Avid Bioservices, Inc. - Quarter Report: 2005 October (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 October 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
|
174,044,349
shares of common stock as of December 5,
2005
|
PEREGRINE
PHARMACEUTICALS, INC.
Page
No.
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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.
ITEM 1. |
FINANCIAL
STATEMENTS
|
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
OCTOBER
31,
2005
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
11,902,000
|
$
|
9,816,000
|
|||
Trade
and other receivables, net of allowance for doubtful accounts of
$72,000
(October) and $69,000 (April)
|
491,000
|
486,000
|
|||||
Inventories
|
1,487,000
|
627,000
|
|||||
Prepaid
expenses and other current assets
|
877,000
|
1,197,000
|
|||||
Total
current assets
|
14,757,000
|
12,126,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
494,000
|
494,000
|
|||||
Laboratory
equipment
|
3,209,000
|
3,029,000
|
|||||
Furniture,
fixtures and computer equipment
|
684,000
|
647,000
|
|||||
4,387,000
|
4,170,000
|
||||||
Less
accumulated depreciation and amortization
|
(2,732,000
|
)
|
(2,532,000
|
)
|
|||
Property,
net
|
1,655,000
|
1,638,000
|
|||||
OTHER
ASSETS:
|
|||||||
Note
receivable, net of allowance of $1,475,000 (October) and $1,512,000
(April)
|
–
|
–
|
|||||
Other
|
554,000
|
481,000
|
|||||
Total
other assets
|
554,000
|
481,000
|
|||||
TOTAL
ASSETS
|
$
|
16,966,000
|
$
|
14,245,000
|
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
OCTOBER
31,
2005
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,161,000
|
$
|
1,325,000
|
|||
Accrued
clinical trial site fees
|
61,000
|
8,000
|
|||||
Accrued
legal and accounting fees
|
176,000
|
549,000
|
|||||
Accrued
royalties and license fees
|
152,000
|
149,000
|
|||||
Accrued
payroll and related costs
|
572,000
|
806,000
|
|||||
Notes
payable, current portion
|
325,000
|
234,000
|
|||||
Other
current liabilities
|
470,000
|
563,000
|
|||||
Deferred
revenue
|
1,060,000
|
517,000
|
|||||
Total
current liabilities
|
3,977,000
|
4,151,000
|
|||||
NOTES
PAYABLE
|
474,000
|
434,000
|
|||||
DEFERRED
LICENSE REVENUE
|
41,000
|
50,000
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDERS'
EQUITY:
|
|||||||
Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting; nil
shares
outstanding
|
–
|
–
|
|||||
Common
stock-$.001 par value; authorized 250,000,000 shares; outstanding
-
166,032,599 (October); 152,983,460 (April)
|
166,000
|
153,000
|
|||||
Additional
paid-in capital
|
191,611,000
|
180,011,000
|
|||||
Deferred
stock compensation
|
(590,000
|
)
|
(751,000
|
)
|
|||
Accumulated
deficit
|
(178,713,000
|
)
|
(169,803,000
|
)
|
|||
Total
stockholders' equity
|
12,474,000
|
9,610,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
16,966,000
|
$
|
14,245,000
|
|||
See
accompanying notes to condensed consolidated financial statements
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
||||||||||||
October
31,
2005
|
October
31,
2004
|
October
31,
2005
|
October
31,
2004
|
||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||
REVENUES:
|
|||||||||||||
Contract
manufacturing revenue
|
$
|
533,000
|
$
|
2,164,000
|
$
|
722,000
|
$
|
2,649,000
|
|||||
License
revenue
|
23,000
|
19,000
|
42,000
|
38,000
|
|||||||||
Total
revenues
|
556,000
|
2,183,000
|
764,000
|
2,687,000
|
|||||||||
COSTS
AND EXPENSES:
|
|||||||||||||
Cost
of contract manufacturing
|
428,000
|
1,544,000
|
732,000
|
1,992,000
|
|||||||||
Research
and development
|
3,244,000
|
3,004,000
|
6,036,000
|
5,574,000
|
|||||||||
Selling,
general and administrative
|
1,570,000
|
1,337,000
|
3,087,000
|
2,304,000
|
|||||||||
Total
costs and expenses
|
5,242,000
|
5,885,000
|
9,855,000
|
9,870,000
|
|||||||||
LOSS
FROM OPERATIONS
|
(4,686,000
|
)
|
(3,702,000
|
)
|
(9,091,000
|
)
|
(7,183,000
|
)
|
|||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||
Interest
and other income
|
128,000
|
64,000
|
204,000
|
132,000
|
|||||||||
Interest
and other expense
|
(13,000
|
)
|
–
|
(23,000
|
)
|
–
|
|||||||
NET
LOSS
|
$
|
(4,571,000
|
)
|
$
|
(3,638,000
|
)
|
$
|
(8,910,000
|
)
|
$
|
(7,051,000
|
)
|
|
WEIGHTED
AVERAGE SHARES
OUTSTANDING:
|
|||||||||||||
Basic
and Diluted
|
165,925,879
|
141,545,829
|
162,980,798
|
141,429,201
|
|||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.05
|
)
|
$
|
(0.05
|
)
|
|
See
accompanying notes to condensed consolidated financial statements
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
SIX
MONTHS ENDED
OCTOBER
31,
|
|||||||
2005
|
2004
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(8,910,000
|
)
|
$
|
(7,051,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
200,000
|
155,000
|
|||||
Stock-based
compensation
|
161,000
|
114,000
|
|||||
Stock
issued for research services
|
678,000
|
307,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
(5,000
|
)
|
739,000
|
||||
Inventories
|
(860,000
|
)
|
(617,000
|
)
|
|||
Prepaid
expenses and other current assets
|
(37,000
|
)
|
106,000
|
||||
Accounts
payable
|
(164,000
|
)
|
353,000
|
||||
Accrued
clinical trial site fees
|
53,000
|
(33,000
|
)
|
||||
Deferred
revenue
|
534,000
|
126,000
|
|||||
Accrued
payroll and related costs
|
(234,000
|
)
|
83,000
|
||||
Other
accrued expenses and current liabilities
|
(463,000
|
)
|
265,000
|
||||
Net
cash used in operating activities
|
(9,047,000
|
)
|
(5,453,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(217,000
|
)
|
(203,000
|
)
|
|||
Increase
in other assets
|
(73,000
|
)
|
(199,000
|
)
|
|||
Net
cash used in investing activities
|
(290,000
|
)
|
(402,000
