Travere Therapeutics, Inc. (TVTX) Q3 2026 Earnings Call Transcript

Operator: 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.

Nivi Nehra: 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 Christopher Cline, our chief financial officer. William E. 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 2000. 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. 11/02/2026. 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.

Eric Dube: Good afternoon. 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 would like to briefly reflect on my upcoming transition that was announced during the quarter. As I prepare to step down in December, I have 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 have 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 have been in regular communication with Bradley as we plan for him joining Travere on December 1. 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 will hear that reflected in the progress we are sharing today. With that, let's turn to the advancements we have made for the quarter. The third quarter was marked by excellent execution across our business and continued progress against our 4 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 Filspari, where strong patient demand growing conversion and consistent commercial execution supported significant revenue growth across IgA 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 IgA 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 FilSPARI's long-term growth potential. In FSGS, we remain encouraged by the early launch performance. with high adoption trends consistent with our expectations. We are still at the beginning of this opportunity and see substantial potential to reach more eligible patients as nephrologists gain experience with FILSPARI. And Peter will provide additional details shortly. This continued commercial momentum reinforces our confidence in achieving or exceeding more than $3 billion in annual FILSPARI sales by 2033. We have also made important progress strengthening FILSPARI's U.S. Patent portfolio including a recently issued patent directed at certain methods of use in IgA nephropathy, and a notice of allowance for a patent application directed to certain methods of use in FSGS. The IgA nephropathy patent and upon issuance, the FSGS patent carry terms extending into 2037. Taken together, this commercial momentum and progress in our patent portfolio reinforce our belief in Filspari'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 FILSPARI, 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, Pegtibatinase represents an important opportunity to improve the lives of the estimated 7 thousand to 10 thousand people in the U.S. living with this devastating disease. Jula will share more on the progress of this important program shortly. We are also advancing our newest pipeline asset, Civorebrutinib. 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 thousand prevalent patients adds another compelling dimension to our long-term growth strategy. As I look at Travere 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 will turn the call over to Peter for an update on our commercial performance. Peter?

Peter Heerma: Sorry about that. Thank you, Eric. The third quarter, we received 1.93 thousand new-patient start forms across IgA nephropathy and FSGS. Reflecting continued strong 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 pay therapy and high patient adherence allowing us to add meaningful numbers of new patients on an already substantial and growing base of patients on FILSPARI. The combination of our expected new patient demand strong conversion, and patient persistence now across 2 indications, puts us well on track to achieve or exceed $3 billion in sales by 2033. Let me start with providing some further color on IgA nephropathy. FILSPARI remains the most prescribed medicine approved for IgA nephropathy, reflecting its differentiated profile and foundational role in treatment. As additional therapies become available and this market evolves, physicians are increasingly considering how to sequence and combine treatment options. We believe FILSPARI is well positioned to remain an important part of these evolving treatment strategies. We continue to see new patient start forms coming from repeat prescribers as well as new physician activation. The vast majority of FILSPARI prescriptions are for patients that have no prior experience with branded therapies. And market research indicate that FILSPARI is considered appropriate for more patients than any other branded high-end medicine. This reflects the confidence that physicians have in FILSPARI's differentiated profile and how it is broadly applicable for their IgAN patients. Within the dynamic and rapidly evolving treatment paradigm, we believe FILSPARI is well established as kidney-targeted treatments, replacing RAS inhibitors consistent with the KDIGO guidelines. As new immune directed therapies replace historical options, we expect these to address the immune mediated processes upstream into the 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 FILSPARI 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 proteinuria below 1.5 grams per gram. This segment represents approximately 70% of the IgAN population. And FILSPARI is well positioned to continue to penetrate these segments. 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 IgAN market 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 start forms. But we see an enduring fundamental role for FILSPARI which reinforces our confidence in a substantial long-term opportunity in this patient population. Turning to FSGS, 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 2-thirds of the nephrologists who have prescribed FILSPARI for FSGS have treated just 1 FSGS patient since launch. FILSPARI's potential use spans eligible adults and children aged 8 and older without nephrotic syndrome. Including patients with primary, secondary, genetic, and unknown-cause of FSGS. Initial prescribing has focused on patients with higher proteinuria across the segments, 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 the nephrologists about the important and broad role that FILSPARI plays in the treatment of FSGS. We expect that the availability of an approved treatment can encourage greater diagnostic evaluation. Including biopsy, 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 FILSPARI for FSGS. And we expect further progress through the end of the year. With strong demand and conversion, we reported approximately $200 million in FILSPARI 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. Looking ahead, we see significant opportunities for FILSPARI as we remain in the early stages of reaching the more than 100 thousand addressable patients with IgA nephropathy. FSGS. Our commercial focus remains on continuing to strengthen FILSPARI's position as a kidney-targeted treatment. Broadening our prescriber base and supporting physicians as they gain experience with FILSPARI 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 will turn the call over to Jula for the medical update. Jula?

