Tuesday, December 13, 2016 1:24:00 PM
12-12-16 Qtly CC-Transcript, PR(Financials Q2FY17/qe10-31-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Oct16: $202.5mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $229.2mm.
Cash at 10-31-16: $49.1mm (Op. Cash Burn for q/e 10-31-16 was $2.6mm – see below).
As of Dec. 8, 2016, there were 257,141,534 shares outstanding.
This large post has 3 sections:
I. 12-12-16 Q2/FY17 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 10-31-16)
II. 12-12-16 PPHM Press Release: Q2/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/z9p7pf4 ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/x8b7exde
FULL TRANSCRIPT…
12-12-2016 FY’17/Q2 Earnings Conf. Call (q/e 10-31-16) (King/Shan/Hutchins/Lytle)
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. I like to begin by just reminding everyone that we operate 2 separate, but linked, businesses under the Peregrine umbrella. These businesses represent our R&D efforts and our contract mfg. business, Avid, respectively. Taken together, our goal is to bring the overall company to profitability within the next 18mos. by controlling costs and growing revenues. Equally important is to make sure that our market cap adequately reflects the value of each of these business units, which currently does not seem to be the case. Given our revenue history, current year revenue projections at $50-55mm, and backlog of future business at over $70mm, we believe just the value of Avid Bioservices is far greater than our current market cap and is only growing in value. The Avid business is on track to continue its revenue growth this FY. Actually, our 2 facilities have the potential to generate in excess of $80mm in revenue, leaving addl. capacity for revenue growth beyond the current FY and into next year. Even with this available capacity, we are moving forward with our plans to construct a 3rd mfg. facility in order to meet the anticipated commercial needs of our clients, while continuing to grow the business by bringing in new projects. As we continue planning the new facility, we're keeping a close eye on efficiencies that will reduce the overall cost of construction, and once built, the cost of operations. While this may delay the new facility launch until later in CY2017, we currently have adequate existing capacity to continue meeting the needs of our current clients while also bringing in new customers. So, we do not expect any delay in construction to impact our near term or long term ability to grow top line revenue as originally planned. Business at Avid is brisk, with several process validation campaigns either underway or completed in our Myford [“Avid II”] facility, continuing commercial & clinical production at our Franklin [Avid I”] facility, and new projects being initiated. Taken together, this gives us great confidence in the future of the business. In addition, another milestone was achieved during the quarter as we successfully completed a pre-approval inspection with Health Canada for a client product that is currently under regulatory review in that country. This adds the Avid’s strong regulatory track record with multiple successful inspections from regulatory agencies in the US, EU, Brazil, and Canada. Our regulatory success, our unique ability to provide a wide range of services from cell line development to commercial mfg., and our reputation for delivering quality products continues to drive demand for Avid’s capacity. We are also continuing to evaluate other growth opportunities for the business. This includes the evaluation of downstream, high margin services, which will allow us to increase our footprint with clients.
On the R&D side of the business, we announced a series of important findings in recent months, all of which will contribute to our future development of bavituximab. Our ongoing analysis of the Phase III SUNRISE data has revealed a promising biomarker that may give us insight into key patient populations. We are currently evaluating addl. biomarkers that we hope will allow us to identify a profile for patients who will receive therapeutic benefits from a bavituximab-containing treatment regimen. Concurrent with our internal clinical work, our collaborators at NCCN are in the process of initiating trials for 3 new bavituximab combination treatments, which we expect to begin enrolling patients in the coming months. What is exciting is that the NCCN studies will help build on developments that we are seeing from our internal scientists, as well as our collaborators at Duke, Rutgers, and Memorial Sloan Kettering Cancer Center. Together, we presented compelling data supporting our long-standing belief that bavituximab significantly impacts the tumor microenvironment, creating a more immune -active environment in which other therapies, including checkpoint inhibitors, are able to have a greater anti-tumor effect. These findings are highly validating and we look forward to continuing our work with these world-class institutions to help guide clinical development. We believe the data from the new clinical studies being initiated, other clinical opportunities in development, and the continuing mechanistic and immune-oncology combination insight provided by our scientists & collaborators can add significant value to our R&D business, including creating partnering opportunities, even with a tight control of expenditures that will allow us to reach our profitability goal. I'll now turn the call over to the other members of our team who will give a detailed overview of our clinical, pre-clinical, and corporate activities, as well as our Avid Bioservices contract mfg. business. We will begin with Joe Shan, VP/Clinical & Regulatory Affairs.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
The SUNRISE Phase 3 trial was discontinued earlier this year. Patient treatment and follow-up on the study were allowed to continue, and currently a number of patients are still receiving bavituximab maintenance. As we previously reported, the study protocol pre-specified the collection of thousands of patient samples for exploratory analyzes over a wide range of potential biomarkers. This analysis has been taking place as patient follow up has continued. Through this biomarker analysis, our team has identified a promising correlation between OS and pre-treatment levels of beta-2 glycoprotein-1 (B2GP1), which was presented at ESMO in October [10-10-16: http://tinyurl.com/hp73njt ]. These results were based on a data cut-off after 70% of the targeted overall survival events in SUNRISE had been reached. Interim analysis demonstrated that patients with pretreatment beta-2 levels between 200 and 240 µg/mL, representing approx. 30% of randomized patients, achieved a statistically significant 5.5mos. improvement in MOS from 7.7mos. in the control group to 13.2mos. in the patients receiving bavituximab & docetaxel. A similar trend was observed with pretreatment B2GP1 levels greater than 200 micrograms per mL, representing approx. 50% of randomized patients. We believe that these observations strongly suggest that B2GP1 levels may be useful for identifying patients who are more likely to benefit from a bavituximab containing therapeutic regimen. We plan to further evaluate the role of B2GP1 levels in response to bavituximab therapy in future clinical trials, and the company has filed a patent application directed to the use of this initial biomarker discovery. While we are disappointed SUNRISE did not meet the pre-specified clinical endpoints, the data from SUNRISE will be critical in guiding the future clinical dev. of bavituximab. In a rapidly changing oncology treatment landscape, biomarkers are playing an increasingly important role in helping identify specific patient subgroup characteristics that may predict response to a treatment. This has been seen historically with targeted therapies, as well as more recently with checkpoint inhibitors, including PD-1 inhibitors. Numerous addl. biomarkers are currently being evaluated with the goal of developing a multi-marker signature that can potentially identify patients that are likely to receive clinical benefit from bavituximab. Ideally, these biomarkers can be applied not only to chemotherapy combination approaches, but also to I-O combinations, including the checkpoint inhibitors. As we'll hear from Jeff in a minute, we and our research collaborators are generating very exciting data to support the advancement of clinical dev. of bavituximab with I_O approaches, and we plan to incorporate potential biomarkers identified from SUNRISE into future clinical trials.
Meanwhile, as Steve mentioned, we're pleased by the NCCN’s award of 3 grants to investigators for clinical trials of bavituximab in combination with other therapeutics for the treatment of Glioblastoma, Head & Neck Cancer and Hepatocellular Carcinoma [9-6-16: http://tinyurl.com/gutgwb5 ]. These grants were awarded to researchers at the Moffitt Cancer Center, Mass General Hospital Cancer Center, and The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. These NCCN studies which we expect to be initiated in the coming months align with our dev. strategy for bavituximab, which is currently focused on small early stage clinical trials evaluating the drug in combination with other cancer treatments, including chemotherapy, radiation, and checkpoint inhibitors. Collaborators such as NCCN play a central role in this strategy and we look forward to integrating the valuable clinical data generated by these investigators to expand our knowledge regarding bavituximab-focused cancer treatment combinations. That concludes my comments today. I’ll now turn the call over to Jeff Hutchins, VP/Pre-Clinical Research.
