Q3 2025 Travere Therapeutics Inc Earnings Call

Speaker #1: Good afternoon and welcome to the Travere Therapeutics . Third quarter 2020 Financial Results conference call . Today's call is being recorded . At this time , I would like to turn the conference call over to Nivi Nehra Vice President , Corporate Communications and Investor Relations .

Nivi Nehra: Good afternoon and welcome to the Travere Therapeutics Q3 2025 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to Nivi Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.

Speaker #1: Please go ahead . Nivi Nehra .

Speaker #2: Thank you . Operator . Good afternoon , and welcome to Travere Therapeutics, Inc. Third quarter 2025 financial results and corporate Update call . Thank you all for joining .

Nivi Nehra: Thank you, Operator. Good afternoon and welcome to Travere Therapeutics Q3 2025 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 Dr. Jula Inrig, our Chief Medical Officer, Peter Heerma, our Chief Commercial Officer, and Chris Kline, our Chief Financial Officer. Dr. Bill Rote, our Chief Research Officer, will join us for the Q&A. Before we begin, I'd 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.

Speaker #2: Today's call will be led by Doctor Eric Dubé , our President and Chief Executive Officer . Eric . And the prepared remarks by Doctor Jula Inrig , our Chief Medical Officer .

Speaker #2: Peter Heerma . Our Chief Commercial officer . And Chris Klein , our two financial officer . Doctor Bill wrote . Our Chief Research officer will join us for the Q&A .

Speaker #2: Before we begin , I'd 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 .

Speaker #2: 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 .

Nivi Nehra: 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 factor 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, October 30, 2025. 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.

Speaker #2: 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 Form 10-Q and 10-K filed with the SEC.

Speaker #2: In addition , any forward looking statements represent our views only as of the date such statements are made . October 30th , 2025 .

Speaker #2: Interviews 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 .

Speaker #3: Thank you . And good afternoon , everyone . The third quarter marked exceptional progress across our three key priorities , delivering strong commercial execution in IGA nephropathy .

Eric Dube: Thank you, Nivi, and good afternoon, everyone. The Q3 marked exceptional progress across our three key priorities: delivering strong commercial execution in IgA nephropathy, preparing for a potential FDA approval in FSGS, and successfully advancing the manufacturing scale-up of pegtibatinase to support restarting enrollment in the pivotal HARMONY study in 2026. The core driver of our performance is FILSPARI's continued growth in IgA nephropathy, where we delivered sustained commercial excellence in the Q3. Physicians continue to confidently adopt FILSPARI as a foundational nephroprotective therapy for their patients. This confidence reflects consistent real-world outcomes, robust long-term data reinforcing FILSPARI's differentiated profile, and its recent inclusion in the KDIGO guidelines for earlier first-line use to optimize nephroprotection in IgA.

Speaker #3: Preparing for a potential FDA approval in FSGS and successfully advancing the manufacturing scale-up of Peg to Betanase to support restarting enrollment in the pivotal Harmony study in 2026.

Speaker #3: The core driver of our performance is Filspari continued growth in IGA nephropathy , where we delivered sustained commercial excellence in the third quarter .

Speaker #3: Physicians continue to confidently adopt Filspari as a foundational nephroprotective therapy for their patients . This confidence reflects consistent real world outcomes , robust long term data reinforcing filspari differentiated profile and its recent inclusion in the Kdigo guidelines for earlier first line use to optimize nephroprotection in Igan .

Speaker #3: Additionally , in August , the FDA approved a modification to the Filspari Rems program , removing the Embryo-fetal toxicity Rems and reducing the liver monitoring frequency to quarterly , which aligns with routine clinical practice and our clinical trial experience .

Eric Dube: Additionally, in August, the FDA approved a modification to the FILSPARI REMS program, removing the embryo-fetal toxicity REMS and reducing the liver monitoring frequency to quarterly, which aligns with routine clinical practice and our clinical trial experience. This change not only simplifies care for physicians and patients but also reinforces FILSPARI's long-term safety profile. Our U.S. performance continues to be complemented by strong progress from our partners globally. In Europe and the U.K., CSL Vifor is expanding access following full regulatory approvals, and the progress has culminated in the recent achievement of a meaningful market access milestone. In Japan, Renalys Pharma has completed enrollment in its registrational trial in IgA and remains on track to deliver top-line data in Q4.

Speaker #3: This change not only simplifies care for physicians and patients , but also reinforces Filspari long term safety profile . Our US performance continues to be complemented by strong progress from our partners globally , in Europe and the UK .

Speaker #3: Kslv four is expanding access following full regulatory approvals and the progress has been has culminated in the recent achievement of a meaningful market access milestone in Japan .

Speaker #3: Renal has completed enrollment in its Registrational trial in Igan and remains on track to deliver top line data in quarter four . The company also reached an agreement with the Pmda of Japan to initiate two phase three trials for Sparsentan in Fsgs and Alport syndrome , and recently announced its planned acquisition by Chugai , a leading innovator in renal and rare disease research in Japan , together , these milestones underscore Filspari expanding global footprint and the growing excitement around its long term potential to transform care for renal rare kidney diseases .

Eric Dube: The company also reached an agreement with the PMDA of Japan to initiate two Phase III trials for sparsentan in FSGS and Alport syndrome, and recently announced its planned acquisition by Chugai Pharmaceutical, a leading innovator in renal and rare disease research in Japan. Together, these milestones underscore FILSPARI's expanding global footprint and the growing excitement around its long-term potential to transform care for rare kidney diseases. Beyond our progress in IgA, addressing the urgent need for an approved medication in FSGS is both central to our mission and represents the next pillar of growth for Travere. Today, there are no FDA-approved medicines for this disease. Patients often experience rapid disease progression, with many reaching kidney failure within just a few years of diagnosis, often requiring a transplant. Even then, the disease recurs in approximately half of transplant recipients. The consequences are devastating for patients and their families.

Speaker #3: Beyond our progress in igan . Addressing the urgent need for an approved medication in Fsgs is both central to our mission and represents the next pillar of growth for Travere .

Speaker #3: Today , there are no FDA approved medicines for this disease . Patients often experience rapid disease progression , with many reaching kidney failure within just a few years of diagnosis , often requiring a transplant .

Speaker #3: Even then , the disease recurs in approximately half of transplant recipients . The consequences are devastating for patients and their families . Earlier and more effective treatment is desperately needed , which is why the opportunity to bring Filspari forward in Fsgs is so meaningful for this community , who have waited far too long in September , the FDA communicated that an advisory committee is no longer needed for our snda and Fsgs .

Eric Dube: Earlier and more effective treatment is desperately needed, which is why the opportunity to bring FILSPARI forward in FSGS is so meaningful for this community who have waited far too long. In September, the FDA communicated that an advisory committee is no longer needed for our sNDA in FSGS. We have been pleased with the progress of our review and our ongoing engagement with the agency to date. Pending approval, FILSPARI will become the first and only approved medication for FSGS, representing a landmark moment for this community and, given the urgent need for an effective, approved medication, a transformational opportunity for Travere. Our teams are fully prepared to execute a rapid launch upon approval, building upon the commercial foundation we've established in IgA nephropathy.

Speaker #3: We have been pleased with the progress of our review and our ongoing engagement with the agency . To date , pending approval . Filspari will become the first and only approved medication for Fsgs , representing a landmark moment for this community .

Speaker #3: And given the urgent need for an effective approved medication , a transformational opportunity for Travere . Our teams are fully prepared to execute a rapid launch upon approval .

Speaker #3: Building upon the commercial foundation we've established in IGA nephropathy beyond Filspari . We have successfully manufactured the first commercial scale batches of Peg to Patanase and are looking forward to an expected restart of the pivotal Harmony study of Peg to Patanase in classical Hcu next year .

Eric Dube: Beyond FILSPARI, we have successfully manufactured the first commercial-scale batches of pegtibatinase and are looking forward to an expected restart of the pivotal HARMONY study of pegtibatinase in classical HCU next year. Pegtibatinase remains a promising, potentially disease-modifying investigational therapy that could address a substantial gap for patients living with this rare metabolic disorder. I'll now turn the call over to Jula for a clinical update. Jula.

Speaker #3: Peg remains a promising , potentially disease modifying investigational therapy that could address a substantial gap for living with this rare metabolic disorder . I'll now turn the call over to Gyula for a clinical update .

Speaker #3: Julia .

Speaker #4: Thank you . Eric . One of the most significant milestones this quarter was the inclusion of dual endothelin angiotensin receptor antagonism in the updated Kdigo guidelines for IGA nephropathy , a strong external validation of Filspari role as foundational treatment .

Nivi Nehra: Thank you, Eric. One of the most significant milestones this quarter was the inclusion of dual-endothelin angiotensin receptor antagonism in the updated KDIGO guidelines for IgA nephropathy, a strong external validation of FILSPARI's role as foundational treatment. KDIGO includes FILSPARI as a first-line option for patients who are at risk of IgA nephropathy progression, recognizing it as the only therapy with proven efficacy versus optimized RAS inhibition. The guidelines also recommend simultaneous treatment of the two drivers of IgA nephropathy progression, targeting both the upstream immune activation that causes pathogenic IgA deposition and the downstream glomerular injury that leads to nephron loss. This holistic framing of disease management aligns with FILSPARI's mechanism of action as the only fully approved non-immunosuppressive nephroprotective treatment, which can be combined with immune-targeted medications to optimize long-term outcomes for patients living with IgA nephropathy.

