Earnings Labs

Agenus Inc. (AGEN)

Q4 2014 Earnings Call· Fri, Feb 27, 2015

$3.82

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Agenus Q4 Earnings Conference Call. As a reminder, today's conference is being recorded. At this time, I would like to turn the conference over to Ms. Christine Klaskin, Vice President of Finance. Please go ahead Ms. Klaskin.

Christine Klaskin

President

Thank you. Welcome to the Agenus conference call to discuss our fourth quarter and year end 2014 financial results. Before I continue, I would like to remind you that this conference call will contain forward-looking statements, including statements regarding the company's potential income stream, research and development and clinical trial activity, the publication of data and potential application of the company's technologies and product candidates and the prevention and treatment of diseases. These forward-looking statements are subjects 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 these 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 broadcast. With me today are Dr. Garo Armen, Chairman and Chief Executive Officer; and Dr. Robert Stein, Chief Scientific Officer. During this call, we will review our financial results, as well as provide a corporate update. We will then open up the call for questions. With that, I will now review our fourth quarter and year end 2014 financial results. Cash, cash equivalents and short-term investments were $40.2 million as of December 31, 2014. Subsequent to year-end, the company received an additional $60 million from its global alliance with Incyte. For the fourth quarter, Agenus reported a net loss attributable to common stockholders of $26 million which includes $14.3 million of non-cash charges bringing our quarterly cash burn to…

Garo Armen

Chairman

Thank you, Christine. Thank you all for joining us this morning. 2014 was a transformative year for Agenus. With our acquisition of 4-Anitbody last February, Agenus today has a broad portfolio of Novel Immuno-Oncology focused on checkpoints. In addition, we have a very powerful platform to discover antibodies to other novel agents. And a combination of strategic alliances with leading partners. We have also positive data from Phase 2 studies involving our autologous cancer vaccine and Dr. Robert Stein will tell you more about the details of that. As you'll hear more from this time, these initiatives are now supported by a world-class R&D organization with expertise in immuno-oncology, antibody generation, Bioinformatics and translational biology, that will help us discover and develop the next generational paradigm shift in treatments for cancer patients. To summarize the key highlights, one year ago we acquired 4-Antibody with its portfolio check point modulator programs and the Retrocyte Display Technology platform for the discovery of antibodies. And since then, we have successfully advanced development candidates into IND enabling studies and leveraged this acquisition into two strategic alliances with leading partners in immuno-oncology. One with Incyte and the other with Merck, both leaders in the field. In addition, our partner GSK reported remarkably positive Phase 3 results from their shingles vaccine candidate containing QS-21 Stimulon adjuvant, providing an opportunities for Agenus to receive potentially significant royalty payments. GSK also filed into malaria vaccine candidate with the EMA which could potentially lead to regulatory approval of the first ever malaria vaccine this year. While royalties from this product are expected to be modest, it is a very significant advanced in the fight against this deadly disease with the potential to save hundreds of thousands of lives annually. We also reported promising Phase 2 study results from our…

Robert Stein

Management

Thank you, Garo. I too have very pleased with our progress that Genesis, Insight joined in the January 2014. As Garo mentioned, we started this year by launching a major global oncology alliance with Insight, built on our checkpoint modulating antibody programs. As many of you know checkpoints are a system of regulatory receptors of ligands expressed on various cells of the immune system and some times on tumor cells. Checkpoint processes function as a kind of thermostat for the immune system, stimulating rapid generation of immunity that combat in infectious organisms but also down regulating the immune response, when appropriate in order to limit the possible damage to otherwise normal tissues. In the last five years, major advances in cancer therapy have risen from a growing appreciation of the roles of checkpoints in the bodies responses to cancer. Antibodies targeting checkpoint receptors or their ligands, checkpoint modulators or CPMs for short such as Bristol-Myers Squibb's anti CTLA-4 for antibody Yervoy are merged recently approved anti PD-1 antibody KEYTRUDA, allow oncologists to unleash the power of the immune system to seek out and destroy cancer cells . In some settings, the benefit to patients of the use CPMs to treat cancer have been truly spectacular such as in the treatment of Metastatic melanoma’s with CPMs to block CTLA-4 and PD-1. We are learning that combining CPMs can produce compelling efficacy but also configure significant immune mediated side effects. The key to the best future treatments were likely be the use of various CPMs such as those in the Genesis portfolio and optimized combinations that are tailored the needs of each patient, with our broad portfolio checkpoint modulators we’ve the opportunity to systematically test rational model CPM combinations. A key advantage to the alliance with Insight is that the for --…

Garo Armen

Chairman

Thank you, Bob. We look forward to providing you with continued updates on our progress on the advancement of our CPM programs and vaccine pipeline and our ongoing collaboration with Insights, Merck and GSK. We remain committed to developing the next generation of immunological therapies for the treatment of cancer and we thank you for your continued support. And with that I will now once again turn the call back to Christine.