JEFF HUTCHINS (VP/PreClinical Res.)
As Joe's team mentioned and the important clinical progress they've made during the qtr, the pre-clinical group has also reported findings that further illuminate bavituximab’s role in treating cancer. In recent months, we have announced results from studies conducted with collaborators at Memorial Sloan Kettering Cancer Center, Duke University, and Rutgers University College of Medicine, as well as our own internally conducted pre-clin. research. The presented results of this work reinforced our belief that bavituximab plays an important role in transforming what we call “cold” tumor microenvironments, which are characterized by immunosuppression and an inability to generate an effective attack on tumors into “hot” tumor microenvironments that exhibit high immune activity and are pronged with specific cells to fight tumors. During the past qtr, we have presented data from several studies showing that meaningful tumor microenvironment shifts occurred when a bavituximab like antibody was administered as part of a combination treatment regime with checkpoint inhibitors such as anti-PD-1, anti-PD-L1, and anti-LAG3, as well as with radiation and/or chemotherapy. This shift in tumor microenvironment from cold to hot as was evidenced by greater increases in the activity of several critical immune activating pathways, including presentation and processing of antigens and signaling and activation of T cells. We believe that these immune activating mechanisms can be an important component of combination treatment approaches to cancer. Currently it is estimated that 40-70% of cancer patients don't respond to available anti-cancer therapies due primarily to the immunosuppression impacting their tumors. Our pre-clinical work suggests that bavituximab can help reverse this immunosuppression creating an immune active environment that can potentially convert these non-responders to responders. Importantly, we think that this priming of the tumor marker environment is not only relevant for enhancing response to immunotherapies, but also for more traditional cancer treatments such as radiation & chemotherapy. While we are excited by the data we've generated, it is important that we also demonstrate the practical impact that this activity can have on tumors. To this end, we have presented promising data from a study in a Triple Negative Breast Cancer model at the 2nd Intl. Cancer Immunotherapy Conference in September [9-27-16/AACR-CRI: http://tinyurl.com/zy9yv78 ]. These findings showed that 80% of animals receiving a pre-clinical bavituximab equivalent combined with anti-PD1 & anti-LAG3 therapies experienced complete tumor regression. This is in contrast to findings that showed no complete regression among the animals in the treatment group that received a combination of anti-PD1 & anti-LAG3 alone, without the equivalent of the bavituximab.
In a follow-up presentation from the same study at the SITC Annual Meeting in November [11-14-16/SITC’16: http://tinyurl.com/js3fca4 ], we reported these complete regressions for long, durable, and suggestive of immune system memory and adaptive immune responses. This is just one example of the type of preclin. work that has generated the excitement at Peregrine about the potential of bavituximab in combination cancer therapy. But we recognize that this work needs independent outside validation from the academic community. To this end, we are thrilled to highlight our ongoing collaboration with scientists at Memorial Sloan Kettering, which is being led by doctors Taha Merghoub & Jedd Wolchok, two of the world's most foremost experts in the field of cancer immunotherapy. Their work in a mouse model of B16 melanoma, also presented at the SITC meeting [11-14-16: http://tinyurl.com/js3fca4 ], showed that PS targeting antibodies synergized with both anti-PD1 & radiation therapy to improve anti-cancer activity for tumor burden & survival. As well, this combination uniquely led to a change in the tumor microenvironment, shifting it from immunosuppressive, in which tumors which are protected, to immune active, in which tumors are more susceptible to immune related treatments. We recognize that these research results while exciting are in preclini. cancer models and must be translated into human studies. This is a key objective of the 3 NCCN clinical trials that Joe just mentioned that are expected to be initiated in the coming months. We look forward to continuing our research activities on bavituximab treatment combinations with our collaborators and present new findings as they are available. That concludes my comments today. I'll turn over the call to Paul Lytle, CFO…
PAUL LYTLE (CFO):
Before I begin, I’d like to reiterate our financial goal of becoming profitable on an overall basis 18mos. from this past qtr-end. Our strategy for achieving this goal is built on growing revenue from our contract mfg. business, Avid Bioservices, while reducing our overall spending on R&D. We have made great strides over the past 2 qtrs in both growing revenue and reducing our R&D spend, thereby reinforcing our commitment to this goal. I’ll first address our contract mfg. revenue. During Q2/FY’17, we achieved all-time high revenue of $23.4mm, and while we expected to have a very strong qtr as some revenue shifted from Q1 to Q2 due to an outside testing delay which was discussed last qtr, I am pleased to say that those delays have been resolved and we have recognized to-date $29mm in revenue over the past 6mos. This represents revenue growth of 53% compared to last FY. Given the performance, we are able to reaffirm our full FY2017 revenue guidance of $50-55mm. We also have a strong revenue backlog of $73mm under signed contracts that supports this revenue growth. This backlog mostly covers services to be completed during the remainder of FY2017 & FY2018. I’ll address the 2nd part of our strategy, which is to reduce our overall spending on R&D. As we announced last June, Peregrine has made a decision to focus our internal drug dev. efforts on small, cost effective, early-stage clinical trials designed to attract potential partners to further advance our products. We believe the strategy will not only help us achieve profitability sooner, but it could also create significant potential upside for our shareholders. As we execute on the strategy, our R&D expenses decreased 51% this qtr compared to the same prior year qtr, and for the current 6mo. period our R&D expenses declined 45% over the same period last year. The result of the strategy has translated into a reduction in our net loss by 69% for the qtr and 44% for the 6mo. period vs. the same prior year periods. And, if you deduct non-cash expenses from our net loss this qtr, we saw our net cash burn rate for the qtr decline 78% to $2.6mm compared to $11.7mm for the same qtr last year. As I mentioned before, we're making great progress towards reaching our goal of profitability. A more detailed analysis of our statement of operations is included in our Form 10-Q that will be filed shortly [ http://tinyurl.com/j2u2bjk ]. This concludes my financial overview. I will now open the call up for questions.
Q&A: [beg. 22:10]
1. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Can you just remind us what was the magnitude of Avid’s delayed revenue recognition between Q1 & Q2?”
Paul Lytle: The overall delay is that last qtr we mentioned that we had an outside testing lab that is responsible for performing certain tests, and that testing lab was backlogged with certain activities and therefore we couldn’t recognize a certain amount of revenue last quarter that was shifted from Q1 into Q2. Well, their delays have now been resolved and we’re back on track and recognizing revenue as we routinely do as we release lots. So, everything has been resolved.
TY: ”Approx. how much was that amount?”
Paul Lytle: If you straight line our revenues, our projections are about $50-55mm over the FY. So you figure at $12.5mm/qtr, you could assume that last qtr was about $5.5mm in total revenue and it could have been on a straight line basis of about $12mm.
TY: ”If I recall correctly the cost of your new [Avid II “Myford”] facility is also included in cost of contract mfg. as well. So how much of the new facility cost is included in Q2/FY17’s contract mfg costs?”