Speaker #4: Kdigo includes filspari as a first line option for patients who are at risk of IGA nephropathy progression , recognizing it

Speaker #4: the only therapy with proven efficacy versus optimized Raas inhibition . The guidelines also recommend simultaneous treatment of the two drivers of IGA nephropathy progression , targeting both the upstream immune activation that causes pathogenic IGA deposition and the downstream glomerular injury that leads to nephron loss .

Speaker #4: This holistic framing of disease management aligns as with Filspari mechanism of action . As the only fully approved non-immunosuppressive nephroprotective treatment , which can be combined with immune targeted medications to optimize long term outcomes for patients living with IGA nephropathy .

Speaker #4: This holistic framing of disease management aligns as with Filspari mechanism of action . As the only fully approved non-immunosuppressive nephroprotective treatment , which can be combined with immune targeted medications to optimize long term outcomes for patients living with IGA nephropathy patients Across our Col engagements following the publication of the guidelines , nephrologists have described the new Kdigo framework as a true paradigm shift that validates early and comprehensive intervention .

Nivi Nehra: Across our KOL engagements following the publication of the guidelines, nephrologists have described the new KDIGO framework as a true paradigm shift that validates early and comprehensive intervention. We believe this recognition cements FILSPARI's position as foundational care in IgA nephropathy, guiding a new era of evidence-based treatment sequencing. A further testament to our leadership in rare kidney disease is our focus on data generation and dissemination, as exemplified by numerous scientific presentations and engagements at recent congresses, including our 11 upcoming presentations at ASN Kidney Week. A few highlights of this data include the Phase II SPARTAN trial in RAS inhibitor-naive patients with IgA nephropathy, demonstrating that irrespective of baseline proteinuria levels, FILSPARI consistently reduced proteinuria and led to significant reductions in urinary biomarkers of disease activity, including reductions in immune system and complement activation markers indicating potential disease-modifying qualities of FILSPARI.

Speaker #4: We believe this recognition cements Filspari position as foundational care in IGA nephropathy , guiding a new era of evidence based treatment sequencing . A further testament to our leadership in rare kidney disease is our focus on data generation and dissemination .

Speaker #4: As exemplified by numerous scientific presentations and engagements at recent congresses , including our 11 upcoming presentations at ASN Kidney Week , a few highlights of this data include the phase two Spartan Trial in Ras inhibitor naive patients with IGA nephropathy , demonstrating that irrespective of baseline proteinuria levels , Filspari consistently reduced proteinuria and led to significant reductions in urinary biomarkers of disease activity , including reductions in immune system and complement activation markers indicating potential disease modifying qualities of filspari .

Speaker #4: We also have two new presentations from the Phase 3 Protect trial in IgA nephropathy: one evaluating efficacy across historical histopathology from kidney biopsies, and another assessing outcomes based on time from IgA nephropathy.

Nivi Nehra: We also have two new presentations from the Phase III PROTECT trial in IgA nephropathy: one evaluating efficacy across historical histopathology from kidney biopsies and another assessing outcomes based on time from IgA nephropathy diagnosis. Both presentations reinforce the SPARTAN findings and align with the KDIGO recommendations, showing that earlier treatment of patients with FILSPARI can lead to greater nephroprotection. We also continue to generate and present real-world and long-term data across a broad spectrum of IgA nephropathy disease severity, demonstrating FILSPARI's consistent benefit in reducing proteinuria and preserving kidney function. In FSGS, as Eric highlighted in his opening remarks, we are pleased with the progress of our review. The agency remains engaged on our submission, and from our perspective, the process continues to be similar to our experience during the IgA nephropathy NDA review.

Speaker #4: Diagnosis: Both presentations reinforce the Spartan findings and align with the KDIGO recommendations, showing that earlier treatment of patients with Filspari can lead to greater nephroprotection.

Speaker #4: We also continue to generate and present real world and long term data across a broad spectrum of IGA nephropathy , disease severity demonstrating filspari consistent benefit in reducing proteinuria and preserving kidney function in fsgs .

Speaker #4: As Eric highlighted in his opening remarks , we are pleased with the progress of our review . The agency remains engaged on our submission and from our perspective , the process continues to be similar to our experience during the Igan NDA review ahead of a potential approval in January 2026 .

Nivi Nehra: Ahead of a potential approval in January 2026, our Medical Affairs teams are deeply engaged, expanding disease education, strengthening nephrologist awareness around the importance of proteinuria in FSGS disease progression, and responding to queries regarding how the DUPLEX data could translate into real-world benefit for this underserved patient population. At ASN, we are presenting several new analyses from the DUPLEX study, including a late-breaking analysis that demonstrates that patients treated with FILSPARI achieved proteinuria levels of less than 0.7 grams per gram more frequently versus maximum labeled dose irbesartan, and patients who achieved this threshold had a lower risk of kidney failure irrespective of treatment arm. This analysis demonstrates further alignment and supports the conclusions of the PARASOL working group that lower levels of proteinuria translate into meaningful improvements in kidney outcomes.

Speaker #4: Our Medical Affairs teams are deeply engaged , expanding disease , education , strengthening nephrologist awareness around the importance of proteinuria , and fsgs fsgs disease progression and responding to queries regarding how the duplex data could translate into real world benefit .

Speaker #4: For this underserved patient population . At HSN , we are presenting several new analyses from the duplex study , including a late breaking analysis that demonstrates that patients treated with Filspari achieved proteinuria levels of less than 0.7g/g , more frequently versus maximum labeled dose irbesartan , and patients who achieve this threshold had a lower risk of kidney failure , irrespective of treatment arm .

Speaker #4: This analysis demonstrates further alignment and supports the conclusions of the Parasol working Group that lower levels of proteinuria translate into meaningful improvements in kidney outcomes .

Speaker #4: We also have data that extrapolates the antiproteinuric treatment effect of filspari versus irbesartan, seen in the two-year Duplex trial, into longer-term kidney failure outcomes from the UK.

Nivi Nehra: We also have data that extrapolates the antiproteinuric treatment effect of FILSPARI versus irbesartan seen in the two-year DUPLEX trial into longer-term kidney failure outcomes from the U.K. Rare Disease Renal Registry, or RADAR. We also have subgroup analyses of pediatric patients and patients with collagen 4 genetic mutations, demonstrating a consistent antiproteinuric treatment effect with FILSPARI versus irbesartan in these two high-risk, difficult-to-treat patient populations. With no approved medicine for patients with FSGS today, the opportunity to bring FILSPARI forward is both urgent and transformative. The supportive data from DUPLEX and our regulatory momentum give us confidence in the path ahead. With our goal to provide FILSPARI as a foundational treatment for patients with IgA nephropathy and ultimately those with FSGS, we are pleased that the FDA approved modifications to our REMS program, removing the embryo-fetal REMS and reducing the frequency of liver monitoring to quarterly.

Speaker #4: Rare Disease Renal Registry , or radar . And we also have subgroup analyses of pediatric patients and patients with collagen for genetic mutations , demonstrating a consistent antiproteinuric treatment effect with Filspari versus Irbesartan .

Speaker #4: In these two high risk , difficult to treat patient populations with no approved medicine for patients with Fsgs today . The opportunity to .

Speaker #4: Bring Filspari forward is both urgent and transformative . The supportive data from duplex and our regulatory momentum give us confidence in the path ahead with our goal to provide Filspari is a foundational treatment for patients with IGA nephropathy and ultimately those with Fsgs .

Speaker #4: We are pleased that the FDA approved modifications to our REMS program, removing the embryo-fetal REMS and reducing the frequency of liver monitoring to quarterly.

Speaker #4: The feedback we've heard from nephrologists is that these changes are welcomed . The monitoring frequency aligns with how they care for their patients in clinical practice , and these changes can help increase access for the subset of patients for whom monthly testing was an impediment .

Nivi Nehra: The feedback we have heard from nephrologists is that these changes are welcomed, the monitoring frequency aligns with how they care for their patients in clinical practice, and these changes can help increase access for the subset of patients for whom monthly testing was an impediment. Turning to our pegtibatinase development program for the treatment of classical HCU, we recently presented long-term data at the ICIEM Congress from Q4 6 in our Phase I2 Compose open-label extension. At the 2.5 mg/kg twice-weekly target dose, patients treated with pegtibatinase achieved sustained and clinically meaningful reductions in total homocysteine and methionine over an additional year of follow-up, remarkable results in the context of an open-label study. Importantly, we have successfully manufactured the first commercial-scale batches of pegtibatinase and have generated data to support FDA interactions.

Speaker #4: Turning to our Peg to Batanes development program for the treatment of classical HCU, we recently presented long-term data at the ICM Congress from cohort six.

Speaker #4: In our phase one two compose open label extension at the 2.5mg/kg , twice weekly target dose . Patients treated with Peg achieved sustained and clinically meaningful reductions in total homocysteine and methionine over an additional year of follow up .

