All right. Good afternoon, everyone, and welcome to TD Cowen's I&I Summit, Day 2, for this next session. Very excited to have a fireside chat with Travere Therapeutics. My name is Tyler Van Buren, Senior Biotech Analyst at TD Cowen. From Travere, we have Eric Dube, the President and CEO, and Chris Cline, the Chief Financial Officer. Eric and Chris, thank you so much for joining us. Thanks for hosting us. Our pleasure. For those of you in the audience, if you have questions, you can submit them via the web portal, and we'll do our best to get them asked. With that, maybe we'll get into it. We're going to start with FSGS, given the upcoming PDUFA. Obviously, you guys had a great quarter in IgAN. We already had our post-earnings huddle, but really want to focus, or at least start with FSGS here. Specifically, you all presented late-breaking data at ASN this past weekend, demonstrating pretty striking continuity across both DUPLEX and RADAR studies for patients achieving that 0.7 gram per gram UPCR target. Maybe you could elaborate on that, walk through the significance of the findings in the context of PARASOL and also ongoing regulatory interactions, even though you don't comment, but significance would be helpful. Yeah, absolutely. For those of you who are joining, I'll be making some forward-looking statements, so go ahead and go online and look at our materials and our disclosures. Tyler, you're absolutely right. It's an incredibly exciting time within rare kidney space and for the work that we're doing at Travere. Last week at ASN Kidney Week, we presented two analyses as part of late-breaker abstracts that further reinforce both the importance of proteinuria as a predictor of kidney failure risk in FSGS, as well as the consistent benefit that we see of sparsentan in our phase three program. The importance of the additional analyses that we presented were at a relatively new threshold of proteinuria reduction of 0.7 g of protein. That really wasn't a common focus of analyses and certainly was not part of our pre-specified analyses. After PARASOL readout last year and the focus on 0.7, we did analyze, you know, the treatment effect there and saw a consistent, nominally significant benefit of sparsentan versus active control irbesartan in our trial. I think the really interesting aspect of the data showed that for those patients that were able to get below 0.7 in our two-year clinical trial, that also conferred a lower rate of kidney failure within two years, regardless of what treatment you were on. If you get to that level of proteinuria, you show a lower rate of kidney failure. Consistent with PARASOL, that extrapolation in RADAR was also consistent when you look beyond two years, showing that you get about an 85% reduction in the risk of kidney failure longer term for those patients that achieve 0.7. Of course, you know, we see, we know that more patients are likely to get to below 0.7 on sparsentan than irbesartan. There was another late-breaker looking at proteinuria change over time as a continuous variable, where we know that there was a 26% difference in treatment effect between the two arms at two years. When we looked at a matched control of patients from that RADAR data set, that also conferred a reduction in the risk of kidney failure of about 24%, 24% lower risk. That is important to note on top of the reduced risk that you already see from RAS inhibition that we know, and that was further elucidated in that. Really consistent, very encouraging. And then with regard to the engagement with the FDA, you know, we're where we would expect to be with this stage in the review of an SNDA, very consistent with our experience of where we were under the SNDA review of IgAN last year. Nothing out of the ordinary that I'd say, and, you know, we can expect draft label around a month before PDUFA. We're not yet at that point. You know, we're excited to ultimately get to our PDUFA date January 13th. I think that answered all your questions, but if I missed something, please let me know. Yeah, you covered most, if not all of it. Just a couple of quick follow-ups. Were these latest analyses or the data of 0.7 grams per gram part of the SNDA submission or shared subsequently? Is there anything you can say regarding that? Yeah, it's important to point out that the data that we use looking at 0.7, within the two-year period, that's part of the larger data set that was submitted as part of the DUPLEX trial to FDA. What was not, however, was 0.7 as a pre-specified endpoint in our statistical analysis plan, given that that really emerged as part of PARASOL. That would have been a post-hoc analysis, and, you know, you would not have expected that to be part of an SNDA. That said, it's part of the larger data set consistently showing that nominally significant treatment benefit. What was included were all the pre-specified endpoints. Those are the ones that were published in the New England Journal of Medicine article. Fair, fair enough. If you're hitting