Good afternoon and welcome to the Travere Therapeutics third quarter 2026 financial results conference call. Today's call is being recorded. At this time, I would like to turn the conference call over to Ryan Hayes, investor relations analyst. Please go ahead, Ryan.

Thank you, operator. Good afternoon and welcome to Travere Therapeutics' third quarter 2026 financial results and corporate update call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Peter Heerma, our Chief Commercial Officer, Dr. Jula Inrig, our Head of R&D and Chief Medical Officer, and Chris Cline, our Chief Financial Officer. Dr. Bill Rote, our Chief Research Officer, will join us for the Q&A. Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factors section in our forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, November 2nd, 2026. and Travere specifically disclaims any obligation to update such statements to reflect future information, events or circumstances. With that, let me now turn the call over to Eric.

Good afternoon and thank you for joining us today as we discuss another quarter of excellent execution and continued momentum across Travere's commercial business and pipeline. Before turning to our results, I'd like to briefly reflect on my upcoming transition that was announced during the quarter. As I prepare to step down in December, I've been reflecting on the people and purpose that have shaped my time at Travere. Being part of this company has been the greatest privilege of my career, and I am deeply proud of what we've accomplished. I have never been more confident that Travere's best days are ahead. With an exceptional executive team, Life Changing Therapies and a Growing Pipeline, and an organization committed to delivering for patients. I've been in regular communication with Bradley as we plan for him joining Travere on December 1st. This time together has only strengthened my conviction that he is the perfect fit to lead Travere into its next chapter. He shares our commitment to patients and brings the experience, perspective, and leadership to build on our momentum. We are approaching this transition from a position of strength, and you'll hear that reflected in the progress we're sharing today. With that, let's turn to the advancements we've made for the quarter. The third quarter was marked by excellent execution across our business and continued progress against our four key pillars of our strategy to drive both near and long-term growth. As we enter the final months of the year and look ahead to 2027, I am very pleased with the momentum we have built and the increasingly durable growth profile of our company. At the center of this momentum is PhilSparry, where strong patient demand, growing conversion and consistent commercial execution supported significant revenue growth across iJ Nephropathy and FSGS. Quarterly net product sales surpassed $200 million for the first time, marking an important milestone as we continue to reach more patients. In IG nephropathy, Filspari continues to demonstrate its foundational role with strong demand, steady conversion to paid prescriptions, and consistently high patient adherence despite new market entrants. Importantly, we are not simply adding new patients each quarter. We are building on a growing base of patients who remain on therapy over time. This dynamic is a powerful driver of recurring revenue and reinforces our confidence in PhilSparry's long-term growth potential. In FSGS, we remain encouraged by the early launch performance with high adoption trends consistent with our expectations. We're still at the beginning of this opportunity and see substantial potential to reach more eligible patients as nephrologists gain experience with PhilSparry and Peter will provide additional details shortly. This continued commercial momentum reinforces our confidence in achieving or exceeding more than $3 billion in annual PhilSparry sales by 2033. We've also made important progress strengthening PhilSparry's U.S. patent portfolio, including a recently issued patent directed at certain methods of use in IG nephropathy and a notice of allowance for a patent application directed to certain methods of use in FSGS. The IGAD Patent and upon issuance, the FSGS Patent carry terms extending into 2037. Taking together this commercial momentum and progress in our patent portfolio reinforce our belief in PhilSparry's potential to reach more patients and continue growing beyond 2033. An important part of that long-term opportunity is reaching more patients earlier in their disease journey. We are also encouraged that earlier diagnosis and treatment of IgA nephropathy and FSGS are being recognized within the federal government through the recently published landmark HHS Kidney Care National Plan. For these rare kidney diseases, timely diagnosis can help physicians and patients consider appropriate treatment options earlier in the patient journey, reflecting more proactive kidney care. These developments reinforce our broader ambition to build a leading rare disease company with multiple opportunities for the long term. Beyond PhilSparry, we are making tangible progress advancing the next growth opportunities for Travere. With the potential to become the first disease modifying therapy for classical HCU, PEG-2-Batinase represents an important opportunity to improve the lives of the estimated 7,000 to 10,000 people in the U.S. living with this devastating disease. Jula will share more on the progress of this important program shortly. We're also advancing our newest pipeline asset, Sivor Brutinib. During the quarter, our licensing and collaboration agreement with Everest became effective, and our teams are making progress. Its potential differentiated profile and opportunity across multiple immune-mediated kidney diseases representing more than 130,000 prevalent patients adds another compelling dimension to our long-term growth strategy. As I look at Truvere today, I see a company with a proven ability to execute a growing and increasingly durable commercial franchise and a pipeline with multiple opportunities to deliver meaningful innovation. We have built the capabilities, relationships, and expertise to lead in rare kidney disease, and we are only beginning to realize the opportunity ahead. With that, I'll turn the call over to Peter for an update on our commercial performance.

Peter?

