Agenus Inc (AGEN) 2007 Q4 法說會逐字稿

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  • Operator

  • Good morning. My name is [Samarian], and I will be your conference operator today. At this time I would like to welcome everyone to the fourth quarter year end 2007 Antigenics conference call.

  • (OPERATOR INSTRUCTIONS)

  • Mr. Anstey, you may begin.

  • Robert Anstey - IR

  • Thank you, Samarian, and good morning, everyone. Welcome to Antigenics' conference call to discuss the financial results for the quarter and year ended December 31, 2007.

  • With me today are Dr. Garo Armen, Chairman and CEO, and Shalini Sharp, Vice President and CFO.

  • 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 but not limited to statements regarding the Company's ongoing commitment to reduce cash burn; the development of products containing QS-21 by the Company's collaborative partners and licensees; current and future development and commercialization activities and timelines for Oncophage, including potential meetings with regulatory authorities and the potential for marketing approval or conditional authorization of Oncophage in certain jurisdictions such as Russia and Europe; and the Company's plans and timelines for additional clinical trials.

  • These risks and uncertainties include, among others, the risk or the inability of the company to operate within its targeted burn rate and identify additional means of cost savings; unfavorable data resulting from the analysis of its and/or its licensees' clinical trials; retention of key employees; clinical trial enrollment; decisions by collaborative partners and licensees; decisions by regulatory agencies; timing and results of clinical and preclinical studies; timely and successful development of QS-21 manufacturing capabilities; timely and successful implementation of a product launch strategy in Russia if Oncophage is approved for commercialization in that territory; and the risk factors described in the company's Form 10-Q as filed with the Securities and Exchange Commission on November 14, 2007.

  • Antigenics cautions investors not to place considerable reliance on these forward-looking statements contained in this call. These statements speak only as of the date of this call, and Antigenics undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics' business is subject to substantial risks and uncertainties, including those identified above. When evaluating Antigenics' business and securities, investors should give careful consideration to these risks and uncertainties.

  • Before we move on, I would like to note that for the purposes of this call the phrase "net burn rate" means cash used in operating activities plus capital expenditures, debt repayment and dividend payments.

  • With that, I'll now turn the call over to Shalini Sharp, who will review the financial results for the quarter and year.

  • Shalini Sharp - CFO & Vice President

  • Thank you, Robert, and good morning, everybody.

  • I will now review our financial results for the quarter ended December 31, 2007.

  • For the fourth quarter of 2007, Antigenics incurred a net loss attributable to common stockholders of $7.7 million, or $0.16 per share. This compared with $11.7 million, or $0.26 per share, for the same period in 2006. For the 12 months ended December 31, 2007, Antigenics incurred a net loss attributable to common stockholders of $37.6 million, or $0.81 per share, compared with $52.7 million, or $1.15 per share, for the same period in 2006.

  • Antigenics recognized revenues for the year of $5.6 million, compared with $0.7 million during 2006, an eight-fold increase. Revenues are comprised primarily of the sale and supply of QS-21, our vaccine adjuvant, which is licensed to a number of corporate partners.

  • Research and development expenses for the year ended December 31, 2007 were $21.8 million, compared with $28.6 million for the comparable period in 2006. General and administrative expenses for the 12 months ended December 31, 2007 were $17 million, compared to $21.3 million in 2006.

  • Our net cash burn for 2007 was $27.5 million, compared with $50.1 million for 2006, representing a 45% reduction. Our results for 2007 reflect the Company's efforts to maintain a low rate of net cash burn and an increase in revenues associated with upfront milestone and manufacturing payments from our QS-21 licensees, among other factors.

  • We had $18.7 million in cash, cash equivalents and short-term investments at the end of the fourth quarter. Subsequent to the end of the year, we raised an additional $26.1 million in a private placement of common stock and warrants, at a significant premium to market price. The transaction involved three high-caliber institutional investors as well as our CEO, Garo Armen. This transaction resulted in a year-end pro forma cash balance of $44.8 million. We believe our current cash balances are sufficient to fund our operations into 2009.

  • This concludes the financial portion of the call. I will now turn it over to Garo to continue.

