Avid Bioservices, Inc. - Quarter Report: 2005 July (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
ý
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the
quarterly period ended July 31, 2005
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: 0-17085
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.)
|
14272
Franklin Avenue, Tustin,
California
|
92780-7017
|
(Address
of principal executive
offices)
|
(Zip
Code)
|
Registrant's
telephone number, including area code: (714)
508-6000
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 ý No o.
Indicate
by check mark whether the registrant is an accelerated filer (as defined in
Rule
12b-2 of the Exchange Act). Yes ý No o.
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date.
Class
|
Number
of Shares Outstanding
|
|
Common
Stock, $0.001 par value
|
166,017,599
shares of common stock as of September 6,
2005
|
PEREGRINE
PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
|
Page
No.
|
||
Item
1.
|
Financial
Statements:
|
||
Condensed
Consolidated Balance Sheets at July 31, 2005 (unaudited) and April
30,
2005
|
1
|
||
Condensed
Consolidated Statements of Operations for the three months ended
July 31,
2005 and 2004 (unaudited)
|
3
|
||
Condensed
Consolidated Statements of Cash Flows for the three months ended
July 31,
2005 and 2004 (unaudited)
|
4
|
||
Notes
to Condensed Consolidated Financial Statements (unaudited)
|
5
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of Operations
|
16
|
|
Company
Overview
|
16
|
||
Risk
Factors of Our Company
|
24
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
25
|
|
Item
4.
|
Controls
and Procedures
|
25
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
25
|
|
Item
2.
|
Changes
in Securities and Use of Proceeds
|
26
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
26
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
26
|
|
Item
5.
|
Other
Information
|
26
|
|
Item
6.
|
Exhibits
and Reports on Form 8-K
|
27
|
|
SIGNATURES
|
28
|
The
terms “we,” “us,” “our,” “the Company,” and “Peregrine,”
as used in this Report on Form 10-Q refers to Peregrine Pharmaceuticals, Inc.
and its wholly-owned subsidiary, Avid Bioservices, Inc.
i
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL
STATEMENTS
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
JULY
31,
2005
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
16,495,000
|
$
|
9,816,000
|
|||
Trade
and other receivables, net of allowance for doubtful accounts of
$70,000
(July) and $69,000 (April)
|
405,000
|
486,000
|
|||||
Inventories
|
811,000
|
627,000
|
|||||
Prepaid
expenses and other current assets
|
938,000
|
1,197,000
|
|||||
Total
current assets
|
18,649,000
|
12,126,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
494,000
|
494,000
|
|||||
Laboratory
equipment
|
3,201,000
|
3,029,000
|
|||||
Furniture,
fixtures and computer equipment
|
683,000
|
647,000
|
|||||
4,378,000
|
4,170,000
|
||||||
Less
accumulated depreciation and amortization
|
(2,633,000
|
)
|
(2,532,000
|
)
|
|||
Property,
net
|
1,745,000
|
1,638,000
|
|||||
OTHER
ASSETS:
|
|||||||
Note
receivable, net of allowance of $1,494,000 (July) and $1,512,000
(April)
|
-
|
-
|
|||||
Other
|
492,000
|
481,000
|
|||||
Total
other assets
|
492,000
|
481,000
|
|||||
TOTAL
ASSETS
|
$
|
20,886,000
|
$
|
14,245,000
|
1
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
JULY
31,
2005
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,078,000
|
$
|
1,325,000
|
|||
Accrued
clinical trial site fees
|
17,000
|
8,000
|
|||||
Accrued
legal and accounting fees
|
458,000
|
549,000
|
|||||
Accrued
royalties and license fees
|
184,000
|
149,000
|
|||||
Accrued
payroll and related costs
|
466,000
|
806,000
|
|||||
Notes
payable, current portion
|
321,000
|
234,000
|
|||||
Other
current liabilities
|
418,000
|
563,000
|
|||||
Deferred
revenue
|
725,000
|
517,000
|
|||||
Total
current liabilities
|
3,667,000
|
4,151,000
|
|||||
NOTES
PAYABLE
|
557,000
|
434,000
|
|||||
DEFERRED
LICENSE REVENUE
|
31,000
|
50,000
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDERS'
EQUITY:
|
|||||||
Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting; nil
shares
outstanding
|
-
|
-
|
|||||
Common
stock-$.001 par value; authorized 200,000,000 shares; outstanding
-
165,690,677 (July); 152,983,460 (April)
|
166,000
|
153,000
|
|||||
Additional
paid-in capital
|
191,254,000
|
180,011,000
|
|||||
Deferred
stock compensation
|
(647,000
|
)
|
(751,000
|
)
|
|||
Accumulated
deficit
|
(174,142,000
|
)
|
(169,803,000
|
)
|
|||
Total
stockholders' equity
|
16,631,000
|
9,610,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
20,886,000
|
$
|
14,245,000
|
See
accompanying notes to condensed consolidated financial
statements
2
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE
MONTHS ENDED
|
|||||||
July
31, 2005
|
July
31, 2004
|
||||||
Unaudited
|
Unaudited
|
||||||
REVENUES:
|
|||||||
Contract
manufacturing revenue
|
$
|
189,000
|
$
|
485,000
|
|||
License
revenue
|
19,000
|
19,000
|
|||||
Total
revenues
|
208,000
|
504,000
|
|||||
COSTS
AND EXPENSES:
|
|||||||
Cost
of contract manufacturing
|
304,000
|
448,000
|
|||||
Research
and development
|
2,792,000
|
2,570,000
|
|||||
Selling,
general and administrative
|
1,517,000
|
967,000
|
|||||
Total
costs and expenses
|
4,613,000
|
3,985,000
|
|||||
LOSS
FROM OPERATIONS
|
(4,405,000
|
)
|
(3,481,000
|
)
|
|||
OTHER
INCOME (EXPENSE):
|
|||||||
Interest
and other income
|
76,000
|
68,000
|
|||||
Interest
and other expense
|
(10,000
|
)
|
-
|
||||
NET
LOSS
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
WEIGHTED
AVERAGE SHARES
OUTSTANDING:
|
|||||||
Basic
and Diluted
|
160,035,717
|
141,312,572
|
|||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
See
accompanying notes to condensed consolidated financial
statements
3
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE
MONTHS ENDED
|
|||||||
July
31, 2005
|
July
31, 2004
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
101,000
|
83,000
|
|||||
Stock-based
compensation
|
104,000
|
95,000
|
|||||
Stock
issued for research services
|
278,000
|
-
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
81,000
|
304,000
|
|||||
Inventories
|
(184,000
|
)
|
(1,032,000
|
)
|
|||
Prepaid
expenses and other current assets
|
(19,000
|
)
|
114,000
|
||||
Accounts
payable
|
(247,000
|
)
|
(140,000
|
)
|
|||
Accrued
clinical trial site fees
|
9,000
|
(21,000
|
)
|
||||
Deferred
revenue
|
189,000
|
1,309,000
|
|||||
Accrued
payroll and related costs
|
(340,000
|
)
|
(168,000
|
)
|
|||
Other
accrued expenses and current liabilities
|
(201,000
|
)
|
42,000
|
||||
Net
cash used in operating activities
|
(4,568,000
|
)
|
(2,827,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(208,000
|
)
|
(24,000
|
)
|
|||
Increase
in other assets
|
(11,000
|
)
|
(134,000
|
)
|
|||
Net
cash used in investing activities
|
(219,000
|
)
|
(158,000
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of notes payable
|
267,000
|
-
|
|||||
Principal
payments on notes payable
|
(57,000
|
)
|
-
|
||||
Proceeds
from issuance of common stock, net of issuance costs of $46,000
(July
2005) and $3,000 (July 2004)
|
11,256,000
|
57,000
|
|||||
Net
cash provided by financing activities
|
11,466,000
|
57,000
|
|||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
6,679,000
|
(2,928,000
|
)
|
||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
9,816,000
|
14,884,000
|
|||||
CASH AND CASH EQUIVALENTS, end of period |
$
|
16,495,000
|
$
|
11,956,000
|
See
accompanying notes to condensed consolidated financial
statements
4
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited)
1. |
BASIS
OF PRESENTATION
|
The
accompanying interim condensed consolidated financial statements include the
accounts of Peregrine Pharmaceuticals, Inc. (“Peregrine”), a biopharmaceutical
company with a broad portfolio of products under development, and its
wholly-owned subsidiary, Avid Bioservices, Inc. (“Avid”), which performs
contract manufacturing of biologics and related services (collectively, the
“Company”). All intercompany balances and transactions have been eliminated.