Steve King: If we're talking about the Myford facility which we commissioned in January of this year, that cost would be included in those numbers. Obviously we're just kind of moving toward a 3rd facility that would primarily be used for clinical production, at least initially, could eventually be commercial as well, but it’s really designed to be a clinical production facility. So those numbers other than where we spent on planning up to this point are not reflected as in the current numbers.
TY: “Re: Bavi, now that we’ve seen some positive pre-clin. data in combination with checkpoint inhibitors and as you outlined earlier, there are a number of collaboration of academic partners. Can you tell us what else is needed to move any potential combination to the clinic and would any of these upcoming trials involve existing academic collaborators?”
Steve King: One of the nice things about the NCCN collaboration, which just to remind everybody was based on a $2mm grant from Peregrine, a lot of which has already been put into the program, but basically the NCCN will oversee all of those 3 clinical studies that will be completed. One of those is in an I-O combination, so it gives us one opportunity already to start looking at kind of an extension if you will of the work we're doing with our collaborators into the clinic and so we can start to validate some of that. In addition, we have interest from other academic collaborators in I-O combinations, so we're currently evaluating those and how those would move forward. So, we're hopeful to have some news in the not too distant future on some of those developments as well. Beyond that, we're really in the process of just looking through the SUNRISE data, identifying what's the best way to identify patients. In addition, some of the other data we can learn from SUNRISE are changes on therapy, the primary hypothesis being that we can take, if you will, immunologically cold tumors and make them hot tumors by breaking down the immunosuppression - that's some of the things that we have an option to learn from the SUNRISE study. Overall, the data from SUNRISE, taken together with the work at Sloan Kettering and our other collaborators, all really build the story very nicely to eventually potentially starting more company-sponsored studies, but that's where the balance of our R&D spend vs. our revenue comes into play. So, whatever studies we start we anticipate would be smaller studies, but ones that will be rich in biomarker-type analysis, which we think will be the key to #1 identifying those successful combinations, but secondly to eventual partnering where we can actually help some of the other drugs that are in development to do better.
TY: ”Thanks again for taking my questions. Looking forward to learn more about these trials in coming months.”
MR. KING’S CLOSING COMMENTS:
I'd like 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. Looking ahead, we are confident in our ability to achieve profitability through cost reduction and revenue growth, while continuing to work with our collaborators to generate the data required to drive partnering and build shareholder value. With that we will now conclude the call. Thank you again.
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12-12-15 PR: Peregrine Pharmaceuticals Reports Financial Results for Second Quarter of FY 2017 and Recent Developments
*Avid Posts Record Revenue of $23.4 Million During Second Quarter FY 2017 with Contracted Backlog of Future Business Currently at $73 Million
*Beta-2 Glycoprotein-1 (B2GP1) Identified as a Biomarker that Correlates with Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination Compared to Chemotherapy Alone from the Phase III SUNRISE Trial
*Multiple Preclinical Presentations Collectively Point to Bavituximab's Ability to Enhance the Efficacy of Checkpoint Inhibitors by Triggering Immune Active Tumor Environment
TUSTIN, Dec. 12, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/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 second quarter of FY (FY) 2017 ended October 31, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.
Highlights Since July 31, 2016
"The Avid business is on track to continue its revenue growth this FY as we move toward overall profitability within the next 18 months. Our two facilities have the potential to generate in excess of $80 million in revenue, leaving additional capacity for revenue growth beyond FY 2017 revenue guidance," stated Steven W. King, President and CEO of Peregrine. "We are moving forward with our plans to construct a third manufacturing facility, with an eye toward efficiencies that will reduce the overall cost of construction and operation. While this may delay the new facility launch until later in calendar year 2017, we currently have adequate existing capacity to continue meeting the needs of our current clients while also bringing in new customers so we do not expect it to impact our near-term ability to grow top-line revenue as originally planned. Independently, Avid is a successful and growing CDMO business generating significant revenue and one of our key goals going forward is to help ensure that its value is appropriately represented in the market cap of our overall business." Mr. King continued, "During, and subsequent to, the second quarter, we announced a series of important findings, all of which will contribute to our future development of bavituximab. Our ongoing analysis of the Phase III SUNRISE data has revealed a promising biomarker that may give us insight into key patient populations. We are actively evaluating additional potential biomarkers and we hope to identify a profile for patients who will receive therapeutic benefit from treatment with bavituximab. Concurrent with our internal clinical work, our collaborators at NCCN are in the process of initiating trials for three new bavituximab combination treatments, which we expect to begin enrolling patients in the coming months. What is exciting is that the NCCN studies will help build on developments we are seeing from our internal scientists, as well as our collaborators at Duke, Rutgers, and Memorial Sloan Kettering Cancer Center. Together, we presented compelling data supporting our long-standing belief that bavituximab significantly impacts the tumor microenvironment, creating a more immune active environment in which other therapies, including checkpoint inhibitors, are able to have a greater anti-tumor effect. These findings are highly validating and we look forward to continuing our work with these world-class institutions to help guide clinical development."
Avid Bioservices Highlights
"Growing top-line revenue is a key focus and we are pleased to report a 53% improvement in contract manufacturing revenue for the current six-month period compared to the same period last FY. In addition, our revenue guidance for the second quarter was targeted to exceed $20 million and we achieved $23.4 million in contract manufacturing revenue as we worked closely with the third-party testing laboratory to resolve the unexpected delays in testing we encountered during the first quarter. As a result, we reaffirm our manufacturing revenue guidance of between $50 and $55 million for the full FY," stated Paul Lytle, CFO of Peregrine. "We also continued to advance the validation of three separate manufacturing processes related to third-party customer products that could lead to future commercial manufacturing for these products. While these activities generally have a higher cost of manufacturing, which impacted our gross margin during the second quarter, we believe our investment in these products will provide us future revenue opportunities once these products are approved."
The company reaffirms its manufacturing revenue guidance for the full FY 2017 of $50 - $55 million.
Avid's current manufacturing revenue backlog is $73 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog mostly covers revenue to be recognized during the remainder of FY 2017 and FY 2018.
Clinical Development Highlights
Through the ongoing analysis of the Phase III SUNRISE data, Peregrine scientists identified a correlation between overall survival and pre-treatment levels of the biomarker, beta-2 glycoprotein-1 (B2GP1), which we presented at ESMO in October [10-10-16: http://tinyurl.com/hp73njt ]. Data demonstrated that patients with pre-treatment B2GP1 levels between 200 and 240 µg/mL - representing approximately 30% of randomized patients - achieved a statistically significant, 5.5-month improvement, from 7.7 months to 13.2 months, in median overall survival as compared to patients in the control group with the same range of B2GP1 levels.
Peregrine's research collaboration with NCCN is advancing as planned, with grants awarded to three investigators [9-6-16: http://tinyurl.com/gutgwb5 ] 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 over the coming months.