  • Garo Armen - Chairman & CEO

  • Good morning, everyone, and thank you for joining us today.

  • Today I will provide an overview of Antigenics' performance in 2007 and our priorities for 2008.

  • 2007 was a year of important achievements for Antigenics on all fronts.

  • First I will review Oncophage. With the results of the more mature data from our large renal cell carcinoma trial, which is the most common form of kidney cancer, and the feedback we have received from a number of high-profile key experts in the field of urology and oncology, we feel that we have begun to reverse the setbacks we experienced in 2006. But, more importantly, we believe we have begun to lay the groundwork for potential further growth and achievement in 2008 and beyond.

  • In May of last year, after an additional 17 months of follow-up from our Oncophage renal cell carcinoma trial, we were pleased to learn that the results were strengthened by a further maturity of our Phase III data set. As you may recall, our key medical advisors had encouraged us to continue to collect data to see if the reduction of 45% in recurrences observed would continue to persist. And this was considered at the time a very significant reduction in recurrences. With the analysis of the more mature data, both the P value and the hazard ratio in the earlier stage or intermediate-risk patients, which constituted about 60% of the patients who were considered truly eligible for the trial, have improved. In addition, we are now seeing a trend in favor of Oncophage in overall survival which was not observed at the time of the earlier analysis in the same patient population.

  • While regulatory hurdles in the U.S. prompted us not to actively pursue approval here, we have been exploring our opportunities to seek approval for Oncophage in other jurisdictions. Based on compelling input received from meetings with key experts in both Russia and Europe, we decided to pursue approval in Russia and explore conditional approval in Europe. To come to this point of determination, my team and I spent much of our time in the second half of 2007, as well as so far in 2008, presenting and discussing our kidney cancer data with key clinical, regulatory and statistical experts from around the world.

  • As you know, our first effort is in Russia, where we filed for approval in the summer of 2007. Review of Oncophage application is still in progress there by the Russian Ministry of Health, and we expect to receive a decision on our application by the middle of 2008. Concurrently with the regulatory review process, we are devoting substantial efforts towards putting in place the systems and other necessary requirements for the potential launch of Oncophage in Russia.

  • Clearly we are excited about prospects of potential first launch of Oncophage in Russia. As you know, this is a market that has experienced substantial growth in recent years, and its forecast is to continue to grow rapidly. The level of sophistication in the Russian market is impressive, especially in the field of oncology, and we look forward to the prospects of introducing the first patient-specific cancer vaccine in Russia. I'm sure that some of you may be aware of the fact that a number of major pharmaceutical companies are investing heavily in Russia, with full knowledge of its potential, and we are eager to join them as pioneers in this exciting and emerging pharmaceutical marketplace.

  • While our Russian plans move forward, we have taken steps to initiate similar commercialization strategies elsewhere. In Europe, we are a little earlier in the process, and the key difference in this region is that we will most likely pursue approval under a relatively new regulatory mechanism referred to as conditional marketing authorization. I have described this mechanism before, but in general it allows for greater flexibility in the approval of certain products when the current available evidence of efficacy is less than comprehensive. But, nonetheless, the existing data allows for a positive risk-benefit assessment.

  • Importantly, only products that address an unmet medical need or a seriously debilitating or life-threatening disease, and/or products that hold orphan drug designation, can be considered for a conditional authorization. Our regulatory strategy in Europe will consist of presenting a thorough plan for how we plan to collect additional comprehensive clinical data as part of our post-approval commitments.

  • The second area of our achievements over the last year involves QS-21. We are enthusiastic about the use of our QS-21 adjuvant by our key QS-21 licensees, GlaxoSmithKline, Elan and Acambis. Significant progress was made with vaccines containing our adjuvant QS-21 in 2007 and so far in 2008. Glaxo initiated a very large Phase III trial in non-small cell lung cancer and reported additional positive results in malaria that add to the long list of published data supporting its malaria vaccine containing our QS-21 adjuvant.

