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 (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. ( 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. (800) 987-8256 info@peregrineinc.com
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. (800) 987-8256 info@peregrineinc.com
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