Avid Bioservices, Inc.

Avid Bioservices, Inc.

$12.39
-0.03 (-0.24%)
NASDAQ Capital Market
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Biotechnology

Avid Bioservices, Inc. (CDMO) Q3 2015 Earnings Call Transcript

Published at 2015-03-12 16:30:00
Executives
Christopher Keenan - Senior Director, Investor Relations Steve King - President and Chief Executive Officer Paul Lytle - Chief Financial Officer Joe Shan - Vice President, Clinical and Regulatory Affairs Jeff Hutchins - Vice President of Preclinical Research Rob Garnick - Head of Regulatory Affairs
Analysts
Joe Pantginis - Roth Capital Partners Thomas Yip - MLV & Company George B. Zavoico - Jones Trading Roy Buchanan - Piper Jaffray
Operator
Good day ladies and gentlemen and welcome to the Peregrine Pharmaceuticals, Incorporated Third Quarter Fiscal Year 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this call is being recorded. I would now like to turn the call over to Christopher Keenan of Peregrine’s Investor Relations group. Mr. Keenan, you may begin.
Christopher Keenan
Thank you, Brandy. Good afternoon and thank you for joining us. On today’s call, we have Steve King, our President and Chief Executive Officer; Paul Lytle, our Chief Financial Officer; Joe Shan, our Vice President of Clinical and Regulatory Affairs, Jeff Hutchins, our Vice President of Preclinical Research and Rob Garnick, our Head of Regulatory Affairs. After their prepared remarks we welcome your questions. Before we begin, we would like to remind you that during this call we will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ. These forward-looking statements reflect our current views about future events and future performance, and are identified by the terms of use and phrases such as believe, expect, plan, anticipate, on target, and similar expressions identifying forward-looking statements. These risks include, but are not limited to, the risk factors detailed from time-to-time in our filings with the Securities and Exchange Commission, including, but not limited to the Quarterly Report on Form 10-Q for the third quarter fiscal year 2015 ended January 31, 2015, which was filed today. Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. And we expressly do not undertake any duties to update these forward-looking statements, whether as a result of new information, future events or otherwise. And with that, I’ll turn the call over to Steve.
Steve King
Thanks, Chris, and thanks to all of you who are participating in this afternoon’s call. This is an exciting for the company on many fronts. Our lead clinical program bavituximab represents the most clinically advanced agents that target the immunosuppressive PS signaling pathway. And we are driven to bring this product to the market. And believe it has the potential to help change the way cancer patients are treated. Bavi is in a unique position as a Phase III immuno-oncology agent that has shown great potential in combination with both current standard cancer treatments such as chemotherapy as well as emerging immuno-oncology agents such as those targeting PD-1 and PDL-1. Leading the way to bring Bavi to the market is our Phase III clinical trial evaluating Bavi with the chemotherapy agent docetaxel in second-line non-small cell lung cancer. We continue to make great progress in this trial and are on track to complete enrollment in the study by year-end. I had the opportunity to visit with investigators in the SUNRISE trial, and I continue to see enthusiasm from the sites as well as a very positive reaction to the recent immuno-oncology combination and translational clinical data coming from the rest of the bavituximab program. After completing enrollment in the SUNRISE trial, our focus is to enter into new clinical collaborations, supported by all the recent immuno-oncology preclinical and translational clinical data we have been generating. This will allow us to further explore clinical combinations of bavituximab with approved and developmental agents targeting PD-1 and PDL-1 in multiple tumor indications. We expect these efforts to be quite visible over the coming months as the planning that is well underway comes to fruition. On top of all the exciting clinical and preclinical developments, we have continued to see remarkable revenue performance from our manufacturing subsidiary Avid Bioservices. We are raising revenue projections for the current fiscal year and bringing on new capacity that will help spur future growth by the middle of this year. This capacity will allow us to continue meeting the growing needs of our existing clients while simultaneously allowing us to be ready for Bavi commercialization. This business is its strongest position ever as we head through the rest of fiscal year 2015 and is in a great position for a very strong fiscal year 2016. We expect over the next few months to have the opportunity to further update you on scientific and clinical data at high profile conferences. To be able to update you on the emergence of clinical collaborations to further explore the potential of bavituximab in combination with other IO agents and to bring online the additional capacity of Bavi that will help grow the business. With that I’ll now turn the call over to Joe to discuss clinical development activities. Joe?
