Agenus Inc.
Q2 2009 Earnings Call Transcript

Published:

  • Operator:
    Good morning. At this time, I would like to welcome everyone to the Antigenics second quarter 2009 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). Ms. Sharp, you may begin your conference.
  • Shalini Sharp:
    Welcome to Antigenics' conference call to discuss the financial results for the quarter ended June 30, 2009. 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 I continue, I would like to remind you that this conference call will contain forward-looking statements, including statements regarding products in development using QS-21, the company’s application for marketing authorization for Oncophage in the EU, the company’s efforts to market Oncophage in Russia and to pursue named patient program, the expanded phase II trial of Oncophage in glioma, and data from the phase I trial of AG-707 in genital herpes. 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 US Securities Exchange Commission. 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 repayments, and dividend payments. With that, I'll now review our financial results for the quarter ended June 30, 2009. For the second quarter of 2009, Antigenics incurred a net loss attributable to common stockholders of $12.3 million, or $0.17 per share. This is compared with a net loss of $12.5 million or $0.19 per share for the same period in 2008. Antigenics recognized revenue for the quarter ended June 30, 2009, of $1.3 million, compared with $595,000 during the same period in 2008. This increase in revenue was primarily driven by an increase in QS-21 license fees, royalties, and product shipments to a number of our corporate partners. R&D expenses for the quarter ended June 30, 2009, were $5 million compared with $5.8 million for the comparable period in 2008. General and administrative expenses for the three months ended June 30, 2009, were $4.2 million compared with $5.7 million in 2008. Our net cash burn for the second quarter of 2009 was $5.7 million compared with $6.9 million for the same period in 2008. The 2009 results reflect among other things the company’s efforts to support Oncophage in Russia, Europe, and other territories while also executing cost containment efforts, while the 2008 results reflect the company’s efforts to obtain registration and conduct pre-commercial launch activities for Oncophase in Russia. We had $21 million in cash, cash equivalents, and short-term investments at the end of the second quarter. We believe our current cash balances are sufficient to fund our operations into 2010. This concludes the financial portion of the call. I will now turn it over to Dr. Garo Armen.
  • Dr. Garo H. Armen:
    I will now provide a corporate update Antigenics beginning with Oncophage, our therapeutic cancer vaccine, and continuing with QS-21. At this year’s American Society of Clinical Oncology meeting known as ASCO, Dr. Christopher Wood from MD Anderson Cancer Center and the lead US investigator of now phase III kidney cancer trial presented positive overall survival data from our ongoing global patient registry. The purpose of the patient registry as you know is to follow patients who are previously enrolled in our phase III kidney cancer trial, so that we can continue to collect the most up to date data on survival. Before highlighting the results of this registry, let me provide a brief history of the key milestones of our phase III study. This is one of the longest trials conducted in cancer. As you may know, cancer drug development historically has focused on patients with advanced stages of disease because it’s easier to do these trials. They’re shorter. Unfortunately, the more advanced the cancer, the more difficult it is to treat, and by contrast, the Oncophage trial in renal cell carcinoma, otherwise known as kidney cancer, was designed for patients with earlier stage disease because cancer vaccines are universally believed to be most appropriate in earlier stages of disease where we had hoped to benefit the patient optimally with the use of a cancer vaccine. To refresh your memory, the Oncophage renal cell carcinoma trial failed to meet its primary end point in the intent to treat population at the first analysis time point which was in November 2005. However, as I said above, given the fact that cancer vaccines are believed to work best in early stage disease, we looked at results by the best available prognostic staging which was independently adapted by ECOG, known as Eastern Cooperative Oncology Group, in 2006. This definition that I’ll be talking about was not known when we started the trial in 2000. Based on the ECOG criteria, the earlier stage patient subset that were defined intermediate risk patients constituted 60% of the patients enrolled in our trial, and this 60% amounted to 362 patients, so a very large patient population. The