Jula Inrig: Thank you, Peter. I will start with FILSPARI. 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 mesangial cell proliferation. While also protecting the glomerular endothelial glycocalyx and podocytes. Key structures involved in maintaining the kidney's filtration barrier. These findings have been supported by our clinical development program in the randomized phase 3 PROTECT study in IgA nephropathy, FILSPARI demonstrated superior proteinuria reduction. And slower eGFR decline compared with maximally dosed irbesartan. 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 2 year results from SPARTAN, where newly diagnosed patients treated with FILSPARI as first line therapy achieved substantial and sustained proteinuria reductions. With 75% achieving complete remission at least once and stable kidney function over 2 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 3 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 irbesartan. Taken together, this growing body of evidence supports a broader understanding of FILSPARI's kidney targeted and disease modifying mechanism. 1 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 FILSPARI's differentiated dual mechanism particularly as treatment goals evolve toward complete remission of proteinuria and long-term preservation of kidney function. In FSGS, there is also increasing appreciation for FILSPARI'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 SPARKS, 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 SPARSLITE later this year, a Phase IV study evaluating FILSPARI in adults and pediatric patients of African ancestry with FSGS who are at risk of disease progression. Turning to Pegtibatinase. Our medical affairs and clinical teams have expanded engagements with metabolic centers, and investigators to support patient identification enrollment in our phase 3 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 peggedabatinib is supported by the Phase III study, which demonstrated approximately a 67% mean relative reduction in total homocysteine the key toxic metabolite responsible for the multisystem complications of classical HCU. By addressing the underlying metabolic defect associated with CBS enzyme deficiency, Pegtibatinase 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 rare disease. Finally, turning to Civorebrutinib, we are making good progress advancing this exciting program toward US clinical development. What attracted us to Civorebrutinib is its potential to offer a differentiated approach to treating immune mediated kidney diseases. While many current and emerging treatment rely on broad immunosuppression or B cell depletion, often requiring IV administration, Civorebrutinib targets BTK signaling a key pathway involved in B cell activation and autoantibody production without directly depleting B cells. Civorebrutinib is an oral highly selective covalent reversible BTK inhibitor with the potential for rapid and sustained immune modulation. Importantly, we have already seen encouraging clinical proof of concept in primary membranous nephropathy, with rapid and substantial reductions in anti PLA 2 R 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 U.S. IND by year-end to support additional dose evaluation and inform our development strategy. In parallel, we are conducting steady 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 will now turn it over to Christopher for the financial update. Christopher?

