All right. Okay, I think we're ready to get started here. Thanks, everyone, for joining us for the second annual Healthcare Innovation Conference here at Guggenheim and our second day. Next up in this room, we have the Travere Therapeutics team. Thanks so much for giving us the time and joining us again this year. I'm Vamil Diva n. For those who do not know me, I'm one of the biopharma analysts here at Guggenheim. Next to me are [Suneja] and [Chattopadhyay] from the team. From the Travere side, we have Eric Dube, the President and CEO, and Chris Cline, the CFO. Travere is a name we've liked for some time. Technically, our best idea in our coverage right now. A lot going on on the FSGS side, IgAN's side, and otherwise. Maybe, Chris, I'll just say any sort of opening comments you have. It's been a busy time for you guys with earnings and then the big ASN meeting last week. I'll just open it up to you if you have any opening comments, and then we'll jump right into the questions. Okay. Thank you both for hosting us. It certainly is a very exciting time. Throughout our discussion, we'll be sharing some forward-looking statements so you can refer to our online disclosures. It's an incredibly exciting time, not just for Travere, but for the rare kidney space. We've been executing for a number of years on bringing therapies to both the IgA nephropathy community as well as the FSGS community. Our launch in IgA nephropathy is going incredibly well with some very strong momentum that we've seen throughout this year that I'm sure we'll get into. We have a PDUFA date for our FSGS SNDA with the FDA on January 13. Everything is on track with our expectations for that review. We also have made very good progress with our enzyme replacement therapy program, pegtibatinase in classical homocystinuria, where we expect to initiate enrollment in our phase three next year. We'll provide further information on the timing here in the near future. Okay. Great. Let's start with FSGS. I think we were just talking before the session here, ASN, I think it was certainly a palpable theme. I feel like IgAN has been the dominant theme for the last few years with FSGS coming. Just any feedback from your conversation with ASN around FSGS, then obviously a lot of interest from investors on how things are progressing with the FDA, especially with some of the sort of senior leadership changes at FDA. Maybe both the scientific community interest, feedback on FSGS, and then the regulatory side. Sure. I would say that there has been one constant that I've seen having joined Travere seven years ago, and we've been on a journey to help address the unmet needs in FSGS for well over that time. The one thing that remains true is that this is an area of the highest unmet need within nephrology. When we survey nephrologists, they say that their patients with FSGS are highly symptomatic, oftentimes have explosive nephrotic-range proteinuria, and are rapidly progressing to kidney failure. The unmet need is high, given that there are no approved medications for this condition. You're right. The eagerness and the enthusiasm for the first potential approval in this condition is palpable, not just within the nephrology community, but also within the FSGS patient community. They've seen what has happened in IgA nephropathy, where we're able to help get patients to a level of proteinuria control within this disease. The fact that there are not just one, but now four approved therapies, with several coming in IgA nephropathy, has really given a number of tools and a tremendous sense of hope to this community and nephrologists that have not had therapies for a number of years. They are hoping to do the same thing in FSGS, for that to spur additional investment and research on the heels of what we expect to be an approval for our therapy. There is certainly a lot of excitement for other rare kidney conditions as well. I would say this congress, which when I joined was very much around how do you innovate dialysis once patients have already hit kidney failure, to now how can we reach patients early enough in their condition that they may never have to face that. Okay. And just any sort of anything you're sharing on the FDA? Right. Yes, of course. Or what you expect between now and January. Yeah. I mean, I would say certainly we see the same headlines, as I'm sure you all do, where there are a lot of changes that are going on within the agency. What I can say in terms of the review team that we engage with is that there has been a steady group of reviewers, both clinical and statistical reviewers. The feedback that they've provided is both consistent over time in terms of what they want to see from a file in FSGS, but also it's consistent with the experience that we've had during the SNDA review that we recently received full approval for IgA nephropathy last September. I think we've been very reassured by the level of consistency. We know, while I do not want to speak for the agency, we know that this is also a focus of theirs to really spur innovation within the rare kidney space, given the lack of innovation that we have seen for decades. Okay. Great. And then do not want to get the cart before the horse, but just thinking about the commercial opportunity, assuming approval, how should we think about, I know you have been increasing your sales force, it is a lot of overlap with some different bodies here, how should we think about what you need to do to be ready to launch? And then how should we think about the uptake relative to maybe what we have seen in the IgAN space with Filspari and others? Sure. If we look at a comparison between IgA nephropathy, which for us, there's about 70,000 patients that are addressable, and compare that to FSGS, where it's about 30,000 patients