all those pre-specified endpoints, that bracket 0.7, it'd be crazy to think that you wouldn't hit it. I'm sure they are probably where the presentations this weekend regardless. The anytime 0.7 gram per gram proteinuria responses relative to responses at two years in DUPLEX, just DUPLEX, I've had some questions on that. If there's a significant difference between the anytime proteinuria response analysis versus the responses at two years, as you think about looking at renal protection or comparing it to irbesartan, if you have any color there, that'd be great. Yeah. I think it's important to note again, this was a post-hoc endpoint of 0.7. What I would say is that, you know, it would be exploratory, but in looking at both of those, you see a consistent treatment effect. Obviously, if you're looking at a single point in time versus at any point in time in the trial, you're going to have lower numbers for both arms, but the treatment effect is still consistent, number one. Number two, the predictive value to kidney failure is, and the relationship to expected kidney failure is consistent. What I would also point to, Tyler, is when we looked at a similar analysis of partial remission, which was the interim endpoint at nine months, that was our primary endpoint, as well as a pre-specified endpoint at two years or at any point, you also see a very consistent treatment effect that was also nominally significant. Regardless of how we look at it or when we look at it, you see a consistent superior treatment effect, in our trial. Okay, that's great. Now, regarding the FDA leadership, obviously, we've experienced a fair amount of volatility throughout the year. You know, as we head into the PDUFA, you know, Ted Marsh just resigned recently. Are you seeing, I guess below Ted Marsh, are you seeing reasonable continuity within the cardiorenal division? You know, to what extent is Eliza Thompson's involvement? Is she ultimately the one who's, has the final sign-off with this particular review? We have been very pleased with the level of consistency and the level of engagement that we have had within cardiorenal. I mean, you know, we have been working with the same reviewers for many years. When we look specifically at the last period of time, this year, where there has been more disruption at FDA, we have also seen a high degree of consistency within our review team. Dr. Thompson is now the Director of Cardiorenal. Because this is an SNDA, she should be the final signatory on this PDUFA. I think a lot of the changes that are occurring above should have little bearing. With that said, we were very pleased to see Dr. Pastor named as head of CBER. I think his reputation and, you know, the work that he's done within the oncology space feels very consistent with what we would hope and expect to see within rare disease in CDER. Yep. I was encouraged to say, to hear him say he's not going to be micromanaging his employees. He's going to trust those underneath him to do the right work. Okay. So, anything else notable about your interactions with the agency or the review process that's worth mentioning, before we move on to other topics? I would say there's nothing that we've seen that has been out of the ordinary. This is simply going to have to be a waiting game until we get to January 13th. You know, we feel very good about the level of engagement, the data, and really the precedent that we're setting for others to follow in our footsteps in FSGS. I think having something like PARASOL really is a framework that we believe is the right approach, the rigorous approach, and the evidence-based approach to define these endpoints. We're quite optimistic and confident going into January 13th. Great. And just so people on the line are aware, you all are planning to go quiet roughly a month out or so, right? Somewhere in early December. That's right. After a number of the conferences that we're attending, we'll be going quiet as we go into the final parts of this final review. Makes sense. All right. Now, with respect to the label, do you expect it to be, kind of broadly aligned with the study with, patients aged, eight years or older? And, and will you need to do another study for patients under eight? How are you thinking about the opportunity in that younger population? Curious to hear your thoughts on that. Yeah. We have requested an indication for the treatment of patients eight and over with FSGS. That is a broad indication statement that is largely aligned with what we've studied. With regard to age, we have data both from our DUET Study as well as our DUPLEX Study to support the safety and efficacy. One of the exciting abstracts we presented last week at Kidney Week was the consistency of treatment effect for pediatric patients with FSGS. Really encouraging. I'd say one of the things I walked away from that conference was just the level of excitement and anticipation amongst pediatric nephrologists for a therapy for their pediatric patients. Something we're really