Research Highlights
Peregrine scientists and collaborators from Duke University Medical Center, Rutgers University College of Medicine, and Memorial Sloan Kettering Cancer Center each presented compelling data demonstrating that shifts in the tumor microenvironment from immune suppressed to immune active occurred when a bavituximab equivalent antibody was administered as part of a combination treatment regimen. Presentations addressed multiple phosphatidylserine (PS)-targeting combinations, including those with checkpoint inhibitors such as anti-PD-1, anti-PD-L1 and anti-LAG3, as well as with radiation or chemotherapy. These data suggest that the addition of PS-targeting reverses an immunosuppressive tumor environment, creating an immune active tumor microenvironment that can potentially convert patients that generally do not respond to immuno-oncology (I-O) therapies into responders. Key presentations were made at the Second International Cancer Immunotherapy Conference in September, the American Association for Cancer Research's Tumor Immunology and Immunotherapy Conference in October, the Society for Immunotherapy of Cancer (SITC) in November, and the San Antonio Breast Cancer Symposium in December.
Financial Highlights and Results
Peregrine continues to execute its previously-announced strategy to reach sustained profitability by increasing contract manufacturing revenue while decreasing research and development expenses, with the goal of reaching profitability 18 months from now. During the first six months of FY 2017, the company made significant progress toward this goal with contract manufacturing revenues increasing 53% compared to the first six months of FY 2016 and research and development expenses decreasing by 45% compared to the first six months of FY 2016.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party customers increased to $23,370,000 for the second quarter of FY 2017 compared to $9,523,000 for the second quarter of FY 2016. In addition, as previously-announced, a backlog at a third-party testing lab, unrelated to product quality, required that the recognition of some revenue be shifted from the first quarter to the second quarter of FY 2017.
Total costs and expenses for the second quarter of FY 2017 were $27,447,000, compared to $23,347,000 for the second quarter of FY 2016. For the second quarter of FY 2017, research and development expenses decreased 51% to $7,022,000, compared to $14,190,000 for the second quarter of FY 2016. Cost of contract manufacturing increased to $15,441,000 in the second quarter of FY 2017 compared to $4,741,000 for the second quarter of FY 2016, primarily due to an increase in the cost of contract manufacturing associated with higher reported revenue. Also contributing to this increase and impacting gross margins for the period is the higher cost of operating the new Myford facility as well as the higher cost associated with performing process validation runs during the quarter. For the second quarter of FY 2017, selling, general and administrative expenses increased to $4,984,000 compared to $4,416,000 for the second quarter of FY 2016 primarily due to the company's growing manufacturing business.
Peregrine's consolidated net loss attributable to common stockholders was $5,498,000 or $0.02 per share, for the second quarter of FY 2017, compared to a net loss attributable to common stockholders of $14,578,000, or $0.07 per share, for the same prior year quarter. [NOTE: Oper. Cash Burn for Q2(q/e 10-31-16): $2.57mm see below.]
Peregrine reported $49,055,000 in cash and cash equivalents as of October 31, 2016, compared to $61,412,000 at FY ended April 30, 2016.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
Conference Call
Peregrine will host a conference call and webcast this afternoon, December 12, 2016, at 4:30PM ET (1:30PM PT). 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. (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 .
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED
OCTOBER 31, SIX MONTHS ENDED
OCTOBER 31 ,
2016 2015 2016 2015
REVENUES:
Contract manufacturing revenue $ 23,370,000 $ 9,523,000 $ 28,979,000 $ 18,902,000
License revenue — — — 292,000
Total revenues 23,370,000 9,523,000 28,979,000 19,194,000
COSTS AND EXPENSES:
Cost of contract manufacturing 15,441,000 4,741,000 18,503,000 9,349,000
Research and development 7,022,000 14,190,000 15,591,000 28,108,000
Selling, general and administrative 4,984,000 4,416,000 10,044,000 9,315,000
Total costs and expenses 27,447,000 23,347,000 44,138,000 46,772,000
LOSS FROM OPERATIONS (4,077,000 ) (13,824,000 ) (15,159,000 ) (27,578,000 )
Interest and other income 21,000 626,000 46,000 657,000
NET LOSS
$ (4,056,000 ) $ (13,198,000) $ (15,113,000) $ (26,921,000)
COMPREHENSIVE LOSS $ (4,056,000 ) $ (13,198,000 ) $ (15,113,000 ) $ (26,921,000 )
Series E preferred stock accumulated dividends (1,442,000 ) (1,380,000 ) (2,477,000 ) (2,413,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ (5,498,000) $ (14,578,000) $ (17,590,000) $ (29,334,000)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 244,815,767 203,942,411 242,205,428 200,629,892
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.02 ) $ (0.07 ) $ (0.07 ) $ (0.15 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31,
2016 APRIL 30, 2016 Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 49,055,000 $ 61,412,000
Trade and other receivables 6,066,000 2,859,000
Inventories 25,924,000 16,186,000
Prepaid expenses and other current assets 1,711,000 1,351,000
Total current assets 82,756,000 81,808,000
Property and equipment, net 23,957,000 24,302,000
Restricted cash 600,000 600,000
Other assets 2,624,000 2,333,000
TOTAL ASSETS $ 109,937,000 $ 109,043,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 11,572,000 $ 8,429,000
Accrued clinical trial and related fees 3,639,000 7,594,000
Accrued payroll and related costs 5,280,000 5,821,000
Deferred revenue 17,980,000 10,030,000
Customer deposits 26,928,000 24,212,000
Other current liabilities 1,012,000 1,488,000
Total current liabilities 66,411,000 57,574,000
Deferred rent, less current portion 1,347,000 1,395,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares; 1,647,760 and 1,577,440 issued and outstanding at October 31, 2016 and April 30, 2016, respectively 2,000 2,000
Common stock-$0.001 par value; authorized 500,000,000 shares; 251,765,279 and 236,930,485 issued and outstanding at October 31, 2016 and April 30, 2016, respectively 252,000 237,000
Additional paid-in capital 566,314,000 559,111,000
Accumulated deficit (524,389,000 ) (509,276,000 )
Total stockholders' equity 42,179,000 50,074,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 109,937,000 $ 109,043,000
Safe Harbor *snip*
CONTACTS:
• 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 Dec. 8 2016, there were 257,141,534 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-16 iss. 7-14-16 PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 10-31-16 iss. 12-12-16 http://tinyurl.com/j2u2bjk PR: http://tinyurl.com/hhn4gga (Cash 10-31-16=$49.1mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY17'Q2(qe 10-7-31-16), per the 10-31-16 10-Q ( http://tinyurl.com/j2u2bjk ) issued 12-12-16.
• Total Revs since May’06: ($202.5mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $229.2mm
• 12-12-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$73mm).
• Deferred-Revs at 10-31-16 total $18.0mm, DOWN from $21.5mm at 7-31-16.
• Cust.Deposits at 10-31-16 total $26.9mm, UP from $21.7mm at 7-31-16.
• Inventories at 10-31-16 total $25.9mm, UP from $25.3mm at 7-31-16.
• Avid’s Gross-Profit over last 4 qtrs: $22.3mm on revs of $54.4mm (GP%=41%)
• Recall, Avid Rev$ 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)
FY’17-Q2 = q/e 10-31-16 – rep. 12-12-16 Mon (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
CASH a/o 10-31-16: $49.1mm
= = = = = = = = = = 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."
=> Total Revs May06-Oct16: $202.5mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $229.2mm.
Cash at 10-31-16: $49.1mm (Op. Cash Burn for q/e 10-31-16 was $2.6mm – see below).
