Avid Bioservices Inc (CDMO)

[cjgaddy]

7-14-16 Qtly CC-Transcript, PR(Fins/Devs Q4FY16/fye4-30-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Apr16: $173.6mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $200.2mm. Cash at 4-30-16: $61.4mm
As of July 11 2016, there were 241,456,721 shares outstanding.

This large post has 3 sections:
I. 7-14-16 Q4/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (fy/e 4-30-16)
II. 7-14-16 PPHM Press Release: Q4/FY16 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’16 = May’15-Apr’16.

((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/zeqcxyc ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/i72j93vc
FULL TRANSCRIPT…
7-14-2016 FY’16/Q4 Earnings Conf. Call (fy/e 4-30-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Rob Garnick, Joe Shan, Jeff Hutchins, Paul Lytle; Q&A session.

CEO STEVE KING – OPENING COMMENTS:
Today, with the filing of the 10-K, it's a good opportunity to take a look back over the past year, a year at Peregrine that was marked by surprising highs and unfortunate lows. Leading the highs was the continued remarkable growth for our biomanufacturing business, Avid Bioservices, which is truly growing at a faster rate than even we expected. And of course, the low coming with the early discontinuation of our Phase III SUNRISE study based on passing the futility threshold at its first interim data analysis. That development was a particularly bitter pill to swallow for everyone that had put in such a phenomenal effort to advance the program up to that point. Following the setback, we took the opportunity to take full stock of the company, including evaluating our key assets, identifying opportunities for development, and strategic approaches for financing the company going forward, with the same ultimate goal of helping patients with devastating diseases while growing shareholder value. Out of this careful analysis, we have settled on a strategy to focus the company's resources primarily on continuing to grow our biomanufacturing business, Avid Bioservices, while continuing to advance R&D efforts through smaller clinical trials and the development of new technologies that can be partnered in an early stage. With the goal of becoming cash flow positive over the next couple of years, this strategy will allow us to increase shareholder value in several ways.

First, grow the value of our base, namely our manufacturing business. Manufacturing companies are currently in high demand, with values ranging from 2 to 5 times sales, depending on the revenue growth potential. We believe Avid should be highly valued from a shareholder perspective, based on the current consistent year-over-year growth, almost a 40% compounded annual growth rate over the past 5 years, with the remarkable 66% growth this past year, all coming from one facility. With the 2nd facility [“Myford”] now in full operation, already booked into next year, adding to the revenue growth potential for FY17 [May16-Apr17], with planning already underway for a 3rd facility that will be commissioned and ready for production in 1H/2017, setting the stage for nice potential growth going into the following FY. Taken together, these 3 facilities have the potential to generate in access of $110mm in revenues, with even more potential upside coming from the possibility of expanding our service offerings and, of course, the success of our commercial clients. So, by focusing our resources on growing Avid's revenues, we simultaneously add shareholder value in 2 ways. We increase the value of the base business, and increasing revenues decreases our need to raise funds through the equity markets, with the goal being to become cash flow positive, potentially eliminating the need for future dilution. We are in a unique position as a contract development and mfg. organization, or CDMO, because we have both drug development & mfg. expertise. We already work with clients ranging from small startups to some of the biggest pharma companies, and we look forward to helping more clients to bring their important products to the patients that need them.

Concurrent with growing our mfg. business, we will also continue to leverage our PS Targeting platform in 2 ways. First, the company will continue to extract clinical data from the SUNRISE Phase III trial. While trial enrollment was discontinued, the trial is still ongoing, with some patients still receiving bavituximab maintenance therapy. In addition, we have collected thousands of samples that are, or will be, analyzed in order to identify those patients that received benefit from including bavituximab into their treatment regimen. We expect this data will be instrumental in guiding the advancement of bavituximab in combination with immune-stimulating therapies. In fact it is very prudent to understand as much as we can from the SUNRISE trial before pushing into future company-sponsored studies, whether alone or with our collaborators. Joe will discuss these efforts during his prepared remarks.

In addition to bavituximab program which continues to have tremendous potential value, the company announced earlier today that it has licensed-in a Novel PS Exosome Technology, with the potential to detect and monitor cancer at an early stage through a simple blood test [ 7-14-16: http://tinyurl.com/zszd4fj ]. I recognize that some of you might think this theme is contrary to controlling spending as we move toward profitability, but in fact we believe that given our already existing knowledge base in Targeting PS and our already available infrastructure for developing & validating tests, that so a very modest capital investment we can quickly reach proof-of-concept with a goal of partnering this technology, which could then bring in additional revenue, with another potential upside of the technology being that it can possibly be useful in the continued development of bavituximab. Jeff will talk more about this during his prepared remarks. Given the strategy of R&D targeted toward early partnering, will allow the company to continue its research and development activities with significant upside coming from partnering as we move to our profitability. With that I will turn the call over to Rob, our Head of Quality and Regulatory for a few thoughts on his perspective of the potential for growing our base CDMO business.

ROBERT GARNICK (Head of Reg. Affairs):
I believe that Avid Bioservices is uniquely positioned in the CDMO industry and offers many clients a perfect opportunity to bring significant development expertise to bear on early development of late stage biomanufacturing projects. In my experience, many biotech companies suffer from the inability to find CDMOs who fully understand their needs, are flexible, and can really deliver products in a timely and high quality manner. Avid is designed and it is now capable of delivering on all of this fronts. This also opens the possibility of bringing Avid's mfg. expertise to bear on potential drug development partnering opportunities as they may arise. This concludes my remarks and I would now like to turn it over to Jeff Hutchins.

