6-2-16/PR: Corp.Update – Avid Expansion & Drug Development - Avid revs for FY16(fye 4-30-16) will be $44mm; since $25.6mm for 1st 3 qtrs, Q4 revs will be ~$18.4mm. Avid B/L currently $56M; guidance for FY17(fye 4-30-17) is $50-55mm. Avid II (Myford) is currently ramping up for runs for “3 current clients”. Peregrine is “in the process of designing a 3rd mfg. Facility focused on clinical manufacturing”; has already secured a 25,000sf location, and “expects the new clinical suite to be complete & ready for clinical mfg. by 1H/2017.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months".
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6-2-16: Peregrine Pharmaceuticals Provides Corporate Update Highlighting Latest Developments for Contract Manufacturing and Drug Development Businesses
*Contract Manufacturing Revenue Hits All-Time High of $44mm for FY Ended April 2016; FY 2017 Contract Manufacturing Revenue Projected Between $50-55 Million; Continued Growth Expected to Lead to Future Sustainable Profitability in 24 Months
*Drug Development Strategy to Focus on Early Stage Clinical Trials of Bavituximab and Immuno-Oncology (I-O) Combinations
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=973959
TUSTIN, June 2, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a company focused on continued revenue growth from its contract manufacturing business and developing its novel immuno-oncology products, today provided a corporate update highlighting the company's operational strategies and latest developments. The company's contract manufacturing subsidiary, Avid Bioservices, continues to experience significant organic growth, generating $44 million in revenue for fiscal year (FY) 2016 compared to $26.7 million in contract manufacturing revenue in FY 2015. Peregrine expects to continue to have double digit contract manufacturing revenue growth, and for FY 2017, the company is providing revenue guidance of $50-55 million for Avid, due in part to the revenue backlog of $56 million under committed contracts from existing clients. Peregrine expects this trend, driven by increasing client demand and several ongoing expansion initiatives, to lead to future sustainable profitability for the company in 24 months.
"The past several months have been a busy and productive time at Peregrine as we work to optimally position the company for future success with both our contract manufacturing and drug development businesses. We are very pleased that Avid exceeded its revenue projections for FY2016 and excited for what we expect will be continued growth for that business," said Steven W. King, President and CEO of Peregrine. "At the same time, we continue to work to advance our phosphatidylserine (PS)-targeting platform. In order to move toward overall profitability while continuing to generate valuable clinical data, we will focus our future development efforts on small, early stage clinical trials evaluating combinations of bavituximab and immuno-oncology (I-O) agents. This strategy will be supported through our current and future collaborations, which we believe will efficiently generate the clinical data required to identify and pursue the most valuable opportunities for bavituximab."
CONTRACTING MANUFACTURING HIGHLIGHTS:
Avid Bioservices exceeded its full FY 2016 revenue target of $40 million, generating $44 million in contract manufacturing revenue.
The company today announced full FY 2017 revenue guidance for Avid Bioservices of $50-55 million.
Avid currently has a revenue backlog of $56 million under committed contracts from existing clients.
The recently commissioned second manufacturing facility [“Myford”] has completed its initial process validation runs and is ramping up to conduct multiple new process validation runs for three current clients. Process validation is a critical element in preparing a facility to launch commercial manufacturing activities. As such, this milestone moves Peregrine a key step closer to realizing revenue from commercial production from this new manufacturing suite.
Based on significant client demand, Peregrine is in the process of designing a third manufacturing facility focused on clinical manufacturing. This suite will significantly increase the company's manufacturing capacity, with the potential to generate up to $30 million in additional revenue annually. The company has secured a 25,000 square foot location in close proximity to its current campus and expects the new clinical suite to be complete and ready for clinical manufacturing activities by the first half of calendar 2017.
In continued efforts to evolve into a fully integrated manufacturing business capable of efficiently meeting all of its clients' needs, Peregrine is in the process of exploring additional service expansion opportunities.
DRUG DEVELOPMENT HIGHLIGHTS:
The company will pursue a clinical development strategy focused on conducting small, early stage studies of bavituximab in combination with I-O agents. These trials may be conducted as part of ongoing collaborations with AstraZeneca and the National Comprehensive Cancer Network (NCCN). The goal of these trials will be to generate compelling data capable of driving partnering interest. As part of this new strategy, the company has discontinued plans to initiate further Phase II and Phase III trials.
The company continues to evaluate data from the SUNRISE trial in order to collect information that can best inform the ongoing clinical development of bavituximab. As part of these efforts, Peregrine is working closely with AstraZeneca to identify the optimal strategy for the companies' clinical development collaboration focused on combining bavituximab with AstraZeneca's PD-L1 inhibitor, durvalumab. It is expected that the initial trial in the collaboration will be a Phase I study evaluating the treatment combination in a range of solid tumors. The expected timing of initiation of any trial will be determined by the continued collection of data from the SUNRISE trial and finalization of the trial design.
