology and biopharmaceutical fields are still
evolving. Accordingly, the degree of future protection for our patent
rights is uncertain. The risks and uncertainties that we face with
respect to our patents include the following:
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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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We
May Become Involved In Lawsuits To Protect Or Enforce Our Patents That Would Be
Expensive And Time Consuming.
In order
to protect or enforce our patent rights, we may initiate patent litigation
against third parties. In addition, we may become subject to
interference or opposition proceedings conducted in patent and trademark offices
to determine the priority and patentability of inventions. The
defense of intellectual property rights, including patent rights through
lawsuits, interference or opposition proceedings, and other legal and
administrative proceedings, would be costly and divert our technical and
management personnel from their normal responsibilities. An adverse
determination of any litigation or defense proceedings could put our pending
patent applications at risk of not being issued.
33
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.
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 Eisai, Inc.,
Temodar® (temozolomide) from Schering-Plough Corporation and Avastin®
(bevacizumab). 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. Avastin® is a
monoclonal antibody that targets vascular endothelial growth factor to prevent
the formation of new tumor blood vessels.
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: 131I-TM601, a radiolabeled chlorotoxin peptide being developed by
TransMolecular, Inc., CDX-110, a peptide vaccine under development by Celldex,
cilengitide, an integrin-targeting peptide being evaluated by Merk KGaA, and
cediranib, a VEGFR tyrosine kinase inibitor being developed by
AstraZeneca. In addition, oncology products marketed for other
indications such as Gleevec® (Novartis), Tarceva® (Genentech/OSI), 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. Other developmental approaches include,
but are not limited to, protease inhibitors such as telaprevir from Vertex
Pharmaceuticals Incorporated and boceprevir from Schering-Plough
Corporation.
34
Avid
Bioservices, Our subsidiary, Is Exposed To Risks Resulting From Its Small
Customer Base.
A significant portion of Avid
Bioservices’ revenues have historically been derived from a small customer
base. These customers typically do not enter into long-term contracts
because their need for drug supply depends on a variety of factors, including
the drug’s stage of development, their financial resources, and, with respect to
commercial drugs, demand for the drug in the market. Our results of
operations could be adversely affected if revenue from any one of our primary
customers is significantly reduced or eliminated
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,
|
·
|
no
stockholder action may be taken without a meeting, without prior notice
and without a vote; solicitations by consent are thus
prohibited;
|
|
·
|
special
meetings of stockholders may be called only by our Board of Directors;
and
|
|
·
|
our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares, of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into a large
number of shares of common stock could prevent a potential acquiror from
gaining effective economic or voting
control.
|
Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
35
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these
provisions may frustrate or prevent any attempts by our stockholders to replace
or remove our current management by making it more difficult for stockholders to
replace members of our Board of Directors, which is responsible for appointing
the members of our management.
ITEM
1B.
|
UNRESOLVED STAFF
COMMENTS
|
Not applicable.
ITEM
2.
|
PROPERTIES
|
Our
corporate, research and development, and clinical trial operations are located
in two Company-leased office and laboratory buildings with aggregate square
footage of approximately 47,770 feet. The facilities are adjacent to
one another and are located at 14272 and 14282 Franklin Avenue, Tustin,
California 92780-7017. We currently make combined monthly lease
payments of approximately $66,000 for these facilities with a 3.35% rental
increase every two years. The next rental increase is scheduled for
January 2011. 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 were involved with the following lawsuit that recently
settled:
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”), Alan Epstein (“Dr. Epstein”), Medibiotech Co., Inc. and Shanghai
Medipharm Biotech Co., Ltd. (collectively “Medipharm”). The lawsuit
alleged claims for breach of contract, interference with contractual relations,
declaratory relief, injunctive relief, and other claims against the
defendants. Our claims stemmed primarily from a 1995 License
Agreement with CTL, and amendments to that Agreement ("License
Agreement"). We claimed 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. We also alleged that Medipharm improperly induced CTL to
enter into a relationship that did not preserve Peregrine's rights.
On March 28, 2007, CTL filed a
cross-complaint, which it amended on May 30, 2007, alleging that we improperly
terminated the License Agreement, and that we interfered with CTL’s agreements
with various Medipharm entities and were double-licensing the technology that
CTL had licensed to Shanghai Medipharm.
36
On February 22, 2008, Medipharm filed a
cross-complaint alleging, as third party beneficiaries, that we breached the
Agreement by double-licensing the technology licensed to CTL to another party,
intentionally interfered with a prospective economic advantage, and unjust
enrichment.
On April
16, 2009, we signed a settlement agreement with Medipharm (“April Settlement
Agreement”) providing for a settlement and release of all claims with respect to
our previously disclosed litigation with Medipharm. Under the April
Settlement Agreement, we agreed to dismiss our respective claims against each
other with prejudice. In connection with the April Settlement
Agreement (1) Medipharm agreed not to sell radiolabelled TNT Products outside of
the Peoples Republic of China (“PRC”) and we agreed not to sell radiolabelled
TNT Products within the PRC; (2) Medipharm agreed that NHS76 (a fully human
equivalent antibody to Cotara) is not part of the License Agreement; (3)
Medipharm agreed to deliver to CTL 1.9 million shares of Medibiotech Co. Inc.
stock; and (4) we relinquished any and all claims we had with respect to
Shanghai Medipharm's use of Vivatuxin, murine clone (TNT-1), or any chimeric
clone derived from any TNT murine clone developed by Medipharm and product
derived thereof in the PRC (with the exception of claims we may choose to assert
related to rhTNT-IL2). Otherwise, the April Settlement Agreement
contained a general release between the Company and Medipharm of all claims
arising out of the License Agreement or the matters of the lawsuit between the
parties.
On June 4, 2009, we signed a settlement
agreement (the “June Settlement Agreement”) with CTL, Dr. Epstein, Clive Taylor,
M.D. and Peisheng Hu, M.D. (collectively, the “CTL Parties”), providing for a
settlement and release of all claims with respect to our previously disclosed
litigation with those CTL Parties. Under the June Settlement
Agreement, the parties dismissed all of their claims against each other in the
lawsuit. In connection with the June Settlement Agreement, (1) we
agreed to pay to CTL the sum of four hundred thousand dollars ($400,000) in
eight equal monthly installments of fifty thousand dollars ($50,000) commencing
upon execution of the June Settlement Agreement and continuing on the first
business day of each succeeding month until paid in full, which amount is
included in selling, general and administrative expenses in the accompanying
consolidated financial statements during fiscal year 2009, (2) CTL agreed to
issue to us 950,000 shares of Medibiotech (which represents fifty percent (50%)
of the shares of Medibiotech to be issued to and owned by CTL under the April
Settlement Agreement), and (3) we entered into a license agreement with Dr.
Epstein effective as of September 20, 1995, pursuant to which Dr. Epstein
granted us (i) a fully paid-up, royalty free, exclusive worldwide license to the
murine clone TNT1 and (ii) a fully paid-up, royalty free, non-exclusive
worldwide (except in the Peoples Republic of China) license to the murine clones
TNT2 and TNT3. The foregoing license grants include our right to
grant sublicenses, to make, have made, modify, have modified, use, sell and
offer for sale, murine clone TNT1, TNT2 and TNT3 products and derivatives
thereof, but not to sell the murine clones. We also granted back to
Dr. Epstein a limited, fully paid-up, royalty free, exclusive license to the
murine clone TNT1, with the right to grant sublicenses, to make, have made,
modify, have modified, offer to sell, sell and use the murine clone TNT1 and its
products solely in the Peoples Republic of China effective as of August 29,
2001. In consideration of the foregoing license grants, we paid Dr.
Epstein the sum of one thousand dollars ($1,000), which amount was deducted from
the initial $50,000 payment. In addition, the June Settlement
Agreement contained full general releases between the Company and the CTL
parties.
37
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, 2009.
PART II
ITEM
5.
|
MARKET FOR
REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY
SECURITIES
|
(a) Market
Information. We are listed on The NASDAQ Capital Market under
the stock trading symbol “PPHM”. The following table shows the high
and low sales price of our common stock for each quarter in the two years ended
April 30, 2009:
Common
Stock
Sales
Price
|
||||||||
High
|
Low
|
|||||||
Fiscal
Year 2009
|
||||||||
Quarter
Ended April 30, 2009
|
$ | 0.52 | $ | 0.30 | ||||
Quarter
Ended January 31, 2009
|
$ | 0.47 | $ | 0.22 | ||||
Quarter
Ended October 31, 2008
|
$ | 0.40 | $ | 0.23 | ||||
Quarter
Ended July 31, 2008
|
$ | 0.53 | $ | 0.31 | ||||
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 |
(b) Holders. As of
June 30, 2009, the number of stockholders of record of our common stock was
5,805.
(c) Dividends. No
dividends on common stock have been declared or paid by us. We intend
to employ all available funds for the development of our business and,
accordingly, do 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. None.
38
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, 2009. 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,
2009, 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,
|
||||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Revenues
|
$ | 18,151,000 | $ | 6,093,000 | $ | 3,708,000 | $ | 3,193,000 | $ | 4,959,000 | ||||||||||
Net
loss
|
$ | (16,524,000 | ) | $ | (23,176,000 | ) | $ | (20,796,000 | ) | $ | (17,061,000 | ) | $ | (15,452,000 | ) | |||||
Basic
and diluted loss per common share
|
$ | (0.07 | ) | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.10 | ) | $ | (0.11 | ) | |||||
Weighted
average common shares outstanding
|
226,231,464 | 221,148,342 | 192,297,309 | 168,294,782 | 144,812,001 |
CONSOLIDATED
BALANCE SHEET DATA
AS
OF APRIL 30,
|
||||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 10,018,000 | $ | 15,130,000 | $ | 16,044,000 | $ | 17,182,000 | $ | 9,816,000 | ||||||||||
Working
capital
|
$ | 1,270,000 | $ | 12,403,000 | $ | 14,043,000 | $ | 15,628,000 | $ | 7,975,000 | ||||||||||
Total
assets
|
$ | 23,127,000 | $ | 23,057,000 | $ | 22,997,000 | $ | 22,676,000 | $ | 14,245,000 | ||||||||||
Long-term
debt
|
$ | 3,212,000 | $ | 22,000 | $ | 149,000 | $ | 545,000 | $ | 434,000 | ||||||||||
Accumulated
deficit
|
$ | (247,360,000 | ) | $ | (230,836,000 | ) | $ | (207,660,000 | ) | $ | (186,864,000 | ) | $ | (169,803,000 | ) | |||||
Stockholders’
equity
|
$ | 901,000 | $ | 15,595,000 | $ | 16,989,000 | $ | 17,626,000 | $ | 9,610,000 |
39
ITEM
7.
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
|
The
following discussion is included to describe our financial position and results
of operations for each of the three years in the period ended April 30,
2009. 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 that manufactures and develops
monoclonal antibodies for the treatment of cancer and serious viral
infections. We are advancing three separate clinical programs with
our first-in-class compounds bavituximab and Cotara®.
We are
currently running four clinical trials using bavituximab for the treatment of
solid tumors. Three of these clinical trials are Phase II trials evaluating
bavituximab in combination with commonly prescribed chemotherapeutic drugs in
patients with advanced breast or lung cancer. Our fourth active
bavituximab oncology clinical trial is a phase I trial evaluating bavituximab
alone in patients with advanced solid tumors that no longer respond to standard
cancer treatments.
We are
currently running two clinical trials using Cotara® for the treatment of
glioblastoma multiforme, a deadly form of brain cancer, Cotara® is currently in
a dose confirmation and dosimetry clinical trial and in a Phase II clinical
trial.
In
addition to our clinical programs, we are performing pre-clinical research on
bavituximab and an equivalent fully human antibody as a potential broad-spectrum
treatment for viral hemorrhagic fever infections under a contract 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 an initial 24-month base period, with $14.3
million having been appropriated through the current federal fiscal year ending
September 30, 2009.
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.
Going
Concern
Our
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, 2009, we had $10,018,000 in cash and cash equivalents. We have
expended substantial funds on the research, development and clinical trials of
our product candidates, and 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, 2009, 2008 and 2007 amounted to
$16,524,000, $23,176,000, and $20,796,000, 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 for the foreseeable
future.