Christopher Cline: Thank you, Jula. Our third quarter results reflect continued strong execution with net product sales reaching a new high as we bring FILSPARI to more patients with IgA 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 FILSPARI. Starting with commercial performance, we generated $220.2 million total U.S. net product sales in the third quarter, The increase in net product sales was driven by FILSPARI performance in the U.S., the building revenue from IgA nephropathy, the first significant contributions from the recently approved FSGS indication. US net product sales of FILSPARI grew approximately 120% year over year to $200.2 million. From a gross to net perspective, FILSPARI had a 1-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 FILSPARI to be in the mid-20 percent range. Thiola and Thiola EC also contributed $20 million in U.S. net product sales during the third quarter. From a licensing collaboration revenue perspective, we recorded $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 3 HARMONY study, and manufacturing activities for Pegtibatinase during the quarter. For SG&A, the year over year increase is primarily attributable to investments in FILSPARI's launch in FSGS including the expanded field team, as well as investments in our foundational positioning in IgA nephropathy. During the quarter, we recognized $113.1 million in IPR&D expense, This was related to the upfront payment of $112.5 million. 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 Thiola royalties expense for the quarter as well as the amortization associated with contractual milestones royalty payments related to FILSPARI that are capitalized to intangible assets. Amortized on a straight line basis over the accounting life. As of 9/30/2026, 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 FILSPARI's continued growth, advance our pipeline with current resources. We will continue to invest with discipline, prioritizing opportunities that could make the greatest difference for patients, and creating lasting value for our stakeholders. Before turning the call back to Eric, I would like to take a moment on behalf of the executive team to recognize his leadership and the strong foundation he had built at Travere. Eric, thank you for your partnership and your unwavering commitment to patients. And a privilege to work with you. Now I will turn the call over to Eric for his closing remarks. Eric?

Eric Dube: Thanks, Christopher. As I reflect on the progress we have 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 and 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 next chapter ahead. Thank you for your continued interest in Travere. With that, operator, we can open the call up for Q&A.

Operator: At this time, if you would like to ask a question, press *, then the number 1 on your telephone keypad. To withdraw your question, simply press *, then 1 again. As a reminder, we ask that you limit yourself to 1 question. If you have another question, please rejoin the queue. We will now take the first question from the line of Anupam Rama with JPMorgan. Your line is now open.

Anupam Rama: Hey, guys. This is Joyce on for Anupam. Thanks for taking our question, and congrats on the quarter. I know you have talked about conversion of patient start form to paid scripts. In FSGS benefiting from having the IGAN approval. But naturally still taking a bit of time since it is still early in the launch. Could you talk about what you are seeing in terms of time to pay a script for FSGS this quarter, and how is that tracking relative to your expectations? Thank you.

Eric Dube: Great. Thank you so much for the question. And, Peter, I will turn that 1 over to you.

Peter Heerma: Yeah. Happy 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 IgA nephropathy. Launch, and that is essentially what we are seeing. Very happy with that most of the payers have already included FILSPARI now, in FSGS specific formularies. And also, if I look at the time to conversion, we are almost at the same level as IgA nephropathy today. Very rapid progress, and, yeah, I think the team is doing a fantastic job here.

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

Tyler Van Buren: Great. Hey, guys. Thank you. And Eric, congratulations on an incredible career and all of your accomplishments. With respect to the question, just Vilspari sales obviously look great, and obviously, that is of most importance. The seasonality of PSFs in Q3 was forecasted. But what have you seen as the 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? Alright.

