Avid Bioservices, Inc. - Quarter Report: 2009 January (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
ý
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For
the quarterly period ended January 31,
2009
|
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For the transition period from
_______________ to
_______________
|
Commission
file number: 0-17085
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
|
95-3698422
|
|
(State or other jurisdiction
of
incorporation or
organization)
|
(I.R.S.
Employer
Identification
No.)
|
|
14282 Franklin Avenue, Tustin,
California
|
92780-7017
|
|
(Address of principal
executive offices)
|
(Zip
Code)
|
(714)
508-6000
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes ý No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one)
Large Accelerated Filer o | Accelerated Filer ý | |
Non- Accelerated Filer o | Smaller reporting company o | |
Indicate
by checkmark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act).
Yes o No ý
As of
January 31, 2009, there were 226,210,617 shares of common stock, $0.001 par
value, outstanding.
PEREGRINE
PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
|
Page
No.
|
||
Item
1.
|
Consolidated
Financial Statements (unaudited):
|
||
Condensed
Consolidated Balance Sheets
|
1
|
||
Condensed
Consolidated Statements of Operations
|
3
|
||
Condensed
Consolidated Statements of Cash Flows
|
4
|
||
Notes
to Condensed Consolidated Financial Statements
|
5
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
16
|
|
Company
Overview
|
16
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
27
|
|
Item
4.
|
Controls
and Procedures
|
27
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
27
|
|
Item
1A.
|
Risk
Factors
|
28
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
43
|
|
Item
3.
|
Defaults
upon Senior Securities
|
43
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
43
|
|
Item
5.
|
Other
Information
|
43
|
|
Item
6.
|
Exhibits
|
43
|
|
SIGNATURES
|
44
|
The terms “we,” “us,” “our,” “the Company,” and “Peregrine,” as used in this Report on Form 10-Q refers to Peregrine
Pharmaceuticals, Inc. and its wholly owned subsidiary, Avid Bioservices,
Inc.
PART I - FINANCIAL
INFORMATION
ITEM
1. CONSOLIDATED FINANCIAL
STATEMENTS
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
JANUARY
31,
2009
|
APRIL
30,
2008
|
|||||||
Unaudited
|
||||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 10,850,000 | $ | 15,130,000 | ||||
Trade
and other receivables
|
1,990,000 | 605,000 | ||||||
Government
contract receivables
|
362,000 | - | ||||||
Inventories,
net
|
5,547,000 | 2,900,000 | ||||||
Debt
issuance costs, current portion
|
248,000 | - | ||||||
Prepaid
expenses and other current assets
|
685,000 | 1,208,000 | ||||||
Total current
assets
|
19,682,000 | 19,843,000 | ||||||
PROPERTY:
|
||||||||
Leasehold
improvements
|
675,000 | 669,000 | ||||||
Laboratory
equipment
|
4,205,000 | 4,140,000 | ||||||
Furniture,
fixtures and office equipment
|
901,000 | 919,000 | ||||||
5,781,000 | 5,728,000 | |||||||
Less
accumulated depreciation and amortization
|
(3,982,000 | ) | (3,670,000 | ) | ||||
Property, net
|
1,799,000 | 2,058,000 | ||||||
OTHER
ASSETS:
|
||||||||
Debt
issuance costs, less current portion
|
189,000 | - | ||||||
Other
assets
|
1,156,000 | 1,156,000 | ||||||
Total other
assets
|
1,345,000 | 1,156,000 | ||||||
TOTAL
ASSETS
|
$ | 22,826,000 | $ | 23,057,000 |
1
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
JANUARY
31,
2009
|
APRIL
30,
2008
|
|||||||
Unaudited
|
||||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 2,886,000 | $ | 2,060,000 | ||||
Accrued
clinical trial site fees
|
744,000 | 237,000 | ||||||
Accrued
legal and accounting fees
|
247,000 | 450,000 | ||||||
Accrued
royalties and license fees
|
123,000 | 222,000 | ||||||
Accrued
payroll and related costs
|
1,010,000 | 1,084,000 | ||||||
Capital
lease obligation, current portion
|
21,000 | 22,000 | ||||||
Notes
payable, current portion and net of discount
|
948,000 | - | ||||||
Deferred
revenue
|
4,805,000 | 2,196,000 | ||||||
Deferred
government contract revenue
|
3,262,000 | - | ||||||
Customer
deposits
|
706,000 | 838,000 | ||||||
Other
current liabilities
|
459,000 | 331,000 | ||||||
Total current
liabilities
|
15,211,000 | 7,440,000 | ||||||
Capital
lease obligation, less current portion
|
6,000 | 22,000 | ||||||
Notes
payable, less current portion and net of discount
|
3,667,000 | - | ||||||
Other
long-term liabilities
|
150,000 | - | ||||||
Commitments
and contingencies
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock-$0.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
- | - | ||||||
Common
stock-$0.001 par value; authorized 325,000,000 shares;
outstanding – 226,210,617 and 226,210,617,
respectively
|
226,000 | 226,000 | ||||||
Additional
paid-in capital
|
247,317,000 | 246,205,000 | ||||||
Accumulated
deficit
|
(243,751,000 | ) | (230,836,000 | ) | ||||
Total stockholders'
equity
|
3,792,000 | 15,595,000 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 22,826,000 | $ | 23,057,000 |
See
accompanying notes to condensed consolidated financial
statements
2
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
|||||||||||||||
January
31,
2009
|
January
31,
2008
|
January
31,
2009
|
January
31,
2008
|
|||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Contract
manufacturing revenue
|
$ | 5,778,000 | $ | 1,662,000 | $ | 7,954,000 | $ | 5,146,000 | ||||||||
Government
contract revenue
|
1,048,000 | - | 2,330,000 | - | ||||||||||||
License
revenue
|
- | 13,000 | - | 46,000 | ||||||||||||
Total
revenues
|
6,826,000 | 1,675,000 | 10,284,000 | 5,192,000 | ||||||||||||
COSTS
AND EXPENSES:
|
||||||||||||||||
Cost
of contract manufacturing
|
4,106,000 | 1,289,000 | 5,672,000 | 3,872,000 | ||||||||||||
Research
and development
|
4,465,000 | 4,941,000 | 12,834,000 | 13,665,000 | ||||||||||||
Selling,
general and administrative
|
1,489,000 | 1,847,000 | 4,722,000 | 5,498,000 | ||||||||||||
Total
costs and expenses
|
10,060,000 | 8,077,000 | 23,228,000 | 23,035,000 | ||||||||||||
LOSS
FROM OPERATIONS
|
(3,234,000 | ) | (6,402,000 | ) | (12,944,000 | ) | (17,843,000 | ) | ||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
Interest
and other income
|
37,000 | 259,000 | 165,000 | 851,000 | ||||||||||||
Interest
and other expense
|
(135,000 | ) | (11,000 | ) | (136,000 | ) | (25,000 | ) | ||||||||
NET
LOSS
|
$ | (3,332,000 | ) | $ | (6,154,000 | ) | $ | (12,915,000 | ) | $ | (17,017,000 | ) | ||||
WEIGHTED
AVERAGE COMMON
SHARES OUTSTANDING:
|
||||||||||||||||
Basic
and Diluted
|
226,210,617 | 226,210,617 | 226,210,617 | 219,497,601 | ||||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.01 | ) | $ | (0.03 | ) | $ | (0.06 | ) | $ | (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,
|
||||||||
2009
|
2008
|
|||||||
Unaudited
|
Unaudited
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (12,915,000 | ) | $ | (17,017,000 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
385,000 | 353,000 | ||||||
Share-based
compensation
|
698,000 | 627,000 | ||||||
Amortization
of expenses paid in shares of common stock
|
255,000 | - | ||||||
Amortization
of discount on notes payable and debt issuance costs
|
61,000 | - | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Trade
and other receivables
|
(1,385,000 | ) | (566,000 | ) | ||||
Government
contract receivables
|
(362,000 | ) | - | |||||
Inventories,
net
|
(2,647,000 | ) | (478,000 | ) | ||||
Prepaid
expenses and other current assets
|
268,000 | (135,000 | ) | |||||
Accounts
payable
|
826,000 | 704,000 | ||||||
Accrued
clinical trial site fees
|
507,000 | 16,000 | ||||||
Accrued
payroll and related costs
|
(74,000 | ) | (16,000 | ) | ||||
Deferred
revenue
|
2,609,000 | 370,000 | ||||||
Deferred
government contract revenue
|
3,262,000 | - | ||||||
Customer
deposits
|
(132,000 | ) | 336,000 | |||||
Other
accrued expenses and current liabilities
|
(24,000 | ) | (197,000 | ) | ||||
Net cash used in operating
activities
|
(8,668,000 | ) | (16,003,000 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Refund
of security deposits on notes payable
|
- | 150,000 | ||||||
Property
acquisitions
|
(126,000 | ) | (314,000 | ) | ||||
Increase
in other assets
|
- | (410,000 | ) | |||||
Net cash used in investing
activities
|
(126,000 | ) | (574,000 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from issuance of common stock, net of issuance costs
of $1,641,000
|
- | 20,932,000 | ||||||
Proceeds
from issuance of notes payable, net of issuance costs
of $469,000
|
4,531,000 | - | ||||||
Principal
payments on notes payable
|
- | (323,000 | ) | |||||
Principal
payments on capital leases
|
(17,000 | ) | (13,000 | ) | ||||
Net cash provided by financing
activities
|
4,514,000 | 20,596,000 | ||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(4,280,000 | ) | 4,019,000 | |||||
CASH AND CASH EQUIVALENTS,
beginning of period
|
15,130,000 | 16,044,000 | ||||||
CASH AND CASH
EQUIVALENTS, end of period
|
$ | 10,850,000 | $ | 20,063,000 | ||||
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||
Applied
security deposit on payoff of notes payable to GE
Capital
|
$ | - | $ | 175,000 | ||||
Fair market value of warrants issued in connection with notes payable | $ | 414,000 | $ | - |
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, 2009 (unaudited)
1. BASIS
OF PRESENTATION
The accompanying interim condensed
consolidated financial statements include the accounts of Peregrine
Pharmaceuticals, Inc. (“Peregrine”), a clinical stage biopharmaceutical company
developing monoclonal antibodies (“MAb”) for the treatment of cancer and
serious viral infections, 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, 2009, and the
condensed consolidated results of our operations and our condensed consolidated
cash flows for the three and nine month periods ended January 31, 2009 and
2008. 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,
2008. 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.
