Q1 2026 Travere Therapeutics Inc Earnings Call

May 4, 2026

Speaker #1: Hello, and welcome to Travere Therapeutics First Quarter 2026 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to Nivi Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.

Operator: Hello, and welcome to Travere Therapeutics' Q1 2026 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 #2: Thank you, Operator. Good afternoon, and welcome to Travere Therapeutics' first quarter 2026 financial results and corporate update call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer, Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer, Peter Heerma, our Chief Commercial Officer, and Chris Cline, our Chief Financial Officer.

Nivi Nehra: Thank you, operator. Good afternoon, and welcome to Travere Therapeutics' Q1 2026 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer, Peter Heerma, our Chief Commercial Officer, and Chris Cline, our Chief Financial Officer. Dr. Bill Rote, our Chief Research Officer, will join us for the Q&A. Before we begin, I'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: Dr. Bill Wrote, 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.

Nivi Nehra: 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: 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 defer 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 Factors section in our Forms 10-Q and 10-K filed with the SEC. Any forward-looking statements represent our views only as of the date such statements are made, 4 May 2026, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, let me now turn the call over to Eric. Eric.

Speaker #2: 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.

Speaker #2: In addition, any forward-looking statements represent our views only as of the dates such statements are made, May 4, 2026, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances.

Nivi Nehra: Any forward-looking statements represent our views only as of the date such statements are made, 4 May 2026, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, let me now turn the call over to Eric. Eric.

Speaker #2: With that, let me now turn the call over to Eric. Eric?

Speaker #3: Thank you, Nivi. Good afternoon and thank you for joining us. This has been a tremendous start to the year for Traverse. We've made significant progress across our three strategic priorities.

Eric Dube: Thank you, Nivi. Good afternoon, and thank you for joining us. This has been a tremendous start to the year for Travere. We made significant progress across our 3 strategic priorities. We achieved the first FDA approval in FSGS. We reported a new high in demand for FILSPARI in IgA nephropathy, and we dosed the first new patient in the phase 3 HARMONY study of pegtibatinase following restart of enrollment. 13 April marked a pivotal point for the FSGS community and Travere. Achieving the first full FDA approval for FILSPARI in FSGS established it as the first and only approved medicine for this rare and devastating kidney condition. With the potential to help more than 30,000 people living with FSGS without nephrotic syndrome, this approval is a significant indication expansion for FILSPARI and meaningfully increases the opportunity ahead for us.

Speaker #3: We achieved the first FDA approval in FSGS, we reported a new high in demand for Philspari and IJ nephropathy, and we dosed the first new patient in the phase three Harmony study of Pegabatinase following restart of enrollment.

Speaker #3: April 13th marked a pivotal point for the FSGS community and Travere. Achieving the first full FDA approval for FILSPARI in FSGS established it as the first and only approved medicine for this rare and devastating kidney condition.

Eric Dube: Achieving the first full FDA approval for FILSPARI in FSGS established it as the first and only approved medicine for this rare and devastating kidney condition. With the potential to help more than 30,000 people living with FSGS without nephrotic syndrome, this approval is a significant indication expansion for FILSPARI and meaningfully increases the opportunity ahead for us.

Speaker #3: With the potential to help more than 30,000 people living with FSGS without nephrotic syndrome, this approval is a significant indication expansion for Philspari and meaningfully increases the opportunity ahead for us.

Speaker #3: The first quarter also marked another period of exceptional commercial performance in IJ nephropathy. We delivered another quarter of record new patient start forms. As we look ahead, we are already building upon our experience gained from the successful launch of Philspari and IJ nephropathy and our executing a strong launch in FSGS.

Eric Dube: The first quarter also marked another period of exceptional commercial performance in IgA nephropathy. We delivered another quarter of record new Patient Start Forms. As we look ahead, we are already building upon our experience gained from the successful launch of FILSPARI in IgA nephropathy and are executing a strong launch in FSGS. Across IgA nephropathy and FSGS, we are now estimating that more than 100,000 patients in the US could be eligible for FILSPARI. Together, we believe this represents a $3 billion potential peak sales opportunity for FILSPARI, reinforcing a compelling long-term growth trajectory for the company. We are also advancing our pipeline to support further sustainable growth. We recently dosed the first new patient in our pivotal Phase III HARMONY study evaluating pegtibatinase in classical homocystinuria following the restart of enrollment.

Speaker #3: Across IJ nephropathy and FSGS, we are now estimating that more than 100,000 patients in the US could be eligible for Philspari. Together, we believe this represents a $3 billion potential peak sales opportunity for Philspari, reinforcing a compelling long-term growth trajectory for the company.

Eric Dube: Together, we believe this represents a $3 billion potential peak sales opportunity for FILSPARI, reinforcing a compelling long-term growth trajectory for the company. We are also advancing our pipeline to support further sustainable growth. We recently dosed the first new patient in our pivotal Phase III HARMONY study evaluating pegtibatinase in classical homocystinuria following the restart of enrollment.

Speaker #3: We are also advancing our pipeline to support further sustainable growth. We recently dosed the first new patient in our pivotal Phase 3 HARMONY study evaluating pegabatinase in classical home-assisted area following the restart of enrollment.

Speaker #3: Importantly, achieving this milestone puts us on track to deliver top-line results in the second half of 2027. Based on the data we've generated to date, we believe this program has the potential to become the first disease-modifying therapy for the HCU community.

Eric Dube: Importantly, achieving this milestone puts us on track to deliver top-line results in the H2 2027. Based on the data we've generated to date, we believe this program has the potential to become the first disease-modifying therapy for the HCU community. We expect there are approximately 7 to 10,000 people living with HCU globally who would be addressable for pegtibatinase. I'm incredibly proud of our team's accomplishments and look forward to accelerating Travere's growth as we expand our reach and serve more patients across the rare disease community. With that, I'll turn it over to Jula for a medical update. Jula?

Speaker #3: We expect there are approximately 7,000 to 10,000 people living with HCU globally who would be addressable for Pegabatinase. I'm incredibly proud of our team's accomplishments and look forward to accelerating Travere's growth as we expand our reach and serve more patients across the rare disease community.

Eric Dube: I'm incredibly proud of our team's accomplishments and look forward to accelerating Travere's growth as we expand our reach and serve more patients across the rare disease community. With that, I'll turn it over to Jula for a medical update. Jula?

Speaker #3: With that, I'll turn it over to Jula for a medical update. Jula?

Speaker #2: Thank you, Eric. I'm very excited to have the first-ever approved medicine for the FSGS community now available for patients. As a reminder, Filspari was approved to reduce proteinuria in adults and children eight years and older with FSGS without nephrotic syndrome.

Jula Inrig: Thank you, Eric. I'm very excited to have the first ever approved medicine for the FSGS community now available for patients. As a reminder, FILSPARI was approved to reduce proteinuria in adults and children 8 years and older with FSGS without nephrotic syndrome. I would like to take a moment to highlight how nephrotic syndrome is defined in clinical practice and what it means in the context of which patients may be eligible for FILSPARI. Nephrotic syndrome is a clinical diagnosis and is typically defined by the presence of all three of the following criteria. High levels of proteinuria greater than 3.5 grams per day, low serum albumin levels of less than 3.0 grams per deciliter, and the presence of edema. If a patient is missing any one of these criteria, they are not considered to have active nephrotic syndrome.

Speaker #2: I would like to take a moment to highlight how nephrotic syndrome is defined in clinical practice and what it means in the context of which patients may be eligible for Philspari.

Speaker #2: Nephrotic syndrome is a clinical diagnosis and is typically defined by the presence of all three of the following criteria: high levels of proteinuria, greater than 3.5 grams per day; low serum albumin levels, less than 3.0 grams per deciliter; and the presence of edema.

Jula Inrig: Nephrotic syndrome is a clinical diagnosis and is typically defined by the presence of all three of the following criteria. High levels of proteinuria greater than 3.5 grams per day, low serum albumin levels of less than 3.0 grams per deciliter, and the presence of edema. If a patient is missing any one of these criteria, they are not considered to have active nephrotic syndrome.

Speaker #2: If a patient is missing any one of these criteria, they are not considered to have active nephrotic syndrome. This is different than nephrotic-range proteinuria, which is typically greater than 3.5 grams per day.

Jula Inrig: This is different than nephrotic range proteinuria, which is typically greater than 3.5 grams per day. For example, a patient with 4 grams of proteinuria, low serum albumin, but no edema, will be eligible for FILSPARI. Importantly, nephrotic syndrome is not a chronic state. If a patient with FSGS presents without nephrotic syndrome, which represents the majority of the FSGS population spanning all types of FSGS, they are immediately available for FILSPARI. For those who initially present with nephrotic syndrome, physicians will typically use immunosuppression induction to try to control the patient's proteinuria and stabilize them, after which these patients may also become eligible for FILSPARI. In addition, based on the data from DUPLEX, patients treated with FILSPARI demonstrated sustained reductions in proteinuria over time, with proteinuria levels reaching approximately 1.5 grams per gram or less on average at study end.

Speaker #2: For example, a patient with 4 grams of proteinuria, low serum albumin, but no edema will be eligible for Philspari. Importantly, nephrotic syndrome is not a chronic state.

Speaker #2: If a patient with FSGS presents without nephrotic syndrome—which represents the majority of the FSGS population, spanning all types of FSGS—they are immediately available for Philspari.

Speaker #2: For those who initially present with nephrotic syndrome, physicians will typically use immunosuppression induction to try to control the patient's proteinuria and stabilize them. After that, these patients may also become eligible for FILSPARI.

Jula Inrig: For those who initially present with nephrotic syndrome, physicians will typically use immunosuppression induction to try to control the patient's proteinuria and stabilize them, after which these patients may also become eligible for FILSPARI. In addition, based on the data from DUPLEX, patients treated with FILSPARI demonstrated sustained reductions in proteinuria over time, with proteinuria levels reaching approximately 1.5 grams per gram or less on average at study end.

Speaker #2: In addition, based on the data from Duplex, patients treated with Philspari demonstrated sustained reductions in proteinuria over time, with proteinuria levels reaching approximately 1.5 grams per gram or less on average at study end.

Speaker #2: At these proteinuria levels, patients would be expected to have a much lower risk of relapsing to nephrotic syndrome. Based on our discussions with key opinion leaders following the approval, there is wide enthusiasm for using Filspari across the types of FSGS.

