Agenus' CEO Discusses Q2 2012 Results - Earnings Call Transcript

Aug. 3.12 | About: Agenus (AGEN)

Agenus Inc. (NASDAQ:AGEN)

Q2 2012 Earnings Call

August 2, 2012, 11:00 am ET


Jonae Barnes - VP, IR & Corporate Communications

Garo Armen - Chairman & CEO

Christine Klaskin - VP, Finance & Principle Financial Officer


John Sonnier - William Blair & Company

Joe Pantginis - Roth Capital

George Zavoico - MLV & Co.


Good morning. My name is Nick and I will be your conference operator today. At this time, I would like to welcome everyone to the second quarter 2012 earnings call. All lines have been placed on-mute to prevent any background noise. After the speakers’ remarks there will be a question-and-answer session. (Operator Instructions) Thank you.

Jonae Barnes you may begin your conference.

Jonae Barnes

Thank you and good morning everyone. Welcome to Agenus’ conference call to discuss the financial results for the second quarter 2012. With me today is Dr. Garo Armen, Chairman and CEO and Christine Klaskin, Vice President of Finance.

During this call, we will review our financial results, as well as provide a corporate update. We will then open up the call to a Q&A session.

But before we continue, I would like to remind you that this conference call will contain forward-looking statements, including statements regarding the company’s cash position, timing of potential income stream and development and commercialization efforts, timelines, the availability of data and potential efficacy and market potential with respect to products and product candidates of the company and its partners.

These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Reference to these risks and uncertainties is made in today’s press release and they are disclosed in more detail in our most recent filings with the U.S. Securities and Exchange Commission.

These statements speak only as of the date of this call and Agenus undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties. As a remainder this call is being recorded for audio replay.

With that, I will now hand over the call to Christine who will review our financial results for the second quarter of 2012.

Christine Klaskin

Thank you, Jonae. Good morning everyone and thank you for joining us on today’s call. By now, we hope you had the opportunity to review this morning’s press release.

For the second quarter of 2012, we reported a net loss attributable to common stockholders of $7.1 million or $0.31 per share basic and diluted. This compares to a net loss attributable to common stockholders in the second quarter of 2011 of $6 million or $0.31 per share basic and diluted.

Cash used in operating activity was $3.3 million for each of the quarter’s ended June 30, 2012 and 2011. For the six months ended June 30, 2012 we incurred a net loss attributable to common stockholders of $551000 or $0.02 per share basic and diluted. This compares to a net loss attributable to common stockholders of $12.1 million or $0.64 per share basic and diluted for the comparable period in 2011.

The decrease in net loss for the six months ended June 30, 2012 compared to the same period in 2011 is due to the revenue generated of $13.4 million during the first quarter of 2012 primarily related to the one-time payments received through expanded agreement with GlaxoSmithKline or GSK and through a license of non-core technologies.

Cash provided by operating activities for the six months ended June 30, 2012 was $7.9 million compared to cash used in operations of $8.7 million for the comparable period in 2011. Cash and cash equivalents were $25.5 million as of June 30, 2012.

During the quarter, we increased our cash position by approximately $4.5 million through equity offerings. Based on our net cash burn for 2012 defined as cash used in operating activities less onetime upfront payment plus capital expenditures and dividend payments which is anticipated to be in the range of $13 million to $16 million; we expect sufficient financial resources to fund operations through 2013.

This concludes the financial portion of the call. Garo will now provide a corporate update.

Garo Armen

Thank you, Jonae and Christine. I will now discuss our progress during the first half of 2012. This is an exciting year for Agenus on a number of fronts. We have seen steady progress in the advancement of our QS-21 adjuvant for both infectious disease and cancer indications through our corporate partner GSK.

In addition to our expanded QS-21 agreement with GSK which was announced during the first quarter of this year, we recently, we’ve seen a new Phase III clinical program which was initiated for the prevention of shingles in immunocompromised patients. This is a randomized placebo controlled Phase III clinical trial in approximately 1,400 patients.

GSK has four QS-21 containing Phase III programs underway which will have their read-out in the near future. They include two MAGE-A3 cancer vaccines, one for non-small cell lung cancer and the other one for melanoma patients. The other two are the RTS,S vaccine for malaria and HZ/su vaccine for shingles. In addition to QS-21, we have also made steady progress in advancing our heat shock protein platform during the first half of 2012.

