Friday, September 09, 2016 3:58:04 PM
9-8-16 Qtly CC-Transcript, PR(Fins/Devs Q1FY17/qe7-31-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Jul16: $179.2mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $205.8mm.
Cash at 7-31-16: $44.2mm (Op. Cash Burn for q/e 7-31-16 was $9.6mm – see below).
As of Sept. 2, 2016, there were 242,381,850 shares outstanding.
There were NO ATM SALES from 7-15-16 – CURRENT(9-8-16) - see http://tinyurl.com/z9asadj
During 8/1/16-9/8/16, 68,910sh. of PREFERRED/10.5%SeriesE were sold for gross=$1,601,000 ($9,134,000 remain available).
This large post has 3 sections:
I. 9-8-16 Q1/FY17 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 7-31-16)
II. 9-8-16 PPHM Press Release: Q1/FY17 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’17 = May’16-Apr’17.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/jt7ljtf ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/vdqbf8gx
FULL TRANSCRIPT…
9-8-2016 FY’17/Q1 Earnings Conf. Call (q/e 7-31-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
CEO STEVE KING – OPENING COMMENTS:
Thanks Tim and thanks to all of you who have dialed in and to all of you who are participating via webcast today. Since the start of the FY back in May, we have steadily advanced our R&D plans, as well as our contract mfg. growth strategies. On the R&D front, we recently announced that we had achieved 2 important milestones. beginning with the recent announcement that the National Comprehensive Cancer Network (NCCN) has awarded grants to 3 investigators to support bavituximab clinical research [9-6-16: http://tinyurl.com/gutgwb5 ]. Our collaboration with the NCCN has been an important part of our strategy for advancing the bavituximab clinical program in a cost effective way. We earlier provided NCCN with a $2mm grant to support bavituximab related clinical research with no further financial obligations, and these grant awards represent the outcome of a competitive selection process for the best proposals. These studies will evaluate novel bavituximab combinations in Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma including an immunotherapy combination [Bavi + Merck’s Keytruda], which is a major focus for advancing the program.
Today, we are very pleased to announce that the topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017. Joe, Jeff, and Rob will provide more insight as part of their prepared remarks.
On the mfg. front, it remains an extraordinarily busy time. We have remained on track for initiating & completing mfg. campaigns, keeping us on track to meet our current FY revenue projections. Our strategy for growing mfg. revenues remains on track as well, continuing to generate revenues in our Franklin facility which last year generated over $40mm in revenues, generate revenues from our new Myford facility, which is already booked well into next year and has another $40mm in revenue potential, and to bring online a new clinical production facility by mid next year which will allow us to continue introducing new clients into our business and to continue bringing in 2nd products from existing clients. The new facility will add another $30mm in revenue potential, and we have already identified a number of projects that can move into this facility as soon as it is completed. Paul will discuss the Avid business in more detail, as we continue to deliver high quality products for our partners. Our ultimate goal remains to reach overall profitability within the next 21 months, and Avid will be an important driver for achieving that goal, in combination with making strategic investments in our R&D while pursuing partnerships to help advance our programs. You can already see these plans playing out, as we are on track to grow revenues significantly this year while simultaneously seeing a significant decrease in R&D spending during the quarter, even though we are continuing to advance our programs. I will now turn the call over to Joe for more details on our clinical dev. efforts.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
As Steve has stated, we are very excited to have the opportunity for a late-breaking oral presentation on the Phase III SUNRISE trial at the ESMO Congress about a month from now [Oct7-11 http://www.esmo.org/Conferences/ESMO-2016-Congress ]. Even as the trial continues to wind down, treatment, follow-up, and data collection are still ongoing for a number of patients, with some continuing to receive bavituximab over a year. At ESMO, we will be presenting both topline clinical data from the trial as well as initial results from our ongoing biomarker analysis, the results of which have been promising to-date. Because these data have been accepted for presentation at ESMO, they are under embargo until the actual presentation, but we will provide addl. details on the ESMO presentation and our findings as soon as we can. As a reminder, the biomarker program was prospectively built into the SUNRISE protocol, and is designed to help us better understand how bavituximab works and which patients may benefit most. This is a massive effort, and though there are still much ongoing sample testing and data analysis, our goal is to share these results as they become available throughout the rest of this year and into 2017.
Now turning to our collaboration with the NCCN. Just a couple of days ago, NCCN announced the oncology research program had awarded grants to 3 investigators to support clinical trials of bavituximab in combination with other therapeutics [9-6-16: http://tinyurl.com/gutgwb5 ].
*One award is for Phase I trial of sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]
*The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.
*The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.
These 3 studies align with our overall dev. strategy and will add to our knowledge about bavituximab-focused cancer treatment combinations. While we are not directly involved with these studies, we’ll be watching the progress carefully and look forward to providing an updates on the 3 NCCN trials in the coming months. That concludes my comments today. Let me now turn the call over to Rob Garnick, Head of Regulatory Affairs.
ROBERT GARNICK (Head of Reg. Affairs):
I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials. I will now turn the call over to Jeff Hutchins, VP of Preclin. Research.
JEFF HUTCHINS (VP/PreClinical Res.)
I’d first like to provide an update on our PS Exosome Program. As we announced in July [7-14-16: http://tinyurl.com/zszd4fj ], we executed a licensing agreement with UT Southwestern Medical Center for a novel exosome technology designed to detect PS-positive exosomes in a patient blood sample. It is our belief that this technology can provide clinicians with detection & monitoring information regarding the presence and the prevalence of cancer. Preliminary indep. studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS positive exosomes detected in the blood of cancer patients and the severity and extent of their disease burden. Given our in-house expertise in PS targeting, we believe that we are uniquely qualified to advance this technology. We believe there are significant opportunities to use this technology as both a complementary tool in bavituximab's ongoing development as well as more broadly as the basis for a novel cancer detection and monitoring test kit that will be the focus of partnering efforts. It is our goal to develop, optimize and validate a functional screening assay capable of detecting PS positive exosomes in a blood sample and to initiate partnering discussions for commercialization of the program in 2017. We are on track to achieve this goal and we look forward to providing further updates.
I would now like to provide an update on Peregrine's preclinical I-O focused internal efforts and our collaboration with Memorial Sloan Kettering Cancer Center. The goal of this work is to evaluate combinations of PS targeting with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anticancer treatments. These programs are advancing well and to-date, we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation. These new combinations are improving overall survival accompanied with increases in cyto-reactive T cells into the tumor tissue. This exciting new internal work will be presented at the AACR/CRI Immunotherapy Meeting in New York later this month [Sept25-28: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101 ] and at ESMO in early October [Oct7-11: http://www.esmo.org/Conferences/ESMO-2016-Congress ]. We expect the first results from our collaboration with MSK’s Wolchok Lab investigators [See MSK Collab: http://tinyurl.com/zkvebh6 ] to be presented at SITC in November [Nov9-13: http://www.sitcancer.org/2016 ] and we will provide more detailed information as that presentation becomes available. That concludes my comments today. And I will turn the call over to Paul Lytle, CFO, who will discuss the company's financial performance including additional details regarding our Avid Bioservices business.
PAUL LYTLE (CFO):
Let me shift gears now and give you a brief overview of our financials. As a backdrop, our goal is to become profitable on an overall basis within the next 21 months, and we intend to reach this goal by growing revenue from our contract mfg. business while also reducing our R&D spending. Let me first talk about our contract mfg. business. During FY2016, our Avid business has experienced substantial revenue growth with a 5-year compounded annual growth rate of 39% and yr-over-yr growth of 66%. However, revenue for Q1 was lower than expected due to delays in 3rd-party testing labs that put revenue recognition for a number of mfg. runs from Q1 to Q2 of FY2017. As a result, contract mfg. revenue for Q1 was $5.6mm, compared to $9.4mm for the same qtr last year. However, as these revenues shift, we now expect to recognize revenue in excess of $20mm in Q2/FY2017. I would also like to reaffirm our full FY2017 revenue guidance of $50-55mm, representing up to 24% and yr-over-yr growth compared to last FY. And it's important to note that our projected revenue growth is supported by current revenue backlog of $71mm under signed contacts covering services to be completed during the remainder of FY17 and into FY18. Now given our corporate goal of reaching profitability in 21 months, it is critical that we continue to grow our contract mfg. business. For this reason and coupled with the high demand for mfg. services, we are planning to construct a 3rd mfg. facility focused on products in clinical development. We believe the 3rd facility will again significantly increase our mfg. capacity and all 3 mfg. facilities will have the potential to generate in total approx. $110mm in annual revenue. We expect the new facility to be complete and ready for clinical mfg. activities by mid calendar year 2017.