that are addressable, you see that there's a magnitude of half the patients in FSGS. The unmet need and the progression rate is much faster in FSGS. The urgency to treat is much faster, whereas with IgA nephropathy, there was a lot of initiative that we had to do to really make sure the physicians know that just because someone has stable, high levels of proteinuria does not mean that they're at low risk. We don't need to do that with FSGS. We do expect that there's going to be a more rapid uptake, particularly because there are no other approved therapies for FSGS. When we look at who treats these patients, there is a high degree of overlap in the nephrology treaters who treat IgA nephropathy and those that treat FSGS. Most of these patients are being treated within the community setting. We have a field force that already is working with the large majority of them. There would be an incremental addition to our field force to prepare for FSGS. We have actually done that in anticipation of approval in January. These patients have been waiting far too long. We want to make sure that we are ready to raise awareness and educate them on day one after approval. There has been some incremental addition. The only change that I would say that should be pointed out is in FSGS, we would expect to have an approval for pediatric patients as well. We would increase and add to be able to reach pediatric nephrologists as well. Smaller proportion, obviously, of treaters, but that is an incremental addition that we had. We will make sure that we are ready again on day one. Okay. Maybe a couple of last ones on the FSGS side. One is the approval itself. We've been getting some questions from investors how to think about primary versus genetic versus secondary. If you can just sort of clarify what you're filing for, what you expect to get approval for, and how you think payers would respond to, obviously, there's different populations here. Sure. Yeah. We've certainly modeled a couple of different aspects of this. First, let me caveat by saying this idea of what the etiology is of FSGS is a hot-button controversy within nephrology. There is a real shift to say and challenge what is the value of identifying someone as secondary versus primary versus, for many patients, FSGS of unknown causes. There is a growing interest among experts to say we should actually just characterize these as podocytopathies because while there is variance in terms of the etiology of the disease, the common injury pathway of podocyte loss is what causes that progressive proteinuria and the eventual decline into kidney failure. When we think about how patients, the majority of patients are diagnosed, it's on biopsy. There are a small number of patients that are diagnosed based on a genetic test. Everyone else, it's based on biopsy. That biopsy cannot determine what the cause is. It can only say that this is FSGS. It is a real challenge for nephrologists to determine what the cause and the type is. It is actually more empirical based on or clinical based on do they respond to steroids or not. It is really an imperfect science. We tried to study only primary and genetic in our phase two and phase three. With that said, and all the challenges, we know that there are some patients of unknown cause and secondary in our trials. We have requested a broad label, particularly because the unmet need is high, and it is difficult to identify who these patients are. There is also not ICD-10 codes to diagnose the differential etiologies of FSGS or different types of FSGS. We have requested a broad label. With that said, it may be that we're limited to the inclusion criteria of primary and genetic. If that is the case, that 30,000 addressable is tied to primary and genetic. If we do have a broad label and physicians are able to prescribe for secondary, it means that there would be a larger number of patients that are addressable. From a payer standpoint, because of the challenges around not knowing this based on biopsy and not having specific diagnostic codes, it will be a challenge for the payers to say, "I'm going to exclude them based on the type of FSGS." We're not hearing that in some of the research that we're doing for payers because these patients are progressive. They don't have other options. They are extraordinarily costly to the system and to those health plans because not only do they have a rapid rate of kidney failure, the number of surgeries these patients have, the likelihood that they're going to have transplant, and oftentimes the failure rate of transplant is over 50%, typically right after the transplant, sometimes within days. It is incredibly costly and a high unmet need. Okay. Last one on this topic is just around the competitive landscapes. Obviously, with the Parasol initiative and then the credit to what you've been able to do on FSGS, a lot of companies now looking at it. How do you see the space evolving? Yeah. We're really hopeful that others will follow our lead if we are approved. I think we've paved the way. These patients, we're really excited about the clinical data and the opportunity for Filspari for these patients. We know that it's not curative. These patients are going to need other options. We're really hopeful that other companies will move into this space. We actually don't see anyone in this space that could come as direct competitors. They're really complementary medicines that could help these patients. Many of them targeted to specific etiologies or types of FSGS, nothing really beyond one other therapy that is in phase three from Dimerix and Amicus that is broad. Even that mechanism of action, as we understand it, could be complementary. We've got years before anything else comes behind us. Great. Let me turn to [Suneja] then