During the second quarter, the National Cancer Institute approved a study of the Prophage Series G-200 vaccine in a large randomized Phase II trial in combination with Avastin in patients with surgically resectable recurrent glioblastoma. This study will be sponsored by the Alliance for Clinical Trials in Oncology, an NCI cooperative group.

The trial will investigate the combination of G-200 and Avastin in a three ARM randomized study over approximately 222 patients with surgically recurrent glioma. This study will use overall survival as its primary endpoint and when compared the efficacy of G-200 given with Avastin either concomitantly or upon progression versus Avastin alone.

Also during the second quarter, additional data and analysis from Phase II study for Prophage Series G-200 in recurrent surgically glioblastoma patients was presented at a Plenary Session at the 80th American Association of Neurological Surgeons Annual Scientific Meeting

The data presented showed that G-200 treated patients live significantly longer than 86 comparable patients treated alternative therapies during the study period. In the analysis, both G-200 group and the control patients underwent greater than 90% resection of the current GBM and had a Karnofsky performance status of better than 70.

The median overall survival for control patients in the study was only 32.8 weeks with a six month survival of 68% as compared to a median survival of 47.6 weeks and a 93% six month survival rate for the vaccine treated group. This analysis had a P value better than 0.01.

More recently, an article titled Immunotherapy for glioma: promises and challenges was published in the July edition of the peer-review journal Neurosurgery Clinics of North America. The article specifically describes the ways in which tumors limit effective communication with immune cells, secrete immune-inhibitory cytokines and molecules, and express molecules that induce apoptosis of immune cells.

It also defines three different immunotherapeutic approaches to counter this tumor-associated immunosuppression. One is cytokine therapy; two is passive immunotherapy and third one is active immunotherapy which includes our Agenus’ Prophage Series of vaccine.

Also we anticipate that during this quarter, a manuscript of Phase I results of Prophage Series G-200 in recurrent glioma will be published in a peer-review scientific journal. In addition to recurrent GBM, with G-200 and planned Phase II cooperative group study, a Phase II trial evaluating the Prophage Series G-100 vaccine in patients with newly diagnosed glioma is now fully enrolled. I'm also pleased to report that the Agenus met the qualifications to join the broad market Russell 300 Index, Russell 2000 Index and Russell Global Index and Russell Microcap Index.

We expect our new presence in these four entities will expose Agenus to a wider range of institutional investors allowing us to broaden our shareholder base. Let me now look at the progress seen during the first half of 2012 and how that will relate to what you may expect from us in the rest of this year and into 2013. So let me briefly discuss now what lies ahead.

With regard to our QS-21 programs, it is anticipated that results from the second Phase 3 trial of IPSS for malaria in infants six weeks to 12 weeks old will be available in the fourth quarter of 2012. The two major Phase 3 programs for melanoma and non-small cell lung cancer are event driven trials meaning that the trial will continue until a fixed number of events have occurred and results from these trials should be available in 2013 according to the latest quarterly report by GlaxoSmithKline.

As a reminder, we are entitled to receive milestone payments as GSK’s QS-21 containing programs advance as well as royalties our net sales for at least 10 years after commercial launch of the first prophylactic and separately their first therapeutic product. With over a dozen QS-21 containing clinical programs in development in the GSK Biologics pipeline, we are certainly pleased to be able to participate in the future success of the world’s number one ranked vaccine company.

Now let me turn to our Heat Shock Protein platform. With regard to the National Cancer Institute approved study of Prophage Series G-200 vaccine, plus a vaccine combination trial and recurrent glioblastoma, we are currently finalizing the protocol and we anticipate that the alliance could begin enrolling patients around the end of this year or in early 2013.

With regard to our partnership with NewVac in Russia for Oncophage, NewVac is continuing to make progress in building out and manufacturing facility, that process has started, preparing for commercial launch and establishing additional clinical development programs with Prophage.

Finally, we look forward to the initiation of our Phase 2 trial of HerpV for the treatment of genital herpes in the fourth quarter of 2012. As a reminder, HerpV is a novel and exciting recombinant off-the-shelf therapeutic vaccine for the treatment of genital herpes, which is caused by the herpes simplex virus 2, also known as the HSV-2 virus.

