Replies to post #114935 on Avid Bioservices Inc (CDMO)

[BioChica]

They did not mention what caused the dose switch though! So everyone is left guessing! I think it is important to inform the investment community what exactly happened! Steve did not clarify what or who caused the problem.

[wilberforce]

cjgaddy,

Are you seeing a strong reason to read "intentional" into the statement, "we did see clear evidence of dose-switching"?

thanks, wil

[cjgaddy]

3-5-13: Piper Jaffray initiates PPHM, Overweight, PT=$2.50

3-5-13 4:34pmET: “Piper Jaffray initiates coverage on Peregrine Pharmaceuticals (NASDAQ: PPHM) with a Overweight, PT $2.50”
StreetInsider link => http://tinyurl.com/ba4soh9

3-6-13/Benzinga: “Piper Jaffray Initiates Peregrine Pharmaceuticals with Overweight on Attractive Risk-Reward Opportunities”
By Dwight Einhorn, Benzinga Staff Writer
In a report published Tuesday, Piper Jaffray initiated coverage on Peregrine Pharmaceuticals (PPHM) with an Overweight rating and $2.50 price target.
Piper Jaffray noted:
“Peregrine is advancing 2 novel cancer drug candidates that, combined with its hybrid business model, present attractive risk-reward opportunities in our view. Lead candidate bavituximab (bavi) has recently endured negative news flow, increasing skepticism from investors but creating a potential buying opportunity, in our view. Bavi has broad potential due to its novel mechanism of action, providing many shots on goal for potentially large oncology markets like non-small cell lung cancer (NSCLC, ~$10bn+ market) and pancreatic cancer (PC), with multiple data-driven & regulatory catalysts in 2013. A 2nd major therapeutic candidate, Cotara, is a high risk but potentially high-return targeted radiopharmaceutical for brain cancer that we believe Peregrine will partner prior to starting a Phase III trial late in ‘13.”
PPHM closed on Tuesday at $1.31.
http://www.benzinga.com/analyst-ratings/analyst-color/13/03/3394234/update-piper-jaffray-initiates-peregrine-pharmaceuticals

=> Per RRDog iHub 115066/83, PJ report also said, “Bavi Controversy unfairly weighing on shares in our view… In addition, we believe the size & fully-human nature may support PGN650’s utility as a 2nd-gen “bavi-better.” Phase I data for PGN650 is expected this year, and this may result in the company becoming an acquisition candidate, vs. simply a partnering candidate, based on broad applicability but also long run-way potential for the emerging PS-targeting franchise."

- - - - - - - - - - -
3-5-13: Charles Duncan, PhD, Piper Jaffray added to Peregrine’s “Analyst Coverage” webpage – not sure when he was added, but very recently for sure…
http://ir.peregrineinc.com/analysts.cfm
Firm. . .Analyst
• JMP Securities - Jason N. Butler, Ph.D
• McNicoll, Lewis & Vlak - George B. Zavoico, Ph.D.
• Piper Jaffray - Charles Duncan, PhD
• ROTH Capital Partners - Joseph Pantginis, Ph.D.

= = = = = = = = = = = = = =
Charles Duncan, PhD
Sr. Research Analyst – Universe “Emerging BioPharma”
Charles Duncan, Ph.D., joined Piper Jaffray in 2012 as a managing director and senior research analyst focused on small- and mid-cap emerging growth biotechnology companies. Duncan brings more than 17 years of sell-side experience during which he has covered a broad range of biopharma companies, most recently serving as an analyst at JMP Securities since 2002. Previously, Duncan covered the sector at Dresdner Kleinwort Wasserstein, Vector Healthcare Group - Prudential Securities, Tucker Anthony Cleary Gull and Chatfield Dean & Co. Duncan has been recognized by industry sources, including the Financial Times and StarMine Analyst Awards, as being among the best analysts for his fundamental and timely analysis. Duncan began his career as a manager of clinical development at Global Drug Dev., Inc., a pharmaceutical development consulting firm, and he also launched InfusionVision Medical, a venture-backed start-up medical device company. He is a graduate of the Univ. of Wisconsin-Madison and holds a doctorate in pharmaceutical sciences with a concentration in neuropharmacology from the Univ. of Colorado.
http://www.piperjaffray.com/2col.aspx?id=7&analystid=1275&title=Analyst%20Information%20for%20Charles%20Duncan,%20PhD


= = = = = = = = = = = = = = = = = = = = =
Excerpts+Slides from CEO S.King’s 3-5-13 COWEN Talk (Boston)
Mar4-6 2013: “Cowen’s 33rd Annual Health Care Conf.”, Boston
CEO Steven King’s 24 min. Presentation – Cowen/Boston
=> http://investorshub.advfn.com/boards/read_msg.aspx?message_id=85315415

[cjgaddy]

The updated PPHM Revs-by-Qtr table, now thru FY13/Q3 (q/e 1-31-13), per the 1-31-13 10-Q ( http://tinyurl.com/cu2qry5 ) issued 3-12-13. Deferred-Revs at 1-31-13, going fwd into FY’13/Q4 (q/e 4-30-13), total $5.06mm, down from the $6.22mm of Deferred-Revs at 10-31-12 that drove into FY’13/Q3.
• Total Revs since May’06: ($76.0mm/Avid + $24.1mm/Govt + $1.9mm/Lic.) = $102.0mm
==> Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com