Jula Inrig: At these proteinuria levels, patients would be expected to have a much lower risk of relapsing to nephrotic syndrome. Based on our discussions with key opinion leaders following the approval, there is wide enthusiasm for using FILSPARI across the types of FSGS, including among secondary and genetic FSGS. This is supported by a recent publication in CJASN demonstrating consistent efficacy and safety in patients with genetic FSGS, a population often considered the most difficult to treat. Physicians consistently highlight the need for effective non-immunosuppressive options for long-term disease management. Now let me talk about IgA nephropathy. We recently published data in CJASN from the PROTECT study showing that patients with IgA nephropathy who achieved complete remission of proteinuria to less than 0.3 g/g experience rates of eGFR decline of less than 1 ml/min/year, a rate which is similar to healthy aging.

Speaker #2: Including among secondary and genetic FSGS. This is supported by a recent publication in CJASN demonstrating consistent efficacy and safety in patients with genetic FSGS.

Speaker #2: A population often considered the most difficult to treat. Physicians consistently highlight the need for effective non-immunosuppressive options for long-term disease management. Now, let me talk about IgA nephropathy.

Jula Inrig: Physicians consistently highlight the need for effective non-immunosuppressive options for long-term disease management. Now let me talk about IgA nephropathy. We recently published data in CJASN from the PROTECT study showing that patients with IgA nephropathy who achieved complete remission of proteinuria to less than 0.3 g/g experience rates of eGFR decline of less than 1 ml/min/year, a rate which is similar to healthy aging.

Speaker #2: We recently published data in CJSN from the Protect study showing that patients with IJ nephropathy who achieved complete remission of proteinuria to less than 0.3 grams per gram experience rates of eGFR decline of less than 1 milliliter per minute per year.

Speaker #2: A rate which is similar to healthy aging. The KGGO guidelines recommend a treatment approach for IJ nephropathy that addresses both kidney injury and upstream immune drivers.

Jula Inrig: The KDIGO guidelines recommend a treatment approach for IgA nephropathy that addresses both kidney injury and upstream immune drivers and include FILSPARI as a first-line option for patients at risk of progression. The data published this month reinforce FILSPARI's role as a foundational medicine in IgA nephropathy, demonstrating that FILSPARI helps more patients reach complete remission, which is associated with improved preservation of kidney function over time. Turning briefly to our pipeline, we are pleased to have reinitiated enrollment in our phase 3 HARMONY study of pegtibatinase, with the first new patient now dosed. HARMONY is a randomized, double-blind study designed to evaluate the efficacy and safety of pegtibatinase compared to placebo, with a primary endpoint focused on reduction in plasma total homocysteine, a key driver of disease in classical HCU.

Speaker #2: And include Philspari as a first-line option for patients at risk of progression. The data published this month reinforce Philspari's role as a foundational medicine in IJ nephropathy demonstrating that Philspari helps more patients reach complete remission, which is associated with improved preservation of kidney function over time.

Speaker #2: Turning briefly to our pipeline, we are pleased to have reinitiated enrollment in our Phase 3 HARMONY study of pegabatinase, with the first new patient now dosed.

Jula Inrig: Turning briefly to our pipeline, we are pleased to have reinitiated enrollment in our phase 3 HARMONY study of pegtibatinase, with the first new patient now dosed. HARMONY is a randomized, double-blind study designed to evaluate the efficacy and safety of pegtibatinase compared to placebo, with a primary endpoint focused on reduction in plasma total homocysteine, a key driver of disease in classical HCU.

Speaker #2: Harmony is a randomized, double-blind study designed to evaluate the efficacy and safety of Pegabatinase compared to placebo, with a primary endpoint focused on reduction in plasma total homocysteine.

Speaker #2: A key driver of disease in classical HCU. The primary endpoint for Harmony is assessed at 12 weeks, consistent with the primary endpoint timing from our phase one-two composed study.

Jula Inrig: The primary endpoint for HARMONY is assessed at 12 weeks, consistent with the primary endpoint timing from our Phase 1/2 COMPOSE study. Patients who complete the HARMONY study are eligible to enroll in the ENSEMBLE extension study. This open label extension will allow us to evaluate long-term outcomes, including sustained homocysteine control, as well as meaningful aspects for patients, such as the potential for greater dietary flexibility and self-administration. This program is supported by data from our Phase 1/2 COMPOSE study, where pegtibatinase demonstrated rapid, sustained, and dose-dependent reductions in total homocysteine levels. At the 2.5 milligram per kilogram dose twice a week, pegtibatinase delivered a 67.1% mean relative reduction in total homocysteine from baseline to 12 weeks, as well as maintenance of mean total homocysteine below the clinically meaningful threshold of 100 micromoles, and was generally well-tolerated.

Speaker #2: Patients who complete the Harmony study are eligible to enroll in the Ensemble extension study. This open-label extension will allow us to evaluate long-term outcomes.

Speaker #2: Including sustained homocysteine control as well as meaningful aspects for patients such as the potential for greater dietary flexibility, and self-administration. This program is supported by data from our phase one-two composed study where Pegabatinase demonstrated rapid sustained and dose-dependent reductions in total homocysteine levels.

Jula Inrig: This program is supported by data from our Phase 1/2 COMPOSE study, where pegtibatinase demonstrated rapid, sustained, and dose-dependent reductions in total homocysteine levels. At the 2.5 milligram per kilogram dose twice a week, pegtibatinase delivered a 67.1% mean relative reduction in total homocysteine from baseline to 12 weeks, as well as maintenance of mean total homocysteine below the clinically meaningful threshold of 100 micromoles, and was generally well-tolerated.

Speaker #2: At the 2.5 milligram-per-kilogram dose, twice a week, Pegabatinase delivered a 67.1% mean relative reduction in total homocysteine from baseline to 12 weeks.

Speaker #2: As well as maintenance of mean total homocysteine below the clinically meaningful threshold of 100 micromoles, and was generally well tolerated. Pegabatinase has the potential to become the first disease-modifying therapy for patients living with classical HCU.

Jula Inrig: Pegtibatinase has the potential to become the first disease-modifying therapy for patients living with classical HCU. As Eric mentioned earlier, we expect top-line data from the HARMONY study in H2 2027. Finally, we continue to generate and share new data across IgA nephropathy, FSGS, and HCU, and we look forward to upcoming medical meetings, including NKF this week and ERA next month, where we will present additional analyses in both IgAN and FSGS. I'll now turn it over to Peter for a commercial update. Peter?

Speaker #2: And as Eric mentioned earlier, we expect top-line data from the Harmony study in the second half of 2027. Finally, we continue to generate and share new data across IgA nephropathy, FSGS, and HCU.

Speaker #2: And we look forward to upcoming medical meetings, including NKF this week and ERA next month, where we will present additional analyses in both IgAN and FSGS.

Speaker #2: I'll now turn it over to Peter for a commercial update. Peter?

Speaker #3: Thank you, Jula. I'm pleased to share that we started the year strongly and set new records with our FILSPARI performance. The first quarter marked the highest demand to date, as we received 993 new patient platforms.

Peter Heerma: Thank you, Jula. I'm pleased to share that we started the year strongly and set new records with our FILSPARI performance. The Q1 marked the highest demand to date as we received 993 new Patient Start Forms, reflecting continued expansion among new prescribers and deepening utilization across established accounts. Importantly, we continue to see an increasing number of practices treating multiple IgA nephropathy patients with FILSPARI, which we view as a meaningful indicator of physicians' confidence with the medicine's foundational and nephroprotective positioning. As new treatment options become available for this indication, FILSPARI remains the most commonly prescribed medicine approved for IgA nephropathy in the US. This broad utilization supports our confidence in FILSPARI's continued growth potential in IgAN, and we are seeing strong demand in the start of the Q2.

Speaker #3: Reflecting continued expansion among new prescribers and deepening utilization across established accounts. Importantly, we continue to see an increasing number of practices treating multiple IJ nephropathy patients with Philspari.

Speaker #3: With review as a meaningful indicator of physicians' confidence with the medicine's foundational and nephroprotective positioning. As new treatment options become available for this indication, Filspari remains the most commonly prescribed medicine approved for IgA nephropathy in the US.

Peter Heerma: As new treatment options become available for this indication, FILSPARI remains the most commonly prescribed medicine approved for IgA nephropathy in the US. This broad utilization supports our confidence in FILSPARI's continued growth potential in IgAN, and we are seeing strong demand in the start of the Q2.

Speaker #3: This broad utilization supports our confidence in Philspari's continued growth potential in IgAN. And we are seeing strong demand in the start of the second quarter.

Speaker #3: For the first quarter of 2026, we reported approximately 105 million dollar in Philspari revenue. Despite the typical beginning of the year insurance resets, and growth to net dynamics, as well as recognizing fewer revenue shipping weeks.

Peter Heerma: For Q1 2026, we reported approximately $105 million in FILSPARI revenue, despite the typical beginning of the year insurance resets and gross to net dynamics, as well as recognizing fewer revenue shipping weeks. The strength of our performance in IgAN and the momentum we have with FILSPARI is directly relevant as we enter the FSGS launch. There is significant overlap in the prescriber base between these two indications, and many nephrologists already have experience with FILSPARI in their IgAN patients. This will support early adoption in FSGS patients, and we anticipate a faster uptake compared to the initial IgAN launch. In fact, early feedback from the FSGS community has been overwhelmingly positive. We received our first Patient Start Forms already on the first day following approval, and we are encouraged by the enthusiasm and engagement we are experiencing.

Speaker #3: The strength of our performance in IgAN, and the momentum we have with FILSPARI, is directly relevant as we enter the FSGS launch. There is significant overlap in the prescriber base between these two indications.

Speaker #3: And many nephrologists already have experience with Philspari in their IgAN patients. This will support early adoption in FSGS patients, and we anticipate a faster uptake compared to the initial IgAN launch.

Peter Heerma: This will support early adoption in FSGS patients, and we anticipate a faster uptake compared to the initial IgAN launch. In fact, early feedback from the FSGS community has been overwhelmingly positive. We received our first Patient Start Forms already on the first day following approval, and we are encouraged by the enthusiasm and engagement we are experiencing.

Speaker #3: In fact, early feedback from the FSGS community has been overwhelmingly positive. We received our first patient start forms already on the first day following approval.

Speaker #3: And we are encouraged by the enthusiasm and engagement we are experiencing. Having spent time in the field over the past two weeks, I have seen that as enthusiasm firsthand in discussions with nephrologists in their offices.

