Avid Bioservices, Inc.
Mar 12, 2013

Peregrine Pharmaceuticals Reports Third Quarter Fiscal Year 2013 Financial Results and Recent Developments

Meaningful Improvement in Median Overall Survival in Patients With Second-Line NSCLC Supports Advancing Bavituximab Into Phase III Development; Contract Manufacturing Revenue Tops $17 Million for Nine Months Ended January 2013

TUSTIN, CA -- (Marketwire) -- 03/12/13 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced financial results for the third quarter ended January 31, 2013 of fiscal year (FY) 2013 and provided an update on its advancing clinical pipeline and other corporate developments.

"A key development this quarter was reporting updated data from our second-line non-small cell lung cancer trial that showed a meaningful improvement in median overall survival in the high dose bavituximab arm that we believe clearly supports advancing the program into Phase III. We are now actively preparing for a meeting with the FDA as part of our plans to initiate the Phase III trial by year-end," said Steven W. King, president and chief executive officer of Peregrine. "These results, along with the promising signs of anti-tumor activity we reported from our Phase II trial in front-line pancreatic cancer, are helping further guide the upcoming development of bavituximab with its broad potential in oncology. We are continuing to update potential partners on the new data as well as our plans for advancing the program."

Lead Indication in Second-Line Non-Small Cell Lung Cancer:

Front-Line Pancreatic Cancer:

Other Oncology Indications:
The company is exploring the potential of bavituximab through a number of other ongoing company-sponsored and investigator-sponsored trials (IST) including:

In addition, Peregrine is continually evaluating its IST program based on a number of factors, including changes in the standard of care of patients and trial enrollment. Following a recent review of the ongoing IST studies, a Phase I/II IST evaluating bavituximab combined with cabazitaxel in patients with second-line castration resistant prostate cancer was discontinued due to slow enrollment and the approvals of two new oral drugs for the same indication which are changing the standard of care treatment for these patients. Peregrine will continue to evaluate proposals for ISTs as part of its overall program to assess new indications and combinations based on the broad potential of bavituximab.

During the quarter, Peregrine announced that it reached agreement with the FDA on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM) following an end-of-Phase II meeting. The company plans to seek partners both in the U.S. and internationally to support the development of Cotara for this deadly form of brain cancer. Cotara has been granted orphan drug status and Fast Track designation for the treatment of GBM and anaplastic astrocytoma by the FDA and orphan drug designation by the European Medicines Agency (EMA).

PS-Targeting Molecular Imaging Program
Peregrine continues to enroll and dose patients in an open-label, single-center trial of its experimental phosphatidylserine (PS)-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. The primary goal of the trial is to estimate radiation dosimetry in critical and non-critical organs. Secondary objectives of the trial are tumor imaging and safety.

"Avid, our wholly-owned manufacturing subsidiary, continues to demonstrate its importance as a non-dilutive source of capital for the company under our hybrid business model," said Paul Lytle, chief financial officer of Peregrine. "Avid generated more than $17 million in contract manufacturing revenue during the recent nine-month period, already exceeding total revenue reported in FY 2012, and we expect third-party contract manufacturing revenue for the full FY 2013 to exceed $20 million. In addition, Avid has commitments for future manufacturing services in excess of $25 million, covering services to be delivered during the fourth quarter of FY 2013 and through FY 2014."

Total revenues for the third quarter of FY 2013 were $7,039,000 compared to $3,281,000, for the same quarter of the prior fiscal year. This increase was primarily attributable to greater contract manufacturing revenue generated by Avid Bioservices, Peregrine's wholly-owned contract manufacturing subsidiary, which generated contract manufacturing revenue of $6,961,000 for the third quarter of FY 2013, compared to $3,203,000 for the same quarter of the prior fiscal year. The increase in contract manufacturing revenue was primarily due to an increase in the number of completed manufacturing runs released and shipped during the current quarter. Based on current manufacturing commitments from Avid's third-party clients for services to be provided during the remainder of FY 2013, Peregrine expects contract manufacturing revenue to be at least $20 million for FY 2013. In addition, Avid will continue to utilize available capacity and resources to continue its preparation for later stage clinical development and potential commercialization of bavituximab and Cotara, while also seeking to grow its services from third-party clients.

Total costs and expenses decreased $2,174,000 to $12,200,000 in the third quarter of FY 2013 from $14,374,000 in the third quarter of FY 2012. This decrease was primarily attributable to lower research and development expenses associated with a decrease in clinical trial costs. For the third quarter of FY 2013, cost of contract manufacturing and research and development expenses were $3,651,000 and $5,437,000, respectively, compared to $2,484,000 and $9,180,000, respectively, for the third quarter of FY 2012. Selling, general and administrative expenses for the third quarter of FY 2013 were $3,112,000 compared to $2,710,000 in the third quarter of FY 2012.

Peregrine's consolidated net loss decreased 56% to $4,914,000, or $0.04 per basic and diluted share, for the third quarter of FY 2013, compared to a net loss of $11,090,000, or $0.13 per basic and diluted share, for the same quarter of the prior year.

