Avid Bioservices, Inc. - Quarter Report: 2007 October (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
|
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
|
For
the quarterly period ended October 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
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
14282
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 x 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 x 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 x
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 December 7, 2007
|
|
Common
Stock, $0.001 par value per share
|
226,210,617
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
|
23
|
|
Item
4.
|
Controls
and Procedures
|
24
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
24
|
|
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
|
38
|
|
Item
6.
|
Exhibits
|
38
|
|
SIGNATURES
|
39
|
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
PART
I - FINANCIAL INFORMATION
ITEM
1. CONSOLIDATED
FINANCIAL STATEMENTS
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
OCTOBER
31,
2007
|
APRIL
30,
2007
|
|||||||
Unaudited
|
||||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ |
26,138,000
|
$ |
16,044,000
|
||||
Trade
and other receivables
|
1,029,000
|
750,000
|
||||||
Inventories,
net
|
2,500,000
|
1,916,000
|
||||||
Prepaid
expenses and other current assets
|
1,484,000
|
1,188,000
|
||||||
Total
current
assets
|
31,151,000
|
19,898,000
|
||||||
PROPERTY:
|
||||||||
Leasehold
improvements
|
656,000
|
646,000
|
||||||
Laboratory
equipment
|
3,687,000
|
3,533,000
|
||||||
Furniture,
fixtures and office equipment
|
905,000
|
873,000
|
||||||
5,248,000
|
5,052,000
|
|||||||
Less
accumulated depreciation and amortization
|
(3,447,000 | ) | (3,212,000 | ) | ||||
Property,
net
|
1,801,000
|
1,840,000
|
||||||
Other
assets
|
1,493,000
|
1,259,000
|
||||||
TOTAL
ASSETS
|
$ |
34,445,000
|
$ |
22,997,000
|
1
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
OCTOBER
31,
2007
|
APRIL
30,
2007
|
|||||||
Unaudited
|
||||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ |
2,455,000
|
$ |
1,683,000
|
||||
Accrued
clinical trial site fees
|
242,000
|
228,000
|
||||||
Accrued
legal and accounting fees
|
277,000
|
392,000
|
||||||
Accrued
royalties and license fees
|
189,000
|
337,000
|
||||||
Accrued
payroll and related costs
|
972,000
|
874,000
|
||||||
Notes
payable, current portion
|
231,000
|
379,000
|
||||||
Capital
lease obligation, current portion
|
17,000
|
17,000
|
||||||
Deferred
revenue
|
1,338,000
|
1,060,000
|
||||||
Other
current liabilities
|
1,207,000
|
885,000
|
||||||
Total
current
liabilities
|
6,928,000
|
5,855,000
|
||||||
Notes
payable, less current portion
|
42,000
|
119,000
|
||||||
Capital
lease obligation, less current portion
|
22,000
|
30,000
|
||||||
Deferred
license revenue
|
-
|
4,000
|
||||||
Commitments
and contingencies
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
-
|
-
|
||||||
Common
stock-$.001 par value; authorized 325,000,000 shares;
outstanding – 226,210,617 and 196,112,201,
respectively
|
226,000
|
196,000
|
||||||
Additional
paid-in capital
|
245,750,000
|
224,453,000
|
||||||
Accumulated
deficit
|
(218,523,000 | ) | (207,660,000 | ) | ||||
Total
stockholders'
equity
|
27,453,000
|
16,989,000
|
||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ |
34,445,000
|
$ |
22,997,000
|
See
accompanying notes to condensed consolidated financial statements
2
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
|||||||||||||||
October
31,
2007
|
October
31,
2006
|
October
31,
2007
|
October
31,
2006
|
|||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Contract
manufacturing revenue
|
$ |
1,863,000
|
$ |
636,000
|
$ |
3,484,000
|
$ |
1,034,000
|
||||||||
License
revenue
|
29,000
|
48,000
|
33,000
|
71,000
|
||||||||||||
Total
revenues
|
1,892,000
|
684,000
|
3,517,000
|
1,105,000
|
||||||||||||
COSTS
AND EXPENSES:
|
||||||||||||||||
Cost
of contract manufacturing
|
1,402,000
|
494,000
|
2,583,000
|
1,024,000
|
||||||||||||
Research
and development
|
5,100,000
|
3,920,000
|
8,724,000
|
7,961,000
|
||||||||||||
Selling,
general and administrative
|
1,943,000
|
1,670,000
|
3,651,000
|
3,311,000
|
||||||||||||
Total
costs and expenses
|
8,445,000
|
6,084,000
|
14,958,000
|
12,296,000
|
||||||||||||
LOSS
FROM OPERATIONS
|
(6,553,000 | ) | (5,400,000 | ) | (11,441,000 | ) | (11,191,000 | ) | ||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
Interest
and other income
|
353,000
|
339,000
|
592,000
|
688,000
|
||||||||||||
Interest
and other expense
|
(7,000 | ) | (9,000 | ) | (14,000 | ) | (24,000 | ) | ||||||||
NET
LOSS
|
$ | (6,207,000 | ) | $ | (5,070,000 | ) | $ | (10,863,000 | ) | $ | (10,527,000 | ) | ||||
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
||||||||||||||||
Basic
and Diluted
|
226,210,617
|
193,793,766
|
216,141,092
|
188,950,924
|
||||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.03 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.06 | ) |
See
accompanying notes to condensed consolidated financial statements
3
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
SIX
MONTHS ENDED
OCTOBER
31,
|
||||||||
2007
|
2006
|
|||||||
Unaudited
|
Unaudited
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (10,863,000 | ) | $ | (10,527,000 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
234,000
|
233,000
|
||||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
395,000
|
970,000
|
||||||
Amortization
of expenses paid in shares of common stock
|
-
|
309,000
|
||||||
Changes
in operating assets and liabilities:
|
||||||||
Trade
and other receivables
|
(279,000 | ) | (222,000 | ) | ||||
Inventories
|
(584,000 | ) | (1,014,000 | ) | ||||
Prepaid
expenses and other current assets
|
(296,000 | ) | (166,000 | ) | ||||
Accounts
payable
|
772,000
|
(140,000 | ) | |||||
Accrued
clinical trial site fees
|
14,000
|
145,000
|
||||||
Deferred
revenue
|
274,000
|
816,000
|
||||||
Accrued
payroll and related costs
|
98,000
|
12,000
|
||||||
Other
accrued expenses and current liabilities
|
59,000
|
(588,000 | ) | |||||
Net
cash used in operating
activities
|
(10,176,000 | ) | (10,172,000 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Property
acquisitions
|
(195,000 | ) | (57,000 | ) | ||||
Increase
in other assets
|
(234,000 | ) |
-
|
|||||
Net
cash used in investing
activities
|
(429,000 | ) | (57,000 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from issuance of common stock, net of issuance costs
of $1,641,000 and $46,000, respectively
|
20,932,000
|
16,659,000
|
||||||
Principal
payments on notes payable and capital lease
|
(233,000 | ) | (218,000 | ) | ||||
Net
cash provided by financing
activities
|
20,699,000
|
16,441,000
|
||||||
NET INCREASE
IN CASH AND CASH EQUIVALENTS
|
10,094,000
|
6,212,000
|
||||||
CASH
AND CASH EQUIVALENTS, beginning of period
|
16,044,000
|
17,182,000
|
||||||
CASH
AND CASH EQUIVALENTS, end of period
|
$ |
26,138,000
|
$ |
23,394,000
|
See
accompanying notes to condensed consolidated financial statements
4
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007
(unaudited)
1.
BASIS OF PRESENTATION
The
accompanying interim condensed
consolidated financial statements include the accounts of Peregrine
Pharmaceuticals, Inc. (“Peregrine”), a biopharmaceutical company developing a
portfolio of clinical stage and pre-clinical product candidates using monoclonal
antibodies (“MAb”) for the treatment of cancer and viral diseases, and its
wholly owned subsidiary, Avid Bioservices, Inc. (“Avid”), a biomanufacturing
company engaged in providing contract manufacturing services for Peregrine
and
outside customers on a fee-for-service basis (collectively, the
“Company”). All intercompany balances and transactions have been
eliminated.
In
addition, the accompanying interim
condensed consolidated financial statements are unaudited; however they contain
all adjustments (consisting only of normal recurring adjustments) which, in
the
opinion of management, are necessary to present fairly the condensed
consolidated financial position of the Company at October 31, 2007, and the
condensed consolidated results of our operations and condensed consolidated
cash
flows for the three and six-month periods ended October 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,
2007. 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.