Shifting gears now to expenses, let me first discuss our R&D strategy. We are focusing our internal drug development efforts on small, cost effective, early stage clinical trials designed to attract potential partners to further advance our products. We believe this strategy will not only help us achieve profitability sooner, but it could also create significant potential upside for our shareholders. As we execute on this strategy, our R&D expenses decreased 38% this qtr compared to the same prior year qtr. And if you compare R&D expenses for the current qtr ended July to the last reported qtr ended April, we saw a 47% decrease in R&D expenses. This decrease in R&D was primarily driven by lower costs associated with our Phase III SUNRISE trial combined with a decrease in related payroll & mfg. costs. Turning to cost of contract mfg., we saw a decrease in mfg. costs during Q1 in relation to the similar decrease in revenue. For G&A expenses, we saw a slight increase in Q1 as compared to the same prior year qtr as we increased our infrastructure to support the expansion of our contract mfg. business. A more detailed analysis of our statement of operations is included in our Form 10-Q that was filed today [ http://tinyurl.com/jmy77g3 ]. This concludes our prepared remarks. We would now like to open the call up for questions.
Q&A: [beg. 19:30]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to your burn rate, how do you look at the burn with regard to R&D pgms vs. expanding Avid pgms vs. expanding clinical studies?”
Steve King: We’ve been trying to find and strike a balance between growing revenues and investments on the R&D side. I think that programs like the NCCN are good examples of how we can cost effectively run a number of studies in order to gather addl. clinical data. As we get more and more information from the SUNRISE study, particularly the biomarker analysis, and other bits of information that will help guide the program, then I think we’ll have to look at how we invest in addl. clinical studies, either in conjunction with some of our collaborators or as standalone company-sponsored clinical studies. Our goal right now is to still keep things in balance and to move towards profitability. We think there is a great upside on the Avid business. Even though revenues were down this qtr because of some delays in shipping out some products, that's really an anomaly. I think you’re going to see that we continue to grow the business throughout this FY, moving into next FY when we’ll bring online our new clinical facility. So that will add more on the revenue side and that helps offset any expenditures we have. Also one of our other major initiatives is to develop enough clinical data for bavituximab that we think can bring onboard a partner who can then really help fund the program going forward. We think we can do that very effectively through smaller studies, particularly biomarker driven studies, or at least studies in which biomarkers play a major role in helping select patients and [????] outcomes.
JP: ”How can you describe over the last few months or so how your interactions with AstraZeneca have been regarding bavituximab?”
Steve King: We continue to discuss the pathway forward. What we’re trying to do is learn as much as we can from SUNRISE, because it's a great opportunity and it’s not often you get a set of data this big in which we had already prospectively built in a lot of biomarker and other types of analysis into the study. And we actually think that the data, even though it’s a docetaxel study, those results will be actually critical in advancing this in I-O combinations in the future as well. And so, it’s just gathering data, discussing the data that's available, but more data is literally coming to light on almost daily basis, it seems. And that's going to continue for the next few months., so I would say “engaged”, and at this point we just need to really find the right balance when we have enough information to clearly define what we want to do going forward.
2. Kumar Raja - Noble Life Science Partners http://noblelsp.com/research
KR: ”For the 3 awards selected by the NCCN, what was the rationale for selecting those 3 different cancers, as well as the rationale for the combinations being selected there? And how much funding is remaining for further grants by NCCN?”
Steve King: I will start and then I turn it over to Joe. So basically the NCCN process, this is a more or less consortium of 27 top medical centers in the U.S. where clinical research is performed. The way it works is, it's a competitive process - any of the institutions or investigators at the institutions can basically submit their proposals. The background data is generally based on when it has been published or what has been presented at conferences, so that becomes some of the background information. But, the process itself is about the most interesting combinations, those that will take advantage of the novel I-O mechanism of action of bavituximab, and then also trials which have the highest probability of being operationalized and successful in a given amount of time. I will turn it over to Joe for maybe some more.
Joe Shan: As Steve mentioned, this is an independent process. They follow a process very similar to an NCI grant funding process, where they look at obviously what concepts have been submitted for consideration and rank those in order of importance, not just from a scientific curiosity standpoint, but a clinical capability and a medical need standpoint as well. So that's the general process. Why those 3 specifically, that was determined by the expert committee that was assigned for this project.
Steve King : I’m very excited about the combinations that were chosen because the radiation combination is one that in preclinical studies, as was mentioned during the prepared remarks, has always shown a lot of promise. It’s great to be able to now see that put into a clinical setting in a couple of different clinical trials. And the I-O combinations, as Jeff mentioned during his prepared remarks, is a major focus of ours. So to see a Pembro [Keytruda] combination picked as well, we are just really excited that these were the 3 winners out of the selection process.
KR: ”And you talked about profitability and using collaborations to develop the pipeline. What would be the strategy there for a collaboration? Would be like equal partnership, or would it be just like Peregrine keeping the U.S. rights and having collaboration for the Ex-US? What's the strategy there for those collaborations?”
Steve King : The collaborations could go on a number of different fronts. One would be true collaborations, like clinical collaborations we’ve put in place already. It could also be more partnerships, which I think is more what you are talking about, in which we have a development partner. We have flexibility in the overall design. Our goal is to keep significant upside of the program - I feel like we’ve added a lot of value to the program and now we want to see the benefit of that down the road. But at the same time, share the risk because we’ve shared all the risk up to this point ourselves. So, someone who could actually help drive the funding forward, because recognize that it’s not just going to be just one more study that should be run when it comes to late stage clinical development, but should be multiple studies, and our goal would be to find a partner who is going to run those not just on a ex-U.S. basis, but also on worldwide basis and to help us advance the program to commercialization.
KR: Re: the biomarker analysis. What are you seeing so far? And what can we expect to see presented at ESMO (Oct7-11)?”
Steve King : Right now all the data is embargoed per the acceptance by ESMO for the oral presentation. So we’re not going to give any details at this point. Some of the other factors are of course that for novel things, intellectual property considerations that we may want to obtain in the meantime before presentation are important. So at this point, we’re not going to give any more details other than, it’ll be a nice rounded set of information available at the ESMO presentation, and we’ll will PR that as well.
3. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Good to hear that Avid is doing well and you guys have continued with the clinical progress with bavituximab. Can you remind us how will the new Avid facility be reflected in the P&L?”
Paul Lytle : We recognized $44mm in revenues last FY (fye 4-30-16) and that all came from our original Franklin facility. In March this year, we commissioned our new Myford facility which is built for late stage Phase III clinical & commercial production, and we are currently going through the motions of multiple process validation runs and those runs right now are built into our financial projections of the $50-55mm, with our goal of turning those process validation runs, which is kind of the final step before submitting something to the FDA under preapproval inspection in terms of producing commercial quantities for those clients. So this year is really a building year in terms of building those process validation runs for our clients, and then we’re hopeful that those will turn into commercial supply needs in future FY’s.
TY: ”Will the cost of that new facility be under cost of contract manufacturing?”
Paul Lytle : Yes. It's built into the cost of goods, the facility overhead, including personnel and everything else.
TY: “Can you give us some more details about the testing backlog of that 3rd-party testing lab and what are the exact reasons and how likely it could happen in the future?”
Steve King : We think it's an anomaly and so we don't expect this to be an ongoing issue. The issue is basically, the testing labs were so busy, there was a backlog or line to get into the queue to actually get the testing completed. Of course, we can't release lots without all the testing results and we can't ship them until they are released, and that's the reason that it hit the bottom line this quarter. We think it’s an anomaly. It's nothing to do with testing results, per se, for the lots. it’s really just getting them in the line to get the testing done and that's the reason we are projecting that Q2 [q/e 10-31-16] will be such a big quarter, because now that backlog seems to have worked itself out and we’ve worked it into our planning to give ourselves a little bit more time. And so we think it's hopefully something that's behind us. Of course, we can't control all the 3rd-party laboratories, but we are certainly working directly with them as well to ensure that we are able to maintain a high priority for them because we do generate a significant amount of business for a lot of our vendors.
TY: ”Re: NCCN trials, from this point on, what addl. info or resources are required from your end?”