Peregrine reported $26,255,000 in cash and cash equivalents at January 31, 2013, compared to $24,443,000 at October 31, 2012.

More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Conference Call
Peregrine will host a conference call and webcast this afternoon, March 12, 2013, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. A replay of the call will be available starting approximately two hours after the conclusion of the call through March 19, 2013 by calling (855) 859-2056, or (404) 537-3406 and using passcode 18046320.

To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm.

About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party 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 major discrepancies discovered with respect to our randomized, double-blind placebo-controlled Phase II trial of bavituximab in patients with refractory NSCLC may cause regulatory authorities to require further clinical trials to support a registration package, the risks that partnering discussions may not result in a partnering transaction or that such discussions could be hindered or delayed as a result of the potential impact on the regulatory pathway for bavituximab caused by the major discrepancies discovered with respect to the Phase II NSCLC trial or the existing class action lawsuits, the risk that results from the front-line NSCLC trial will not be consistent with results experienced in earlier trials and may not support advancing this indication into later stage trials, the risk that data from a Cotara pivotal trial may not support BLA submission or registration, the risk that the company does not have, or is unable to raise, sufficient capital to fund a pivotal Cotara trial, the risk that the company is unable to find a suitable partner to advance the Cotara program, the risk that Peregrine may not have or raise adequate financial resources to complete its other planned clinical programs, 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, and the risk that one or more existing Avid customers terminates its contract prior to completion. 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 our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2012 and our quarterly report on Form 10-Q for the quarter ended January 31, 2013. 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.



                         Three Months Ended           Nine Months Ended

                             January 31,                 January 31,

                         2013          2012          2013          2012

                     ------------  ------------  ------------  ------------

                       Unaudited     Unaudited     Unaudited     Unaudited




 revenue             $  6,961,000  $  3,203,000  $ 17,157,000  $ 12,796,000

License revenue            78,000        78,000       272,000       372,000

                     ------------  ------------  ------------  ------------

  Total revenues        7,039,000     3,281,000    17,429,000    13,168,000


Cost of contract

 manufacturing          3,651,000     2,484,000     9,378,000     9,219,000

Research and

 development            5,437,000     9,180,000    18,471,000    26,758,000

Selling, general and

 administrative         3,112,000     2,710,000     9,469,000     8,371,000

                     ------------  ------------  ------------  ------------

  Total costs and

   expenses            12,200,000    14,374,000    37,318,000    44,348,000

                     ------------  ------------  ------------  ------------

LOSS FROM OPERATIONS   (5,161,000)  (11,093,000)  (19,889,000)  (31,180,000)

                     ------------  ------------  ------------  ------------



Interest and other

 income                   255,000         9,000       307,000        31,000

Interest and other

 expense                   (8,000)       (6,000)      (53,000)      (88,000)

Loss on early

 extinguishment of

 debt                           -             -    (1,696,000)            -

                     ------------  ------------  ------------  ------------

NET LOSS             $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000)

                     ============  ============  ============  ============




  Basic and Diluted   131,489,994    87,149,770   114,726,569    78,443,114

                     ============  ============  ============  ============



 SHARE               $      (0.04) $      (0.13) $      (0.19) $      (0.40)

                     ============  ============  ============  ============

COMPREHENSIVE LOSS   $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000)

                     ============  ============  ============  ============



                                                JANUARY 31,     APRIL 30,

                                                    2013           2012

                                               -------------  -------------




  Cash and cash equivalents                    $  26,255,000  $  18,033,000

  Trade and other receivables, net                 1,983,000      2,353,000

  Inventories, net                                 4,635,000      3,611,000

  Prepaid expenses and other current assets,

   net                                               878,000        795,000

                                               -------------  -------------

    Total current assets                          33,751,000     24,792,000

Property, net                                      2,783,000      2,900,000

Other assets                                         623,000        570,000

                                               -------------  -------------

TOTAL ASSETS                                   $  37,157,000  $  28,262,000

                                               =============  =============



Accounts payable                               $   1,620,000  $   3,492,000

Accrued clinical trial and related fees            1,478,000      2,111,000

Accrued payroll and related costs                  2,949,000      2,468,000

Deferred revenue                                   5,061,000      3,651,000

Customer deposits                                  6,729,000      4,865,000

Other current liabilities                            930,000      1,052,000

                                               -------------  -------------

    Total current liabilities                     18,767,000     17,639,000

Deferred revenue                                     292,000        361,000

Other long-term liabilities                          699,000        779,000

Commitments and contingencies


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 - 133,770,614

 and 101,421,365, respectively                       134,000        101,000

Additional paid-in capital                       376,720,000    347,506,000

Accumulated deficit                             (359,455,000)  (338,124,000)

                                               -------------  -------------

    Total stockholders' equity                    17,399,000      9,483,000

                                               -------------  -------------

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY     $  37,157,000  $  28,262,000

                                               =============  =============

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Christopher Keenan or Jay Carlson

Peregrine Pharmaceuticals, Inc.

(800) 987-8256


Source: Peregrine Pharmaceuticals

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