to talk on the I gAN's side. Yeah. Coming back to IgAN, just a few years ago, you were the second therapy approved for IgA nephropathy, the first non-steroid drug in IgA nephropathy. Now there are four approved treatments. Maybe you could comment a little on how the market has changed during this time, how Filspari's role has changed, and the perception of Filspari among nephrologists. Yeah. I mean, I think first I'll say it's incredibly exciting to see the number of treatment options. There is a real view that for a patient with IgA nephropathy, whereas typically they would be told you have to prepare for kidney failure at some point in your adult life, given that many of these patients are young adults, to now potentially a future where they may never have to face kidney failure. It's really exciting to see that physicians have treatment options and that the new treatment guidelines, the KDIGO Guidelines, recommend simultaneous combination if a patient has proteinuria and a diagnosis of IgA nephropathy. I think there's a real shift to be more aggressive in treating this condition. We're starting to see that in the prescribing patterns. We've been very pleased with the uptake and really the broad use of Filspari aligned with our label and with the guidelines. We would expect that that's going to continue even with other treatment options coming because the guidelines clearly say you've got to optimize the nephroprotection. That's the role that we play in a targeted therapy that addresses the kidney specifically, and then also in combination with immune targeted therapies, B-cell complement and steroids. There is a lot of discussion around additional options, competitors. We do not see it that way. We see very, very clear roles for Filspari and a clear role for these immune targeted therapies as well. When we look at the competitive dynamics in 2025 or commercial dynamics in 2025 versus 2024, I know historically third quarter is sometimes a little lower than second quarter because of some seasonality. You have certain gross-to-net dynamics throughout the year. What are you seeing in 2025 that is maybe similar or different from 2024? Yeah. Maybe I'll talk in terms of demand. Chris, you can talk about gross-to-net. We do expect that we should continue to reach new patients to a similar degree that we have thus far, over 700 new patients each quarter. The ability for us to convert that to patients that are on therapy and are reimbursed continues to improve. We are in a really great spot in terms of that conversion. We expect incremental improvements over time as payer plans continue to reflect the broad label that we now have under full approval. We do expect that to continue while there is anticipation that there is going to be greater dynamism with new entrants, potentially the first B-cell therapy later this quarter. Again, that plays a very different role than what we have. The demand is still there. The only competitor that we really see for Filspari is the generic use of RAS inhibition. We have the only head-to-head trial within this space showing clear superiority that is now reflected in the KDIGO guidelines. In fact, our phase three program is the largest trial ever done on RAS inhibition within this disease. There is a recognition of the quality of data that we have. I think that is going to continue to drive further growth and use of Filspari, particularly early in disease. On gross-to-net, last year we had seen mid to high teens. That was relatively consistent with what we have seen in our commercial portfolio. Overall, you have an increase in the gross-to-net discount in the first quarter, and then you see that come back a little bit throughout the balance of the year. This year is a little bit different. This is the first year in which we have Filspari that actually qualifies for Part D redesign. We have guided to for the year being around 20% in our gross-to-net discounts. We saw a similar effect in the first quarter where that was the widest quarter that we have seen. The second quarter and the third quarter were a bit lower. We did comment on our earnings call that we had about a $2 million tailwind in 3Q related to gross-to-nets. 4Q, we do expect it to come back up and be a little bit higher. That 20% is roughly where we're expecting to land for the year. You also had some label updates with the REMS requirement being made less frequent. You also generated some new data, including data in newly diagnosed patients in IgAN. Maybe you could talk just a little about how that's resonating with nephrologists. Yeah. First, with regard to the REMS, there were two really important changes that occurred in August. The first is the removal of the embryo fetal toxicity REMS consistent with the endothelin class. FDA made that change. The second was to reduce the frequency of liver testing as part of our REMS from monthly in the first year to now quarterly. That was really well received by nephrologists, making it just that much easier and very aligned with how the average patient is being seen and tested for their kidney function. I think we're really pleased with how that's being received. With regard to the data, the way that I'll describe our strategy for evidence generation is to really understand the breadth of use for Filspari. If we think about Filspari aligned to the guidelines saying should be used first line and for a patient's life as they have proteinuria, that's what we want to make sure that we're studying. We have data now in first line. It's the only study in a treatment-naive setting across all of IgAN. These patients have a repeat biopsy to understand not only what's going on functionally with their kidney, but what's going on within the kidney structurally. We're really excited to continue to