Shalini Sharp - VP and CFO
Garo Armen - Chairman and CEO
Ren Benjamin - Rodman
Antigenics Inc. (AGEN) Q2 2010 Earnings Call July 29, 2010 11:00 AM ET
At this time, I would like to welcome everyone to the Antigenics second quarter 2010 earnings call. (Operator Instructions) I will now turn the call over to Ms. Sharp, Vice President and CFO.
Welcome to Antigenics conference call to discuss the financial results for the quarter ended June 30, 2010. With me today is Dr. Garo Armen, Chairman and CEO.
We hope that all of you have had a chance to review the press release that was issued this morning. During this call, we will review the financial results as well as provide a corporate update. We will then have a Q&A session.
But before we continue, I would like to remind you that this conference call will contain forward-looking statements, including without limitation statements regarding the company's cash position, timing of potential royalty streams and development and commercialization efforts, timelines, availability of data and potential efficacy with respect to products and product candidates of the company and/or its licensees and 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're disclosed in more detail in our most recent filings with the U.S. SEC. These statements speak only as of the date of this call and Antigenics 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 Antigenics' business and securities, investors should give careful consideration to these risks and uncertainties.
For the purpose of this call, the phrase 'net cash' is used in operating activities plus capital expenditures, debt repayments and dividend payments. As a reminder, this call is being recorded for audio replay.
With that, I will now review our financial results for the quarter ended June 30, 2010.
For the quarter ended June 30, 2010, Antigenics incurred a net loss attributable to common stockholders of $5.2 million or $0.05 per share. This is compared with a net loss of $12.3 million or $0.17 per share for the same period in 2009. For the six months ended June 30, 2010, the company incurred a net loss of $14.2 million or $0.15 per share compared with $22 million or $0.31 per share for the comparable period in 2009.
Antigenics recognized revenues in this quarter of $805,000 compared with $1.3 million during the same period in 2009. The decrease is primarily due to timing of shipments of QS-21 to our licensees.
Research and development expenses in the second quarter of 2010 were $2.6 million compared with $5 million for the comparable period in 2009. General and administrative expenses in the second quarter of 2010 were $2.8 million compared with $4.2 million in the second quarter of 2009. These decreases reflect, among other items, our cost containment efforts.
Cash, cash equivalents and short-term investments amounted to $28.7 million as of June 30, 2010. Our net cash burn for Q2 2010 was $3.5 million compared with $5.7 million in 2009. This reduction primarily reflects our cost containment efforts. We continue to anticipate that our net cash burn for the full year 2010 will be in the range of $16 million to $18 million.
This concludes the financial portion of the call. I will now provide a brief corporate update. I'll begin with an update on AG-707, our off-the-shelf genital herpes therapeutic vaccine.
Just this past Tuesday, data from the Phase 1 trial measuring safety and immunogenicity was presented at the International Herpes Workshop. The data showed that all evaluable patients treated with AG-707 and our proprietary QS-21 adjuvant amounted to CD4+ T-cell response and 63% amounted to CD8+ T-cell response. This finding was the first of its kind in genital herpes therapy according to our investigators.
The trial was conducted at the University of Washington Virology Center, which is the world-leading center for herpes therapy. And the investigators involved with the trial are considered among the top world experts in this area. According to the Centers for Disease Control, genital herpes affects more than 60 million Americans. There is no cure and there is increasing resistance to current therapies.
AG-707 may hold promise in managing outbreaks and disease transmission. Current antivirals require typically daily administration and only work while the patient is taking the medication. Our vaccine approach potentially offers a fundamentally new way to treat this virus by eradicating it altogether and not just suppressing it. Additionally, our vaccine approach could address a significant potential compliance issues associated with current approaches.
AG-707 consists of recombinant human heat shock protein-70 complexed with 32 distinct 35-mer synthetic peptides from the HSV-2 proteome. This extraordinarily broad spectrum of herpes antigens is intended to allow for more accurate immune targeting and surveillance. Further, the diversity of antigens in AG-707 increases the chance of providing efficacy for a wider segment of the patient population.
Potentially, this product concept of combining Antigenics' peptides and heat shock proteins could be a fight to many infectious disease pathogens. This data represents our first human proof-of-concept for this entire infectious disease platform. It also corroborates what we have seen to date in a number of cancer indications with HSV-based therapy.