Going Concern – Our interim
condensed consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the satisfaction
of liabilities in the normal course of business. The financial
statements do not include any adjustments relating to the recoverability of the
recorded assets or the classification of liabilities that may be necessary
should it be determined that we are unable to continue as a going
concern.
At
January 31, 2009, we had $10,850,000 in cash and cash equivalents. We
have expended substantial funds on the research, development and clinical trials
of our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2008, 2007 and 2006 amounted
to $23,176,000, $20,796,000, and $17,061,000, respectively. 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, we expect such losses to continue for the foreseeable
future.
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 will
need to raise additional capital through one or more methods, including but not
limited to, issuing additional equity or debt, in order to support the costs of
our research and development programs.
5
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Regarding
possible issuance of equity to raise additional capital, as of January 31, 2009,
we had 4,851,454 shares available under an existing effective Form S-3
registration statement for possible future registered transactions provided,
however, we issue these shares prior to April 12, 2009 (the expiration date of
this registration statement). 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.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While 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 Avid to complete the research,
development, and clinical testing of our product candidates. Based on
our current projections, which include projected revenues under signed contracts
with existing customers of Avid, combined with the projected revenues from our
government contract, we believe we have sufficient cash on hand combined with
amounts expected to be received from Avid customers and from our government
contract to meet our obligations as they become due through at least the second
quarter of our fiscal year 2010 ending October 31, 2009. There are a
number of uncertainties associated with our financial projections, including but
not limited to, termination of contracts and technical challenges, which could
reduce or delay our future projected cash-inflows. In addition, under
the Loan Agreement, in the event our contract with the Defense Threat Reduction
Agency is terminated or canceled for any reason, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessable by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
second quarter of our fiscal year 2010 unless we raise additional
capital. The uncertainties surrounding our future cash inflows have
raised substantial doubt regarding our ability to continue as a going
concern.
2. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Revenue Recognition – We
currently derive revenues primarily from contract manufacturing services
provided by Avid and from services performed under a government contract awarded
to Peregrine through the Transformational Medical Technologies Initiative (TMTI)
of the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) that
was signed on June 30, 2008.
6
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
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 Emerging
Issues Task Force (“EITF”) Issue No. 00-21, Revenue Arrangements with Multiple
Deliverables, EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent, and Accounting Research Bulletin No. 43
Chapter 11, Government
Contracts.
Revenues associated with contract
manufacturing services provided by Avid 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 during which they are determined.
Our
contract with the DTRA is a “cost-plus-fixed-fee”
contract. Reimbursable costs under the contract primarily
include direct labor, subcontract costs, materials, equipment, travel, indirect
costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is recognized as we perform the underlying
research and development activities. However, progress payments
associated with contract manufacturing services performed under the DTRA
contract are classified as Deferred Government Contract Revenue and are
recognized as revenue upon delivery or transfer of legal title of the product to
the DTRA.
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, 2009, 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.
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,
2009 and April 30, 2008:
January
31,
2009
|
April
30,
2008
|
|||||||
Raw
materials
|
$ | 2,176,000 | $ | 1,115,000 | ||||
Work-in-process
|
3,371,000 | 1,785,000 | ||||||
Total
inventories, net
|
$ | 5,547,000 | $ | 2,900,000 |
Comprehensive Loss –
Comprehensive loss is equal to net loss for all periods presented.
Reclassification – Certain
amounts in the fiscal year 2008 condensed consolidated financial statements have
been reclassified to conform to the current year presentation.
Customer Deposits – Customer
deposits primarily represent advance billings and/or advance payments received
from customers prior to the initiation of contract manufacturing
services.
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, 2009 and 2008.
7
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
The calculation of weighted average
diluted shares outstanding excludes the dilutive effect of options and warrants
to purchase up to 209,136 and 132,286 shares of common stock for the three and
nine months ended January 31, 2009, respectively, and 357,542 and 722,641
shares of common stock for the three and nine months ended January 31, 2008,
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 12,790,740 and 13,101,259 shares of common stock
for the three and nine months ended January 31, 2009, respectively, and
11,193,227 and 10,530,120 shares of common stock for the three and nine months
ended January 31, 2008, respectively, as the exercise prices of those options
were greater than the average market price of our common stock during the
respective periods, resulting in an anti-dilutive effect.
Recent Accounting
Pronouncements - In September 2006, the Financial Accounting Standards
Board (“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 establishes a three-level hierarchy that
prioritizes the inputs used to measure fair value. The hierarchy
defines the three levels of inputs to measure fair value, as
follows:
·
|
Level
1 – Quoted prices in active markets for identical assets or
liabilities.
|
·
|
Level
2 – Observable inputs other than quoted prices included in Level 1, such
as assets or liabilities whose value are based on quoted market prices in
markets where trading occurs infrequently or whose values are based on
quoted prices of instruments with similar attributes in active
markets.
|
·
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and significant to the overall fair value
measurement.
|
We adopted SFAS No. 157 on
May 1, 2008, which did not have a material impact on our consolidated financial
statements as we currently do not have any Level 2 or Level 3 financial assets
or liabilities and cash and cash equivalents are carried at fair value based on
quoted market prices for identical securities (Level 1 input).
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. We adopted SFAS No. 159 on May 1, 2008, which did not
have a material impact on our consolidated financial statements as the fair
value option was not elected for any of our financial assets or financial
liabilities.
8
PEREGRINE PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
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. We adopted the provisions of
EITF No. 07-3 on May 1, 2008, which did not have a material impact on
our consolidated financial statements.
In November 2007, the FASB ratified
EITF Issue 07-01 (“EITF No. 07-01”), Accounting for Collaborative
Arrangements, which defines collaborative arrangements and requires that
revenues and costs incurred with third parties that do not participate in the
collaborative arrangements be reported in the statement of operations gross or
net pursuant to the guidance in EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent. Classification of payments
made between participants of a collaborative arrangement are to be based on
other applicable authoritative accounting literature or, in the absence of other
applicable authoritative accounting literature, based on analogy to
authoritative accounting literature or a reasonable, rational, and consistently
applied accounting policy election. EITF No. 07-01 will be
effective for fiscal years beginning after December 15, 2008, which we
would be required to implement no later than May 1, 2009, and applied as a
change in accounting principal to all prior periods retrospectively for all
collaborative arrangements existing as of the effective date. We have
not yet evaluated the potential impact of adopting EITF No. 07-01 on our
consolidated financial statements.
We account for stock options granted
under our equity compensation plans in accordance with Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment (Revised
2004). SFAS No. 123R requires the recognition of compensation
expense, using a fair value based method, for costs related to all share-based
payments including grants of employee stock options. In addition,
SFAS No. 123R requires companies to estimate the fair value of share-based
payment awards on the date of grant using an option-pricing
model. The value of the portion of the award that is ultimately
expected to vest is recognized as expense on a straight-line basis over the
requisite service periods (typically 2 to 4 years).
The fair value of each option grant is
estimated using the Black-Scholes option valuation model. The use of
a valuation model requires us to make certain estimates and assumptions with
respect to selected model inputs including estimated stock price volatility,
risk-free interest rate, expected dividends and projected employee stock option
exercise behaviors. 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.
9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Total share-based compensation expense
related to employee stock option grants for the three and nine-month periods
ended January 31, 2009 and 2008 are included in the accompanying condensed
consolidated statements of operations as follows:
Three
Months Ended
January
31,
|
Nine
Months Ended
January
31,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Research
and development
|
$ | 106,000 | $ | 147,000 | $ | 370,000 | $ | 416,000 | ||||||||
Selling,
general and administrative
|
97,000 | 84,000 | 320,000 | 196,000 | ||||||||||||
Total
|
$ | 203,000 | $ | 231,000 | $ | 690,000 | $ | 612,000 |
As of
January 31, 2009, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,314,000. This cost is expected to be
recognized over a weighted average vesting period of 2.17 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. Share-based compensation expense
recorded during the three and nine months ended January 31, 2009 associated with
non-employees amounted to
$2,000 and $8,000,
respectively. Share-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.
4. GOVERNMENT
CONTRACT
On June 30, 2008, we were awarded a
five-year contract potentially worth up to $44.4 million to test and develop
bavituximab and an equivalent fully human antibody as potential broad-spectrum
treatments for viral hemorrhagic fever infections. The initial
contract was awarded through the Transformational Medical Technologies
Initiative (TMTI) of the U.S. Department of Defense's Defense Threat Reduction
Agency (DTRA). This federal contract is expected to provide us with
up to $22.3 million in funding over a 24-month base period, with $14.3
million having been appropriated through the current federal fiscal year
ending September 30, 2009. The remainder of the $22.3 million in
funding is expected to be appropriated over the remainder of the two-year base
period ending June 29, 2010. Subject to the progress of the program
and budgetary considerations in future years, the contract can be extended
beyond the base period to cover up to $44.4 million in funding over the
five-year contract period through three one-year option terms. Work
under this contract commenced on June 30, 2008 and direct costs associated with
the contract are included in research and development expense in the
accompanying condensed consolidated statements of operations.
5. NOTE
PAYABLE
On December 9, 2008, we
entered into a loan and security agreement pursuant to which we have the ability
to borrow up to $10,000,000 (“Loan Agreement”) with MidCap Financial LLC and
BlueCrest Capital Finance, L.P. On December 19, 2008, we received
initial funding of $5,000,000. In addition, we have an option, which
expires on June 30, 2009, to borrow a second tranche in the amount of $5,000,000
upon the satisfaction of certain clinical and financial conditions as
set forth in the Loan Agreement. As
of January 31, 2009, we had met all clinical conditions under the Loan
Agreement, however, we had not met the required financial
conditions. In order for us to meet the financial conditions and
receive the second tranche of $5,000,000 under the Loan Agreement (provided we
are not otherwise in default of any of our obligations under the Loan
Agreement), we must raise at least $7,500,000 in gross proceeds from the
issuance of new equity or obtain a defined amount in net proceeds from the
potential sale of our wholly owned subsidiary, Avid Bioservices, no later than
the expiration of the option.
