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XenoPort, Inc. (NASDAQ:XNPT)

Q3 2012 Earnings Call

October 24, 2012 5:00 p.m. ET

Executives

Ron Barrett – CEO

Bill Harris – Vice President, Finance and CFO

Vince Angotti – COO

Jackie Cossmon – Investor Relations

Analysts

Michael Yee – RBC Capital Markets

Brian Abrahams – Wells Fargo Securities

Marko Kozul - Leerink Swann

David Amsellem - Piper Jaffray

Juan Sanchez - Ladenburg Thalman

David Friedman – Morgan Stanley

Imran Babar - Cowen & Co.

Operator

Good afternoon. My name is Brian and I will be your conference operator today. At this time, I would like to welcome everyone to the XenoPort Third Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions) Thank you.

Ms. Cossmon. You may begin your conference.

Jackie Cossmon

Thank you, Brian. Good afternoon and thank you for joining us on the call. Here with me today are Ron Barrett, our Chief Executive Officer; Bill Harris, our Vice President of Finance and Chief Financial Officer; and Vince Angotti, our Chief Operating Officer.

Before we begin our discussion of today's news, I would like to note that the information to be discussed on this conference call and webcast, including answers to questions asked during this call will include forward-looking statements that involve risks and uncertainties, including statements relating to the future sales of and promotional activities for gabapentin enacarbil, our current and future clinical development programs and clinical trials, the release of additional clinical trial data and the timing thereof, potential advantages of our product candidates, our dependence on collaborative partners and the therapeutic and commercial potential of our product candidates.

XenoPort can give no assurance with respect to these statements and we assume no obligation to update them. For detailed information about the risks and uncertainties that could cause actual results to differ materially from those implied by or anticipated in these forward-looking statements, please refer to the Risk Factor section of our most recent SEC filings, including our discussion of the inherent risks of clinical trials and regulatory matters. This webcast is a copyright of XenoPort.

At this time, I would like to turn the presentation over to Ron.

Ron Barrett

Thanks Jackie. Thank you all for joining us on the call today. I’d like to begin today’s call with an update on our business progress and then I will turn it over to Bill who will briefly discuss our financial results for the quarter. We’ll then take your questions.

One highlight for the quarter was the results of our first phase 1 trial for XP23829 which I will refer to as 829. Since early October, we’ve had a chance to review the data with experts in the treatment of multiple sclerosis and psoriasis. The feedback has been encouraging.

We continue to believe in the potential of 829 to be better tolerated than other fumaric acid ester based products. One interesting question that has arisen in our discussions with experts is whether the efficacy of FUMADERM and/or BG-12 in psoriasis and/or MS could be improved upon. A better tolerated MMF pro-drug may allow testing of higher MMF levels.

Alternatively an appropriately formulated MMF pro-drug that provided sustained MMF levels above a required threshold for a longer duration of time may provide improved efficacy. We believe that the formulation of 829 that we identified in our phase 1 study could provide the tools to address these questions of potential differentiation in terms of tolerability and efficacy.

We are busy finalizing the plans for the next studies for 829. One study will be a dose escalation multiple dose phase 1 trial in healthy subjects, designed to further establish the safety, tolerability and pharmacokinetics of 829. We plan to take both the formulations of 1 and 2 into the study. We expect it will be -- there will be approximately 75 subjects and if all goes as planned, we would anticipate the results from this trial by mid next year.

We are also planning to conduct a drug metabolism disposition study with radio labelled 829 in healthy subjects. The goal of the study will be to fully characterize and quantitate the metabolites of 829 and how they are eliminated from the body. We hope to be able to demonstrate to regulatory authorities that any metabolites of 829 in humans have been adequately studied in our animal tox studies. This study is planned to commence in the first half of 2013.

Another action we’ve taken to advance the 829 program is to initiate 13-week animal tox studies to support human studies of longer duration. We would expect to have preliminary results of these studies by mid-year next year. We continue to explore the opportunities for developing 829 as potential treatment for relapsing and remitting multiple sclerosis and as a potential treatment for psoriasis.

In addition, in collaboration with The Michael J. Fox Foundation we’re looking at 829 in an experimental pre-clinical model progression in Parkinson’s disease. I will remind you that we have an issued composition of meta patent in the U.S. which extends into at least 2029. In our thinking about how to best develop 829, we’re carefully considering the potential sequencing of indications during the product’s lifecycle.