data from our Oncophage trial has been analyzed at three time points over 3-1/2 years, and the latest data presented at ASCO by Dr. Wood represent the most recent analysis which showed a statistically significant survival benefit in the intermediate risk subset, in other words these 362 patients. The previous two analysis points had shown, just to refresh your memory, a successively improving statistically significant benefit in the primary endpoint of the trial which is recurrence-free survival, so with the most recent survival analysis, we now have a correlation between the primary and the secondary endpoints which are both statistically significant and clinically very meaningful because they seemed to reduce the risk of death by 46%. Of course, all of this is with the qualifier that this is a subset analysis, which most regulatory agencies frown upon, but we have a high level of conviction regarding the efficacy of our product and the support by a substantial number of the top prominent specialists and experts in the field of urology and oncology, primarily in Europe, but also in the US and throughout the world, who believe that Oncophage provides a significant benefit in intermediate risk kidney cancer patients which has not been before with any product. In spite of the regulatory hurdles, we continue with the support of key experts, of course, to pursue a path to make Oncophage commercially available in renal cell carcinoma patients and Europe and several other major geographies. In addition to kidney cancer, Oncophage is also being studied in a clinical trial for the treatment of glioma. In late June, the investigators sponsored a phase II study expanded to include Columbia University, a major center for glioma, which has already begun enrolling patients. Furthermore, Case Western Reserve University Hospital is now also participating and expects to begin enrolling patients next month. The study is designed to recruit approximately 30 patients diagnosed with first recurrence of high-grade glioma. The trial is designed to evaluate overall survival, time to progression, and also very importantly immune response, and we expect interim results from this trial to be presented in late 2009. Based on the current ongoing glioma trial, which has enrolled about 25 patients, there is substantial excitement by our investigators regarding results achieved thus far, which cover both clinical and immunological outcomes. That ends my Oncophage section of the update. Now let me turn to our vaccine adjuvant business, QS-21. Glaxo Smith Klein continues to make significant advancements with its both prophylactic and therapeutic vaccines which contain QS-21. We’re pleased to note that QS-21 has now entered a pivotal phase II trial with Glaxo Smith Klein’s very high profile novel malaria vaccine, which is expected to be the largest study conducted in this indication. QS-21 has become a key component of Glaxo Smith Klein’s proprietary adjuvant systems underscored by four phase III studies of Glaxo Smith Klein including infectious diseases as well as their MAGE-A3 antigen specific cancer immunotherapeutic vaccine for both lung cancer and melanoma. As a reminder, GSK will make payments contingent upon successful milestones achievements of course and will also pay royalties on sales for a period of at least 10 years after their commercial sales commence, which could be as early as 2011 with their first QS-21 containing vaccine product. All in all, there are now 15 products in clinical trials that contain QS-21. Finally, a development that also deserves mention is the recent GSK-Abbott agreement which highlights the growing interest from larger pharmaceutical and device companies in the cancer vaccine market and their commitment to identifying in this particular deal highly specific and targeted patient populations. This agreement announced in June will develop an automated molecular diagnostic test to screen non-small cell lung cancer patients or tumors for the expression of MAGE-A3 antigen, the key antigenic target in GSK’s lung and melanoma vaccine which contains QS-21. Those are the two major areas of highlights for us, certainly the Oncophage program and QS-21 which we hope and expect to be the major drivers of value for the company in the coming years. Now, I will turn the call to open up any questions that you may have for Shalini or me.
  • Operator:
    (Operator Instructions). Your first question comes from the line of Ren Benjamin - Rodman & Renshaw.
  • Ren Benjamin:
    Starting off with Oncophage, thanks for the review of the clinical data. I thought that the subset analysis actually got split into three groups, with intermediate being one of them and then a high-risk group and a much lower risk group. If that’s the case, can you give us an idea as to how the curves have done in the lower and high-risk groups as well?