In
addition, the accompanying interim condensed consolidated financial statements
are unaudited; however they contain all adjustments (consisting only of normal
recurring adjustments) which, in the opinion of management, are necessary to
present fairly the condensed consolidated financial position of the Company
at
July 31, 2005, and the condensed consolidated results of our operations and
our
condensed consolidated cash flows for the three month periods ended July 31,
2005 and 2004. We prepared the condensed consolidated financial statements
following the requirements of the Securities and Exchange Commission (or SEC)
for interim reporting. As permitted under those rules, certain footnotes or
other financial information that are normally required by U.S. generally
accepted accounting principles (or GAAP) can be condensed or omitted. Although
we believe that the disclosures in the financial statements are adequate to
make
the information presented herein not misleading, the information included in
this quarterly report on Form 10-Q should be read in conjunction with the
consolidated financial statements and accompanying notes included in our Annual
Report on Form 10-K for the year ended April 30, 2005. Results of operations
for
interim periods covered by this quarterly report on Form 10-Q may not
necessarily be indicative of results of operations for the full fiscal
year.
As
of
July 31, 2005, we had $16,495,000 in cash and cash equivalents on hand. We
have
expended substantial funds on the development of our product candidates and
we
have incurred negative cash flows from operations for the majority of our years
since inception. Since inception, we have generally financed our operations
primarily through the sale of our common stock and issuance of convertible
debt,
which has been supplemented with payments received from various licensing
collaborations and through the revenues generated by Avid. We expect negative
cash flows from operations to continue until we are able to generate sufficient
revenue from the contract manufacturing services provided by Avid and/or from
the sale and/or licensing of our products under development.
Revenues
earned by Avid during the three months ended July 31, 2005 and 2004 amounted
to
$189,000 and $485,000, respectively. We expect that Avid will continue to
generate revenues which should lower consolidated cash flows used in operations,
although we expect those near term revenues will be insufficient to fully cover
anticipated cash flows used in operations. In addition, revenues from the sale
and/or licensing of our products under development are always uncertain.
Therefore, we expect we will continue to need to raise additional capital to
continue the development of our product candidates, including the anticipated
development and clinical costs of Tarvacin™ and Cotara®, the anticipated
research and development costs associated with our other technology platforms
and the potential expansion of our manufacturing capabilities.
We
plan
to raise additional capital primarily through the offer and sale of shares
of
our common stock. However, given uncertain market conditions and the volatility
of our stock price and trading volume, we may not be able to sell our securities
at prices or on terms that are favorable to us, if at all.
5
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
In
addition to equity financing, we explore various other sources of funding,
including possible debt financing and leveraging our many assets, including
our
intellectual property portfolio and the operations of Avid. Our broad
intellectual property portfolio allows us to develop products internally while
at the same time we are able to out-license certain areas of the technology
which would not interfere with our internal product development efforts. We
also
have the facilities of Avid that we may leverage in a strategic transaction
if
the right opportunity and financial terms are presented to us, provided that
the
manufacturing needs of our customers and Peregrine are not jeopardized.
There
can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all (from either debt, equity or the licensing,
partnering or sale of technology assets and/or the sale of all or a portion
of
Avid), or that sufficient additional revenues will be generated from Avid or
under potential licensing agreements to complete the research, development,
and
clinical testing of our product candidates beyond fiscal year 2006.
2. |
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Cash
and Cash Equivalents -
We
consider all highly liquid, short-term investments with an initial maturity
of
three months or less to be cash equivalents.
Allowance
for Doubtful Receivables
-
We
continually monitor our allowance for all receivables. A considerable amount
of
judgment is required in assessing the ultimate realization of these receivables
and we estimate an allowance for doubtful accounts based on factors that appear
reasonable under the circumstances.
Prepaid
Expenses -
Our
prepaid expenses primarily represent pre-payments made to secure the receipt
of
services at a future date. During fiscal year 2005, we prepaid various research
and development related services through the issuance of our shares of common
stock with unrelated entities, which are expensed once the services have been
provided under the terms of the arrangement. As of July 31, 2005, prepaid
research and development services of $759,000 paid in shares of our common
stock
is included in prepaid expenses and other current assets in the accompanying
condensed consolidated financial statements.
Inventories
-
Inventories are stated at the lower of cost or market and primarily include
raw
materials, direct labor and overhead costs associated with our wholly-owned
subsidiary, Avid. Inventories consist of the following at July 31, 2005 and
April 30, 2005:
July
31,
2005
|
April
30,
2005
|
||||||
Raw
materials
|
$
|
474,000
|
$
|
445,000
|
|||
Work-in-process
|
337,000
|
182,000
|
|||||
Total
inventories
|
$
|
811,000
|
$
|
627,000
|
Concentrations
of Credit Risk - The
majority of trade and other receivables are from customers in the United States.
Most contracts require up-front payments and installment payments as the project
progresses. We perform periodic evaluations of our ongoing customers and
generally do not require collateral, although we can terminate any contract
if a
material default occurs. Reserves are maintained for potential credit losses,
and such losses have been minimal and within our estimates.
6
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
Comprehensive
Loss
-
Comprehensive loss is equal to net loss for all periods presented.
Deferred
Revenue - Deferred
revenue primarily consists of up-front contract fees and installment payments
received prior to the recognition of revenues under contract manufacturing
and
development agreements and up-front license fees received under technology
licensing agreements. Deferred revenue is generally recognized once the service
has been provided, all obligations have been met, and/or upon shipment of the
product to the customer.
Revenue
Recognition - We
currently derive revenues primarily from licensing agreements associated with
Peregrine’s technologies under development and from contract manufacturing
services provided by Avid.
We
recognize revenues pursuant to Staff Accounting Bulletin No. 101 (“SAB No.
101”), Revenue
Recognition in Financial Statements
and
Staff Accounting Bulletin No. 104 (“SAB No. 104”), Revenue
Recognition.
These
bulletins draw on existing accounting rules and provide specific guidance on
how
those accounting rules should be applied. Revenue is generally realized or
realizable and earned when (i) persuasive evidence of an arrangement exists,
(ii) delivery has occurred or services have been rendered, (iii) the seller's
price to the buyer is fixed or determinable, and (iv) collectibility is
reasonably assured.
In
addition, we comply with Financial Accounting Standards Board’s Emerging Issues
Task Force No. 00-21 (“EITF 00-21”), Revenue
Arrangements with Multiple Deliverables.
In
accordance with EITF 00-21, we recognize revenue for delivered elements only
when the delivered element has stand-alone value and we have objective and
reliable evidence of fair value for each undelivered element. If the fair value
of any undelivered element included in a multiple element arrangement cannot
be
objectively determined, revenue is deferred until all elements are delivered
and
services have been performed, or until fair value can objectively be determined
for any remaining undelivered elements.
Revenues
associated with licensing agreements primarily consist of nonrefundable up-front
license fees and milestone payments. Revenues under licensing agreements are
recognized based on the performance requirements of the agreement. Nonrefundable
up-front license fees received under license agreements, whereby continued
performance or future obligations are considered inconsequential to the relevant
licensed technology, are generally recognized as revenue upon delivery of the
technology. Nonrefundable up-front license fees, whereby ongoing involvement
or
performance obligations exist, are generally recorded as deferred revenue and
generally recognized as revenue over the term of the performance obligation
or
relevant agreement.
Contract
manufacturing revenues are generally recognized once the service has been
provided and/or upon shipment of the product to the customer. We also record
a
provision for estimated contract losses, if any, in the period in which they
are
determined.
In
July
2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF
99-19”), Reporting
Revenue Gross as a Principal versus Net as an Agent.
EITF
99-19 summarized the EITF’s views on when revenue should be recorded at the
gross amount billed to a customer because it has earned revenue from the sale
of
goods or services, or the net amount retained (the amount billed to the customer
less the amount paid to a supplier) because it has earned a fee or commission.
In addition, the EITF released Issue 00-10 (“EITF 00-10”),
Accounting
for Shipping and Handling Fees and Costs,
and
Issue 01-14 (“EITF 01-14”), Income
Statement Characterization of Reimbursements Received for “Out-of-Pocket”
Expenses Incurred.
EITF
00-10 summarized the EITF’s views on how the seller of goods should classify in
the income statement amounts billed to a customer for shipping and handling,
and
the costs associated with shipping and handling. EITF 01-14 summarized the
EITF’s views on when the reimbursement of out-of-pocket expenses should be
characterized as revenue or as a reduction of expenses incurred. Our revenue
recognition policies are in compliance with EITF 99-19, EITF 00-10 and EITF
01-14 whereby we recorded revenue for the gross amount billed to customers
(the
cost of raw materials, supplies, and shipping, plus the related handling mark-up
fee) and we recorded the cost of the amounts billed as cost of sales as we
act
as a principal in these transactions.