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of notes payable
|
267,000
|
–
|
|||||
Principal
payments on notes payable
|
(136,000
|
)
|
–
|
||||
Proceeds
from issuance of common stock, net of issuance costs of $46,000
(October
2005) and $15,000 (October 2004)
|
11,292,000
|
1,296,000
|
|||||
Net
cash provided by financing activities
|
11,423,000
|
1,296,000
|
|||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
2,086,000
|
(4,559,000
|
)
|
||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
9,816,000
|
14,884,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$
|
11,902,000
|
$
|
10,325,000
|
|||
NON-CASH
FINANCING ACTIVITIES:
|
|||||||
Common
stock issued for research fees and prepayments for future
research
services
|
$
|
321,000
|
$
|
–
|
|||
See
accompanying notes to condensed consolidated financial statements
PEREGRINE
PHARMACEUTICALS, INC.
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 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
October 31, 2005, and the condensed consolidated results of our operations
and
our condensed consolidated cash flows for the three and six month periods ended
October 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
October 31, 2005, we had $11,902,000 in cash and cash equivalents on hand.
In
addition, we received an additional $6,720,000 in net proceeds from the sale
of
shares of our common stock under a Common Stock Purchase Agreement dated
November 23, 2005 (Note 6). As of November 30, 2005, including the $6,720,00
in
proceeds from the Common Stock Purchase Agreement dated November 23, 2005,
we
had $17,011,000 in cash and cash equivalents. 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 six months ended October 31, 2005 and 2004 amounted
to
$722,000 and $2,649,000, 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.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
We
plan
to raise additional capital primarily through the registered offer and sale
of
shares of our common stock from our shelf registration statements on Form S-3,
which as of December 5, 2005, we had an aggregate of approximately 4,576,000
shares available for possible future registered transactions. 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 explore various other sources of funding,
including possible debt financing and leveraging our many assets, including
our
intellectual property portfolio. Our broad intellectual property portfolio
allows us to develop products internally while at the same time we are able
to
out-license certain areas of the technology which would not interfere with
our
internal product development efforts.
There
can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all (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 our quarter ending October
31,
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 years 2005 and 2006, 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 October 31, 2005,
prepaid expenses and other current assets include $650,000 in research and
development services prepaid in shares of our common stock.
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 October 31, 2005
and
April 30, 2005:
October
31,
2005
|
April
30,
2005
|
||||||
Raw
materials
|
$
|
547,000
|
$
|
445,000
|
|||
Work-in-process
|
940,000
|
182,000
|
|||||
Total
inventories
|
$
|
1,487,000
|
$
|
627,000
|
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
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.
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.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
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.
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 calculated in accordance
with the treasury stock method, but are excluded if their effect is
anti-dilutive.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 3,140,081
and 3,205,261 shares
of
common stock for the three and six months ended October 31, 2005,
respectively, and 7,645,598
and 7,886,527 shares
of
common stock for the three and six months ended October 31, 2004,
respectively, as the impact
of
options and warrants are anti-dilutive during periods of net loss.
The
calculation of weighted average diluted shares outstanding also excludes options
and warrants to purchase up to 14,516,913 and 14,621,138 shares of common stock
for the three and six months ended October 31, 2005, respectively, and
12,084,093 and 11,427,939 shares of common stock for the three and six months
ended October 31, 2004, respectively, as the exercise price of those
options was greater than the average market price of our common stock during
the
respective periods, resulting in an anti-dilutive effect.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
On
November 23, 2005, we entered into a Common Stock Purchase Agreement
with one
institutional investor whereby we sold 8,000,000 shares of our common
stock for
gross proceeds of $6,720,000 (Note 6), which additional shares have
been
excluded from basic and dilutive net loss per common share for the
three and six
months ended October 31, 2005.
Stock-Based
Compensation
- In
December 2002, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards No. 148 (“SFAS No. 148”),
Accounting
for Stock-Based Compensation-Transition and Disclosure.
SFAS No. 148 amends SFAS No. 123 (“SFAS No. 123”), Accounting
for Stock-Based Compensation,
and
provides alternative methods of transition for a voluntary change to
the fair
value based method of accounting for stock-based employee compensation. In
addition, SFAS No. 148 amends the disclosure requirements of SFAS No.