40
Therefore,
our ability to continue our clinical trials and development efforts and to
continue as a going concern 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.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
With respect to financing our
operations through the issuance of equity, on March 26, 2009, we entered
into an At Market Issuance Sales Agreement (“AMI Agreement”) with Wm Smith &
Co., pursuant to which we may sell shares of our common stock through Wm Smith
& Co., as agent, in registered transactions from our shelf registration
statement on Form S-3, File Number 333-139975, for aggregate gross proceeds of
up to $7,500,000. Shares of common stock sold under this arrangement
were to be sold at market prices. As of April 30, 2009, we had sold
1,477,938 shares of common stock under the AMI Agreement for aggregate net
proceeds of $550,000. Subsequent to April 30, 2009, we sold and
additional 9,275,859 shares of common stock under the AMI Agreement for
aggregate net proceeds of $6,685,000 after deducting commissions of 3% paid to
Wm Smith & Co. As of June 30, 2009, we had raised the aggregate
gross proceeds of $7,500,000 permitted under the AMI Agreement.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we had the
ability to borrow up to $10,000,000 (“Loan Agreement”). On December
19, 2008, we received initial funding of $5,000,000, in which principal and
interest are payable over a thirty (30) month period commencing after the
initial six month interest only period. The amount payable under the
Loan Agreement is secured by generally all assets of the Company as further
explained in Note 5 to the consolidated financial statements. Under
the Loan Agreement, we had an option, which expired June 30, 2009, to borrow a
second tranche in the amount of $5,000,000 upon the satisfaction of certain
clinical and financial conditions as set forth in the Loan
Agreement. Although we had satisfied the required clinical and
financial conditions by June 30, 2009, we determined that exercising the option
to borrow the second tranche, and issuing the additional warrants to the
Lenders, was not in the best interest of the Company or our
stockholders.
In
addition to the above, we may also raise additional capital through additional
equity offerings or licensing our products or technology platforms or entering
into similar collaborative arrangements. In order to raise capital
through the issuance of equity, we plan to file a new shelf registration
statement on Form S-3 to register up to $50 million in proceeds from the sale of
our common stock. Although we are not required to issue any shares of
common stock under this registration statement, we plan to register the
underlying shares of common stock as a potential method of raising additional
capital to support our drug development efforts.
While we
will continue to consider and 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 to
complete the research, development, and clinical testing of our product
candidates. Based on our current projections and assumptions, which
include projected revenues under signed contracts with 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
2010. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of third party
or government contracts, technical challenges, or possible reductions in funding
under our government contract, which could reduce or delay our future projected
cash-inflows. In addition, under the Loan Agreement, in the event our
government contract with the Defense Threat Reduction Agency is terminated or
canceled for any reason, including reasons pertaining to budget cuts by the
government or reduction in government funding for the program, we would be
required to set aside cash and cash equivalents in an amount equal to 80% of the
outstanding loan balance in a restricted collateral account non-accessible by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
fiscal year 2010 unless we raise additional capital. The
uncertainties surrounding our future cash inflows have raised substantial doubt
regarding our ability to continue as a going concern.
41
Results
of Operations
The following table compares the
consolidated statements of operations for the fiscal years ended April 30, 2009,
2008 and 2007. 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,
|
|||||||||||||||||||||||
2009
|
2008
|
$
Change
|
2008
|
2007
|
$
Change
|
|||||||||||||||||||
REVENUES:
|
||||||||||||||||||||||||
Contract
manufacturing
|
$ | 12,963,000 | $ | 5,897,000 | $ | 7,066,000 | $ | 5,897,000 | $ | 3,492,000 | $ | 2,405,000 | ||||||||||||
Government
contract revenue
|
5,013,000 | - | 5,013,000 | - | - | - | ||||||||||||||||||
License
revenue
|
175,000 | 196,000 | (21,000 | ) | 196,000 | 216,000 | (20,000 | ) | ||||||||||||||||
Total
revenues
|
18,151,000 | 6,093,000 | 12,058,000 | 6,093,000 | 3,708,000 | 2,385,000 | ||||||||||||||||||
COST
AND EXPENSES:
|
||||||||||||||||||||||||
Cost
of contract manufacturing
|
9,064,000 | 4,804,000 | 4,260,000 | 4,804,000 | 3,296,000 | 1,508,000 | ||||||||||||||||||
Research
and development
|
18,424,000 | 18,279,000 | 145,000 | 18,279,000 | 15,876,000 | 2,403,000 | ||||||||||||||||||
Selling,
general and administrative
|
6,979,000 | 7,150,000 | (171,000 | ) | 7,150,000 | 6,446,000 | 704,000 | |||||||||||||||||
Total
cost and expenses
|
34,467,000 | 30,233,000 | 4,234,000 | 30,233,000 | 25,618,000 | 4,615,000 | ||||||||||||||||||
LOSS
FROM OPERATIONS
|
(16,316,000 | ) | (24,140,000 | ) | 7,824,000 | (24,140,000 | ) | (21,910,000 | ) | (2,230,000 | ) | |||||||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||||||||||
Interest
and other income
|
200,000 | 989,000 | (789,000 | ) | 989,000 | 1,160,000 | (171,000 | ) | ||||||||||||||||
Interest
and other expense
|
(408,000 | ) | (25,000 | ) | (383,000 | ) | (25,000 | ) | (46,000 | ) | 21,000 | |||||||||||||
NET
LOSS
|
$ | (16,524,000 | ) | $ | (23,176,000 | ) | $ | 6,652,000 | $ | (23,176,000 | ) | $ | (20,796,000 | ) | $ | (2,380,000 | ) |
42
Contract
Manufacturing Revenue
Year
Ended April 30, 2009 Compared to the Year Ended April 30, 2008:
The
increase in contract manufacturing revenue of $7,066,000 during the year ended
April 30, 2009 compared to the prior year was primarily due to increases in both
manufacturing and process development services provided by Avid to unrelated
entities on a fee-for-service basis including an increase in the number of
completed manufacturing runs and the mix of completed manufacturing runs
utilizing our larger capacity bioreactors compared to the prior
year.
We expect
to continue to generate contract manufacturing revenue during fiscal year 2010
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, 2008 Compared to the Year Ended April 30, 2007:
The
increase in contract manufacturing revenue of $2,405,000 during the year ended
April 30, 2008 compared to fiscal year 2007 was primarily due to an increase in
services provided by Avid to unrelated entities on a fee-for-service basis
associated with an increase in process development services including an
increase in the number of completed manufacturing runs compared to the year
ended April 30, 2007.
Government
Contract Revenue
Year
Ended April 30, 2009 Compared to the Year Ended April 30, 2008:
The
increase in government contract revenue of $5,013,000 during the year ended
April 30, 2009 compared to the prior year is related to research and development
services performed under our government contract with the Defense Threat
Reduction Agency (“DTRA”), a division of the Department of
Defense. The contract was signed on June 30, 2008 and therefore,
there was no corresponding revenue in the prior year.
The
contract was awarded through the Transformational Medical Technologies
Initiative (“TMTI”) of the U.S. Department of Defense's Defense Threat Reduction
Agency (“DTRA”). The purpose of the contract is to test and develop
bavituximab and an equivalent fully human antibody as potential broad-spectrum
treatments for viral hemorrhagic fever infections. We expect to
continue to generate government contract revenue associated with our contract
with the DTRA. The contract has an initial 24-month base period with
up to $22.3 million in funding with $14.3 million having been appropriated
through the current federal fiscal year ending September 30,
2009. The contract also includes up to three one-year option periods
and aggregate funding under the contract is potentially worth up to $44.4
million over the entire five year period. Subject to the progress of
the program and budgetary considerations, the contact can be canceled by the
DTRA at any time.
Cost
of Contract Manufacturing
Year
Ended April 30, 2009 Compared to the Year Ended April 30, 2008:
The
increase in cost of contract manufacturing of $4,260,000 during the year ended
April 30, 2009 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 revenue
improved from 81% in fiscal year 2008 to 70% in fiscal year 2009, which was
primarily due to an increase in contract manufacturing revenue combined with
improved efficiencies in costs associated with contract manufacturing services
and the mix of completed manufacturing runs from the utilization of our larger
capacity bioreactors. We expect to continue to incur contract
manufacturing costs during fiscal year 2010 based on the anticipated completion
of customer projects under our current contract manufacturing
agreements.
43
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 fiscal year 2007 was directly related to the fiscal
year 2008 increase in contract manufacturing revenue. In addition,
the cost of contract manufacturing as a percentage of contract manufacturing
revenue improved from 94% in fiscal year 2007 to 81% in fiscal year 2008, which
was primarily due to an increase in contract manufacturing revenue combined with
improved efficiencies in costs associated with manufacturing runs.
Research
and Development Expenses
Year
Ended April 30, 2009 Compared to the Year Ended April 30, 2008:
The
increase in research and development (“R&D”) expenses of $145,000 during the
year ended April 30, 2009 compared to the prior year was primarily due to the
following changes associated with each of our following platform technologies
under development:
R&D
Expenses –
Fiscal
Year Ended April 30,
|
||||||||||||
2009
|
2008
|
$
Change
|
||||||||||
Technology
Platform:
|
||||||||||||
Anti-PS
(bavituximab)
|
$ | 13,779,000 | $ | 11,371,000 | $ | 2,408,000 | ||||||
TNT
(Cotara®)
|
4,351,000 | 3,942,000 | 409,000 | |||||||||
VTA
and Anti-Angiogenesis Agents
|
262,000 | 2,350,000 | (2,088,000 | ) | ||||||||
VEA
|
32,000 | 616,000 | (584,000 | ) | ||||||||
Total
R&D Expenses
|
$ | 18,424,000 | $ | 18,279,000 | $ | 145,000 |
|
o
|
Anti-Phosphatidylserine
(“Anti-PS”)Program (bavituximab) – The increase in Anti-PS program
expenses of $2,408,000 during the year ended April 30, 2009 compared to
the prior year is primarily due to an increase in clinical trial 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. Patient enrollment for all
three of our Phase II studies using bavituximab in combination with
chemotherapy advanced to the second stage of our two-stage Phase II study
designs during fiscal year 2009. The increase in Anti-PS
program expenses was further supplemented with an increase in R&D
expenses directly associated with increased efforts to advance the
development of bavituximab and a fully human antibody as potential
broad-spectrum treatments for viral hemorrhagic fever infections under our
federal contract with the U.S. Department of Defense’s Defense Threat
Reduction Agency ("DTRA"), which was awarded to us on June 30,
2008.
|
|
o
|
Tumor Necrosis Therapy (“TNT”)
(Cotara®) – The increase in TNT program expenses of $409,000 during
the year ended April 30, 2009 compared to the prior year is primarily due
to increases in clinical trial and payroll expenses to support the
continued advancement of our two ongoing Cotara® clinical trials for the
treatment of brain cancer.
|
|
o
|
Vascular Targeting Agents
(“VTAs”) and Anti-Angiogenesis Agents – The decrease in VTA and
Anti-Angiogenesis Agents program expenses of $2,088,000 during the year
ended April 30, 2009 compared to the prior year is primarily due to our
efforts to significantly curtail our development expenses associated with
this program while focusing our efforts on seeking partners to further
advance these technologies.
|
44
|
o
|
Vasopermeation Enhancements
Agents (“VEAs”) – The decrease in
VEA program expenses of $584,000 during the year ended April 30, 2009
compared to the prior year is primarily due to our efforts to
significantly curtail our development expenses associated with this
program while focusing our efforts on seeking partners to further advance
this technology. During fiscal year 2009, our rights to the VEA
technology expired in accordance with our license
agreement.
|
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 2010 to increase in comparison to fiscal year 2009 as we expect to
continue the advancement of our bavituximab and Cotara® clinical programs and
the development of bavituximab as a potential broad-spectrum treatment for viral
hemorrhagic fever infections under our federal contract with the
DTRA. During fiscal year 2010, we expect to direct the majority of
our research and development expenses towards our Anti-PS and TNT technology
platforms.
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
(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”)Program (bavituximab) – The increase in Anti-PS program
expenses of $2,047,000 during the year ended April 30, 2008 compared to
fiscal year 2007 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,
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 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 program
expenses were offset by a decrease in non-cash stock-based compensation
expense associated with shares of common stock earned by employees during
fiscal year 2007 under a stock bonus plan, which expired in fiscal year
2007.
|
45
|
o
|
Tumor Necrosis Therapy (“TNT”)
(Cotara®) – TNT program expenses remained in line with fiscal year
2007 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.
|
|
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 fiscal year 2007 is primarily due to
increases in manufacturing expenses as we developed a manufacturing
process at a 1,000 liter scale for our anti-angiogenesis
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 fiscal year 2007, we have significantly
curtailed these research efforts and are currently seeking partners to
further advance these technologies.
|
|
o
|
Vasopermeation Enhancements
Agents (“VEAs”) – VEA program
expenses remained in line with fiscal year 2007 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.
|
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 terms related to potential future partnering or licensing
arrangements;
|
|
●
|
the
uncertainty of protocol changes and modifications in the design of our
clinical trial studies, which may increase or decrease our future costs;
and
|
|
●
|
the
uncertainty of our ability to raise additional capital to support our
future research and development efforts beyond fiscal year
2010.
|
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.
