UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report (Date of earliest event reported): March 12, 2009
PEREGRINE PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
0-17085
|
95-3698422
|
||
|
(State
of other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
14282
Franklin Avenue, Tustin, California 92780
(Address
of Principal Executive Offices)
Registrant’s
telephone number, including area code: (714) 508-6000
Not
Applicable
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
o
Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425).
o
Soliciting material pursuant to Rule 14A-12 under the Exchange Act (17
CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
ITEM
2.02 RESULTS OF OPERATIONS AND FINANCIAL CONDITION
On March
12, 2009, Peregrine Pharmaceuticals, Inc. issued a press release to report the
Company’s financial results for the third quarter ended January 31,
2009. A copy of the press release is attached to this current report
on Form 8-K as Exhibit 99.1. No additional information is included in
this Current Report on Form 8-K.
The
information included in this Current Report on Form 8-K, including the exhibit
hereto, shall not be deemed “filed” for purposes of, nor shall it be deemed
incorporated by reference in, any filing under the Securities Act of 1933 or the
Securities Exchange Act of 1934, except as expressly set forth by specific
reference in such a filing.
ITEM
7.01 REGULATION
FD DISCLOSURE
On March 12, 2009, at 11:30 a.m.
EDT/8:30 a.m. PDT, the Company hosted a conference call to discuss its Third
Quarter Fiscal Year 2009 financial results. The webcast of the
conference call will be archived on the Company’s website for approximately 30
days.
ITEM
9.01 FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits. The
following material is filed as an exhibit to this Current Report on Form
8-K:
Exhibit
Number
99.1 Press
Release issued March 12, 2009
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 hereunto
duly authorized.
| PEREGRINE PHARMACEUTICALS, INC. | |||
|
Date:
March 12, 2009
|
By:
|
/s/ Paul J. Lytle | |
| Paul J. Lytle | |||
| Chief Financial Officer | |||
EXHIBIT
INDEX
Exhibit
Number Description
|
99.1
|
Press
Release issued March 12, 2009
|
Exhibit
99.1
|
Contacts:
|
||
|
Investors
|
Media
|
|
|
info@peregrineinc.com
|
Barbara
Lindheim
|
|
|
(800)
987-8256
|
GendeLLindheim
BioCom Partners
|
|
|
(212)
918-4650
|
PEREGRINE
PHARMACEUTICALS REPORTS FINANCIAL RESULTS FOR THE THIRD QUARTER OF FISCAL
YEAR 2009
--Total
Revenues Rose Over 300% and Net Loss Declined 46% Quarter-Over-Quarter,
with Avid Revenues Reaching a Record $5.8 Million--
--Two
Additional Bavituximab Phase II Cancer Trials Met Pre-Specified Endpoints for
Expansion--
--All
Three Bavituximab Phase ll Cancer Trials Have Now Successfully Achieved
Their Initial Efficacy Milestones--
TUSTIN, Calif., March 12, 2009
- -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced financial
results for the third quarter of fiscal year (FY) 2009 ended January 31,
2009.
Total
revenues for the current quarter increased 308% to $6,826,000, compared to
$1,675,000 for the comparable quarter in FY 2008. The increase in
total revenues primarily stems from increased contract manufacturing revenues
provided by Avid Bioservices, Peregrine’s wholly owned biomanufacturing
subsidiary. Contract manufacturing revenues generated by Avid were
$5,778,000 for the third quarter of FY 2009 compared to $1,662,000 for the
comparable prior year quarter. The increase in Avid revenues reflects
increased production of biological products for third-party customers during the
quarter, as well as the timing of certain product shipments. In
addition to Avid’s contract manufacturing revenues, Peregrine also generated
contract revenues during the quarter for services provided under its contract
with the U.S. Defense Threat Reduction Agency (DTRA) to evaluate bavituximab for
the treatment of viral hemorrhagic fever infections. For the nine
months ended January 31, 2009, total revenues increased to $10,284,000, up 98%
from the first nine months of FY 2008.
Total
costs and expenses increased 25% to $10,060,000 in the third quarter of FY 2009
from $8,077,000 in the same prior year quarter. The increase
primarily reflects an increase in the cost of contract manufacturing associated
with the 248% increase in third-party contract manufacturing revenues recorded
by Avid during the current quarter. During the third quarter of FY
2009, R&D expenses declined as a result of planned reductions in R&D
costs associated with Peregrine’s preclinical programs. R&D
expenses were $4,465,000 in the third quarter of FY 2009, compared to $4,941,000
in the third quarter of FY 2008. SG&A expenses declined 19%
quarter-over-quarter, from $1,847,000 in the third quarter of FY 2008 to
$1,489,000 in the third quarter of FY 2009. This decrease is the
result of reductions in SG&A expenses across the board, reflecting the
company’s focus on stringent management of all discretionary expense
categories. For the nine months, total costs and expenses were
virtually unchanged, rising slightly from $23,035,000 in the period ended
January 31, 2008 to $23,228,000 in the comparable period in 2009.
