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AVEO Pharmaceuticals (NASDAQ:AVEO)

Q2 2012 Earnings Call

August 02, 2012 10:00 am ET

Executives

Monique Allaire

Tuan Ha-Ngoc - Chief Executive Officer, President and Director

William J. Slichenmyer - Chief Medical Officer

David B. Johnston - Chief Financial Officer and Principal Accounting Officer

Michael P. Bailey - Chief Commercial Officer

Analysts

John S. Sonnier - William Blair & Company L.L.C., Research Division

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Anupam Rama - JP Morgan Chase & Co, Research Division

Marshall Urist - Morgan Stanley, Research Division

Thomas Wei - Jefferies & Company, Inc., Research Division

Salveen J. Richter - Canaccord Genuity, Research Division

Howard Liang - Leerink Swann LLC, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the AVEO Oncology Second Quarter 2012 Financial Results Conference Call. My name is Derek, and I'll be your operator for today. [Operator Instructions] As a reminder, this conference is the recorded for replay purposes. I would now like to turn the conference over to Ms. Monique Allaire, Director of Investor Relations. Please proceed.

Monique Allaire

Thank you, Derek, and good morning, everyone. Today, we'll be talking about our second quarter 2012 financial results and key recent developments and achievements. With me are Tuan Ha-Ngoc, our President and Chief Executive Officer; Bill Slichenmyer, our Chief Medical Officer; and David Johnston, our Chief Financial Officer. In addition, joining us for the Q&A session will be Michael Bailey, our Chief Commercial Officer; and Elan Ezickson, our Executive Vice President and Chief Operating Officer.

The press release issued earlier today detailing our results is available on our website at aveooncology.com.

During this call, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements about AVEO's future expectations and plans, clinical development and regulatory timeline, the potential success of our product candidates and financial projections. These statements involve risks and uncertainties, which are described in the Risk Factors section of our most recent Form 10-Q filed with the SEC and available online at www.sec.gov.

While these forward-looking statements represent our views as of today, they should not be relied upon as representing our views in the future. We may update these statements in the future, but we are not taking on an obligation to do so.

With that, let me pass the call over to Tuan.

Tuan Ha-Ngoc

Thank you, Monique, and thank you, all, for joining us this morning. The first half of the year was quite productive for AVEO. While this call closely follows our last one in June during ASCO, Let me ask Bill to review the key results from TIVO-1 with you. Bill?

William J. Slichenmyer

Thanks, Tuan. In the TIVO-1 trial, tivozanib achieved a statistically significant improvement in PFS in the overall patient population, meeting the primary endpoint of the trial. In these patients, tivozanib had a medium PFS of 11.9 months compared to 9.1 month for sorafenib. In those patients, who were treatment naïve, tivozanib demonstrated a statistically significant improvement in PFS with 12.7 months compared to 9.1 for sorafenib. Among pivotal studies in treatment-naive patients to date, tivozanib has demonstrated the longest PFS.

Tivozanib demonstrated a favorable tolerability profile as illustrated by the significantly lower rates of dose interruptions and reductions for those patients taking tivozanib compared with sorafenib, as well as low rates of the 3 most concerning adverse events for patients treated for RCC, fatigue, diarrhea and hand-foot syndrome. We've also reported early data on overall survival, which are not yet mature, and the mediums have not yet been reached. The estimated overall survival rate at one year was 81% among patients randomized to the sorafenib arm and 77% among patients randomized to tivozanib. However, as reported at ASCO, 53% of patients randomized to the sorafenib arm of the trial went on to receive subsequent therapy, nearly all of them received tivozanib after sorafenib. In comparison, only 17% of patients randomized to tivozanib went on to receive a subsequent therapy.

In the course of our discussions with the FDA, the agency has expressed concern regarding this OS trend and has said that it will review the findings at the time of the NDA filing, as well as during the review of the NDA. They're conducting additional analyses to be included in the NDA submission that demonstrate that the OS data from TIVO-1 are consistent with improved clinical outcomes in RCC patients receiving more than one line of therapy, analyses that we believe, will directly address this issue. We are continuing to work towards submitting the NDA by the end of the third quarter. However, there is a chance that the additional OS analyses may cause the submission to slip into the fourth quarter.