Joe Shan
Thanks Steve. As Steve just clearly outlined for you, while we remain focused on advancing bavituximab toward market approval, we’re simultaneously laying the groundwork for expanding potential use beyond non-small cell lung cancer. SUNRISE, our Phase III lung cancer trial is progressing according to plan, with more than 150 clinical centers spanning 14 countries now open for enrollment, our focus is fully transitioned from the start-up to the enrollment phase. And we remain on-track to complete patient enrollment by the end of this calendar year. We’re also pleased with the progress made to date and encouraged by the positive feedback we have heard directly from investigators, who recognize the potential immuno-modulating mechanism of bavituximab and appreciate its safety profile to date. As a reminder, SUNRISE is designed as a Phase III registration trial and has two planned interim analyses. The first is purely to assess safety and the second will assess both safety and efficacy. As the interim analyses are triggered and a certain number of trial events are reached, in this case deaths, we cannot at this point guide to when these might occur. To protect the integrity of this double-blind trial, an independent data safety monitoring committee has been established to evaluate the data on an ongoing basis and make recommendations to Peregrine as to when the trial should be un-blinded. In addition to this most advanced clinical trial, our clinical pipeline is supplemented by trials all designed to expand the therapeutic potential of our novel immunotherapy bavituximab. Today we announced that final data from a Phase I investigator sponsored trial which evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer has been accepted for publication in the peer-reviewed journal Cancer Medicine and will be available online in the coming weeks. The positive data from this trial along with data from two prior clinical trials in advanced breast cancer makes this an exciting opportunity for the company and we continue to evaluate opportunities to advance the clinical development of bavituximab in this indication. Also during the quarter, we announced data from the Phase II IST evaluating bavituximab in combination with sorafenib in patients with advanced liver cancer which was conducted by Dr. Adam Yopp, Assistant Professor of Surgery at the University of Texas Southwestern Medical Center. Data demonstrated that the combination of bavituximab in sorafenib is also in an improved Time to Progression of 6.7 months and the disease specific survival of 8.7 months. Importantly, the combination of bavituximab and sorafenib was well tolerated in patients with advanced HCC with no indications of auto-immune adverse events which have been seen with other check-point immunotherapies. This trial is also the subject of an oral presentation by Dr. Yopp at the Society of Surgical Oncology at the Annual Cancer Symposium towards the end of this month. Also recall that translational data from six patients in this study were presented last November at the Society of Immunotherapy of Cancer Annual Meeting. These data were generative through Dr. Dmitry Gabrilovich, a member of our Scientific Advisory Board and program leader of translational tumor immunology at the Wistar Institute. These data demonstrated an increase in cytotoxic T lymphocytes in the tumor following just one cycle of treatment with bavituximab and sorafenib. These results from treated patients are consistent with that which has been shown previously with PS targeting antibodies and multiple preclinical cancer models, specifically that bavituximab can block immunosuppression within the tumor microenvironment and induce an anti-tumor immune response. Taking together, we along with Dr. Yopp believe that further evaluation is warranted in a larger randomized trial as resources permit. Finally, over the past year, we’ve also invested in developing new assays that we are incorporating into trials to assess immune changes within the tumor microenvironment and characterize changes in numbers and types of immune cells. Today we announced that three posters have been accepted for presentation at the upcoming AACR Annual Meeting in April. And one of these posters will discuss data generated using a proprietary ex vivo system using patient tumors which was developed by the lab of Dr. Scott Antonia, another member of our Scientific Advisory Board and the Thoracic Oncology Department Chair, in the immunology program leader at the H. Lee Moffitt Cancer Center in Florida. We believe that these activities and accomplishments over the past year further build on our foundation for development of bavituximab in combination with chemotherapies as well as with immune-checkpoint inhibitors. Meanwhile we continue to expand our growing network of thought leaders as well as potential clinical collaborators with the goal of spreading the word about our novel PS targeting based immunotherapy platform and plan to advance the most promising combinations into the clinic as opportunities and resources permit. And with that, I’ll turn the call over to Jeff.