As of Dec. 8, 2016, there were 257,141,534 shares outstanding.
This large post has 3 sections:
I. 12-12-16 Q2/FY17 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 10-31-16)
II. 12-12-16 PPHM Press Release: Q2/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/z9p7pf4 ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/x8b7exde
FULL TRANSCRIPT…
12-12-2016 FY’17/Q2 Earnings Conf. Call (q/e 10-31-16) (King/Shan/Hutchins/Lytle)
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. I like to begin by just reminding everyone that we operate 2 separate, but linked, businesses under the Peregrine umbrella. These businesses represent our R&D efforts and our contract mfg. business, Avid, respectively. Taken together, our goal is to bring the overall company to profitability within the next 18mos. by controlling costs and growing revenues. Equally important is to make sure that our market cap adequately reflects the value of each of these business units, which currently does not seem to be the case. Given our revenue history, current year revenue projections at $50-55mm, and backlog of future business at over $70mm, we believe just the value of Avid Bioservices is far greater than our current market cap and is only growing in value. The Avid business is on track to continue its revenue growth this FY. Actually, our 2 facilities have the potential to generate in excess of $80mm in revenue, leaving addl. capacity for revenue growth beyond the current FY and into next year. Even with this available capacity, we are moving forward with our plans to construct a 3rd mfg. facility in order to meet the anticipated commercial needs of our clients, while continuing to grow the business by bringing in new projects. As we continue planning the new facility, we're keeping a close eye on efficiencies that will reduce the overall cost of construction, and once built, the cost of operations. While this may delay the new facility launch until later in CY2017, we currently have adequate existing capacity to continue meeting the needs of our current clients while also bringing in new customers. So, we do not expect any delay in construction to impact our near term or long term ability to grow top line revenue as originally planned. Business at Avid is brisk, with several process validation campaigns either underway or completed in our Myford [“Avid II”] facility, continuing commercial & clinical production at our Franklin [Avid I”] facility, and new projects being initiated. Taken together, this gives us great confidence in the future of the business. In addition, another milestone was achieved during the quarter as we successfully completed a pre-approval inspection with Health Canada for a client product that is currently under regulatory review in that country. This adds the Avid’s strong regulatory track record with multiple successful inspections from regulatory agencies in the US, EU, Brazil, and Canada. Our regulatory success, our unique ability to provide a wide range of services from cell line development to commercial mfg., and our reputation for delivering quality products continues to drive demand for Avid’s capacity. We are also continuing to evaluate other growth opportunities for the business. This includes the evaluation of downstream, high margin services, which will allow us to increase our footprint with clients.
On the R&D side of the business, we announced a series of important findings in recent months, all of which will contribute to our future development of bavituximab. Our ongoing analysis of the Phase III SUNRISE data has revealed a promising biomarker that may give us insight into key patient populations. We are currently evaluating addl. biomarkers that we hope will allow us to identify a profile for patients who will receive therapeutic benefits from a bavituximab-containing treatment regimen. Concurrent with our internal clinical work, our collaborators at NCCN are in the process of initiating trials for 3 new bavituximab combination treatments, which we expect to begin enrolling patients in the coming months. What is exciting is that the NCCN studies will help build on developments that we are seeing from our internal scientists, as well as our collaborators at Duke, Rutgers, and Memorial Sloan Kettering Cancer Center. Together, we presented compelling data supporting our long-standing belief that bavituximab significantly impacts the tumor microenvironment, creating a more immune -active environment in which other therapies, including checkpoint inhibitors, are able to have a greater anti-tumor effect. These findings are highly validating and we look forward to continuing our work with these world-class institutions to help guide clinical development. We believe the data from the new clinical studies being initiated, other clinical opportunities in development, and the continuing mechanistic and immune-oncology combination insight provided by our scientists & collaborators can add significant value to our R&D business, including creating partnering opportunities, even with a tight control of expenditures that will allow us to reach our profitability goal. I'll now turn the call over to the other members of our team who will give a detailed overview of our clinical, pre-clinical, and corporate activities, as well as our Avid Bioservices contract mfg. business. We will begin with Joe Shan, VP/Clinical & Regulatory Affairs.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
The SUNRISE Phase 3 trial was discontinued earlier this year. Patient treatment and follow-up on the study were allowed to continue, and currently a number of patients are still receiving bavituximab maintenance. As we previously reported, the study protocol pre-specified the collection of thousands of patient samples for exploratory analyzes over a wide range of potential biomarkers. This analysis has been taking place as patient follow up has continued. Through this biomarker analysis, our team has identified a promising correlation between OS and pre-treatment levels of beta-2 glycoprotein-1 (B2GP1), which was presented at ESMO in October [10-10-16: http://tinyurl.com/hp73njt ]. These results were based on a data cut-off after 70% of the targeted overall survival events in SUNRISE had been reached. Interim analysis demonstrated that patients with pretreatment beta-2 levels between 200 and 240 µg/mL, representing approx. 30% of randomized patients, achieved a statistically significant 5.5mos. improvement in MOS from 7.7mos. in the control group to 13.2mos. in the patients receiving bavituximab & docetaxel. A similar trend was observed with pretreatment B2GP1 levels greater than 200 micrograms per mL, representing approx. 50% of randomized patients. We believe that these observations strongly suggest that B2GP1 levels may be useful for identifying patients who are more likely to benefit from a bavituximab containing therapeutic regimen. We plan to further evaluate the role of B2GP1 levels in response to bavituximab therapy in future clinical trials, and the company has filed a patent application directed to the use of this initial biomarker discovery. While we are disappointed SUNRISE did not meet the pre-specified clinical endpoints, the data from SUNRISE will be critical in guiding the future clinical dev. of bavituximab. In a rapidly changing oncology treatment landscape, biomarkers are playing an increasingly important role in helping identify specific patient subgroup characteristics that may predict response to a treatment. This has been seen historically with targeted therapies, as well as more recently with checkpoint inhibitors, including PD-1 inhibitors. Numerous addl. biomarkers are currently being evaluated with the goal of developing a multi-marker signature that can potentially identify patients that are likely to receive clinical benefit from bavituximab. Ideally, these biomarkers can be applied not only to chemotherapy combination approaches, but also to I-O combinations, including the checkpoint inhibitors. As we'll hear from Jeff in a minute, we and our research collaborators are generating very exciting data to support the advancement of clinical dev. of bavituximab with I_O approaches, and we plan to incorporate potential biomarkers identified from SUNRISE into future clinical trials.
Meanwhile, as Steve mentioned, we're pleased by the NCCN’s award of 3 grants to investigators for clinical trials of bavituximab in combination with other therapeutics for the treatment of Glioblastoma, Head & Neck Cancer and Hepatocellular Carcinoma [9-6-16: http://tinyurl.com/gutgwb5 ]. These grants were awarded to researchers at the Moffitt Cancer Center, Mass General Hospital Cancer Center, and The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. These NCCN studies which we expect to be initiated in the coming months align with our dev. strategy for bavituximab, which is currently focused on small early stage clinical trials evaluating the drug in combination with other cancer treatments, including chemotherapy, radiation, and checkpoint inhibitors. Collaborators such as NCCN play a central role in this strategy and we look forward to integrating the valuable clinical data generated by these investigators to expand our knowledge regarding bavituximab-focused cancer treatment combinations. That concludes my comments today. I’ll now turn the call over to Jeff Hutchins, VP/Pre-Clinical Research.