proud of because we not only have our DUET and DUPLEX study that included pediatric patients, we also have the EPIC study, which is a basket study across multiple rare kidney diseases in patients that are below eight years of age. That potentially could serve to expand the age range. That would be something we would obviously look to in the future, but a very important set of studies that we've conducted. The other aspect of the indication statement is, you know, whether it's for broad FSGS or whether it is for genetic and primary FSGS, which is what our aim was to study. Secondary FSGS has got a little bit more complications because you've got, you know, typically comorbidities that would drive the disease. With that said, there's a high area of unmet need across all of them, and it's oftentimes difficult for a physician to determine or diagnose the subset of FSGS. That's the rationale that we've requested. If we are limited to primary and secondary, it would be aligned with the addressable population that we've estimated to be about 30,000 patients. If it is the broader label that we've requested, then there would be more patients that potentially could be served. Great. Now, upon a potential approval in January, I think the broader investor audience is still really underappreciating the potential rapidity of this launch, given all the groundwork you've laid in IgAN. So maybe you could just talk about some of the key differences between this launch and what the initial IgAN launch was like, maybe in terms of patient demographics, physician awareness, and, and payer dynamics. Okay. I think the first is if we look at the size of this patient community that is addressable, it's about half that of IgAN. There are fewer patients with FSGS. With that said, however, there is a greater recognition and urgency to treat within FSGS. That's the first difference that I want to point out. When we launched in IgA nephropathy, there was a lot of effort that we did to both support the evidence as well as educate nephrologists that a patient with IgA nephropathy that may have a stable proteinuria, stability does not mean low risk. We had to really educate around the need for more aggressive treatment. In FSGS, nephrologists oftentimes see these patients who are symptomatic and are actively progressing and know that the high rates of proteinuria suggest a prognosis of rapid decline. We do not need to do that. We think that is going to drive a significant uptake. I think there are other two important aspects. The first is when we launched in IgA nephropathy, it was under accelerated approval. We had limited data to talk to that was really only nine months' worth of data and only on proteinuria and safety. We also had a REMS for monthly testing. When we look at FSGS, there will be, you know, not just the broad awareness and use within IgAN, we will have two-year data because the study is already complete. We have asked for full approval. There is not that issue. The REMS has recently been modified. That should extend to FSGS as well. Also, because we already have payer coverage policies in IgAN, it should be much faster to be able to extend that to FSGS. All of those aspects we believe will be in our favor for a much faster uptake. We've been, you know, working with this community, hearing their stories and knowing their journey. We know that they are looking at, at, you know, the approval. We want to move really, really quickly to make sure that we're able to, to reach them. Great. Also, because it is double the dose, we would expect it to be double the price. For adult patients, yes, the target dose was double. So you would expect that dynamic as well. Okay. Perfect. The competitive landscape in FSGS, I mean, historically it's been basically absent, right? Or very limited. But, you know, some say if FILSPARI gets approved, with proteinuria as the primary endpoint and consideration, how might that influence development in the space? As we know, as you guys well know, there are APRIL/BAFF assets that are lowering proteinuria. Do you think that the floodgates will, I mean, obviously they're years behind you guys. It's a very significant first mover advantage. But do you think the floodgates will open and then all the APRILs will start seeing similar proteinuria reductions in FSGS patients and running these trials? How are you guys thinking about this? Yeah, we certainly hope so. I mean, we're excited about the opportunity to be first, and we're really proud of all the work that we've done to pave the way for others. But patients are going to need multiple options, and many of these are going to need to be, you know, combination therapy. There's another company that has a phase three that's ongoing now. We're excited to see how they progress. And we would expect that others will follow through, you know, but in FSGS, because it's more heterogeneous, some of the mechanisms are going to need to be targeted to only specific subsets of patients. While there could be other