  • We also saw Elan's initiation of Phase II testing of its Alzheimer's disease vaccine, which also includes QS-21. And most recently we are pleased to report that Acambis decided to exercise their option for a full license to QS-21 after completing a Phase I study that compared various formulations of their influenza vaccine. In this study, the arm that contained the vaccine plus QS-21 performed better than three other arms, including one that contained a standard aluminum hydroxide adjuvant. The arm which QS-21 was associated with was a virus-specific immune response in 90% of the subjects.

  • QS-21's ability to elicit specifically especially strong immune responses as compared to other adjuvants was highlighted in another source recently. As mentioned in our release this morning, a study was recently published in the journal Vaccine that compared four adjuvant systems, three of which contained QS-21. All three adjuvant cocktails that included QS-21 were shown to elicit stronger cellular and humoral responses than the fourth adjuvant system, which contained a CpG oligonucleotide.

  • As you can see, the case for QS-21 as a critical adjuvant continues to grow. The pipeline of product candidates, which now contain approximately 16 vaccines in clinical development, is advancing through the clinic towards registration and potential future royalty payments to Antigenics. Meanwhile, many of the studies being conducted are indicating improved efficacy with QS-21, both in combination and as a standalone adjuvant over its competitors. We are hopeful that additional progress will be made in 2008 with QS-21-containing vaccines, including possibly an initial BLA filing.

  • Our third area of achievement last year, as Shalini had mentioned, we recently raised approximately $26 million in a private placement with some very diligent long-term investors. I contributed $5.1 million of the total amount invested personally and through an investment firm which I control. My decision to contribute such a large sum of money was driven by my belief in the value of Antigenics and its products. Antigenics has a level of balance that is uncommon for companies of our size in our industry. QS-21 is a generally low-risk but potentially high-reward business that is already profitable for us, while Oncophage provides a blockbuster upside potential and could be experiencing an increase in momentum.

  • Also very importantly, through Oncophage we have the potential to dramatically alter the way cancer is treated, and this potential paradigm shift towards fully personalized medicine in the patients who can benefit from it is as close as we have ever come to fulfilling this potential currently.

  • I thank you for your joining us this morning, and we should probably start the Q&A session.

  • Robert?

  • Robert Anstey - IR

  • Thank you, Garo.

  • At this time we are ready to take questions. Samarian, could you please review the Q&A process?

  • Operator

  • Okay.

  • (OPERATOR INSTRUCTIONS)

  • And your first question comes from the line of Ren Benjamin.

  • Ren Benjamin - Analyst

  • Hi, good morning, and thanks for taking the question. A couple of questions, maybe starting off the first one for Shalini. Shalini, can you provide some guidance regarding 2008? I mean, clearly the -- there are efforts on the regulatory front for Oncophage that are ongoing. There are still trials that are ongoing. And Aroplatin's being developed, which we didn't talk about on the conference call today. But what sort of expenses do you see and cash utilization do you see for 2008?

  • Shalini Sharp - CFO & Vice President

  • Thank you for the question, Ren. We are actually projecting a similar cash burn for 2008 as for 2007, potentially slightly elevated because of the pre-launch activities and launch activities that we are anticipating in Russia. So I would expect to see a cash burn figure for this year in the range of $30 million to $35 million.

  • Ren Benjamin - Analyst

  • Okay, great. And I guess moving on to the programs, and these are more for you, Garo, if we can just tackle each sort of country separately, starting with Russia, what discussions have you had with their agency so far? At least in the U.S. there's kind of a back and forth between the agency, and you're consistently updated as to sort of what their thoughts are, where they're going, until, of course, the very end. Can you give us some clues or some guidance as to how the discussions have been going? And then also, I don't know if you're aware, but if you could provide us with any examples of drugs that may be on the Russian market, are available on the Russian market, but not necessarily available anywhere else.

  • Garo Armen - Chairman & CEO

  • Okay. So let me tackle the second question first, Ren. As I mentioned in my conversation before, the Russian market is a relatively new market. Up until about two years ago this market, practically speaking, did not exist, because there was no reimbursement until about two years ago. So if one is looking for precedence, there isn't any, because it's a newly developing market. And that's one of the reasons, for example, several of the major companies that pulled out of the Russian market prior to the last two years have yet to come in, and also companies that got into the market in the last two years are prospering tremendously.