Steve King : Basically, that's one of the beauties of working with NCCN - they actually run the clinical studies themselves. So, they take care of all the database management, all the site visits, start up, all that stuff is handled through the consortium. For us at this point, it's just more being supportive of their efforts. One of the things that we would potentially want to help out on will be some of the biomarker-type testing, particularly as we learn more from the SUNRISE study, building those into some of the clinical trials as they make sense, so they can collect samples that can be tested and then we can add that to our database in conjunction with the rest of our biomarker testing plans. Other than that, our only other obligation is to provide bavituximab for the clinical trials, and as we have discussed before, we have a stockpile of that, so that's not really an issue at this point.
MR. KING’S CLOSING COMMENTS:
I want to thank all of you again for participating in today's phone call. As always, I want to thank our stockholders for their continued support and I would like to especially thank our patients, their families and the investigators that are participating in our bavituximab clinical trials. With that, we will conclude the call.
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9-8-15 PR: Peregrine Pharmaceuticals Reports Financial Results for First Quarter of Fiscal Year 2017 and Recent Developments
– SUNRISE Top-line Data Accepted for Late-Breaking Oral Presentation at European Society of Medical Oncology Congress in October 2016
-- Avid First Quarter Revenue of $5.6 Million with Over $20 Million in Revenue Projected in Second Quarter
-- Company Reaffirms Revenue Projection of $50-55 Million for Full FY 2017 with Growing Backlog of Business Currently at $71 Million
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=988439
TUSTIN, Sept. 8, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced financial results for the first quarter of fiscal year (FY) 2017 ended July 31, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.
HIGHLIGHTS SINCE APRIL 30, 2016
"Since the start of our first quarter, we have steadily executed on our R&D and contract manufacturing objectives. On the R&D front, we recently achieved two important milestones beginning with the recent announcement [9-6-16: http://tinyurl.com/gutgwb5 ] that the National Comprehensive Cancer Network (NCCN) has awarded grants to three investigators to support bavituximab clinical research. In addition, we are pleased to announce today, that top-line data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming meeting of the European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October," stated Steven W. King, President and CEO of Peregrine. "The presentation at ESMO [Oct7-11-16: http://www.esmo.org/Conferences/ESMO-2016-Congress ] will be a great opportunity to share clinical data from the trial in conjunction with initial results from our ongoing biomarker analyses which are already highly encouraging. The primary goal of the biomarker analysis is to identify a biomarker pattern for patients that receive the most benefit from a bavituximab-containing therapeutic regimen and we look forward to sharing the results of the ongoing analysis with more data expected later in the year. Our collaboration with the NCCN has been an important part of our plans for advancing the bavituximab clinical program in a cost effective way. The grants that were awarded represent clinical trials with novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination, which is a major focus for advancing the program. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017."
Mr. King continued, "On the manufacturing front, it remains an extraordinarily busy time. Based on the high demand for services, we remain on track to meet our current fiscal year revenue projections as we look to continue growing the business. Our ultimate goal remains to reach overall profitability within the next 21 months and Avid will be an important driver for achieving that goal in combination with making strategic investments in R&D while pursuing partnerships to help advance our programs."
AVID BIOSERVICES HIGHLIGHTS
"Our biomanufacturing business was extremely busy this past quarter as the team remained on track according to the planned production schedule including initiating several process validation runs and ongoing commercial manufacturing activities. Despite being on track from a production standpoint, first quarter FY 2017 revenues were lower than expected due to a testing backlog at a third-party testing laboratory that delayed the shipment of manufacturing runs. As a result of the backlog being resolved, we expect revenue to exceed $20 million in the second quarter as we shift revenue recognition from the first quarter to the second quarter of fiscal year 2017. We believe this delay to be an anomaly, and we reaffirm our revenue guidance of between $50 and $55 million for the full fiscal year," stated Paul Lytle, CFO of Peregrine.
The company is projecting manufacturing revenue for the full FY 2017 of $50-$55 million.
Avid's current manufacturing revenue backlog is $71 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog covers revenue to be recognized during the remainder of fiscal year 2017 and into fiscal year 2018.
In response to demand for manufacturing services, the company is designing a third manufacturing facility dedicated to clinical manufacturing that is anticipated to significantly increase Avid's manufacturing capacity. The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid calendar year 2017.
CLINICAL DEVELOPMENT HIGHLIGHTS
SUNRISE top-line data, including initial biomarker profile data, have been accepted for oral presentation at the European Society of Medical Oncology (ESMO) Congress in October 2016.
Peregrine's research collaboration with NCCN is advancing as planned, with grants awarded to 3 investigators to support research of bavituximab in combination with other therapeutics for the following studies:
1. Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma
2. Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma
3. Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The company expects these trials to begin in early calendar year 2017.
RESEARCH HIGHLIGHTS
Our internal efforts and collaboration with Memorial Sloan Kettering Cancer Center continues to advance. The goal of this pre-clinical work is to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. We expect initial results from our internal work and this collaboration to be presented at multiple conferences during the Fall of 2016.
Peregrine in-licensed a novel exosome technology from UT Southwestern [7-14-16: http://tinyurl.com/zszd4fj ] that has potential for cancer detection and monitoring applications. This technology aligns directly with the company's expertise, its proprietary PS-targeting platform and the bavituximab development program. As such, there are opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts.
FINANCIAL RESULTS
Total revenues for the first quarter of FY 2017 were $5,609,000, compared to $9,671,000 for the same quarter of the prior fiscal year. The first quarter FY 2017 decrease in revenues was primarily attributed to a decrease in contract manufacturing revenue.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients decreased to $5,609,000 for the first quarter of FY 2017 compared to $9,379,000 for the first quarter of FY 2016. The first quarter decrease was primarily due to a backlog at a third-party testing lab and unrelated to product quality that shifted the timing of revenue recognition from the first quarter to the second quarter of fiscal year 2017. The company does not expect this delay to further impact revenue projections for the fiscal year, and the company remains on track to generate revenue in excess of $20 million in the second quarter FY 2017.
Total costs and expenses for the first quarter of FY 2017 were $16,691,000, compared to $23,425,000 for the first quarter of FY 2016. This decrease for the first quarter of FY 2017 was primarily attributable to a decrease in research and development expenses associated with the Phase III SUNRISE trial combined with a decrease in personnel cost and manufacturing costs related to preparing bavituximab for commercial manufacturing.
For the first quarter of FY 2017, research and development expenses decreased 38% to $8,569,000, compared to $13,918,000 for the first quarter of FY 2016. In addition, cost of contract manufacturing decreased to $3,062,000 in the first quarter of FY 2017 compared to $4,608,000 for the first quarter of FY 2016, primarily due to lower reported revenue compared to the same prior year period. For the first quarter of FY 2017, selling, general and administrative expenses were $5,060,000 compared to $4,899,000 for the first quarter of FY 2016.
Peregrine's consolidated net loss attributable to common stockholders was $12,437,000 or $0.05 per share, for the first quarter of FY 2017, compared to a net loss attributable to common stockholders of $15,101,000, or $0.08 per share, for the same prior year quarter.
Peregrine reported $44,195,000 in cash and cash equivalents as of July 31, 2016, compared to $61,412,000 at fiscal year ended April 30, 2016.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/jmy77g3 ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, September 8, 2016, 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. 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 committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit http://www.avidbio.com .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED
JULY 31,
2016 2015
REVENUES :
Contract manufacturing revenue $ 5,609,000 $ 9,379,000
License revenue — 292,000
Total revenues 5,609,000 9,671,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,062,000 4,608,000
Research and development 8,569,000 13,918,000
Selling, general and administrative 5,060,000 4,899,000
Total costs and expenses 16,691,000 23,425,000
LOSS FROM OPERATIONS (11,082,000 ) (13,754,000 )
Interest and other income 25,000 31,000
NET LOSS $ (11,057,000 ) $ (13,723,000 )
Comprehensive loss $ (11,057,000 ) $ (13,723,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,378,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (12,437,000 ) $ (15,101,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
Basic and diluted 239,595,089 197,317,374
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.05 ) $ (0.08 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JULY 31,
2016 APRIL 30,
2016
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 44,195,000 $ 61,412,000
Trade and other receivables 7,537,000 2,859,000
Inventories 25,274,000 16,186,000
Prepaid expenses and other current assets 1,235,000 1,351,000
Total current assets 78,241,000 81,808,000
Property and equipment, net 24,261,000 24,302,000
Restricted cash 600,000 600,000
Other assets 2,502,000 2,333,000
TOTAL ASSETS $ 105,604,000 $ 109,043,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 9,095,000 $ 8,429,000
Accrued clinical trial and related fees 6,577,000 7,594,000
Accrued payroll and related costs 3,653,000 5,821,000
Deferred revenue 21,531,000 10,030,000
Customer deposits 21,731,000 24,212,000
Other current liabilities 669,000 1,488,000
Total current liabilities 63,256,000 57,574,000
Deferred rent, less current portion 1,414,000 1,395,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares;
1,577,440 and 1,577,440 issued and outstanding at July 31, 2016
and April 30, 2016, respectively 2,000 2,000
Common stock - $0.001 par value; authorized 500,000,000 shares;
241,456,721 and 236,930,485 issued and outstanding at July 31,
2016 and April 30, 2016, respectively 241,000 237,000
Additional paid-in capital 561,024,000 559,111,000
Accumulated deficit (520,333,000 ) (509,276,000 )
Total stockholders' equity 40,934,000 50,074,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 105,604,000 $ 109,043,000
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
- - - - - - - - -
[From 10-Q header: “As of Sept. 2 2016, there were 242,381,850 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-16 iss. 7-14-16 http://tinyurl.com/zgognwz PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 7-31-16 iss. 9-8-16 http://tinyurl.com/jmy77g3 PR: http://tinyurl.com/jydtkoy (Cash 7-31-16=$44.2mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
FY'17/Q1(qe 7-310-16) PR: The company is projecting mfg. revenue for the full FY’17 of $50-55mm. Avid's current backlog is $71mm (committed contracts). In response to demand for mfg. services, the company is designing a 3rd mfg. Facility dedicated to clinical mfg. that is anticipated to significantly increase Avid's mfg. capacity. The new clinical suite is expected to be complete & ready for clinical mfg. activities by mid 2017.
