Hi, good afternoon, everyone. My name is Edward Nash, Senior Biotech Analyst at Canaccord Genuity on the equity research team. It is my pleasure to have with us Travere Therapeutics. From Travere, joining us, we have Chris Cline, who is the company's Chief Financial Officer. Thanks very much for joining us today. Thank you very much for having us. Travere. So maybe to kick off the conversation, if you could just give us a 10,000 ft view on Travere, and mainly focus on the company's clinical focus, and then we will dive into the individual programs as we go forward. Sure, happy to do that. Before I jump in, we will be making forward-looking statements, so please review our disclosures on our Forms 10-K and 10-Q filed with the SEC. At Travere, we are exclusively focused on rare disease, and we are a commercial-stage biotech with really a key focus on four main pillars. The first two pillars are focused on FILSPARI, which is the only approved dual endothelin and angiotensin receptor antagonist. There, it is really focused on driving both our near- and long-term growth. The first of those two pillars is continuing the momentum that we have built over time with IgA nephropathy. For those of you that are familiar with the IgA nephropathy market, we have really seen a great evolution of more and more treatments becoming available for patients. FILSPARI has been able to develop and maintain a foundational positioning there. Our goal here is really to continue that positioning and maintain our growth as we go forward here and as you see more entrants coming into the market. The second pillar tied to FILSPARI is going to be the continued strong uptake in FSGS. We just got approval for our second indication for FILSPARI in FSGS in April. What we've seen so far in the launch has been a very strong start and very encouraging trends from a demand perspective, and our focus really is to make sure we can keep that going. Those two together will really be big drivers for FILSPARI's growth in the near and long term. The other two pillars are tied to our pipeline. As you mentioned, the clinical activity, and there we've got the potential for two best-in-class medicines. The first is pegtibatinase. That's going to be our third pillar, where we're really focused on advancing our phase III HARMONY study. This is a pivotal study of pegtibatinase, the first and potentially only disease-modifying therapy for something called classical homocystinuria. That's a rare disease that typically has very limited treatment options and affects roughly 7,000 - 10,000 patients in the U.S. and abroad. So a great opportunity there with data coming up in the near term. Then the fourth pillar, and really focused on driving that long-term growth both alongside and beyond FILSPARI, is the newly in-licensed civorebrutinib. This is a next-generation BTK inhibitor that we recently brought into the pipeline. There we see a really great strategic fit to not only add to our pipeline, but also to extend, again, the growth potential both alongside FILSPARI and pegtibatinase through multiple rare kidney indications. A lot going on in the company. We've made great progress and excited to jump into some of that. I'm always happy when the companies beat our number and consensus, and you guys did a great job with that this quarter, being the first really full quarter, I guess, with FSGS on board. You already talked about the strong growth there, but did it internally seem to beat your expectations as far as its performance? Well, we had high expectations going into the launch. I think that there is a very clear need for the first medicine approved in FSGS, and our commercial and field teams were ready. Not only had we been preparing for quite some time, but also we were able to leverage our learnings from being in the field with IgA nephropathy, and there's significant overlap there. We had expected to have very high demand and to hit the ground running from an execution standpoint. What we saw did exceed our expectations. I think the most notable aspect of that is the breadth of demand that we've seen. We've been very pleased to see that you have a very wide prescribing group of physicians early on here, and we expect that to be able to continue. I assume PARASOL was a real big help for that, I guess, with physicians and really realizing that proteinuria really is what you should be focused on with the treatment of FSGS. Yeah. I think PARASOL certainly played a role in helping everybody in the nephrology community understand the importance of proteinuria in FSGS. It gave something for people to talk about over time when we were working through the process with FDA and how that regulatory decision was unfolding. That definitely heightened the awareness of FSGS and potentially FILSPARI coming to market. From the second quarter results, or from internally, have you seen any evidence there's any warehousing of the drug at all, or is what's going out is going directly to patients? No evidence that we believe of a warehousing