Christine Klaskin

Operator

Thank you, Garo. Valerie, you can now open the call for questions.

Operator

Operator

[Operator Instructions] And we'll move to our first question from Robert LeBoyer of Maxim Group. Please go ahead.

Robert LeBoyer

Analyst · Maxim Group. Please go ahead

Good morning and congratulations on a nice quarter. My question has to do with the European regulatory action on the malaria vaccine. And is there any better timeframe other than just this year or can you let us just remind us as to when the filing was made? Thanks.

Garo Armen

Chairman

The filing was accepted, filing was made in July but it was accepted in late July, early August, I believe for review. And typically the agency should take the prescribed amount of time for the review, which should be about a year give and take. Now given the high profile nature of this vaccine, which as Dr. Stein alluded to could save hundreds of, thousands of lives of children in Africa we would expect expeditious action. Now once the European agency approves the product, then the product needs to go through the individual country bureaucracies in Africa for commercialization. And the timelines for that will be a little bit longer beyond this year but we hope that based on the preferences of these individual countries and the sense of urgency provided by not just GlaxoSmithKline, by the World Health Organization, as well as the Gates Foundation, our hope is that this vaccine will get to the children in Africa as quickly as possible. Bob, would you like to add anything to that?

Robert Stein

Management

Just one thing for perspective. There are almost 900,000 deaths a year from malaria in Africa and 70% of those are in kids under the age of five years. And this vaccine is reduces the incidence of the malarial infection by 50%. So there is over 2,000 kids dying everyday from malaria in Africa and this could prevent 1,000 deaths a day. So its important question about when it will get approved and when it will get distributed.

Robert LeBoyer

Analyst · Maxim Group. Please go ahead

Okay. Thank you.

Operator

Operator

Thank you. And we will move to our next question from Reni Benjamin of H.C. Wainwright. Please go ahead.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

Good morning guys and thanks for taking the questions. I guess just starting off with the vaccine, the shingles vaccine, I probably heard it wrong, I thought you’d mentioned that its under review at the EMA but that’s probably the malaria vaccine. Can you just give us an update, when will see the filings for the shingles vaccine take place and when you think it could, be on the market.

Garo Armen

Chairman

Well, as you know this is GlaxoSmithKline’s vaccine and we’re not at liberty to make disclosures on their plan, so however within constant contact with them and the moment as they make the proclamation as to when the product will be filed, which would hope to be in an expatiated timeline given the high level of efficacy. We will let you know but at this point we don’t know the answer to that question and if we did, we would still have to wait for their public disclosure about the timeline Ren. So fact that to say, there are not there is only one vaccine available right now, that’s by Merck and the efficacy differential between this vaccine, which is 97.2% nearly a 100% versus the other vaccine which is in the range of 50% to 70% depending on the age group and depending on how many years after the vaccination were would looking at protection. We believe not only will the GlaxoSmithKline vaccine will it’s much higher efficacy rate would be the standard but we also believe that it will have the opportunity to expand the market very significantly.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

And can you talk, I know Bob, kind of touched upon some of the other competitive advantages including this being a subunit vaccine but can you talk a little bit about, what sort of sales Zostavax already seen and any other comparative advantages outside of efficacy that you believe, might be important in marketing the product.

Garo Armen

Chairman

Sure. Bob?

