Avid Bioservices, Inc. - Quarter Report: 2008 January (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 January 31, 2008
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For the
transition period from _______________ to _______________
Commission
file number: 0-17085
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
|
95-3698422
|
(State or other jurisdiction
of
|
(I.R.S.
Employer
|
incorporation or
organization)
|
Identification
No.)
|
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 March 7, 2008
|
|
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
|
24
|
|
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
|
37
|
|
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.
i
PART I - FINANCIAL INFORMATION
ITEM
1. CONSOLIDATED
FINANCIAL
STATEMENTS
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
JANUARY
31,
2008
|
APRIL
30,
2007
|
|||||||
Unaudited
|
||||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 20,063,000 | $ | 16,044,000 | ||||
Trade
and other receivables
|
1,316,000 | 750,000 | ||||||
Inventories,
net
|
2,394,000 | 1,916,000 | ||||||
Prepaid
expenses and other current assets
|
1,140,000 | 1,188,000 | ||||||
Total
current assets
|
24,913,000 | 19,898,000 | ||||||
PROPERTY:
|
||||||||
Leasehold
improvements
|
669,000 | 646,000 | ||||||
Laboratory
equipment
|
3,756,000 | 3,533,000 | ||||||
Furniture,
fixtures and office equipment
|
913,000 | 873,000 | ||||||
5,338,000 | 5,052,000 | |||||||
Less
accumulated depreciation and amortization
|
(3,537,000 | ) | (3,212,000 | ) | ||||
Property,
net
|
1,801,000 | 1,840,000 | ||||||
Other
assets
|
1,527,000 | 1,259,000 | ||||||
TOTAL
ASSETS
|
$ | 28,241,000 | $ | 22,997,000 |
1
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
JANUARY
31,
2008
|
APRIL
30,
2007
|
|||||||
Unaudited
|
||||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 2,387,000 | $ | 1,683,000 | ||||
Accrued
clinical trial site fees
|
244,000 | 228,000 | ||||||
Accrued
legal and accounting fees
|
390,000 | 392,000 | ||||||
Accrued
royalties and license fees
|
124,000 | 337,000 | ||||||
Accrued
payroll and related costs
|
858,000 | 874,000 | ||||||
Notes
payable, current portion
|
- | 379,000 | ||||||
Capital
lease obligation, current portion
|
17,000 | 17,000 | ||||||
Deferred
revenue
|
1,434,000 | 1,060,000 | ||||||
Other
current liabilities
|
1,239,000 | 885,000 | ||||||
Total
current liabilities
|
6,693,000 | 5,855,000 | ||||||
Notes
payable, less current portion
|
- | 119,000 | ||||||
Capital
lease obligation, less current portion
|
17,000 | 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
|
245,982,000 | 224,453,000 | ||||||
Accumulated
deficit
|
(224,677,000 | ) | (207,660,000 | ) | ||||
Total
stockholders' equity
|
21,531,000 | 16,989,000 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 28,241,000 | $ | 22,997,000 |
2
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
|||||||||||||||
January
31,
2008
|
January
31,
2007
|
January
31,
2008
|
January
31,
2007
|
|||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Contract
manufacturing revenue
|
$ | 1,662,000 | $ | 347,000 | $ | 5,146,000 | $ | 1,381,000 | ||||||||
License
revenue
|
13,000 | 16,000 | 46,000 | 87,000 | ||||||||||||
Total
revenues
|
1,675,000 | 363,000 | 5,192,000 | 1,468,000 | ||||||||||||
COSTS
AND EXPENSES:
|
||||||||||||||||
Cost
of contract manufacturing
|
1,289,000 | 223,000 | 3,872,000 | 1,247,000 | ||||||||||||
Research
and development
|
4,941,000 | 3,907,000 | 13,665,000 | 11,868,000 | ||||||||||||
Selling,
general and administrative
|
1,847,000 | 1,513,000 | 5,498,000 | 4,824,000 | ||||||||||||
Total
costs and expenses
|
8,077,000 | 5,643,000 | 23,035,000 | 17,939,000 | ||||||||||||
LOSS
FROM OPERATIONS
|
(6,402,000 | ) | (5,280,000 | ) | (17,843,000 | ) | (16,471,000 | ) | ||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
Interest
and other income
|
259,000 | 267,000 | 851,000 | 955,000 | ||||||||||||
Interest
and other expense
|
(11,000 | ) | (12,000 | ) | (25,000 | ) | (36,000 | ) | ||||||||
NET
LOSS
|
$ | (6,154,000 | ) | $ | (5,025,000 | ) | $ | (17,017,000 | ) | $ | (15,552,000 | ) | ||||
WEIGHTED
AVERAGE COMMON
SHARES
OUTSTANDING:
|
||||||||||||||||
Basic
and Diluted
|
226,210,617 | 195,299,586 | 219,497,601 | 191,067,145 | ||||||||||||
BASIC
AND DILUTED LOSS PER
COMMON
SHARE
|
$ | (0.03 | ) | $ | (0.03 | ) | $ | (0.08 | ) | $ | (0.08 | ) |
See accompanying notes to
condensed consolidated financial statements
3
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
NINE
MONTHS ENDED JANUARY 31,
|
||||||||
2008
|
2007
|
|||||||
Unaudited
|
Unaudited
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (17,017,000 | ) | $ | (15,552,000 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
353,000 | 355,000 | ||||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
627,000 | 1,153,000 | ||||||
Amortization
of expenses paid in shares of common stock
|
- | 362,000 | ||||||
Loss
on disposal of property
|
- | 1,000 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Trade
and other receivables
|
(566,000 | ) | (378,000 | ) | ||||
Inventories
|
(478,000 | ) | (1,986,000 | ) | ||||
Prepaid
expenses and other current assets
|
(135,000 | ) | (221,000 | ) | ||||
Accounts
payable
|
704,000 | 206,000 | ||||||
Accrued
clinical trial site fees
|
16,000 | 149,000 | ||||||
Deferred
revenue
|
370,000 | 1,626,000 | ||||||
Accrued
payroll and related costs
|
(16,000 | ) | (87,000 | ) | ||||
Other
accrued expenses and current liabilities
|
139,000 | (310,000 | ) | |||||
Net
cash used in operating activities
|
(16,003,000 | ) | (14,682,000 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Refund
of security deposits on notes payable (net of applied security deposits on
notes payable of $175,000)
|