- - - - - - - - - -
Updated PPHM REVS-BY-QTR TABLE, now thru FY17'Q1(qe 7-31-16), per the 7-31-16 10-Q ( http://tinyurl.com/jmy77g3 ) issued 9-8-16.
• Total Revs since May’06: ($179.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $205.8mm
• 9-8-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$71mm).
• Deferred-Revs at 7-31-16 total $21.5mm, UP from $10.0mm at 4-30-16.
• Cust.Deposits at 7-31-16 total $21.7mm, DOWN from $24.2mm at 4-30-16.
• Inventories at 7-31-16 total $25.3mm, UP from $16.2mm at 4-30-16.
• Avid’s Gross-Profit over last 4 qtrs: $19.2mm on revs of $40.6mm (GP%=47%)
• Recall, Avid Rev$ 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
*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 (after 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. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
FY’15-Q2 = q/e 10-31-14 – rep. 12-10-14 Wed (after mkt)
FY’15-Q3 = q/e 1-31-15 – rep. 3-12-15 Thu (after mkt)
FY’15-Q4 = q/e 4-30-15 – rep. 7-14-15 Tue (after mkt)
FY’16-Q1 = q/e 7-31-15 – rep. 9-9-15 Wed (after mkt)
FY’16-Q2 = q/e 10-31-15 – rep. 12-10-15 Thu (after mkt)
FY’16-Q3 = q/e 1-31-16 – rep. 3-9-16 Wed (B4 mkt)
FY’16-Q4 = q/e 4-30-16 – rep. 7-14-16 Thu (after mkt)
FY’17-Q1 = q/e 7-31-16 – rep. 9-8-16 Thu (after mkt)
= = = = = = = = = = = =
“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 & 2015 10-K's: http://tinyurl.com/p58jcbw etc...=> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
CASH a/o 1-31-15: $55.2mm
CASH a/o 4-30-15: $68.0mm
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
CASH a/o 4-30-16: $61.4mm
CASH a/o 7-31-16: $44.2mm
= = = = = = = = = = A look at #Employees per the 10K’s…
2011 10-K: "As of 4-30-11, we employed 154 full-time emps & 2 part-time emps”
2012 10-K: "As of 4-30-12, we employed 172 full-time emps & 2 part-time emps."
2013 10-K: "As of 4-30-13, we employed 182 full-time emps & 5 part-time emps."
2014 10-K: "As of 4-30-14, we employed 180 full-time emps & 4 part-time emps."
2015 10-K: "As of 4-30-15, we employed 211 full-time emps & 4 part-time emps."
2016 10-K: "As of 4-30-16, we employed 281 full-time emps & 3 part-time emps."
= = = = = = = = = = = = = = = = = =
9-9-16: FBR Analyst Thomas Yip Reiterates Outperform on Peregrine (PPHM) Following F1Q17: “…A negative for the biotech firm, PPHM revealed that a hopefully 1-time only backlog from a 3rd-party testing lab resulted in delayed revenue recognition. Revenue of $5.6mm for the qtr fell vastly below Yip’s projected $11.2mm, but mgt. indicates plans for shortfall recovery by next quarter, with a $20mm forecast outclassing Yip’s prior est. of $11.4mm. Peregrine maintained previous guidance for the FY2017 of $50-55 million for its contract mfg. subsidiary Avid Bioservices. Yip asserts, “Therefore, we do not believe this abnormality will affect Avid’s long-term growth prospects. On the clinical front, we look forward to learning more about bavituximab responders from a biomarker analysis that is part of the Phase III SUNRISE trial, to be presented at a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) Congress on Oct. 7–11, 2016. We continue to think PPHM shares are currently undervalued given Avid’s growth potential and bavituximab’s potential as an immuno-oncology treatment combination,” Yip added.
9-6-16: NCCN to Initiate 3 Bavi-Trials Early’17 (Moffitt,MassGEN,JohnHopkins) http://tinyurl.com/gutgwb5
=> Ph1/HepC-Related-Hepatocellular/MOFFITT, Ph1-2/Glioblastoma/MASS-GEN, Ph2/Head+Neck/JOHN-HOPKINS
7-14-16 Qtly. Conf. Call (King/Garnick/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/h8eqtg5 (Avid revs guidance for FY17=$50-55mm, curr. committed B/L=$68mm)
...CEO SK: “The recent licensing of Novel PS Exosome Tech. for detection/monitoring of cancer from UTSW will allow the co. to continue its R&D activities with significant upside coming from partnering as we move towards profitability.”
EXOSOME-BASED CANCER DETECTION & MONITORING TECHNOLOGY ("Liquid Biopsy") - Excellent Exosome info: http://www.exosome-rna.com
7-14-16: Peregrine Licenses Exosome-based technology from UTSW (Inventors: Alan Schroit/Philip Thorpe) http://tinyurl.com/zszd4fj
...“relates to assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample as a way to detect cancer at a very early stage of development.”
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
...Avid Revs for FY16(fye 4-30-16) will be $44mm; B/L=$56M; FY17/guidance=$50-55mm(3 curr. clients). Avid III being designed/already secured 25,000sf loc/expect complete=1H/2017. “Expect future sustainable profitability for the company in 24mos.”
3-9-16 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/gom7md5
...CEO SK: “Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomfg. business... We believe our relationships with AstraZeneca, Mem. Sloan Kettering, UTSW, & NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers.”
3-7-16: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
2-25-16: IDMC Halts Ph.3/NSCLC SUNRISE Trial at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm
=> Total Revs May06-Jul16: $179.2mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $205.8mm.
Cash at 7-31-16: $44.2mm (Op. Cash Burn for q/e 7-31-16 was $9.6mm – see below).
As of Sept. 2, 2016, there were 242,381,850 shares outstanding.
There were NO ATM SALES from 7-15-16 – CURRENT(9-8-16) - see http://tinyurl.com/z9asadj
During 8/1/16-9/8/16, 68,910sh. of PREFERRED/10.5%SeriesE were sold for gross=$1,601,000 ($9,134,000 remain available).
This large post has 3 sections:
I. 9-8-16 Q1/FY17 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 7-31-16)
II. 9-8-16 PPHM Press Release: Q1/FY17 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’17 = May’16-Apr’17.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/jt7ljtf ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/vdqbf8gx
FULL TRANSCRIPT…
9-8-2016 FY’17/Q1 Earnings Conf. Call (q/e 7-31-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
CEO STEVE KING – OPENING COMMENTS:
Thanks Tim and thanks to all of you who have dialed in and to all of you who are participating via webcast today. Since the start of the FY back in May, we have steadily advanced our R&D plans, as well as our contract mfg. growth strategies. On the R&D front, we recently announced that we had achieved 2 important milestones. beginning with the recent announcement that the National Comprehensive Cancer Network (NCCN) has awarded grants to 3 investigators to support bavituximab clinical research [9-6-16: http://tinyurl.com/gutgwb5 ]. Our collaboration with the NCCN has been an important part of our strategy for advancing the bavituximab clinical program in a cost effective way. We earlier provided NCCN with a $2mm grant to support bavituximab related clinical research with no further financial obligations, and these grant awards represent the outcome of a competitive selection process for the best proposals. These studies will evaluate novel bavituximab combinations in Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma including an immunotherapy combination [Bavi + Merck’s Keytruda], which is a major focus for advancing the program.