I’d like to turn now to AP, arbaclofen placarbil. We’re nearing completion of enrollment in the phase 3 efficacy trial in MS patients with spasticity. After being randomized subjects are in the study for 12 weeks. We expect to randomize less subjects in the next few weeks. With the customary time for data checking and statistical analysis, our best estimate is that we will be reporting preliminary top line results in early in Q2 2013. This is somewhat later than the Q1 estimate we last provided and has been driven by the slower enrollment we experienced in July and August which failed to revamp to the extent we thought it might in September.

However as I said, we are close to completing enrollment now. The important thing is that we continue to apply our entry criteria to get the right subjects and rigorously assess the efficacy, safety and tolerability of AP in this trial. We look forward to seeing the results as I said in early Q2 2013.

Finally, next week we expect Astellas to report Q3 sales of Regnite in Japan for restless legs syndrome. Our agreement with Astellas stipulates that a high-teen royalty on Regnite sales is paid to us one quarter in arrears. So we will be reporting a royalty payment beginning next quarter.

We are encouraged by Astellas’ efforts to promote Regnite in Japan. However as we understand from the communication with the Astellas, early sales and a newly approved product in Japan can be influenced by the fact that the regulations require that a patient return to physician’s office every two weeks to obtain a prescription for the product. RLS patients in Japan typically see their physician every two to three months. Thus we believe that initial sales of Regnite may be dampened by this process but the 14-day restriction will be removed next year.

And finally with regard to Regnite, we recently received notification of our patent term extension in Japan. Our composition of meta patent now extends into August 2025 and our crystalline form patent extends until June 2027.

And with that, I will turn it over to Bill.

Bill Harris

Thanks Ron. Thanks to all of you for joining us today on the call. I’ll spend few minutes reviewing our financial results for the third quarter of 2012.

Before discussing our financial results for the quarter, I'll start with a brief update regarding Horizant. Horizant net sales as recorded by GSK were $1.6 million and $4.4 million for the third quarter and nine months ended September 30, 2012, respectively.

Pursuant to the terms of our collaboration agreement with GSK, our share of losses from the Horizant joint P&L statement will be for given up to a maximum of $10 million. As of September 30, our share of the joint P&L losses totaled approximately $9.6 million.

Collaboration revenues for both periods was $0.4 million representing the amortization of revenue recognized from an upfront license payment related to our agreement with Astellas.

Research and development expenses decreased in the third quarter of 2012 to $9.4 million, compared to $11.5 million for the same period in 2011. This decrease was principally due to decreased net costs for XP21279

And XP23829 as well as decreased personnel costs primarily related to decreased head count and decreased non-cash stock based compensation as well as decreased office and facility overhead expenses.

Selling, general and administrative expenses remained relatively constant for the third quarter compared to the same period in 2011.

Net loss for the third quarter of 2012 was $16.8 million, compared to a net loss of $18.8 million for the same period in 2011. Basic and diluted net loss per share were both $0.41 for the third quarter of 2012 versus basic and diluted net loss per share of $0.53 in the same period in 2011.

In terms of cash, we ended the quarter with cash, cash equivalents and short-term investments of $112.9 million.

With that, we will open the call to questions. Operator?

Question-and-Answer Session

Operator

(Operator Instructions)

And now our first question comes from the line of Michael Yee from RBC Capital Markets.

Michael Yee – RBC Capital Markets

Hey Ron, first question is as you may know, BG-12 from Biogen recently had a regulatory delay, at the same time there was some noise out of Abbott regarding bardoxolone which is speculated to be also an Nrf2 related drug. And so I was wondering if you could pontificate about whether or not there is any scientific rationale for Nrf2 and renal tox and have you had any discussion at all or have been in contact with the FDA since that or do you think there is nothing related there?

And the second question is related to these studies that you are starting up. At what point would you actually start dosing, when would we know that? And how much do you think that these studies will cost you?

Ron Barrett

Okay. On the first question, obviously it caught our attention last week on the announcements that occurred, in the same morning and we don’t have any belief – any reason to believe that they are related to one another. I think it’s not surprising given the scope of the BG-12 development program and the historical practice of the FDA to request more time to review the drug.