10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Under the
Loan Agreement, the outstanding principal balance each month will bear interest
at the then current thirty (30) day LIBOR rate (set at a floor of 3%) plus
9%. The Loan Agreement allows for interest-only payments during the
initial six (6) months or until July 2009 followed by thirty (30) equal monthly
principal payments plus interest. The Loan Agreement, which is
secured by generally all assets of the Company, contains customary covenants
that, among other things, generally restricts our ability to incur additional
indebtedness. In addition, the Loan Agreement contains a covenant,
whereby if our contract with the Defense Threat Reduction Agency (Note 4) is
terminated while the loan is outstanding, we would be required to set aside cash
and cash equivalents in an amount equal to at least 80% of the outstanding loan
balance in a secured account over which we will not be permitted to make
withdrawals or otherwise exercise control. Moreover,
the Loan Agreement includes a Material Adverse Change clause whereby if there is
a material impairment in the priority of lenders’ lien in the collateral or in
the value of such collateral, or if we encounter a material adverse change in
our business, operations, or condition (financial or otherwise), or a material
impairment of the prospect of repayment of any portion of the loan, then an
event of default can be invoked by the lender.
The terms
of the Loan Agreement also include a provision for warrant coverage equal to 10%
of each tranche amount divided by the warrant exercise price. The warrant
exercise price was calculated based on the average closing price of our common
stock for the 20-day period prior to the date of the Loan
Agreement. The warrants are exercisable immediately, include
piggy-back registration rights, and have a five-year term. In
connection with the first tranche advance of $5,000,000, we issued MidCap
Financial LLC and BlueCrest Capital Finance, L.P. warrants of 1,184,433 and
507,614, respectively, to purchase an aggregate of 1,692,047 shares of our
common stock at an exercise price of $0.2955 per share. At the date
of the first tranche advance, the fair value of the warrants was $414,000, and
this amount was credited to additional paid-in capital and reduced the carrying
value of the debt, reflected as a debt discount in the accompanying condensed
consolidated financial statements. The debt discount is being
amortized as a non-cash interest expense over the term of the outstanding loan
using the effective interest method. The fair value of the warrants
was determined using the Black-Scholes model with the following
assumptions: estimated volatility of 70.72%; risk free interest rate
of 2.00%; an expected life of five years; and no dividend yield.
In
connection with the Loan Agreement, we also incurred $469,000 in financing fees
and legal costs related to closing the Loan Agreement. These fees and
costs are classified as debt issuance costs, and the short-term and long-term
portions of these costs are included in current assets and other long-term
assets, respectively, in the accompanying condensed consolidated financial
statements and are being amortized as a non-cash interest expense over the term
of the outstanding loan using the effective interest method. Included
in debt issuance costs is a final payment fee of $150,000, which is due and
payable on the maturity date of the outstanding loan balance, and is equal to 3%
of the total amount funded under the Loan Agreement. The final
payment fee payable of $150,000 is classified as other long-term liabilities in
the accompanying condensed consolidated financial statements.
As of
January 31, 2009, we will make the following principal payments in the years
ending April 30:
2009
|
$ | - | ||
2010
|
1,667,000 | |||
2011
|
2,000,000 | |||
2012
|
1,333,000 | |||
Total
|
$ | 5,000,000 |
11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
6. STOCKHOLDERS’
EQUITY
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, 2009, we could potentially raise up to $7,500,000 in remaining gross
proceeds under the January 2007 Shelf.
In
addition, as of January 31, 2009, an aggregate of 4,851,454 shares of common
stock were available for issuance under an existing effective shelf registration
statement, provided, however, we issue these shares prior to April 12, 2009 (the
expiration date of this registration statement).
As of January 31, 2009, we have
reserved 22,002,346 additional shares of our common stock which may be issued
under our shelf registration statement, 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 one registration
statement
|
4,851,454 | |||
Shares
of common stock reserved for issuance upon exercise of outstanding
options
|
14,199,500 | |||
Shares
of common stock reserved for future option grants under our Option
Plans
|
1,259,345 | |||
Shares
of common stock reserved for issuance under outstanding warrant
arrangements
|
1,692,047 | |||
Total shares of common stock
reserved for issuance
|
22,002,346 |
7. WARRANTS
During
December 2008, we issued 1,692,047 warrants in connection with the loan and
security agreement we entered into on December 9, 2008 (Note 5). The
warrants, which are exercisable immediately, have an exercise price of $0.2955,
include piggy-back registration rights, and have a five-year term.
During
the nine months ended January 31, 2009, no warrants were exercised. 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, 2009, warrants to purchase up to 1,692,047 shares of our common
stock were issued and outstanding at an exercise price of $0.2955 per share and
expire in December 2013.
8. SEGMENT
REPORTING
Our
business is organized into two reportable operating
segments. Peregrine is engaged in the research and development of
monoclonal antibody-based therapies for the treatment of cancer and serious
viral infections. Avid is engaged in providing contract manufacturing
services for Peregrine and outside customers on a fee-for-service
basis.
12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
The
accounting policies of the operating segments are the same as those described in
Note 2. We primarily evaluate the performance of our contract
manufacturing services segment based on gross profit or
loss. However, our products in the research and development segment
are not evaluated based on gross profit or loss, but rather based on scientific
progress of the technologies. As such, gross profit is only provided
for our contract manufacturing services segment in the below
table. All revenues shown below are derived from transactions with
external customers.
Segment
information for the three-month periods is summarized as follows:
Three
Months Ended January 31,
|
||||||||
2009
|
2008
|
|||||||
Contract
manufacturing services revenue
|
$ | 5,778,000 | $ | 1,662,000 | ||||
Cost
of contract manufacturing services
|
4,106,000 | 1,289,000 | ||||||
Gross
profit
|
1,672,000 | 373,000 | ||||||
Revenues
from products in research and development
|
1,048,000 | 13,000 | ||||||
Research
and development expense
|
(4,465,000 | ) | (4,941,000 | ) | ||||
Selling,
general and administrative expense
|
(1,489,000 | ) | (1,847,000 | ) | ||||
Other
income (expense), net
|
(98,000 | ) | 248,000 | |||||
Net
loss
|
$ | (3,332,000 | ) | $ | (6,154,000 | ) | ||
Revenues
generated from our contract manufacturing services segment were from the
following customers:
Three
Months Ended January 31,
|
||||||||||
2009
|
2008
|
|||||||||
Customer
revenues as a % of revenues:
|
||||||||||
United
States (customer A)
|
43% | 90% | ||||||||
United
States (customer B)
|
26% | 0% | ||||||||
Germany
(one customer)
|
28% | 10% | ||||||||
Other
customers
|
3% | 0% | ||||||||
Total
customer revenues as a % of revenues
|
100% | 100% |
Segment
information for the nine-month periods is summarized as follows:
Nine
Months Ended January 31,
|
||||||||
2009
|
2008
|
|||||||
Contract
manufacturing services revenue
|
$ | 7,954,000 | $ | 5,146,000 | ||||
Cost
of contract manufacturing services
|
5,672,000 | 3,872,000 | ||||||
Gross
profit
|
2,282,000 | 1,274,000 | ||||||
Revenues
from products in research and development
|
2,330,000 | 46,000 | ||||||
Research
and development expense
|
(12,834,000 | ) | (13,665,000 | ) | ||||
Selling,
general and administrative expense
|
(4,722,000 | ) | (5,498,000 | ) | ||||
Other
income (expense), net
|
29,000 | 826,000 | ||||||
Net
loss
|
$ | (12,915,000 | ) | $ | (17,017,00 | ) | ||
13
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
Revenues
generated from our contract manufacturing services segment were from the
following customers:
Nine
Months Ended January 31,
|
||||||||||
2009
|
2008
|
|||||||||
Customer
revenues as a % of revenues:
|
||||||||||
United
States (customer A)
|
56% | 86% | ||||||||
United
States (customer B)
|
20% | 3% | ||||||||
Germany
(one customer)
|
22% | 6% | ||||||||
Other
customers
|
2% | 5% | ||||||||
Total
customer revenues as a % of revenues
|
100% | 100% |
Revenues
generated from our products in our research and development segment during the
three and nine months ended January 31, 2009 were from revenues earned under the
government contract with the DTRA (Note 4). Revenues generated from
our products in our research and development segment during the three and nine
months ended January 31, 2008 were from an annual license fee and the amortized
portion of an up-front license fee received under a license
agreement.
Our
long-lived assets consist of leasehold improvements, laboratory equipment, and
furniture, fixtures and computer equipment and are net of accumulated
depreciation. Long-lived assets by segment consist of the
following:
January
31,
2009
|
April
30,
2008
|
|||||||
Long-lived
Assets, net:
|
||||||||
Contract
manufacturing services
|
$ | 1,633,000 | $ | 1,825,000 | ||||
Products
in research and development
|
166,000 | 233,000 | ||||||
Total
long-lived assets, net
|
$ | 1,799,000 | $ | 2,058,000 |
9.
|
LITIGATION
|
In the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. We currently are not aware of any such
legal proceedings or claims that we believe will have, individually or in the
aggregate, a material adverse effect on our business, operating results or cash
flows. However, we did file or are involved with the following
lawsuits:
On
January 12, 2007, we filed a complaint in the Superior Court of the State of
California for the County of Orange against Cancer Therapeutics Laboratories
(“CTL”). The original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai Medipharm Biotech Co.,
Ltd. (“Shanghai Medipharm”) and its related entities. The lawsuit
alleges claims for breach of contract, interference with contractual relations,
declaratory relief, and injunctive relief against the
defendants. Peregrine's claims stem from a 1995 license agreement
with CTL, and two amendments thereto (collectively referred to as the "License
Agreement"). Peregrine claims that CTL breached the License Agreement
by, among other things, (i) not sharing with Peregrine all inventions,
technology, know-how, patents and other information, derived and/or developed in
the People’s Republic of China and/or at the CTL laboratory, as was required
under the License Agreement; (ii) not splitting revenue appropriately with
Peregrine as required under the License Agreement; (iii) utilizing Peregrine's
licensed technologies outside of the People’s Republic of China; and (iv)
failing to enter a sublicense agreement with a Chinese sponsor obligating the
Chinese sponsor to comply with the terms and obligations in the License
Agreement. Peregrine further alleges that Medibiotech Co., Inc. and
Shanghai Medipharm ("Medipharm Entities") interfered with the License Agreement,
leading to CTL's breaches. This interference by the Medipharm
Entities includes: 1) posturing Shanghai Medipharm as the designated sublicensee
under the License Agreement, without binding any of the Medipharm
Entities to the terms and obligations of an appropriate sublicense
agreement called for under the License Agreement; 2) entering into a license
agreement with Alan Epstein, M.D. ("Epstein License Agreement") instead of CTL;
3) restricting the information CTL was allowed to provide to Peregrine, thereby
prohibiting CTL from providing to Peregrine all information required under the
License Agreement; and 4) providing compensation to CTL, and its principals, so
that CTL would enter agreements that prohibited CTL from performing under the
License Agreement.