Today, we are very pleased to announce that the topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017. Joe, Jeff, and Rob will provide more insight as part of their prepared remarks.
On the mfg. front, it remains an extraordinarily busy time. We have remained on track for initiating & completing mfg. campaigns, keeping us on track to meet our current FY revenue projections. Our strategy for growing mfg. revenues remains on track as well, continuing to generate revenues in our Franklin facility which last year generated over $40mm in revenues, generate revenues from our new Myford facility, which is already booked well into next year and has another $40mm in revenue potential, and to bring online a new clinical production facility by mid next year which will allow us to continue introducing new clients into our business and to continue bringing in 2nd products from existing clients. The new facility will add another $30mm in revenue potential, and we have already identified a number of projects that can move into this facility as soon as it is completed. Paul will discuss the Avid business in more detail, as we continue to deliver high quality products for our partners. Our ultimate goal remains to reach overall profitability within the next 21 months, and Avid will be an important driver for achieving that goal, in combination with making strategic investments in our R&D while pursuing partnerships to help advance our programs. You can already see these plans playing out, as we are on track to grow revenues significantly this year while simultaneously seeing a significant decrease in R&D spending during the quarter, even though we are continuing to advance our programs. I will now turn the call over to Joe for more details on our clinical dev. efforts.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
As Steve has stated, we are very excited to have the opportunity for a late-breaking oral presentation on the Phase III SUNRISE trial at the ESMO Congress about a month from now [Oct7-11 http://www.esmo.org/Conferences/ESMO-2016-Congress ]. Even as the trial continues to wind down, treatment, follow-up, and data collection are still ongoing for a number of patients, with some continuing to receive bavituximab over a year. At ESMO, we will be presenting both topline clinical data from the trial as well as initial results from our ongoing biomarker analysis, the results of which have been promising to-date. Because these data have been accepted for presentation at ESMO, they are under embargo until the actual presentation, but we will provide addl. details on the ESMO presentation and our findings as soon as we can. As a reminder, the biomarker program was prospectively built into the SUNRISE protocol, and is designed to help us better understand how bavituximab works and which patients may benefit most. This is a massive effort, and though there are still much ongoing sample testing and data analysis, our goal is to share these results as they become available throughout the rest of this year and into 2017.
Now turning to our collaboration with the NCCN. Just a couple of days ago, NCCN announced the oncology research program had awarded grants to 3 investigators to support clinical trials of bavituximab in combination with other therapeutics [9-6-16: http://tinyurl.com/gutgwb5 ].
*One award is for Phase I trial of sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]
*The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.
*The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.
These 3 studies align with our overall dev. strategy and will add to our knowledge about bavituximab-focused cancer treatment combinations. While we are not directly involved with these studies, we’ll be watching the progress carefully and look forward to providing an updates on the 3 NCCN trials in the coming months. That concludes my comments today. Let me now turn the call over to Rob Garnick, Head of Regulatory Affairs.
ROBERT GARNICK (Head of Reg. Affairs):
I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials. I will now turn the call over to Jeff Hutchins, VP of Preclin. Research.
JEFF HUTCHINS (VP/PreClinical Res.)
I’d first like to provide an update on our PS Exosome Program. As we announced in July [7-14-16: http://tinyurl.com/zszd4fj ], we executed a licensing agreement with UT Southwestern Medical Center for a novel exosome technology designed to detect PS-positive exosomes in a patient blood sample. It is our belief that this technology can provide clinicians with detection & monitoring information regarding the presence and the prevalence of cancer. Preliminary indep. studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS positive exosomes detected in the blood of cancer patients and the severity and extent of their disease burden. Given our in-house expertise in PS targeting, we believe that we are uniquely qualified to advance this technology. We believe there are significant opportunities to use this technology as both a complementary tool in bavituximab's ongoing development as well as more broadly as the basis for a novel cancer detection and monitoring test kit that will be the focus of partnering efforts. It is our goal to develop, optimize and validate a functional screening assay capable of detecting PS positive exosomes in a blood sample and to initiate partnering discussions for commercialization of the program in 2017. We are on track to achieve this goal and we look forward to providing further updates.
I would now like to provide an update on Peregrine's preclinical I-O focused internal efforts and our collaboration with Memorial Sloan Kettering Cancer Center. The goal of this work is to evaluate combinations of PS targeting with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anticancer treatments. These programs are advancing well and to-date, we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation. These new combinations are improving overall survival accompanied with increases in cyto-reactive T cells into the tumor tissue. This exciting new internal work will be presented at the AACR/CRI Immunotherapy Meeting in New York later this month [Sept25-28: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101 ] and at ESMO in early October [Oct7-11: http://www.esmo.org/Conferences/ESMO-2016-Congress ]. We expect the first results from our collaboration with MSK’s Wolchok Lab investigators [See MSK Collab: http://tinyurl.com/zkvebh6 ] to be presented at SITC in November [Nov9-13: http://www.sitcancer.org/2016 ] and we will provide more detailed information as that presentation becomes available. That concludes my comments today. And I will turn the call over to Paul Lytle, CFO, who will discuss the company's financial performance including additional details regarding our Avid Bioservices business.
PAUL LYTLE (CFO):
Let me shift gears now and give you a brief overview of our financials. As a backdrop, our goal is to become profitable on an overall basis within the next 21 months, and we intend to reach this goal by growing revenue from our contract mfg. business while also reducing our R&D spending. Let me first talk about our contract mfg. business. During FY2016, our Avid business has experienced substantial revenue growth with a 5-year compounded annual growth rate of 39% and yr-over-yr growth of 66%. However, revenue for Q1 was lower than expected due to delays in 3rd-party testing labs that put revenue recognition for a number of mfg. runs from Q1 to Q2 of FY2017. As a result, contract mfg. revenue for Q1 was $5.6mm, compared to $9.4mm for the same qtr last year. However, as these revenues shift, we now expect to recognize revenue in excess of $20mm in Q2/FY2017. I would also like to reaffirm our full FY2017 revenue guidance of $50-55mm, representing up to 24% and yr-over-yr growth compared to last FY. And it's important to note that our projected revenue growth is supported by current revenue backlog of $71mm under signed contacts covering services to be completed during the remainder of FY17 and into FY18. Now given our corporate goal of reaching profitability in 21 months, it is critical that we continue to grow our contract mfg. business. For this reason and coupled with the high demand for mfg. services, we are planning to construct a 3rd mfg. facility focused on products in clinical development. We believe the 3rd facility will again significantly increase our mfg. capacity and all 3 mfg. facilities will have the potential to generate in total approx. $110mm in annual revenue. We expect the new facility to be complete and ready for clinical mfg. activities by mid calendar year 2017.
Shifting gears now to expenses, let me first discuss our R&D strategy. We are focusing our internal drug development efforts on small, cost effective, early stage clinical trials designed to attract potential partners to further advance our products. We believe this strategy will not only help us achieve profitability sooner, but it could also create significant potential upside for our shareholders. As we execute on this strategy, our R&D expenses decreased 38% this qtr compared to the same prior year qtr. And if you compare R&D expenses for the current qtr ended July to the last reported qtr ended April, we saw a 47% decrease in R&D expenses. This decrease in R&D was primarily driven by lower costs associated with our Phase III SUNRISE trial combined with a decrease in related payroll & mfg. costs. Turning to cost of contract mfg., we saw a decrease in mfg. costs during Q1 in relation to the similar decrease in revenue. For G&A expenses, we saw a slight increase in Q1 as compared to the same prior year qtr as we increased our infrastructure to support the expansion of our contract mfg. business. A more detailed analysis of our statement of operations is included in our Form 10-Q that was filed today [ http://tinyurl.com/jmy77g3 ]. This concludes our prepared remarks. We would now like to open the call up for questions.
Q&A: [beg. 19:30]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to your burn rate, how do you look at the burn with regard to R&D pgms vs. expanding Avid pgms vs. expanding clinical studies?”