7
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
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 trials and pre-clinical testing of technologies under development,
(iii) the costs to manufacture the product candidates, including raw materials
and supplies, (iv) technology access and maintenance fees, including amounts
incurred under licensing agreements and intellectual property access fees,
(v)
expenses for research and services rendered under outside contracts, including
sponsored research funding paid to universities, and (vi) facility and other
research and development expenses.
Reclassification
-
Certain
amounts in fiscal year 2005 condensed consolidated financial statements have
been reclassified to conform to the current year presentation.
Basic
and Dilutive Net Loss Per Common Share
- Basic
and dilutive net loss per common share is 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. Potentially dilutive
common shares consist of stock options and warrants calculated in accordance
with the treasury stock method, but are excluded if their effect is
antidilutive. Because the impact of options and warrants are antidilutive during
periods of net loss, there was no difference between basic and diluted loss
per
share amounts for the three months ended July 31, 2005 and July 31, 2004. The
dilutive effect of 3,261,033 and 8,183,453 shares of potentially issuable common
stock from the exercise of options and warrants calculated under the treasury
stock method were excluded from net loss per common share for the three months
ended July 31, 2005 and 2004, respectively, because their effect was
antidilutive since we reported a net loss in both three-month periods
presented.
Weighted
average outstanding options and warrants to purchase up to 14,742,319 and
11,379,093 shares of common stock for the three months ended July 31, 2005
and
July 31, 2004, respectively, were also excluded from the calculation of diluted
earnings per common share because their exercise prices were greater than the
average market price during the period.
Stock-Based
Compensation
- In
December 2002, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards No. 148 (“SFAS No. 148”),
Accounting
for Stock-Based Compensation-Transition and Disclosure.
SFAS No. 148 amends SFAS No. 123 (“SFAS No. 123”), Accounting
for Stock-Based Compensation,
and
provides alternative methods of transition for a voluntary change to the fair
value based method of accounting for stock-based employee compensation.
In
addition, SFAS No. 148 amends the disclosure requirements of SFAS No. 123 to
require prominent disclosures in both annual and interim financial statements
about the method of accounting for stock-based employee compensation, and the
effect of the method used on reported results.
8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
We
have
not adopted a method under SFAS No. 148 to expense stock options but rather
we
continue to apply the provisions of SFAS No. 123; however, we have adopted
the
additional disclosure provisions of the statement. As SFAS No. 123 permits,
we
elected to continue accounting for our employee stock options in accordance
with
Accounting Principles Board Opinion No. 25 (“APB No. 25”), Accounting
for Stock Issued to Employees and Related Interpretations.
APB No.
25 requires compensation expense to be recognized for stock options when the
market price of the underlying stock exceeds the exercise price of the stock
option on the date of the grant.
We
utilize the guidelines in APB No. 25 for measurement of stock-based transactions
for employees and, accordingly, no compensation expense has been recognized
for
the options in the accompanying condensed consolidated financial statements
for
the three-month periods ended July 31, 2005 and July 31, 2004.
Had
we
used a fair value model for measurement of stock-based transactions for
employees under SFAS No. 123 and amortized the expense over the vesting period,
pro forma information would be as follows:
THREE
MONTHS ENDED
|
|||||||
July
31,
2005
|
July
31,
2004
|
||||||
Net
loss, as reported
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
Stock-based
employee compensation cost that would have been
included
in the determination of net loss if the fair value based
method
had been applied to all awards
|
(643,000
|
)
|
(790,000
|
)
|
|||
Pro
forma net loss as if the fair value based method had
been
applied to all awards
|
$
|
(4,982,000
|
)
|
$
|
(4,203,000
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
Stock-based
compensation expense recorded during the three months ended July 31, 2005 and
July 31, 2004 primarily relates to stock option grants made to consultants
or
non-employees and has been measured utilizing the Black-Scholes option valuation
model and is being amortized over the estimated period of service or related
vesting period. Stock-based compensation expense recorded during the three
months ended July 31, 2005 and July 31, 2004 amounted to $104,000 and $95,000,
respectively.
In
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
123R (“SFAS No. 123R”), Share-Based
Payment (Revised 2004),
which
requires companies to recognize in the income statement the fair value of all
employee share-based payments, including grants of employee stock options as
well as compensatory employee stock purchase plans, for interim periods
beginning after June 15, 2005. In April 2005, the Securities and Exchange
Commission adopted a rule amendment that delayed the compliance dates of SFAS
No. 123R such that we are now allowed to adopt the new standard no later than
May 1, 2006. SFAS No. 123R eliminates the ability to account for share-based
compensation using APB No. 25, and the pro forma disclosures previously
permitted under SFAS No. 123 no longer will be an alternative to financial
statement recognition. Although we have not yet determined whether the adoption
of SFAS No. 123R will result in amounts that are similar to the current pro
forma disclosures under SFAS No. 123 (as shown above), we are evaluating the
requirements under SFAS No. 123R including the valuation methods and support
for
the assumptions that underlie the valuation of the awards, as well as the
transition methods (modified prospective transition method or the modified
retrospective transition method) and expect the adoption to have a significant
impact on our consolidated statements of operations and net loss per share
and
minimal impact on our consolidated statement of financial position.
9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
In
addition, during August 2003, a member of our Board of Directors voluntarily
cancelled an option to purchase shares of our common stock due to an
insufficient number of stock options available in our stock option plans for
new
employee grants. During October 2003, we received stockholder approval for
our
2003 Stock Incentive Plan (“2003 Plan”) and the director was re-granted options
to purchase shares under the 2003 Plan. In accordance with FASB Interpretation
No. 44 (“FIN No. 44”), Accounting
for Certain Transactions Involving Stock Compensation,
the
option granted to the director under the 2003 Plan is subject to variable
accounting, which could result in an increase in compensation expense in
subsequent periods if the market price of our common stock exceeds the original
exercise price of the option until the date the option is exercised, forfeited,
or expires unexercised. If the market price of stock decreases, then decreases
in compensation expense would be recognized, limited to the net expense
previously reported. During the three months ended July 31, 2005 and July 31,
2004, we did not record compensation expense with respect to such option in
accordance with FIN No. 44 since the market price of our stock was less than
the
exercise price of the option at the end of the respective periods.
Recent
Accounting Pronouncement
- In
November 2004, the FASB issued Statement of Financial Accounting Standards
No.
151 (“SFAS No. 151”), Inventory
Costs.
SFAS
No. 151 amends the guidance in ARB No. 43, Chapter 4, Inventory
Pricing,
to
improve financial reporting by clarifying that abnormal amounts of idle facility
expense, freight, handling costs, and wasted materials (spoilage) should be
recognized as current-period charges and by requiring the allocation of fixed
production overheads to inventory based on the normal capacity of the production
facilities. The standard is effective for inventory costs incurred during fiscal
years beginning after June 15, 2005. We would be required to implement this
standard no later than May 1, 2006, unless adopted earlier. We are currently
evaluating the impact of SFAS No. 151 on our financial position and results
of
operations.
3. |
NOTE
RECEIVABLE
|
During
December 1998, we completed the sale and subsequent leaseback of our two
facilities and recorded an initial note receivable from the buyer of $1,925,000.
The note receivable bears interest at 7.5% per annum and payments are due
monthly based on a 20-year amortization period. The note receivable is due
on
the earlier to occur of (i) December 1, 2010 or (ii) upon the sale of the
facility and the transfer of title. In addition, if we default under the lease
agreement, including but not limited to, filing a petition for bankruptcy or
failure to pay the basic rent, the note receivable shall be deemed to be
immediately satisfied in full and the buyer shall have no further obligation
to
us for such note receivable, as defined in the note agreement. Although we
have
made all payments under the lease agreement and we have not filed for protection
under the laws of bankruptcy, during the quarter ended October 31, 1999, we
did
not have sufficient cash on hand to meet our obligations on a timely basis
and
we were operating at significantly reduced levels. In addition, at that time,
if
we could not raise additional cash by December 31, 1999, we may have had to
file
for protection under the laws of bankruptcy. Due to the uncertainty of our
ability to pay our lease obligations on a timely basis, we established a 100%
reserve for the note receivable in the amount of $1,887,000 as of October 31,
1999. We reduce the reserve as payments are received and we record the reduction
as interest and other income in the accompanying condensed consolidated
statements of operations. Due to the uncertainty of our ability to fund our
operations beyond fiscal year 2006, the carrying value of the note receivable
approximates its fair value at July 31, 2005. We have received all payments
to
date under the note receivable.