JEFF HUTCHINS (VP/PreClinical Res.)
I'm very happy to be able to discuss a number of exciting developments in our preclinical group. First, as Steve discussed, we have executed the licensing agreement with UT Southwestern Medical Center, for novel exosome technology [ 7-14-16: http://tinyurl.com/zszd4fj ] . While many of you are familiar with exosomes, I’ll provide a brief overview for those who are not. Exosomes are cell-secreted vesicles, or mini-cells if you will, that are present in nearly all bodily fluids, including blood. Likewise, tumor-derived exosomes represent small pieces of tumor cells that are released into the blood as tumors grow. As well, these tumor-derived exosomes have Phosphatidylserine or PS on their surface as a marker and can also contain DNA, RNA and proteins as markers of malignant disease. It is believed that even small tumors begin to release PS-positive exosomes, and thus the ability to detect these exosomes in the blood may be an indicator of presence or progression of a tumor. The licensed technology is designed to detect & monitor PS-positive exosomes in a patient's blood sample, providing clinicians with detection & monitoring information regarding the presence & prevalence of cancer. These exosomes have PS flipped to the outside of the surface and demonstrate immunosuppressive activity, just as we find with tumor cells. Preliminary 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 that are detected in the blood of cancer patients and the severity or extent of their disease burden. Given our in-house expertise in PS-targeting, we believe that we are uniquely qualified to advance this technology. As Steve stated, there are significant opportunities to use this technology as both a complimentary tool in bavituximab's ongoing development, which Joe will address later, as well as more broadly as the basis for a novel cancer detection & monitoring test kit that will be the focus of our partnering efforts. It is our goal to develop, optimize, and validate a functional detection & monitoring assay capable of detecting PS-positive exosomes from a simple blood sample, and, given the company's extensive experience in developing assays of this type, we do not anticipate the need for added personnel or any specialized equipment for this project. Once we have successfully validated this assay, we plan to establish proof-of-concept through an efficient preclinical & clinical testing program. We have no intention of conducting further development work beyond the proof-of-concept stage. Rather, we expect to initiate partnering discussions for commercialization of this program in 2017. We're very excited to begin this work on this new program and we'll have more details to offer in the coming months.

I'd now like to provide an update on Peregrine's preclinical I-O focused collaboration with Memorial Sloan Kettering Cancer Center. Our goal of this collaboration is to evaluate combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new & increasingly effective anticancer treatments. This program is advancing well and to-date we have seen initial signs of activity with new combinations with bavituximab and other treatment modalities such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend this next year investigating these potential combinations and we understand that initial results from this collaboration will be presented at scientific conferences later in the year. This concludes my comments and I will turn the call over to Joe Shan.

JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I'd first like to comment on our new exosome program. One of the most exciting aspects of this technology is the potential synergy that it offers with our bavituximab clinical dev. program. Through our ongoing work with bavituximab, we have gained significant understanding of PS-mediated immuno-suppression in cancer. The availability of the PS specific biomarker, which can be implemented in our planned future bavituximab clinical trials, aligns nicely with our refocused bavituximab dev. strategy aimed at generating the most meaningful data possible from small, early stage clinical trials to support partnering efforts. We are very anxious to bring this new technology to Peregrine and we look forward to the value it brings to our bavituximab program.

Let me now provide a brief update on the Phase III SUNRISE trial. At present, we are continuing to conduct a thorough evaluation of the available clinical data and are testing the numerous biomarker samples collected in order to determine if certain subgroups or patients with other characteristics benefited more from bavituximab treatment. We believe such information could be critical in helping guide the bavituximab clinical program, including our collaborations with NCCN, AstraZeneca and other clinical collaborators. Meanwhile, we continue to collect addl. data even as the trial winds down over the coming months. It is important to remember that at the time of patient unblinding, those who are still receiving steady treatment were given the option of completing the chemotherapy, and those patients assigned to the bavituximab arm were given the option to continue receiving bavituximab if the investigators believed it is in the patient's best interest. Because I-O agents can illicit delayed responses and prolonged survival, we are continuing to follow these patients to evaluate their outcomes. Such information may inform future decisions for the company, and it's our plan to present our findings from the SUNRISE trial when the evaluation is complete. Looking ahead, our priority is to generate clinical evidence of bavituximab's ability to improve patient outcomes when combined with immune-stimulating therapies. We believe our collaborations with the NCCN will play an important role in achieving this goal. The purpose of this collaboration is to expand the company's ongoing clinical research & dev. of bavituximab for the treatment of a range of tumors. I'm pleased to report that the NCCN research collaboration is advancing according to plan, and selected trials are expected to be initiated by the end of calendar 2016 or early 2017. That concludes my comments today. Let me turn the call now over to all Paul Lytle.

PAUL LYTLE (CFO):
We're pleased to report that our mfg. operations continues to experience substantial revenue growth, with a 5-year compounded annual growth rate of 39%, and yr-over-yr growth of 66%. And it's also important to note that this revenue was entirely derived from our Franklin facility, which is our 1st mfg. facility. Looking ahead, we have positioned the company for continued revenue growth with a launch of our 2nd mfg. facility [“Myford”] that was commissioned in March 2016 [3-7-16: http://tinyurl.com/za2j9mt ]. With these 2 operational facilities, we are projecting mfg. revenue of $50-55mm for FY2017. And this projection is supported by current revenue backlog of $68mm under committed contracts, covering services to be completed during this FY2017 and into FY2018. Now turning to Q4/FY'16, we generated contract mfg. revenue of $18.8mm, representing a 102% increase in revenue compared to the same prior year qtr., and for FY2016, we generated mfg. revenue of $44.4mm. Our corporate goal of reaching profitability in 24mos., 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 product & clinical development. We believe this 3rd mfg. facility will again significantly increase our mfg. Capacity, and all 3 facilities will have the potential to generate in total approx. $110mm in annual revenues. As we execute on our plans, we execute a 25,000sf building in close proximity to our current campus and we expect a new clinical suite to be complete and ready for clinical mfg. activities by mid-2017.