46
Selling,
General and Administrative Expenses
Year
Ended April 30, 2009 Compared to the Year Ended April 30, 2008:
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
slight decline in selling, general and administrative expenses of $171,000
during the year ended April 30, 2009 compared to the prior year is primarily due
to our efforts to curtail discretionary expenses. The
decrease in discretionary expenses were offset by an increase in legal fees
associated with the lawsuit described in this Annual Report on Form 10-K under
Part I, Item 3, “Legal Proceedings”, offset by an overall decrease in other
general corporate matters.
Year
Ended April 30, 2008 Compared to the Year Ended April 30, 2007:
The
increase in selling, general and administrative expenses of $704,000 during the
year ended April 30, 2008 compared to fiscal year 2007 is primarily due to
increases in payroll and related expenses, corporate legal fees, and travel and
related expenses. The increase in payroll and related expenses
was 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. The
increase in corporate legal fees compared to fiscal year 2007 was primarily
related to a recently settled lawsuit described in this Annual Report on Form
10-K under Part I, Item 3, “Legal Proceedings”. In addition, travel
and related expenses increased compared to fiscal year 2007 primarily due to
increased business development efforts in the U.S., Europe and Asia and
increased participation in corporate and investor relation
activities. These increased costs were offset with a decrease in
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 and non-cash expenses associated with shares of common stock
earned by employees during fiscal year 2007 under a stock bonus plan, which
expired in fiscal year 2007.
Interest
and Other Income
Year
Ended April 30, 2009 Compared to the Year Ended April 30, 2008
The
decrease in interest and other income of $789,000 during the year ended April
30, 2009 compared to the prior year is primarily due to an $800,000 decrease in
interest income as a result of a lower average cash balance on hand combined
with lower prevailing interest rates during the current year compared to the
prior year.
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 fiscal year 2007 is due to a $129,000 decrease in other
income primarily associated with the sale of a trademark name in fiscal year
2007 combined with a $42,000 decrease in interest income primarily resulting
from lower prevailing interest rates.
47
Interest
and Other Expense
Year
Ended April 30, 2009 Compared to the Year Ended April 30, 2008
The
increase in interest and other expense of $383,000 during the year ended April
30, 2009 compared to the prior year is due to a $199,000 increase in interest
expense associated with the loan and security agreement we entered into during
December 2008 combined with a $184,000 increase in non-cash interest expense
resulting from the amortization of the loan and security agreement discount
associated with the fair value of detachable warrants and related debt issuance
costs.
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:
Revenue
Recognition
We
currently derive revenue from contract manufacturing services provided by Avid,
from licensing agreements associated with Peregrine’s technologies under
development, and from services performed under a government contract awarded to
Peregrine through the Transformational Medical Technologies Initiative (“TMTI”)
of the U.S. Department of Defense’s Defense Threat Reduction Agency (“DTRA”)
that was signed on June 30, 2008.
We
recognize revenue 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 (or passage of title) 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.
We also
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.
In
addition, we also follow the guidance of the Emerging Issues Task Force Issue
No. 99-19 (“EITF 99-19”), Reporting Revenue Gross as a
Principal versus Net as an Agent. Pursuant to EITF 99-19, for
transactions in which we act as a principal, have discretion to choose
suppliers, bear credit risk and performs a substantive part of the services,
revenue is recorded at the gross amount billed to a customer and costs
associated with these reimbursements are reflected as a component of cost of
sales for contract manufacturing services or research and development expense
for services provided under our contract with the DTRA.
48
Revenue associated with contract
manufacturing services provided by Avid are recognized once the service has been
rendered and/or upon shipment (or passage of title) of the product to the
customer. On occasion, we recognize revenue on a “bill-and-hold”
basis. Under “bill-and-hold” arrangements, revenue is recognized in
accordance with the “bill-and-hold” requirements under SAB No. 104 once the
product is complete and ready for shipment, title and risk of loss has passed to
the customer, management receives a written request from the customer for
“bill-and-hold” treatment, the product is segregated from other inventory, and
no further performance obligations exist. Any amounts received prior
to satisfying our revenue recognition criteria are recorded as deferred revenue
in the accompanying consolidated financial statements. We also record
a provision for estimated contract losses, if any, in the period in which they
are determined.
License revenue primarily consists of
annual license fees paid under one license agreement. Annual license
fees are recognized as revenue on the anniversary date of the agreement in
accordance with the criteria under SAB No. 104. We deem service to
have been rendered if no continuing obligation exists.
Our
contract with the DTRA is a “cost-plus-fixed-fee” contract whereby we recognize
government contract revenue in accordance with the revenue recognition criteria
noted above and in accordance with Accounting Research Bulletin No. 43, Chapter
11, Government
Contracts. Reimbursable costs under the contract primarily
include direct labor, subcontract costs, materials, equipment, travel, indirect
costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is generally recognized as we perform the
underlying research and development activities. However, progress
billings and/or payments associated with services that are billed and/or
received in a manner that is not consistent with the timing of when services are
performed are classified as deferred government contract revenue in the
accompanying consolidated financial statements and are recognized as revenue
upon satisfying our revenue recognition criteria.
Share-based Compensation
Expense
We
currently maintain four equity compensation plans which provide for the granting
of options to our employees 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.
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 2 to 4 years). Use of a valuation model requires us
to make certain estimates and assumptions with respect to selected model
inputs. Expected volatility is based on daily historical volatility
of our stock covering the estimated expected term. The expected term
of options reflects actual historical exercise activity and assumptions
regarding future exercise activity of unexercised, outstanding
options. 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.
If factors change and we employ
different assumptions in the application of SFAS No. 123R in future
periods, the share-based compensation expense that we record under
SFAS No. 123R may differ significantly from what we have recorded in
the current period. There are a number of factors that affect the amount of
share-based compensation expense, including the number of employee options
granted during subsequent fiscal years, the price of our common stock on the
date of grant, the volatility of our stock price, the estimate of the expected
life of options granted and the risk-free interest rates.
49
Our loss from operations for fiscal
years ended April 30, 2009, 2008 and 2007 included share-based compensation
expenses of $857,000, $829,000 and $964,000, respectively, associated with
grants of employee stock options.
As of April 30, 2009, the total
estimated unrecognized compensation cost related to non-vested employee stock
options was $1,128,000. This cost is expected to be recognized over a
weighted average period of 2.16 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. With respect to our trade and other receivables, we determined
no allowance for doubtful accounts was necessary based on our analysis as of
April 30, 2009.
Amounts
billed under our contract with Transformational Medical Technologies Initiative
(“TMTI”) of the U.S. Department of Defense’s Defense Threat Reduction Agency
(“DTRA”) include reimbursement for provisional rates covering allowable indirect
overhead and general and administrative cost (“Indirect
Rates”). These Indirect Rates are initially estimated based on
financial projections and are subject to change based on actual costs incurred
during each fiscal year. In addition, these Indirect Rates are
subject to annual audits by the Defense Contract Audit Agency ("DCAA") for cost
reimbursable type contracts. As of April 30, 2009, we recorded an
unbilled receivable of $51,000 pertaining to the calculated difference between
estimated and actual Indirect Rates for fiscal year 2009. As of April
30, 2009, we determined it appropriate to record a corresponding allowance for
doubtful account in the amount of $51,000 due to the uncertainty of its
collectability given that our actual Indirect Rates have not been audited by the
DCAA since we signed the contract on June 30, 2008.
Fair Value Measurements
On May 1, 2008, we adopted 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 establishes a three-level hierarchy that prioritizes the inputs used to
measure fair value. The hierarchy defines the three levels of inputs
to measure fair value, as follows:
|
●
|
Level
1 – Quoted prices in active markets for identical assets or
liabilities.
|
|
●
|
Level
2 – Observable inputs other than quoted prices included in Level 1, such
as assets or liabilities whose value are based on quoted market prices in
markets where trading occurs infrequently or whose values are based on
quoted prices of instruments with similar attributes in active
markets.
|
|
●
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and significant to the overall fair value
measurement.
|
The adoption of SFAS No. 157 did
not have a material impact on our consolidated financial statements as we
currently do not have any Level 2 or Level 3 financial assets or
liabilities.
The
carrying amounts of our short-term financial instruments, which include cash and
cash equivalents, accounts receivable, accounts payable, and accrued liabilities
approximate their fair values due to their short maturities. The fair
value of our note payable is estimated based on the quoted prices for the same
or similar issues or on the current rates offered to us for debt of the same
remaining maturities.
50
Liquidity
and Capital Resources
At April
30, 2009, we had $10,018,000 in cash and cash equivalents. We have
expended substantial funds on the research, development and clinical trials of
our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2009, 2008 and 2007 amounted
to $16,524,000, $23,176,000, and $20,796,000, 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 for the foreseeable
future.
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 to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
With
respect to financing our operations through the issuance of equity, on
March 26, 2009, we entered into an At Market Issuance Sales Agreement (“AMI
Agreement”) with Wm Smith & Co., pursuant to which we may sell shares of our
common stock through Wm Smith & Co., as agent, in registered transactions
from our shelf registration statement on Form S-3, File Number 333-139975, for
aggregate gross proceeds of up to $7,500,000. Shares of common stock
sold under this arrangement were to be sold at market prices. As of
April 30, 2009, we had sold 1,477,938 shares of common stock under the AMI
Agreement for aggregate net proceeds of $550,000. Subsequent to April
30, 2009, we sold and additional 9,275,859 shares of common stock under the AMI
Agreement for aggregate net proceeds of $6,685,000 after deducting commissions
of 3% paid to Wm Smith & Co. As of June 30, 2009, we had raised
the aggregate gross proceeds of $7,500,000 as permitted under the AMI
Agreement.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we had the
ability to borrow up to $10,000,000 (“Loan Agreement”). On December
19, 2008, we received initial funding of $5,000,000, in which principal and
interest are payable over a thirty (30) month period commencing after the
initial six month interest only period. The amount payable under the
Loan Agreement is secured by generally all assets of the Company as further
explained in Note 5 to the consolidated financial statements. Under
the Loan Agreement, we had an option, which expired June 30, 2009, to borrow a
second tranche in the amount of $5,000,000 upon the satisfaction of certain
clinical and financial conditions as set forth in the Loan
Agreement. Although we had satisfied the required clinical and
financial conditions by June 30, 2009, we determined that exercising the option
to borrow the second tranche, and issuing the additional warrants to the
Lenders, was not in the best interest of the Company or our
stockholders.
In
addition to the above, we may also raise additional capital through additional
equity offerings or licensing our products or technology platforms or entering
into similar collaborative arrangements. In order to raise additional
capital through the issuance of equity, we plan to file a new shelf registration
statement on Form S-3 to register up to $50 million in proceeds from the sale of
our common stock. Although we are not required to issue any shares of
common stock under this registration statement, we plan to register the
underlying shares of common stock as a potential method of raising additional
capital to support our drug development efforts.
51
While we
will continue to consider and 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 to
complete the research, development, and clinical testing of our product
candidates. Based on our current projections and assumptions, which
include projected revenues under signed contracts with 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
2010. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of third party
or government contracts, technical challenges, or possible reductions in funding
under our government contract, which could reduce or delay our future projected
cash-inflows. In addition, under the Loan Agreement, in the event our
government contract with the Defense Threat Reduction Agency is terminated or
canceled for any reason, including reasons pertaining to budget cuts by the
government or reduction in government funding for the program, we would be
required to set aside cash and cash equivalents in an amount equal to 80% of the
outstanding loan balance in a restricted collateral account non-accessible by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
fiscal year 2010 unless we raise additional capital. 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, 2009 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, 2009, cash used in operating activities decreased $10,897,000 to
$10,030,000 compared to $20,927,000 for the year ended April 30,
2008. This decrease in cash used in operating activities was
primarily due to a decrease of $7,125,000 in net loss reported during fiscal
year 2009 after taking into consideration non-cash operating
expenses. This amount was supplemented by a net change in operating
assets and payment or reduction of liabilities in the aggregate amount of
$3,772,000. The decrease in our fiscal year 2009 net loss was
primarily due to current period increases in contract manufacturing revenue and
government contract revenue offset by an increase in the cost of contract
manufacturing.