Peter Heerma: Having spent time in the field over the past two weeks, I've seen that enthusiasm firsthand in discussions with nephrologists in their offices, and it reinforces our belief that the FSGS opportunity is expected to be even bigger than IgA nephropathy. Established payer access in IgAN is helping to position FILSPARI for a supportive access environment in FSGS. In fact, we saw our first FSGS reimbursement approvals already in the first week. Payers often manage access at the product and indication level, and our team is focused on expanding payer plans and formularies to include FILSPARI for FSGS. While education on the FSGS indication will be important, we are starting from a position of strength with an experienced commercial team and an established infrastructure.

Speaker #3: And it reinforces our belief that the FSGS opportunity is expected to be even bigger than IgAN. Established payer access in IgAN is helping to position Filspari for a supportive access environment in FSGS.

Speaker #3: In fact, we saw our first FSGS reimbursement approvals already in the first week. Payers often manage access at the product and indication level. And our team is focused on expanding payer plans and formularies to include FILSPARI for FSGS.

Peter Heerma: Payers often manage access at the product and indication level, and our team is focused on expanding payer plans and formularies to include FILSPARI for FSGS. While education on the FSGS indication will be important, we are starting from a position of strength with an experienced commercial team and an established infrastructure.

Speaker #3: While education on the FSGS indication will be important, we are starting from a position of strength with an experienced commercial team and an established infrastructure.

Speaker #3: We believe there are more than 30,000 patients in the US with FSGS who are currently eligible for Philspari. And we expect that number to grow.

Peter Heerma: We believe there are more than 30,000 patients in the US with FSGS who are currently eligible for FILSPARI, we expect that number to grow. In summary, the start of 2026 reflects exceptional commercial execution with record demand and revenue growth. With our continuing performance in IgA nephropathy and FILSPARI's recent FSGS approval, I am confident in our ability to continue to delivering strong, sustained growth and long-term leadership across these rare kidney disease indications. I am incredibly proud of our team and the impact they continue to have on patients and physicians, I'm excited for what lies ahead for us in 2026. I'll now turn the call over to Chris for the financial update. Chris?

Speaker #3: In summary, the start of 2026 reflects exceptional commercial execution, with record demand and revenue growth. With our continuing performance in IgA nephropathy and Filspari's recent FSGS approval, I am confident in our ability to continue to deliver strong, sustained growth and long-term leadership across these rare kidney disease indications.

Speaker #3: I am incredibly proud of our team and the impact they continue to have on patients and physicians. And I'm excited for what lies ahead for us in 2026.

Peter Heerma: I am incredibly proud of our team and the impact they continue to have on patients and physicians, I'm excited for what lies ahead for us in 2026. I'll now turn the call over to Chris for the financial update. Chris?

Speaker #3: I'll now turn the call over to Chris for the financial update. Chris?

Speaker #4: Thank you, Peter. As you've heard from the team, we delivered another strong quarter of execution across the business. And recently, we achieved an important milestone with Philspari's approval in FSGS that further strengthens our outlook for continued growth.

Chris Cline: Thank you, Peter. As you've heard from the team, we delivered another strong quarter of execution across the business. Recently, we achieved an important milestone with FILSPARI's approval in FSGS that further strengthens our outlook for continued growth. In Q1, we generated $124.5 million in total US net product sales, reflecting strong year-over-year growth. Importantly, US net product sales of FILSPARI grew approximately 88% year-over-year to $105.2 million, despite typical beginning of year gross net impacts and fewer revenue recognition days. As Peter noted, for FILSPARI, we recognize revenue when product is delivered to our specialty pharmacies. This typically occurs a couple of days after shipment from our logistics partner. Due to the quarter end timing and typical early reordering patterns, Q1 had 1 fewer shipping week than usual.

Speaker #4: In the first quarter, we generated $124.5 million in total US net product sales, reflecting strong year-over-year growth. Importantly, US net product sales of Philspari grew approximately 88% year-over-year to $105.2 million, despite typical beginning-of-year gross to net impacts and fewer revenue recognition days.

Chris Cline: Importantly, US net product sales of FILSPARI grew approximately 88% year-over-year to $105.2 million, despite typical beginning of year gross net impacts and fewer revenue recognition days. As Peter noted, for FILSPARI, we recognize revenue when product is delivered to our specialty pharmacies. This typically occurs a couple of days after shipment from our logistics partner. Due to the quarter end timing and typical early reordering patterns, Q1 had 1 fewer shipping week than usual.

Speaker #4: As Peter noted, for Philspari, we recognize revenue when product is delivered to our specialty pharmacies. This typically occurs a couple of days after shipment from our logistics partner.

Speaker #4: Due to the quarter-end timing and typical early week ordering patterns, the first quarter had one fewer shipping week than usual. As a result, some Philspari shipments made in the first quarter will be recognized in the second quarter.

Chris Cline: As a result, some FILSPARI shipments made in Q1 will be recognized in Q2. Adjusting for this dynamic, supported by record demand during Q1, we believe FILSPARI is on a strong trajectory in IgA nephropathy for the balance of the year. Elsewhere, THIOLA and THIOLA EC contributed $19.3 million in US net product sales during Q1. We recognized $2.7 million in license and collaboration revenue, resulting in $127.2 million in total revenue for Q1. Moving to operating expenses, our research and development expenses for Q1 of 2026 were $57.1 million compared to $46.9 million for the same period in 2025.

Speaker #4: Adjusting for this dynamic, and supported by record demand during the first quarter, we believe Philspari is on a strong trajectory in IgA nephropathy for the balance of the year.

Speaker #4: Elsewhere, Viola and Thiola EC contributed 19.3 million dollars in US net product sales during the first quarter. And we recognize 2.7 million dollars in licensing collaboration revenue, resulting in 127.2 million dollars in total revenue for the first quarter.

Chris Cline: We recognized $2.7 million in license and collaboration revenue, resulting in $127.2 million in total revenue for Q1. Moving to operating expenses, our research and development expenses for Q1 of 2026 were $57.1 million compared to $46.9 million for the same period in 2025.

Speaker #4: Moving to operating expenses, our research and development expenses for the first quarter of 2026 were 57.1 million dollars, compared to 46.9 million dollars for the same period in 2025.

Speaker #4: Our non-gap adjusted basis, R&D expenses were 51.5 million dollars, compared to 42.2 million dollars for the same period in 2025. The increase is primarily driven by the restart of enrollment in the phase three harmony study of Pectibatinase during the quarter.

Chris Cline: On a non-GAAP adjusted basis, R&D expenses were $51.5 million compared to $42.2 million for the same period in 2025. The increase is primarily driven by the restart of enrollment in the Phase 3 HARMONY study of pegtibatinase during the quarter. Selling, general, and administrative expenses for Q1 2026 were $80.3 million compared to $60.4 million for the same period in 2025. On a non-GAAP adjusted basis, SG&A expenses were $69.3 million compared to $53.3 million for the same period in 2025. The increase is primarily attributable to investments in preparation for FILSPARI's launch in FSGS, including an expanded field team, as well as investments in IgA nephropathy.

Speaker #4: Selling general and administrative expenses for the first quarter of 2026 were 80.3 million dollars, compared to 60.4 million dollars for the same period in 2025.

Speaker #4: On a non-gap adjusted basis, SGNA expenses were 69.3 million dollars, compared to 53.3 million dollars for the same period in 2025. The increase is primarily attributable to investments in preparation for Philspari's launch in FSGS, including an expanded field team, as well as investments in IJ nephropathy.

Chris Cline: On a non-GAAP adjusted basis, SG&A expenses were $69.3 million compared to $53.3 million for the same period in 2025. The increase is primarily attributable to investments in preparation for FILSPARI's launch in FSGS, including an expanded field team, as well as investments in IgA nephropathy.

Speaker #4: Beginning in the first quarter, we revised the presentation of our amortization expense associated with royalty and milestone payments to a separate royalty expense line item in order to provide greater transparency to underlying operating expenses.

Chris Cline: Beginning in Q1, we revised the presentation of our amortization expense associated with royalty and milestone payments to a separate royalty expense line item in order to provide greater transparency to underlying operating expenses. For the quarter, we recognized $24.8 million in royalty expense compared to $12.4 million for the same period in 2025. The increase is primarily a result of the THIOLA intangible asset reaching the end of its accounting useful life, resulting in amortization of the full amount of the royalty payments accrued this quarter, as well as an increase in capitalized FILSPARI royalties. Under accounting policy, THIOLA royalties will now be expensed to royalty expense in the same quarter as the corresponding net sales.

Speaker #4: For the quarter, we recognized 24.8 million dollars in royalty expense, compared to 12.4 million dollars for the same period in 2025. The increase is primarily a result of the Thiola intangible asset reaching the end of its accounting useful life resulting in amortization of the full amount of the royalty payments accrued this quarter, as well as an increase in capitalized Philspari royalties.

Chris Cline: The increase is primarily a result of the THIOLA intangible asset reaching the end of its accounting useful life, resulting in amortization of the full amount of the royalty payments accrued this quarter, as well as an increase in capitalized FILSPARI royalties. Under accounting policy, THIOLA royalties will now be expensed to royalty expense in the same quarter as the corresponding net sales.

Speaker #4: Under our accounting policy, Thiola royalties will now be expensed to royalty expense in the same quarter as the corresponding net sales. Contractual milestones in royalty payments related to Philspari will continue to be capitalized to intangible assets and amortized on a straight-line basis over its useful life, with only the amortized expense recognized within royalty expense.

Chris Cline: Contractual milestones and royalty payments related to FILSPARI will continue to be capitalized to intangible assets and amortized on a straight-line basis over its useful life, with only amortized expense recognized within royalty expense. Total other income net for Q1 2026 was less than $1 million, compared to $1.5 million for the same period in 2025. Net loss for Q1 2026 was $37.1 million, or $0.40 per basic share, compared to a net loss of $41.2 million, or $0.47 per basic share for the same period in 2025.

Speaker #4: Total other income net for the first quarter of 2026 was less than 1 million dollars, compared to 1.5 million dollars for the same period in 2025.

Speaker #4: Net loss for the first quarter of 2026 was 37.1 million dollars, or 40 cents per basic share, compared to a net loss of 41.2 million dollars, or 47 cents per basic share for the same period in 2025.

Speaker #4: On a non-gap adjusted basis, net income for the first quarter was 4.1 million dollars, or 5 cents per basic share, compared to a net loss of 16.9 million dollars, or 19 cents per basic share for the same period in 2025.

