Avid Bioservices, Inc. - Quarter Report: 2007 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, 2007
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
|
(I.R.S.
Employer
|
incorporation
or organization)
|
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. See definition of “an accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one)
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 5, 2007
|
|
Common
Stock, $0.001 par value per share
|
196,112,201
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
|
15
|
|
Company
Overview
|
15
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
24
|
|
Item
4.
|
Controls
and Procedures
|
24
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
25
|
|
Item
1A.
|
Risk
Factors
|
25
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
37
|
|
Item
3.
|
Defaults
upon Senior Securities
|
37
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
37
|
|
Item
5.
|
Other
Information
|
37
|
|
Item
6.
|
Exhibits
|
37
|
|
SIGNATURES
|
38
|
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,
2007
|
APRIL
30,
2006
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
20,114,000
|
$
|
17,182,000
|
|||
Trade
and other receivables
|
957,000
|
579,000
|
|||||
Inventories
|
2,871,000
|
885,000
|
|||||
Prepaid
expenses and other current assets
|
1,325,000
|
1,466,000
|
|||||
Total
current assets
|
25,267,000
|
20,112,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
640,000
|
618,000
|
|||||
Laboratory
equipment
|
3,488,000
|
3,444,000
|
|||||
Furniture,
fixtures and office equipment
|
808,000
|
666,000
|
|||||
4,936,000
|
4,728,000
|
||||||
Less
accumulated depreciation and amortization
|
(3,091,000
|
)
|
(2,822,000
|
)
|
|||
Property,
net
|
1,845,000
|
1,906,000
|
|||||
Other
assets
|
1,259,000
|
658,000
|
|||||
TOTAL
ASSETS
|
$
|
28,371,000
|
$
|
22,676,000
|
1
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
JANUARY
31,
2007
|
APRIL
30,
2006
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,439,000
|
$
|
1,233,000
|
|||
Accrued
clinical trial site fees
|
319,000
|
170,000
|
|||||
Accrued
legal and accounting fees
|
185,000
|
250,000
|
|||||
Accrued
royalties and license fees
|
249,000
|
138,000
|
|||||
Accrued
payroll and related costs
|
724,000
|
850,000
|
|||||
Notes
payable, current portion
|
440,000
|
429,000
|
|||||
Capital
lease obligation, current portion
|
16,000
|
15,000
|
|||||
Deferred
revenue
|
2,202,000
|
563,000
|
|||||
Other
current liabilities
|
480,000
|
836,000
|
|||||
Total
current liabilities
|
6,054,000
|
4,484,000
|
|||||
Notes
payable, less current portion
|
168,000
|
498,000
|
|||||
Capital
lease obligation, less current portion
|
35,000
|
47,000
|
|||||
Deferred
license revenue
|
8,000
|
21,000
|
|||||
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
- 196,112,201 and 179,382,191, respectively
|
196,000
|
179,000
|
|||||
Additional
paid-in capital
|
224,326,000
|
204,546,000
|
|||||
Deferred
stock compensation
|
-
|
(235,000
|
)
|
||||
Accumulated
deficit
|
(202,416,000
|
)
|
(186,864,000
|
)
|
|||
Total
stockholders' equity
|
22,106,000
|
17,626,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
28,371,000
|
$
|
22,676,000
|
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,
2007
|
January
31,
2006
|
January
31,
2007
|
January
31,
2006
|
||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||
REVENUES:
|
|||||||||||||
Contract
manufacturing revenue
|
$
|
347,000
|
$
|
1,505,000
|
$
|
1,381,000
|
$
|
2,227,000
|
|||||
License
revenue
|
16,000
|
23,000
|
87,000
|
65,000
|
|||||||||
Total
revenues, net
|
363,000
|
1,528,000
|
1,468,000
|
2,292,000
|
|||||||||
COSTS
AND EXPENSES:
|
|||||||||||||
Cost
of contract manufacturing
|
223,000
|
1,088,000
|
1,247,000
|
1,820,000
|
|||||||||
Research
and development
|
3,907,000
|
3,294,000
|
11,868,000
|
9,330,000
|
|||||||||
Selling,
general and administrative
|
1,513,000
|
1,628,000
|
4,824,000
|
4,715,000
|
|||||||||
Total
costs and expenses
|
5,643,000
|
6,010,000
|
17,939,000
|
15,865,000
|
|||||||||
LOSS
FROM OPERATIONS
|
(5,280,000
|
)
|
(4,482,000
|
)
|
(16,471,000
|
)
|
(13,573,000
|
)
|
|||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||
Interest
and other income
|
267,000
|
1,381,000
|
955,000
|
1,585,000
|
|||||||||
Interest
and other expense
|
(12,000
|
)
|
(12,000
|
)
|
(36,000
|
)
|
(35,000
|
)
|
|||||
NET
LOSS
|
$
|
(5,025,000
|
)
|
$
|
(3,113,000
|
)
|
$
|
(15,552,000
|
)
|
$
|
(12,023,000
|
)
|
|
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
|||||||||||||
Basic
and Diluted
|
195,299,586
|
171,355,523
|
191,067,145
|
165,772,373
|
|||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.08
|
)
|
$
|
(0.07
|
)
|
See
accompanying notes to condensed consolidated financial statements
3
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
NINE
MONTHS ENDED JANUARY 31,
|
|||||||
2007
|
2006
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(15,552,000
|
)
|
$
|
(12,023,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
355,000
|
302,000
|
|||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
1,153,000
|
361,000
|
|||||
Amortization
of expenses paid in shares of common stock
|
362,000
|
844,000
|
|||||
Recovery
of note receivable
|
-
|
(1,229,000
|
)
|
||||
Loss
(gain) on disposal of property
|
1,000
|
(6,000
|
)
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
(378,000
|
)
|
(195,000
|
)
|
|||
Inventories
|
(1,986,000
|
)
|
(433,000
|
)
|
|||
Prepaid
expenses and other current assets
|
(221,000
|
)
|
(193,000
|
)
|
|||
Accounts
payable
|
206,000
|
168,000
|
|||||
Accrued
clinical trial site fees
|
149,000
|
203,000
|
|||||
Deferred
revenue
|
1,626,000
|
70,000
|
|||||
Accrued
payroll and related costs
|
(87,000
|
)
|
(189,000
|
)
|
|||
Other
accrued expenses and current liabilities
|
(310,000
|
)
|
(662,000
|
)
|
|||
Net
cash used in operating activities
|
(14,682,000
|
)
|
(12,982,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(105,000
|
)
|
(423,000
|
)
|
|||
Proceeds
from sale of property
|
-
|
6,000
|
|||||
Recovery
of note receivable
|
-
|
1,229,000
|
|||||
Decrease
(increase) in other assets
|
184,000
|
(199,000
|
)
|
||||
Net
cash provided by investing activities
|
79,000
|
613,000
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from borrowings under notes payable
|
-
|
370,000
|
|||||
Principal
payments on notes payable and capital lease
|
(330,000
|
)
|
(218,000
|
)
|
|||
Proceeds
from issuance of common stock, net of issuance costs of
$46,000
and $47,000, respectively
|
17,865,000
|
18,065,000
|
|||||
Net
cash provided by financing activities
|
17,535,000
|
18,217,000
|
|||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
2,932,000
|
5,848,000
|
|||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
17,182,000
|
9,816,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$
|
20,114,000
|
$
|
15,664,000
|
|||
NON-CASH
FINANCING ACTIVITIES:
|
|||||||
Common
stock issued for research fees and prepayments for future research
fees
|
$
|
975,000
|
$
|
321,000
|
|||
Property
acquired under capital lease
|
$
|
-
|
$
|
65,000
|
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, 2007 (unaudited)
1. BASIS
OF
PRESENTATION
The
accompanying interim condensed consolidated financial statements include the
accounts of Peregrine Pharmaceuticals, Inc. (“Peregrine”), a clinical stage
biopharmaceutical company developing targeted therapeutics for the treatment
of
cancer and hepatitis C virus infection, 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, 2007, and the condensed consolidated results of our operations
and
our condensed consolidated cash flows for the three and nine-month periods
ended
January 31, 2007 and 2006. 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, 2006.
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.
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 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, 2007 and 2006 amounted
to $1,381,000 and $2,227,000, respectively. We expect that Avid will continue
to
generate revenues which should partially offset our consolidated cash flows
used
in operations, although we expect those near term revenues will be insufficient
to fully cover our anticipated consolidated cash flows used in operations.
In
addition, revenues that may be generated from the sale and/or licensing of
our
products under development are always uncertain. Therefore, our ability to
continue our clinical trials and development efforts is highly dependent on
the
amount of cash and cash equivalents on hand combined with our ability to raise
additional capital to support our future operations. At January 31, 2007, we
had
$20,114,000 in cash and cash equivalents, which we currently believe is
sufficient capital to maintain our operations through at least November 2007
based on our current projections.
We
may
raise additional capital through the registered offer and sale of shares of
our
common stock. At January 31, 2007, we had approximately 5,031,000 shares
available for possible future registered transactions under two separate shelf
registration statements. In addition during January 2007, we filed a separate
registration statement on Form S-3, File Number 333-139975, which allows us
to
issue, from time to time, in one or more offerings, shares of our common stock
for proceeds up to $30,000,000. 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, 2007 (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 beyond
November 2007.
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. We have prepaid various research and development
related services through the issuance of shares of our common stock to unrelated
entities, which are expensed once the services have been provided under the
terms of the arrangement. As of January 31, 2007 and April 30, 2006, prepaid
expenses and other current assets in the accompanying condensed consolidated
financial statements include $504,000 and $866,000, respectively, in research
and development services prepaid with shares of our common stock. These prepaid
research and development balances as of January 31, 2007 and April 30, 2006
include amounts paid in shares of our common stock to Affitech AS of $475,000
under a research collaboration agreement for the generation of fully human
monoclonal antibodies against two targets that are currently undefined and
contain no expiration clauses. We will expense these prepaid targets once they
are defined and delivered to Affitech AS in accordance with the terms of the
agreement, which we expect will occur within the next twelve
months.
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, 2007
and
April 30, 2006:
January
31,
2007
|
April
30,
2006
|
||||||
Raw
materials
|
$
|
709,000
|
$
|
565,000
|
|||
Work-in-process
|
2,162,000
|
320,000
|
|||||
Total
inventories
|
$
|
2,871,000
|
$
|
885,000
|
Comprehensive
Loss
-
Comprehensive loss is equal to net loss for all periods presented.
Basic
and Dilutive Net Loss Per Common Share -
Basic
and dilutive net loss per common share are calculated in accordance with
Statement of Financial Accounting Standards No. 128, Earnings
per Share.
Basic
net loss per common share is computed by dividing our net loss by the weighted
average number of common shares outstanding during the period excluding the
dilutive effects of options and warrants. Diluted net loss per common share
is
computed by dividing the net loss by the sum of the weighted average number
of
common shares outstanding during the period plus the potential dilutive effects
of options and warrants outstanding during the period calculated in accordance
with the treasury stock method, but are excluded if their effect is
anti-dilutive. Because the impact of options and warrants are anti-dilutive
during periods of net loss, there was no difference between basic and diluted
loss per share amounts for the three and nine months ended January 31, 2007
and
2006.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 1,301,525
and 2,531,546 shares
of
common stock for the three and nine months ended January 31, 2007,
respectively, and 2,524,463 and 2,997,181
shares
of
common stock for the three and nine months ended January 31, 2006, respectively,
since 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, 2007 (unaudited)
(continued)
The
calculation of weighted average diluted shares outstanding also excludes
weighted average outstanding options and warrants to purchase up to 8,525,781
and 7,116,306 shares of common stock for the three and nine months ended
January 31, 2007, respectively, and 11,176,382 and 9,592,777 shares of
common stock for the three and nine months ended January 31, 2006, respectively,
as the exercise prices of those options were greater than the average market
price of our common stock during the respective periods, resulting in an
anti-dilutive effect.