Speaker #4: Remarkable results in the context of an open label study . Importantly , we have successfully manufactured the first commercial scale batches of Peg to Batanes and have generated data to support FDA interactions .

Speaker #4: This progress positions us for an expected restart of enrollment in the pivotal phase three Harmony study next year , reinforcing our commitment to advancing the only investigational therapy with disease modifying potential for patients with classical hcu .

Nivi Nehra: This progress positions us for an expected restart of enrollment in the pivotal Phase III HARMONY study next year, reinforcing our commitment to advancing the only investigational therapy with disease-modifying potential for patients with classical HCU. I will now turn the call over to Peter for a commercial update. Peter.

Speaker #4: I will now turn the call over to Peter for a commercial update . Peter .

Speaker #5: Thank you . Julia . I am very pleased to share that the third quarter marked another period of strong commercial performance and continued momentum for Filspari in IGA nephropathy , reinforcing its position as a foundational therapy in sales reached approximately $91 million in the third quarter , representing another quarter of strong growth driven by consistent demand and deepening engagement among new and experienced prescribers .

Eric Dube: Thank you, Jula. I am very pleased to share that Q3 marked another period of strong commercial performance and continued momentum for FILSPARI in IgA nephropathy, reinforcing its position as a foundational therapy. FILSPARI net product sales reached approximately $91 million in Q4, representing another quarter of strong growth driven by consistent demand and deepening engagement among new and experienced prescribers. Demand for FILSPARI remains robust, with 731 new patient start forms received during the quarter, despite experiencing summer seasonality, as is typical in the summer months. In fact, in September, we recorded our highest daily patient start form rate since launch, and we are seeing that trend continue into October. Throughout the quarter, we saw durable utilization among existing nephrologists and a continuation of new prescribers.

Speaker #5: Demand for Filspari remains robust , with 731 new patients start forms received during the quarter despite experiencing some summer seasonality . As is typical in the summer months , in fact , in September we recorded our highest daily patient start form rate since launch , and we are seeing that trend continue into October .

Speaker #5: Throughout the quarter, we saw durable utilization among the existing nephrologists network and the continuation of new prescribers. Importantly, we are seeing a steady increase in the number of practices treating multiple patients with Filspari, with highlights growing confidence in the therapy's profile and real-world performance.

Eric Dube: Importantly, we are seeing a steady increase in the number of practices treating multiple patients with FILSPARI, which highlights growing confidence in the therapy's profile and real-world performance. As the IgA nephropathy treatment landscape evolves, we continue to hear consistent feedback from the nephrology community, reinforcing that physicians view FILSPARI as the preferred novel therapy. Not only because of its proteinuria efficacy, but because it delivers a meaningful long-term improvement in kidney outcomes while allowing patients to maintain a normal lifestyle through a once-daily oral regimen. We are encouraged by the response of the nephrology community to the modification of our REMS program. This simplification makes FILSPARI treatment even more convenient, particularly for newly diagnosed or lower-risk patients as quarterly monitoring is consistent with nephrology's clinical practice.

Speaker #5: As the IGA nephropathy treatment landscape evolves . We continue to hear consistent feedback from the community , reinforcing the physicians view . Filspari as the preferred novel therapy not only because of its proteinuria efficacy , but because it delivers a meaningful long term improvement in kidney outcomes while allowing patients to maintain a normal lifestyle through a once daily oral regimen .

Speaker #5: And we are encouraged by the response of the nephrology community to the modification of our Rems program . This simplification makes Filspari treatment even more convenient , particularly for newly diagnosed or lower risk patients .

Speaker #5: As quarterly monitoring is consistent with nephrologists' clinical practice, we are pleased to see continued uptake of filspari among patients with lower urea levels.

Eric Dube: We are pleased to see continued uptake of FILSPARI among patients with lower proteinuria levels, reflecting growing recognition that patients above 0.5 grams per gram remain at risk of progression, in alignment with our broader label and the KDIGO guidelines. Patient satisfaction is strong, as evidenced by consistently high compliance and persistence. As we continue to expand FILSPARI's reach, our patient services and fulfillment programs remain an important contributor. We have maintained broad payer coverage, with easing of prior authorization requirements to reflect FILSPARI's broader label, long-term evidence, and positioning in the guidelines. Turning to FSGS. If approved, FILSPARI will become the first approved medicine for FSGS, a leading cause of kidney failure.

Speaker #5: Reflecting growing recognition that patients above 0.5g/g remain at risk of progression in alignment with our broader label and kdigo guidelines . Patient satisfaction is strong , as evidenced by consistently high compliance and persistence as we continue to expand .

Speaker #5: Filspari treats our patient services and fulfillment programs remain an important contributor . We have maintained broad payer coverage with easing of prior authorization requirements to reflect Filspari broader label , long term evidence , and positioning in the guidelines .

Speaker #5: During to Fsgs , if approved , Filspari will become the first approved medicine for Fsgs , a leading cause of kidney failure . Given the high degree of overlap between the fsgs and the IGA nephropathy , prescriber base , we will be able to build upon strong brand awareness and familiarity of Filspari with many physicians that have already had experience with the products .

Eric Dube: Given the high degree of overlap between the FSGS and the IgA nephropathy prescriber base, we will be able to build upon strong brand awareness and familiarity of FILSPARI with many physicians that have already had experience with the product. Given the high unmet needs for an approved medication and the progressive nature of FSGS, we believe this could be an even bigger opportunity with a more rapid uptake since our launch in IgA nephropathy. We know the FSGS community is eagerly awaiting an effective medicine, and we will be ready to launch in January if approved. In summary, the Q4 represents another quarter of exquisite execution and continued growth for FILSPARI in IgA nephropathy. The combination of clinical product differentiation, early intervention, strong prescriber confidence, and a consistent patient experience continues to drive momentum and position FILSPARI as a foundational and nephroprotective choice among IgA nephropathy therapies.

Speaker #5: Given the high unmet need for approved medication in the progressive nature of fsgs , we believe this could be an even bigger opportunity with a more rapid uptake versus our launch in IGA nephropathy .

Speaker #5: We know Fsgs community is eagerly awaiting an effective medicine , and we will be ready to launch in January . If approved . In summary , the third quarter represents another quarter of exquisite execution in continued growth for Filspari in IGA nephropathy .

Speaker #5: The combination of clinical product differentiation , early intervention , strong prescriber confidence , and a consistent patient experience continues to drive momentum and position .

Speaker #5: Filspari as a foundational and nephroprotective choice among IGA nephropathy therapies . With with our strong commercial foundation and expanding real world experience , we remain confident in Filspari ability to deliver sustainable growth and long term leadership .

Eric Dube: With our strong commercial foundation and expanding real-world experience, we remain confident in FILSPARI's ability to deliver sustainable growth and long-term leadership in rare kidney disease care. I am sincerely proud of the continued performance of our commercial teams and the dedication they bring every day to support patients and physicians. Their success in establishing FILSPARI in IgA nephropathy gives us great confidence in our ability to execute effectively in FSGS, and we will be ready if approved. Let me now turn the call over to Chris for the financial update. Chris.

Speaker #5: In rare kidney disease care . I am sincerely proud of the continued performance of our commercial teams and the dedication they bring every day to support patients and physicians .

Speaker #5: Their success in establishing filspari in IGA nephropathy gives us great confidence in our ability to execute effectively in Fsgs , and we will be ready if approved .

Speaker #5: Let me now turn the call over to Chris for the financial update . Chris .

Speaker #6: Thank you, Peter, and good afternoon. This quarter, we delivered another strong set of financial results with continued significant revenue growth and disciplined financial investments.

Chris Cline: Thank you, Peter, and good afternoon. This quarter, we delivered another strong set of financial results with continued significant revenue growth and disciplined financial investment. As Peter mentioned, our top-line expansion reflects the strength of our underlying FILSPARI business and the consistent execution across our key commercial initiatives, momentum that we believe sets us up for durable growth ahead. We also further strengthened our financial foundation by repaying our remaining 2025 convertible notes, and significant value was generated from our partnerships, including the recently achieved $40 million market access milestone from CSL Vifor and the announced acquisition of Renalys Pharma by Chugai Pharmaceutical, both great examples of how our collaborations continue to create value and validate the potential of FILSPARI globally. Starting with revenue, in Q3, we generated U.S. net product sales of $113.2 million. FILSPARI continued to grow significantly in Q3, generating $90.9 million in U.S.

Speaker #6: As Peter mentioned , our top line expansion reflects the strength of our underlying business and the consistent execution across our key commercial initiatives .

Speaker #6: Momentum that we believe sets us up for durable growth ahead. We also further strengthen our financial foundation by repaying our remaining 2025 convertible notes, and significant value was generated from our partnerships, including the recently achieved $40 million market access milestone from V4 and the announced acquisition of Renalase by Chugai.

Speaker #6: Both great examples of how our collaborations continue to create value and validate the potential globally. Starting with revenue in the third quarter, we generated U.S. net product sales of $113.2 million.

Speaker #6: Filspari continued to grow significantly in the third quarter , generating $90.9 million in net product sales , which represents an increase of more than 155% year over year from a gross to net perspective , Filspari had a one time benefit of less than $2 million during the quarter , and we continue to anticipate higher discounts in the fourth quarter .