At
October 31, 2007, we had $26,138,000
in cash and cash equivalents. We have expended substantial funds on
the development of our product candidates and we have incurred negative cash
flows from operations for the majority of years since our
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 six months ended October 31, 2007 and 2006 amounted
to
$3,484,000 and $1,034,000, 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. Therefore, our ability to continue our clinical trials
and development efforts is highly dependent on the amount of cash and cash
equivalents on hand combined with our ability to raise additional capital to
support our future operations.
We
may raise additional capital through
the sale of shares of our common stock to fund our research, development, and
clinical testing of our product candidates. We have approximately
5,031,000 shares available for possible future registered transactions under
two
separate registration statements. In addition, during January 2007,
we filed a separate registration statement on Form S-3, File Number 333-139975,
under which we may issue, from time to time, in one or more offerings, shares
of
our common stock for remaining gross proceeds of up to
$7,500,000. 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 SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
In
addition to financing our operations through the sale of shares of common stock,
we are actively exploring various other sources of capital by 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. We will continue to explore ways to leverage our broad
intellectual property portfolio in addition to pursuing potential licensing
and
partnering collaborations for our products in clinical and pre-clinical
development. In addition, we have recently been approached by outside
companies interested in a possible transaction related to our wholly owned
subsidiary, Avid Bioservices, Inc. In this regard, we have only
initially begun to explore strategic alternatives for Avid as a means
of raising additional capital. We have not classified the related
assets as held for sale in accordance with Statement of Financial Accounting
Standards No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, since we are strictly exploring the possibility of a partnering or
sale arrangement and the partnering or sale of the asset is not currently
probable under Statement of Financial Accounting Standards No. 5, Accounting
for Contingencies.
Although
we will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid
Bioservices, Inc. to complete the research, development, and clinical testing
of
our product candidates. At October 31, 2007, we had $26,138,000 in
cash and cash equivalents, which we currently believe is sufficient capital
to
maintain our operations through at least September 2008 based on our current
projections.
2.
SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Inventories
–
Inventories
are stated at the lower of cost or market and primarily include raw materials,
direct labor and overhead costs associated with our wholly owned subsidiary,
Avid. Inventories consist of the following at October 31, 2007 and
April 30, 2007:
October
31,
2007
|
April
30,
2007
|
|||||||
Raw
materials, net
|
$ |
1,230,000
|
$ |
810,000
|
||||
Work-in-process
|
1,270,000
|
1,106,000
|
||||||
Total
inventories, net
|
$ |
2,500,000
|
$ |
1,916,000
|
Comprehensive
Loss–
Comprehensive loss is equal to net loss for all periods presented.
Income
taxes– In June 2006,
the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No.
48 (“FIN No. 48”), Accounting for Uncertainty in Income Taxes—An
Interpretation of FASB Statement No. 109, which prescribes a recognition
threshold and measurement attribute for the financial statement recognition
and
measurement of a tax position taken or expected to be taken in a tax
return. Under FIN No. 48, tax positions are recognized in the
financial statements when it is more likely than not the position will be
sustained upon examination by the tax authorities. An uncertain
income tax position will not be recognized if it has less than a 50% likelihood
of being sustained upon examination by the tax authorities. FIN No.
48 also provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosures and
transition.
6
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
We
adopted FIN No. 48 on May 1, 2007
and determined that the adoption of FIN No. 48 did not have a material impact
on
our consolidated financial statements. In addition, there are no
unrecognized tax benefits included in our consolidated balance sheet that would,
if recognized, affect our effective tax rate.
It
is our policy to recognize interest
and penalties related to income tax matters in interest and other expense in
our
consolidated statement of operations. We did not recognize interest
or penalties related to income taxes during the three and six months ended
October 31, 2007 and 2006, and we did not accrue for interest or penalties
as of
October 31, 2007 or April 30, 2007.
We
are primarily subject to U.S.
federal and California state jurisdictions. To our knowledge, all tax
years remain open to examination by U.S. federal and state
authorities.
At
April 30, 2007, we had total
deferred tax assets of $59.4 million. The deferred tax assets
are primarily comprised of federal and state tax net operating loss (“NOL”)
carryforwards. Due to uncertainties surrounding our ability to
generate future taxable income to realize these tax assets, a full valuation
has
been established to offset our total deferred tax
assets. Additionally, the future utilization of our NOL carryforwards
to offset future taxable income may be subject to an annual limitation as a
result of ownership changes that may have occurred previously or that could
occur in the future. We have not yet determined whether such an
ownership change has occurred, however we plan to complete an analysis regarding
the limitation of the NOL carryforwards. Therefore, it is possible
that a portion of these deferred tax assets may be limited in their use after
this study is completed. If necessary, the deferred tax assets will
be reduced by any carryforwards that expire prior to utilization as a result
of
such limitations, with a corresponding reduction of the valuation
allowance. Due to the existence of the valuation allowance, future
changes in our unrecognized tax benefits will not impact our effective tax
rate.
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 six months ended October
31, 2007 and 2006.
The
calculation of weighted average
diluted shares outstanding excludes the dilutive effect of options and warrants
to purchase up to 586,110 and 740,421 shares of common stock for the three
and
six months ended October 31, 2007, respectively, and 1,801,130 and
3,204,557 shares of common stock for the three and six months ended October
31,
2006, respectively, since the impact of such options and warrants are
anti-dilutive during periods of net loss.
The
calculation of weighted average
diluted shares outstanding also excludes weighted average outstanding options
and warrants to purchase up to 10,601,888 and 10,428,091 shares of common stock
for the three and six months ended October 31, 2007, respectively, and
7,364,621 and 6,770,174 shares of common stock for the three and six months
ended October 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.
7
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
Recent
Accounting
Pronouncements– 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. Our adoption of SFAS No. 157 is not
expected to have a material impact 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. Our adoption of SFAS No. 159 is not expected to
have
a material impact on our consolidated financial statements.
In
June 2007, the FASB ratified EITF
Issue No. 07-3 (“EITF No. 07-3”), Accounting for Non-Refundable Advance
Payments for Goods or Services to Be Used in Future Research and Development
Activities, which requires nonrefundable advance payments for goods and
services that will be used or rendered for future research and development
activities be deferred and capitalized. These amounts will be
recognized as expense in the period that the related goods are delivered or
the
related services are performed. EITF No. 07-3 will be effective for
fiscal years beginning after November 15, 2007, which we would be required
to
implement no later than May 1, 2008. Our adoption of EITF No. 07-3 is
not expected to have a material impact 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 a four year period and no options are exercisable after
ten
years from the date of grant.
On
May 1, 2006, we adopted Statement of
Financial Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based
Payment (Revised 2004), which requires the recognition of compensation
expense, using a fair value based method, for costs related to all share-based
payments including grants of employee stock options. 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 No. 123R
using the modified-prospective method and, accordingly, stock-based compensation
cost recognized beginning May 1, 2006 includes: (i) 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 (ii) 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.
8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
Our
net loss for the three and
six-month periods ended October 31, 2007 and 2006, increased 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
October
31,
|
Six
Months Ended
October
31,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Research
and development
|
$ |
140,000
|
$ |
177,000
|
$ |
269,000
|
$ |
343,000
|
||||||||
Selling,
general and administrative
|
58,000
|
133,000
|
112,000
|
266,000
|
||||||||||||
Total
|
$ |
198,000
|
$ |
310,000
|
$ |
381,000
|
$ |
609,000
|
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 (“SAB 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. The expected dividend yield assumption is based on our
expectation of future dividend payouts. We have never declared or
paid cash dividends on our common stock and currently do not anticipate paying
such cash dividends. In addition, SFAS No. 123R requires forfeitures
to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. The fair
value of stock options on the date of grant and the weighted-average assumptions
used to estimate the fair value of the stock options using the Black-Scholes
option valuation model during the periods presented, were as
follows:
Three
Months Ended
October
31,
|
Six
Months Ended
October
31,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Risk-free
interest rate
|
4.31% | 4.88% | 4.45% | 4.94% | ||||||||||||
Expected
life (in years)
|
6.25
|
6.25
|
6.10
|
6.25
|
||||||||||||
Expected
volatility
|
88% | 99% | 87% | 100% | ||||||||||||
Expected
dividend yield
|
-
|
-
|
-
|
-
|
As
of October 31, 2007, options to
purchase up to 11,913,145 shares of our common stock were issued and outstanding
under the Option Plans with a weighted average exercise price of $1.49 per
share, and will expire at various dates through October 30,
2017. Options to purchase up to 4,154,990 shares of common stock were
available for future grant under the Option Plans as of October 31,
2007.