52
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,
|
||||||||
2009
|
2008
|
|||||||
Net
loss, as reported
|
$ | (16,524,000 | ) | $ | (23,176,000 | ) | ||
Less
non-cash operating expenses:
|
||||||||
Depreciation and
amortization
|
503,000 | 486,000 | ||||||
Stock-based compensation and
common stock
issued under stock bonus plan
|
866,000 | 850,000 | ||||||
Amortization of expenses paid in
shares of common
stock
|
255,000 | - | ||||||
Amortization of discount on
notes payable and debt issuance costs
|
185,000 | - | ||||||
Net
cash used in operating activities before changes in operating assets and
liabilities
|
$ | (14,715,000 | ) | $ | (21,840,000 | ) | ||
Net
change in operating assets and liabilities
|
$ | 4,685,000 | $ | 913,000 | ||||
Net
cash used in operating activities
|
$ | (10,030,000 | ) | $ | (20,927,000 | ) |
Cash Used In Investing
Activities. Net cash used in investing activities decreased
$440,000 to $140,000 for the year ended April 30, 2009 compared to net cash used
in investing activities of $580,000 during the year ended April 20,
2008. This decrease was primarily due to a decrease in cash outflows
associated with property acquisitions of $565,000 offset by the receipt of
$150,000 in security deposits, net of amounts payable to GE Capital Corporation
during fiscal year 2008.
Cash Provided By Financing
Activities. Net
cash provided by financing activities decreased $15,535,000 to $5,058,000 for
the year ended April 30, 2009 compared to net cash provided of $20,593,000 for
the year ended April 30, 2008. Cash provided by financing activities
during fiscal year 2009 was primarily due to net proceeds of $4,531,000 received
from notes payable under a loan and security agreement we entered into on
December 9, 2008, net of debt issuance costs in the amount of
$469,000. In addition, during fiscal year 2009, we received proceeds
under an At Market Issuance Sales Agreement we entered into on March 26, 2009
whereby we sold 1,477,938 shares of our common stock for proceeds of $550,000,
net of commissions and issuance costs of $58,000. 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.
53
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, 2009, aggregated by
type:
Payments
Due by Period
|
||||||||||||||||||||
Total
|
<
1 year
|
1-3
years
|
4-5
years
|
After
5 years
|
||||||||||||||||
Operating
leases, net (1)
|
$ | 7,451,000 | $ | 849,000 | $ | 2,520,000 | $ | 1,710,000 | $ | 2,372,000 | ||||||||||
Note
payable obligation (2)
|
5,888,000 | 2,199,000 | 3,689,000 | - | - | |||||||||||||||
Capital
lease obligation (3)
|
22,000 | 18,000 | 4,000 | - | - | |||||||||||||||
Other
long-term liabilities - minimum license obligations (4)
|
- | - | - | - | - | |||||||||||||||
Total
contractual obligations
|
$ | 13,361,000 | $ | 3,066,000 | $ | 6,213,000 | $ | 1,710,000 | $ | 2,372,000 |
______________
|
(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 and expires in February 2011, and
(iii) various office equipment leases, which generally have three year
lease terms.
|
|
(2)
|
Amounts
represent anticipated principal and interest payments on our security and
loan agreement. Under the security and loan agreement, the
outstanding principal balance each month will bear interest at a monthly
variable rate equal to the then current thirty (30) day LIBOR rate (set at
a floor of 3%) plus 9%. Anticipated interest payments were
calculated using an interest rate of 12% (representing a LIBOR floor rate
of 3% plus 9%). As of April 30, 2009. the thirty (30) day LIBOR
rate was less than the minimum 3%
floor.
|
|
(3)
|
Represents
capital lease agreements to finance certain equipment. Amounts
include principal and interest.
|
|
(4)
|
Represents
licensing agreements we periodically enter into with third parties to
obtain exclusive or non-exclusive licenses for certain
technologies. The terms of certain of these agreements require
us to pay future milestone payments based on product development
success. We 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 2010 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
See Note
2, Summary of Significant
Accounting Policies – Recently Adopted Accounting Standards and New Accounting Standards Not Yet
Adopted, in the accompanying Notes to Consolidated Financial Statements
for a discussion of recent accounting pronouncements and their effect, if any,
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 and interest expense on our outstanding notes payable, however,
they would not have an affect on our capital leases, which have fixed interest
rates and terms.
Based on
our overall cash and cash equivalents interest rate exposure at April 30, 2009,
a near-term change in interest rates, based on historical movements, would not
have a material adverse effect on our financial position or results of
operations.
At April
30, 2009, we had an outstanding notes payable balance of $5,000,000 under a loan
and security agreement, which bear interest at a monthly variable rate equal to
the then current thirty (30) day LIBOR rate (set at a floor of 3%) plus 9%,
which may expose us to market risk due to changes in interest
rates. However, based on current LIBOR interest rates, which are
currently under the minimum floor set at 3% under our loan and security
agreement and based on historical movements in LIBOR rates, we believe a
near-term change in interest rates would not have a material adverse effect on
our financial position or results of operations.
54
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, 2009. 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, 2009
to ensure the timely disclosure of required information in our Securities and
Exchange Commission filings.
Because
of inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. In addition, the design of any
system of control is based upon certain assumptions about the likelihood of
future events, and there can be no assurance that any design will succeed in
achieving its stated goals under all future events, no matter how
remote. Accordingly, even effective internal control over financial
reporting can only provide reasonable assurance of achieving their control
objectives.
(b) Management’s Report
on Internal Control Over Financial Reporting. Management’s
Report on Internal Control Over Financial Reporting 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, 2009 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
ITEM
9B.
|
OTHER INFORMATION
|
None.
55
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, 2009.
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 10,
2009
56
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board
of Directors and Stockholders of Peregrine Pharmaceuticals, Inc.
We have
audited Peregrine Pharmaceuticals, Inc.’s (the “Company”) internal control over
financial reporting as of April 30, 2009, 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, and for its assessment of the effectiveness of internal
control over financial reporting included in the accompanying Peregrine
Pharmaceuticals, Inc.’s Management’s Report on Internal Control Over Financial
Reporting. Our responsibility is to express an opinion on 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, assessing the risk that a material weakness exists, testing
and evaluating the design and operating effectiveness of internal control based
on the assessed risk, 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, 2009, 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, 2009 and 2008, and the related
consolidated statements of operations, stockholders' equity and cash flows for
each of the three years in the period ended April 30, 2009 and our report dated
July 10, 2009 expressed an unqualified opinion including an explanatory
paragraph with respect to the Company's ability to continue as a going concern
thereon.
/s/
Ernst & Young LLP
Orange
County, California
July 10,
2009
57
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 2009 Definitive Proxy Statement to be
filed within 120 days after the end of our fiscal year ended April 30, 2009 (the
“2009 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 2009 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 2009 Definitive Proxy Statement to be filed within
120 days after the end of our fiscal year ended April 30,
2009.
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 2009 Definitive
Proxy Statement to be filed within 120 days after the end of our fiscal
year ended April 30, 2009.
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 2009 Definitive Proxy
Statement to be filed within 120 days after the end of our fiscal year
ended April 30, 2009.
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 2009 Definitive
Proxy Statement to be filed within 120 days after the end of our fiscal
year ended April 30, 2009.
58
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, 2009 and 2008
|
F-2
|
|||
Consolidated
Statements of Operations for each of the three years in the period ended
April 30, 2009
|
F-4
|
|||
Consolidated
Statements of Stockholders' Equity for each of the three years in the
period ended April 30, 2009
|
F-5
|
|||
Consolidated
Statements of Cash Flows for each of the three years in the period ended
April 30, 2009
|
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, 2009
|
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.
59
(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).
|
60
Exhibit
Number
|
Description
|
||
4.0
|
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).
|
4.1
|
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)).*
|
||
4.2
|
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)).*
|
||
4.3
|
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)).*
|
||
4.4
|
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).
|
4.5
|
1996
Stock Incentive Plan (Incorporated by reference to the exhibit contained
in Registrant's Registration Statement in form S-8 (File No.
333-17513)).*
|
||
4.6
|
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).
|
||
4.7
|
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).
|
||
4.8
|
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).*
|
||
4.9
|
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)).*
|
||
4.10
|
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).*
|
||
4.11
|
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).*
|
||
4.12
|
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).*
|
61
Exhibit
Number
|
Description
|
||
10.1
|
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).
|
||
10.2
|
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).
|
||
10.3
|
Government contract by and
between Peregrine Pharmaceuticals, Inc. and the Defense Threat Reduction
Agency dated June 30, 2008 (Incorporated by reference to Exhibit
10.110 to Registrant’s Current Report on Form 10-Q as filed with the
Commission on September 9, 2008).
|
||
10.4
|
Loan
and Security Agreement dated December 9, 2008 between Registrant and
BlueCrest Capital Finance, L.P. (Incorporated by reference to
Exhibit 10.111 to Registrant’s Current Report on Form 10-Q as filed with
the Commission on March 12, 2009).**
|
||
10.5
|
Secured
Term Promissory Note dated December 19, 2008 between Registrant and
BlueCrest Capital Finance, L.P. (Incorporated by reference to
Exhibit 10.112 to Registrant’s Current Report on Form 10-Q as filed with
the Commission on March 12, 2009).
|
||
10.6
|
Secured
Term Promissory Note dated December 19, 2008 between Registrant and MidCap
Funding I, LLC. (Incorporated by reference to
Exhibit 10.113 to Registrant’s Current Report on Form 10-Q as filed with
the Commission on March 12, 2009)
|
||
10.7
|
Intellectual
Property Security Agreement dated December 19, 2008 between Avid
Bioservices, Inc. and MidCap Funding I, LLC. (Incorporated by reference to
Exhibit 10.114 to Registrant’s Current Report on Form 10-Q as filed with
the Commission on March 12, 2009).
|
||
10.8
|
Intellectual
Property Security Agreement dated December 19, 2008 between Registrant and
MidCap Funding I, LLC. (Incorporated by reference to
Exhibit 10.115 to Registrant’s Current Report on Form 10-Q as filed with
the Commission on March 12, 2009).
|
||
10.9
|
Warrant to
purchase 507,614 shares of Common Stock of Registrant issued to BlueCrest
Capital Finance, L.P. dated December 9, 2008. (Incorporated by reference to
Exhibit 10.116 to Registrant’s Current Report on Form 10-Q as filed with
the Commission on March 12, 2009).
|
||
10.10
|
Warrant
to purchase 1,184,433 shares of Common Stock of Registrant issued to
MidCap Funding I, LLC dated December 9, 2008. (Incorporated by reference to
Exhibit 10.117 to Registrant’s Current Report on Form 10-Q as filed with
the Commission on March 12, 2009).
|
||
10.11
|
At
Market Issuance Sales Agreement, dated March 26, 2009, by and between
Peregrine Pharmaceuticals, Inc. and Wm. Smith & Co. (Incorporated by reference to
Exhibit 10.118 to Registrant’s Current Report on Form 8-K as filed with
the Commission on March 27, 2009).
|
||
10.12
|
Employment
Agreement by and between Peregrine Pharmaceuticals, Inc.
and Steven W. King,
dated March 18, 2009.
(*)(***)
|
62
Exhibit
Number
|
Description
|
||
10.13
|
Employment
Agreement by and between Peregrine Pharmaceuticals, Inc.
and Paul J. Lytle,
dated March 18, 2009. (*)(***)
|
||
10.14
|
Employment
Agreement by and between Peregrine Pharmaceuticals, Inc.
and Joseph Shan,
dated March 18, 2009. (*)(***)
|
||
10.15
|
Employment
Agreement by and between Peregrine Pharmaceuticals, Inc.
and Shelley P.M.
Fussey, Ph.D., dated March 18, 2009. (*)(***)
|
||
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.
|
63
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this Report to be signed on its behalf by
the undersigned, thereunto duly authorized.
PEREGRINE
PHARMACEUTICALS, INC.
|
|||
Dated:
July 10, 2009
|
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
10, 2009
|
||
/s/ Paul J. Lytle
Paul J. Lytle |
Chief
Financial Officer (Principal Financial and Principal Accounting
Officer)
|
July
10, 2009
|
||
/s/ Carlton M. Johnson
Carlton M. Johnson |
Director
|
July
10, 2009
|
||
/s/ David H. Pohl
David H. Pohl |
Director
|
July
10, 2009
|
||
/s/ Eric S. Swartz
Eric S. Swartz |
Director
|
July
10, 2009
|
64
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, 2009 and 2008, and the
related consolidated statements of operations, stockholders’ equity, and cash
flows for each of the three years in the period ended April 30,
2009. 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, 2009 and 2008, and the consolidated
results of its operations and its cash flows for each of the three years in the
period ended April 30, 2009, 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.
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.
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, 2009, 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, 2009 expressed an unqualified opinion thereon.