  • For example, while there was no precedence for oncology drugs selling in big numbers in Russia up until about two years ago, starting two years ago, now a product like Velcade, for example, sells more in Russia than any other European country, and at prices or reimbursement either equal to or better than in other parts of the world. So there are no precedents for the Russian markets, because it's a new market. In terms of products that are available in Russia that haven't been made available elsewhere, outside of mostly Russian-designed products, there is no precedence for that, either. So we would be pioneering in this area should we be successful in achieving approval.

  • With regard to the process, to our surprise, the Russian regulatory process is very interactive. We have had constant dialog with the regulatory agencies and committees in Russia so far, and things are proceeding on track towards a decision-making process, most likely by the middle of this year.

  • Ren Benjamin - Analyst

  • Is there any sort of a panel discussion or public forum or -- you know, like in the EU you may have a closed-door or even public meetings -- is there anything such as that that we might expect from the Russian regulatory agencies?

  • Garo Armen - Chairman & CEO

  • There is no public forum, per se, but there are various committees that would consider the application. And I cannot tell you where we are with regard to that process, because we haven't made anything public yet. But we're proceeding through that process as planned so far.

  • Ren Benjamin - Analyst

  • Okay. Regarding the EU and this -- the whole idea of the conditional marketing authorization, where are you in that process, and can you give us some ideas as to when you plan on filing the application, and then maybe give us an idea of the timeline there?

  • Garo Armen - Chairman & CEO

  • Okay. So we're contemplating on having several meetings, additional meetings, in Europe. These will include additional meetings with experts as well as meetings with the EMEA and potentially (inaudible) country representatives. And a decision will be made towards the end of the summer as to how to proceed in the EU.

  • Ren Benjamin - Analyst

  • Okay. Okay. Let's see. Moving to QS-21, clearly you have, I think it's now probably over 16 or so partner companies that are evaluating QS-21 in various stages of development. And sort of based on your knowledge of the timelines, do you have an idea as to what sort of milestones you may expect to come in -- not only milestone payments but also milestones that may be hit in 2008 from any of your --?

  • Garo Armen - Chairman & CEO

  • Okay. So it is possible that this year we may have at least one BLA filing for a product that contains QS-21. Obviously we're not at liberty to disclose which product or which product that may be. But we anticipate potential product launches in as early as 2009, but certainly an acceleration of number of product filings and launches in the 2011, 12, 13 time frame.

  • Ren Benjamin - Analyst

  • Do you expect any milestone payments this year?

  • Garo Armen - Chairman & CEO

  • Yes, of course, and I'll let Shalini answer that question.

  • Shalini Sharp - CFO & Vice President

  • Ren, just to clarify, we do expect some milestone payments potentially to come in this year, but because the milestones are contingent upon development of products by collaborators, we cannot sort of forecast specifically which products will generate milestones on which timelines. And so the net cash burn figures that I gave you earlier do not actually include any milestone payments for QS-21. They essentially include a couple that are guaranteed that we've already disclosed, and mainly manufacturing payments.

  • Ren Benjamin - Analyst

  • And can you just remind me again of those -- of the guaranteed payments?

  • Shalini Sharp - CFO & Vice President

  • Well, the significant one would be from the GlaxoSmithKline agreement that we executed in July of '07, and under that agreement we are entitled to $1.75 million in the latter half of this year.

  • Ren Benjamin - Analyst

  • Okay, great. And then one final question, we didn't talk about programs such as Aroplatin and the general herpes program. Can we just very quickly -- can you remind us what's happening there? And if you can end with just the type of milestones and maybe clinical data presentations that might be coming out this year.

  • Garo Armen - Chairman & CEO

  • Sure. Those programs are alive and well, just to reassure you. We haven't talked about them in detail because they're earlier stage programs. They are, as you said, Ren, they are in Phase I development. And with regard to Aroplatin, we are still going through the final stages of completing the Phase I trial. We were hoping that we would hit a milestone on dose based on toxicity. I think we may be there, but we have to still enroll the last cohort of patients. That may be good news in some ways because of the formulation. The toxicity profile of the product or the safety profile seems to be quite good so far in patients that we've tested. So we need to complete that dose escalation study in order to decide on which steps to take with regard to further clinical development for Aroplatin.