123 to
require prominent disclosures in both annual and interim financial
statements
about the method of accounting for stock-based employee compensation,
and the
effect of the method used on reported results.
We
have
not adopted a method under SFAS No. 148 to expense stock options, but rather
we
continue to apply the provisions of SFAS No. 123; however, we have adopted
the
additional disclosure provisions of the statement. As SFAS No. 123 permits,
we
elected to continue accounting for our employee stock options in accordance
with
Accounting Principles Board Opinion No. 25 (“APB No. 25”), Accounting
for Stock Issued to Employees and Related Interpretations.
APB No.
25 requires compensation expense to be recognized for stock options when the
market price of the underlying stock exceeds the exercise price of the stock
option on the date of the grant.
We
utilize the guidelines in APB No. 25 for measurement of stock-based transactions
for employees and, accordingly, no compensation expense has been recognized
for
the options in the accompanying condensed consolidated financial statements
for
the three and six months ended October 31, 2005 and October 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
|
SIX
MONTHS ENDED
|
||||||||||||
October
31,
2005
|
October
31,
2004
|
October
31,
2005
|
October
31,
2004
|
||||||||||
Net
loss, as reported
|
$
|
(4,571,000
|
)
|
$
|
(3,638,000
|
)
|
$
|
(8,910,000
|
)
|
$
|
(7,051,000
|
)
|
|
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
|
(570,000
|
)
|
(718,000
|
)
|
(1,213,000
|
)
|
(1,508,000
|
)
|
|||||
Pro
forma net loss as if the fair value based method had been applied
to all
awards
|
$
|
(5,141,000
|
)
|
$
|
(4,356,000
|
)
|
$
|
(10,123,000
|
)
|
$
|
(8,559,000
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.05
|
)
|
$
|
(0.05
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.06
|
)
|
$
|
(0.06
|
)
|
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
Stock-based
compensation expense recorded during the three and six months ended
October 31,
2005 and October 31, 2004 relate to stock option grants issued to non-employee
consultants. The fair value of these options are measured utilizing
the
Black-Scholes option valuation model and are being amortized over the
estimated
period of service or related vesting period in accordance with the
provisions of
SFAS No. 123 and EITF 96-18, Accounting
for Equity Instruments That Are Issued to Other Than Employees for
Acquiring, or
in Conjunction with Selling, Goods or Services.
Stock-based compensation expense recorded during the three and six
months ended
October 31, 2005 amounted to $57,000 and $161,000, respectively. Stock-based
compensation expense recorded during the three and six months ended
October 31,
2004 amounted to $19,000 and $114,000, 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.
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 our common stock decreases,
then
decreases in compensation expense would be recognized, limited to the net
expense previously reported. During the three and six months ended October
31,
2005 and October 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
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
153 (“SFAS No. 153”), Exchanges
of Nonmonetary Assets - An Amendment of APB Opinion No. 29, Accounting for
Nonmonetary Transactions.
SFAS
No. 153 eliminates the exception from fair value measurement for nonmonetary
exchanges of similar productive assets in paragraph 21(b) of APB Opinion No.
29,
Accounting
for Nonmonetary Transactions,
and
replaces it with an exception for exchanges that do not have commercial
substance. SFAS No. 153 specifies that a nonmonetary exchange has commercial
substance if the future cash flows of the entity are expected to change
significantly as a result of the exchange. SFAS No. 153 is effective for
the fiscal periods beginning after June 15, 2005 and we would be required
to adopt this standard no later than May 1, 2006. The adoption of SFAS No.
153
is not expected to have a material impact on our consolidated financial position
and results of operations.
PEREGRINE PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
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 our quarter ending October 31, 2006, the carrying value of
the
note receivable approximates its fair value at October 31, 2005. We have
received all payments to date under the note receivable.
The
following represents a rollforward of the allowance of the note receivable
for
the six months ended October 31, 2005:
Allowance
balance, April 30, 2005
|
$
|
1,581,000
|
||
Principal
payments received
|
(34,000
|
)
|
||
Allowance
balance, October 31, 2005
|
$
|
1,547,000
|
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 a second 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.
PEREGRINE PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
During
June 2005, we entered into a third 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
October 31, 2005, we owed GE an aggregate amount of $799,000 under all note
payable agreements. Minimum future principal payments on notes payable as of
October 31, 2005 are as follows:
Year
ending April 30:
|
||||
2006
|
$
|
160,000
|
||
2007
|
336,000
|
|||
2008
|
279,000
|
|||
2009
|
24,000
|
|||
Total
|
$
|
799,000
|
5. |
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. However, a tentative settlement of most and potentially all of these
claims are currently being negotiated following non-binding mediation held
on
October 21, 2005.
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.
The
claims asserted by USC against the Company are included in the mediation
discussions described above and will be dismissed by USC with prejudice at
such
time as a settlement agreement is finalized.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
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. Our pending discussions with USC include a negotiation
and
potential resolution of the claims that were asserted in this
action.
In
addition, we have been 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 have determined that we do not have any
specific rights to technology licensed by USC to Pivotal, although a part of
our
dispute with USC is whether the Principal Investigator applied our funds paid
to
his laboratory under our Sponsored Research Agreement with USC in order to
develop technology that is benefiting Pivotal Biosciences. Resolution of that
dispute with USC is a part of the negotiations of the litigation with USC
described above. In addition, we initiated discussions with Pivotal Biosciences,
Inc. to verify whether our rights to materials loaned to the Principal
Investigator but being utilized by him in connection with technology licensed
by
Pivotal from USC, was impacted. Pivotal has provided us written assurances
that
it does not have any of our materials and would not attempt to make use of
our
materials commercially without our consent or that of our licensee.