9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
The
following summarizes all stock
option transaction activity for the six months ended October 31,
2007:
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
||||||||||||
Outstanding,
May 1, 2007
|
11,537,946
|
$ |
1.54
|
|||||||||||||
Granted
|
866,040
|
$ |
0.76
|
|||||||||||||
Exercised
|
(45,000 | ) | $ |
0.60
|
||||||||||||
Canceled
or expired
|
(445,841 | ) | $ |
1.42
|
||||||||||||
Outstanding,
October 31, 2007
|
11,913,145
|
$ |
1.49
|
5.57
|
$ |
312,000
|
||||||||||
Exercisable
and expected to vest
|
11,676,834
|
$ |
1.49
|
5.51
|
$ |
312,000
|
||||||||||
Exercisable,
October 31, 2007
|
9,445,048
|
$ |
1.58
|
4.85
|
$ |
311,000
|
||||||||||
The
weighted-average grant date fair
value of options granted during the six-month periods ended October 31, 2007
and
2006 was $0.58 per share and $1.15 per share, respectively. The
aggregate intrinsic value of options exercised during the six-month periods
ended October 31, 2007 and 2006 was $19,000 and $23,000,
respectively.
Cash
proceeds from stock options
exercised during the six-month periods ended October 31, 2007 and 2006 totaled
$27,000 and $53,000, respectively.
We
issue shares of common stock that
are reserved for issuance under the Option Plans upon the exercise of stock
options, and we do not expect to repurchase shares of common stock from any
source to satisfy our obligations under our compensation plans.
As
of October 31, 2007, the total
estimated unrecognized compensation cost related to non-vested stock options
was
$1,777,000. This cost is expected to be recognized over a weighted
average vesting period of 2.86 years based on current assumptions.
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 six months ended October 31, 2007 associated with
non-employees amounted to nil and $14,000,
respectively. Stock-based compensation expense recorded during the three and
six
months ended October 31, 2006 associated with non-employees amounted to $26,000
and $52,000, respectively.
4. STOCKHOLDERS’
EQUITY
On
October 22, 2007, the stockholders of the Company approved an increase in the
number of authorized shares of common stock from 250,000,000 to
325,000,000. In November, we filed an amendment to our Certificate of
Incorporation with the Secretary of State of Delaware which effected the
foregoing increase.
10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
On
June
28, 2007, we entered into a Securities Purchase Agreement with several
institutional investors whereby we sold 30,000,000 shares of our common stock
in
exchange for gross proceeds of $22,500,000. After deducting placement
agent fees, legal fees and other costs associated with the offering, we received
net proceeds of $20,859,000. The shares of common stock were issued
from our shelf registration statement on Form S-3, File Number 333-139975
(“January 2007 Shelf”), which allows us to issue, in one or more offerings,
shares of common stock for proceeds up to $30,000,000. As of October
31, 2007, we could raise up to $7,500,000 in remaining gross proceeds under
the
January 2007 Shelf.
In
addition, as of October 31, 2007, an aggregate of 5,030,634 shares of common
stock were available for issuance under two separate effective shelf
registration statements.
As
of October 31, 2007, we have
reserved 21,458,769 additional shares of our common stock which may be issued
under our shelf registration statements, stock option plans and outstanding
warrants, excluding shares of common stock that could potentially be issued
under the January 2007 Shelf, as further described in the following
table:
Number
of Shares
Reserved
|
|
Shares
of common stock reserved for issuance under two registration
statements
|
5,030,634
|
Shares
of common stock reserved for issuance upon exercise of outstanding
options
|
11,913,145
|
Shares
of common stock reserved for future option grants under our Option
Plans
|
4,154,990
|
Shares
of common stock reserved for issuance under outstanding warrant
arrangements
|
360,000
|
Total
shares of common stock
reserved for issuance
|
21,458,769
|
5.
WARRANTS
During
the six months ended October 31, 2007, warrants to purchase 53,416 shares of
our
common stock were exercised for net proceeds of $46,000. As of
October 31, 2007, warrants to purchase up to 360,000 shares of our common stock
were issued and outstanding at a weighted average exercise price of $1.50 per
share and will expire in March 2008 if unexercised.
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 services for Peregrine and outside customers on a fee-for-service
basis.
The
accounting policies of the operating segments are the same as those described
in
Notes 1 and 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.
11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
Segment
information for the three-month periods is summarized as follows:
Three
Months Ended October 31,
|
||||||||
2007
|
2006
|
|||||||
Net
Revenues:
|
||||||||
Contract
manufacturing and development of biologics
|
$ |
1,863,000
|
$ |
636,000
|
||||
Products
in research and development
|
29,000
|
48,000
|
||||||
Total
revenues, net
|
$ |
1,892,000
|
$ |
684,000
|
||||
Gross
Profit:
|
||||||||
Contract
manufacturing and development of biologics
|
$ |
461,000
|
$ |
142,000
|
||||
Products
in research and development
|
29,000
|
48,000
|
||||||
Total
gross profit
|
490,000
|
190,000
|
||||||
Research
and development expense
|
(5,100,000 | ) | (3,920,000 | ) | ||||
Selling,
general and administrative expense
|
(1,943,000 | ) | (1,670,000 | ) | ||||
Other
income, net
|
346,000
|
330,000
|
||||||
Net
loss
|
$ | (6,207,000 | ) | $ | (5,070,000 | ) |
Net
revenues generated from Avid for the three-month periods were from the following
customers:
Three
Months Ended October 31,
|
||||||||
2007
|
2006
|
|||||||
Customer
revenues as a % of net revenues:
|
||||||||
United
States (customer A)
|
89% | 6% | ||||||
United
States (customer B)
|
0% | 17% | ||||||
Australia
(one customer)
|
3% | 19% | ||||||
China
(one customer)
|
0% | 55% | ||||||
Other
customers
|
8% | 3% | ||||||
Total
customer revenues as a % of net revenues
|
100% | 100% |
12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
Segment
information for the six-month periods is summarized as follows:
Six
Months Ended October 31,
|
||||||||
2007
|
2006
|
|||||||
Net
Revenues:
|
||||||||
Contract
manufacturing and development of biologics
|
$ |
3,484,000
|
$ |
1,034,000
|
||||
Products
in research and development
|
33,000
|
71,000
|
||||||
Total
revenues, net
|
$ |
3,517,000
|
$ |
1,105,000
|
||||
Gross
Profit:
|
||||||||
Contract
manufacturing and development of biologics
|
$ |
901,000
|
$ |
10,000
|
||||
Products
in research and development
|
33,000
|
71,000
|
||||||
Total
gross profit
|
934,000
|
81,000
|
||||||
Research
and development expense
|
(8,724,000 | ) | (7,961,000 | ) | ||||
Selling,
general and administrative expense
|
(3,651,000 | ) | (3,311,000 | ) | ||||
Other
income, net
|
578,000
|
664,000
|
||||||
Net
loss
|
$ | (10,863,000 | ) | $ | (10,527,000 | ) |
Net
revenues generated from Avid for the six-month periods were from the following
customers:
Six
Months Ended October 31,
|
||||||||
2007
|
2006
|
|||||||
Customer
revenues as a % of net revenues:
|
||||||||
United
States (customer A)
|
84% | 4% | ||||||
United
States (customer B)
|
4% | 11% | ||||||
Australia
(one customer)
|
1% | 48% | ||||||
China
(one customer)
|
0% | 34% | ||||||
Other
customers
|
11% | 3% | ||||||
Total
customer revenues as a % of net revenues
|
100% | 100% |
Net
revenues generated from products in research and development during the three
and six months ended October 31, 2007 were from an annual license fee and the
amortized portion of the up-front license fee received under the August 2005
license agreement with Medarex, Inc. In September 2007, Medarex
terminated the August 2005 license agreement and discontinued its internal
research program covering our intellectual property under the
agreement. Net revenues generated from products in research and
development during the three and six months ended October 31, 2006 were from
the
amortized portion of the up-front license fees received under the December
2002
license agreement with Schering A.G and the August 2005 license agreement with
Medarex, Inc., combined with an annual license fee received under the August
2005 license agreement with Medarex, Inc.