Robert Stein

Management

Yeah, so Zostavax is a very significant product, it does a reasonable protection that if you are between 50 and 59 after a for the first year after vaccination about 70% reduced chance and getting shingles but out of four years its only 50% in that range and if you’re above 60 and for one year point its only 50% protection. So this GSK vaccine at 3.5 to 4 years gave 97% or greater protection, 97.2% protection. And the other piece of it is, that it is not live attenuated virus the way the Zostavax is, so Zostavax has an issue in it, if your immuno compromised that can disseminate, if you get neat immuno component then become immuno compromised that can be activate and actually produce its own formed shingles, it can be transmitted from a vaccinated person to immuno compromised contact and it’s not a good thing to have around if you pregnant. And despite of that it is a $750 million year product; the amazing thing about the GSK vaccine that was given in conjunction with QS-21 Stimulon is that with the single subunit like a protein E, they have been able to achieve very powerful and lasting protection. Now shingles itself is a painful experience and there is no fun but lot of us when they getting it if we are vaccinated but even that happens about one in four to five people will get – to be 80 years old, that the other pieces this that about 30 of those people get lets called Postherpetic neuralgia which is a terribly painful chronic condition in the region where your shingles had occurred. And so the advantages that the subunit vaccine has none of the concerns about immuno compromise reactivation or transmission and it’s also easier to shift and distribute because you’re not be live attenuated virus you have to keep viable. So my belief is that, as soon as this vaccine becomes approved, I’m going to go out and get it being over 50 right and I think it’s a very significant future product of course that’s my opinion and doesn’t reflect anything that GSK would say officially but I think that is a very powerful advance.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

Got it, just switching gears now to that the CPM programs, one having to do with the timing of the recognition of the upfront, is – are you expecting I guess from a housekeeping perspective, the entire upfront to be recognized in the first quarter, I think by March 1 is when you suppose to get it but I just want to know if there is something that gets amortized over, the life of the collaboration or you will see that lump sum in the income statement.

Christine Klaskin

Operator

Yeah, so we have received the cash since year end that was the $60 million mentioned in the opening remarks and it will be amortized over the period of the agreement.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

Which is about how many years?

Christine Klaskin

Operator

Yeah, it will be amortized in the range about 3 to 5 years.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

Excellent, okay and then regarding the two IND’s that would be submitted this year and the two IND’s next year, can you give us any more color as to which particular targets are might be and how that development is coming along or they are all in IND enabling studies or seem to be.

Garo Armen

Chairman

Everything that we have described is in IND enabling studies, we are very conscientious about pushing those forward aggressively and appropriately we have all the programs are moving forward on track and we will make those filings on time but we aren’t going to disclose it at this point which of our products are going what order its impart, because its our own information that has some competitive positioning aspects and also because now some of that’s with our partner insight, so we have a concerted communication policy there.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

Fair enough, is the Merck undisclosed targets, in IND enabling studies as well?

Garo Armen

Chairman

That is for Merck to disclose a usually pretty close about things like that but that program is going a long run.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

Very nice. And just one last question that the QS-21, call a platform, what’s the latest count as to the number of partners that are on board, evaluating QS-21 and what’s the latest number of call it most advanced clinical trials that are currently ongoing.

Garo Armen

Chairman

The most advanced programs are obviously in the hands of GSK, and we as you know we also have a clinical program with J&J in phase II. Most of the, rest of QS-21 varying programs are with academic centers, there are a significant number of programs around the country and around the world in the hands of academicians that advance their own trials and they’re owned on basically but so far as to say as Bob as alluded to, this is an adjuvant that is extensively studied in well over 50,000 patients right now. And so there safety is not a consideration any more obviously particularly given the fact that it is not a subject of a vaccine to be used in children including infants. And we believe it is our belief that QS-21 is one of the major drivers of efficacy and the two vaccine candidates that are right now in advanced stages of development and review. So that's I think sums it up.

Reni Benjamin

Analyst · H.C. Wainwright. Please go ahead

Terrific. Thanks very much, good luck in 2015.

Operator

Operator

Thank you. And we will move to our next question from George Zavoico of Jones Trading. Please go ahead.

George Zavoico

Analyst · Jones Trading. Please go ahead

Christine, couple of questions first one about the Retrocyte Display Technology and your ability to rapidly discover and optimize antibody candidates, its question is wrong but its been implied mainly just to your candidates, how would you intend to leverage that given the commodity that antibody discovery now is concerning that [indiscernible] process and antibody discovered platforms as well, how do you intend to leverage that into partnerships or collaborations.

Garo Armen

Chairman

One thing that before Bob goes into the deals of this, as you know we’ve disclosed some information about our Retrocyte Display platform and just to correct what you said, it is in just for our antibodies for example Merck came to us with their own target and this is the source of discovery for antibodies for that. There is a lot of confidential developments within our company advancements that we don’t want to specifically elaborate on but I think Bob could give you a little sense of direction to field is going at and what our competitive advantage will be?