14
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED JANUARY 31, 2009 (unaudited)
(continued)
On March
28, 2007, CTL filed a cross-complaint, which has been amended three times,
alleging that the Company breached the Agreement by improperly terminating the
Agreement and double-licensing the technology licensed to CTL to another party,
interfered with CTL’s agreements with various Medipharm Entities and unjust
enrichment. CTL’s cross-complaint, which seeks $20 million in
damages, is in part predicated on the existence of a sublicense agreement
between CTL and Shanghai 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 Shanghai Medipharm despite our repeated demands, and
they have not suffered any compensable damages.
On
February 22, 2008, Medibiotech Co., Inc. (“Medibiotech”) filed a cross-complaint
alleging, as a third party beneficiary, 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
enrichment. Medibiotech’s subsidiary, Shanghai Medipharm filed an
almost identical cross-complaint on February 17, 2009. These
cross-complaints, each seek $30 million in damages, in part predicated on
Medibiotech and Shanghai Medipharm being the “Chinese Sponsor” under the
Agreement. We intend to bring pre-trial motions in an attempt to
dispose of these cross-complaints.
The
discovery phase on the aforementioned cases is still 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.
15
ITEM
2.
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
|
This Quarterly Report on Form 10-Q
contains “forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, which represent our projections, estimates,
expectations or beliefs concerning among other things, financial items that
relate to management’s future plans or objectives or to our future economic and
financial performance. In some cases, you can identify these
statements by terminology such as “may”, “should”, “plans”, “believe”, “will”,
“anticipate”, “estimate”, “expect” “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 clinical stage
biopharmaceutical company developing monoclonal antibodies for the
treatment of cancer and hepatitis C virus (“HCV”) infection. We are
advancing three separate clinical programs with our first-in-class compounds
bavituximab and Cotara® that employ our two platform
technologies: Anti-Phosphatidylserine (“Anti-PS”) therapeutics 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 patients
with brain cancer.
We are
organized into two reportable operating segments: (i) Peregrine, the parent
company, is engaged in the research and development of monoclonal antibody
products for the treatment of cancer and serious viral infections and (ii) Avid
Bioservices, Inc., (“Avid”) a wholly owned subsidiary, is engaged in providing
contract manufacturing services for Peregrine and outside customers on a
fee-for-service basis.
Going
Concern
The Company’s consolidated financial
statements have been prepared on a going concern basis, which contemplates the
realization of assets and the satisfaction of liabilities in the normal course
of business. The financial statements do not include any adjustments
relating to the recoverability of the recorded assets or the classification of
liabilities that may be necessary should it be determined that we are unable to
continue as a going concern.
At
January 31, 2009, we had $10,850,000 in cash and cash equivalents. We
have expended substantial funds on the research, development and clinical trials
of our product candidates, and 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 to continue to experience negative cash flows from operations for the
foreseeable future. Our net losses incurred during the past three
fiscal years ended April 30, 2008, 2007 and 2006 amounted to $23,176,000,
$20,796,000, and $17,061,000, respectively. 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, we
expect such losses to continue for the foreseeable future.
16
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. As discussed in Note 1 to the condensed consolidated
financial statements, there exists substantial doubt regarding our ability to
continue as a going concern.
We will
need to raise additional capital through one or more methods, including but not
limited to, issuing additional equity or debt, in order to support the costs of
our research and development programs.
Regarding
possible issuance of equity to raise additional capital, as of January 31, 2009,
we had 4,851,454 shares available under an existing effective Form S-3
registration statement for possible future registered transactions provided,
however, we issue these shares prior to April 12, 2009 (the expiration date of
this registration statement). 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.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While 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 Avid to complete the research,
development, and clinical testing of our product candidates. Based on our current
projections, which include projected revenues under signed contracts with
existing customers of Avid Bioservices,
Inc.,
combined with the projected revenues from our government contract, we believe we
have sufficient cash on hand combined with amounts expected to be received from
Avid customers and from our government contract to meet our obligations as they
become due through at least the second fiscal quarter of our
fiscal year 2010 ending October 31,
2009. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of contracts
and technical challenges, which could reduce or delay our future projected
cash-inflows. In addition, under the Loan Agreement, in the
event our contract with the Defense Threat Reduction Agency is terminated or
canceled for any reason, we would be required to set aside cash and cash
equivalents in an amount equal to 80% of the outstanding loan balance in a
restricted collateral account non-accessable by us. In the event our
projected cash-inflows are reduced or delayed or if we default on a loan
covenant that limits our access to our available cash on hand, we might not have
sufficient capital to operate our business through the second quarter of our
fiscal year 2010 unless we raise additional capital. The
uncertainties surrounding our future cash inflows have raised substantial doubt
regarding our ability to continue as a going concern.
17
Clinical
Trial Programs
The following represents a summary of
our ongoing clinical trial programs:
Product
|
Indication
|
Trial
Design
|
Trial
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
I monotherapy repeat dose safety study designed to treat up to 28
patients.
|
Patient
enrollment is continuing in this study.
|
Bavituximab
plus docetaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
has been expanded to treat up to a total of 46 patients because six or
more objective tumor responses were observed in the initial 15
patients.
|
Patient
enrollment for the first 15 patients in Stage A is
complete. The pre-specified number of objective tumor responses
was obtained in Stage A. Stage B enrollment is continuing for
this study.
|
Bavituximab
plus carboplatin and paclitaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
may be expanded to treat up to a total of 46 patients because promising
results were observed in the initial 15 patients.
|
Patient
enrollment for the first 15 patients in Stage A is
complete. The pre-specified number of objective tumor responses
was obtained in Stage A. Clinical data is continuing to be
collected on the initial 15 patients.
|
Bavituximab
plus carboplatin and paclitaxel
|
Non-small
cell lung cancer (NSCLC)
|
Phase
II study designed to treat 21 patients initially. Study may be expanded to
treat up to a total of 49 patients because promising results were observed
in the initial 21 patients.
|
Patient
enrollment for the first 21 patients in Stage A is
complete. The pre-specified number of objective tumor responses
was obtained in Stage A. Clinical data is continuing to be
collected on the initial 21 patients.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
Patient
enrollment is continuing in this study.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Phase
II safety and efficacy study to treat up to 40 patients at first
relapse.
|
Patient
enrollment is continuing in this study.
|
Bavituximab
|
Chronic
hepatitis C virus (“HCV”) infection co-infected with HIV
|
Phase
Ib repeat dose safety study designed to treat up to 24
patients.
|
Patient
enrollment is continuing in this
study.
|
18
Results
of Operations
The following table compares the
unaudited condensed consolidated statements of operations for the three and
nine-month periods ended January 31, 2009 and 2008. This table
provides you with an overview of the changes in the condensed consolidated
statements of operations for the comparative periods, which are further
discussed below.
Three
Months Ended
January
31,
|
Nine
Months Ended
January
31,
|
|||||||||||||||||||||||
2009
|
2008
|
$
Change
|
2009
|
2008
|
$
Change
|
|||||||||||||||||||
REVENUES:
|
||||||||||||||||||||||||
Contract
manufacturing revenue
|
$ | 5,778,000 | $ | 1,662,000 | $ | 4,116,000 | $ | 7,954,000 | $ | 5,146,000 | $ | 2,808,000 | ||||||||||||
Government
contract revenue
|
1,048,000 | - | 1,048,000 | 2,330,000 | - | 2,330,000 | ||||||||||||||||||
License
revenue
|
- | 13,000 | (13,000 | ) | - | 46,000 | (46,000 | ) | ||||||||||||||||
Total
revenues
|
6,826,000 | 1,675,000 | 5,151,000 | 10,284,000 | 5,192,000 | 5,092,000 | ||||||||||||||||||
COST
AND EXPENSES:
|
||||||||||||||||||||||||
Cost
of contract manufacturing
|
4,106,000 | 1,289,000 | 2,817,000 | 5,672,000 | 3,872,000 | 1,800,000 | ||||||||||||||||||
Research
and development
|
4,465,000 | 4,941,000 | (476,000 | ) | 12,834,000 | 13,665,000 | (831,000 | ) | ||||||||||||||||
Selling,
general and administrative
|
1,489,000 | 1,847,000 | (358,000 | ) | 4,722,000 | 5,498,000 | (776,000 | ) | ||||||||||||||||
Total
cost and expenses
|
10,060,0000 | 8,077,000 | 1,983,000 | 23,228,000 | 23,035,000 | 193,000 | ||||||||||||||||||
LOSS
FROM OPERATIONS
|
(3,234,000 | ) | (6,402,000 | ) | 3,168,000 | (12,944,000 | ) | (17,843,000 | ) | 4,899,000 | ||||||||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||||||||||
Interest
and other income
|
37,000 | 259,000 | (222,000 | ) | 165,000 | 851,000 | (686,000 | ) | ||||||||||||||||
Interest
and other expense
|
(135,000 | ) | (11,000 | ) | (124,000 | ) | (136,000 | ) | (25,000 | ) | (111,000 | ) | ||||||||||||
NET
LOSS
|
$ | (3,332,000 | ) | $ | (6,154,000 | ) | $ | 2,822,000 | $ | (12,915,000 | ) | $ | (17,017,000 | ) | $ | 4,102,000 |
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.
Contract Manufacturing
Revenue.
Three and
nine months: The increases in contract manufacturing revenue of
$4,116,000 and $2,808,000 during the three and nine months ended January 31,
2009, respectively, compared to the same periods in the prior year were
primarily due to increases in services provided to unrelated entities on a
fee-for-service basis including an increase in the number of completed
manufacturing runs utilizing our larger capacity bioreactors 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 under
signed and outstanding proposals.
Government
Contract Revenue.
Three and
nine months: The increases in government contract manufacturing revenue of
$1,048,000 and $2,330,000 during the three and nine months ended January 31,
2009, respectively, compared to the same periods in the prior year is related to
research and development services performed under our government contract with
the Defense Threat Reduction Agency (DTRA), a division of the Department of
Defense, which commenced during the current fiscal year.
