Hi everyone, my name is Maury Raycroft, and I'm one of the biotech analysts at Jefferies. It's with great pleasure that I'd like to welcome the Travere management team. We've got Eric Dube, the CEO, and Peter Heerma, the Chief Commercial Officer. Thanks so much for joining us today. We're going to do fireside chat format, so maybe for those who are new to the story, if you can give a one-minute intro to Travere. Sure, absolutely. Thank you for hosting us. We are a rare disease company that's based in San Diego. We're both commercial as well as late-stage development. Throughout the discussion, we will be referencing forward-looking statements, so please refer to our materials on our website. We're a company that is really innovating, particularly within the space of rare kidney disease. Our medicine, FILSPARI, is approved in the U.S. as well as within Europe and the U.K., and really is redefining the approach to the treatment of IgA nephropathy. We have a therapy, also same medicine, that has a PDUFA date early next year for FSGS, another devastating rare kidney disease, and we expect that we'll be the first therapy, first medicine approved for FSGS. We also have an enzyme replacement therapy, pegtibatinase in phase III for the treatment of classical homocystinuria or HCU, which is a rare metabolic genetic disorder. Also an area that is in need of innovation. We're pleased to be here. We're pleased to be leaders within the space and look forward to taking your questions. Great. Yeah, that was a great intro. Yeah, it's a critical time for the company. The FILSPARI commercial is doing really well, and you've got this FSGS approval coming up soon. A lot of focus on that. Let's talk about the FSGS setup. Since the AdCom cancellation, what's been the feedback from the FDA that you've gotten, and have they requested any additional data beyond what was initially submitted? Sure. We don't comment on the specifics of our interactions. What I can tell you is that the engagement with the FDA has been very consistent with our experience with IgA nephropathy. Around the time that we were expecting that the FDA would have their internal mid-cycle review meeting, important note, because this is an SNDA, we wouldn't expect to have a meeting with them as a mid-cycle or late-cycle. Around the time that they would have their internal meeting is when we received the notice that upon further review of our file, they deemed that the advisory committee is no longer necessary. That's when they canceled it. Throughout the engagement, we've had information requests. The file is, their review is continuing. From everything that we see, we're on track for our PDUFA date on the 13th of January. Got it. There have been changes at FDA. I guess, have there been any personnel or process changes or updates at FDA related to the handling of your application? Nothing of note. I mean, this is, cardiorenal has been very consistent both in their review as well as with their personnel. So we've been very pleased that despite a lot of the changes within FDA, that our review team has been steadily working on our file. Got it. Can you talk about the steps remaining in the approval process? From our understanding, Aliza Thompson is the designated final signatory for the supplemental NDAs at cardior enal. Is this correct? Are there other key people involved worth flagging? Sure. So because this is an SNDA, this would be the Director of the division that would be the final signatory. That would be Dr. Thompson. She's been part of our review team for many years, and we've seen very little in terms of changes within the review team. So we feel like we're in good hands with this division. Got it. Okay. In the past, you've mentioned interactions for FSGS have been consistent with your IgA experience. Can you talk more about your IgA experience and the frequency and types of interactions? Sure. That also was an SNDA with the same clinical and statistical reviewers within cardiorenal. In that review, we had a good sense of the types of questions, the cadence of information requests and questions that would come in, how they think about statistical analyses, things like sensitivity analyses, et cetera. We were well prepared for what to anticipate. Our experience with their review of our FSGS SNDA has been very consistent. One final aspect, just to go back to your last question about what can we expect in terms of review, I want to make sure that we also mention that the next step really is anticipation of draft labeling. That typically occurs about a month before the PDUFA date. We are still on track. We would not be in that position just yet, but we can anticipate that very soon. Got it. Okay. So interactions have been pretty similar. Nothing notable. That's right. You were recently at ASN where you had some updates there. Talk about how the new disclosure helped strengthen your story for the FSGS approval. Sure. Everything that we've seen with the pre-specified data that was submitted as part of this SNDA demonstrates that there is a treatment effect on proteinuria. Just for background, when we reported out our two-year trial of DUPLEX, which was our phase III trial and the only pivotal trial conducted with an FSGS, we saw a consistent benefit on proteinuria, but we missed on the confirmatory endpoint of eGFR or the measure of kidney function at two years. That really caused the community to take a step back and say, "What are we missing here?" because you typically would see a profound reduction in proteinuria translate to an improvement in kidney function. While we saw a numeric benefit in terms of kidney function, we did not see that translate statistically into superiority versus our active control. In taking a step back, the community, including FDA, said, "We need to really better understand what might be the endpoints for this disease." The Parasol Group was formed. This is a public-private organization that really is meant to understand this space. What they did is they showed that the measure of eGFR would not be feasible within a clinical trial because the variability within FSGS is far too great. Both intrapersonal and interpersonal