Avid Bioservices, Inc. - Quarter Report: 2006 January (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
ý
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
|
For
the
quarterly period ended January 31, 2006
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)
|
(714)
508-6000
(Registrant's
telephone number, including area code)
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 a large accelerated filer, an
accelerated filer, or a non-accelerated filer (as defined in Rule 12b-2 of
the
Exchange Act).
Large
Accelerated Filer o Accelerated
Filer ý Non-
Accelerated Filer o
Indicate
by checkmark whether the registrant is a shell company (as defined in Rule
12b-2
of the Exchange Act).
Yes
o
No ý
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date.
Class
|
Shares
Outstanding at March 3, 2006
|
|
Common
Stock, $0.001 par value per share
|
175,318,259
shares
|
PEREGRINE
PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
|
Page
No.
|
||
Item
1.
|
Consolidated
Financial Statements (unaudited):
|
||
Condensed
Consolidated Balance Sheets
|
1
|
||
Condensed
Consolidated Statements of Operations
|
3
|
||
Condensed
Consolidated Statements of Cash Flows
|
4
|
||
Notes
to Condensed Consolidated Financial Statements
|
5
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of Operations
|
16
|
|
Company
Overview
|
16
|
||
Risk
Factors of Our Company
|
26
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
27
|
|
Item
4.
|
Controls
and Procedures
|
27
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
27
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
28
|
|
Item
3.
|
Defaults
upon Senior Securities
|
28
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
28
|
|
Item
5.
|
Other
Information
|
28
|
|
Item
6.
|
Exhibits
|
28
|
|
SIGNATURES
|
29
|
||
The
terms “we,” “us,” “our,” “the Company,” and “Peregrine,”
as used in this Report on Form 10-Q refers to Peregrine Pharmaceuticals, Inc.
and its wholly-owned subsidiary, Avid Bioservices, Inc.
i
PART
I - FINANCIAL INFORMATION
ITEM
1. CONSOLIDATED
FINANCIAL STATEMENTS
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
JANUARY
31,
2006
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
15,664,000
|
$
|
9,816,000
|
|||
Trade
and other receivables, net of allowance for doubtful accounts
of
nil (January) and $69,000 (April)
|
681,000
|
486,000
|
|||||
Inventories
|
1,060,000
|
627,000
|
|||||
Prepaid
expenses and other current assets
|
867,000
|
1,197,000
|
|||||
Total
current assets
|
18,272,000
|
12,126,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
503,000
|
494,000
|
|||||
Laboratory
equipment
|
3,365,000
|
3,029,000
|
|||||
Furniture,
fixtures and office equipment
|
666,000
|
647,000
|
|||||
4,534,000
|
4,170,000
|
||||||
Less
accumulated depreciation and amortization
|
(2,710,000
|
)
|
(2,532,000
|
)
|
|||
Property,
net
|
1,824,000
|
1,638,000
|
|||||
OTHER
ASSETS:
|
|||||||
Note
receivable, net of allowance of nil (January) and
$1,512,000
(April)
|
-
|
-
|
|||||
Other
|
680,000
|
481,000
|
|||||
Total
other assets
|
680,000
|
481,000
|
|||||
TOTAL
ASSETS
|
$
|
20,776,000
|
$
|
14,245,000
|
1
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
JANUARY
31,
2006
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,493,000
|
$
|
1,325,000
|
|||
Accrued
clinical trial site fees
|
211,000
|
8,000
|
|||||
Accrued
legal and accounting fees
|
174,000
|
549,000
|
|||||
Accrued
royalties and license fees
|
158,000
|
149,000
|
|||||
Accrued
payroll and related costs
|
617,000
|
806,000
|
|||||
Notes
payable, current portion
|
363,000
|
234,000
|
|||||
Capital
lease obligation, current portion
|
15,000
|
-
|
|||||
Deferred
revenue
|
612,000
|
517,000
|
|||||
Other
current liabilities
|
267,000
|
563,000
|
|||||
Total
current liabilities
|
3,910,000
|
4,151,000
|
|||||
Notes
payable, less current portion
|
457,000
|
434,000
|
|||||
Capital
lease obligation, less current portion
|
50,000
|
-
|
|||||
Deferred
license revenue
|
25,000
|
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
- 174,109,349 (January); 152,983,460 (April)
|
174,000
|
153,000
|
|||||
Additional
paid-in capital
|
198,305,000
|
180,011,000
|
|||||
Deferred
stock compensation
|
(319,000
|
)
|
(751,000
|
)
|
|||
Accumulated
deficit
|
(181,826,000
|
)
|
(169,803,000
|
)
|
|||
Total
stockholders' equity
|
16,334,000
|
9,610,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
20,776,000
|
$
|
14,245,000
|
See
accompanying notes to condensed consolidated financial
statements
2
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
||||||||||||
January
31,
2006
|
January
31,
2005
|
January
31,
2006
|
January
31,
2005
|
||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||
REVENUES:
|
|||||||||||||
Contract
manufacturing revenue
|
$
|
1,505,000
|
$
|
1,334,000
|
$
|
2,227,000
|
$
|
3,983,000
|
|||||
License
revenue
|
23,000
|
19,000
|
65,000
|
57,000
|
|||||||||
Total
revenues
|
1,528,000
|
1,353,000
|
2,292,000
|
4,040,000
|
|||||||||
COSTS
AND EXPENSES:
|
|||||||||||||
Cost
of contract manufacturing
|
1,088,000
|
1,273,000
|
1,820,000
|
3,265,000
|
|||||||||
Research
and development
|
3,294,000
|
2,548,000
|
9,330,000
|
8,122,000
|
|||||||||
Selling,
general and administrative
|
1,628,000
|
1,338,000
|
4,715,000
|
3,642,000
|
|||||||||
Total
costs and expenses
|
6,010,000
|
5,159,000
|
15,865,000
|
15,029,000
|
|||||||||
LOSS
FROM OPERATIONS
|
(4,482,000
|
)
|
(3,806,000
|
)
|
(13,573,000
|
)
|
(10,989,000
|
)
|
|||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||
Interest
and other income
|
1,381,000
|
65,000
|
1,585,000
|
197,000
|
|||||||||
Interest
and other expense
|
(12,000
|
)
|
(3,000
|
)
|
(35,000
|
)
|
(3,000
|
)
|
|||||
NET
LOSS
|
$
|
(3,113,000
|
)
|
$
|
(3,744,000
|
)
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
WEIGHTED
AVERAGE
SHARES
OUTSTANDING:
|
|||||||||||||
Basic
and Diluted
|
171,355,523
|
145,175,059
|
165,772,373
|
142,677,820
|
|||||||||
BASIC
AND DILUTED LOSS PER
COMMON
SHARE
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.08
|
)
|
See
accompanying notes to condensed consolidated financial
statements
3
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