Peregrine's research collaboration with the NCCN, a not-for-profit alliance of 27 of the world's leading cancer centers, is underway. The NCCN is currently accepting proposals from its member institutions and their affiliate community hospitals to conduct clinical trials combining bavituximab with I-O agents for the treatment of a range of cancers. It is expected that between two and five different clinical studies will be conducted as part of this collaboration, potentially providing Peregrine with a wealth of valuable human data to steer future development of bavituximab. While specific timing has not been established, it is expected that the first studies will be initiated in late calendar year 2016 or early 2017.
Peregrine's ongoing preclinical research collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) continues to progress as planned. Researchers at MSKCC are evaluating novel combinations of bavituximab and other relevant I-O therapeutic approaches including checkpoint inhibitors, adoptive T-cell therapy and oncogenic virus, in multiple preclinical cancer models. Initial data from these studies is expected to be presented at scientific conferences later in calendar year 2016.
FINANCIAL STRENGTH SUPPORTING ONGOING ACTIVITIES
Peregrine remains in a strong financial position to continue to execute against its operational strategies for its contract manufacturing and drug developments businesses. As of April 30, 2016, the company had $61 million in cash and cash equivalents.
ABOUT BAVITUXIMAB: A TARGETED INVESTIGATIONAL IMMUNOTHERAPY
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a company focused on continued revenue growth from its contract manufacturing business and developing its novel immuno-oncology products. The company is working to evaluate its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. Peregrine's in-house cGMP manufacturing capabilities are provided 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. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
Contacts:
Jay Carlson, Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
Stephanie Diaz (Investors), Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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AVID REVENUES/GROSS PROFIT ESCALATION PER THE 6-2-16 PR
(GP% est. at 48%, which is ACTUAL for the 3Qtrs ended 1-31-16, latest 10Q's)
FY'16/Actual (fye 4-30-16): Revs=$44.0mm, Gross-Profit=$21.2mm
FY'17/Guidance (fye 4-30-17): Revs=$52mm, Gross-Profit=$25.0mm
WHEN AVID II (“Myford” +$40mm) at Full Capacity: Revs=$88mm, Gross-Profit=$42.2mm
WHEN AVID III (25000sq Facility per 6-2-16 PR +$30mm) at Full Capacity: Revs=$118mm, Gross-Profit=$56.6mm
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AVID PROFORMA – Based on 6-2-16 PR (FY16 Revs will be: $44mm)...
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 6-2-16 Corp. update PR ( http://tinyurl.com/zntvudj ):
• Total Revs since May’06: ($173.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $199.8mm
• 6-2-16: FY'17 (May'16-Apr'17) Avid revs guidance raised to $50-55mm.
• Avid’s Gross-Profit over last 4 qtrs: $21.2mm on revs of $44.0mm (GP%=48%)
• Recall, Avid Rev$ 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$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
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%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16 18,400,000 9,600,000 8,800,000 48% <=Per 6-2-16 PR
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: 44,000,000 22,800,000 21,200,000 48%*
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
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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
FY13Q4 4-30-13 4176 0 78 4254 4171 0 4339
FY14Q1 7-31-13 4581 0 107 4688 4164 0 5679
FY14Q2 10-31-13 7354 0 0 7354 3468 0 4033
FY14Q3 1-31-14 3885 0 0 3885 4329 0 5224
FY14Q4 4-30-14 6474 0 0 6474 5241 0 5530
FY15Q1 7-31-14 5496 0 0 5496 4670 0 5998
FY15Q2 10-31-14 6263 0 37 6300 3612 0 5379
FY15Q3 1-31-15 5677 0 0 5677 5752 0 6148
FY15Q4 4-30-15 9308 0 0 9308 6630 0 6148
FY16Q1 7-31-15 9379 0 292 9671 8291 0 10457
FY16Q2 10-31-15 9523 0 0 9523 9688 0 12554
FY16Q3 1-31-16 6672 0 37 6709 15418 0 15189
FY16Q4 4-30-16 18400 0 0 18400 ?? 0 ??
Totals: 173186 24149 2453 199788 <=since5/1/2006
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AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
5-23-16: Pete Gagnon (100pubs/presentations, 12+patents, 30 pending patents) Appointed VP/Process-Services of Avid http://tinyurl.com/hg6abdq – See Oct'15: https://www.youtube.com/watch?v=JqJIH33JY8g
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
12-10-15/Avid II: Avid Expansion into MYFORD Facility now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
6-17-15: Avid’s John Haney (ex-Genentech/Pfizer) speaking at BIO-INTL’5/Philly http://tinyurl.com/pnlquu3 & http://tinyurl.com/nl4vbgk
...”Designing & Implementing Avid’s New State-of-the-Art Single-Use Facility for Late Ph.3 & Commercial Prod.” - SK: "We've seen tremendous interest for production in the new facility, both from new & existing clients"
12-10-14: Avid to Double Mfg. Capacity (“expanding client roster; potential commercial launch of bavituximab”) http://tinyurl.com/mmc3qgy & http://tinyurl.com/kmdgq8t
3-24-15: Avid Receives CMO Leadership Awards for Its Commitment to Innovation & Reliability http://tinyurl.com/psep47f