Recent
Accounting Pronouncements
- In
June 2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48 (“FIN 48”), Accounting
for Uncertainty in Income Taxes—An Interpretation of FASB Statement No. 109,
which
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. FIN 48 will be effective for fiscal years beginning
after
December 15, 2006, which we would be required to implement no later than May
1,
2007. We have not yet evaluated the potential impact of adopting FIN 48 on
our
consolidated financial statements.
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157 (“SFAS No. 157”), Fair
Value Measurements,
which
defines fair value, establishes a framework for measuring fair value under
GAAP,
and expands disclosures about fair value measurements. SFAS No. 157 will be
effective for fiscal years beginning after November 15, 2007, which we
would be required to implement no later than May 1, 2008. We have not yet
evaluated the potential impact of adopting SFAS No. 157 on our consolidated
financial statements.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
No.
159 (“SFAS No. 159”), The
Fair Value Option for Financial Assets and Financial Liabilities
-
Including an amendment of FASB statement No. 115 .
SFAS
No.
159
permits entities to choose to measure many financial instruments and certain
other items at fair value. If the fair value method is selected, a business
entity shall report unrealized gains and losses on
elected items in earnings at each subsequent reporting date. The
standard also establishes presentation and disclosure requirements designed
to
facilitate comparisons between companies that choose different measurement
attributes for similar types of assets and liabilities. SFAS No.
159
is effective for fiscal years beginning after November 15, 2007, which we would
be required to implement no later than May 1, 2008. We have not yet
evaluated the potential impact of adopting SFAS No. 159 on our consolidated
financial statements.
3. STOCK-BASED
COMPENSATION
We
currently maintain four equity compensation plans referred to as the 1996 Plan,
the 2002 Plan, the 2003 Plan, and the 2005 Plan (collectively referred to as
the
“Option Plans”). The Option Plans provide for the granting of options to
purchase shares of our common stock at exercise prices not less than the fair
market value of our common stock at the date of grant. The options generally
vest over four years and generally expire ten years after the date of grant.
7
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2007 (unaudited)
(continued)
Prior
to
fiscal year 2007, we accounted for options granted under the Option Plans in
accordance with Accounting Principles Board No. 25 (“APB No. 25”), Accounting
for Stock Issued to Employees and Related Interpretations,
as
permitted by FASB Statement of Financial Accounting Standard No. 123 (“SFAS No.
123”), Accounting
for Stock-Based Compensation.
Accordingly, no compensation expense was recognized in the accompanying
condensed statements of operations for the three and nine months ended January
31, 2006 related to stock option grants, as all options granted under the Option
Plans had an exercise price at least equal to the fair market value of the
underlying common stock on the grant date.
Effective
May 1, 2006, we adopted Statement of Financial Accounting Standards No. 123R
(“SFAS No. 123R”), Share-Based
Payment (Revised 2004),
which
supersedes our previous accounting under APB No. 25. SFAS No. 123R requires
the
recognition of compensation expense, using a fair value based method, for costs
related to all share-based payments including grants of employee stock options.
In addition, SFAS No. 123R requires companies to estimate the fair value of
share-based payment awards on the date of grant using an option-pricing model.
The value of the portion of the award that is ultimately expected to vest is
recognized as expense on a straight-line basis over the requisite service
periods (vesting period). We adopted SFAS 123R using the modified-prospective
method and, accordingly, stock-based compensation cost recognized beginning
May
1, 2006 includes: (a) compensation cost for all share-based payments granted
prior to, but not yet vested as of May 1, 2006, based on the grant date fair
value estimated in accordance with the original provisions of SFAS No. 123,
and
(b) compensation cost for all share-based payments granted on or subsequent
to
May 1, 2006, based on the grant date fair value estimated in accordance with
the
provisions of SFAS No. 123R. Results for prior periods have not been
restated.
Our
net
loss for the three and nine months ended January 31, 2007 increased by $187,000
and $796,000, respectively, as a result of the application of SFAS No. 123R,
which costs are included in the accompanying condensed consolidated statements
of operations as follows:
Three
Months Ended
January
31, 2007
|
Nine
Months Ended
January
31, 2007
|
||||||
Research
and development
|
$
|
129,000
|
$
|
472,000
|
|||
Selling,
general and administrative
|
58,000
|
324,000
|
|||||
Total
|
$
|
187,000
|
$
|
796,000
|
The
fair
value of each option grant is estimated using the Black-Scholes option valuation
model and is amortized as compensation expense on a straight-line basis over
the
requisite service period of the award, which is generally the vesting period
(typically 4 years). The use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model inputs. The expected
volatility is based on the daily historical volatility of our stock covering
the
estimated expected term. The expected term of options granted is based on the
expected time to exercise using the “simplified” method allowable under the
Security and Exchange Commission’s Staff Accounting Bulletin No. 107. The
risk-free interest rate is based on U.S. Treasury notes with terms within the
contractual life of the option at the time of grant. In addition, SFAS No.
123R requires forfeitures
to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. The fair value of
stock options on the date of grant and the weighted-average assumptions used
to
estimate the fair value of the stock options using the Black-Scholes option
valuation model during the periods presented, were as follows:
8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2007 (unaudited)
(continued)
Three
Months Ended
January
31,
|
Nine
Months Ended
January
31,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Risk-free
interest rate
|
4.72%
|
|
3.88%
|
|
4.87%
|
|
3.88%
|
|
|||||
Expected
life (in years)
|
6.25
|
5.49
|
6.25
|
5.49
|
|||||||||
Expected
volatility
|
97%
|
|
103%
|
|
99%
|
|
103%
|
|
|||||
Expected
dividend yield
|
-
|
-
|
-
|
-
|
As
of
January 31, 2007, options to purchase up to 11,608,165 shares of our common
stock were issued and outstanding under the Option Plans with a weighted average
exercise price of $1.54 per share and expire at various dates through January
29, 2017. Options to purchase up to 4,616,329 shares of common stock were
available for future grant under the Option Plans as of January 31, 2007. The
total options available for grant of 4,616,329 excludes shares of our common
stock reserved for under our February 2006 Stock Bonus Plan, which plan will
remain in effect through fiscal year ending April 30, 2007, due to the
uncertainty of achieving the performance milestones that are required to be
achieved before shares of common stock are issued under the Stock Bonus Plan.
We
carefully assess the likelihood of achieving each predetermined performance
milestone on a quarterly basis and record compensation expense when it becomes
probable that a predetermined performance milestone under the Stock Bonus Plan
will be achieved. During the nine months ended January 31, 2007, 249,326 shares
of common stock have been earned by eighteen participants under the February
2006 Stock Bonus Plan, based on the achievement of various milestones. In the
event that all remaining milestones are achieved under the Stock Bonus Plan,
we
would issue up to 221,624 additional shares of common stock under the February
2006 Stock Bonus Plan during fiscal year 2007 for the achievement of performance
milestones.
The
following summarizes all stock option transaction activity for the nine months
ended January 31, 2007:
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
|||||||||
Outstanding,
May 1, 2006
|
11,307,279
|
$
|
1.56
|
||||||||||
Granted
|
846,680
|
$
|
1.34
|
||||||||||
Exercised
|
(65,350
|
)
|
$
|
0.90
|
|||||||||
Canceled
or expired
|
(480,444
|
)
|
$
|
1.64
|
|||||||||
Outstanding,
January 31, 2007
|
11,608,165
|
$
|
1.54
|
6.02
|
$
|
1,358,000
|
|||||||
Exercisable
and expected to vest
|
11,388,535
|
$
|
1.55
|
5.97
|
$
|
1,348,000
|
|||||||
Exercisable,
January 31, 2007
|
9,087,459
|
$
|
1.60
|
5.34
|
$
|
1,255,000
|
|||||||
The
weighted-average grant date fair value of options granted during the nine-month
periods ended January 31, 2007 and 2006 were $1.09 per share and $0.81 per
share, respectively. Cash proceeds from stock options exercised during the
nine-month periods ended January 31, 2007 and 2006 totaled $59,000 and $90,000,
respectively. The aggregate intrinsic value of options exercised during the
nine-month periods ended January 31, 2007 and 2006 was $38,000 and $35,000,
respectively.
9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2007 (unaudited)
(continued)
We
issue
shares of common stock that are reserved for under the Option Plans upon the
exercise of stock options, and we do not expect to repurchase shares of common
stock from any source to satisfy our obligations under our compensation
plans.
As
of
January 31, 2007, the total estimated unrecognized compensation cost related
to
non-vested stock options was $1,842,000. This cost is expected to be recognized
over a weighted average vesting period of 2.91 years based on current
assumptions.
As
discussed above, results for prior periods have not been restated to reflect
the
effects of implementing SFAS No. 123R. The following table illustrates the
effect on net loss and net loss per share for the three and nine-month periods
ended January 31, 2007 as compared to the pro forma financial results for the
three and nine-month periods ended January 31, 2006, adjusted for stock-based
compensation:
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
||||||||||||
January
31,
2007
|
January
31,
2006
|
January
31,
2007
|
January
31,
2006
|
||||||||||
Net
loss, excluding the effect of employee stock-based
compensation
|
$
|
(4,838,000
|
)
|
$
|
(3,113,000
|
)
|
$
|
(14,756,000
|
)
|
$
|
(12,023,000
|
)
|
|
Deduct:
Total stock-based employee compensation determined under the fair
value
based method for all awards
|
(187,000
|
)
|
(291,000
|
)
|
(796,000
|
)
|
(1,504,000
|
)
|
|||||
Net
loss, including the effect of stock-based compensation
|
$
|
(5,025,000
|
)
|
$
|
(3,404,000
|
)
|
$
|
(15,552,000
|
)
|
$
|
(13,527,000
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||||||||
Excluding
the effect of stock-based compensation
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.08
|
)
|
$
|
(0.07
|
)
|
|
Including
the effect of stock-based compensation
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.08
|
)
|
$
|
(0.08
|
)
|
Periodically,
we grant stock options to non-employee consultants. The fair value of options
granted to non-employees are measured utilizing the Black-Scholes option
valuation model and are amortized over the estimated period of service or
related vesting period in accordance with EITF 96-18, Accounting
for Equity Instruments That Are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services.
Stock-based compensation expense recorded during the three and nine months
ended
January 31, 2007 associated with non-employees amounted to $2,000 and $54,000,
respectively. Stock-based compensation expense recorded during the three and
nine months ended January 31, 2006 associated with non-employees amounted to
$200,000 and $361,000, respectively.
4.
STOCKHOLDERS’
EQUITY
During
June 2006, we entered into a Common Stock Purchase Agreement with one
institutional investor pursuant to which we sold 9,285,714 shares of our common
stock in exchange for net proceeds of $12,970,000. The shares of common stock
were issued from our shelf registration statement on Form S-3, File Number
333-132872. No commissions were paid, nor warrants issued, in connection with
this transaction.
10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2007 (unaudited)
(continued)
During
January 2007, we issued and sold 862,832 shares of our common stock to Affitech
AS as payment for certain amounts due under a research collaboration agreement
dated October 4, 2004 for the generation of fully human monoclonal antibodies
against three additional antibody targets that are currently undefined and
have
no expiration clauses. The shares of common stock were issued from our shelf
registration statement on Form S-3, File Number 333-132872. The value of the
shares issued of $975,000 is included in other assets in the accompanying
condensed consolidated balance sheets at January 31, 2007 as we do not currently
expect to define these three targets within the next twelve months. We will
expense each target as a research and development expense once the targets
are
defined and delivered to Affitech AS in accordance with the terms of the
agreement.