Eric Dube: Tyler, first, thank you very much for your kind words, and I will. I think there were 3 questions, so I am gonna cover them first. We will start with sort of the most recent. What are we seeing in October? What I would say for October is it is still early in the SSGS launch, and, you know, we are obviously seeing a lot of increased dynamism within the IgAN 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 are 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 are hearing from nephrologists around their enthusiasm that continues for Filspari even with the dynamics in the IgA nephropathy market. And importantly, as we look longer term, everything that we are 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 did not capture correctly, 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 are just getting started in terms of reaching these patients, educating nephrologists, activating patients, And, also, there is a lot of, evolution within IgA nephropathy. We are not gonna 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. 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 Vilspari. And we expect that accelerated adoption curve and then a sustained demand moving forward is very in line with our expectations. With IgA nephropathy, it is a very dynamic market. Vilspari will maintain its foundational positioning. And we do expect that we are 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 gonna be constrained. These are all things that we have anticipated, but they do not under undermine the strength and the outlook for FILSPARI. So I hope Tyler, that gives you a sense of sort of how we are thinking about the evolution and the demand. And I am sure Peter will speak more to that in the Q&A. The third question was around patient segments. Is that right? Yeah. Sequencing of new treatments. Yeah. Okay. Patient sequencing. So this, I think, is maybe the most important. that I want to convey. Because I have 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 is 1 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 will invite Peter and Jula to add any further color. When we look specifically at IgA nephropathy. Because sequencing really is around IgA nephropathy. We look at 2 segments of patients. Those patients that are higher risk, and we characterize that as about 30 percent 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 is how nephrologists think about making sure that they can get these patients under control. Once they have that, that is where they begin to optimize kidney directed care like Vilspari and SGLT2s. that is 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 Tilspari and SGLT 2. And a B cell therapy. These are the patients that need it most. When we look at the second segment of patients, that is about 70% of patients, and they are lower risk but still at risk of progressing to kidney failure. This is where we have 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 is 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 are adding an immune suppressive therapy like a B cell therapy. Therapy. But if we take a step back and we look at the outlook for FILSPARI 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 KDIGO guidelines now recommend. It gives us great confidence that we will play a very important role in better care for IgA nephropathy patients. I know that was a very long question. Hopefully, I answer. Hopefully, addressed your questions. No. That was great. Thanks so much. Thank you.

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

Laura Chico: Congratulations. Eric. Definitely gonna miss you there. I guess 1 just related to the PSF question, a follow-up. Could you just clarify if you were seeing sequential growth in the IgAN segment on the PSF? And then, you know, Peter made a number of comments about the durability of patients on FILSPARI. Could you expand on perhaps how treatment duration looks like in FSGS thus far compared to IgAN at that point in the launch? You very much.

Eric Dube: Thanks so much, Laura. Yeah. I will hand those questions over to Peter.

Peter Heerma: Yeah. Thanks, Laura, for, for that question. We have commented earlier is that we are not breaking out the performance by indication. Gavin said that, I wanna give a little more color here, on FSGS, We saw slight sequential growth from the second quarter to the third quarter. And while eigen demand remained high, we saw a small decrease relative to Q2. Think that is, consistent to our expectations. 1, because of the summer seasonality, but also since we saw a little bit pent up demand in the second quarter, that is why I am really pleased with the continuation and the sequential growth that we saw in the third quarter for FSGS. I think Eric was talking earlier about the dynamic market of IgA nephropathy where physicians are increasing considering the sequencing and the combination therapy, and I think Eric clearly outlined the different patient segments that we see and how we think about the continuing opportunity for filspire as a fundamental part of the treatment paradigm. And in FSGS, it is early in the launch. And we are seeing that across the different segments that I was mentioning in the prepared remarks primary, secondary, unknown cars, but also genetic, that we see utilization across the different segments. And as we saw in, in the initial eigenvalues, we also see the initial utilization in FSGS is for the higher proteinuria targets, But we see a slow. Slowly moving that to. Towards the left to, like, less high proteinuria target. So very consistent to our expectations. And, overall, I am really happy with the strong demand that we saw in the third quarter.

Eric Dube: And the durability, Peter, do you wanna talk a little bit more about what you are seeing in terms of the durability of patients on both Yeah.

Peter Heerma: I am sorry. I missed that the question. Although the I have spoken about in the past is the high compliance rate as well as the consistency and the persistence of patients on FILSPARI. We do not see changes in trends there. You would expect because, like, other therapies are complementary and not competing with filspari. With regards to the b sales, we often hear that this is added on top of sales party rather than instead of FILSPARI. Very consistent to the KDIGO guidelines and very consistent to our expectations.