Now, turning to expenses, cost of contract mfg. increased during the current qtr and FY in relation to the increase in revenue. In addition, we saw our R&D expenses for FY2016 increase to $59.5mm or +38% compared to FY2015. This expected increase was primarily due to increased mfg. costs associated with preparing bavituximab for commercial production, combined with the increased cost associated with the Phase III SUNRISE trial and the 2 previously planned Phase III trials in breast & lung cancers. As we look ahead, our R&D strategy has changed. We are focusing our internal drug development efforts on small, cost effective, early phase clinical trials designed to attract potential partners to further advance our products. We believe this strategy will not only help us achieve probability sooner, but it will also create significant potential upside for our shareholders. As we execute on the strategy, our goal is to reduce spending by approx. 50% this year in R&D. With that being said, it's important to highlight that we will continue to incur significant costs this FY to wrap up the Phase III SUNRISE trial and to analyze the underlying data. This is an extremely important endeavor that potentially helps us drive both each of partnering interest and our future dev. plans. Turning to G&A expenses, we saw a slight decline in G&A qtr-over-qtr, while G&A remained relatively flat yr-over-yr, decreasing 1%. A more detailed analysis of our state of operations is included in our Form 10K that will be filed later today [ http://tinyurl.com/zgognwz ].

CEO STEVE KING – FURTHER COMMENTS:
It is our goal today to convey the progress that we're making in each area of our business. Our contract mfg. business is thriving and growing and we are projecting record revenues between $50mm & $55mm for next year. We also plan to open a new clinical bioprocessing facility in 2017 that we expect will further extend our revenue potential for the Avid business. Our collaborations are advancing, setting the stage to generate considerable amounts of biomarker, translational, and clinical data. The goal of these studies is to demonstrate the bavituximab mechanism of action in combination treatment settings and attract partnering opportunities. And lastly, we've in-licensed a new exosome technology for a minimal cost that leverages our existing in-house expertise and provides us with another opportunity for us to create value to product development. Together, we believe the strategy will provide success, as it will allow us to focus the majority of our resources on achieving our primary corporate goal, future sustainable profitability within 24 months. At same time, we will focus our R&D efforts on small early stage trials and development of the exosome technology in an effort to attract partners. We believe this strategy will allow us to build near-term revenues through Avid, while maintaining the potential for significant additional value creation associated with our R&D efforts. This concludes our prepared remarks, and we'd now like to open the line for questions.

Q&A: [beg. 23:50]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”On the Exosome program, how might it be differentiated from other cancer diagnostics? Secondly, if I heard Jeff correctly, there are some exosomes that are PS expressing in normal individuals. What work might be needed to identify relevant thresholds, or has that been done already.”
Jeff Hutchins: On your 2nd question, we have looked at normal individuals, it’s really a low incidence and certainly we know from our other R&D work that there are PS-positive exosomes in viral infections. Whether that has to be in acute infection that's blood borne is another issue. So, we're looking at that possibility, understanding that they are going to be interferences and false positives, but I think what we’re really impressed around is really the false negative rate at this point, and so that’s where we want to make sure we don’t deliver the wrong message to the patient with an assay like this.
Steve King: To extend on that, so I think what made this attractive is of course that PS is the target for our lead clinical compound bavituximab, so we had really a large amount of knowledge in targeting this molecule and agents that bind to it and so it really fit into our wheel house. And the fact that it goes after the same target as we're targeting with bavituximab gives it that potential of really adding to the clinical program as a potential sort of like a liquid biopsy that would allow you to test blood samples for potentially the presence of your target and then correlate that with patient outcome. That's going to take some work to do in upcoming studies and we’re evaluating what we can do with samples that have already been collected, but that makes it attractive in and of itself. From a standalone development, what drew us to this technology was just really how clean it has been in the ability to differentiate between healthy individuals and those with various stages of cancer. And as Jeff said, so far the false negative & positive rates have been pretty outstanding. So it’s work in progress, again it fits right in; we’re not having to hire addl. people, we’re not having to bring in addl. equipment. This really fits in with everything we are doing on both studying PS, as well as on the assay development side of the business. We think it’s actually going to be complementary. There are other technologies out there looking at exosomes; they're are all taking a very different approach to what we’re doing and we actually think they could be very complementary to each other. We also see a need, even as interest in exosomes begins to pick up, to actually utilize this in conjunction with other things that are in development.
JP: ”Regarding Avid III, how will the size of this facility relate to the other ones and that are currently in place obviously and what kind of costsyou’re looking at to bring it up to speed?”
Steve King: It will be a smaller facility, really geared towards clinical stage products. So, we don’t need as many, if you will, bells & whistles, that go along with it - that helps save a lot of space. So the construction costs we expect to be much less than, for instance, the Myford facility which was the commercial facility we recently commissioned. I think the good news here is that already have a backlog of business to go into that facility. It’s going to allow us, we think, to capture even more business over the coming months as we finish up the facility and can bring customers into what will be, if you will, kind of like a miniature version of our commercial facility we just commissioned, so that they can come in, they can be in the same equipment and as they advance through clinical dev. toward commercialization, we could then transition them over actually to one of our commercial facilities. So, it creates a lot of continuity for the customers coming in, and it’s already received a lot of interest. We’re excited about it getting it up and running.
JP: ”On SUNRISE, you guys mentioned that patients are still able to receive bavituximab. Since patients are still on drug, are you getting anecdotes from physicians that you are seeing some longer term survival based on the potential immunotherapy tail?”
Joe Shan: The data is continuing to come in and I think it's a reasonable conclusion that there are obviously patients that are on therapy a long time. We're right now focused on trying to identify characteristics of those patients that are benefiting the most from Bavi, and I think the biomarker analysis is really going to help provide a lot more clarity & information. We anticipate some results pretty soon.