Chris Cline: On a non-GAAP adjusted basis, net income for Q1 was $4.1 million, or $0.05 per basic share, compared to a net loss of -$16.9 million, or -$0.19 per basic share for the same period in 2025. As of 31 March 2026, we had cash equivalents, marketable securities, and receivables of approximately $352 million. Receivables includes the $25 million sales-based milestone payment from Mirum Pharmaceuticals that was recognized in Q4 2025 and received in April. This is not yet reflected in our cash balance of approximately $264.7 million as of 31 March. Looking ahead, we are well-positioned to fund our operations with existing resources.

Speaker #4: As of March 31st, 2026, we had cash, cash equivalents, marketable securities, and receivables of approximately 352 million dollars. Receivables include the 25 million dollars sales-based milestone payment from Miram Pharmaceuticals that was recognized in the fourth quarter of 2025 and received in April.

Chris Cline: Receivables includes the $25 million sales-based milestone payment from Mirum Pharmaceuticals that was recognized in Q4 2025 and received in April. This is not yet reflected in our cash balance of approximately $264.7 million as of 31 March. Looking ahead, we are well-positioned to fund our operations with existing resources.

Speaker #4: This has not yet reflected in our cash balance of approximately $264.7 million as of March 31. Looking ahead, we are well positioned to fund our operations with existing resources.

Speaker #4: We are investing with discipline across our key priorities, including the commercialization of Philspari and IJ nephropathy in FSGS, ongoing evidence generation, and advancement of the pivotal harmony study of Pectibatinase in HCU, alongside building further Pectibatinase supply.

Chris Cline: We're investing with discipline across our key priorities, including the commercialization of FILSPARI and IgA nephropathy in FSGS, ongoing evidence generation, and advancement of the pivotal HARMONY study of pegtibatinase in HCU, alongside building further pegtibatinase supply. We expect continued strong demand in IgA nephropathy to drive sustained revenue growth, with FSGS further contributing to our top line trajectory. Overall, we believe our balance sheet expected top line expansion and disciplined approach to investing in our priorities position us to execute with confidence and deliver durable long-term growth. I'll now turn the call over to Eric for his closing remarks. Eric?

Speaker #4: We expect continued strong demand in IJ nephropathy to drive sustained revenue growth, with FSGS further contributing to our top-line trajectory. Overall, we believe our balance sheet expected top-line expansion and disciplined approach to investing in our priorities position us to execute with confidence and deliver durable, long-term growth.

Chris Cline: Overall, we believe our balance sheet expected top line expansion and disciplined approach to investing in our priorities position us to execute with confidence and deliver durable long-term growth. I'll now turn the call over to Eric for his closing remarks. Eric?

Speaker #4: I'll now turn the call over to Eric for his closing remarks. Eric?

Speaker #5: Thank you, Chris. As we look ahead, our priorities are clear. Continue to drive growth by reaching more patients with IJ nephropathy, execute a strong launch in FSGS, and enroll our harmony study of Pectibatinase.

Eric Dube: Thank you, Chris. As we look ahead, our priorities are clear. Continue to drive growth by reaching more patients with IgA nephropathy, execute a strong launch in FSGS, and enroll our HARMONY study of pegtibatinase. With FILSPARI now approved in IgA nephropathy and FSGS, and a pipeline progressing into late-stage development, we believe we are well-positioned to deliver meaningful value for patients and shareholders over the near and long term. With that, I'll turn the call back over to Nivi for Q&A. Nivi?

Speaker #5: With Philspari now approved in IJ nephropathy and FSGS and a pipeline progressing into late-stage development, we believe we are well positioned to deliver meaningful value for patients and shareholders over the near and long term.

Speaker #5: With that, I'll turn the call back over to Nivi for Q&A. Nivi?

Speaker #3: Thank you, Eric. Operator, we can now open up the line for Q&A.

Nivi Nehra: Thank you, Eric. Operator, we can now open up the line for Q&A.

Speaker #6: Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star 1 on your keypad to raise your hand.

Operator: Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star one on your keypad to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the queue. Please stand by while we compile the Q&A roster. Your first question comes from the line of Joseph Schwartz with Leerink Partners. Joseph, your line is open. Please go ahead.

Speaker #6: To withdraw your question, press star 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality.

Speaker #6: If you are muted locally, please remember to unmute your device. As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the queue.

Operator: If you have another question, please rejoin the queue. Please stand by while we compile the Q&A roster. Your first question comes from the line of Joseph Schwartz with Leerink Partners. Joseph, your line is open. Please go ahead.

Speaker #6: Please stand by while we compile the Q&A roster. Your first question comes from the line of Joseph Schwartz with Lyrinc Partners. Joseph, your line is open.

Speaker #6: Please go ahead.

Speaker #7: Hey, guys. This is Will Suhikin on for Joe. Thanks for taking our question and congrats on all the progress this quarter. The one for us on FSGS, you guys have messaged several times at the launch is expected to progress at a faster rate than IJ nephropathy.

Will Sahiki: Hey, guys. This is Will Sahiki on for Joe. Thanks for taking our question and congrats on all the progress this quarter. The one for us on FSGS. You guys have mentioned several times that the launch is expected to progress at a faster rate than IgA nephropathy. Could you please characterize what you are seeing at this early stage and how it compares to the original IgAN rollout a few years ago? It seems like the full approval here could also make a difference, especially since we know nephrologists are sometimes slower to adopt innovative medicines. Is what you're seeing in these early days supportive of a more rapid FSGS launch? Thanks so much.

Will Soghikian: Hey, guys. This is Will Sahiki on for Joe. Thanks for taking our question and congrats on all the progress this quarter. The one for us on FSGS. You guys have mentioned several times that the launch is expected to progress at a faster rate than IgA nephropathy.

Speaker #7: Could you please characterize what you are seeing at this early stage, and how it compares to the original IJ rollout a few years ago?

Will Soghikian: Could you please characterize what you are seeing at this early stage and how it compares to the original IgAN rollout a few years ago? It seems like the full approval here could also make a difference, especially since we know nephrologists are sometimes slower to adopt innovative medicines. Is what you're seeing in these early days supportive of a more rapid FSGS launch? Thanks so much.

Speaker #7: It seems like the full approval here could also make a difference, especially since we know nephrologists are sometimes slower to adopt innovative medicines. Is what you're seeing in these early days supportive of a more rapid FSGS launch?

Speaker #7: Thanks so much.

Speaker #5: Will, thank you so much for the question. And I am very pleased with the early performance and particularly the execution from our field teams.

Eric Dube: Will, thank you so much for the question, and I am very pleased with the early performance and particularly the execution from our field teams. Peter, with that, why don't you give some color to what you are seeing in the early part of the launch.

Speaker #5: Peter, with that, why don't you give some color to what you are seeing in the early part of the launch?

Speaker #8: Absolutely, Eric. And Will, thank you for that question. And indeed, we are confident in a faster uptake in FSGS relative to the IGAN launch.

Peter Heerma: Absolutely, Eric, and Will, thank you for that question. Indeed, we are confident in a faster uptake in FSGS relative to the IgAN launch for multiple reasons. First of all, this is a very high unmet need, this is the fastest progressive glomerular disease as well, where for IgAN we really had to establish the urgency to intervene earlier. In addition to that, we built upon a very strong brand awareness, many of the physicians already have the experience with FILSPARI, given this is basically the same core point for IgA nephropathy. From a payer perspective, we already are in most of the formularies and payer plans. We have currently over 97% access, pathway to access for patients.

Speaker #8: For multiple reasons. First of all, this is a very high-invent need. And this is a fastest progressive glomerular disease as well. Where for IGAN, we really had to establish the urgency to intervene earlier.

Speaker #8: In addition to that, we built upon very strong brand awareness, and many of the physicians already have experience with FILSPARI given that this is basically the same core point for IgA nephropathy.

Peter Heerma: In addition to that, we built upon a very strong brand awareness, many of the physicians already have the experience with FILSPARI, given this is basically the same core point for IgA nephropathy. From a payer perspective, we already are in most of the formularies and payer plans. We have currently over 97% access, pathway to access for patients.

Speaker #8: And from a payer perspective, we already are in most of the formularies and payer plans. We have currently over 97% access pathway to access for patients.

Speaker #8: So we built upon a very strong foundation, and that gives me confidence that we will have a more rapid uptake in FSGS relative to our initial IGAN launch.

Peter Heerma: We built upon a very strong foundation, and that gives me confidence that we will have a more rapid uptake in FSGS relative to our initial IgAN launch. We believe it's an even bigger opportunity with FSGS than IgA.

Speaker #8: And we believe it's an even bigger opportunity with FSGS than IGA.

Will Sahiki: Thank you so much.

Will Soghikian: Thank you so much.

Speaker #5: Thank you so much.

Speaker #6: Your next question comes from the line of Tyler Van Buren with TD Cowen. Tyler, your line is open. Please go ahead.

Operator: Your next question.

Operator: Your next question. Comes from the line of Tyler Van Buren with TD Cowen. Tyler, your line is open. Please go ahead.

Will Sahiki: Thank you.

Operator: comes from the line of Tyler Van Buren with TD Cowen. Tyler, your line is open. Please go ahead.

Speaker #9: Hi, this is Greg on for Tyler. Thanks for taking my question. So, you noted that the first FSGS TFFs arrived the day after approval, and reimbursed treatments started within one week.

Greg Harrison: Hi, this is Greg on for Tyler. Thanks for taking my question. You noted that the first FSGS PSFs arrived the day after approval and reimbursed treatment started within one week. How many FSGS PSFs have you recorded thus far in the launch? What proportion of early starts are coming through payer authorizations versus exceptions or appeals? What are you seeing on initial payer behavior in general? Thanks.

Greg Wiessner: Hi, this is Greg on for Tyler. Thanks for taking my question. You noted that the first FSGS PSFs arrived the day after approval and reimbursed treatment started within one week. How many FSGS PSFs have you recorded thus far in the launch? What proportion of early starts are coming through payer authorizations versus exceptions or appeals? What are you seeing on initial payer behavior in general? Thanks.

Speaker #9: So, how many FSGS PFFs have you recorded thus far in the launch, and what proportion of early starts are coming through payer authorizations versus exceptions or appeals?

Speaker #9: And what are you seeing on initial payer behavior in general? Thanks.

Speaker #5: Greg, thanks it's too early for us to be able to quantify some of that, Peter certainly can provide some qualitative and directional views on the demand and the payer dynamics.

Eric Dube: Greg, thanks so much for the question. While it's too early for us to be able to quantify some of that, Peter certainly can provide some qualitative and directional views on the demand and payer dynamics. Peter?

Speaker #5: Peter?

