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Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX)

Q3 2012 Earnings Call

November 1, 2012 4:30 PM ET

Executives

Teri Dahlman – IR

Daniella Beckman – SVP and CFO

Ron Renaud – President and CEO

David Standring – EVP and Chief Scientific Officer

Doug Mayers – EVP and Chief Medical Officer

Analysts

Geoff Meacham – JP Morgan

Katherine Xu – William Blair

Gena Wang – Leerink Swann

Matthew Roden – UBS

David Friedman – Morgan Stanley

Brian Skorney – Brean Capital

Ying Huang – Barclays

Operator

Good day, ladies and gentlemen and welcome to the Idenix Pharmaceuticals Reports Third Quarter 2012 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-answer-session and instructions will follow at that time. (Operator Instructions.) As a reminder, today’s conference is being recorded.

I would now like to introduce our host for this conference call, Ms. Teri Dahlman, you may begin.

Teri Dahlman

Thank you. Good afternoon and welcome to Idenix’s conference call to discuss the company’s financial results for the third quarter and nine months ended 2012. We’ll also provide an update on our HCV development pipeline. With me today are Ron Renaud, President and Chief Executive Officer; Daniella Beckman, Chief Financial Officer; David Standring, Chief Scientific Officer, and Doug Mayers, Chief Medical Officer.

Before we begin, I’ll review our Safe Harbor statement. Today’s discussion contains estimates and other statements that are forward-looking under the Private Securities Litigation Reform Act of 1995. Such estimates and statements are based on current expectations and assumptions that are subject to risks and uncertainties and involve a number of factors that could cause actual results to differ materially. Additional information concerning these factors is contained in our filings with the SEC, which are available on the Investor section of our website. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates or assumptions change. You should not rely on these forward-looking statements as representing our estimates as of any date subsequent to today.

On today’s call, Daniella will review the financial results, and then Ron will provide a pipeline update. We’ll then open the call for Q&A for which David and Doug will also be available.

I’ll now turn the call over to Daniella.

Daniella Beckman

Thank you, Teri. For the third quarter ended September 30, 2012, we reported total revenues of $32.3 million, compared to total revenues of $2.6 million in the third quarter of 2011. We reported a net income of $4.3 million or $0.03 per basic and diluted share for the third quarter ended September 30, 2012, compared to a net loss of $11.7 million or $0.12 per basic and diluted share for the third quarter ended September 30, 2011.

For the nine months ended September 30, 2012, we reported total revenues of $69.3 million compared to total revenues of $7.7 million for the nine months ended September 30, 2011. We reported a net loss of $9.7 million or $0.09 per basic and diluted share for the nine months ended September 30, 2012 compared to a net loss of $33.9 million or $0.39 per basic and diluted share for the nine months ended September 30, 2011.

The change in net loss is mainly due to additional revenue as a result of the recognition of $36.1 million of deferred revenue in the first quarter of 2012 related to the termination of the license agreement with ViiV Healthcare Company, and $27.1 million of additional revenue recognized in the third quarter of 2012 as a result of the restructuring of our collaboration with Novartis Pharma AG in July 2012.

The revenue recognized as a result of the restructured Novartis agreement consists of $19.7 million of deferred revenue recognized as a revenue and $7.4 million of reimbursement revenue recognized as a result of Novartis’s obligation to reimburse Idenix for contractual royalty payments to third parties. The additional revenue was offset by an increase in R&D expenses of $24.1 million, related primarily to IDX184 and IDX719, an increase in professional legal costs of $4.5 million and an $8 million intangible asset impairment charge in the third quarter of 2012, related to the termination agreement with Novartis.

At September 30, 2012, our cash and cash equivalents totaled $251.9 million, and we expect that this will be sufficient to sustain our operations through at least March 31, 2014. This guidance assumes ongoing and future development of IDX184 and IDX19368. It also assumes no milestone payments, license fees, reimbursement for development programs and no financing activities.

I will now, turn the call over to Ron.

