Agenus Inc (AGEN) 2011 Q1 法說會逐字稿

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  • Operator

  • Good morning. My name is Denise and I will be your conference operator today. At this time, I would like to welcome everyone to the first-quarter 2011 earnings conference 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. Ms. Shalini Sharp, Vice President and CFO of Agenus, you may begin your conference.

  • Shalini Sharp - VP and CFO

  • Thank you, Denise, and good morning, everyone. Welcome to Agenus' conference call to discuss the financial results for the first-quarter 2011. With me today is 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 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 call will contain forward-looking statements, including statements regarding the Company's cash position, timing of potential income streams, and development and commercialization efforts; time lines; 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 are disclosed in more detail in our most recent filings with the US 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's business in securities, investors should give careful consideration to these risks and uncertainties.

  • For the purpose of this call, the phrase "net cash burn" means cash used in operating activities less 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 first-quarter 2011.

  • The Company reported a net loss attributable to common stockholders of $6.2 million, or $0.05 per share basic and diluted for the first quarter of 2011, compared with a net loss attributable to common stockholders in the first quarter of 2010 of $9 million, or $0.10 per share, basic and diluted. The Company's net cash burn for the first quarter of 2011 and 2010 was $4.9 million and $6.1 million, respectively. The 2011 net cash burn figure primarily reflects the Company's efforts to support the Prophage series of vaccines.

  • Cash, cash equivalents and short-term investments were $15.6 million as of March 31, 2011. On February 24, 2011, Agenus announced that it had restructured and extended the maturity of its 8% senior secured convertible notes to August 31, 2014. These notes have an aggregate current principal amount of approximately $34.7 million, and originally had a maturity date of August 30, 2011.

  • I would like to remind you that during the fourth quarter of 2010, Agenus completed the retirement of approximately $50 million of the Company's 5.25 convertible subordinated note issued in 2005. In total, the Company has used approximately $9.8 million in cash and 15.5 million shares of common stock. As a result of these transactions, Agenus has addressed approximately $85 million of its potential short-term debt payment obligations.

  • Highlighting some of our cost-cutting efforts, on April 11, 2011, Agenus executed an amendment to the Company's Lexington, Massachusetts lease, and it is estimated that this amendment will decrease the Company's annual facilities costs by approximately $1.5 million. Importantly, I would like to note that while this results in significant cost savings to us, this reduction in space does not alter the Company's current manufacturing capabilities and capacity.

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

  • Garo Armen - Chairman and CEO

  • Thank you, Shalini. I will start with some brief comments regarding recent advances in the field of immunology and cancer vaccines. We believe that these advances are marking the beginning of a new era, which will provide substantially improved benefits and reduce side effects for patients diagnosed with serious illnesses such as cancer.

  • The advances I am referring to specifically include the approval of Prophage, which is the cancer vaccine for prostate cancer, and very recently, ipilimumab, which was approved for melanoma, but which is a very important immune system-modifying drug, broadly speaking.

  • After many years of skepticism about the ability to harness the immune system for treating diseases, these approvals now validate the fact that, in addition to preventing diseases, immune-based drugs can now be used for treatment of serious illnesses such as cancer.

  • These advances also provide another important benefit -- we now have the tools and the knowledge to advance combinations of immune-based drugs such as Prophage series of vaccines. Now why are these combinations such an important thing? For one, they're likely to improve the efficacy of immune-based drugs, including cancer vaccines, very substantially. And secondly, by doing so, they will allow the development of cancer vaccines to be used in later stages of cancer, thereby making development timelines much shorter and overall process of development much more practical.

  • It is also important to note that we are positioned to benefit from these new trends in validation of immune-based approaches with several shots at potential success. The first one is our Prophage series of cancer vaccines. Second is our infectious diseases platform represented with HerpV for the treatment of genital herpes. And thirdly, and very broadly, is our QS-21 adjuvant platform. As you are aware, QS-21 is currently used in four vaccines in Phase 3 development by GSK, and 11 additional vaccines in clinical development by GSK and J&J.