We remain confident in our data supporting tivozanib and first-line RCC and believe that tivozanib represents an important new treatment option for patients with kidney cancer. To further establish the potential for tivozanib, we announced the TAURUS study designed to demonstrate patient preference of tivozanib compared to sunitinib as first-line therapy. We also expect to initiate a breast cancer study with tivozanib later this year.

Let me now pass the call back to Tuan.

Tuan Ha-Ngoc

Thanks for that update Bill. Turning to ficlatuzumab. In May, we reported preliminary PFS findings from our exploratory Phase II study, evaluating ficlatuzumab in combination with gefitinib versus gefitinib monotherapy in previously untreated patients with advanced non-small cell lung cancer. The trial did not meet its end point in the overall population. The data is still maturing and more detailed findings on this study has been accepted for our presentation at ESMO in September. We expect to provide additional information regarding our plans in support of further development of ficlatuzumab at that time.

Finally, we initiated Phase I development of AV-203, our internally discovered ErbB3 inhibitory antibody. AV-203 marks AVEO's third product candidate to enter the clinic. We are pleased with our accomplishments thus far this year and are continuing preparations for tivozanib's commercialization.

With that, I'll ask Dave to review our financials, Dave?

David B. Johnston

Thanks, Tuan. Since we issued a press release this morning, outlining our second quarter 2012 financial results, let me just review the highlights, and then I'll speak to our cash balance and our guidance.

Total collaboration revenues for the second quarter were approximately $1.9 million. Research and development expense for the second quarter was $21.5 million. General and administrative expense for the quarter was $9.2 million. And net loss for the second quarter 2012 was $29.5 million or $0.68 per share based on 43.3 million weighted average shares outstanding. AVEO ended the second quarter of 2012 with cash and marketable securities of $215.9 million.

Looking ahead, AVEO's maintaining its financial guidance and continues to expense -- to expect year-end 2012 cash and marketable securities of at least $120 million. Assuming development success across all of our programs, we anticipate a full year 2012 research and development spending of approximately $130 million, net of our cost sharing with Astellas.

Based on our current operating plan, we expect this capital is sufficient to fund our operations into the second half of 2013. And we believe, this puts us in a position to maintain flexibility and functionality [ph] to access additional capital, if we so choose, as we head into the anticipated launch of tivozanib in 2013, the time when we want to ensure we have the proper resources necessary to execute effectively in the marketplace.

So with that, let's open the call for your questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] And our first question is coming from the line of John Sonnier from William Blair.

John S. Sonnier - William Blair & Company L.L.C., Research Division

Maybe talk just a little bit more about the discordance of performance between the 2 arms in TIVO-1. It sounds like the trial design might have influenced that. But talk a little bit about this one-way randomization, and also, whether or not you think the geographical sites where the trial is conducted might have influenced subsequent therapies?

William J. Slichenmyer

Sure. Yes, just to review, the design of the trial was set up, so that patients were randomized one to one to either tivozanib or sorafenib. And then followed for disease progression, PFS as the end point. And for those in the sorafenib arm, there was the opportunity to cross over after radiographic progression, the opportunity to cross over to receive tivozanib as second line therapy. And there was not a similar crossover built into the study for those patients randomized to tivozanib. After they progressed, they then went on to receive standard-of-care therapy. And as you point out, the geographic distribution of enrollment is an important consideration here. Because over 80% of the patients in the trial came from Central and Eastern Europe, where the standard of care does not routinely involve second-line therapy for RCC. And so, what we have found is that, given that the one-way cross over, those patients initially randomized to sorafenib had a high rate of utilization of active second-line therapy, tivozanib. Whereas those randomized to tivozanib, had a much lower rate of second-line therapy. So we believe that, that's the key driver in this discordance as you say, between the overall survival end point and the PFS end point, which PFS of course, being statistically significant in favor of tivozanib. So does that answer your question?

John S. Sonnier - William Blair & Company L.L.C., Research Division

It does. And maybe just to follow up to that, maybe a silver lining to all of this could be that you presumably then learned a fair amount about how tivozanib performs in Nexavar failures. Can you comment on that? And whether or not that, I guess, informs future studies in that setting?