2. Kumar Raja - Noble Life Science Partners http://noblelsp.com/research
KR: ”Are there any differences in PS expression in various cancers, especially the magnitude, like are there some cancers that you have higher expression compared to others? Also [on the Exosomes licensing], is there already existing IP on this or do you need to file a patent on this technology?”
Steve King: It’s always been a bit of an open question what you asked. It's a good question, because you can’t just take tumor out and sort of slice it and then a look at what’s inside the tumor because there’s PS inside of every cell. So, you temd to get a lot of background when you try to do histological analysis and what have you. We are hopeful that we can actuall,y utilizing this new test, be able to monitor through blood samples actually how much overall PS positive micro particles and tumor cells are there throughout the patient. And that could really be a big benefit in correlating that with which patients do well and which patients don’t do well. At this point I think it remains an open question, but we think this could be actually very nice tool to use in conjunction with that. That's one of our key goals is to be able now implement this in our own clinical studies and get firsthand knowledge of the overall magnitude of PS exposure and how that relates to, actually not just bavituximab treatment, but also other I-O agents. One important thing to keep in mind is that PS positive micro particles are immunosuppressive, so there actually could be a nice correlation between this particular blood marker and outcome on other treatments as well, because they may really portend to a more immunosuppressive environment in those negative patients that don’t do as well for instance. So, we see a lot of utility for this and we think it’s just can really be used in conjunction with a lot of different types of tumors as well as different treatment modalities.
Jeff Hutchins: And filed IP is included in the Univ. of Texas license that we recently put together. [U.S. Patent App# 20150241431 http://tinyurl.com/jtgqfes ]
KR: ”On the Memorial Sloan combination trials, are there any specific combinations that you’re seeing increased response vs. others?”
Steve King: We’re seeing good activity in combination with multiple different types of reagents. Obviously, we are very interested in I-O agents, but it does extend beyond that as well to combinations with, not just in PD-1/PD-L1s, but also agonists, as well as antagonists. In addition, a lot of interest in combinations with things like radiation - radiation almost acts like an adjuvant and so that’s an attractive combination. I think across the board, they haven’t really zeroed in on one particular area that is outshining the others at this point, but as we go on certainly the hope is we will see those combinations that are really just pop and give us the best results.
Jeff Hutchins: To extend that, what we are seeing, and early our contention was, is that PS targeting agents really operate outside of these downstream kind of checkpoint inhibitors. The evidence that we’re seeing with such varied & breadth of combination responses reinforces that idea that we are really affecting an immune suppressive element and reversing that really helps out benefits these other type of approaches whether it’s T-Cell agonist or checkpoint inhibitor or presenting antigen with radiation therapy.

3. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Congratulations on a very impressive qtr from Avid and also on your newly acquired Exosome Technology as well. Re: your Exosome technology, you’ve set a timeline of within 18mos to generate significant value from this program. I'm assuming that means the end game is to out-license... Can you outline for us the key steps that needed within 18mos to reach that goal?”
Steve King: Yes, short term goals, and actually we're already been working on this. Keep in mind that we do have a research collaboration with UT Southwestern, so we didn’t just start looking at this technology this morning; we've been working on for quite some time. Again, it's such a nice fit with what we do already because we already in-house have a lot of PS finding agents that we’ve evaluated, so we already had a lot of the base raw materials to work with. Right now the primary goal is to optimize the assay to achieve the best sensitivity that we can as we go into testing patient samples. So, a lot of work on just designing, the format of the assay, so that we can have a lowest noise and be able to detect levels of PS Exosomes in patients. The next step will be to validate that through patient samples. The beauty of this is that while you do need IRB approval of course, you’re not running really clinical trials, so this can be done in conjunction with either our ongoing trials or partners' trials, or there are many other sources of just receiving these types of blood samples. This gives us the ability to very quickly go through and test hundreds or thousands of patient samples as part of the validation process. At that point, we can zero in on what are the potential applications of the technology, outside of what we might do with our own PS Targeting programs – what would be the potential utility of this for patients. Our goal is not to become a diagnostics company, but to put this in the hands of a good organization that's already established in the diagnostics area and then have them finish up the commercialization and expansion of the utility of the actual assay itself. Our benefit at that point would become, hopefully, some residual royalties, milestones and what have you, which feeds back into our revenue goals of becoming profitable. So, we thought that this is a very attractive technology that just fits right in with what we’re doing and requires almost no additional resources whatsoever.
TY: ”Re: the preliminary data that you already have for exosome, will there be a formal presentation sometime this year or when should we expect to see more preclinical data on this front?”
Steve King: Our goal is, probably towards for the end of this year, to be in a position to have data that we can present. That will come in a lot of different formats, so it will be in conjunction with other ongoing studies that maybe taking place already to be standalone just on the diagnostic itself. So, you'll be hearing a lot about this, and one of the reasons when to get this news out there is because what you think sooner than later we will build a talk about this technology.
TY: ”I just want to confirm that we should expect R&D in FY'17 to be lower, and will the staff count for the new Avid facility ramp up?”
Paul Lytle: Our goal is to basically take R&D spending from FY'16 and reduce it by 50%. All the activities that are related to our mfg. operations go into COG or G&A type expenses, but our goal of this new approach of running smaller earlier stage proof-of-concept type trials is to build value in the program and we think we can do that and reduce our spending by 50% this year.
Steve King: It's important that in that reduction, wrapping up SUNRISE which has been a significant portion of the R&D budget. As that wraps up and we close out the databases and get final data from the study, then you'll probably get a little bit more true view of what we expect the R&D spend to be. The goal here is really different types of studies - they can certainly answer very critical questions, running those in conjunction with our partners, generate data that will then bring on that marketing partner that can really help bear the burden going through into finishing up and into commercialization. As we wrap up SUNRISE, you'll see our R&D expenditures really significantly go down and then it'll be a little bit more of a steady state after that.

4. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”I notice that you’re now calling Avid a CDMO rather than a CMO, which is distinctive and Rob certainly alluded to that. Do you see this as adding addl. value to clients? Is it an add on that you would then put an addl. premium cost to it, rather than just providing API? How are you going to leverage that CDMO?”
Steve King: “CDMO” is a relatively recent term that's has been used by a number of organizations that offer more than mfg. services. In our case, it's really quite broad, because we do have drug dev. experience, we have the ability to do regulatory filings, regulatory document preparation. Really, top to bottom, we, from the CMC side especially, have the ability to basically almost be their entire mfg. arm. That's really where the customers are seeing the value - we're not just offering a service and they tell us what to do and we do it, but we actually get to add a lot of value along the way through our knowledge of what the regulatory bodies expect, both in the U.S. & abroad. Over the long run this is going to end up being opportunities for not just services, but actually for partnering, because this is a service and these are capabilities that almost no small companies have that we have a lot of experience with. I see this as a phenomenal opportunity to continue to expand the business well beyond just bulk drug substance into a lot of different areas of development.
Rob Garnick: Good point Steve. We have a lot of expertise and [????], which are very complicated and something that most more drug development companies who might enjoy such an opportunity would have very little experience with. And so by bringing & leveraging our analytical, our manufacturing and regulatory capabilities, this is really kind of unique. I think most companies would really like to take advantage of that because it allows them to leapfrog their competition and bring their drugs to market much earlier. I really think we’re in a fantastic position with respect to that and as Steve said, some of these companies who are flush with money, and yet don’t have this expertise, might well want to consider a partnering opportunity as a way of speeding up & financing the drug's development.
Steve King: In conjunction with that, when we think about expanding our offerings, its most than just new drug substance facilities, but also could extend into small fill/finish to help out our clinical stage customers with their needs. It could extend eventually even into things like antibody drug conjugates, which is something we have a lot of in-house expertise working on. So, there’s a lot of opportunity here where we see market need from our existing clients, and they’re actually having trouble finding the services that they so desperately need. We see a lot of opportunity, and it’s all based on demand from customers saying, can you do this, and I think that’s really the exciting part. We're not building things we're hoping people come to, but things that people are already asking us for.
GZ: ”The only thing you didn’t provide yet is fill/finish. Are you making room in your new 3rd facility to perhaps provide that service?”
Steve King: Yes, we’re looking at that as part of the new facility, particularly for clinical stage products, because we see it as such a big burden on the clients - they got to arrange runs with us and we’ve got to release this and they've got to have a spot open, and if there's any sort of movement of the timelines, it's a real hassle for them. So, we think that will be a major draw for actually bringing in new business. Our goal for the new facility is, it's almost like the funnel that leads into our commercial facilities, which is where we can make a lot of revenue progress. So, basically feed as many people into clinical, so we get those coming through that are successful into the commercial facilities and that really we think is the key to growing a long-term successful business. So yes, fill/finish is definitely high on the list, and this is just because our clients are just clamoring for something that would be much easier for them to manage.
GZ: ”So, you'll be doing development consulting services, and some of the expertise doesn't really lie in Avid, it lies in Peregrine. So that means that Rob, Jeff, Joe will be going back & forth across the 2 divisions of the company as needed. Is that correct?”
Steve King: Absolutely, that’s already happening. We're finding that we have so much expertise across the board, and the customers have reacted very positively to having that additional expertise available, because either they have it in-house, and a lot of them just don’t have that particular expertise in-house, so they have to go out and hire a consultant - it’s easier for them if they can work with a one-stop-shop that provides them with everything they need, and then they can to limit the number of different groups they have to work with.
GZ: ”Sometimes it’s better just to get another opinion on a question that needs answering in the mfg. process.”
Steve King: Yes, true. The biggest thing that sets us apart is our knowledge of the regulatory bodies and what their expectations are. In particular, that’s a huge benefit for the clients as they're making process changes or filings overseas - it’s an area where we can help them out a lot.
GZ: ”Re: Exosomes. 1St, can you say what you're budgeting for that? 2nd, you've already done imaging of PS for many years now with florescent or otherwise tagged Bavituximab antibodies. Is this exosomes technology antibody based? Finally, you’re entering a rather competitive and very interesting space for liquid biopsies - do you see this competing or being supplementary to measuring circulating T-cells or circulating tumor DNA?”
Steve King: Yes, we see this as being very complementary to other technologies that are being developed; that's one of the things that made it very attractive. I think the ease of collecting samples would put it way ahead of an imaging agent, because those by their very nature you've got to put something in, take scans - long days for the patient, where this is a simple blood draw from a patient perspective and then the results come in. We see this as a very interesting space, just because we know that the PS exosomes are going to be immunosuppressive. So, the ability to correlate this with overall immune status of patients - there is a lot of utility of the technology we think that can be brought to bear, not just for Bavituximab, but for a lot of other I-O type technologies. We think it could be very nice to pair that up with the other types of analysis that are being done - T-cells or other emulator cells or even T-rigs, and how do they correlate with this simple test.
GZ: ”Then, is it antibody based or come in with a budget if you can.”
Steve King: We can't really say at this point, because we want to make sure we get perfect amount of protection around it. As you know we have all kinds of agents to bind the PS. We’ve got betabodies, we’ve got antibodies, we’ve got all kinds of things that bind to PS. The beauty of this technology is that we understand it really well, because we've already studied it, we've already made all the agents. And so I think we're in a great position to really quickly move this forward to proof of concept.