  • Dr. Garo H. Armen:
    I think what you’re referring to Ren is the ECOG definition. ECOG definition includes low risk, intermediate risk, and high risk, but patients enrolled in our trial have been in intermediate risk and high risk. We haven’t had low-risk patients, and the reason for that is as you remember I remarked that this has been one of the longest trials in studying a cancer drug. If we had included low-risk patients, instead of it being an 8- to 10-year trial, which would have been a 15- to 20-year trial. That would have rendered it very impractical to complete, and that’s why we’ve taken the low-risk patients out at the start of the trial, but when we started the trial and designed the trial, the adjuvant patient population which comprised of both staging and grading criteria were lumped in one group because it was thought that they had a risk of approximately 50% chance of relapse. And then subsequently when ECOG designed their trial in 2006, they redefined populations of renal cell carcinoma based on the latest prognostic criteria, and certainly the field had advanced by then between 2000 and 2006, and this is a field that’s continuously evolving in many other cancers in terms of staging and grading and classification of these patients. So if apply the ECOG criteria to classify patients in our trial, they fell into two groups, intermediate risk and high risk. Now, if you look at for example the old staging, we had patients with stage I and II high grade tumors and stage III low grade and high grade tumors, and stage IV non-metastatic patients. That comprised the entire patient population in our trial. If you looked at by prospectively defined staging, we still see the same trend. In other words, the trend that you see in intermediate risk curves are the trends also present in stage I and stage II high-grade patients but because we did not have the numbers of patients, the results were not yet statistically significant in those populations. When you add the additional patients defined in the ECOG trial, then the results become statistically significant, and as I remarked, yes, this is a subset analysis; however, it is a subset that is externally defined, and that is one of the reasons a key group of advisors that number in several dozens, well-known prominent physicians around the world, are very supportive of this particular analysis, and that includes also very well known globally well known world-class biostatisticians who are on board with this analysis because of the biological rationale. So there is a lot of concordance between the ECOG subgroups that I defined versus the older subgroups that were included in our prospective analysis.
  • Ren Benjamin:
    Can you give us some ideas as to what’s happening in Russia? Clearly, there is progress being made, but as a pharmaceutical market and a regulatory market, it’s a little bit of a black box for us in the US, but clearly you’re having dialog on a daily or weekly basis over there. Can you shed some light and give us some color as to what’s happening with the negotiations there?
  • Dr. Garo H. Armen:
    I think it’s fair to say that we have made considerable progress, and when I considerable progress, tangible progress in obtaining the necessary permits. In fact, we have obtained a number of the permits that are necessary very recently to transact business in Russia. The last thing that we’re waiting for is reimbursement, and we’re negotiating with the government directly, officials of Kremlin, in order to see if we can allocate a certain amount of monies for reimbursement of Oncophage, and I hope that that will come to resolution also shortly.
  • Ren Benjamin:
    Would it be fair to say that it could come to resolution and sales could begin by the end of this year, or do you think based on your negotiations so far that frankly time if sort of up in the air and it could just slip?
  • Dr. Garo H. Armen:
    That is our hope and expectation, Ren.
  • Ren Benjamin:
    Regarding the EMEA, can you remind us where you are in the whole question and answer dialog between the EMEA and you? Clearly this is a process. Can you remind me where we are and how much further we have to go?
  • Dr. Garo H. Armen:
    Without getting very specific, EMEA process involves our filing which was done on October 22, 2008, and after that, there are defined periods within which they come back to us with questions. As you may also know, we’ve had a number of inspections of our clinical sites. They do that to make sure that the data you’re reporting corroborates with actually what’s in the source documentation. Those are completed. They’ve done an inspection of our manufacturing site. We hope based on the comments that we’ve gotten that within a reasonable amount of time after we’ve put in the recommendations and the requirements that they have set forth we will be compliant in that site by EMEA standards, and the rest is best on deliberation and final oral hearing which we hope will be by the end of this year, and I think it’s reasonable to expect that an oral hearing may be held by the end of this year, and at that oral hearing, we will be get the decision as to yes or no. And so, that’s the process, and that’s we’re working very hard towards, addressing all the questions as much as they’re addressable so that we can progress to an oral hearing and put on a good argument.
  • Ren Benjamin:
    In the discussions so far, do you get a sense or has there been talk that potentially additional clinical trials may be needed, or are the discussions pertaining primarily to the data that’s already been generated?
  • Dr. Garo H. Armen:
    As you know, in my talk, I mentioned that the general hang-up of most regulatory agencies is subset analysis, and if it was not for that, I’m sure that our path forward would be quite well defined, and so because of the subset analysis deficit, it is a hurdle, and what we’re hoping for is that with the conviction of the experts in the field we can overcome that major issue.
  • Ren Benjamin:
    The EMEA also at least has approved several drugs that have had to undergo similar analysis under their accelerated, I think it’s accelerated or conditional, approval route.