William J. Slichenmyer

Yes. Exactly right. The crossover does provide us data on tivozanib in patients after a progression on sorafenib. And that is data that will be included in our NDA. We've not yet disclosed those publicly but plan to do so at a scientific meeting in the future. And definitely, that's the sort of data that we'll be of interest to us, as we think about other studies in the future.

Operator

Your next question is coming from the line of Adnan Butt from RBC Capital.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

I guess, the first question I have is can you share with us what exactly the FDA asks for? And whether you have that data in-house, or do you need to conduct further studies to get to that data?

William J. Slichenmyer

Right. So in discussing this with the FDA, we -- I guess, maybe I should first say that it's not our intention to get into details about our ongoing dialogue with the agency, but I can share with you our thoughts about some of the additional analyses that we intend to include in the NDA to address this observation that we've got with the overall survival data from the study. And so part of it will just be a comparison of the one year overall survival estimates that we see in our study compared to historical data from the other approved agents. We have a set of analyses that focus on the differences between the 2 arms in the utilization of second line therapy, and that includes breaking it down by geography and also by class of agent. We're going to also provide an update on overall survival by region. And then we've got another set of analyses that highlight the activity of tivozanib in the second line, and some of that relates to conventional end points like PFS, response rates, reduced control rate. In addition, we're looking at the PFS ratio and post-progression overall survival. The key thing to know is that any way we look at these, all of the findings are -- they're indicating to us that the OS results are entirely consistent with the demonstrated activity of tivozanib. And we feel very good. We believe that our current data package should be sufficient to gain approval.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

And have you had similar discussions with the EU regulators, and what's their perspective? Or you haven't done that yet?

William J. Slichenmyer

We have had meetings with the rapporteurs and co-rapporteurs, and overall, I would say that they too are interested in seeing the types of analyses that I just mentioned. And we look forward to including that in the MAA.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

And you figure that you can conduct these analyses with whatever data has been generated for the TIVO-1 study to date? You don't have to wait for the final OS analysis?

William J. Slichenmyer

That is correct.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

And could you just please remind me when the final OS analysis is expected?

William J. Slichenmyer

Yes. So the protocol specified in analysis at a time point, 2 years after the last patient was enrolled. And so we will be conducting a sweep of the data -- of the study sites to gather those data later in this quarter and intend to include that information in our 120-day update to the MDA .

Operator

Your next question is coming from the line of Geoff Meacham from JP Morgan.

Anupam Rama - JP Morgan Chase & Co, Research Division

This is Anupam Rama in for Geoff Meacham. Just to -- kind of a broader question. So based on these additional analyses, what impact, if any, would you expect on the ultimate label for tivozanib here in the U.S.? And then another broad question, just in -- any sort of market implications based on these analyses as well?

William J. Slichenmyer

So maybe I'll start with the label, and then I'll pass it over to Michael to comment on the implications. I think at this point, it's maybe premature to speculate on what the results [ph] might mean to the label. We -- as I mentioned before, we remain confident that these data can be explained very clearly by the activity of tivozanib in the second line. And given this unusual circumstance where patients in the other arm of the trial went on to receive standard of care, which unfortunately for many of the patients meant no second-line therapy. So don't anticipate that there will be anything untoward in our label, because it is so readily explained by these data.

Michael P. Bailey

Thanks, Bill. This is Michael Bailey. And yes, absolutely, overall survival is an important end point. However, the difference between the 2 arms is explainable as Bill has described previously. Importantly, KOLs have not expressed concern about this trend that they've seen in overall survival, and they clearly appreciate the crossover confounds those data. But importantly, the one-year overall survival rates we've seen to date are very consistent with standards such as Sutent and pazopanib.

Operator

Your next question is coming from the line of Marshall Urist from Morgan Stanley.

Marshall Urist - Morgan Stanley, Research Division

So just my first one is just on the FDA process. Obviously, the crossover, the fact that this could happen, given the crossover design was a sort of predictable -- or theoretically predictable outcome of the trial, so -- and something that was presumably discussed with the FDA, on the -- when you were discussing the Phase III trial design. So I'm just trying to get a sense, is it just a different group who's seeing this again? Has something changed? Was the magnitude of the difference sort of more than expected relative to kind of what you initially discussed?