JEFF HUTCHINS (VP/PreClinical Res.)
As Joe's team mentioned and the important clinical progress they've made during the qtr, the pre-clinical group has also reported findings that further illuminate bavituximab’s role in treating cancer. In recent months, we have announced results from studies conducted with collaborators at Memorial Sloan Kettering Cancer Center, Duke University, and Rutgers University College of Medicine, as well as our own internally conducted pre-clin. research. The presented results of this work reinforced our belief that bavituximab plays an important role in transforming what we call “cold” tumor microenvironments, which are characterized by immunosuppression and an inability to generate an effective attack on tumors into “hot” tumor microenvironments that exhibit high immune activity and are pronged with specific cells to fight tumors. During the past qtr, we have presented data from several studies showing that meaningful tumor microenvironment shifts occurred when a bavituximab like antibody was administered as part of a combination treatment regime with checkpoint inhibitors such as anti-PD-1, anti-PD-L1, and anti-LAG3, as well as with radiation and/or chemotherapy. This shift in tumor microenvironment from cold to hot as was evidenced by greater increases in the activity of several critical immune activating pathways, including presentation and processing of antigens and signaling and activation of T cells. We believe that these immune activating mechanisms can be an important component of combination treatment approaches to cancer. Currently it is estimated that 40-70% of cancer patients don't respond to available anti-cancer therapies due primarily to the immunosuppression impacting their tumors. Our pre-clinical work suggests that bavituximab can help reverse this immunosuppression creating an immune active environment that can potentially convert these non-responders to responders. Importantly, we think that this priming of the tumor marker environment is not only relevant for enhancing response to immunotherapies, but also for more traditional cancer treatments such as radiation & chemotherapy. While we are excited by the data we've generated, it is important that we also demonstrate the practical impact that this activity can have on tumors. To this end, we have presented promising data from a study in a Triple Negative Breast Cancer model at the 2nd Intl. Cancer Immunotherapy Conference in September [9-27-16/AACR-CRI: http://tinyurl.com/zy9yv78 ]. These findings showed that 80% of animals receiving a pre-clinical bavituximab equivalent combined with anti-PD1 & anti-LAG3 therapies experienced complete tumor regression. This is in contrast to findings that showed no complete regression among the animals in the treatment group that received a combination of anti-PD1 & anti-LAG3 alone, without the equivalent of the bavituximab.
In a follow-up presentation from the same study at the SITC Annual Meeting in November [11-14-16/SITC’16: http://tinyurl.com/js3fca4 ], we reported these complete regressions for long, durable, and suggestive of immune system memory and adaptive immune responses. This is just one example of the type of preclin. work that has generated the excitement at Peregrine about the potential of bavituximab in combination cancer therapy. But we recognize that this work needs independent outside validation from the academic community. To this end, we are thrilled to highlight our ongoing collaboration with scientists at Memorial Sloan Kettering, which is being led by doctors Taha Merghoub & Jedd Wolchok, two of the world's most foremost experts in the field of cancer immunotherapy. Their work in a mouse model of B16 melanoma, also presented at the SITC meeting [11-14-16: http://tinyurl.com/js3fca4 ], showed that PS targeting antibodies synergized with both anti-PD1 & radiation therapy to improve anti-cancer activity for tumor burden & survival. As well, this combination uniquely led to a change in the tumor microenvironment, shifting it from immunosuppressive, in which tumors which are protected, to immune active, in which tumors are more susceptible to immune related treatments. We recognize that these research results while exciting are in preclini. cancer models and must be translated into human studies. This is a key objective of the 3 NCCN clinical trials that Joe just mentioned that are expected to be initiated in the coming months. We look forward to continuing our research activities on bavituximab treatment combinations with our collaborators and present new findings as they are available. That concludes my comments today. I'll turn over the call to Paul Lytle, CFO…
PAUL LYTLE (CFO):
Before I begin, I’d like to reiterate our financial goal of becoming profitable on an overall basis 18mos. from this past qtr-end. Our strategy for achieving this goal is built on growing revenue from our contract mfg. business, Avid Bioservices, while reducing our overall spending on R&D. We have made great strides over the past 2 qtrs in both growing revenue and reducing our R&D spend, thereby reinforcing our commitment to this goal. I’ll first address our contract mfg. revenue. During Q2/FY’17, we achieved all-time high revenue of $23.4mm, and while we expected to have a very strong qtr as some revenue shifted from Q1 to Q2 due to an outside testing delay which was discussed last qtr, I am pleased to say that those delays have been resolved and we have recognized to-date $29mm in revenue over the past 6mos. This represents revenue growth of 53% compared to last FY. Given the performance, we are able to reaffirm our full FY2017 revenue guidance of $50-55mm. We also have a strong revenue backlog of $73mm under signed contracts that supports this revenue growth. This backlog mostly covers services to be completed during the remainder of FY2017 & FY2018. I’ll address the 2nd part of our strategy, which is to reduce our overall spending on R&D. As we announced last June, Peregrine has made a decision to focus our internal drug dev. efforts on small, cost effective, early-stage clinical trials designed to attract potential partners to further advance our products. We believe the strategy will not only help us achieve profitability sooner, but it could also create significant potential upside for our shareholders. As we execute on the strategy, our R&D expenses decreased 51% this qtr compared to the same prior year qtr, and for the current 6mo. period our R&D expenses declined 45% over the same period last year. The result of the strategy has translated into a reduction in our net loss by 69% for the qtr and 44% for the 6mo. period vs. the same prior year periods. And, if you deduct non-cash expenses from our net loss this qtr, we saw our net cash burn rate for the qtr decline 78% to $2.6mm compared to $11.7mm for the same qtr last year. As I mentioned before, we're making great progress towards reaching our goal of profitability. A more detailed analysis of our statement of operations is included in our Form 10-Q that will be filed shortly [ http://tinyurl.com/j2u2bjk ]. This concludes my financial overview. I will now open the call up for questions.
Q&A: [beg. 22:10]
1. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Can you just remind us what was the magnitude of Avid’s delayed revenue recognition between Q1 & Q2?”
Paul Lytle: The overall delay is that last qtr we mentioned that we had an outside testing lab that is responsible for performing certain tests, and that testing lab was backlogged with certain activities and therefore we couldn’t recognize a certain amount of revenue last quarter that was shifted from Q1 into Q2. Well, their delays have now been resolved and we’re back on track and recognizing revenue as we routinely do as we release lots. So, everything has been resolved.
TY: ”Approx. how much was that amount?”
Paul Lytle: If you straight line our revenues, our projections are about $50-55mm over the FY. So you figure at $12.5mm/qtr, you could assume that last qtr was about $5.5mm in total revenue and it could have been on a straight line basis of about $12mm.
TY: ”If I recall correctly the cost of your new [Avid II “Myford”] facility is also included in cost of contract mfg. as well. So how much of the new facility cost is included in Q2/FY17’s contract mfg costs?”
Steve King: If we're talking about the Myford facility which we commissioned in January of this year, that cost would be included in those numbers. Obviously we're just kind of moving toward a 3rd facility that would primarily be used for clinical production, at least initially, could eventually be commercial as well, but it’s really designed to be a clinical production facility. So those numbers other than where we spent on planning up to this point are not reflected as in the current numbers.