effect or a bolus. Some people use that term. Really, we look at those as acute increases in demand or acute starts in demand that then decline significantly thereafter. We are not seeing any evidence of demand trends that would support that. Really what we look at is, taking a step back at the market as a whole, more than 30,000 patients out there that would be qualified candidates for FILSPARI. So you are talking about a meaningful population to start. We expect that to also grow over time as those patients that are in a current nephrotic state come out of that. But I think that the most important telling piece of what we have seen so far in launch is, again, going back to that breadth of prescribers. We have seen a very wide range of physicians writing, and the vast majority of those have only written one script thus far in launch. So when you think about on average for the nephrologist community, you have got a handful or more FSGS patients. They are just in the early stages of writing to their patients, and so we expect to see continued demand as we go forward. Do you guys internally have any thoughts on what you think your ultimate ability to address the whole market will be? What percentage of that market? You are the only drug out there, right? Not really sure what would be holding physicians back. We do not have safety issues with the drug. And clearly, like you mentioned, this is the first drug approved, so you would expect you would see an even greater conversion rate as you move forward now that the longer the drug has been on the market. We certainly have very high hopes for FILSPARI, and I think we are uniquely placed in that we are the only approved medicine for FSGS. When you think about the numbers that we have provided from an opportunity perspective, the more than 30,000 patients are those patients that are currently identified in the care of a physician, biopsy confirmed, and are aligned with our label. So that states those patients that do not have active nephrotic syndrome. What the 30,000 or the more than 30,000 does not include are patients that can come out of that active nephrotic state. So if you treat a patient with either diuretic or you address the proteinuria, elevated proteinuria up front, you can get them to become out of the nephrotic state, and then would be eligible for therapy. The other thing that we expect to occur is even more diagnosis to occur, as now there are tools, specifically FILSPARI, to be able to address their FSGS. I think you're going to see greater biopsy rates and earlier identification. We do anticipate that docs are going to continue to reach for FILSPARI for all their FSGS patients that would be aligned with the label, and we expect that number to continue to grow. This would be the phenotypic evolution over time of what you would see, of how doctors would continue to treat over the entire group of nephrotic patients. Yeah. There's not a reason to believe that FILSPARI wouldn't be applicable for any particular type of FSGS. It's really getting to those patients that don't have active nephrotic syndrome and have diagnosed FSGS. I think it's very well suited for what physicians have really been looking for now for decades. Yep. I'd like to switch to IgA nephropathy for a little bit, because since the drug first launched, or its initial accelerated approval more than two years ago, it's been demonstrating strong and continued growth. With the first quarter this year, you reported more than 990-ish Patient Start Forms for that quarter. In second quarter, the total Patient Start Forms, including both indications, FSGS and IgAN together, is over 2,000. I would like to ask you about moving forward, how do you see this opportunity in IgAN evolving? Sure. We have been very pleased with the continued progress in IgA nephropathy, and I mentioned in the earlier remarks that FILSPARI is the most prescribed medicine for IgA nephropathy, and we do not see anything that takes that opportunity away from us in the future. Just in terms of growth, you have it right. We had more than 900 PSFs the last two quarters that we reported that specific indication, and we said on our 2Q call that we saw sequential growth in IgAN. Continuing to see robust demand there, and we would expect that to continue. If I take a step back, we have provided guidance that we believe FILSPARI as a whole has the potential to reach more than 100,000 patients, so more than 70,000 patients for IgA, more than 30,000 patients for FSGS, and that is a peak sales opportunity of more than $3 billion. For both of these indications, we believe we have got a long ways to go, and we are excited about the opportunity to be able to help patients. Sounds great. You recently announced the allowance of the method- of- use patent for IgAN, and could you tell us more about what does this mean for FILSPARI loss of exclusivity? Sure. We are not commenting specifically on loss of exclusivity, but we are very pleased with the recent Notice of Allowance. That came through in June. That