19
We expect
to continue to generate government contract revenue associated with our contract
with the DTRA, which was awarded to us on June 30, 2008 and is a five-year
contract potentially worth up to $44.4 million to test and develop bavituximab
and an equivalent fully human antibody as potential broad-spectrum treatments
for viral hemorrhagic fever infections. The initial contract was
awarded through the Transformational Medical Technologies Initiative (TMTI) of
the U.S. Department of Defense's Defense Threat Reduction Agency
(DTRA). This contract is expected to provide us with up to
$22.3 million in funding over a 24-month base period, with $14.3 million
having been appropriated through the current federal fiscal year ending
September 30, 2009. The remainder of the $22.3 million in funding is
expected to be appropriated over the remainder of the two-year base period
ending June 29, 2010. Subject to the progress of the program and
budgetary considerations in future years, the contract can be extended beyond
the base period to cover up to $44.4 million in funding over the five-year
contract period through three one-year option terms.
Cost of Contract
Manufacturing.
Three and
Nine Months: The increases in cost of contract manufacturing of
$2,817,000 and $1,800,000 during the three and nine months ended January 31,
2009, respectively, compared to the same periods in the prior year are primarily
related to the current year three and nine-month increases in contract
manufacturing revenue. We expect to continue to incur contract
manufacturing costs during the remainder of the current fiscal year based on the
anticipated completion of customer projects under our current contract
manufacturing agreements.
Research and
Development Expenses.
Three and
Nine Months: The decreases in research and development (“R&D”)
expenses of $476,000 and $831,000 during the three and nine months ended January
31, 2009 compared to the same periods in the prior year were primarily due to
the following changes associated with each of our following platform
technologies under development:
Technology
Platform
|
R&D
Expenses –
Three
Months
Ended
January 31,
|
R&D
Expenses –
Nine
Months
Ended
January 31,
|
||||||||||||||||||||||
2009
|
2008
|
$
Change
|
2009
|
2008
|
$
Change
|
|||||||||||||||||||
Anti-PS
Immunotherapeutics
(bavituximab)
|
$ | 3,378,000 | $ | 2,943,000 | $ | 435,000 | $ | 9,479,000 | $ | 8,158,000 | $ | 1,321,000 | ||||||||||||
TNT
(Cotara®)
|
1,050,000 | 1,065,000 | (15,000 | ) | 3,164,000 | 2,742,000 | 422,000 | |||||||||||||||||
VTA
and Anti-Angiogenesis Agents
|
33,000 | 767,000 | (734,000 | ) | 171,000 | 2,266,000 | (2,095,000 | ) | ||||||||||||||||
VEA
|
4,000 | 166,000 | (162,000 | ) | 20,000 | 499,000 | (479,000 | ) | ||||||||||||||||
Total
R&D Expenses
|
$ | 4,465,000 | $ | 4,941,000 | $ | (476,000 | ) | $ | 12,834,000 | $ | 13,665,000 | $ | (831,000 | ) |
o
|
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) – The increase in
Anti-PS Immunotherapeutics program expenses of $435,000 and $1,321,000
during the three and nine months ended January 31, 2009, respectively,
compared to the same periods in the prior year is primarily due to an
increase in clinical trial expenses to support the advancement of four
clinical trials using bavituximab for the treatment of solid tumors and
one clinical trial for the treatment of HCV patients co-infected with
HIV. The increase in Anti-PS Immunotherapeutics program
expenses was further supplemented with an increase in R&D expenses
directly associated with increased efforts to advance the development of
bavituximab and a fully human antibody as potential broad-spectrum
treatments for viral hemorrhagic fever infections under our federal
contract with the U.S. Department of Defense’s Defense Threat Reduction
Agency (DTRA), which was awarded to us on June 30,
2008.
|
o
|
Tumor Necrosis Therapy (“TNT”)
(Cotara®) – TNT program expenses for the three months ended January
31, 2009 remained in line with the same period in the prior year
decreasing slightly by $15,000. TNT program expenses for the
nine months ended January 31, 2009 increased $422,000 compared to the same
period in the prior year primarily due to increases in clinical trial and
payroll expenses to support the continued advancement of our two ongoing
Cotara® clinical trials for the treatment of brain
cancer.
|
20
o
|
Vascular Targeting Agents
(“VTAs”) and Anti-Angiogenesis Agents – The decrease in
VTA and Anti-Angiogenesis Agents program expenses of $734,000 and
$2,095,000 during the three and nine months ended January 31, 2009,
respectively, compared to the same periods in the prior year is primarily
due to our efforts to significantly curtail our development expenses
associated with this program while focusing our efforts on seeking
partners to further advance these
technologies.
|
o
|
Vasopermeation Enhancement
Agents (“VEAs”) – The decrease in VEA program expenses of $162,000
and $479,000 during the three and nine months ended January 31, 2009,
respectively, compared to the same periods in the prior year is primarily
due to our efforts to significantly curtail our development expenses
associated with this program while focusing our efforts on seeking
partners to further advance this
technology.
|
Looking
beyond the current fiscal year, it is extremely difficult for us to reasonably
estimate all future research and development costs associated with each of our
technologies due to the number of unknowns and uncertainties associated with
pre-clinical and clinical trial development. These unknown variables
and uncertainties include, but are not limited to:
·
|
the
uncertainty of future clinical trial
results;
|
·
|
the
uncertainty of the ultimate number of patients to be treated in any
current or future clinical trial;
|
·
|
the
uncertainty of the U.S. Food and Drug Administration allowing our studies
to move forward from Phase I clinical studies to Phase II and Phase III
clinical studies;
|
·
|
the
uncertainty of the rate at which patients are enrolled into any current or
future study. Any delays in clinical trials could significantly
increase the cost of the study and would extend the estimated completion
dates;
|
·
|
the
uncertainty of terms related to potential future partnering or licensing
arrangements;
|
·
|
the
uncertainty of protocol changes and modifications in the design of our
clinical trial studies, which may increase or decrease our future costs;
and
|
·
|
The
uncertainty of our ability to raise additional capital to support our
future research and development efforts beyond the second quarter of our
fiscal year 2010 ending October 31,
2009.
|
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, share-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.
21
Three and Nine Months: The
decreases in selling, general and administrative expenses of $358,000 and
$776,000 during the three and nine months ended January 31, 2009, respectively,
compared to the same periods in the prior year are primarily due to decreases in
travel and related expenses, corporate legal fees and payroll and related
expenses. Travel and related expenses decreased $162,000 and $349,000
during the current year three and nine-month periods, respectively, primarily
due to a decrease in business development efforts in the U.S. and abroad and
decreased participation in corporate and investor relation activities compared
to the prior year in an effort to curtail corporate and business development
related expenditures. Corporate legal fees decreased $108,000 and
$279,000 during the current year three and nine-month periods, respectively,
primarily due to an overall decrease in legal fees associated with general
corporate matters. Payroll and related expenses decreased $60,000 and
$111,000 during the current year three and nine-month periods, respectively,
primarily due to a decrease in compensation and related expenses. In
addition, we incurred incremental decreases in other general corporate related
expenses primarily associated with facility related expenses and public relation
fees. These decreases in selling, general and administrative expenses
were offset with increases in non-cash stock based compensation expenses of
$13,000 and $123,000 during the three and nine-month periods, respectively,
associated with the amortization of the fair value of options granted to
employees.
Interest and
Other Income.
Three and
Nine Months: The decreases in interest and other income of $222,000
and $686,000 during the three and nine months ended January 31, 2009,
respectively, compared to the same periods in the prior year was primarily due
to decreases in interest income as a result of a lower average cash balance on
hand combined with lower prevailing interest rates during the current year
compared to the prior year.
Interest and
Other Expense.
Three and Nine Months: The
increases in interest and other expense of $124,000 and $111,000 during the
three and nine months ended January 31, 2009, respectively, compared to the same
periods in the prior year was primarily due to increases in interest expense
associated with the loan and security agreement we entered into during December
2008 combined with increases in non-cash interest expense regarding the
amortization of the loan and security agreement discount associated with the
fair value of detachable warrants and related debt issuance costs.
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.
We also
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.
22
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.
Revenues
associated with contract manufacturing services provided by Avid 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.
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.
Revenues
associated with our government contract are recognized in accordance with
Accounting Research Bulletin No. 43 Chapter 11, Government
Contracts. Our government contract with the Defense Threat
Reduction Agency (DTRA), a division of the Department of Defense, is a
“cost-plus-fixed-fee” contract. Reimbursable costs under the contract
primarily include direct labor, subcontract costs, materials, equipment, travel,
indirect costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is recognized as we perform the underlying
research and development activities. However, progress payments
associated with contract manufacturing services performed under the DTRA
contract are classified as Deferred Government Contract Revenue and are
recognized as revenue upon delivery or transfer of legal title of the product to
the DTRA.
Share-based
Compensation Expense
We
currently maintain four equity compensation plans which provide for the granting
of options to our employees 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.
23
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 2 to 4
years). Use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model
inputs. Expected volatility is based on daily historical volatility
of our stock covering the estimated expected term. The expected term
of options granted 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 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 is 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 loss
from operations for the three and nine-month periods ended January 31, 2009
included share-based compensation expense of $203,000 and $690,000,
respectively. Our loss from operations for the three and nine-month
periods ended January 31, 2008 included share-based compensation expense of
$231,000 and $612,000, respectively. We believe that non-cash
share-based compensation expense for the remaining three months of fiscal year
2009 may be up to approximately $161,000 based on actual shares granted and
unvested as of January 31, 2009. However, the actual expense may
differ materially from this estimate as a result of changes in a number of
factors that affect the amount of non-cash compensation expense, including the
number of options granted by our Board of Directors during the remainder of the
fiscal year, the price of our common stock on the date of grant, the volatility
of our stock price, the estimate of the expected life of options granted and the
risk-free interest rates.
As of January 31, 2009, the total
estimated unrecognized compensation cost related to non-vested stock options was
$1,314,000. This cost is expected to be recognized over a weighted
average period of 2.17 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, 2009, 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
At
January 31, 2009, we had $10,850,000 in cash and cash equivalents. We
have expended substantial funds on the research, development and clinical trials
of our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2008, 2007 and 2006 amounted
to $23,176,000, $20,796,000, and $17,061,000, respectively. 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, we expect such losses to continue for the foreseeable
future.