Eric Dube: Yes. Thank you, Peter. And maybe 1 thing that I will just add there because it is implicit, but I wanna make it very explicit. We do not see a change in trend of switching away from Filspari. So you may have some baseline rate of switches, etcetera, 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, etcetera. Super helpful. Thank you, Eric. Thanks, Peter. Thanks, Laura.

Operator: Your next question comes from the line of Joe Schwartz with Leerink Partners. Your line is open.

Joseph Schwartz: Great. Thanks for taking my question, and thanks for the great leadership, Eric. Gavin the FOLSPARI label goes down to age 8, 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?

Eric Dube: Great questions. Thanks, Joe. Peter, I will turn those over to you.

Peter Heerma: 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 is what we see in the commercial utilization so far as well. Yeah.

Eric Dube: Any difference in access, Peter?

Peter Heerma: A or access to PedNest? 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 is no difference between pediatric patients and adult patients.

Eric Dube: Alright. Thanks.

Joseph Schwartz: Thank you.

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

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

Eric Dube: Yeah. it is it is tough to be able to give you specifics because we are not commenting on some of those. But I would say it is largely within the range. And those things could evolve over time as we look at, you know, continuing growing access, etcetera. So what I would say just taking step back is we are very pleased, and I will just reinforce Peter, I think what you said, which is the conversion rate that we are seeing now, it is time to conversion is close to reaching what we are seeing with IgAN. Still some room to improve. We wanna 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 is helpful. And, Christopher, anything else you wanna add to that?

Christopher Cline: No. Okay.

Operator: Your next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald. Your line is open.

Prakhar Agrawal: Hi. Thank you so much for taking my questions, and congrats Eric, as well, and my wishes to you. So maybe on Q4 as well, trends that you are seeing, it seems like you have used dynamic and evolving eigen market few times in prepared remarks and Q and A. So maybe if you can just comment on given you are seeing in iGAN plus FSGS still early in the launch, do you still expect PFS to grow sequentially in Q4? If you could just on that, that would be super helpful. And maybe secondly, on the pipeline, can you talk about Civorebrutinib and the next steps there and the indications that you are trying to prioritize. You so much.

Eric Dube: Sure. Thanks, Prakhar. I will take the first 1 around what we are expecting for Q4. I will have Jula talk about next steps for Civorebrutinib. Prakhar, I just wanna remind that we do not provide guidance on PSS. I think with regard to which I know you are not specifically asking, but with regard to what is the magnitude of growth we do believe that we have strong opportunity to continue to reach more patients, both with IgA 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 help them reach their patients, whether it is with IgA nephropathy or FSGS? So we have have 2 months to go. Peter's team is absolutely ready to make sure that we are 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 is important also as we have a durable business that we continue to convert quickly and we keep these patients on. All 3 of those things are very, very important. As we think about the strong revenue outlook that we have for Filspari. I will reiterate that 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, Okay. Thanks, Peter.

Jula Inrig: Jula? Jula? Yeah. For Civorebrutinib, our next step is to open the US IND, and that is planned for this quarter. We are also planning, and what that would enable us to do is 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 are also working on feasibility and plans for our late stage programs. And as we have said, membranous is likely gonna be the first program because we have preclinical data, We are 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 have not released those yet.

Operator: Your next question comes from the line of Ygal Nachomovitz with Citi. Your line is open.

Yigal Nochomovitz: Hi. Hi. This is Caroline on for Yigal. Thanks for taking our question. You touched on KOL feedback regarding the ASN updates. You tell us more about how nephrologists are reacting to the 2 year SPARTAN results specifically? You believe the data increase the likelihood FILSPARI is used earlier following diagnosis? Thanks.

Eric Dube: Thanks, Caroline. Jula, why do not you take that question?