6. |
STOCKHOLDERS’
EQUITY
|
During
the six months ended October 31, 2005, we entered into various financing
transactions 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
|
||||
Common
stock issued to an unrelated entity for research services
|
299,422
|
$
|
321,000
|
||||
13,006,639
|
$
|
11,577,000
|
In
addition, we filed a registration statement on Form S-3, File Number 333-128322
during September 2005, 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 12,000,000 shares of our common stock (“September 2005 Shelf”).
As of October 31, 2005, all 12,000,000 shares of common stock were available
for
issuance under the September 2005 Shelf.
On
November 23, 2005, we entered into a Common Stock Purchase Agreement with one
institutional investor whereby we agreed to sell 8,000,000 shares of our common
stock under the September 2005 Shelf at the per share price of $0.84 (“November
23, 2005 Financing”) in exchange for net proceeds of $6,720,000. We paid no
commissions nor issued any warrants in connection with the November 23, 2005
Financing.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
As
of
December 5, 2005, we had an aggregate of 4,575,578 shares of common stock
available for future issuance under two 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
34,911,753 shares of our common stock at October 31, 2005 for possible future
issuance, calculated as follows:
Number
of Shares of Common Stock Reserved For Issuance
|
||||
Shares
reserved under shelf registration statements
|
4,575,578
|
|||
Options
issued and outstanding
|
11,114,831
|
|||
Options
available for future grant
|
5,679,548
|
|||
Warrants
issued and outstanding
|
13,541,796
|
|||
Total
shares reserved
|
34,911,753
|
On
December 1, 2005, warrants to purchase 3,825,000 and 1,000,000 shares of our
common stock at the exercise price of $3.00 and $5.00, respectively, expired
unexercised.
7. |
STOCK
OPTIONS
|
As
of
October 31, 2005, options to purchase up to 11,114,831 shares of our common
stock were issued and outstanding and exercisable under all of our option plans
at prices ranging between $0.34 and $5.28 per share with an average exercise
price of $1.58 per share and expire at various dates through October 24,
2015.
During
October 2005, our stockholders approved the 2005 Stock Incentive Plan (“2005
Plan”) for the granting of options to purchase up to 5,000,000 shares of our
common stock. The 2005 Plan provides for the granting of options to purchase
shares of our common stock at prices not less than its fair market value at
the
date of grant and which generally expire ten years after the date of grant.
As
of October 31, 2005, options to purchase up to 5,679,548 shares of common stock
were available for future grant under all stock option plans.
8. |
WARRANTS
|
As
of
October 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. On December 1, 2005, warrants
to
purchase 3,825,000 and 1,000,000 shares of our common stock at the exercise
price of $3.00 and $5.00, respectively, expired unexercised.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
9. |
SEGMENT
REPORTING
|
Our
business is organized into two reportable operating segments. Peregrine is
engaged in the research and development of targeted therapeutics for the
treatment of viruses and cancer. 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 October 31, 2005 and October 31, 2004 is
summarized as follows:
Three
Months Ended October 31,
|
|||||||
2005
|
2004
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
533,000
|
$
|
2,164,000
|
|||
Research
and development of biotherapeutics
|
23,000
|
19,000
|
|||||
Total
net revenues
|
$
|
556,000
|
$
|
2,183,000
|
|||
Gross
Profit:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
105,000
|
$
|
620,000
|
|||
Research
and development of biotherapeutics
|
23,000
|
19,000
|
|||||
Total
gross profit
|
128,000
|
639,000
|
|||||
Research
and development expense of biotherapeutics
|
(3,244,000
|
)
|
(3,004,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,570,000
|
)
|
(1,337,000
|
)
|
|||
Other
income, net
|
115,000
|
64,000
|
|||||
Net
loss
|
$
|
(4,571,000
|
)
|
$
|
(3,638,000
|
)
|
|
Net
revenues generated from Avid during the three months ended October 31, 2005
and
October 31, 2004 were primarily from two customers located in the U.S and one
customer headquartered in Israel as follows:
Three
Months Ended October 31,
|
|||||||
2005
|
2004
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
97%
|
|
46%
|
|
|||
United
States (customer B)
|
2%
|
|
16%
|
|
|||
Israel
(one customer)
|
1%
|
|
38%
|
|
|||
Total
customer revenues as a % of net revenues
|
100%
|
|
100%
|
|
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
Segment
information for six months ended October 31, 2005 and October 31, 2004 is
summarized as follows:
Six
Months Ended October 31,
|
|||||||
2005
|
2004
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
722,000
|
$
|
2,649,000
|
|||
Research
and development of biotherapeutics
|
42,000
|
38,000
|
|||||
Total
net revenues
|
$
|
764,000
|
$
|
2,687,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
(10,000
|
)
|
$
|
657,000
|
||
Research
and development of biotherapeutics
|
42,000
|
38,000
|
|||||
Total
gross profit
|
32,000
|
695,000
|
|||||
Research
and development expense of biotherapeutics
|
(6,036,000
|
)
|
(5,574,000
|
)
|
|||
Selling,
general and administrative expense
|
(3,087,000
|
)
|
(2,304,000
|
)
|
|||
Other
income, net
|
181,000
|
132,000
|
|||||
Net
loss
|
$
|
(8,910,000
|
)
|
$
|
(7,051,000
|
)
|
|
Net
revenues generated from Avid during the six months ended October 31, 2005 and
October 31, 2004 were primarily from three customers located in the U.S and
one
customer headquartered in Israel as follows:
Six
Months Ended October 31,
|
|||||||
2005
|
2004
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
82%
|
|
45%
|
|
|||
United
States (customer B)
|
6%
|
|
13%
|
|
|||
United
States (customer C)
|
10%
|
|
0%
|
|
|||
Israel
(one customer)
|
2%
|
|
41%
|
|
|||
Other
customers
|
0%
|
|
1%
|
|
|||
Total
customer revenues as a % of net revenues
|
100%
|
|
100%
|
|
Long-lived
assets consist of the following at October 31, 2005 and April 30,
2005:
October
31,
2005
|
April
30,
2005
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,336,000
|
$
|
1,291,000
|
|||
Research
and development of biotherapeutics
|
319,000
|
347,000
|
|||||
Total
long-lived assets, net
|
$
|
1,655,000
|
$
|
1,638,000
|
|||
Net
revenues generated from Peregrine during the three and six months ended October
31, 2005 and October 31, 2004 were primarily from the amortized portion of
the
up-front license fees under the December 2002 license agreement with Schering
A.G.