  • I will first begin with a discussion of our Prophage series of vaccines. We are studying the Prophage Series G in two different settings of glioma -- one newly diagnosed and two recurrent disease. Glioma is the deadliest form of brain cancer with an average survival of six to 14 months. A Phase 2 trial testing the Prophage Series vaccine G-100 in patients with newly diagnosed glioma is actively enrolling patients, with approximately 20 patients have been treated already.

  • In this trial, G-100 is being used on top of standard of care, which includes Temodar and radiation. We believe the efficacy of G-100 potentially can be enhanced through a combination regimen such as Temodar, for reasons that have been recently become much more scientifically clear.

  • Based on promising early signals, the trial is being extended beyond University of California in San Francisco to include up to 10 prominent brain tumor research centers across the US. It is anticipated that this expansion could assist in advancing the program more rapidly into a potential late-stage trial for regulatory approval.

  • Regarding our efforts in recurrent glioma, we are pleased to report that the data from our Phase 2 trial for Prophage Series G-200 will be presented in the poster session in [2011] ASCO Annual Meeting in Chicago in early June. Based on our early discussions with experts in the field, and promising overall survival trends, we think that we can now support a randomized study using a combination regimen, which may include Avastin. Once again, recent scientific evidence suggests that the rationale for potential synergies between Avastin and cancer vaccines are strong.

  • In addition to these two glioma programs, we're also, in conjunction with UCFS, are working to initiate a Phase 1 trial, testing the Prophage Series vaccine NP-150 in pediatric brain tumors, where there are very few available treatment options, as you know. The trial is anticipated to begin mid-year, and the area of glioma and brain cancer represents a top priority for our Company.

  • Consistent with our premise of advancing our Prophage Series of vaccines in combinations with newly available tools, as well as prospective agents in development, we're working with Memorial Sloan-Kettering Cancer Center. And I'm pleased to report that preclinical experiments have begun in our collaborative work.

  • This work involves testing our Prophage Series in combination with therapeutics that provide -- or prevent down-regulation of the immune system. And these include the antibodies to CTLA-4 and PDL-1. This group of antibodies represents a new class of immunotherapeutic agents that clearly have synergistic mechanisms of action with cancer vaccines. This initiative is particularly timely because of the increased level of interest in the medical community regarding the pursuit of combination trials in immunotherapies of cancer, particularly with the recent approval of ipilimumab.

  • We believe that novel immunological drugs and cancer vaccines have the potential to be used in combinations in order to improve outcomes in late-stage cancer patients. And through these combinations, we may be able to achieve benefits not previously seen in the history of cancer treatment.

  • Separate from preclinical studies being performed at Memorial Sloan-Kettering, we're exploring clinical development collaborations to test Prophage Series of cancer vaccines in combination with other investigational and/or commercially available therapies, in an attempt to enhance the efficacy of our vaccines in late-stage cancer.

  • Now let me turn briefly to QS-21. Key licensees include GlaxoSmithKline and Janssen Alzheimer's immunotherapy, which is a division of J&J. Data from Phase 3 pivotal trials for three of our vaccine candidates, or three of the vaccines candidates containing QS-21, include malaria, non-small cell lung cancer, and melanoma. These results from pivotal trials are expected to be released starting about mid-year this year into the middle of next year. In addition, a Phase 3 vaccine program for shingles is also continuing to rapidly advance in the clinic.

  • Apart from all of these, Janssen has a QS-21-containing vaccine candidate in Phase 2 development for the treatment of Alzheimer's disease. In total, as I have mentioned, approximately 15 vaccine candidates containing our QS-21 Stimulon immune adjuvant are currently in clinical development. Pending favorable data, the first of these vaccines containing QS-21 are expected to be launched in the 2013/2014 timeframe.