NINE
MONTHS ENDED JANUARY 31,
|
|||||||
2006
|
2005
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
302,000
|
235,000
|
|||||
Stock-based
compensation
|
361,000
|
134,000
|
|||||
Stock
issued for research services
|
844,000
|
336,000
|
|||||
Gain
on sale of property
|
(6,000
|
)
|
-
|
||||
Recovery
of note receivable
|
(1,229,000
|
)
|
-
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
(195,000
|
)
|
1,006,000
|
||||
Inventories
|
(433,000
|
)
|
(305,000
|
)
|
|||
Prepaid
expenses and other current assets
|
(193,000
|
)
|
30,000
|
||||
Accounts
payable
|
168,000
|
41,000
|
|||||
Accrued
clinical trial site fees
|
203,000
|
(9,000
|
)
|
||||
Deferred
revenue
|
70,000
|
(552,000
|
)
|
||||
Accrued
payroll and related costs
|
(189,000
|
)
|
63,000
|
||||
Other
accrued expenses and current liabilities
|
(662,000
|
)
|
316,000
|
||||
Net
cash used in operating activities
|
(12,982,000
|
)
|
(9,500,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(423,000
|
)
|
(584,000
|
)
|
|||
Proceeds
from sale of property
|
6,000
|
-
|
|||||
Increase
in other assets
|
(199,000
|
)
|
(450,000
|
)
|
|||
Recovery
of note receivable
|
1,229,000
|
-
|
|||||
Net
cash provided by (used in) investing activities
|
613,000
|
(1,034,000
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from borrowings under notes payable
|
370,000
|
733,000
|
|||||
Principal
payments on notes payable
|
(218,000
|
)
|
(9,000
|
)
|
|||
Proceeds
from issuance of common stock, net of issuance costs of
$47,000
(January 2006) and $48,000 (January 2005)
|
18,065,000
|
5,365,000
|
|||||
Net
cash provided by financing activities
|
18,217,000
|
6,089,000
|
|||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
5,848,000
|
(4,445,000
|
)
|
||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
9,816,000
|
14,884,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$
|
15,664,000
|
$
|
10,439,000
|
|||
NON-CASH
INVESTING AND FINANCING ACTIVITIES:
|
|||||||
Property
acquired under capital lease
|
$
|
65,000
|
$
|
-
|
|||
Common
stock issued for research fees and as prepayments for future research
services
|
$
|
321,000
|
$
|
903,000
|
See
accompanying notes to condensed consolidated financial
statements
4
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (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
January 31, 2006, and the condensed consolidated results of our operations
and
our condensed consolidated cash flows for the three and nine month periods
ended
January 31, 2006 and 2005. 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
January 31, 2006, we had $15,664,000 in cash and cash equivalents on hand.
We
have expended substantial funds on the development of our product candidates
and
we have incurred negative cash flows from operations for the majority of our
years since inception. Since inception, we have generally financed our
operations primarily through the sale of our common stock and issuance of
convertible debt, which has been supplemented with payments received from
various licensing collaborations and through the revenues generated by Avid.
We
expect negative cash flows from operations to continue until we are able to
generate sufficient revenue from the contract manufacturing services provided
by
Avid and/or from the sale and/or licensing of our products under development.
Revenues
earned by Avid during the nine months ended January 31, 2006 and 2005 amounted
to $2,227,000 and $3,983,000, respectively. We expect that Avid will continue
to
generate revenues which should lower consolidated cash flows used in operations,
although we expect those near term revenues will be insufficient to fully cover
anticipated cash flows used in operations. In addition, revenues from the sale
and/or licensing of our products under development are always uncertain.
Therefore, we expect we will continue to need to raise additional capital to
continue the development of our product candidates, including the anticipated
development and clinical costs of Tarvacin™ and Cotara®, the anticipated
research and development costs associated with our other technology platforms
and the potential expansion of our manufacturing capabilities.
We
plan
to raise additional capital primarily through the registered offer and sale
of
shares of our common stock from our shelf registration statements on Form S-3,
which, as of March 3, 2006, we had an aggregate of approximately 4,179,000
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.
5
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
There
can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all, or that sufficient additional revenues will
be generated from Avid or under potential licensing agreements to complete
the
research, development, and clinical testing of our product candidates. We
currently have sufficient cash on hand, including anticipated amounts to be
received from the exercise of outstanding warrants, to pay our anticipated
obligations in the ordinary course of business, as estimated, through at least
December 31, 2006.
2. |
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Prepaid
Expenses -
Our
prepaid expenses primarily represent pre-payments made to secure the receipt
of
services at a future date. During fiscal years 2006 and 2005, we prepaid various
research and development related services through the issuance of shares of
our
common stock to unrelated entities, which are expensed once the services have
been provided under the terms of the arrangement. As of January 31, 2006 and
April 30, 2005, prepaid expenses and other current assets include $483,000
and
$1,028,000, respectively, 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 January 31, 2006
and
April 30, 2005:
January
31,
2006
|
April
30,
2005
|
||||||
Raw
materials
|
$
|
614,000
|
$
|
445,000
|
|||
Work-in-process
|
446,000
|
182,000
|
|||||
Total
inventories
|
$
|
1,060,000
|
$
|
627,000
|
Comprehensive
Loss
-
Comprehensive loss is equal to net loss for all periods presented.
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 are calculated in accordance with
Statement of Financial Accounting Standards No. 128, Earnings
per Share.