Specifically with regard to the implications of the toxicity of bardoxolone to MMF, one can never exclude that possibility but I would just point out that bardoxolone is a completely different chemical structure that if you look at some of the studies that have been reported on bardoxolone, I see side effects that are not seeing with BG-12, or FUMADERM. And given the chemical structure, the highly reactive kind of cyano steroid type structure, it’s likely that bardoxolone interacts with more than just Nrf2. And as most of you know, while DMF and MMF are thought to activate Nrf2 and that plays a role in the efficacy, it may not be the sole mechanism by which MMF is working.

So my assessment is with just the publicly available information is that it would be likely that the toxicity for bardoxolone is something related to that particular molecule.

Michael Yee – RBC Capital Markets

So have you been – have you had any discussion directly, not actually to look at any sort of renal toxicity whether at the cellular level or what aim your ongoing studies that they can actually look at that?

Ron Barrett

So you may know more than me. I don’t know that we – Abbott disclosed the source of the toxicity that they saw in their study, or the reason for why they stopped the study. So I don’t know what the cause of the concern was. We typically don’t comment on interactions with the FDA but I think that I wouldn’t be as bullish on starting the next studies if we were on some type of discussion with the FDA about toxicity.

So your second question – so we haven’t commented other than what I said earlier is that the multiple ascending dose study, we’d hope to have the results of that by mid-year. The real level study we’re still working on some of the logistics but we hope to start that early next year and it’s a relatively short study. So again we would expect the results by mid-next year.

We don’t break out the costs of particular studies but 75 patient healthy subject study is not a huge expense and certainly the expense of dose studies as well as other studies we’re contemplating within next year would fit within our financial guidance of our current cash and it’s padded revenue into the fourth quarter – sorry first quarter of ’14. Hope that helps.

Operator

And now our next question comes from the line of Brian Abrahams from Wells Fargo Securities.

Brian Abrahams – Wells Fargo Securities

You talked at the beginning of the call little bit about feedback from experts suggesting that it might be interesting to explore whether you can improve upon BG-12’s efficacy. So I wanted to ask a little bit about the dose exposure relationships and what you’ve seen thus far in animal models. Can you remind us the degree of linearity in the MMF dose exposure relationship that you have seen? I am just wondering to the degree of increasing MMF exposures you think you can get to with higher doses. Is there any theoretical limits, how confident are you that you can get to exposures that are at least on par in terms of the AUCs with equivalent doses or with the studied doses of BG-12 and how confident are you that you could even get beyond that given what you’ve seen so far?

Ron Barrett

So I said the animal data is limited, that we have done. We have done some work in the EAE model as well as in psoriasis models in. While I would say – the trends we’re in the right direction, I am not sure that we’ve carefully established a dose response and were established what the maximum efficacy that can be achieved in those models. Those studies that we have done were primarily intended to demonstrate that we had equivalent efficacy to DMF at equivalent lower doses to establish that. It’s MMF that is the active metabolites.

I think the question of can you improve upon FUMADERM and BG-12 in MS and/or psoriasis is an interesting one, and we’ve gone through all of the FUMADERM data and tried to understand is there a dose response relationship? Is there – why was it that they stopped that 240 milligrams twice – three times a day. In the case of the MS studies on BG-12, it was a phase 2 study that looked at once a day 120, three times a 120 and three times a day 240 DMF, but it was only the highest dose that was affected. And I think that’s what led to the selection of the doses for the phase 3 studies. Some have said, well two times a day worked, it did confirm and define, three times a day didn’t provide that much benefit, maybe that shows that the efficacy has been maxed out. And I would just say a 50% demands in total dose is not that big a change in dose particularly when you consider that just the average weight of subjects in studies is going to vary more than 50% and so on a milligram per kilogram basis there is a high overlap of exposures there that are likely occur in those studies.