Antigenics plans to submit a manuscript for publication in a peer-reviewed journal. Now that the data is public, we are beginning efforts to seek a partner to continue further development of AG-707 and the associated platform technology.
Moving on to Oncophage, our investigational therapeutic cancer vaccine, we currently have two investigator-sponsored Phase 2 clinical trials ongoing testing Oncophage in recurrent as well as newly diagnosed glioma or brain cancer. These trials are being led by Dr. Andrew Parsa at the University of California at San Francisco and are externally funded by patient advocacy groups and the National Institutes of Health. The trials will evaluate overall survival, progression-free survival and immunological response.
On May 20, 2010, data from the Phase 2 clinical trial testing Oncophage in recurrent glioma was presented at the International Conference on Brain Tumor Research and Therapy. Data from the first 32 patients showed median survival of 44 weeks compared with a historical median of 26 weeks. Approximately 70% of these patients survived beyond 36 weeks, and 41% survived for at least one year. All patients tested exhibited a significant generalized innate immune response, and 92% showed an adaptive tumor-antigen specific immune response demonstrated by a significant increase in CD4+ and CD8+ T-cell responses.
In the first eight patients with newly diagnosed glioma trial, no serious adverse events have been associated with combination therapy with temozolomide, the current standard-of-care. Additional data should be forthcoming from one or both of these trials by the end of the year. Based on the survival and immunology data of served to date and on Oncophage's tolerability, we are hopeful that Oncophage will have a place in the treatment of this disease, which represents an area of high unmet medical need.
We plan to review the Phase 2 data as it matures and evaluate potential registration pathways for Oncophage in the treatment of glioma. In addition, Antigenics is working with the Pediatric Brain Tumor Consortium to explore initiation of a Phase 1 trial testing Oncophage in pediatric brain tumors.
At the same time, we've continued to work towards commercialization of Oncophage in the treatment of renal cell carcinoma, RCC, or kidney cancer. This product has been approved in Russia in limitation and the patients have been treated with Oncophage in a commercial setting. We continue to explore local distribution partners who might support potentially broader commercialization as well as efforts to obtain government reimbursement for the product.
Antigenics continues to evaluate its options in Europe with respect to Oncophage for adjuvant RCC. Potential outcomes include discontinuation of efforts in Europe, planning for resubmission of a marketing authorization application, implementation of named patient or similar programs and/or a local partnership agreement. We expect to make a final decision by the end of the year.
Meanwhile, we have closed the INSPIRE survival registry following patients from our Phase 3 trial testing Oncophage in non-metastatic RCC. Final data analysis is underway. Enrollment continues in this trial of testing immunology endpoints in RCC patients. We are contemplating further preclinical and/or clinical works testing Oncophage in potentially synergistic combinations, for example, with anti-CTLA-4 antibody.
We continue to restore potential partnerships for Oncophage in order to seek additional resources to bring the product into broader late-stage clinical development. Discussions are still ongoing with respective potential or R&D oriented collaborations and local commercially-oriented partnerships in various territories.
Moving on to QS-21, our proprietary investigational adjuvant or ingredient added to vaccines to boost immune response. Our licensees such as GlaxoSmithKline and Johnson & Johnson continue clinical development of multiple vaccines containing QS-21 investigational adjuvant. Phase 3 programs include vaccines for malaria, melanoma and non-small cell lung cancer.
Antigenics was typically entitled to milestone payments as these programs progress, as well as royalties for at least 10 years after commercial launch with little associated costs. The cost of developing and marketing these vaccines is assumed by the company's licensees. Any costs of Antigenics are typically reimbursed on a cost-plus basis.
The relative guidance we have received is that the first products containing QS-21 could be launched in the 2013, 2014 timeframe. This is an important asset for the company as it diversifies our pipeline, minimizes execution risks, and the clinical key programs are being run by large pharmaceutical companies. And Antigenics does not bear any of the expense related to these programs.
We hope that you have found this update to be helpful, and I will now conclude my remarks. We are now ready to take any questions.
(Operator Instructions) Our first question comes from the line of Ren Benjamin with Rodman.