10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
The
following represents a rollforward of the allowance of the note receivable
for
the three months ended July 31, 2005:
Allowance
balance, April 30, 2005
|
$
|
1,581,000
|
||
Principal
payments received
|
(17,000
|
)
|
||
Allowance
balance, July 31, 2005
|
$
|
1,564,000
|
4. |
NOTES
PAYABLE
|
During
November 2004, we entered into a note agreement with General Electric Capital
Corporation (“GE”) in the amount of $350,000 collateralized by certain
laboratory equipment. The note bears interest at a rate of 5.78% per annum
with
payments due monthly in the amount of approximately $11,000 over 36 months
commencing January 1, 2005. Under the terms of the agreement, we paid to GE
a
security deposit of 25%, or approximately $88,000, which is due and payable
to
us at the end of the note term. The deposit is included in other long term
assets in the accompanying consolidated financial statements.
During
December 2004, we entered into an additional note agreement with GE in the
amount of $383,000 collateralized by certain laboratory equipment. The note
bears interest at a rate of 5.85% per annum with payments due monthly in the
amount of approximately $12,000 over 36 months commencing February 1, 2005.
Under the terms of the agreement, we paid to GE a security deposit of 25%,
or
approximately $96,000, which is due and payable to us at the end of the note
term. The deposit is included in other long term assets in the accompanying
consolidated financial statements.
During
June 2005, we entered into an additional note agreement with GE in the amount
of
$267,000 collateralized by certain laboratory equipment. The note bears interest
at a rate of 6.39% per annum with payments due monthly in the amount of
approximately $8,000 over 36 months which commenced in August 2005. Under the
terms of the agreement, we paid to GE a security deposit of 25%, or
approximately $67,000, which is due and payable to us at the end of the note
term. The deposit is included in other long term assets in the accompanying
consolidated financial statements.
As
of
July 31, 2005, we owed GE an aggregate amount of $878,000 under all note payable
agreements. Minimum future principal payments on notes payable as of July 31,
2005 are as follows:
Year
ending April 30:
|
||||
2006
|
$
|
239,000
|
||
2007
|
336,000
|
|||
2008
|
279,000
|
|||
2009
|
24,000
|
|||
Total
|
$
|
878,000
|
11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
5. |
LICENSING,
RESEARCH AND DEVELOPMENT AGREEMENTS
|
During
August 2005, we licensed certain intellectual property rights under our Vascular
Targeting Agent technology to Medarex, Inc. (“Medarex”), which allows Medarex to
develop and commercialize certain monoclonal antibodies for the treatment of
a
wide range of solid tumors. Under the terms of the agreement, we will receive
an
up-front payment and annual maintenance fees. In addition, we could also receive
future payments based on the achievement of clinical milestones and a royalty
on
net sales, as defined in the agreement.
6. |
LITIGATION
|
In
the
ordinary course of business, we are at times subject to various legal
proceedings, including licensing and contract disputes and other matters,
which
are
further discussed below:
On
December 16, 2004, we filed a lawsuit against the University of Southern
California (“USC”) and Alan Epstein, M.D. The lawsuit was filed in the Superior
Court of the State of California for the County of Los Angeles, Central
District. The lawsuit alleges that USC has breached various agreements with
the
Company by (i) failing to protect the Company’s patent rights in Japan with
respect to certain technology exclusively licensed from USC due to non-payment
of annuities, (ii) failing to provide accounting documentation for research
expenditures, and (iii) misusing certain antibodies the Company provided to
USC
and Dr. Epstein for research. The claims against Dr. Epstein, who was a
scientific advisor and former consultant to the Company, involve breach of
contract for misusing certain antibodies and breach of fiduciary duties. The
Company is seeking unspecified damages, declaratory relief with respect to
its
rights under the option and license agreement pursuant to which it acquired
the
rights to the technology, and an accounting of research expenditures. Because
the lawsuit is ongoing, the final outcome of this matter cannot be determined
at
this time.
On
August
3, 2005, USC filed a cross-complaint against the Company relating to the
above-mentioned lawsuit. The cross-complaint alleges that the Company has
breached various agreements with USC by (i) breaching reporting and diligence
provisions of the option and license agreements, (ii) failing to make payments
under a sponsored research agreement, and (iii) failing to exercise its rights
under the product and option license agreement for hybridoma clones. USC is
seeking unspecified punitive damages with respect to its rights under the option
and license agreements and the sponsored research agreement. The Company
believes that the cross-complaint is erroneous and without merit and intends
to
contest it vigorously. The Company does not believe any such claim, proceeding,
or litigation, either alone or in the aggregate, will have a material adverse
effect on the Company's consolidated financial statements taken as a whole.
In
addition, we are in active discussions with USC, Dr. Epstein and Knobbe,
Martens, Olson & Bear, LLP to resolve the disputes through
mediation.
On
September 30, 2004, we filed a lawsuit against Knobbe, Martens, Olson &
Bear, LLP and Joseph Reisman, of the law firm Knobbe, Martens, Olson & Bear,
LLP, in San Diego Superior Court. This suit is related to USC’s above-mentioned
failure to protect patent rights in Japan. Accordingly, the case against the
Knobbe firm was dismissed in connection with receiving a tolling agreement
extending the statute of limitations on our claims against the firm while USC
pursues those claims.
In
addition, we are currently investigating whether certain technologies developed
at USC and subsequently licensed to a private company, Pivotal BioSciences,
Inc., an entity we believe is partially owned by the principal investigator
and
others at USC, were developed using resources under our sponsored
research agreement with USC and/or funding provided from another source for
which we have geographic technology rights. We are in active discussions with
Pivotal BioSciences, Inc. to resolve the matter in an amicable manner. The
current investigation does not affect our current rights to our technologies
under development nor should it have any effect, regardless of the outcome
of
the investigation, on the development of any of our existing
technologies.
12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
7.
|
STOCKHOLDERS’
EQUITY
|
During
the three months ended July 31, 2005, we entered into three separate security
purchase agreements with unrelated entities as summarized below:
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Net
Issuance Value
|
|||||
Common
stock purchase agreement dated January 31, 2005
|
1,582,217
|
$
|
1,576,000
|
||||
Common
stock purchase agreement dated May 11, 2005
|
3,125,000
|
$
|
2,989,000
|
||||
Common
stock purchase agreement dated June 22, 2005
|
8,000,000
|
$
|
6,691,000
|
||||
12,707,217
|
$
|
11,256,000
|
As
of
July 31, 2005, an aggregate of 962,558 shares of common stock were available
for
issuance under our shelf registration statements on Form S-3, as filed with
the
Securities and Exchange Commission.
Shares
of Common Stock Authorized and Reserved For Future
Issuance
In
accordance with our shares reserved for issuance under our shelf registration
statements, stock option plans and warrant agreements, we have reserved
26,341,233 shares of our common stock at July 31, 2005 for possible future
issuance, calculated as follows:
Number
of Shares
of
Common Stock Reserved For
Issuance
|
||||
Shares
reserved under shelf registration statements
|
962,558
|
|||
Options
issued and outstanding
|
11,236,215
|
|||
Options
available for future grant
|
600,664
|
|||
Warrants
issued and outstanding
|
13,541,796
|
|||
Total
shares reserved
|
26,341,233
|
13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
8.
|
STOCK
OPTIONS AND WARRANTS
|
As
of
July 31, 2005, options to purchase up to 11,236,215 shares of our common stock
were issued and outstanding and exercisable at prices ranging between $0.34
and
$5.28 per share with an average exercise price of $1.60 per share and expire
at
various dates through June 27, 2015.
As
of
July 31, 2005, warrants to purchase up to 13,541,796 shares of our common stock
were issued and outstanding and exercisable at prices ranging between $0.71
and
$5.00 per share with an average exercise price of $1.81 per share and expire
at
various dates through March 31, 2008.
9. |
SEGMENT
REPORTING
|
Our
business is organized into two reportable operating segments. Peregrine is
engaged in the research and development of targeted biotherapeutics for the
treatment of cancer, viruses, and other diseases. Avid is engaged in providing
contract manufacturing of biologics and related services to biopharmaceutical
and biotechnology businesses.
The
accounting policies of the operating segments are the same as those described
in
Note 2. We primarily evaluate the performance of our segments based on net
revenues, gross profit or loss (exclusive of research and development expenses,
selling, general and administrative expenses, and interest and other
income/expense) and long-lived assets. Our segment net revenues shown below
are
derived from transactions with external customers. Our segment gross profit
or
loss represents net revenues less the cost of sales. Our long-lived assets
consist of leasehold improvements, laboratory equipment, and furniture, fixtures
and computer equipment and are net of accumulated depreciation.