variability on eGFR is too variable. They also then showed that if you can reduce proteinuria to these very deep levels of reduction, that can translate to reduction in the risk of kidney failure. One of the endpoints that they determined is getting below 0.7 grams of protein. That was not a pre-specified endpoint. That was not really ever an endpoint that was discussed within the field of FSGS. As part of our work, we did a post-hoc analysis looking at this specific threshold. That is what was presented at ASN. What we showed is that patients were able to get to rates of below 0.7 early and at a greater rate throughout the two-year trial. For those patients, regardless of what treatment arm you are on, if you are able to get your proteinuria level below 0.7, it actually is correlated with lower rates of kidney failure. When we look at projecting beyond the two-year trial, we also see that there is a substantial reduction in the risk associated with kidney failure using the U.K. RaDaR dataset showing an 86% reduction in the rates of kidney failure. We were very encouraged by that. We also had a late-breaker abstract looking at the continuous variable of eGFR or of proteinuria over time, and that treatment effect of about 26% that we see of sparsentan versus irbesartan translates into an incremental 24% reduced rate of kidney failure, again using the RaDaR dataset. That is on top of the reduction that you would expect that you get from RAS inhibition. An incremental 24% reduction in kidney failure, which again, we believe reflects both a consistency of those findings from PARASOL, but also really helps to translate the clinical meaningfulness of our phase III results using proteinuria. Got it. Makes sense. Realizing that eGFR is not a priority for the FSGS review, have you supplemented data from the DUPLEX open-label extension analyzing eGFR correlation with proteinuria responders to give FDA additional confidence in longer-term treatment benefit? You're correct. In meeting with the FDA during our type C meeting where they said that they were okay with our submission, eGFR did not come up. We do have data looking at eGFR in our phase II study longer term in the open-label extension where we were able to follow patients seven, eight years. What we were able to show in that open-label extension is that for those patients that were able to reach complete or partial remission of proteinuria, you're able to see a meaningful difference in their kidney function over time, about 1.7 mL per minute per year loss for those patients that achieved rigorous control of their proteinuria compared to 7 or 8 mL per minute per year loss. A very meaningful difference. All the caveats that this is open label, we've not done the same analysis yet of our phase III open-label extension. That is ongoing. You can imagine that that's the kind of analysis as we look. While we've had a very robust dataset that we submitted as part of our SNDA, those kind of post-hoc analyses of our open-label extension would not yet be part of it. Got it. At some point from the phase III, from the open-label extension data, you would publish that at a later date? That's the plan. Got it. Okay. And checking, are you, so presumably you're not in label discussions yet? You would expect that about a month before the PDUFA date. Got it. What is your base and bulk case scenario for the label and whether all FSGS, or will it be restricted to primary only, and what are the implications for the FSGS market opportunity? Sure. We're really thinking about two different scenarios when we look at the label and the indication statement. We have requested a broad indication statement for the treatment of FSGS similar to what we have in IgA nephropathy, the reduction of proteinuria in FSGS. We would expect that we would get labeled for patients eight years and above. That's what we study in our phase III program. The two scenarios in terms of the indication statement, one that would be broad would essentially be for the treatment of any type of FSGS. For background, there's really four main categories of FSGS: primary FSGS, genetic FSGS, secondary FSGS, and FSGS of unknown cause. We tried to focus our phase III in enrolling genetic and primary. That represents about 30,000 patients that are addressable in the U.S., similar numbers in Europe. If we get a broader label, we would be able to reach more patients. There really, we would expect there's potential upside if we get a broad label. If we're restricted to primary and genetic, it would be very aligned with our estimates of the addressable population today. Got it. Presumably for your draft label, you're going to go for broad population? That's right. I mean, the unmet need is substantial. Within FSGS, it's oftentimes very difficult for physicians, and particularly on biopsy, to determine the etiology of the disease. Got it. Okay. Do you think FDA could ask for any post-marketing requirements, and is there anything in particular you anticipate? They certainly could. There's nothing of note at this point. Got it. Okay. Where are you at with commercial launch preparations? What is the size of your sales force currently, and how much do you have to expand for the FSGS opportunity? Yeah, the best preparation for FSGS is to continue to do very well for IgA nephropathy. It's basically the same goal points. The only nephrology group that we haven't focused on so far are pediatric nephrologists. That's part of the segment that Eric was talking about, 10%-15% is pediatric. Overall, we have a good footprint with nephrologists based on our performance in IgA. Yeah, really pleased with that continued performance. I think that allows also to perform very well in FSGS. With regards to your question on what is the size of the field force, what we have disclosed in the past is 80-plus field force right now, and we will have an incremental increase to make sure that we continue to do very well in IgA nephropathy while also to really maximize that opportunity in FSGS. Got it. You have talked about pricing in the past for IgA nephropathy versus FSGS. Maybe just kind of recap how that could work. Yeah. Go ahead. No, go ahead. Yeah, I