As
of
January 31, 2007, 4,851,454 shares of common stock were available for issuance
under our shelf registration statement on Form S-3, File Number
333-132872.
During
January 2007, we filed a registration statement on Form S-3, File Number
333-139975 (the “January 2007 Shelf”) which was declared effective by the
Securities and Exchange Commission, allowing us to issue, from time to time,
in
one or more offerings, shares of common stock for proceeds up to $30,000,000.
As
of January 31, 2007, we have not issued any shares of common stock under the
January 2007 Shelf.
As
of
January 31, 2007, we have reserved 21,677,993 additional shares of our common
stock which may be issued under our shelf registration statements, stock option
plans and outstanding warrants, as further described in the following table:
Number
of Shares
of
Common Stock
Reserved
For
Issuance
|
||||
Shares
reserved under two effective shelf registration statements
|
5,030,634
|
|||
Options
issued and outstanding
|
11,608,165
|
|||
Options
available for future grant
|
4,616,329
|
|||
Warrants
issued and outstanding
|
422,865
|
|||
Total
shares reserved
|
21,677,993
|
The
above
table does not include shares of common stock that we could issue under the
January 2007 Shelf due to the indeterminable number of shares that could
potentially be issued under this shelf, which allows us to issue, from time
to
time, in one or more offerings, shares of common stock for proceeds up to
$30,000,000.
5. WARRANTS
During
the nine months ended January 31, 2007, warrants to purchase 6,266,788 shares
of
our common stock were exercised for cash under four separate transactions for
net proceeds of $4,852,000. As of January 31, 2007, warrants to purchase up
to
422,865 shares of our common stock were issued and outstanding and exercisable
at prices ranging between $0.86 and $2.50 per share with a weighted average
exercise price of $1.40 per share and expire at various dates through March
31,
2008.
11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2007 (unaudited)
(continued)
Additional
information regarding warrants outstanding as of January 31, 2007, is as
follows:
Per
Share
Exercise
Price
|
Number
of
Warrants
Outstanding
|
Weighted
Average
Per
Share
Exercise
Price
|
Expiration
Date
|
|||||||
$0.86
|
62,865
|
6/8/07
|
||||||||
$1.47
|
350,000
|
3/31/08
|
||||||||
$2.50
|
10,000
|
3/25/08
|
||||||||
$0.86
- $2.50
|
422,865
|
|
$
1.40
|
6/8/07
- 3/31/08
|
6. SEGMENT
REPORTING
Our
business is organized into two reportable operating segments. Peregrine is
engaged in the research and development of targeted products for the treatment
of cancer and viral infections using monoclonal antibodies. 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 the three-month periods is summarized as follows:
Three
Months Ended January 31,
|
|||||||
2007
|
2006
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
347,000
|
$
|
1,505,000
|
|||
Products
in research and development
|
16,000
|
23,000
|
|||||
Total
revenues, net
|
$
|
363,000
|
$
|
1,528,000
|
|||
Gross
Profit:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
124,000
|
$
|
417,000
|
|||
Products
in research and development
|
16,000
|
23,000
|
|||||
Total
gross profit
|
140,000
|
440,000
|
|||||
Research
and development expense
|
(3,907,000
|
)
|
(3,294,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,513,000
|
)
|
(1,628,000
|
)
|
|||
Other
income, net
|
255,000
|
1,369,000
|
|||||
Net
loss
|
$
|
(5,025,000
|
)
|
$
|
(3,113,000
|
)
|
12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2007 (unaudited)
(continued)
Net
revenues generated from Avid for the three-month periods were from the following
customers:
Three
Months Ended January 31,
|
|||||||
2007
|
2006
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
77%
|
|
72%
|
|
|||
United
States (customer B)
|
18%
|
|
0%
|
|
|||
Germany
(one customer)
|
3%
|
|
20%
|
|
|||
Other
customers
|
2%
|
|
8%
|
|
|||
Total
customer revenues as a % of net revenues
|
100%
|
|
100%
|
|
Segment
information for the nine-month periods is summarized as follows:
Nine
Months Ended January 31,
|
|||||||
2007
|
2006
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,381,000
|
$
|
2,227,000
|
|||
Products
in research and development
|
87,000
|
65,000
|
|||||
Total
net revenues
|
$
|
1,468,000
|
$
|
2,292,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
134,000
|
$
|
407,000
|
|||
Products
in research and development
|
87,000
|
65,000
|
|||||
Total
gross profit
|
221,000
|
472,000
|
|||||
Research
and development expense
|
(11,868,000
|
)
|
(9,330,000
|
)
|
|||
Selling,
general and administrative expense
|
(4,824,000
|
)
|
(4,715,000
|
)
|
|||
Other
income, net
|
919,000
|
1,550,000
|
|||||
Net
loss
|
$
|
(15,552,000
|
)
|
$
|
(12,023,000
|
)
|
|
Net
revenues generated from Avid for the nine-month periods were from the following
customers:
Nine
Months Ended January 31,
|
|||||||
2007
|
2006
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
22%
|
|
75%
|
|
|||
United
States (customer B)
|
12%
|
|
0%
|
|
|||
Germany
(one customer)
|
1%
|
|
13%
|
|
|||
Australia
(one customer)
|
36%
|
|
3%
|
|
|||
China
(one customer)
|
25%
|
|
0%
|
|
|||
Other
customers
|
4%
|
|
9%
|
|
|||
Total
customer revenues as a % of net revenues
|
100%
|
|
100%
|
|
13
Net
revenues generated from products in research and development during the three
and nine months ended January 31, 2007 and 2006 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,
2007
|
April
30,
2006
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,510,000
|
$
|
1,516,000
|
|||
Products
in research and development
|
335,000
|
390,000
|
|||||
Total
long-lived assets, net
|
$
|
1,845,000
|
$
|
1,906,000
|
14
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”
“project”, 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.
Company
Overview
We
are
organized into two reportable operating segments: (i) Peregrine Pharmaceuticals,
Inc. (“Peregrine”), the parent company, is a clinical stage biopharmaceutical
company developing targeted therapeutics for the treatment of cancer and
hepatitis C virus infection and (ii) Avid Bioservices, Inc. (“Avid”), a wholly
owned subsidiary, is engaged in providing bio-manufacturing services for
Peregrine and outside customers on a fee-for-service basis.
The
following represents a summary of our ongoing clinical trial
programs:
Product
|
Indication
|
Trial
Design
|
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
Ia repeat dose monotherapy safety study to treat up to 28 patients.
|
Patients
are currently being screened and enrolled at up to 5 centers in the
U.S.
|
Bavituximab
plus chemotherapy
|
Solid
tumor cancers
|
Phase
Ib repeat dose combination therapy safety study to treat up to 12
patients
with 8 weekly doses of bavituximab in combination with chemotherapy
agents.
|
Patients
are currently being screened and enrolled at up to 3 centers in India.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients at
1st
and 2nd
relapse in collaboration with New Approaches to Brain Tumor Therapy
consortium.
|
Patients
are currently being screened and enrolled at up to 4 centers in the
U.S.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme)
|
Phase
II safety and efficacy study to treat up to 40 patients at 1st
relapse.
|
Regulatory
approval has been received for the protocol in India. Manufacturing
development is proceeding in India and approval is anticipated in
the near
term.
|
Bavituximab
|
Chronic
Hepatitis C Virus (“HCV”) infection
|
Phase
Ib repeat dose safety study in 24 patients.
|
Phase
Ib study is complete. We are currently evaluating the data in designing
the next set of studies. We expect to initiate these studies in the
coming
months.
|
15
Results
of Operations
The
following table compares the unaudited condensed consolidated statements of
operations for the three and nine-month periods ended January 31, 2007 and
2006.
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,
|
||||||||||||||||||
2007
|
2006
|
$
Change
|
2007
|
2006
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing revenue
|
$
|
347
|
$
|
1,505
|
$
|
(1,158
|
)
|
$
|
1,381
|
$
|
2,227
|
$
|
(846
|
)
|
|||||
License
revenue
|
16
|
23
|
(7
|
)
|
87
|
65
|
22
|
||||||||||||
Total
revenues
|
363
|
1,528
|
(1,165
|
)
|
1,468
|
2,292
|
(824
|
)
|
|||||||||||
COST
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
223
|
1,088
|
(865
|
)
|
1,247
|
1,820
|
(573
|
)
|
|||||||||||
Research
and development
|
3,907
|
3,294
|
613
|
11,868
|
9,330
|
2,538
|
|||||||||||||
Selling,
general and administrative
|
1,513
|
1,628
|
(115
|
)
|
4,824
|
4,715
|
109
|
||||||||||||
Total
cost and expenses
|
5,643
|
6,010
|
(367
|
)
|
17,939
|
15,865
|
2,074
|
||||||||||||
LOSS
FROM OPERATIONS
|
(5,280
|
)
|
(4,482
|
)
|
(798
|
)
|
(16,471
|
)
|
(13,573
|
)
|
(2,898
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Interest
and other income
|
267
|
1,381
|
(1,114
|
)
|
955
|
1,585
|
(630
|
)
|
|||||||||||
Interest
and other expense
|
(12
|
)
|
(12
|
)
|
-
|
(36
|
)
|
(35
|
)
|
(1
|
)
|
||||||||
NET
LOSS
|
$
|
(5,025
|
)
|
$
|
(3,113
|
)
|
$
|
(1,912
|
)
|
$
|
(15,552
|
)
|
$
|
(12,023
|
)
|
$
|
(3,529
|
)
|
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
Nine Months: The decrease in total revenues of $1,165,000 and $824,000 during
the three and nine months ended January 31, 2007, respectively, compared to
the
same periods in the prior year was primarily due to a decrease in contract
manufacturing revenue of $1,158,000 and $846,000, 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
prior year periods. The decrease in contract manufacturing revenue for the
current year nine-month period was offset by the collection of a disputed
receivable in the amount of $300,000 during the quarter ended October 31, 2006,
associated with services performed under a contract during the year ended April
30, 2005. Since collectibility of the receivable was not reasonably assured,
in
accordance with SAB No. 104, we did not recognize revenue in prior years and
the
related work-in-process inventory was written off and included in cost of
contract manufacturing during the year ended April 30, 2005.
We
expect
an increase in contract manufacturing revenue during the remainder of the
current fiscal year based on completed projects to date in the fourth quarter
and the anticipated completion of in-process customer related projects and
the
anticipated demand for Avid’s services under outstanding proposals. Avid is
presently working on several active projects for existing clients and has
submitted project proposals to various potential clients. Since the timing
to
initiate and complete projects from existing clients and our ability to convert
outstanding proposals into new contracts and new business is at the discretion
of our clients or potential clients, we cannot reasonably estimate with a high
degree of likelihood our revenues for the remainder of fiscal year 2007 nor
for
fiscal year 2008 beyond the approximate $1.9 million of work we have completed
as of the date of this Quarterly Report.
16
Cost
of Contract Manufacturing.