TY: “Re: Bavi, now that we’ve seen some positive pre-clin. data in combination with checkpoint inhibitors and as you outlined earlier, there are a number of collaboration of academic partners. Can you tell us what else is needed to move any potential combination to the clinic and would any of these upcoming trials involve existing academic collaborators?”
Steve King: One of the nice things about the NCCN collaboration, which just to remind everybody was based on a $2mm grant from Peregrine, a lot of which has already been put into the program, but basically the NCCN will oversee all of those 3 clinical studies that will be completed. One of those is in an I-O combination, so it gives us one opportunity already to start looking at kind of an extension if you will of the work we're doing with our collaborators into the clinic and so we can start to validate some of that. In addition, we have interest from other academic collaborators in I-O combinations, so we're currently evaluating those and how those would move forward. So, we're hopeful to have some news in the not too distant future on some of those developments as well. Beyond that, we're really in the process of just looking through the SUNRISE data, identifying what's the best way to identify patients. In addition, some of the other data we can learn from SUNRISE are changes on therapy, the primary hypothesis being that we can take, if you will, immunologically cold tumors and make them hot tumors by breaking down the immunosuppression - that's some of the things that we have an option to learn from the SUNRISE study. Overall, the data from SUNRISE, taken together with the work at Sloan Kettering and our other collaborators, all really build the story very nicely to eventually potentially starting more company-sponsored studies, but that's where the balance of our R&D spend vs. our revenue comes into play. So, whatever studies we start we anticipate would be smaller studies, but ones that will be rich in biomarker-type analysis, which we think will be the key to #1 identifying those successful combinations, but secondly to eventual partnering where we can actually help some of the other drugs that are in development to do better.
TY: ”Thanks again for taking my questions. Looking forward to learn more about these trials in coming months.”
MR. KING’S CLOSING COMMENTS:
I'd like 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. Looking ahead, we are confident in our ability to achieve profitability through cost reduction and revenue growth, while continuing to work with our collaborators to generate the data required to drive partnering and build shareholder value. With that we will now conclude the call. Thank you again.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = == = = =
12-12-15 PR: Peregrine Pharmaceuticals Reports Financial Results for Second Quarter of FY 2017 and Recent Developments
*Avid Posts Record Revenue of $23.4 Million During Second Quarter FY 2017 with Contracted Backlog of Future Business Currently at $73 Million
*Beta-2 Glycoprotein-1 (B2GP1) Identified as a Biomarker that Correlates with Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination Compared to Chemotherapy Alone from the Phase III SUNRISE Trial
*Multiple Preclinical Presentations Collectively Point to Bavituximab's Ability to Enhance the Efficacy of Checkpoint Inhibitors by Triggering Immune Active Tumor Environment
TUSTIN, Dec. 12, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/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 second quarter of FY (FY) 2017 ended October 31, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.
Highlights Since July 31, 2016
"The Avid business is on track to continue its revenue growth this FY as we move toward overall profitability within the next 18 months. Our two facilities have the potential to generate in excess of $80 million in revenue, leaving additional capacity for revenue growth beyond FY 2017 revenue guidance," stated Steven W. King, President and CEO of Peregrine. "We are moving forward with our plans to construct a third manufacturing facility, with an eye toward efficiencies that will reduce the overall cost of construction and operation. While this may delay the new facility launch until later in calendar year 2017, we currently have adequate existing capacity to continue meeting the needs of our current clients while also bringing in new customers so we do not expect it to impact our near-term ability to grow top-line revenue as originally planned. Independently, Avid is a successful and growing CDMO business generating significant revenue and one of our key goals going forward is to help ensure that its value is appropriately represented in the market cap of our overall business." Mr. King continued, "During, and subsequent to, the second quarter, we announced a series of important findings, all of which will contribute to our future development of bavituximab. Our ongoing analysis of the Phase III SUNRISE data has revealed a promising biomarker that may give us insight into key patient populations. We are actively evaluating additional potential biomarkers and we hope to identify a profile for patients who will receive therapeutic benefit from treatment with bavituximab. Concurrent with our internal clinical work, our collaborators at NCCN are in the process of initiating trials for three new bavituximab combination treatments, which we expect to begin enrolling patients in the coming months. What is exciting is that the NCCN studies will help build on developments we are seeing from our internal scientists, as well as our collaborators at Duke, Rutgers, and Memorial Sloan Kettering Cancer Center. Together, we presented compelling data supporting our long-standing belief that bavituximab significantly impacts the tumor microenvironment, creating a more immune active environment in which other therapies, including checkpoint inhibitors, are able to have a greater anti-tumor effect. These findings are highly validating and we look forward to continuing our work with these world-class institutions to help guide clinical development."
Avid Bioservices Highlights
"Growing top-line revenue is a key focus and we are pleased to report a 53% improvement in contract manufacturing revenue for the current six-month period compared to the same period last FY. In addition, our revenue guidance for the second quarter was targeted to exceed $20 million and we achieved $23.4 million in contract manufacturing revenue as we worked closely with the third-party testing laboratory to resolve the unexpected delays in testing we encountered during the first quarter. As a result, we reaffirm our manufacturing revenue guidance of between $50 and $55 million for the full FY," stated Paul Lytle, CFO of Peregrine. "We also continued to advance the validation of three separate manufacturing processes related to third-party customer products that could lead to future commercial manufacturing for these products. While these activities generally have a higher cost of manufacturing, which impacted our gross margin during the second quarter, we believe our investment in these products will provide us future revenue opportunities once these products are approved."
The company reaffirms its manufacturing revenue guidance for the full FY 2017 of $50 - $55 million.
Avid's current manufacturing revenue backlog is $73 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog mostly covers revenue to be recognized during the remainder of FY 2017 and FY 2018.
Clinical Development Highlights
Through the ongoing analysis of the Phase III SUNRISE data, Peregrine scientists identified a correlation between overall survival and pre-treatment levels of the biomarker, beta-2 glycoprotein-1 (B2GP1), which we presented at ESMO in October [10-10-16: http://tinyurl.com/hp73njt ]. Data demonstrated that patients with pre-treatment B2GP1 levels between 200 and 240 µg/mL - representing approximately 30% of randomized patients - achieved a statistically significant, 5.5-month improvement, from 7.7 months to 13.2 months, in median overall survival as compared to patients in the control group with the same range of B2GP1 levels.
Peregrine's research collaboration with NCCN is advancing as planned, with grants awarded to three investigators [9-6-16: http://tinyurl.com/gutgwb5 ] 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 over the coming months.
Research Highlights
Peregrine scientists and collaborators from Duke University Medical Center, Rutgers University College of Medicine, and Memorial Sloan Kettering Cancer Center each presented compelling data demonstrating that shifts in the tumor microenvironment from immune suppressed to immune active occurred when a bavituximab equivalent antibody was administered as part of a combination treatment regimen. Presentations addressed multiple phosphatidylserine (PS)-targeting combinations, including those with checkpoint inhibitors such as anti-PD-1, anti-PD-L1 and anti-LAG3, as well as with radiation or chemotherapy. These data suggest that the addition of PS-targeting reverses an immunosuppressive tumor environment, creating an immune active tumor microenvironment that can potentially convert patients that generally do not respond to immuno-oncology (I-O) therapies into responders. Key presentations were made at the Second International Cancer Immunotherapy Conference in September, the American Association for Cancer Research's Tumor Immunology and Immunotherapy Conference in October, the Society for Immunotherapy of Cancer (SITC) in November, and the San Antonio Breast Cancer Symposium in December.