150,000 | - | ||||||
Property
acquisitions
|
(314,000 | ) | (105,000 | ) | ||||
(Increase)
decrease in other assets
|
(410,000 | ) | 184,000 | |||||
Net
cash (used in) provided by investing activities
|
(574,000 | ) | 79,000 | |||||
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 | 17,865,000 | ||||||
Principal
payments on notes payable and capital lease (net of applied security
deposits on notes payable of $175,000)
|
(336,000 | ) | (330,000 | ) | ||||
Net
cash provided by financing activities
|
20,596,000 | 17,535,000 | ||||||
NET INCREASE
IN CASH AND CASH EQUIVALENTS
|
4,019,000 | 2,932,000 | ||||||
CASH AND CASH EQUIVALENTS,
beginning of period
|
16,044,000
|
17,182,000 | ||||||
CASH AND CASH
EQUIVALENTS, end of period
|
$ | 20,063,000 | $ | 20,114,000 | ||||
SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
Applied
security deposit on payoff of notes payable to GE Capital
|
$ | 175,000 | $ | - |
See
accompanying notes to condensed consolidated financial statements
4
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2008 (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 bio-manufacturing 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
January 31, 2008, and the condensed consolidated results of our operations and
condensed consolidated cash flows for the three and nine-month periods ended
January 31, 2008 and 2007. 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
January 31, 2008, we had $20,063,000 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 nine months ended January 31, 2008 and 2007 amounted
to $5,146,000 and $1,381,000, 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 NINE MONTHS ENDED JANUARY 31, 2008 (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, our wholly owned subsidiary, Avid
Bioservices, Inc., represents an additional asset in our portfolio and we are
actively pursuing 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, as 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 January 31, 2008, we had $20,063,000 in
cash and cash equivalents, which we currently believe is sufficient capital to
maintain our operations through at least October 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 January 31,
2008 and April 30, 2007:
January
31,
2008
|
April
30,
2007
|
|||||||
Raw
materials, net
|
$ | 1,139,000 | $ | 810,000 | ||||
Work-in-process
|
1,255,000 | 1,106,000 | ||||||
Total
inventories, net
|
$ | 2,394,000 | $ | 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 NINE MONTHS ENDED JANUARY 31, 2008 (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 nine months ended January 31, 2008 and 2007,
and we did not accrue for interest or penalties as of January 31, 2008 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 nine months ended January
31, 2008 and 2007.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 357,542 and 722,641 shares of
common stock for the three and nine months ended January 31, 2008,
respectively, and 1,301,525 and 2,531,546 shares of common stock for the three
and nine months ended January 31, 2007, 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 11,193,227
and 10,530,120 shares of common stock for the three and nine months ended
January 31, 2008, respectively, and 8,525,781 and 7,116,306 shares of
common stock for the three and nine months ended January 31, 2007, 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 NINE MONTHS ENDED JANUARY 31, 2008 (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 two to 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 NINE MONTHS ENDED JANUARY 31, 2008 (unaudited) (continued)
Our net
loss for the three and nine-month periods ended January 31, 2008 and 2007,
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
January
31,
|
Nine
Months Ended
January
31,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Research
and development
|
$ | 147,000 | $ | 129,000 | $ | 416,000 | $ | 472,000 | ||||||||
Selling,
general and administrative
|
84,000 | 58,000 | 196,000 | 324,000 | ||||||||||||
Total
|
$ | 231,000 | $ | 187,000 | $ | 612,000 | $ | 796,000 |
The fair
value of each option grant is estimated using the Black-Scholes option valuation
model and is amortized as compensation expense on a straight-line basis over the
requisite service period of the award, which is generally the vesting period
(typically 2 to 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 prior to November 1, 2007 was based on the
expected time to exercise using the “simplified” method allowable under the
Security and Exchange Commission’s (“SEC’s”) Staff Accounting Bulletin No. 107
(“SAB No. 107”). Effective
November 1, 2007, the expected term reflects actual historical exercise activity
and assumptions regarding future exercise activity of unexercised, outstanding
options and will be applied to all
option grants subsequent to October 31, 2007. 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 we currently
do not anticipate paying future 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
January
31,
|
Nine
Months Ended
January
31,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Risk-free
interest rate
|
3.60 | % | 4.72 | % | 3.79 | % | 4.87 | % | ||||||||
Expected
life (in years)
|
6.00 | 6.25 | 6.02 | 6.25 | ||||||||||||
Expected
volatility
|
81 | % | 97 | % | 82 | % | 99 | % | ||||||||
Expected
dividend yield
|
- | - | - | - |
As of
January 31, 2008, options to purchase up to 14,970,819 shares of our common
stock were issued and outstanding under the Option Plans with a weighted average
exercise price of $1.26 per share, and will expire at various dates through
January 14, 2018. Options to purchase up to 1,082,556 shares of
common stock were available for future grant under the Option Plans as of
January 31, 2008.