  • With regard to the herpes program, that is strictly a -- or largely an immunology study. As you know, our product contains 32 different peptides, and those peptides cover a quite wide spectrum of targets in the herpes [bug] as well as a variety of HLA compatibility in patients. That was one of the paramount reasons for the design of the multivalent product that contains 32 peptides, or antigens. That program will start yielding immunology results for us in the second half of this year -- perhaps before, but certainly in the second half of this year, and we will share with our investment community what those results are as soon as we have them. So that trial is still underway, and we're collecting all the blood and vials for immunological studies to be completed this year.

  • Ren Benjamin - Analyst

  • Any presentations at AACR or ASCO, anything along those lines?

  • Garo Armen - Chairman & CEO

  • Well, as you may know, we have some presentations coming up. I'm not sure what we have made public, but Sunny is here. Sunny, have we made any of these presentations public so far?

  • Sunny Uberoi - VP, Corporate Communications

  • Not yet, but we will be issuing the press release announcing presentation at EAU, which will be at the end of March.

  • Ren Benjamin - Analyst

  • Thank you.

  • Sunny Uberoi - VP, Corporate Communications

  • The actual -- if you go to the EAU website, you'll actually be able to see the contents --

  • Garo Armen - Chairman & CEO

  • Of our RCC presentation.

  • Sunny Uberoi - VP, Corporate Communications

  • -- of the RCC presentation.

  • Garo Armen - Chairman & CEO

  • And that's coming up at the end of March.

  • Ren Benjamin - Analyst

  • Perfect. Thank you very much.

  • Operator

  • And your next question comes from the line of Aaron Lindberg.

  • Aaron Lindberg - Analyst

  • Hello. Just a couple of quick questions here. Can you give us any more clarity on your communication with the Russian regulatory body in terms of additional data that's been provided to them? Have you been providing additional clinical data along the way, or has it been solely a dialog between yourselves and the --?

  • Garo Armen - Chairman & CEO

  • Aaron, let me just take that by saying that we -- as you know, we submitted an application in Russia in June of last year, and since then there has been constant dialog with the various committees and the Health Ministry with regard to lots of clarification of what is in the application. So we haven't provided additional clinical data, but because of the novelty of our product, we have provided lots of clarification along the way. We are very encouraged with that interactive process, but beyond that I cannot unfortunately share anything else with you. When we have the decision we will certainly make that known immediately. And, as I said, we anticipate that a decision will be forthcoming by the middle of this year.

  • Aaron Lindberg - Analyst

  • Oh, that's hopeful. What -- specifically what pre-launch activities are underway for Oncophage currently?

  • Garo Armen - Chairman & CEO

  • Well, what we are doing is certainly there are a number of rules and regulations that govern the level of pre-launch activities, and one of the things we are doing, for example, is we have selected, with the help of our local representatives in Russia, we've selected a number of key centers which will constitute the potential initial launch targets for Oncophage. And we are in the process of working with various physicians, pathologists, nurses in these centers to make sure that they understand, as we had done previously, by the way, in the context of our clinical trials.

  • As some of you may know, Russia was a very heavy enroller in our trial, enrolled about 25% of our patients. And so they already have substantial experience when it comes to the specific handling requirements of the tumor to be shipped to Antigenics here in Massachusetts and the product being shipped back to the centers for administration. So, but there are a number of new centers that will be included in this process, obviously, if we launch the product there. And so we are in the process of now going through center by center and making sure that we go through an orientation process of teaching them what the key determinants of success will be and making sure that we get the tumors securely and then ship the product back to them.

  • In addition to that, there are also programs to find out what are the determinants of reimbursement and what the sources of those reimbursements will be so that should we get a positive decision from the Russian authorities we have everything lined up for a quick, successful launch. So we typically are in Russia at a frequency of once a month now, typically 7 to 10 days each time, to work on all of these details.

  • Aaron Lindberg - Analyst

  • Can you provide any more detail around the determinants of reimbursement and what that might look like? Is that something that you would anticipate having all figured out and completed at launch, or is that something that's going to take some time to work out beyond the launch date?