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. As discussed in Note 1 to
the condensed consolidated financial statements, there exists substantial doubt
regarding our ability to continue as a going concern.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
24
Regarding possible issuance of equity
to raise additional capital, as of January 31, 2009, we had 4,851,454 shares
available under an existing effective Form S-3 registration statement for
possible future registered transactions provided, however, we issue these shares
prior to April 12, 2009 (the expiration date of this registration
statement). 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.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While 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 Avid to complete the research,
development, and clinical testing of our product candidates. Based on
our current projections, which include projected revenues under signed contracts
with existing customers of Avid, combined with the projected revenues from our
government contract, we believe we have sufficient cash on hand combined with
amounts expected to be received from Avid customers and from our government
contract to meet our obligations as they become due through at least the second
quarter of our fiscal year 2010 ending October 31, 2009. There are a
number of uncertainties associated with our financial projections, including but
not limited to, termination of contracts and technical challenges, which could
reduce or delay our future projected cash-inflows. In addition, under
the Loan Agreement, in the event our contract with the Defense Threat Reduction
Agency is terminated or canceled for any reason, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessable by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
second quarter of our fiscal year 2010 unless we raise additional
capital. The uncertainties surrounding our future cash inflows have
raised substantial doubt regarding our ability to continue as a going
concern.
Significant components of the changes
in cash flows from operating, investing, and financing activities for the nine
months ended January 31, 2009 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, 2009, cash used in operating activities decreased
$7,335,000 to $8,668,000 compared to $16,003,000 for the nine months ended
January 31, 2008. This decrease in net cash used in operating
activities was primarily due to a decrease of $4,521,000 in our net loss
reported in the current nine-month period after taking into consideration
non-cash operating expenses. This amount was supplemented by a net
change in operating assets and payment or reduction of liabilities in the
aggregate amount of $2,814,000. The decrease in our current
nine-month period net loss was primarily due to current period increases in
contract manufacturing revenue and government contract revenue combined with
decreases in cost of contract manufacturing, research and development expenses
and selling, general and administrative expenses.
25
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,
2009
|
January
31,
2008
|
|||||||
Net
loss, as reported
|
$ | (12,915,000 | ) | $ | (17,017,000 | ) | ||
Less
non-cash expenses and adjustments to net loss:
|
||||||||
Depreciation
and amortization
|
385,000 | 353,000 | ||||||
Share-based
compensation
|
698,000 | 627,000 | ||||||
Amortization
of expenses paid in shares of common
stock
|
255,000 | - | ||||||
Amortization
of discount on notes payable and debt
issuance costs
|
61,000 | - | ||||||
Net
cash used in operating activities before changes in operating assets and
liabilities
|
$ | (11,516,000 | ) | $ | (16,037,000 | ) | ||
Net
change in operating assets and liabilities
|
$ | 2,848,000 | $ | 34,000 | ||||
Net
cash used in operating activities
|
$ | (8,668,000 | ) | $ | (16,003,000 | ) |
Cash Used In Investing
Activities. Net cash used in investing activities decreased
$448,000 to $126,000 for the nine months ended January 31, 2009 compared to net
cash used of $574,000 for the nine months ended January 31,
2008. This decrease was primarily due to a decrease in cash outflows
associated with other assets of $410,000 combined with a $188,000 decrease in
property acquisitions. The decrease in other assets of $410,000 was
primarily due to prior year progress payments of $413,000 made on certain
property related improvements associated with our manufacturing
facility. These decreases were offset by the prior year receipt of
$150,000 in net security deposits from GE Capital Corporation during the prior
year period upon the payment in full of various note payable
amounts.
Cash Provided By Financing
Activities. Net cash provided by financing activities
decreased $16,082,000 for the nine months ended January 31, 2009 compared to the
same prior year period. During the nine months ended January 31,
2009, we received net proceeds of $4,531,000 from notes payable under a loan and
security agreement we entered into on December 9, 2008, net of debt issuance
costs in the amount of $469,000. In addition, principal payments on
capital leases were $17,000 for the nine months ended January 31, 2009 compared
to capital lease and notes payable principal payments of $336,000 paid in the
same prior year period, or a decrease of $319,000. In addition,
during the nine months ended January 31, 2008, we received $20,932,000 from the
sale of common stock. In the prior year period, we entered into a
securities 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. This amount was supplemented with net proceeds of
$73,000 from the exercise of stock options and warrants.
Commitments
At January 31, 2009, we had no material
capital commitments.
26
ITEM
3.
|
QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Changes in United States interest rates
would affect the interest earned on our cash and cash equivalents and interest
expense on our outstanding notes payable, however, they would not have an affect
on our capital leases, which have fixed interest rates and terms.
Based on our overall cash and cash
equivalents interest rate exposure at January 31, 2009, a near-term change in
interest rates, based on historical movements, would not have a material adverse
effect on our financial position or results of operations.
At
January 31, 2009, we had an outstanding notes payable balance of $5,000,000
under a loan and security agreement, which bear interest at a monthly variable
rate equal to the then current thirty (30) day LIBOR rate (set at a floor of 3%)
plus 9%, which may expose us to market risk due to changes in interest
rates. However, based on current LIBOR interest rates, which are
currently under the minimum floor set at 3% under our loan and security
agreement and based on historical movements in LIBOR rates, we believe a
near-term 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, 2009, 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, 2009.
There were no significant changes in
the Company’s internal controls over financial reporting, during the quarter
ended January 31, 2009, that have materially affected, or are reasonably likely
to materially affect, the Company’s internal controls over financial
reporting.
PART II OTHER
INFORMATION
ITEM
1.
|
LEGAL
PROCEEDINGS.
|
In the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. 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:
27
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 original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai Medipharm Biotech Co.,
Ltd. (“Shanghai Medipharm”) and its related entities. The lawsuit
alleges claims for breach of contract, interference with contractual relations,
declaratory relief, and injunctive relief against the
defendants. Peregrine's claims stem from a 1995 license agreement
with CTL, and two amendments thereto (collectively referred to as the "License
Agreement"). Peregrine claims that CTL breached the License Agreement
by, among other things, (i) not sharing with Peregrine all inventions,
technology, know-how, patents and other information, derived and/or developed in
the People’s Republic of China and/or at the CTL laboratory, as was required
under the License Agreement; (ii) not splitting revenue appropriately with
Peregrine as required under the License Agreement; (iii) utilizing Peregrine's
licensed technologies outside of the People’s Republic of China; and (iv)
failing to enter a sublicense agreement with a Chinese sponsor obligating the
Chinese sponsor to comply with the terms and obligations in the License
Agreement. Peregrine further alleges that Medibiotech Co., Inc. and
Shanghai Medipharm ("Medipharm Entities") interfered with the License Agreement,
leading to CTL's breaches. This interference by the Medipharm
Entities includes: 1) posturing Shanghai Medipharm as the designated sublicensee
under the License Agreement, without binding any of the Medipharm
Entities to the terms and obligations of an appropriate sublicense
agreement called for under the License Agreement; 2) entering into a license
agreement with Alan Epstein, M.D. ("Epstein License Agreement") instead of CTL;
3) restricting the information CTL was allowed to provide to Peregrine, thereby
prohibiting CTL from providing to Peregrine all information required under the
License Agreement; and 4) providing compensation to CTL, and its principals, so
that CTL would enter agreements that prohibited CTL from performing under the
License Agreement.
On March
28, 2007, CTL filed a cross-complaint, which has been amended three times,
alleging that the Company breached the Agreement by improperly terminating the
Agreement and double-licensing the technology licensed to CTL to another party,
interfered with CTL’s agreements with various Medipharm Entities and unjust
enrichment. CTL’s cross-complaint, which seeks $20 million in
damages, is in part predicated on the existence of a sublicense agreement
between CTL and Shanghai 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 Shanghai Medipharm despite our repeated demands, and
they have not suffered any compensable damages.
On
February 22, 2008, Medibiotech Co., Inc. (“Medibiotech”) filed a cross-complaint
alleging, as a third party beneficiary, 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
enrichment. Medibiotech’s subsidiary, Shanghai Medipharm filed an
almost identical cross-complaint on February 17, 2009. These
cross-complaints, each seek $30 million in damages, in part predicated on
Medibiotech and Shanghai Medipharm being the “Chinese Sponsor” under the
Agreement. We intend to bring pre-trial motions in an attempt to
dispose of these cross-complaints.
The
discovery phase on the aforementioned cases is still 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 for the fiscal year
ended April 30, 2008.
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, 2009, we had $10,850,000
in cash and cash equivalents. We have expended substantial funds on
the research, development and clinical trials of our product candidates, and
funding the operations of Avid. As a result, we have historically
experienced negative cash flows from operations since our inception and we
expect to continue to experience negative cash flows from operations for the
foreseeable future. Our net losses incurred during the past three
fiscal years ended April 30, 2008, 2007 and 2006 amounted to $23,176,000,
$20,796,000, and $17,061,000, respectively. 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, we
expect such losses to continue for the foreseeable future.
28
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. As discussed in Note 1 to
the condensed consolidated financial statements, there exists substantial doubt
regarding our ability to continue as a going concern.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
Regarding
possible issuance of equity to raise additional capital, as of January 31, 2009,
we had 4,851,454 shares available under an existing effective Form S-3
registration statement for possible future registered transactions provided,
however, we issue these shares prior to April 12, 2009 (the expiration date of
this registration statement). 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.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we have
the ability to borrow up to $10,000,000 (“Loan Agreement”). On
December 19, 2008, we received initial funding of $5,000,000, which amount is
payable over a thirty-six (36) month term and is secured by generally all assets
of the Company as further explained in Note 5. Under the Loan
Agreement, we have an option, which expires June 30, 2009, to borrow a second
tranche in the amount of $5,000,000 upon the satisfaction of certain clinical
and financial conditions as set forth in the Loan Agreement. As of
January 31, 2009, we had met the clinical conditions under the Loan Agreement,
however, we had not met the required financial conditions. In order
for us to meet the financial conditions and receive the second tranche of
$5,000,000 under the Loan Agreement (provided we are not otherwise in default of
any of our obligations under the Loan Agreement), we must raise at least
$7,500,000 in gross proceeds from the issuance of new equity or obtain a defined
amount in net proceeds from the potential sale of our wholly owned subsidiary,
Avid Bioservices, no later than the expiration of the option.