/s/ Ernst & Young LLP
Orange
County, California
July 10,
2009
F-1
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2009 AND 2008
2009
|
2008
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 10,018,000 | $ | 15,130,000 | ||||
Trade
and other receivables
|
1,770,000 | 605,000 | ||||||
Government
contract receivables
|
1,944,000 | - | ||||||
Inventories,
net
|
4,707,000 | 2,900,000 | ||||||
Debt
issuance costs, current portion
|
229,000 | - | ||||||
Prepaid
expenses and other current assets, net
|
1,466,000 | 1,208,000 | ||||||
Total
current assets
|
20,134,000 | 19,843,000 | ||||||
PROPERTY:
|
||||||||
Leasehold
improvements
|
675,000 | 669,000 | ||||||
Laboratory
equipment
|
4,180,000 | 4,140,000 | ||||||
Furniture,
fixtures and computer equipment
|
902,000 | 919,000 | ||||||
5,757,000 | 5,728,000 | |||||||
Less
accumulated depreciation and amortization
|
(4,076,000 | ) | (3,670,000 | ) | ||||
Property,
net
|
1,681,000 | 2,058,000 | ||||||
Debt
issuance costs, less current portion
|
142,000 | - | ||||||
Other
assets
|
1,170,000 | 1,156,000 | ||||||
TOTAL
ASSETS
|
$ | 23,127,000 | $ | 23,057,000 |
F-2
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2009 AND 2008 (continued)
2009
|
2008
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 3,518,000 | $ | 2,060,000 | ||||
Accrued
clinical trial site fees
|
955,000 | 237,000 | ||||||
Accrued
legal and accounting fees
|
667,000 | 450,000 | ||||||
Accrued
royalties and license fees
|
182,000 | 222,000 | ||||||
Accrued
payroll and related costs
|
1,580,000 | 1,084,000 | ||||||
Capital
lease obligation, current portion
|
17,000 | 22,000 | ||||||
Notes
payable, current portion and net of discount
|
1,465,000 | - | ||||||
Deferred
revenue
|
3,776,000 | 2,196,000 | ||||||
Deferred
government contract revenue
|
3,871,000 | - | ||||||
Customer
deposits
|
2,287,000 | 838,000 | ||||||
Other
current liabilities
|
546,000 | 331,000 | ||||||
Total
current liabilities
|
18,864,000 | 7,440,000 | ||||||
Capital
lease obligation, less current portion
|
4,000 | 22,000 | ||||||
Notes
payable, less current portion and net of discount
|
3,208,000 | - | ||||||
Other
long-term liabilities
|
150,000 | - | ||||||
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 -
227,688,555 and 226,210,617, respectively
|
227,000 | 226,000 | ||||||
Additional
paid-in-capital
|
248,034,000 | 246,205,000 | ||||||
Accumulated
deficit
|
(247,360,000 | ) | (230,836,000 | ) | ||||
Total
stockholders' equity
|
901,000 | 15,595,000 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 23,127,000 | $ | 23,057,000 |
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, 2009
2009
|
2008
|
2007
|
||||||||||
REVENUES:
|
||||||||||||
Contract
manufacturing revenue
|
$ | 12,963,000 | $ | 5,897,000 | $ | 3,492,000 | ||||||
Government
contract revenue
|
5,013,000 | - | - | |||||||||
License
revenue
|
175,000 | 196,000 | 216,000 | |||||||||
Total
revenues
|
18,151,000 | 6,093,000 | 3,708,000 | |||||||||
COSTS
AND EXPENSES:
|
||||||||||||
Cost
of contract manufacturing
|
9,064,000 | 4,804,000 | 3,296,000 | |||||||||
Research
and development
|
18,424,000 | 18,279,000 | 15,876,000 | |||||||||
Selling,
general and administrative
|
6,979,000 | 7,150,000 | 6,446,000 | |||||||||
Total
costs and expenses
|
34,467,000 | 30,233,000 | 25,618,000 | |||||||||
LOSS
FROM OPERATIONS
|
(16,316,000 | ) | (24,140,000 | ) | (21,910,000 | ) | ||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||
Interest
and other income
|
200,000 | 989,000 | 1,160,000 | |||||||||
Interest
and other expense
|
(408,000 | ) | (25,000 | ) | (46,000 | ) | ||||||
NET
LOSS
|
$ | (16,524,000 | ) | $ | (23,176,000 | ) | $ | (20,796,000 | ) | |||
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
226,231,464 | 221,148,342 | 192,297,309 | |||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.07 | ) | $ | (0.10 | ) | $ | (0.11 | ) |
See
accompanying notes to consolidated financial statements.
F-4
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2009
Additional
|
Deferred
|
Total
|
||||||||||||||||||||||
Common
Stock
|
Paid-In
|
Stock
|
Accumulated
|
Stockholders’
|
||||||||||||||||||||
Shares
|
Amount
|
Captital
|
Compensation
|
Deficit
|
Equity
|
|||||||||||||||||||
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
|
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 | |||||||||||||||||
Common
stock issued for cash under March 26, 2009 Financing, net of issuance
costs of $58,000
|
1,477,938 | 1,000 | 549,000 | - | - | 550,000 | ||||||||||||||||||
Fair
market value of warrants issued with notes payable
|
- | - | 414,000 | - | - | 414,000 | ||||||||||||||||||
Stock-based
compensation
|
- | - | 866,000 | - | - | 866,000 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (16,524,000 | ) | (16,524,000 | ) | ||||||||||||||||
BALANCES,
April 30, 2009
|
227,688,555 | $ | 227,000 | $ | 248,034,000 | $ | - | $ | (247,360,000 | ) | $ | 901,000 |
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, 2009
2009
|
2008
|
2007
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (16,524,000 | ) | $ | (23,176,000 | ) | $ | (20,796,000 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
503,000 | 486,000 | 475,000 | |||||||||
Share-based
compensation and issuance of common stock under stock bonus
plan
|
866,000 | 850,000 | 1,324,000 | |||||||||
Amortization
of expenses paid in shares of common stock
|
255,000 | - | 391,000 | |||||||||
Loss
on sale of property
|
- | - | 1,000 | |||||||||
Amortization
of discount on notes payable and debt issuance costs
|
185,000 | - | - | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Trade
and other receivables
|
(1,165,000 | ) | 145,000 | (171,000 | ) | |||||||
Government
contract receivables
|
(1,944,000 | ) | - | - | ||||||||
Inventories,
net
|
(1,807,000 | ) | (984,000 | ) | (1,031,000 | ) | ||||||
Prepaid
expenses and other current assets, net
|
(513,000 | ) | (203,000 | ) | (113,000 | ) | ||||||
Accounts
payable
|
1,458,000 | 377,000 | 450,000 | |||||||||
Accrued
clinical trial site fees
|
718,000 | 9,000 | 58,000 | |||||||||
Accrued
payroll and related expenses
|
496,000 | 210,000 | 63,000 | |||||||||
Deferred
revenue
|
1,580,000 | 1,132,000 | 480,000 | |||||||||
Deferred
government contract revenue
|
3,871,000 | - | - | |||||||||
Customer
deposits
|
1,449,000 | 253,000 | 194,000 | |||||||||
Other
accrued expenses and current liabilities
|
542,000 | (26,000 | ) | 196,000 | ||||||||
Net
cash used in operating activities
|
(10,030,000 | ) | (20,927,000 | ) | (18,479,000 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Refund
of security deposits on notes payable
|
- | 150,000 | - | |||||||||
Property
acquisitions
|
(126,000 | ) | (691,000 | ) | (220,000 | ) | ||||||
(Increase)
decrease in other assets, net
|
(14,000 | ) | (39,000 | ) | 140,000 | |||||||
Net
cash used in investing activities
|
(140,000 | ) | (580,000 | ) | (80,000 | ) | ||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from issuance of common stock, net of issuance costs
of $58,000,
$1,641,000, and $46,000, respectively
|
550,000 | 20,932,000 | 17,865,000 | |||||||||
Proceeds
from issuance of notes payable, net of issuance costs of $469,000
|
4,531,000 | - | - | |||||||||
Principal
payments on notes payable
|
- | (323,000 | ) | (429,000 | ) | |||||||
Principal
payments on capital leases
|
(23,000 | ) | (16,000 | ) | (15,000 | ) | ||||||
Net
cash provided by financing activities
|
5,058,000 | 20,593,000 | 17,421,000 |
See
accompanying notes to consolidated financial statements.
F-6
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2009 (continued)
2009
|
2008
|
2007
|
||||||||||
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
$ | (5,112,000 | ) | $ | (914,000 | ) | $ | (1,138,000 | ) | |||
CASH
AND CASH EQUIVALENTS, Beginning of year
|
15,130,000 | 16,044,000 | 17,182,000 | |||||||||
CASH
AND CASH EQUIVALENTS, End of year
|
$ | 10,018,000 | $ | 15,130,000 | $ | 16,044,000 | ||||||
SUPPLEMENTAL
INFORMATION:
|
||||||||||||
Interest
paid
|
$ | 174,000 | $ | 25,000 | $ | 50,000 | ||||||
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||||||
Fair
market value of warrants issued in connection with notes
payable
|
$ | 414,000 | $ | - | $ | - | ||||||
Property
acquired under capital lease
|
$ | - | $ | 13,000 | $ | - | ||||||
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 |
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, 2009
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
– We are a clinical stage biopharmaceutical company that
manufactures and develops monoclonal antibodies for the treatment of cancer
and serious viral infections. We are advancing three separate
clinical programs with our first-in-class compounds bavituximab and
Cotara®.
We are
currently running four clinical trials using bavituximab for the treatment of
solid tumors. Three of these clinical trials are Phase II trials evaluating
bavituximab in combination with commonly prescribed chemotherapeutic drugs in
patients with advanced breast or lung cancer. Our fourth active
bavituximab oncology clinical trial is a phase I trial evaluating bavituximab
alone in patients with advanced solid tumors that no longer respond to standard
cancer treatments.
We are
currently running two clinical trials using Cotara® for the treatment of
glioblastoma multiforme, a deadly form of brain cancer. Cotara® is
currently in a dose confirmation and dosimetry clinical trial and in a Phase II
clinical trial.
In
addition to our clinical programs, we are performing pre-clinical research on
bavituximab and an equivalent fully human antibody as a potential broad-spectrum
treatment for viral hemorrhagic fever infections under a contract 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 an initial 24-month base period, with $14.3
million having been appropriated through the current federal fiscal year ending
September 30, 2009.
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.
Going Concern – Our
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, 2009, we had $10,018,000 in cash and cash equivalents. We have
expended substantial funds on the research, development and clinical trials of
our product candidates, and 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, 2009, 2008 and 2007 amounted to
$16,524,000, $23,176,000, and $20,796,000, 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 for the foreseeable future.
F-8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
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.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
With
respect to financing our operations through the issuance of equity, on
March 26, 2009, we entered into an At Market Issuance Sales Agreement (“AMI
Agreement”) with Wm Smith & Co., pursuant to which we may sell shares of our
common stock through Wm Smith & Co., as agent, in registered transactions
from our shelf registration statement on Form S-3, File Number 333-139975, for
aggregate gross proceeds of up to $7,500,000. Shares of common stock
sold under this arrangement were to be sold at market prices. As of
April 30, 2009, we had sold 1,477,938 shares of common stock under the AMI
Agreement for aggregate net proceeds of $550,000. Subsequent to April
30, 2009, we sold and additional 9,275,859 shares of common stock under the AMI
Agreement for aggregate net proceeds of $6,685,000 after deducting commissions
of 3% paid to Wm Smith & Co. As of June 30, 2009, we had raised
the aggregate gross proceeds of $7,500,000 as permitted under the AMI
Agreement.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we had the
ability to borrow up to $10,000,000 (“Loan Agreement”). On December
19, 2008, we received initial funding of $5,000,000, in which principal and
interest are payable over a thirty (30) month period commencing after the
initial six month interest only period. The amount payable under the
Loan Agreement is secured by generally all assets of the Company as further
explained in Note 5. Under the Loan Agreement, we had an option,
which expired June 30, 2009, to borrow a second tranche in the amount of
$5,000,000 upon the satisfaction of certain clinical and financial conditions as
set forth in the Loan Agreement. Although we had satisfied the
required clinical and financial conditions by June 30, 2009, we determined that
exercising the option to borrow the second tranche, and issuing the additional
warrants to the Lenders, was not in the best interest of the Company or our
stockholders.