  • Garo Armen - Chairman & CEO

  • Okay. So there are several different types of sources of reimbursement, and not every source will be lined up by the launch date, only because certain applications cannot be processed until the actual approval of the product. However, let me just review the kinds of reimbursements available in Russia, which were not in existence up until about starting two years ago.

  • One is regional reimbursement. As you may know, Russia has a number of reasonably economist -- economically and otherwise regional governments, and some of them are quite prosperous because of oil and natural resources. And they provide their own reimbursement program for patients. And in order to secure these reimbursements you have to go region by region and talk to them about the attributes of your product and how reimbursement could be secured. We have been doing this already for regional reimbursement, and we continue to do it. And we will continue to do this up until launch and beyond, perhaps.

  • The second source of reimbursement is central government reimbursement. There you cannot apply for it until the final stamp is achieved. And so, while we try to now figure out exactly how to get all of our ducks in order so that the process will be as expedited possible, and so we're in the knowledge-building process with regard to central government reimbursement.

  • The third source of reimbursement, as you may know, Russia is becoming a more prosperous country, not just in the context of only a few wealthy individuals but that circle of few is widening very, very rapidly. And so there's a fair amount of out-of-pocket payments that are made for products. This we have seen with other expensive oncology products that have grown in the last two years. And this requires patient information, working with patient interest groups and making sure that you have the appropriate communication strategy once the product approval is achieved. And so we are working very actively in that area as well, both ourselves as well as with the help of local agents.

  • Aaron Lindberg - Analyst

  • Excellent. And it appears that the results from the melanoma trial, somewhat similar to the RCC trial, were very favorable in a specific subset but not statistically significant in the overall trial population?

  • Garo Armen - Chairman & CEO

  • Yes.

  • Aaron Lindberg - Analyst

  • What can be done in terms of preclinical work and trial design just to maximize the impact of future trials? And maybe glioma would be a good example.

  • Garo Armen - Chairman & CEO

  • Certainly. As you're aware, the glioma trial, which started several years ago in the U.S., is continuing because of the high level of enthusiasm of the participating physicians, the clinicians. And we're now expanding that trial both in terms of the number of patients as well as the number of participating centers. And, as you also may know, that trial is funded through external sources. We make the product for the trials, but funding comes from external sources.

  • And the trial -- in the early trial, which was a Phase II -- I mean, Phase I trial with 12 patients, included both gross observations of clinical outcomes as well as, very, very importantly, very specific immunological measurements. And, as we published, 12 out of 12 patients showed immunological response with testing that involved some very sophisticated methodologies for patient-specific immune response. And so that was very positive. That was the impetus for extending the trial. And through this process we have been very encouraged as to the relevance or the relationship, the correlation, between immunological response and potential clinical response.

  • And so one potential for us in moving forward is doing immunology trials, which we're contemplating, involving smaller numbers of patients, but trials that will objectively show that the administration of Oncophage in patients who are stricken with cancer is actually prompting a patient-specific immune response. When we talk to a number of the clinicians and regulatory experts around the world, they consider this as a very important potential surrogate determinant of product activity in the future. So that's one path that we're going towards now.

  • Aaron Lindberg - Analyst

  • And then with the immunological trials, was that something where you would perhaps do, say, a Phase III trial in RCC in the U.S., or is that -- I guess what I'm looking at, is that something where you can start at a later stage or is that something where you kind of go back to square one as far as new indications?

  • Garo Armen - Chairman & CEO

  • Well, we haven't really discussed all of this in detail, but for the European conditional authorization process, it's conceivable -- conceivable that after the conditional authorization is granted, that we would do another trial in RCC. And we haven't discussed publicly the size of that trial, but that would be in connection with marketing the product. And so in addition to doing an efficacy trial specifically in patient population that we're seeing activity in -- more specifically, in renal cell carcinoma -- we will most likely do immunological trials as well.

  • Aaron Lindberg - Analyst

  • Okay. And so that would be more typically used in that situation versus new indications down the road, or kind of down the road you may start new indications in that same fashion?

  • Garo Armen - Chairman & CEO

  • Well, I think it's too early to speculate. However, the hope would be at some point to gain acceptance of immunological markers as indications of efficacy in other indications.