In
addition to the above, we may also raise additional capital though licensing our
products or technology platforms or entering into similar collaborative
arrangements. In addition to these potential sources of capital, Avid
represents an additional asset in our portfolio and although we are not actively
pursuing this option, we could continue to pursue strategic initiatives for Avid
as a means of potentially raising additional capital.
While 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 Avid to complete the research,
development, and clinical testing of our product candidates. Based on
our current projections, which include projected revenues under signed contracts
with existing customers of Avid, combined with the projected revenues from our
government contract, we believe we have sufficient cash on hand combined with
amounts expected to be received from Avid customers and from our government
contract to meet our obligations as they become due through at least the second
quarter of our fiscal year 2010 ending October 31, 2009. There are a
number of uncertainties associated with our financial projections, including but
not limited to, termination of contracts and technical challenges, which could
reduce or delay our future projected cash-inflows. In addition, under
the Loan Agreement, in the event our contract with the Defense Threat Reduction
Agency is terminated or canceled for any reason, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessable by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
second quarter of our fiscal year 2010 unless we raise additional
capital. The uncertainties surrounding our future cash inflows have
raised substantial doubt regarding our ability to continue as a going
concern.
29
Our Outstanding
Indebtedness To MidCap Finacial LLC and BlueCrest Capital Finance, L.P. Imposes
Certain Restrictions On How We Conduct Our Business. In Addition, All
Of Our Assets, Including Our Intellectual Property, Are Pledged To Secure This
Indebtedness. If We Fail To Meet Our Obligations To The Lenders, Our
Payment Obligations May Be Accelerated And The Collateral Securing The Debt May
Be Sold To Satisfy These Obligations.
Pursuant
to a Loan and Security Agreement dated December 9, 2008 (the “Loan
Agreement”), MidCap Financial LLC and BlueCrest Capital Finance, L.P. (the
“Lenders”) have provided us a three-year, $5,000,000 working capital loan, which
funded on December 19, 2008 and may be increased to $10,000,000 upon our
attainment of certain additional clinical and financial conditions by June 30,
2009 as outlined in the Loan Agreement. As collateral to secure our
repayment obligations to the Lenders, we and our wholly-owned subsidiary, Avid
Bioservices, Inc., have granted the Lenders a first priority security interest
in generally all of our respective assets, including our intellectual
property.
The
Loan Agreement contains various covenants that restrict our operating
flexibility. Pursuant to the Loan Agreement, we may not, among other
things:
·
|
incur
additional indebtedness, except for certain permitted indebtedness.
Permitted indebtedness is defined to include accounts payable incurred in
the ordinary course of business, leases of equipment or property incurred
in the ordinary course of business not to exceed in the aggregate $100,000
outstanding at any one time;
|
·
|
incur
additional liens on any of our assets except for certain permitted
liens including but not limited to non-exclusive licenses of our
intellectual property in the ordinary course of business and exclusive
licenses of intellectual property provided they are approved by our board
of directors and do not involve bavituximab or
Cotara;
|
·
|
Make
any payment of subordinated debt, except as permitted under the applicable
subordination or intercreditor
agreement;
|
·
|
merge
with or acquire any other entity, or sell all or substantially all of our
assets, except as permitted under the Loan
Agreement;
|
·
|
pay
dividends (other than stock dividends) to our
shareholders;
|
·
|
redeem
any outstanding shares of our common stock or any outstanding options or
warrants to purchase shares of our common stock except in connection with
a share repurchase pursuant to which we offer to pay our then existing
shareholders not more than
$250,000;
|
·
|
enter
into transactions with affiliates other than on arms-length terms;
and
|
·
|
make
any change in any of our business objectives, purposes and operations
which has or could be reasonably expected to have a material adverse
effect on our business.
|
These
provisions could have important consequences for us, including (i) making
it more difficult for us to obtain additional debt financing from another
lender, or obtain new debt financing on terms favorable to us, because a new
lender will have to be willing to be subordinate to the lenders,
(ii) causing us to use a portion of our available cash for debt repayment
and service rather than other perceived needs and/or (iii) impacting our
ability to take advantage of significant, perceived business
opportunities. Our failure to timely repay our obligations under the
Loan Agreement or meet the covenants set forth in the Loan Agreement could give
rise to a default under the agreement. In the event of an uncured default, the
Loan Agreement provides that all amounts owed to the lender may be declared are
immediately due and payable and that the Lenders have the right to enforce their
security interest in the assets securing the Loan Agreement. In such event, the
Lenders could take possession of any or all of our assets in which they hold a
security interest, and dispose of those assets to the extent necessary to pay
off our debts, which would materially harm our business.
In
The Event Our Contract With The DTRA Is Terminated, Our Loan Requires Us To
Place A Significant Amount Of Our Cash In A Restricted Bank
Account.
Under the terms of the Loan Agreement,
if our contract with the Defense Threat Reduction Agency is terminated while any
principal balance of the loan is outstanding, we will be required to at all
times thereafter maintain cash and cash equivalents in an amount of at least
eighty percent (80%) of the then outstanding principal balance of the loan in a
restricted account over which we will not be permitted to make withdrawals or
otherwise exercise control.
30
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 for the nine months ended January 31, 2009 and
for each of the past three fiscal years:
Net Loss | |
Nine months ended January 31, 2009 (unaudited) | $12,915,000 |
Fiscal Year 2008 | $23,176,000 |
Fiscal Year 2007 | $20,796,000 |
Fiscal Year 2006 | $17,061,000 |
As of
January 31, 2009, we had an accumulated deficit of
$243,751,000. 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 and/or
royalty revenues sufficient to become profitable or to sustain
profitability.
The Sale Of
Substantial Shares Of Our Common Stock May Depress Our Stock Price.
As of January 31, 2009, there were
226,210,617
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 22,002,346
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 one effective shelf registration
statement
|
4,851,454 | ||||
Common
shares reserved for issuance upon exercise of outstanding options
or
reserved
for future option grants under our stock incentive plans
|
15,458,845 | ||||
Common
shares issuable upon exercise of outstanding warrants
|
1,692,047 | ||||
Total
|
22,002,346 |
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 options and warrants
outstanding as of January 31, 2009, 5,885,770 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, 2009.
31
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.
Current
Economic Conditions And Capital Markets Are In A Period Of Disruption And
Instability Which Could Adversely Affect Our Ability To Access The Capital
Markets, And Thus Adversely Affect Our Business And Liquidity.
The
current economic conditions and financial crisis have had, and will continue to
have, a negative impact on our ability to access the capital markets, and thus
have a negative impact on our business and liquidity. The shortage of liquidity
and credit combined with recent substantial losses in worldwide equity markets
could lead to an extended worldwide recession. We may face
significant challenges if conditions in the capital markets do not
improve. Our ability to access the capital markets has been and
continues to be severely restricted at a time when we need to access such
markets, which could have a negative impact on our business plans, including our
pre-clinical studies and clinical trial schedules and other research and
development activities. Even if we are able to raise capital, it may
not be at a price or on terms that are favorable to us. We cannot
predict the occurrence of future disruptions or how long the current conditions
may continue.
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, 2008, and our three fiscal quarters ended
January 31, 2009:
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
Fiscal
Year 2009
|
||||||||||||||||
Quarter
Ended January 31, 2009
|
$ | 0.47 | $ | 0.22 | 1,298 | 93 | ||||||||||
Quarter
Ended October 31, 2008
|
$ | 0.40 | $ | 0.23 | 1,318 | 77 | ||||||||||
Quarter
Ended July 31, 2008
|
$ | 0.53 | $ | 0.31 | 2,997 | 103 | ||||||||||
Fiscal
Year 2008
|
||||||||||||||||
Quarter
Ended April 30, 2008
|
$ | 0.73 | $ | 0.35 | 3,846 | 130 | ||||||||||
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 |
32
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, including our abilities to
continue as a going concern;
|
·
|
the
offering and sale of shares of our common stock at a discount under an
equity transaction;
|
·
|
changes
in our capital structure, including but not limited to any potential
reverse stock split;
|
·
|
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.
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 required under NASDAQ listing rules. 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. After the initial 180 calendar day period, we remained
noncompliant with the minimum closing bid price requirement but because we were
in compliance with all other initial listing requirements, we were afforded an
additional “compliance period” of 180 calendar days, or until July 21,
2008. Because we did not regain compliance, i.e., the closing bid
price of the Company’s common stock did not meet or exceed $1.00 per share for a
minimum of ten (10) consecutive business days prior to July 21, 2008, on July
22, 2008 we received a notice from The NASDAQ Stock Market indicating that we
were not in compliance with the minimum bid price requirement for continued
listing, and as a result our common stock is subject to delisting. On
July 28, 2008, we requested a hearing with the NASDAQ Listing Qualifications
Panel (“Panel”) to review the delisting determination. Our request
for a hearing stayed the delisting pending a decision by the
Panel. The oral hearing took place September 4, 2008 at which we
presented to the Panel our definitive plan to achieve and sustain long-term
compliance with the listing requirements of the NASDAQ Capital
Market. On September 16, 2008, we received a letter from the NASDAQ
Stock Market informing us that the Panel had determined to grant our request to
remain listed, subject to the condition that on or before January 20, 2009, we
must evidence a closing bid price for our common stock of $1.00 or more for a
minimum of ten prior consecutive trading days.
33
On October 21, 2008, we conducted our
2008 annual meeting of stockholders at which our stockholders approved an
amendment to our certificate of incorporation to effect a reverse stock split of
the outstanding shares of our common stock at a ratio to be determined by our
Board of Directors within a range of three-for-one and
ten-for-one. Subsequent to our annual meeting of stockholders, NASDAQ
Stock Market suspended the bid price and market value of publicly held shares
continued listing requirements through April 17, 2009. As a result of
this suspension, the exception granted to us by the Panel, which required us to
demonstrate compliance with the closing minimum bid price requirement by January
20, 2009, has been extended to July 27, 2009.
We intend
to pursue all available options to ensure our continued listing on the Nasdaq
Stock Market, including, if necessary, effecting the reverse stock split of our
outstanding common stock previously approved by our
stockholders. 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 of The Nasdaq Capital Market
listing requirements, the market value of our common stock could fall and
holders of common stock would likely find it more difficult to dispose of the
common stock.