Chris Cline: net product sales, which represents an increase of more than 155% year-over-year. From a gross-to-net perspective, FILSPARI had a one-time benefit of less than $2 million during the quarter, and we continue to anticipate higher discounts in Q4. Elsewhere, Thiola and Thiola EC contributed $22.3 million in U.S. net product sales, and we also recognized $51.7 million of licensing and collaboration revenue, which results in total revenue of $164.9 million for the quarter. Included in the licensing and collaboration revenue line this quarter is the $40 million market access milestone that was achieved by CSL Vifor. We recently received payment, which will be reflected in our cash balance in Q4. Also included in the licensing and collaboration this quarter is $9.3 million in non-cash revenue that resulted from the relinquishment of our option to acquire Renalys Pharma in anticipation of their agreement to be acquired by Chugai Pharmaceutical.

Speaker #6: Elswhere and contributed $22.3 million in US net product sales , and we also recognized $51.7 million of licensing and collaboration revenue , which results in total revenue of $164.9 million for the quarter .

Speaker #6: Included in the license and collaboration revenue line this quarter is a $40 million mark . Is a $40 million market access milestone that was achieved by Kslv for .

Speaker #6: We recently received payment , which will be reflected in our cash balance in the fourth quarter . Also included in the license and collaboration this quarter is $9.3 million in non-cash revenue that resulted from the relinquishment of our option to acquire Renalase in anticipation of their agreement to be acquired by Chugai .

Chris Cline: Moving to operating expenses, our research and development expenses for Q3 of 2025 were $51.9 million compared to $51.7 million for the same period in 2024. On a non-GAAP-adjusted basis, R&D expenses were $47.8 million compared to $48.4 million for the same period in 2024. Selling, general and administrative expenses for Q3 were $86.5 million compared to $65.6 million for the same period in 2024. On a non-GAAP-adjusted basis, SG&A expenses were $63.5 million for Q3 compared to $49.7 million for the same period in 2024. The increase in SG&A is primarily attributable to investments and preparations for a potential launch in FSGS in January, increased amortization expense related to FILSPARI royalties, as well as an increased investment in supporting commercial efforts for FILSPARI in IgA nephropathy following full approval.

Speaker #6: Moving to operating expenses . Our research and development expenses for the third quarter of 2025 were $51.9 million , compared to $51.7 million for the same period in 2024 .

Speaker #6: On a non-GAAP adjusted basis , R&D expenses were $47.8 million , compared to $48.4 million for the same period in 2020 . For .

Speaker #6: Selling , general and administrative expenses for the third quarter were $86.5 million , compared to $65.6 million for the same period in 2020 .

Speaker #6: Four . On a non-GAAP adjusted basis , SG&A expenses were $63.5 million for the third quarter , compared to $49.7 million for the same period in 2020 .

Speaker #6: The increase in CA is primarily attributable to investments in preparations for a potential launch in FSGS in January, increased amortization expense related to Filspari royalties, as well as increased investment in supporting commercial efforts for Filspari in IgA nephropathy.

Speaker #6: Following full approval , total other income , net for the third quarter of 2025 , was less than $1 million , compared to $1.3 million for the same period in 2020 .

Chris Cline: Total other income net for Q3 of 2025 was less than $1 million compared to $1.3 million for the same period in 2024. Net income for Q3 of 2025 was $25.7 million, or $0.29 per basic share, compared to a net loss of $54.8 million, or $0.70 per basic share for the same period in 2024. On a non-GAAP-adjusted basis, net income for Q3 of 2025 was $52.8 million, or $0.59 per basic share, compared to a net loss of $35.6 million, or $0.46 per basic share for the same period in 2024. As of Q3 30, 2025, we had cash, cash equivalents, and marketable securities totaling approximately $254.5 million.

Speaker #6: For . Net income for the third quarter of 2025 was $25.7 million , or $0.29 per basic share , compared to a net loss of $54.8 million , or $0.70 per basic share , for the same period in 2020 .

Speaker #6: Four . On a non-GAAP adjusted basis , net income for the third quarter of 2025 was $52.8 million , or $0.59 per basic share , compared to a net loss of $35.6 million , or $0.46 per basic share , for the same period of 2020 .

Speaker #6: For . As of September 30th , 2025 , we had cash , cash equivalents and marketable securities totaling approximately $254.5 million . This balance reflects our repayment of the remaining $69 million in 2025 convertible notes , and as I highlighted earlier , it does not yet reflect the proceeds of the $40 million milestone payment from Vifor .

Chris Cline: This balance reflects our repayment of the remaining $69 million in 2025 convertible notes, and as I highlighted earlier, it does not yet reflect the proceeds of the $40 million milestone payment from CSL Vifor, and it also does not yet include any proceeds from the recently announced acquisition of Renalys Pharma by Chugai Pharmaceutical. As we move forward, we are well-positioned to sustain our momentum in IgA nephropathy, execute a successful launch in FSGS if approved, and advance the reinitiation of enrollment in our pegtibatinase Phase III study next year. Importantly, we're doing all of this from a position of financial strength with no near-term need for additional capital to execute on our core objectives. This foundation gives us confidence in our ability to execute on our key priorities and continue advancing our mission for patients. I'll now turn it over to Eric for his closing comments. Eric?

Speaker #6: And it also does not yet include any proceeds from the recently announced acquisition of Renalase by Chugai. As we move forward, we are well positioned to sustain our momentum in IgA nephropathy and execute a successful launch in FSGS.

Speaker #6: If approved, we will advance the reinitiation of enrollment in our Phase 3 study next year. Importantly, we're doing all of this from a position of financial strength, with no near-term need for additional capital to execute on our core objectives.

Speaker #6: This foundation gives us confidence in our ability to execute on our key priorities and continue advancing our mission for patients . I'll now turn it over to Eric for his closing comments .

Speaker #6: Eric .

Speaker #3: Thank you . Chris . In Q3 , we made tremendous strides across all of our programs , and I am proud of how every employee shows up with passion and focus to advance our mission .

Eric Dube: Thank you, Chris. In Q3, we made tremendous strides across all of our programs, and I am proud of how every employee shows up with passion and focus to advance our mission. One great example is our pegtibatinase team, who has diligently solved scale-up challenges so that we are positioned to restart the HARMONY trial next year. October is HCU Awareness Month, and it is a fitting reminder of how much work is still needed to allow families affected by HCU to live with a little less worry and a bit more hope. We've entered the final months of 2023 confident in our ability to sustain FILSPARI's growth in IgA nephropathy, to successfully execute on a potential approval and launch in FSGS, and to advance our pipeline with focus.

Speaker #3: One great example is our peg to Botanics team , who is diligently solved , scale up challenges so that we are positioned to restart the Harmony trial next year .

Speaker #3: October is HQ Awareness Month and it is a fitting reminder of how much work is still needed to allow families affected by Hcu to live with a little less worry and a bit more hope .

Speaker #3: We've entered the final months of 2025 confident in our ability to sustain Filspari growth in Igan to successfully execute on a potential approval and launch an Fsgs , and to advance our pipeline with focus .

Speaker #3: We have the right people , a strong financial foundation and the momentum to bring incredible innovation to the rare disease communities that have been waiting far too long .

Eric Dube: We have the right people, a strong financial foundation, and the momentum to bring incredible innovation to the rare disease communities that have been waiting far too long. I'll now turn the call over to Nivi for Q&A. Nivi?

Speaker #3: I'll now turn the call over to Nivi for Q&A . Nivi .

Speaker #2: Thank you . Eric . Operator . We can now open up the line for Q&A .

[Company Representative]: Thank you, Eric. Operator, we can now open up the line for Q&A.

Speaker #1: Thank you . Ladies and gentlemen , we will now begin the question and answer session . To ask the question , you may press star , then one on your touchtone phone .

Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. To ask a question, you may press Star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To enter your question, please press the pound key. 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 Joe Schwartz from Leerink Partners. Your line is open.

Speaker #1: If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press the pound key. As a reminder, we ask that you limit yourself to one question.

Speaker #1: If you have another question , please rejoin the queue . We will now take the first question from the line of Josh Schwartz from Leerink Partners .

Speaker #1: Your line is open .

Speaker #6: Great , thanks .

[Analyst 1]: Great. Thanks, and congrats on another strong quarter of execution. With the new label approved in August, can you quantify, either qualitatively or quantitatively, the early impact of the REMS adjustment? Are you seeing new prescribers or a new patient base that might have been more reluctant previously? It seems like with such a strong beat this quarter, you might not be seeing any competition. Competitive impacts, or are you seeing any at all? It was just offset by the updated label. Any color you could provide would be great. Thanks.

Speaker #7: And congrats on another strong quarter of execution . With the new label approved in August . Can you quantify either qualitatively or quantitatively the early impact of the Rems adjustment ?

Speaker #7: Are you seeing new prescribers or a new patient base that might have been more reluctant previously? It seems like with such a strong beat this quarter, you might not be seeing any competition in competitive impacts, or are you seeing any at all?

Speaker #7: And it was just offset by the updated label . Any color you could provide would be great . Thanks .

Speaker #3: Thanks , Joe . Peter , why don't you take that question ?