9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2008 (unaudited)
(continued)
The
following summarizes all stock option transaction activity for the nine months
ended January 31, 2008:
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
|
4,025,714 | $ | 0.47 | |||||||||||||
Exercised
|
(45,000 | ) | $ | 0.60 | ||||||||||||
Canceled
or expired
|
(547,841 | ) | $ | 1.38 | ||||||||||||
Outstanding,
January 31, 2008
|
14,970,819 | $ | 1.26 | 6.20 | $ | 510,000 | ||||||||||
Exercisable
and expected to vest
|
14,595,271 | $ | 1.27 | 6.14 | $ | 494,000 | ||||||||||
Exercisable,
January 31, 2008
|
9,598,938 | $ | 1.57 | 4.64 | $ | 173,000 |
The
weighted-average grant date fair value of options granted during the
nine-month periods ended January 31, 2008 and 2007 was $0.35 per share and $1.09
per share, respectively. The aggregate intrinsic value of options
exercised during the nine-month periods ended January 31, 2008 and 2007 was
$19,000 and $38,000, respectively.
Cash
proceeds from stock options exercised during the nine-month periods ended
January 31, 2008 and 2007 totaled $27,000 and $59,000,
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
January 31, 2008, the total estimated unrecognized compensation cost related to
non-vested stock options was $2,332,000. This cost is expected to be
recognized over a weighted average vesting period of 2.47 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 nine months ended January 31, 2008 associated with
non-employees amounted to $1,000 and $15,000,
respectively. Stock-based compensation expense recorded during the three and
nine months ended January 31, 2007 associated with non-employees amounted to
$2,000 and $54,000, respectively.
4. | NOTES PAYABLE |
During
fiscal years 2005 and 2006, we entered into five separate note payable
agreements with an aggregate original principal amount of approximately
$1,299,000 (the “Notes”) with General Electric Capital (“GE”) to finance certain
laboratory equipment. The Notes bore interest at various rates
ranging from 5.78% to 6.87% per annum with monthly payments ranging from
approximately $3,000 to $12,000 over a period of 36 months. In
addition, under the terms of the Notes, we paid GE a security deposit equal to
25% of the original principal amount of the Notes that totaled $325,000 in
aggregate. The security deposits were due and payable to us at the
time the Notes were paid in full.
10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2008 (unaudited)
(continued)
During
the quarter ended January 31, 2008, we paid in full the balance of the Notes,
which amount was offset by an applied security deposit in the amount of
$175,000 .
5. | 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.
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 January
31, 2008, we have up to $7,500,000 in remaining gross proceeds available to
be issued under the January 2007 Shelf.
In
addition, as of January 31, 2008, an aggregate of 5,030,634 shares of common
stock were available for issuance under two separate effective shelf
registration statements.
As of
January 31, 2008, we have reserved 21,444,009 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
|
14,970,819 | |||
Shares
of common stock reserved for future option grants under our Option
Plans
|
1,082,556 | |||
Shares
of common stock reserved for issuance under outstanding warrant
arrangements
|
360,000 | |||
Total
shares of common stock reserved for issuance
|
21,444,009 |
6. |
WARRANTS
|
During
the nine months ended January 31, 2008, warrants to purchase 53,416 shares of
our common stock were exercised for net proceeds of $46,000. As of
January 31, 2008, 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.
11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2008 (unaudited) (continued)
7. | SEGMENT REPORTING |
Our
business is organized into two reportable operating
segments. Peregrine is engaged in the research and development of
monoclonal antibodies products for the treatment of cancer and viral
infections. 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.