Sorry about that. Thank you, Eric. In the third quarter, we received 1,932 new patient start forms across IAGA nephropathy and FSDS, reflecting continued strong and steady demand during a period when we typically see summer seasonality. We are pleased with this performance and the underlying dynamics of our business. We also continue to see strong conversion of new prescriptions to paid therapy and high patient adherence, allowing us to add meaningful numbers of new patients to an already substantial and growing base of patients on PhilSparry. The combination of our expected new patient demand, strong conversion and patient persistence, now across two indications, puts us well on track to achieve or exceed $3 billion in PhilSparry sales by 2033. Let me start with providing some protocol on IgA nephropathy. TILSPARI remains the most prescribed medicine approved for IgA nephropathy, reflecting its differentiated profile and foundational role in treatments. As additional therapies become available and this market evolves, physicians are increasingly considering how to sequence and combine treatment options. We believe filspary is well positioned to remain an important part of these evolving treatment strategies. We continue to see new patient stock forms coming from repeat prescribers as well as new physician activation. The vast majority of filspary prescriptions are for patients that have no prior experience with branded therapies. and market research indicate that Vilspari is considered appropriate for more patients than any other branded IGAM medicine. This reflects the confidence that physicians have in Vilspari's differentiated profile and how it is broadly applicable for their IGAM patients. Within the dynamic and rapidly evolving treatment paradigm, we believe Vilspari is well established as kidney targeted treatments, replacing RAS inhibitors consistent with the KEDIGO guidelines. As new immune-directed therapies replace historical options, we expect these to address the immune-mediated processes upstream in the disease manifestation, while Filspari continues to provide kidney protection superior to maximally tolerated RAS inhibition. We believe these approaches will continue to be complementary for patients requiring proteinuria reduction and Slowing Disease Progression. Our conversations with physicians, most recently at the ASN Kidney Week, reinforced their view of filspary as a preferred kidney targeted medicine and a strong foundation for combination therapy, a pattern we are beginning to see in prescribing practice. We left ASN with even greater confidence in this positioning, and Jula will discuss the supporting clinical evidence shortly. We also see a particular opportunity among patients with partenuria below 1.5 gram per gram. This segment represents approximately 70% of the IgM population, and Filspari is well positioned to continue to penetrate this segment. This is also where we expect to see increasing biopsies, resulting in earlier diagnosis and a growing number of patients that can benefit from Filspari. As the eigenmarket is continuing to expand, and as more companies increase their commercial activities, nephrologists are evaluating how to sequence and combine therapies amidst greater demands on their time and attention. We expect these dynamics to contribute in quarter-over-quarter variability in new IgA nephropathy patient stores. but we see an enduring fundamental role for Felspari which reinforces our confidence in a substantial long-term opportunity in this patient population. Turning to FHDS, we remain encouraged by the performance of the launch as we saw further strong demand during the third quarter. Our prescriber base expanded and nephrologists began treating additional patients within their practices. Approximately 40% of the first time FSGS prescribers during the quarter were new to Filspari, expanding the brand's reach and creating additional opportunities in IgA nephropathy as well. We also see substantial opportunity to deepen prescribing within practices. Approximately two-thirds of the nephrologists who have prescribed Filspari for FSGS have treated just one FSGS patient since launch. Phil Sparrow's potential use spans eligible adults and children aged eight and older without nephrotic syndrome, including patients with primary, secondary, genetic, and unknown cause FSGS. Early prescribing has focused on patients with higher proteinuria across the segments, and as nephrologists gain experience, we expect broader use within practices, including among eligible patients with lower proteinuria similar to the evolution we have seen in IgA nephropathy. Our conviction is reinforced by what we hear from nephrologists about the important and broad role that filspirase should play in the treatment of FSGS. We expect that the availability of an approved treatment can encourage greater diagnostic evaluation, including biopsy and genetic testing when appropriate, helping to identify more patients who may benefit over time. Access is advancing as most payers have already updated their coverage policies to include sales parity for FSDS, and we expect further progress through the end of the year. With strong demand and conversion since launch, we reported approximately $200 million in sales parity net product sales for the third quarter. Orders from our specialty pharmacy partners increased inventory above historical levels, and this contributed to approximately 8 million of the third quarter net sales. We expect fourth quarter net sales to be reduced by approximately the same amount as the specialty pharmacies will dispense existing stock to get back to normal levels. Moving ahead, we see significant opportunities for PhilSparry as we remain in the early stages of reaching the more than 100,000 addressable patients with IgA nephropathy and FSGS. Our commercial focus remains on continuing to strengthen PhilSparry's position as kidney targeted treatment, broadening our prescriber base and supporting physicians as they gain experience with PhilSparry to incorporate it more broadly into their practices. I am incredibly proud of our team and the impact they continue to have on patients and their physicians. With that, I'll turn the call over to Jula for the medical update. Jula?