mean, let me talk about our strategy for pricing, and Peter can speak about how that might play out. Our approach for both IgA and FSGS really is to make sure that we're pricing for broad access. We want to make sure that because of the mechanism of action and the breadth of use that we expect, that we have broad access for both of these indications. We've been very pleased with how that's played out with IgA nephropathy. I think Peter can talk about how the dynamics of pricing may play out in FSGS. Yeah, overall, the health economic analysis for FSGS is very strong because this is the most rapidly progressive disease, and we have a very strong position already in formularies, payer plans, and so we can really leverage that for FSGS as well. It's easier to get an indication added to a product rather than get a product into the formulary. I think we built upon a strong position there. Got it. Okay. Let's see. Let's move on to FILSPARI commercial then. Quarterly sales have continued to be strong, driven by strong demand, and tailwinds from the REMS adjustment, which is now quarterly, as well as the inclusion in KDIGO guidelines. Looking ahead, can you comment on estimates for peak sales and how to contextualize given atrasentan as a direct competitor and emerging threats from biologics? Yeah, so there's a couple of questions in one. Maybe good to kind of like set the ground on the REMS modification. We had a REMS program for liver monitoring that was monthly for the first year and then quarterly after the first year. That has been reduced to quarterly from the beginning, which is much more consistent to how patients are being treated in routine by nephrologists. Every quarter. Basically, it's similar to what they're doing right now. That certainly gives a tailwind. I think there are multiple tailwinds for us moving forward. The recent publication of KDIGO, the global guidelines, where FILSPARI is mentioned with a higher or a more rigorous treatment target, that will help us commercializing FILSPARI, the REMS modification that we talked about, and the preparation for FSGS and the incremental increase of our field force that I just talked about. All of those will help to continue to do well in IgA nephropathy. And then once you have the FSGS approval next year, I think there will also be a halo effect then moving forward from FSGS on IgA and vice versa. Got it. That was the second part of your question. The third part of your question was the competitive landscape that is evolving, which I think is a good thing. I mean, this is a market that historically was treated with generic medicine. Since we had our full approval in September last year, we have seen an incremental increase in our demand, and we have done really well. The biggest challenge we had was really to elevate the urgency to intervene earlier. I think the new guidelines will help with that, but I think more competition will also help to further develop that market. I think we are well positioned from a competitive perspective with regards to the differentiated profile with the dual mode of action, our long-term data, long-term evidence, and a strong efficacy profile that is well recognized in clinical practice now as well. I think we are in a strong position, and that gives me confidence that we will remain the category leader as well. Yeah. Maybe just to take a step back, I think one of the most important things that I hear from the rare disease community is that we now are living in a time of such hope that with all of this innovation coming, we could expect to see an IgA nephropathy patient who is diagnosed never have to see kidney failure. It is because of all of these treatment options and the guidelines now really saying that patients need to have simultaneous combination therapy. Of course, that is going to have to be worked through in terms of what does that treatment algorithm look like, what does the payer access look like. The amount of innovation that we are seeing and the hope that these therapies would be used in combination with FILSPARI, I think has given tremendous hope to the rare disease community. Is the combination use, is that something you guys could proactively look at, or is it once the biologics get approved, doctors will basically figure that out on their own? I think there's different layers to that question. The first is many of these therapies, well, all of them are being used on top of foundational therapy, nephroprotective therapy. Some of them include endothelin receptor antagonists. All of them include RAS inhibition. We'll have some coming out of those trials, albeit probably limited in terms of the dual background combination. The second is physicians will look to try these in clinical practice. The third is we'd be very happy to collaborate with these companies to do the combination studies. That is what the guidelines really reflect today. I think we've tried to answer the questions that the nephrology community have of us. I hope that the other companies would look to do the same with us. Got it. Yeah, maybe just to add, I think it's also important to realize nephrologists are really looking for long-term data. We saw a meaningful uptake after we had our full approval without the proteinuria target. Why that is important is that 70% of the market is in patients with proteinuria levels of 1.5 or lower. If you have new medicine coming to the market and you were referring to the APOL1 compounds, for example, they will have the more limited initial label in the higher, more sicker patient population, while FILSPARI has broad access to that full patient population. That is where we make very nice inroads. I think there is a place for APOL1 compounds in combination, but it's a stepwise approach. It's more sequencing, and I think FILSPARI is really positioned for that foundational treatment in a broad-based population. Got it. Okay. You have noted high compliance and persistence along with operational efficiency as drivers of the strong quarter-over-quarter growth commercially. What is the persistence rate currently, and do you have a sense of what proportion of the patients have proteinuria below the 1.5 