Segment
information for the three-month periods is summarized as follows:
Three
Months Ended January 31,
|
||||||||
2008
|
2007
|
|||||||
Net
Revenues:
|
||||||||
Contract
manufacturing and development of biologics
|
$ | 1,662,000 | $ | 347,000 | ||||
Products
in research and development
|
13,000 | 16,000 | ||||||
Total
revenues, net
|
$ | 1,675,000 | $ | 363,000 | ||||
Gross
Profit:
|
||||||||
Contract
manufacturing and development of biologics
|
$ | 373,000 | $ | 124,000 | ||||
Products
in research and development
|
13,000 | 16,000 | ||||||
Total
gross profit
|
386,000 | 140,000 | ||||||
Research
and development expense
|
(4,941,000 | ) | (3,907,000 | ) | ||||
Selling,
general and administrative expense
|
(1,847,000 | ) | (1,513,000 | ) | ||||
Other
income, net
|
248,000 | 255,000 | ||||||
Net
loss
|
$ | (6,154,000 | ) | $ | (5,025,000 | ) |
Net
revenues generated from Avid for the three-month periods were from the following
customers:
Three
Months Ended January 31,
|
||||||||
2008
|
2007
|
|||||||
Customer
revenues as a % of net revenues:
|
||||||||
United
States (customer A)
|
90%
|
77% | ||||||
United
States (customer B)
|
0%
|
18% | ||||||
Germany
(one customer)
|
10% |
|
3% | |||||
Other
customers
|
0% | 2% | ||||||
Total
customer revenues as a % of net revenues
|
100% | 100% |
12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2008 (unaudited) (continued)
Segment
information for the nine-month periods is summarized as follows:
Nine
Months Ended January 31,
|
||||||||
2008
|
2007
|
|||||||
Net
Revenues:
|
||||||||
Contract
manufacturing and development of biologics
|
$ | 5,146,000 | $ | 1,381,000 | ||||
Products
in research and development
|
46,000 | 87,000 | ||||||
Total
revenues, net
|
$ | 5,192,000 | $ | 1,468,000 | ||||
Gross
Profit:
|
||||||||
Contract
manufacturing and development of biologics
|
$ | 1,274,000 | $ | 134,000 | ||||
Products
in research and development
|
46,000 | 87,000 | ||||||
Total
gross profit
|
1,320,000 | 221,000 | ||||||
Research
and development expense
|
(13,665,000 | ) | (11,868,000 | ) | ||||
Selling,
general and administrative expense
|
(5,498,000 | ) | (4,824,000 | ) | ||||
Other
income, net
|
826,000 | 919,000 | ||||||
Net
loss
|
$ | (17,017,000 | ) | $ | (15,552,000 | ) |
Net
revenues generated from Avid for the nine-month periods were from the following
customers:
Nine
Months Ended January 31,
|
||||||||
2008
|
2007
|
|||||||
Customer
revenues as a % of net revenues:
|
||||||||
United
States (customer A)
|
86% | 22% | ||||||
United
States (customer B)
|
3% | 12% | ||||||
Australia
(one customer)
|
1% | 36% | ||||||
China
(one customer)
|
0% | 25% | ||||||
Other
customers
|
10% | 5% | ||||||
Total
customer revenues as a % of net revenues
|
100% | 100% |
Net
revenues generated from products in research and development during the three
and nine months ended January 31, 2008 and 2007 were from license fees received
from two licensees in accordance with the terms of the licensing agreements and
have been recognized in accordance SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition.
13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2008 (unaudited) (continued)
Long-lived
assets by segment consist of the following:
January
31, 2008
|
April
30, 2007
|
|||||||
Long-lived
Assets, net:
|
||||||||
Contract
manufacturing and development of biologics
|
$ | 1,513,000 | $ | 1,527,000 | ||||
Products
in research and development
|
288,000 | 313,000 | ||||||
Total
long-lived assets, net
|
$ | 1,801,000 | $ | 1,840,000 |
8. | 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 filed 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 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 it 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. 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.
On
February 22, 2008, the MediPharm entities filed a cross-complaint alleging, as a
third party beneficiary, that that the Company breached the Agreement by
double-licensing the technology licensed to CTL to another party, intentionally
interfered with a prospective economic advantage, and unjust
enrichement. MediPharm’s cross-complaint, which seeks $30 million in
damages, is in part predicated on MediPharm being the “Chinese Sponsor” under
the Agreement. We will be objecting to the cross-complaint on several
grounds.
In
addition, Dr. Epstein has attempted to have our claims against him referred to
binding Arbitration. The Superior Court has declined his request and
he is appealing that decision to the Court of Appeal.
The
discovery phase on the aforementioned cases is ongoing. Until we
complete the 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 being
evaluated under two separate clinical programs 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 study to treat up to 28
patients.
|
Study
is open for enrollment in the U.S.
|
|||
Bavituximab
plus chemotherapy agent docetaxel
|
Breast
cancer
|
Phase
II combination therapy study to treat up to 46 patients.
|
Study
is open for enrollment in the Republic of Georgia.
|
|||
Bavituximab
plus chemotherapy agents carboplatin/paclitaxel
|
Breast
cancer
|
Phase
II combination therapy study to treat up to 46 patients.
|
Clinical
protocol approved by regulatory authorities in India. Patient enrollment
is expected to initiate in the near term.
|
|||
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 approved by regulatory authorities in India. Patient enrollment
is expected to initiate in the near term.
|
|||
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
|
Co-infection
with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus
(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 nine-month periods ended January 31, 2008 and
2007. This table provides an overview of the changes in the condensed
consolidated statements of operations for the comparative periods, which are
further discussed below.