  • Dr. Garo H. Armen:
    It’s a conditional approval route because accelerated is in the US; conditional is in Europe.
  • Ren Benjamin:
    The Pediatric Brain Consortium, you had guided a phase I-2 glioma study would be funded and run by them. Can you just remind me what’s the status there?
  • Dr. Garo H. Armen:
    I think it’s fair to say that because of mainly financial hurdles we have slowed down some of these programs. As you know, we’re down to only a few people at the company attending to all of these activities, so there is a limited number of things that we can do, and so in essence, we have slowed down some programs only because of lack of resources. We’re very excited, suffice it to say, about the glioma program because of the excitement of investigators. There is a lot of enthusiasm about data that’s been generated so far which is way beyond what you’d expect these patients to survive. Glioma is a tough field. There aren’t very many things that work even with the recent approval of Avastin. The benefit of Avastin is very limited, and so it’s a disease with a major unmet need, and so we’re hopeful that with a little bit additional news coming through with glioma, we’ll be able to expand that program in the coming years.
  • Ren Benjamin:
    Any guidance, information, or color you can provide regarding partnerships? I know you’ve pretty much decided to go through this on your own at least for right now, but with the Russian approval, is it inconceivable that there are companies in Russia who wouldn’t mind marketing this, so that you would team with them or has there been more of a wait and see approach?
  • Dr. Garo H. Armen:
    We’ve had discussions with Western companies that are operating in Russia as well as local distributors that have a very good grip on the Russian market, and it’s fair to say over the next few months, we will decide which is the prudent way forward in Russia. There are some advantages to having local players because it’s always good to have participation by locals, and it may make it easier in many ways to have consideration by the Russian government, if we were to do that. In Europe, in addition to the EMEA process, we’re also actively looking at named patient programs. Just as a reminder, the named patient program is a program where we cannot market product, but if physicians request the product essentially for any indication, we can sell product based on a prescription that will be written by physicians, and so there are a handful of companies that have done reasonably well with those programs. You do not need approval for that, but you do need GMP manufacturing, and that’s one of the reasons we are aggressively pursuing GMP certification in addition to potential European approval because it would be of great help in Europe, and certainly the EMEA process has helped scrutinize our manufacturing facility to the point where we may be able to get GMP certification in a reasonable amount of time.
  • Ren Benjamin:
    Regarding QS-21, I believe you mentioned that you’re hopeful that maybe some data would be available from the vaccines that contain QS-21 by 2011.
  • Dr. Garo H. Armen:
    Not data. I said royalties would start by 2011. It’s conceivable that data will be available next year.
  • Operator:
    Your next question comes from the line of Daniel Powell.
  • Daniel Powell:
    I’m a stock owner. With I was reading about the US Healthcare Act that’s about to be passed or trying to be passed, is there any risk that you guys are looking at that healthcare reform and your clinical trials or getting to market?
  • Dr. Garo H. Armen:
    In the US?
  • Daniel Powell:
    Yes.
  • Dr. Garo H. Armen:
    We haven’t really had any direct interactions with the US FDA for about three years now, and I know that there is some misperception out there that we have gone to the FDA and we’ve been rejected by the FDA. That is not a fact actually. We’ve never gone to the FDA to file or consider filing for approval, only because we have had a realistic posture. US regulation has absolutely no guidelines at the moment. There may be guidelines in the future, but right now, there are no guidelines that would consider the kind of analysis that we have conducted for approval. The reason we went to Europe was with the hope that under conditional approval, it may be possible. So I think it’s fair to say as more data is generated and more reason and rationale comes into the equation of looking at data based on science, biological rationale, and the knowledge of disease, it’s possible that in the future we may feel to see the temperature to see if there is anyway in the US for consideration, but because so far it’s been difficult to identify that, we have not made the attempt.
  • Operator:
    Your next question comes from the line of Michael [Zaveri].
  • Michael Zaveri:
    This issue with reimbursement in Russia, you have been working with them for about 1-1/2 years now or somewhere close to that. Since you have approval in Russia, what’s stopping somebody that has kidney cancer in Russia to come to you and say I want to pay you for this drug directly out of pocket? Have you had any request from anyone in Russia that has sought your medicine or your vaccine to pay out of pocket?