Three
and
Nine Months: The decrease in cost of contract manufacturing of $865,000 and
$573,000 during the three and nine months ended January 31, 2007, respectively,
compared to the same periods in the prior year was primarily related to the
current year decreases in contract manufacturing revenue. In addition, the
current year nine-month decrease in cost of contract manufacturing was offset
by
the write-off of unusable work-in-process inventory and estimated contract
loss
provisions associated with two unrelated entities during the six-month period
ending October 31, 2006 of $412,000. 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
and
Nine Months: The increase in research and development expenses of $613,000
and
$2,538,000 during the three and nine-month periods ended January 31, 2007,
respectively, compared to the same periods in the prior year was due to an
increase in expenses associated with each of our following platform technologies
under development:
R&D
Expenses -
Three
Months Ended
January
31,
|
R&D
Expenses -
Nine
Months Ended
January
31,
|
||||||||||||||||||
2007
|
2006
|
$
Change
|
2007
|
2006
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
Technology
Platform:
|
|||||||||||||||||||
Anti-PS
Immunotherapeutics
(bavituximab)
|
$
|
1,974
|
$
|
2,174
|
$
|
(200
|
)
|
$
|
7,081
|
$
|
6,290
|
$
|
791
|
||||||
TNT
(Cotara®)
|
1,301
|
641
|
660
|
2,829
|
1,710
|
1,119
|
|||||||||||||
VTA
and Anti-Angiogenesis Agents
|
487
|
369
|
118
|
1,531
|
1,033
|
498
|
|||||||||||||
VEA
|
145
|
110
|
35
|
427
|
297
|
130
|
|||||||||||||
Total
R&D Expenses
|
$
|
3,907
|
$
|
3,294
|
$
|
613
|
$
|
11,868
|
$
|
9,330
|
$
|
2,538
|
o
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) -
Three
Months: The decrease in Anti-PS Immunotherapeutics program expenses during
the
three months ended January 31, 2007 compared to the same period in the prior
year is primarily due to a decrease in allocated manufacturing expenses
associated with our first Anti-PS Immunotherapeutic agent, bavituximab. The
decrease in allocated manufacturing expenses is primarily associated with a
decrease in the utilization of our in-house manufacturing facility during the
current year quarter to support our bavituximab research and clinical programs
compared to the same period in the prior year. During the current year quarter,
our manufacturing efforts were primarily focused on both clinical platforms,
bavituximab and Cotara®, as we prepared to initiate the Cotara® brain cancer
study in India. Whereas in the prior year quarter, our manufacturing efforts
were primarily focused on bavituximab. This decrease in allocated manufacturing
expenses was offset by an increase in payroll and related expenses primarily
related to increased headcount to support the clinical development of
bavituximab in the U.S. and abroad including the advancement of our pre-clinical
product candidates under our Anti-PS platform technology.
17
Nine
Months: The increase in Anti-PS Immunotherapeutics program expenses during
the
nine months ended January 31, 2007 compared to the same period in the prior
year
is primarily from continuing efforts to support the development and clinical
development of our first Anti-PS Immunotherapeutic agent, bavituximab. During
the current nine-month period, clinical trial expenses increased as we advanced
the development of two separate Phase I clinical programs using bavituximab
for
the treatment of advanced solid cancers and chronic hepatitis C virus infection
(“HCV”), including the initiation of a Phase Ib study in India during the
current year using bavituximab for the treatment of advanced solid cancers
in
combination with chemotherapy. These increases in clinical trial expenses were
further supplemented with increases in payroll and related expenses including
non-cash stock-based compensation expense associated with the amortization
of
the fair value of options granted to employees in accordance with the adoption
of SFAS No. 123R on May 1, 2006 and non-cash expenses associated with shares
of
common stock earned by employees under our February 2006 Stock Bonus Plan.
These
increases in Anti-PS Immunotherapeutics program expenses were offset by a
decrease in technology license and access fees expensed in the prior year period
in support of the bavituximab clinical program and pre-clinical product
candidates.
o Tumor
Necrosis Therapy (“TNT”) (Cotara®) - Three
and
Nine Months: The increase in TNT program expenses during the three and nine
months ended January 31, 2007 compared to the same periods in the prior year
resulted primarily from increased clinical trial expenses to support the Cotara®
dose confirmation and dosimetry clinical trial for the treatment of glioblastoma
multiforme (a deadly form of brain cancer) in collaboration with the New
Approaches to Brain Tumor Therapy consortium and an increase in expenses to
support the initiation of a Phase II clinical trial in India to treat up to
40
patients with glioblastoma multiforme. These increases in clinical trial
expenses were further supplemented with increases in payroll and related
expenses, manufacturing expenses, and non-cash stock-based compensation expense
associated with the amortization of the fair value of options granted to
employees in accordance with the adoption of SFAS No. 123R on May 1,
2006.
o
|
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis Agents -
Three and Nine Months: The increase in VTA and Anti-Angiogenesis
Agents
program expenses during the three and nine-months ended January 31,
2007
compared to the same periods in the prior year is primarily due to
increases in payroll and related expenses, sponsored research fees,
manufacturing expenses, and outside research studies associated with
increased efforts to advance the pre-clinical development of our
VTA and
Anti-Angiogenesis Agents programs. These increases were further
supplemented by an increase in non-cash stock-based compensation
expense
associated with the amortization of the fair value of options granted
to
employees in accordance with the adoption of SFAS No. 123R on May
1,
2006.
|
o
VEA
-
Three
and Nine Months: The increase in VEA program expenses during the three and
nine
months ended January 31, 2007 compared to the same periods in the prior year
is
primarily due to increases in payroll and related expenses and laboratory
materials associated with increased efforts to advance the pre-clinical
development of our VEA program. These increases were further supplemented by
an
increase in non-cash stock-based compensation expense associated with the
amortization of the fair value of options granted to employees in accordance
with the adoption of SFAS No. 123R on May 1, 2006. The above VEA increases
were
offset with a decrease in technology license fees incurred in the prior year
associated with an annual license fee due under a former license
agreement.
18
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 November 2007;
|
§
|
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;
|
§
|
the
uncertainty of future clinical trial results;
|
§
|
the
uncertainty of the ultimate number of patients to be treated in
any
current or future clinical trial;
|
§
|
the
uncertainty of the Food and Drug Administration allowing our studies
to
move forward from Phase I clinical studies to Phase II and Phase
III
clinical studies;
|
§
|
the
uncertainty of the rate at which patients are enrolled into any
current or
future study. Any delays in clinical trials could significantly
increase
the cost of the study and would extend the estimated completion
dates;
|
§
|
the
uncertainty of terms related to potential future partnering or
licensing
arrangements; 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, stock-based compensation
expense, investor and public relation fees, insurance, and other expenses
relating to general management, administration, and business development
activities of the Company.
Three
Months: The decrease in selling, general and administrative expenses of $115,000
during the three months ended January 31, 2007 compared to the same period
in
the prior year is primarily due to decreases in payroll and related expenses
and
non-cash expenses associated with stock-based compensation. Payroll and related
expenses decreased $65,000 from $773,000 in fiscal year 2006 to $708,000 in
fiscal year 2007 primarily due to certain severance expenses that did not
reoccur in the current period. This was offset by a current quarter increase
in
payroll expenses primarily associated with an increase in headcount across
most
corporate functions to support our expanding operations. Non-cash stock-based
compensation expense decreased $58,000 from $118,000 in fiscal year 2006 to
$60,000 in fiscal year 2007 primarily due to the prior year amortization of
the
fair value of warrants provided to a non-employee consultant for business
development services related to Avid’s operations, which was offset by an
increase in stock-based compensation associated with the adoption of SFAS No.
123R on May 1, 2006. These
decreases were further supplemented with decreases associated with corporate
legal fees and investor and public relation fees offset with incremental
increases in facility other general corporate expenses.
19
Nine
Months: The increase in selling, general and administrative expenses of $109,000
during the nine months ended January 31, 2007 compared to the same period in
the
prior year is primarily due to an increase in (i) payroll and related expenses,
(ii) corporate facility and related expenses, (iii) non-cash stock-based
compensation expense, and (iv) non-cash stock bonus expense. Payroll and related
expenses slightly increased $53,000 from $2,083,000 in fiscal year 2006 to
$2,136,000 in fiscal year 2007 primarily due to an increase in headcount across
most corporate functions to support our increased operations offset by a
decrease in prior year severance expenses. Corporate facility and related
expenses increased $94,000 from $257,000 in fiscal year 2006 to $351,000 in
fiscal year 2007 primarily due to the increase in employee headcount across
most
corporate functions combined with an increased allocation of lease expense
resulting from the expiration of a sub-lease agreement. Non-cash stock-based
compensation expense increased $89,000 from $243,000 in fiscal year 2006 to
$332,000 in fiscal year 2007 primarily due to the adoption of SFAS No. 123R
on
May 1, 2006. In addition, we expensed $150,000 in non-cash stock bonuses during
the current year nine-month period, which we did not incur in the prior year,
associated with the fair value shares of common stock earned by employees upon
the achievement of pre-determined performance milestones as set forth under
the
Company’s February 2006 Stock Bonus Plan. These increases were offset with a net
decrease in other corporate related expenses of $248,000, which primarily
includes decreases in corporate legal fees and public and investor relation
fees.
Interest
and Other Income.
Three
and
Nine Months: The decrease in interest and other income of $1,114,000 and
$630,000 during the three and nine months ended January 31, 2007, respectively,
compared to the same periods in the prior year was primarily due to the
collection of a previously fully reserved note receivable in the amount of
$1,229,000 reflected in the prior year quarter and nine-months ended January
31,
2006. The decrease in other income was partially offset by increases in interest
income of $122,000 and $478,000 during the current year three and nine-month
periods, respectively, as a result of a higher average cash balance on hand
and
higher prevailing interest rates during the current year periods compared to
the
same prior year periods. In addition, the current year nine-month decrease
in
other income was offset by the sale of a trademark name during the current
year
quarter ended July 31, 2006 in the amount of $130,000.
Critical
Accounting Policies
The
methods, estimates, and judgments we use in applying our most critical
accounting policies have a significant impact on the results we report in our
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
recognize revenues pursuant to the SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition.
In
accordance with SAB No. 104, revenue is generally realized or realizable and
earned when (i) persuasive evidence of an arrangement exists, (ii) delivery
has
occurred or services have been rendered, (iii) the seller's price to the buyer
is fixed or determinable, and (iv) collectibility is reasonably assured.
In
addition, we comply with Financial Accounting Standards Board’s Emerging Issues
Task Force No. 00-21 (“EITF 00-21”), Revenue
Arrangements with Multiple Deliverables.
In
accordance with EITF 00-21, we recognize revenue for delivered elements only
when the delivered element has stand-alone value and we have objective and
reliable evidence of fair value for each undelivered element. If the fair value
of any undelivered element included in a multiple element arrangement cannot
be
objectively determined, revenue is deferred until all elements are delivered
and
services have been performed, or until fair value can objectively be determined
for any remaining undelivered elements.
20
Revenues
associated with licensing agreements primarily consist of nonrefundable up-front
license fees and milestones payments. Revenues under licensing agreements are
recognized based on the performance requirements of the agreement. Nonrefundable
up-front license fees received under license agreements, whereby continued
performance or future obligations are considered inconsequential to the relevant
licensed technology, are generally recognized as revenue upon delivery of the
technology. Nonrefundable up-front license fees, whereby we have an ongoing
involvement or performance obligations, are generally recorded as deferred
revenue and generally recognized as revenue over the term of the performance
obligation or relevant agreement. Milestone payments are generally recognized
as
revenue upon completion of the milestone assuming there are no other continuing
obligations. Under some license agreements, the obligation period may not be
contractually defined. Under these circumstances, we must exercise judgment
in
estimating the period of time over which certain deliverables will be provided
to enable the licensee to practice the license.
Contract
manufacturing revenues are generally recognized once the service has been
provided and/or upon shipment of the product to the customer. We also record
a
provision for estimated contract losses, if any, in the period in which they
are
determined.
In
July
2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF
99-19”), Reporting
Revenue Gross as a Principal versus Net as an Agent.
EITF
99-19 summarized the EITF’s views on when revenue should be recorded at the
gross amount billed to a customer because it has earned revenue from the sale
of
goods or services, or the net amount retained (the amount billed to the customer
less the amount paid to a supplier) because it has earned a fee or commission.