Three
Months Ended
January
31,
|
Nine
Months Ended
January
31,
|
|||||||||||||||||||||||
2008
|
2007
|
$
Change
|
2008
|
2007
|
$
Change
|
|||||||||||||||||||
(in
thousands)
|
(in
thousands)
|
|||||||||||||||||||||||
REVENUES:
|
||||||||||||||||||||||||
Contract
manufacturing revenue
|
$ | 1,662 | $ | 347 | $ | 1,315 | $ | 5,146 | $ | 1,381 | $ | 3,765 | ||||||||||||
License
revenue
|
13 | 16 | (3 | ) | 46 | 87 | (41 | ) | ||||||||||||||||
Total
revenues
|
1,675 | 363 | 1,312 | 5,192 | 1,468 | 3,724 | ||||||||||||||||||
COST
AND EXPENSES:
|
||||||||||||||||||||||||
Cost
of contract manufacturing
|
1,289 | 223 | 1,066 | 3,872 | 1,247 | 2,625 | ||||||||||||||||||
Research
and development
|
4,941 | 3,907 | 1,034 | 13,665 | 11,868 | 1,797 | ||||||||||||||||||
Selling,
general and administrative
|
1,847 | 1,513 | 334 | 5,498 | 4,824 | 674 | ||||||||||||||||||
Total
cost and expenses
|
8,077 | 5,643 | 2,434 | 23,035 | 17,939 | 5,096 | ||||||||||||||||||
LOSS
FROM OPERATIONS
|
(6,402 | ) | (5,280 | ) | (1,122 | ) | (17,843 | ) | (16,471 | ) | (1,372 | ) | ||||||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||||||||||
Interest
and other income
|
259 | 267 | (8 | ) | 851 | 955 | (104 | ) | ||||||||||||||||
Interest
and other expense
|
(11 | ) | (12 | ) | 1 | (25 | ) | (36 | ) | 11 | ||||||||||||||
NET
LOSS
|
$ | (6,154 | ) | $ | (5,025 | ) | $ | (1,129 | ) | $ | (17,017 | ) | $ | (15,552 | ) | $ | (1,465 | ) |
Results
of operations for interim periods covered by this quarterly report on Form 10-Q
may not necessarily be indicative of results of operations for the full fiscal
year.
Total
Revenues.
Three and
Nine Month Periods: The increases in total revenues of $1,312,000 and
$3,724,000 during the three and nine months ended January 31, 2008,
respectively, compared to the same periods in the prior year were primarily due
to increases in contract manufacturing revenue of $1,315,000 and
$3,765,000, 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 product development
services including an increase in the number of shipped manufacturing runs
compared to the same three and nine-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. 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
Nine Month Periods: The increases in cost of contract manufacturing
of $1,066,000 and $2,625,000 during the three and nine months ended January 31,
2008, respectively, compared to the same periods in the prior year were
primarily related to the three and nine-month period increases in contract
manufacturing revenue offset by a prior year charge of $412,000 related to a
write-off of unusable work-in-process inventory and estimated contract loss
provisions associated with two unrelated entities, which did not re-occur in the
current nine-month period. 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
Nine Month Periods: The increase in research and development
(“R&D”) expenses of $1,034,000 and $1,797,000 during the three and nine
months ended January 31, 2008, 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
January 31,
|
R&D
Expenses –
Nine
Months
Ended
January 31,
|
|||||||||||||||||||||||
2008
|
2007
|
$
Change
|
2008
|
2007
|
$
Change
|
|||||||||||||||||||
(in
thousands)
|
(in
thousands)
|
|||||||||||||||||||||||
Technology
Platform:
|
||||||||||||||||||||||||
Anti-PS
Immunotherapeutics
(bavituximab)
|
$ | 2,943 | $ | 1,974 | $ | 969 | $ | 8,158 | $ | 7,081 | $ | 1,077 | ||||||||||||
TNT
(Cotara®)
|
1,065 | 1,301 | (236 | ) | 2,742 | 2,829 | (87 | ) | ||||||||||||||||
VTA
and Anti-Angiogenesis Agents
|
767 | 487 | 280 | 2,266 | 1,531 | 735 | ||||||||||||||||||
VEA
|
166 | 145 | 21 | 499 | 427 | 72 | ||||||||||||||||||
Total
R&D Expenses
|
$ | 4,941 | $ | 3,907 | $ | 1,034 | $ | 13,665 | $ | 11,868 | $ | 1,797 |
o
|
Anti-PhosphatidylSerine
(“Anti-PS”) Immunotherapeutics
(bavituximab)
|
Three
Month Period: The increase in Anti-PS Immunotherapeutics program
expenses of $969,000 during the three months ended January 31, 2008 compared to
the same period in the prior year is primarily due to increases in manufacturing
expenses and clinical trial expenses to support our four clinical trials using
bavituximab for the treatment of solid tumors and one clinical trial for the
treatment of HCV/HIV co-infection.
Nine
Month Period: The increase in Anti-PS Immunotherapeutics program
expenses of $1,077,000 during the nine months ended January 31, 2008 compared to
the same period in the prior year is primarily due to increases in manufacturing
expenses to support our four clinical trials using bavituximab for the treatment
of solid tumors and one clinical trial for the treatment of HCV/HIV
co-infection. During the current year nine-month period, 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 breast
cancer in combination with chemotherapy, both of which received protocol
approval in January 2008. In addition, we submitted a separate Phase
II clinical protocol in the Republic of Georgia to treat patients with breast
cancer in combination with chemotherapy, which trial 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 a net decrease in clinical trial related
expenses primarily associated with a decrease in patient fees due to the timing
of initiating new studies. However, the decrease in patient fees was
offset with increases in clinical trial related expenses associated with the
initiation of three separate Phase II clinical 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 plan expired in the prior
fiscal year.
17
o
|
Tumor
Necrosis Therapy (“TNT”) (Cotara®)
|
Three
Month Period: The decrease in TNT program expenses of $236,000 during
the three months ended January 31, 2008 compared to the same period in the prior
year is primarily due to a decrease in manufacturing expenses associated with
the TNT program combined with a decrease in clinical program expenses associated
with the two ongoing Cotara® clinical trials for the treatment of brain cancer
in the U.S. and India.