Basic
net loss per common share is computed by dividing our net loss by the weighted
average number of common shares outstanding during the period excluding the
dilutive effects of options and warrants. Diluted net loss per common share
is
computed by dividing the net loss by the sum of the weighted average number
of
common shares outstanding during the period plus the potential dilutive effects
of options and warrants outstanding during the period calculated in accordance
with the treasury stock method, but are excluded if their effect is
anti-dilutive.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 2,524,463
and 2,997,181 shares
of
common stock for the three and nine months ended January 31, 2006,
respectively, and 5,466,924
and 7,074,278 shares
of
common stock for the three and nine months ended January 31, 2005,
respectively, as the impact
of
such options and warrants are anti-dilutive during periods of net
loss.
6
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
The
calculation of weighted average diluted shares outstanding also excludes options
and warrants to purchase up to 11,176,382 and 9,592,777 shares of common stock
for the three and nine months ended January 31, 2006, respectively, and
13,788,339 and 11,869,284 shares of common stock for the three and nine months
ended January 31, 2005, respectively, as the exercise prices of those
options was greater than the average market price of our common stock during
the
respective periods, resulting in an anti-dilutive effect.
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 nine months ended January 31, 2006 and January 31, 2005.
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
|
NINE
MONTHS ENDED
|
||||||||||||
January
31,
2006
|
January
31,
2005
|
January
31,
2006
|
January
31,
2005
|
||||||||||
Net
loss, as reported
|
$
|
(3,113,000
|
)
|
$
|
(3,744,000
|
)
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
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
|
(291,000
|
)
|
(630,000
|
)
|
(1,504,000
|
)
|
(2,232,000
|
)
|
|||||
Pro
forma net loss as if the fair value based method had
been
applied to all awards
|
$
|
(3,404,000
|
)
|
$
|
(4,374,000
|
)
|
$
|
(13,527,000
|
)
|
$
|
(13,027,000
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.08
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.08
|
)
|
$
|
(0.09
|
)
|
7
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
Stock-based
compensation expense recorded during the three and nine months ended January
31,
2006 and January 31, 2005 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 nine months
ended
January 31, 2006 amounted to $200,000 and $361,000, respectively. Stock-based
compensation expense recorded during the three and nine months ended January
31,
2005 amounted to $20,000 and $134,000, 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. 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 nine months ended January
31,
2006 and January 31, 2005, 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.
8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
3.
|
NOTE
RECEIVABLE
|
During
December 1998, we completed the sale and subsequent leaseback of our two
facilities in Tustin, California, and recorded an initial note receivable from
the buyer of $1,925,000 as part of the consideration. During the quarter ended
October 31, 1999, we established a 100% reserve for the note receivable in
the
amount of $1,887,000 based on the terms of the note agreement. We subsequently
received all payments under the note agreement and reduced the reserve as
payments were received and we recorded these payments as interest and other
income in the accompanying condensed consolidated statements of operations.
On
December 22, 2005, we entered into a First Amendment to Lease and Agreement
of
Lease (“First Amendment”) with the landlord to our original lease dated December
24, 1998 and extended the original lease term for seven additional years, which
extends our contractual commitment under the operating lease through December
2017. In addition, the monthly lease payment terms under the original lease,
which increase at a rate of 3.35% every two years, were not modified under
the
First Amendment. In connection with this First Amendment, we entered into a
separate agreement with the landlord on December 22, 2005 regarding the
immediate payoff of our note receivable at a 20% discount in the amount of
$1,229,000, which amount was recorded as interest and other income in the
accompanying condensed consolidated statements of operations.
4. |
NOTES
PAYABLE
|
During
fiscal years 2006 and 2005, we entered into the following note payable
agreements with General Electric Capital Corporation (“GE”) to finance certain
laboratory equipment. Notes payable consist of the following at January 31,
2006
and April 30, 2005:
January
31,
2006
|
April
30,
2005
|
||||||
Note
payable dated November 2004, 5.78% per annum,
monthly
payments of $11,000 due through December 2007
|
$
|
231,000
|
$
|
314,000
|
|||
Note
payable dated December 2004, 5.85% per annum,
monthly
payments of $12,000 due through January 2008
|
263,000
|
354,000
|
|||||
Note
payable dated June 2005, 6.39% per annum,
monthly
payments of $8,000 due through July 2008
|
226,000
|
-
|
|||||
Note
payable dated November 2005, 6.63% per annum,
monthly
payments of $3,000 due through December 2008
|
100,000
|
-
|
|||||
820,000
|
668,000
|
||||||
Less
current portion
|
(363,000
|
)
|
(234,000
|
)
|
|||
Notes
payable, less current portion
|
$
|
457,000
|
$
|
434,000
|
Under
the
terms of the GE note payable agreements, we paid security deposits equal to
25%
of the amount financed, which are due and payable to us at the end of the term
of each note agreement. As of January 31, 2006 and April 30, 2005, security
deposits totaling $276,000 and $183,000, respectively, are included in other
long-term assets in the accompanying consolidated financial
statements.
9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
As
of
January 31, 2006, minimum future principal payments on notes payable as of
January 31, 2006 are as follows:
Year
ending April 30:
|
||||
2006
(remaining 3 months)
|
$
|
89,000
|
||
2007
|
368,000
|
|||
2008
|
314,000
|
|||
2009
|
49,000
|
|||
Total
|
$
|
820,000
|
5. |
CAPITAL
LEASE OBLIGATION
|
During
December 2005, we financed certain equipment under a capital lease agreement
in
the amount of $65,000. The agreement bears interest at a rate of 6.30% per
annum
with payments due monthly in the amount of approximately $1,600 through December
2009.
The
equipment purchased under the capital lease is included in property in the
accompanying consolidated financial statements as follows at January 31, 2006:
Furniture,
fixtures and office equipment
|
$
|
68,000
|
||
Less
accumulated depreciation
|
(1,000
|
)
|
||
Net
book value
|
$
|
67,000
|
Minimum
future lease payments under the capital lease as of January 31, 2006 are as
follows:
Year
ending April 30:
|
||||
2006
(remaining 3 months)
|
$ | 4,000 | ||
2007
|
19,000
|
|||
2008
|
19,000
|
|||
2009
|
19,000
|
|||
2010
|
13,000
|
|||
Total
minimum lease payments
|
74,000
|
|||
Amount
representing interest
|
(9,000
|
)
|
||
Net
present value minimum lease payments
|
65,000
|
|||
Less
current portion
|
15,000
|
|||
$
|
50,000
|
6. |
LITIGATION
|
In
the
ordinary course of business, we are at times subject to various legal
proceedings, including licensing and contract disputes and other matters, which
are further discussed below:
On
December 16, 2004, we filed a lawsuit against the University of Southern
California (“USC”) and Alan Epstein, M.D. The lawsuit was filed in the Superior
Court of the State of California for the County of Los Angeles, Central
District. The lawsuit alleges that USC has breached various agreements with
the
Company by (i) failing to protect the Company’s patent rights in Japan with
respect to certain technology exclusively licensed from USC due to non-payment
of annuities, (ii) failing to provide accounting documentation for research
expenditures, and (iii) misusing certain antibodies the Company provided to
USC
and Dr. Epstein for research. The claims against Dr. Epstein, who was a
scientific advisor and former consultant to the Company, involve breach of
contract for misusing certain antibodies and breach of fiduciary duties. The
Company is seeking unspecified damages, declaratory relief with respect to
its
rights under the option and license agreement pursuant to which it acquired
the
rights to the technology, and an accounting of research expenditures.