  • We have the benefit of working with a giant in the field such as GSK, entirely underwriting the cost of development of a very diversified portfolio of 14 clinical stage compounds, including four in Phase 3. Additionally, we have the benefit of a significant organization such as GSK, providing the development capability. And after the products are launched, we have the benefit of a substantial commercial organization launching and selling these products.

  • This is an unusual luxury for a company of our size and value to be able to benefit from -- and to benefit, obviously, from the outcome of their success, which is disproportional. The value of all this is disproportional to the current value represented by our Company today.

  • Finally, I will discuss our third and very important immunological vaccine-based program, HerpV, our therapeutic vaccine candidate for the treatment of genital herpes. We recently completed our Phase 1 trial, which showed 100% of the evaluable patients receiving HerpV with QS-21, demonstrated that statistically significant CD4+ T cell response to the HSV-2 antigen.

  • In addition, 63% of the same patients [also listed today] CD4+ T cell response -- CD8+ T cell response. I would like to note that eliciting both of these types of immune responses, the CD4+ and CD8+ immune responses, was the first of a kind achievement in herpes therapy.

  • HerpV represents our first proof of concept study for the application of HSV platform in the infectious diseases space, and in theory, almost any pathogen could be addressed with a similarly derived vaccine. We're currently exploring Phase 2 development of HerpV. A report of these findings will be submitted for publication in a peer review journal by mid-year.

  • We hope that you have found this update to be helpful, and now I'll conclude my remarks. And we're ready for question and answers.

  • Operator

  • (Operator Instructions). Ren Benjamin, Rodman & Renshaw.

  • Ren Benjamin - Analyst

  • Congratulations on the progress. A couple of questions, maybe starting off with QS-21. Obviously, a key near-term driver for shareholders in the Company. Can you talk a little bit about the milestones? Obviously, over the next 12 months, some key data points are coming out. Can you talk a little bit about the milestone payments that the Company may receive as data comes out? And then as they go through regulatory approval, how long do you think it would take as it goes through regulatory approval?

  • And then in the cases of an indication like malaria, who is really the purchaser of choice? Right? Because it's unlike non-small cell and melanoma -- obviously, this is something that affects more Third World countries. Could we really expect much sales for something like this?

  • Garo Armen - Chairman and CEO

  • Sure. I will let Shalini answer both of these questions, Ren. And then if I need to interject at the end, will do so.

  • Ren Benjamin - Analyst

  • Okay.

  • Shalini Sharp - VP and CFO

  • Okay, well, your first question, Ren, was regarding milestone payments. So there are no milestone payments owing to us on the reporting of any pivotal data. Milestone payments are owing to us depending on who the partner is, potentially, as we move into Phase 3 trials and, potentially, upon filing an approval in major markets. So that's how the milestones work.

  • In terms of timing of approval -- so, as we've stated, the first approval we anticipate to begin in the 2013/2014 timeframe. You have rightly pointed out that malaria is a very different indication from the cancer vaccine, for example. So I think the timing depends very much on the nature of the vaccine. So for example, the cancer vaccines we anticipate would be typical US FDA priority review type filings. And I think you're very familiar with what those time frames would look like.

  • Now for malaria, for example, it's a much more complex filing process. So I don't have a specific timeline that I can give you, because this is not our program. But, suffice it to say, I believe it would take longer. It would involve multiple regulatory authorities in Third World countries to be involved in approving the compound.

  • And then you also asked about malaria as a commercial opportunity. So again, you've rightly pointed out that this is a Third World vaccine, very different in nature from the others in the portfolio. And I believe that you're right, that the cost of the vaccine per patient will be much smaller than what you anticipate, for example, from a cancer vaccine program. But that being said, I think we've read press articles about the vaccine where GlaxoSmithKline has mentioned that they would plan on making a small margin on the vaccine and things like that. So we at least know that it's not going to be given away.