Given the significant medical needs represented by genital herpes, we believe that HerpV is shown to be safe and effective; it has a true blockbuster potential. HerpV contains 32 HSV-2 derived immunogenic antigens and was designed with intend of treating a broad population of HSV-2 infected individuals. We are currently in the process of preparing our manufacturing lots of HerpV for our phase 2 clinical trials.

We are particularly excited about the HerpV product for several reasons. First, in contrast to longer and more extensive trials in oncology, it is anticipated that we could have initial results from our HerpV trials as early as the end of 2013. This is due to the fact that the Phase 2 study for HerpV will measure the effects of vaccination on viral shedding in HSV-2 infected individuals by the way which is key expert's lead in the field that would be the best predictor of eventually showing a reduction in recurrent outbreaks and transmission from this disease.

Second, HerpV uses both of our platform technologies, Heat Shock Protein and QS-21. Not only is HerpV the most advanced herpes vaccine currently in the clinic, but it is the only one to our knowledge that uses a polyvalent antigenic construct combined with one of the most powerful adjuvants available which is our QS-21.

In closing, we are excited about our future with [Agenus] and its partners there are number of up coming milestone events all of which could be of great value to us and to our share holders.

Importantly, our strength in financial position during the first half of this year allows us to reach these key milestones with our existing resources. Once again thank you very much for your interest in Agenus.

We hope that you have found this update to be of help and we will now conclude my remarks and we are ready for Q&A.

Question-and-Answer Session


(Operator Instructions) Your first question comes from John Sonnier. Your line is now open.

John Sonnier - William Blair & Company

Garo, you went through a lot of information, a lot of clinical programs, what might be helpful, is just look forward may be this day next year, a year from today give us I guess a picture what it could look like what reads out between now and a year from today and kind of how does that shape the profile of the company?

Garo Armen

Let me paint a picture John of what could certainly happen. As I said in my call, the malaria trial the second (inaudible) trial results on a very large Phase 3 trial will be out and that will further confirm the efficacy of both the malaria vaccine and the attributes of QS-21 in powering an unprecedented vaccine. As you know, there are no other malaria vaccines that have shown to be efficacious thus far. So this is a major milestone, although malaria is a public service product and the commercial impact will be more modest.

It will, for a company of our size, it won't be insignificant but it will be certainly more modest as compared to the potential blockbuster potential of the Phase 3 program. Now in the first half of next year, so this time next year, we could have the results out of both the melanoma program that's the Phase 3 vaccine as well as the lung cancer program.

If these programs are targeted, clearly not only will this mean a tremendous event for cancer patients but it will also mean a game changer for our company. It will result in a potential royalty stream for us which is going to be very significant particularly in relation to the size and the scope of our company, and there are various estimates by analyst out there in terms of what the size of this market can be for GSK.

GSK has made a number of public remarks about how excited they are for these programs or seeing these programs come to potential portion but given our size, the impact on us would be orders of magnitude greater than the impact on GSK. So we could have that.

By the middle of next year, we could be well underway in terms of the enrollment of the NCI sponsored randomized trials. This will be the first randomized trial in glioma and very importantly, the first trial that will test Oncophage in glioma in combination with a standard of care right now which is a vaccine for these patients and the excitement of this is that as you know from the earlier studies, even though these are single-arm studies we've seen some very, very exciting results when we do an analysis in comparison to an honest reference arm.

Now if we can combine Prophage with a product like Avastin which is not only the standard of care in the field, but there are also scientific and clinical reasons to believe that synergies exist from a mechanistic perspective. This could be an exciting program and that trial being well under way will get us closer to the finished line in terms of readouts and again this would be by the middle of next year.

We could be all, but completely enrolled in our HSV-2 vaccine program by the middle of next year. As I alluded to this is a relatively quick trial with quick readouts and we would hope that the readouts would come in as early as the end of next year. So lots of programs, getting more and more traction if you will between now and the next 12 months. But getting to the bottom line in terms of financial and commercial impact, certainly the MAGE-3 programs are something to watch for very closely. And as well the malaria program with additional data would get us to a comfort level as to the financial windfall coming from that. Does that answer your question?