10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
On
August
3, 2005, USC filed a cross-complaint against the Company relating to the
above-mentioned lawsuit. The cross-complaint alleged 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 sought
unspecified punitive damages with respect to its rights under the option and
license agreements and the sponsored research agreement.
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 (“Knobbe”), 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 Knobbe was dismissed in connection with receiving a tolling agreement
extending the statute of limitations on our claims against the firm while USC
pursued those claims.
On
March
7, 2006, we reached a global settlement with USC, Dr. Epstein and Knobbe with
respect to the matters set forth above. The settlement entails (i) relief from
future minimum annual royalties due to USC under our Vasopermeation Enhancement
Agent (“VEA”) licensing agreement, (ii) reduction in royalties due on net sales
to USC with respect to our VEA license agreement, (iii) a release from USC
of
any claimed obligation for past sponsored research fees in the amount of
$187,500, and (iv) consideration from Knobbe comprised of cash and a credit
for
future legal services.
7. |
STOCKHOLDERS’
EQUITY
|
During
the nine months ended January 31, 2006, 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 purchase agreement dated November 23, 2005
|
8,000,000
|
$
|
6,719,000
|
||||
Common
stock issued to an unrelated entity for research services
|
299,422
|
$
|
321,000
|
||||
21,006,639
|
$
|
18,296,000
|
11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
In
addition, on February 3, 2006, we issued and sold 396,398 shares of our common
stock to an unrelated entity for the pre-payment of fees due under two sponsored
research agreements. The value of the shares issued of $586,000 was recorded
as
prepaid expenses, which we will expense once the services have been provided
under the terms of the agreements.
As
of
March 3, 2006, we had an aggregate of 4,179,180 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
28,673,974 shares of our common stock at January 31, 2006 for possible future
issuance, calculated as follows:
Number
of Shares
of
Common Stock Reserved For
Issuance
|
||||
Shares
reserved under shelf registration statements
|
4,179,180
|
|||
Options
issued and outstanding
|
11,116,778
|
|||
Options
available for future grant
|
5,600,851
|
|||
Warrants
issued and outstanding
|
7,777,165
|
|||
Total
shares reserved
|
28,673,974
|
8. |
STOCK
OPTIONS
|
As
of
January 31, 2006, options to purchase up to 11,116,778 shares of our common
stock were issued and outstanding and exercisable under all of our stock option
plans at prices ranging between $0.34 and $5.28 per share with an average
exercise price of $1.56 per share and various expiration dates through January
23, 2016.
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 January 31, 2006, options to purchase up to 5,600,851 shares of common stock
were available for future grant under all stock option plans.
9. |
WARRANTS
|
As
of
January 31, 2006, warrants to purchase up to 7,777,165 shares of our common
stock were issued and outstanding and exercisable at prices ranging between
$0.71 and $2.50 per share with an average exercise price of $0.85 per share
and
various expiration dates through March 31, 2008. Subsequent to our quarter
ended
January 31, 2006 and through March 3, 2006, we received gross proceeds of
$611,000 upon the exercise of warrants to purchase an aggregate of 812,512
shares of common stock at an average exercise price of $0.75 per
share.
12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
10.
|
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 for Peregrine and outside
customers.
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 office equipment and are net of accumulated depreciation.
Segment
information the three-month periods is summarized as follows:
Three
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,505,000
|
$
|
1,334,000
|
|||
Research
and development of targeted therapeutics
|
23,000
|
19,000
|
|||||
Total
net revenues
|
$
|
1,528,000
|
$
|
1,353,000
|
|||
Gross
Profit:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
417,000
|
$
|
61,000
|
|||
Research
and development of targeted therapeutics
|
23,000
|
19,000
|
|||||
Total
gross profit
|
440,000
|
80,000
|
|||||
Research
and development expense
|
(3,294,000
|
)
|
(2,548,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,628,000
|
)
|
(1,338,000
|
)
|
|||
Other
income, net
|
1,369,000
|
62,000
|
|||||
Net
loss
|
$
|
(3,113,000
|
)
|
$
|
(3,744,000
|
)
|
Three
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
72
|
%
|
45
|
%
|
|||
United
States (customer B)
|
1
|
%
|
26
|
%
|
|||
Germany
(one customer)
|
20
|
%
|
0
|
%
|
|||
Israel
(one customer)
|
1
|
%
|
29
|
%
|
|||
Other
customers
|
6
|
%
|
0
|
%
|
|||
Total
customer revenues as a % of net revenues
|
100
|
%
|
100
|
%
|
13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
Segment
information for the nine-month periods is summarized as follows:
Nine
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
2,227,000
|
$
|
3,983,000
|
|||
Research
and development of targeted therapeutics
|
65,000
|
57,000
|
|||||
Total
net revenues
|
$
|
2,292,000
|
$
|
4,040,000
|
|||
Gross
Profit:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
407,000
|
$
|
718,000
|
|||
Research
and development of targeted therapeutics
|
65,000
|
57,000
|
|||||
Total
gross profit
|
472,000
|
775,000
|
|||||
Research
and development expense
|
(9,330,000
|
)
|
(8,122,000
|
)
|
|||
Selling,
general and administrative expense
|
(4,715,000
|
)
|
(3,642,000
|
)
|
|||
Other
income, net
|
1,550,000
|
194,000
|
|||||
Net
loss
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
Nine
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
75
|
%
|
45
|
%
|
|||
United
States (customer B)
|
3
|
%
|
17
|
%
|
|||
Germany
(one customer)
|
13
|
%
|
0
|
%
|
|||
Israel
(one customer)
|
2
|
%
|
37
|
%
|
|||
Other
customers
|
7
|
%
|
1
|
%
|
|||
Total
customer revenues as a % of net revenues
|
100
|
%
|
100
|
%
|
Net
revenues generated from Peregrine during the three and nine months ended January
31, 2006 and January 31, 2005 were primarily from the amortized portion of
the
up-front license fees under the December 2002 license agreement with Schering
A.G.