Speaker #8: Yeah, Greg, I would love to answer that question, but this is a Q1 call, so I'm looking forward to sharing that with you in the second quarter call.

Peter Heerma: Yeah, Greg, I would love to answer that question, this is a Q1 call, I'm looking forward to share that with you in the Q2 call. Following my answer of the earlier question on the faster uptake in IgA nephropathy, I would say everything we are seeing so far is confirming what I have said with regards to a faster uptake than our initial IgA nephropathy launch. That goes both for demand as well as for the early approval rate that we are seeing with payers. We're seeing actually a higher first-pass approval at the payer level than what we saw initially for IgA.

Speaker #8: But following my answer of the earlier question on the faster uptake in IJ nephropathy, I would say everything we are seeing so far is confirming what I have said with regards to a faster uptake than our initial IJ nephropathy launch.

Speaker #8: That counts both for demand as well as for the early approval rates that we are seeing with payers. We're seeing actually a higher first-pass approval at the payer level than what we saw initially for IGA.

Speaker #6: Your next question comes from the line of Anupam Rama with JPMorgan. Anupam, your line is open. Please go ahead.

Operator: Your next question comes from the line of Anupam Rama with JP Morgan. Anupam, your line is open. Please go ahead.

Speaker #10: Hey, guys. Thanks so much for taking the question. I was wondering, on the FSGS launch, if you could build upon some of your prior comments. I know you mentioned that there's a need to further educate physicians.

Anupam Rama: Hey, guys. Thanks so much for taking the question. I was wondering on the FSGS launch, if you could build upon some of your prior comments, which was, I know you mentioned that there's a need to further educate physicians. I know that it's only three weeks post-approval. I was wondering if you could speak to what's resonating with physicians in terms of the product label and the product profile. Within that, where do you think the education is required? Thanks so much.

Speaker #10: I know that it's only three weeks post-approval, but I was wondering if you could speak to what's resonating with physicians in terms of the product label and the product profile?

Speaker #10: And then within that, where do you think the education is required? Thanks so much.

Speaker #5: Hi, Paul. Thanks so much for the questions. Peter, why don't you take that? And Jula, I know your team has got extensive engagements with thought leaders, so you can add anything that you might want to.

Eric Dube: Anupam, thanks so much for the questions. Peter, why don't you take that? Jula, I know your team has got extensive engagements with thought leaders, so you can add anything that you might want to. Peter?

Speaker #5: Peter?

Speaker #8: Yeah, happy to take that question, Anupam. And to my earlier point, overwhelmingly positive responses from the physicians, but you still have to educate them.

Peter Heerma: Yeah, happy to take that question, Anupam. To my earlier point, overwhelmingly positive responses from the physicians. You still have to educate them. You still have to reach them. I was in the field a few days and many of the community nephrologists in particular, they may not know yet that FILSPARI was approved. That, that awareness you have to build, you have to educate the physicians also on the label in particular with like not being in the nephrotic syndrome that requires some education. Once you explain that, it resonates with physicians because it's very similar to how patients are being treated today. It's actually very consistent also to the guidelines, KDIGO guidelines, but maybe Jewel can provide some sort of context on that.

Speaker #8: You still have to read them. I was in the field a few days and many of the community nephrologists, in particular, they may not know yet that Philspari was approved.

Speaker #8: And so that awareness you have to build. You have to educate the physicians also on the label in particular with not being in the product syndrome.

Speaker #8: That requires some education. Once you explain that, it resonates with physicians because it's very similar to how patients are being treated today. It's actually very consistent also to the guidelines that maybe Jula can provide some sort of context on that.

Peter Heerma: Once you explain that, it resonates with physicians because it's very similar to how patients are being treated today. It's actually very consistent also to the guidelines, KDIGO guidelines, but maybe Jewel can provide some sort of context on that.

Speaker #11: Yeah, thanks. Our team, as Eric mentioned, has been out at conferences, advisory boards, seminars, and I would say that the approval is getting resoundingly positive feedback from physicians.

Jula Inrig: Yeah. Thanks. Our team, as Eric mentioned, has been out at conferences, advisory board seminars, and I would say that the approval is getting resoundingly positive feedback from physicians. They are excited to have a non-immunosuppressive treatment options to control these patients and get their proteinuria down. You did ask about education. Part of it is a reminder about active nephrotic syndrome is not the same as nephrotic range proteinuria, we are educating around that. As Peter mentioned, very positive and excitement to have this option to treat their patients.

Speaker #11: This patient community has been waiting a long time, and they are excited to have a non-immunosuppressive treatment options to control these patients and get their proteinuria down.

Speaker #11: You did ask about education. Part of it is a reminder about active nephrotic syndrome is not the same as nephrotic range proteinuria. So we are educating around that.

Speaker #11: But as Peter mentioned, very positive and excitement to have this option to treat their patients.

Speaker #5: Thanks so much for taking our question.

Anupam Rama: Thanks so much for taking the question.

Speaker #12: Thanks, Anupam.

Eric Dube: Thanks, Anupam.

Speaker #6: Your next question comes from the line of Prakhar Agrawal with Cancer Fitzgerald. Prakhar, your line is open. Please go ahead.

Operator: Your next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald. Prakhar, your line is open. Please go ahead.

Speaker #13: Hi. Thank you for taking my questions, and congrats on the quarter. So, maybe going back to your comments on faster uptake than IgAN, when I go back to the IgAN launch in the first few full quarters, you had 400 to 450 patients start forms.

Prakhar Agrawal: Hi, thank you for taking my questions, and congrats on the quarter. Maybe going back to your comments on faster uptake than IgAN. When I go back to the IgAN launch, in the first few full quarters, you had 400 to 450 Patient Start Forms. Is that how should we think about the uptake for FSGS as well? Secondly, on access, do you expect payers to cover the secondary FSGS patients broadly as well, despite the segment not being tested in phase 3? Are you hearing any pushbacks from the payers? Thank you so much.

Speaker #13: Is that how should we think about the uptake for FSGS as well? And secondly, on access, do you expect payers to cover the secondary FSGS patients broadly as well despite the segment not being tested in phase three?

Speaker #13: Are you hearing any pushbacks from the payers? Thank you so much.

Speaker #5: Prakhar, thanks for the questions. With regard to the uptake, we're not going to be providing guidance. And we won't be breaking out the PSS by indication as we move forward.

Eric Dube: Prakash, thanks for the questions. With regard to the uptake, we're not gonna be providing guidance, and we won't be breaking out the PSF by indication as we move forward. I will reinforce what Peter shared, that everything that we're seeing so far in the first 3 weeks of launch has confirmed what we've been saying around a faster uptake, around an eagerness to prescribe. The payer dynamics, really, I think, helping getting patients from PSF onto therapy. With that said, Peter, why don't you take the question around payer access and the different types of FSGS secondary, et cetera, and any pushback, I think.

Speaker #5: I will reinforce what Peter shared, that everything we're seeing so far in the first three weeks of launch has confirmed what we've been saying around a faster uptake, around an eagerness to prescribe.

Speaker #5: And the payer dynamics really, I think, help in getting patients from PSF onto therapy. With that said, Peter, why don't you take the question around payer access and the different types of FSGS—secondary, etc.?

Eric Dube: The payer dynamics, really, I think, helping getting patients from PSF onto therapy. With that said, Peter, why don't you take the question around payer access and the different types of FSGS secondary, et cetera, and any pushback, I think.

Speaker #5: And any pushback, I

Peter Heerma: No, absolutely. May be good to start with repeating what I just mentioned, that I'm mostly encouraged by the early approval rates that we are seeing for FSGS that is higher than what we saw initially for IgA nephropathy. Before specifically answer the question, maybe it's good to provide a little bit of context that payers understand that FSGS is a more rare disease compared to IgA nephropathy with a more progressive nature. This is what we have been educating payers on over the last 6, 7 months. In that context, payers are not really focused on like types or subtypes of FSGS. They understand the common injury pathway and how FILSPARI is the first approved medicine for this patient population that is rapidly progressing.

Speaker #8: Yeah, no, absolutely. And maybe good to start with repeating what I just mentioned, that I'm mostly encouraged by the early approval rates that we are seeing for FSGS, which are higher than what we saw initially for IgA nephropathy.

Speaker #8: Before specifically answering the question, maybe it's good to provide a little bit of context that payers understand that FSGS is a more rare disease compared to IgA nephropathy.

Speaker #8: With a more progressive nature. This is what we have been educating payers on over the last six, seven months. And in that context, payers are not really focused on types or subtypes of FSGS.

Peter Heerma: This is what we have been educating payers on over the last 6, 7 months. In that context, payers are not really focused on like types or subtypes of FSGS. They understand the common injury pathway and how FILSPARI is the first approved medicine for this patient population that is rapidly progressing.

Speaker #8: They understand the common injury pathway and how Philspari is the first approved medicine for this patient population that is rapidly progressing. So that's what I would say what we are hearing and seeing so far.

Peter Heerma: That's what I would say, what we are hearing and seeing so far in the context of conversations we have had with payers over the last six, seven months.

Speaker #8: And context of conversations we have had with payers over the last six or seven months.

Speaker #5: Thank you.

Prakhar Agrawal: Thank you.

Speaker #12: Thank you.

Peter Heerma: Thank you.

Speaker #6: Your next question comes from the line of Vamil Devon with Guggenheim Security. Vamil, your line is open. Please go ahead.

Operator: Your next question comes from the line of Vamil Divan with Guggenheim Securities. Vamil, your line is open. Please go ahead.

Speaker #13: Great. Thanks for taking my question. So I want to just get back to the topic rather than history and the product syndrome. I think as we've spoken to some physicians since the approval, there's seemed to be some confusion about this and whether they can prescribe Philspari in these patients or not.

Vamil Divan: Great. Thanks for taking my question. I wanted to get back to the topic around the history of nephrotic syndrome. I think as we've spoken to some physicians since the approval, there seems to be some confusion about this and whether they can prescribe FILSPARI in these patients or not. I'm just curious maybe you can elaborate there in terms of, do you think if, you know, will payers, physicians focus on, you know, the history of nephrotic syndrome? It sounds like maybe you mentioned that maybe some education still need to work on that topic. Maybe just elaborate on that in terms of what you're doing to make sure it's clear, because it certainly sounds like from your perspective that this should not be a limiting factor.

Speaker #13: So I'm just curious maybe you can elaborate there. In terms of do you think will patients will payers, physicians focus on the history of nephrotic syndrome and it sounds like maybe you mentioned that maybe some education is still need to work on that topic.