Segment
information for three months ended July 31, 2005 and July 31, 2004 is summarized
as follows:
Three
Months Ended July 31,
|
|||||||
2005
|
2004
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
189,000
|
$
|
485,000
|
|||
Research
and development of biotherapeutics
|
19,000
|
19,000
|
|||||
Total
net revenues
|
$
|
208,000
|
$
|
504,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
(115,000
|
)
|
$
|
37,000
|
||
Research
and development of biotherapeutics
|
19,000
|
19,000
|
|||||
Total
gross profit (loss)
|
(96,000
|
)
|
56,000
|
||||
Research
and development expense of biotherapeutics
|
(2,792,000
|
)
|
(2,570,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,517,000
|
)
|
(967,000
|
)
|
|||
Other
income, net
|
66,000
|
68,000
|
|||||
Net
loss
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
14
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2005 (unaudited) (continued)
Long-lived
assets consist of the following at July 31, 2005 and April 30,
2005:
July
31,
2005
|
April
30,
2005
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,400,000
|
$
|
1,291,000
|
|||
Research
and development of biotherapeutics
|
345,000
|
347,000
|
|||||
Total
long-lived assets, net
|
$
|
1,745,000
|
$
|
1,638,000
|
Net
revenues generated from Avid during the three months ended July 31, 2005 and
July 31, 2004 were primarily from three customers located in the U.S and one
customer headquartered in Israel as follows:
Three
Months Ended July 31,
|
|||||||
2005
|
2004
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
37%
|
|
41%
|
|
|||
United
States (customer B)
|
20%
|
|
1%
|
|
|||
United
States (customer C)
|
37%
|
|
0%
|
|
|||
Israel
(one customer)
|
6%
|
|
56%
|
|
|||
Other
customers
|
0%
|
|
2%
|
|
|||
Total
customer revenues as a % of net revenues
|
100%
|
|
100%
|
|
Net
revenues generated from Peregrine during the three months ended July 31, 2005
and July 31, 2004 were from the amortized portion of the up-front license fee
under the December 2002 license agreement with Schering A.G.
15
ITEM
2. MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
This
Quarterly Report on Form 10-Q contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended,
and
Section 21E of the Securities Exchange Act of 1934, as amended, which
represent our projections, estimates, expectations or beliefs concerning among
other things, financial items that relate to management’s future plans or
objectives or to our future economic and financial performance. In
some cases, you can identify these statements by terminology such as “may”,
“should”, “plans”, “believe”, “will”, “anticipate”, “estimate”, “expect”, or
“intend”, including their opposites or similar phrases or expressions. You
should be aware that these statements are projections or estimates as to future
events and are subject to a number of factors that may tend to influence the
accuracy of the statements. These forward-looking statements should not be
regarded as a representation by the Company or any other person that the events
or plans of the Company will be achieved. You should not unduly rely on these
forward-looking statements, which speak only as of the date of this Quarterly
Report. We undertake no obligation to publicly revise any forward-looking
statement to reflect circumstances or events after the date of this Quarterly
Report or to reflect the occurrence of unanticipated events. You should,
however, review the factors and risks we describe in the reports we file from
time to time with the Securities and Exchange Commission (“SEC”) after the date
of this Quarterly Report. Actual results may differ materially from any forward
looking statement.
To
gain a better understanding of the risk factors that may tend to influence
the
accuracy of our forward looking statements, we recommend that you read the
risk
factors identified in the Company's Annual Report on Form 10-K for the year
ended April 30, 2005 and all other reports we file from time to time with the
Securities and Exchange Commission (“SEC”) after the date of this Quarterly
Report. Although we believe that the risks described in the 10-K and other
reports filed with the SEC represent all material risks currently applicable
to
us, additional risks and uncertainties not presently known to us or that are
currently not believed to be important to us may also affect our actual future
results and could harm our business, financial condition, and results of
operations.
Company
Overview
We
are a
biopharmaceutical company primarily developing broad-based therapeutics directed
towards the treatment of cancer and viruses using targeted monoclonal
antibodies. We are organized into two reportable operating segments: (i)
Peregrine Pharmaceuticals, Inc. (“Peregrine”), the parent company, is engaged in
the research and development of targeted broad-based therapeutics and (ii)
Avid
Bioservices, Inc. (“Avid”), our wholly-owned subsidiary, is engaged in providing
manufacturing expertise of biologics for biopharmaceutical and biotechnology
companies, including Peregrine.
16
Recent
Developments
The
following table provides you with an overview of our products in clinical trials
and the current clinical status of each trial:
Products
in Clinical Trials
|
||||
Technology
Platform
|
Product
Name
|
Disease
|
Stage
of
Development
|
Development
Status Overview
|
Tumor
Necrosis Therapy (“TNT”)
|
Cotara®
|
Brain
Cancer
|
Phase
II/III registration trial
|
Peregrine,
in collaboration with New Approaches to Brain Tumor Therapy (“NABTT”), a
brain tumor consortium, have initiated the first part of the Phase
II/III
product registration study to evaluate Cotara® for the treatment of brain
cancer. This study is partially funded by the National Cancer Institute
("NCI”) and will treat up to 28 patients. The study is being conducted
at
the following four NABTT institutions: Wake Forest University, Emory
University, University of Alabama at Birmingham and University of
Pennsylvania.
|
Anti-Phospholipid
Therapy
|
Tarvacin™
|
Advanced
Solid Cancers
|
Phase
I
|
This
phase I clinical study is a single and repeat dose escalation study
designed to enroll up to 28 patients with advanced solid tumors that
no
longer respond to standard cancer treatments. Patient enrollment
is open
at the Scottsdale and Tucson sites of the Arizona Cancer Center and
recently at Premiere Oncology in Santa Monica, CA.
|
Anti-Phospholipid
Therapy
|
Tarvacin™
|
Hepatitis
C Virus
|
Phase
I
|
This
phase I clinical study is a single dose-escalation study in up to
32 adult
patients with chronic hepatitis C virus (HCV) infection who either
no
longer respond to or failed standard therapy with pegylated interferon
and
ribavirin combination therapy. Patient enrollment is open at Bach
and
Godofsky Infectious Diseases located in Bradenton, FL.
|
17
Results
of Operations
The
following table compares the condensed consolidated statements of operations
for
the three-month periods ended July 31, 2005 and July 31, 2004. This table
provides you with an overview of the changes in the condensed consolidated
statements of operations for the comparative periods, which changes are further
discussed below.
Three
Months Ended July 31,
|
||||||||||
2005
|
2004
|
$
Change
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
189,000
|
$
|
485,000
|
$
|
(296,000
|
)
|
|||
License
revenue
|
19,000
|
19,000
|
-
|
|||||||
Total
revenues
|
208,000
|
504,000
|
(296,000
|
)
|
||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
304,000
|
448,000
|
(144,000
|
)
|
||||||
Research
and development
|
2,792,000
|
2,570,000
|
222,000
|
|||||||
Selling,
general & administrative
|
1,517,000
|
967,000
|
550,000
|
|||||||
Total
costs and expenses
|
4,613,000
|
3,985,000
|
628,000
|
|||||||
LOSS
FROM OPERATIONS
|
(4,405,000
|
)
|
(3,481,000
|
)
|
(924,000
|
)
|
||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Interest
and other income
|
76,000
|
68,000
|
8,000
|
|||||||
Interest
and other expense
|
(10,000
|
)
|
-
|
(10,000
|
)
|
|||||
NET
LOSS
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
$
|
(926,000
|
)
|
Results
of operations for interim periods covered by this quarterly report on Form
10-Q
may not necessarily be indicative of results of operations for the full fiscal
year.
Total
Revenues.
The
decrease in total revenues of $296,000 during the three months ended July 31,
2005 compared to the same period in the prior year was due to a decrease in
contract manufacturing revenue of the same amount. The decrease in contract
manufacturing revenue was primarily due to a decrease in the number of active
projects associated with unrelated entities compared to the same period in
the
prior year. In addition, during the current quarter, we significantly increased
our utilization of our manufacturing facility to manufacture clinical grade
materials to support Peregrine’s three active clinical trials and other products
under development.
We
expect
contract manufacturing revenue to increase during the remainder of the current
fiscal year based on the anticipated completion of in-process customer related
projects and the anticipated demand for Avid’s services under outstanding
proposals. Although Avid is presently working on active projects and has
submitted various project proposals with various potential customers, we cannot
estimate nor can we determine the likelihood that we will be successful in
completing these ongoing projects or converting any of these project proposals
into definitive agreements during the remainder of fiscal year
2006.
Cost
of Contract Manufacturing.