Steve King: We’ve been trying to find and strike a balance between growing revenues and investments on the R&D side. I think that programs like the NCCN are good examples of how we can cost effectively run a number of studies in order to gather addl. clinical data. As we get more and more information from the SUNRISE study, particularly the biomarker analysis, and other bits of information that will help guide the program, then I think we’ll have to look at how we invest in addl. clinical studies, either in conjunction with some of our collaborators or as standalone company-sponsored clinical studies. Our goal right now is to still keep things in balance and to move towards profitability. We think there is a great upside on the Avid business. Even though revenues were down this qtr because of some delays in shipping out some products, that's really an anomaly. I think you’re going to see that we continue to grow the business throughout this FY, moving into next FY when we’ll bring online our new clinical facility. So that will add more on the revenue side and that helps offset any expenditures we have. Also one of our other major initiatives is to develop enough clinical data for bavituximab that we think can bring onboard a partner who can then really help fund the program going forward. We think we can do that very effectively through smaller studies, particularly biomarker driven studies, or at least studies in which biomarkers play a major role in helping select patients and [????] outcomes.
JP: ”How can you describe over the last few months or so how your interactions with AstraZeneca have been regarding bavituximab?”
Steve King: We continue to discuss the pathway forward. What we’re trying to do is learn as much as we can from SUNRISE, because it's a great opportunity and it’s not often you get a set of data this big in which we had already prospectively built in a lot of biomarker and other types of analysis into the study. And we actually think that the data, even though it’s a docetaxel study, those results will be actually critical in advancing this in I-O combinations in the future as well. And so, it’s just gathering data, discussing the data that's available, but more data is literally coming to light on almost daily basis, it seems. And that's going to continue for the next few months., so I would say “engaged”, and at this point we just need to really find the right balance when we have enough information to clearly define what we want to do going forward.
2. Kumar Raja - Noble Life Science Partners http://noblelsp.com/research
KR: ”For the 3 awards selected by the NCCN, what was the rationale for selecting those 3 different cancers, as well as the rationale for the combinations being selected there? And how much funding is remaining for further grants by NCCN?”
Steve King: I will start and then I turn it over to Joe. So basically the NCCN process, this is a more or less consortium of 27 top medical centers in the U.S. where clinical research is performed. The way it works is, it's a competitive process - any of the institutions or investigators at the institutions can basically submit their proposals. The background data is generally based on when it has been published or what has been presented at conferences, so that becomes some of the background information. But, the process itself is about the most interesting combinations, those that will take advantage of the novel I-O mechanism of action of bavituximab, and then also trials which have the highest probability of being operationalized and successful in a given amount of time. I will turn it over to Joe for maybe some more.
Joe Shan: As Steve mentioned, this is an independent process. They follow a process very similar to an NCI grant funding process, where they look at obviously what concepts have been submitted for consideration and rank those in order of importance, not just from a scientific curiosity standpoint, but a clinical capability and a medical need standpoint as well. So that's the general process. Why those 3 specifically, that was determined by the expert committee that was assigned for this project.
Steve King : I’m very excited about the combinations that were chosen because the radiation combination is one that in preclinical studies, as was mentioned during the prepared remarks, has always shown a lot of promise. It’s great to be able to now see that put into a clinical setting in a couple of different clinical trials. And the I-O combinations, as Jeff mentioned during his prepared remarks, is a major focus of ours. So to see a Pembro [Keytruda] combination picked as well, we are just really excited that these were the 3 winners out of the selection process.
KR: ”And you talked about profitability and using collaborations to develop the pipeline. What would be the strategy there for a collaboration? Would be like equal partnership, or would it be just like Peregrine keeping the U.S. rights and having collaboration for the Ex-US? What's the strategy there for those collaborations?”
Steve King : The collaborations could go on a number of different fronts. One would be true collaborations, like clinical collaborations we’ve put in place already. It could also be more partnerships, which I think is more what you are talking about, in which we have a development partner. We have flexibility in the overall design. Our goal is to keep significant upside of the program - I feel like we’ve added a lot of value to the program and now we want to see the benefit of that down the road. But at the same time, share the risk because we’ve shared all the risk up to this point ourselves. So, someone who could actually help drive the funding forward, because recognize that it’s not just going to be just one more study that should be run when it comes to late stage clinical development, but should be multiple studies, and our goal would be to find a partner who is going to run those not just on a ex-U.S. basis, but also on worldwide basis and to help us advance the program to commercialization.
KR: Re: the biomarker analysis. What are you seeing so far? And what can we expect to see presented at ESMO (Oct7-11)?”
Steve King : Right now all the data is embargoed per the acceptance by ESMO for the oral presentation. So we’re not going to give any details at this point. Some of the other factors are of course that for novel things, intellectual property considerations that we may want to obtain in the meantime before presentation are important. So at this point, we’re not going to give any more details other than, it’ll be a nice rounded set of information available at the ESMO presentation, and we’ll will PR that as well.
3. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Good to hear that Avid is doing well and you guys have continued with the clinical progress with bavituximab. Can you remind us how will the new Avid facility be reflected in the P&L?”
Paul Lytle : We recognized $44mm in revenues last FY (fye 4-30-16) and that all came from our original Franklin facility. In March this year, we commissioned our new Myford facility which is built for late stage Phase III clinical & commercial production, and we are currently going through the motions of multiple process validation runs and those runs right now are built into our financial projections of the $50-55mm, with our goal of turning those process validation runs, which is kind of the final step before submitting something to the FDA under preapproval inspection in terms of producing commercial quantities for those clients. So this year is really a building year in terms of building those process validation runs for our clients, and then we’re hopeful that those will turn into commercial supply needs in future FY’s.
TY: ”Will the cost of that new facility be under cost of contract manufacturing?”
Paul Lytle : Yes. It's built into the cost of goods, the facility overhead, including personnel and everything else.
TY: “Can you give us some more details about the testing backlog of that 3rd-party testing lab and what are the exact reasons and how likely it could happen in the future?”
Steve King : We think it's an anomaly and so we don't expect this to be an ongoing issue. The issue is basically, the testing labs were so busy, there was a backlog or line to get into the queue to actually get the testing completed. Of course, we can't release lots without all the testing results and we can't ship them until they are released, and that's the reason that it hit the bottom line this quarter. We think it’s an anomaly. It's nothing to do with testing results, per se, for the lots. it’s really just getting them in the line to get the testing done and that's the reason we are projecting that Q2 [q/e 10-31-16] will be such a big quarter, because now that backlog seems to have worked itself out and we’ve worked it into our planning to give ourselves a little bit more time. And so we think it's hopefully something that's behind us. Of course, we can't control all the 3rd-party laboratories, but we are certainly working directly with them as well to ensure that we are able to maintain a high priority for them because we do generate a significant amount of business for a lot of our vendors.
TY: ”Re: NCCN trials, from this point on, what addl. info or resources are required from your end?”
Steve King : Basically, that's one of the beauties of working with NCCN - they actually run the clinical studies themselves. So, they take care of all the database management, all the site visits, start up, all that stuff is handled through the consortium. For us at this point, it's just more being supportive of their efforts. One of the things that we would potentially want to help out on will be some of the biomarker-type testing, particularly as we learn more from the SUNRISE study, building those into some of the clinical trials as they make sense, so they can collect samples that can be tested and then we can add that to our database in conjunction with the rest of our biomarker testing plans. Other than that, our only other obligation is to provide bavituximab for the clinical trials, and as we have discussed before, we have a stockpile of that, so that's not really an issue at this point.
MR. KING’S CLOSING COMMENTS:
I want to thank all of you again for participating in today's phone call. As always, I want to thank our stockholders for their continued support and I would like to especially thank our patients, their families and the investigators that are participating in our bavituximab clinical trials. With that, we will conclude the call.
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9-8-15 PR: Peregrine Pharmaceuticals Reports Financial Results for First Quarter of Fiscal Year 2017 and Recent Developments
– SUNRISE Top-line Data Accepted for Late-Breaking Oral Presentation at European Society of Medical Oncology Congress in October 2016
-- Avid First Quarter Revenue of $5.6 Million with Over $20 Million in Revenue Projected in Second Quarter
-- Company Reaffirms Revenue Projection of $50-55 Million for Full FY 2017 with Growing Backlog of Business Currently at $71 Million
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=988439
TUSTIN, Sept. 8, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced financial results for the first quarter of fiscal year (FY) 2017 ended July 31, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.