gram per gram mark to avoid potential switches to biologics? Yeah, so the compliance and the persistence rates have been really high, much higher to what I had anticipated based on my experience in chronic non-symptomatic diseases. We haven't disclosed the specific, but it remains very high. You could argue as you go in less sicker patients, less sicker with lower proteinuria levels, is the compliance level staying at the same level? We see that compliance and persistence remains very high. Got it. Okay. The second part of your question was proteinuria levels. I missed it. Yeah, for the patients who have proteinuria below the 1.5 gram per gram mark to avoid potentially switching to biologics. I think what we have seen historically, when you think about the two treatment categories, the kidney targeted category and the immune suppressive category, historically, that's where you had the steroids. Now you have the complement inhibitors, and in the future, you may have the APOL1, APOL1, BAF compounds. Historically, they are used in the more sicker patient population. I think their initial label may guide physicians in that direction, but it's yet to be seen. Yeah. I think we've not heard anything in our market research that suggests that physicians think about switching from FILSPARI to an immune targeted therapy. This is about combination. I've not heard that from the nephrology community, nor have we seen that in market research. The other aspect is most of the growth that we're seeing is coming from the earlier patients below 1.5. That's where 70% of the addressable patients are. Okay. It's probably fair to assume that that proportion of patients would be preserved if they're less than 1.5 gram per gram because of the biologics having the accelerated approval limitation. We don't see that as a major challenge because these patients, the patients that are above 1.5, they're the ones that are going to really more likely need combination therapy early on. That's where physicians are going to be looking. We would expect to see combination therapy. Just to put a finer point on that, I mean, the way FILSPARI is positioned, it's not competing against immune suppressive agents. I mean, immune suppressive agents are always studied on top of kidney targeted therapies. FILSPARI's consistent nephroprotection profile positions us very strongly to replace historical RAS inhibitors, ACE inhibitors, and ARBs. That's where FILSPARI plays. The second category, immune suppressive, I think is an additional option, but it's not competing against FILSPARI. Yeah. Okay. Makes sense. Novartis reported some data at ASN showing that Benraphia efficacy was the same regardless of whether patients were on max dose of RAS inhibitor. How do you interpret this, and could this information be leveraged commercially? Yeah, I think two things are important to notice. RAS inhibition has been the golden standard for the last 30-35 years. They are known for their nephroprotective effect. What physicians like and understand well and appreciate is the consistent nephroprotection that FILSPARI offers by simultaneously blocking angiotensin as well as endothelin. The long-term data shows that that matters. I think we are well positioned versus the data that you are referring to. Okay. Got it. I wanted to briefly talk about your HCU program. Do you have more granular details on when in 2026 you could restart the phase III and any thoughts on how the study design would look relative to your prior study? We're on track for reinitiating enrollment next year. We've not narrowed down the guidance just yet. We'll provide updates once we're back enrolling patients. The trial design has not changed. Seventy patients, placebo-controlled, we'll be looking at changes in homocystinuria over time as the primary endpoint. The other aspect that I think is important to call out with this trial design is that we are looking at a sub-study for patients that are able to achieve rigorous control of their homocystine levels. We're looking at how do we increase protein intake in their diet, which is the number one need that patients tell us. Got it. Okay. For contingencies, if FSGS is delayed or not approved, I guess, how do you think about that in respect to adjusting operations? We are planning on approval January 13th. We have a very healthy and growing business with FSGS and IgA nephropathy. We have not even reached 10% of the patients that need something more than RAS inhibition. We are really excited about our pegtibatinase program getting back into phase III. We have a very diversified business, but our number one priority is to launch FSGS. These patients have been waiting far too long. Got it. Maybe looking ahead, can you talk more on pipeline expansion and BD opportunities near term? Sure. Our number one focus is to make sure that we can execute exquisitely on our current portfolio, including a rapid uptake and launch within FSGS. With that said, we will be in a very strong position with growing revenues to continue to look at those areas that really in rare disease need something else. We are interested in business development, but our short-term focus is no distraction to get us into the launch of FSGS. Got it. Makes sense. Maybe in closing, we're almost out of time. If you can just comment on cash position and runway assumptions and then just key events ahead investors should be focused on, just recapping. Sure. We ended Q3 with about $255 million in cash. We also had a milestone payment that we received in October. We're nearly $300 million in cash. We do not have any near-term needs for capital, and that amount of funds plus our growing revenues allows us to invest the proper amount in those three opportunities, which are our three key milestones: continue growth in IgA nephropathy. We're just getting started. The number two is to launch FSGS with the planned approval January 13th. We expect the uptake to be even faster than what we saw in IgA nephropathy. Then executing very well on our phase III program in pegtibatinase. We'll provide further updates on timelines next year. Got it. Eric, Peter, thanks so much for joining us today. Great. Thanks, Maury.