 
 (in thousands)                           DEFERRED                  
                  -------REVENUES-------   REVENUES  INVEN-     
 Quarter          Avid  Govt Lic.  TOTAL  Avid Govt  TORIES 
 FY07Q1  7-31-06   398     0   23    421   317    0    971 
 FY07Q2 10-31-06   636     0   48    684  1388    0   1899 
 FY07Q3  1-31-07   347     0   16    363  2202    0   1325 
 FY07Q4  4-30-07  2111     0  129   2240  1060    0   1916 
 FY08Q1  7-31-07  1621     0    4   1625  1820    0   2363 
 FY08Q2 10-31-07  1863     0   29   1892  1338    0   3500 
 FY08Q3  1-31-08  1662     0   13   1675  1434    0   2394 
 FY08Q4  4-30-08   751     0  150    901  2196    0   2900 
 FY09Q1  7-31-08  1193   324    0   1517  4021  980   4628 
 FY09Q2 10-31-08   983   958    0   1941  6472 1701   6700 
 FY09Q3  1-31-09  5778  1048    0   6826  4805 3262   5547 
 FY09Q4  4-30-09  5009  2683  175   7867  3776 3871   4707 
 FY10Q1  7-31-09  2070  4671    9   6750  5755 2332   6177 
 FY10Q2 10-31-09  5308  1510   78   6896  4260 3989   5850 
 FY10Q3  1-31-10  2945  6854   78   9877  3052   76   3861 
 FY10Q4  4-30-10  2881  1461   78   4420  2406   78   3123 
 FY11Q1  7-31-10   983  2111  115   3209  3719   47   4692  
 FY11Q2 10-31-10  3627   966   78   4671  2447   35   3555 
 FY11Q3  1-31-11  1922   882   79   2883  4300   40   3915 
 FY11Q4  4-30-11  1970   681   78   2729  5617    0   5284 
 FY12Q1  7-31-11  5439     0  216   5655  4145    0   4481 
 FY12Q2 10-31-11  4154     0   78   4232  2012    0   3178 
 FY12Q3  1-31-12  3203     0   78   3281  2552    0   2722 
 FY12Q4  4-30-12  1987     0   78   2065  3651    0   3611 
 FY13Q1  7-31-12  4135     0  116   4251  6056    0   5744 
 FY13Q2 10-31-12  6061     0   78   6139  6221    0   5426 
 FY13Q3 1-31-13   6961     0   78   7039  5061    0   4635 
 Totals:         75998 24149 1902 102049 <=since5/1/2006 
 . 
 TOTAL REV’s BY YEAR (Avid+Gov’t): 
 FY04 4-30-04  3,314 …Avid(CMO)= 3,039 (Avid-Revs don’t incl. Govt-SVCS) 
 FY05 4-30-05  4,959 …Avid(CMO)= 4,684 
 FY06 4-30-06  3,193 …Avid(CMO)= 3,005 
 FY07 4-30-07  3,708 …Avid(CMO)= 3,492 
 FY08 4-30-08  6,093 …Avid(CMO)= 5,897 
 FY09 4-30-09 18,151 …Avid(CMO)= 12,963 
 FY10 4-30-10 27,943 …Avid(CMO)= 13,204 
 FY11 4-30-11 13,492 …Avid(CMO)= 8,502 
 FY12 4-30-12 15,233 …Avid(CMO)= 14,783 
 ...Total Gov’t Revs from 7-2008 inception thru FY11Q4(Apr’11): $24.15mm 
 . 
 AVID “Total Services”: 
 AVID OUTPUT$   3rd-PARTY + PEREGRINE = TOTAL-OUTPUT$ 
 FY09  4-30-09    13mm       10mm         $23mm # 
 FY10  4-30-10    13mm       17mm         $30mm # 
 FY11  4-30-11     9mm       11mm         $19mm # 
 CY10 12-31-10 3rd/$15.3mm + Govt/$8.3mm + PPHM/$8.8mm = $32.4mm * 
 #SKing 7-12-2012 JMP/NYC Conf. (Slide27) http://tinyurl.com/csdclwb   
 *SKing 3-17-2010 RothOC/DanaPT Conf. (Slide18) http://tinyurl.com/ye9v7jq  
 . 
 PPHM’S QTLY. NET LOSS TREND BY QTR: 
 FY08Q1  7-31-07 4,656,000  
 FY08Q2 10-31-07 6,207,000 
 FY08Q3  1-31-08 6,154,000 
 FY08Q4  4-30-08 6,159,000  
 FY09Q1  7-31-08 5,086,000 
 FY09Q2 10-31-08 4,497,000 
 FY09Q3  1-31-09 3,332,000 
 FY09Q4  4-30-09 3,609,000 
 FY10Q1  7-31-09 2,428,000 
 FY10Q2 10-31-09 2,787,000 
 FY10Q3  1-31-10 1,538,000 
 FY10Q4  4-30-10 7,741,000 
 FY11Q1  7-31-10 7,695,000 
 FY11Q2 10-31-10 7,513,000 
 FY11Q3  1-31-11 8,929,000 
 FY11Q4  4-30-11 10,014,000 
 FY12Q1  7-31-11 8,092,000 
 FY12Q2 10-31-11 12,055,000 
 FY12Q3  1-31-12 11,090,000 
 FY12Q4  4-30-12 10,882,000 
 FY13Q1  7-31-12 7,664,000 
 FY13Q2 10-31-12 8,753,000 
 FY13Q3  1-31-13 4,914,000 
  
 - - - - - - - - Fiscal Qtr’s: 
 FY’10-Q3 = q/e 1-31-10  – rep. 3-11-10 Thu (B4 mkt)  
 FY’10-Q4 = q/e 4-30-10  – rep. 7-14-10 Wed (fter mkt) 
 FY’11-Q1 = q/e 7-31-10  – rep. 9-9-10  Thu (after mkt) 
 FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt) 
 FY’11-Q3 = q/e 1-31-10  – rep. 3-11-11 Fri (after mkt) 
 FY’11-Q4 = q/e 4-30-11  – rep. 7-14-11 Thu (after mkt) 
 FY’12-Q1 = q/e 7-31-11  – rep. 9-9-11  Fri (B4 mkt) 
 FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt) 
 FY’12-Q3 = q/e 1-31-12  – rep. 3-9-12  Fri (after mkt) 
 FY’12-Q4 = q/e 4-30-12  – rep. 7-16-12 Mon (after mkt) 
 FY’13-Q1 = q/e 7-31-12  – rep. 9-10-12 Mon (B4 mkt) 
 FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt) 
 FY’13-Q3 = q/e  1-31-13 – rep. 3-12-13 Tue (after mkt) 
 FY’13-Q4 = q/e  4-30-13 – rep. 7-xx-13                 
 . 
 = = = = = = =  
 OPER. BURNS* FOR FY’10/11 (FROM THE 10-Q/K’S): 
 FY10Q1  7-31-09  2,024,000 (from 10Q pg.25)    
 FY10Q2 10-31-09  2,351,000 (Q1+Q2: 4,375,000 pg.28)   
 FY10Q3  1-31-10  1,158,000 (Q1+Q2+Q3: 5,533,000 pg.30) 
 FY10Q4  4-30-10  6,375,000 (FY’10: 11,908,000 10K pg.58) 
 FY11Q1  7-31-10  6,567,000 (from 10Q pg.24) 
 FY11Q2 10-31-10  6,167,000 (Q1+Q2: $12,734,000 pg.25) 
 FY11Q3  1-31-11  7,736,000 (Q1+Q2+Q3: $20,470,000 pg.26) 
 FY11Q4  4-30-11  8,961,000 (FY’11: 29,431,000 10K pg.54) 
 FY12Q1  7-31-11  6,984,000 (from 10Q pg.25) 
 FY12Q2 10-31-11 11,668,000 (Q1+Q2: 18,652,000 pg.25) 
 FY12Q3  1-31-12  8,490,000 (Q1+Q2+Q3: 27,142,000 pg.25) 
 FY12Q4  4-30-12 11,265,000 (FY’12: 38,407,000 10K pg.55) 
 FY13Q1  7-31-12  6,742,000 (from 10Q pg.21) 
 FY13Q2 10-31-12  6,162,000 (Q1+Q2: 12,904,000 pg.23) 
 FY13Q3  1-31-13  3,597,000 (Q1+Q2+Q3: 16,501,000 pg.23) 
 FY’09 total Op-Burn:  $14,715,000 
 FY’10 total Op-Burn:  $11,908,000 
 FY’11 total Op-Burn:  $29,431,000 
 FY’12 total Op-Burn:  $38,407,000 

*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”

= = = = = = = = = = = = =
Latest 10K 4-30-12 iss. 7-16-12: http://tinyurl.com/79o57b2 PR: http://tinyurl.com/c8nytow (Cash 4-30-12 $18.0mm)
Latest 10Q 1-31-13 iss. 3-12-13: http://tinyurl.com/cu2qry5 PR: http://tinyurl.com/SeeBelow (Cash 1-31-13 $2x.4mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
3-12-13 PR: Peregrine Pharmaceuticals Reports Q3/FY2013 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 9 Months Ended January 2013
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=747593

TUSTIN, 3/12/13: 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 CEO 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."

BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
• Recently announced updated results from its Phase II randomized, double-blind, placebo-controlled trial of bavituximab in second-line non-small cell lung cancer (NSCLC).
• Promising 60% improvement in median overall survival (OS) in the 3mg/kg bavituximab plus docetaxel arm compared to the control arm and that bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.
• Additional data from the trial, including subgroup analysis and safety data, to be presented at an upcoming scientific meeting.
• Planning for a meeting with the U.S. Food and Drug Administration (FDA) in the first half of calendar year 2013 with the goal of initiating the Phase III trial by calendar year-end.