Ron Renaud

Thanks a lot, Daniella. As we move toward the end of the year, we’re laying the groundwork across our HCV programs to generate all oral combination data in 2013, internally and/or through collaboration. We currently have three primary areas of focus. First, as you know, in August, 2012, the FDA placed IDX184 and IDX19368 on hold due to serious cardiac-related adverse events, seen with BMS-986094. We are working diligently to assemble all of the data requested by the FDA regarding IDX184. As always, patient safety is our top priority. We have obtained cardiac safety measurements from the ongoing Phase IIb study of IDX184 in combination with pegylated interferon and ribavirin, and it is important to note that we have found no evidence of severe cardiac findings to date.

Additional preclinical and clinical data are being reviewed and further testing is underway. These data, along with an independent expert review and a proposed plan for patient monitoring, will be part of the response package that we anticipate submitting to the FDA by year-end. We expect to receive a response from the FDA early in 2013. A poster from the ongoing IDX184 Phase IIb study that includes many of these cardiac safety findings will be presented at next week’s Annual Meeting for the American Association of the Study of Liver Diseases here in Boston.

Secondly, we are very excited about IDX719, a potentially best in class pan-genotypic NS5A inhibitor. To our knowledge, this is the first NS5A inhibitor to show potent antiviral activity across multiple genotypes in HCV patients and we will be presenting data from the three-day proof of concept study in genotypes 1, 2, 3, and 4 at the upcoming liver meeting. We look forward to moving this program into Phase II clinical development and anticipate that a clinical trial evaluating IDX719 in combination therapy will begin in 2013.

And lastly, as part of our ongoing extensive nucleotide discovery program, we are exploring a diverse spectrum of nucleotides with novel bases, prodrugs, and sugar moieties. In 2013, we will begin to see the results of these robust efforts, with at least one IND to be filed next year. Our focus is on non-guanidine based compounds that generate very high triphosphate levels in vivo. In fact, we’ve begun IND-enabling studies for a urodine-based nucleotide prodrug. We’ve also initiated a dialogue and intend to have discussions with the FDA prior to submitting the IND, which is expected to be filed in 2013.

Our goal remains to develop an all-oral, pan-genotypic regimen that will play a significant role in future HCV treatment. With a strong cash position and the restructured Novartis collaboration, we believe we’ll be able to maximize opportunities for advancing our programs in order to achieve that goal.

With that, I will now open the call for Q&A. Operator, are there any questions?

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Geoff Meacham with JP Morgan.

Geoff Meacham – JP Morgan

A couple of pipeline questions. What inning – if you could characterize it as such – what inning are you guys in to get to an IND for your urodine prodrug. And the second part to that is what sort of differentiation do you think will be made from a regulatory perspective on nucs with any non-G bases? And then, I have one follow up.

Ron Renaud

Okay. Geoff, I’m going to let David Standring talk about where we are in terms of the IND enabling studies and then, I’ll let Doug talk a little bit about where the FDA is in terms of their evaluation of these compounds, not ours specifically, but in general. Go ahead, David.

David Standring

So we expect to file an IND sort of in the second quarter of next year, basically, and we’re moving ahead pretty fast with the IND enabling studies. I mean, clearly, we’re looking, as you know, for a compound that has a high triphosphate level in vivo, but we’ve also been looking very carefully at the safety barrier and we’re looking for a compound that has a very good safety profile. I’ll let Doug speak to the regulatory response.

Doug Mayers

At this point, it’s clear that after the 094 issues occurred in August that the FDA became very – looked very carefully at the two methyl-G compounds, but they have said they’re going to look at nucleoside, nucleotide class as a whole. I think the nucleoside, nucleotides have traditionally had somewhat lower safety margins than some of the other classes and so they’re going to look very carefully at each company’s molecules.

That being said, I think if you have a reasonable safety package and a reasonable expectation of good potency, that they will let you assess them similar to any other molecule, but they’re going to look very carefully at everyone’s package, and they’re going to be less forgiving of a very tight safety margin; that’s for sure.

Geoff Meacham – JP Morgan

Got you, okay. And as opposed to waiting for more clarity from FDA on either one of your nucs, what would be the bias, you think, the partner for a combination study of 719 and something else, as opposed to taking it both into the clinic as two wholly owned assets?