13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2007 (unaudited)
(continued)
Long-lived
assets by segment consist of the following:
October
31,
2007
|
April
30,
2007
|
|||||||
Long-lived
Assets, net:
|
||||||||
Contract
manufacturing and development of biologics
|
$ |
1,501,000
|
$ |
1,527,000
|
||||
Products
in research and development
|
300,000
|
313,000
|
||||||
Total
long-lived assets, net
|
$ |
1,801,000
|
$ |
1,840,000
|
7.
LITIGATION
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 or are involved with a lawsuit against Cancer
Therapeutics Laboratories (“CTL”). 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. Based on early discovery, we amended the
complaint on May 4, 2007 to include claims against Shanghai MediPharm and its
related entities, and Alan Epstein, M.D alleging that these defendants
collaborated to interfere with the Agreement by entering into an economic
relationship between themselves and designed not to share profits and know-how
with the Company in violation of the Agreement, including proprietary
technologies that they developed and are required to share with the
Company. 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 have been paid or given to the Company under the
Agreement.
On
March
28, 2007, CTL filed a cross-complaint, which they amended on May 30, 2007,
alleging that the Company breached the Agreement, improperly terminated the
Agreement, is interfering with CTL’s agreements with various MediPharm entities
and is double-licensing the technology licensed to CTL to another
party. CTL’s cross-complaint, which seeks $20 million in damages, is
in part predicated on the existence of a sublicense agreement between CTL and
MediPharm. While we are objecting to the cross-complaint on several
grounds, we are challenging the cross-complaint on the basis that not only
did
CTL fail to allege an agreement with which the Company interfered, they have
been unable to produce the alleged sublicense agreement with MediPharm despite
our repeated demands.
The
discovery phase on the aforementioned cases is ongoing. Until we
complete the initial discovery phase and our objections are considered, we
cannot estimate the magnitude of the claims of the parties against each other
or
probable outcome of the litigation.
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 a biopharmaceutical company
developing a portfolio of clinical stage and pre-clinical product candidates
using monoclonal antibodies (“MAb”) for the treatment of cancer and viral
diseases. We are advancing three separate clinical programs
encompassing two platform technologies: Anti-PhosphatidylSerine (“Anti-PS”)
Immunotherapeutics and Tumor Necrosis Therapy (“TNT”). Our lead
Anti-PS product, bavituximab, is in separate clinical trials for the treatment
of solid cancers and hepatitis C virus (“HCV”) infection. Under our
TNT technology platform, our lead candidate, Cotara®, is advancing through two
clinical studies for the treatment of brain cancer.
The
following represents a summary of our clinical trials and the status of each
clinical trial:
Product
|
Indication
|
Trial
Design
|
Status
|
Bavituximab
|
Solid
tumors
|
Phase
I repeat dose monotherapy safety
study
to treat
up to 28 patients.
|
Study
is open for enrollment in the U.S.
|
Bavituximab
plus chemotherapy
agent
docetaxel
|
Metastatic
breast cancer
|
Phase
II combination therapy study to
treat
up to
46 patients.
|
Clinical
protocol approved by regulatory authorities in the Republic of
Georgia. Patient enrollment is expected to initiate by early
2008.
|
Bavituximab
plus chemotherapy
agents
carboplatin/paclitaxel
|
Metastatic
breast cancer
|
Phase
II combination therapy study to
treat
up to
46 patients.
|
Clinical
protocol submitted with the regulatory authorities in India. We are
awaiting regulatory clearance to initiate the clinical
trial.
|
Bavituximab
plus chemotherapy
agents
carboplatin/paclitaxel
|
Non-small
cell lung cancer (NSCLC)
|
Phase
II combination therapy study to
treat
up to
49 patients.
|
Clinical
protocol submitted with the regulatory authorities in India. We are
awaiting regulatory clearance to initiate the clinical
trial.
|
Cotara®
|
Brain
cancer (glioblastoma
multiforme
or GBM)
|
Dosimetry
and dose confirmation study
designed
to
treat up to 12 patients with
recurrent
GBM.
|
Study
is open for enrollment in the U.S.
|
Cotara®
|
Brain
cancer (glioblastoma
multiforme
or GBM)
|
Phase
II safety and efficacy study to treat
up
to 40
patients at 1st
relapse.
|
Study
is open for enrollment in India.
|
Bavituximab
|
Chronic
Hepatitis C Virus
(“HCV”)
infection
(co-infected
with
HIV)
|
Phase
Ib repeat dose safety study in
24
patients.
|
Study
is open for enrollment in the U.S.
|
15
In
addition, Avid Bioservices, Inc.
(“Avid”), our wholly owned subsidiary, is engaged in providing contract
manufacturing services for Peregrine and outside customers on a fee-for-service
basis.
Results
of Operations
The
following table compares the
unaudited condensed consolidated statements of operations for the three and
six-month periods ended October 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 are further
discussed below.
Three
Months Ended
October
31,
|
Six
Months Ended
October
31,
|
|||||||||||||||||||||||
2007
|
2006
|
$
Change
|
2007
|
2006
|
$
Change
|
|||||||||||||||||||
(in
thousands)
|
(in
thousands)
|
|||||||||||||||||||||||
REVENUES:
|
||||||||||||||||||||||||
Contract
manufacturing revenue
|
$ |
1,863
|
$ |
636
|
$ |
1,227
|
$ |
3,484
|
$ |
1,034
|
$ |
2,450
|
||||||||||||
License
revenue
|
29
|
48
|
(19 | ) |
33
|
71
|
(38 | ) | ||||||||||||||||
Total revenues
|
1,892
|
684
|
1,208
|
3,517
|
1,105
|
2,412
|
||||||||||||||||||
COST
AND EXPENSES:
|
||||||||||||||||||||||||
Cost
of contract manufacturing
|
1,402
|
494
|
908
|
2,583
|
1,024
|
1,559
|
||||||||||||||||||
Research
and development
|
5,100
|
3,920
|
1,180
|
8,724
|
7,961
|
763
|
||||||||||||||||||
Selling,
general and administrative
|
1,943
|
1,670
|
273
|
3,651
|
3,311
|
340
|
||||||||||||||||||
Total
cost and expenses
|
8,445
|
6,084
|
2,361
|
14,958
|
12,296
|
2,662
|
||||||||||||||||||
LOSS
FROM OPERATIONS
|
(6,553 | ) | (5,400 | ) | (1,153 | ) | (11,441 | ) | (11,191 | ) | (250 | ) | ||||||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||||||||||
Interest
and other income
|
353
|
339
|
14
|
592
|
688
|
(96 | ) | |||||||||||||||||
Interest
and other expense
|
(7 | ) | (9 | ) |
2
|
(14 | ) | (24 | ) |
10
|
||||||||||||||
NET
LOSS
|
$ | (6,207 | ) | $ | (5,070 | ) | $ | (1,137 | ) | $ | (10,863 | ) | $ | (10,527 | ) | $ | (336 | ) |
Results
of operations for interim
periods covered by this quarterly report on Form 10-Q may not necessarily be
indicative of results of operations for the full fiscal year.
Total
Revenues.
Three
and
Six Months: The increases in total revenues of $1,208,000 and
$2,412,000 during the three and six months ended October 31, 2007, respectively,
compared to the same periods in the prior year were primarily due to an
increases in contract manufacturing revenue of $1,227,000 and $2,450,000,
respectively. These increases in contract manufacturing revenue were
due to an increase in services provided to unrelated entities on a
fee-for-service basis associated with an increase in active projects including
an increase in the number of completed manufacturing runs compared to the same
three and six-month periods in the prior year.
We
expect
to continue to generate contract manufacturing revenue during the remainder
of
the current fiscal year based on the anticipated completion of in-process
customer related projects and the anticipated demand for Avid’s services under
outstanding proposals. 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 2008.
16
Cost
of Contract Manufacturing.
Three
and
Six Months: The increases in cost of contract manufacturing of
$908,000 and $1,559,000 during the three and six months ended October 31, 2007,
respectively, compared to the same periods in the prior year were primarily
related to the three and six-month period increases in contract manufacturing
revenue. These increases were offset by the prior year write-off of
unusable work-in-process inventory and estimated contract loss provisions
associated with two unrelated entities during the three and six months ended
October 31, 2006, which amounts in the aggregate totaled $204,000 and $412,000,
respectively. We expect contract manufacturing costs to continue
during the remainder of the current fiscal year based on the anticipated
completion of customer projects under our current contract manufacturing
agreements.