5. FOLLOWUP: Joe Pantginis – Roth Capital Partners:
JP: ”Re: Avid's Gross Margins - is this something that you think you can improve upon as your facilities expand?”
Paul Lytle: Our GM's for FY15 was ~42%, and FY16 improved to 48%. It really depends on the mix of services and the mix of activities that are currently ongoing. I can say that our new micro facility does have a slightly higher COGS because we've got an asset there that needs to be depreciated every month, which contributes to the COGS of that facility, whereas our pre-existing Franklin facility has been fully depreciated for some time. Our goal overall is to maximize our GM's from this business, and we're really geared towards doing that. Other than that, we really can't predict what the COGS will be, because it's really based on the mix of services within that facility.

MR. KING’S CLOSING COMMENTS:
I’d like to thank you all once 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 precipitating in bavituximab clinical trials. With that, we will now conclude the call. Thank you.

= = = = = = = = = = = = = = = = = = = = = = = = = = = = = == = = =
7-14-15 PR: Peregrine Pharmaceuticals Reports Financial Results for Quarter and Fiscal Year Ended April 30, 2016 and Recent Developments
-- Avid Contract Manufacturing Revenues Increased 66% to $44.4 Million with a Revenue Backlog of $68 Million Heading into Fiscal Year 2017
-- Growing Biomanufacturing Demand Prompts Plans for Third Manufacturing Facility Expected to be Commissioned by mid-2017
-- Analysis of Data from SUNRISE Phase III Trial Ongoing with New Clinical Trials Expected to Commence Late 2016 to Early 2017
-- Novel PS-Exosome Technology In-Licensed for Cancer Detection and Monitoring
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=979668

TUSTIN, July 14, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by delivering high quality biological products through its contract development and manufacturing organization (CDMO) services and by advancing its novel R&D pipeline, today announced financial results for the fourth quarter and fiscal year (FY) ended April 30, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.

HIGHLIGHTS SINCE JANUARY 31, 2016
"Peregrine's business strategy is to focus the company's resources primarily on continuing to grow its biomanufacturing business while advancing R&D efforts through small, proof of concept clinical trials and the development of new technologies. Together, this will allow Peregrine to reach profitability, increase shareholder value by steadily increasing the worth of the company's established CDMO business, and retain significant upside potential from bavituximab and other R&D programs," stated Steven W. King, President and CEO of Peregrine. "Over the past year, the company has taken huge strides toward future revenue growth, including the commissioning of a new commercial facility which is already completely booked into early next year with potential new commercial projects. The facility has the potential to generate over $40 million in revenue at full capacity during commercial production. The company continues to see such a high demand for additional manufacturing capacity and in response, has already begun designing a new facility for clinical stage products that could eventually transfer into one of our commercial production facilities. We expect this new facility to be commissioned by the middle of 2017, and there is already a backlog of existing business earmarked for the new facility. The company expects the continued growth of its manufacturing revenues at these new facilities, as well as the potential addition of new capabilities, to be a major driver toward consistent overall profitability."

Mr. King continued, "Concurrent with growing its manufacturing business, Peregrine will continue to leverage its phosphatidylserine (PS)-targeting platform in two ways. First the company will continue to extract critical data from the SUNRISE Phase III trial that can be instrumental in guiding the advancement of bavituximab in combination with immune stimulating therapies. In addition, the company announced earlier today that it has signed a license agreement with its long-term collaborator, UT Southwestern Medical Center, for a novel PS-exosome technology with the potential to detect and monitor cancer at an early stage through a simple blood test. Given the company's tremendous knowledge base in targeting PS and its infrastructure for developing and validating tests for biologic samples, Peregrine is uniquely positioned to advance this technology. The company believes that, for a modest capital investment, it can quickly reach proof of concept with a goal of partnering the technology with an established diagnostics company. Overall, Peregrine believes this strategy will allow the company to continue its research and development activities with significant upside coming from partnering as it moves toward profitability."

AVID BIOSERVICES HIGHLIGHTS
"The company's manufacturing business has experienced substantial revenue growth over the past several fiscal years with a 5-year compounded annual growth rate of 39% and year-over-year growth of 66%. In addition, this revenue growth came entirely from Avid's first manufacturing facility and the company is positioned for continued revenue growth with the launch of its second manufacturing facility that became fully operational in March 2016," stated Paul Lytle, CFO of Peregrine. "With these two operational facilities, the company is projecting manufacturing revenue of $50 to $55 million for fiscal year 2017 that is supported by a current revenue backlog of $68 million under committed contracts."

On June 2, 2016, the company announced the goal of achieving overall future sustained profitability in 24 months.

The company is projecting manufacturing revenue for FY 2017 of $50 - $55 million.

Avid's current manufacturing revenue backlog is $68 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog covers revenue to be recognized in fiscal year 2017 and into fiscal year 2018.

In March 2016, the company formally commissioned its new, state-of-the-art biomanufacturing facility (Myford facility) [3-7-16/PR: http://tinyurl.com/za2j9mt ]. The Myford facility is designed to utilize the most cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. The facility was designed to operate in commercial campaign mode whereby multiple bioreactors are simultaneously in operation, which more than doubles the facility's manufacturing capacity.

The recently commissioned Myford facility [“Avid II”] has completed an initial process validation campaign with a second process validation underway and two more planned for later this year.

In response to demand for manufacturing services, the company is now 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-2017.

CLINICAL DEVELOPMENT HIGHLIGHTS

SUNRISE Phase III Trial - Peregrine is currently conducting an extensive review and analysis of the available clinical data and testing the numerous collected biomarker samples in order to determine if certain subgroups or patients with other characteristics benefited more from bavituximab treatment. The company believes such information could be critical in helping guide the bavituximab clinical program including its collaborations with the National Comprehensive Cancer Network (NCCN), AstraZeneca, and other clinical collaborators.

Going forward, Peregrine's clinical development strategy is to focus on small, early stage proof of concept trials with other immune stimulating therapies. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program.

As part of this clinical strategy, Peregrine's research collaboration with the NCCN is advancing as planned. The purpose of this collaboration is to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. Selected trials are expected to be initiated by the end of calendar 2016, or early 2017.