Thank you, Peter. I'll start with Vilspari, where new data presented at ASN builds on years of preclinical and clinical research, strengthening our understanding of its differentiated mechanism and foundational role across IgA nephropathy and FSGS. Beginning with our preclinical work, we demonstrated that dual endothelin and angiotensin receptor blockade reduces pathogenic IgA deposition and misangial cell proliferation, while also protecting the glomerular endothelial glycocalyx and podocytes, key structures involved in maintaining the kidneys filtration barrier. These findings have been supported by our clinical development program. In the randomized phase three PROTECT study in IgA nephropathy, Philspari demonstrated superior proteinuria reduction and slower EGFR decline compared with maximally dosed erbicertin. Similarly, our new analysis of duplex in patients with FSGS without nephrotic syndrome demonstrated greater proteinuria reduction, and nominally significant slowing of EGFR decline. At ASN, we also presented the final two-year results from Spartan where newly diagnosed patients treated with Vilspari as first-line therapy achieved substantial and sustained proteinuria reductions with 75% achieving complete remission at least once and stable kidney function over two years without immunosuppression. Biomarker analyses from SPARTAN also clearly demonstrated reductions in markers associated with inflammation and fibrosis. Importantly, new analysis from the randomized Phase III PROTECT study confirmed the activity seen in SPARTAN. The results demonstrated reductions in biomarkers associated with macrophage activation, inflammatory and immune-mediated cytokines, and complement related pathways compared with erbisartan. Taken together, this growing body of evidence supports a broader understanding of filspari's kidney targeted and disease modifying mechanism, one that extends to address multiple pathways involved in kidney injury and disease progression without systemic immunosuppression. Our recent interactions with nephrologists at scientific congresses reinforce the clinical importance of these findings. We are hearing growing recognition of PhilSparry's differentiated dual mechanism, particularly as treatment goals evolve toward complete remission of proteinuria and long-term preservation of kidney function. In FSGS, there's also increasing appreciation for PhilSparry's potential podocyte protective effects across different forms of the disease. Our new patient-reported outcomes analyses from Duplex further reinforce the clinical relevance of these goals. demonstrating an association between lower proteinuria and improvements in measurements of quality of life. Looking ahead, we are advancing additional studies to further strengthen Filspari's evidence base across IgA nephropathy and FSGS. Enrollment is complete in SPARCS, our study evaluating Filspari in patients with recurrent FSGS and IgA nephropathy following kidney transplantation. And we anticipate sharing data in 2027. We are also on track to initiate SPARlight later this year, a phase four study evaluating Silspari in adults and pediatric patients of African ancestry with FSGS who are at risk of disease progression. Turning to PEGtobatinase, our medical affairs and clinical teams have expanded engagements with metabolic centers and investigators to support patient identification and enrollment in our phase three Harmony study. We have made substantial progress with enrollment, reinforcing our confidence in delivering top-line results in the second half of 2027. Our conviction in PEG-tobatinase is supported by the Phase 1-2 COMPOSE study, which demonstrated approximately a 67% mean relative reduction in total homocysteine, the key toxic metabolite responsible for the multi-system complications of classical HCU. By addressing the underlying metabolic defect associated with CBS enzyme deficiency, PEGtobatinase has the potential to become the first disease-modifying therapy for classical HCU, which would offer a meaningful new treatment option for patients living with this rare disease. Finally, turning to Sivorebrutinib, we are making good progress advancing this exciting program toward U.S. clinical development. What attracted us to Sivorebrutinib is its potential to offer a differentiated approach to treating immune-mediated kidney diseases. While many current and emerging treatment strategies rely on broad immunosuppression or B-cell depletion, often requiring IV administration, Sivorebrutinib targets BTK signaling, a key pathway involved in B-cell activation and autoantibody production without directly depleting B-cells. Thivaribrutinib is an oral, highly selective covalent reversible BTK inhibitor with the potential for rapid and sustained immune modulation. Importantly, we've already seen encouraging clinical proof of concept in primary membranous nephropathy with rapid and substantial reductions in anti-PLA2R antibodies followed by meaningful reductions in proteinuria. We believe this combination of targeted mechanism convenient oral administration, and early clinical activity provides a compelling foundation for development across multiple immune-mediated kidney diseases, including primary membranous nephropathy, immune-mediated FSGS, and minimal change disease. We anticipate submitting a US IND by year-end to support additional dose evaluation and inform our development strategy. In parallel, we're conducting study feasibility assessments and planning for future late-stage clinical studies, with FDA engagement expected to help shape global development pathways across our priority indications. I'll now turn it over to Chris for the financial update. Chris?