Vamil Divan: It sounds like maybe you mentioned that maybe some education still need to work on that topic. Maybe just elaborate on that in terms of what you're doing to make sure it's clear, because it certainly sounds like from your perspective that this should not be a limiting factor.

Speaker #13: So maybe just elaborate on that in terms of what you're doing to make sure it's clear because it certainly sounds like from your perspective that that should not be a limiting factor.

Speaker #5: Thank you, Vamil, for the question. And we firmly believe this is not going to be a challenge. It's certainly an opportunity to educate Jula.

Eric Dube: Thank you, Vamil, for the question. We firmly believe this is not going to be a challenge. It's certainly an opportunity to educate. Jula, why don't you talk about the efforts that you're doing and the reaction from nephrologists. Peter, you can talk about how payers may be thinking about this topic.

Speaker #5: Why don't you talk about the efforts that you're doing in the reaction from nephrologists? Peter, you can talk about how payers may be thinking about this topic.

Speaker #11: Yeah. This is not been an area of focus from physicians, and we've had a fair bit of engagement and so has Peter's team. So we do not believe that history of nephrotic syndrome should reserve a physician from prescribing Philspari.

Jula Inrig: This has not been an area of focus from physicians, and we've had a fair bit of engagement and so has Peter Heerma's team. We do not believe that history of nephrotic syndrome should reserve a physician from prescribing FILSPARI. Really the reason for that is because of our labeled indication. It's for patients without active nephrotic syndrome. This is very much aligned with KDIGO. It recommends patients with active nephrotic syndrome be treated with immunosuppression, while those without it receive optimized supportive foundational care. That's where FILSPARI provides the best treatment option for these patients.

Speaker #11: And really the reason for that is because of our labeled indication. It's for patients without active nephrotic syndrome. And this is very much aligned with KDGO.

Jula Inrig: This is very much aligned with KDIGO. It recommends patients with active nephrotic syndrome be treated with immunosuppression, while those without it receive optimized supportive foundational care. That's where FILSPARI provides the best treatment option for these patients.

Speaker #11: It recommends patients without active nephrotic syndrome be treated with immunosuppression. While those without it receive optimized supportive foundational care, and that's where Philspari provides the best treatment option for these patients.

Speaker #5: And happy to build upon that from a payer perspective. And maybe good to build on what I just mentioned with regards to a more rare disease with a more rapidly progressive disease manifestation.

Peter Heerma: Happy to build upon that from a payer perspective, and maybe good to build on what I just mentioned with regards to a more rare disease with a, with a more rapidly progressive disease manifestation. The most important one is to educate payers on that, what Jula said, nephrotic syndrome is a dynamic state. It's not like a chronic state, and payers understand that. These conversations haven't really come up, given what I said earlier, this is a rapid progressing disease and payers understand that as well.

Speaker #5: The most important one is to educate payers on that what Jula said, nephrotic syndrome is a dynamic state. It's not like a chronic state.

Speaker #5: And payers understand that. These conversations haven't really come up given what I said earlier. This is a rapid progressing disease and payers understand that as well.

Speaker #13: Okay. Thank you.

Vamil Divan: Okay. Thank you.

Speaker #5: Thanks, Vamil.

Peter Heerma: Thanks, Vamil.

Speaker #6: Your next question comes from the line of Gavin Clark Gartner with Evercore. Gavin, your line is open. Please go ahead.

Operator: Your next question comes from the line of Gavin Clark-Gartner with Evercore. Gavin, your line is open. Please go ahead.

Speaker #14: Hey, guys. Thanks for taking the question. I actually wanted to pivot over to IgAN nephropathy quickly. What do you see as discontinuation rates over time here?

Gavin Clark-Gartner: Hey, guys. Thanks for taking the question. I actually wanted to pivot over to IgA nephropathy quickly. What are you seeing as the discontinuation rates over time here, let's say maybe at the 1-year mark and the 2-year mark since patients start therapy, and how does that actually compare to what you saw in the IgA Phase III?

Speaker #14: Let's say maybe at the one-year mark and the two-year mark since patients start therapy. And how does that actually compare to what you saw in the IGA phase three?

Speaker #5: All right. Peter, why don't you take that question?

Eric Dube: All right. Peter, why don't you take that question?

Speaker #8: Yeah. The compliance and the persistence rates for IGA nephropathy, Philspari, and IGA nephropathy have been very high. We haven't given specifics on the numbers, but we haven't seen any change or disruption in those rates as well which gives me high confidence both on the effect it has for patients that they're being helped with it, but also the physician that they are seeing that this product works for a patient population that historically didn't have a treatment option.

Peter Heerma: Yeah. The compliance and the persistence rates for IgA nephropathy, FILSPARI and IgA nephropathy have been very high. We haven't given specifics on the numbers, but we haven't seen any change or disruption in those rates as well, which gives me high confidence both on the effect it had for patients that they are being helped with it, but also the physician that they are seeing that this product works for a patient population that historically didn't have a treatment option. Jula, maybe you can provide the context what we are seeing versus what we saw in the PROTECT trial.

Speaker #8: Jula, maybe you can provide the context what we are seeing versus what we saw in the PROTECT trial.

Speaker #11: Yeah, I would say consistent. We saw a fairly high persistence of patients staying on treatment during the two-year double-blind trial. And I think it's very aligned with what we're seeing commercially.

Jula Inrig: Yeah, I would say consistent. We saw a fair high persistence of patients staying on treatment during the 2-year double-blind trial. I think it's very aligned with what we're seeing commercially. Part of the reason for that is patients have that positive reinforcement. Their proteinuria goes down, they see it, and they feel like they're getting better. With very consistent side effect profile to irbesartan. Patients tend to stay on therapy, and they understand this should be truly a lifelong as long as they keep their kidneys, they should stay on FILSPARI.

Speaker #11: And part of the reason for that is patients have that positive reinforcement. Their proteinuria goes down. They see it. And they feel like they're getting better.

Speaker #11: And so with very consistent side effect profile to irbesartan. And so patients tend to stay on therapy, and they understand this should be truly a lifelong as long as they keep their kidneys, they should stay on Philspari.

Speaker #14: Great. Thanks.

Eric Dube: Great. Thanks.

Speaker #6: Your next question. Comes from the line of Mohit Bansal with Wells Fargo. Mohit, your line is open. Go ahead.

Operator: Your next question comes from the line of Mohit Bansal with Wells Fargo. Mohit, your line is open.

Savia Rahman: Hi.

Operator: Go ahead.

Savia Rahman: Hi. This is Savia Rahman on for Mohit. Thanks for taking our question. The Patient Start Form number this quarter again looks very impressive. Can you provide some color on the conversion rate for these forms to patients ultimately starting treatment and any reasons for any drop-offs along the way? Thank you.

Speaker #15: Hi. This is Sadia Rahman on for Mohit. Thanks for taking our question. So the patients start form number this quarter again looks very impressive.

Speaker #15: Can you provide some color on the conversion rate for these forms to patients ultimately starting treatment and any reasons for any drop-offs along the way?

Speaker #15: Thank you.

Speaker #5: Thanks, Sadia. Peter, why don't you take that?

Eric Dube: Thanks, Savia. Peter, why don't you take that?

Speaker #8: Yeah. I'm glad you reflect on the 993 patient platforms as impressive because I'm really impressed with my team that is continuing to show growth and IJ nephropathy in a rapidly changing environment.

Peter Heerma: Yeah. I'm glad you that you reflect on the 993 Patient Start Forms as impressive because I'm really impressed with my team that is continuing to show growth in IgA nephropathy in a rapidly changing environment. With regard to conversion, I would say we continue to convert those patients quite rapidly over time. We continue to make improvements, but where we are right now, that is not as dramatic as what you saw in the beginning. We don't see any drop-offs or changes. I think with regards to translation, Patient Start Forms into revenue, that may be part of your question.

Speaker #8: With regards to conversion, I would say we continue to convert those patients quite rapidly over time. We continue to make improvements with where we are right now that is not as dramatic as what you saw in the beginning.

Speaker #8: But we don't see any drop-offs or changes. And I think with regards to translation, patients platforms into revenue—that may be part of your question—I think Chris was providing some thought on that with regards to less ordering shipment weeks in Q1, relative to also having the typical gross-to-net dynamic that you see usually in Q1.

Peter Heerma: I think Chris was providing some color on that with regards to less ordering shipment weeks in Q1 relative to also the having the typical gross to net dynamic that you see, you know, usually in Q1. I hope that answers your question, Savia Rahman.

Speaker #8: I hope that answers your question, Tony.

Speaker #15: Yeah. Thank you.

Savia Rahman: Yep. Thank you.

Speaker #5: Thank you.

Eric Dube: Thank you.

Speaker #6: Your next question comes from the line of Laura Chico with Wedbush Securities. Laura, your line is open. Please go ahead.

Operator: Your next question comes from the line of Laura Chico with Wedbush Securities. Laura, your line is open. Please go ahead.

Speaker #16: Thank you very much for taking the questions. I apologize if this has been asked already, but one question I had was on IgA nephropathy dynamics for Filspari.

Laura Chico: Thank you very much for taking the questions. I apologize if this has been asked already. One question I had was on IgA nephropathy dynamics for FILSPARI. You know, it's great to see the PSF number continuing to increase, and I'm presuming that's predominantly from IgA nephropathy patients. We also had a competitive update. Novartis indicated the ALIGN confirmatory study for Vanrafia did not reach statistical significance. While they will pursue an FDA approval, full approval, I'm just wondering how that changes your views on the competitive landscape dynamics for IgA nephropathy with FILSPARI. How are you thinking about pushes and pulls on demand drivers in 2026? Then I have a quick follow-up, if that's okay.

Speaker #16: It's great to see the PSF number continuing to increase and I'm presuming that's predominantly from IGA nephropathy patients. But we also had a competitive update, Novartis indicated the aligned confirmatory study for Van Raphael did not reach the statistical significance.

Speaker #16: And while they will pursue an FDA approval—a full approval—I’m just wondering how that changes your views on the competitive landscape dynamic for IgA nephropathy with Filspari.

Laura Chico: While they will pursue an FDA approval, full approval, I'm just wondering how that changes your views on the competitive landscape dynamics for IgA nephropathy with FILSPARI. How are you thinking about pushes and pulls on demand drivers in 2026? Then I have a quick follow-up, if that's okay.

Speaker #16: How are you thinking about pushes and pulls on demand drivers in '26? And then I have a quick follow-up if that's okay.