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)
10. |
SUBSEQUENT
EVENTS
|
On
November 18, 2005, we entered into a fourth note payable agreement with GE
in
the amount of approximately $103,000 collateralized by certain laboratory
equipment. The note bears interest at a rate of 6.63% per annum with payments
due monthly in the amount of approximately $3,000 over 36 months commencing
January 1, 2006. Under the terms of the agreement, we paid to GE a security
deposit of 25%, or approximately $26,000, which is due and payable to us at
the
end of the note term.
On
November 23, 2005, we entered into a Common Stock Purchase Agreement with one
institutional investor whereby we sold 8,000,000 shares of our common stock
at
the per share price of $0.84 in exchange for net proceeds of $6,720,000 (Note
6).
ITEM2. |
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
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.
We
are a
biopharmaceutical company primarily developing targeted therapeutics directed
towards the treatment of viruses and cancer using 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 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.
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 following clinical sites: MD Anderson Cancer Center
in Houston, Texas; Arizona Cancer Center in Tucson,
Arizona; Premiere Oncology in Scottsdale, Arizona; Premiere
Oncology in Santa Monica, California and; Scott & White
Hospital & Clinic in Temple, Texas.
|
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.
|
Results
of Operations
The
following table compares the unaudited condensed consolidated statements of
operations for the three and six-month periods ended October 31, 2005 and
October 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
October
31,
|
Six
Months Ended
October
31,
|
||||||||||||||||||
2005
|
2004
|
$
Change
|
2005
|
2004
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing revenue
|
$
|
533
|
$
|
2,164
|
$
|
(1,631
|
)
|
$
|
722
|
$
|
2,649
|
$
|
(1,927
|
)
|
|||||
License
revenue
|
23
|
19
|
4
|
42
|
38
|
4
|
|||||||||||||
Total
revenues
|
556
|
2,183
|
(1,627
|
)
|
764
|
2,687
|
(1,923
|
)
|
|||||||||||
COST
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
428
|
1,544
|
(1,116
|
)
|
732
|
1,992
|
(1,260
|
)
|
|||||||||||
Research
and development
|
3,244
|
3,004
|
240
|
6,036
|
5,574
|
462
|
|||||||||||||
Selling,
general and administrative
|
1,570
|
1,337
|
233
|
3,087
|
2,304
|
783
|
|||||||||||||
Total
cost and expenses
|
5,242
|
5,885
|
(643
|
)
|
9,855
|
9,870
|
(15
|
)
|
|||||||||||
LOSS
FROM OPERATIONS
|
(4,686
|
)
|
(3,702
|
)
|
(984
|
)
|
(9,091
|
)
|
(7,183
|
)
|
(1,908
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Interest
and other income
|
128
|
64
|
64
|
204
|
132
|
72
|
|||||||||||||
Interest
and other expense
|
(13
|
)
|
-
|
(13
|
)
|
(23
|
)
|
-
|
(23
|
)
|
|||||||||
NET
LOSS
|
$
|
(4,571
|
)
|
$
|
(3,638
|
)
|
$
|
(933
|
)
|
$
|
(8,910
|
)
|
$
|
(7,051
|
)
|
$
|
(1,859
|
)
|
|
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.
Three
and
Six Months: The decrease in total revenues of $1,627,000 and $1,923,000 during
the three and six months ended October 31, 2005, respectively, compared to
the
same periods in the prior year was primarily due to a decrease in contract
manufacturing revenue of $1,631,000 and $1,927,000, respectively. The decrease
in contract manufacturing revenue was primarily due to a decrease in the number
of completed manufacturing runs associated with unrelated entities compared
to
the same three and six-month periods in the prior year. In addition, during
the
three and six months ended October 31, 2005, we significantly increased our
utilization of our manufacturing facility to manufacture clinical grade
materials to support Peregrine’s three active clinical trials and other products
under development.
We
expect
to continue to generate contract manufacturing revenue during 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 several active
projects for unrelated entities and has submitted project proposals with various
potential customers, we cannot estimate nor can we determine the likelihood
that
we will be successful in completed these ongoing projects or converting any
of
these outstanding project proposals into definitive agreements during the
remainder of fiscal year 2006.