"Peregrine
has achieved significant financial successes since the start of the third fiscal
quarter,” said Paul Lytle, chief financial officer of
Peregrine. “Last year we began implementing a strategy to conserve
cash by controlling costs and growing revenues through our government DTRA
contract and through contract manufacturing services provided to outside
clients, while also continuing to advance our clinical trial
programs. This strategy is clearly producing results, as demonstrated
by the three-fold increase in our third quarter revenues, reflecting the growing
volume of biomanufacturing business at our Avid subsidiary and work performed
under our contract with the DTRA. At the same time, we continued to
achieve significant reductions in non-essential R&D costs and SG&A
expenses, reducing our net loss in the quarter by almost half compared to last
year. We believe these successes in effectively deploying our capital
resources while achieving important operational milestones are helping to
provide a sound foundation for our progress going forward.”
Peregrine
reported a consolidated net loss of $3,332,000, or $0.01 per basic and diluted
share, compared to a consolidated net loss of $6,154,000, or $0.03 per basic and
diluted share for the same prior year period, a decrease of 46%. The
consolidated net loss for the nine months declined 24%, from $17,017,000 in the
period ended January 31, 2008 to $12,915,000 in the comparable period in
2009. The declines in net loss are the result of increases in the
company’s total revenues combined with decreased costs in many areas of
Peregrine’s business.
At
January 31, 2009, the company had $10.9 million in cash and cash
equivalents.
“Over the
past few months we achieved a number of noteworthy advancements in our
development efforts, including promising data from our ongoing Phase II
bavituximab clinical studies and a high profile publication for our bavituximab
anti-viral program,” said Steven W. King, president and CEO of
Peregrine. “Last year we initiated three separate Phase II clinical
trials designed to evaluate bavituximab in combination with standard cancer
therapies. These trials have a two-stage design that requires
achievement of pre-specified efficacy endpoints to expand enrollment beyond the
pilot stage. With our recent announcement that our Phase ll trials in
breast cancer and non-small cell lung cancer (NSCLC) had achieved these
criteria, all three of our bavituximab Phase ll cancer trials have now
decisively met their respective pre-established endpoints for expanding
enrollment.”
Mr. King
added, “In addition to advancing our clinical programs, during the third quarter
we also received significant validation for our anti-PS anti-viral technology
platform through the publication in the highly regarded journal Nature Medicine of impressive
preclinical data evaluating bavituximab and related anti-PS antibodies for the
treatment of lethal virus infections. The recent clinical results
from our bavituximab cancer program and the Nature Medicine article were
widely reported in both industry periodicals and in the mainstream media,
raising awareness for our bavituximab program and heightening interest from
potential development partners. We anticipate that these ongoing
clinical studies will continue to generate additional newsflow and interest over
the coming months as we prepare for a number of important scientific
presentations and publications.”
Mr. King
concluded, “This is an exciting time for Peregrine and we look forward to
continuing to advance the programs that we believe will build value in our
company while providing potential new treatment options for patients confronting
life threatening diseases.”
Recent
Operating Highlights
Bavituximab
Anti-Cancer Program
Peregrine
reported progress in all three Phase II trials in the bavituximab cancer
program:
|
§
|
Initiated
patient dosing in Stage B of the Phase II trial of bavituximab in
combination with docetaxel in advanced breast cancer
patients.
|
|
§
|
Completed
patient enrollment in Stage A of the Phase II trial of bavituximab in
combination with carboplatin and paclitaxel in patients with advanced
breast cancer. Reported positive initial results from this
trial that exceeded the pre-specified endpoint for proceeding to Stage B,
with seven of 14 evaluable patients achieving an objective response
according to RECIST criteria. Of note, this 50% response rate
in patients with locally advanced or metastatic breast cancer was observed
after only two 28-day treatment cycles. Patients in the trial
are eligible for up to six cycles.
|
|
§
|
Completed
patient enrollment in Stage A of the Phase II trial of bavituximab in
combination with carboplatin and paclitaxel in patients with non-small
cell lung cancer. Reported positive initial results from this
trial that exceeded the pre-specified endpoint for proceeding to Stage B,
with seven of 17 evaluable patients achieving an objective response
according to RECIST criteria after four 21-day treatment cycles out of a
possible six cycles.