Robert Stein

Management

I think it’s a good question George and you’re right that to some extent antibody discovery is practice in a variety of different ways some of other competing technologies produce very reasonable antibodies and sometimes they have snagged and being develop above because of levels of expression or other pharmaceutical properties that are less attractive. Our technology is very nice and that it doesn’t require immunization but it doesn’t lead as -- bunch of blind alleys, we get antibodies out of it that already well expressed on the surface of malignant B lymphocytes and therefore are pretty well behaved, when we take them forward as potential development candidates. We have since the acquisition for antibody continue to improve on the platform and were in the midst of building out, what I think will be a world class development and discovery organization focused on producing top quality antibodies. We’re leveraging that with our Insight partnership right now, its not only that the programs that we have but additional future programs that we’re contemplating with our partner. And as we move forward, if we have additional bandwidth we may elect to the partner more broadly for other targets outside of immuno-oncology related to flip side Pharmacodynamics in the checkpoint space and there are number of other opportunities that we’re discussing with outside parties that I guess the best I can say as stay tuned.

Garo Armen

Chairman

And George just to make one correction even though, the perception is of antibody discovery platforms being a commodity that’s a perception. There are very important unique nuances that not only are as Bob said our platform has but that we are advancing our platforms capabilities to drive that will even make us more unique. Now there is clearly a reason, why Merck came to us as suppose to go into others for the discovery of antibodies for their target and that’s fixed to I think the some of the unique attributes or what we have.

George Zavoico

Analyst · Jones Trading. Please go ahead

Yeah, Bob, like commodity I didn’t mean that every platform was the same each one clearly has certain damages and probably some cost advantages do so Bob thank you for eliminating the, the advantages of the Retrocyte Display. And I will stay tuned, I expect this, mostly likely be leveraged into some new announcements this year, not this year then next year but for the meanwhile between Merck and Insights it seems to goes pretty busy with optimizing it and getting into work for your first two partnership collaborations in that regard.

Robert Stein

Management

That’s one of that point, we do – have use Retrocyte Display and we think it has great characteristics, it however is a tool not a religion and were opened to and do employee whatever its going to work the best in every particular setting, so we’re looking at the emerged approaches from different perspectives for making best in class antibodies cost effectively and quickly.

George Zavoico

Analyst · Jones Trading. Please go ahead

Okay, great. And second question is you mentioned Bob all the options you have for combining your CPMs and optimized combos, not only between certain differentiated CPMs or different CPMs, you mentioned either one of the Insights and with your vaccines. There is a lot of choices, here lot of options and you could do dozens of studies and lot of is going to be personalized, I mentioned it would have to be regarding which checkpoints are expressed by which cancers in which patients. And so in that regard do you have Biomarker in every platform or you working with anybody in that regard to trying narrow down and includes the different criteria and which combinations to go forward with?

Robert Stein

Management

I think, you are making a very important point and part of the way the entire field is moving is to understand that their optimized treatment. They want to have better appreciation of the detailed pathobiology in each patient, which will required not so much the type of biomarker when you measure one thing as a sophisticated immuno monitoring capability both for patient stratification and for deciding. What the implications are about potential therapeutic interventions to track whether those interventions are having Pharmacodynamics effect to intend them to have and then to make better predications about whether, they changes the observed indicates of the patients on the way to benefit or not and we have build out in the increasingly high quality, our translational capabilities. The companies you can imagine has been in the immuno-oncology space and vaccine space and working to understand the interaction between the immune system in cancer for two decades of this has been a really deep focus of the company and that’s one of the thing I think that advantages are in the movement into the checkpoint space there is long and deep appreciation of the underlying pathobiology. So I think its going to be absolute proof show and we will certainly use that to help design and focus our early development explorations on the things where we think have the best chance of matching up the patients needs with our interventions and combinations.

George Zavoico

Analyst · Jones Trading. Please go ahead

That's great. And exceedingly important given Obama's recent initiative, I don’t know if you saw in New York Times today, they had a story about going into personalized cancer medicine in couple of examples, so its getting a lot of lot more press more broadly into the lay public. So that's great that you’re going in that direction. Okay, thank you very much.

Robert Stein

Management

Thank you for the questions George.

Operator

Operator

Thank you. There are no further questions at this time. Please continue.

Christine Klaskin

Operator

Thank you, Valerie. I would like to remind listeners that our replay of this call will be available approximately two hours after the call and that the call will also be accessible from the company's website at www.agenusbio.com. On behalf of the management team at Agenus, I would like to thank everyone for joining us on today's call. We will be available to receive any further inquiries following the conclusion of this call. With that Valerie, please conclude the call.

Operator

Operator

Thank you. Ladies and gentleman, this does conclude your conference call for today. We thank you for your participation. You may now disconnect your lines and have a great day.