was specifically directed at certain uses in IgA nephropathy, and we do expect that to be granted here in the near term, and then we would expect that to be Orange Book- listed. That would go out to October of 2037. We are very pleased with that progress. We also have a similar patent that we are prosecuting for FSGS with the USPTO at the moment as well. Do we have an estimate about when we will hear more feedback on the FSGS side? I would love to be able to give you a date, but unfortunately, it is an iterative process without hard dates to point to. Yes, of course. You mentioned, at the beginning of our discussion about the ongoing phase III HARMONY study for pegtibatinase in HCU, which is actively enrolling. Can you speak to timing for a readout from this trial? How do you see the, assuming impactful positive data, what do you expect the impact for this program? Sure. Peg tibatinase continues to be a very exciting opportunity for us. If you take a step back and think about classical homocystinuria, you are talking about roughly 7,000-10,000 patients in the U.S., similar numbers in Europe. About half of those are addressable. We say half because unfortunately, diagnosis is quite poor for HCU. In HCU, there is testing on newborn screening where you can measure methionine levels, but those are not always elevated at birth. Oftentimes patients are missed. The currently available medicines or treatment options are very limited. There is a clear need for something that can lower total homocysteine levels and get patients to below 100 µmol or 50 µmol, the two key levels that physicians are really aiming to help patients avoid really awful clinical outcomes such as cognitive decline, ocular lens dislocation, osteoporosis, and stroke, or ischemic events such a stroke. We are very hopeful that the HARMONY study will be able to read out positive data in the second half of next year. That is our guided timeframe. In that, we would hope to see a robust reduction in total homocysteine levels. We saw that in our phase I/II COMPOSE study. In our highest cohort, we saw roughly 67% reduction from baseline. We got all patients below that important level of 100 µmol. If we can replicate those data or even get close to those data, I think it is going to be a very important tool for physicians as they are looking to address the decline that comes with classical homocystinuria. For patients, it would be the first treatment option that truly is effective, and gives them hope for a better future. How should we think about the HCU market opportunity then? Sure. So, again, it's about 3,500 patients that are addressable in the U.S. today, a similar number outside the United States, and we expect that number to grow. You typically see that in rare disease, once you have a treatment that's identified or that's approved, you tend to see an uptick in identification of patients. With education awareness, we would anticipate that. But also going back to what I had mentioned about the diagnostic process, right now there are clear gaps there, and I think that there are some efforts that we would be able to help facilitate in order to improve that over time. I think that the addressable population is only going to continue to grow for HCU, and that's where we believe we have a really meaningful opportunity. Does that also apply to FSGS, or was FSGS never difficult to identify? We knew it was there, we just didn't have a treatment option. Or do you believe now that we have a therapeutic, there's also perhaps patients out there, maybe it's a bigger market because of this identification, because we now have a therapeutic? I think there are elements of it that are applicable to FSGS. In FSGS, you do have better diagnostics, right? So genetic testing and biopsy can more clearly confirm FSGS. But you also have secondary FSGS that is secondary to other things like, whether it's diabetes or something else, where you may take more time to actually get to that diagnosis. I think that now, with a treatment approved specifically for the disease, you're likely to see physicians seeking out a biopsy confirmation earlier and treat as soon as they possibly can. So I do think that there's an element there that we will see more FSGS patients identified over time. You mentioned earlier in your comments that you just recently entered into the license agreement with Everest for a BTK inhibitor. Maybe could you talk a little bit about that molecule and how you're seeing that fit into the overall pipeline of Travere? Sure. From a fit perspective, we have a very clear, built, strong infrastructure for rare renal. If you think about what we have done with FILSPARI, we ran two large phase III studies in addition to a whole bunch of other efforts for evidence generation. All of that clinical infrastructure would be directly applicable to the early days with civorebrutinib, or civo, just to make it easy, as we look to establish the clinical development program there. Bigger picture, we also have the regulatory, even recent