Nine
Month Period: The decrease in TNT program expenses of $87,000 during
the nine months ended January 31, 2008 compared to the same period in the prior
year is primarily due to a decrease in manufacturing expenses associated with
the TNT program offset by an increase in clinical trial expenses associated with
the two ongoing Cotara® clinical trials for the treatment of brain cancer in the
U.S. and India.
o
|
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis
Agents
|
Three and
Nine Month Periods: The increases in VTA and Anti-Angiogenesis Agents
program expenses of $280,000 and $735,000 during the three and nine months ended
January 31, 2008, 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 pre-clinical program expenses associated with our
VTA program.
o
|
Vasopermeation Enhancement
Agents (“VEAs”) – Three and Nine Months: The increase in
VEA program expenses of $21,000 and $72,000 during the three and nine
months ended January 31, 2008, 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;
|
18
●
|
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 not certain whether
these product candidates will be successful or whether 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.
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
Nine Month Periods: The increases in selling, general and
administrative expenses of $334,000 and $674,000 during the three and nine
months ended January 31, 2008, 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 $152,000 and $430,000 during the current year three
and nine-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 $176,000 and $355,000
during the current year three and nine-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 $103,000 and $178,000 during the current year three
and nine-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. These increases in
selling, general and administrative expenses were offset with a net decrease in
other general corporate expenses of $118,000 and $24,000 during the three and
nine-month periods, respectively, primarily associated with audit and accounting
fees. In addition, the nine-month period increase in selling, general
and administrative expenses was offset with a nine-month period decrease in
non-cash stock-based compensation expense of $286,000 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 plan expired
in the prior year.
19
Interest and
Other Income.
Nine
Months: The decrease in interest and other income of $104,000 during
the nine months ended January 31, 2008 compared to the same period in the prior
year was due to a $129,000 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 $25,000 increase in interest income.
Critical
Accounting Policies
The
methods, estimates, and judgments we use in applying our most critical
accounting policies have a significant impact on the results we report in our
condensed consolidated financial statements. We evaluate our
estimates and judgments on an ongoing basis. We base our estimates on
historical experience and on assumptions that we believe to be reasonable under
the circumstances. Our experience and assumptions form the basis for
our judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may vary from
what we anticipate and different assumptions or estimates about the future could
change our reported results. We believe the following accounting
policies are the most critical to us, in that they are important to the
portrayal of our financial statements and they require our most difficult,
subjective or complex judgments in the preparation of our condensed consolidated
financial statements:
Revenue
Recognition
We
recognize revenues pursuant to the SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition. In accordance with SAB No. 104, revenue is
generally realized or realizable and earned when (i) persuasive evidence of an
arrangement exists, (ii) delivery has occurred or services have been rendered,
(iii) the seller's price to the buyer is fixed or determinable, and (iv)
collectibility is reasonably assured.
In
addition, we comply with Financial Accounting Standards Board’s Emerging Issues
Task Force No. 00-21 (“EITF 00-21”), Revenue Arrangements with Multiple
Deliverables. In accordance with EITF 00-21, we recognize
revenue for delivered elements only when the delivered element has stand-alone
value and we have objective and reliable evidence of fair value for each
undelivered element. If the fair value of any undelivered element
included in a multiple element arrangement cannot be objectively determined,
revenue is deferred until all elements are delivered and services have been
performed, or until fair value can objectively be determined for any remaining
undelivered elements.
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.
20
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.
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 two to four 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 prior to November 1, 2007 was based on the
expected time to exercise using the “simplified” method allowable under the
Security and Exchange Commission’s (SEC’s) Staff Accounting Bulletin No. 107
(“SAB No. 107”). Effective November 1, 2007, the expected term
reflects actual historical exercise activity and assumptions regarding future
exercise activity of unexercised, outstanding options and will be applied to all
option grants subsequent to October 31, 2007. 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 nine-month periods ended January 31,
2008 included stock-based compensation expenses of $231,000 and $612,000,
respectively. Our losses from operations for the three and nine-month
periods ended January 31, 2007 included stock-based compensation expenses of
$187,000 and $796,000, respectively. We believe that non-cash
stock-based compensation expense for the remaining three months of fiscal year
2008 may be up to approximately $231,000 based on actual options granted and
unvested as of January 31, 2008. 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.
21
As of
January 31, 2008, the total estimated unrecognized compensation cost related to
non-vested stock options was $2,332,000. This cost is expected to be
recognized over a weighted average period of 2.47 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. As of January 31, 2008, based on our analysis of our accounts
receivable balances and based on historical collectibility of receivables from
our current customers we determined no allowance for doubtful accounts was
necessary.
Liquidity
and Capital Resources
As of
January 31, 2008, we had $20,063,000 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 October
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 nine months ended January 31, 2008 and 2007 amounted
to $5,146,000 and $1,381,000, 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.
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, our wholly owned subsidiary Avid
Bioservices, Inc. represents an additional asset in our portfolio and we are
actively pursuing strategic alternatives for Avid as a means of raising
additional capital.
22
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 nine months ended January 31, 2008 compared to the same prior
year period are as follows:
Cash Used In Operating
Activities. Cash used in operating activities is primarily
driven by changes in our net loss. However, cash used in operating
activities generally differs from our reported net loss as a result of non-cash
operating expenses or differences in the timing of cash flows as reflected in
the changes in operating assets and liabilities. During the nine
months ended January 31, 2008, cash used in operating activities increased
$1,321,000 to $16,003,000 compared to $14,682,000 for the nine months ended
January 31, 2007. This increase in net cash used in operating
activities was primarily due to an increase in net loss reported during the
current nine-month period after taking into consideration non-cash operating
expenses in the amount of $2,356,000. This amount was offset by a net
change in operating assets and payment or reduction of liabilities in the
aggregate amount of $1,035,000. The increase in our current
nine-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.