  • I think that the market size is certainly smaller in dollar terms than the cancer vaccine products, but we believe it's still a substantial market opportunity and that for -- it could easily be something like a nine-figure-type product. But again, these are not our programs. We're not really at liberty to disclose projections regarding the program.

  • Garo Armen - Chairman and CEO

  • Okay. (multiple speakers) Then just comment --

  • Garo Armen - Chairman and CEO

  • (multiple speakers) Ren, the time frames that we've provided for the commercial launches to begin to 2013, 2014, are not meant for malaria. Those are the time frames for the therapeutic vaccines.

  • Ren Benjamin - Analyst

  • Okay. And then just to help us or maybe to guide us regarding the milestones on filing and approval, what should we be thinking about -- single digits? Low double-digits? Can you guide us a little bit as to where that would be?

  • Shalini Sharp - VP and CFO

  • These are single-digit, million-dollar royalties -- or sorry, not royalties, milestones. I think the real economics obviously kick in with the royalty payments. The milestones will be nice to have and helpful, but they're not going to be game-changing from a financial perspective.

  • Ren Benjamin - Analyst

  • And regarding the royalties, is there any sort of a step-up function based on sales? Or is it pretty much a flat royalty rate all the way through?

  • Shalini Sharp - VP and CFO

  • It depends on which agreement you're referring to. So some agreements work with a step-up and some don't.

  • Ren Benjamin - Analyst

  • Okay. Just switching gears very quickly to the Prophage Series of vaccines that you have. You mentioned that the collaboration with Memorial Sloan-Kettering has begun, and you're evaluating the vaccines in combination with, obviously, several other products, some that are already on the market and some that aren't.

  • Can you give us a sense -- is there an early look as to whether the hypothesis of the combination is working synergistically or additively or not at all? And might we see some of these data this year, maybe at the upcoming [ASR and CIOTC] Conference?

  • Garo Armen - Chairman and CEO

  • Okay. So, let me address -- let me go back a little bit to address this issue with some level of detail. As you may know, the discoverer of the CTLA-4 antibody has published on this subject, indicating that a product like ipilimumab would be active only in the presence of a resident immune response.

  • In other words, if you wipe out a resident immune response -- and by resident immune response, I mean in our body there's always an ongoing immune response; it's just that, in some instances, it's not sufficient enough to get the job done. But unless there is that ongoing immune response, these products do not work. So by inference, you can assume that for a product like ipilimumab to work, you're counting on the residual immune response or the resident immune response that's in the body already.

  • Now we also know objectively in our trials that our Prophage Series of vaccines do up-regulate a very targeted immune response in the patients. So it would be logical to assume that if you get that immune response, uplift it a bit, these products will work that much better.

  • Now, in experimental models several years ago, we had been able to obtain -- this is our Company -- some mouse anti-CTLA-4 antibody. And we know, based on our internal work, that the combination of the Prophage Series with the mouse anti-CTLA-4 antibody in experimental models was significantly better in activity than either one of the agent alone. Okay.

  • And this thought has become now a bit more prevalent in the scientific and the clinical circles, and hence, the reason for our collaboration with Memorial Sloan-Kettering, because we wanted to be able to show this now with a number of agents in the kinds of settings that are relevant. And so there is substantial evidence, both scientifically as well as experimentally, to suggest that these combinations work. And now we will take this to the next level. That's the reason for the collaboration.

  • Ren Benjamin - Analyst

  • And when might we see the preliminary results from these efforts?

  • Garo Armen - Chairman and CEO

  • I think it's too early to really comment on it, because the results have to be generated. The work has begun, certainly; the results have to be generated, compiled. And so the earliest I think presentations on this will be probably towards the end of the year.

  • Ren Benjamin - Analyst

  • Okay. You mentioned that G-200, the data -- that there will be updated data presented at ASCO?

  • Garo Armen - Chairman and CEO

  • Yes.