experience on navigating pathways based on new or developing data sets within rare kidney space, and working with cardiorenal on clear endpoints in the space. We will be able to leverage all of that as we get into the regulatory phase. When you think about the commercial aspect, this fits perfectly in with what we currently have because there is a complementary element of it with FILSPARI, where civorebrutinib can potentially address the immune-mediated aspect of something like FSGS, whereas with FILSPARI, we are really focused on addressing the overactivation specifically within the kidney. There is that combination that you could use both independently together, and in the future that I think can be very beneficial. From that perspective, it is a clear fit from the rare renal side for us, and it layers in potential growth both alongside FILSPARI and pegtibatinase, and then extends it beyond those as well. Some of these additional indications that it would be addressing that FILSPARI is not currently addressing, how big are those additional markets? Yeah. Are there any other drugs that are currently approved to address those? Sure. There's three indications that we've identified thus far, and if you think about the prevalent population for those three combined, it's around 130,000 patients overall. There's a meaningful opportunity to reach a significant number of patients, and that covers PMN or primary membranous nephropathy, immune-mediated FSGS, and minimal change disease. I think that there's a great opportunity there to be able to help patients. There is nothing yet approved for PMN. There's likely to be something soon. Nothing yet for minimal change, and FSGS, obviously we have FILSPARI. This would be more focused towards the immune-mediated specific aspect of FSGS, so it layers in very well. All of these are orphan indications we're talking about? Mm-hmm. Yes. So, as you think about, this was great timing to be doing this, right? Because you've kind of now gotten two indications on the FSGS that's been watched by the [Street] for quite some time. You got through the whole regulatory process, got that drug approved, so now you've got the two indications there. You're now able to achieve something that I think it's been difficult for a lot of biotech to do, right? Is we've done this, we got drug approved, now we've got to find something else that's in the area that we're looking at, right? Rather than saying, oh, now we're going to be looking at cardiovascular disease, right? For a renal company. But it's kind of probably hard to replicate that on a continual basis. So how are you thinking about beyond [civorebrutinib] when you go out further? Yeah, it's always tough to do it again, right? Yeah, right. But I think with civorebrutinib, we've really found a great opportunity to do that. Yeah. Because it fits all those bills that I had mentioned before, where you've got the very clear alignment with our internal expertise and our recent progress. I think that there are potentially other opportunities out there to layer into our pipeline, whether that's continuing to leverage the rare renal focus or even the rare metabolic focus. With pegtibatinase, we've developed a different expertise that is more towards the ultra rare side and obviously on the metabolic side, but there are interesting things on that front as well that could potentially be good fits for us. We're going to continue to be very choiceful in what we're looking to add into the pipeline, but we're going to continue to look and see if there are other opportunities that we can keep going with the success we've had so far. In Europe, you have a partner now with FILSPARI, and that also accounts for FSGS as well, right? It's the drug for all indications that are there. For civorebrutinib, as you're developing this drug, are you going to be looking to do kind of the same BD opportunity for Europe as well, or is this something you would potentially want to do commercial on your own? Normally, I would think most biotech say we would want to get a partner, but I do have a couple in my universe that have. Yeah. That have gone out and decided to do their own commercial opportunities in Europe, for better or for worse, in the face of MFN. Sure. Just wanted to get your thoughts on that going forward. Yeah, maybe it's worth taking a step back in time to what we did with FILSPARI prior to getting to the collaboration with, at the time it was Vifor, now it's CSL, after CSL acquired Vifor. The way we approached that was we did parallel tracking. We were looking at plans to go ourselves and build the infrastructure and do all the work in Europe at the same time as we were going to be launching in the U.S., and we were also evaluating potential partnerships. I would anticipate that we'll do the same thing here, and we'll make the right decision at the right juncture. It came down to, for us with the European collaboration that at the time, Vifor had a very clear expertise in rare renal in Europe. They were absolutely the