Thank you, Jula. Our third quarter results reflect continued strong execution, with net product sales reaching a new high as we bring PhilSparry to more patients with IJ nephropathy and FSGS. Alongside this commercial progress, we continue to advance our pipeline during the quarter, building additional opportunities to serve patients and create long-term value alongside and beyond PhilSparry. Starting with commercial performance, we generated $220.2 million in total U.S. net product sales in the third quarter. The significant increase in net product sales was driven by PhilSparry performance in the U.S., the building revenue from IGN nephropathy, and the first significant contributions from the recently approved FSGS syndication. U.S. net product sales of PhilSparry grew approximately 120% year-over-year to $200.2 million. From a gross-to-net perspective, PhilSparry had a one-time benefit of less than $2 million during the quarter. And looking ahead, we continue to anticipate higher discounts in the fourth quarter and full-year gross-to-net discounts for PhilSparry to be in the mid-20% range. Iola and Viola EC also contributed $20 million in U.S. net product sales during the third quarter. From a licensing collaboration revenue perspective, we recognized $4.4 million for the quarter, resulting in $224.6 million in total revenue for the third quarter. Total GAAP, R&D, and SG&A expenses for the quarter were $168.7 million, which includes approximately $23.8 million in non-cash, stock-based compensation, and depreciation expense. Year-over-year increase in R&D expense is primarily driven by increased enrollment in the Phase III Harmony Study. and manufacturing activities for PEG-2 hepatitis during the quarter. For SG&A, the year-over-year increase is primarily attributable to investments until SPARES launch in FSGS, including the expanded field team, as well as investments in our foundational positioning and IJ nephropathy. During the quarter, we recognized $113.1 million in IPR&D expense. This was related to the upfront payment of $112.5 million in related costs for the closing of the Everest licensing agreement that occurred in the third quarter. Royalty expense for the quarter was approximately $8 million, which reflects Viola Royalty's expense for the quarter, as well as the amortization associated with contractual milestones and royalty payments related to Fils Pari that are capitalized to intangible assets and amortized on a straight line-based and surrogate accounting line. As of September 30, 2026, we had cash, cash equivalents, and marketable securities of approximately $471.8 million. Our growing revenue base and strong cash position provide a solid foundation to support PhilSparry's continued growth and advance our pipeline with current resources. We will continue to invest with discipline, prioritizing opportunities that can make the greatest difference for patients and creating lasting value for our stakeholders. Before turning the call back to Eric, I'd like to take a moment on behalf of the executive team to recognize his leadership and the strong foundation he has built at Travere. Eric, thank you for your partnership and your unwavering commitment to patients and a privilege to work with you. I'll now turn the call over to Eric for his closing remarks. Eric.

Thanks, Chris. As I reflect on the progress we've made this year, I am incredibly proud of what our teams have accomplished and the consistency with which they continue to execute. We have built a company with a growing commercial franchise, an exciting pipeline, and the capabilities to deliver meaningful progress for patients. As Travere enters its next chapter, I have tremendous confidence in my colleagues and their ability to build on this momentum, creating a stronger future for the company and, most importantly, for the rare disease communities we serve. I want to close by returning to the HHS Kidney Care National Plan, which I believe reflects an important shift in how we approach kidney disease in this country. For the first time, rare kidney disease is receiving this level of federal attention with a focus on earlier detection and intervention. If we can translate that ambition into action, more patients with diseases like IgA nephropathy and FSGS could be diagnosed earlier and have the opportunity to benefit from treatment before irreversible damage occurs. For Travere, this represents another potential source of long-term growth, but for patients and families, it represents something far more important, the possibility of earlier answers, more treatment options, and a better future. That is what has always inspired our work at Travere, and it is why I am so confident in the company's chapter ahead. Thank you for your continued interest in Travere, and with that, operator, we can open the call up for Q&A.

Thank you. At this time, if you'd like to ask a question, press star, then the number one on your telephone keypad. To withdraw your question, simply press star one again. As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the queue. We will now take the first question from the line of Anupam Rama with JP Morgan. Your line is now open.

Hey guys, this is Joyce on for Onupom.

Thanks for taking our question and congrats on the quarter. I know you've talked about conversion of patient start form to paid script in FSGS benefiting from having the IGAN approval, but naturally still taking a bit of time since it's still early in the launch. Could you talk about what you're seeing in terms of time to pay script? for FSGS this quarter, and how is that tracking relative to your expectations? Thank you.

Great. Thank you so much for the question, and Peter, I'll turn that one over to you.

Yeah, I have to take that question. What I had mentioned during the approval call of FSGS, that we were expecting a faster uptake in conversion relative to the IGI nephropathy launch, and that's exactly what we are seeing. I'm very happy with that most of the payers have already included Phil Spirey now in FSGS specific formularies. And also, if I look at the time to conversion, we're almost at the same level as IGN Property today. So very rapid progress. And yeah, I think the team is doing a fantastic job here.

Your next question comes from the line of Tyler Van Buren with TD Cohen. Your line is now open.

Great. Hey guys, thank you. And Eric, congratulations on an incredible career and all of your accomplishments. With respect to the question, Phil's party sales obviously look great, and obviously that's of most importance. The seasonality of PSFs in Q3 was forecasted. But what have you seen in September, October, and what do you envision PSF growth to look like moving forward as you think about that translating to long-term sales growth and being a driver of revenue? And how do you envision the sequencing of new treatments in the IGAN market to progress?

All right, Tyler, first, thank you very much for your kind words. And I think there are three questions, so I'm going to cover them first. We'll start with sort of the most recent. What are we seeing in October? What I would say for October is it's still early in the SSGS launch, and we're obviously seeing a lot of increased dynamism within the IGAM market, both of which we believe not only favor better treatment for patients, but also we think that we are very well suited for continued demand. We're not going to be providing intra-quarter trends. What I would say is that we continue to see strong demand in both indications and our metrics overall continue to support What we're hearing from nephrologists around their enthusiasm that continues for Filspari, even with the dynamics in the IGN of property market. And importantly, as we look longer term, everything that we're seeing, including in October, are aligned with our long-term goals of achieving $3 billion by 2033. I think your second question, and Tyler, please correct me if I didn't capture it correctly, is what do we foresee in terms of demand moving forward? Is that right?