Ren Benjamin - Rodman
Maybe we can start off with Oncophage first. You mentioned that there was a handful of patients that have already been treated in the private-payer setting. Can you tell us how many patients have been treated, and is there any clarity at all regarding what the pipeline looks like, or is it just hard to tell this early during this launch?
Ren, let me take a crack at this. First few patients, and there are only a handful, we have done just to make sure that the system is working as we would have anticipated in a full commercial setting. So I would not characterize this as a commercial effort rather than the fact that we have actually received payment for treating patients in the commercial setting in the private pay market.
But the true efforts cannot start until we have a full partner on board or a full distributor on board. And the hope is that that will commence sometime in September, perhaps towards the end of September. And within the first six months of that effort, we will have a better guidance on what the true private pay market is in Russia. And based on that, we'll have also more accurate guidance on how we can tap into the government pay market in addition to the private pay market.
So this is exploratory effort, and I know that everybody has been very patient in this regard. We have been approaching this brand new market with a very novel product. There is no pressure on what we are doing in terms of the logistics or what's going down with Oncophage in any commercial setting.
So bear with us. We're not giving up. And we have an interested partner who was working with us or a distributor who was working with us to explore the market and see if it makes sense for us to launch a full commercial effort in Russia.
Ren Benjamin - Rodman
In regards to partnership with a distributor, you were mentioned around the September or late September timeline. Could that in any way be impacted by the progress being made with the government in terms of reimbursement? Do the guidelines for reimbursement need to be in place in order for that ownership to take place? Or is there a group that will help in obtaining government reimbursement? And if you can talk to us just a little bit about the steps that are in place and may be still needed to be completed in Russia to get reimbursement.
The first question, this initial effort is not contingent on government reimbursement. The initial effort will be based on the private pay market exclusively and nothing else.
Now, what we know is that the distributor that we're working with has already generated demand or inquiries by the physicians who are familiar with Oncophage in Russia.
You may remember that in the last two years, we have done methodically and quietly a very good job of increasing physician awareness that includes most physicians who were part of our clinical trials. You may remember approximately 25% of the patients enrolled in our renal cell carcinoma trial did come from Russia. So there's a fair amount of local experience with the product and liking of the product.
So the distributor has been further exploring demand and generating initial demand before commercial launch. And none of this is contingent on the government reimbursement.
We need to make sure jointly with them that there is a commercial market, because the government reimbursement is never a certain thing. And so if we wait until we get government reimbursement, it may be a while longer, and it would be prudent for us to see if there is a viable market in the private pay area. And if there is, then there will be even more justification to pursue government reimbursement.
And this local Russian company or an affiliate of a European company, which is in Russia, will be able to be in a much better position to secure government reimbursement. But again, it's very preliminary and it requires patients and methodical plotting of the next trial.
Ren Benjamin - Rodman
Can you talk to us a little bit about the progress or your thoughts regarding the EU and potentially submitting an appeal? Is that something that is still on the table? And then I think at least previously you were thinking about some additional countries, maybe like the BRIC countries. Can you give us your latest thoughts as to what's happening with new applications?
Certainly. Given the resources of our company, given our carefulness about how much monies are being spent, and as you could see from the results of this quarter, there has been terrific progress made in reducing costs, while also advancing a number of programs including the AG-707 program among others.
So we're approaching things rather conservatively, which means that we're not spending monies and much effort on any of these programs with regard to the renal cell carcinoma field without having other stakeholders in the game.
So both in Europe and in some of the BRIC countries that you're talking about, we are actively exploring the next steps with potential collaborators. So for example in Europe, we have been working with a local company. It's a small company, and they are very interested in the product. And we have been waiting for them to put in their cash resources, which now they have potentially taken the right steps to do that, to explore Europe further.
So it's very important for everyone to understand that Antigenics monies are going to be spent very sparingly to further explore the renal cell carcinoma opportunities. Luckily, we have a number of parties, both in Russian, Europe and South America. Some of them have come to us unsolicited to further investigate opportunities in renal cell carcinoma. And so we will work with them further.
Now, in terms of the regulatory steps in Europe, it will be contingent on our agreement with the local partner as to how much additional work is required on the regulatory side and how much resources they will be able to bring into the party to take these steps. And it's prudent for us, particularly in Europe, to work with local companies, to engage local companies, because they have more leverage and better understanding of the local politics and what have you.