Jeff Hutchins
Thanks Joe. As Steve mentioned, as part of our immuno-oncology development program, we have continued to deliver snapshots aimed at elucidating and highlighting a broad picture of bavituximab in multiple preclinical indications with the ultimate goal of uncovering the most effective immune activating combinations. When we initiated this program in June of 2013, we assembled a detailed plan designed to guide clinical development decision making through a series of preclinical studies to lead into translational trials in patients. These steps are absolutely critical when building a foundation for future clinical trials. I am proud of what Peregrine and our collaborators have accomplished in examining both the preclinical PS science and targeting platform by looking at multiple combinations thereby discovering the most robust immune oncology combination. With us seeing today now how bavituximab potentially plays a role in breaking resistance to anti-PD1 monotherapy. Building on our strategy to disseminate our findings within the scientific and clinical medical communities, we recently presented data at the 2014 San Antonio Breast Cancer Symposium showing that the single-agent pre-clinical equivalent to bavituximab demonstrated statistically significant tumor growth inhibition as well as statistically significant increases in the percentages of CD4 and CD8 tumor infiltrating lymphocytes and decreases in tumor associated myeloid-derived suppressor cells, all of which are key indicators of immune activation in breast tumor models when compared to a control antibody. These data confirms that the mechanism of action of bavituximab functions independent of PD-1 checkpoint blockade therefore further highlighting our opportunity for additive or synergistic effects with IO combination therapy. As well, as the Keystone Immunology Meeting, which brought together leading scientists across multiple disciplines, we presented data showing that PS targeting antibodies, when combined with an anti PD-1 antibody displayed statistically significant improvements in the number of tumor fighting immune cells, their activation signals associated with these cells and the immune activated in cytokines in models of melanoma compared to an anti PD-1 antibody alone. In addition, we saw that the cells that suppress the immune system’s ability to recognize the tumor such as MDSCs were reduced by more than 40% in combination with the PS targeting antibodies versus anti PD-1 antibody alone. I hope that what you can see from our very successful IO development program, is that our results are not only positive but very consistent across multiple tumor types. These data demonstrate that the combination of a PS targeting antibody and the checkpoint inhibitor achieve statistically significant tumor growth suppression as well as significantly increased levels of immune cell expansion and activation. As Joe mentioned in his remarks, similar immune activation events were observed in HCC patients, thus painting a consistent translational picture from preclinical to clinical as to the breadth of bavituximab’s ability as a combination therapy. I can tell you that data from these studies and clinical translational data from trials are being well received and as such we plan to continue to actively engage members of the scientific and medical communities with the goal of highlighting this potential of bavituximab throughout the coming years. Looking to next month, two preclinical posters have been accepted for presentation at the 2015 AACR Annual Meeting focusing further on defining the deep impact of PS targeting agents in combination with immune checkpoint inhibitors on stimulating and sustaining T-Cell activation. It is our strong belief that these data along with the data that we have discussed with you over the past several months support bavituximab as a potential treatment capable of converting these non-responding anti-PD-1 therapy patients into clinical responders. With that, I’ll turn the call over to Paul for an update on our financials and Avid business. Paul?
Paul Lytle
Thanks Jeff. Now, turning to our financials it’s important to note that we continue to closely manage our operations in-line with our cap position while balancing our various sources of capital. And one important source of capital is derived from our contract manufacturing business Avid Bioservices, which generated $5.7 million in revenue this quarter and $17.4 million for the current nine-month period. This represents a 46% increase in revenue over the same prior year quarter and a 10% increase over the same nine-month period. As we look to the future, I would also like to emphasize that we have a strong backlog for future services in the amount of $29 million as of January 31. This current backlog covers services to be completed during the remainder of fiscal year 2015 and into fiscal year 2016. And based on our fiscal year-to-date revenue and our anticipated completion of near-term projects under this backlog, we are raising our contract manufacturing revenue guidance from a range of $19 million to $23 million to a range of $23 million to $25 million for the full fiscal year 2015. In addition to a strong revenue quarter, last December we shared with you strategic plans to expand our manufacturing capacity to help support the revenue growth of Avid as well as creating sufficient manufacturing capacity for the potential commercial launch of bavituximab. And growing this revenue generating business is very important to us as it reduces the amount of capital and funding we would need to raise by other means. And we have made significant progress this quarter in constructing this new manufacturing clean-room and we remain on track to commence manufacturing in this new facility during mid-2015. Now turning to expenses, we saw an expected increase in R&D spending this quarter to $11.3 million as we continue to invest in the SUNRISE Phase III trial. This resulted in an increase in our net loss to approximately $13 million this quarter with a corresponding increase in our net cash burn from operations to $11.1 million representing our reported net loss minus non-cash expenses. In conclusion, let me say that our financial goals are centered on maintaining a solid cash position and investing these proceeds into our novel immuno-oncology program led by bavituximab and our revenue generating manufacturing business. We will continue to closely manage our operations in-line with our cap position while balancing our various sources of capital. We look forward to keeping you updated on our progress. And we will now open the call up for your questions. Brandy.
Operator
[Operator Instructions]. Our first question comes from the line of Joe Pantginis from Roth Capital Partners. Your line is open.
Operator
Thank you. Our next question comes from Thomas Yip from MLV & Company. Your line is now open.
Operator
Thank you. Our next question comes from the line of George Zavoico from Jones Trading. Your line is now open.
Operator
Thank you. [Operator Instructions]. Our next question comes from Charles Duncan from Piper Jaffray. Your line is now open.
Operator
Thank you. And I’m not showing any further questions at this time. I’d like to turn it back over to management for closing remarks.
Steve King
Yes, I’d like to thank all of you again for participating in today’s call. We strongly believe that the path we are taking on the development front-end will add significant value to the bavituximab program by expanding potential indications and combinations which helps ensure commercial success. Along with the continued growth of Avid, which adds value through growing third party revenues which increases the value of the business by helping offset the overall cash burn and perhaps most importantly allowing us to be prepared for bavituximab’s success. Taking together all these activities should increase shareholder value. And we look forward to that reflection in our market valuation. I thank you all again for your continued support.
Operator
Ladies and gentlemen thank you for participating today’s conference. This concludes the program. And you may all disconnect. Everyone have a good day.