The
decrease in cost of contract manufacturing of $144,000 during the three months
ended July 31, 2005 compared to the same period in the prior year was primarily
related to the current quarter decrease in contract manufacturing revenue,
offset by additional costs incurred during the current quarter to provide
additional data to support required studies for current customers. We expect
contract manufacturing costs to increase during the remainder of the current
fiscal year based on the anticipated completion of customer projects under
our
current contract manufacturing agreements.
18
Research
and Development Expenses.
The
increase in research and development expenses of $222,000 during the three
months ended July 31, 2005 compared to the same period in the prior year was
primarily due to a net increase in expenses associated with the following
platform technologies under development:
Tumor
Necrosis Therapy (“TNT”) (Cotara®)
- During
the quarter ended July 31, 2005, TNT (Cotara®) program expenses increased
$378,000 from $390,000 in fiscal year 2005 to $768,000 in fiscal year 2006.
The
increase in TNT (Cotara®) program expenses of $378,000 is primarily due to an
increase in allocated manufacturing expenses and payroll and related expenses
to
support the first part of the Cotara® Phase II/III registration trial for the
treatment of brain cancer in collaboration with the New Approaches to Brain
Tumor Therapy consortium, and to support the increase in research and
development programs associated with our TNT technology platform.
Anti-Phospholipid
Therapy (Tarvacin™) - During
the quarter ended July 31, 2005, Anti-Phospholipid Therapy (Tarvacin™) program
expenses increased $300,000 from $1,271,000 in fiscal year 2005 to $1,571,000
in
fiscal year 2006. The increase in Anti-Phospholipid Therapy (Tarvacin™)
program expenses of $300,000 is primarily due to an increase in allocated
manufacturing expenses and various clinical trial start-up expenses to support
the initiation of two separate Phase I clinical studies using Tarvacin™ for the
treatment of advanced solid cancers and chronic hepatitis C virus infection
combined with an increase in sponsored research fees associated with
Anti-Phospholipid Therapy development. These increases were offset by a decrease
in pre-clinical toxicology study expenses incurred in the prior year quarter
to
support the Tarvacin™ Investigational New Drug (“IND”) applications that were
filed in the prior fiscal year with the U.S. Food & Drug Administration
combined with a decrease in technology license fees regarding an up-front
license fee expensed in the prior year quarter under a licensing agreement
we
entered into with The University of Texas M.D. Anderson Cancer Center.
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis - During
the quarter ended July 31, 2005, VTA and Anti-Angiogenesis program expenses
decreased $253,000 from $604,000 in fiscal year 2005 to $351,000 in fiscal
year
2006. The decrease in VTA and Anti-Angiogenesis program expenses of $253,000
is
primarily due to a decrease in intellectual property access fees and sponsored
research fees associated with VTA development, offset with an increase in
payroll and related fees and development expenses to support our increase in
active VTA and Anti-Angiogenesis pre-clinical research programs.
Vasopermeation
Enhancements Agents (“VEAs”) - During
the quarter ended July 31, 2005, VEA program expenses decreased $194,000 from
$296,000 in fiscal year 2005 to $102,000 in fiscal year 2006. The decrease
in
VEA program expenses of $194,000 is primarily due to a decrease in sponsored
research fees paid to University of Southern California combined with a decrease
in antibody development fees regarding expenses incurred in the prior year
associated with a research study that was completed in the prior year. In
January 2005, we entered into an agreement with Merck KGaA of Darmstadt,
Germany, that will give us access to Merck's technology and expertise in protein
expression to advance the development of our VEA technology and other platform
technologies. Merck KGaA is presently working on a clinical candidate under
the
VEA technology platform.
We
expect
research and development expenses to increase over the near term primarily
under
the following ongoing research and development programs:
1.
|
Clinical
programs associated with the commencement of two separate Phase I
clinical
trials to evaluate Tarvacin™ for the treatment of solid tumors and chronic
hepatitis C virus infection;
|
2.
|
Cotara®
clinical study for the treatment of brain cancer in collaboration
with New
Approaches to Brain Tumor Therapy (“NABTT”), a brain tumor treatment
consortium, representing the first part of our Phase II/III registration
trial;
|
3.
|
Anti-Phospholipid
Therapy research and development
program;
|
4.
|
2C3
(anti-angiogenesis antibody) research and development
program;
|
5.
|
Vascular
Targeting Agent research and development program;
and
|
6.
|
Vasopermeation
Enhancement Agent research and development
program.
|
19
Due
to
the number of ongoing research programs, if we fail to obtain additional funding
during fiscal year 2006, we may be forced to scale back our product development
efforts or our operations in a manner that will ensure we can pay our
obligations as they come due in the ordinary course of business beyond fiscal
year 2006.
The
following represents the research and development expenses (“R&D Expenses”)
we have incurred by each major technology platform under
development:
Technology
Platform
|
R&D
Expenses-
Quarter
Ended
July
31, 2004
|
R&D
Expenses-
Quarter
Ended
July
31, 2005
|
R&D
Expenses-
May
1, 1998 to
July
31, 2005
|
|||||||
TNT
(Cotara®)
|
$
|
390,000
|
$
|
768,000
|
$
|
29,584,000
|
||||
Anti-Phospholipid
Therapy (Tarvacin™)
|
1,271,000
|
1,571,000
|
9,453,000
|
|||||||
VTA
and Anti-Angiogenesis
|
604,000
|
351,000
|
11,106,000
|
|||||||
VEA
|
296,000
|
102,000
|
5,470,000
|
|||||||
Other
research programs
|
9,000
|
-
|
13,441,000
|
|||||||
Total
R&D Expenses
|
$
|
2,570,000
|
$
|
2,792,000
|
$
|
69,054,000
|
From
inception to April 30, 1998, we expensed $20,898,000 on research and development
of our product candidates, with the costs primarily being closely split between
the TNT and prior developed technologies. In addition to the above costs, we
expensed an aggregate of $32,004,000 for the acquisition of our TNT and VTA
technologies, which were acquired during fiscal years 1995 and 1997,
respectively.
Looking
beyond the current fiscal year, it is extremely difficult for us to reasonably
estimate all future research and development costs associated with each of
our
technologies due to the number of unknowns and uncertainties associated with
pre-clinical and clinical trial development. These unknown variables and
uncertainties include, but are not limited to:
§ |
The
uncertainty of our capital resources to fund research, development
and
clinical studies beyond the current fiscal year;
|
§ |
The
uncertainty of future costs associated with our pre-clinical candidates,
including Vascular Targeting Agents, Anti-angiogensis Agents, and
Vasopermeation Enhancement Agents, which costs are dependent on the
success of pre-clinical development. We are uncertain whether or
not these
product candidates will be successful and we are uncertain whether
or not
we will incur any additional costs beyond pre-clinical development;
|
§ |
The
uncertainty of future clinical trial results;
|
§ |
The
uncertainty of the ultimate number of patients to be treated in any
clinical trial;
|
§ |
The
uncertainty of the Food and Drug Administration allowing our studies
to
move into and forward from Phase I clinical studies to Phase II and
Phase
III clinical studies;
|
§ |
The
uncertainty of the rate at which patients are enrolled into any current
or
future study. Any delays in clinical trials could significantly increase
the cost of the study and would extend the estimated completion
dates;
|
§ |
The
uncertainty of terms related to potential future partnering or licensing
arrangements; and
|
§ |
The
uncertainty of protocol changes and modifications in the design of
our
clinical trial studies, which may increase or decrease our future
costs.
|
20
We
or our
potential partners will need to do additional development and clinical testing
prior to seeking any regulatory approval for commercialization of our product
candidates as all of our products are in discovery, pre-clinical or clinical
development. Testing, manufacturing, commercialization, advertising, promotion,
exporting, and marketing, among other things, of our proposed products are
subject to extensive regulation by governmental authorities in the United States
and other countries. The testing and approval process requires substantial
time,
effort, and financial resources, and we cannot guarantee that any approval
will
be granted on a timely basis, if at all. Companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in conducting
advanced human clinical trials, even after obtaining promising results in
earlier trials. Furthermore, the United States Food and Drug Administration
may
suspend clinical trials at any time on various grounds, including a finding
that
the subjects or patients are being exposed to an unacceptable health risk.
Even
if regulatory approval of a product is granted, such approval may entail
limitations on the indicated uses for which it may be marketed. Accordingly,
we
or our potential partners may experience difficulties and delays in obtaining
necessary governmental clearances and approvals to market our products, and
we
or our potential partners may not be able to obtain all necessary governmental
clearances and approvals to market our products.
Selling,
General and Administrative Expenses. Selling,
general and administrative expenses consist primarily of payroll and related
expenses, director fees, legal and accounting fees, investor and public relation
fees, insurance, and other expenses relating to our general management,
administration, and business development activities of the Company.