Ren Benjamin - Rodman
Just switching gears to AG-707, congratulations on the results. You mentioned that you would like to move forward in this program with a partner. And I wanted to get a sense, since the date has been announced, what the partnership level or interest has been.
And at one point, with every company, you won't have to sort of juggle the relative evaluation and earliness of a program versus the monetization of that program. And so at one point for Antigenics, does it become a decision where you guys decided that you want to take the trial on yourself, the next trial, instead of partnering, because they're taking too long or the monies they are offering is too low? Or is it something that you will only move forward with a partner.
So your first question was what is the level of interest? You must remember that we debuted this program for the first time. In fact, no one knew about this development outside of the company except the investigator community that we have been working with very intimately. No one knew about the results and the implications of the results, including partners or any commercial entities, until Tuesday.
So this was just recently debuted. There has been no lead time. There has been nothing that at least I heard of from the trade. So it's brand new. And since it's been debuted in the last two days, do we have people who are interested in it? The answer is yes. We prepared very carefully all the materials, because this was debuted at a very important herpes conference in Salt Lake City dedicated to herpes simplex.
And so there has been a fair amount of initial interest. And part of the reason is, as Shalini mentioned, this is the very first time that one has observed a very powerful dual immune response with the herpes vaccine with such a multivalent reach to the herpes.
It's not an insignificant early advance. The herpes field has been quite for a while. In the '90s, there was a lot of effort with herpes vaccines. All of them had limitations. We were aware of what those limitations were. When we designed this product, the addressing of these limitations was factored in very carefully, both the multivalency and the CD8 plus CD4 immune activation component.
And so we are very heartened that experts in the field from the world's top center are very excited about these results. They're much more qualified than we are, and their excitement is more important than ours is. So we've very heartened with that. And if they are excited about it, it deserves further advance.
Now in terms of your question, is further advance in the clinic contingent on the partnership, the answer is no for the following reason. Could we potentially manage a second trial? Yes, we can, because we're not talking about humongous costs, but still important costs. I am reasonably confident that the money will be available most likely through a partnership of some sort or a licensing arrangement of some sort, but potentially also without it.
We've been already in discussions with the key people in the field on what the next trial design should be. It will be a randomized trial of some sort, not randomized, but it will be a trial most likely where the patient will be used as their own control, and it will look at more importantly both from immunological endpoint as well as clinically meaningful endpoints.
Also, if you dig into the details, you'll see that this trial that we did was a four on trial. So it was a very unusual Phase 1 trial, a four on trial that very carefully looked at immune response with each component of the trial. And that's one of the reasons we're very excited about it.
Ren Benjamin - Rodman
Just switching back to Oncophage for a second, in the glioma studies, those were also very impressive results that were presented in May. Can you tell us when is the next data update from the ongoing studies that we should look forward to, and what are the plans to initiate a Phase 3 program, if any, in glioma? Or is this something that again you would be looking to or currently talking to partners about?
Certainly by the end of the year, there will be more information, because as you said, there are now quite a few patients who have been on treatment in several different settings, and the results continue to come in, and the investigators are very eager to continue with the program. And as you may know, the investigators who are involved in these trials are among the top people in the field, both from Columbia as well as UCSF and so on.
With regard to a Phase 3 program, here the Phase 3 program would involve a meaningful investment. And at this moment, Antigenics doesn't have the resources to do a Phase 3 trial. We wish we did, but we do not. So a Phase 3 program initiation in glioma will certainly be contingent on a partner's contribution.
At this moment, we are in active discussions, specifically for glioma, on how do we advance the glioma program with several potential partners, including foreign and domestic companies.
As Shalini mentioned, glioma does represent a major unmet need. Very importantly, the Pediatric Glioma Consortium is very interested in this product, partly because of the initial results we've seen, also partly because of the safety profile of the product. There is really not much going on in the field in pediatric glioma. So in both settings, both through pediatric glioma, which is an exploratory study, but for the Phase 3 program, we are engaging others and we are in discussions with others.