I think the really interesting question, as I tried to refer to in my comments is was the top dose of BG-12 chosen because if you went any higher which is going to be intolerable and we have a better tolerated dose – better tolerated drug, would we be able to push up to total exposures to beyond that was achieved with BG-12. And the other aspect of this, and I don’t think we’ll have any dose (inaudible) the answer is, is it Cmax driven or is it timed above a certain threshold and with the formulation two that we have for 829, I think it would allow us to answer a question, if we have a longer duration of time over a certain threshold level that’s required for activation of the genes that are involved in the efficacy of these molecules, would that mean to more efficacy? We simply don’t know. But it is an intriguing question and obviously experts in the field, particularly in MS, would Tysabri be in the kind of the holy grail in terms of efficacy? Everybody wants to try to get to that level of efficacy with oral compound or alternative. The data on the oral compounds at this point suggests that you’re not at that same level of efficacy and everybody wants to know. If you push the MMF exposure, would it be tolerated and would that lead to higher efficacy? And so we have the tools to do that.

Brian Abrahams – Wells Fargo Securities

And then just a quick follow up, does the push-out in timelines for potential BG-12 approval affect your plans? I know you are considering running comparative studies at some point. How do you think about that strategy?

Ron Barrett

Yeah, we won’t be ready to run those studies if until their approval day. I think one question is the approval, the second is when is BG-12 available after approval. And it could become an issue down the line but my anticipation is that Biogen is probably gearing up to launch it shortly after approval and if they do so after this three month extension, then it would be available for us to do comparative studies.

Operator

And now our next question comes from the line of Marko Kozul from Leerink Swann.

Marko Kozul - Leerink Swann

I wanted to ask you one point in the development path of 829. And can you say making the decision to go ahead at alone rather than generating broad database of differentiation and it might be more conducive through a partnership with someone interested in the 505(b)(2) process?

Ron Barrett

Yeah, it’s a great question. I don’t have a line in the sand here. I have said before that one of the important things that happened in the last quarter was the financing which allowed us to continue to invest in this to derive important new data and to understand the product profile and then either on our own or with a partner to figure out which indication is the first step we want to go to. And so I can’t give you an answer right now as to what data would drive the decision in terms of what indication to go to. Obviously the requirement for differentiation of BG-12 really hinges on your estimate of how long it will take us to develop this and when exclusivity of BG-12 might be lost. Psoriasis issues are quite different. And so we are doing all the work both in terms of the development and the studies and also we went to work with regard to analysing the dynamics of these markets. And we’re just not prepared at this point to say which direction we want to go.

Marko Kozul - Leerink Swann

Maybe just a quick one on baclofen, I was wondering what kind of market research you have or what does it suggest about potential price elasticity with this drug? Thanks.

Ron Barrett

Yeah, I’ll let Vince take that call. We have done quite a lot of market research, and maybe Vincent, you can comment on kind of the consistency of market research.

Vince Angotti

So as it relates to that market, I will just touch briefly on a couple of things and then talk to you directly about the pricing that you mentioned. Just as a reminder, the market as of the end of September of this year, between tizanidine and baclofen, we’re looking at a total of about 10.6 million prescriptions on an annual run rate. When you factor that perspective, that’s you’re looking in the neighborhood of about 4.1 million prescriptions mow.

When we try to qualify that on daily pricing based on a potential label, we are looking at a window somewhere in the neighborhood of $7.50 per day to $10 a day – I am sorry, the $15 a day depending on the dose you would take. The most recent price point in the market when we look at sanity, that’s the most common we branded utilizing it 4 mix, I think it was -- PID was between $8 and $9 a day, and we feel like we’ll potentially have a profile that will compete very favorably with that. So again that’s $7.50 to $15 a day, likely towards the middle or higher end of that particular range.

Ron Barrett

And we anticipate that patients will likely have different doses, they will likely be titrated. And so we’re going to launch with the 15 milligram tablets which would allow for flexibility, 15 twice a day, 30 twice a day for the patients who require it, 45 twice a day. So that explains why we have a range depending on what the daily dose is.

Operator

And our next question comes from the line of David Amsellem from Piper Jaffray.

David Amsellem - Piper Jaffray

Just another question on AP, any new thoughts on commercialization, in other words, is the plan still to take it forward and build a specialty sales around it, is there something that you are looking at possibly partnering? What’s your latest thinking there, at least domestically? Thanks.

Ron Barrett

Yeah, I will just make the general comment, in the U.S. our thinking has not changed, and Vince can speak to why we think it’s a market that we could address ourselves and then we haven’t talked about it today but as you know we are in litigation with GSK. And one possible conclusion from that discussion is that Horizant, we would either be co-promoting Horizant which is good, or the rights would be returned to us. But taken AP alone, we do think it’s something that we would want to commercialize on our own.