In addition to the above,
we may also raise additional capital through additional equity offerings or
licensing our products or technology platforms or entering into similar
collaborative arrangements. While we will continue to consider
and explore these potential opportunities, there is no certainty that such
offerings or collaborative agreements will be successful as they are dependent
on the market conditions. Therefore, 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 to complete the research,
development, and clinical testing of our product candidates. Based on
our current projections and assumptions, which include projected revenues under
signed contracts with 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 2010. There are a number of uncertainties
associated with our financial projections, including but not limited to,
termination of third party or government contracts, technical challenges, or
possible reductions in funding under our government contract, which could reduce
or delay our future projected cash-inflows. In addition, under the
Loan Agreement, in the event our government contract with the Defense
Threat Reduction Agency is terminated or canceled for any reason, including
reasons pertaining to budget cuts by the government or reduction in government
funding for the program, we would be required to set aside cash and cash
equivalents in an amount equal to 80% of the outstanding loan balance in a
restricted collateral account non-accessible by us. In the event our
projected cash-inflows are reduced or delayed or if we default on a loan
covenant that limits our access to our available cash on hand, we might not have
sufficient capital to operate our business through the fiscal year 2010 unless
we raise additional capital. The uncertainties surrounding our future
cash inflows have raised substantial doubt regarding our ability to continue as
a going concern.
F-9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
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.
Government Contract
Receivables – Government contract receivables includes amounts billed
under our contract with Transformational Medical Technologies Initiative
(“TMTI”) of the U.S. Department of Defense’s Defense Threat Reduction Agency
(“DTRA”) that was signed on June 30, 2008. In addition, amounts
unbilled at April 30, 2009 were $151,000, of which amount, included $141,000 in
prepaid expenses and other current assets and included $10,000 in other assets
in the accompanying consolidated financial statements.
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. With respect to our trade and other receivables, we determined
no allowance for doubtful accounts was necessary based on our analysis as of
April 30, 2009 and 2008.
Amounts
billed to the DTRA during fiscal year 2009 include reimbursement for provisional
rates covering allowable indirect overhead and general and administrative cost
(“Indirect Rates”). These Indirect Rates are initially estimated
based on financial projections and are subject to change based on actual costs
incurred during each fiscal year. In addition, these Indirect Rates
are subject to annual audits by the Defense Contract Audit Agency (“DCAA”) for
cost reimbursable type contracts. As of April 30, 2009, we recorded
an unbilled receivable of $51,000 pertaining to the calculated difference
between estimated and actual Indirect Rates for fiscal year 2009. As
of April 30, 2009, we determined it appropriate to record a corresponding
allowance for doubtful account in the amount of $51,000 due to the uncertainty
of its collectability given that our actual Indirect Rates have not been audited
by the DCAA since we signed the contract on June 30, 2008.
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, 2009 and
2008, prepaid expenses and other current assets in the accompanying consolidated
financial statements include $220,000 and $475,000, respectively, 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.
F-10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (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,:
2009
|
2008
|
|||||||
Raw
materials, net
|
$ | 1,654,000 | $ | 1,115,000 | ||||
Work-in-process
|
3,053,000 | 1,785,000 | ||||||
Total inventories
|
$ | 4,707,000 | $ | 2,900,000 |
Concentrations of Credit Risk
- The majority of trade
and other receivables as of April 30, 2009, are from customers in the United
States, Germany and Canada. The majority of trade and other
receivables as of April 30, 2008, are from customers in the United States and
Germany. 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.
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 billings and/or payments received from
customers prior to the initiation of contract manufacturing
services.
Deferred Revenue - Deferred
revenue consists of installment billings and/or payments received by Avid prior
to the recognition of revenues under customer service
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 revenue from contract manufacturing services provided by Avid,
from licensing agreements associated with Peregrine’s technologies under
development, and from services performed under a government contract awarded to
Peregrine through the Transformational Medical Technologies Initiative (“TMTI”)
of the U.S. Department of Defense’s Defense Threat Reduction Agency (“DTRA”)
that was signed on June 30, 2008.
We
recognize revenue 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 (or passage of title) 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-11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
We also
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.
In
addition, we also follow the guidance of the Emerging Issues Task Force Issue
No. 99-19 (“EITF 99-19”), Reporting Revenue Gross as a
Principal versus Net as an Agent. Pursuant to EITF 99-19, for
transactions in which we act as a principal, have discretion to choose
suppliers, bear credit risk and performs a substantive part of the services,
revenue is recorded at the gross amount billed to a customer and costs
associated with these reimbursements are reflected as a component of cost of
sales for contract manufacturing services or research and development expense
for services provided under our contract with the DTRA.
Revenue
associated with contract manufacturing services provided by Avid are recognized
once the service has been rendered and/or upon shipment (or passage of title) of
the product to the customer. On occasion, we recognize revenue on a
“bill-and-hold” basis. Under “bill-and-hold” arrangements, revenue is
recognized in accordance with the “bill-and-hold” requirements under SAB No. 104
once the product is complete and ready for shipment, title and risk of loss has
passed to the customer, management receives a written request from the customer
for “bill-and-hold” treatment, the product is segregated from other inventory,
and no further performance obligations exist. Any amounts received
prior to satisfying our revenue recognition criteria are recorded as deferred
revenue in the accompanying consolidated financial statements. We
also record a provision for estimated contract losses, if any, in the period in
which they are determined.
License revenue primarily consists of
annual license fees paid under one license agreement. Annual license
fees are recognized as revenue on the anniversary date of the agreement in
accordance with the criteria under SAB No. 104. We deem service to
have been rendered if no continuing obligation exists.
Our
contract with the DTRA is a “cost-plus-fixed-fee” contract whereby we recognize
government contract revenue in accordance with the revenue recognition criteria
noted above and in accordance with Accounting Research Bulletin No. 43, Chapter
11, Government
Contracts. Reimbursable costs under the contract primarily
include direct labor, subcontract costs, materials, equipment, travel, indirect
costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is generally recognized as we perform the
underlying research and development activities. However, progress
billings and/or payments associated with services that are billed and/or
received in a manner that is not consistent with the timing of when services are
performed are classified as deferred government contract revenue in the
accompanying consolidated financial statements and are recognized as revenue
upon satisfying our revenue recognition criteria.
Fair Value of Financial Instruments
- The carrying amounts of
our short-term financial instruments, which include cash and cash equivalents,
accounts receivable, accounts payable, and accrued liabilities approximate their
fair values due to their short maturities. The fair value of our note
payable is estimated based on the quoted prices for the same or similar issues
or on the current rates offered to us for debt of the same remaining
maturities.
F-12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
Reclassification – Certain
amounts in fiscal year 2008 and 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,
2009.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 234,439, 928,801 and 2,071,087
shares of common stock for the fiscal years ended April 30, 2009, 2008 and 2007,
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 13,007,072,
10,455,216 and 7,218,883 shares of common stock for the fiscal years ended April
30, 2009, 2008 and 2007, 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.
Subsequent
to April 30, 2009, we issued an aggregate of 9,275,859 shares of our common
stock under an At Market Issuance Sales Agreement (Note 8) in exchange for
aggregate net proceeds of $6,685,000 after deducting commissions of 3%, which
additional shares have been excluded from the calculation of basic and dilutive
net loss per common share for the year ended April 30, 2009.
Share-based Compensation
-
We account
for stock options granted under our equity compensation plans in accordance with
Statement of Financial Accounting Standards No. 123R (“SFAS No. 123R”),
Share-Based Payment (Revised
2004). SFAS No. 123R requires the recognition of compensation
expense, using a fair value based method and 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 (typically 2 to 4
years). See Note 3 for further discussion regarding share-based
compensation.
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.
F-13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
In
addition, 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.
Recently Adopted Accounting
Standards -In September 2006, the
FASB issued Statement of Financial Accounting Standards No. 157 (“SFAS No.
157”), Fair Value
Measurements, which defines fair value, establishes a framework for
measuring fair value under GAAP, and expands disclosures about fair value
measurements. SFAS No. 157 establishes a three-level hierarchy that
prioritizes the inputs used to measure fair value. The hierarchy
defines the three levels of inputs to measure fair value, as
follows:
|
●
|
Level
1 – Quoted prices in active markets for identical assets or
liabilities.
|
|
●
|
Level
2 – Observable inputs other than quoted prices included in Level 1, such
as assets or liabilities whose value are based on quoted market prices in
markets where trading occurs infrequently or whose values are based on
quoted prices of instruments with similar attributes in active
markets.
|
|
●
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and significant to the overall fair value
measurement.
|
We adopted SFAS No. 157 on May 1,
2008, which did not have a material impact on our consolidated financial
statements as we currently do not have any Level 2 or Level 3 financial assets
or liabilities and cash and cash equivalents are carried at fair value based on
quoted market prices for identical securities (Level 1
input).
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. We adopted SFAS No. 159 on May 1, 2008,
which did not have a material impact on our consolidated financial
statements as the fair value option was not elected for any of our financial
assets or financial liabilities.
F-14
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
In June
2007, the FASB ratified EITF Issue No. 07-3 (“EITF 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. We adopted EITF 07-3 on May 1,
2008, which did not have a
material impact on our consolidated financial statements.
New Accounting Standards Not Yet
Adopted - In November 2007, the FASB ratified EITF Issue 07-01 (“EITF
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 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 07-01 will be effective for
fiscal years beginning after December 15, 2008, which we would be required
to implement during our quarter ending July 31, 2009, and applied as a change in
accounting principal to all prior periods retrospectively for all collaborative
arrangements existing as of the effective date. Our adoption of EITF
07-01 is not expected to have a material impact on our consolidated financial
statements.
In May
2008, the FASB issued SFAS No. 162, Hierarchy of Generally Accepted
Accounting Principles (“SFAS No. 162”).
This statement is intended to improve financial reporting by identifying a
consistent framework, or hierarchy, for selecting accounting principles to be
used in preparing financial statements of nongovernmental entities that are
presented in conformity with GAAP. This statement will be effective
60 days following the SEC’s approval of the Public Company Accounting
Oversight Board amendment to AU Section 411, The Meaning of Present Fairly in
Conformity with Generally Accepted Accounting Principles. Our
adoption of SFAS No. 162 is not expected to have a material impact on
our consolidated financial statements.
In June
2008, the FASB issued EITF Issue No. 07-5, Determining Whether an Instrument
(or Embedded Feature) Is Indexed to an Entity's Own
Stock (“EITF No. 07-5”). EITF 07-5 supersedes EITF
Issue No. 01-6, The Meaning of 'Indexed to a Company's Own Stock', and
provides guidance in evaluating whether certain financial instruments or
embedded features can be excluded from the scope of SFAS 133, Accounting for Derivatives and
Hedging Activities (“SFAS 133”). EITF No. 07-5 sets
forth a two-step approach that evaluates an instrument's contingent exercise and
settlement provisions for the purpose of determining whether such instruments
are indexed to an issuer's own stock (a requirement necessary to comply with the
scope exception under SFAS 133). EITF No. 07-5 will be
effective for financial statements issued for fiscal years beginning after
December 15, 2008, and interim periods within those fiscal years. Our
adoption of EITF No. 07-5 is not expected to have a material impact on our
consolidated financial statements.
In April
2009, the FASB issued Staff Position No. FAS 107-1 and APB 28-1, Interim Disclosures about Fair Value
of Financial Instruments (“FAS 107-1” and “APB 28-1”), which requires
publicly traded companies to include in their interim financial reports certain
disclosures about the carrying value and fair value of financial instruments
previously required only in annual financial statements and to disclose changes
in significant assumptions used to calculate the fair value of financial
instruments. FAS 107-1 and APB 28-1 is effective for all interim
reporting periods ending after June 15, 2009, which we would be required to
adopt during our quarter ending July 31, 2009. Our adoption of FSP
FAS 107-1 and APB 28-1 is not expected to have a material impact on our
consolidated financial statements.
F-15
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
In May
2009, the FASB issued SFAS No. 165, Subsequent Events (“SFAS No.
165”). SFAS No. 165 establishes general standards of accounting for
and disclosure of events that occur after the balance sheet date but before
financial statements are issued or are available to be issued. SFAS No. 165 is effective for interim or
annual financial periods ending after June 15, 2009, which we would be required
to adopt during our quarter ending July 31, 2009. Our adoption of
SFAS No. 165 is not expected to have a material impact on our consolidated
financial statements.
3.
|
SHARE-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 expire ten years from the date
of grant, if unexercised.
We
account for stock options granted under our Option Plans in accordance with
Statement of Financial Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment (Revised
2004). 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 (typically 2 to 4 years).