Research
and Development Expenses.
Three
and
Six Months: The increase in research and development (“R&D”)
expenses of $1,180,000 and $763,000 during the three and six months ended
October 31, 2007, respectively, compared to the same periods in the prior year
were primarily due to increases in expenses associated with each of our
following platform technologies under development:
R&D
Expenses –
Three
Months
Ended
October 31,
|
R&D
Expenses –
Six
Months
Ended
October 31,
|
|||||||||||||||||||||||
2007
|
2006
|
$
Change
|
2007
|
2006
|
$
Change
|
|||||||||||||||||||
(in
thousands)
|
(in
thousands)
|
|||||||||||||||||||||||
Technology
Platform:
|
||||||||||||||||||||||||
Anti-PS
Immunotherapeutics
(bavituximab)
|
$ |
2,920
|
$ |
2,549
|
$ |
371
|
$ |
5,214
|
$ |
5,107
|
$ |
107
|
||||||||||||
TNT
(Cotara®)
|
969
|
696
|
273
|
1,678
|
1,528
|
150
|
||||||||||||||||||
VTA
and Anti-Angiogenesis Agents
|
1,035
|
512
|
523
|
1,499
|
1,044
|
455
|
||||||||||||||||||
VEA
|
176
|
163
|
13
|
333
|
282
|
51
|
||||||||||||||||||
Total
R&D Expenses
|
$ |
5,100
|
$ |
3,920
|
$ |
1,180
|
$ |
8,724
|
$ |
7,961
|
$ |
763
|
o
|
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) – The increases in
Anti-PS Immunotherapeutics program expenses of $371,000 and $107,000
during the three and six months ended October 31, 2007, respectively,
compared to the same periods in the prior year are primarily due
to
increases in manufacturing expenses to support the current Phase
I studies
using bavituximab to treat patients with solid cancers and the Hepatitis
C
Virus infection and to support the initiation of our anticipated
Phase II
clinical studies using bavituximab for the treatment of various solid
cancers in combination with chemotherapy. During the current
fiscal year, we submitted two separate Phase II clinical protocols
in
India, one to treat patients with non-small cell lung cancer (“NSCLC”) and
one to treat patients with metastatic breast cancer in combination
with
chemotherapy. In addition, during October 2007, we submitted a
separate Phase II clinical protocol in the Republic of Georgia to
treat
patients with metastatic breast cancer in combination with chemotherapy,
which was approved in November 2007. The foregoing
expenses were further supplemented by increases in pre-clinical
development expenses to support the possible expansion of bavituximab
to
treat other viral infections. These increases in Anti-PS
program expenses were offset by decreases in clinical trial patient
fees
and related expenses due to the timing of initiating new
studies. The decreases in clinical trial related expenses were
further supplemented by decreases in non-cash stock-based compensation
expense associated with the amortization of the fair value of options
granted to employees in accordance with the adoption of SFAS No.
123R and
non-cash expenses associated with shares of common stock earned by
employees under a stock bonus plan, which expired in the prior fiscal
year.
|
17
o
|
Tumor
Necrosis Therapy (“TNT”) (Cotara®) – The increases in TNT program
expenses of $273,000 and $150,000 during the three and six months
ended
October 31, 2007, respectively, compared to the same periods in the
prior
year are primarily due to increases in clinical trial patient fees
and
related expenses associated with the two ongoing Cotara® clinical trials
for the treatment of brain cancer.
|
o
|
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis Agents – The
increases in VTA and Anti-Angiogenesis Agents program expenses of
$523,000
and $455,000 during the three and six months ended October 31, 2007,
respectively, compared to the same periods in the prior year are
primarily
due to increases in manufacturing expenses associated with manufacturing
our clinical candidate to support the advancement of our anti-angiogenesis
program. These increases in manufacturing expenses were offset
by decreases in technology license fees and sponsored research fees
associated with our VTA program.
|
o
|
Vasopermeation
Enhancement Agents (“VEAs”) – The increase in VEA program expenses of
$13,000 and $51,000 during the three and six months ended October
31,
2007, respectively, compared to the same periods in the prior year
are
primarily due to increases in payroll and related expenses and outside
research studies associated with our efforts to advance the pre-clinical
development of our VEA program.
|
Looking
beyond the current fiscal year, it is difficult for us to reasonably estimate
all future research and development costs associated with each of our
technologies due to the number of unknowns and uncertainties associated with
pre-clinical and clinical trial development. These unknown variables
and uncertainties include, but are not limited to:
·
|
the
uncertainty of future clinical trial
results;
|
·
|
the
uncertainty of the ultimate number of patients to be treated in any
current or future clinical trial;
|
·
|
the
uncertainty of the U.S. Food and Drug Administration allowing our
studies
to move forward from Phase I clinical studies to Phase II and Phase
III
clinical studies;
|
·
|
the
uncertainty of the rate at which patients are enrolled into any current
or
future study. Any delays in clinical trials could significantly
increase the cost of the study and would extend the estimated completion
dates;
|
·
|
the
uncertainty of 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 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.
18
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 the general management,
administration, and business development activities of the Company.
Three
and
Six Months: The increases in selling, general and administrative
expenses of $273,000 and $340,000 during the three and six months ended October
31, 2007, respectively, compared to the same periods in the prior year are
primarily due to increases in payroll and related expenses, corporate legal
fees, and travel and related expenses. Payroll and related expenses
increased $242,000 and $278,000 during the current year three and six-month
periods, respectively, primarily due to an increase in headcount to support
increased operations combined with an increase in consulting fees primarily
associated with the expansion of our business development
activities. Corporate legal fees increased $136,000 and $177,000
during the current year three and six-month periods, respectively, primarily
related to legal fees associated with the lawsuit described in this Quarterly
Report on Form 10-Q under Part II, Item 1, “Legal Proceedings”, combined with
legal fees associated with other corporate matters. Travel and
related expenses increased $48,000 and $74,000 during the current year three
and
six-month periods, respectively, primarily due to increased business development
efforts in the U.S., Europe and Asia and increased participation in corporate
and investor relation activities. In addition, these current year
three and six-month period increases were supplemented by incremental increases
in other general corporate related expenses primarily associated with facility
related expenses and tradeshow expenses associated with Avid. These
increases in selling, general and administrative expenses were offset with
decreases in non-cash stock-based compensation expenses of $226,000 and $313,000
during the three and six-month periods, respectively, primarily associated
with
the amortization of the fair value of options granted to employees in accordance
with the adoption of SFAS No. 123R and non-cash expenses associated with shares
of common stock earned by employees under a stock bonus plan, which expired
in
the prior year.
Interest
and Other
Income.
Six
Months: The decrease in
interest and other income of $96,000 during the six months ended October 31,
2007 compared to the same period in the prior year was due to a $131,000
decrease in other income primarily associated with the sale of a trademark
name
in the prior year quarter ended July 31, 2006 offset with a $35,000 increase
in
interest income as a result of higher prevailing interest rates during the
current year period compared to the prior year period.
Critical
Accounting Policies
The
methods, estimates, and judgments we use in applying our most critical
accounting policies have a significant impact on the results we report in our
condensed consolidated financial statements. We evaluate our estimates and
judgments on an ongoing basis. We base our estimates on historical
experience and on assumptions that we believe to be reasonable under the
circumstances. Our experience and assumptions form the basis for our
judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may vary from
what we anticipate and different assumptions or estimates about the future
could
change our reported results. We believe the following accounting
policies are the most critical to us, in that they are important to the
portrayal of our financial statements and they require our most difficult,
subjective or complex judgments in the preparation of our condensed consolidated
financial statements:
19
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.
Revenues
associated with licensing
agreements primarily consist of nonrefundable up-front license fees and
milestone payments. Revenues under licensing agreements are
recognized based on the performance requirements of the
agreement. Nonrefundable up-front license fees received under license
agreements, whereby continued performance or future obligations are considered
inconsequential to the relevant licensed technology, are generally recognized
as
revenue upon delivery of the technology. Nonrefundable up-front
license fees, whereby we have an ongoing involvement or performance obligations,
are recorded as deferred revenue and 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
We
currently maintain four equity compensation plans which 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 granting of options are share-based payments and are
subject to the fair value recognition provisions of Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment
(Revised 2004), which requires the recognition of compensation expense,
using a fair value based method, for costs related to all share-based payments
including grants of employee stock options. On May 1, 2006, we
adopted SFAS No. 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. Under the modified-prospective method
results for prior periods are not restated.