Vince Angotti

And when you think about the potential infrastructure required to cover the market, we would look primarily at the neurology and PM&R physicians and combined, we would likely target that the top eight deciles which would be represented by about 9400 physicians in total. The required size of the sales team to penetrate at audience like that would be anywhere from maybe 50 to 75 people in total. So we feel like we could support that infrastructure on our own with the potential of that product and the limited size of the audience that typically prescribe to price elasticity.

David Amsellem - Piper Jaffray

And then another question, just one on Horizant, let’s assume that you do get rights back to the profits, is that a product where you feel you can leverage your infrastructure that does go through support AP or it seems that because it’s a fairly wide label in PHN that you would need -- ultimately still need a partner for that product. How are you thinking about that?

Ron Barrett

Well, as I just mentioned, I think there is – if we stay in the arrangement as it is we do have a co-promote right which would somewhat offset the costs of our own sales force through the detail fee. If we were to return, we are certainly thinking about that as a possibility but it really is premature to talk about how we would commercialize Horizant if they were to return to us.

Vince Angotti

The one thing I will mention is that the predominant number of scripts, 60% plus of the prescriptions of Horizant today are coming from specialty with the bulk of that coming from the neurology audience. So we anticipate a fairly high overlap at least from the neurology segment that’s currently prescribing Horizant, they are open to prescribing Horizant along with AP and moving forward.

Operator

Our next question comes from the line of Juan Sanchez from Ladenburg.

Juan Sanchez - Ladenburg Thalman

I have only one big question on AP and toxicity. And given the commercial challenges of baclofen and also sustained release from lesser compounds where there is generics out there. What’s different in this market? I mean what’s the level of confidence with this time around this could be a successful endeavour? And what’s different in this market versus the other markets and how much work have you done on that?

And then second question is just please update on the number of outstanding options and warrants related numbers?

Ron Barrett

I will talk about the first question. So the first thing I would say is that I would not use Horizant to indicate how AP will do. I can’t go into details about how we believe Horizant has not done as well as we had originally intended. But they are quite different markets. The AP is really focused in the specialty area. I would not characterize AP as just a sustained release formulation of baclofen. We have been doing a fair amount of work to really build the case around the benefit of the single isomer versus the receiving mixture with certainly some really interesting data, the most recent of which is a knocked-out mice, GABA-B receptor knockout mice in which baclofen still retains its toxic effects as well as its hypersomnia effects with no GABA-B receptor present in these mice, suggesting that there is a non-GABA B target that may be responsible for these and we don’t know whether the S-isomer may be hitting that target in addition to the R-isomer.

And I think there is a case to be made that the R-isomer may be providing for this better tolerability that we’ve observed consistently in the studies that we have done to date. I think the other thing that’s clear in the specificity area is the level of dissatisfaction with the currents of oral drugs and the lack of good options for patients who failed for whatever reason that first line baclofen are presented, and maybe Vince, you want to comment for that.

Vince Angotti

Yeah, thinking of the factors it’s a relatively well educated market and the physicians are well called tolerating the current options as it relates to first line therapy. When you consider on the oral stuff based reagents in general and specifically look at baclofen, it’s failing as a first line treatment according to survey results, over 40% of the time. So it’s requiring either discontinuation or often additional therapy moving forward. And the reason which is very well known is this combination of a lack of efficacy coupled with the side effect profile they are not reaching the levels they need to because it’s intolerable, specifically because of typically the semblance that’s associated with it.

So it’s a well known issue without real good alternatives other than combination therapy with benzodiazepines removing the more expensive therapies that require procedures like the botulinum toxins et cetera. So we feel like there is a real gap I believe in the next agents where they would typically use it. As it relates to and you compare that to the RLS market, it’s a relatively youthful market as in maturation. As it relates to commercialization again I will reiterate the fact it was only promoting for 3 years, the only drugs available is dopamine agonist. And since that time, even more recently guidelines have been published that project that there might be better alternatives too moving forward for some case of patient populations.