HIGHLIGHTS SINCE APRIL 30, 2016
"Since the start of our first quarter, we have steadily executed on our R&D and contract manufacturing objectives. On the R&D front, we recently achieved two important milestones beginning with the recent announcement [9-6-16: http://tinyurl.com/gutgwb5 ] that the National Comprehensive Cancer Network (NCCN) has awarded grants to three investigators to support bavituximab clinical research. In addition, we are pleased to announce today, that top-line data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming meeting of the European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October," stated Steven W. King, President and CEO of Peregrine. "The presentation at ESMO [Oct7-11-16: http://www.esmo.org/Conferences/ESMO-2016-Congress ] will be a great opportunity to share clinical data from the trial in conjunction with initial results from our ongoing biomarker analyses which are already highly encouraging. The primary goal of the biomarker analysis is to identify a biomarker pattern for patients that receive the most benefit from a bavituximab-containing therapeutic regimen and we look forward to sharing the results of the ongoing analysis with more data expected later in the year. Our collaboration with the NCCN has been an important part of our plans for advancing the bavituximab clinical program in a cost effective way. The grants that were awarded represent clinical trials with novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination, which is a major focus for advancing the program. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017."
Mr. King continued, "On the manufacturing front, it remains an extraordinarily busy time. Based on the high demand for services, we remain on track to meet our current fiscal year revenue projections as we look to continue growing the business. Our ultimate goal remains to reach overall profitability within the next 21 months and Avid will be an important driver for achieving that goal in combination with making strategic investments in R&D while pursuing partnerships to help advance our programs."
AVID BIOSERVICES HIGHLIGHTS
"Our biomanufacturing business was extremely busy this past quarter as the team remained on track according to the planned production schedule including initiating several process validation runs and ongoing commercial manufacturing activities. Despite being on track from a production standpoint, first quarter FY 2017 revenues were lower than expected due to a testing backlog at a third-party testing laboratory that delayed the shipment of manufacturing runs. As a result of the backlog being resolved, we expect revenue to exceed $20 million in the second quarter as we shift revenue recognition from the first quarter to the second quarter of fiscal year 2017. We believe this delay to be an anomaly, and we reaffirm our revenue guidance of between $50 and $55 million for the full fiscal year," stated Paul Lytle, CFO of Peregrine.
The company is projecting manufacturing revenue for the full FY 2017 of $50-$55 million.
Avid's current manufacturing revenue backlog is $71 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog covers revenue to be recognized during the remainder of fiscal year 2017 and into fiscal year 2018.
In response to demand for manufacturing services, the company is designing a third manufacturing facility dedicated to clinical manufacturing that is anticipated to significantly increase Avid's manufacturing capacity. The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid calendar year 2017.
CLINICAL DEVELOPMENT HIGHLIGHTS
SUNRISE top-line data, including initial biomarker profile data, have been accepted for oral presentation at the European Society of Medical Oncology (ESMO) Congress in October 2016.
Peregrine's research collaboration with NCCN is advancing as planned, with grants awarded to 3 investigators to support research of bavituximab in combination with other therapeutics for the following studies:
1. Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma
2. Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma
3. Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The company expects these trials to begin in early calendar year 2017.
RESEARCH HIGHLIGHTS
Our internal efforts and collaboration with Memorial Sloan Kettering Cancer Center continues to advance. The goal of this pre-clinical work is to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. We expect initial results from our internal work and this collaboration to be presented at multiple conferences during the Fall of 2016.
Peregrine in-licensed a novel exosome technology from UT Southwestern [7-14-16: http://tinyurl.com/zszd4fj ] that has potential for cancer detection and monitoring applications. This technology aligns directly with the company's expertise, its proprietary PS-targeting platform and the bavituximab development program. As such, there are opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts.
FINANCIAL RESULTS
Total revenues for the first quarter of FY 2017 were $5,609,000, compared to $9,671,000 for the same quarter of the prior fiscal year. The first quarter FY 2017 decrease in revenues was primarily attributed to a decrease in contract manufacturing revenue.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients decreased to $5,609,000 for the first quarter of FY 2017 compared to $9,379,000 for the first quarter of FY 2016. The first quarter decrease was primarily due to a backlog at a third-party testing lab and unrelated to product quality that shifted the timing of revenue recognition from the first quarter to the second quarter of fiscal year 2017. The company does not expect this delay to further impact revenue projections for the fiscal year, and the company remains on track to generate revenue in excess of $20 million in the second quarter FY 2017.
Total costs and expenses for the first quarter of FY 2017 were $16,691,000, compared to $23,425,000 for the first quarter of FY 2016. This decrease for the first quarter of FY 2017 was primarily attributable to a decrease in research and development expenses associated with the Phase III SUNRISE trial combined with a decrease in personnel cost and manufacturing costs related to preparing bavituximab for commercial manufacturing.
For the first quarter of FY 2017, research and development expenses decreased 38% to $8,569,000, compared to $13,918,000 for the first quarter of FY 2016. In addition, cost of contract manufacturing decreased to $3,062,000 in the first quarter of FY 2017 compared to $4,608,000 for the first quarter of FY 2016, primarily due to lower reported revenue compared to the same prior year period. For the first quarter of FY 2017, selling, general and administrative expenses were $5,060,000 compared to $4,899,000 for the first quarter of FY 2016.
Peregrine's consolidated net loss attributable to common stockholders was $12,437,000 or $0.05 per share, for the first quarter of FY 2017, compared to a net loss attributable to common stockholders of $15,101,000, or $0.08 per share, for the same prior year quarter.
Peregrine reported $44,195,000 in cash and cash equivalents as of July 31, 2016, compared to $61,412,000 at fiscal year ended April 30, 2016.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/jmy77g3 ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, September 8, 2016, 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. 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 committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit http://www.avidbio.com .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED
JULY 31,
2016 2015
REVENUES :
Contract manufacturing revenue $ 5,609,000 $ 9,379,000
License revenue — 292,000
Total revenues 5,609,000 9,671,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,062,000 4,608,000
Research and development 8,569,000 13,918,000
Selling, general and administrative 5,060,000 4,899,000
Total costs and expenses 16,691,000 23,425,000
LOSS FROM OPERATIONS (11,082,000 ) (13,754,000 )
Interest and other income 25,000 31,000
NET LOSS $ (11,057,000 ) $ (13,723,000 )
Comprehensive loss $ (11,057,000 ) $ (13,723,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,378,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (12,437,000 ) $ (15,101,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
Basic and diluted 239,595,089 197,317,374
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.05 ) $ (0.08 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JULY 31,
2016 APRIL 30,
2016
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 44,195,000 $ 61,412,000
Trade and other receivables 7,537,000 2,859,000
Inventories 25,274,000 16,186,000
Prepaid expenses and other current assets 1,235,000 1,351,000
Total current assets 78,241,000 81,808,000
Property and equipment, net 24,261,000 24,302,000
Restricted cash 600,000 600,000
Other assets 2,502,000 2,333,000
TOTAL ASSETS $ 105,604,000 $ 109,043,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 9,095,000 $ 8,429,000
Accrued clinical trial and related fees 6,577,000 7,594,000
Accrued payroll and related costs 3,653,000 5,821,000
Deferred revenue 21,531,000 10,030,000
Customer deposits 21,731,000 24,212,000
Other current liabilities 669,000 1,488,000
Total current liabilities 63,256,000 57,574,000
Deferred rent, less current portion 1,414,000 1,395,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares;
1,577,440 and 1,577,440 issued and outstanding at July 31, 2016
and April 30, 2016, respectively 2,000 2,000
Common stock - $0.001 par value; authorized 500,000,000 shares;
241,456,721 and 236,930,485 issued and outstanding at July 31,
2016 and April 30, 2016, respectively 241,000 237,000
Additional paid-in capital 561,024,000 559,111,000
Accumulated deficit (520,333,000 ) (509,276,000 )
Total stockholders' equity 40,934,000 50,074,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 105,604,000 $ 109,043,000
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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[From 10-Q header: “As of Sept. 2 2016, there were 242,381,850 shares outstanding.”
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Latest 10K 4-30-16 iss. 7-14-16 http://tinyurl.com/zgognwz PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 7-31-16 iss. 9-8-16 http://tinyurl.com/jmy77g3 PR: http://tinyurl.com/jydtkoy (Cash 7-31-16=$44.2mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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FY'17/Q1(qe 7-310-16) PR: The company is projecting mfg. revenue for the full FY’17 of $50-55mm. Avid's current backlog is $71mm (committed contracts). In response to demand for mfg. services, the company is designing a 3rd mfg. Facility dedicated to clinical mfg. that is anticipated to significantly increase Avid's mfg. capacity. The new clinical suite is expected to be complete & ready for clinical mfg. activities by mid 2017.
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Updated PPHM REVS-BY-QTR TABLE, now thru FY17'Q1(qe 7-31-16), per the 7-31-16 10-Q ( http://tinyurl.com/jmy77g3 ) issued 9-8-16.
• Total Revs since May’06: ($179.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $205.8mm
• 9-8-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$71mm).