Ron Renaud

Yeah, I mean I think Jeff, for us it’s the same strategy as we even originally had for IDX184. What’s important for 719 is now that we’ve completed the proof of concept study, we need to get – we need to generate 12 weeks of data both to get the antiviral activity information, but to get the safety information. so that when the next compound is ready to come into the clinic, we’re not putting two virtually early stage assets together. We’ve done that before, if you remember, with 184 and 320. So that way, when we do move forward with our next nuc, we’ll at least have a more comprehensive safety package with 719, so that if anything was to show up, we could actually be able to delineate that a lot easier that we were able to in the past.

So really just getting the safety profile, getting that 12 weeks of data much like we wanted to do in the past is still critically important to us.

Geoff Meacham – JP Morgan

Okay. Thanks.

Operator

Our next question comes from Katherine Xu with William Blair.

Katherine Xu – William Blair

I’m just wondering with regards to 719, what kind of combination studies are you thinking about? Is it going to be a combination with some other classes, some other companies, or peg-riba or even just riba alone? And I have a couple of more questions.

Ron Renaud

Yes. Katherine, so good question, and I would tell you we’re considering all of the above, but our primary objective here with 719 is to be in a combination study and an all oral, all direct acting antiviral setting. So that’s our primary objective. Clearly, it’s easily available to us to do a peg-riba study with 719, and that’s not something that hasn’t been done in the past with other NS5As. I’m not sure we are that enthusiastic right now, about doing a 719 with ribavirin study at this point. It’s something we could think about, but I think given the generally low barriers to resistance for NS5As in general, that’s something we’ll let others do and we’ll see what happens.

Katherine Xu – William Blair

Right. And then, my other questions are with regard to the nuc program. Can you just remind us the package that you are submitting to the FDA at the end of the year and the components there? And also, another general question is, you saw BioCryst, their nuc also got – basically the IND was not allowed to go through and that’s adenine-based nucleoside. I’m just wondering is that just urodine based right now is safe in FDA’s mind? For other INDs to pass through in the future, what extra do you think the FDA is looking for in the data in the preclinical and IND package, and is there any hope for any non-urodine based...

Ron Renaud

Yeah. I’ll let David and Doug jump in, but in terms of what we’re going to submit to the FDA, it’s no different than what we outlined back late in the summertime, when we got the, or in September, when we got the letter from the FDA. Clearly, they want a full safety accounting of the ongoing Phase IIb trial, which included a number of looks at cardiac safety. So we’ll pull together the entire safety package; we’re in the process of completing that for all of the patients that were on the Phase IIb study. And then there were some non-clinical tests that they wanted to have as part of the package as well. So, we’re in the process of wrapping that all up. So that’s – nothing has changed in terms of what we’ll submit to the FDA in the form of our response.

I think with regard to what’s happening from a regulatory perspective, it’s hard for me to sit here and say – and again, Doug and David can jump in as well – and say that this is a, purely a guanosine or an adenosine issue or uracil. I think right now they’re looking at the merits of what’s in the IND package. And as Doug said, they see something that gives them concern. I think in the past, you would do your standard battery of test to put in your IND and you could get past certain margin issues if it was reasonable that you could predict that toxicity in the clinical setting.

I think, given what’s happened now with the Bristol-Myers situation and the fact that maybe some of the stuff is very difficult to predict, I think the appetite to let those things go through has probably dropped pretty dramatically. So, that’s why we have initiated, and intend to have a dialogue with the FDA as we go along here with our IND enabling studies for our urodine analog; that’s to make sure that we don’t miss any steps along the way here.

Katherine Xu – William Blair

Thank you.

Operator

Our next question comes from Howard Liang with Leerink Swann.

Gena Wang – Leerink Swann

This is Gena dialing for Howard. I kind of have a few questions after following Katherine’s questions on nuc. So, I’m wondering what kind of additional preclinical study do the FDA ask for the 368?

Ron Renaud

Yeah. they asked for – we haven’t clarified exactly what the additional non-clinical assays were. But there were additional preclinical and non-clinical tests that they were looking for. I would say that they were more – probably more cardiac in nature.

Gena Wang – Leerink Swann

I see. Okay. So, then, you also mentioned there is no severe cardiac findings. Just wondering, are there any cardiac findings at all, like not as severe but any carding findings?