Ron Barrett

But I would say the recognition of the limitation is dopamine agonist compared to the recognition of the limitations of baclofen and tizanidine is quite different. And therefore we do think that there will be a very receptive audience for our product of second line therapy and over time we hope that the profile would lead to feed first line use. Even in second line we think it’s a very attractive market given the fact that the failure rate is so high, and the alternatives for failure are so expensive and invasive.

Juan Sanchez - Ladenburg Thalman

But do you think the payers of insurance companies talk to this or would it be more the Netherlands, because the specialty product or you think you can face any challenges or any more --

Vince Angotti

Well, currently there is a wide range of pricing this particular in the managed market segment. So if you consider the first line of toxins, or even if you consider symptomatic agents used in MS like impaired, you’re looking at products that are 30 to 40 plus dollars a day. We certainly, as mentioned, we wouldn’t anticipate a pricing window there. And the managed markets companies based on our research to date are well aware of the limitations of the current oral agents and the concerns of moving them to the potential combination therapies and more expensive agents from there. So we think there is a window of opportunities with the managed markets for this patient population in particular.

Ron Barrett

Yeah I think spinal cord injury and MS patients, if there is a good pharmacoeconomic argument in our data it’s found I think payers will put it on formulary. I think the question of whether we will get unrestricted access in all programs, initially I wouldn’t anticipate we would get that, we would probably get stuff out of it in many programs over time, maybe two phase 4 studies and experience with the drug we would be able to move up. But as I said, we are not unhappy with second line therapy because the dissatisfaction rate is high, and pricing is good. And innovations are not having satisfaction in first line therapy anyhow. So you will satisfy that step at it rather quickly.

Bill Harris

So in terms of options and RSUs outstanding it’s about 6.4 million and another kind of 280,000 of warrants.

Operator

And our next question comes from the line of David Friedman from Morgan Stanley.

David Friedman – Morgan Stanley

Just two quick ones, one, just on the accounting side, even when the losses of the current Horizant setup crossed $10 million. Does that get recognized within the year or does that end up getting deferred until a time when the partnership may end up being profitable? And the other question is just as you are thinking about trying to potentially differentiate 829 on an efficacy basis, can you maybe just discuss how that would impact a potential 505(b)(2) pathway?

Bill Harris

Hi David, it’s Bill. Let me take your first question. Once our share of losses exceeds $10 million, we are recognizing our share of the loss. On a real-time basis it will be recognized in the revenue from unconsolidated joint operating activities line item as the negative revenue item and it will be accrued liability in the balance sheet. We will continue to accrue our share of losses until the P&L reaches profitability after which we will repay the accrued amount ratably over 16 quarters.

Ron Barrett

And your question about 505(b)(2), I should just remind you that while we think the legal basis for 505(b)(2) is sound, we have not had discussion in depth with the FDA regarding this as a possibility. And 505(b)(2) applications run the gamut from bio-equivalence based applications that are approved to full NDAs. I will remind you in the case of gabapentin enacarbil in the U.S. we originally submitted as a full B1 NDA and converted into a B2 in order of reference in historical gabapentin data.

And so I don’t think whether it’s B1 or B2 really kind of dictates, if you wanted to show differentiation and if you wanted to keep that in your label, I would think that you would have to have two studies to support the superiority claim. Obviously that’s something we would have to discuss with the FDA, and I think if we do see in early studies the opportunity to differentiate on the basis of efficacy I would think that we would want to invest and be able to promote that advantage of the product.

Operator

(Operator Instructions) Our next question comes from the line of Imran Babar from Cowen.

Imran Babar - Cowen & Co.

Hey guys, thanks for taking my question. And actually couple of my questions are already asked. But I want to ask – I am curious if you have any update on 2009 infectious disease and the pivotal study, is there anything that I might have missed on that?

Ron Barrett

No, as I indicated our intention is to file a protocol with the FDA and initiate the dialogue with regard to getting an SPA. We had very clear feedback in our end of phase 2 meeting as to what they are looking for but we want to kind of formalize that in an SPA. So that process of finalizing the protocol and submitting that and getting the process started is ongoing.

Operator

And we have no further questions at this time.

Ron Barrett

Okay. Thank you again for joining us on the call today. And we look forward to updating you on our progress and as always if you have questions, please call us at 408-616-7220. Thanks and have a good afternoon.

Operator

This concludes today’s conference call. You may now disconnect.

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