20
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 (“SAB 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.
Our
losses from operations for the
three and six-month periods ended October 31, 2007 included stock-based
compensation expenses of $198,000 and $381,000, respectively. Our losses from
operations for the three and six-month periods ended October 31, 2006 included
stock-based compensation expenses of $310,000 and $609,000,
respectively. We believe that non-cash stock-based compensation
expense for the remaining six months of fiscal year 2008 may be up to
approximately $338,000 based on actual options granted and unvested as of
October 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 October 31, 2007, the total
estimated unrecognized compensation cost related to non-vested stock options
was
$1,777,000. This cost is expected to be recognized over a weighted
average period of 2.86 years.
Allowance
for Doubtful Accounts
We
continually monitor our allowance for doubtful accounts for all
receivables. A considerable amount of judgment is required in
assessing the ultimate realization of these receivables and we estimate an
allowance for doubtful accounts based on these factors at that point in
time.
Liquidity
and Capital Resources
As
of October 31, 2007, we had
$26,138,000 in cash and cash equivalents on hand compared to $16,044,000 at
April 30, 2007. Although we have sufficient cash on hand to meet our
planned obligations through at least September 2008 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 years
since our 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 six months ended October 31, 2007 and 2006 amounted
to
$3,484,000 and $1,034,000, 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. 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.
21
We
may
raise additional capital through the sale of shares of our common stock to
fund
our research, development, and clinical testing of our product
candidates. We have approximately 5,031,000 shares available
for possible future registered transactions under two separate registration
statements. In addition, during January 2007, we filed a separate
registration statement on Form S-3, File Number 333-139975, under which we
may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000. 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 financing our operations through the sale of shares of common stock,
we are actively exploring various other sources of capital by 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. We will continue to explore ways to leverage our broad
intellectual property portfolio in addition to pursuing potential licensing
and
partnering collaborations for our products in clinical and pre-clinical
development. In addition, we have recently been approached by outside
companies interested in a possible transaction related to our wholly owned
subsidiary, Avid Bioservices, Inc. In this regard, we have only
initially begun to explore strategic alternatives for Avid as a means
of raising additional capital.
Although
we will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid
Bioservices, Inc. 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 six
months ended October 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 six
months ended October 31, 2007, cash used in operating activities slightly
increased $4,000 to $10,176,000 compared to $10,172,000 for the six months
ended
October 31, 2006. This increase in net cash used in operating
activities was primarily due to an increase in net loss reported during the
current six-month period after taking into consideration non-cash operating
expenses in the amount of $1,219,000. This amount was offset by a net
change in operating assets and payment or reduction of liabilities in the
aggregate amount of $1,215,000. The increase in our current six-month
period net loss was primarily due to current period increases in cost of
contract manufacturing, research and development expenses and selling, general
and administrative expenses, which were offset by an increase in contract
manufacturing revenue.
22
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:
SIX
MONTHS ENDED
|
||||||||
October
31,
2007
|
October
31,
2006
|
|||||||
Net
loss, as reported
|
$ | (10,863,000 | ) | $ | (10,527,000 | ) | ||
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
|
234,000
395,000
-
|
233,000
970,000
309,000
|
||||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$ | (10,234,000 | ) | $ | (9,015,000 | ) | ||
Net
change in operating assets and liabilities
|
$ |
58,000
|
$ | (1,157,000 | ) | |||
Net
cash used in operating activities
|
$ | (10,176,000 | ) | $ | (10,172,000 | ) |
Cash
Used In Investing
Activities. Net cash used in investing activities increased
$372,000 to $429,000 for the six months ended October 31, 2007 compared to
net
cash used of $57,000 for the six months ended October 31, 2006. This
increase was primarily due to progress payments of $305,000 made on certain
property related improvements associated with our manufacturing facility offset
by the reclassification of a $67,000 security deposit from other long-term
assets to other current assets during the current year period as such deposit
becomes due and payable to us within the next twelve months. The
increase in net cash used in investing activities was further supplemented
by a
$138,000 increase in property acquisitions.
Cash
Provided By Financing
Activities. Net cash provided by financing activities increased
$4,258,000 to $20,699,000 for the six months ended October 31, 2007 compared
to
net cash provided of $16,441,000 for the six months ended October 31,
2006. Cash provided by financing activities during the six months
ended October 31, 2007 was due to proceeds received under a security purchase
agreement whereby we sold and issued a total of 30,000,000 shares of our common
stock in exchange for net proceeds of $20,859,000, which was supplemented with
net proceeds of $73,000 from the exercise of stock options and
warrants. Cash provided by financing activities during the six months
ended October 31, 2006 was due to net proceeds received from the sale of our
common stock under a security purchase agreement in the amount of $12,970,000
supplemented with net proceeds of $3,689,000 from the exercise of stock options
and warrants.
Commitments
At
October 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 October
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.
23
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 October
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 October 31, 2007.
There
were no significant changes in
the Company’s internal controls over financial reporting, during the quarter
ended October 31, 2007, that have materially affected, or are reasonably likely
to materially affect, the Company’s internal controls over financial
reporting.
PART
II OTHER INFORMATION
ITEM
1.
|
LEGAL
PROCEEDINGS.
|
In
the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. Although we currently are not aware of any
such legal proceedings or claim that we believe will have, individually or
in
the aggregate, a material adverse effect on our business, operating results
or
cash flows, however, we did file or are involved with the following
lawsuits:
On
January 12, 2007, we filed a
complaint in the Superior Court of the State of California for the County of
Orange against Cancer Therapeutics Laboratories (“CTL”). 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. Based on early discovery, we amended the
complaint on May 4, 2007 to include claims against Shanghai MediPharm and its
related entities, and Alan Epstein, M.D alleging that these defendants
collaborated to interfere with the Agreement by entering into an economic
relationship between themselves and designed not to share profits and know-how
with the Company in violation of the Agreement, including proprietary
technologies that they developed and are required to share with the
Company. 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 have been paid or given to the Company under the
Agreement.
24
On
March 28, 2007, CTL filed a
cross-complaint, which they amended on May 30, 2007, alleging that the Company
breached the Agreement, improperly terminated the Agreement, is interfering
with
CTL’s agreements with various MediPharm entities and is double-licensing the
technology licensed to CTL to another party. CTL’s cross-complaint,
which seeks $20 million in damages, is in part predicated on the existence
of a
sublicense agreement between CTL and MediPharm. While we are
objecting to the cross-complaint on several grounds, we are challenging the
cross-complaint on the basis that not only did CTL fail to allege an agreement
with which the Company interfered, they have been unable to produce the alleged
sublicense agreement with MediPharm despite our repeated demands.
The
discovery phase on the
aforementioned cases is ongoing. Until we complete the initial
discovery phase and our objections are considered, we cannot estimate the
magnitude of the claims of the parties against each other or probable outcome
of
the litigation.
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, 2007.
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
October 31, 2007, we had
approximately $26.1 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.
Revenues
earned by Avid during the six
months ended October 31, 2007 and 2006 amounted to $3,484,000 and $1,034,000,
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 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 fiscal year 2008.
We
currently expect our monthly
negative cash flow to continue for the foreseeable future due to the anticipated
increase in clinical trials, including trials associated with bavituximab for
the treatment of both solid tumors and hepatitis C virus (“HCV”) infection and
trials associated with Cotara® for the treatment of brain cancer. In
addition, we plan to expend additional resources on our continued research
and
development directed towards our other technologies in pre-clinical development,
and our possible expansion of our manufacturing capabilities.
We
plan
to obtain any necessary funding to support the costs of our clinical and
pre-clinical programs through one or more methods including either equity or
debt financing and/or negotiating additional licensing or collaboration
agreements for our technology platforms. As of October 31, 2007, we
had an aggregate of approximately 5,031,000 shares available under our existing
Form S-3 registration statements for possible future registered
transactions. In addition, we filed a separate shelf registration
statement on Form S-3, File Number 333-139975, under which we may issue, from
time to time, in one or more offerings, shares of our common stock for remaining
gross proceeds of up to $7,500,000. 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. 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
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
six months ended October 31, 2007:
Net
Loss
|
||||
Six
months ended October 31, 2007 (unaudited)
|
$ |
10,863,000
|
||
Fiscal
Year 2007
|
$ |
20,796,000
|
||
Fiscal
Year 2006
|
$ |
17,061,000
|
||
Fiscal
Year 2005
|
$ |
15,452,000
|
As
of
October 31, 2007, we had an accumulated deficit of
$218,523,000. 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.