Front-Line Pancreatic Cancer:
• Recently announced data from its open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in 70 patients with previously untreated, advanced Stage IV pancreatic cancer.
• Enrollment included patients with poor prognosis including advanced metastatic disease with significant liver involvement and poor performance status associated with rapid disease progression.
• Results showed a more than a doubling of overall response rate (ORR) in the bavituximab-containing arm, a positive safety profile and a modest improvement in median OS.
• Additional data from the trial, including subgroup analysis and safety data, to be presented at an upcoming scientific meeting.
• Encouraging signs of activity from the trial support advancing this program, potentially in combination with new treatment options.

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:
• A randomized, open-label, Phase II clinical trial evaluating bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in 86 patients with previously untreated Stage IIIb or Stage IV NSCLC. Peregrine expects to report median OS from this trial, an event driven endpoint, in the first half of calendar year 2013.
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC.
• A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
• A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma.

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.

COTARA PROGRAM HIGHLIGHTS
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).

IMAGING PROGRAM HIGHLIGHTS
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.

FINANCIAL RESULTS
"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, CFO of Peregrine. "Avid generated more than $17 million in contract manufacturing revenue during the recent 9-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 4th 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 [phone] or [phone] 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 [phone], or [phone] 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. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Contact: Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. [phone] [e-mail]

 
 
PEREGRINE PHARMACEUTICALS, INC. 
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 
  
                          Three Months Ended           Nine Months Ended 
                              January 31,                 January 31, 
                          2013          2012          2013          2012 
                      ------------  ------------  ------------  ------------ 
                        Unaudited     Unaudited     Unaudited     Unaudited 
 REVENUES: 
 Contract  manufacturing 
  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 
  
 COSTS AND EXPENSES: 
 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) 
                      ------------  ------------  ------------  ------------ 
  
 OTHER INCOME 
  (EXPENSE): 
 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) 
                      ============  ============  ============  ============ 
 WEIGHTED AVERAGE 
  COMMON SHARES 
  OUTSTANDING: 
   Basic and Diluted   131,489,994    87,149,770   114,726,569    78,443,114 
                      ============  ============  ============  ============ 
 BASIC AND DILUTED 
  LOSS PER COMMON 
  SHARE               $      (0.04) $      (0.13) $      (0.19) $      (0.40) 
                      ============  ============  ============  ============ 
 COMPREHENSIVE LOSS   $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000) 
                      ============  ============  ============  ============ 
  
                       PEREGRINE PHARMACEUTICALS, INC. 
                    CONDENSED CONSOLIDATED BALANCE SHEETS 
                                                 JANUARY 31,     APRIL 30, 
                                                     2013           2012 
                                                -------------  ------------- 
                                                  Unaudited 
 ASSETS 
 CURRENT ASSETS: 
   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 
                                                =============  ============= 
  
 LIABILITIES AND STOCKHOLDERS' EQUITY 
 CURRENT LIABILITIES: 
 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 
  
 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 - 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 
                                                =============  ============= 
 Contact: 
 Christopher Keenan or Jay Carlson 
 Peregrine Pharmaceuticals, Inc. [phone] [e-mail] 
  
 

[cjgaddy]

3-12-13 Qtly CC Transcript (Q3FY’13 q/e 1-31-13), and the 3-12-13 PR (Financials & Devs), and the updated Avid Revenues History Chart By Quarter (May’06-Current)…

This large post has 3 sections:
I. 3-12-2013 Q3/FY’13 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 1-31-13)
II. 3-12-13 PPHM Press Release: Q3/FY’13 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’13 = May’12-Apr’13.

((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/ao5esyl ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/eventdetail.cfm?eventid=126414
3-12-13 C.C. EXCERPTS:
…STEVE KING (CEO): “The data from this updated analysis (2nd-Line NSCLC) shows a compelling improvement in MOS for patients receiving 3mg bavituximab, and we are confident that the overall data from the trial provides a strong rationale for advancing this dose combination in the later-stage clinical development.”
…ROB GARNICK (HEAD/REGULATORY): “(Re: 2nd-Line NSCLC): …and the 3rd piece, which is important, is the efficacy piece, and as I point out to many people, there are very few and far between Phase II trials that ever show statistical significance in efficacy - that's an absolutely unbelievable hurdle for a Phase II product. And, what you're really looking for is an ability to describe that you do have clinical efficacy, and as Joe has said, showing 11.7 mos. for the 3mg arm and a difference in the pooled dataset for the product of 7.3 mos. when you combine the control & the placebo, definitely gives you the indication that in overall survival, we have a potentially highly efficacious product… we're going to discuss the entire situation of the investigation with the agency, as well as all the data I just described, and we feel pretty confident that we have enough data to move the product effectively into Phase III.”

FULL TRANSCRIPT…
3-12-2013 Q3 FY’13 Earnings Conf. Call (q/e 1-31-13)
WELCOME & FWD-LOOKING STATEMENTS: Jay Carlson (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Robert Garnick, Paul Lytle; Q&A session at end.

CEO Steve King – OPENING COMMENTS:
Since the last quarterly conf. call, we've made significant advancements in our drug development programs and have seen continued solid performance from our manufacturing business as part of our hybrid business model. We have successfully executed toward our stated goals for advancing our lead clinical programs, bavituximab & Cotara, and have already surpassed last year's manufacturing revenue total with still one quarter to go before fiscal year-end.

Perhaps at the forefront of these advancements was completing and announcing the results of our internal review of data from our Phase II clinical trial of bavituximab in 2nd-Line NSCLC. The review was prompted by the discovery of bio-coding discrepancies in 2 arms of the study and was very comprehensive. It involved testing thousands of product vials, patient samples, and a thorough review of data from the study. Results from the review did not indicate any evidence of discrepancies in coding assignments at the high dose, or 3mg, bavituximab arm of the trial, while there was ample evidence of coding discrepancies between the placebo and the low dose, or 1mg, bavituximab arm. Based on the thorough review, we chose to move forward with the conservative, and in the end, the least subjective approach to the updating of the data from the trial, combining the 1mg & placebo arms into a single control arm and comparing those results with the 3mg arm of the study. As Joe will discuss in a moment, the data from this updated analysis shows a compelling improvement in MOS for patients receiving 3mg bavituximab, and we are confident that the overall data from the trial provides a strong rationale for advancing this dose combination in the later-stage clinical development. Rob will provide additional insight during his upcoming section.

We also continued to make progress in the rest of our bavituximab clinical program. In addition to the 2nd-Line NSCLC data, during the quarter we also announced encouraging data from our randomized Phase II Front-Line Pancreatic Cancer study. Joe will cover the data in greater detail, but I can tell you that we are encouraged by the early signs of activity we saw in this very sick patient population with advanced disease, and that we look forward to presenting addl. data from the study in an upcoming medical conference and to working closely with our clinical advisors to establish the next step toward advancing the program. In addition, we and our clinical collaborators are continuing to study bavituximab in different indications & combinations, and we look forward to presenting data from these studies as it becomes available.

We are also continuing our clinical evaluation of our PS-targeted Imaging Agent, PGN650, in solid tumors and look forward to providing results from the study at an appropriate time point.

Our partnering goals for bavituximab program have not changed. We are pursuing, in parallel with our development efforts, potential partnerships for the program as we look to move into later-stage clinical studies.

This quarter also saw the continued advancement of our Cotara program, following the successful discussions with the FDA on a Phase III trial design announced in December. We are continuing our plans for moving the program toward a pivotal trial in patients with recurrent GBM while we move in parallel with partnering discussions of the program.