Speaker #5: Okay. Thanks, Laura. Peter, why don't you take that and certainly, Jula, add anything further as you see the evolution or consistency of the treatment landscape.

Eric Dube: Okay. Thanks, Laura. Peter, why don't you take that and certainly, Jula, add anything further as you see the, you know, evolution or consistency of the treatment landscape.

Speaker #8: Yeah. I'm happy to answer that question. I think most important that this is a market in development. Most growth in this marketplace is not coming from competitive share, but mainly from continuation of growing the market.

Peter Heerma: Yeah. Maybe to answer that question, I think most important that this is a market in development. Most growth in this marketplace is not coming from competitive share, but mainly from continuation of growing the market. That's exactly what we see. That's what we were anticipating. I think FILSPARI is very well-positioned to continue to grow in this marketplace because it's really replacing RAS inhibition. There is no other product that has that ability to do so. Most competition is in the other sector, more in immune suppressive agents, where the B cells are now playing together with the complement inhibitors and historically steroids. What I would say, physicians understand the positioning of FILSPARI well as the foundational nephroprotective treatment option, and understand also FILSPARI's positioning relative to atrasentan.

Speaker #8: And that's exactly what we see. That's what we were anticipating. I think Philspari is very well positioned to continue to grow in this marketplace because it's really replacing RAS inhibition.

Speaker #8: There's no other product that has that ability to do so. Most competition is in the other sector, more in immune suppressive agents where the B cells are now playing together with the complement inhibitors and historically the steroids.

Peter Heerma: There is no other product that has that ability to do so. Most competition is in the other sector, more in immune suppressive agents, where the B cells are now playing together with the complement inhibitors and historically steroids. What I would say, physicians understand the positioning of FILSPARI well as the foundational nephroprotective treatment option, and understand also FILSPARI's positioning relative to atrasentan.

Speaker #8: What I would say physicians understand the positioning of Philspari well as the foundational nephro protective treatment option. And understand also Philspari's positioning relative to atorvastatin.

Speaker #5: And just one thing, Laura, before you get to your next question. You had asked about the PSF increase—that is all based in Q1.

Eric Dube: Just one thing, Laura, before you get to your next question. You had asked about the PSF increase. That is all based in Q1, so that would be IgA nephropathy before the approval of FSGS. We do expect to see, you know, an acceleration of the demand over time as we look at both indications. That very solid number of 993 Patient Start Forms in Q1 reflects our performance in an increasingly, you know, landscape of multiple treatment options. I think it's a really impressive number that Peter's team has been able to deliver. Why don't we go to your next question, Laura?

Speaker #5: So that would be IgA nephropathy before the approval of FSGS. So we do expect to see an acceleration of the demand over time as we look at both indications.

Speaker #5: But that very, very solid number of 993 patients start forms in Q1 reflects our performance in an increasingly landscape of multiple treatment options. So I think it's a really impressive number that Peter's team has been able to deliver.

Speaker #5: And why don't we go to your next question.

Laura Chico: Thanks for the clarification, Eric.

Speaker #16: Thanks for the clarification, Eric. Yeah, just real quick. So, we've got a few weeks in April with the FSGS approval. It does seem like a couple of PSFs are coming through here.

Eric Dube: Of course.

Laura Chico: Yeah, just real quick. We've got a few weeks in April with the FSGS approval. It does seem like a couple PSFs are coming through here. Just out of curiosity, are these originating from existing FILSPARI IgAN prescribers or versus kind of newly activated FSGS prescribers? I'm just kind of curious, should we be presuming these are already established prescribers in these early days, in these early quarters of launch? Thanks very much.

Speaker #16: Just out of curiosity, are these originating from existing Filspari IgM prescribers or versus kind of newly activated FSGS prescribers? And I'm just kind of curious, should we be presuming these are already established prescribers in these early days and these early quarters of launch?

Speaker #16: Thanks very much.

Speaker #5: Laura, thanks so much for the question. It is early. Peter, why don't you comment on what you're seeing thus far?

Eric Dube: Laura, thanks so much for the question. It is early. Peter, why don't you comment on what you're seeing thus far?

Speaker #8: Yeah, it's indeed early. We see both, to be honest. And more color to come in the Q2 call. But I think in this context, it's good to talk about the halo effect.

Peter Heerma: Yeah. It's indeed early. We see both, to be honest, and more color to come in the Q2 call. I think in this context, it's good to talk about the halo effect. I've spoken about the halo effect in the past and halo effects from the experienced prescribers for IgA that now also adopt FILSPARI for FSGS. Vice versa, we're starting to hear anecdotes as well from physicians that have been on the fence are excited about starting for FSGS and based on that now are also excited to start prescribing in IgA. I think the halo effect will benefit both indications.

Speaker #8: I've spoken about the halo effect in the past, and halo effects from the experienced prescribers for IgAN that now also adopt Filspari for FSGS.

Speaker #8: But vice versa, we're starting to hear anecdotes as well from physicians that have been on the fence, are excited about starting for FSGS and, based on that, now are also excited to start prescribing in IgA.

Speaker #8: So, I think a halo effect will benefit both indications.

Speaker #6: Your next question comes from the line of Maury Raykop sorry, Maury Raycroft with Jefferies. Maury, your line is open. Please go ahead.

Operator: Your next question comes from the line of Maury Raycroft, sorry, Maury Raycroft with Jefferies. Maury, your line is open. Please go ahead.

Speaker #17: Hi. Thanks for retaining my question and congrats on the quarter. Maybe following up on Laura's question, focusing on PSFs. I'm trying to think about how to estimate that going forward for IgM.

Maury Raycroft: Hi. Thanks for taking my question, and congrats on the quarter. Maybe following up on Laura's question, focusing on PSFs. I'm trying to think about how to estimate that going forward for IgAN, and you talked about atrasentan as a competitor, Otsuka also had a good quarter for PSF growth in IgAN. I'm wondering if you have any perspective in how Otsuka is launching their drug, and how are you factoring that into your estimates? If there's any more perspective you can offer on just switching to biologics and how you're thinking about that in your total estimate for $3 billion in peak sales.

Speaker #17: And you talked about after sentinel as a competitor, but Atuka also had a good quarter for PSFs growth in IgM. And so I'm wondering if you have any perspective in how Atuka is launching their drug and how are you factoring that into your estimates and if there's any more perspective you can offer on just switching to biologics and how you're thinking about that in your total estimate for 3 billion in peak sales.

Speaker #5: Okay. Let me take a couple of those. And Peter, why don't you comment on what you're seeing from a competitive standpoint and switching. The first is that the PSFs moving forward will provide an aggregate.

Eric Dube: Let me take a couple of those, then Peter, why don't you comment on what you're seeing from a competitive standpoint and switching. The first is that the PSFs, moving forward, we'll provide an aggregate. I recognize, Maury, what you're probably trying to figure out is what in IgAN alone. What I would say is there's no reason to believe we can't continue the, this level of performance because of the number of patients out there and the very unique positioning that non-immunosuppressive kidney-targeted therapies are, which Peter can speak to. With regard to the peak year sales of $3 billion, that really is based on continued growth in both indications. We've talked about FSGS being a larger opportunity than IgA nephropathy.

Speaker #5: So I recognize Maury what you're probably trying to figure out is what in IgM alone. What I would say is there's no reason to believe we can't continue this level of performance because of the number of patients out there.

Eric Dube: What I would say is there's no reason to believe we can't continue the, this level of performance because of the number of patients out there and the very unique positioning that non-immunosuppressive kidney-targeted therapies are, which Peter can speak to. With regard to the peak year sales of $3 billion, that really is based on continued growth in both indications. We've talked about FSGS being a larger opportunity than IgA nephropathy.

Speaker #5: And the very unique positioning that non-immunosuppressive kidney-targeted therapies are, which Peter can speak to. With regard to the peak year sales, 3 billion, that really is based on continued growth in both indications and we've talked about FSGS being a larger opportunity than IgA nephropathy.

Speaker #5: So we fully expect there to be growth in both, but a much faster uptake in FSGS is going to allow us to really reach more of those patients over time and contribute more meaningfully to the growth at peak.

Eric Dube: We fully expect there to be growth in both, a much faster uptake in FSGS is gonna allow us to really reach more of those patients over time and contribute more meaningful to the growth at peak. What I would say is that we really don't see the dynamics as, you know, taking away from our opportunity or performance. Peter, why don't you talk about that in the context of new patients as well as switches?

Speaker #5: What I would say is that we really don't see the dynamics as taking away from our opportunity or performance. But Peter, why don't you talk about that in the context of new patients as well as switches?

Speaker #8: Yeah. Maury, I think the most important one is that we don't see B cells as a direct competitor for Philspari. I think conceptually, the way patients are being treated for IgA nephropathy is how it was done in the past with RAS inhibition.

Peter Heerma: Yeah, Maury, I think the most important one is that we don't see B cells as a direct competitor for FILSPARI. Conceptually, the way patients are being treated for IgA nephropathy is how it was done in the past with RAS inhibition, and on top of that, you use steroids when needed. That concept is not changing. Well, for RAS inhibition, you have now FILSPARI as a superior option for those patients. For those patients that need additional treatment, you have now B cells as potentially replacing steroids. The growth in this market is not so much competitive growth. It's really like developing the market. This is a highly underdeveloped market historically. There are still so many patients that are treated with generic RAS inhibitors and generic steroids. You have better options available right now. The KDIGO guideline is reinforcing that.

Speaker #8: And on top of that, you use steroids when needed. That concept is not changing while for RAS inhibition, you have now Philspari as a superior option for those patients.

Speaker #8: And for those patients that are needing additional treatment, you have now B cells as potentially replacing steroids. The growth in this market is not so much competitive growth.

Peter Heerma: The growth in this market is not so much competitive growth. It's really like developing the market. This is a highly underdeveloped market historically. There are still so many patients that are treated with generic RAS inhibitors and generic steroids. You have better options available right now. The KDIGO guideline is reinforcing that.

Speaker #8: It's really developing the market. This is a highly underdeveloped market historically. There are still so many patients that are treated with generic RAS inhibitors and generic steroids.

Speaker #8: You have better options available right now. The KADEEDO guideline is reinforcing that. I think you have a more ambitious treatment target nowadays, so that requires, often, more combination therapy as well.

Peter Heerma: I think you have a more ambitious treatment target nowadays, that requires often more combination therapy as well. I think there is space for multiple players to grow, and I think FILSPARI is very well-positioned in that nephroprotective foundational treatment category.