The
increase in selling, general and administrative expenses of $550,000 during
the
three months ended July 31, 2005 compared to the same period in the prior year
is primarily due to an increase in (i) payroll and related expenses of $156,000
from $461,000 in fiscal year 2005 to $617,000 in fiscal year 2006 primarily
due
to an increase in headcount across most corporate functions to support the
increased operations primarily pertaining to Avid and the expansion of our
pre-clinical and clinical development plans, (ii) audit and accounting fees
of
$100,000 from $41,000 in fiscal year 2005 to $141,000 in fiscal year 2006
primarily related to the implementation of Section 404 of the Sarbanes-Oxley
Act
of 2002, (iii) legal fees of $119,000 from $72,000 in fiscal year 2005 to
$191,000 in fiscal year 2006 primarily pertaining to the general corporate
matters and lawsuits described in the Quarterly Report on Form 10-Q under Part
II, Item 1, Legal Proceedings, (iv) investor and public relation fees increased
$49,000 from $26,000 in fiscal year 2005 to $75,000 in fiscal year 2006
primarily due to services provided by public relation firms assisting the
Company with its investor and public relations activities, whose services were
not utilized in the same prior year period, (v) director fees of $49,000 from
$57,000 in fiscal year 2005 to $106,000 in fiscal year 2006 primarily due to
an
increase in the number of non-employee directors combined with an increase
in
the number of Company Board meetings, and (vi) travel and related expenses
of
$53,000 from $54,000 in fiscal year 2005 to $107,000 in fiscal year 2006 related
primarily due to Peregrine’s increased business development activities.
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
condensed 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
condensed consolidated financial statements:
Revenue
Recognition.
We
currently derive revenues primarily from licensing agreements associated with
Peregrine’s technologies under development and from contract manufacturing
services provided by Avid. We recognize revenues pursuant to Staff Accounting
Bulletin No. 101, Revenue
Recognition in Financial Statements,
as well
as the recently issued Staff Accounting Bulletin No. 104, Revenue
Recognition.
These
bulletins draw on existing accounting rules and provide specific guidance on
how
those accounting rules should be applied. Revenue is generally realized or
realizable and earned when (i) persuasive evidence of an arrangement exists,
(ii) delivery has occurred or services have been rendered, (iii) the seller's
price to the buyer is fixed or determinable, and (iv) collectibility is
reasonably assured.
21
In
addition, we comply with Financial Accounting Standards Board’s Emerging Issues
Task Force No. 00-21 (“EITF 00-21”), Revenue
Arrangements with Multiple Deliverables.
In
accordance with EITF 00-21, we recognize revenue for delivered elements only
when the delivered element has stand-alone value and we have objective and
reliable evidence of fair value for each undelivered element. If the fair value
of any undelivered element included in a multiple element arrangement cannot
be
objectively determined, revenue is deferred until all elements are delivered
and
services have been performed, or until fair value can objectively be determined
for any remaining undelivered elements.
Revenues
associated with licensing agreements primarily consist of nonrefundable up-front
license fees and milestone payments. Revenues under licensing agreements are
recognized based on the performance requirements of the agreement. Nonrefundable
up-front license fees received under license agreements, whereby continued
performance or future obligations are considered inconsequential to the relevant
licensed technology, are generally recognized as revenue upon delivery of the
technology. Milestone payments are generally recognized as revenue upon
completion of the milestone assuming there are no other continuing obligations.
Nonrefundable up-front license fees, whereby we have an ongoing involvement
or
performance obligation, are generally recorded as deferred revenue and generally
recognized as revenue over the term of the performance obligation or relevant
agreement. Under some license agreements, the obligation period may not be
contractually defined. Under these circumstances, we must exercise judgment
in
estimating the period of time over which certain deliverables will be provided
to enable the licensee to practice the license.
Contract
manufacturing revenues are generally recognized once the service has been
provided and/or upon shipment of the product to the customer. We also record
a
provision for estimated contract losses, if any, in the period in which they
are
determined.
In
July
2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF
99-19”), Reporting
Revenue Gross as a Principal versus Net as an Agent.
EITF
99-19 summarized the EITF’s views on when revenue should be recorded at the
gross amount billed to a customer because it has earned revenue from the sale
of
goods or services, or the net amount retained (the amount billed to the customer
less the amount paid to a supplier) because it has earned a fee or commission.
In addition, the EITF released Issue 00-10 (“EITF 00-10”), Accounting
for Shipping and Handling Fees and Costs,
and
Issue 01-14 (“EITF 01-14”), Income
Statement Characterization of Reimbursements Received for “Out-of-Pocket”
Expenses Incurred.
EITF
00-10 summarized the EITF’s views on how the seller of goods should classify in
the income statement amounts billed to a customer for shipping and handling
and
the costs associated with shipping and handling. EITF 01-14 summarized the
EITF’s views on when the reimbursement of out-of-pocket expenses should be
characterized as revenue or as a reduction of expenses incurred. Our revenue
recognition policies are in compliance with EITF 99-19, EITF 00-10 and EITF
01-14 whereby we record revenue for the gross amount billed to customers (the
cost of raw materials, supplies, and shipping, plus the related handling mark-up
fee) and record the cost of the amounts billed as cost of sales as we act as
a
principal in these transactions.
Allowance
for Doubtful Receivables. We
continually monitor our allowance for all receivables. A considerable amount
of
judgment is required in assessing the ultimate realization of these receivables
and we estimate an allowance for doubtful accounts based on factors that appear
reasonable under the circumstances.
Liquidity
and Capital Resources
As
of
July 31, 2005, we had $16,495,000 in cash and cash equivalents on hand. Although
we have sufficient cash on hand to meet our current planned obligations through
at least the current fiscal year, our development efforts are dependent on
our
ability to raise additional capital to support our future
operations.
22
We
have
expended substantial funds on the development of our product candidates and
we
have incurred negative cash flows from operations for the majority of our years
since inception. Since inception, we have generally financed our operations
primarily through the sale of our common stock and issuance of convertible
debt,
which has been supplemented with payments received from various licensing
collaborations and through the revenues generated by Avid. We expect negative
cash flows from operations to continue until we are able to generate sufficient
revenue from the contract manufacturing services provided by Avid and/or from
the sale and/or licensing of our products under development.
Revenues
earned by Avid during the three months ended July 31, 2005 and 2004 amounted
to
$189,000 and $485,000, respectively. We expect that Avid will continue to
generate revenues which should lower consolidated cash flows used in operations,
although we expect those near term revenues will be insufficient to cover
anticipated cash flows used in operations. In addition, revenues from the sale
and/or licensing of our products under development are always uncertain.
Therefore, we expect we will continue to need to raise additional capital to
continue the development of our product candidates, including the anticipated
development and clinical trial costs of Tarvacin™ and Cotara®, the anticipated
research and development costs associated with our other technology platforms
and the potential expansion of our manufacturing capabilities.
We
plan
to raise additional capital primarily through the offer and sale of shares
of
our common stock. However, given uncertain market conditions and the volatility
of our stock price and trading volume, we may not be able to sell our securities
at prices or on terms that are favorable to us, if at all.
In
addition to equity financing, we actively explore various other sources of
funding, including possible debt financing and leveraging our many assets,
including our intellectual property portfolio and the operations of Avid. Our
broad intellectual property portfolio allows us to develop products internally
while at the same time we are able to out-license certain areas of the
technology which would not interfere with our internal product development
efforts. We also have the facilities of Avid that we may leverage in a strategic
transaction if the right opportunity and financial terms are presented to us,
provided that the manufacturing needs of our customers and Peregrine are not
jeopardized.
There
can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all (from either debt, equity or the licensing,
partnering or sale of technology assets and/or the sale of all or a portion
of
Avid), or that sufficient additional revenues will be generated from Avid or
under potential licensing agreements to complete the research, development,
and
clinical testing of our product candidates beyond fiscal year 2006.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the three months ended July 31, 2005 compared to the same prior
year period 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 three months ended July 31, 2005, cash used in operating activities
increased $1,741,000 to $4,568,000 compared to $2,827,000 for the three months
ended July 31, 2004. The increase in cash used in operating activities was
primarily related to the timing of cash flows as reflected in the changes in
operating assets and payment or reduction of liabilities in the aggregate amount
of $712,000, the amount of which was further supplemented by an increase of
$621,000 in net cash used in operating activities after deducting non-cash
operating expenses and before considering the changes in operating assets and
liabilities. This increase was primarily due to an increase in general and
administrative expenses supplemented by an increase in research and development
expenses.