Ron Renaud

Yeah. I’ll let Doug take you through what we’ve seen generally. Keep in mind that these are HCV patients that have been treated with pegylated interferon and ribavirin. They’re middle aged folks. Doug, why don’t you walk through a little bit of what we’ve seen?

Doug Mayers

We’ve done four tests for cardiac safety as primary tests. The first one was we measured ultra-sensitive troponins, which is a marker of cardiac injury, and they were all negative throughout the study. We also measured EKGs in all the patients, independent reads of the EKGs, We’ve had an independent group review all the EKGs; they’ve concluded that there were no EKG findings in the study, specifically no QTc and no conduction abnormalities.

The place where it gets a little more difficult is with the – we measured N-terminal proBNP, which is a hormone that’s excreted by the left ventricle when there is more stretch on it, so it’s sort of an indicator of potential heart failure. And the problem the proBNPs is that they go up with anemia and they go up with peg-riba therapy, and then they come back down after you stop them, after the anemia reverses or the peg-riba therapy stops.

So we did have some elevations of NT-ProBNPs: it went up with treatment with came down when treatment was stopped. So those are – we’re getting some external cardiac consultants to help us look at those a little more closely.

Finally we have echo cardiograms, and I can tell you that the majority of echo cardiograms were completely normal. But as Ron mentioned, we have 65-year-old patients, many of whom have hypertension, diabetes, some of whom have a history of drug use. And so we do have a few patients with various abnormalities – nothing consistent, being a 65-year-old patient population. And because we have no baseline in EKGs, those are a little more challenging to interpret. So at this point, we’re having all of our data reviewed with an external panel in the near future. We’re going to the review of our hepatology consultants, and we’ll then forward the whole package into the FDA.

So at this point, nothing severe, nothing serious. We’ve had no cardiac or renal SAEs, our AE pattern is consistent without a peg-riba with no increase in either dyspnea or fatigue. But I can’t say that everything was completely normal, but we aren’t any of the severe events were seen in the BMS study.

Gena Wang – Leerink Swann

Thank you. My last question is you mentioned a little bit, just wanted to – I wonder if you could provide more color of how different is the new nucleotide from 184 and 368?

Ron Renaud

Yeah. Well, as I mentioned it’s a urodine analog while 184 and 368 are both guanosine analogs and that’s about the extent that we’ll take you through the differences there.

Gena Wang – Leerink Swann

Okay. Thank you.

Ron Renaud

Sure.

Operator

The next question comes from Matthew Roden with UBS.

Matthew Roden – UBS

Thanks for taking the question, guys. This risk mitigation program that you’re going through with 184 is been conducted in collaboration with Bristol. I was just wondering if you can comment on whether or not Bristol has identified the cause of the tox or whether or not there is any read-through from their data to yours incremental to the last update we had. And then I have a second question to follow.

Ron Renaud

At this point the FDA is reviewing both our data and Bristol’s data. I think the fundamental issue is we both have 2-methyl guanosine in the blood and they have significantly higher exposures to 2-methyl guanosine than we do. At this point you’d have to ask BMS for the mechanistic understanding. I don’t – I’m not aware of any significant increase in our mechanistic understanding of what happened in the BMS study.

As far as similarities and differences, we, at this point, have compared our data, but I don’t see any common trends.

Matthew Roden – UBS

Okay. And then in terms of your next generation nuc, you told us it’s urodine. Can you comment on the prodrug technology that you have available to yourselves and whether that’s the same or different than what’s been used with 184 and 386? Just trying to understand what you have at your disposal and whether or not it’s something that could be potentially different?

David Standring

Yeah. I mean, I’m not going to comment on the specific prodrug technology that we’re using in detail, but we’ve looked at over 23 different prodrugs, basically as part of the work we’ve done. As you recall we’ve been working on this for about two years at this point and we’ve looked at more than 1,900 different prodrugs with many different pieces of prodrug technology, and out of that, I think we’ve identified prodrugs and we have a standard set that we use at this point and some variants on that as well.

Prodrugs that give us both very high triphosphate levels, extremely high triphosphate levels in vivo, but also as part of the whole program, we’ve sort of looked at the safety aspect and we believe that with each molecule we push forward, we’re raising the safety bar more. So we feel pretty comfortable at this point we’ll have a good molecule.