Yep, yep.

Okay. Yeah, so as we think about moving forward, what I would say is just reinforcing the same aspect of the FSGS market, we're just getting started in terms of reaching these patients, educating nephrologists, activating patients, and also there's a lot of evolution within IG nephropathy. We're not going to be providing projections on patient start forms. What I can say is that we are very confident in our ability to continue to generate strong demand in both indications. You know, if we look specifically at FSGS We saw and expected a very rapid uptake that was not just some of the pent-up demand that we saw earlier. This was very much around the excitement of reaching patients and treating them with dilspari. And we expected that accelerated adoption curve and then a sustained demand moving forward. is very in line with our expectations. With IG Nephropathy, it's a very dynamic market. PhilSparry will maintain its foundational positioning. And we do expect that we're going to continue to see strong demand moving forward but there will be some variability as nephrologists' time just to meet with more companies is going to be constrained. These are all things that we've anticipated, but they do not undermine the strength and the outlook for Phil Sparey. So I hope, Tyler, that gives you a sense of sort of how we're thinking about the evolution and the demand. And I'm sure, you know, Peter will speak more to that in the Q&A. The third question was around patient segments. Is that right?

Yeah, sequencing of nutrients.

Yeah, okay. Patient sequencing. So this I think is maybe the most important that I want to convey because I've been doing this for decades and I understand physician behavior and how they absorb new information and how that translates into behavior change. If there's one thing as I reflect on my career, I come at this very uniquely as a behavioral scientist. This is something that I really understand. So let me share with you my perspective, and then I'll invite Peter and Jula to give any further color. When we look specifically at IG nephropathy, because sequencing really is around IG nephropathy, we look at two segments of patients. Those patients that are higher risk, and we've characterized that as about 30% of patients that are higher risk oftentimes characterized by higher proteinuria levels above 1.5 grams and oftentimes have more rapid progression of EGFR. Historically, those patients have been started initially with steroids or immunosuppressants because that's how nephrologists think about making sure that they can get these patients under control. Once they have that, that's where they begin to optimize kidney-directed care like Filspari and SGLT2s. That's been this sequencing that has taken place to date. And that likely is going to be the same, but B-cell therapies will replace and are replacing the historic roles of steroids. When we look at the need for something like Filspari in the segment, these are the patients that need combination most. So ultimately, many of these patients, as we forecasted and are starting to see, are on that combination. And we hear the same thing probably that many of you do, that investors are appearing from nephrologists that the ideal combination moving forward is Filspari and SGLT2 and a B-cell therapy. These are the patients that need it most. When we look at the second segment of patients, that's about 70% of patients, and they're lower risk, but still at risk of progressing to kidney failure. This is where we've been growing most. and this is really where we are excited about the new evidence that Jula's team have generated showing that when you can reach patients earlier with Filspari, you have astounding results. 75% of patients get to complete remission if you can get these patients on Filspari before seeing a RAS inhibitor. And so we really do see that that's likely going to be the sequence moving forward is getting patients kidney directed care get them under control. And for those patients that may need more, that may be where they're adding an immune suppressive therapy like a B-cell therapy. But if we take a step back and we look at the outlook for filspore in both of those segments, The sequencing may be different for some patients or how some nephrologists sequence differently, but at the end of the day, the combination of a B-cell therapy and Filspari is fully aligned with what the Cadego guidelines now recommend, and it gives us great confidence that we will play a very important role in better care for IgG nephropathy patients. Tyler, I know that was a very long question. Hopefully, I answered. I hopefully addressed your questions.

No, that was great. Thanks so much.

Thank you.

Our next question comes from the line of Laura Chico with Wedbush Securities. Your line is open.

Hey, good afternoon. Thanks very much for taking the question. Congratulations, Eric. Definitely going to miss you there. I guess one just related to the PSF question, a follow-up. Could you just clarify if you were seeing sequential growth in the IGAM segment on the PSF? and then, you know, Peter made a number of comments about the durability of patients on Silspari. Could you expand on perhaps how treatment duration looks like in FSGS thus far compared to IGAN at that point in the launch? Thank you very much.

Thanks so much, Laura. Yeah, I'll hand those questions over to Peter.

Yeah, I thank Laura for that question. What we have commented earlier is that we are not breaking out the performance by indication. Having said that, I want to give a little more color here. On FSGS, we saw slight sequential growth from the second quarter to the third quarter. And while eigen demands remained high, we saw a small decrease relative to Q2. I think that is consistent to our expectations. One, because of the summer seasonality, but also since we saw a little bit of demand in the second quarter, and that's why I'm really pleased with the continuation of the sequential growth that we saw in the third quarter for FSDS. I think Eric was talking earlier about the dynamic market of IGA nephropathy. where physicians are increasingly considering the sequencing and accommodation therapy. And I think Eric clearly outlined the different patient segments that we see and how we think about the continuing opportunity for Phil Spirey as a fundamental part of the treatment paradigm. And in FSGS, it's early in the loss. And we are seeing that across the different segments. And I was mentioning in the prepared remarks primary, secondary, unknown cause, but also genetic that we see utilization across the different segments. And as we saw in the initial eigen months, we also see the initial utilization in FSDS is for the higher proteinuria targets. but we see slowly moving that towards the left to like less high proteinuria targets. So very consistent to our expectations and overall I'm really happy with the strong demand that we saw in the third quarter.