Financial Highlights and Results
Peregrine continues to execute its previously-announced strategy to reach sustained profitability by increasing contract manufacturing revenue while decreasing research and development expenses, with the goal of reaching profitability 18 months from now. During the first six months of FY 2017, the company made significant progress toward this goal with contract manufacturing revenues increasing 53% compared to the first six months of FY 2016 and research and development expenses decreasing by 45% compared to the first six months of FY 2016.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party customers increased to $23,370,000 for the second quarter of FY 2017 compared to $9,523,000 for the second quarter of FY 2016. In addition, as previously-announced, a backlog at a third-party testing lab, unrelated to product quality, required that the recognition of some revenue be shifted from the first quarter to the second quarter of FY 2017.
Total costs and expenses for the second quarter of FY 2017 were $27,447,000, compared to $23,347,000 for the second quarter of FY 2016. For the second quarter of FY 2017, research and development expenses decreased 51% to $7,022,000, compared to $14,190,000 for the second quarter of FY 2016. Cost of contract manufacturing increased to $15,441,000 in the second quarter of FY 2017 compared to $4,741,000 for the second quarter of FY 2016, primarily due to an increase in the cost of contract manufacturing associated with higher reported revenue. Also contributing to this increase and impacting gross margins for the period is the higher cost of operating the new Myford facility as well as the higher cost associated with performing process validation runs during the quarter. For the second quarter of FY 2017, selling, general and administrative expenses increased to $4,984,000 compared to $4,416,000 for the second quarter of FY 2016 primarily due to the company's growing manufacturing business.
Peregrine's consolidated net loss attributable to common stockholders was $5,498,000 or $0.02 per share, for the second quarter of FY 2017, compared to a net loss attributable to common stockholders of $14,578,000, or $0.07 per share, for the same prior year quarter. [NOTE: Oper. Cash Burn for Q2(q/e 10-31-16): $2.57mm see below.]
Peregrine reported $49,055,000 in cash and cash equivalents as of October 31, 2016, compared to $61,412,000 at FY ended April 30, 2016.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
Conference Call
Peregrine will host a conference call and webcast this afternoon, December 12, 2016, at 4:30PM ET (1:30PM PT). 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. (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 .
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED
OCTOBER 31, SIX MONTHS ENDED
OCTOBER 31 ,
2016 2015 2016 2015
REVENUES:
Contract manufacturing revenue $ 23,370,000 $ 9,523,000 $ 28,979,000 $ 18,902,000
License revenue — — — 292,000
Total revenues 23,370,000 9,523,000 28,979,000 19,194,000
COSTS AND EXPENSES:
Cost of contract manufacturing 15,441,000 4,741,000 18,503,000 9,349,000
Research and development 7,022,000 14,190,000 15,591,000 28,108,000
Selling, general and administrative 4,984,000 4,416,000 10,044,000 9,315,000
Total costs and expenses 27,447,000 23,347,000 44,138,000 46,772,000
LOSS FROM OPERATIONS (4,077,000 ) (13,824,000 ) (15,159,000 ) (27,578,000 )
Interest and other income 21,000 626,000 46,000 657,000
NET LOSS
$ (4,056,000 ) $ (13,198,000) $ (15,113,000) $ (26,921,000)
COMPREHENSIVE LOSS $ (4,056,000 ) $ (13,198,000 ) $ (15,113,000 ) $ (26,921,000 )
Series E preferred stock accumulated dividends (1,442,000 ) (1,380,000 ) (2,477,000 ) (2,413,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ (5,498,000) $ (14,578,000) $ (17,590,000) $ (29,334,000)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 244,815,767 203,942,411 242,205,428 200,629,892
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.02 ) $ (0.07 ) $ (0.07 ) $ (0.15 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31,
2016 APRIL 30, 2016 Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 49,055,000 $ 61,412,000
Trade and other receivables 6,066,000 2,859,000
Inventories 25,924,000 16,186,000
Prepaid expenses and other current assets 1,711,000 1,351,000
Total current assets 82,756,000 81,808,000
Property and equipment, net 23,957,000 24,302,000
Restricted cash 600,000 600,000
Other assets 2,624,000 2,333,000
TOTAL ASSETS $ 109,937,000 $ 109,043,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 11,572,000 $ 8,429,000
Accrued clinical trial and related fees 3,639,000 7,594,000
Accrued payroll and related costs 5,280,000 5,821,000
Deferred revenue 17,980,000 10,030,000
Customer deposits 26,928,000 24,212,000
Other current liabilities 1,012,000 1,488,000
Total current liabilities 66,411,000 57,574,000
Deferred rent, less current portion 1,347,000 1,395,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares; 1,647,760 and 1,577,440 issued and outstanding at October 31, 2016 and April 30, 2016, respectively 2,000 2,000
Common stock-$0.001 par value; authorized 500,000,000 shares; 251,765,279 and 236,930,485 issued and outstanding at October 31, 2016 and April 30, 2016, respectively 252,000 237,000
Additional paid-in capital 566,314,000 559,111,000
Accumulated deficit (524,389,000 ) (509,276,000 )
Total stockholders' equity 42,179,000 50,074,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 109,937,000 $ 109,043,000
Safe Harbor *snip*
CONTACTS:
• 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 Dec. 8 2016, there were 257,141,534 shares outstanding.”
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Latest 10K 4-30-16 iss. 7-14-16 PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 10-31-16 iss. 12-12-16 http://tinyurl.com/j2u2bjk PR: http://tinyurl.com/hhn4gga (Cash 10-31-16=$49.1mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY17'Q2(qe 10-7-31-16), per the 10-31-16 10-Q ( http://tinyurl.com/j2u2bjk ) issued 12-12-16.
• Total Revs since May’06: ($202.5mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $229.2mm
• 12-12-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$73mm).
• Deferred-Revs at 10-31-16 total $18.0mm, DOWN from $21.5mm at 7-31-16.
• Cust.Deposits at 10-31-16 total $26.9mm, UP from $21.7mm at 7-31-16.
• Inventories at 10-31-16 total $25.9mm, UP from $25.3mm at 7-31-16.
• Avid’s Gross-Profit over last 4 qtrs: $22.3mm on revs of $54.4mm (GP%=41%)
• Recall, Avid Rev$ 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%
FY17Q2 10-31-16 23,370,000 15,441,000 7,929,000 34%
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
FY17Q2 10-31-16 23370 0 0 23370 21531 0 25274
Totals: 202548 24149 2453 229150 <=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
FY17Q2 10-31-16 4,056,000
= = = = = = = =
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)
FY17Q2 10-31-16 2,565,000 (Q1+Q2: 12,172,000 10Q pg.24)
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%
Q/E 10-31-16 77% 10% 13%
- - - - - - - - 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)
FY’17-Q2 = q/e 10-31-16 – rep. 12-12-16 Mon (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
CASH a/o 10-31-16: $49.1mm
= = = = = = = = = = 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."
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