Cost
of Contract Manufacturing.
Three
and
Six Months: The decrease in cost of contract manufacturing of $1,116,000 and
$1,260,000 during the three and six months ended October 31, 2005, respectively,
compared to the same periods in the prior year was primarily related to the
current year three and six-month period decreases in contract manufacturing
revenue. However, the six month decrease in cost of contract manufacturing
was
offset by additional costs incurred during the first quarter of the current
year
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.
Research
and Development Expenses.
Three
Months: The increase in research and development expenses of $240,000 during
the
three months ended October 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:
Anti-Phospholipid
Therapy (Tarvacin™) - During
the three months ended October 31, 2005, Anti-Phospholipid Therapy (Tarvacin™)
program expenses increased $1,240,000 from $1,274,000 in fiscal year 2005 to
$2,514,000 in fiscal year 2006. The increase in Anti-Phospholipid
Therapy (Tarvacin™)
program expenses of $1,240,000 is primarily due to an increase in manufacturing
expenses and various clinical trial expenses to support 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 technology
access fees associated with Tarvacin™ Phase I clinical trial milestones achieved
during the current quarter in accordance with third party licensing agreements.
These increases were supplemented with an increase in sponsored research fees
and payroll and related expenses 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
Investigational New Drug (“IND”) applications that were filed for Tarvacin™ in
the prior fiscal year with the U.S. Food & Drug Administration combined with
a decrease in antibody development fees regarding an up-front technology access
fee incurred in the prior year quarter under an antibody research collaboration
for the generation of a human antibody under our Anti-Phospholipid Therapy
technology platform.
Tumor
Necrosis Therapy (“TNT”) (Cotara®) -
During
the three months ended October 31, 2005, TNT (Cotara®) program expenses
decreased $433,000 from $734,000 in fiscal year 2005 to $301,000 in fiscal
year
2006. The decrease in TNT (Cotara®) program expenses of $433,000 is primarily
due to a decrease in payroll and related expenses and radiolabeling process
development expenses incurred in the prior year to support the initiation of
the
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 other development programs associated with our TNT
technology platform. These decreases were further supplemented by a decrease
in
technology access fees incurred in the same prior year quarter supporting the
production of monoclonal antibodies for the Cotara® antibody.
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis - During
the three months ended October 31, 2005, VTA and Anti-Angiogenesis program
expenses decreased $535,000 from $880,000 in fiscal year 2005 to $345,000 in
fiscal year 2006. The decrease in VTA and Anti-Angiogenesis program expenses
of
$535,000 is primarily due to a decrease in intellectual property access fees,
sponsored research fees, and technology access fees associated with VTA
development.
Vasopermeation
Enhancements Agents (“VEAs”) - During
the three months ended October 31, 2005, VEA program expenses decreased $28,000
from $112,000 in fiscal year 2005 to $84,000 in fiscal year 2006. The decrease
in VEA program expenses of $28,000 is primarily due to a decrease in
manufacturing development expenses. 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.
Six
Months: The increase in research and development expenses of $462,000 during
the
six months ended October 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:
Anti-Phospholipid
Therapy (Tarvacin™) - During
the six months ended October 31, 2005, Anti-Phospholipid Therapy (Tarvacin™)
program expenses increased $1,539,000 from $2,545,000 in fiscal year 2005 to
$4,084,000 in fiscal year 2006. The increase in Anti-Phospholipid
Therapy (Tarvacin™)
program expenses of $1,539,000 is primarily due to an increase in manufacturing
expenses and various clinical trial expenses to support 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 technology
access fees associated with Tarvacin™ Phase I clinical trial milestones achieved
during the current year in accordance with third party licensing agreements.
These increases were supplemented with an increase in sponsored research fees
and payroll and related expenses associated with Anti-Phospholipid Therapy
development. These increases were primarily offset by a decrease in pre-clinical
toxicology study expenses incurred in the prior year 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 antibody development fees regarding an up-front technology access
fee incurred in the prior year under an antibody research collaboration for
the
generation of a human antibody under our Anti-Phospholipid Therapy technology
platform.
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis -
During
the six months ended October 31, 2005, VTA and Anti-Angiogenesis program
expenses decreased $788,000 from $1,484,000 in fiscal year 2005 to $696,000
in
fiscal year 2006. The decrease in VTA and Anti-Angiogenesis program expenses
of
$788,000 is primarily due to a decrease in intellectual property access fees,
sponsored research fees, and technology access fees associated with VTA
development.
Vasopermeation
Enhancements Agents (“VEAs”) - During
the six months ended October 31, 2005, VEA program expenses decreased $222,000
from $408,000 in fiscal year 2005 to $186,000 in fiscal year 2006. The decrease
in VEA program expenses of $222,000 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.
Tumor
Necrosis Therapy (“TNT”) (Cotara®)
- During
the six months ended October 31, 2005, TNT (Cotara®) program expenses decreased
$55,000 from $1,124,000 in fiscal year 2005 to $1,069,000 in fiscal year 2006.
The decrease in TNT (Cotara®) program expenses of $55,000 is primarily due to a
decrease in payroll and related expenses and radiolabeling process development
expenses incurred in the same prior year period to support the initiation of
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 other development programs associated with our TNT
technology platform. These decreases were further supplemented by a decrease
in
technology access fees incurred in the same prior year period supporting the
production of monoclonal antibodies for the Cotara®. These decreases in expenses
were offset by an increase in manufacturing expenses incurred to support the
TNT
development program.