As Ron mentioned earlier, we’ve actually reached out to the FDA to find out if there are any hurdles we specifically need to pass and everything, and we’re looking at this very carefully and we will continue to do so in our program.

Matthew Roden – UBS

Okay. And then just lastly on 719, can you guys just kind of walk through where you are in advancing that program? I understand previously you were working through some scale-ups, et cetera. Just wondering if you can walk us through the sort of steps you’re going through there as you approach Phase II program there?

Ron Renaud

Yeah. So, Matt, 719, I mean, remains on the schedule that we’ve always had for it this year. If you remember, our original plan was to combine 719 with 184 by the end of this year. So a few of the things that we needed to get wrapped up obviously was to, we wanted to get more API developed, as well as getting a formulation that we believe we could bring forward through to commercial status in place. So, those are both on track.

From a formulation perspective, we’re now, we’ve whittled down the program to a handful of formulations that look attractive and we need to figure out which one we want to take forward. I think one component of what we’re trying to figure out here on the formulation strategy is not just a formulation for 719 that we could take forward, but one that will be probably most amenable to co-formulation with a nucleotide prodrug. And we’ve also completed the three-month GLP tox studies. So we’re in a very good place with 719 to move forward into combination studies.

Matthew Roden – UBS

Great. Thanks very much.

Ron Renaud

Thanks.

Operator

Our next question comes from David Friedman with Morgan Stanley.

David Friedman – Morgan Stanley

Just more of a broad strategic type question, but given that the pipeline is now focused exclusively on hep C, is there a point where you step back and broaden it to more antiviral type drugs for other diseases, as you had in the past, or maybe if you could just sort of comment on how you’re thinking about that over the next 12 to 24 months?

Ron Renaud

You know Dave, it’s a great question and it’s one that we – it’s been very difficult for us to entertain over the past, given the Novartis relationship. We have a library right now that has thousands of nucleoside and nucleotide compounds in it and we’re looking at these compounds and we know we have hits. In the course of doing our work in HCV, and of course in HPV and HIV, we know we have hits against other viruses and other flaviviruses and other viruses in general. So it’s very, very interesting question.

That being said, having Novartis in the background has always been something that’s probably taken a little bit of the enthusiasm out of moving forward there, because they’ve had first rights on everything in the pipeline. Now that they’re away and they have no rights to anything outside of HCV in the pipeline, that gets to be more interesting.

And I think what’s been interesting about the whole issue is that since we were able to renegotiate the Novartis collaboration, we’ve actually had a number of people call us and ask us about screening the library and our interest in going into non-HCV areas. So it’s something we’re thinking about.

But I will tell you, as far as speaking for myself and the team around the table right now, we want to get HCV right first; this is our first and foremost priority. We’re very excited about the next nuc that’s coming along.719, as a NS5A inhibitor, in our minds still has the potential to be best in class. To my mind, nobody else has generated the kind of data that we’ve generated across the genotypes within NS5A inhibitors. So we still think our ability to be successful in HCV is very high and, as we think about things beyond HCV, we’ll consider what we can do to best leverage the assets in place right now, but HCV is still the primary focus.

David Friedman – Morgan Stanley

Great. Thanks very much.

Ron Renaud

Yeah.

Operator

Our next question comes from Brian Skorney with Brean Capital.

Brian Skorney – Brean Capital

Thanks for taking my questions. You said in your prepared remarks now that the focus is on non-guanosine based nucs, and I’m just wondered in your dialogue with the FDA, are they – is the Agency actually concerned that guanosine is triggering the tox, or is this just more of a reflection of the potential difficulty to get physicians back on board with using a guanosine? I guess what I’m really trying to ask is if you could characterize the Agency’s perception of risk focus. Is it on the base or on the sugar or is it just more of fear of the unknown?

David Standring

I think their fears are based on the 094 clinical safety data. The issue is not guanosine per se, because there are lots of guanosine drugs that are currently in clinical development. I think the issue is around 2-methylguanosine specifically, and the fact that they had significant higher levels than we did and had clinical events and we had lower levels and had adverse events with respect to peg and riba, but could be associated with the cardiac findings.