The
Sale Of Substantial Shares Of Our Common Stock May Depress Our Stock
Price.
As
of October 31, 2007, we had
approximately 226,211,000
shares of our common stock outstanding. Substantially all of these
shares are eligible for trading in the public market, subject in some cases
to
volume and other limitations. The market price of our common stock
may decline if our common stockholders sell a large number of shares of our
common stock in the public market, or the market perceives that such sales
may
occur.
We
could also issue up to approximately
21,459,000 additional shares of our common stock that are reserved for future
issuance under our shelf registration statements, stock option plans and for
outstanding warrants, as further described in the following table:
Number
of Shares
of
Common Stock
Reserved
For Issuance
|
||
Shares
reserved for issuance under two effective shelf
registration statements
|
5,030,634
|
|
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
16,068,135
|
|
Common
shares issuable upon exercise of outstanding warrants
|
360,000
|
|
Total
|
2
1,458,769
|
In
addition, the above table does not
include shares of common stock that we could issue from the registration
statement we filed during January 2007 on Form S-3, File Number 333-139975,
under which we may issue, from time to time, in one or more offerings, shares
of
our common stock for remaining gross proceeds of up to $7,500,000.
Of
the
total warrants and options outstanding as of October 31, 2007, approximately
1,533,000 options 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 October 31, 2007.
26
In
addition, we will need to raise
substantial additional capital in the future to fund our
operations. If we raise additional funds by issuing equity
securities, the market price of our securities may decline and our existing
stockholders may experience significant dilution.
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock.
The
market price of our common stock
and the market prices of securities of companies in the biotechnology sector
have generally been highly volatile and are likely to continue to be highly
volatile.
The
following table shows the high and
low sales price and trading volume of our common stock for each quarter in
the
three fiscal years ended April 30, 2007, and our two fiscal quarters ended
October 31, 2007:
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
Fiscal
Year 2008
|
||||||||||||||||
Quarter
Ended October 31, 2007
|
$ |
0.79
|
$ |
0.54
|
2,631
|
169
|
||||||||||
Quarter
Ended July 31, 2007
|
$ |
1.40
|
$ |
0.72
|
21,653
|
237
|
||||||||||
Fiscal
Year 2007
|
|
|
|
|||||||||||||
Quarter
Ended April 30, 2007
|
$ |
1.26
|
$ |
0.86
|
6,214
|
408
|
||||||||||
Quarter
Ended January 31, 2007
|
$ |
1.39
|
$ |
1.09
|
4,299
|
203
|
||||||||||
Quarter
Ended October 31, 2006
|
$ |
1.48
|
$ |
1.12
|
3,761
|
277
|
||||||||||
Quarter
Ended July 31, 2006
|
$ |
1.99
|
$ |
1.30
|
23,790
|
429
|
||||||||||
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
|
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;
|
·
|
the
offering and sale of shares of our common stock at a discount under
an
equity transaction;
|
·
|
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;
|
27
·
|
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.
The
Liquidity Of Our Common Stock Will Be Adversely Affected If Our Common Stock
Is
Delisted From The Nasdaq Capital Market.
Our
common stock is presently traded on
The Nasdaq Capital Market. To maintain inclusion on The Nasdaq
Capital Market, we must continue to meet the following six listing
requirements:
|
1.
|
Net
tangible assets of at least $2,500,000 or market capitalization of
at
least $35,000,000 or net income of at least $500,000 in either our
latest
fiscal year or in two of our last three fiscal
years;
|
|
2.
|
Public
float of at least 500,000 shares;
|
|
3.
|
Market
value of our public float of at least
$1,000,000;
|
|
4.
|
A
minimum closing bid price of $1.00 per share of common stock, without
falling below this minimum bid price for a period of thirty consecutive
trading days;
|
|
5.
|
At
least two market makers; and
|
|
6.
|
At
least 300 stockholders, each holding at least 100 shares of common
stock.
|
On
July 25, 2007, we received a
deficiency notice from The Nasdaq Stock Market notifying us that we had not
met
the $1.00 minimum closing bid price requirement for thirty consecutive trading
days as set forth above. According to the Nasdaq notice, we
automatically have been afforded an initial “compliance period” of 180 calendar
days, or until January 22, 2008, to regain compliance with this
requirement. To regain compliance, the closing bid price of our
common stock must meet or exceed $1.00 per share for 10 consecutive business
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 regain compliance
with the minimum closing bid price requirement or fail to comply with any other
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.
Although
we currently meet all other
Nasdaq listing requirements, the market price of our common stock has generally
been highly volatile and we cannot guarantee that we will be able to regain
compliance with the minimum closing bid price requirement within the required
compliance period.
If
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.
28
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
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.
Our
Product Development Efforts May Not Be Successful.
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:
29
·
|
obtaining
regulatory approval to commence a clinical
trial;
|
·
|
reaching
agreement on acceptable terms with prospective clinical research
organizations, or CROs, and trial sites, the terms of which can be
subject
to extensive negotiation and may vary significantly among different
CROs
and trial sites;
|
·
|
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
·
|
the
inability of patients to meet FDA or other regulatory authorities
imposed
protocol requirements;
|
·
|
the
inability to retain patients who have initiated a clinical trial
but may
be prone to withdraw due to various clinical or personal reasons,
or who
are lost to further follow-up;
|
·
|
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.
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.
Our
International Clinical Trials May Be Delayed Or Otherwise Adversely
Impacted By Social, Political And Economic Factors Affecting The
Particular Foreign
Country.
|
We
are
presently conducting a clinical trial in India, and we recently received
regulatory approval to commence a clinical trial in the Republic of
Georgia. Our ability to successfully initiate, enroll and complete a
clinical trial in either country, or in any future foreign country in which
we
may initiate a clinical trial, are subject to numerous risks unique to
conducting business in foreign countries, including:
·
|
difficulty
in establishing or managing relationships with clinical research
organizations and physicians;
|
·
|
different
standards for the conduct of clinical trials and/or health care
reimbursement;
|
·
|
our
inability to locate qualified local consultants, physicians, and
partners;
|
·
|
the
potential burden of complying with a variety of foreign laws, medical
standards and regulatory requirements, including the regulation of
pharmaceutical products and treatment;
and
|
·
|
general
geopolitical risks, such as political and economic instability, and
changes in diplomatic and trade
relations.
|
Because
we will be conducting a number of our Phase II clinical trials in India and
potentially other foreign countries, any disruption to our international
clinical trial program could significantly delay our product development
efforts.
30
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 I studies we have completed to date have been
designed to primarily assess safety in a small number of
patients. The limited results we have obtained may not predict
results for any future studies and also may not predict future therapeutic
benefit. We will be required to demonstrate through larger-scale
clinical trials that bavituximab and Cotara® are safe and effective for use in a
diverse population before we can seek regulatory approval for their commercial
sale. There is typically an extremely high rate of attrition from the
failure of drug candidates proceeding through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of
many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be
Profitable.
Even
if bavituximab, Cotara®, or any
future product candidate is approved for commercial sale by the FDA or other
regulatory authorities, the degree of market acceptance of any approved product
candidate by physicians, healthcare professionals and third-party payors and
our
profitability and growth will depend on a number of factors,
including:
·
|
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.
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.
31
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We
have completed Phase I and Phase
I/II studies with Cotara® for the treatment of brain cancer. In
addition, we are currently conducting a dose confirmation and dosimetry clinical
trial in patients with recurrent glioblastoma multiforme (“GBM”) in the
U.S. In June 2007, we opened enrollment in a Phase II safety and
efficacy study in India using a single administration of the drug through an
optimized delivery method. Taken together, the current
U.S. study along with data collected from the Phase II safety and efficacy
study
in India should provide the safety, dosimetry and efficacy data that will
support the final design of the larger Phase III study. Once we
complete these two Cotara® studies for the treatment of GBM, substantial
financial resources will be needed to complete the final part of the trial
and
any additional supportive clinical studies necessary for potential product
approval. We do not presently have the financial resources internally
to complete the larger Phase III study. We therefore intend to
continue to seek a licensing or funding partner for Cotara®, and hope that the
data from the U.S. and the Phase II study in India will enhance our
opportunities of finding such partner. If a partner is not found for
this technology, we may not be able to advance the project past its current
state of development. Because there are a limited number of companies
which have the financial resources, the internal infrastructure, the technical
capability and the marketing infrastructure to develop and market a
radiopharmaceutical based oncology drug, we may not find a suitable partnering
candidate for Cotara®. We also cannot 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 Our Radiolabeling Suppliers May Negatively Impact Our Ability
To
Complete Clinical Trials And Market Our Products.