Now, the next step for the registration of glioma may be a Phase 2 randomized study. In glioma, it has to be a randomized study; otherwise, it will give us limited information. It could be an expanded Phase 2 randomized study that will be rolled into a Phase 3 registrational study. So that's something that's under active discussion.
Ren Benjamin - Rodman
And I guess just one final question regarding QS-21. Did I write it down wrong in my notes that I thought originally we were hoping that QS-21 that there could be a potential for a QS-21 launch in the 2012 timeframe? Am I remembering that incorrectly, or has there been a slight delay due to, whatever it could be, the enrollment of trials by your partners? Can you just re-update me? Is this pretty much staying on track?
Your memory is correct. There is no slippage there in terms of your memory. We get updates from our partners on their status. These are written updates we get once a year, sometimes more often. But once a year, they're required to do that. And there is a tendency to move timelines back and forth. So the numbers that we're giving you are very conservative numbers. There could be opportunities. Or based on earlier looks, these will shift to earlier dates.
But what we have guided you on this call and in the earnings release are very conservative numbers based on the guidance we are getting from them, not our own projections.
Your next question comes from the line of (Orsen Barrett).
I have a question. Are you going to present Oncophage in U.S.?
At the moment, we have no plans to pursue renal cell carcinoma in the U.S. with Oncophage. However, as we spoke about, for example, with the glioma program, any registration plans will involve certainly the U.S.
Your next question comes from the line (Joe Bidlack), a private investor.
A couple of quick questions kind of follow-up on what Randy was asking there. You mentioned that you've had a couple of people come forward to you as far as maybe partnering down in South America or wherever. Are there any other companies I guess on the partnership trail here that are approaching you? Is there more excitement with the glioma? I know AG-707 are just current results here. But I guess maybe where's the excitement right now out there, maybe going forward here?
I didn't catch your name. Could you repeat it one more time?
My name is Joe.
Joe, you may have heard in our previous discussions that I mentioned we are in discussions with regard to the next steps with glioma, involving several potential partners and licensees that include U.S. companies as well as multinational foreign companies.
I guess my question is in your negotiations with some of these folks here, what are the positives? Are you looking I guess for partners that bring other technologies in addition to what your platforms are telling you here or product and also obviously some cash?
Our number one priority is to advance the program. So a partner who is willing to invest in advancing the program properly will be our top priority now. In addition to that, there will be additional considerations. But foremost in our mind is to put in the resources to advance the program, so that we can bring this very valuable product to patients and the commercial setting. Other than that, it would be premature to guess right now.
As far as timelines, is there one of the products that may be a little more fast track, if there is such a thing with the FDA actually? And I know, in your own wordings, there is, but in actuality, maybe glioma or the new herpes vaccine is one of those maybe it would be a little quicker to market. I know there's a lot of things behind the scenes partnerships and more trials and all that. But between the product line, there is one that possibly be could just ahead of the class a little quicker?
Well, quicker to market is really a function of many things. It's a function of how quickly you can enroll your trials, how good the results are and how quickly the regulatory consideration will materialize.
Now, in terms of the first component of it, how quickly we can enroll, that is very much dependant on the enthusiasm of the investigators involved and whether or not they can bring patients to the trial.
Now, both for Oncophage and glioma particularly as well as for AG-707, we have amongst the top investigators who are very enthusiastic about the product. So presumably that will help the first enrollment stage, so the trials enroll quickly and the results could come out quickly.
With regard to the robustness of the results, there is no way to speculate on that based on what we have seen. We hope that the results will be as robust going forward as what we have seen in our preliminary finding so far.
With regard to the regulatory process, if you are talking about an orphan indication like glioma where there's a huge unmet need, one would presume the regulatory process would be quicker than that. But it depends on the FDA and the officials at the FDA.
With a product like herpes, which is much more wider in terms of its reach to the population, I am sure the process will be much more carefully managed by regulators, because you are dealing with tens of millions of potential people that could be target for this product. And they need to be very careful that a product like that is considered fully at rush to in the market.
Since you obviously deal with these things everyday, has there been any loosening enough, I guess in layman's terms here, of the thinking for new technologies with the FDA or is it still kind of for the most part status quo? Are we seeing any semblance of them being a little more receptive to new technologies, new thinking? If you're having conversation among your peers there instead of slugs like me, what's the conversation behind the scenes? Is there any loosening up or is it the same old same old?