In addition, the EITF released Issue 00-10 (“EITF 00-10”), Accounting
for Shipping and Handling Fees and Costs, and Issue 01-14
(“EITF
01-14”), Income
Statement Characterization of Reimbursements Received for “Out-of-Pocket”
Expenses Incurred.
EITF
00-10 summarized the EITF’s views on how the seller of goods should classify in
the income statement amounts billed to a customer for shipping and handling
and
the costs associated with shipping and handling. EITF 01-14 summarized the
EITF’s views on when the reimbursement of out-of-pocket expenses should be
characterized as revenue or as a reduction of expenses incurred. Our revenue
recognition policies are in compliance with EITF 99-19, EITF 00-10 and EITF
01-14 whereby we record revenue for the gross amount billed to customers (the
cost of raw materials, supplies, and shipping, plus the related handling mark-up
fee) and we record the cost of the amounts billed as cost of sales as we act
as
a principal in these transactions.
Stock-based
Compensation Expense
Prior
to
May 1, 2006, we accounted for our equity compensation plans in accordance with
Accounting Principles Board No. 25 (“APB No. 25”), Accounting
for Stock Issued to Employees and Related Interpretations,
as
permitted by Financial Accounting Standards Board Statement of Financial
Accounting Standard No. 123 (“SFAS No. 123”), Accounting
for Stock-Based Compensation.
Accordingly, no compensation expense was recognized in our financial statements
related to stock option grants, as all options granted under our equity
compensation plans had an exercise price at least equal to the fair market
value
of the underlying common stock on the grant date. Effective May 1, 2006, we
adopted the fair value recognition provisions of Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based
Payment (Revised 2004),
using
the modified-prospective method. Under the modified-prospective method,
stock-based compensation cost recognized beginning May 1, 2006 includes: (a)
compensation cost for all share-based payments granted prior to, but not yet
vested as of May 1, 2006, based on the grant date fair value estimated in
accordance with the original provisions of SFAS No. 123, and (b) compensation
cost for all share-based payments granted on or subsequent to May 1, 2006,
based
on the grant date fair value estimated in accordance with the provisions of
SFAS
No. 123R. Results for prior periods have not been restated.
The
fair
value of each option grant is estimated using the Black-Scholes option valuation
model and are amortized as compensation expense on a straight-line basis over
the requisite service periods of the awards, which is generally the vesting
period (typically 4 years). Use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model inputs. Expected
volatility is based on daily historical volatility of our stock covering the
estimated expected term. The expected term of options granted is based on the
expected time to exercise using the "simplified" method allowable under the
Security and Exchange Commission's Staff Accounting Bulletin No. 107. The
risk-free interest rate is based on U.S. Treasury notes with terms within the
contractual life of the option at the time of grant. In addition, SFAS No.
123R
requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those
estimates.
21
Our
loss
from operations for the three and nine-month periods ended January 31, 2007
included stock-based compensation expense of $187,000 and $796,000,
respectively. We believe that non-cash stock-based compensation expense for
the
remaining three months of fiscal year 2007 may be up to approximately $200,000
based on actual shares granted and unvested as of January 31, 2007. However,
the
actual expense may differ materially from this estimate as a result of changes
in a number of factors that affect the amount of non-cash compensation expense,
including the number of options granted by our Board of Directors during the
remainder of the fiscal year, the price of our common stock on the date of
grant, the volatility of our stock price, the estimate of the expected life
of
options granted and the risk-free interest rates.
As
of
January 31, 2007, the total estimated unrecognized compensation cost related
to
non-vested stock options was $1,842,000. This cost is expected to be recognized
over a weighted average period of 2.91 years.
Allowance
for Doubtful Accounts
We
continually monitor our allowance for doubtful accounts for all receivables.
A
considerable amount of judgment is required in assessing the ultimate
realization of these receivables and we estimate an allowance for doubtful
accounts based on factors that appear reasonable under the
circumstances.
Liquidity
and Capital Resources
As
of
January 31, 2007, we had $20,114,000 in cash and cash equivalents on hand
compared to $17,182,000 at April 30, 2006. Although we have sufficient cash
on
hand to meet our planned obligations through at least November 2007 based on
our
current projections, our development efforts are highly 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 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
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, 2007 and 2006 amounted
to $1,381,000 and $2,227,000, respectively. We expect that Avid will continue
to
generate revenues which should partially offset our consolidated cash flows
used
in operations, although we expect those near term revenues will be insufficient
to cover total anticipated cash flows used in operations. In addition, revenues
that may be generated from the sale and/or licensing of our products under
development are always uncertain. Therefore, our ability to continue our
clinical trials and development efforts is highly dependent on the amount of
cash and cash equivalents on hand combined with our ability to raise additional
capital to support our future operations beyond November 2007.
We
may
raise additional capital through the registered offer and sale of shares of
our
common stock. At January 31, 2007, we had approximately 5,031,000 shares
available for possible future registered transactions under two separate shelf
registration statements. Also, during January 2007, we filed a separate
registration statement on Form S-3, File Number 333-139975, which allows us
to
issue, from time to time, in one or more offerings, shares of our common stock
for proceeds up to $30,000,000. 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.
22
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.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the nine months ended January 31, 2007 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 nine months ended January 31, 2007, cash used in operating activities
increased $1,700,000 to $14,682,000 compared to $12,982,000 for the nine months
ended January 31, 2006. The increase in cash used in operating activities was
primarily related to an increase of $1,930,000 in net cash used in operating
activities before considering changes in operating assets and liabilities.
This
increase was primarily due to increases in research and development expenses
and
selling, general and administrative expenses combined with a decrease in cost
of
contract manufacturing. This increase in cash used in operating activities
before changes in operating assets and liabilities was offset by a net change
in
operating assets and payment or reduction of liabilities in the aggregate amount
of $230,000.
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:
NINE
MONTHS ENDED
|
||||||
January
31,
2007
|
January
31,
2006
|
|||||
Net
loss, as reported
|
$
|
(15,552,000
|
)
|
$
|
(12,023,000
|
)
|
Less
non-cash expenses and adjustments to net loss:
Depreciation
and amortization
Stock-based
compensation and common stock issued under stock
bonus
plan
Amortization
of expenses paid in shares of common stock
Recovery
of note receivable
Loss (gain)
on disposal of property
|
355,000
1,153,000
362,000
-
1,000
|
302,000
361,000
844,000
(1,229,000
(6,000
|
)
)
|
|||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(13,681,000
|
)
|
$
|
(11,751,000
|
)
|
Net
change in operating assets and liabilities
|
$
|
(1,001,000
|
)
|
$
|
(1,231,000
|
)
|
Net
cash used in operating activities
|
$
|
(14,682,000
|
)
|
$
|
(12,982,000
|
)
|
Cash
Provided by Investing Activities.
Net
cash provided by investing activities decreased $534,000 to $79,000
for the nine months ended January 31, 2007 compared to net cash provided by
$613,000 for the nine months ended January 31, 2006. This decrease in net
cash provided by investing activities was primarily due to the
recovery of a note receivable in the amount of $1,229,000 during the prior
year
period combined with a current year decrease in property acquisitions and a
decrease in other assets primarily related to security deposits paid in the
prior year to GE Capital Corporation on notes payable and prior year installment
payments made on certain laboratory equipment.
23
Cash
Provided By Financing Activities.
Net
cash provided by financing activities decreased $682,000 to $17,535,000 for
the
nine months ended January 31, 2007 compared to net cash provided of $18,217,000
for the nine months ended January 31, 2006. Cash provided by financing
activities during the nine months ended January 31, 2007 was primarily due
to
proceeds received under a security purchase agreement whereby we sold and issued
a total of 9,285,714 shares of our common stock in exchange for aggregate net
proceeds of $12,970,000, which was supplemented with net proceeds of $4,895,000
from the exercise of stock options and warrants. Cash provided by financing
activities during the nine months ended January 31, 2006 was primarily due
to
net proceeds received from the sale of our common under various security
purchase agreements in the amount of $17,975,000 supplemented with proceeds
received from the financing of laboratory equipment with GE Capital Corporation.
Commitments
At
January 31, 2007, we had no material capital commitments.
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,
2007, 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, 2007, 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, 2007.
There
were no significant changes in the Company’s internal controls over financial
reporting, during the quarter ended January 31, 2007, that have materially
affected, or are reasonably likely to materially affect, the Company’s internal
controls over financial reporting.
24
PART
II OTHER INFORMATION
ITEM
1.
LEGAL
PROCEEDINGS.
In
the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. Although we currently are not aware of any such legal
proceedings or claim that we believe will have, individually or in the
aggregate, a material adverse effect on our business, operating results or
cash
flows we did file the following lawsuit:
On
January 12, 2007, we filed a lawsuit against the Cancer Therapeutics
Laboratories (“CTL”). The lawsuit was filed in the Superior Court of the State
of California for the County of Orange, Central Justice Center. The lawsuit
alleges that CTL has breached various agreements with the Company by (i) failing
to pay to the Company its contractual share of the proceeds received by CTL
when
it formed a joint venture with a company in China involving the Company’s
technology that had been licensed to CTL pursuant to an earlier agreement (the
“Agreement”), (ii) failing to procure a sublicense with the company in China
prior to transferring the Company’s technology to such company in China; and
(iii) failing to provide the Company with access to CTL’s books and records, as
required by the Agreement. The Company is seeking unspecified damages and
declaratory relief with respect to the termination of the Agreement with CTL,
the exclusion of certain technology from the Agreement, and an accounting of
all
monies, data and other items that should been paid to the Company under the
Agreement.
ITEM
1A.
|
RISK
FACTORS
|
The
following risk factors below update, and should be considered in addition to,
the risk factors previously disclosed by us in Part 1, Item 1A of our Annual
Report on Form 10-K for the fiscal year ended April 30, 2006.
If
We Cannot Obtain Additional Funding, Our Product Development And
Commercialization Efforts May Be Reduced Or Discontinued And We May Not Be
Able
To Continue Operations.
At
January 31, 2007, we had approximately $20.1 million in cash and cash
equivalents. We have expended substantial funds on (i) the research, development
and clinical trials of our product candidates, and (ii) funding the operations
of our wholly owned subsidiary, Avid Bioservices, Inc. As a result,
we
have
historically experienced negative cash flows from operations since our inception
and we expect the negative cash flows from operations to continue for the
foreseeable future, unless and until we are able to generate sufficient revenues
from Avid’s contract manufacturing services and/or from the sale and/or
licensing of our products under development. While we expect Avid to continue
to
generate revenues in the foreseeable future, we expect our monthly negative
cash
flow to continue for the foreseeable future due to our clinical trial activities
using bavituximab for the treatment of both solid cancer tumors and hepatitis
C
virus infection and Cotara® for the treatment of brain cancer, including
supporting trials outside the United States, our anticipated research and
development costs associated with the possible expansion of our clinical
indications using bavituximab for
the
treatment of other viral indications, our continued research directed towards
our other technologies in pre-clinical development, and our possible expansion
of our manufacturing capabilities. We believe we have sufficient cash on hand
to
meet our obligations on a timely basis through
at least November 2007 based on our current projections.
In
addition to the operations of Avid, we plan to obtain any necessary financing
through one or more methods including either equity or debt financing and/or
negotiating additional licensing or collaboration agreements for our technology
platforms. We currently have an aggregate of approximately 5,031,000 shares
available under two of our existing Form S-3 registration statements for
possible future registered transactions. In addition during January 2007, we
filed a separate registration statement on Form S-3, File Number 333-139975,
which allows us to issue, from time to time, in one or more offerings, shares
of
our common stock for proceeds up to $30,000,000. However, there can be no
assurances that we will be successful in raising such funds on terms acceptable
to us, or at all, or that sufficient additional capital will be raised to
complete the research, development, and clinical testing of our product
candidates.