And durability, Peter, do you want to talk a little bit more about what you're seeing in terms of the durability of patients on both?

Yeah, I'm sorry I missed that question, Laura. So overall, what I've spoken about in the past is the high compliance rate as well as the consistency and the persistence of patients on Vilspari. We don't see changes in trends there, as you would expect, because, like, other therapies are complementary and not competing with Vilspari. With regards to the B cells, we often hear that this is added on top of Vilspari rather than instead of Vilspari, very consistent to the Cadego guidelines and very consistent to our expectations.

Yeah, thank you, Peter. And maybe one thing that I'll just add there because it's implicit, but I want to make it very explicit. We do not see a change in trend of switching away from Silspari. So you may have some baseline rate of switches, et cetera, over time. This has been consistently low, even with the new entrants, which further reinforces that the likely sequencing and treatment algorithm is going to be combination, not switching from a kidney directed to immune, et cetera.

Super helpful. Thank you, Eric. Thanks, Peter.

Thanks, Laura.

Your next question comes from the line of Joe Schwartz with Lear Inc. Partners. Your line is open.

Great. Thanks for taking my question, and thanks for the great leadership, Eric. Given the Falspari label goes down to age eight, we were wondering what share of FSGS start forms are pediatric now, and is pediatric access proving to be any different from adults on anything such as the gross-to-net or REMS logistics?

Great questions. Thanks, Joe. Peter, I'll turn those over to you.

Yeah, overall, I would say the utilization in pediatric patients is consistent to what we saw in the duplex trial. Up to 10% of the patients are pediatric, and that's what we see in the commercial utilization so far as well.

Yeah. Any difference in access, Peter?

No difference in access between pediatric and adult patients. I would say overall, very happy with the rapid progress that our national account team has been made with payers. And we see utilization consistent to the label. And like I said, there's no difference between pediatric patients and adult patients.

All right, thanks.

Your next question comes from the line of Gavin Clark Gartner with Evercore ISI. Your line is now open.

Hey, guys. Thanks for taking the question. We'll add my congrats and well wishes to Eric as well. So we're just trying to back solve versus the revenue you reported. We're calculating around 80%, maybe a bit above 80% conversion rate for the FSGS PSFs, which seems to be in line with other rare disease analogs. I know you're not reporting explicitly, but are you able to say if we're in the right range there?

It's tough to be able to give you specifics because we are not commenting on some of those, but I would say it's largely within the range, and those things could evolve over time as we look at continuing growing access, etc. So what I would say, just taking a step back, is we are very pleased, and I'll just reinforce, Peter, I think what you said, which is the conversion rate that we're seeing now and time to conversion is close to reaching what we're seeing with IGAN. Still some room to improve. We want to do everything possible, but, you know, largely in line. So maybe what you assume for IGAN is close to what we have for FSGS.

That's helpful.

Chris, anything else you want to add to that? Okay.

Your next question comes from the line of Prakur Agrawal with Cantor Fitzgerald. Your line is open.

Thank you so much for taking my questions, and congrats, Eric, as well, and my wishes to you. So maybe on 4Q as well, the trends that you're seeing seems like you have used dynamic and evolving eigenmarket a few times in prepared remarks and Q&As. Maybe if you can just comment on, given what you're seeing in IGAN plus SSGS still early in the launch, do you still expect PSFs to grow sequentially in 4Q? If you could just comment on that, that would be super helpful. And maybe secondly, on the pipeline, can you talk about the next steps there and the indications that you are trying to prioritize? Thank you so much.

Sure. Thanks, Prakhar. I'll take the first one around what we are expecting for Q4. I'll have Jula talk about next steps for stevorabrutinin. Prakhar, I just want to remind that we don't provide guidance on PSS, I think, you know, with regard to, which I know you're not specifically asking, but with regard to, you know, what's the magnitude of growth? We do believe that we have strong opportunity to continue to reach more patients both with IGN nephropathy and with FSGS. As I mentioned, we see strong demand in October. Our teams, most importantly, this is about execution. How do we make sure that we continue every day to reach nephrologists and help them reach their patients, whether it's with IG nephropathy or FSGS? So we've got two months to go. Peter's team is absolutely ready to make sure that we're doing all we can. and the opportunity is there and the trends are there. So I will leave it at that in terms of what our expectations are is our expectations are very strong for continued demand. But it's important also as we have a durable business that we continue to convert quickly. and we keep these patients on. All three of those things are very, very important as we think about the strong revenue outlook that we have for Phil Sparry. I will reiterate that, you know, we could see variability quarter to quarter, but everything that we see thus far are very aligned with our internal planning assumptions. Peter, anything else that you want to comment on?

No, I think you commented well, Eric.

Okay. Thanks, Peter. Jula?