Long-lived
assets by segment consist of the following:
January
31,
2006
|
April
30,
2005
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,376,000
|
$
|
1,291,000
|
|||
Research
and development of targeted therapeutics
|
448,000
|
347,000
|
|||||
Total
long-lived assets, net
|
$
|
1,824,000
|
$
|
1,638,000
|
14
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2006 (unaudited) (continued)
11.
|
SUBSEQUENT
EVENTS
|
On
February 13, 2006, our Compensation Committee of the Board of Directors approved
the Company’s Stock Bonus Plan to promote the interests of the Company and its
stockholders by providing a total of nineteen key employees and consultants
with
financial rewards upon achievement of various research and clinical goals
(“Performance Goals”). The Plan will remain effective through fiscal year ending
April 30, 2007. A series of company Performance Goals have been established,
with each Performance Goal having a specific targeted attainment date (the
“Target Date”). Up to 1,737,166 shares of our common stock could be issued under
the Stock Bonus Plan upon the achievement of all Performance Goals by the
respective Target Dates. Shares earned under the Stock Bonus Plan will be issued
from our 2005 Stock Incentive Plan, which was approved by our stockholders
at
the 2005 Annual Meeting of Stockholders.
15
ITEM 2. |
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS
OF OPERATIONS
|
This
Quarterly Report on Form 10-Q contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, which
represent our projections, estimates, expectations or beliefs concerning among
other things, financial items that relate to management’s future plans or
objectives or to our future economic and financial performance. In
some cases, you can identify these statements by terminology such as “may”,
“should”, “plans”, “believe”, “will”, “anticipate”, “estimate”, “expect”, or
“intend”, including their opposites or similar phrases or expressions. You
should be aware that these statements are projections or estimates as to future
events and are subject to a number of factors that may tend to influence the
accuracy of the statements. These forward-looking statements should not be
regarded as a representation by the Company or any other person that the events
or plans of the Company will be achieved. You should not unduly rely on these
forward-looking statements, which speak only as of the date of this Quarterly
Report. We undertake no obligation to publicly revise any forward-looking
statement to reflect circumstances or events after the date of this Quarterly
Report or to reflect the occurrence of unanticipated events. You should,
however, review the factors and risks we describe in the reports we file from
time to time with the Securities and Exchange Commission (“SEC”) after the date
of this Quarterly Report. Actual results may differ materially from any forward
looking statement.
To
gain a better understanding of the risk factors that may tend to influence
the
accuracy of our forward looking statements, we recommend that you read the
risk
factors identified in the Company's Annual Report on Form 10-K for the year
ended April 30, 2005 and all other reports we file from time to time with the
SEC after the date of this Quarterly Report. Although we believe that the risks
described in the 10-K and other reports filed with the SEC represent all
material risks currently applicable to us, additional risks and uncertainties
not presently known to us or that are currently not believed to be important
to
us may also affect our actual future results and could harm our business,
financial condition, and results of operations.
Company
Overview
We
are a
biopharmaceutical company primarily developing 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 Peregrine and outside customers.
16
Recent
Developments
The
following table provides you with an overview of our products in clinical trials
and the current clinical status of each trial:
Products
in Clinical Trials
|
||||
Technology
Platform
|
Product
Name
|
Disease
|
Stage
of
Development
|
Development
Status
Overview
|
Tumor
Necrosis Therapy (“TNT”)
|
Cotara®
|
Brain
Cancer
|
Phase
II/III registration trial
|
Peregrine,
in collaboration with New Approaches to Brain Tumor Therapy (“NABTT”), a
brain tumor consortium, have initiated the first part of the Phase
II/III
product registration study to evaluate Cotara® for the treatment of brain
cancer. This study is partially funded by the National Cancer Institute
("NCI”) and will treat up to 28 patients. The study is being conducted
at
the following four NABTT institutions: Wake Forest University, Emory
University, University of Alabama at Birmingham and University of
Pennsylvania.
|
Anti-Phospholipid
Therapy
|
Tarvacin™
|
Advanced
Solid Cancers
|
Phase
I
|
This
phase I clinical study is a single and repeat dose escalation study
designed to enroll up to 28 patients with advanced solid tumors that
no
longer respond to standard cancer treatments. Patient enrollment
is open
at the 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. Planned enrollment and treatment of
24
patients was completed in February 2006 at Bach and Godofsky Infectious
Diseases located in Bradenton, FL. Based on the safety profile seen
to
date in the first 24 patients, an additional dose level may be added
to
the study. Meanwhile, a repeat dose study and a combination therapy
dose
study are currently being planned.