If our
common stock is delisted, we would apply to have our common stock quoted on the
over-the-counter electronic bulletin board. Upon any such delisting,
our common stock would become subject to the regulations of the Securities and
Exchange Commission relating to the market for penny stocks. A penny
stock, as defined by the Penny Stock Reform Act, is any equity security not
traded on a national securities exchange that has a market price of less than
$5.00 per share. The penny stock regulations generally require that a
disclosure schedule explaining the penny stock market and the risks associated
therewith be delivered to purchasers of penny stocks and impose various sales
practice requirements on broker-dealers who sell penny stocks to persons other
than established customers and accredited investors. The
broker-dealer must make a suitability determination for each purchaser and
receive the purchaser’s written agreement prior to the sale. In
addition, the broker-dealer must make certain mandated disclosures, including
the actual sale or purchase price and actual bid offer quotations, as well as
the compensation to be received by the broker-dealer and certain associated
persons. The regulations applicable to penny stocks may severely
affect the market liquidity for our common stock and could limit your ability to
sell your securities in the secondary market.
If
We Effect A Reverse Stock Split, The Liquidity of Our Common Stock And Market
Capitalization Could Be Adversely Affected.
A reverse
stock split is often viewed negatively by the market and, consequently, can lead
to a decrease in our overall market capitalization. If the per share
market price does not increase proportionately as a result of the reverse split,
then the value of our company as measured by our market capitalization will be
reduced, perhaps significantly. In addition, because the reverse
split will significantly reduce the number of shares of our common stock that
are outstanding, the liquidity of our common stock could be adversely affected
and you may find it more difficult to purchase or sell shares of our common
stock.
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:
34
·
|
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 the commercial sale of any 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 various 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 or obtain regulatory
approval to conduct additional clinical trials, 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:
·
|
obtaining
regulatory approval to commence a clinical
trial;
|
·
|
reaching
agreement on acceptable terms with prospective contract 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;
|
35
·
|
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 the
Republic of Georgia and potentially other foreign countries, any disruption to
our international clinical trial program could significantly delay our product
development efforts. In addition, doing business in the Republic of
Georgia, which is in Eastern Europe, involves other significant risks which
could materially and adversely affect our business as there remains a high
degree of political instability in many parts of Eastern Europe.
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.
36
Positive
results from our pre-clinical studies, Phase I and the first stage of our Phase
II 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. In addition, while we have completed the first
stage of all three of our Phase II studies, and obtained positive results with
respect to our primary endpoints, our Phase II trials are open-label, Simon
two-stage design trials to evaluate the safety and efficacy on bavituximab in
combination with chemotherapy drugs in a limited number of
patients. The limited results we have obtained, and will obtain in
the Phase II trials, 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. We are also currently conducting 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.
37
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.
38
We
Currently Depend On a Government Contract To Partially Fund Our Research And
Development Efforts. If Our Current Government Funding Is Reduced Or
Delayed, Our Drug Development Efforts May Be Negatively Affected.
On June
30, 2008, we were awarded up to a five-year contract potentially worth up to
$44.4 million to test and develop bavituximab and an equivalent fully human
antibody as potential broad-spectrum treatments for viral hemorrhagic fever
infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (TMTI) of the U.S. Department
of Defense's Defense Threat Reduction Agency (DTRA). This federal
contract is expected to provide us with up to $22.3 million in funding over
a 24-month base period, with $14.3 million having been appropriated through the
current federal fiscal year ending September 30, 2009. The remainder
of the $22.3 million in funding is expected to be appropriated over the
remainder of the two-year base period ending June 29, 2010. Subject
to the progress of the program and budgetary considerations in future years, the
contract can be extended beyond the base period to cover up to $44.4 million in
funding over the five-year contract period. Work under this contract
commenced on June 30, 2008. If we do not receive the expected funding
under this contract, we may not be able to develop therapeutics to treat
hemorrhagic fever virus infection nor otherwise receive the other indirect
benefits that may be derived from receipt of the full funding under this
contract.
Federal
government contracts contain provisions giving government customers a variety of
rights that are unfavorable to us, including the ability to terminate a contract
at any time for convenience.
Federal
government contracts, such as our contract with the DTRA, contain provisions,
and are subject to laws and regulations, that give the government rights and
remedies not typically found in commercial contracts. These provisions may allow
the government to:
·
|
Reduce,
cancel, or otherwise modify our contracts or related
subcontract agreements;
|
·
|
Decline
to exercise an option to renew a multi-year
contract;
|
·
|
Claim
rights in products and systems produced by
us;
|
·
|
Prohibit
future procurement awards with a particular agency as a result of a
finding of an organizational conflict of interest based upon prior related
work performed for the agency that would give a contractor an unfair
advantage over competing
contractors;
|
·
|
Subject
the award of contracts to protest by competitors, which may require the
contracting federal agency or department to suspend our performance
pending the outcome of the protest;
|
·
|
Suspend
or debar us from doing business with the federal government or with a
governmental agency; and
|
·
|
Control
or prohibit the export of our products and
services.
|
If the
government terminates our contract for convenience, we may recover only our
incurred or committed costs, settlement expenses and profit on work completed
prior to the termination. If the government terminates our contract for default,
we may not recover even those amounts, and instead may be liable for excess
costs incurred by the government in procuring undelivered items and services
from another source. If the DTRA were to unexpectedly terminate or cancel, or
decline to exercise the option to extend our contract beyond the base period,
our revenues, product development efforts and operating results would be
materially harmed.
39
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.
|
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.
40
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. 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: 131I-TM601,
a radiolabeled chlorotoxin peptide being developed by TransMolecular, Inc.,
Neuradiab, a radiolabeled anti-tenascin monoclonal antibody sponsored by Bradmer
Pharmaceuticals, CDX-110, a peptide vaccine under development by Celldex,
cilengitide, an integrin-targeting peptide being evaluated by Merk KGaA, and
cediranib, a VEGFR tyrosine kinase inibitor 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.
Bavituximab is currently in clinical
trials for the treatment of advanced solid cancers. 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 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 are evaluating
bavituximab for the treatment of HCV. Bavituximab is a first-in-class
approach for the treatment of HCV. We are aware of no other products
in development targeting phosphatidylserine as a potential therapy for
HCV. There are a number of companies that have products approved and
on the market for the treatment of HCV, including but not limited
to: Peg-Intron® (pegylated interferon-alpha-2b), Rebetol®
(ribavirin), and Intron-A (interferon-alpha-2a), which are marketed by
Schering-Plough Corporation, and Pegasys® (pegylated interferon-alpha-2a),
Copegus® (ribavirin USP) and Roferon-A® (interferon-alpha-2a), which are
marketed by Roche Pharmaceuticals, and Infergen® (interferon alfacon-1) now
marketed by 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.
41
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. Other developmental approaches include,
but are not limited to, protease inhibitors such as telaprevir from Vertex
Pharmaceuticals Incorporated and boceprevir from Schering-Plough
Corporation.
Avid
Bioservices, Our subsidiary, Is exposed To Risks Resulting From Its Small
Customer Base.
A
significant portion of Avid Bioservices’ revenues have historically been derived
from a small customer base. These customers typically do not enter
into long-term contracts because their need for drug supply depends on a variety
of factors, including the drug’s stage of development, their financial
resources, and, with respect to commercial drugs, demand for the drug in the
market. Our results of operations could be adversely affected if
revenue from any one of our primary customers is significantly reduced or
eliminated
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 & Chief Executive Officer and Director, would adversely
affect our development efforts and clinical trial programs during the six to
twelve month period that we estimate it would take to find and train a qualified
replacement.
We also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical
personnel. We face intense competition in our recruiting activities,
including competition from larger companies with greater
resources. We do not know if we will be successful in attracting or
retaining skilled personnel. The loss of certain key employees or our
inability to attract and retain other qualified employees could negatively
affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to
protect stockholders against unsolicited attempts to acquire control of us that
do not offer a fair price to our stockholders as determined by our Board of
Directors. Under the plan, the acquisition of 15% or more of our
outstanding common stock by any person or group, unless approved by our board of
directors, will trigger the right of our stockholders (other than the acquiror
of 15% or more of our common stock) to acquire additional shares of our common
stock, and, in certain cases, the stock of the potential acquiror, at a 50%
discount to market price, thus significantly increasing the acquisition cost to
a potential acquiror. In addition, our certificate of incorporation
and by-laws contain certain additional anti-takeover protective
devices. For example,
·
|
no
stockholder action may be taken without a meeting, without prior notice
and without a vote; solicitations by consent are thus
prohibited;
|
·
|
special
meetings of stockholders may be called only by our Board of Directors;
and
|
·
|
our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares, of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into a large
number of shares of common stock could prevent a potential acquiror from
gaining effective economic or voting
control.
|
42
Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these
provisions may frustrate or prevent any attempts by our stockholders to replace
or remove our current management by making it more difficult for stockholders to
replace members of our Board of Directors, which is responsible for appointing
the members of our management.
ITEM
2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS.
None.
|
ITEM
3.
|
DEFAULTS
UPON SENIOR
SECURITIES. None.
|
ITEM
4.
|
SUBMISSION OF MATTERS TO A VOTE OF
SECURITY
HOLDERS. None
|
ITEM
5.
|
OTHER
INFORMATION. None.
|
ITEM
6.
|
EXHIBITS.
|
(a)
|
Exhibits:
|
|
10.111
|
Loan
and Security Agreement dated December 9, 2008 between Registrant and
BlueCrest Capital Finance, L.P.
|
10.112
|
Secured
Term Promissory Note dated December 19, 2008 between Registrant and
BlueCrest Capital Finance, L.P.
|
|
10.113
|
Secured
Term Promissory Note dated December 19, 2008 between Registrant and MidCap
Funding I, LLC.
|
|
10.114
|
Intellectual
Property Security Agreement dated December 19, 2008 between Avid
Bioservices, Inc. and MidCap Funding I,
LLC.
|
10.115
|
Intellectual
Property Security Agreement dated December 19, 2008 between Registrant and
MidCap Funding I, LLC.
|
10.116
|
Warrant to
purchase 507,614 shares of Common Stock of Registrant issued to BlueCrest
Capital Finance, L.P. dated December 9,
2008.
|
10.117
|
Warrant
to purchase 1,184,433 shares of Common Stock of Registrant issued to
MidCap Funding I, LLC dated December 9,
2008.
|
31.1
|
|
31.2
|
Certification
of the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
43
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 11, 2009 | By: /s/ STEVEN W. KING | ||
Steven
W. King
President,
Chief Executive Officer, and Director
|
|||
Date: March 11, 2009 | 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)
|
44