25
Successful
Development Of Our Products Is Uncertain. To Date, No Revenues Have Been
Generated From The Commercial Sale Of Our Products And Our Products May Not
Generate Revenues In The Future.
Our
development of current and future product candidates is subject to the risks
of
failure inherent in the development of new pharmaceutical products and products
based on new technologies. These risks include:
·
|
delays
in product development, clinical testing or
manufacturing;
|
·
|
unplanned
expenditures in product development, clinical testing or
manufacturing;
|
·
|
failure
in clinical trials or failure to receive regulatory
approvals;
|
·
|
emergence
of superior or equivalent products;
|
·
|
inability
to manufacture on our own, or through others, product candidates
on a
commercial scale;
|
·
|
inability
to market products due to third party proprietary rights;
and
|
·
|
failure
to achieve market acceptance.
|
Because
of these risks, our research and development efforts or those of our partners
may not result in any commercially viable products. If significant portions
of
these development efforts are not successfully completed, required regulatory
approvals are not obtained, or any approved products are not commercially
successful, our business, financial condition and results of operations may
be
materially harmed.
Because
our licensing partners and we have not begun commercial sales of our products,
our revenue and profit potential is unproven and our limited operating history
makes it difficult for an investor to evaluate our business and prospects.
Our
technology may not result in any meaningful benefits to our current or potential
partners. No revenues have been generated from the commercial sale of our
products, and our products may not generate revenues in the future. Our business
and prospects should be considered in light of the heightened risks and
unexpected expenses and problems we may face as a company in an early stage
of
development in a new and rapidly evolving industry.
We
Have Had Significant Losses And We Anticipate Future
Losses.
We
have
incurred net losses in most fiscal years since we began operations in 1981.
The
following table represents net losses incurred during the past three fiscal
years and during the nine months ended January 31, 2007:
Net
Loss
|
||||
Nine
months ended January 31, 2007 (unaudited)
|
$
|
15,552,000
|
||
Fiscal
Year 2006
|
$
|
17,061,000
|
||
Fiscal
Year 2005
|
$
|
15,452,000
|
||
Fiscal
Year 2004
|
$
|
14,345,000
|
As
of
January 31, 2007, we had an accumulated deficit of $202,416,000. While we expect
to continue to generate revenues from Avid’s contract manufacturing services, in
order to achieve and sustain profitable operations, we must successfully develop
and obtain regulatory approval for our products, either alone or with others,
and must also manufacture, introduce, market and sell our products. The costs
associated with clinical trials and product manufacturing is very expensive
and
the time frame necessary to achieve market success for our products is long
and
uncertain. We do not expect to generate product or royalty revenues
for at least the next two years, and we may never generate product revenues
sufficient to become profitable or to sustain profitability.
26
Our
Product Development Efforts May Not Be Successful.
Since
our
inception, we have been engaged in the development of drugs and related
therapies for the treatment of patients with cancer. During fiscal year 2005,
we
began exploring the use of one of our product candidates, bavituximab, for
the
treatment of viral infections (in particular enveloped viruses). In August
2006
we completed a single dose Phase Ia trial for the treatment of patients with
the
hepatitis C virus (“HCV”) infection and in January 2007 completed a repeat dose
Phase Ib HCV trial. In addition, we are planning additional dosing studies
and
combination therapy studies using bavituximab with standard anti-viral
therapies. We also recently initiated a Phase Ib repeat dose combination study
in India using bavituximab for the treatment of solid cancer tumors in
combination with chemotherapy. Our product candidates have not received
regulatory approval and are generally in research, pre-clinical and clinical
stages of development. If the results from any of the clinical trials are poor,
those results may adversely affect our ability to raise additional capital,
which will affect our ability to continue full-scale research and development
for our antibody technologies. In addition, our product candidates may take
longer than anticipated to progress through clinical trials, or patient
enrollment in the clinical trials may be delayed or prolonged significantly,
thus delaying the clinical trials. Patient enrollment is a function of many
factors, including the size of the patient population, the nature of the
protocol, the proximity of patients to the clinical sites, and the eligibility
criteria for the study. In addition, because our Cotara® product currently in
clinical trials represents a departure from more commonly used methods for
cancer treatment, potential patients and their doctors may be inclined to use
conventional therapies, such as chemotherapy, rather than enroll patients in
our
clinical study.
Clinical
Trials Required For Our Product Candidates Are Expensive And Time Consuming,
And
Their Outcome Is Uncertain.
In
order
to obtain FDA approval to market a new drug product, we or our potential
partners must demonstrate proof of safety and efficacy in humans. To meet these
requirements, we or our potential partners will have to conduct extensive
pre-clinical testing and “adequate and well-controlled” clinical trials.
Conducting clinical trials is a lengthy, time-consuming and expensive process.
The length of time may vary substantially according to the type, complexity,
novelty and intended use of the product candidate, and often can be several
years or more per trial. Delays associated with products for which we are
directly conducting pre-clinical or clinical trials may cause us to incur
additional operating expenses. Moreover, we may continue to be affected by
delays associated with the pre-clinical testing and clinical trials of certain
product candidates conducted by our partners over which we have no control.
The
commencement and rate of completion of clinical trials may be delayed by many
factors, including, for example:
·
|
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
·
|
the
inability of patients to meet FDA imposed protocol
requirements;
|
·
|
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices, or cGMPs, for use in
clinical
trials;
|
·
|
the
need or desire to modify our manufacturing processes;
|
·
|
the
inability to adequately observe patients after
treatment;
|
·
|
changes
in regulatory requirements for clinical trials;
|
·
|
the
lack of effectiveness during the clinical trials;
|
·
|
unforeseen
safety issues;
|
·
|
delays,
suspension, or termination of the clinical trials due to the institutional
review board responsible for overseeing the study at a particular
study
site; and
|
·
|
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
|
Even
if
we obtain positive results from pre-clinical or initial clinical trials, we
may
not achieve the same success in future trials. Clinical trials may not
demonstrate statistically sufficient safety and effectiveness to obtain the
requisite regulatory approvals for product candidates employing our
technology.
27
Clinical
trials that we conduct or that third-parties conduct on our behalf may not
demonstrate sufficient safety and efficacy to obtain the requisite regulatory
approvals for any of our product candidates. We expect to commence new clinical
trials from time to time in the course of our business as our product
development work continues. The failure of clinical trials to demonstrate safety
and effectiveness for our desired indications could harm the development of
that
product candidate as well as other product candidates. Any change in, or
termination of, our clinical trials could materially harm our business,
financial condition and results of operations.
Success
In Early Clinical Trials May Not Be Indicative Of Results Obtained In Later
Trials.
A
number
of new drugs and biologics have shown promising results in initial clinical
trials, but subsequently failed to establish sufficient safety and effectiveness
data to obtain necessary regulatory approvals. Data obtained from pre-clinical
and clinical activities are subject to varying interpretations, which may delay,
limit or prevent regulatory approval.
Positive
results from pre-clinical studies and our Phase I clinical trials should not
be
relied upon as evidence that later or larger-scale clinical trials will succeed.
The Phase Ia and Ib clinical trials of bavituximab for the treatment of the
Hepatitis C virus (“HCV”) infection have been conducted only in small numbers of
patients that may not fully represent the diversity present in larger
populations infected with HCV. The limited results we have obtained may not
predict results from studies in larger numbers of patients drawn from more
diverse populations and also may not predict the ability of bavituximab to
achieve a sustained anti-viral response or the ability to provide a long-term
therapeutic benefit. These initial trials in HCV have not been designed to
assess the long-term therapeutic utility of bavituximab. We will be required
to
demonstrate through larger-scale clinical trials that bavituximab is safe and
effective for use in a diverse population before we can seek regulatory approval
for its commercial sale. There is typically an extremely high rate of attrition
from the failure of drug candidates proceeding through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of
many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be
Profitable.
Even
if
bavituximab, Cotara®, or any future product candidate is approved for commercial
sale by the FDA or other regulatory authorities, the degree of market acceptance
of any approved product candidate by physicians, healthcare professionals and
third-party payors and our profitability and growth will depend on a number
of
factors, including:
·
our
ability to provide acceptable evidence of safety and efficacy;
·
relative
convenience and ease of administration;
·
the
prevalence and severity of any adverse side effects;
·
availability
of alternative treatments;
·
pricing
and cost effectiveness;
·
effectiveness
of our or our collaborators’ sales and marketing strategy; and
·
our
ability to obtain sufficient third-party insurance coverage or
reimbursement.
In
addition, if bavituximab, Cotara®, or any future product candidate that we
discover and develop does not provide a treatment regimen that is more
beneficial than the current standard of care or otherwise provide patient
benefit, that product likely will not be accepted favorably by the market.
If
any products we may develop do not achieve market acceptance, then we may not
generate sufficient revenue to achieve or maintain
profitability.
28
In
addition, even if our products achieve market acceptance, we may not be able
to
maintain that market acceptance over time if new products or technologies are
introduced that are more favorably received than our products, are more cost
effective or render our products obsolete.
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We
have
completed Phase I and Phase I/II studies with Cotara® for the treatment of
recurrent glioblastoma multiforme (“GBM”), a deadly form of brain cancer. We are
currently collaborating with various universities that are members of the New
Approaches to Brain Tumor Therapy (“NABTT”) consortium to complete the dose
confirmation and dosimetry clinical trial. The next step in the development
of
Cotara® is to treat a group of approximately 40 patients using a single
administration of the drug with an optimized delivery using two catheters which
we plan to initiate in India. Taken together, the NABTT study along with data
collected from the treatment of the approximately 40 additional patients should
provide the safety, dosimetry and efficacy data that will support the final
design of the larger Phase III study. Once we complete the initial two parts
of
the Cotara® study for brain cancer, substantial financial resources will be
needed to complete the final part of the trial and any additional supportive
clinical studies necessary for potential product approval. We do not presently
have the financial resources internally to complete the larger Phase III study.
We therefore intend to continue to seek a licensing or funding partner for
Cotara®, and hope that the data from this collaboration with members of NABTT
together with other data from additional 40 patients, will enhance our
opportunities of finding such partner. If a partner is not found for this
technology, we may not be able to advance the project past its current state
of
development. Because there are a limited number of companies which have the
financial resources, the internal infrastructure, the technical capability
and
the marketing infrastructure to develop and market a radiopharmaceutical based
anti-cancer drug, we may not find a suitable partnering candidate for Cotara®.
We also cannot assure you that we will be able to find a suitable licensing
partner for this technology. Furthermore, we cannot assure you that if we do
find a suitable licensing partner, the financial terms that they propose will
be
acceptable to the Company.
Our
Dependency On One Radiolabeling Supplier May Negatively Impact Our Ability
To
Complete Clinical Trials And Market Our Products.
We
have
procured our antibody radioactive isotope combination services (“radiolabeling”)
with Iso-tex Diagnostics, Inc. for all U.S. clinical trials using Cotara®. If
this supplier is unable to continue to qualify its facility or radiolabel and
supply our antibody in a timely manner, our current clinical trial or potential
licensing partner’s clinical trials using radiolabeling technology could be
adversely affected and delayed. While there are other suppliers for radioactive
isotope combination services, our clinical trial would be delayed for up to
twelve to eighteen months because it may take that amount of time to certify
a
new facility under current Good Manufacturing Practices and qualify the product,
plus we would incur significant costs to transfer our technology to another
vendor. Prior to commercial distribution of any of our products, if approved,
we
will be required to identify and contract with a company for commercial antibody
manufacturing and radioactive isotope combination services. An antibody that
has
been combined with a radioactive isotope, such as Iodine 131, cannot be stored
for long periods of time, as it must be used within one week of being
radiolabeled to be effective. Accordingly, any change in our existing or future
contractual relationships with, or an interruption in supply from, any such
third-party service provider or antibody supplier could negatively impact our
ability to complete ongoing clinical trials conducted by us or a potential
licensing partner.