John Sonnier - William Blair & Company

That’s a great overview and Gary you been at this for a long time. I have to think this is the most informative window of 6 months to a year in the company's history. Is there a long side of that with malaria or the MAGE programs in particular, are there milestones tied Phase III readouts?

Garo Armen

There are milestones that John, will be paid based on reaching a certain timeline. I know it sounds strange to say that but for example there are milestones that will be paid to us because we've reached the end of this year for example. So these are time-related milestones. There are additional milestones that will be payable upon filing the first BLA or NDA applications associated with these products. There also other milestones from other companies that I didn’t allude to in our remarks today. For example there are milestones associated with our full-time MAGE program with J&J (inaudible) and Pfizer and those two will be payable upon the achievement of, for example initiation of a Phase III trail.


Your next question comes from the line of Joseph Pantginis [Roth Capital].

Joe Pantginis - Roth Capital

First a question if you don’t mind on the recurring glioblastoma study that's upcoming, the randomized study. As you know recently we had discussions with a KOL in the space who really focused on the aspects of how stringent the process is to get involved with the Alliance and then with obviously the feather in your cap that the Alliance was very accepting and wanted to really be involved with the study.

So with that study I was just wondering if we could get more of a present day update of what’s going on behind the scenes and sort of a growing interest presumably of the physicians for this study and then I have a follow up.

Garo Armen

Certainly Joe. As you said the field has a gotten a lot more competitive meaning because of the scarcity of money, the scrutiny applied to NCI sponsored trial is much greater today than it was several years ago. So we are very delighted by the fact that Alliance and NCI chose to undertake this significant study. As you know it’s a very large study, it's randomized study. So the cost and the effort associated with underwriting the study for NCI is not insignificant.

And so that’s a very nice compliment for our programs. But also as you know there isn’t much going on in the field of glioma and so there is a level of enthusiasm by the key opinion leaders and the practitioners, clinicians to engage in a study where there is a clear rationale, a clear path as to why one could expect a potential positive readout.

Avastin is an approved product, but its effect is marginal and so to augment the effect of a biologic that seems to have some underlying immunological activity with a targeted vaccine like ours, that has a clear immunological activity. The combination of the two could be a very exciting outcome. So we’re very, very honored to be part of this program and honored to have a critical number of physicians who by the way went through the process of this approval with Alliance and the NCI on our side. So because of this pressed enthusiasm, our hope is that the enrollment would be rather expeditious in this trial.

Joe Pantginis - Roth Capital

That’s helpful and then you raised the point actually before my second question about combining the two products. Obviously, each has its potential activities, but also I guess, you know, more to the potential synergies because if I recall correctly the role of VEGF actually has an inhibitory effect on dendritic cells and using Avastin could actually bolster the effect of Prophage.

Garo Armen

That’s exactly right.

Joe Pantginis - Roth Capital

Great, thanks and then just so the second question is I guess more of a macroscopic aspect when you look at the company is I guess the hard aspect of the question is you have so much going on right now with all these different programs. And I guess the hard part of the question would be, what are you most excited about? I know you talked about your enthusiasm about the HerpV program. So I guess I will ask the question a little different. You know, when you look at all your programs, what do you believe would be, say the top one or two programs that you think might have the most hidden value who are not getting credit for on the street?

Garo Armen

Well, I will put it this way. Certainly the outcome from the MAGE-3 trial would be a validation of the cancer vaccine therapeutics yield because the MAGE-3 vaccines are truly cancer vaccines. They are not sort of going about this in a about way, is the targeted vaccine, powered by QS-21 targeting a specific antigen that is known as a cancer antigen. So the trial is very well designed and optimized because it enroll patients who are MAGE-3 over expected, a very large number of patients, 2200 patients in one trial and 1300 in the other trial.

So the outcome from these trials will be a game changer. For patients, the industry certainly GSK, but very importantly in terms of the impact on us they will be a game changer. Also very importantly there are a significant number of other candidates in the GSK pipeline that has a different antigen which also alludes to QS-21 by the way and those vaccines will be very aggressively developed for launch. So that MAGE-3 program is a major, major driver commercially and otherwise for us and also a big deal for our patients.