On the manufacturing front, Avid continues to have an outstanding year, with record revenues in sight. As Paul will outline at the end of the call, Avid is an instrumental part to keeping our burn rate in check, as well as providing a key strategic role for our internal clinical development programs and possible future commercial manufacturing needs.

As we look forward, in the coming months we anticipate meeting with the FDA in the Q2/2013 to discuss our plans for moving bavituximab toward Phase III development in 2nd-Line NSCLC; presenting addl. data from both our 2nd-Line NSCLC clinical trial, as well as our Front-Line Pancreatic Cancer study; MOS data from the randomized Phase II bavituximab study in Front-Line NSCLC; presentation of data from ongoing ISTs, as well as the Imaging clinical program; and continued stellar performance at Avid Bioservices. I will now turn the call over to Joe, who will review in greater detail recent clinical developments.

JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
The clinical activities during the quarter were highlighted by data readouts from 2 of our 3 company-sponsored Phase II clinical trials.

Beginning with our randomized double-blind placebo-controlled trial of bavituximab in 2nd-Line NSCLC, let me remind you that the updated efficacy analysis now compares the 3mg bavituximab arm to a control arm comprising the pooled data from the placebo & 1mg bavituximab arms. This analysis resulted in a MOS estimate of 11.7 mos. in the 3mg bavituximab arm, compared to 7.3 mos. in the control arm, representing a meaningful 60% improvement. Bavituximab was also well-toleratedwith no significant differences in the adverse event profiles across the trial arms. We plan to report addl. data from this trial, including updated subgroup analyses and safety data at an upcoming medical conference. In the meantime, these data are compelling and allow us to move with confidence into discussions regarding a Phase III trial design, which Rob will talk about shortly.

The 2nd trial to read out during the quarter is our open-label randomized trial with bavituximab in combination with gemcitabine in 70 patients with previously untreated Stage IV Pancreatic Cancer. The Phase II trial was our first in Pancreatic Cancer and was designed to cast a wide net. Eligibility criteria were relatively broad, allowing enrollment of adults with no upper age limit, inclusion of distant metastases and ECOG performance status of 0-2. The combination of bavituximab & gemcitabine resulted in more than a doubling of overall response rate of 28% vs. 13%, an encouraging sign of anti-tumor activity. In addition, a modest improvement in MOS was observed, 5.6 mos. vs. 5.2 mos., despite enrollment of older patients with poor performance status and rapid disease progression as evidenced by the short survival time in the control arm. Further analysis including subgroups are underway, which we plan to present at a future medical conference. Meanwhile, we are encouraged by the trial results to date and are evaluating next steps for how best to advance the pancreatic program in order to take advantage of bavituximab's immunologic mechanism of action. We are looking to define a patient population that would allow a potentially longer dosing duration. In addition, we are considering strategies which factor in the recent development in the treatment of Pancreatic Cancer. We look forward to sharing these plans with you when finalized. I'll now turn the call over to Rob, who will review our regulatory strategy for the late-stage development of bavituximab.

Dr. Robert Garnick (Head of Regulatory Affairs)
The Clinical & Regulatory Affairs group has had a really busy quarter, and as you have heard, the next quarter will certainly be no different. With respect to our lead indication, bavituximab, in 2nd-Line NSCLC, we are in the midst of planning for a meeting with the FDA some time during Q2/2013 to discuss the size & design of our proposed Phase III trial. What I can tell you is given the reanalysis of the Phase II data that both Steve & Joe have alluded to, we anticipate that this trial will be in the 600-pt. range and could involve an interim analysis. Our goal is to initiate a Phase III trial by the end of the year.

I would like to point out that our bavituximab Phase II trial accomplished what it was designed to do, in that it achieved the determination of the intended dose for Phase III, expanded our understanding of the favorable safety profile of bavituximab, and produced a clear signal of clinical efficacy. Having accomplished these 3 critical things, we feel confident in moving the bavituximab 3mg dose into Phase III, that this dose has a favorable safety profile, and has demonstrated promising signs of clinical activity. With this data in hand, we feel that we have a strong package of information ready for discussion with the FDA and are confident that this program should move forward into late-stage development.

CFO Paul Lytle:
Shifting gears now, I'd like to spend the next few moments covering a few financial highlights and our related financial goals. As I mentioned on the last call, it's important to note that we operate a hybrid business model that includes a revenue-generating contract manufacturing business and an advancing drug development business.

Let me first focus on the revenue-generating business, Avid Bioservices. During the recent quarter, Avid generated $7 million in contract manufacturing revenue and $17.2 million for the recent 9-mo. period. This represents a 34% increase in revenue over the prior year 9-mo. period and so far, exceeds the total contract manufacturing revenue reported during the entire FY2012. And, as a result of the mutual successes of both Avid and its customers, we are raising our revenue guidance from $18 million for the entire FY2013 to at least $20 million, representing potential revenue growth of over 35% compared to last FY. In addition to revenue growth, it's important to note that we have a backlog for future services that currently extends through FY2014 [May’13-Apr’14]. As of Jan. 31, 2013, Avid had customer commitments in excess of $25 million, covering services to be delivered during the remaining quarter of FY2013 and into FY2014.

Let me turn to our net loss. Strong revenue growth combined with an expected decrease in R&D spending have significantly reduced our net loss for the current quarter and current 9-month period. Our net loss this quarter has decreased 56% to $4.9 million. And for the recent 9-mo. period, we saw a 32% decrease in our net loss to $21.3 million. In addition, this reduction in our net loss has translated into a 64% reduction in our cash burn rate during the recent quarter to $3.6 million, representing a reported net loss minus non-cash expenses.

Let me now talk about our financing goals. As a backdrop, let me emphasize that we are closely managing our business, our cash position, and our various sources of capital as we prioritize and advance our later-stage clinical pipeline. Investing in our clinical programs is the most important and significant potential value driver for Peregrine. Over the past several years, we have invested in these programs using a balanced financial approach. We have closely matched our capital needs with our various sources of capital, and we always seek non-dilutive capital as a preferred source of capital, such as manufacturing revenue, to reduce our overall reliance on the capital markets. Looking ahead, we will continue to closely manage our operations in line with our cash position while balancing our various sources of capital. We look forward to keeping you updated on our progress. And we will now open the call up for your questions.