William J. Slichenmyer

Yes, I think it is. This is a different magnitude than had been anticipated when the study kicked off. Traditionally, studies in RCC for the approved agents in the first-line setting have been conducted compared to either placebo or alpha interferon, and then with the crossover. And in those settings, the crossover from an inactive agent to the new agent, then in comparison with the new agent, effectively, one active drug compared to one active drug. In our case, we're comparing 2 sequential active drugs -- or should I say, 2 active drugs given sequentially compared to one active drug. So it's a very unique situation that we're in here, so there really wasn't a lot of precedent to point to. But I think the magnitude of the difference that we're seeing is greater than we might have anticipated, and I think, largely a reflection of the standard of care in the absence of second-line therapy for so many of the patients.

Marshall Urist - Morgan Stanley, Research Division

That's helpful. And then just a question on trial design, is there any risk of kind of ascertainment bias in subsequent therapies, because patients from the Nexavar arm we're obviously rolled over into a protocol, whereas, the TIVO patients weren't? So is the sort of quality of the follow-up data on subsequent therapies comparable between the 2 arms? And is there any risk there?

William J. Slichenmyer

It is comparable. And the reason for that is as soon as we started to recognize this phenomenon, we built in, to the study, some additional steps for a very thorough follow-up at the study sites, built in a new case report form into our data collection and in our database. So It's been a very thorough and carefully monitored data collection.

Marshall Urist - Morgan Stanley, Research Division

Perfect. And then just one more in -- it sounds like though, from what you're saying that this is -- that the difference between these 2 arms when you do, do the next survival analysis should be sort of similar to what we've seen before, is that correct? And then what is your guide, sort of view of the historical one-year survival data for historical agents? And if you could, your guys read of the literature and kind of how that compares to what you've seen? Because due to -- the absolute difference is obviously not that big between the 2 arms.

William J. Slichenmyer

Right. So in terms of continuation of this trend, we do think that although, there may be some minor fluctuations going forward between the 2 arms, we think that this separation of the curves is likely to continue as the data mature, and again, reflecting the activity of tivozanib in the second line. Regarding the comparisons to other agents, we have reviewed published literature for some of the other drugs, and if we compare it to what we've seen in TIVO-1, for example, in the tivozanib arm,-- from our study, we see the one-year overall survival rate at 77%. That's right in line with what we've seen for pazopanib at 75% or Sutent at 78%. But where we see a bigger and more interesting difference is in the sorafenib arm. If we compare to the target study, that was the original pivotal trial for sorafenib that got it approved, one-year overall survival rate there is approximately 64% compared to the 81% we've seen in the TIVO-1 trial. Now we recognize the target study and the TIVO-1 study. These were not identical study populations in that they were separated by a few years that have passed since then. But it seems likely that the biggest difference between those 2 trials is that most of the patients in TIVO-1 had the opportunity to cross over and receive an active TKI, which was not an option, back at the time that the original sorafenib study was run. And so to see that jump from 64% one-year survival to 81%, we can't say that this is definitive proof, but we think that it's very consistent with the activity of tivozanib.

Operator

Your next question is coming from the line of Thomas Wei from Jefferies.

Thomas Wei - Jefferies & Company, Inc., Research Division

So on the overall survival analyses, it sounds like you're doing a lot of extra cuts of the data by geography, by patients who are able to take subsequent therapy. Do you have any of that data right now to be able to share with us? And if not, how and when will we actually see some of the supporting analyses that you're going to submit to address the overall survival concern? Is that ESMO? Is that a press release later this quarter?

William J. Slichenmyer

So yes, we have seen the results from some of these analyses, but not all. And we do intend to submit them to a scientific meeting in the future. We've not made a definitive decision yet about which meeting that would be.

Thomas Wei - Jefferies & Company, Inc., Research Division

So it sounds like it's unlikely to be ESMO?

William J. Slichenmyer

It will not be ESMO.

Thomas Wei - Jefferies & Company, Inc., Research Division

Okay. And also, unlikely for you to press release any of that top line in advance, like you did to top line TIVO-1 data before the actual presentation?

William J. Slichenmyer

Yes, unlikely.