But in addition to that, we have our HerpV program. Now this is a vaccine as I said not only is this the most advanced clinical vaccine program in the field of herpes today, it sounds strange because it’s in the hands of a small company like ours, but this is the most the advanced program, there is no other ahead of us, but this vaccine has shown some immunological and multi-antigen related attributes that we have not seen with any other herpes vaccine in the past; meaning if you have a product that does more of the same as other field programs you would be little skeptical, but our product does things that no other vaccine has shown in terms of interactivity.

So that’s an exiting program and frankly if we finally succeed with the herpes vaccine, I can tell you what the potential of this would be; it’s a very, very significant blockbuster potential product and our challenge here is how do we make sure that we advance this program and not prematurely give away a lot of the upside associated with it to a potential product. So that would be something to manage very, very closely.

Thirdly, the Avastin in combination with Prophage could also be a very exciting program. Now as you know, up until very, very recently there were no opportunities to combine immunotherapeutic agents in order to further leverage the activity associated with vaccines, cancer vaccines that is. Since the introduction of several products, like Ipilimumab and other, there is a flow of activity with these combinations now and we are not behind, certainly not behind.

We maybe in some cases ahead of others because this is a randomized trial and it’s an indication that’s very tough indication or an indication where there isn’t much going on. So any activity there even with a randomized Phase II trial could be very meaningful from a regulatory perspective as well as a patient perspective.


Your next question comes from George Zavoico [MLV & Co.]. Your line is now open.

George Zavoico - MLV & Co.

A couple of questions regarding the GBM trial that you talked about the results of which you talked about at the AANS meeting. We are already like three months past that, I am wondering if you could -- if there is any additional data as to the durability of some of those responses; you had absolutely great six months survival rate; is that holding out at nine months if you know that data and how long is the longest survivor in that trial [list]?

Garo Armen

Well George, I as you know, the only reason we have reported the six months and also we presented you that we have given is, because the trial was designed to follow patients for a period of time. Now the question is have any of these patients been cured, the answer is no. This is deadly disease, so it’s a question of how much you can extend their lives and the major is what given is that eventually all of these patients will succumb and die. So there is no real ambiguity about that.

Now, the combination trial on the other hand is a whole different story that’s NCI trial obviously. Will there be additional presentations on the clinical outcomes from these trials? I would say there may be. There are probably publication associated with it, just like there was a publication with a phase 1 trial but I don’t anticipate that additional data analysis will shed anymore light than what we’ve seen.

So, the key question for these patients is, how many weeks can you extend their lives and what the quality of life for them is during that period of time, which I hope all of that will be captured in the context of the publication that will come out.

George Zavoico - MLV & Co.

Okay, and with regard to the trial, that’s combination of Avastin trial; it's obviously done with the NCI. Avastin is a very expensive drug. Are all of the costs of that trial being picked up by the NCI?

Garo Armen

The question is, the last part of the question, once again can you repeat?

George Zavoico - MLV & Co.

Avastin was a very expensive trial. I mean Avastin is not a cheap drug. It’s a 220 patient trial. What are you going to say the cost of that to be and how much of the cost is coming out of your budget if any?

Garo Armen

Okay, the answer is because it is an Alliance and NCI sponsored drug trial, we had no cost associated with it, with regard to any of the agents that are going to be using combination like Avastin. So, the only thing we do George is to provide them with our product and all of the trial effort is underwritten by Alliance and NCI. If there are some additional ancillary study that will be part of the trial at our request we may provide a very modest grant associated with it but certainly, Avastin cost have nothing to do with that.

George Zavoico - MLV & Co.

That’s great. And then final, I have a question about the HerpV trial. This phase 2?

Garo Armen

Before you get into that question, the Head of Clinical Development Kerry Wentworth passed asked me a little note saying that the longest survivor in the trial that you are referencing before is over two years.

George Zavoico - MLV & Co.

That’s great. Thank you for that and with regard to HerpV like you said, the primary endpoint is near is viral shedding. So you can make it a fairly short trial. I presume you will also be measuring outbreaks during that period and the following question, that is if the trial is successful and you have significant viral shedding, improvement viral shedding do you, just phase III trial will be the rate of outbreaks? Will that be what will have to be the endpoint of the registrational trial?