The
changes in operating activities as a result of non-cash operating expenses or
differences in the timing of cash flows as reflected by the changes in operating
assets and liabilities are as follows:
NINE
MONTHS ENDED
|
||||||||
January
31,
2008
|
January
31,
2007
|
|||||||
Net
loss, as reported
|
$ | (17,017,000 | ) | $ | (15,552,000 | ) | ||
Less non-cash expenses and adjustments to net loss: | ||||||||
Depreciation
and amortization
|
353,000 | 355,000 | ||||||
Stock-based
compensation and common stock
issued
under stock bonus plan
|
627,000 | 1,153,000 | ||||||
Amortization
of expenses paid in shares of common stock
|
- | 362,000 | ||||||
Loss
on disposal of property
|
- | 1,000 | ||||||
Net
cash used in operating activities before changes in operating assets and
liabilities
|
$ | (16,037,000 | ) | $ | (13,681,000 | ) | ||
Net
change in operating assets and liabilities
|
$ | 34,000 | $ | (1,001,000 | ) | |||
Net
cash used in operating activities
|
$ | (16,003,000 | ) | $ | (14,682,000 | ) |
Cash (Used In) Provided By Investing
Activities. Net cash used in investing activities amounted to
$574,000 for the nine months ended January 31, 2008 compared net cash provided
by investing activities of $79,000 for the nine months ended January
31, 2007. This decrease in net cash provided by investing activities
of $653,000 was primarily due to an increase in cash used in investing
activities associated with an increase in property acquisitions to support our
current operations combined with current year progress payments of $413,000 made
on certain property related improvements associated with our manufacturing
facility. These increases in net cash used in investing
activities were offset by the receipt of $150,000 in net security deposits from
GE Capital Corporation during the current period upon the payment in full of
various note payable amounts.
23
Cash Provided By Financing
Activities. Net cash provided by financing activities
increased $3,061,000 to $20,596,000 for the nine months ended January 31, 2008
compared to net cash provided of $17,535,000 for the nine months ended January
31, 2007. Net cash provided by financing activities during the nine
months ended January 31, 2008 was primarily 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. Net cash provided by financing activities during the
nine months ended January 31, 2007 was primarily 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 $4,895,000 from the
exercise of stock options and warrants.
Commitments
At
January 31, 2008, we had no material capital commitments.
ITEM
3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
Changes
in United States interest rates would affect the interest earned on our cash and
cash equivalents. Based on our overall interest rate exposure at
January 31, 2008, a near-term change in interest rates, based on historical
movements, would not materially affect the fair value of interest rate sensitive
instruments. Our debt instruments have fixed interest rates and terms
and, therefore, a significant change in interest rates would not have a material
adverse effect on our financial position or results of operations.
ITEM
4. CONTROLS
AND PROCEDURES
The
Company maintains disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e)) under the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), that are designed to ensure that information
required to be disclosed in its reports filed under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and
communicated to our management, including its Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and
procedures, management recognized that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management necessarily was
required to apply its judgment in evaluating the cost-benefit relationship of
possible controls and procedures.
The
Company carried out an evaluation, under the supervision and with the
participation of management, including its Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of its
disclosure controls and procedures as of January 31, 2008, the end of the period
covered by this Quarterly Report. Based on that evaluation, the
Company’s Chief Executive Officer and Chief Financial Officer concluded that its
disclosure controls and procedures were effective at the reasonable assurance
level as of January 31, 2008.
There
were no significant changes in the Company’s internal controls over financial
reporting, during the quarter ended January 31, 2008, that have materially
affected, or are reasonably likely to materially affect, the Company’s internal
controls over financial reporting.
ITEM 1. LEGAL
PROCEEDINGS.
In the
ordinary course of business, we are at times subject to various legal
proceedings 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:
24
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 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 it 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. 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.
On
February 22, 2008, the MediPharm entities filed a cross-complaint alleging, as a
third party beneficiary, that that the Company breached the Agreement by
double-licensing the technology licensed to CTL to another party, intentionally
interfered with a prospective economic advantage, and unjust
enrichement. MediPharm’s cross-complaint, which seeks $30 million in
damages, is in part predicated on MediPharm being the “Chinese Sponsor” under
the Agreement. We will be objecting to the cross-complaint on several
grounds.
In
addition, Dr. Epstein has attempted to have our claims against him referred to
binding Arbitration. The Superior Court has declined his request and
he is appealing that decision to the Court of Appeal.
The
discovery phase on the aforementioned cases is ongoing. Until we
complete the 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
January 31, 2008, we had approximately $20.1 million in cash and cash
equivalents. We have expended substantial funds on (i) the research,
development and clinical trials of our product candidates, and (ii) funding the
operations of our wholly owned subsidiary, Avid Bioservices, Inc. As
a result, we have historically experienced negative cash flows from operations
since our inception and we expect the negative cash flows from operations to
continue for the foreseeable future, unless and until we are able to generate
sufficient revenues from Avid’s contract manufacturing services and/or from the
sale and/or licensing of our products under development.