• Deferred-Revs at 7-31-16 total $21.5mm, UP from $10.0mm at 4-30-16.
• Cust.Deposits at 7-31-16 total $21.7mm, DOWN from $24.2mm at 4-30-16.
• Inventories at 7-31-16 total $25.3mm, UP from $16.2mm at 4-30-16.
• Avid’s Gross-Profit over last 4 qtrs: $19.2mm on revs of $40.6mm (GP%=47%)
• Recall, Avid Rev$ 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 18,783,000 9,721,000 9,062,000 48%
FY17Q1 7-31-16 5,609,000 3,062,000 2,547,000 45%
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: 44,357,000 22,966,000 21,391,000 48%*
*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
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 18783 0 0 18783 15418 0 15189
FY17Q1 7-31-16 5609 0 0 5609 21531 0 25274
Totals: 179178 24149 2453 205780 <=since5/1/2006
.
TOTAL REV’s BY YEAR (Avid+Gov’t+Lic):
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
FY13 4-30-13 21,683 …Avid(CMO)= 21,333
FY14 4-30-14 22,401 …Avid(CMO)= 22,294
FY15 4-30-15 26,781 …Avid(CMO)= 26,744
FY16 4-30-16 44,686 …Avid(CMO)= 44,357
...Total Gov’t Revs from 7-2008 inception thru FY11Q1(Apr’11): $24.15mm
.
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
FY13Q4 4-30-13 8,449,000
FY14Q1 7-31-13 7,600,000
FY14Q2 10-31-13 7,790,000
FY14Q3 1-31-14 9,724,000
FY14Q4 4-30-14 10,248,000
FY15Q1 7-31-14 13,129,000
FY15Q2 10-31-14 12,100,000
FY15Q3 1-31-15 12,994,000
FY15Q4 4-30-15 12,135,000
FY16Q1 7-31-15 13,723,000
FY16Q2 10-31-15 13,198,000
FY16Q3 1-31-16 16,847,000
FY16Q4 4-30-16 11,884,000
FY17Q1 7-31-16 11,057,000
= = = = = = = =
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)
FY13Q4 4-30-13 7,053,000 (FY’13: 23,554,000 10K pg.60)
FY14Q1 7-31-13 5,750,000 (from 10Q pg.23)
FY14Q2 10-31-13 5,834,000 (Q1+Q2: 11,584,000 10Q pg.24)
FY14Q3 1-31-14 7,875,000 (Q1+Q2+Q3: 19,459,000 10Q pg.26)
FY14Q4 4-30-14 8,706,000 (FY’14: 28,165,000 10K pg.55)
FY15Q1 7-31-14 11,076,000 (from 10Q pg.23)
FY15Q2 10-31-14 9,947,000 (Q1+Q2: 21,023,000 10Q pg.25)
FY15Q3 1-31-15 11,116,000 (Q1+Q2+Q3: 32,139,000 10Q pg.26)
FY15Q4 4-30-15 10,474,000 (FY’15: 42,613,000 10K pg.54)
FY16Q1 7-31-15 12,306,000 (from 10Q pg.25)
FY16Q2 10-31-15 11,701,000 (Q1+Q2: 24,007,000 10Q pg.26)
FY16Q3 1-31-16 15,086,000 (Q1+Q2+Q3: 39,093,000 10Q pg.27)
FY16Q4 4-30-16 10,112,000 (FY'16: 49,205,000 10K pg.39)
FY17Q1 7-31-16 9,607,000 (from 10Q pg.22)
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
FY’13 total Op-Burn: $23,554,000
FY’14 total Op-Burn: $28,165,000
FY’15 total Op-Burn: $42,613,000
FY’16 total Op-Burn: $49,205,000
*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.”
Period Halozyme Cust-A Other-Custs
FYE 4-30-14 91% 1% 8%
FYE 4-30-15 79% 12% 9%
FYE 4-30-16 69% 26% 5%
Q/E 7-31-16 65% 29% 6%
- - - - - - - - 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 (after 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. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
FY’15-Q2 = q/e 10-31-14 – rep. 12-10-14 Wed (after mkt)
FY’15-Q3 = q/e 1-31-15 – rep. 3-12-15 Thu (after mkt)
FY’15-Q4 = q/e 4-30-15 – rep. 7-14-15 Tue (after mkt)
FY’16-Q1 = q/e 7-31-15 – rep. 9-9-15 Wed (after mkt)
FY’16-Q2 = q/e 10-31-15 – rep. 12-10-15 Thu (after mkt)
FY’16-Q3 = q/e 1-31-16 – rep. 3-9-16 Wed (B4 mkt)
FY’16-Q4 = q/e 4-30-16 – rep. 7-14-16 Thu (after mkt)
FY’17-Q1 = q/e 7-31-16 – rep. 9-8-16 Thu (after mkt)
= = = = = = = = = = = =
“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 & 2015 10-K's: http://tinyurl.com/p58jcbw etc...=> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
CASH a/o 1-31-15: $55.2mm
CASH a/o 4-30-15: $68.0mm
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
CASH a/o 4-30-16: $61.4mm
CASH a/o 7-31-16: $44.2mm
= = = = = = = = = = A look at #Employees per the 10K’s…
2011 10-K: "As of 4-30-11, we employed 154 full-time emps & 2 part-time emps”
2012 10-K: "As of 4-30-12, we employed 172 full-time emps & 2 part-time emps."
2013 10-K: "As of 4-30-13, we employed 182 full-time emps & 5 part-time emps."
2014 10-K: "As of 4-30-14, we employed 180 full-time emps & 4 part-time emps."
2015 10-K: "As of 4-30-15, we employed 211 full-time emps & 4 part-time emps."
2016 10-K: "As of 4-30-16, we employed 281 full-time emps & 3 part-time emps."
= = = = = = = = = = = = = = = = = =
9-9-16: FBR Analyst Thomas Yip Reiterates Outperform on Peregrine (PPHM) Following F1Q17: “…A negative for the biotech firm, PPHM revealed that a hopefully 1-time only backlog from a 3rd-party testing lab resulted in delayed revenue recognition. Revenue of $5.6mm for the qtr fell vastly below Yip’s projected $11.2mm, but mgt. indicates plans for shortfall recovery by next quarter, with a $20mm forecast outclassing Yip’s prior est. of $11.4mm. Peregrine maintained previous guidance for the FY2017 of $50-55 million for its contract mfg. subsidiary Avid Bioservices. Yip asserts, “Therefore, we do not believe this abnormality will affect Avid’s long-term growth prospects. On the clinical front, we look forward to learning more about bavituximab responders from a biomarker analysis that is part of the Phase III SUNRISE trial, to be presented at a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) Congress on Oct. 7–11, 2016. We continue to think PPHM shares are currently undervalued given Avid’s growth potential and bavituximab’s potential as an immuno-oncology treatment combination,” Yip added.
9-6-16: NCCN to Initiate 3 Bavi-Trials Early’17 (Moffitt,MassGEN,JohnHopkins) http://tinyurl.com/gutgwb5
=> Ph1/HepC-Related-Hepatocellular/MOFFITT, Ph1-2/Glioblastoma/MASS-GEN, Ph2/Head+Neck/JOHN-HOPKINS
7-14-16 Qtly. Conf. Call (King/Garnick/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/h8eqtg5 (Avid revs guidance for FY17=$50-55mm, curr. committed B/L=$68mm)
...CEO SK: “The recent licensing of Novel PS Exosome Tech. for detection/monitoring of cancer from UTSW will allow the co. to continue its R&D activities with significant upside coming from partnering as we move towards profitability.”
EXOSOME-BASED CANCER DETECTION & MONITORING TECHNOLOGY ("Liquid Biopsy") - Excellent Exosome info: http://www.exosome-rna.com
7-14-16: Peregrine Licenses Exosome-based technology from UTSW (Inventors: Alan Schroit/Philip Thorpe) http://tinyurl.com/zszd4fj
...“relates to assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample as a way to detect cancer at a very early stage of development.”
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
...Avid Revs for FY16(fye 4-30-16) will be $44mm; B/L=$56M; FY17/guidance=$50-55mm(3 curr. clients). Avid III being designed/already secured 25,000sf loc/expect complete=1H/2017. “Expect future sustainable profitability for the company in 24mos.”
3-9-16 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/gom7md5
...CEO SK: “Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomfg. business... We believe our relationships with AstraZeneca, Mem. Sloan Kettering, UTSW, & NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers.”
3-7-16: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
2-25-16: IDMC Halts Ph.3/NSCLC SUNRISE Trial at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm
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