Q&A: [16:45 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: A couple of questions, if you don't mind. You've obviously come a long way with regard to answering the questions in the 2nd-Line lung study. And now, as you've mentioned, you're preparing for the EOP2 meeting and talk about the pivotal study with the FDA. Can you provide a little additional color as to how you're preparing for this meeting? Obviously, you might be talking to some FDA consultants or what have you, and I guess the ultimate question as part of this discussion is, what's really giving you the true comfort after all your analyses from the study and the discrepancies in the study - the comfort that you can really get back to your original plan to move this into Phase III?
SK: I’ll can take a quick stab at that, then I'll turn it over to Rob to fill in some of the details, but this is obviously a very expansive process of going through and reviewing the data from the trial and making sure that we understood it as well as we possibly could. And I think that really forms now the basis of how we view our clinical experience of bavituximab, achieving our goals in the Phase II study by identifying a dose we're comfortable moving forward with at 3mg, and then also further establishing a safety profile. And, it's not just from this 2nd-Line study, but it's the total experience. So clearly, we've treated patients in a lot of different studies and now built a very nice safety database for the program. So I think overall, that's what gives us the confidence, before actually advancing the program into Phase III to begin with. And also one of the reasons that we undertook the relatively conservative analysis approach that we did for the 2nd-Line data was that it would allow us then to really have what we think is a good way to estimate the size of the Phase III clinical study. And so, because we've taken a conservative approach, we feel like, if anything, we're at a disadvantage, from the numbers standpoint, and if anything, should be in the end probably overpowering the study. But, we certainly want to take a conservative approach given the nature of what we had to review and the analysis that had to take place. So, that's what's given us the confidence moving into the discussion with the FDA and beyond that, of course, into starting the study. Rob, I'll turn over to you as far as kind of the preparations and what the group is doing.
Robert Garnick:
We have quite a whole plethora of regulatory things that we're dealing with right now to get ready for the EOP2 meeting with FDA. And that meeting, as you know, really encompasses all of the information we have on the drug. We're tying up all the bows right now on the Chemistry, Manufacturing & Controls section of the IND and actually ready to make a submission to FDA shortly to cover that section of Phase II, of which there is no surprises and which has gone extremely well. So, we can certainly make the material; we can make it reliably; we can make it at an economical level. And then, of course, we have to deal with all the issues on the clinical side. And as Steve said, the 3 things you really need to know for EOP2 with FDA is that you need, and the actual purpose of Phase II, is to determine the dose that you're going to take forward into Phase III, and we certainly have done that with the 3mg dose. The next is the summary of all the safety data, and we’ve really integrated all the safety information from our Phase I and previous Phase II trials, as well as the randomized controlled 2nd-Line trial. And we'll be presenting that entire summary and safety profile of the drug, which is also extremely good and actually better than we anticipated. And the 3rd piece, which is important, is the efficacy piece, and as I point out to many people, there are very few and far between Phase II trials that ever show statistical significance in efficacy - that's an absolutely unbelievable hurdle for a Phase II product. And, what you're really looking for is an ability to describe that you do have clinical efficacy, and as Joe has said, showing 11.7 mos. for the 3mg arm and a difference in the pooled dataset for the product of 7.3 mos. when you combine the control & the placebo, definitely gives you the indication that in overall survival, we have a potentially highly efficacious product. So, I think the 3 critical things have been identified. And again, we're going to discuss the entire situation of the investigation with the agency, as well as all the data I just described, and we feel pretty confident that we have enough data to move the product effectively into Phase III.
JP: That's helpful Rob. I want to switch gears while staying with bavi. I guess I'll ask this question from a devil's advocate perspective regarding the pancreatic data. Joe, you started to throw some additional plans in there with how you're viewing the data. But first, I would ask the question, response rates are one thing, but in oncology, when you view the gold standard being essentially survival, the study didn't really show a difference in survival. So I guess, before we talk about or get some more color about the plans you alluded to, why were you encouraged with this current study on the pancreatic side, and then maybe just a little more color about what you look to be doing next as you look to, like you said, identify maybe a different patient population or what have you?
Joe Shan: Obviously, in Pancreatic Cancer, it's no secret that it's a difficult-to-treat disease and survival is extremely hard to improve upon. I think we were encouraged by what we saw in our trial in that, despite a very advanced set of Stage IV patients, we still did see some activity in the response rate. And it did translate to, albeit modest, survival - there was still a survival difference in our bavituximab-containing arm. As I mentioned previously, what we are looking at is what's the best way to advance bavituximab in this indication, given what's going on in the space right now. Obviously, with Abraxane’s positive data, that's going to shift the landscape we believe. But, it's not curing Pancreatic Cancer yet, so there's potential opportunity there if we can consider adding bavituximab to some of these newer regimens. The other aspect is, clearly, because we allowed some of these sicker patients, we ended up enrolling some sicker patients and one thing we're learning about the drug is that it does have an immune sort of mechanism and perhaps we have to be a little bit more selective on the type of patients for the development, so that we can give them more of a fighting chance to mount an immune response. So those are the types of things that we are sort of looking very closely at right now.
JP: So, on that last point, that makes sense if you're looking at the immune component of bavi, I guess whether it's some cancer vaccines or immune-related types of therapies, the speculation is for others that have failed in advanced Pancreatic Cancer is that the immune systems have not had time to essentially be in engaged or activated because the patients were so far in advanced and would pass away before the immune system could be activated. So that's what you're alluding to?
Joe Shan: Yes, that's a big part of it.
SK: Just to expand on that, because I think that's one of the things we've learned over the last few years in further mechanistic studies and all the work that's been going on in the preclinical side is that there is a kind of a dual activity of the antibody, and part of it is sort of this ADCC and the kind of activity you might see early on after just the initiation of reactivating the immune system. So, that's the kind of thing that shows up in tumor response rates. But clearly, the survival benefit is probably mediated through more of boosting the immune system, allowing the immune system to really build up a robust immune response. And what we're talking about here is that it takes a number of doses to get to that point. So, we look forward to being able to talk about some of the subset data and how we view the program going forward. But certainly, by selecting a slightly healthier patient population as has been done with most of the other studies which have had recent readouts, you're going to automatically start to extend that sort of time-to-progression and thereby the number of doses the patients can receive. Then, I think one of the other beauties of this drug is with the positive safety profile and the fact that we believe any of these chemotherapy combinations will up regulate the target, combining this with now more effective combinations, such as the Abraxane combination, now even further extends that runway of getting doses in and stimulating the immune system. So, we're really anxious now to get together with our advisors and determine the next steps for the program, but I think there's a lot of really positive things we learned from this study and we can employ in the next study.

2. Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
Congratulations on the progress in the qtr as well as the Avid revenues. My question is on bavi in 2nd-Line Lung. You mentioned going to the EOP2 meeting with the agency and possibly proposing an approx. 600-pt trial. Can you share with us addl. information on the powering assumptions that you have there in terms of at least kind of the magnitude of benefit that you'd expect to be able to show out of that size of a trial?
SK: I think that it's probably premature to come out with too many details on what we're considering here. I think we certainly want to put our best foot forward and put together a plan and present that to the FDA that they will be able to accept. If you look at the std. powering assumptions of other Phase III trials, it's going to be in the same range as those studies are. But, until we have a chance to get some initial feedback from the agency, we probably would want to hold off on announcing too much and sort of putting that out there into people's thinking before we've had a chance to fully vet it out.
CD: That said, Steve, or Joe, perhaps, when you look at the Phase II and the standard idea is to reduce a little bit in terms of the expectations for the magnitude of benefit, have you taken that similar conservative approach and looked at the magnitude of benefit that you saw in Phase II and cut it by some amount to design your Phase III?
Joe Shan: Yes, there's definitely that factored into the powering assumptions. Most Phase II’s that are positive and move into Phase III’s, are not replicated at that magnitude difference, so we recognize that. You really have to factor in a larger study and perhaps in some sense, a broader total exposure that you can't be quite as bullish.
SK: Just to expand on that. Basically, we feel like we've taken a pretty conservative approach to the data analysis by including in the combined control arm, both placebo and patients that were receiving active drug, and so that probably becomes something of a buffer when considering just that aspect. And then, as Joe said, on top of that, we're still going one step further and that is planning a Phase III trial that would easily meet that goal, plus some buffering additional built in.
CD: OK. And then you mentioned possibly presenting a full dataset at a clinical meeting coming up. Is it possible that it could be ASCO or would it be ESMO or something along those lines? I realize that you probably haven't had abstracts actually, accepted yet, but is that a possibility?”
Joe Shan: Yes, it's certainly a possibility.
CD: And then, I guess I assumed that with regard to the Pancreatic Cancer trial that you just spoke of, as well as the 1st-Line Lung cancer trial, you used vendors or CRO’s than you used in the 2nd-Line trial?
SK: While we've certainly used some of the same vendors, I think there's just a basic difference in the trial design of the 2nd-Line study vs. the other studies. The 2nd-Line study, if you remember, was double-blind & placebo controlled, which means that there was actually an extra step in which there were vials that were labeled in and every patient received a study drug plus the chemotherapy in the study, whether it was placebo, low-dose, or high-dose bavituximab. In the open label studies, the pancreatic study, as well as the Front-Line NSCLC study, while those were randomized, they were not placebo controlled, so basically, there was only 1 dosage that was provided for patients. So, not the same opportunities for the same sorts of things we saw in the 2nd-Line study.
CD: That make sense. Finally, my last question on the IST’s. First of all, have you been talking to the investigators about how those are going, and are there any settings that you're particularly intrigued with and would look forward to reading out at, at say, ASCO or something like that?
Joe Shan: I think we're definitely intrigued by it, by all the ones we support that have the potential to lead to some company-sponsored indications. But, I think we are really interested in the one with Sorafenib with HCC [Liver Cancer/UTSW http://clinicaltrials.gov/ct2/show/NCT01264705 ]. That's a fairly large study at the end of the day; it's enrolling well. And, there's a HER2- breast study that’s interesting, given that we have prior Phase II data in breast cancer that were very promising. I think the [bavi] combination with pemetrexed in Front-Line NSCLC is also interesting given our current focus in lung cancer. Yes, we are constantly getting updates. We do monitor the enrollment and the usage, but whether data are available is really up to the investigators at this point.
SK: Charles, just to expand on that. As we think about partnering, and as you know, our stated goals have been primarily ex-US partnering, at least maintaining some commercialization rights in the U.S. Indications like Liver Cancer become potentially very important, because while it's a relatively small indication in the U.S., it's a very large indication throughout Asia, where the incidence is very high. So, it also creates more value potential in that regard as well as we're entering into partnering discussions and have ongoing partnering discussions.