  • Ren Benjamin - Analyst

  • When might we see results or data from the G-100 study, where 20 patients have already been treated?

  • Garo Armen - Chairman and CEO

  • Right. So, as you know, that study is targeting to enroll 50 patients. And along the way, we will have updates on the survival trends in patients that have been already treated. We have some updates on the first 10 patients, and they look pretty good to us and to the investigators. And that was the reason why the trial was expanded in the first place, both in terms of the number of patients to be enrolled, numbers of patients to be enrolled, as well as the number of centers where patients are being enrolled.

  • So as we indicated, now that is being expanded to 10 centers for reasons of encouraging early signals. So perhaps in the next six, nine months, we'll have additional data to report on this.

  • Ren Benjamin - Analyst

  • Okay. And I guess just one final question -- obviously, with the space, as you started off in your prepared comments, with the space of immunotherapy really starting to take fold, almost resembling monoclonal antibodies back in the late '80s, and people starting to think about combinations such as CTLA-4 antibodies and the fact that you need a resident immune reaction or immune response already in the patient, it would seem that more and more partners or potential pharmaceutical or big biotech partners would be increasing their number of interactions with smaller biotech companies in this space.

  • Can you comment a little bit about what is happening from the partnership level? And give us an idea as to what sort of interest is being generated right now, given the portfolio that you have?

  • Garo Armen - Chairman and CEO

  • Certainly. I mean, I think you said it all very well. The field is now, for the first time, becoming important to many of the companies, including large companies, foreign and domestic, to consider. Whereas a year ago, as early as a year ago, before the program's approval, we were getting pushbacks based on two things -- one, that therapeutic vaccines still are a controversial field; two, that on top of that, we had a patient-specific vaccine, so that added to the next layer of complexity.

  • Now if you have been following some of the industry press and industry publications, the subject of therapeutic cancer vaccines and therapeutic immunological drugs such as ipilimumab -- this has dominated the -- at least the industry press for the last month or so. And as you know, between Prophage and ipilimumab, the treatment cycle is now in the $90,000 to $120,000 range.

  • So this is becoming a clearer and clearer picture as a significant commercial opportunity to large companies. And I am encouraged by early trends in the last several months, that companies that were really not interested in pursuing this, have now started biting on it more and more. I cannot tell you where we will be six months from now, but the early trends are encouraging.

  • And whereas we may have been looking for a more modest arrangement, now perhaps the recent opportunity to do something more meaningful with a company that wants to put in the resources to get to the finish line quickly. I think it's fair to say that we have spent a significant amount of money and 17 years to develop the field, and advance the field to where it is today, within the context of our Company.

  • So for a corporate collaborator to come in, they'd have to basically be -- they'd be starting near the finish line. And that would be a major advantage. And we have all the resources from an infrastructure perspective to be able to help them in that process.

  • Ren Benjamin - Analyst

  • Terrific, guys. Well, thank you very much and congratulations. Good luck going forward.

  • Operator

  • [Eric Werk], private investor.

  • Eric Werk - Private Investor

  • The G Series -- excuse me with the nomenclature, I'm still trying to get used to it -- but the G Series with the Prophage for the glioma. Statistically, what is the Company looking for, for the G-200 series, the standalone? Is the Company planning to go forward with that alone if that shows statistically that it has a relevance or bearing on glioma? And with the G-100 Series, again, what is the Company considering statistically -- an improvement of life one month beyond immunotherapy? Three months beyond immunotherapy? Six months beyond immunotherapy?

  • Garo Armen - Chairman and CEO

  • So, very good questions. As you know, you cannot do statistics on a single arm trial. And so what we have been doing in both settings, in the recurrent disease setting as well as in the newly diagnosed patients, so far is single arm trials.

  • Now the good news about glioma is that because of the limited treatment options, and because of the limited number of centers where these patients are treated pretty much -- these are typically teaching institutions -- the data is quite consistent on survival. And furthermore, we can also, and have been doing, additional rigorous analysis of patients, their circumstances, to find out if the data that we are relying on has any special nuances that would suggest any deviation from the expected norm.