|
Bavituximab
Anti-Viral Program
The
company continued to advance the bavituximab anti-viral program and received
major validation for its anti-PS anti-viral platform:
|
§
|
Reported
publication of data in Nature Medicine that
supports the broad anti-viral potential of Peregrine’s anti-PS antibody
platform, showing that its PS-targeting drug bavituximab can cure lethal
virus infections in animal disease
models.
|
|
§
|
Ramped
up activities under its multi-year contract with the U.S. DTRA to assess
bavituximab and other anti-PS antibodies for biodefense applications
against viral hemorrhagic fevers.
|
Other
Developments
|
§
|
Entered
into a loan agreement for up to $10 million in funding to finance ongoing
development efforts.
|
|
§
|
Avid
Bioservices expanded its biomanufacturing capabilities with the
installation of two Thermo Scientific HyClone Single-Use Bioreactors,
which further enhance Avid's ability to meet the growing demand for its
cell culture production services. Data from Avid’s experience
with these units and other advanced technology was highlighted at a recent
industry conference.
|
Conference
Call
The
company will host a conference call today, March 12, 2009 at 11:30 a.m. EDT/8:30
a.m. PDT to discuss its Third Quarter FY 2009 financial results.
To listen
to a live broadcast of the call over the Internet or to review the archived
call, please visit: http://www.peregrineinc.com.
The webcast will be archived on Peregrine's website for approximately 30
days.
To listen
to the conference call via telephone, please call the following number
approximately 10 minutes prior to the scheduled start time and request to join
the Peregrine Pharmaceuticals call: (800) 860-2442. A telephonic replay of the
conference call will be available starting approximately one hour after the
conclusion of the call through March 19, 2009 by calling (877) 344-7529,
passcode 382933#.
About
Peregrine Pharmaceuticals
Peregrine
Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of
innovative monoclonal antibodies in clinical trials for the treatment of cancer
and serious viral infections. The company is pursuing three separate clinical
programs in cancer and HCV infection with its lead product candidates
bavituximab and Cotara®. Peregrine also has in-house manufacturing
capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com),
which provides development and biomanufacturing services for both Peregrine and
outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in
this press release which are not purely historical, including statements
regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations,
representations, projections, plans or predictions of the future are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. The forward-looking statements involve risks and
uncertainties including, but not limited to the risk that the company may
experience delays in clinical trial patient enrollment, the results of future
clinical trials may not correlate with the results from prior clinical and
preclinical studies, the risk that Avid’s revenue growth may slow or decline,
the risk that Avid may experience technical difficulties in processing customer
orders which could delay delivery of products to customers and receipt of
payment, the risk that one or more existing Avid customers terminates its
contract prior to completion, the risk that the company does not receive all of
its funding under the DTRA contract, the risk that future protocol submissions
may not be approved, the risk that the company is not able to generate
sufficient interest in any of its clinical programs from potential development
partners, the risk that the company does not satisfy the conditions under its
loan agreement necessary to receive the second $5 million tranche,
the risk that the company does not generate cash flow sufficient to service the
debt or repay the principal amount and the risk that the company may not be able
to monetize any of its assets. It is important to note that the company's actual
results could differ materially from those in any such forward-looking
statements. Factors that could cause actual results to differ materially
include, but are not limited to, uncertainties associated with completing
preclinical and clinical trials for our technologies; the early stage of product
development; the significant costs to develop our products as all of our
products are currently in development, preclinical studies or clinical trials;
obtaining additional financing to support our operations and the development of
our products; obtaining regulatory approval for our technologies; anticipated
timing of regulatory filings and the potential success in gaining regulatory
approval and complying with governmental regulations applicable to our business.
Our business could be affected by a number of other factors, including the risk
factors listed from time to time in the company's SEC reports including, but not
limited to, the annual report on Form 10-K for the year ended April 30, 2008 or
our quarterly report on Form 10-Q for the period ended January 31, 2009. The
company cautions investors not to place undue reliance on the forward-looking
statements contained in this press release. Peregrine Pharmaceuticals, Inc.
disclaims any obligation, and does not undertake to update or revise any
forward-looking statements in this press release.
-financial tables to
follow-
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 | ||||
-continued-
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-$.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
- | - | ||||||
|
Common
stock-$.001 par value; authorized 325,000,000 shares;
outstanding – 226,210,617 and 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 | ||||
-continued-
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 | ) | ||||
####