Jula Inrig: 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, using FILSPARI in treatment naive patients. You can about 75 percent of patients to complete remission and stabilization of eGFR. That in combination with the biomarker data, both from SPARTAN as well as PROTECT, further solidify you use FILSPARI earlier, and you tend to have better outcomes in these patients. And that really does-- is You have heard from Eric, use early, particularly in treatment naive patients, you see even better outcomes, and that resonated quite well at ASN.

Eric Dube: Thank you.

Operator: Your next question comes from the line of Sadia Rahman with Wells Fargo. Your line is open.

Sadia Rahman: Congrats on a great quarter and also want to add my congratulations on your career, Eric. So my question is on the free drug programs for Vilspari, the quick start and bridge programs. That are being used, how they are being used in FSGS, and I think there was a recent change with extending that program to now 12 months. So I was just trying to understand how we should think about the rate of conversion with that program in place. You know, are you expecting that change to help convert more patients to paid drug? Thanks.

Eric Dube: Thanks, Sadia. Peter, I will turn that 1 over to you.

Peter Heerma: Yeah. Happy to provide some sort of color on that 1. 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 FSGS. Is consistent how we have done it for IgA nephropathy. My earlier point, I mean, we see high levels of conversion to paid products. So but we also have a paradigm that no patients left behind. So every patient, we wanna make sure that they have access to the drug. And that it does not take too long because time is kidney. We do have that program, but, overall, I would say we see a strong trend of converting patient's platforms to paid scripts. And, yeah. Very pleased with that.

Operator: Your next question comes from the line of Alexander Thompson with Stifel. Your line is open.

Alexander Thompson: Hey, great. Thanks for taking our question. Maybe another 1 about Membraneus nephropathy. I guess you know, PARASOL had a meeting back in September to discuss membranous nephropathy. I am curious if, Jula, 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.

Eric Dube: Thanks, Alex. Yes. it is very much a little turn it to you. Sorry.

Jula Inrig: it is 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 is GFR decline or kidney failure. And essentially looking at proteinuria and then ideally to look at other biomarkers like phospholipase A2 receptor antibodies, for example, It is earlier in the stage of this program with regards to looking at that. What they have seen is that clearly proteinuria is. We know that is an agreed upon endpoint with the agency, does predict future declines in GFR decline and kidney failure. it is too early to say other biomarkers. that is partly because the datasets, they still need to aggregate them and bring them together to look at endpoints that potentially could be used either for accelerated or full or for full approval. So more to come over time as more people generate. Generously donate some data to be able to look at this further.

Operator: Your next question comes from the line of Analyst (Vamil Divan): Your line is open.

Vamil Divan: I hope you can hear me a little loud. Well, hey. I am the first question on the IgAN space. And I am just curious if you can talk about their ERA market shares or think about FILSPARI versus atrasentan. And how that is evolved in the, you know, past year or so. And then my second question, 1 thing we were impressed by at ASN was just how even the patients on the BAFF/APRIL therapies seemed to still have pretty significant residual proteinuria. Post after 9 months or 2 years. Maybe you could just talk about how you see that evolving in terms of the need to keep giving something like FILSPARI on top of the BAFF/APRIL therapies over time on the proteinuria side. Thanks.

Eric Dube: Vamil, thanks so much for the questions. Peter, why do not you take the first 1 on evolution of the ERA? And, Jula, you can take 1 on the combination B cell residual proteinuria. Peter?

Peter Heerma: Yeah. Thanks, Vamil. I would say overall, FILSPARI remains the preferred, endothelin inhibitor across the IgA nephropathy patient population at But what I frequently hear from, from physicians, most recently at the ASN Kidney Week, is that 1 pill versus an add on matters for patients, and also the efficacy profile of sales per FILSPARI versus atrasentan. I think it is beneficial for So we see continued, more utilization for filspari relative to the alternative. Thanks, Peter.