We
have procured our antibody
radioactive isotope combination services (“radiolabeling”) for Cotara® with
Iso-tex Diagnostics, Inc. for all U.S. clinical trials and with the Board of
Radiation & Isotope Technology (“BRIT”) for our Phase II study in
India. If either of these suppliers is unable to continue to qualify
its respective facility or radiolabel and supply our antibody in a timely
manner, our current clinical trials using radiolabeling technology could be
adversely affected and significantly delayed. While there are other
suppliers for radioactive isotope combination services in the U.S., our clinical
trial would be delayed for up to twelve to eighteen months because it may take
that amount of time to certify a new facility under current Good Manufacturing
Practices and qualify the product, plus we would incur significant costs to
transfer our technology to another vendor. In addition, the number of
companies in India that could perform these radiolabeling services is very
limited. Prior to commercial distribution of any of our products, if
approved, we will be required to identify and contract with a company for
commercial antibody manufacturing and radioactive isotope combination
services. An antibody that has been combined with a radioactive
isotope, such as Iodine-131, cannot be stored for long periods of time, as
it
must be used within one week of being radiolabeled to be
effective. Accordingly, any change in our existing or future
contractual relationships with, or an interruption in supply from, any such
third-party service provider or antibody supplier could negatively impact our
ability to complete ongoing clinical trials conducted by us or a potential
licensing partner.
Our
Manufacturing Facilities May Not Continue To Meet Regulatory Requirements And
Have Limited Capacity.
Before
approving a new drug or biologic product, the FDA requires that the facilities
at which the product will be manufactured be in compliance with current Good
Manufacturing Practices, or cGMP requirements. To be successful, our
therapeutic products must be manufactured for development and, following
approval, in commercial quantities, in compliance with regulatory requirements
and at acceptable costs. Currently, we manufacture all pre-clinical
and clinical material through Avid Bioservices, our wholly owned
subsidiary. While we believe our current facilities are adequate for
the manufacturing of product candidates for clinical trials, our facilities
may
not be adequate to produce sufficient quantities of any products for commercial
sale.
32
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 or other regulatory authorities regulations, including the
demonstration of purity and
potency;
|
·
|
changes
in FDA or other regulatory authorities
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, provided
it had not already registered. The facilities will be subject to
inspections confirming compliance with cGMP or other regulations. If
any of our third-party manufacturers or we fail to maintain regulatory
compliance, the FDA can impose regulatory sanctions including, among other
things, refusal to approve a pending application for a new drug product or
biologic product, or revocation of a pre-existing approval. As a
result, our business, financial condition and results of operations may be
materially harmed.
We
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.
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.
33
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 have a material adverse effect on
our business and our financial results.
We
May Not Be Able To Compete With Our Competitors In The Biotechnology Industry
Because Many Of Them Have Greater Resources Than We Do And They Are Further
Along In Their Development Efforts.
The
pharmaceutical and biotechnology
industry is intensely competitive and subject to rapid and significant
technological change. Many of the drugs that we are attempting to
discover or develop will be competing with existing therapies. In
addition, we are aware of several pharmaceutical and biotechnology companies
actively engaged in research and development of antibody-based products that
have commenced clinical trials with, or have successfully commercialized,
antibody products. Some or all of these companies may have greater
financial resources, larger technical staffs, and larger research budgets than
we have, as well as greater experience in developing products and running
clinical trials. We expect to continue to experience significant and
increasing levels of competition in the future. In addition, there
may be other companies which are currently developing competitive technologies
and products or which may in the future develop technologies and products that
are comparable or superior to our technologies and products.
34
We
are
conducting the Cotara® dose confirmation and dosimetry clinical trial for the
treatment of recurrent glioblastoma multiforme (“GBM”), the most aggressive form
of brain cancer. We also recently opened enrollment in a Phase II
study in India using Cotara® to treat up to 40 patients for the treatment of GBM
at first relapse. Approved 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 products in development may
compete with Cotara® should they become approved for marketing. These
products include, but are not limited to CDX-110, a peptide vaccine under
development by Celldex. Merck KGaA is evaluating cilengitide in newly
diagnosed GBM patients. AstraZeneca is developing cediranib for
patients with recurrent GBM. In addition, oncology products marketed
for other indications such as Gleevec® (Novartis), Tarceva® (Genentech/OSI),
Avastin® (Genentech) and Nexavar® (Bayer), are being tested in clinical trials
for the treatment of brain cancer.
Bavituximab
for the treatment of
advanced solid cancers is currently in a Phase I clinical trial in the
U.S. In addition, during November 2007, we announced that our Phase
II protocol filed in the Republic of Georgia received approval to treat patients
with metastatic breast cancer in combination with chemotherapy. We
have also filed two separate Phase II protocols in India to treat patients
with
non-small cell lung cancer in combination with chemotherapy and patients with
metastatic breast cancer in combination with chemotherapy. There are
a number of possible competitors with approved or developmental targeted agents
used in combination with standard chemotherapy for the treatment of
cancer, including but not limited to, Avastin® by Genentech, Inc., Gleevec®
by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and Genentech, Inc., Erbitux®
by ImClone Systems Incorporated and Bristol-Myers Squibb Company, Rituxan® and
Herceptin® by Biogen Idec Inc. and Genentech, Inc., and Vectibix™ by
Amgen. There are a significant number of companies developing cancer
therapeutics using a variety of targeted and non-targeted
approaches. A direct comparison of these potential competitors will
not be possible until bavituximab advances to later-stage clinical
trials.
In
addition, we have completed Phase Ia
single-dose and Phase Ib multiple dose clinical trials evaluating bavituximab
for the treatment of HCV. In addition, we recently initiated a Phase
I study in HCV patients co-infected with HIV over a longer dosing
period. 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, but are not
limited to, protease inhibitors such as telaprevir from Vertex Pharmaceuticals
Incorporated and SCH7 from Schering-Plough Corporation.
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 six months ended October 31, 2007, our
loss from operations included non-cash stock-based compensation expense of
$198,000 and $381,000, 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
$338,000 based on actual shares granted and unvested as of October 31,
2007. However, the actual share-based compensation expense recorded
during the remainder of fiscal year 2008 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 2008, 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.
We
held
our annual meeting of stockholders’ on October 22, 2007. The
following represents the matters voted upon and the results of the
voting:
Routine
Matters
|
For
|
Withheld
|
|||
1)
Election
of Directors:
|
|||||
Carlton
M.
Johnson
|
179,743,877
|
15,247,779
|
|||
Steven
W. King
|
180,637,223
|
14,354,433
|
|||
David
H. Pohl
|
179,653,510
|
15,338,146
|
|||
Eric
S. Swartz
|
179,927,414
|
15,064,242
|
|||
Dr.
Thomas A.
Waltz
|
180,386,309
|
14,605,347
|
|||
For
|
Against
|
Abstain
|
|||
2) To
ratify the appointment of Ernst & Young LLP as independent auditors of
the Company for the fiscal year ending April 30, 2008.
|
174,710,149
|
17,641,298
|
2,640,208
|
||
3) To
approve an amendment to the Company’s Certificate of Incorporation to
increase the number of authorized shares of the Company’s common stock
from 250 million to 325 million.
|
166,605,904
|
27,183,319
|
1,202,432
|
||
4) To
approve the implementation of majority voting for directors, including
the
implementation of a director resignation provision for an unsuccessful
incumbent director.
|
17,383,982
|
36,483,184
|
1,441,462
|
||
5) To
require the Company to nominate more candidates than open seats on
the
Board of Directors for all elections of Directors.
|
15,508,979
|
38,989,642
|
810,007
|
37
ITEM
5. OTHER
INFORMATION. None.
ITEM
6. EXHIBITS.
(a)
|
Exhibits:
|
|
3.8
|
Certificate
of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals,
Inc. to increase the number of authorized shares of common stock
from 250
million to 325 million.
|
|
31.1
|
Certification
of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
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.
|
38
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: December 7, 2007 |
By:
/s/ STEVEN W. KING
Steven
W. King
President
and Chief Executive Officer,
Director
|
Date: December 7, 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)
|
39