generate. It's a smaller study, as you might imagine, but very, very informative. We have two studies that have been completed looking at the combination of SGLT2 showing an additive benefit on proteinuria. The other aspect of the data that we had, both some analyses of our PROTECT phase three study as well as that first line SPARTAN study, is the earlier you reach these patients, the better their response. We saw, for example, when you treat first line, two-thirds of these patients get into complete remission, and you have a stabilization of their eGFR. That is incredibly exciting. That is what we are hearing is the ideal profile in treating these patients. Really promising. We also have initiated this year studies looking at recurrent disease post-transplant, which is a really high unmet need and particularly concerning the use of immunosuppressants in that setting. To have a kidney-targeted therapy that could be safe and effective is one that we are really excited about the potential. Let me turn it back to Vami I to talk about the commercial opportunity in HCU. Yeah. Maybe last few minutes here, I want to touch on a few things. One is pegtibatinase. Good progress you've made there. Maybe you can just summarize what we should expect from the restart of the phase three. If you can sort of frame the commercial opportunity in HCU overall. Sure. Yeah. So this program we're very excited about. This is a community that is essentially being treated by very old nutraceuticals or vitamin B6, as well as medical protein powder and an incredibly strict diet that really limits the amount of protein in a patient's diet. This is a genetic disease where patients have an issue with their CBS enzyme that is responsible for metabolizing methionine and homocysteine in a person's diet and protein. Over time, this leads to toxic accumulation of homocysteine. When we think about what really is needed, having an enzyme replacement therapy that really addresses the enzymatic defect, it's very promising. There are about 7,000-10,000 patients in the US based on our estimates. That could be even higher because many patients are missed on newborn screening and only are diagnosed once they have symptoms such as an ischemic event or eye problems in their teenage years. It is a really exciting opportunity to have something that could come and address the fundamental defect of this disease. We ran into a manufacturing challenge as we went from clinical scale to commercial scale. We paused to make sure that we can work on some of the refinements. We now are manufacturing comparable material at that commercial scale and are now engaging with the FDA to make sure that they are aligned with some of the results that we have there. We are on track to reinitiate enrollment in that phase three next year. We will provide greater details on guidance and timeline, etc., once we are close to that happening. Okay. Great. Another question I had was you're now a $3 billion market cap company. You've got a nice sort of runway here, it looks like, with Filspari getting into FSGS, pegtibatinase. How are you thinking about the longer-term Travere story, whether it's expansion of these products or bringing in other assets? Just what are you thinking strategically? Yeah. I'll answer it in two components. The first is we have three incredible opportunities to really transform the outlook for these patient communities. We want to make sure that we move very, very quickly because these are communities that have been waiting for something approved for many years. Our primary goal is to execute as well as we have within IgA nephropathy and also to continue the growth that we have in IgA nephropathy. With that said, on the other side of a potential FSGS approval, we believe we have the opportunity to continue to diversify our pipeline and our portfolio. We will be looking at business development, particularly within rare disease and in those areas such as rare kidney disease where we have expertise. Okay. And then just maybe last couple of minutes, just your current cash position, if you can talk about, and your runway. And then maybe just sort of summarizing the key events to be looking out for in terms of catalysts over the next 12 months or so. Sure. I'll start on the cash piece. We ended the quarter with $255 million in cash. If you look at it on a pro forma basis with the milestone payment that we just received from Vifor, just under $300 million. That puts us in a very strong financial position where no near-term capital is needed. We do have some investments that we're going to make, and Eric touched on a number of these when it comes to evidence generation or kidney transplant. Also, with an FSGS approval, we see some areas where we can do some additional work to help uptake there. With pegtibatinase, we're also going to be investing in the phase three and getting that operationalized globally. We're also looking at some investments to help even speed that up further. Some work still to go from the R&D investment side and incrementally SGNA to support FSGS, but we're very strong in the balance sheet to be able to support all that. With regard to catalysts, certainly the most highly anticipated is our PDUFA date for FSGS. That is January 13th. You can also expect continued updates on the progress of our performance in IgA nephropathy, particularly given the important changes we discussed, like the treatment guidelines, as well as additional data evidence within that space. Finally, with regard to pegtibatinase, we expect to provide updates on the restart and when that study could complete sometime next year. Okay. Great. I think we'll leave it at that for now. Congrats on all the progress over the last little bit and exciting 12 months ahead. Great. Thank you. Thank you.