  • Dr. Garo Armen:
    A very good question. Let me answer it in the following way. In addition to reimbursement, on obstacle was present in Russia up until very recently, meaning last week, was the fact that we did not have permission to export the tumor out of Russia and import the product back into Russia, so we did have approval for the product itself, but the exportation of the tumor to make the product required a different set of permits. We just obtained that very recently, about a week ago, and so we have not yet tested those permits. In other words, we haven’t yet shipped tumor and shipped back the product; we will very shortly, but theoretically with this permit, your question of could a patient pay out of pocket in Russia, the answer to that question would be yes, but this phenomena is only a week old, so we have just gotten the ability to do this. Now, we have had patients, Russian patients, who have gone to Europe to be operated on and have been willing to pay for the product under the named patient program, so to speak, so it’s been a strange phenomenon because we have approval in Russia, but up until recently, we did not have the exportation of tumor permission, and this patient went to Europe to be surgically excised in order to have access to the vaccine, so the answer is yes to these questions, but it is very recent that we can do this, and so we are going to put in a bit of effort behind this and try to optimize at least revenues based on out-of-pocket reimbursement, but the meaningful revenues will come when the government agrees to make a certain allocation of monies for reimbursing for Oncophage.
  • Michael Zaveri:
    Is that also true for any patient in the US? If you have patients in US that want to approach you and say make a vaccine for my kidney cancer. Can they do that in the US?
  • Dr. Garo Armen:
    Unfortunately there is no such allowance for payment in the US.
  • Michael Zaveri:
    What if they want to pay out-of-pocket?
  • Dr. Garo Armen:
    It doesn’t matter. In the US, you can’t provide them product. In Europe, you can do it under the named patient program, but in the US, you cannot do that because there is no regulation governing this. There is a compassionate use program for which companies cannot charge, so under that program, we would have to be providing the product on gratis. Now, we have done this on a number of occasions. We have done it. We have pretty much stopped it in the US because of lack of resources and because of financials. The US system, even under the compassionate program, requires an ungodly amount of paperwork, so it id not just the cost of making the vaccine and providing to the patient out of goodwill, it is also an enormous amount of paperwork that needs to be done from regulatory perspective even though we have no gain out of it per se, but you still have to do the paperwork, and it becomes a huge burden to do it, so that’s why we pretty much stopped that program.
  • Michael Zaveri:
    What about these trials that you are running in San Francisco? If the patient wants to join that trial, is it closed at this point or is it still open and patients can join or how does that trial work and what stage are you in at this point?
  • Dr. Garo Armen:
    There are two trials that are open to enrollment right now based on specific inclusion criteria. One trial has enrolled about 25 patients, and it is close to closing because I believe the limit was 30 patients, but I’m sure that there is still room for enrollment in that trial. The other trial, the one that I spoke about, after relapse from first line treatment, that just opened, and so with that trial there is the possibility to enroll patients at Columbia, Case Western Reserve, as well as in San Francisco.
  • Michael Zaveri:
    When you just opened marketing with Russia, is there a possibility you could have, is marketing done in Russia that people can come to this marketing company that you just signed a contract with and ask for the drug or how is the average person in Russia informed that there is such a therapy available to them?
  • Dr. Garo Armen:
    So we have had some articles written on this in Russian locally. There are designated hospitals that have been qualified already where they have the training and the infrastructure to secure the tumor and then secure the product once it’s shipped back, so with those hospitals, and they are well known hospitals in Moscow and several other places where patients could go and be treated starting essentially now.
  • Michael Zaveri:
    So there should be hopefully good news underway pretty soon.
  • Dr. Garo Armen:
    I would hope that. I think the setups and some of the additional logistics will probably take another several months, but as Ren had asked, we hope that by the end of this year, particularly if we receive government reimbursement, we will be able to start registering sales.
  • Operator:
    The next line comes from the line of Edward Mullen.
  • Edward Mullen:
    Is QS-21 used in any of the current H1N1 vaccines, and if so, is there any potential for any near-term revenues from that?