So I think as we’ve gotten our echo cardiograms back, we haven’t had any of the significant myocardial depression that was seen in the BMS study. We’ve become much more comforted that we don’t have a similar circumstance. But I think, specifically early on in August, it was 2-methylguanosine and drugs that release 2-methylguanosine that were the primary focus. But they’d always said that they were going broaden it out to look at all of the nucs in development and I think you’ve seen they’re doing that.

Brian Skorney – Brean Capital

Got you. And then just a separate question. You mentioned the urodine prodrug is the next nuc in the pipeline. To me, it would seem that the stated position of the company’s IP would provide some reasonable rationale for actually using the sugar-based backbone of Sofosbuvir with a potentially different prodrug, which would seem to de-risk the safety and efficacy of your molecule. I just wonder, am I reading too much into it to think that there would be some initiation of a more similar drug to Sofosbuvir, given that the current IP debate that you’re having with Gilead does provide some justification to say that you have the rights to that backbone?

Ron Renaud

Yeah. It’s a good question, Brian, but unfortunately I can’t give you any insights. We’ll disclose the structure at the right time, but now is not that time. But it’s a good question, nonetheless.

Brian Skorney – Brean Capital

Okay. Thanks, Ron. Fair enough.

Ron Renaud

You bet. Yeah.

Operator

Our next question comes from Ying Huang with Barclays.

Ying Huang – Barclays

My question is if, I know it’s as if, if FDA does require further cardiovascular monitoring for every single patient in any trials going forward for IDX184 and 368, do you guys still plan to move this nuc forward or you’ll just focus on the new urodine based nucs? Thank you.

Ron Renaud

Yeah. Ying, it’s a good question. I think you got to consider a lot of things. Even if there is a fast-forward for 184 you’ve got consider a lot of things, right. What kind of screening would be required, what kind of monitoring would be required. So, just that right there you have to ask yourself, would it be onerous, would it not be onerous, would it be a one-time, one-study type issue or is it something that would have to be done for all two prime methyl-Gs going forward? That’s the first question, and then you if you have that and you have to consider, okay, compared to other clinical trials that are being run out there, how attractive is that and how difficult will that make it to put patients on your studies.

So, these are all the things that we have to consider and you do. You’re exactly right, you’ve got to weigh that against what’s coming up next in the pipeline and how quickly we can combine 719 with another direct-acting antiviral.

So these are probably much less clinical decisions as they are business decisions, in terms of what kind of return on investment you can get if you continue to move forward under those kind of conditions that you laid out there. But we’re not in a position yet to have to make that decision where we’re still getting everything aggregated and we’ll talk to our outside experts and we’ll talk to the FDA and we’ll see what we get to before we have to make that decision. But I think you’re insights are well-founded.

Ying Huang – Barclays

Thank you very much, Ron, for that insight. That’s very helpful. If I may have a follow-up. So, have you guys been able to pinpoint exactly what’s causing the toxicity? I know it’s kind of beating dead horse, but I assume Bristol has shared some data with the Agency, and then probably Agency has shared that with you guys. So, you have some sort of clarity exactly what they’re looking for in terms of echo cardio program here?

Ron Renaud

Yeah, I mean, Ying, unfortunately, it’s a pretty complex issue and if you look at the difference in the compounds, we believe there are more differences than there are similarities. But unfortunately, there is one similarity, and that is that the active metabolite is 2-methylguanosine triphosphate. That’s what the two compounds have primarily in common, and that’s where their concern primarily lies.

I think from a medicinal chemistry perspective, we can start pointing to all the differences and trying to figure out which of those differences mechanistically might be causing the tox, and we do have some belief that that the differences in chemistry are what is driving the tox. But again, that could take years, people could do an entire PhD thesis just trying to figure out the mechanistic tox between these two compounds and I’m not sure that it’s going to be helpful at this point anyway. So we’re going to carry on with what we’ve begun in terms of the clinical safety analysis and the non-clinical safety analysis and we’ll see where that takes us.

Ying Huang – Barclays

Thank you, Ron.

Ron Renaud

sure.

Operator

And I’m not showing any other questions at this time. I’d like to turn the conference back to our host for closing remarks.

Teri Dahlman

Thank you for your time today and your interest in Idenix. Please feel free to call if you have any questions.

Ron Renaud

Thanks everyone.

Operator

Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day.

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