|
17
Results
of Operations
The
following table compares the unaudited condensed consolidated statements of
operations for the three and nine-month periods ended January 31, 2006 and
January 31, 2005. 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
January
31,
|
Nine
Months Ended
January
31,
|
||||||||||||||||||
2006
|
2005
|
$
Change
|
2006
|
2005
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing revenue
|
$
|
1,505
|
$
|
1,334
|
$
|
171
|
$
|
2,227
|
$
|
3,983
|
$
|
(1,756
|
)
|
||||||
License
revenue
|
23
|
19
|
4
|
65
|
57
|
8
|
|||||||||||||
Total
revenues
|
1,528
|
1,353
|
175
|
2,292
|
4,040
|
(1,748
|
)
|
||||||||||||
COSTS
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
1,088
|
1,273
|
(185
|
)
|
1,820
|
3,265
|
(1,445
|
)
|
|||||||||||
Research
and development
|
3,294
|
2,548
|
746
|
9,330
|
8,122
|
1,208
|
|||||||||||||
Selling,
general and administrative
|
1,628
|
1,338
|
290
|
4,715
|
3,642
|
1,073
|
|||||||||||||
Total
costs and expenses
|
6,010
|
5,159
|
851
|
15,865
|
15,029
|
836
|
|||||||||||||
LOSS
FROM OPERATIONS
|
(4,482
|
)
|
(3,806
|
)
|
(676
|
)
|
(13,573
|
)
|
(10,989
|
)
|
(2,584
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Interest
and other income
|
1,381
|
65
|
1,316
|
1,585
|
197
|
1,388
|
|||||||||||||
Interest
and other expense
|
(12
|
)
|
(3
|
)
|
(9
|
)
|
(35
|
)
|
(3
|
)
|
(32
|
)
|
|||||||
|
|||||||||||||||||||
NET
LOSS
|
$
|
(3,113
|
)
|
$
|
(3,744
|
)
|
$
|
631
|
|
$
|
(12,023
|
)
|
$
|
(10,795
|
)
|
$
|
(1,228
|
)
|
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
Months: The increase in total revenues of $175,000 during the three months
ended
January 31, 2006 compared to the same period in the prior year was primarily
due
to an increase in contract manufacturing revenue of $171,000. The increase
in
contract manufacturing revenue was primarily due to an increase in the number
of
active projects associated with unrelated entities compared to the same
three-month period in the prior year.
Nine
Months: The decrease in total revenues of $1,748,000 during the nine months
ended January 31, 2006 compared to the same period in the prior year was
primarily due to a decrease in contract manufacturing revenue of $1,756,000.
The
decrease in contract manufacturing revenue was primarily due to a decrease
in
the number of completed manufacturing runs associated with unrelated entities
compared to the same nine-month period in the prior year. In addition, during
the nine months ended January 31, 2006, 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.
18
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 completing 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
Months: The decrease in cost of contract manufacturing of $185,000 during the
three months ended January 31, 2006 compared to the same period in the prior
year was primarily related to a loss provision of $243,000 recorded in the
prior
year three-month period associated with a previous contract that did not recur
in the current year period offset by an increase in cost of contract
manufacturing primarily associated with the current year three-month period
increase in contract manufacturing revenue.
Nine
Months: The decrease in cost of contract manufacturing of $1,445,000 during
the
nine months ended January 31, 2006 compared to the same period in the prior
year
was primarily related to the current nine-month period decrease in contract
manufacturing revenue. We expect contract manufacturing costs to continue 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 $746,000 during
the
three months ended January 31, 2006 compared to the same period in the prior
year was primarily due to a net increase in expenses associated with our
following platform technologies under development:
o |
Anti-Phospholipid
Therapy (Tarvacin™) - During
the three months ended January 31, 2006, Anti-Phospholipid Therapy
(Tarvacin™) program expenses increased $1,489,000 from $685,000 in fiscal
year 2005 to $2,174,000 in fiscal year 2006. The increase in
Anti-Phospholipid Therapy (Tarvacin™)
program expenses is primarily due to an increase in manufacturing
and
in-house antibody development expenses combined with an increase
in
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. These increases were supplemented with an increase in
sponsored
research fees and payroll and related expenses associated with the
Anti-Phospholipid Therapy development program. 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, which was offset by a similar increase in outside animal
research studies to support the possible expansion of Tarvacin™ clinical
trials in other anti-viral
indications.
|
o |
Vasopermeation
Enhancements Agents (“VEAs”) - During
the three months ended January 31, 2006, VEA program expenses increased
$32,000 from $78,000 in fiscal year 2005 to $110,000 in fiscal year
2006.
The increase in VEA program expenses is primarily due to an increase
in
resources focused on the VEA program compared to the prior year period.
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.
|
19
o |
Tumor
Necrosis Therapy (“TNT”) (Cotara®) - During
the three months ended January 31, 2006, TNT (Cotara®) program expenses
decreased $571,000 from $1,212,000 in fiscal year 2005 to $641,000
in
fiscal year 2006. The decrease in TNT (Cotara®) program expenses is
primarily due to a decrease in manufacturing, antibody development,
and
radiolabeling expenses incurred in the current quarter as the majority
of
in-house resources have recently been focused on the development
of the
Tarvacin™ program.
|
o |
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis - During
the three months ended January 31, 2006, VTA and Anti-Angiogenesis
program
expenses decreased $204,000 from $573,000 in fiscal year 2005 to
$369,000
in fiscal year 2006. The decrease in VTA and Anti-Angiogenesis program
expenses is primarily due to a decrease in intellectual property
access
fees and sponsored research fees as our outside researchers are primarily
focused on the development of
Tarvacin™.
|
Nine
Months: The increase in research and development expenses of $1,208,000 during
the nine months ended January 31, 2006 compared to the same period in the prior
year was primarily due to a net increase in expenses associated with our
following platform technologies under development:
o |
Anti-Phospholipid
Therapy (Tarvacin™) - During
the nine months ended January 31, 2006, Anti-Phospholipid Therapy
(Tarvacin™) program expenses increased $2,849,000 from $3,442,000 in
fiscal year 2005 to $6,291,000 in fiscal year 2006. The increase
in
Anti-Phospholipid Therapy (Tarvacin™)
program expenses is primarily due to an increase in manufacturing
and
in-house antibody development expenses combined with an increase
in
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. In addition, the increase in
program
expenses was supplemented with an increase in technology access fees
associated with Tarvacin™ Phase I clinical trial milestones achieved
during the current nine month period in accordance with third party
licensing agreements, an increase in sponsored research fees, and
an
increase in outside animal research studies to support the possible
expansion of Tarvacin™ clinical trials in other anti-viral indications.