  • So we've discussed these issues with a good number of experts in the field. And what we're looking for is combination studies in both settings. So, so far, with the exception of our newly-diagnosed patient trial, Oncophage has been studied, and G series, Prophage has been studied as a single agent, as monotherapy.

  • And so where there is a rationale, as I explained earlier, in combining our Prophage Series of vaccines with a compound like Avastin or a compound like Temozolomide, Temodar, where there is rationale, we would be designing randomized Phase 2 trials to move forward. And that would be the precursor for our registration strategy.

  • In other words, we can envision a study where you have -- you take Prophage G-200 in combination with Avastin in a randomized Phase 2 trial. And depending on the outcomes, you can potentially consider that as a registrational trial.

  • Eric Werk - Private Investor

  • The second question that I have -- I have a series of questions, I'm sorry. The next question I have is how much input or feedback are you allowed to give UCSF in their study, since they are the financial -- they're taking on the financial burden of doing the study?

  • Garo Armen - Chairman and CEO

  • When you say input, it is very much a collaborative effort. And we discuss these subjects regularly, and not just between us and UCSF, but we bring in other third-party experts into this effort. And the outcome, as you will see, hopefully, soon, in terms of the next steps that will be defined in our glioma programs, the outcomes will be the result of a collaborative effort. And it's possible that some of these collaborative forums would be undertaken at ASCO this year.

  • Eric Werk - Private Investor

  • Okay. And then my next question is, academic institutions are just as protective as private companies are when it comes to royalties. If anything would be commercially launched with doing the Prophage Series with glioma, would you have to pay royalties of any sort to UCSF?

  • Garo Armen - Chairman and CEO

  • No. The answer is no.

  • Eric Werk - Private Investor

  • No? Okay. My next question deals with the immune response. Do you guys have any plans -- so, in the past, you guys had a very informative video on your website dealing with the RCC, showing how you had a model or a mode of action, a mechanism, how you believed your therapy works. Do you plan to collaborate with UCSF and putting a model on or propose a model of how Prophage is working and treating and curing people with glioma?

  • Garo Armen - Chairman and CEO

  • Okay. So, there are two questions, if I understand it correctly. One would be the mechanism of action of how Prophage works.

  • That mechanism is quite well-established. It's been published. The first publication on this came out in the Journal of Science in 1995. We published it, our scientist published it. And then beyond that, multiple laboratories have done work and independently published on the mechanism of action of our Prophage Series of vaccines.

  • In other words, when the vaccine is injected into the dermis, it gets taken up dendritic cells by a receptor that has been discovered. And once it's taken up by dendritic cells, the antigens are represented on the dendritic cell and thereby magnify the signals to the immune system. So this is very well-established.

  • Now, the second question is on the measurement of immune response. And that's where I think UCSF has contributed very significantly, based on standardized tests. When I say standardized tests, you can't do these things in a community hospital, but you can do them in a hospital where there is specialized expertise. You can measure specific signals after and before vaccination, and show that there's a statistically significant increase in T cell [tizers via] surrogate measurements of cytokines that are released.

  • Now we have the expertise to do this in-house. And a center like UCSF, MD Andersen, Sloan-Kettering and so on, have their resident expertise in the field as well. And that is a collaborative effort between us and UCSF, and us and Sloan-Kettering. And previously, it's been a collaborative effort with us and MD Andersen when we were doing melanoma trials there.

  • Eric Werk - Private Investor

  • Okay. If I could intervene. I do have -- I guess -- I'm not an immunologist, I'm not an expert in immunology, but I do think that the Company or UCSF needs to -- yes, I've read the publications, I've seen them all about how you believe the Prophage is working, but you're dealing with the blood brain barrier.