Speaker #8: So, I think there is space for multiple parties to grow. And I think Filspari is very well positioned in that nephrotic—in that nephroprotective foundational treatment category.

Speaker #5: Yeah. Thank you, Peter. And Maury, maybe if we just take a step back, one of the things that I'd like to reinforce is we talked over the last couple of years around the new entrants coming and really helping to accelerate growth within the IgA nephropathy market that is not going to take away our performance and our outlook.

Eric Dube: Yeah. Thank you, Peter. Maury, maybe if we just take a step back, one of the things that I'd like to reinforce is we talked over the last couple of years around the new entrants coming and really helping to accelerate growth within the IgA nephropathy market. That is not going to take away our performance and our outlook. That's exactly what we're seeing with the entrants that have come to the IgA nephropathy foundation. I think that the performance that we've posted this quarter really reflects the opportunity that we have, but perhaps more importantly, the opportunity that patients that have been undertreated with off-label therapies have the opportunity to really have innovation moving forward, both with FILSPARI as well as the other therapies. That's really, I think, gonna be the foundation for continued performance of our, of FILSPARI.

Speaker #5: That's exactly what we're seeing with the entrants that have come to the IgA Nephropathy Foundation. And I think that the performance that we've posted this quarter really reflects the opportunity that we have, but perhaps more importantly, the opportunity that patients that have been undertreated with off-label therapies have—the opportunity to really have innovation moving forward, both with Filspari as well as the other therapies.

Eric Dube: I think that the performance that we've posted this quarter really reflects the opportunity that we have, but perhaps more importantly, the opportunity that patients that have been undertreated with off-label therapies have the opportunity to really have innovation moving forward, both with FILSPARI as well as the other therapies. That's really, I think, gonna be the foundation for continued performance of our, of FILSPARI.

Speaker #5: And that's really, I think, going to be the foundation for continued performance of our Philspari. Got it. That's really helpful. Thank you very much.

Maury Raycroft: Got it. That's really helpful. Thank you very much.

Speaker #5: Thanks, Maury.

Eric Dube: Thanks, Maury.

Speaker #6: Your next question comes from the line of Jason Zemansky with Bank of America. Jason, your line is open. Please go ahead.

Operator: Your next question comes from the line of Jason Zemansky with Bank of America. Jason, your line is open. Please go ahead.

Speaker #18: Good afternoon. Congrats on the progress, and thanks so much for taking our question. Maybe, Jula, one for you. I was curious as to where you get the sense, or are seeing, Filspari's use sequenced in FSGS.

Jason Zemansky: Good afternoon. Congrats on the progress, and thanks so much for taking our question. Maybe Jula, one for you. I was curious as to where you get the sense or are seeing, FILSPARI's use sequenced in FSGS. Is it in lieu of the ACE ARBs? Are these patients usually already on SGLT2s? We've just gotten some mixed feedback regarding, you know, if this drug is gonna be used first line or whether in those, I guess, uncontrolled while already on an ARB or an ACE and an SGLT2. Thanks.

Speaker #18: Is it in lieu of the ACE/ARBs? Are these patients usually already on SGLT2s? We've just gotten some mixed feedback regarding if this drug is going to be used first-line, or whether in those, I guess, uncontrolled while already on an ARB or an ACE and an SGLT2.

Speaker #18: Thanks.

Speaker #19: Yeah, thanks for the question. So, just like IgA nephropathy, the vast majority of patients are already on some form of a RAS inhibitor—an ACE or an ARB.

Jula Inrig: Yeah. Thanks for the question.

Jason Zemansky: Mm-hmm.

Jula Inrig: Just like IgA nephropathy, the vast majority of patients are already on some form of a RAS inhibitor, an ACE or an ARB, even by the time they get sent to the nephrologist, so predating their diagnosis. It's slightly lower than IgA nephropathy because kids may or may not always be on an ACE inhibitor, but you're still talking at more than 70%, at least 80% of patients are on some form of foundational treatment. As far as SGLT2 inhibitor, I would say it is used, just potentially not quite as prevalent because we don't have as great of data around SGLT2s. As Peter has mentioned multiple times, these patients are very high risk for rapid progression to kidney failure. Physicians will be pulling at, as many things as they can in their tool belt to try and stabilize these patients.

Speaker #19: Even by the time they get sent to the nephrologist, so predating their diagnosis, it's slightly lower than IgA nephropathy because kids may or may not always be on an ACE inhibitor, but you're still talking about more than 70, at least 80 percent of patients are on some form of foundational treatment.

Speaker #19: And as far as SGLT2 inhibitor, I would say it is used—just potentially not quite as prevalent because we don't have as great of data around SGLT2s.

Jula Inrig: As far as SGLT2 inhibitor, I would say it is used, just potentially not quite as prevalent because we don't have as great of data around SGLT2s. As Peter has mentioned multiple times, these patients are very high risk for rapid progression to kidney failure. Physicians will be pulling at, as many things as they can in their tool belt to try and stabilize these patients.

Speaker #19: But as Peter has mentioned multiple times, these patients are very high risk for rapid progression to kidney failure. So physicians will be pulling at as many things as they can in their tool belt.

Speaker #19: To try and stabilize these patients. And now they have Philspari which is better and a head-to-head versus a RAS inhibitor. So they are going to take patients off their RAS inhibitor and initiate Philspari.

Jula Inrig: Now they have FILSPARI, which is better in a head-to-head versus a RAS inhibitor. They are going to take patients off their RAS inhibitor and initiate FILSPARI, and ideally at their next clinic visit when they see these patients.

Speaker #19: And ideally, at their next clinic visit when they see these patients.

Speaker #5: And Jula, maybe I can add something else for Jason's question. Particularly for those patients with primary FSGS, and particularly those with active nephrotic syndrome, they are, based on the guidelines, going to be treated with an immunosuppressant.

Eric Dube: Jula, maybe I can add something else for Jason’s question. Particularly for those patients with primary FSGS and particularly those with, you know, active nephrotic syndrome, they are, based on the guidelines, gonna be treated with an immunosuppressant. Once they are not in active nephrotic syndrome, they would be eligible and likely placed on FILSPARI. In terms of them not being, you know, first line use, it’s a slight nuance, but that’s also an opportunity moving forward. Jula, please clarify if there’s anything further you’d like to add.

Speaker #5: And once they are not in active nephrotic syndrome, they would be eligible and likely placed on Philspari. So in terms of them not being first-line use, it's a slight nuance, but that's also an opportunity moving forward.

Eric Dube: Once they are not in active nephrotic syndrome, they would be eligible and likely placed on FILSPARI. In terms of them not being, you know, first line use, it’s a slight nuance, but that’s also an opportunity moving forward. Jula, please clarify if there’s anything further you’d like to add.

Speaker #5: But Jula, please clarify if there's anything further you'd like to add.

Jula Inrig: No, that's accurate.

Speaker #19: accurate.

Speaker #5: Great. Thanks, Jason.

Eric Dube: Okay. Thanks, Jason.

Speaker #18: Thanks.

Alex Thompson: Thanks.

Jason Zemansky: Thanks.

Speaker #6: Your next question comes from the line of Alex Thompson with Stifel. Alex, your line is open. Please go ahead.

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

Operator: Your next question comes from the line of Alex Thompson with Stifel. Alex, your line is open. Please go ahead.

Alex Thompson: Hey, great.

Operator: Please go ahead.

Speaker #20: Awesome. Thanks so much. Just a quick follow-up question on IgAN, and then maybe I'd like to ask about Pig to Bat Mase as well.

Alex Thompson: Awesome. Thanks so much. Just a quick follow-up question on IgAN, maybe I'd like to ask about pegtibatinase as well. Maybe Chris, are you able to quantify the shipping week impact at all? That would be helpful for the quarter. For pegtibatinase in the phase 3, congrats on restarting that. You know, have you met with sort of the FDA review division recently, and how confident are you that total homocysteine is still going to be an approvable endpoint here? Thank you.

Speaker #20: Maybe Chris, are you able to quantify the shipping week impact at all? That'd be helpful for the quarter. And then for Pig to Bat Mase in the phase three, congrats on restarting that.

Speaker #20: Have you met with sort of the FDA review division recently and how confident are you that total homocysteine is still going to be an approvable endpoint here?

Speaker #20: Thank you.

Speaker #5: All right. Chris, and then we can turn that over to Bill for the Peggy question.

Eric Dube: All right, Chris, and then we can turn that over to Bill for the pegtibatinase question.

Speaker #20: Yeah. Thanks for the question, Alex. We don't typically break down individual weeks of revenue. So what I would point you to is the best proxy is to take the average for the quarter we had about 12 weeks of revenue recognition within the quarter.

Chris Cline: Yeah. Thanks for the question, Alex. We don't typically break down individual weeks of revenue. What I would point you to as the best proxy is to take the average for the quarter. We had about 12 weeks of revenue recognition within the quarter, and that will get you to the best proxy there.

Speaker #20: And that will get you to the best proxy there.

Eric Dube: Bill?

Speaker #5: Bill?

Speaker #21: And I will take the Peggy question. We've got breakthrough therapy designation for Peggy. So that allows us to have a lot of interaction with the FDA and through that process, we reached alignment on the endpoint for that Harmony study.

William Rote: I will take the pegtibatinase question. We've got breakthrough therapy designation for pegtibatinase, so that allows us to have a lot of interaction with the FDA. Through that process, we reached alignment on the endpoint for that HARMONY study. It was noted in the prepared remarks that mirrors the timing of what we saw in the COMPOSE study. It was in a collaborative discussion with the agency where we settled on that 12-week endpoint.

Speaker #21: And it was noted in the prepared remarks that mirrors the timing of what we saw in the composed study. So it was in a collaborative discussion with the agency where we settled on that 12-week endpoint.

Speaker #20: Has that happened since the original alignment this year or since you redosed or was that originally the alignment?

Alex Thompson: Has that happened since the original alignment this year or since you redosed, or was that originally the alignment?

William Rote: That's the original discussion. We haven't had reason to discuss the endpoints of the trial once it was agreed and aligned upon.

Speaker #21: That's the original discussion. We haven't had reason to discuss the endpoints of the trial once it was agreed and aligned upon.

William Rote: That's the original discussion. We haven't had reason to discuss the endpoints of the trial once it was agreed and aligned upon.

Speaker #20: Okay. Thank you.

Alex Thompson: Okay. Thank you.

William Rote: Mm-hmm.

Speaker #6: 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 #19: Great. Thank you, everyone, for joining today's call. Have a great rest of your day.

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

Operator: Thank you for attending. You may now disconnect.