programs, it's unlikely that those are going to be able to offer the broad approach like FILSPARI will. Great. Now we've got a few minutes left, so let's touch on IgAN. You know, maybe you could start by highlighting some of the takeaways from ASN in IgAN based upon what you all presented for FILSPARI. Yeah. So what I would say is that there is, there's a strong support and enthusiasm for FILSPARI. Of course, there's a lot of focus on the emerging data with APRIL/BAFF and APRIL. They're going to have a really important role to play in IgAN, but they're going to need to be used in combination with nephroprotective foundational therapy. That's where both the data that we presented showing a consistent benefit, whether you use FILSPARI early, you know, regardless of what the biopsy shows in terms of MEST-C score, there's a consistency that we see with FILSPARI, but also the recently published final KDIGO Guidelines also further reinforces the need for combination in order to get patients down to the more rigorous target. We expect there's going to be a continued growth in the use of FILSPARI. That's great. Are you hearing from physicians or payers on an appetite for combination use, with FILSPARI and the B-cell modulators? How are you thinking about that? Yeah, I think there's certainly an anticipation. I think we're going to need to see, you know, the pricing there. We're going to need to see what the data looks like, and also we would expect that they're going to have an indication under accelerated approval that's limited. They're going to be used in the more severe patients. That's where combination is likely going to be more necessary. I think we're going to need to see those dynamics play out. As we look to continue to see a lot of our growth coming from the earlier patients with lower proteinuria, we're very confident in the ability for us to continue to grow, but also to help patients reach those goals, with FILSPARI. Great. And maybe just a couple more before we wrap, but, for the third quarter, you guys once again exceeded expectations, by a meaningful amount. How should we think about, patient start form and revenue growth as we move into Q4 in, in 2026? You should expect, you know, to see similar levels of demand. You know, Peter said that, you know, after full approval, 700 or above is the new base for demand for new patients. That is going to continue to drive meaningful growth in revenue, even though we expect to see some headwinds on gross to net this quarter and in Q1. We do expect to see continued growth because the level of compliance adherence is so high that we have a stable base of continuing patients upon which those PSFs and the new patients will add. Okay. Obviously, Vanraf ia has been launching, some competition for you all, although it doesn't appear to be having too much of an impact yet. It's obviously got a limited indication, so, you know, just curious to get your thoughts on a potential full REMS removal. Do you think that could come before Vanraf ia is converted to a full approval? How are you thinking about the timing on that? Yeah, it's certainly possible. We are continuing to amass more exposure data, which is what is going to be important for FDA to see. This is a conversation, you know, we've had early conversations with the agency around, you know, our plan to request full removal. That is a discussion that we want to have after we get FSGS approval. We should have better visibility into that in the future. Our focus now with FDA is to ultimately become the first therapy approved for FSGS. Great. Chris, maybe I'll throw you one before we wrap, but how are you feeling about cash runway and cash needs moving forward and the ability to potentially start, generating some cash, right, and become profitable? Sure. We ended the third quarter with $255 million in cash in the balance sheet. When you look at it from a pro forma basis with the V4 milestone that we received in October, just out the $300 million. With that, we feel like we're in a very good position, especially with the inflecting revenue growth expected to continue, to be able to use the balance sheet to support all of our current programs. There's no near-term need for capital. We're not yet in a position to guide towards profitability or cash flow generation, given we still have investments to make, right? We still have things that we're going to do on the evidence generation side for FILSPARI, support for an FSGS launch and making sure Peter and his team are successful. And then pegtibatinase, which we haven't spent time on now, but is an exciting program that we have a lot of hope for. And that's going to restart enrollment in, you know, next year. And we'll want to make sure that we're investing that appropriately to get it across the finish line as fast as we can. Wonderful. With that, we'll go ahead and wrap up. Eric and Chris, thank you so much for your time. And thanks to everyone for logging in. Great. Thanks, Tom. Thanks, everybody. Take care.