  • Dr. Garo Armen:
    The answer is no, not to our knowledge, and so because this program had to get started very quickly and did not require actually any clinical trials, there has been very limited time to really consider using even QS-21 by some of the players in the field, and up until now, QS-21 supply has been designated for trials that are underway, so because of the rapid unset of these programs and the decisions by the major contractors that have been assigned to the development of these vaccines, we don’t have QS-21 at this point in any of these H1N1 products.
  • Operator:
    The next line comes from the line of Robert Crawler.
  • Robert Crawler:
    Right now your company has a market capitalization of under $200 million. It is my understanding that the QS-21 royalties have the potential of being somewhere around $500 million at some point. What would prevent a company like Glaxo from coming in and making an offer to buy the company? It would seem to be cheaper in the long run for them to buy your company as opposed to paying you those kinds of royalties over time, and my question is would you be open to that possibility, and what’s your feeling on that?
  • Dr. Garo Armen:
    I can’t really comment and opine on what they may do or may not. In terms of what our position would be, clearly we’d want to optimize the potential of our pipeline as much as possible for the benefit of our shareholders and the benefit of the science and the patients, but on the other hand, if there is an offer to buy the company, that’s a consideration for our Board of Directors and for our shareholders, so it would depend on the level of consideration and the conviction of our shareholders and Board of Directors as to whether or not that represents the best value realization for the company, so anything that comes needs to be considered for governance and other responsible reasons.
  • Operator:
    The next line comes from the line of Daniel Powell.
  • Daniel Powell:
    With the economic downturn globally, how is that affecting you guys for staffing up and also is there any kind of government programs that you found overseas where they will help you guys get tax breaks or incentives to ramp up production of your drug facilities, sending reps in the field, and things like that. Have you all looked into that or is there any risk with the downturn in the economy?
  • Dr. Garo Armen:
    In terms of the downturn in the economy, certainly it affects everybody. It is demoralizing to all, but other than that, if the circumstances become serious enough that healthcare expenditures are reduced by governments for serious diseases like cancer, and unless until that happens, and I don’t know if that would happen, it is difficult to speculate on that, but until that happens, it shouldn’t really technically affect the prospects of our business. With regard to staffing, unfortunately, many people have lost their jobs, and it makes it a bit easier to get high quality people, but we as a company have been blessed by the fact that we had a group of very dedicated executives and employees who have longevity with the company, and so our first order of business is to really advance the people we have as the opportunities come along and then add people as appropriate. The third part of our question about government programs that may be beneficial, again unfortunately, even though from a risk-benefit perspective, it makes a lot of sense, we haven’t had the people resources to look into these programs. We’ve dabbled in it a bit, but we haven’t had a serious effort to see if can tap into some of these programs, major grants, and so on and so forth. As you know, some companies modify their business plan in order to take advantage of these programs. Because we have had the conviction internally that there are worthy programs internally to pursue, we haven’t had the opportunity to modify our business plan to take advantage of many of these programs, but it certainly deserves attention, and as we get a little breathing room, we’ll look at that.
  • Daniel Powell:
    You guys roughly had a $12.3 million loss for the quarter if I’m remembering correctly, and then you had a previous $12.5 million dollar loss. Are those losses in the same areas or have you al learned from the previous losses and adjusted your expenditures so you wouldn’t be losing money on those areas or what? How are you learning from the previous losses?
  • Shalini Sharp:
    As we’ve described in our earnings release, we have been trying to control on the cost side some of our outflows related to both general and administrative expenses and research and development expenses. As Garo alluded to, we’ve taken some measures to reduce our personnel cost as well as external services cost and other costs, so there is no one specific category in which you’d see a major change from quarter to quarter. Generally speaking, you can see the variance in R&D and G&A from quarter to quarter, and those are the kinds of steps that we take to make cost containment efforts.
  • Operator:
    At this time, there are no further questions.
  • Dr. Garo Armen:
    Thank you very much for your time, and we certainly appreciate your interest and participation, and we look forward to speaking to you at the next opportunity. Thank you very much.
  • Shalini Sharp:
    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 August 13, 2009. Please dial 1-800-642-1687 from the U.S., or use the international number which is 706-645-9291. The access code is 19055786. This replay will also be available on our company website in approximately two hours. If you have any additional questions after today's call, please call us at 1-800-962-2436. Thank you.