EXOSOME PROGRAM [ See 7-14-16/PR: http://tinyurl.com/zszd4fj ]
Peregrine in-licensed a novel exosome technology from the UT Southwestern 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.

The licensed technology is designed to detect PS-positive exosomes within the blood. These exosomes are highly immunosuppressive, which is consistent with the immunosuppression that is often seen in tumor microenvironments.

Preliminary studies have provided evidence 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 of disease burden.

Peregrine has the existing infrastructure, staff and expertise to develop, optimize and validate testing methodologies for detecting PS-positive exosomes in blood samples. The company expects to secure a partner to develop the final commercial test kit.

SUPPORTIVE RESEARCH HIGHLIGHTS
Peregrine plans to continue conducting pre-clinical and translational studies to support ongoing and future clinical development activities. The goal of these studies will be to generate compelling translational biomarker data that inform the selection of treatment combinations featuring bavituximab. The company believes that data from these studies will be important for partnering bavituximab.

Positive results presented at the 2016 American Association for Cancer Research (AACR) Annual Meeting [4-20-16: http://tinyurl.com/jyox458 ] provided further support for Peregrine's strategy of evaluating bavituximab in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. The presentation of preclinical study data demonstrated enhanced anti-tumor activity and immune activation for a combination of the preclinical bavituximab equivalent (ch1N11) and anti-PD-1 therapy in models of breast cancer, including triple negative breast cancer (TNBC).

FINANCIAL RESULTS
Total revenues for the fourth quarter FY 2016 were $18,783,000, compared to $9,308,000 for the same quarter of the prior fiscal year. For FY 2016, total revenues were $44,686,000, compared to $26,781,000 for the prior fiscal year. The fourth quarter and fiscal year 2016 increases were attributed to an increase in contract manufacturing revenue.

Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients increased 102% to $18,783,000 for the fourth quarter of FY 2016 compared to $9,308,000 for the fourth quarter of FY 2015 and increased 66% to $44,357,000 for FY 2016 compared to $26,744,000 for FY 2015. The fourth quarter and fiscal year increases were primarily attributed to an increase in demand for contract manufacturing services. Current contract manufacturing commitments from Avid's third-party customers are approximately $68 million, covering services to be provided during FY 2017 and into FY 2018. Based on this current backlog, Peregrine expects contract manufacturing revenue for FY 2017 to be between $50 and $55 million.

Total costs and expenses for the fourth quarter of FY 2016 were $30,698,000, compared to $21,477,000 for the fourth quarter of FY 2015. For FY 2016, total costs and expenses were $101,046,000 compared to $77,280,000 for FY 2015. These increases for both fourth quarter and fiscal year 2016 were primarily attributable to an increase in research and development expenses associated with the Phase III SUNRISE trial, the clinical costs associated with two previously planned phase II trials, and higher manufacturing costs related to preparing bavituximab for commercial manufacturing. For the fourth quarter of FY 2016, research and development expenses were $16,265,000, compared to $11,531,000 for the fourth quarter of FY 2015, and for FY 2016 were $59,529,000 compared to $42,996,000 for FY 2015. In addition, cost of contract manufacturing increased 104% to $9,721,000 and 47% to $22,966,000 for the fourth quarter of FY 2016 and full FY 2016, respectively, primarily due to higher reported revenue compared to the same prior year periods. For the fourth quarter of FY 2016, selling, general and administrative expenses were $4,712,000, compared to $5,188,000 for the fourth quarter of FY 2015 and for FY 2016 were $18,551,000 compared to $18,691,000 for FY 2015.

Peregrine's consolidated net loss attributable to common stockholders was $13,264,000 or $0.05 per share, for the fourth quarter of FY 2016, compared to a net loss attributable to common stockholders of $13,513,000, or $0.07 per share, for the same prior year quarter. For FY 2016, net loss attributable to common stockholders was $60,136,000, or $0.28 per share, compared to $54,054,000, or $0.30 per share, for FY 2015.

Peregrine reported $61,412,000 in cash and cash equivalents as of April 30, 2016, compared to $68,001,000 at fiscal year ended April 30, 2015.

More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/zgognwz ]

CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, July 14, 2016, at 4:30 PM EDT (1:30 PM PDT). To listen to the conference call, please dial [phone] or [phone] and request the Peregrine Pharmaceuticals conference call. 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. ( http://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.
CONSOLIDATED BALANCE SHEETS
AS OF APRIL 30, 2016 AND 2015
2016 2015
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 61,412,000 $ 68,001,000
Trade and other receivables, net 2,859,000 3,813,000
Inventories 16,186,000 7,354,000
Prepaid expenses and other current assets, net 1,351,000 1,355,000
Total current assets 81,808,000 80,523,000
PROPERTY AND EQUIPMENT:
Leasehold improvements 19,610,000 1,538,000
Laboratory equipment 10,257,000 5,965,000
Furniture, fixtures, office equipment and software 4,045,000 3,991,000
Construction-in-progress - 11,819,000
33,912,000 23,313,000
Less accumulated depreciation and amortization (9,610,000 ) (8,189,000 )
Property and equipment, net 24,302,000 15,124,000
Restricted cash 600,000 -
Other assets 2,333,000 1,817,000
TOTAL ASSETS $ 109,043,000 $ 97,464,000

LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 8,429,000 $ 10,385,000
Accrued clinical trial and related fees 7,594,000 3,910,000
Accrued payroll and related costs 5,821,000 4,606,000
Deferred revenue 10,030,000 6,630,000
Customer deposits 24,212,000 11,363,000
Other current liabilities 1,488,000 437,000
Total current liabilities 57,574,000 37,331,000
Deferred rent, less current portion 1,395,000 1,098,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $.001 par value; authorized 5,000,000 shares;
issued and outstanding - 1,577,440 and 1,574,764, respectively 2,000 2,000
Common stock - $.001 par value; authorized 500,000,000
shares; issued and outstanding - 236,930,485 and 193,346,627,
respectively 237,000 193,000
Additional paid-in-capital 559,111,000 512,464,000
Accumulated deficit (509,276,000 ) (453,624,000 )
Total stockholders' equity 50,074,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 109,043,000 $ 97,464,000

PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
FOR EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2016
2016 2015 2014
REVENUES:
Contract manufacturing revenue $ 44,357,000 $ 26,744,000 $ 22,294,000
License revenue 329,000 37,000 107,000
Total revenues 44,686,000 26,781,000 22,401,000
COSTS AND EXPENSES:
Cost of contract manufacturing 22,966,000 15,593,000 13,110,000
Research and development 59,529,000 42,996,000 27,723,000
Selling, general and administrative 18,551,000 18,691,000 17,274,000
Total costs and expenses 101,046,000 77,280,000 58,107,000
LOSS FROM OPERATIONS (56,360,000 ) (50,499,000 ) (35,706,000 )
OTHER INCOME (EXPENSE):
Interest and other income 722,000 142,000 349,000
Interest and other expense (14,000 ) (1,000 ) (5,000 )
NET LOSS $ (55,652,000 ) $ (50,358,000 ) $ (35,362,000 )
COMPREHENSIVE LOSS $ (55,652,000 ) $ (50,358,000 ) $ (35,362,000 )
Series E preferred stock accumulated
dividends (4,484,000 ) (3,696,000 ) (401,000 )
NET LOSS ATTRIBUTABLE TO
COMMON STOCKHOLDERS $ (60,136,000 ) $ (54,054,000 ) $ (35,763,000 )
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING:
Basic and Diluted 216,265,620 182,558,332 161,579,649
BASIC AND DILUTED LOSS PER
COMMON SHARE $ (0.28 ) $ (0.30 ) $ (0.22 )

CONTACTS:
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 [e-mail]
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 [e-mail]
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 [e-mail]
- - - - - - - - -
[ From 10-K header: “As of July 11 2016, there were 241,456,721 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 1-31-16 iss. 3-9-16 http://tinyurl.com/hdgto9y PR: http://tinyurl.com/gom7md5 (Cash 1-31-16=$67.5mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8

= = = = = = = = = = = = = = = = = = = = = = = = = = = =
FY'16/Q4(qe 4-30-16) Avid Revs doubled prev.record to $18.8mm; FY16=$44.4mm(+66% yr-over-yr.). GROSS PROFIT Q4=$9.1mm; $21.4mm for FY16 (GM=48%). Guidance for FY17(fye 4-30-17)=$50-55mm. Committed B/L a/o 7-14-16=$68mm. Avid II (Myford) went fully operational 3-2016. (6-2-16/PR: “Myford ramping up for runs for 3 current clients”). Peregrine is in the process of designing a 3rd mfg. facility “focused on clinical manufacturing”; has already secured a 25,000sf location, and “expect this new (3rd Avid) facility to be commissioned by mid-2017; there is already a backlog of existing business earmarked for the new facility.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months".
- - - - - - - - - -
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 4-30-16 10-K ( http://tinyurl.com/zgognwz ) issued 7-14-16.
• Total Revs since May’06: ($173.6mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $200.2mm
• 7-14-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$68mm).
• Deferred-Revs at 4-30-16 total $10.0mm, DOWN from $15.4mm at 1-31-16.
• Cust.Deposits at 4-30-16 total $24.2mm, UP from $22.4mm at 1-31-16.
• Inventories at 4-30-16 total $16.2mm, UP from $15.2mm at 1-31-16.
• Avid’s Gross-Profit over last 4 qtrs: $21.4mm on revs of $44.4mm (GP%=48%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com

  
 AVID PROFITABILITY (GROSS*) BY QTR:  
 QTR              Avid-Rev$  CostofMfg$  Gross-Profit$   GP% 
 FY13Q1  7-31-12  4,135,000   2,024,000      2,111,000   51% 
 FY13Q2 10-31-12  6,061,000   3,703,000      2,358,000   39% 
 FY13Q3  1-31-13  6,961,000   3,651,000      3,310,000   47% 
 FY13Q4  4-30-13  4,176,000   3,217,000        959,000   23% 
 FY14Q1  7-31-13  4,581,000   2,670,000      1,911,000   42% 
 FY14Q2 10-31-13  7,354,000   4,195,000      3,159,000   43% 
 FY14Q3  1-31-14  3,885,000   2,416,000      1,469,000   38% 
 FY14Q4  4-30-14  6,474,000   3,829,000      2,645,000   41% 
 FY15Q1  7-31-14  5,496,000   3,583,000      1,913,000   35% 
 FY15Q2 10-31-14  6,263,000   4,139,000      2,124,000   34% 
 FY15Q3  1-31-15  5,677,000   3,113,000      2,564,000   45% 
 FY15Q4  4-30-15  9,308,000   4,758,000      4,550,000   49% 
 FY16Q1  7-31-15  9,379,000   4,608,000      4,771,000   51% 
 FY16Q2 10-31-15  9,523,000   4,741,000      4,782,000   50% 
 FY16Q3  1-31-16  6,672,000   3,896,000      2,776,000   42% 
 FY16Q4  4-30-16 18,783,000   9,721,000      9,062,000   48% 
  
 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 
 Totals:        173569 24149 2453 200171 <=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         
   
 = = = = = = = =  
 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)   
   
 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.”

 
 FY/E     Halozyme  Cust-A/U.S.  Other-Custs 
 4-30-14       91%         1%          8%     
 4-30-15       79%        12%          9% 
 4-30-16       69%        26%          5% 

- - - - - - - - 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)

= = = = = = = = = = = =
“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
= = = = = = = = = = 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."

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