Thomas Wei - Jefferies & Company, Inc., Research Division

Okay. And then it also sounds like you're doing a sweep of the overall survival data at the end of the third quarter, given the amount of time that's lapsed between the preliminary overall survival analyses. Is it fair to say that you're unlikely to hit the median overall survival? When is the actual overall survival data from the full study going to be mature?

William J. Slichenmyer

Yes, so that's a good question. We -- as I mentioned, the protocol prespecified this time point, the 2-year time point, 2 years post-enrollment of the last patient. But if we get into a scenario where we look at those data, and we've not yet reached the medians, I think, it's likely that we will continue to follow the patients even longer, and then report yet another subsequent update to those data at some subsequent scientific meeting. But until we see those data, it's hard to know if we would really need to do that.

Thomas Wei - Jefferies & Company, Inc., Research Division

And then, would you be able to help us understand, based on your discussions with the agency -- let's say that these additional analyses that you're submitting actually are ultimately not sufficient to address their concerns on overall survival. What are the different pathways that you would have going forward to get TIVO approved? Is it waiting for the overall survival data to mature? Are there are other possibilities that maybe the FDA outlined to you as a way to fix this issue?

William J. Slichenmyer

Yes. So first, I want to reaffirm that we believe that the current data package should be sufficient to gain approval. But in the unlikely scenario that we might get into something like you described there. I can't speculate on what the agency might be thinking or what additional actions might be necessary, it would, obviously, be tailored to what, if any, concerns they have.

Thomas Wei - Jefferies & Company, Inc., Research Division

And then just lastly, to clarify, the additional data that you're submitting to address this concern are just other analyses of the TIVO-1 data. It doesn't involve looking at kind of the historical literature for renal cell carcinoma in patients treated with 2 TKIs versus 1, right? It's just TIVO-1 data?

William J. Slichenmyer

Largely, the TIVO-1 data. We will refer to the one-year overall survival rates for the other drugs that are -- have already been published, as I mentioned. And there are some additional points from the literature or recent presentations at scientific meetings that provide additional support for the general concept that second and subsequent therapies in RCC have a beneficial impact on overall survival.

Operator

Your next question is coming from the line of Salveen Richter from Canaccord.

Salveen J. Richter - Canaccord Genuity, Research Division

I just wanted to follow up on what Tom was saying. So when you met with the FDA, and they brought up their concerns, did they kind of point you towards a direction of what studies they wanted to acquire? And when you commented on these analyses that you're doing, were they comfortable with that? Or did they kind of push you into a different direction of maybe doing some additional new analyses or additional studies?

William J. Slichenmyer

Yes. So we're not going to get into the details of our ongoing discussions with the agency at this point. And really, the key thing about our updating today is because of the potential impact on our NDA submission timeline. And so regarding any future study, I think again, I just can't speculate on what the agency might want us to do in the future.

Salveen J. Richter - Canaccord Genuity, Research Division

And is there any precedent for this? I mean, we -- typically, we see a filing and then, we see the FDA comment post-filings to get them to ask you to provide additional data ahead of it. Have you seen anything like this with -- and what's been required from the data set?

William J. Slichenmyer

So I think the key thing to remember is that, this is, as far as we can tell, a fairly unique situation where we do have this opportunity for patients to cross over in one arm, receive active therapy in the other arm, standard of care which, for many of the patients meant no additional therapy. And that there -- at least in RCC, we don't know of any relevant comparison. So I think, we're in something of a uncharted territory here. But as Michael mentioned, one thing that has reassured us is that as we've shown these data to experts in RCC, they feel very comfortable that it can all be explained by the confounding effect of tivozanib as second-line therapy.

Operator

Your next question is from the line of Howard Liang from Leerink.

Howard Liang - Leerink Swann LLC, Research Division

Was there an agreement with the agency on the trial design? And why was there a cross over to begin with as it was a PFS study?

William J. Slichenmyer

So the design was discussed with the agency at the end of Phase II meeting. There was not a SPA though, in place. But the key elements of the design were discussed at the -- in the Phase II meeting, and so we've continued on from there.

Howard Liang - Leerink Swann LLC, Research Division

Why was there a crossover for PFS?