25
Revenues
earned by Avid during the nine months ended January 31, 2008 and 2007 amounted
to $5,146,000 and $1,381,000, 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
October 2008 based on our current projections.
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.
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. In addition, our wholly owned
subsidiary Avid Bioservices, Inc., represents an additional asset in our
portfolio and we are actively pursuing strategic alternatives for Avid as a
means of raising additional capital. As of January 31, 2008, 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.
We
Have Had Significant Losses And We Anticipate Future Losses.
We have
incurred net losses in most fiscal years since we began operations in
1981. The following table represents net losses incurred during the
past three fiscal years and during the nine months ended January 31,
2008:
Net
Loss
|
||||
Nine months ended January 31, 2008 (unaudited) | $ | 17,017,000 | ||
Fiscal Year 2007 | $ | 20,796,000 | ||
Fiscal Year 2006 | $ | 17,061,000 | ||
Fiscal Year 2005 | $ | 15,452,000 |
As of
January 31, 2008, we had an accumulated deficit of
$224,677,000. While we expect to continue to generate revenues from
Avid’s contract manufacturing services, in order to achieve and sustain
profitable operations, we must successfully develop and obtain regulatory
approval for our products, either alone or with others, and must also
manufacture, introduce, market and sell our products. The costs
associated with clinical trials and product manufacturing is very expensive and
the time frame necessary to achieve market success for our products is long and
uncertain. We do not expect to generate product or royalty revenues
for at least the next two years, and we may never generate product revenues
sufficient to become profitable or to sustain profitability.
26
The Sale Of
Substantial Shares Of Our Common Stock May Depress Our Stock Price.
As of
January 31, 2008, 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 21,444,009 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
|
16,053,375 | |||
Common
shares issuable upon exercise of outstanding warrants
|
360,000 | |||
Total
|
21,444,009 |
In
addition, the above table does not include shares of common stock that
we have available to 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 January 31, 2008, approximately
4,194,000 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 January 31, 2008.
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 three fiscal quarters ended January 31, 2008:
27
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
|||||||||
High
|
Low
|
High
|
Low
|
|||||||
Fiscal
Year 2008
|
||||||||||
Quarter
Ended January 31, 2008
|
$0.65
|
$0.35
|
3,111
|
140
|
||||||
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;
|
●
|
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.
28
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 were automatically afforded an initial “compliance period” of
180 calendar days, or until January 22, 2008, to regain compliance with this
requirement. Although we did not achieve compliance with
the minimum closing bid price requirement after the initial 180 calendar day
period, on January 22, 2008, we received a letter from the Nasdaq Stock Market
providing us with the additional “compliance period” of 180 calendar days, or
until July 21, 2008, to regain compliance. In order to regain
compliance with the minimum closing bid price, the closing bid price of our
common stock must be $1.00 or more for at least 10 consecutive trading
days. If we are not able to demonstrate compliance with the minimum
bid price rule by July 21, 2008, the company would be notified by the Nasdaq
Stock Market that our common stock will be delisted. If that were to occur, we
would have the opportunity to appeal the determination to delist our common
stock and we intend to pursue all available options to ensure our continued
listing on the Nasdaq Stock Market. 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 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.
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.
29
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:
30
●
|
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 clinical trials in India and 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.
31
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.
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 ensure that we will be able to
find a suitable licensing partner for this technology. Furthermore,
we cannot ensure that if we do find a suitable licensing partner, the financial
terms that they propose will be acceptable to the Company.
32
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 facilities that can 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.
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.
33
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.
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.
|
34
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.
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: Neuradiab, a radiolabeled anti-tenascin monoclonal antibody
sponsored by Bradmer Pharmaceuticals, CDX-110, a peptide vaccine under
development by Celldex, cilengitide in newly diagnosed GBM patients being
evaluated by Merk KGaA, and cediranib for patients with recurrent GBM being
developed by AstraZeneca. 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.
35
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 breast cancer in combination with
chemotherapy. In January 2008, this Phase II study was open for
enrollment. We also recently received approval during January 2008
for two separate Phase II protocols filed in India to treat patients with
non-small cell lung cancer in combination with chemotherapy and patients with
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. We
also 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 Three Rivers Pharmaceuticals, LLC. 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.
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.
36
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,
●
|
no
stockholder action may be taken without a meeting, without prior notice
and without a vote; solicitations by consent are thus
prohibited;
|
●
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special
meetings of stockholders may be called only by our Board of Directors;
and
|
●
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our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares, of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into a large
number of shares of common stock could prevent a potential acquiror from
gaining effective economic or voting
control.
|
Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these
provisions may frustrate or prevent any attempts by our stockholders to replace
or remove our current management by making it more difficult for stockholders to
replace members of our Board of Directors, which is responsible for appointing
the members of our management.
ITEM
2. UNREGISTERED
SALES OF EQUITY SECURITIES AND
USE OF PROCEEDS. None.
ITEM
3. DEFAULTS
UPON SENIOR SECURITIES. None.
ITEM
4. SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS. None.
ITEM
5. OTHER
INFORMATION. None.
37
ITEM 6. EXHIBITS.
(a)
|
Exhibits:
|
|
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:
March 10, 2008
|
By:
|
/s/ STEVEN W. KING | |
Steven W. King | |||
President and Chief Executive Officer, | |||
Director |
Date:
March 10,
2008
|
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