Our
Manufacturing Facilities May Not Continue To Meet Regulatory Requirements And
Have Limited Capacity.
Before
approving a new drug or biologic product, the FDA requires that the facilities
at which the product will be manufactured be in compliance with current Good
Manufacturing Practices, or cGMP requirements. To be successful, our therapeutic
products must be manufactured for development and, following approval, in
commercial quantities, in compliance with regulatory requirements and at
acceptable costs. Currently, we manufacture all pre-clinical and clinical
material through Avid Bioservices, our wholly owned subsidiary. While we believe
our current facilities are adequate for the manufacturing of product candidates
for clinical trials, our facilities may not be adequate to produce sufficient
quantities of any products for commercial sale.
29
If
we are
unable to establish and maintain a manufacturing facility or secure third-party
manufacturing capacity within our planned time frame and cost parameters, the
development and sales of our products, if approved, may be materially harmed.
We
may
also encounter problems with the following:
·
|
production
yields;
|
·
|
quality
control and quality assurance;
|
·
|
shortages
of qualified personnel;
|
·
|
compliance
with FDA regulations, including the demonstration of purity and
potency;
|
·
|
changes
in FDA requirements;
|
·
|
production
costs; and/or
|
·
|
development
of advanced manufacturing techniques and process
controls.
|
In
addition, we or any third-party manufacturer will be required to register the
manufacturing facilities with the FDA and other regulatory authorities. The
facilities will be subject to inspections confirming compliance with cGMP or
other regulations. If any of our third-party manufacturers or we fail to
maintain regulatory compliance, the FDA can impose regulatory sanctions
including, among other things, refusal to approve a pending application for
a
new drug product or biologic product, or revocation of a pre-existing approval.
As a result, our business, financial condition and results of operations may
be
materially harmed.
We
May Have Significant Product Liability Exposure Because We Maintain Only Limited
Product Liability Insurance.
We
face
an inherent business risk of exposure to product liability claims in the event
that the administration of one of our drugs during a clinical trial adversely
affects or causes the death of a patient. Although we maintain product liability
insurance for clinical studies in the amount of $3,000,000 per occurrence or
$3,000,000 in the aggregate on a claims-made basis, this coverage may not be
adequate. Product liability insurance is expensive, difficult to obtain and
may
not be available in the future on acceptable terms, if at all. Our inability
to
obtain sufficient insurance coverage on reasonable terms or to otherwise protect
against potential product liability claims in excess of our insurance coverage,
if any, or a product recall, could negatively impact our financial position
and
results of operations.
In
addition, the contract manufacturing services that we offer through Avid expose
us to an inherent risk of liability as the antibodies or other substances
manufactured by Avid, at the request and to the specifications of our customers,
could possibly cause adverse effects or have product defects. We obtain
agreements from our customers indemnifying and defending us from any potential
liability arising from such risk. There can be no assurance that such
indemnification agreements will adequately protect us against potential claims
relating to such contract manufacturing services or protect us from being named
in a possible lawsuit. Although Avid has procured insurance coverage, there
is
no guarantee that we will be able to maintain our existing coverage or obtain
additional coverage on commercially reasonable terms, or at all, or that such
insurance will provide adequate coverage against all potential claims to which
we might be exposed. A partially successful or completely uninsured claim
against Avid would have a material adverse effect on our consolidated
operations.
30
The
Liquidity Of Our Common Stock Will Be Adversely Affected If Our Common Stock
Is
Delisted From The Nasdaq Capital Market.
Our
common stock is presently traded on The Nasdaq Capital Market. To maintain
inclusion on The Nasdaq Capital Market, we must continue to meet the following
six listing requirements:
1.
|
Net
tangible assets of at least $2,500,000 or market capitalization of
at
least $35,000,000 or net income of at least $500,000 in either our
latest
fiscal year or in two of our last three fiscal
years;
|
2.
|
Public
float of at least 500,000 shares;
|
3.
|
Market
value of our public float of at least
$1,000,000;
|
4.
|
A
minimum closing bid price of $1.00 per share of common stock, without
falling below this minimum bid price for a period of thirty consecutive
trading days;
|
5.
|
At
least two market makers; and
|
6.
|
At
least 300 stockholders, each holding at least 100 shares of common
stock.
|
We
cannot
guarantee that we will be able to maintain the minimum closing bid price
requirement or maintain any of the other requirements in the future. The market
price of our common stock has generally been highly volatile. During the nine
months ended January 31, 2007, the trading price of our common stock on The
Nasdaq Capital Market ranged from $1.09 per share to $1.99 per share. Most
recently, the closing bid price of our common stock has been below $1.00 since
March 5, 2007. If the closing bid price of our common stock is below $1.00
per
share for a period of thirty consecutive trading days, we will receive a
deficiency notice from NASDAQ®,
and we
will automatically be afforded a "compliance period" of 180 calendar days within
which to regain compliance. To demonstrate compliance with the minimum closing
bid price requirement, we must maintain a closing bid price of at least $1.00
per share for 10 consecutive trading days. If we are still not in compliance
with the minimum closing bid price requirement after the initial 180 calendar
day period but we are in compliance with all initial listing requirements other
than the bid requirement, we will be afforded an additional "compliance period"
of 180 calendar days within which to regain compliance.
If
we
fail to comply with any of The Nasdaq Capital Market listing requirements,
the
market value of our common stock could fall and holders of common stock would
likely find it more difficult to dispose of the common stock.
If
our
common stock is delisted, we would apply to have our common stock quoted on
the
over-the-counter electronic bulletin board. Upon any such delisting, our common
stock would become subject to the regulations of the Securities and Exchange
Commission relating to the market for penny stocks. A penny stock, as defined
by
the Penny Stock Reform Act, is any equity security not traded on a national
securities exchange, that has a market price of less than $5.00 per share.
The
penny stock regulations generally require that a disclosure schedule explaining
the penny stock market and the risks associated therewith be delivered to
purchasers of penny stocks and impose various sales practice requirements on
broker-dealers who sell penny stocks to persons other than established customers
and accredited investors. The broker-dealer must make a suitability
determination for each purchaser and receive the purchaser’s written agreement
prior to the sale. In addition, the broker-dealer must make certain mandated
disclosures, including the actual sale or purchase price and actual bid offer
quotations, as well as the compensation to be received by the broker-dealer
and
certain associated persons. The regulations applicable to penny stocks may
severely affect the market liquidity for our common stock and could limit your
ability to sell your securities in the secondary market.
31
The
Sale Of Substantial Shares Of Our Common Stock May Depress Our Stock
Price.
As
of
January 31, 2007, we had approximately 196,112,000 shares of our common stock
outstanding, and for that date the last reported sales price of our common
stock
was $1.17 per share.
We
could
also issue up to approximately 21,678,000 additional shares of our common stock
that are reserved for future issuance under our shelf registration statements,
stock option plans and outstanding warrants, as further described in the
following table:
Number
of Shares
of
Common Stock
Reserved
For
Issuance
|
||||
Shares
reserved for under two effective shelf
registration statements
|
5,030,634
|
|||
Common
shares reserved for issuance under stock option plans
|
11,608,165
|
|||
Common
shares available for future grant under option plans
|
4,616,329
|
|||
Common
shares issuable upon exercise of outstanding warrants
|
422,865
|
|||
21,677,993
|
The
above
table does not include shares of common stock that we could issue under the
registration statement we filed during January 2007 on Form S-3, File Number
333-139975 due to the indeterminable number of shares that could potentially
be
issued under this shelf, which allows us to issue, from time to time, in one
or
more offerings, shares of common stock for proceeds up to
$30,000,000.
Of
the
total warrants and options outstanding as of January 31, 2007, approximately
3,545,000 options and warrants would be considered dilutive to stockholders
because we would receive an amount per share which is less than the market
price
of our common stock at January 31, 2007.
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock
The
market price of our common stock and the market prices of securities of
companies in the biotechnology sector have generally been highly volatile and
are likely to continue to be highly volatile.
32
The
following table shows the high and low sales price and trading volume of our
common stock for each quarter in the three years ended April 30, 2006, and
our
three fiscal quarters ended January 31, 2007:
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
Fiscal
Year 2007
|
|||||||||||||
Quarter
Ended January 31, 2007
|
$
|
1.39
|
$
|
1.09
|
4,299
|
203
|
|||||||
Quarter
Ended October 31, 2006
|
$
|
1.49
|
$
|
1.12
|
3,761
|
277
|
|||||||
Quarter
Ended July 31, 2006
|
$
|
1.99
|
$
|
1.30
|
23,790
|
429
|
|||||||
Fiscal
Year 2006
|
|||||||||||||
Quarter
Ended April 30, 2006
|
$
|
1.76
|
$
|
1.20
|
9,922
|
391
|
|||||||
Quarter
Ended January 31, 2006
|
$
|
1.40
|
$
|
0.88
|
12,152
|
251
|
|||||||
Quarter
Ended October 31, 2005
|
$
|
1.28
|
$
|
0.91
|
4,619
|
156
|
|||||||
Quarter
Ended July 31, 2005
|
$
|
1.31
|
$
|
0.92
|
7,715
|
178
|
|||||||
Fiscal
Year 2005
|
|||||||||||||
Quarter
Ended April 30, 2005
|
$
|
1.64
|
$
|
1.11
|
5,945
|
223
|
|||||||
Quarter
Ended January 31, 2005
|
$
|
1.45
|
$
|
0.99
|
6,128
|
160
|
|||||||
Quarter
Ended October 31, 2004
|
$
|
1.96
|
$
|
0.95
|
2,141
|
148
|
|||||||
Quarter
Ended July 31, 2004
|
$
|
1.92
|
$
|
0.88
|
1,749
|
131
|
|||||||
Fiscal
Year 2004
|
|||||||||||||
Quarter
Ended April 30, 2004
|
$
|
2.85
|
$
|
1.56
|
3,550
|
320
|
|||||||
Quarter
Ended January 31, 2004
|
$
|
3.14
|
$
|
2.01
|
6,062
|
201
|
|||||||
Quarter
Ended October 31, 2003
|
$
|
2.44
|
$
|
1.25
|
18,060
|
314
|
|||||||
Quarter
Ended July 31, 2003
|
$
|
2.19
|
$
|
0.60
|
12,249
|
255
|
The
market price of our common stock may be significantly impacted by many factors,
including, but not limited to:
·
|
Announcements
of technological innovations or new commercial products by us or
our
competitors;
|
·
|
publicity
regarding actual or potential clinical trial results relating to
products
under development by us or our
competitors;
|
·
|
our
financial results or that of our
competitors;
|
·
|
published
reports by securities analysts;
|
·
|
announcements
of licensing agreements, joint ventures, strategic alliances, and
any
other transaction that involves the sale or use of our technologies
or
competitive technologies;
|
·
|
developments
and/or disputes concerning our patent or proprietary
rights;
|
·
|
regulatory
developments and product safety
concerns;
|
·
|
general
stock trends in the biotechnology and pharmaceutical industry
sectors;
|
·
|
public
concerns as to the safety and effectiveness of our
products;
|
·
|
economic
trends and other external factors, including but not limited to,
interest
rate fluctuations, economic recession, inflation, foreign market
trends,
national crisis, and disasters; and
|
·
|
healthcare
reimbursement reform and cost-containment measures implemented by
government agencies.
|
These
and
other external factors have caused and may continue to cause the market price
and demand for our common stock to fluctuate substantially, which may limit
or
prevent investors from readily selling their shares of common stock, and may
otherwise negatively affect the liquidity of our common stock.