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.
|
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
October
31, 2004
|
R&D
Expenses-Quarter Ended
October
31, 2005
|
R&D
Expenses-
May
1, 1998 to
October
31, 2005
|
|||||||
TNT
(Cotara®)
|
$
|
734,000
|
$
|
301,000
|
$
|
29,885,000
|
||||
Anti-Phospholipid
Therapy (Tarvacin™)
|
1,274,000
|
2,514,000
|
11,967,000
|
|||||||
VTA
and Anti-Angiogenesis
|
880,000
|
345,000
|
11,451,000
|
|||||||
VEA
|
112,000
|
84,000
|
5,554,000
|
|||||||
Other
research programs
|
4,000
|
-
|
13,441,000
|
|||||||
Total
R&D Expenses
|
$
|
3,004,000
|
$
|
3,244,000
|
$
|
72,298,000
|
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 our quarter ending October 31, 2006;
|
§ |
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.
|
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.
Three
Months: The increase in selling, general and administrative expenses of $233,000
during the three months ended October 31, 2005 compared to the same period
in
the prior year is primarily due to an increase in (i) legal fees of $92,000
from
$86,000 in fiscal year 2005 to $178,000 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, (ii) investor and public
relation fees increased $79,000 from $73,000 in fiscal year 2005 to $152,000
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, and (iii) stock-based
compensation expense of $41,000 from zero expense in fiscal year 2005 to $41,000
in fiscal year 2006 due to the amortization expenses associated with the fair
value of stock options granted to non-employee consultants performing business
development activities.
Six
Months: The increase in selling, general and administrative expenses of $783,000
during the six months ended October 31, 2005 compared to the same period in
the
prior year is primarily due to an increase in (i) legal fees of $211,000 from
$159,000 in fiscal year 2005 to $370,000 in fiscal year 2006 primarily
pertaining to the general corporate matters and litigation matters described
in
the Quarterly Report on Form 10-Q under Part II, Item 1, Legal Proceedings,
(ii)
payroll and related expenses of $176,000 from $1,133,000 in fiscal year 2005
to
$1,309,000 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, (iii) investor and public relation fees increased $128,000
from $99,000 in fiscal year 2005 to $227,000 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, (iv) travel and related expenses of $99,000 from
$104,000 in fiscal year 2005 to $203,000 in fiscal year 2006 related primarily
to Peregrine’s increased business development activities, (v) director fees of
$85,000 from $124,000 in fiscal year 2005 to $209,000 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) audit and
accounting fees of $65,000 from $111,000 in fiscal year 2005 to $176,000 in
fiscal year 2006 primarily related to the implementation of Section 404 of
the
Sarbanes-Oxley Act of 2002.
Interest
and Other Income.
Three
and
Six Months: The increase in interest and other income of $64,000 and $72,000
during the three and six months ended October 31, 2005, respectively, compared
to the same periods in the prior year was primarily due to an increase in
interest income as a result of a higher average cash balance on hand and higher
prevailing interest rates during the current year compared to the same prior
year period.
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.
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
October 31, 2005, we had $11,902,000 in cash and cash equivalents on hand.
In
addition, we received an additional $6,720,000 in net proceeds from the sale
of
shares of our common stock under a Common Stock Purchase Agreement dated
November 23, 2005. As of November 30, 2005, including the $6,720,00 in proceeds
from the Common Stock Purchase Agreement dated November 23, 2005, we had
$17,011,000 in cash and cash equivalents. Although we have sufficient cash
on
hand to meet our current planned obligations through our quarter ending October
31, 2006, our development efforts are dependent on our ability to raise
additional capital to support our future operations.
We
have
expended substantial funds on the development of our product candidates and
we
have incurred negative cash flows from operations for the majority of our years
since inception. Since inception, we have generally financed our operations
primarily through the sale of our common stock and issuance of convertible
debt,
which has been supplemented with payments received from various licensing
collaborations and through the revenues generated by Avid. We expect negative
cash flows from operations to continue until we are able to generate sufficient
revenue from the contract manufacturing services provided by Avid and/or from
the sale and/or licensing of our products under development.
Revenues
earned by Avid during the six months ended October 31, 2005 and 2004 amounted
to
$722,000 and $2,649,000, 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 registered offer and sale
of
shares of our common stock from our shelf registration statements on Form S-3,
which as of December 5, 2005, we had an aggregate of approximately 4,576,000
shares available for possible future registered transactions. However, given
uncertain market conditions and the volatility of our stock price and trading
volume, we may not be able to sell our securities at prices or on terms that
are
favorable to us, if at all.
In
addition to equity financing, we actively explore various other sources of
funding, including possible debt financing and leveraging our many assets,
including our intellectual property portfolio. Our broad intellectual property
portfolio allows us to develop products internally while at the same time we
are
able to out-license certain areas of the technology which would not interfere
with our internal product development efforts.
There
can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all (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 for our quarter ending October 31,
2006.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the six months ended October 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 six months ended October 31, 2005, cash used in operating activities
increased $3,594,000 to $9,047,000 compared to $5,453,000 for the six months
ended October 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 $2,198,000, the amount of which was further supplemented by an increase
of
$1,396,000 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 a decrease in contract
manufacturing revenue combined with an increase in research and development
expenses and general and administrative expenses.