Jula Inrig: Jula? Yeah. And, Vamil, thanks for that commentary. We know that proteinuria is bad. The way it is agreed with the agency to be utilized as a biomarker for a for patients with IgA nephropathy. And the RaDaR data says any proteinuria is bad. So that is why the KDIGO guidelines have evolved to say, ideally, you get patients to complete remission of proteinuria to less than zero point 3 grams per day. And we know that no agent gets all patients there. When you. As you commented, the sibeprenlimab data at 2 years about 22 percent 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 FILSPARI early in the treatment paradigm like we saw in spartan, you get nearly 75 percent of patients into complete remission. But, again, that is not 100%. So the future paradigm, which is aligned with KDIGO, is you are likely gonna need to use combination therapies for these patients to reduce their life-long 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 is really not that different. Patients at high risk can have residual proteinuria, they are likely gonna need multiple agents to reduce their risk until FILSPARI offers the kidney targeted nephroprotective benefit compared to a maximum dose irbesartan.

Operator: Your next question comes from the line of Jason Zemansky with Bank of America. Your line is open.

Jason Zemansky: Good afternoon. Thanks so much for taking our Congrats on the progress. And, Eric, it is been a pleasure working with you, and best wishes on what is next. Maybe to connect a few of the previous thoughts on the sequential IgAN trends you noted, appreciating no details, but qualitatively, can you speak how much of this reflects seasonality and pent up second quarter demand versus the multiple BAFF/APRIL companies competing for nephrologist time? With new patients, including those below 1.5 grams. Who start on a BAFF/APRIL therapy, 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 a BAFF/APRIL therapy? Especially with payers? And is this gonna be a barrier moving forward, and when does it sort of alleviate? Thanks.

Eric Dube: Thanks so much for the questions, Jason, and the questions. Peter, why do not we go through the first, how are we seeing with regard to the Q3 versus Q2 on seasonality versus competing for time?

Peter Heerma: Yeah. Very good, Jason. Thanks for the question. And I did write down 3 different questions. So let me try to answer that in the right order. So 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 patients start forms, I am actually very pleased with that. The other part of your question was, like, how many page below 1.5 do you see, first priority relative to a BAFF/APRIL therapy? I would say where we see most utilization of the b cells is in the higher proteinuria 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 does not mean that patient is not a FILSPARI candidate over time because to Jula point, the vast majority of those patients still have residual high proteinuria. More specifically on your question below 1.5, I think that is where FILSPARI 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 is 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 FILSPARI after B cell, I would turn that around because you build upon a strong base of filspiracy patients already. And what I am hearing, what I heard clearly at ASM, many of the b cells are actually added on top of FILSPARI. FILSPARI is still the preferred kidney-targeted medicine, and especially when you think about, like, early in the disease when FILSPARI is added, but they still do not 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 segment, sicker patient population, you may see initial sequencing on B cells. Those patients still remain a candidate for filspari. We see that in practice, and we do not really see a pushback from payers. But more in importantly, in the lower proteinuria target where most of the patients reside, over 70% of the patient population, FILSPARI has a very strong established position and the first change physician makes is to change RAS inhibitor for FILSPARI. So feel that we are strongly positioned there. Great. Thanks for the color.

Operator: And our final question comes from the line of Analyst (Maury Raycroft): Your line is open.

Maury Raycroft: Hi, thanks for taking my question. And I will add my congrats Eric, on your great tenure at Trevere 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. What proportion of patients are able to maintain the 800 mg dose.

Eric Dube: Laura, thanks so much for the comments and the questions. Peter, I will turn that last question to you.

Peter Heerma: Thanks, Eric. And, Maury, thanks for that question. I would say it is still early in the launch, but what we are seeing so far, I am really pleased with, like, the compliance and the persistence, including the titration up to the 800-milligram where appropriate. Gavin 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.

Maury Raycroft: Got it. Thanks for taking my question.

Operator: Thank you. Ladies and gentlemen, this concludes the question and answer session of today's conference call. I will hand the call back over to Nivi.

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

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