3. George Zavoico (MLV): [ 2-8-10 coverage init: http://tinyurl.com/yech7gz ]
Question regarding the Pancreatic Cancer, and your discussion about the immune response and speaking about the robustness of the immune response. Was this part of a pre-specified endpoint? And how are you gauging how robust the immune response is? What exactly are you measuring in the Pancreatic Cancer patients?
SK: We have built into some of the IST trials the ability to go in and look at the maturation of the immune response as a better way to gauge that. We did not necessarily build that into the Pancreatic Cancer study itself. I think what we're alluding to is the fact that if you look in our trial, we had relatively short MOS, again, probably because of the broad nature of our entry criteria into the study. And just the fact that we know, even from preclinical studies, that it takes some time to generate and then boost what eventually turns out to be an adaptive immune response in animals that are treated with bavituximab. And so we're just extrapolating from that into the fact that we really want to ideally pick combinations & patient populations that will give us enough doses in patients to potentially achieve that robust immune response.
GZ: So are you measuring white blood cell count? Are you measuring antibodies? Or is it just an extrapolation of your expectation there and you're going to come up with some metrics going forward?
SK: It's more of an extrapolation of our experience throughout other studies and preclinical studies. And just the fact that we're recognizing much more now even than we did when we very first designed the study, that this immune stimulation component of bavituximab's activity is probably very important, particularly as it relates to overall survival, and that's kind of what you've seen with other immunotherapies as well.
GZ: Yes, that's a logical way to interpret it and to look at it going forward, and it would be really interesting to see that verified. I have another question regarding the Avid business. You say you've gotten a little bit of a backlog, are you guys running Avid now 24 hours a day? If I came in and said I need a job, I'd have to wait until your 1Q or 2Q 2014? Are you, and in that regard, are you planning some expansion?
SK: Yes, we are evaluating expansion. But the way we operate the business is we have a number of different bioreactors, size reactors. So, at any given time, even with our backlog of business, there is still adequate capacity, depending on the scale, for new clients coming in. So in fact, as you have seen, we've brought on board, not too long ago, another client. We obviously have our bavituximab production, which is also in the reactors themselves. So, there's still currently some capacity that we can continue to generate addl. revenues and create addl. projects from. But, it would really just depend on the size of the reactor, and some of them are quite booked up, and other ones are relatively available. But certainly, it's a nice growth business and we've been extremely happy with the performance this year.
GZ: And like you said, you have to make sure that you manufacture enough bavi for all the ongoing trials, and then trials you're expecting to start later on this year and next?
SK: Yes, and as Rob alluded to, the fact that a lot of the background work is making sure that - there's 2 ways to increase capacity, one is productivity of your existing cell line, which means you're just getting more per batch and then there's actually scaling up to different size. So we've been looking at that part of the business also. In fact, we're in a really strong position going into the Phase III to be able to fully support as many Phase III’s that we're likely to run and also looking in the future at commercialization.
GZ: Yes, if you increase productivity, that will certainly help your costs going forward, for sure. The event-driven Front-Line NSCLC trial, these patients, after they progress, they probably had a number of different subsequent therapies, which will also probably reflect, to some extent, and then some of them maybe have even gone into some clinical trials, I would imagine. How are you going to evaluate the overall survival of these patients based on the variety of drugs that they may have taken after they failed the Front-Line combination?
Joe Shan: Yes, I think that's a great question. And clearly, with the survival endpoint, subsequent treatment could affect the outcome. Yes, the FDA guidance basically weighs the next line of treatment as the primary driver, so our analysis will be looking at primarily what patients went on next, if anything, and if there's significant differences between 2 arms, that is a confounding factor when looking at survival.
GZ: I guess, you can group everyone, but I suppose if you have enough patients or multiple patients, I suppose, in any one particular subsequent chemotherapy, then you could maybe, whether it's 2 lines or 3 lines, you might be able to compare those, like you said, as a subgroup, is that correct?
Joe Shan: Yes, the study that we have is not terribly large. But if there are some patterns with different classes of chemotherapies, then yes, we'll be looking at sort of pooling those patients.
GZ: Of course, the most desirable result would be a difference in survival regardless of what subsequent therapy they went on?
Joe Shan: That's right.
GZ: One last question. The coding discrepancy, are you putting into place in subsequent trials any additional measures to be sure that there's no repeat?
SK: Yes, certainly, we'll be implementing corrective & preventive actions going forward. We want to make sure that, clearly, there's no possibly of this happening, as much as you can humanly control such things. We'll be looking at ways in which we can mitigate, in future clinical studies, any possibility of this happening. It's such a shocking thing to happen in a clinical study, and we certainly don't want any repeat of this experience.

4. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: I want to follow up on one of my earlier questions, and I want to ask it a little differently and I'm not sure you're going to answer it, but I'll ask anyway. The earlier question that I had was sort of like your background activities going on right now in prepping for the (EOP2) FDA meeting, and the comfort level that you have to move forward, and you did address that and Rob was very helpful, too, in addressing that. What I was going to ask is on the BP side, obviously without naming names, would you be able to provide any level of anecdotes about during your partnering discussions, the level of comfort your potential discussions are having with regard to moving forward as well?
SK: Just talking in generalities, I think everyone understands how we did our review of the data. I think everyone agrees that the way we've done the data analysis is, in the end, the most reasonable way and conservative way to analyze the data. We haven't tried to take advantage or stack things in our favor. So I think in general, there's been a comfort level with those activities, with the results. I think, as with all of us, right, I mean, they're just now looking forward to continuing the review, continuing their diligence, and looking forward to the FDA meeting next and then what is the final Phase III trial design look like and all those sort of related activities to getting ready for a Phase III study toward year end.
JP: And I guess it might be a fair assumption, whether a term sheet is ultimately signed or not, that the visibility surrounding your EOP2 meeting would be very important to a potential partner?
SK: I think naturally, everyone looks at your next kind of milestone coming up and that's just seen as the next big milestone, the meeting with the FDA, getting our plans for Phase III in front of them, getting some sort of buyoff. And just as a comfort level, it gives people more confidence as you're moving toward the Phase III study.