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:
SIX
MONTHS ENDED
|
|||||||
October
31,
2005
|
October
31,
2004
|
||||||
Net
loss, as reported
|
$
|
(8,910,000
|
)
|
$
|
(7,051,000
|
)
|
|
Less
non-cash operating expenses:
|
|||||||
Depreciation
and amortization
|
200,000
|
155,000
|
|||||
Stock-based
compensation
|
161,000
|
114,000
|
|||||
Common
stock issued for services
|
678,000
|
307,000
|
|||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(7,871,000
|
)
|
$
|
(6,475,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(1,176,000
|
)
|
$
|
1,022,000
|
||
Net
cash used in operating activities
|
$
|
(9,047,000
|
)
|
$
|
(5,453,000
|
)
|
Cash
Used In Investing Activities.
Net cash
used in investing activities decreased $112,000 to $290,000 for the six months
ended October 31, 2005 compared to $402,000 for the six months ended October
31,
2004. Cash used in investing activities during the six months ended October
31,
2005 was primarily due to the purchase of laboratory equipment to support the
continued research and development efforts of Peregrine and the expanded
manufacturing services of Avid combined with an increase in security deposits
paid to GE Capital Corporation on notes payable to finance the purchase of
laboratory equipment. Cash used in investing activities during the six months
ended October 31, 2004 was primarily due to the purchase of laboratory equipment
combined with installment payments made on a 1,000-liter
bioreactor.
Cash
Provided By Financing Activities.
Net cash
provided by financing activities increased $10,127,000 to $11,423,000 for the
six months ended October 31, 2005 compared to net cash provided of $1,296,000
for the six months ended October 31, 2004. Cash provided by financing activities
during the six months ended October 31, 2005, was 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 six-month increase
in proceeds received from notes payable in the amount of $267,000, the amount
of
which was offset by $136,000 in principal payments made on notes payable during
the current six-month period. Cash provided by financing activities during
the
six months ended October 31, 2004, was primarily due to proceeds received under
a security purchase agreement whereby we sold and issued 1,000,000 shares of
our
common stock in exchange for aggregate net proceeds of $1,238,000.
Commitments
At
October 31, 2005, we had no material capital commitments, other than the
commitments for laboratory equipment in the amount of approximately $100,000.
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.
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 October 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.
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 October 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
October 31, 2005.
There
were no significant changes in the Company’s internal controls over financial
reporting, during the quarter ended October 31, 2005, that have materially
affected, or are reasonably likely to materially affect, the Company’s internal
controls over financial reporting.
ITEM 1. |
LEGAL
PROCEEDINGS.
|
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. However, a tentative settlement of most and potentially all of these
claims are currently being negotiated following non-binding mediation held
on
October 21, 2005.
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.
The
claims asserted by USC against the Company are included in the mediation
discussions described above and will be dismissed by USC with prejudice,
provided a settlement agreement is finalized.
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. Our pending discussions with USC include a negotiation
and
potential resolution of the claims that were asserted in this
action.
In
addition, we have been 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 have determined that we do not
have any specific rights to technology licensed by USC to Pivotal, although
a
part of our dispute with USC is whether the Principal Investigator applied
our
funds paid to his laboratory under our Sponsored Research Agreement with USC
in
order to develop technology that is benefiting Pivotal Biosciences. Resolution
of that dispute with USC is a part of the negotiations of the litigation with
USC described above. In addition, we initiated discussions with Pivotal
Biosciences, Inc. to verify whether our rights to materials loaned to the
Principal Investigator but being utilized by him in connection with technology
licensed by Pivotal from USC, was impacted. Pivotal has provided us written
assurances that it does not have any of our materials and would not attempt
to
make use of our materials commercially without our consent or that of our
licensee.
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.
|
We
held
our annual meeting of stockholders’ on October 24, 2005. The following
represents the matters voted upon and the results of the voting:
Routine
Matters
|
For
|
Against
or Withheld
|
||||||
1) |
Election
of Directors:
|
|||||||
Carlton
M. Johnson
|
138,710,144
|
4,979,764
|
||||||
Steven
W. King
|
139,864,463
|
3,825,445
|
||||||
David
Pohl
|
139,366,179
|
4,323,729
|
||||||
Eric
Swartz
|
139,382,032
|
4,307,876
|
||||||
Dr.
Thomas Waltz
|
140,021,781
|
3,668,127
|
||||||
2) |
To
ratify the appointment of Ernst & Young LLP as independent auditors of
the Company for the fiscal year ending April 30, 2006.
|
145,126,370
|
1,363,457
|
|||||
3) |
To
approve an amendment to the Company’s Certificate of Incorporation to
increase the number of authorized shares of the Company’s common stock
from 200 million to 250 million.
|
138,592,173
|
7,897,654
|
|||||
4) |
To
approve the adoption of the Company’s 2005 Stock Incentive
Plan
|
20,228,710
|
11,321,265
|
|||||
5) |
To
require the nomination of two individuals for each open seat on the
board
of directors.
|
11,282,794
|
20,267,182
|
|||||
6) |
To
require stockholder approval of all option and warrant grants to
members
of the board of directors and officers of the Company.
|
12,235,968
|
19,314,008
|
ITEM 5. |
OTHER
INFORMATION.
None.
|
ITEM 6. |
EXHIBITS.
|
(a) |
Exhibits:
|
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
|
By: | /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)
|
||
-32-
|