William J. Slichenmyer

Yes. So the crossover was built in largely to make tivozanib available to the patients enrolled in the trial, who by luck of randomization, did not get it at the outset. This had been a standard feature in the other -- almost all of the other RCC pivotal trials. And it was felt -- especially, after discussion with our principal investigator Bob Motzer that it would be appropriate and desirable to do this, to provide an option for the patients who participated in the trial.

Howard Liang - Leerink Swann LLC, Research Division

Okay, and the treatment arm, tivozanib arm patients who were not offered to receive Nexavar?

William J. Slichenmyer

Correct, that was not part of the study.

Howard Liang - Leerink Swann LLC, Research Division

Okay. Have you shared more updated overall survival data with the agency than the one-year data that you've mentioned to us?

William J. Slichenmyer

That's the only data cut that we've shared at this point.

Howard Liang - Leerink Swann LLC, Research Division

Okay. And can you -- I don't remember if there was in the presentation, what was the mortality due to adverse event to arms?

William J. Slichenmyer

So we haven't disclosed the specific numbers around that at this point. I will maybe put in a plug though for a presentation that we'll have at the ESMO meeting, a detailed summary of safety from the TIVO-1 trial. But I can tell you that overall, the bottom line is that there is no increase in fatal adverse events when they compare across the 2 arms.

Operator

Your next question is a follow-up question from the line of John Sonnier with William Blair.

John S. Sonnier - William Blair & Company L.L.C., Research Division

Just a little bit of a shift in focus. I want to talk a little bit about the decision to pursue breast cancer. And it's obviously been a dynamic space with the Doxil shortage and all that's going on with Avastin. I guess, what did you learn from the Avastin experience? Do we understand at a molecular level why patients respond and why patients failed that might've informed your decision to make the investment there?

William J. Slichenmyer

Yes. So we go back to the mechanism of action for Avastin and look at that relative to, and maybe in contrast to the mechanism for tivozanib. And we think that -- and when we look at that, we see a real opportunity for tivozanib in breast cancer. Remember that Avastin is very selective, very specific for one of the isoforms of VEGF, and that's VEGF-A. But it has no effect on other important proangiogenic ligands, including VEGF-C and D and others. Those all act through the VEGF receptors, and tivozanib is a very potent and selective inhibitor of all 3 of the VEGF receptors. So effectively, tivozanib can shut down angiogenesis, whether it comes from VEGF-A, the target of Avastin, or any of these other ligands that act through the VEGF receptors too. So we are focusing our study -- and although, we've not yet disclosed the details of the design, I can tell you that we are going to apply biomarkers in a way that we believe will allow us to exploit this difference and to generate data that will highlight the potential -- not only potential benefit for patients with breast cancer to get tivozanib, but also, a path to differentiate it from Avastin along the way.

John S. Sonnier - William Blair & Company L.L.C., Research Division

So you might select for example, for patients that are overexpressors of DD?

William J. Slichenmyer

That's the kind of conceptual framework that we're using, yes.

John S. Sonnier - William Blair & Company L.L.C., Research Division

What does the population look like? In terms of percentage, when you look at over-expression. Is it -- how much is A versus DD ?

William J. Slichenmyer

So I don't have those statistics at my fingertips, but my impression has been roughly 1/3 of the patients with -- and again, it depends on which subpopulation of breast cancer you're talking about. But to 1/3 have elevated levels of VEGF-A. Tricky though, because VEGF-A is not so easy to measure. There are [indiscernible] literature looking at serum levels, but there have also been conflicting reports that those results may not be accurate due to methodological issues. Others measure intratumoral levels, so it's fairly complicated area. And maybe we can talk about more at the time that we announce our study design.

Operator

At this time, I'm showing no further questions in queue. I would like to turn the call back over to Mr. Tuan Ha-Ngoc for any closing remarks.

Tuan Ha-Ngoc

Thank you, operator. In conclusion, with the accomplishments realized to date, and the substantial work ahead, we believe we are well on our way to realizing our ultimate vision of delivering a meaningful therapy to patients living with cancer, and we look forward to updating you on our continued progress. Thank you for your attention today.

Operator

Ladies and gentlemen, that concludes today's conference. We thank you for your participation, you may now disconnect. Have a great day.

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