Chris Cline: Thanks, Joe. Peter, why don't you take that question?

Speaker #5: Yeah , I think , Joe , it's a good question . I think you're asking two questions . One is , what is the impact of the Rems modification ?

Peter Heerma: Yeah, thanks, Joe. It's a good question. I think you're asking two questions. One is, what is the impact of the REMS modification so far, and two, are you seeing any impact of competitive dynamics? I think overall, I would say we see very consistent demand since we had our full approval last year, and that consistency has not been impacted by launches of new products that came into the marketplace. I think very robust continuation of growth. To your first question with regards to the REMS modification, I think that is certainly a tailwind that we are having and that has been very positively received by the nephrology community. What we are seeing is that we have a continuation of new prescribers while we also continue to expand within experienced prescribers.

Speaker #5: So far ? And to are you seeing any impact of competitive dynamics ? I think overall I would say we see very consistent demand since we had our full approval last last year .

Speaker #5: And that consistency has not been impacted by launches of new products that came into the marketplace . I think very robust continuation of of growth .

Speaker #5: I think , to your first question with regards to the Rems modification , I think that is certainly a tailwind that we are having , and that has been very positively received by the nephrology community .

Speaker #5: What we are seeing is that we have a continuation of new prescribers . Well , we also continue to expand within experienced prescribers .

Speaker #5: And I think especially the Rems modification from a monthly base to a quarterly basis . In the first year , really helps for those patients that are not as sick as the higher proteinuria levels , but still are at significant risk of progression of disease .

Peter Heerma: I think especially the REMS modification from a monthly base to a quarterly base in the first year really helps for those patients that are not as sick as the higher proteinuria levels but still are at significant risk of progression of disease. Those patients may not see their physician on a monthly base or may not do traditional testing on a monthly base, but certainly do that at a quarterly base. I think the timing of the REMS modification fits very nicely in the expansion of the patient population that we are seeing.

Speaker #5: Those patients may not see their physician on a monthly basis or may not do a traditional testing on a monthly basis , but certainly do that quarterly basis .

Speaker #5: I think the timing of the Rems modification fits very nicely in the expansion of the patient population that we are seeing .

Speaker #7: Very helpful. Any insights into any competitive pressures at all, or have you not detected any?

[Analyst 1]: Very helpful. Any insight into any competitive pressures at all, or have you not detected any?

Speaker #5: Yeah . As I mentioned , we have seen very consistent demand . I would say Q3 we saw less of an impact of seasonality than we saw last year , and that in a more competitive landscape .

Peter Heerma: Yeah, as I mentioned, we have seen very consistent demand. I would say Q3, we saw less of an impact of seasonality than we saw last year, and that in a more competitive landscape. I would say that gives you a color of our execution and performance in Q3.

Speaker #5: So I would say that that gives you a color of our execution and performance in Q3 .

Speaker #7: Yeah , very helpful .

[Analyst 1]: Yeah, that's great, Peter. The only thing that I would offer in addition, Joe, is that not only did we see the modification of the REMS program, as you alluded to, which makes it just that much easier for physicians and patients, we also saw the publication of the KDIGO guidelines that further reinforced the positioning of FILSPARI. I think both of those in combination, of course, with the phenomenal execution of Peter's team, continue to reinforce our strong position within this market. Thank you.

Speaker #3: That's great . Peter . And the only thing that I would I would offer , in addition , Joe , is that not only did we see the modification of Rems , as you alluded to , which makes it just that much easier for physicians and patients .

Speaker #3: But we also saw the publication of the Kdigo guidelines that further reinforce the positioning of Filspari . And and I think both of those in combination , of course , with the phenomenal execution of Peter's team , continues to reinforce our strong position within this market .

Speaker #7: Thank you .

Speaker #3: Thank you .

Chris Cline: Thank you.

Speaker #1: Laura . Kiko from Wedbush . Your line is open .

Operator: Laura Chico from Wedbush, your line is open.

Speaker #7: Good afternoon . Thanks very much for taking the question . Just two quick ones for me . First , with respect to Filspari , at this point , do you have a sense as to what the typical baseline proteinuria level is at start of prescribing ?

[Analyst 2]: Good afternoon. Thanks very much for taking the question. Just two quick ones for me. First, with respect to FILSPARI at this point, do you have a sense as to what the typical baseline proteinuria level is at the start of prescribing? I think Peter made a comment about perhaps some patients coming in now with a lower level. Second, are you detecting any off-label use in the FSGS setting at this point? Thank you very much.

Speaker #7: I think Peter made a comment about perhaps some patients coming in now with a lower level . Second , are you detecting any off label use in the fsgs setting at this point ?

Speaker #7: Thank you very much .

Speaker #3: Thanks , Laura , for those questions . I'll take the second one regarding Fsgs . We do see some limited prescribing and use in Fsgs .

Chris Cline: Thanks, Laura, for those questions. I'll take the second one regarding FSGS. We do see some limited prescribing and use in FSGS. We, of course, do nothing to promote that, but we are seeing some physicians make that choice. I will turn it over to Peter to answer your question about baseline UPC.

Speaker #3: We of course do nothing to to promote that . But we are seeing physicians some physicians make that make that choice . And I will turn it over to Peter to ask your question or answer your question about baseline UPC .

Speaker #5: Yeah . Thanks , Laura . So what we have seen since we had a full approval last year in September is that we have seen consistently the baseline proteinuria levels are well beyond below 1.5g/g .

Peter Heerma: Yeah, thanks, Laura. What we have seen since we had the full approval last year in September is that we have seen consistently the baseline proteinuria levels are well below 1.5 grams per gram. It's what you would expect. The larger patient population, about 65% of the patient population, has proteinuria levels below 1.5, and we're making good inroads in penetrating that market segment. What you would expect is that you will see a continuation of lower proteinuria levels at initiation.

Speaker #5: And it's what you would expect . I mean , the larger patient population , about 65% of the patient population has proteinuria levels below 1.5 .

Speaker #5: And we're making good inroads in penetrating that market segment, and, as you would expect, you will see a continuation of lower proteinuria levels at initiation.

Speaker #7: Thanks very much .

[Analyst 2]: Thanks very much.

Speaker #3: Thank you .

Chris Cline: Thank you.

Speaker #1: Anupama Rama from J.P. Morgan . Your line is open .

Operator: Anupam Rama from JPMorgan, your line is open.

Speaker #7: Hey guys , thanks so much for taking the question and congrats on the quarter . Just in the context of the beat that you guys had here with Filspari .

[Analyst 1]: Hey, guys. Thanks so much for taking the question and congrats on the quarter. Just in the context of the beat that you guys had here with FILSPARI, how do we think about the quarter-over-quarter declines in patient start forms? I know you mentioned some summer seasonality, but there were those tailwinds from guidelines and REMS. What are the considerations there? Anything to note on gross to net or inventory?

Speaker #8: How do we think about sort of the quarterly quarter , over quarter declines in patients start forms ? I know you mentioned some summer seasonality , but there were those tailwinds from guidelines and Rems .

Speaker #8: What are the considerations there ? Anything to note on gross to net or inventory ?

Speaker #3: Yeah , maybe maybe I can frame this and then and then have Peter and Chris offer anything further . I think the the strong performance in demand in Q3 really reflects , you know , that underlying expectation .

Chris Cline: Yeah, maybe I can frame this and then have Peter and Chris offer anything further. I think the strong performance in demand in Q3 really reflects that underlying expectation. I'll have Peter talk about some of the trends within the quarter that we saw, but it really is about the seasonality. While we didn't see as much impact this year as we did last year, we certainly did see some of that in terms of the slower months. Peter, maybe you can allude to that, and Chris, you can talk about the gross to net impact in Q3.

Speaker #3: And I'll have Peter talk about some of the trends within the quarter that we saw . But it really is about the seasonality .

Speaker #3: While we didn't see as much impact this year as we did last year , we certainly did see some of that . You know , in terms of the the slower months .

Speaker #3: And Peter , maybe you can allude to that . And , Chris , you can talk about the gross to net impact in Q3 .

Speaker #5: Yeah . Happy to comment on that . Thanks for that question . I'm actually really pleased with the performance and demand we saw in Q3 in particular , what I outlined during the call .

Peter Heerma: Yeah, happy to comment on that, Anupam. Thanks for that question. I'm actually really pleased with the performance and the demand we saw in Q3. In particular, what I outlined during the call, September, we had the strongest daily patient start form generation, and that trend is continuing in October. I think very strong demand. As I mentioned earlier, we have seen less of an impact of seasonality in a more competitive environment. I think the performance is really strong. Yeah, I couldn't be more proud of the team to continue to execute in the way they do.

Speaker #5: September , we had a strongest daily patient start from generation , and that trend is continuing in October . So I think very strong demand .

Speaker #5: And as I mentioned earlier , we have seen less of an impact of seasonality in a more competitive environment . So I think the performance is really strong .

Speaker #5: And yeah , I couldn't be more proud of the team to continue to execute in the way they do .

Speaker #6: And on the gross to net factor for this quarter , we did highlight that there was less than $2 million benefit . And really that's just working through the first year here .