Total
share-based compensation expense related to employee stock option grants for
fiscal years ended April 30, 2009, 2008 and 2007 are included in the
accompanying consolidated statements of operations as follows:
2009
|
2008
|
2007
|
||||||||||
Research
and development
|
$ | 475,000 | $ | 534,000 | $ | 589,000 | ||||||
Selling,
general and administrative
|
382,000 | 295,000 | 375,000 | |||||||||
Total
|
$ | 857,000 | $ | 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 subsequent to the adoption of SFAS No. 123R
(adopted May 1, 2006) 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, 2009, 2008 and 2007, were as follows:
F-16
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
Year
Ended April 30,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Risk-free
interest rate
|
3.10 | % | 3.77 | % | 4.83 | % | ||||||
Expected
life (in years)
|
6.00 | 6.02 | 6.25 | |||||||||
Expected
volatility
|
79 | % | 82 | % | 98 | % | ||||||
Expected
dividend yield
|
- | - | - |
As of
April 30, 2009, options to purchase up to 14,193,164 shares of our common stock
were issued and outstanding under the Option Plans with a weighted average
exercise price of $1.21 per share and expire at various dates through April 14,
2019. Options to purchase up to 1,261,681 shares of common stock were
available for future grant under the Option Plans as of April 30,
2009.
The
following summarizes all stock option transaction activity for fiscal year ended
April 30, 2009:
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding,
May 1, 2008
|
14,689,064 |
$
|
1.24 | ||||||||||||||
Granted
|
644,550 |
$
|
0.36 | ||||||||||||||
Exercised
|
- |
$
|
- | ||||||||||||||
Canceled
or expired
|
(1,140,450 | ) |
$
|
1.04 | |||||||||||||
Outstanding,
April 30, 2009
|
14,193,164 |
$
|
1.21 | 5.11 |
$
|
62,000 | |||||||||||
Exercisable
and expected to vest
|
13,898,377 |
$
|
1.22 | 5.04 |
$
|
60,000 | |||||||||||
Exercisable,
April 30, 2009
|
11,459,197 |
$
|
1.36 | 4.34 |
$
|
43,000 |
The
weighted-average grant date fair value of options granted during the years ended
April 30, 2009, 2008 and 2007 was $0.25, $0.35 and $1.05 per share,
respectively.
The
aggregate intrinsic value of stock options exercised during the years ended
April 30, 2008 and 2007 was $19,000 and $38,000, respectively. Cash proceeds
from stock options exercised during the years ended April 30, 2008 and 2007
totaled $27,000 and $59,000, respectively. No stock options
were exercised during fiscal year ended April 30, 2009.
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, 2009, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,128,000. This cost is expected to be
recognized over a weighted average vesting period of 2.16 years based on current
assumptions.
F-17
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
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. Share-based compensation expense
recorded during fiscal years 2009, 2008 and 2007 associated with non-employees
amounted to $9,000,
$21,000 and $57,000, 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 Accounting
Principles Board No. 25, Accounting for Stock Issued to
Employees and Related Interpretations, 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 year 2007, we recorded $304,000 in share-based compensation expense under
the Stock Bonus Plan.
4.
|
GOVERNMENT
CONTRACT
|
On June
30, 2008, we were awarded a five-year contract potentially 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 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 an initial
24-month base period, with $14.3 million having been appropriated through the
current federal fiscal year ending September 30, 2009. 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 through three one-year option
terms. Work under this contract commenced on June 30, 2008 and direct
costs associated with the contract are included in research and development
expense in the accompanying condensed consolidated statements of
operations.
5.
|
NOTES
PAYABLE AND CAPITAL LEASE
OBLIGATIONS
|
Notes
Payable Obligations
On
December 9, 2008, we entered into a loan and security agreement pursuant to
which we have the ability to borrow up to $10,000,000 (“Loan Agreement”) with
MidCap Financial LLC and BlueCrest Capital Finance, L.P. On December
19, 2008, we received initial funding of $5,000,000. In addition, we
had an option, which expired on June 30, 2009, to borrow a second tranche in the
amount of $5,000,000 upon the satisfaction of certain clinical and financial
conditions as set forth in the Loan Agreement. Although we had
satisfied the required clinical and financial conditions by June 30, 2009, we
determined that exercising the option to borrow the second tranche, and issuing
warrant coverage equal to 10% of the second tranche, was not in the best
interest of the Company or our stockholders.
F-18
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
Under the
Loan Agreement, the outstanding principal balance each month will bear interest
at the then current thirty (30) day LIBOR rate (set at a floor of 3%) plus 9%
(12% at April 30, 2009). The Loan Agreement allows for interest-only
payments during the initial six (6) months or until July 2009 followed by thirty
(30) equal monthly principal payments plus interest. The Loan
Agreement, which is secured by generally all assets of the Company, contains
customary covenants that, among other things, generally restricts our ability to
incur additional indebtedness. In addition, the Loan Agreement
contains a covenant, whereby if our contract with the DTRA (Note 4) is
terminated while the loan is outstanding, we would be required to set aside cash
and cash equivalents in an amount equal to at least 80% of the outstanding loan
balance in a secured account over which we will not be permitted to make
withdrawals or otherwise exercise control. Moreover, the Loan
Agreement includes a Material Adverse Change clause whereby if there is a
material impairment in the priority of lenders' lien in the collateral or in the
value of such collateral, or if we encounter a material adverse change in our
business, operations, or condition (financial or otherwise), or a material
impairment of the prospect of repayment of any portion of the loan, then an
event of default can be invoked by the lender.
The terms
of the Loan Agreement also include a provision for warrant coverage equal to 10%
of each tranche amount divided by the warrant exercise price. The
warrant exercise price was calculated based on the average closing price of our
common stock for the 20-day period prior to the date of the Loan
Agreement. The warrants are exercisable immediately, include
piggy-back registration rights, and have a five-year term. In
connection with the first tranche advance of $5,000,000, we issued warrants to
purchase an aggregate of 1,692,047 shares of our common stock at an exercise
price of $0.2955 per share. The fair value of the warrants was
$414,000, and this amount was credited to additional paid-in capital and reduced
the carrying value of the debt, reflected as a debt discount in the accompanying
consolidated financial statements. The debt discount is being
amortized as a non-cash interest expense over the term of the outstanding loan
using the effective interest method. The fair value of the warrants
was determined using the Black-Scholes model with the following
assumptions: estimated volatility of 70.72%; risk free interest rate
of 2.00%; an expected life of five years; and no dividend yield.
In
connection with the Loan Agreement, we also incurred $469,000 in financing fees
and legal costs related to closing the Loan Agreement. These fees and
costs are classified as debt issuance costs, and the short-term and long-term
portions of these costs are included in current assets and other long-term
assets, respectively, in the accompanying consolidated balance sheet as of April
30, 2009 and are being amortized as a non-cash interest expense over the term of
the outstanding loan using the effective interest method. Included in
debt issuance costs is a final payment fee of $150,000, which is due and payable
on the maturity date of the outstanding loan balance, and is equal to 3% of the
total amount funded under the Loan Agreement. The final payment fee
payable of $150,000 is classified as other long-term liabilities in the
accompanying consolidated balance sheet as of April 30, 2009.
We will
make the following note payable principal payments in the years ending April
30:
2010
|
$ | 1,667,000 | ||
2011
|
2,000,000 | |||
2012
|
1,333,000 | |||
Total
|
$ | 5,000,000 |
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. 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.
F-19
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
During
fiscal year 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
during fiscal year 2008.
Capital
Lease Obligations
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, 2009 as
follows:
Laboratory
equipment
|
$ | 13,000 | ||
Furniture,
fixtures and office equipment
|
68,000 | |||
Less
accumulated depreciation
|
(48,000 | ) | ||
Net
book value
|
$ | 33,000 |
Minimum
future capital lease payments as of April 30, 2009 are as follows:
Year
ending April 30:
|
|||||
2010
|
|
18,000 | |||
2011
|
|
4,000 | |||
Total
minimum lease payments
|
22,000 | ||||
Amount
representing interest
|
(1,000 | ) | |||
Net
present value minimum lease payments
|
21,000 | ||||
Less current
portion
|
17,000 | ||||
$ | 4,000 |
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 2009, 2008 and
2007.
F-20
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
At April 30, 2009, future minimum lease
payments under all non-cancelable operating leases are as follows:
Year
ending April 30:
|
Minimum
Lease
Payments
|
|||
2010
|
$ | 849,000 | ||
2011
|
854,000 | |||
2012
|
834,000 | |||
2013
|
832,000 | |||
2014
|
850,000 | |||
Thereafter
|
3,232,000 | |||
$ | 7,451,000 |
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 were involved with the following lawsuit that recently
settled:
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”), Alan Epstein (“Dr. Epstein”), Medibiotech Co., Inc. and Shanghai
Medipharm Biotech Co., Ltd. (collectively “Medipharm”). The lawsuit
alleged claims for breach of contract, interference with contractual relations,
declaratory relief, injunctive relief, and other claims against the
defendants. Our claims stemmed primarily from a 1995 License
Agreement with CTL, and amendments to that Agreement ("License
Agreement"). We claimed 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. We also alleged that Medipharm improperly induced CTL to
enter into a relationship that did not preserve Peregrine's rights.
On March
28, 2007, CTL filed a cross-complaint, which it amended on May 30, 2007,
alleging that we improperly terminated the License Agreement, and that we
interfered with CTL’s agreements with various Medipharm entities and were
double-licensing the technology that CTL had licensed to Shanghai
Medipharm.
On
February 22, 2008, Medipharm filed a cross-complaint alleging, as third party
beneficiaries, that we breached the Agreement by double-licensing the technology
licensed to CTL to another party, intentionally interfered with a prospective
economic advantage, and unjust enrichment.
On April
16, 2009, we signed a settlement agreement with Medipharm (“April Settlement
Agreement”) providing for a settlement and release of all claims with respect to
our previously disclosed litigation with Medipharm. Under the April
Settlement Agreement, we agreed to dismiss our respective claims against each
other with prejudice. In connection with the April Settlement
Agreement (1) Medipharm agreed not to sell radiolabelled TNT Products outside of
the Peoples Republic of China (“PRC”) and we agreed not to sell radiolabelled
TNT Products within the PRC; (2) Medipharm agreed that NHS76 (a fully human
equivalent antibody to Cotara) is not part of the License Agreement; (3)
Medipharm agreed to deliver to CTL 1.9 million shares of Medibiotech Co. Inc.
stock; and (4) we relinquished any and all claims we had with respect to
Shanghai Medipharm's use of Vivatuxin, murine clone (TNT-1), or any chimeric
clone derived from any TNT murine clone developed by Medipharm and product
derived thereof in the PRC (with the exception of claims we may choose to assert
related to rhTNT-IL2). Otherwise, the April Settlement Agreement
contained a general release between the Company and Medipharm of all claims
arising out of the License Agreement or the matters of the lawsuit between the
parties.
F-21
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
On June
4, 2009, we signed a settlement agreement (the “June Settlement Agreement”) with
CTL, Dr. Epstein, Clive Taylor, M.D. and Peisheng Hu, M.D. (collectively, the
“CTL Parties”), providing for a settlement and release of all claims with
respect to our previously disclosed litigation with those CTL
Parties. Under the June Settlement Agreement, the parties dismissed
all of their claims against each other in the lawsuit. In connection
with the June Settlement Agreement, (1) we agreed to pay to CTL the sum of four
hundred thousand dollars ($400,000) in eight equal monthly installments of fifty
thousand dollars ($50,000) commencing upon execution of the June Settlement
Agreement and continuing on the first business day of each succeeding month
until paid in full, which amount is included in selling, general and
administrative expenses in the accompanying consolidated financial statements
during fiscal year 2009, (2) CTL agreed to issue to us 950,000 shares of
Medibiotech (which represents fifty percent (50%) of the shares of Medibiotech
to be issued to and owned by CTL under the April Settlement Agreement), and (3)
we entered into a license agreement with Dr. Epstein effective as of September
20, 1995, pursuant to which Dr. Epstein granted us (i) a fully paid-up, royalty
free, exclusive worldwide license to the murine clone TNT1 and (ii) a fully
paid-up, royalty free, non-exclusive worldwide (except in the Peoples Republic
of China) license to the murine clones TNT2 and TNT3. The foregoing
license grants include our right to grant sublicenses, to make, have made,
modify, have modified, use, sell and offer for sale, murine clone TNT1, TNT2 and
TNT3 products and derivatives thereof, but not to sell the murine
clones. We also granted back to Dr. Epstein a limited, fully paid-up,
royalty free, exclusive license to the murine clone TNT1, with the right to
grant sublicenses, to make, have made, modify, have modified, offer to sell,
sell and use the murine clone TNT1 and its products solely in the Peoples
Republic of China effective as of August 29, 2001. In consideration
of the foregoing license grants, we paid Dr. Epstein the sum of one thousand
dollars ($1,000), which amount was deducted from the initial $50,000
payment. In addition, the June Settlement Agreement contained full
general releases between the Company and the CTL parties.