23
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:
THREE
MONTHS ENDED
|
|||||||
July
31,
2005
|
July
31,
2004
|
||||||
Net
loss, as reported
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
Less
non-cash operating expenses:
Depreciation
and amortization
Stock-based
compensation
Stock
issued for services
|
101,000
104,000
278,000
|
83,000
95,000
-
|
|||||
Net
cash used in operating activities before
changes
in operating assets and liabilities
|
$
|
(3,856,000
|
)
|
$
|
(3,235,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(712,000
|
)
|
$
|
408,000
|
||
Net
cash used in operating activities
|
$
|
(4,568,000
|
)
|
$
|
(2,827,000
|
)
|
Cash
Used In Investing Activities.
Net cash
used in investing activities increased $61,000 to $219,000 for the three months
ended July 31, 2005 compared to $158,000 for the three months ended July 31,
2004. This increase was primarily due to the purchase of laboratory equipment
to
support the expanded research efforts of Peregrine and the expanded services
of
Avid offset by a decrease in other assets related to prior quarter security
deposits paid to GE Capital Corporation on notes payable to finance laboratory
equipment.
Cash
Provided By Financing Activities.
Net cash
provided by financing activities increased $11,409,000 to $11,466,000 for the
three months ended July 31, 2005 compared to net cash provided of $57,000 for
the three months ended July 31, 2004. The increase in financing activities
during the current three month period is primarily due to proceeds received
under three separate security purchase agreements whereby we sold and issued
12,707,217 shares of our common stock in exchange for aggregate net proceeds
of
$11,256,000. This was supplemented by a current quarter increase in proceeds
received from notes payable in the amount of $267,000, the amount of which
was
offset by $57,000 in principal payments made on notes payable during the current
quarter.
Commitments
At
July
31, 2005, we had no material capital commitments. In addition, we have
significant obligations under license agreements that are contingent on clinical
trial development milestones. We currently anticipate clinical development
milestone obligation payments in the amount of $425,000 during the remainder
of
fiscal year 2006.
Risk
Factors of Our Company
The
biotechnology industry includes many risks and challenges. Our challenges may
include, but are not limited to: uncertainties associated with completing
pre-clinical and clinical trials for our technologies; the significant costs
to
develop our products as all of our products are currently in development,
pre-clinical studies or clinical trials and no revenue has been generated from
commercial product sales; obtaining additional financing to support our
operations and the development of our products; obtaining regulatory approval
for our technologies; complying with governmental regulations applicable to
our
business; obtaining the raw materials necessary in the development of such
compounds; consummating collaborative arrangements with corporate partners
for
product development; achieving milestones under collaborative arrangements
with
corporate partners; developing the capacity to manufacture, market, and sell
our
products, either directly or indirectly with collaborative partners; developing
market demand for and acceptance of such products; competing effectively with
other pharmaceutical and biotechnological products; attracting and retaining
key
personnel; protecting intellectual property rights; and accurately forecasting
operating and capital expenditures, other capital commitments, or clinical
trial
costs, and general economic conditions. A more detailed discussion regarding
our
industry and business risk factors can be found in our Annual Report on Form
10-K for the year ended April 30, 2005, as filed with the Securities and
Exchange Commission on July 14, 2005.
24
ITEM 3. |
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
Changes
in United States interest rates would affect the interest earned on our cash
and
cash equivalents. Based on our overall interest rate exposure at July 31, 2005,
a near-term change in interest rates, based on historical movements, would
not
materially affect the fair value of interest rate sensitive instruments. Our
debt instruments have fixed interest rates and terms and, therefore, a
significant change in interest rates would not have a material adverse effect
on
our financial position or results of operations.
ITEM
4.
|
CONTROLS
AND PROCEDURES
|
The
Company maintains disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e)) under the Securities Exchange Act of
1934,
as amended (the “Exchange Act”), that are designed to ensure that information
required to be disclosed in its reports filed under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and
communicated to our management, including its Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures,
management recognized that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, and management necessarily was required to apply
its
judgment in evaluating the cost-benefit relationship of possible controls and
procedures.
The
Company carried out an evaluation, under the supervision and with the
participation of management, including its Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of its
disclosure controls and procedures as of July 31, 2005, the end of the period
covered by this Quarterly Report. Based on that evaluation, the Company’s Chief
Executive Officer and Chief Financial Officer concluded that its disclosure
controls and procedures were effective at the reasonable assurance level as
of
July 31, 2005.
There
were no significant changes in the Company’s internal controls over financial
reporting, during the quarter ended July 31, 2005, that have materially
affected, or are reasonably likely to materially affect, the Company’s internal
controls over financial reporting.
PART
II OTHER INFORMATION
ITEM 1. |
LEGAL
PROCEEDINGS.
|
We
are a
party to various legal proceedings, including licensing and contract disputes
and other matters.
On
December 16, 2004, we filed a lawsuit against the University of Southern
California (“USC”) and Alan Epstein, M.D. The lawsuit was filed in the Superior
Court of the State of California for the County of Los Angeles, Central
District. The lawsuit alleges that USC has breached various agreements with
the
Company by (i) failing to protect the Company’s patent rights in Japan with
respect to certain technology exclusively licensed from USC due to non-payment
of annuities, (ii) failing to provide accounting documentation for research
expenditures, and (iii) misusing certain antibodies the Company provided to
USC
and Dr. Epstein for research. The claims against Dr. Epstein, who was a
scientific advisor and former consultant to the Company, involve breach of
contract for misusing certain antibodies and breach of fiduciary duties. The
Company is seeking unspecified damages, declaratory relief with respect to
its
rights under the option and license agreement pursuant to which it acquired
the
rights to the technology, and an accounting of research expenditures. Because
the lawsuit is ongoing, the final outcome of this matter cannot be determined
at
this time.
25
On
August
3, 2005, USC filed a cross-complaint against the Company relating to the
above-mentioned lawsuit. The cross-complaint alleges that the Company has
breached various agreements with USC by (i) breaching reporting and diligence
provisions of the option and license agreements, (ii) failing to make payments
under a sponsored research agreement, and (iii) failing to exercise its rights
under the product and option license agreement for hybridoma clones. USC is
seeking unspecified punitive damages with respect to its rights under the option
and license agreements and the sponsored research agreement. The Company
believes that the cross-complaint is erroneous and without merit and intends
to
contest it vigorously. The Company does not believe any such claim, proceeding,
or litigation, either alone or in the aggregate, will have a material adverse
effect on the Company's consolidated financial statements taken as a whole.
In
addition, we are in active discussions with USC, Dr. Epstein and Knobbe,
Martens, Olson & Bear, LLP to resolve the disputes through
mediation.
On
September 30, 2004, we filed a lawsuit against Knobbe, Martens, Olson &
Bear, LLP and Joseph Reisman, of the law firm Knobbe, Martens, Olson & Bear,
LLP, in San Diego Superior Court. This suit is related to USC’s above-mentioned
failure to protect patent rights in Japan. Accordingly, the case against the
Knobbe firm was dismissed in connection with receiving a tolling agreement
extending the statute of limitations on our claims against the firm while USC
pursues those claims.
In
addition, we are currently investigating whether certain technologies developed
at USC and subsequently licensed to a private company, Pivotal BioSciences,
Inc., an entity we believe is partially owned by the principal investigator
and
others at USC, were developed using resources under our sponsored
research agreement with USC and/or funding provided from another source for
which we have geographic technology rights. We are in active discussions with
Pivotal BioSciences, Inc. to resolve the matter in an amicable manner. The
current investigation does not affect our current rights to our technologies
under development nor should it have any effect, regardless of the outcome
of
the investigation, on the development of any of our existing
technologies.
ITEM
2.
|
CHANGES
IN SECURITIES AND USE OF PROCEEDS.
None.
|
ITEM 3. |
DEFAULTS
UPON SENIOR SECURITIES.
None.
|
ITEM 4. |
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
|
ITEM 5.
|
OTHER
INFORMATION.
None.
|
26
ITEM 6. |
EXHIBITS
AND REPORT ON FORM
8-K.
|
(a)
|
Exhibits:
|
31.1 |
31.2 |
Certification
of the 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.
|
(b)
|
Reports
on Form 8-K:
|
(i)
|
Current
report on Form 8-K as filed with the Commission on July 15, 2005
reporting
the Company’s financial results for the fiscal year ended April 30, 2005.
|
27
SIGNATURES
Pursuant
to the requirements 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.
By: /s/
STEVEN W. KING
Steven
W.
King
President
and Chief Executive Officer,
Director
/s/
PAUL J. LYTLE
Paul
J.
Lytle
Chief
Financial Officer
(signed
both as an
officer
duly authorized to sign on
behalf
of
the Registrant and principal
financial
officer and chief accounting
officer)
28