Chris Cline: Anupam, on the gross to net factor for this quarter, we did highlight that there was less than $2 million benefit. That's just working through the first year here in Part D and having the true-ups as we go throughout the year. Looking ahead, we've guided throughout the year that the back half may have higher growth than us. That remains the same for the fourth quarter, but we're still right around that guidance of around 20% for the year. The fundamentals, as Eric and Peter highlighted, are very strong. We're looking forward to the end of the year here. Thanks, Anupam.

Speaker #6: In part D and having the true ups as we go throughout the year . Looking ahead , we've guided to throughout the year that the back half may have higher growth than s .

Speaker #6: That remains the same for the fourth quarter , but we're still right around that guidance of of around 20% for the year . And , you know , the fundamentals as Eric and Peter highlighted , very strong .

Speaker #6: So we're looking forward to the end of the year here.

Speaker #3: Thanks , Bob .

Speaker #1: Tyler Van Buren from TD Cohen . Your line is open .

Operator: Tyler Van Buren from Q1 Calling, your line is open.

Speaker #9: Hi . This is Francis on for Tyler . What can we expect in terms of communication leading up to the Fsgs produced data in January ?

[Analyst 3]: Hi, this is Francis on for Tyler. What can we expect in terms of communication leading up to the FSGS PDUFA date in January? Is it possible that you'll disclose if and when you're in labeling discussions?

Speaker #9: Is it possible that you'll disclose if and when you're in labeling discussions ?

Speaker #3: Francis, thanks for the question. It's been our practice not to comment on ongoing FDA interactions, and like we did during our igan review, we'll be entering a quiet period as we approach the date.

Chris Cline: Francis, thanks for the question. It's been our practice not to comment on ongoing FDA interactions. Like we did during our IgA nephropathy review, we'll be entering a quiet period as we approach the PDUFA date. You wouldn't expect any updates from us during that time, but we will provide and look forward to providing updates on January 13.

Speaker #3: So you wouldn't expect any updates from us during that time . But we will provide and look forward to providing updates on January the 13th .

Speaker #1: He got it from Citigroup . Your line is open .

Operator: Higa Nosher Movitz from CD Group, your line is open.

Speaker #7: Hi guys . Thank you very much .

[Analyst 4]: Hi, guys. Thank you very much for taking the question. I wanted to ask about REMS and KDIGO. I'm just curious, when you're in the field now, with the new message around the reduced REMS and the better KDIGO guidelines, how many of the practitioners are sort of aware of these changes or were informed outside of the channels through Travere, or is it really that everyone that the information is coming from Travere in terms of learning about the better REMS and the KDIGO? Just how is that information flowing? It'd be interesting to understand a little better. Thank you.

Speaker #6: For taking the .

Speaker #8: Questions .

Speaker #7: So I wanted to ask about about Rems and . Kdigo .

Speaker #10: I'm just curious, when you're in the field now with the new message around the reduced REMS and the better KDIGO guidelines, you know how many of the practitioners are sort of aware of these changes?

Speaker #10: Or were informed outside of the channels through Travere or or is it really that everyone that the information is coming from Travere in terms of learning about the better Rems and the Kdigo , just how is that information flowing ?

Speaker #10: It'd be interesting to understand a little better . Thank you .

Speaker #3: Yeah . Peter .

Speaker #7: Do you .

Speaker #3: Want to take that ? And then , Julia , if you have anything further from your engagement with Kols .

Chris Cline: Yeah, Peter, do you want to take that? Jula, if you have anything further from your engagement with KOLs, Peter?

Speaker #5: Peter happy to take that one . I mean , it was a year ago that Diego disclosed their draft guidelines , and I think familiar the key opinion leaders and thought leaders , they were well familiar with the Kdigo guidelines .

Peter Heerma: Happy to take that one. It was a year ago that KDIGO disclosed their draft guidelines. I think the key opinion leaders and the thought leaders were well familiar with the KDIGO guidelines. What we are seeing now is the full publication that really trickles down to the community nephrologists as well. That publication really helps there, and our team is certainly—it fits nicely in our educational efforts with physicians. With regard to the REMS modification, that is really up to us to communicate to physicians. Like I said in the prepared remarks, I'm really pleased with the reaction and the response we got from physicians of that modification in the first year and how this fits very nicely with their clinical practice, not having to have that monthly monitoring, but doing it at a quarterly base from the get-go.

Speaker #5: But what we are seeing now is the full publication , that it really trickles down to the community , nephrologists as well . And so that publication really helps .

Speaker #5: There . And our team is certainly it fits nicely in our educational efforts with with physicians , with regards to the Rems modification , that is really up to us to communicate to physicians .

Speaker #5: And like I said in the prepared remarks , I'm really pleased with the reaction and the response we got from physicians of that modification in the first year and how this fits very nicely with their clinical practice .

Speaker #5: Not having to have that monthly monitoring . We're doing it at a quarterly base from the get go . And like I said , I mean , this is something that they're doing on a quarterly basis anyway .

Peter Heerma: Like I said, this is something that they're doing on a quarterly base anyway, so there is no additional burden for the physician, neither for the patient.

Speaker #5: So there is no additional burden for the physician , neither for the patient .

Speaker #10: Okay . And then on Peg , just very quickly , is the scale up basically a completed project now or is there any more work to do to make sure you have enough supply for the for the whole HQ market ?

[Analyst 4]: Okay. On pegtibatinase, just very quickly, is the scale-up basically a completed project now, or is there any more work to do to make sure you have enough supply for the whole HCU market?

Speaker #3: Thanks . Yigal . Bill , why don't you take that one ?

Chris Cline: Thanks, Yugal. Bill, why don't you take that one?

Speaker #8: Certainly .

Speaker #7: Well , we're very pleased .

[Analyst 1]: Certainly. We are very pleased to have completed our first commercial batches. This enables us to engage with the FDA as was planned, which enables the restart of the study in the next year. We will continue additional manufacturing campaigns in parallel with the study running to do the further characterization work that's required for the BLA and to build stock for launch. The key milestone is getting to this scale of manufacture so that we can restart enrollment in the Phase III study.

Speaker #8: To be complete . Have completed our first commercial batches . This enables us to engage with the FDA , as was planned , which enables the restart of the study in the next year .

Speaker #8: We will continue . Additional manufacturing campaigns in parallel with the study running to do the further characterization work that's required for the Bla and to build stock for launch .

Speaker #8: But it's a the key milestone is getting to this scale of manufacture so that we can restart enrollment in the phase three study .

Speaker #1: Gavin Clark Gardner from Evercore . Your line is open .

Operator: Gavin Clark Gardner from Evercore, your line is open.

Speaker #11: Hey guys . Thanks for taking the question . And I'm sorry to go back to kind of the net price discussion , but even if I take a couple million out there for the one time net price , net price boost , I think the revenue is still a bit higher than some investors were anticipating .

[Analyst 5]: Hey, guys. Thanks for taking the question. I'm sorry to go back to kind of the net price discussion, but even if I take a couple million out there for the one-time net price boost, I think the revenue is still a little bit higher than some investors were anticipating based on the PSF trajectory. I'm just curious, is this volume of PSF trajectory that you got this quarter and last quarter, which is fairly consistent, is the revenue growth you're seeing based on that something we should be extrapolating going forward? How much is the Q4 gross to net impact? Thanks so much.

Speaker #11: Based on the SPH trajectory . I'm just curious , like , is this volume of PS trajectory that you got like this quarter and last quarter , which is fairly consistent , is the revenue growth you're seeing based on that something we should be extrapolating going forward .

Speaker #11: And like how much is the Q4 gross to net impact ? Thanks so much .

Speaker #3: Thanks , Kevin . Chris , why don't you take that ?

Chris Cline: Thanks, Kevin. Chris, why don't you take that?

Speaker #6: Sure . So I think one of the things that Peter has mentioned along the way is that we've continued to refine our , you know , our pull through process , and we've really made good progress there .

Nivi Nehra: Sure. I think one of the things that Peter has mentioned along the way is that we've continued to refine our pull-through process, and we've really made good progress there. I think that's part of what's driving the revenue growth that has been able to outpace the PSF growth over time. We've also seen very strong compliance and persistence. I think, again, that's another testament to the overall profile for FILSPARI. On the gross to net front, we haven't broken it down specifically by quarter, but the third quarter was similar to the second quarter, slightly lower. We would expect that to increase in the fourth quarter. Overall, for the year, we're expecting to come out right around the 20% mark. That's about as much of the guidance as we can provide at this point, but hopefully, that gives you a better sense for how to model that out, Gavin.

Speaker #6: So I think that's part of what's driving the revenue growth that has been able to outpace the SPH growth over time . We've also seen very strong compliance and persistence .

Speaker #6: You know , I think again , that's another testament to the overall profile for Filspari . And on the gross to net front , we haven't broken it down specifically by quarter .

Speaker #6: But the third quarter was similar to the second quarter , slightly lower . We would expect that to increase in the fourth quarter .

Speaker #6: And overall for the year . We're expecting to come out right around the 20% mark . So that's about as much of the guidance as we can provide at this point .

Speaker #6: But hopefully that gives you a better sense for how to model that out . Gavin .

Speaker #11: Yeah , that's really helpful . Thanks , guys .