So is there any agency-wide change in policy that we have noticed? The answer is no. Are there individuals within the agency that understand issues and are interested in working to further the science and technology, the novel technologies, not just our, but other number of technologies? The answer is yes. But we're dealing with a big agency and individuals cannot drive the process on their own.
One last question. Financing going forward, I think Randy kind of hit upon that, enough money is going it looks like going forward into second quarter 2011. Am I kind of doing my math here correct or I guess maybe if you could touch upon that issue just for a second?
As Shalini mentioned, we closed the quarter with approximately $27 million in cash, and our projected annual burn rate is about $16 million to $18 million conservatively. So you can project from that how much money will be available for what.
However, we also have balance sheet challenges coming up, not immediate, but in the next year to two years. And as you maybe aware, we have done a fair amount of purchasing of our publicly-traded debt down from $50 million to $17 million. But $17 million is still not chump change. So we need to make sure that we take the appropriate steps to not allow any balance sheet issues to get in the way of our operations.
(Operator Instructions) Your next question comes from (Eric Warrick), a private investor.
I have a question about the RCC survival registry. I came a little bit late in the conference call. So you guys may have already gone over this. But when do you expect the final results to be published or to be forthcoming and who is reviewing the data?
So the final results are in the process of being tabulated now and analyzed. They will be submitted for formal publication. As you know, we have informed the world of the interim survival of our results. And so what you can expect is a formal publication that will be submitted in the next six months or so. And sometime next year, it will be available in the form of a scientific study. Your question about, by the way, who is looking at it, it'll be peer-reviewed clearly.
You guys have a statistician on board to analyze the statistics of the study?
And then the second question is with this data that you're going to gather in the next six months to a year, are there plans to resubmit to the EMEA?
The answer is that all will contingent on our potential partner in Europe. There is one party that we have been working with for the next steps with regard to renal cell carcinoma in Europe specifically, but we are not expending company's resources on it going forward. It will be strictly based on the contributions of a local partner.
I found something online about the EMEA evaluation and medicines for human use, and there was something in there that said that they had questioned the means of which the company is (quantitating) the heat shock factor protein-96. I know you guys are proposed to do reverse phase HPLC. Have you guys had a chance or an opportunity at address this issue?
We are in the process of addressing whatever outstanding issues there are on the product side. But frankly, our concern is not on the product side. I think we have put to rest the majority of the questions on the product side. And we continue to work with the agency obviously to make sure that we're completely compliant on the product side. We hope to get there within the next six to nine months.
I now have a couple of questions about AG-707. I see that you have a CD4, CD8 immune response. But did they ever look for outbreak? Just because you have immune response does not mean correlation that you are not going to have outbreaks of herpes or shedding at a virus. I mean you would hope so. But is there any correlation? Have you guys looked to that.
You are absolutely right, by the way. I am not an absolute expert in this field. I am going by what the key people from the University of Washington Virology Center are saying to us. And we defer to them, because they are the key experts.
Two or three important attributes of this product: One is that they have never seen a dual immune response the way we have seen them in this trial, meaning the combination of CD8 and CD4 response. So that's the first, number one.
Number two, this is a massively multivalent product. As Shalini mentioned, we target 32 different peptides that are representative of the herpes genome. So if some of these peptides or sequences become irrelevant immunologically, it doesn't really matter, because you are targeting 32.
The third issue is there is some recent studies, completely independent of all of this work, that has come out that talk about the criticality of both the CD4 and the CD8 immune response and are combating this disease immunologically. So that's all we know thus far.
In the next trial that will be undertaken, as you've mentioned, we will locate in addition to immunological endpoints. We will also be looking at doing right viral shedding, the frequency of outbreaks and so on so forth.
Are there any plans to compare that to antivirals that are (inaudible) time?
At this time, there are no further questions.
Thank you. I would like to remind listeners that a replay of this call will be available approximately two hours from now through midnight Eastern Time on October 29, 2010. Please dial 800-642-1687 from the U.S. or use the international number which is 706-645-9291. The access code is 69675455. The replay will also be available on our company website in approximately two hours.
If you have additional questions after today's call, you may call us at 800-962-AGEN or 2436.
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