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.
F-22
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
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.
Anti-Phosphatidylserine
(“Anti-PS”) Program
Bavituximab
is the generic name for our first product in clinical trials under our Anti-PS
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 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 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 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 year 2008, we expensed $50,000 upon the completion of clinical milestones
in accordance with in-licensing agreements covering our Anti-PS technology
platform, which amount is included in research and development expense in the
accompanying consolidated financial statements. We did not incur any
milestone related expenses during fiscal years 2009 and 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-23
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (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
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
2009, we expensed $255,000 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. We also do not
anticipate making any milestone payments for at least the next fiscal year under
these agreements.
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. In accordance with
the June Settlement Agreement (Note 6), CTL agreed to issue to Peregrine 950,000
shares of Medibiotech (which represents 50% of the shares of Medibiotech owned
by CTL) in lieu of any of the financial terms included in the September 1995
agreement.
F-24
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (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, 2009, 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 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.
8.
|
STOCKHOLDERS'
EQUITY
|
Adoption
of a Stockholder Rights Agreement
On March
16, 2006, our Board of Directors adopted a Stockholder Rights Agreement (“Rights
Agreement”) that is designed to strengthen the ability of the Board of Directors
to protect the interests of our stockholders against potential abusive or
coercive takeover tactics and to enable all stockholders the full and fair value
of their investment in the event that an unsolicited attempt is made to acquire
Peregrine. The adoption of the Rights Agreement is not intended to
prevent an offer the Board of Directors concludes is in the best interest of
Peregrine and its stockholders.
Under the
Rights Agreement, the Board of Directors declared a dividend of one preferred
share purchase right (a “Right”) for each share of our common stock held by
shareholders of record as of the close of business on March 27,
2006. Each Right will entitle holders of each share of our common
stock to buy one thousandth (1/1,000th) of a
share of Peregrine’s Series D Participating Preferred Stock, par value $0.001
per share, at an exercise price of $11.00 per share, subject to
adjustment. The Rights are neither exercisable nor traded separately
from our common stock. The Rights will become exercisable and will
detach from the common shares if a person or group acquires 15% or more of our
outstanding common stock, without prior approval from our Board of Directors, or
announces a tender or exchange offer that would result in that person or group
owning 15% or more of our common stock. Each Right, when exercised,
entitles the holder (other than the acquiring person or group) to receive common
stock of the Company (or in certain circumstances, voting securities of the
acquiring person or group) with a value of twice the Rights exercise price upon
payment of the exercise price of the Rights.
F-25
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
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 in the number of shares authorized.
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. As
of June 30, 2009, we had raised the $30,000,000 in gross proceeds permitted
under the January 2007 Shelf registration statement under the following
agreements:
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.
On
March 26, 2009, we entered into an At Market Issuance Sales Agreement (“AMI
Agreement”) with Wm Smith & Co., pursuant to which we may sell shares of our
common stock through Wm Smith & Co., as agent, in registered transactions
from our January 2007 Shelf, for aggregate gross proceeds of
$7,500,000. Shares of common stock sold under this arrangement were
to be sold at market prices. As of April 30, 2009, we had sold
1,477,938 shares of common stock under the AMI Agreement for aggregate net
proceeds of $550,000. Subsequent to April 30, 2009, we sold and
additional 9,275,859 shares of common stock under the AMI Agreement for
aggregate net proceeds of $6,685,000 after deducting commissions of 3% paid to
Wm Smith & Co. As of June 30, 2009, we had raised the aggregate
gross proceeds of $7,500,000 permitted under the AMI Agreement.
During
fiscal year 2007, we entered into two separate financing transactions under a
shelf registration statement on Form S-3, File Number 333-132872, which was
declared effective by the Securities and Exchange Commission, allowing us to
issue, from time to time, in one or more offerings, up to 15,000,000 shares of
our common stock. The following table summarizes the two financing
transactions we entered into during fiscal year 2007 under this shelf
registration statement:
F-26
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
Description
of Financing Transaction
|
Number
of Shares of Common Stock 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 |
Shares
Of Common Stock Authorized And Reserved For Future Issuance
In
accordance with our shares reserved for issuance under our stock option plans
and warrant agreements, we have reserved 26,422,751 shares of our common stock
at April 30, 2009 for future issuance, calculated as follows:
Number
of
shares
reserved
|
||||
Options
issued and outstanding
|
14,193,164 | |||
Options
available for future grant
|
1,261,681 | |||
Warrants
issued and outstanding
|
1,692,047 | |||
Shares
reserved for issuance under AMI Agreement
|
9,275,859 | |||
Total
shares reserved
|
26,422,751 |
9.
|
WARRANTS
|
Granted - As of April 30,
2009, we had warrants outstanding to purchase up to 1,692,047 shares of our
common stock at an exercise price of $0.2955 per share and an expiration date of
December 19, 2013. These warrants were issued during fiscal year 2009
in connection with the loan and security agreement we entered into on December
9, 2008, as further discussed in Note 5. There were no warrants
granted during fiscal years 2008 and 2007.
Exercised - 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. There were no warrants exercised during fiscal year
2009.
10.
|
SEGMENT
REPORTING
|
Our
business is organized into two reportable operating
segments. Peregrine is engaged in the research and development of
monoclonal antibody-based therapies for the treatment of cancer and serious
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 contract
manufacturing services segment based on gross profit or
loss. However, our products in the research and development segment
are not evaluated based on gross profit or loss, but rather based on scientific
progress of the technologies. As such, gross profit is only provided
for our contract manufacturing services segment in the below
table. All revenues shown below are derived from transactions with
external customers.
F-27
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
Segment
information is summarized as follows:
2009
|
2008
|
2007
|
||||||||||
Contract
manufacturing services revenue
|
$ | 12,963,000 | $ | 5,897,000 | $ | 3,492,000 | ||||||
Cost
of contract manufacturing services
|
9,064,000 | 4,804,000 | 3,296,000 | |||||||||
Gross
profit
|
$ | 3,899,000 | $ | 1,093,000 | $ | 196,000 | ||||||
Revenues
from products in research and development
|
$ | 5,188,000 | $ | 196,000 | $ | 216,000 | ||||||
Research
and development expense
|
(18,424,000 | ) | (18,279,000 | ) | (15,876,000 | ) | ||||||
Selling,
general and administrative expense
|
(6,979,000 | ) | (7,150,000 | ) | (6,446,000 | ) | ||||||
Other
income (expense), net
|
(208,000 | ) | 964,000 | 1,114,000 | ||||||||
Net
loss
|
$ | (16,524,000 | ) | $ | (23,176,000 | ) | $ | (20,796,000 | ) |
Revenue
generated from our contract manufacturing segment was from the following
customers:
2009
|
2008
|
2007
|
||||||||||||
Customer
revenue as a % of revenue:
|
||||||||||||||
United
States (one customer)
|
57 | % | 84 | % | 11 | % | ||||||||
Germany
(one customer)
|
25 | % | 7 | % | 51 | % | ||||||||
Canada
(one customer)
|
16 | % | 3 | % | 0 | % | ||||||||
Australia
(one customer)
|
0 | % | 2 | % | 14 | % | ||||||||
China
(one customer)
|
0 | % | 0 | % | 10 | % | ||||||||
Other
customers
|
2 | % | 4 | % | 14 | % | ||||||||
Total
customer revenue as a % of revenue
|
100 | % | 100 | % | 100 | % |
Revenue
generated from our products in our research and development segment during
fiscal year 2009 were primarily from revenue earned under the government
contract with the DTRA (Note 4). The remainder of revenue generated
from our products in our research and development segment during fiscal year
2009 was from an annual license fee received under our license agreement with
SuperGen, Inc. (Note 7). Revenue generated from our products in our
research and development segment during fiscal years 2008 and 2007 was from
revenue earned under various license agreements including SuperGen,
Inc.
F-28
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
Our
long-lived assets consist of leasehold improvements, laboratory equipment, and
furniture, fixtures and computer equipment and are net of accumulated
depreciation. Long-lived assets by segment consist of the
following:
2009
|
2008
|
|||||||
Long-lived
Assets, net:
|
||||||||
Contract
manufacturing services
|
$ | 1,531,000 | $ | 1,825,000 | ||||
Products
in research and development
|
150,000 | 233,000 | ||||||
Total
long-lived assets, net
|
$ | 1,681,000 | $ | 2,058,000 |
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 fiscal years ended April 30, 2009 and 2008, and we did not
accrue for interest or penalties as of April 30, 2009 and 2008.
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, 2009, we had total deferred
tax assets of $6,327,000. 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
$70,136,000 and general business and research and development credits of
$118,000 generated through April 30, 2009 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.
F-29
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
At April
30, 2009, we had federal net operating loss carry forwards and tax credit carry
forwards of approximately $177,376,000 and $118,000,
respectively. The net operating loss carry forwards expire in fiscal
years 2010 through 2029. 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 2010 and are available to
offset the future taxes of our subsidiary. We also have state net
operating loss carry forwards of approximately $111,182,000 at April 30, 2009,
which begin to expire in fiscal year 2015.
The
provision for income taxes consists of the following for the three years ended
April 30, 2009:
2009
|
2008
|
2007
|
||||||||||
Provision
for federal income taxes at statutory rate
|
$ | (5,618,000 | ) | $ | (7,880,000 | ) | $ | (7,071,000 | ) | |||
State
income taxes, net of federal benefit
|
(926,000 | ) | (1,309,000 | ) | (1,202,000 | ) | ||||||
Expiration
and adjustment of loss carry forwards
|
3,917,000 | 64,484,000 | 73,000 | |||||||||
Change
in valuation allowance
|
2,405,000 | (55,510,000 | ) | 8,132,000 | ||||||||
Other,
net
|
222,000 | 215,000 | 68,000 | |||||||||
Income
tax (expense) benefit
|
$ | - | $ | - | $ | - |
Deferred income taxes reflect the net
effects of temporary differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts for income tax
purposes. Significant components of our deferred tax assets at April
30, 2009 and 2008 are as follows:
2009
|
2008
|
|||||||
Stock-based
compensation
|
$ | 1,988,000 | $ | 1,891,000 | ||||
Deferred
revenue
|
3,046,000 | 875,000 | ||||||
Accrued
liabilities
|
1,293,000 | 1,156,000 | ||||||
Total
deferred tax assets
|
6,327,000 | 3,922,000 | ||||||
Less
valuation allowance
|
(6,327,000 | ) | (3,922,000 | ) | ||||
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 $16,500. We made no
matching contributions to the Plan since its inception.
F-30
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
13.
|
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, 2009 |
January
31, 2009 |
October
31, 2008 |
July
31, 2008 |
April
30, 2008 |
January
31, 2008 |
October
31, 2007 |
July
31, 2007 |
|||||||||||||||||||||||||
Net revenues
|
$ | 7,867,000 | $ | 6,826,000 | $ | 1,941,000 | $ | 1,517,000 | $ | 901,000 | $ | 1,675,000 | $ | 1,892,000 | $ | 1,625,000 | ||||||||||||||||
Loss
from operations
|
$ | (3,372,000 | ) | $ | (3,234,000 | ) | $ | (4,550,000 | ) | $ | (5,160,000 | ) | $ | (6,297,000 | ) | $ | (6,402,000 | ) | $ | (6,553,000 | ) | $ | (4,888,000 | ) | ||||||||
Net
loss
|
$ | (3,609,000 | ) | $ | (3,332,000 | ) | $ | (4,497,000 | ) | $ | (5,086,000 | ) | $ | (6,159,000 | ) | $ | (6,154,000 | ) | $ | (6,207,000 | ) | $ | (4,656,000 | ) | ||||||||
Basic
and diluted loss per common share
|
$ | (0.02 | ) | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.03 | ) | $ | (0.02 | ) |
F-31
PEREGRINE PHARMACEUTICALS, INC. |
SCHEDULE
II
|
VALUATION
OF QUALIFYING ACCOUNTS
FOR EACH OF THE THREE YEARS IN
THE PERIOD ENDED APRIL 30, 2009 (continued)
Description
|
Balance
at Beginning |
Charged to
deferred |
Deductions
|
Balance at
end |
||||||||||||
Valuation
reserve for unbilled receivables for the year ended April 30,
2007
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Valuation
reserve for unbilled receivables for the year ended April 30,
2008
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Valuation
reserve for unbilled receivables for the year ended April 30,
2009
|
$ | - | $ | 51,000 | $ | - | $ | 51,000 |
F-32