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 combined with a decrease in outside antibody
development fees related to our humanized antibody in development
and a
decrease in intellectual property access
fees.
|
o |
Tumor
Necrosis Therapy (“TNT”) (Cotara®)
-
During the nine months ended January 31, 2006, TNT (Cotara®) program
expenses decreased $626,000 from $2,336,000 in fiscal year 2005 to
$1,710,000 in fiscal year 2006. The decrease in TNT (Cotara®) program
expenses 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 Cotara®.
|
o |
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis -
During the nine months ended January 31, 2006, VTA and Anti-Angiogenesis
program expenses decreased $811,000 from $1,844,000 in fiscal year
2005 to
$1,033,000 in fiscal year 2006. The decrease in VTA and Anti-Angiogenesis
program expenses is primarily due to a decrease in intellectual property
access fees and sponsored research fees as our outside researchers
are
currently focused on the development of
Tarvacin™.
|
20
o |
Vasopermeation
Enhancements Agents (“VEAs”) - During
the nine months ended January 31, 2006, VEA program expenses decreased
$191,000 from $487,000 in fiscal year 2005 to $296,000 in fiscal
year
2006. The decrease in VEA program expenses is primarily due to a
decrease
in sponsored research fees, combined with a decrease in antibody
development fees regarding expenses incurred in the prior year associated
with a research study that was completed in the prior year. In January
2005, we entered into an agreement with Merck KGaA of Darmstadt,
Germany,
that will give us access to Merck's technology and expertise in protein
expression to advance the development of our VEA technology and other
platform technologies. Merck KGaA is presently working on a clinical
candidate under the VEA technology
platform.
|
We
expect
research and development expenses to increase over the near term primarily
under
the following ongoing research and development programs:
1.
|
Tarvacin™
clinical studies 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;
|
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
January
31, 2005
|
R&D
Expenses-Quarter Ended
January
31, 2006
|
R&D
Expenses-
May
1, 1998 to
January
31, 2006
|
|||||||
Anti-Phospholipid
Therapy (Tarvacin™)
|
$
|
685,000
|
$
|
2,174,000
|
$
|
14,405,000
|
||||
TNT
(Cotara®)
|
1,212,000
|
641,000
|
30,526,000
|
|||||||
VTA
and Anti-Angiogenesis
|
573,000
|
369,000
|
11,556,000
|
|||||||
VEA
|
78,000
|
110,000
|
5,664,000
|
|||||||
Other
research programs
|
-
|
-
|
13,441,000
|
|||||||
Total
R&D Expenses
|
$
|
2,548,000
|
$
|
3,294,000
|
$
|
75,592,000
|
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 December 31, 2006;
|
§ |
The
uncertainty of future costs associated with our pre-clinical candidates,
including Vascular Targeting Agents, Anti-Angiogenesis Agents, and
Vasopermeation Enhancement Agents, which costs are dependent on the
success of pre-clinical development. We are uncertain whether or
not these
product candidates will be successful and we are uncertain whether
or not
we will incur any additional costs beyond pre-clinical development;
|
21
§
|
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 $290,000
during the three months ended January 31, 2006 compared to the same period
in
the prior year is primarily due to an increase in (i) payroll and related
expenses of $236,000 from $537,000 in the prior three-month period to $773,000
in the current three-month period primarily due to an increase in headcount
across most corporate functions to support our increased operations, (ii) stock
based compensation expense of $118,000 from nil in the comparative period in
fiscal year 2005 primarily associated with the amortization of the fair value
of
warrants provided for business development services related to Avid’s
operations, (iii) travel and related expenses of $54,000 from $27,000 in fiscal
year 2005 to $81,000 in fiscal year 2006 primarily associated with our
participation in several investor conferences and non-deal marketing road shows
over the past quarter and an increase in travel associated with business
development. These increases in expenses were supplemented with incremental
increases in public relation expenses, board fees, and other general corporate
expenses. These increases in expenses were offset by a current quarter decrease
in audit and accounting fees of $108,000 from $200,000 in fiscal year 2005
to
$92,000 in fiscal year 2006 primarily related to the implementation of Section
404 of the Sarbanes-Oxley Act of 2002 in the prior year quarter combined with
a
decrease in legal fees of $107,000 from $205,000 in fiscal year 2005 to $98,000
in fiscal year 2006 primarily pertaining to a decrease in general corporate
matters and lawsuits described in the Quarterly Report on Form 10-Q under Part
II, Item 1, Legal Proceedings.
22
Nine
Months: The increase in selling, general and administrative expenses of
$1,073,000 during the nine months ended January 31, 2006 compared to the same
period in the prior year is primarily due to an increase in (i) payroll and
related expenses of $412,000 from $1,671,000 in the prior nine-month period
to
$2,083,000 in the current nine-month period primarily due to an increase in
headcount across most corporate functions to support our increased operations,
(ii) stock based compensation expense of $161,000 from $82,000 in fiscal year
2005 to $243,000 in fiscal year 2006 associated with the amortization of the
fair value of options and warrants provided for business development and general
corporate services, (iii) investor and public relation fees of $160,000 from
$170,000 in fiscal year 2005 to $330,000 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 $154,000 from
$130,000 in fiscal year 2005 to $284,000 in fiscal year 2006 primarily
associated with our participation in several investor conferences and non-deal
marketing road shows over the past nine months combined with an increase in
travel associated with business development and other corporate activities,
(v)
board fees of $114,000 from $200,000 in the prior nine-month period to $314,000
in the current nine month period primarily due to an increase in the number
of
non-employee directors combined with an increase in the number of Company Board
meetings, (vi) legal fees of $104,000 from $364,000 in fiscal year 2005 to
$468,000 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. The current period increases in
general and administrative expense were supplemented with incremental increases
in other general corporate expenses.
Interest
and Other Income.
Three
and
Nine Months: The increase in interest and other income of $1,316,000 and
$1,388,000 during the three and nine months ended January 31, 2006,
respectively, compared to the same periods in the prior year was primarily
due
to the recovery of a previously fully reserved note receivable in the amount
of
$1,229,000 during the current quarter combined with 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 periods.
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 the 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.
23
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
January 31, 2006, we had $15,664,000 in cash and cash equivalents on hand.
Although we have sufficient cash on hand to meet our current planned obligations
through at least December 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.
24
Revenues
earned by Avid during the nine months ended January 31, 2006 and 2005 amounted
to $2,227,000 and $3,983,000, 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 March 3, 2006, we had an aggregate of approximately 4,179,000
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 beyond December 31, 2006.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the nine months ended January 31, 2006 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 by the changes in operating assets and liabilities.