leader over there, and it was clear to us that we were going to have a lot that we needed to execute on very well in the U.S. with two indications launching in what we thought was going to be a pretty close period of time. There it made sense to do our agreement with Vifor and advance that. We'll see how that goes with civorebrutinib, but I think we've also built up a very strong infrastructure now already that we can leverage in the U.S. that may give additional bandwidth down the road. One of the things that's kind of impressed me in the whole renal space is specifically with IgAN, is that we went from really nothing to just, wow, lots of drugs very quickly, right? You guys were one of the first ones to get out there and get approved, I guess, a real molecule that wasn't something like a steroid, right? That was getting approved. This is now the space has been transformed a lot, and we're hearing a lot more about APRIL and BLyS and stuff. If you could just talk a little bit about that, about where you fit in and what the shortcomings are of some of these other mechanisms, versus the dual mechanism we have for FILSPARI. Sure. It has been great to see the evolution in the IgA space. I think it is amazing that patients have many options now, right? To your point, if you go back even five or eight years ago, you probably had two or three clinical trials in development, and now we have multiple options for patients to choose from on the commercial side of things. What I think is important to remember is from the KDIGO guidelines, which is basically one of the main governing tools for physicians, it tells you that you need to address the overactivation in the kidney, and you need to address the overactivation of the immune system. So you need to be able to tackle both of those things, and the main goal is to get patients to 0.3 g or 0.5 g of proteinuria. So basically, complete remission. In order to be able to do that, for many patients, it is going to require combination therapy. That has been our view for quite some time, that we will be able to get some patients there on FILSPARI. You will be able to get some patients there on other modalities. But at the end of the day, to get the vast majority of patients all into complete remission, you are going to have to have combination therapy. That is what KDIGO guidelines say. I think as it comes to specifically the APRIL -class and the next generation of medicines that is coming, the data look very encouraging. It is exciting to have treatment options. They are certainly going to get utilization. It is important to remember that they are all trialed on top of standard of care, right? RAS. That is really what we are aiming to replace. We are not aiming to replace the historical role of steroids or TARPEYO or other things. That is why we believe that we are going to continue to have that foundational positioning, and we will continue to be used in combination with the other medicines that are coming forward. At the end of the day, it is great for the IgA community because they are really going to have the ability to get into remission. Is this kind of? I guess I've always seen and I've always heard when I talk to other docs and other indications, they always say it's the nephrologists are the real thinkers. They're the smart ones out there. It's a very difficult therapeutic area to work in. Just wanted to understand what feedback you're getting from them with regards to these other mechanisms. Is what you're stating is how they're thinking on how they would eventually incorporate some of these other mechanisms into their practice? It's very aligned with what we hear from the nephrology community. We base a lot of our thinking, we try to incorporate that very early on in all of our planning. I think you obviously hear evolution over time as you see more data, and there's certainly excitement for the new generation of medicines, but they also look at it the same way that KDIGO does and say, "Okay, this is great. Now we've got two things that we can use together, and patients are going to benefit." We're certainly hearing that, and we're seeing early but anecdotal evidence of that combination occurring in the commercial setting. We are seeing FILSPARI being used with SGLT2s, we're seeing FILSPARI being used with some of the new APRILs, we're seeing FILSPARI used with TARPEYO and some of the other steroids. I think that that movement is clear, and the thing that is most consistent amongst all nephrologists, they now finally believe in that target of 0.3 g or 0.5 g proteinuria, and that's the best thing for patients and for all the treatments in the IgA space. Well, this has been fantastic. I think it is still the very early days of this launch, and it has been growing fantastic, and so both I think for IgAN as well as FSGS. Really excited about what is next to come with the pipeline and with the continued growth on the commercial side. We look forward to keeping you posted. Thank you for joining us. Thank you very much. Thank you.