Yeah. For ceferebrutinib, our next step is to open the US IND, and that's planned for this quarter. We're also planning, and what that would enable us to do is to generate additional bridging PKPD data, and subsequently to align with the FDA on the development plans going forward. As I mentioned on the call, we're also working on feasibility and plans for our late stage programs. And as we've said, Memberness is likely going to be the first program because we have preclinical data. We're also prioritizing FSGS and minimal change disease. And based on the mechanism of action, we do have plans to develop an additional indication, but we haven't released those yet.

Your next question comes from the line of Egal Nachamuvitz with Citi. Your line is open.

Hi, this is Caroline Onfigal. Thanks for taking our question. You touched on KOL feedback regarding the ASN updates. Can you tell us more about how nephrologists are reacting to the two-year spartan results specifically? Do you believe these data increase the likelihood fulcibari is used earlier following diagnosis? Thanks.

Thanks, Caroline. Jula, why don't you take that question?

Yeah, we were really pleased about the data we were able to present at ASN because it really supports the kidney targeted and disease modifying effects of Filspari. And as you commented, the data resonated really well with nephrologists because they previously asked the research questions, where should we use different agents? Where should Filspari be used? And this helps to support the utilization of Filspari earlier in the treatment paradigm with great outcomes. As I mentioned on the call, you use Filspari in treatment-naive patients, you get about 75% of patients to complete remission and stabilization of EGFR. That, in combination with the biomarker data, both from Spartan as well as Protect, further solidifies You use Svilspari earlier, you tend to have better outcomes in these patients. And that really does, as you heard from Eric, use early, particularly in treatment-naive patients, you see even better outcomes. And that resonated quite well at ASN.

Thank you. Your next question comes from the line of Saidiya Raman with Wells Fargo. Your line is open.

Hi, thanks for taking the question and congrats on a great quarter and also want to add my congratulations on your career, Eric. My question is on the free drug programs for filspari, the Quick Start and Bridge programs that are being used, how they're being used in FSJS. And I think there was a recent change with extending that program to now 12 months. So just trying to understand how we should think about the rate of conversions with that program in place. Are you expecting that change to help convert more patients to paid drugs? Thanks.

Thanks, Adria. Peter, I'll turn that one over to you.

Yeah, happy to provide some sort of call on that one. We do have a free drug program, especially for patients early on. in the launch, as payers may not have yet evaluated the formularies for FHGS. This is consistent with how we have done it for IJ nephropathy. To my earlier point, I mean, we see high levels of conversion to paid products. But we also have a paradigm that no patient is left behind. So every patient, we want to make sure that they have access to the drug and that it doesn't take too long because time is kidney. So we do have that program. But overall, I would say we see a strong trend of converting patient start forms to paid scripts. And yeah, very pleased with that.

Your next question comes from the line of Alex Thompson with Stiefel. Your line is open.

Hey, great. Thanks for taking our question. Maybe another one about membranous nephropathy. I guess, you know, Parasol had a meeting back in September to discuss membranous nephropathy. I'm curious if, Julie, you could provide some, you know, color on what was discussed and sort of what the next steps are for membranous nephropathy for Parasol. Thanks. Thanks, Alex. Sorry, Julie, we'll turn it over to you. Sorry.

Similar to the other parasol projects, really the goal is to understand what biomarkers are associated with really the long-term kidney outcomes, whether it's GFR decline or kidney failure. And essentially looking at proteinuria and then ideally to look at other biomarkers, phospholipase A2 antibodies, for example. It is earlier in the stage of this program with regards to looking at that. What they've seen is that clearly proteinuria, as we know that's an agreed upon endpoint with the agency, does predict future declines in GFR decline and kidney failure. It's too early to say other biomarkers. That's partly because the data sets, they still need to aggregate them and bring them together to look at other endpoints that potentially could be used either for accelerated or for full approval. So more to come over time as more people generously donate some data to be able to look at this further.

Your next question comes from the line of Vamil Devon with Guggenheim Securities. Your line is open.

Yeah, thanks for taking the question. I hope you can hear me. It's a little loud. Well, I have the first question on the IGAM space. and I'm just curious if you can talk about their ERA market shares or think about Sospari versus Atrasentin and how that's evolved in the past year or so. And then my second question, one thing we were impressed by at ASN was just how even the patients on the April baths seem to still have pretty significant residual proteinuria post, after nine months or two years. So maybe you could just talk about how you see that evolving in terms of the need to keep giving something like Sospari on top of the April baths over time on the proteinuria side. Thanks.

Thomas, thanks so much for the questions. Peter, why don't you take the first one on evolution of the ERA, and Julie, you can take one on the combination B-cell residual proteinuria.

Peter? Yeah, thanks, Daniel. I would say overall, PILS-Pyri remains the preferred endothelin inhibitors across the IJ Nephropathy Patient Population. What I frequently hear from physicians, most recently at the AFN Kidney Week, is that one pill versus an add-on matters for patients, and also the efficacy profile of filspary versus artrosocamp I think is beneficial for filspary. So we see continued more utilization for filspary relative to the alternative.

Thanks, Peter. Jula?