During the nine months ended January 31, 2006, cash used in operating activities
increased $3,482,000 to $12,982,000 compared to $9,500,000 for the nine months
ended January 31, 2005. 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 $1,821,000, the amount of which was further supplemented by an increase
of
$1,661,000 in net cash used in operating activities after deducting non-cash
expenses and adjustments to net loss 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 selling, 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 by the changes in operating
assets and liabilities are as follows:
25
NINE
MONTHS ENDED
|
|||||||
January
31,
2006
|
January
31,
2005
|
||||||
Net
loss, as reported
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
Less non-cash expenses and adjustments to net loss: | |||||||
Depreciation
and amortization
|
302,000
|
235,000
|
|||||
Stock-based
compensation
|
361,000
|
134,000
|
|||||
Stock
issued for research services
|
844,000
|
336,000
|
|||||
Gain
on sale of property
|
(6,000
|
)
|
- | ||||
Recovery
of note receivable
|
(1,229,000
|
)
|
-
|
||||
Net
cash used in operating activities before changes in
operating
assets and liabilities
|
$
|
(11,751,000
|
)
|
$
|
(10,090,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(1,231,000
|
)
|
$
|
590,000
|
||
Net
cash used in operating activities
|
$
|
(12,982,000
|
)
|
$
|
(9,500,000
|
)
|
Cash
Used In Investing Activities.
During
the nine months ended January 31, 2006, net cash provided by investing
activities amounted to $613,000 primarily due to the recovery of a note
receivable in the amount of $1,229,000 offset by the purchase of property in
the
amount of $423,000 to support the expanded research efforts of Peregrine and
the
expanded services of Avid combined with an increase in other assets of $199,000.
Net cash used in investing activities for the nine months ended January 31,
2005
was primarily due to the purchase of laboratory equipment to support our
research efforts and the expanded services of Avid, combined with an increase
in
other assets related to security deposits paid to GE Capital Corporation on
notes payable and installment payments made on a 1,000-liter bioreactor.
Cash
Provided By Financing Activities.
Net cash
provided by financing activities increased $12,128,000 to $18,217,000 for the
nine months ended January 31, 2006 compared to net cash provided of $6,089,000
for the nine months ended January 31, 2005. Cash provided by financing
activities during the nine months ended January 31, 2006 was primarily due
to
proceeds received under four separate security purchase agreements whereby
we
sold and issued a total of 20,707,217 shares of our common stock in exchange
for
aggregate net proceeds of $17,975,000. Cash provided by financing activities
during the nine months ended January 31, 2005 was primarily due to proceeds
received from the sale of stock supplemented with proceeds received from the
financing of property with GE Capital Corporation.
Commitments
At
January 31, 2006, we had no material capital commitments.
Risk
Factors of Our Company
The
biotechnology industry includes many risks and challenges. Our challenges may
include, but are not limited to: uncertainties associated with completing
pre-clinical and clinical trials for our technologies; the significant costs
to
develop our products as all of our products are currently in development,
pre-clinical studies or clinical trials and no revenue has been generated from
commercial product sales; obtaining additional financing to support our
operations and the development of our products; obtaining regulatory approval
for our technologies; complying with governmental regulations applicable to
our
business; obtaining the raw materials necessary in the development of such
compounds; consummating collaborative arrangements with corporate partners
for
product development; achieving milestones under collaborative arrangements
with
corporate partners; developing the capacity to manufacture, market, and sell
our
products, either directly or indirectly with collaborative partners; developing
market demand for and acceptance of such products; competing effectively with
other pharmaceutical and biotechnological products; attracting and retaining
key
personnel; protecting intellectual property rights; and accurately forecasting
operating and capital expenditures, other capital commitments, or clinical
trial
costs, and general economic conditions. A more detailed discussion regarding
our
industry and business risk factors can be found in our Annual Report on Form
10-K for the year ended April 30, 2005, as filed with the Securities and
Exchange Commission on July 14, 2005.
26
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 January 31,
2006, a near-term change in interest rates, based on historical movements,
would
not materially affect the fair value of interest rate sensitive instruments.
Our
debt instruments have fixed interest rates and terms and, therefore, a
significant change in interest rates would not have a material adverse effect
on
our financial position or results of operations.
ITEM 4. |
CONTROLS
AND
PROCEDURES
|
The
Company maintains disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e)) under the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), that are designed to ensure that information
required to be disclosed in its reports filed under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and
communicated to our management, including its Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures,
management recognized that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, and management necessarily was required to apply
its
judgment in evaluating the cost-benefit relationship of possible controls and
procedures.
The
Company carried out an evaluation, under the supervision and with the
participation of management, including its Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of its
disclosure controls and procedures as of January 31, 2006, 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
January 31, 2006.
There
were no significant changes in the Company’s internal controls over financial
reporting, during the quarter ended January 31, 2006, that have materially
affected, or are reasonably likely to materially affect, the Company’s internal
controls over financial reporting.
PART
II OTHER INFORMATION
ITEM 1. |
LEGAL
PROCEEDINGS.
|
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.
27
On
August
3, 2005, USC filed a cross-complaint against the Company relating to the
above-mentioned lawsuit. The cross-complaint alleged 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 sought
unspecified punitive damages with respect to its rights under the option and
license agreements and the sponsored research agreement.
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 (“Knobbe”), 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 Knobbe was dismissed in connection with receiving a tolling agreement
extending the statute of limitations on our claims against the firm while USC
pursued those claims.
On
March
7, 2006, we reached a global settlement with USC, Dr. Epstein and Knobbe with
respect to the matters set forth above. The settlement entails (i) relief from
future minimum annual royalties due to USC under our Vasopermeation Enhancement
Agent (“VEA”) licensing agreement, (ii) reduction in royalties due on net sales
to USC with respect to our VEA license agreement, (iii) a release from USC
of
any claimed obligation for past sponsored research fees in the amount of
$187,500, and (iv) consideration from Knobbe comprised of cash and a credit
for
future legal services.
ITEM 2. |
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
|
ITEM 3. |
DEFAULTS
UPON SENIOR SECURITIES.
None.
|
ITEM 4. |
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
|
ITEM 5. |
OTHER
INFORMATION.
None.
|
ITEM 6. |
EXHIBITS.
|
(a)
|
Exhibits:
|
31.1 |
31.2 |
Certification
of the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32 |
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
28
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
PEREGRINE
PHARMACEUTICALS, INC.
|
||
|
|
|
Date: March 10, 2006 | By: | /s/ STEVEN W. KING |
|
||
Steven
W. King
President
and Chief Executive Officer,
Director
|
|
|
|
Date: March 10, 2006 | 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)
|
29