MR. KING’S CLOSING COMMENTS:
I'd like to thank all of you again today for joining us for the qtly. conf. call. As we outlined today, this is an exciting time for Peregrine, and we are positioned for several near-term milestones. We hope that you share our enthusiasm. I look forward to updating you over the next quarter. Thank you again.
*end*
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = == = = = = = = = = = =
3-12-13 PR: Peregrine Pharmaceuticals Reports Q3/FY2013 Financial Results and Recent Developments
• Meaningful Improvement in Median Overall Survival in Patients With 2nd-Line NSCLC Supports Advancing Bavituximab Into Phase III Development
• Contract Manufacturing Revenue Tops $17 Million for 9 Months Ended January 2013
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=747593

TUSTIN, 3/12/13: 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 2nd-Line NSCLC 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 CEO 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."

BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in 2nd-Line NSCLC:
• Recently announced updated results from its Phase II randomized, double-blind, placebo-controlled trial of bavituximab in 2nd-Line NSCLC (NSCLC).
• Promising 60% improvement in median overall survival (OS) in the 3mg/kg bavituximab plus docetaxel arm compared to the control arm and that bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.
• Additional data from the trial, including subgroup analysis and safety data, to be presented at an upcoming scientific meeting.
• Planning for a meeting with the U.S. Food and Drug Administration (FDA) in the first half of calendar year 2013 with the goal of initiating the Phase III trial by calendar year-end.

Front-Line Pancreatic Cancer:
• Recently announced data from its open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in 70 patients with previously untreated, advanced Stage IV Pancreatic Cancer.
• Enrollment included patients with poor prognosis including advanced metastatic disease with significant liver involvement and poor performance status associated with rapid disease progression.
• Results showed a more than a doubling of overall response rate (ORR) in the bavituximab-containing arm, a positive safety profile and a modest improvement in median OS.
• Additional data from the trial, including subgroup analysis and safety data, to be presented at an upcoming scientific meeting.
• Encouraging signs of activity from the trial support advancing this program, potentially in combination with new treatment options.

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:
• A randomized, open-label, Phase II clinical trial evaluating bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in 86 patients with previously untreated Stage IIIb or Stage IV NSCLC. Peregrine expects to report median OS from this trial, an event driven endpoint, in the first half of calendar year 2013.
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC.
• A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
• A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma.

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 2nd-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.

COTARA PROGRAM HIGHLIGHTS
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).

IMAGING PROGRAM HIGHLIGHTS
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.

FINANCIAL RESULTS
"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, CFO of Peregrine. "Avid generated more than $17 million in contract manufacturing revenue during the recent 9-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 4th 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 & 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 [Note: Cash-Burn was $3,597,000 – from pg.23 of 10-Q – see below], or $0.04 per basic and diluted share, for Q3/FY2013, 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 [phone] or [phone] 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 [phone], or [phone] 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. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Contact: Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. [phone] [e-mail]

 
 PEREGRINE PHARMACEUTICALS, INC. 
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 
  
                          Three Months Ended           Nine Months Ended 
                              January 31,                 January 31, 
                          2013          2012          2013          2012 
                      ------------  ------------  ------------  ------------ 
                        Unaudited     Unaudited     Unaudited     Unaudited 
 REVENUES: 
 Contract  manufacturing 
  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 
  
 COSTS AND EXPENSES: 
 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) 
                      ------------  ------------  ------------  ------------ 
  
 OTHER INCOME 
  (EXPENSE): 
 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) 
                      ============  ============  ============  ============ 
 WEIGHTED AVERAGE 
  COMMON SHARES 
  OUTSTANDING: 
   Basic and Diluted   131,489,994    87,149,770   114,726,569    78,443,114 
                      ============  ============  ============  ============ 
 BASIC AND DILUTED 
  LOSS PER COMMON 
  SHARE               $      (0.04) $      (0.13) $      (0.19) $      (0.40) 
                      ============  ============  ============  ============ 
 COMPREHENSIVE LOSS   $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000) 
                      ============  ============  ============  ============ 
  
                       PEREGRINE PHARMACEUTICALS, INC. 
                    CONDENSED CONSOLIDATED BALANCE SHEETS 
                                                 JANUARY 31,     APRIL 30, 
                                                     2013           2012 
                                                -------------  ------------- 
                                                  Unaudited 
 ASSETS 
 CURRENT ASSETS: 
   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 
                                                =============  ============= 
  
 LIABILITIES AND STOCKHOLDERS' EQUITY 
 CURRENT LIABILITIES: 
 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 
  
 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 - 133,770,614 
  and 101,421,365, respectively                       134,000        101,000 
 Note: From 10Q Cover page, “O/S Shares at 3-11-13 = 137,110,758” 
 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 
                                                =============  ============= 

Contact:
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. [phone] [e-mail]

- - - - - - - - - - - - - - - - -
Latest 10K 4-30-12 iss. 7-16-12: http://tinyurl.com/79o57b2 PR: http://tinyurl.com/c8nytow (Cash 4-30-12 $18.0mm)
Latest 10Q 1-31-13 iss. 3-12-13: http://tinyurl.com/cu2qry5 PR: http://tinyurl.com/c48osut (Cash 1-31-13 $26.3mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
The updated PPHM REVS-BY-QTR TABLE, now thru FY13/Q3 (q/e 1-31-13), per the 1-31-13 10-Q ( http://tinyurl.com/cu2qry5 ) issued 3-12-13. Deferred-Revs at 1-31-13, going fwd into FY’13/Q4 (q/e 4-30-13), total $5.06mm, down from the $6.22mm of Deferred-Revs at 10-31-12 that drove into FY’13/Q3.
• Total Revs since May’06: ($76.0mm/Avid + $24.1mm/Govt + $1.9mm/Lic.) = $102.0mm
==> Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com