  • Aaron Lindberg - Analyst

  • Okay. And then melanoma is on hold at this point just until Antigenics has more financial resources?

  • Garo Armen - Chairman & CEO

  • I think melanoma is on hold for two reasons even though there is some very encouraging data that was recently published, as you remarked. One is that from a regulatory perspective, the renal cell carcinoma trial was a large trial, a clean trial, that required a particular type of analysis, but the experts feel that that analysis may be convincing from the perspective of demonstration of efficacy. Melanoma trial was -- had less tight attributes, if you will. So the hope would be to cross the bridge first with the renal cell carcinoma trial, and when we become successful with that to try to see what we can do with the melanoma effort. So --

  • Aaron Lindberg - Analyst

  • Is that something that you might potentially, after a successful launch, say in Russia in RCC, you may go ex-U.S. with melanoma to get started, as well, something like that?

  • Garo Armen - Chairman & CEO

  • Well, I think it would be reasonable to expect that to go with a melanoma trial we would probably have to do some additional work.

  • Aaron Lindberg - Analyst

  • Okay.

  • Garo Armen - Chairman & CEO

  • Whether that work would be immunological studies and other studies, that remains to be seen. But it would be reasonable to assume that additional work would be needed in melanoma.

  • Aaron Lindberg - Analyst

  • Great. Thanks. And last question is, can you just comment on when you expect the next receive date on GSK's non-small cell lung cancer trial and Elan's Alzheimer's trial?

  • Garo Armen - Chairman & CEO

  • Well, the first challenge with the GSK trial would be to complete enrollment. And we know, and I think they have remarked about this publicly, as well, that they have designed some interim analyses to that trial. So, realistically, once the approval is completed, we would anticipate that -- I'm sorry, once the enrollment is completed, we would anticipate results not to be earlier than the following nine months post-completion of enrollment.

  • Aaron Lindberg - Analyst

  • Okay.

  • Garo Armen - Chairman & CEO

  • And with regard to Elan's Alzheimer's trial, that trial in certain geographies has enrolled very, very rapidly, as you can imagine. But I think we won't see any results of that trial in terms of efficacy read-outs for some time. Some time may mean a couple of years.

  • Aaron Lindberg - Analyst

  • Great. Thank you.

  • Operator

  • And your next question comes from the line of Robert [Petrildo].

  • Robert Petrildo - Analyst

  • Good morning. Thank you for taking my questions. If all goes well with the approval process in Russia, when can we expect to see revenues from Russia?

  • Garo Armen - Chairman & CEO

  • I think if all goes well we hope to see revenues in the second half of this year.

  • Robert Petrildo - Analyst

  • Okay. And on the business development side, you spoke earlier in the conference call that many pharma companies are looking to get into Russia or other companies are looking to get back into Russia. Where is Antigenics on the business development side, both in Russia and in the U.S.?

  • Garo Armen - Chairman & CEO

  • Well, we haven't discussed publicly other than to say that we have ongoing discussions with major pharma companies at the moment. Some include global partnering opportunities. Others include ex-U.S. partnering opportunities. And we hope that we will provide more clarity as these things come to a conclusion, perhaps towards the end of this year.

  • Robert Petrildo - Analyst

  • Great. Thank you very much.

  • Garo Armen - Chairman & CEO

  • My pleasure. Thank you very much.

  • Operator

  • (OPERATOR INSTRUCTIONS)

  • And at this time, sir, there are no further audio questions.

  • Garo Armen - Chairman & CEO

  • Thank you very much for your participation.

  • Robert, you have some closing remarks.

  • Robert Anstey - IR

  • I'd just like to remind listeners today that a replay of the call will be available approximately two hours from now through midnight Eastern time on March 6. Please dial 1-800-642-1687 from the U.S., or 707-645-9291 internationally. The access code is 35347193. Replay will also be available on our website in approximately two hours. If you have any additional questions after today's call, please call us at 1-800-962-AGEN, or 1-800-962-2436. Thanks.

  • Operator

  • And this concludes today's fourth quarter year end 2007 Antigenics conference call. You may now disconnect.