[Analyst 5]: Yeah, that's really helpful. Thanks, guys.

Speaker #3: Thank you .

Chris Cline: Thank you.

Speaker #1: Mohit Bansal from Wells Fargo , your line is open .

Operator: Mohit Bansal from Wells Fargo, your line is open.

Speaker #12: For Moorhead . Thanks for taking my question . And congrats on the progress . So in Fsgs , I think we might see some data from Novartis soon with Atrasentan from their basket trial .

[Analyst 6]: Thanks for taking my question and congrats on the progress. In FSGS, I think we might see some data from Novartis soon with atrozantan from their basket trial. Can you talk about advantages you see with a dual ERA mechanism in this indication, compared with an agent like atrozantan, which doesn't have the RAS inhibitor component, especially this being an indication where there is not as high background use of RAS inhibitors compared with IgA nephropathy? Thanks.

Speaker #12: Can you talk about advantages ? You see with a dual era mechanism in this indication compared with an agent like Atrasentan , which doesn't have the Ras inhibitor component ?

Speaker #12: Especially , you know , this being an indication where there is not as high background use of Raas inhibitors compared with Igan . Thanks .

Speaker #3: Thank you for that question , Julia . Why don't we have you answer that ?

Chris Cline: Thanks for that question. Jula, why don't we have you answer that?

Speaker #4: Certainly it is quite important in fsgs , which is a true podocytopathy that's at the heart of the disease , to target it with both endothelin and angiotensin two together , to have the greatest nephroprotective potential .

Jula Inrig: Certainly. It is quite important in FSGS, which is a true podocytopathy that's at the heart of the disease, to target it with both endothelin and angiotensin II together to have the greatest nephroprotective potential. We also see that with the magnitude of proteinuria reduction we see in this patient population of FILSPARI being used, we see about a 50% reduction in proteinuria that's durable out to two years. That is where we have the confidence that this is the right way to target these patients to provide them long-term kidney protection. I understand there might be some use of single agents. I won't comment on the lack of data that we have regarding atrasentan. We really haven't seen anything to date, so I can't comment on what that gap might leave behind when you don't target both mechanisms.

Speaker #4: And we also see that with the magnitude of proteinuria reduction, we see in this patient population of Filspari being used, we see about a 50% reduction in proteinuria.

Speaker #4: That's durable up to two years . And that's where we have the confidence that this is the right way to target these patients , to provide them term kidney protection .

Speaker #4: long Thank

Speaker #4: I understand there might be some use of single agents . I won't comment on the lack of data that we have regarding Atrasentan .

Speaker #4: We really haven't seen anything to date , so I can't comment on what that gap might leave behind when you don't target both mechanisms .

Speaker #4: We know when we target both mechanisms we have , we get more patients into complete remission as well as greater reductions in proteinuria and fsgs .

Jula Inrig: We know when we target both mechanisms, we get more patients into complete remission, as well as greater reductions in proteinuria in FSGS, and that's what really matters.

Speaker #4: And that's what really matters .

Speaker #12: Thank you .

[Analyst 6]: Got it. Thank you.

Speaker #3: Thank you .

Chris Cline: Thank you.

Operator: Prakhar Agrawal from Cantor, your line is open.

Speaker #1: From Cantor . Your line is open .

Speaker #13: Hi . Thank you for taking my questions . So noticed during the earnings . Said that they have 20% NBS share , 10% of that is coming from raffia and the rest is from Alta .

[Analyst 7]: Hi. Thank you for taking my questions. Novartis during their earnings said that they have 20% NVRS share. 10% of that is coming from Winraphia and the rest is from Febralta. Maybe you can expand on where you are seeing Winraphia and Febralta as gaining share. Another follow-up on eye gain. You said September was the strongest month, and October you're also seeing good consistent demand. Should we expect the new patient start forms to increase sequentially in Q4? Thank you.

Speaker #13: So maybe if we can expand on where you are seeing when raffia and fabhalta as gaining share and then another follow up on Igan .

Speaker #13: You said September was the strongest month , and October you're also seeing good , consistent demand . So should we expect the new patients start forms to increase sequentially in 4K ?

Speaker #13: Thank you .

Speaker #3: you for the questions , Peter . Why don't you take those ?

Chris Cline: Thank you for the questions. Peter, why don't you take those?

Speaker #5: Yeah I'm happy to take that question . I mean , what we have seen and I mentioned that before , is that we see very consistent and steadily growing demand since we had our full approval in September last year .

Peter Heerma: Yeah, I'm happy to take that question. What we have seen, and I mentioned that before, is that we see very consistent and steadily growing demand since we had our full approval in September last year. The launch of atrasentan or ipepepan has not really changed that. I mean, ipepepan was launched basically at the same time as we had full approval. Atrasentan was launched like six months ago, but it hasn't really changed our trajectory and our continuation of the momentum. I couldn't be more pleased with the execution and what we are seeing. I think now with the REMS modification, as well as the KDIGO guidelines, those are additional momentum builders for us. I remain very confident in a more competitive landscape.

Speaker #5: And the launch of other symptoms or Iptacopan has not really changed that . I mean , it was launched basically at the same time as we have full approval .

Speaker #5: Atrasentan was launched like six months ago , but it hasn't really changed our trajectory and our continuation of the momentum . So I couldn't be more pleased with the execution and and what we are seeing .

Speaker #5: And I think now with the Rams modification as well as the guidelines , I think those are additional momentum builders for us . And so I remain very confident in a more competitive landscape .

Speaker #3: Yeah . And just to add with regard to whether you can expect sequential increase , we've not provided guidance . What what Peter shared in the past is , is , I think to really important components of that one is we expect that demand to be , you know , above 700 in terms of , you know , that quarterly demand .

Chris Cline: Yeah. Just to add with regard to whether you can expect sequential increase, we've not provided guidance. What Peter shared in the past is, I think, two really important components of that. One is we expect that demand to be above 700 in terms of that quarterly demand. We certainly have seen that, as he talked about. We also think about the large opportunity to be able to have these patients move from RAS inhibition to dual inhibition with something like FILSPARI or the addition of the ERA. Most of these patients still are on only RAS, so there's a tremendous opportunity for growth. We're clearly making that progress. We're seeing those occur. I don't want to speak about other companies' performance. They're clearly helping to be able to increase the shift from RAS inhibition. As you can see, we've not really seen an impact from their launches.

Speaker #3: We certainly have seen that as he talked about , but also we think about the large opportunity to be able to have these patients move from rats inhibition to dual inhibition with something like like Filspari or the addition of the era .

Speaker #3: Most of these patients still are on only Ras . So there's a tremendous opportunity for growth . We're clearly making that progress . We're seeing , you know , those occur .

Speaker #3: And I don't want to speak about other companies performance . There clearly , you know , helping to be able to to increase the the the shift from Rast inhibition .

Speaker #3: But as you can see , we've not really seen an impact from their from their launches .

Speaker #1: Mommy, wake up from Jefferies. Your line is open.

Operator: Maury Raycroft from Jefferies, your line is open.

Speaker #14: Hi . Congrats on the quarter and thanks for taking my question . You mentioned that your increased SG&A for third quarter includes additional investment in preparation for potential fsgs launch .

[Analyst 4]: Hi. Congrats on the quarter, and thanks for taking my question. You mentioned that your increased SG&A for the third quarter includes additional investment in preparation for potential FSGS launch. Can you talk more about how you're prepping for the launch and how we should think about SG&A expectations going forward?

Speaker #14: Can you talk more about how you're prepping for the launch and how we should think about SG&A expectations going forward ?

Speaker #3: Sure . Peter , why don't you take the question with regard to how your team is preparing for the approval ? And , Chris , you can talk about G&A .

Chris Cline: Sure. Peter, why don't you take the question with regard to how your team is preparing for the approval? Chris, you can talk about SG&A.

Speaker #5: Yeah , happy to get Laurie . First of all , I think it's good to realize that this is basically the same prescriber base in Fsgs as what we have seen for IGA nephropathy .

Peter Heerma: Yeah, happy to do that. Lori, first of all, I think it's good to realize that this is basically the same prescriber base in FSGS as what we have seen for IgA nephropathy. Basically, the only nephrology segment that we haven't called upon is the pediatric nephrology, but overall, there's a high level of overlap. We build upon strengths and high brand familiarity. We will have an incremental increase in our commercial footprint to really continue that momentum in IgA nephropathy while also enabling the early uptake that we are envisioning for FILSPARI. We are building upon strengths. Like I said, we have that incremental increase of our commercial footprint.

Speaker #5: Basically , the only nephrology segment that we haven't called upon is the pediatric nephrologist . But overall , there's a high level of overlap .

Speaker #5: So we built upon strengths and high brand familiarity . We will have an incremental increase in our commercial footprint to really continue that momentum .

Speaker #5: And I IGA nephropathy , while also enabling the early uptake that we are investing for , for Filspari . So we are building upon upon strengths .

Speaker #5: And like I said , we have that incremental increase in our commercial footprint .

Speaker #6: And as you can as you can take from Peter's comments with bringing on some additional sales team members and some some other support services , here , we do expect to see an incremental increase in SG&A .