Yeah, and Vamal, thanks for that commentary. We know that proteinuria is bad. That's why it's agreed with the agency to be utilized as a biomarker for approval for patients with IgA nephropathy. And the radar data says any proteinuria is bad. So that's why we, the KDGO guidelines have evolved to say, ideally, you get patients to complete remission of proteinuria to less than 0.3 grams per day. and we know that no agent gets all patients there. As you commented, the Sibimprinlimab data at two years, about 22% of patients got to complete remission. At least a fair number of patients who still have residual proteinuria that puts them at risk for longer-term outcomes as well as the cardiovascular risk associated with having proteinuria. As I said earlier, if you use for sentential sparring early in the treatment paradigm like we saw in Spartan. You get nearly 75% of patients into complete remission. But again, that's not 100%. So the future paradigm, which is aligned with KDGO, is you're likely going to need to use combination therapies for these patients to reduce their lifetime risk of kidney failure as well as their long-term cardiovascular risk. So it is going to be important and Eric highlighted the potential sequencing that may change over time and evolve, but it's really not that different. Patients at high risk and have residual proteinuria, they're likely going to need multiple agents to reduce their risk until SPARI offers the kidney-targeted nephroprotective benefits compared to a maximum-dosed erbosartan.

Your next question comes from the line of Jason Zemanski with Bank of America. Your line is open.

Good afternoon. Thanks so much for taking our question. Congrats on the progress, and Eric, it's been a pleasure working with you, and best wishes on what's next. Maybe to connect a few of the previous dots on the sequential eigentrends you noted, appreciating the no details, but qualitatively, Can you speak to how much of this reflects seasonality and pent-up second quarter demand versus the multiple BAF April companies competing for nephrologist time with new patients, including those below 1.5 grams who start on a BAF April 1st and then maybe secondarily for those patients who do need the added benefit of a kidney sparing regimen? How challenging is it adding Filspari on top of the April BAF? especially with payers and is this going to be a barrier moving forward and when does it sort of alleviate? Thanks.

Thanks so much for the comments, Jason, and the questions. Peter, why don't we go through the first, how are we seeing with regard to the Q3 versus Q2 on seasonality versus competing for time?

Yeah, very good, Jason. Thanks for that question. And I did write down three different questions, so let me try to answer that in the right order. So, I mean, seasonality is a fact. We know that less FSGS and IgA patients see their physician during the summer months. We have seen it in the past, and so in that context, I think the number that we had in patient start forms, I'm actually very pleased with that. The other part of your question was like how many patients below 1.5 do you see filspary relative to April and April bath? I would say where we see most utilization of the B cells is in the higher proteinuria levels. And I think Eric was speaking to that earlier on as well. I think Jula was commenting on that. That means that in the sequencing as physicians are considering like how do I sequence and when do I combine? Some of those patients, a physician may decide to go initially to a B-cell, which doesn't mean that that patient is not a filspary candidate over time, because to Jula's point, the vast majority of those patients still have residual high proteinuria. More specifically on your question below 1.5, I think that's where filspary has really made its inroads. I mentioned in the prepared remarks that The vast majority of patients on FilSpari, FilSpari is the first branded therapy. So they are naive to therapies approved for IgA nephropathy. If you compare it to B cells, it's about half. So B cells are mostly added after they have tried other branded therapies. Your third part of the question was with regards to the payer and how does the payer have an appetite to reimburse filspary after a B-cell. I would turn that around because you build upon a strong base of filspary patients already. And what I'm hearing, what I heard clearly at ASN, many of the B cells are actually added on top of filspirase. Filspirase is still the preferred kidney targeted medicine. And especially when you think about like early in the disease when filspirase is added, but they still don't have residual, they still have residual proteinuria, they could add a B cell. So overall, I think reinforcing what Eric said earlier about the patient segments, the sicker patient population, you may see initial sequencing on B cells. Those patients still remain a candidate for filspary. We see that in practice, and we don't really see a pushback from players. But more importantly, in the lower protein area target, where most of the patients reside, over 70% of the patient population, Phil Sparry has a very strong established position. And the first change physician makes is to change RAS inhibitor for Phil Sparry. So I feel that we have strongly positioned there.

Great. Thanks for the color.

And our final question comes from the line of Mari Raycroft with Jefferies. Your line is open.

Hi, thanks for taking my question, and I'll add my congrats, Eric, on your great tenure at Travere and wishing you all the best going forward. For FSGS, wondering if you can comment on the share of your FSGS patients who are on the 800 mg dose, and how quickly are patients titrating up to that dose, and what proportion of patients are able to maintain the 800 mg dose?

Maury, thanks so much for the comments and the questions. Peter, I'll turn that last question to you.

Thanks, Eric, and Maury, thanks for that question. I would say it's still early in the launch, but what we are seeing so far, I'm really pleased with the compliance and the persistence, including the titration up to the 800 milligram where appropriate. Having said that, we also know that not all patients will stay on the 800, but overall, very pleased where we are, and I would say consistent to what we saw in the duplex study.

Got it. Okay, thanks for taking my question.

Ladies and gentlemen, this concludes the question and answer session of today's conference call. I'll hand the call back over to Ryan.

Thanks all for joining today's call. Have a great rest of your day.

Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.