 
 AVID PROFITABILITY (GROSS*) BY QTR: 
 QTR              Avid-Rev$  CostofMfg$  Gross-Profit$   GM% 
 FY13Q2 10-31-12  6,061,000   3,703,000      2,358,000   39%  
 FY13Q3  1-31-13  6,961,000   3,651,000      3,310,000   47%  
 *Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials. 
 . 
 PPHM REVENUES (in thousands)              DEFERRED                  
                  -------REVENUES-------   REVENUES  INVEN-     
 Quarter          Avid  Govt Lic.  TOTAL  Avid Govt  TORIES 
 FY07Q1  7-31-06   398     0   23    421   317    0    971 
 FY07Q2 10-31-06   636     0   48    684  1388    0   1899 
 FY07Q3  1-31-07   347     0   16    363  2202    0   1325 
 FY07Q4  4-30-07  2111     0  129   2240  1060    0   1916 
 FY08Q1  7-31-07  1621     0    4   1625  1820    0   2363 
 FY08Q2 10-31-07  1863     0   29   1892  1338    0   3500 
 FY08Q3  1-31-08  1662     0   13   1675  1434    0   2394 
 FY08Q4  4-30-08   751     0  150    901  2196    0   2900 
 FY09Q1  7-31-08  1193   324    0   1517  4021  980   4628 
 FY09Q2 10-31-08   983   958    0   1941  6472 1701   6700 
 FY09Q3  1-31-09  5778  1048    0   6826  4805 3262   5547 
 FY09Q4  4-30-09  5009  2683  175   7867  3776 3871   4707 
 FY10Q1  7-31-09  2070  4671    9   6750  5755 2332   6177 
 FY10Q2 10-31-09  5308  1510   78   6896  4260 3989   5850 
 FY10Q3  1-31-10  2945  6854   78   9877  3052   76   3861 
 FY10Q4  4-30-10  2881  1461   78   4420  2406   78   3123 
 FY11Q1  7-31-10   983  2111  115   3209  3719   47   4692  
 FY11Q2 10-31-10  3627   966   78   4671  2447   35   3555 
 FY11Q3  1-31-11  1922   882   79   2883  4300   40   3915 
 FY11Q4  4-30-11  1970   681   78   2729  5617    0   5284 
 FY12Q1  7-31-11  5439     0  216   5655  4145    0   4481 
 FY12Q2 10-31-11  4154     0   78   4232  2012    0   3178 
 FY12Q3  1-31-12  3203     0   78   3281  2552    0   2722 
 FY12Q4  4-30-12  1987     0   78   2065  3651    0   3611 
 FY13Q1  7-31-12  4135     0  116   4251  6056    0   5744 
 FY13Q2 10-31-12  6061     0   78   6139  6221    0   5426 
 FY13Q3 1-31-13   6961     0   78   7039  5061    0   4635 
 Totals:         75998 24149 1902 102049 <=since5/1/2006 
 . 
 TOTAL REV’s BY YEAR (Avid+Gov’t): 
 FY04 4-30-04  3,314 …Avid(CMO)= 3,039 (Avid-Revs don’t incl. Govt-SVCS) 
 FY05 4-30-05  4,959 …Avid(CMO)= 4,684 
 FY06 4-30-06  3,193 …Avid(CMO)= 3,005 
 FY07 4-30-07  3,708 …Avid(CMO)= 3,492 
 FY08 4-30-08  6,093 …Avid(CMO)= 5,897 
 FY09 4-30-09 18,151 …Avid(CMO)= 12,963 
 FY10 4-30-10 27,943 …Avid(CMO)= 13,204 
 FY11 4-30-11 13,492 …Avid(CMO)= 8,502 
 FY12 4-30-12 15,233 …Avid(CMO)= 14,783 
 ...Total Gov’t Revs from 7-2008 inception thru FY11Q4(Apr’11): $24.15mm 
 . 
 AVID “Total Services”: 
 AVID OUTPUT$   3rd-PARTY + PEREGRINE = TOTAL-OUTPUT$ 
 FY09  4-30-09    13mm       10mm         $23mm # 
 FY10  4-30-10    13mm       17mm         $30mm # 
 FY11  4-30-11     9mm       11mm         $19mm # 
 CY10 12-31-10 3rd/$15.3mm + Govt/$8.3mm + PPHM/$8.8mm = $32.4mm * 
 #SKing 7-12-2012 JMP/NYC Conf. (Slide27) http://tinyurl.com/csdclwb   
 *SKing 3-17-2010 RothOC/DanaPT Conf. (Slide18) http://tinyurl.com/ye9v7jq  
 . 
 PPHM’S QTLY. NET LOSS BY QTR: 
 FY08Q1  7-31-07 4,656,000  
 FY08Q2 10-31-07 6,207,000 
 FY08Q3  1-31-08 6,154,000 
 FY08Q4  4-30-08 6,159,000  
 FY09Q1  7-31-08 5,086,000 
 FY09Q2 10-31-08 4,497,000 
 FY09Q3  1-31-09 3,332,000 
 FY09Q4  4-30-09 3,609,000 
 FY10Q1  7-31-09 2,428,000 
 FY10Q2 10-31-09 2,787,000 
 FY10Q3  1-31-10 1,538,000 
 FY10Q4  4-30-10 7,741,000 
 FY11Q1  7-31-10 7,695,000 
 FY11Q2 10-31-10 7,513,000 
 FY11Q3  1-31-11 8,929,000 
 FY11Q4  4-30-11 10,014,000 
 FY12Q1  7-31-11 8,092,000 
 FY12Q2 10-31-11 12,055,000 
 FY12Q3  1-31-12 11,090,000 
 FY12Q4  4-30-12 10,882,000 
 FY13Q1  7-31-12 7,664,000 
 FY13Q2 10-31-12 8,753,000 
 FY13Q3  1-31-13 4,914,000 
 . 
 = = = = = = =  
 OPER. CASH BURNS* BY QTR(FROM THE 10-Q/K’S): 
 FY10Q1  7-31-09  2,024,000 (from 10Q pg.25)    
 FY10Q2 10-31-09  2,351,000 (Q1+Q2: 4,375,000 pg.28)   
 FY10Q3  1-31-10  1,158,000 (Q1+Q2+Q3: 5,533,000 pg.30) 
 FY10Q4  4-30-10  6,375,000 (FY’10: 11,908,000 10K pg.58) 
 FY11Q1  7-31-10  6,567,000 (from 10Q pg.24) 
 FY11Q2 10-31-10  6,167,000 (Q1+Q2: $12,734,000 pg.25) 
 FY11Q3  1-31-11  7,736,000 (Q1+Q2+Q3: $20,470,000 pg.26) 
 FY11Q4  4-30-11  8,961,000 (FY’11: 29,431,000 10K pg.54) 
 FY12Q1  7-31-11  6,984,000 (from 10Q pg.25) 
 FY12Q2 10-31-11 11,668,000 (Q1+Q2: 18,652,000 pg.25) 
 FY12Q3  1-31-12  8,490,000 (Q1+Q2+Q3: 27,142,000 pg.25) 
 FY12Q4  4-30-12 11,265,000 (FY’12: 38,407,000 10K pg.55) 
 FY13Q1  7-31-12  6,742,000 (from 10Q pg.21) 
 FY13Q2 10-31-12  6,162,000 (Q1+Q2: 12,904,000 pg.23) 
 FY13Q3  1-31-13  3,597,000 (Q1+Q2+Q3: 16,501,000 pg.23) 
 FY’09 total Op-Burn:  $14,715,000 
 FY’10 total Op-Burn:  $11,908,000 
 FY’11 total Op-Burn:  $29,431,000 
 FY’12 total Op-Burn:  $38,407,000 

*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
.
- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (fter mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-xx-13

[cjgaddy]

S.King’s Roth webcast today at 2pmPT 5pmET - link…

Mar17-20 2013: “Roth’s 25th Annual OC Growth Stock Conf.”, DanaPT, CA
http://www.roth.com/main/Page.aspx?PageID=7260

CEO Steven King’s Presentation – Roth/DanaPT CA
3-18-2013 2pmPT WEBCAST: http://ir.peregrineinc.com/events.cfm

= = = = = = = = = =
Roth Capital /Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$4.00 http://www.roth.com
. . .Universe: http://roth.bluematrix.com/docs/pdf/BLUE.pdf
. . .1-14-13: Roth raises PPHM PT 2.70=>$4.00 ("partnering discussions have new found life") http://tinyurl.com/a9t29lb
. . .1-7-13: Roth ups Neutral to BUY, PT 1.25=>$2.70 (after 2nd-Line NSCLC Review Upd) http://tinyurl.com/bfj7mva
. . .12-11-12: Roth ups PT $.70=>$1.25 after Cotara Ph3 design approval & 12-10-12/10Q-CC.
. . .9-24-12: Roth cuts PT $9=>$.70 after PPHM PR about 2nd-Line NSCLC trial data problems.
. . .9-10-12: Roth ups PT $5=>$9 ("highly encouraged by 2ndLine NSCLC clinical data") http://tinyurl.com/9blrqk7