Garo Armen

So, the reason we’re doing this trial that measuring viral shedding, is because when we met with key opinion leaders which numbered about seven or eight, before we decided to initiate this trial, it’s a universal conviction that reduction in viral shedding that is in viral shedding days prior to vaccination as compared to post vaccination is really the gold standard [heroics] through potential clinical activity.

As you know in our earlier trial we measured immunological activity and so some unprecedented immunological activity in the context of both CD4+ and CD8+ mediated immune response. That combination of the two was unprecedented. The next major milestone which will be a very important [heroics] for clinical activity is going to be the reduction in viral shedding days and so this trial will strictly capture that and that will be a meaningful enough of an endpoint for us than to do a larger trials that will do the regulatory standard for activity is and that will be the outbreaks of the disease.

George Zavoico - MLV & Co.

And is that based on what kind of patients you would be enrolling and the response you've seen or do you predict, you are hoping to see with viral shedding, would that be over a period of a year or two years, I am just wondering about how long that trial might be?

Garo Armen

Okay, so are you talking about the current trials that we are going to undertake?

George Zavoico - MLV & Co.

No the current trial is going to be pretty quick. I'm talking about where you might be considering for the Phase 3 registration trial?

Garo Armen

That would probably a one year period, but certainly the details of that protocol need to be worked out after the results from this trial. But typically it will be one year.

George Zavoico - MLV & Co.

Yeah, so that also could potentially be a fairly quick trial.

Garo Armen



(Operator Instructions) Your next question comes from (inaudible).

Unidentified Analyst

Just two things, could you remind us about the GSK MAGE-3 royalties, is it a tiered royalty based on sales or a flat rate and is the royalty triggered on per sale of product and I apologize if I miss this, but are you still expecting the Phase II data for the Alzheimer’s program sometimes this year and if so is there a milestone associated with that as well.

Garo Armen

The first question is it's not a tiered royalty, it is a flat royalty and we've said in the past that it is in the mid single digit range. In terms of the initiation of the royalty upon sales, it’s -- the royalty is triggered. And with regard to the Alzheimer’s trial this Phase II program containing QS-21 has been underway for some time now on multiple trials that have been underway and so while there was no real, [Jonas] asked me a total of nine actually Phase II trials and it's our belief that there is some interest by the sponsors to see the outcome of the BAPI trial at least and that may or may not influence the speed and the structure of the Phase III trial that will be getting under way with the active vaccine that contains QS-21. There is a milestone associated with the initiation of a Phase III study.

Unidentified Analyst

So is it fair just to characterize that it might be your belief that any news about that the vaccine trial won’t really be known until after sometime in the fourth quarter in terms of the momentum, the forward moment rather of that trial.

Garo Armen

I believe the news about BAPI, the trial that's expected now in ApoE4 absentee patient, that result will be out in the fall I believe. And so any development with regard to the next steps for the active vaccine product will probably not come until after that?

Unidentified Analyst

And just I can sneak one more and just with respect to -- you made a mention of equity sales in the quarter. So I am assuming that these came from the open ATM program. Can you just give us a status update as to where that stands?

Garo Armen

That we take advantage of opportunistic price moments from time to time and we've made some sales during the quarter, yes.

Unidentified Analyst

Okay so are you able to speak to just what is left on that program?

Garo Armen

It is not so much what's left on the program. It is really driven by our decision that any given moment to make sales or not to make sales and we have been very price conscious as you can see. So we had done this from time to time with price limitations and no other bells and whistles that would come with typically make the other equity offerings. Certainly there are no warrants or anything like that associated with the sales.

So we've thought from time to time when the price is right and we need a little additional cushion on our balance sheet, it would be appropriate to do it then. We are in a much more comfortable position right now than we were in the beginning of the year. So we will evaluate any future action from time to time.


There are no further questions at this time. I turn the call back over to the presenters.

Jonae Barnes

Great, thank you. I would like to remind listeners that a replay will be available approximately two hours after the call through midnight on Eastern Time on February 3rd, 2013. The replay number is 855-859-2056 domestic or 404-537-3046 international and the access code is 10811038. The replay will also be available on the company’s website approximately two hours after the live call. If you have any additional questions after today’s call, you may call us anytime at 800-962-2436. Thank you very much.


This concludes today’s conference call. You may now disconnect.

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