Nivi Nehra: Maury, as you can take from Peter's comments with bringing on some additional sales team members and some other support services here, we do expect to see an incremental increase in SG&A. We started to onboard a number of those people this quarter, but really, you'll see more of that effect in Q4 and going forward. Around the time of launch, you would also anticipate that we'll have an increase in investment level as we're really making sure that we're providing the right resources to have a very strong start out of the gates early next year. Incremental increases as we go, but we are building from a very strong base, and we're going to be able to leverage a lot of synergies from Peter's team that's performing quite well right now.

Speaker #6: We started to onboard a number of those people this quarter . But really , you'll see more of that effect in four . Q and going forward , and then around the time of launch , you would also anticipate that we'll have an increase in investment level as we're really making sure that we're providing the right resources to have a very strong start out of the gates early next year .

Speaker #6: So incremental increases as we go . But we are building from a very strong base , and we're to be able to leverage a lot of synergies from Peter's team that's performing quite well right now .

Speaker #14: Got it . Okay . Thanks for taking .

[Analyst 4]: Got it. Okay. Thanks for taking my question.

Speaker #3: Thanks , Mari .

Chris Cline: Thanks, Mori.

Speaker #1: Jason Zimansky from Bank of America . Your line is open .

Operator: Jason Zemansky from Bank of America, your line is open.

Speaker #15: Good afternoon . Thanks . On the great congrats on the great progress . And thanks for taking our question . I wanted to revisit the efforts to now completely remove the Rems .

[Analyst 8]: Good afternoon. Congrats on the great progress, and thanks for taking our question. I wanted to revisit the efforts to now completely remove the REMS. I guess, first, given the acceleration in patient starts here and therefore overall exposure to FILSPARI, have your timelines changed at all? I guess, any other updates on this front now that the original REMS modification has occurred? Thanks.

Speaker #15: I guess first , given the acceleration in patient starts here and therefore overall exposure to Filspari have your timelines changed at all , and then I guess any other updates on this front ?

Speaker #15: Now you know that the the original Rems modification has occurred . Thanks .

Speaker #3: Thanks , Jason . Bill , why don't you take that question ?

Chris Cline: Thanks, Jason. Bill, why don't you take that question?

Speaker #8: Sure . And we're excited about the Rems modification that was granted in August . And I think we've we've seen the tailwinds that that provides in the positive feedback from physicians and patients .

[Analyst 1]: Certainly. We're excited about the REMS modification that was granted in August. I think we've seen the tailwinds that that provides and the positive feedback from physicians and patients. Our strategy has always been for ultimate removal of the REMS. With our prior interactions with the agency, we've approached it with a two-step process, seeing the frequency change first and then removal second. As we've noted in the past, the FDA has been anchored on our PMR study, which requires exposure across about 3,000 patients for two years. Our process really hasn't changed. Consistent with our approach, we'll continue to engage with the agency and align with them on our next steps.

Speaker #8: For strategies . Always been for ultimate removal of the Rems . And with our prior interactions with the agency , we've approached it with a two step process with seeking the the frequency change first and then removal second .

Speaker #8: As we've noted in the past , the FDA has been anchored on our P.m.r study , which requires exposure across about 3000 patients for two years .

Speaker #8: So our process really hasn't changed , consistent with our approach . We'll continue to engage with the agency and align with them on our next steps .

Speaker #1: Alex Thompson from Stifel . Your line is open .

Operator: Alex Thompson from State Failure, your line is open.

Speaker #16: Hey , great . Thanks for taking our question . Maybe a follow up on on the commentary on some off label fsgs use .

[Analyst 4]: Hey, great. Thanks for taking our question. Maybe a follow-up on the commentary on some off-label FSGS use. I wonder if you could comment as to whether those patients are coming in at about 2x the IgA nephropathy dose or if they're still early in their treatment course and maybe not titrate up fully yet. Thanks.

Speaker #16: I wonder if you could comment as to whether those patients are coming in at about two x the igan dose , or if they're still early in their treatment course , and maybe not titrate up fully yet .

Speaker #16: Thanks .

Speaker #3: Alex , thanks for the question . So we do have limited insight into some of that information , and I would not want to generalize around the dosing at this point .

Nivi Nehra: Alex, thanks for the question. We do have limited insight into some of that information, and I would not want to generalize around the dosing at this point. I think what's important is that upon an approval, we would make sure that physicians are appropriately educated on the label, on the target dose. Of course, as we have with IgA, we've got strong patient services support for the patients and their offices to ensure that they're at the appropriate dose.

Speaker #3: I think what's important is that upon an approval , we would make sure that physicians are appropriately educated on the label , on the target dose .

Speaker #3: And of course , as we have with Igan , we've got strong patient services support for the patients and their offices to ensure that they're at the appropriate dose .

Speaker #1: So from each Wainwright , your line is open .

Operator: Joe Panchinis from H.C. Wainwright, your line is open.

Speaker #17: Hi . Thanks and good afternoon . So first I want to talk more about the expenses that you mentioned earlier . But to the totality of the expenses going forward , I won't ask you to project profitability timing , but I guess can you directionally speak to , you know , especially R&D going forward ?

Chris Cline: Hi, thanks, and good afternoon. First, I want to talk more about the expenses that you mentioned earlier, but to the totality of the expenses going forward. I won't ask you to project profitability timing, but I guess, can you directionally speak to especially R&D going forward as you're going to bring pegtibatinase back into the clinic and how we should sort of view that, offset by FILSPARI revenues? Secondly, I'm just curious with regard to Renalys Pharma and Chugai Pharmaceutical, any change in timelines for development of sparsentan in Japan, South Korea, and Taiwan?

Speaker #17: As you know , you're going to bring bringing Peg back into the clinic and how we should sort of view that . Offset by Filspari revenues .

Speaker #17: And then secondly , just curious with regard to Renalase and Chugai , any change in timelines for development of Sparsentan in Japan , South Korea and Taiwan ?

Speaker #3: Joe , thanks for the questions . I'll quickly address the last one and then turn it over to Chris to answer the questions on on expenses .

Nivi Nehra: Joe, thanks for the questions. I'll quickly address the last one and then turn it over to Chris to answer the questions on expenses. No change in timelines. We've been incredibly impressed with the speed and quality of work from Renalys. We have a high regard for Chugai Pharmaceutical. We would expect that they would be just as focused when they initiate the FSGS and Alport syndrome programs. We can't speak for them, but what I can say is what we've seen thus far has been very impressive. Chris? And Joe, on the R&D front for operating expenses, we're in the midst of the budgeting process now, so I'll be able to come back with a little bit more clarity on that post Q4. You are right that we do expect to have additional investments for pegtibatinase as that clinical operation really ramps up once we restart.

Speaker #3: No change in timelines . We've been incredibly impressed with the speed and quality of work from Renalase and we have a high regard for Chugai Pharmaceuticals .

Speaker #3: We would expect that they would be , you know , just as focused when they initiate the Fsgs and Alport syndrome programs . We can't speak for them , but what I can say is what we've seen thus far has been very impressive .

Speaker #3: Chris .

Speaker #6: And Joe , on the R&D front for operating expenses , we are we're in the midst of the budgeting process now , so I'll be able to come back with a little bit more clarity on that post for Q but you are right that we do expect to have additional investments for Peg to as that clinical operation really ramps up once we restart and we're we're looking at investments there to , you know , have that be the fastest enrollment and timeline to top line data while maintaining quality that we can .

Nivi Nehra: We're looking at investment there to have that be the fastest enrollment and timeline to top-line data while maintaining quality that we can. For FILSPARI, there are, as you might imagine, with DUPLEX and PROTECT, we do see a ramp down in activity in that. There are also other evidence generation efforts that could potentially be helpful, both in IgA nephropathy, but then also in FSGS pending approval here where we believe we can help generate even more value. The last thing I'll highlight with FILSPARI that's still going to be an investment is going to be the transplant studies that recently kicked off and are in the recruiting phase now. There are still investments that we need to make on the R&D front.

Speaker #6: And for Sparsentan , there are , as you might imagine , with Duplex and Protect , we do see a ramp down in activity in that .

Speaker #6: But there are also other evidence generation efforts that could potentially be helpful , both in IGA nephropathy . But then also in fsgs pending approval .

Speaker #6: Here , where we believe we can help generate even more value . And then the last thing I'll highlight with Filspari , that's still going to be an investment , is going to be the transplant studies that that recently kicked off and are in the recruiting phase now .

Speaker #6: So there are still investments that we need to make on the R&D front . But to your your point or question around , you know , the context of the revenue , we expect revenue to continue to grow very nicely and be able to support our efforts here .

Nivi Nehra: To your point or question around the context of end revenue, we expect revenue to continue to grow very nicely and be able to support our efforts here.

Speaker #17: Thank you .

[Analyst 4]: Thank you.

Speaker #3: Thank you .

Nivi Nehra: Thank you.

Speaker #1: Ladies and gentlemen , this concludes the question and answer session of today's conference call . I'll hand the call back over to Nivi .

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

Speaker #2: Thank you , everyone for joining today's call . Have a great rest of your day .

Nivi Nehra: Thank you, everyone, for joining today's call. Have a great rest of your day.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.