  • And to assume that, yes, you have T cell response, the brain has its own mechanism for dealing with infections. The brain has its own mechanism. Antibodies don't pass the blood brain barrier or very -- rather, very small percentage of antibodies pass the blood brain barrier. So you are measuring the blood serum, you are measuring what you are pumping into someone through the dermis. I don't know, I'm just -- I'm sorry, I just would like you to think about that.

  • The second -- my next question deals with the RCC -- it's been about two years. And I was wondering, are you planning to still post or publish the update of the survival registry from the RCC about two years ago?

  • Garo Armen - Chairman and CEO

  • Right. So, let me answer the first question. The first question about the blood brain barrier, I think it's a very good question. And this was very carefully considered in the beginning of the process, before we even started the glioma program.

  • And one of the reasons we decided to go into glioma, in spite of the traditional concerns about the blood brain barrier, is because in glioma patients, the blood brain barrier becomes very leaky, trafficking cells and other things back and forth much more easily than you would find in patients that don't suffer from glioma. So this is not an issue at all. And in fact, it's an advantage in many ways, because of this leakiness.

  • In terms of the question on the survival registry, will we publish this? If it's worth publishing, as you say, this trial has had many points at which the results have been obtained over the years. If the results are such that they're dramatically different -- and I have no reason to believe they would be -- than the previous results that we got, and it warrants publication, we will do so. But if not, I think we will just gather the data for potential future regulatory filings.

  • Eric Werk - Private Investor

  • My final question. Thank you. My final question is, what is the status with Russia and EMEA?

  • Garo Armen - Chairman and CEO

  • Okay. The status with Russia is the following. We are looking at, talking to, continuing to -- and I hope that this will come to an end soon -- several local companies and parties in Russia that would be essentially our marketing and distribution partners in Russia.

  • As you may know, doing this on our own with the resources that we have would be quite impossible. We have approval, we have all the barriers pretty much undone. So the only thing waiting is an arrangement with a local partner that has the capacity to do this. And we've had some unsolicited inquiries in the last month, in fact, by local players coming to us and saying, "You have approval; would you consider discussing a potential distribution arrangement with us?" And we are; we are having those discussions.

  • In terms of Europe, I think our hope is based on the new level of interest in the field, based on regulatory clarity in terms of what is needed from us on the product specification front from the EMEA. If you recall, we filed in Europe. We were rejected on the basis of a number of things. Part of it was some ambiguity in their minds about the product characterization. Those ambiguities essentially have been put to rest entirely based on the feedback we had gotten from them early on and how we have addressed them.

  • The ambiguity regarding the subset analysis still remains. And the question will be, will the regulatory agencies be more open-minded? Because the subset analysis we conducted was not a cherry picking exercise. It was based on an externally defined earlier-stage subset that was not available to us. This information was not available to us and to the field in 2000, whereas it became more available in 2006. So there was no way of us incorporating this consideration of the correct definition of the adjuvant patient populations in our trial.

  • But if you look at this trial objectively, with an externally defined subset, the benefit we'd have demonstrated is significant. So, will we have additional discussions with the European agency once we have some more resources and have a bit more breathing room? The answer is yes, we will have those discussions. And depending on how they go, we will consider refiling.

  • Eric Werk - Private Investor

  • Thank you.

  • Operator

  • (Operator Instructions). Seeing there are no further questions at this time, I'd like to turn the call back over to Mr. Armen.

  • Garo Armen - Chairman and CEO

  • Thank you very much, and I will turn the call over to Shalini Sharp.

  • Shalini Sharp - VP and CFO

  • Thank you, Garo. I would like to remind listeners that a replay will be available approximately two hours after the call through midnight Eastern Time on October 28. The replay number is 800-642-1687 domestically, or 706-45-9291 international. The access code is 60618309. The replay will also be available on the Company's website approximately two hours after the live call. Thank you.

  • Operator

  • This concludes today's conference call. You may now disconnect.