33
If
We Are Unable To Obtain, Protect And Enforce Our Patent Rights, We May Be Unable
To Effectively Protect Or Exploit Our Proprietary Technology, Inventions And
Improvements.
Our
success depends in part on our ability to obtain, protect and enforce
commercially valuable patents. We try to protect our proprietary positions
by
filing United States and foreign patent applications related to our proprietary
technology, inventions and improvements that are important to developing our
business. However, if we fail to obtain and maintain patent protection for
our
proprietary technology, inventions and improvements, our competitors could
develop and commercialize products that would otherwise infringe upon our
patents.
Our
patent position is generally uncertain and involves complex legal and factual
questions. Legal standards relating to the validity and scope of claims in
the
biotechnology and biopharmaceutical fields are still evolving. Accordingly,
the
degree of future protection for our patent rights is uncertain. The risks and
uncertainties that we face with respect to our patents include the
following:
·
|
the
pending patent applications we have filed or to which we have exclusive
rights may not result in issued patents or may take longer than we
expect
to result in issued patents;
|
·
|
the
claims of any patents that issue may not provide meaningful
protection;
|
·
|
we
may be unable to develop additional proprietary technologies that
are
patentable;
|
·
|
the
patents licensed or issued to us may not provide a competitive
advantage;
|
·
|
other
parties may challenge patents licensed or issued to
us;
|
·
|
disputes
may arise regarding the invention and corresponding ownership rights
in
inventions and know-how resulting from the joint creation or use
of
intellectual property by us, our licensors, corporate partners and
other
scientific collaborators; and
|
·
|
other
parties may design around our patented
technologies.
|
We
May Become Involved In Lawsuits To Protect Or Enforce Our Patents That Would
Be
Expensive And Time Consuming.
In
order
to protect or enforce our patent rights, we may initiate patent litigation
against third parties. In addition, we may become subject to interference or
opposition proceedings conducted in patent and trademark offices to determine
the priority and patentability of inventions. The defense of intellectual
property rights, including patent rights through lawsuits, interference or
opposition proceedings, and other legal and administrative proceedings, would
be
costly and divert our technical and management personnel from their normal
responsibilities. An adverse determination of any litigation or defense
proceedings could put our pending patent applications at risk of not being
issued.
Furthermore,
because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of litigation.
For example, during the course of this kind of litigation, confidential
information may be inadvertently disclosed in the form of documents or testimony
in connection with discovery requests, depositions or trial testimony. This
disclosure could materially adversely affect our business and financial
results.
We
May Not Be Able To Compete With Our Competitors In The Biotechnology Industry
Because Many Of Them Have Greater Resources Than We Do And They Are Further
Along In Their Development Efforts.
The
pharmaceutical and biotechnology industry is intensely competitive and subject
to rapid and significant technological change. Many of the drugs that we are
attempting to discover or develop will be competing with existing therapies.
In
addition, we are aware of several pharmaceutical and biotechnology companies
actively engaged in research and development of antibody-based products that
have commenced clinical trials with, or have successfully commercialized,
antibody products. Some or all of these companies may have greater financial
resources, larger technical staffs, and larger research budgets than we have,
as
well as greater experience in developing products and running clinical trials.
We expect to continue to experience significant and increasing levels of
competition in the future. In addition, there may be other companies which
are
currently developing competitive technologies and products or which may in
the
future develop technologies and products which are comparable or superior to
our
technologies and products.
34
We
are
conducting the Cotara® dose confirmation and dosimetry clinical trial for the
treatment of recurrent brain cancer as a stand-alone study in collaboration
with
New Approaches to Brain Tumor Therapy (“NABTT”) consortium. In addition, we plan
to initiate patient enrollment in a Phase II study to treat up to 40 patients
in
India in the near term. Existing treatments for brain cancer include the
Gliadel® Wafer (polifeprosan 20 with carmustine implant) from MGI Pharma, Inc.
and Temodar® (temozolomide) from Schering-Plough Corporation. Gliadel® is
inserted in the tumor cavity following surgery and releases a chemotherapeutic
agent over time. Temodar® is administered orally to patients with brain cancer.
Because
Cotara® targets brain tumors from the inside out, it is a novel treatment
dissimilar from other drugs in development for this disease. Some of the
products that may compete within the brain cancer category include: IL13-PE38QQR
(cintredekin besudotox) from NeoPharm continuing in a Phase III trial in
patients with first recurrent GBM; enzastuarin (oral serine-threonine kinase
inhibitor) is in a Phase III trial for patients with recurrent GBM sponsored
by
Eli Lilly and Company; TransMID (diphtheria toxin), developed by Xenova Group
plc, began a Phase III trial in May 2004 in patients with progressive or
recurrent non-operable GBM. In addition, Gleevec® by Novartis, which is an
oncology product marketed for other indications, is being tested in clinical
trials for the treatment of brain cancer.
Bavituximab
for the treatment of advanced solid cancers is currently in Phase Ia clinical
trial in the U.S. and a Phase Ib combination therapy study in India. There
are a
number of possible competitors with approved or developmental targeted agents
used in combination with standard chemotherapy for the treatment of
cancer, including but not limited to, Avastin® by Genentech, Inc., Gleevec®
by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and Genentech, Inc., Erbitux®
by ImClone Systems Incorporated and Brystol-Myers Squibb Company, Rituxan® and
Herceptin® by Biogen Idec Inc. and Genentech, Inc., Herceptin® by Genentech,
Inc. and Vectibix™ by Amgen, Inc. There are a significant number of companies
developing cancer therapeutics using a variety of targeted and non-targeted
approaches. A direct comparison of these potential competitors will not be
possible until bavituximab advances to later-stage clinical trials.
In
addition, we have completed Phase Ia single-dose and Phase Ib multiple dose
clinical trials evaluating bavituximab for the treatment of HCV. Bavituximab
is
a first-in-class approach for the treatment of HCV. We are aware of no other
products in development targeting phosphatidylserine as a potential therapy
for
HCV. There are a number of companies that have products approved and on the
market for the treatment of HCV, including but not limited to: Peg-Intron®
(pegylated interferon-alpha-2b), Rebetol® (ribavirin), and Intron-A
(interferon-alpha-2a), which are marketed by Schering-Plough Corporation, and
Pegasys® (pegylated interferon-alpha-2a), Copegus® (ribavirin USP) and
Roferon-A® (interferon-alpha-2a), which are marketed by Roche Pharmaceuticals,
and Infergen® (interferon alfacon-1) now marketed by Valeant Pharmaceuticals
International. First line treatment for HCV has changed little since alpha
interferon was first introduced in 1991. The current standard of care for HCV
includes a combination of an alpha interferon (pegylated or non-pegylated)
with
ribavirin. This combination therapy is generally associated with considerable
toxicity including flu-like symptoms, hematologic changes and central nervous
system side effects including depression. It is not uncommon for patients to
discontinue alpha interferon therapy because they are unable to tolerate the
side effects of the treatment.
Future
treatments for HCV are likely to include a combination of these existing
products used as adjuncts with products now in development. Later-stage
developmental treatments include improvements to existing therapies, such as
Albuferon™ (albumin interferon) from Human Genome Sciences, Inc. and Viramidine™
(taribavirin), a prodrug analog of ribavirin being developed by Valeant
Pharmaceuticals International. Other developmental approaches include protease
inhibitors such as VX-950 from Vertex Pharmaceuticals Incorporated, and SCH7
from Schering-Plough Corporation, and NM283, a polymerase inhibitor by Idenix
Pharmaceuticals, Inc.
35
New
And Potential New Accounting Pronouncements May Impact Our Future Financial
Position And Results Of Operations
There
may
be potential new accounting pronouncements or regulatory rulings, which may
have
an impact on our future financial position and results of operations. For
example, in December 2004, the FASB issued an amendment to SFAS No. 123,
Accounting For Stock-Based Compensation (“SFAS No. 123R”), which we adopted May
1, 2006, as discussed in Note 3, “Stock-Based Compensation,” in the notes to the
condensed consolidated financial statements. SFAS No. 123R eliminates the
ability to account for share-based compensation transactions using Accounting
Principles Board Opinion No. 25 (“APB No. 25”), and instead requires
companies to recognize compensation expense using a fair-value based method
for
costs related to share-based payments including stock options. Our adoption
of
SFAS No. 123R is expected to materially impact our financial position and
results of operations for future periods. During the three and nine months
ended
January 31, 2007, our loss from operations included non-cash stock-based
compensation expense of $187,000 and $796,000, respectively, related to the
adoption of SFAS No. 123R. In addition, we believe that non-cash stock-based
compensation expense for the remainder of fiscal year 2007 may be up to
approximately $200,000 based on actual shares granted and unvested as of January
31, 2007. However, the actual share-based compensation expense recorded during
the remaining three months of fiscal year 2007 may differ materially from this
estimate as a result of changes in a number of factors that affect the amount
of
non-cash compensation expense, including the number of options granted by our
Board of Directors during the remainder of fiscal year 2007, the price of our
common stock on the date of grant, the volatility of our stock price, the
estimate of the expected life of options granted and the risk free interest
rates. Also, a change in accounting pronouncements or taxation rules or
practices can have a significant effect on our reported results and may even
affect our reporting of transactions completed before the change is effective.
Other new accounting pronouncements or taxation rules and varying
interpretations of accounting pronouncements or taxation practice have occurred
and may occur in the future. Changes to existing rules, future changes, if
any,
or the questioning of current practices may adversely affect our reported
financial results or the way we conduct our business, which may also adversely
affect our stock price.
If
We Lose Qualified Management And Scientific Personnel Or Are Unable To Attract
And Retain Such Personnel, We May Be Unable To Successfully Develop Our Products
Or We May Be Significantly Delayed In Developing Our
Products.
Our
success is dependent, in part, upon a limited number of key executive officers,
each of whom is an at-will employee, and also upon our scientific researchers.
For example, because of his extensive understanding of our technologies and
product development programs, the loss of Mr. Steven W. King, our President
and
Chief Executive Officer, would adversely affect our development efforts and
clinical trial programs during the six to twelve month period that we estimate
it would take to find and train a qualified replacement.
We
also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical personnel.
We
face intense competition in our recruiting activities, including competition
from larger companies with greater resources. We do not know if we will be
successful in attracting or retaining skilled personnel. The loss of certain
key
employees or our inability to attract and retain other qualified employees
could
negatively affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By
the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to protect
stockholders against unsolicited attempts to acquire control of us that do
not
offer a fair price to our stockholders as determined by our Board of Directors.
Under the plan, the acquisition of 15% or more of our outstanding common stock
by any person or group, unless approved by our board of directors, will trigger
the right of our stockholders (other than the acquiror of 15% or more of our
common stock) to acquire additional shares of our common stock, and, in certain
cases, the stock of the potential acquiror, at a 50% discount to market price,
thus significantly increasing the acquisition cost to a potential acquiror.
In
addition, our certificate of incorporation and by-laws contain certain
additional anti-takeover protective devices. For example,
36
·
|
no
stockholder action may be taken without a meeting, without prior
notice
and without a vote; solicitations by consent are thus
prohibited;
|
·
|
special
meetings of stockholders may be called only by our Board of Directors;
and
|
·
|
our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares,
of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into
a large
number of shares of common stock could prevent a potential acquiror
from
gaining effective economic or voting
control.
|
Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of
the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these provisions may
frustrate or prevent any attempts by our stockholders to replace or remove
our
current management by making it more difficult for stockholders to replace
members of our Board of Directors, which is responsible for appointing the
members of our management.
ITEM
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.
|
37
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 12, 2007
|
By:
/s/ STEVEN W.
KING
|
|
Steven
W. King
|
||
President
and Chief Executive Officer, Director
|
||
Date:
March 12, 2007
|
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)
|
38